Moderna

Started with fatigue,. chills, fever up to 100.3, muscle aches, severe chest discomfort , heart rate up to 130 . Is an EMS provider, went to fire house and EKG was normal, just elevated heart rate and BP around 130/80 Fatigue - resulting in lack of eating /appetite

Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm

I woke up at approximately 4:00 am with an extremely dry mouth. I went into the bathroom and took a drink of water. I returned to bed. I noticed that my breathing was becoming more rapid. I had trouble catching my breath. I sat up on the side of the bed. My heart was pounding and quick. My breathing was difficult. I woke up my wife. After about 5 minutes my symptoms improved. She took my pulse which was now at 62ppm. I laid back down in a reclined position. My symptoms of difficulty breathing and elevated heart rate quickly returned. My pulse was now up to 98 ppm. I sat up again. My symptoms gradually improved. Being unsure of what was going on my wife called 911. The ambulance arrived in about 8 minutes. I was about 60% better. Vitals were improving other than my blood pressure which was 180/100 Being unsure of what was happening, I was transported to Hospital. I had a chest x-ray, a chest CT scan with contrast to rule out a blood clot, blood work including tests to rule out MI x2. All test were negative. By about 6:30 am I was feeling at least 80% better. My breathing I felt had returned to normal. My pulse was down into the 50"s which is my normal range.

Vagal response--lightheaded, nausea, queasy, cold sweats, felt like I might pass out--lasted about 10-15 minutes and then

1. Incontrollable Shaking of body and limbs-- for 2 days, 2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days

Began to feel ill ( stomach pain / Headache ) .. my skin became flushed ( face was very red ) blood pressure was elevated ( 180/90) I normally have low BP.

5 hours post vaccination broke out with a hive on my face, felt lightheaded and heavy in the chest but not short of breath. went to bed around 10 that evening and slept well. felt fine the next morning, hive stayed for about 2 days.

DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for 2/5/2021 at 7:15am

20 MINUTES AFTER INJECTION CLIENT COMPLAINED OF VISUAL DISTURBANCES. HE STATES THE WHITE TRUCK PARKED NEXT TO HIM APPEARED PINK FOR A SPLIT SECOND THEN RETURNED BACK TO LOOKING WHITE. CALLED EMS PER PROTOCOL MANUAL B/P 220/90, PATIENT THEN ALSO COMPLAINED OF CHEST PAIN/TIGHTNESS. ASA 325MG WAS GIVEN TO PATIENT PER PROTOCOL AND 4 L OXYGEN VIA NC. PATIENT WAS TRANSPORTED VIA EMS TO HOSPITAL.

Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.

Approximately 5 hours after my injection, I started to feel fatigue. Went to bed, awoke around 0039 1/26/2021 with mild shortness of breath and slight chest pressure. Around 0500 I started with chills, muscle, joint, bone pain. I went back to bed and awoke around 1200 with throat tightness, SOB, chest pressure and diaphoretic accompanied by the other symptoms. I went to my local ER.

DVT blood clot; A spontaneous report was received from a 60-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) blood clot. The patient's medical history, as provided by the reporter, included factor V Leiden, enlarged prostate, DVT, pulmonary embolism and hypertension. Concomitant medications reported included valsartan, alfuzosin, and acetylsalicylic acid. On 07 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient developed DVT blood clot and experienced leg pain so intense that he could not walk. A doppler exam showed the DVT was from the top of the calf to mid-thigh. Treatment for the event included a rivaroxaban starter pack with dose tapering. Action taken with mRNA-1273 in response to the event deep vein thrombosis (DVT) blood clot was not reported. The outcome of the event, DVT blood clot, was unknown.; Reporter's Comments: This case concerns a 60-year-old male patient with a relevant medical history of factor V Leiden, DVT, pulmonary embolism and hypertension who received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient experienced the medically significant unlisted event of Deep vein thrombosis approximately four days after administration of vaccine. Treatment for the event included rivaroxaban. Based on the temporal association between the use of the product and the event occurring after receiving the vaccine, a causal relationship cannot be excluded and the event of Deep vein thrombosis is possibly related to the product. Of note, the patient's underlying Factor V Leiden which predispose to developing abnormal blood clots, and prior medical history of DVT with pulmonary embolism are considered risk factors to the occurrence of the event.

On 1/14/2021 ( about 14 days from dose # 1) Tachycardia of unknown origin, 120 BPM for 6 hours, Called Cardiologist and was seen @ MD next business day, and given EKG and Bystolic 10 MG to "add" to daily regimin IF it returned. It retuned to normal after 6 hours, and then occurred again 1 week later...for 6 hours. I took Bystolic, and about 8 hours later it returned to baseline (about 62/min. on Sun 1/24/2021, I woke up to bloody diarrhea x several episodes...this continued until Wed 27th, at which time my son (a 4th year graduating MD student) drove me to hospital and I was seen in ER room by MD. I was admitted, and had emergency surgery 1/27/2021 straight from Er Room. I had life saving surgery the next day to stop a lower GI bleed (of unknown origin). I was discharged 3 days later, and I am awaiting more testes, appts, etc.... I have lost time, money, and work from this near death experience... and the tachycardia still needs to be followed up on . I am EXTREMELY upset by these events, as I almost died....was hospitalized, incurred a lot of expense, used up all my sick pay and personal days, and out-of -pocket to my healthcare insurer.

Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.

Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack. On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG) – results not provided. The patient also stated he had blood pressure issues but did not provide any further information. On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding. Treatment for the event included surgery. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Patient developed SVT on January 31. He presented to the ER and received two doses of adenosine to convert back to a normal sinus rhythm.

On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7, CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.

The patient was given his vaccine at 11:40am and a few minutes later 11:43am he said he was feeling very flushed and off. He said this extremities (hands and feet) felt hot and blotchy which is not normal for him (he does have neuropathy). He was sitting down for a couple minutes and I gave him water to drink just to calm down if it had been anxiety, but it did not seem to help. He started to complain of his heart pounding and beating rapidly. He said he was sweating and just felt very strange. I asked if he was short of breath at all which he denied. I immediately called 911 to have him be checked out and make sure he was ok since his symptoms had been going on for a few minutes, he was still complaining, and was not resolved with sitting or drinking a cold water. The patient did state that he had not eaten yet today (he does intermittent fasting and normally does not eat until 2pm), he did not take his blood pressure medication atenolol, and had driven about an hour here with his mother as she also got the vaccine today. While waiting for the ambulance I took his blood pressure which was very high 187/95mmHg which the patient confirmed is high for him. The ambulance arrived within 10 minutes and they checked him out. He did decline to go to the hospital after a thorough evaluation. The patient left once the paramedics cleared him at about 12:35pm so he was sitting and being monitored for a good 45 minutes before he left the store. The patient was never given any meds during this process and was cleared to go home by paramedics.

RPh administered the vaccine, and the patient passed out 10 minutes afterwards and hit his head. Patient felt very faint even after sat up with feet up. Patient was given orange juice and he drank it all. Paramedics arrived and checked him out. 45 minutes after him passing out, patient felt fine and went back to work. He had gashed his head open on the fall.

Patient began feeling tingling sensation and tightness in chest. Denies difficulty swallowing, swollen tongue, or shortness of breath. States he feels like heart is racing. Lungs auscultated and BBS clear. EMT in attendance. Patient declines w/c to private observation area. Patient called wife to come into vaccine building (she is outside in car). 1630: HR 113; O2 sat 99% 1632: Patient having vigorous tremors. Fingers cold to touch. Gave Benadryl liquid 20 mL/50 mg PO. Patient declines ambulance transport. Patient wants to go home with wife. BP 158/98. 1635 wife in attendance. Wife states he will not want to go via ambulance. Strongly recommended that patient transports via ambulance. Recommended that patient go to urgent care clinic or ED for further evaluation. Wife went to bring car to exit area. 1640: O2 99%, HR: 105; no shortness of breath noted. Patient remains alert and oriented, still having tremors. 1645: convinced patient to go outside in w/c for fresh air. Patient agreed and taken to private observation area out back door. Patient removed mask and patient encouraged to deep breath. Upper body shaking continues. Hands remain very cold. 1650: patient's wife returned. Wife states she will take him to an urgent care area. She states she also has an epi pen if he worsens. She states if he improves she will take him home and monitor him. Patient declined w/c transport to private vehicle. 1655: patient left ambulatory with wife, no shortness of breath. Continues to shake.

Heart palpitations; shortness of breath; dizziness; hands shaken. Events lasted about 3 minutes. Then disappeared. They checked my blood pressure and it was elevated 155/110. High blood pressure remained for 2 days.

Patient had vaccine and waited the 15 minute waiting period. He felt well after 15 minutes and left the observation waiting area. He went up front to purchase something 5 minutes later and collapsed face first on the floor as observed by a nearby customer. The customer said he started having convulsing seizures and the customer went to aid in keeping the patient safe. the pharmacy manager (myself) was alerted and I immediately ran upfront to the patient with the emergency bag. 911 was already on the cashiers phone. They dispatched an ambulance. The only treatment was keeping the patient on his side and safe. He was having some labored breathing initially which quickly calmed down. The EMT arrived and they called his Dr office off the VAR. They said he had some hx of seizure. He had selected no to question #6 on VAR (Have you had History of seizure for which you are on medication for). He became conscious before transport to the hospital. The EMT stated that he seemed to be covering as expected from seizure. He was then transported to Hospital Center.

Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the area of the heart. Went to ER and was given EKG, Chest X-Ray, and blood tests to check for heart attack. Symptoms subsided after a bit. Labs were inconclusive. Sent home. Continued to have lingering aching in the heart region the next day. Throughout the weekend, continued to experience alternating sweats and chills, nausea and increased pain in hip joints causing difficulty to walk. Stayed home from work on Monday, March 8, 2021 with the same symptoms continuing. Tuesday, March 9, 2021 began experiencing excruciating thigh and knee pain to the point of barely being able to stand or walk. Returned to the ER where they administered Torodol and pain subsided. Will be seeing primary care physician Tuesday afternoon.

Syncope. Did not fully pass out, but felt a wave of tightness, followed by paleness (tech said color drained), followed by lightheadedness.

Vomiting, diarrhea, shaking, difficulty breathing, OSat down to 90, whole body sensitive to touch, pain in left arm

Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

08:10 vaccine administered 08:14 dizzy, light headed, room spinning. Sat down 08:25 felt lump in throat, contacted clinic nurse in waiting area. Uncomfortable but never to the point of difficulty breathing. ~08:30, BP 128/99 (I think) Systolic up only a bit. Diastolic very high for me sent to urgent care part of clinic. Monitored BP, oxygen, did EKG (normal), symptoms started easing ~ 09:40. Sent home. Attending PA though it might just be a Vaso-Vagel response, but, after hundreds upon hundred of needles, I've never had such a response, and, my symptoms did not involve a low BP, fainting or nausea, rather I remained conscious, had throat constriction with increased BP and a narrowed pulse pressure range.

patient reported any allergies to medication or food. patient signed consent for vaccine and vaccine administered per protocol then proceeded to designated wait area. Patients wife called for assistance 10 minutes after vaccine was administered due to patient being faint and light headed. Medic and RN begin to assess vital signs and patient became unresponsive. Patient was given EPI via EPI pen and 911 was called for assistance. Patient vitals continued to be assessed, patient was also given 50mg Benadryl IM, EMS arrived and assessed patient. Patient regained consciousness and was transferred to hospital for further assessment.

Patient reports feeling lightheaded, dizzy. Passed out a couple times. Presents sweating, flushing, and clammy skin. Patient reports having veso vagal previously. EMs preformed EKG and results were normal. Refused EMS transport

At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.

about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn't slrrp took benadryl called 911 they came and took my vitals highblood pressure a fever of 101 it wasn't to bad so they left i stayed awake all night and started to feel better the next day

Deceased received second Moderna dose on 3/11/2021 at unknown location and unknown time. Complained of 'side effects' which are unclear at this time. Had a sudden witnessed cardiac event on 3/14/2021 and was rushed to a local emergency department. Diagnosed with ST elevation MI and could not be fully resuscitated.

3/4/21 out of breath , peaked 3/08/21. 3/09 pain in right lower leg Hospitalized 4 days - 5 hour procedure for Acute DVT and Acute Saddle pulmonary Embolus

pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection

The day after the shot 3/9/2021 pt had 104 degree fever and shortness of breath and chest pain. This continued for a couple days. By 3/13/2021 pt went the hospital and he was confirmed to be having an active heart attack.

IMMEDIATELY AFTER DOSE WAS ADMINISTERED PATIENT COMPLAINED OF DIZZINESS WHILE SEATED. IMMUNIZING TECHNICIAN IMMEDIATELY CAME AND NOTIFIED ME, AT WHICH POINT I ENTERRED OUR VACCINATION ROOM AND KNELT DOWN NEXT TO SEATED PATIENT. HE CONFIRMED THAT HE FELT REALLY DIZZY AT WHICH POINT I ENCOURAGED HIM TO SIT BACK IN THE SEAT AND RELAX AND I WOULD STAND BY HIM. WITHIN APROX 5 MINUTES OF VACCINATION PATIENT FAINTED IN THE CHAIR AT WHICH POINT EMS WAS CONTACTED. WITHIN APROX 30 SECONDS PATIENT STARTED TO REGAIN CONCIOUSNESS (NOTED BY EYE, MUSCLE MOVEMENT) OVER THE COURSE OF THE NEXT FEW MINUTES PATIENT SLOWLY BECAME ALERT AND ORIENTED AT WHICH POINT EMS ARRIVED AND TOOK OVER HIS CARE. AFTER APROX 15 MINUTES OF CARE FROM EMS PATIENT OPTED TO GO HOME WITH HIS DRIVER. I CONTACTED THE PATIENT AT APROX 130 TO CHECK IN ON HIM AND HE ADVISED ME HE WAS FEELING NORMAL AND THANKED US FOR HELPING HIM THROUGH HIS FAINTING EPISODE.

Arm sore for a week Hurt into chest Felt extremely fatigued for about 5 days. Ran fever over 100 for 2 days. Felt fine after 5 days.

Patient received his first dose of Moderna vaccine and reported feeling his heart rate go up around 20 minutes later. He alerted the nurse, who checked his vital signs, which were slightly elevated with a minor elevation in heart rate at 106. He denied dizziness, chest pain, extremity numbness/tingling, and any other signs. He continued to feel palpitations for about 30 minutes, but HR continued within normal limits < 100 during that time. After about a half an hour he began to feel better, and was assisted to his car by county staff. EMS offered and declined.

Patient called me this morning to advise me that he experienced heart attack symptoms 45 minutes after receiving his first does of Moderna and self-admitted to the ER. ER confirmed that he had experienced a heart attack and had one clogged artery. He asked about reporting and I told him I would report to VAERS on his behalf as his doctor and the hospital refused to do so. He asked whether or not I would suggest he receive his second dose and I suggested that he speak with his cardiologist and doctor to make that decision. I also informed him that he can search VAERS to see what the other reactions may have been that were reported. Patient indicated that he felt well and has recovered.

Patient received their vaccine and sat in a chair, within approx. two minutes the patient told another patient they felt hot, I was already walking to the patient to check on them,. The patient's eyes were glazed, Almost immediately the patients eyes rolled back in his head. I shook his arm and shouted to him , he was unresponsive with agonal breaths.. I shouted for help from the other nurses. RNs came immediately. We moved him to the floor, called for an epinephrine injection to be prepared, I began to prepare the site for epinephrine injection to his thigh, nurse checked for pulse... at this time the patient was still unresponsive with agonal breaths... no pulse was felt so compressions were commenced by RN. Nurse gave approx. 15 compressions to the patients chest , the patient spontaneously began to recover. Carotid and radial pulses were felt at this time. Breathing returned to normal. While this was occurring, we called a code blue and 911 was activated. By the time 911 responded the patient was fully conscious , alert and responsive. He could tell us his name and how he felt prior to this incident. The patient was transferred via a stretcher by EMS 911 and RN accompanied him to the ER to give a report. The timeframe for being pulseless and having agonal breaths lasted no more than 30-40 seconds. Patient denied any history of a seizure disorder. No epinephrine or IM Benadryl were administered at the incident site by the responding staff due to the spontaneous recovery.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: IRREGULAR HEART BEATS. PATIENT REFUSED TO HAVE US CALL PARAMEDICS. WIFE IS TAKING HIM HOME. WE DID SUGGEST FOR HIM TO GO TO THE HOSPITAL AND PROVIDED THE ADDRESS OF THE CLOSEST HOSPITAL BUT PATIENT REFUSED.

4 days after the vaccination I started having breathing problems and a racing heart. I first went to Urgent Care and they sent me to the E.R. immediately. They x-rayed my chest and ran 3 EKG's which all came out normal. However, they wanted to check my into the hospital to run a heart stress test the next day. I chose to go see and cardiologist and a pulmonary specialist. Those are appointments are being scheduled.

1- On Day one few ours after the 2nd shot, I had my heart flutter and lost by breath few times, next day was gone. 2- Knee joint pain and tendons pain still ongoing was very hard to walk. Improving very slowly. 3-Felt like I had the flue the next day with a headache, flue like symptoms gone within 2 days, however I am on week 3 with a non stop headache. I usually never have a headaches, and now I have it every day and night since the 2nd shot.

Woke up, approximately 36hrs after first vaccine dose, circa 0200hrs on 24MAR2021, with a bit of a racing heart. Felt almost as if the heart wasn't "doing" much -- in terms of pumping blood. Not aware of anything ingested to have caused this and I do not recall this having happened before (hence the association, possibly having to do with the vaccine -- speculative, obviously). Uncertain how long it lasted. Guessing 20-30mins(?).

I am a physician working for the state. I have a history of PAF and had tow prior pulmonary vein isolation ablations in November 2019 and July 2020. I was atrial fibrillation free for 7 months, no medications, until two days after my second Moderna COVID-19 vaccine. Since then, i have had recurrent atrial fibrillation and some episodes of atrial flutter which my cardiologist believes could be related to the vaccine.

ended up with high blood pressure , diabetes , cellulitis of scrotum. Had to be transported by ambulance to hospital and spent eight days there. Currently on antibiotics , blood pressure medication , insulin and have had a catheter for 5 and 1/2 weeks.

At 10:40pm, i was awakened by a high heart beat, approx 86 while sleeping, then had very short breath which i had to deep breath for about 2.5 hours , plus shakes, headache , and body aches, after about 3-4 hours i fell back to sleep and the next day at 12 noon, Everything was back to normal and totally fine.

Patient received the 1st dose of Moderna on 03/29/21 with no immediate reactions. The patient presented to the emergency room 04/03/2021 with high blood pressure, pulse, and chest pain.

I was extremely tired on Saturday. My shoulder hurt. About 3 pm, while urinating, I felt very light-headed as if I was about to faint. I stopped urinating and went back to bed. That evening, about 8:30, I tried to eat dinner, but after three bites, I felt extremely tired. I leaned back in my chair, and I passed out. My wife woke me, but it took several minutes. She said my eyes rolled back in my head. She splashed water on my face. She said that I stopped breathing. I woke up, then pushed my plate away and put my head on the table. I could not hold it up. I was sweating profusely. After several minutes, I felt that I was about to have diarrhea. My daughter and wife tried to walk me to the bathroom, but I did not have the energy to get there. I collapsed in the hall and hit my head on the door jamb. After several minute of trying , they pulled me up, and I then got the strength to walk the rest of the way. I had diarrhea, not suddenly, but it was as if my GI system emptied. It was soft, not loose, and there was a lot. I went back to bed, and eventually slept. I felt queasy the next day (Sunday), and I felt lightheaded at times, so I just sat or laid down. But I was feeling better. Today (Monday) I feel much better. A little tired, but much better. I went to the Pharmacy this morning, and they referred me to this website. I did not see the doctor.

High fever reaching at least 103.8 overnight following receiving the vaccine that morning. Fever accompanied by chills,, shaking, headache, rapid heart rate, and sweats continuing until approximately 8:00 am the following morning. Fatigue lingering after fever broke for 2-3 more days.

Patient had history of COPD, MS. Treated for pneumonia in February. Recently discharged from the hospital 2/24/2021 for pneumonia. Seen in the office on 3/1/2021 as a follow up. Given Covid vaccine on 3/15/2021. Patient was reportedly feeling well the day of vaccine. Patient collapsed on 3/19/2021 and died.

Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMLODIPINE for an unknown indication. The patient's past medical history included No adverse event (No medical history reported. ). On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

On 4/7/2021 I was hospitalized with a heart attack due to an embolism in my LAD. Had to be re-stented. In ICU for 5 days- regular hospital 2 and discharged after total of 7 days

Purpuric rash; Accelerated hypertension; Systolic congestive heart failure exacerbation; nausea; Generalized non-itchy, non-painful rash a day after receiving the vaccine; Thrombocytopenia; few loose stools; Fever; Chills; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) and NAUSEA (nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Purpuric Rash and Thrombocytopenia After the mRNA-1273 (Moderna) COVID-19 Vaccine. Cureus. 2021;13:4 Previously administered products included for Viral hepatitis C: Interferon. Concurrent medical conditions included Viral hepatitis C, Chronic kidney disease (Stage 4, with a baseline creatinine of 3 mg/dl.), Uncontrolled hypertension, Systolic heart failure (Ejection fraction of 35%.) and Liver cirrhosis. 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 RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine) (seriousness criterion hospitalization), THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization prolonged and medically significant), PURPURA (Purpuric rash) (seriousness criterion hospitalization), ACCELERATED HYPERTENSION (Accelerated hypertension) (seriousness criterion hospitalization), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized for 3 days due to ACCELERATED HYPERTENSION, ACUTE LEFT VENTRICULAR FAILURE, NAUSEA, PURPURA, RASH and THROMBOCYTOPENIA. At the time of the report, RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. In March 2021, Alanine aminotransferase: 90 (abnormal) 90 U/L. In March 2021, Aspartate aminotransferase: 196 (abnormal) 196 U/L. In March 2021, Bilirubin conjugated: 5 (abnormal) 05 mg/dl. In March 2021, Blood albumin: 1.9 (abnormal) 1.9 gm/dl. In March 2021, Blood alkaline phosphatase: 216 (abnormal) 216 U/L. In March 2021, Blood creatinine: 3.2 (Inconclusive) 3.2 mg/dl. In March 2021, Blood lactate dehydrogenase (122-222): 381 (High) high. In March 2021, Chest X-ray: abnormal (abnormal) Findings consistent with pulmonary edema.. In March 2021, Glomerular filtration rate: 19 (Low) eGFR - 19. In March 2021, International normalised ratio: 1.13 (Inconclusive) INR - 1.13. In March 2021, Platelet count: 84000 (Low) 84000/uL. In March 2021, Serum ferritin (24-336): 2400 (High) 2400 mg/ml. In March 2021, Ultrasound liver: abnormal (abnormal) Ultrasound of the liver confirmed liver cirrhosis.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered THROMBOCYTOPENIA (Thrombocytopenia) and PURPURA (Purpuric rash) to be possibly related. No further causality assessments were provided for RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). Concomitant medications were not provided. Hepatitis panel showed a heavy viral load of more than 11 (no reference range was provided). Per reporter, on presentation to the emergency room the patient was afebrile, had a blood pressure 183/106 mmHg, pulse rate of 82 per minute and oxygen saturation of 96% on room air. Treatment included anti-hypertensives and intravenous diuretics. On day 3 of hospitalization, patient left the hospital against medical advice. Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.; Sender's Comments: Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.

Clinic visit 4/7/21: "60 y.o. year-old male who presents for left calf pain, swelling, and bruising that began on 03/27/2021. Patient states that 2 days prior to symptom onset he received the Moderna COVID-19 vaccine. He did have symptoms of fever 102 F for approximately 24 hours. After the resolution of his fever he notice swelling of the leg with tenderness any line of bruising going down the medial aspect of his leg. He noticed more prominence of varicose veins of the left leg and began using a compression stocking. His varicose veins seem to worsen with sitting as well as tenderness, and improves with walking. He notes a tenderness over the upper calf. He denies any history of DVT/PE. He notes that two brothers sustained blood clots, one he believes was in varicose veins which were ultimately stripped and the other he is not sure of the exact nature of the clots. He is unaware of any hereditary clotting disorder in his family. He denies any shortness of breath, difficulties breathing, or chest pains." He was sent home with aspirin 325mg daily. Hospital admission 4/11/21 " 60 year old male with no PMH comes in c/o LLE pain that originally started 2 weeks ago and intermittently getting worse. The pain started around the left calf and has moved its way up to his thigh/groin area. The pain is sharp, 7/10, worse when standing, slight improvement with aspirin. Pt denies tingling, numbness, CP, shob, N/V/D, blurry vision or weakness. Associated symptoms include erythematic rash around left inner thigh, tender to touch, and swelling of calf/thigh. He works with heavy machinery but is always sitting down 1-2 hours at a time. He does have family history of DVT/PE. He is not on any daily NSAIDs or other anticoagulation and denies smoking." he was started on a heparin drip then transitioned to Eliquis and discharged the next day.

In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.

Patient had the vaccine in the arm for approximately 1 minute before becoming pale and beginning to shake. The patient had a representative that stated he was a diabetic and did not eat before the vaccine, believing that his glucose was dropping. He was given a shot of glucose before having an episode similar to a seizure. Diphenhydramine and an Epipen were obtained but were not needed to be administered as the side effects subsided. The patient wanted EMS to be called. EMS arrived at the facility and the patient was assessed. Patient left on his on will.

Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.

Approximately 1 hour after the vaccination, Patient reported feeling a sudden "pop" in his head. That was followed by loss of balance, weakness, and inability to walk. He collapsed and either passed out or slept for 2-3 hours. Upon awakening he still felt weak and unbalanced. He also had bitten his tongue and lip while unconscious. He slowly recovered over a period of 3-4 days after the vaccination. He has never before had a stroke or a seizure. No one was with him to observe any of his symptoms.

2 lower- left leg Superficial blood clots; ~ a DVT Deep Vein Thrombosis per Ultrasound on 4/12/21, was diagnosis ; ER Dr. on 4/12/21 prescribed Eliquis 60 day Treatment.

Within an hour or two of the vaccine second dose every area where I have ever had joint problems gave me problems. The worst was the arthritis in my left thumb, which also suffers from Carpal tunnel. My thumb where I do have arthritis became so painful and sensitive to any movement that I could not use it. At one point the pain took me to my knees. I now think that the far above average pain in that joint that I have been having for several weeks may have been from the first dose but the extreme increase in pain right after the vaccine seems very likely to be the vaccine. I also had painful electric like jolts in my back and ankle and have been experiencing higher than normal chest, center of rib cage pain. All these areas are problem spots for me but for all of them to flare up at once right after the vaccine is unprecedented as was the pain in my left wrist/thumb.

FIRST 24 hrs Fever, headache, dizziness , body pain, joints pain, Increase heart rate 74 beats per minute (14 above normal) After 36 hrs most of the symptoms decrease, but heart rate and dizziness kept high, but irregular heart beats started, I feel a strong beat, then a little time with no beats and recover the rithm. I feel my chest oppressed and feel not fine. These last symptoms are maintained up to now and that worries me

Day after getting vaccine shot i had a scheduled dr appointment with my dr, she noticed my heart not beating regularly during examination she gave me EKG it showed my heart was in AFIB, (i never had any heart issues) sent me immediately to cardiologist who confirmed AFIB, and had me wear heart mointer later that evening mointer notified the cardiologist my heart was racing at 200 bpm, i was told to go immediately to emergency room , all test were negative EKG was normal, blood work normal, i was put on medication Amiodarone and Eliquis for 40 days , then taken off these two medications when Heart Mointering results showed no other episodes of AFIB, it should also be noted I didn?t feel any symptoms of AFIB even when my heart was racing at 200 bpm.

Had a patient yesterday that had a COVID infection 10 weeks ago. Was having abdominal pain and rapid heart rate since infection, had not been seen by a medical provider during or after infection. No PCP. He reported during observation time that he had a rapid heartrate. I monitored him for another 20 minutes with no improvement (HR in 120?s, regular. No other symptoms) and sent him to the ED.

Because pt was uncomfortable he did not use his CPAP machine. 45 hours after second dose was administered my husband was sitting up in bed eating breakfast, He tilted his head back to swallow his his escitalopram and baby aspirin, sipped his coffee chewed and swallowed. He then went speechless and began staring off to his left. He lost consciousness. His chin stretched out to the left and his head rolled back as did his eyes. Eyelids remained open. His head and upper body began to tremble and seemed stiff though his hands remained down by his side. Time slows when in such an emotional situation but I think the complete event lasted about 35 real seconds. I wonder if his temperature being elevated a couple of degrees and with his absolute lymphocytes on the rise if his strong immune response revealed a family predisposition to dystonia?

Patient presented to hospital on 4/9 with worsening dyspnea on exertion and fatigue and brown colored urine. Patient was diagnosed by hematology service with warm autoimmune hemolytic anemia (Evan's disease). It was refractory to high dose steroids, rituximab, cyclophosphamide and required splenectomy. He has required multiple blood transfusions.

Passed Out; Suspecting Seizures pending EEG Results; Sore Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (medication history was not reported) and Pacemaker insertion (cardiac) since an unknown date. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed Out) (seriousness criteria hospitalization and medically significant) and SEIZURE (Suspecting Seizures pending EEG Results) (seriousness criterion hospitalization). On 10-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported. diagnosis yet to be determent Suspecting Seizures pending EEG results 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, Very limited information is available at this time. Further information is 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.However, Very limited information is available at this time. Further information is requested.

Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.

Afib and now an irregular heart rhythm, a never before heart arrhythmia.. Also newly diagnosed PVC.. And constantly breaking out in cool clammy sweats and shortness of breath. Never had this issue until 2 weeks after my first moderna vaccination

Left deltoid IM injection was attempted, but suspect it was actually a SQ injection. Injection placed two to three cm below left acromion process. Met firm resistance with needle (1.5" 23 gauge needle) at a depth of approximately 1/2" and suspected that the tip of the needle was deep enough within muscle. Injected 0.5ml of Moderna COVID 19 vaccine and noted skin blanching after injection. Patient otherwise tolerated procedure well and there were no other complications.

Difficulty breathing due to heart pounding and could not walk more than 50 feet. Had ECHO yesterday 4/26/21, which revealed inflammation. Provider recommended waiting to do second dose for now.

After second dose 3/10/21 started having chills, myalgia. On 3/24/21 hospitalized with respiratory failure, kidney failure, heart attack, sepsis and liver malfunction. Had subsequent GI bleed

COVID-19 symptoms starting 3/25/21, hospital admission 4/14/21 - 4/24/21 with hypoxia, multiple pulmonary emboli

On 4/9/20 patient developed bilateral numbness and tingling to arms, hands, feet and legs. Went to ED on 4/16/20 Labs and CT head were normal. Had decreased strength and sensitivity in extremities and Babinski's were upward going. Discharged to home without medication and to F/U with PCP in 4-6 days. Saw PCP on 4/20/21. He had S&G hyeresthesia, + Rhomberg, failed tandem walk, and dysdiadochokinesia. Neuropatic pain in shoulders, arms, legs, hands, and feet with weakness in hands and arms and sensory loss in left leg. Was unable to get immediate MRI so patient was admitted directly to hospital. MRI showed concern for transverse myelitis felt to be secondary to Covid 19 vaccine. He will not get second dose. Improved to near baseline with treatment of high dose steroids. He also had an STEMI and was taken to the Cath lab where they found 50% blockage in a coronary artery. They felt STEMI was caused by spasm. Pt was discharged home on 4/26/21 and is having physical therapy to help regain his mobility.

Pt developed symptoms of COVID-19 and was placed on bedrest on 03/28/2021. The patient was sent to local ED on 04/01/2021 and then tested for COVID-19 with a positive result. Patient was intubated and placed on ventilator. Pt. spent 22 days in ICU. Pt expired on 04/22/2021 with cause of death listed as MODS and COVID-19 related PNA. Related causes of death were listed as HTN, DMII, and ARDS.

Started with hard to get up off of low seating area. weakness in chest muscles. legs,arms. severe pain in chest muscles,shoulders biceps, then radiating down in arms and hands.. trouble walking up stairs, raising arms above my head. getting dressed, washing my hair and general hygine issues. My hands started swelling very bad and continue. The amount of muscle weekness and pain i have i have never experienced in my lifetime. I have been to multiple doctors and have had many tests done. Prior to the Covid 19 vaccine i was a 60 yr old and now feel like a 90 yr old with many health problems.

After receiving the immunization patient became unconscious, unresponsive, diaphoretic, incontinent and was drooling from the mouth. The patient did not respond to verbal or physical stimuli and his pulse was weak. Due to the patients position it is unknown if the patient was breathing or not. At this point epinephrine was administered into the patients left thigh. Within a 2-5 minutes the patient regained consciousness. He was alert and oriented at this time. His blood sugar was testing using his continuous glucose monitoring system and was 191. 911 was called and the paramedics took the patient to the hospital.

"Moderna COVID-19 Vaccine Was relaxing and getting ready to read my book on phone. A few minutes after taking the vaccine, blood pressure fell, dizzy with risk of passing out, weak, very rapid heart beat, nausea. Jumped up and starting moving to create energy to avoid passing out. The dizziness reduced somewhat and did not get worse, but was still present. Heart rate slowed after a significant period of time. Then symptoms resolved. No emotional triggers and no history of any such events at any time in 60 years.

Moderna COVID-19 Vaccine EUA: patient seen in emergency department two hours and seven days after vaccination for tachycardia and chest pain. First visit pulse 125 beats per minute, bloodp ressure 186/108 mmHg, rest of vitals within normal ranges. Patient administered intravenous fluids, Maalox + lidocaine, NSAID, and discharged to home stable when symptoms resolved and vitals improved. Second visit pulse 103 beat per minute, blood pressure 170/101 mmHg, rest of vitals within normal ranges. No medications administered and patient discharged to home stable when symptoms resolved and vitals improved with prescription for antihypertnsive medication.

Pt admitted complaining of palpitations and admitted for afib with RVR. Pt started on diltiazem drip and metoprolol. Pt converted to normal sinus rhythm after 16 hours of treatment with diltiazem drip. Pt was discharged within 24h of admission and sent home on metoprolol.

Inflammation of the tissue which surrounds the heart. Pericarditis. Taking Colchicine and Indomethacin.

Extreme pain experienced on right side just below rib cage. Went to Emergency Room and Pulmonary Embolism in both lung was diagnosed.

presented with chest pressure and difficulty breathing 4/15/21, eventually admitted 5/6/21 for pericarditis with atrial flutter. No PE on CT chest

Extremely high glucose following the vaccine. I'm staying 225-275 no matter the activity or insulin dose. This was not mentioned in the list of adverse side effects. This condition was present after dose #1, but much worse after dose #2.

05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT FELT FINE AFTER THE CLINIC BUT LATER AT HOME STARTED FEELING SICK. PATIENT WAITED UNTIL SUNDAY 5/9/21 TO SEEK MEDICAL ATTENTION AT THE HOSPITAL AND WAS ADMITTED FOR STROKE. PATIENT REPORTED LOSS OF VISION IN ONE EYE. THE HOSPITAL NEUROLOGIST TOLD PATIENT THAT IT WAS DUE TO CLOTS IN HIS EYE. PATIENT IS WATING TO SEE AN OPTHALMALOGIST ABOUT THE EYE CLOTS. PATIENT HAS NOT BEEN BACK TO WORK SINCE FEELING SICK. EMPLOYER STATES HAS NOT RECEIVED ANY NOTICE FROM DOCTOR STATING ANY CAUSE OR RELATION TO VACCINE

PATIENT HAD BEEN SHOPPING IN THE STORE AND WAS IN AND OUT OF CONSCIOUSNESS WHEN I WAS CALLED OVER FROM THE PHARMACY TO CHECK ON HIM. PT ALSO USES OXYGEN AT HOME AND DID NOT BRING WITH HIM. BLOOD SUGAR WAS HIGH (>220) AND PARAMETICS ARRIVED ON SCENE AND TOOK HIM INTO AMBULANCE TO BE EVALUATED. THEY WERE NOTIFIED THAT HE RECEIVED VACCINE APPROXIMATELY 1 HOUR BEFORE EVENT.

Patient was diagnosed with bilateral LE DVT's on 5/10/21. Sx started a few days after the vaccine as per patient's report. No prior hx of DVT or known thrombophilia or other major antecedent clinical event prior to diagnosis.

The morning of April 13,2021, I was taken to the emergency room with heart attack like symtems. After blood test a CT was done and multipul blood colts were found in both my lungs. I was then placed on blood thinners a low salt diet. I remained in the hospital until the April 16,2021.

Three days after the first vaccination I went into AFIB, I waited 13 hrs at home until my heart reset itself. Three days after the second vaccination, I went into AFIB once again and went to emergency with heart racing at 176. Approximately 8 hrs later my heart reset with the aid of medication. I stayed in the hospital over night for observation then released @ 2 PM. I am now under the care of a cardiologist monitoring and now taking other medications for my heart

Three days after first vaccination I went into AFIB for 13 hours where I stayed at home. Three days after second vaccination I went into AFIB again, this time my heart was racing at 176 and went to emergency. I was admitted, observed overnight where my heart reset @ 8 hrs later

Stroke; Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021 at 10:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021). On 06-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. On 30-Apr-2021 at 10:30 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood test: normal (normal) Normal. On 01-May-2021, Computerised tomogram: normal (normal) Normal. On 01-May-2021, Electrocardiogram: normal (normal) Normal. Concomitant medications were not reported. On 30 Apr 2021, the patient's right arm was numb and he had no feeling in it. He went to the emergency room on 01 May 2021. They thought he had a blood clot. His EKG, blood tests and CAT scan were normal. The patient reported his arm was still numb on 04 May 2021. It's like it was limp; he couldn't coordinate his hand when he tried to mow the law. He stated that he had no feeling in his arm and can't control his right hand. The patient was reported to have been diagnosed with a stroke on 06 May 2021 2021 and was to start rehab on 07 May 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Stroke added as an event.

On or around April 15th I developed a pain in my left calf. As a senior citizen and avid golfer I chalked this up to age and activity. But the problem didn't go away and on some days would be more painful than others. Additionally, the point where my calf hurt seem to move around and sometimes be higher on my calf behind my knee. Some days the pain was gone altogether only to return the later that same day or the next. At the beginning of May I started to develop a cough. I had no fever or other symptoms so I thought it might be seasonal allergies. The cough continued to get worse so I made an appointment with my doctor on 5/26/21 and was seen that day. I was given a COVID test even though I had taken the vaccine and scheduled for an ultrasound on Friday 5/28/21. During the ultrasound they discovered a DVT in my left calf that extended from my ankle to behind my knee. Since I was also coughing they scheduled me for a CT scan that same day. The CT scan showed multiple PE's in both lungs. They sent me to the hospital.

Several days after vaccine administration patient developed shortness of breath, orthopnea, tachycardia, leg swelling, cough. Seen by Cardiology outpatient, had Echo which showed EF 15%. Admitted to medical center. Patient diagnosed with myocarditis post vaccine administration by ID.

Passed out in traffic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in traffic) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in traffic) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in traffic) had resolved. No relevant concomitant medications were provided. No treatment medication was provided. Patient also went to emergency room on 10 Apr 2021 and was examined for stroke and heart which came normal. No treatment information was provided. He wanted to know if Moderna can pay bills for the incurred loss. 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. This case was linked to MOD-2021-142984 (E2B Linked Report).; 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. MOD-2021-142984:dose 1 case

Per patient report: The patient reported chest pain along with flulike symptoms soon after his first dose of the Moderna vaccine. He called today to cancel his second dose appointment. The patient reported that he went to the hospital after the development of chest pain, and was told that his electrolytes were "off". Per the patient, he was not given a definitive explanation of what caused the chest pain.

Patient presented to the ED on 3/29/2021 "for evaluation of right groin, right flank pain and gross hematuria." Patient presented to the ED on 4/4/2021 for UTI. Patient presented to the ED on 4/19/2021 for dependent edema. Patient presented to the ED and was subsequently hospitalized for alcoholic intoxication. Patient had second vaccination on 4/26/2021. Patient presented to the ED and was subsequently hospitalized on 5/19/2021 for atrial fibrillation. These visits are within 6 weeks of receiving COVID vaccination.

5/16- symptoms started- cough, fever body aches. admitted 5/19 with SOB in addition. COVID pnuemonitis, 5/23-sudden decrease in saturation - placed on BiPAP and transferred to the ICU. further decline and arrested on 5/27. PEA and agonal breathing. intubated and ACLS meds given. Coded a second time and family elected to halt heroic measures.

Patient sustained DVT on 5/26/2021 after receiving Moderna COVID-19 vaccine on 5/17/2021. patient has history of prostate cancer that was diagnosed 6 weeks ago with prostate cancer. No previous clot history.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 4/20/21 for small bowel obstruction and on 5/2/21 with near syncope.

COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status, cardiomyopathy, septic shock, and multiorgan failure; also tested positive for haemophilus influenza.

Patient received 1st vaccine on 4/29/2021 (no side effects), 2nd vaccine on 5/27/2021 (patient states he had sore joints). On 6/5 He awoke at 3:00 a.m. in the setting of leg cramps. He got out of bed to walk off the cramps, but then developed substernal chest pain. He describes the pain as ?squeezing? and cramping with radiation towards the left shoulder. He began to feel lightheaded and diaphoretic, and thus began driving himself to the ED. On the way, he felt his symptoms were worsening so he called dispatch he recommended he pull over at a nearby gas station. EMS met him there and transported him the rest of the way to the ED. In the outside ED, he was initially hypertensive to 175/99.

He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.

chills, fatigue, throbbing headache, nausea, fever,no appetite, rapid heart beat, rt lymph node swollen,

Patient is a 60-year-old gentleman with a history of tonsillar and skin cancer with mets to the lymph nodes status post chemotherapy and radiation, BPH, hypertension, hyperlipidemia, and CKD stage 4. Patient presented to the emergency department for complaint of dizziness x4-5 days with diarrhea x3 days and syncope today , pt noted hypotensive in ER but per ER physician not orthostatic, Dr spoke with pt oncologist and seems his Blood cell count close to his baseline, but his baseline creat 2.1 so does have acute on CKD and dehydration. pt noted COVID 19 positive and cxr suggestive covid pneumonia, his cxr was better couple of days ago when pt wasin ER as well. pt did recived his covid vacine 1st dose on Saturday. He finished his chemo on May 13th.

On the evening of the 27th day (02/11/21) after the first Moderna shot, I had an ischemic stroke on my Right Middle Cerebral Artery and was hospitalized

Atrial fibrillation; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product SELEXIPAG for Pulmonary hypertension. The patient's past medical history included Arrhythmia (Abnormal heart beat Rhythmn) on 26-Apr-2021. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 1600 mcg twice a day. On 10-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-May-2021 to 15-May-2021 due to ATRIAL FIBRILLATION. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Blood disorder NOS, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was seen by his primary care physician on 10-May-2021, 12 hours after getting the Moderna vaccine. The physician admitted the patient to the hospital due to atrial fibrillation. The patient was discharged on 15-May-2021. The patient reported that he was in the hospital from 26-Apr-2021to 01-May-2021for abnormal heartbeat rhythm and the hospital ended up having to shock his heart to get it back to normal. The patient had the second Covid vaccine done around 1 week before reporting date 02-Jun-2021 and said he seems to be doing well. Treatment was not reported. 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.; 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.

Like he was going to pass out; Weakness; Cold sweat; The vaccinator pulled out the needle, blood came out and ran down his arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Like he was going to pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Passed out (Patient has history of passing out when blood drawn from right arm as it usually hits a nerve). On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Like he was going to pass out) (seriousness criterion medically significant), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm). At the time of the report, LOSS OF CONSCIOUSNESS (Like he was going to pass out), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm) outcome was unknown. Patient has drank water & ate M&M to relieve the symptoms. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's history of 'passing out when he gets blood drawn on his right arm because they usually hit a nerve' is a confounding factor that may play a possible contributory role.

ON 04/29/2021 HEAVY INDEGESTION, CHEST PAINS ACROSS FULL CHEST, CHILLS, FEVER 98-100 DEGREE RANGE SPENT 36 HRS IN HOSPITAL DID CARDIAC STRESS TEST AND LUNG IMAGING, DISCOVERED SWELLING IN NOGILES REALEASED ON THE 31st.

On the evening after receiving the COVID19 vaccination (May 7), I experienced severe flu-like symptoms. On May 8 these symptoms gradually disappeared, but during the night I woke and was drenched in sweat. The night sweats continued for the next four nights and then disappeared. On May 13 my wife heard a strange noise in my chest which I later identified as a heart murmur. I did not have any pain or other obvious symptoms, but I felt a slight tingling in my toes and fingers. I went to urgent care, where I was referred for an echocardiogram. The echocardiogram was performed on the morning of May 21, and endocarditis with highly mobile vegetation on the right coronary cusp leaflet of the aortic valve was identified.

Patient passed out, fell to floor, got up in sweats, shaking. Patient was given water, orange juice, BP taken, BP rose with second reading, called paramedics, patient was checked out by EMS and was ok after 30 or so minutes. patient was able to go home by himself.

Enlarged heart from 05-24-21 to 05-25-21. Insomnia from 05-22-21 to the present and continuing. Treatment received - none.

Heart is fluttering; Erratic heartbeat; Feeling a distress in the chest; Feeling like a "bu-bump, bu-bump"; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) and ARRHYTHMIA (Erratic heartbeat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), ARRHYTHMIA (Erratic heartbeat) (seriousness criterion medically significant), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump"). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), ARRHYTHMIA (Erratic heartbeat), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient reported that he was experiencing heart fluttering (2 or 3 times a day); at least twice a day, usually in the morning, he was feeling a distress in the chest, like a "bu-bump, bu-bump" for the last week and a half, along with erratic heartbeat, but not shortness of breath. The patient stated that he never felt this before. Treatment information was unknown. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.

"swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown. the swelling and hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.

I went to the ER on 06-14-2021 due to having symptoms I was experiencing to my heart. At the hospital they told me I had a condition called A-fib, they kept me there for one day for observation and performed complete lab work. I am currently following up with my cardiologist for treatment of A-fib.

PER NURSES NOTES AT APPROX 10:15 PM, THE NURSING ASSISTANT WAS MAKING ROUNDS AND NOTICED THE RESIDENT DID NOT LOOK "LIKE HIMSELF". RESIDENT WAS SWEATING/VERY WARM. SPO2 64-70% ON ROOM AIR. BLOOD SUGAR READING "HI". TUBE FEEDING TURNED OFF, PLACED RESIDENT ON 5L O2, SPO2 INCREASED TO 71%. RESIDENT TAKEN TO THE HOSPITAL. VITAL SIGNS AT TRANSFER: BP 98/59, PULSE 132, RESP 36, TEMP 101.9, SPO2 66% (STATED ON ROOM AIR). HCP AT FACILITY STATES HE IS NOW IN THE INTENSIVE CARE UNIT.

DX: Pericarditis 01/20/2021 S/S: Neck pain, acute chest pain or pressure, Chest pain, more on the left side at the anterior axillary line radiating across the chest while watching a movie occurred previous day and again day of admission while walking. Possible alternative etiology: Initial concern for ischemia given history (prior MI with stenting, significant residual disease), but pharmacologic stress perfusion study did not show change from prior. One note describes pain reproducible with palpation, raising question of chest wall pain, but not mentioned elsewhere in notes, so appears pericarditis was considered the most likely etiology. 60 year old male with extensive CAD history with new chest pain. Was hospitalized with new diagnosis of probable pericarditis. Reported first dose vaccine given 01/14/2021, 4 days prior to initial symptoms. Of note, would not meet case definition for pericarditis (has chest pain but no other finding), but would meet myocarditis case definition (chest pain and troponin elevation); potential myocarditis is not discussed in the clinical notes, perhaps because the troponin elevation was fairly minimal.

60-year-old male with complaint of palpitations and shortness of breath since 3 days ago after getting his 1st Moderna COVID vaccine. He states that the palpitations started right when they put the needle in his arm. He states that he does have some history of anxiety and depression but that this feels different.

Delayed anaphylactic reaction. Evening of receiving injection he didn't feel well, oxygen dropped to 80s on pulse ox and patient self administered epi pen at home and went back to sleep. Later this happened again and he developed throat closing and gave himself a second shot. He went to the ER the following day 7/26/21 where he received treatment with dexamethasone, pepcid, and benadryl. He also had labwork completed, EKG, and Chest xray. He did well with treatment and was discharged home.

Patient presenting with a segmental pulmonary embolism 2 weeks after first dose of the Moderna COVID-19 vaccination. Has history of provoked DVT from knee replacement surgery.

Chills, body aches, headache, BP increased, pulse increased, lightheadedness, sweats the day after the vaccine. (The evening and the whole night.)

about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )

heavy sweating, then passed out twice ,hitting the floor 5 hours after getting shot . went to summa ed the next day , cat scan,bloodwork and ekg came back ok. on jan 16th i went to a dentist for a abscessed tooth.after i passed out i had a headache for 2 days and felt out of sorts.

Freezing to death, chills, sweating. hurting everywhere so bad, and really bad headache, nausea, chest pain, lowered his blood pressure, sore muscles, extreme tiredness, ambulance picked him up and was in the ER all day giving him fluids, took about 2-3 days before he started feeling better. The whites of his eyes are still red.

Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F

I started feeling flush and got a pain in the center of my chest. At first it felt like congestion, but then started radiating into my shoulders, then into my arms and up into my neck. They called an ambulance. They gave me Benadryl and aspirin, which made me feel better. They missed twice trying to blood, but said I refused, so they couldn't get blood results. I don't know if it was an allergic reaction.

Bilateral swollen forearms, numbness on left fingers, chest tightness; seen & cleared by EMS. Due to past medical history of asbestos lungs, client instructed to go to emergency room

approximately 24 hours after the injection, I had no fever, but chills, sweats and overall since of fatigue. My resting heart rate was at 100 for a few hours. Normally, it's around 76. I noticed on deep breaths, I felt the need to cough (no phlegm, just a dry cough. One or two coughs per attempt). No medical care sought. Those symptoms dissipated and I felt good. Then on January 20 and 21, the chills returned. They lasted about 8-10 hours, then they were gone. I also developed a headache during the 20 and 21 episodes. I checked yes in the below adverse recovery box, but I am uncertain as to what tonight and the rest of the days have in store.

Dizzy, lightheaded, severe headache, shaking, freezing cold, profuse sweating, muscle aches, joint pain, tachycardia, minor chest pain, nausea, dehydration with constant thirst, metallic taste in mouth. Took 2 tylenol pm pills, drank water and 7-up. Symptoms were gone 20 hours later except for very sore right arm, neck and back muscles which were completely gone and normal by day 3.

patient received the Moderna Covid 19 vaccine on 1/23/2021 around 5:45pm wife called management today and reported that he had collapsed and passed away today around noon

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.

injection site pain and tenderness. fatigue , headache, muscle pain , joint pain , chills, fast heartbeat.

Rapid heartbeat that lingered for a couple of days. Cold symptoms (runny nose) started 4 days later (may be unrelated)

5 minutes after injection, patient started complaining of sever chest pressure, shortness of breath. EKG was done and EMS was called. Patient was transported to ED since he continues to exhibit shortness of breath and still complaining of chest pain/pressure.

approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling

2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.

Gave moderna vaccine at 3:23pm in right deltoid. During observation period, patient was experiencing tingling in both of his hands. Due to past history of allergic reactions, gave him diphenhydramine at 3:42pm. He felt okay for a short period of time and then started to have tightness in his chest. He could still breathe fine, but called 911 due to past anaphylactic reactions. While on the phone with 911 he stated feeling more tightness in his and then decided to give epi-pen shot in left upper left thigh at 4:02pm. The EMT showed up immediately after and took patients vitals. EMT advised if wanted follow up monitoring could take him to ER. Patient wanted to go to ER for further monitoring. We followed up with patient's wife and she said he was still not feeling very good and had follow up appointments with his cardiologist. He also came in the store on 2-26-21 and all his test were normal, but still was not feeling like himself.

Heart rate became elevated from 7pm to 12:30am. Averaging around 100bpm. Had the chills during this time period with temperatures of 95.5 and 97. I feel asleep and woke up around 3:30am and deltas if I broke through.

Had COVID vaccine on 02.11.21. States the next morning his anxiety was very high. States he did not know who he was. Still experiencing a lot of anxiety at night. Admits to heart palpitations and hard time breathing. Can't sit still. Reports manic episodes and cycles of depression over the course of hours. Patient states it has gotten a tiny bit better. Tried trazodone which helps temporarily. Denies chest pain. Patient states he has no appetite. Palpitations resolved pretty quickly. Shortness of breath is described as tightness that comes with anxiety feeling. Resolves with shoulder massage. Occurring three times per day. Also admits to dry mouth. Patient admits to needing to sleep with multiple pillows or feeling like he had to sit up and couldn't lay down as shortness of breath would get worse. EKG in office on 2/24/21 showed ST-T changes and given symptoms patient was transferred to emergency room via ambulance. Work up in hospital was unremarkable and patient was diagnosed with pericarditis (unknown etiology) and prescribed NSAIDS from ER and discharged. Admission not required. Patient followed up to us as outpatient on 03.02.21. Patient felt much better and had not take motrin for 1 day. COVID testing obtained at this point (unclear why ER did not send it). Patient referred to outpatient cardiology given risk of cardiovascular disease, stress echo, and event monitor.

EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy

Next day developed right leg pain. Following day diagnosed with a new deep venous thrombosis of the popliteal vein, right leg

Pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection; Sugar was very high; Blood pressure was very high; Face look flushed; A spontaneous report was received from a consumer concerning a 61-years-old male patient who experienced pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection (cellulitis), sugar was very high (blood glucose increased), blood pressure was very high (blood pressure increased), and face looked flushed (flushing). The patient's medical history included diabetes mellitus, heart disease (unspecified), kidney failure, and chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the event, included insulin and oral medications for diabetes (unspecified), rosuvastatin calcium, acetylsalicylic acid, umeclidinium bromide and vilanterol trifenatate, diuretics unspecified (water pills), omeprazole magnesium, and cortisone. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient got cortisone injection. On 18 Feb 2021, the patient experienced high sugar level, high blood pressure and face looked flushed. On 20 Feb 2021, the patient started having pain in the ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection. Treatment for the events included Keflex. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events of pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection, sugar was very high, blood pressure was very high, and face looked flushed, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing. Was transported to Medical Center for further evaluation.

1. Shaking chills, fever and flu symptoms for one day followed by a day with malaise. 2. Daily diarrhea, watery stool, cramping and bleeding lasting one month. Currently slowly resolving. Treated with a variety of remedies over the month, individually and in combination. ( Pepto bismol, charcoal capsules, imodium, rice, tumeric, and Xifaxin) Imodium would stop the cramping but not the wateriness of the stool. Unlike any diarrhea over the course of my life. I will not be taking any booster shots.

Client reported being bothered by 'blurry vision' about 25 minutes after receiving the Moderna vaccine, accompanied by feeling dizzy and lightheaded. Speech was normal, grip strength equal and strong. Blood pressure was low (85/58), HR 94. Client drank 12 oz water over 5 minutes, BP improved to 95/60 w/ HR 86 (11:48). Client still c/o blurry vision and light headedness, but was talkative and making jokes. He started to stand (to test his balance) but was still unsteady. Gave him another bottle of water, explaining re: low BP and hydration. Reassessed after an additional 5 minutes (11:53) with BP further improved to 100/62. Denied improvement in vision or lightheadedness. Client sat for 30 more minutes. I attended to another client at 12:00, with another RN monitoring him. When I returned to check on him, she said he did not exhibit any signs of being in distress and got up to leave voluntarily.

received vaccine friday afternoon saturday started feeling extremely dizzy and weak, difficulty walking sunday unable to walk, blood pressure high, tremors called 911

March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch. March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.

Patient had 2 waves of cold sweats during his 15 minutes waiting period. Patient also felt palpitation or racing heartbeat. Throat became scratchy. Globus sensation. Denied swelling of the throat.

Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vaccine. Each time the patient received the vaccine, he presented to the emergency department the following day with the following signs and symptoms: AMS, tachycardia, fever (Tmax 104.5), lactic acid 3.8, CRP 1.65, CPK 298, Troponin T 0.107, WBC WNL.

The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:00 AM with significant discomfort in my chest. My chest felt heavy and when I inhaled it felt like someone was squeezing both lobes of my lungs. I got out of bed and went to the bathroom to urinate. I went back to bed and tried to get back to sleep. The discomfort in my chest continued and seemed to get worse. I got back out of bed at about 2:45 AM and went downstairs where I walked around my living room to see if that would help me feel better. I continued to feel severe discomfort in my chest and lungs. I did not otherwise feel bad. I was not congested. I could still take a deep breath but it hurt to do so. I took my temperature and I did not have a fever. At about 3:00 AM I woke up my wife and she drove me to the emergency room at Medical Center. On the car ride to the hospital I started to feel much better. By the time I checked into the emergency room most of my discomfort had dissipated and only a very slight feeling of heaviness remained in my chest.

fainting, sweating, eyes rolled back, slouched over in chair then perked back up. still complained of dizziness and sweating. called 911 within 1 min of episode and paramedics came to take over. Patient was talking and coherent but sweaty.

Maderna Covid Vaccine 2nd dose Extreme chills that night, got up to go the bathroom,, had sweats and suddenly felt very dizzy and fainted on the bathroom floor. Felt very weak and couldn't get off the floor. Had a fever of 101.6, Wife had to help me get up after some time on the floor.

Received vaccine, and no reactions. Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye. General soreness around his mouth when he tries to eat or talk a lot. Limited movement of his face do to swelling, difficulty closing his eye, and headache. Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21. Was given corticosteroids for 9 days Prednisone 60 mg. The symptoms are slowly improving but still has the Bell's palsy.

Normal side effects of fatique, aches but have been getting worse and worse chest congestion and wet coughing. Chest hurts.

Patient taken to the Emergency Department following first dose. He felt like his heart was racing and his hands and feet tingling. Was given benadryl in the ED and advised to discuss second dose with his primary care provider. He has a history of allergies to shellfish and possibly other allergens.

experienced extreme shortness of breath a day or two after receiving 2nd COVID-19 vaccine. Breathing became worse at night, more so in reclined position than upright. Thinking it was a vaccine side effect waited for it to subside, when it did not sought medical attention. Doctors determined to be acute congestive heart failure exacerbation. Treated with diuretics and blood pressure medications. Hospitalized from 3/14/2021 to 3/19/2021.

Started to have chills around 7:00pm Friday night, then around 4:00am Saturday morning, I got up to use the bathroom and pasted out in the bathroom. My wife sad she heard a loud noise and came into the bathroom to see what had happened. She called my daughter and son-in law to come over and get me up I couldn't move at the time, I must have hit my back and neck because they are sore. Then Saturday night I had sweats all night, today I fell a little better except for my back and neck, I have a doctor's app. Friday. I am concerned about the 2nd shot if the 1st shot did this to me.

Rapid heartbeat that lasted one (1) minute +/-. Slight swelling in throat for maybe 45 minutes +/-. Was able to breathe fine.

Severe headache, 97.1 temp with extremely hot skin, rapid heartbeat (120 bpm). Next day felt fine with elevated heart rate. Monday, 3/22, all normal, including normal 60 bpm heart rate

Chest/heart stabbing pains started 10am following day. Lasted all day until sleep. Woke up next day and pains had gone

Patient had first Moderna Covid IMZ on 3/6 and had a stroke on 3/18. His doctors do not believe this was related to the vaccine and want him to get the second dose.

patient experienced heart attack and subsequently passed away approximately 2 weeks following vaccination. it is not believed to be related to the vaccination.

Please note: The vaccination record I received with lot number is very difficult to read!!! My first vaccination was 12/31/20 and lot number written down but hard to read is (U37K2OA but could be V37K20A) The second shot was 1/27/21 and lot number written down could be (0412OA, or could read O912OA!) I had symptoms of a Pulmonary embolism while cross country skiing March 18 and officially diagnosed with PE on March 22, 2021. I was tested for Covid 19 on March 23, 2021 with negative results. I had been reporting my side effects (which were none) for the previous 6 weeks following the second vaccination. I did have cramping like feeling in my right calf following a x-country ski weekend about 4 weeks prior to the actual PE (2/22/21) but it appeared to resolve after about 7-10 days

Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted at least 1 hour). Eventually went away. Then two days later, Tinitus and lethargy similar to past MS symptoms, felt "off".

Pt was treated in the emergency department for pleuritic chest pain, pneumonia, and nonspecific left greater than right lower lobe ground glass opacities found on CT scan on February 27, 2021 beginning at 1826.

Patient was in observation area after vaccine administration. Twelve minutes after vaccination, he fell to the floor and appeared to be having a seizure. Staff protected him from injury, and administered oxygen, and called EMS. He stopped seizing, then had another seizure before EMS came to transport him to the ER.

Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough. The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue. On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious. On 25 Mar 2021, he coughed up some yellow mucus. Treatment for the events reported included pacemaker and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.

Chills, shaking, cold, sleeplessness - 12hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination. Experienced a continuous and higher than normal rest heart rate, up to 120 ppm, for two days straight after vaccination - this is 30 to 40 bpm above my normal rest heart rate - on day three my rest heart rate returned to normal (80-90bpm) Blood glucose levels were unexplainably higher than expected on the morning reading after the vaccination - 176 mg/dl. Normal expected result range 90 to 135 mg/dl.

high fever (103F) despite Tylenol. low O2 (92%), raised resting heart rate, fatigue and chest discomfort

After feeling well and dinner I passed out. I came to after a minute or so. Everything was spinning and I was sweating profusely and had pretty strong chills and shivering. I stood on the floor until I felt better. I was able to go upstairs and I went to bed. I did continue to shiver for about 15 minutes. I have felt ok since then. I am not sure if I will get the second dose after that experience.

member recieved the first covid vaccine dose at 9:20 am . At 9:29 am member complained of feeling dizzy and sweating. Member was still being observed . at 0929 am Overhead page for MD assistance to evaluate member. Found member sitting in chair in covid vaccine area. Member able to answer questions, member oriented times 4 , respirations even and unlabored. his eyes closed and head tilted forward , skin pale and wet . Pt c/o dizziness.First BP reading 59/32 p42 , 02 saturation 100% on room air . This RN rechecked BP 68/33 and pulse 32 via machine ,this RN checked radial pulse 40. At 0933 this RN gave epi auto injector to left thigh . At 0935 911 called and Dr. and this RN assisted member to floor and elevated legs , applied O2 2l n.c. repeat BP 88/47 p-42 lying , then second lying BP 98/56 P 51 . Machine read 156. Member stated he was feeling better, less dizzy and was answering all questions and speaking in full clear sentences. Skin pale and wet. 911 arrived at 0942.

Sore arm, prolonged fever lasting 32 hours so far, the fever has not subsided yet. Extreme tiredness, I have slept for almost 30 hours. Aches and a side ribs are sore. I also fainted and fell several times during the night.

During daytime of 3/25/2021, began to feel discomfort on the left arm. The discomfort worsened to inability to move the left arm, left hand, or fingers. Admitted to the emergency room, then hospitalized for 3 days. Diagnosed as an Ischemic Stroke.

After 12 hours of being vaccinated was bed ridden, high fever, unable to walk for 12 hours. , skin color turned grayish and very pale for 24hours. Broke out in hives, particularly on back and chest area. Several bumps per sq/in., unbelievably itchy. 5 days later hives seriously affect sleeping habits and can barely sleep at night. Have had mild eczema for years, 95% out breaks occur on hands and forearms, never back. Vaccine cleared up eczema on fingertips and one small spot on forearm. Now 30% of body covered in hives (ie, small itchy bumps). 5 days later still have slight headache, thinking still a little cloudy.

Atrial fibrillation; Tested positive for COVID; Minor Aches like he was getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and COVID-19 (Tested positive for COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Minor Aches like he was getting a cold). On 25-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion hospitalization) and COVID-19 (Tested positive for COVID) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), COVID-19 (Tested positive for COVID) and MYALGIA (Minor Aches like he was getting a cold) outcome was unknown. She said they had been very careful, but had met with some friends and 2 of their friends also tested positive. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The day after he received the vaccine he felt minor aches, like he was coming down with a cold. On that Thursday he went into a fib. She took him to the ER and it took several hours to regulate his heart rate. While making arrangement to transfer him to a new hospital they did a COVID test and it was positive. They were shocked as he had not been showing any symptoms. He spent the night in the hospital. Very limited information regarding the even tof A fib has been provided at this time. Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.; Sender's Comments: Very limited information regarding the even tof A fib has been provided at this time. Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.

Day 3 (4/4/2021): Nose bleed, R nostril. Likely prompted with nose swipe. Resolved within 2 hours. Day 15 (4/13/2021): Nose bleed, mainly R nostril, Seemingly unprompted (just started gushing). Took 24 hours to resolve, likely would have been faster to resolve if proper decongestant was available. Day 15, approximately consistent with 2nd nose bleed, some malaise.

Tachycardia and lower than normal blood pressure; continuously for the past 11 days. Normal HR is 65-70 and since vaccination is irregular from 85 to 152. Most of the time in the low 100 with normal to low Blood Pressure

He was given the Covid vaccine at a pharmacy and not at my office. 4 days after the vaccine he noticed discomfort in the right calf. Initially he dismissed it but then gradually the calf started to swell. Once he noticed some shortness of breath he decided to come into the office. He was seen on 4/12/21 and diagnosed with a pulmonary embolism. He was then admitted to Hospital for IV therapy and monitoring.

Pt found unresponsive in hospital room with large amount of vomit. Patient pronounced dead shortly after with cause of death noted to be aspiration pneumonia with hypoxemia leading to cardiac arrest. Pt received vaccine 1 month prior so I wanted to report this.

Client's wife called and reported that client had a heart attack 5 days after receiving the vaccine. He also had blood clots.

The individual felt faint / light headed as he walked towards his vehicle following 15 min observation period . He Did not feel that he would be able to safely operate his vehicle . Returned to the observation area Glucose levels were within normal range reading was normal. Blood Pressure reading and pulse were within normal limits. No abnormal respirations. Appeared flushed and slightly diaphoretic after additional 10 min of observation at vaccine site . Decision made at 3:30 PM to transport to the ER. Patient agreed

Patient received the first Moderna Covid-19 vaccine and a few weeks later he noticed jaundice and hematuria. He was admitted to the Hospital, and was noted to have dramatically elevated eosinophils (26.29 k/uL), elevated creatinine (2.36 mg/dL) and elevated LFTs (AST/AST/Alk Phos/Tbili all up, mostly direct). His eosinophils improved with pulse dose steroids and the diagnostic work up continues. There is diagnostic uncertainty about what caused this dramatic increase in eosinophilia, but it appears temporally related to getting the vaccination. Our working diagnosis is autoimmune vasculitis, but he is also being treated for possible parasitic infection, and will require very close follow-up. 61M with PMHx HTN p/w generalized fatigue, L flank pain, and decreased UOP. He was in his usual state of health until 5 days prior to admission with onset of general fatigue/sluggishness. This was followed by a few days of dull abdominal pain, watery bowel movements, and increased frequency which spontaneously resolved, though the fatigue persisted. Yesterday evening, he noticed new L flank pain, red urine, and decreased UOP associated with mild dysuria (he describes it as needle-like pain in his urethra) which prompted him to call EMS. Denies fevers/chills/night sweats, myalgias, respiratory symptoms, melena/hematochezia. He's never had pyelonephritis or kidney stones before, no recent urinary instrumentation, antibiotic use, or hospital stays. He recently received the first COVID vaccine and is due for the second COVID shot on Monday. He lives with his sister and works as a mechanic. He is not on any other medications or supplements. Not currently sexually active. ED Course Vitals: Temperature: 36.7 °C (98 °F) | Heart Rate: (!) 103 | BP: (!) 169/121 | Respiratory Rate: 18 | SpO2: 96 % | | FIO2 | Weight: 104.3 kg (230 lb) Exam: L CVA TTP Labs: Cr 2.34, bicarb 18, WBC 37, UA w/ 3+ blood, +1 LE, nitrates, >182 RBCs, 32 WBC, no bacteria, no casts Imaging: CT/AP with mild L hydrouretonephrosis, b/l periureteral and perinephric stranding, b/l urothelial thickening Interventions: CTX 1g, ketorolac, 1L LR, morphine ===================== Hospital Course 4/10-4/16 ===================== #B/l Pyeloureteritis with Eosinophilia c/f Eosinophilic Pyeloureteritis #B/l L Hydroureter/Hydronephrosis, B/l Perinephric Stranding and Pericystic Stranding #Profound Eosinophilia Pt presented with malaise, hematuria, decreased UOP and markedly leukocytosis with predominant eosinophilia to 26k and was found to have L hydroureter/hydronephrosis, b/l perinephric stranding and pericystic stranding on CT A/P (4/10). Notably has been afebrile and fairly well appearing. Symptoms were preceded by several days of watery diarrhea, cough with sputum production and subjective weight loss. Recently received moderna vaccine, and he was concerned it causes his symptoms. Underwent extensive workup as below with involvement of multiple services including Renal, Pulm, Rheum, Allergy, ENT, and Cardiology. Had one nasal lesion biopsied by ENT, which was non-diagnostic. Renal bx prelim without clear e/o vaculitis, although obtained after steroids. Negative testing for primary hypereosinophilic syndrome. Extensive w/u notable for ANCA positive at 1:80 with MPO only slightly elevated (20, uln 19) and PR3 wnl. cMRI with eosinophilic cardiomyopathy, for which cards was consulted as below. Additionally, toxacara ab positive and schistosoma ab indeterminate, although per ID both schistosomiasis and toxacara infection unlikely. Per rheum, overall felt presentation 2/2 hypereosinophilic syndrome, potentially the eosinophilic stage of EGPA (given low + ANCA, low + MPO) vs. End organ effects of idiopathic eosinophilia. Briefly received CTX 2g IV qd (4/10 - 4/12) until diagnostics returned. Treated with solumedrol 1g qd x3d (4/11-4/13) transitioned to prednisone 60 mg qd (4/14-) to be continued until rheum f/u, with rapid decline in eosinophilia. Received pre-treatment with PO ivermectin 20 mg before steroids. Treated with flonase nasal spray, symbicort and albuterol for respiratory symptoms. Deferred cyclophosphamide, with consideration of IL-5 or IL-5R targeted biologics as an outpatient. Treated with atovaquone for PCP ppx. Per ID, treated with praziquantel (for schistosomiasis) and albendazole (for toxacara) out of an abundance of caution, although low c/f visceral larva migrans given lack of compatible imaging findings and no known exposure to dogs and cats or schistosomiasis given remove travel history. Data - CT A/P (4/10): Mild L hydroureteronephrosis with b/l periureteral and perinephric stranding and b/l urothelial thickening. Pericystic stranding. - 4/11 CT Chest with parasinus mucosal thickening and sclerotic 1 cm lesion likely benign lesion or bone island - 4/11 CT Face with parasinus mucosal thickening and small fluid levels and sclerotic ovoid 1 cm lesion in neck of right mandible potentially representing benign fibro osseous lesion or bone island - PFT with severe obstruction and elevated FeNO c/w eosinophilic infiltration - Heme review of smear with normal Eos - Echo TTE with LVH nl EF 52% - Vitamin B12 >2000 - Urine Eos undetectable after steroids - SPEP with polyclonal hypergammaglobulinemia - Sinus Bx equivocal - ANA, ANCA (1:80; MPO 20, PR3 3), ESR (128), CRP (66), RF (<13), C3 (82, slightly low), C4 (10) - IgE 355 - Aspergillus IgG and IgE <19 - HIV non-reactive - RHP with CHIP mutation which will need f/u - FIP1L1 negative - Schistosoma ab equivocal - Strongy ab negative - Toxacara ab positive - Leptospira ab negative - Tryptase wnl - RHP notable for CHIP mutation as below - BCR-ABL negative - FIP1L1-PDGFRA negative - peripheral blood flow cytometry unremarkable #AKI on CKD #Nephritic syndrome #Urinary retention/hydronephrosis Cr 2.34 on admission. Baseline Cr unknown but Cr was 1.5 (OSH BI) and urine alb:Cr was elevated to 36 in 6/2018, at which time CKD was thought to be 2/2 untreated HTN. Now presented with persistent hematuria, HTN and proteinuria with UCx without e/o infection, all favoring nephritic process. Renal and urology consulted MALB/CCR 994.5. CT scan with hydronephrosis, felt to be eosinophilic pyelonephritis. Pt underwent uncomplicated renal bx 4/14 (after steroids) which showed preliminary very mild focus of interstitial nephritis with scattered eosinophils and immunofluorescence evidence suggestive of a mild immune complex-mediated disease without current activity. EM pending. He was treated with sodium bicarb 1300 mg bid. Hematuria improved but did not resolved by time of discharge. Cr on discharge 1.6, close to baseline of 1.5 in 2018. #Sclera Icterus #CBD Dilation on CT #Elevated LFT Sclera icteric and CBD dilation on RUQUS to 1.8cm with gallbladder sludge and small gallstones. MRCP with diffuse intrahepatic and extrahepatic biliary ductal dilatation to the level of ampulla, with associated ductal and gallbladder wall edema, complex material in the gallbladder lumen and CBD, and confluent periportal lymphadenopathy. No obstructing stone or discrete mass. Findings likely represent cholangitis such as eosinophilic cholangitis in light of severe eosinophilia.. No documented LFTs here, but OSH (BI) records indicate normal LFTs and viral hepatitis studies in 6/2018. Repeat Hep B non-reactive non immune, HCV non immune, HAV non-reactive. BIli remained stable and ALT and AST continued to rise after initiation of steroids. GI was consulted. RUQUS 4/15 with dopplers with persistently dilated CBD to 1.4 cm with sludge in CBD but with patent portal vein and hepatic veins. Anti smooth muscle ab positive on day of discharge; antimitochondrial ab pending. LFT uptrending at time of discharge, although patient declined to stay inpatient for further workup. LFT at discharge ALT 194, AST 114, ALP 262, TBili 6.3, DBili 5.3. ERCP to be considered as an outpatient. #HTN SBP on admission 160-180. History of HTN, not on any home anti-hypertensives. Per BI records, he was prescribed amlodipine 10/valsartan 160 in 6/2019, but pt reports self-discontinuation after ~2 doses. BP remains poorly controlled. Likely related to potential nephritic syndrome or renal infiltration by eosinophils, likely with contribution of high dose steroids. While inpatient, treated with hydralazine, labetalol, carvedilol, and amlodipine. BP regimen on discharge amlodipine 10 mg qd, carvedilol 25 mg qd. Avoiding ARBs and ACEI per Renal, although will likely need to add once AKI resolved. #Microcytic Anemia Patient with drop in Hct from 14.1 on admission to 11.4 4/14. Continues with hematuria, but denies current hematochezia. Suspect combination of blood loss and hypopoliferation given RPI 0.29, likely anemia of inflammation/acute illness given ferritin 1.010. Vitamin B12 >2000, Folate 11. Iron 151, unable to calculate TIBC. Noted to have persistently low MCV in low 70. Hemoglobin electrophoresis ordered. #Vitamin D deficiency #HyperPTH 25-OH Vitamin D 6. No e/o hypocalcemia. Phos slightly elevated on admission, but subsequently downtrending, likely iso renal dysfunction. Treated with ergocalciferol 50,000 U weekly x12 weeks #Right mandible lesion Sclerotic changes of the right mandible near the condyle noted on CT scan. Surgeon recommends outpatient follow-up, although patient declined. #Hematochezia #Hemorrhoids Patient with new bloody diarrhea 4/11. Some e/o hemorrhoids on exam. CBC stable. Treated with tucks pads, dibucaine ointment and hydrocortisone cream. #Little Medical Follow-up Pt reports that he has not seen a doctor in ~3 years.Cholesterol 124l LDL 73, HDL 10. HgbA1c 5.2. Will join Dr's panel on discharge #CHIP mutation RHP with DNMT3A mutation at low VAF. Will follow in cancer precursor clinic

After my second shot after approximately 8 hours I got a severe headache perfuse sweating and vomiting, this went on continuously until Monday when I went to a family practitioner, she blew off my symptoms and sent me home where I continued to have these symptoms on and off. When on I was completely disabled. I filed a complaint they called on 4/15/2021, and told me I should go to ER, I told them I was flying the next day to see my mother who is passing away. I promised if my symptoms were still there in morning I would go to ER. I woke up feeling great and then I had a bowel movement my headache was so bad I thought I was having a stroke, I started sweating bullets and vomiting. it was so bad the only thing I can compare it to was when I had Tick fever in the early 90's. I called 911 at hospital I was in a dangerous arrhythmia throwing PAC's and going in and out of 2nd third degree heart blocks. They can not figure out why, the neurologist I saw theory is the same I had, a severe inflammatory reaction to the 2nd moderna shot. He put me on a 3 day course of prednisone which helped a lot in my recovery. I am currently on a heart monitor to see if the heart block was just temporary. I see the neurologist again in 3 weeks.

Received Moderna Covid Vaccine on 3/3/21 and 4/8/2021. Nted onset 4/24 of right calf discomfort, swelling and firmess and at same time began to have exertional dyspnea with chest heaviness. U/S RLE - extensive DVT. CTA - multiple segmental vessels with clot, dilated right ventricle

Evening that I received the shot, became extremely light headed and diaphoretic (outcome resolved). The next day, temperature rose to 103 F (treated with acetaminophen, outcome resolved) . The following day had chest pains which continue to persist. Saw Family Physician on 4/26. (ECG, Pulse Ox done, Dx Costochondritis most likely related to the vaccine, outcome not resolved).

complained he is hot then he was passed out---he was sweating a lot . We called 911 . was back when ambulance came----they checked on him and saidis fine--and they left. is fine after that then he left 30 min later.

Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose. Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. 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.

Monday night Fever and chills Tuesday - Sat Pain in elbows and shoulders and back EKG Wednesday Bad pain Thursday and Friday 4:30 am Sat admitted to Yale : heart attack back dated to Tuesday. Needed 1 stint

He is newly hypertensive with blood pressure 160/72 with continued cold sweats/"blah" feelings for the month since his second covid vaccine. Suspect he's having symptomatic hypertension. BP has never been uncontrolled recently and he was last seen 3/21

right leg DVT and bilateral pulmonary embolisms. Symptoms of cough, chest pain and dyspnea on exertion started on (about) 4/19/21. Patient presented to urgent care on 4/26/21 and again on 4/30/21 at which time the diagnosis was made.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was CVA.

32 hours after the vaccine, he suffered a massive heart attack due to a blood clot and a massive clot in the right arm. He went to the hospital and under went surgery at 12 am on Saturday. The coronary surgeon mentioned that this was not from heart disease as all vessels were clear. Rather, this was due to an embolism due to an unknown origin. A further work up concluded that he also had blood clots throughout his body (both lungs, one kidney, heart, liver, legs, arms, and possibly brain). By 12 p.m. we were asked back to the hospital as he was worsening. Treatment options included a heparin drip, which caused a brain hemorrhage. He was just at the doctors two times this week, on Tuesday and Wednesday and was fine no issues found. They went through with the 2nd dose and came to our home on Thursday.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was respiratory failure with hypoxia due to COVID-19 infection.

vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown. No concomitant medications were reported. No corrective treatment was provided. 28-Feb-2021, he was hospitalized for vertigo for 3 days. 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. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time. Further information has been requested.

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. 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.

I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.

Complained of chest pain at 3:50 pm may 15th. He went and layed down across his bed was coherent and talking, suddenly passed out. 911 was called and chest compressions were started. Ambulance arrived his condition was 60/40 bp and heart rate of 40. Taken to hospital where he never recovered and passed away.

Started with slurred speech, difficulty with balance, weakness on 5-1-21. Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness. Admitted to hospital and was diagnosed with stroke.

Presents to emergency department with complaints of intermittent chest pain for 4 days. Denies any radiation of his chest pain. He also complains of having leg weakness with trying to stand or ambulate x4 days. States that his legs feel like "gummy". Wife notes that the patient has to hold onto objects to aid in ambulation which is not normal for him. The patient denies any headache or dizziness. He denies any acute vision changes. He denies any numbness or tingling to his lower extremities. Denies any history of stroke.

Diagnosed with Afib. Tiredness,/fatigue for 3 days, palpitations, elevated heart rate 2 days in the hospital receiving intravenous drug treatment (don't know the drugs). Drug treatment got me to atrial flutter. Had to have a cardioversion to get back to normal sinus rhythm. Fine since then.

Blood sugar rose from 120-140- to consistently 300 -400 with normal meds. Unable to compensate with Insulin increase

Immediate chills and fever 101 degree out of work for 2 1/2 weeks morning fatigue and fever both knees/ inflamed could not walk loss of appetite severe insomnia chest pains went to hospital fear of heart attack

Went in to physician due to shortness of breath. Found pericarditis. The physician went in to do a pericardial window and the patient experienced bleeding so the surgeon had to perform a sternotomy to determine where the bleeding originated. Once the chest was opened the surgeon noted a mass that appeared to look like a fungus on the heart. Biopsy of the heart mass, pericardial fluid and a mass on the liver were performed. The biopsy results originally came back as adenocarcinoma of the urinary (bladder, kidneys) origin. The physicians noted that that would be highly unlikely since there were no tumors noted in the urinary area. Pathology was sent off again from the pericardial fluid that was obtained by "extracting RNA from tumor enriched sections. This pathology showed the cells to be squamous cell carcinoma with 90% probability of coming from the lung. The doctors are finding this very unusual . My husband was very healthy prior to this with no symptoms. Could this be caused by the vaccine?

Heart failure with reduced ejection fraction (15 to 20%) Atrial fibrillation with RVR at a ventricular rate of approximately 100 bpm.

Patient presented 5/22 with acute onset right sided weakness and aphasia, found to have left MCA stroke. He was last normal at 0200 and was found at 0600 when he was found by hi wife. He was not a candidate for tPA as he was outside of the time window once he arrived to ER. He underwent IR thrombectomy with TICI 2B, residual clot in the left A1 and left M3 vessels. He suffered a large territory stroke with malignant cerebral edema requiring emergent decompressive hemicraniectomy. He has been unable to be extubated thus far, as he is unable to protect his airway. He has severe aphasia and right hemiplegia.

Cardiac Arrest (38 days after second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was cardiac arrest (38 days after second vaccine). It is unknown if an autopsy was performed. It was reported that Lot number 023M20A was the only lot on the vaccination card. Caller was not sure if this lot is from first or second vaccine." Treatment information was not reported but it was reported "Paramedics were there at home and they could not resuscitate him." Concomitant medication was not reported. 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.; 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.; Reported Cause(s) of Death: Cardiac Arrest (38 days after second vaccine)

Had shortness of breath and admitted to hospital for blood clot/pulmonary embolism on 4/28/21 * Hematologist suggested I should report for information purposes. Not stating this is believed to be the cause of the event - just reporting as requested

Moderna Dose 1 3/5/21 (029A21A) Moderna Dose 2 4/16/21 (027B21A) COVID Positive 5/20/21 5/20/21: Presented to ED. The patient presents with fever. 61 year old male presents to the emergency department for a fever with an onset of 1 day. Patient was diagnosed with pancreatic cancer in April 2021. Patient states he has had 2 rounds of chemotherapy but states he could not have his 3 round last week because his white count was too low. Patient is also complaining of dull chest pain that is exacerbated with deep breathing, cough, and a headache but denies vomiting, diarrhea, neck pain, dysuria, hematuria, and nausea. Patient was diagnosed with blood clots on 05/09/2021 but states that he is not having similar symptoms to when he was diagnosed with blood clots. Patient is taking Xarelto. He has never had COVID but is vaccinated. Patient sees Dr. (Name) at the UI Oncology clinic. 5/25/21: 61-year-old male on chemotherapy for pancreatic cancer, also recently diagnosed pulmonary embolism on rivaroxaban, presents with 1 day of fever. Initially, did not have any cough or shortness of breath, was admitted to the hospital, where a chest x-ray, urinalysis and examination failed to reveal an exact source of the fever. His absolute neutrophil count was less than 500, so he was admitted for neutropenic fever. Cultures were obtained. IV antibiotics started. COVID-19 was tested and, surprisingly, came back positive. The patient has actually had both of his COVID-19 vaccines and basically, does not have pneumonia, shortness of breath, or hypoxemia. We did not use any medications for COVID while in the hospital, watching for any signs of respiratory compromise, but none developed. Blood cultures were negative. He was switched from ceftazidime to doxycycline at time of discharge. Will follow up with Dr. (Name) for his next cycle of chemotherapy. Because of his COVID-19 positivity, we will not schedule any immediate followup appointments, although the patient will call if he has persistent fever, dyspnea, or signs of hypoxemia. For the past 2 days, the T- max has been 99.9, and most the time 98.6. He was seen the day of discharge, doing quite well. Blood pressure 153/80, pulse 90, regular, oximetry 95% on room air. Glucose was 210. Discharged on Rivaroxaban 15 mg b.i.d., doxycycline 100 mg b.i.d., Robitussin AC as needed for cough, Lantus 28 units at bedtime, atorvastatin 80 mg daily, aspirin 81 mg daily. The patient did get 1 dose of Neupogen 480 mcg subcu while in the hospital.

on 4/12/2021 found to have severe elevated BP 180/80 range which persisted despite BP medications. On May 12, 2021 found to have elevated creatinine, potassium and decreased E GFR. Duplex ultrasound on the left kidney demonstrated renal artery stenosis to 80%+. After renal parameters were improved with fluids, left kidney artery was stented (X2) with resolution of the high BP. No clear etiology for stenosis was noted (no plaque, no clot etc)

Patient presented to emergency department around 7:00pm with signs and symptoms consistent with stoke. In the drive to the hospital, patient could not speak, move the right side of his body, and was drooling. Patient was immediately taken for a head CT and was diagnosed with a massive hemorrhagic stroke. The on call neurosurgeon wall called in the perform and emergency craniotomy. Patient underwent craniotomy and neurosurgeon was unable to find source or cause of bleed. Patient was sent to ICU for recovery. Patient was on a ventilator and receiving hypertonic saline for brain swelling. Patient never regained mobility in right side of body or speech. Patient tried rehabilitation, but patient's brain continued to swell with increase neuro-cognitive decline. Neurosurgeon was unable to determine cause of recurring edema and patient was not a candidate for repeat surgery. Patient failed rehab qualifications due to repeat brain swelling and was eventually placed in hospice care to pass.

After the second dose of Moderna vaccine I slept at night for about 2 hours and I was feeling muscle fatigue. When I woke up, my body temperature was 100.4 F. Around 10 am I went to the kitchen to prepare my breakfast. During this time I was feeling that my head was heavy. Then I start to feel that I cannot stay anymore and I sat down on my stool. I don't know what happened after that because I lost my consciousness. After that I found myself lying on the back of my kitchen floor and I was completely wet. Few minutes later my body temperature was normal 97.88 F and I started to feel much better.

DVT- developed leg pain and swelling for several days. Presented to ED for evaluation. Found to have RLE DVT

Cellulitis; Pain; oxygen saturation decreased; Headache; Chills; Pyrexia; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bypass surgery in July 2020. Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol and Hypertension. Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), LOSARTAN, METOPROLOL, VITAMIN D NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). 10-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen saturation decreased). At the time of the report, CELLULITIS (Cellulitis), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and OXYGEN SATURATION DECREASED (oxygen saturation decreased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: clear (Inconclusive) Clear. On 10-Feb-2021, Oxygen saturation: 92% (Low) 92%. On 10-Feb-2021, Pyrexia: 102 degrees (High) 102 degrees. On 10-Feb-2021, SARS-CoV-2 test: no results (Inconclusive) no results and inconclusive (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was injected on 08-Feb-2021. He began getting headache the afternoon of the 10-Feb-2021 and developed sever night chills by 11.30 pm the night of the 10-Feb-2021, along with fever of 102 degrees, body aches and pain. He experienced low O2 saturation at 92%. Though possibly unrelated the patient developed cellulitis at incision on left knee which was being treated with unspecified antibiotics. The patient was directed to and seen by urgent care facility. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

10 days post-injection, became very lethargic with discomfort in chest and shortness of breath. Reported to emergency room two days later, and admitted for cardiac tests, including echo and stress tests. Found to have high blood pressure, slight thickening of heart wall. Given prescription for high blood pressure and discharged next day. Subsequent follow up with PCP and cardiologist has focused on high heart rate and continued shortness of breath as of 6/11/2021. Condition seems to be improving, but slowly.

Racing heart, blood pressure drops feel clammy. 2 severe events many smaller events. Heart rate gets to near 100. My idle heart rate is in the mid 50's.

new A fib started on Eliquis 5 mg BID, carvedilol 6.25 mg BIDWC, amiodarone 200 mg BID, and aspirin 81 mg discharge home

Mini-stroke; Mini-stroke; Stroke; Blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stenosis. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN 81) and EVOLOCUMAB (REPATHA) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 09-Mar-2021, the patient experienced the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On 10-May-2021, the patient experienced the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was high). The patient was hospitalized from 06-Mar-2021 to 07-Mar-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with NITROGLYCERIN on 10-Mar-2021 for Hypertension, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), the last episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and BLOOD PRESSURE INCREASED (Blood pressure was high) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 06March2021 he was taken to the hospital by ambulance where he was diagnosed with having had a stroke. He was discharged home on 07March2021. The evening of 09March2021 he had a mini-stroke but remainded at home. Early morning on 10March2021 he had another mimi-stroke and was taken to the emergency room by ambulance. Patient states his blood pressure was high and he thinks he was treated with nitroglyercin but cannot recall the names of other meds given. He was discharged from the emergency room later that night of 10March2021. Patient declines to give me his full list of daily meds because that are too many 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. Other contributing factors were reported (concomitant disease). This case was linked to MOD-2021-209430 (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. Other contributing factors were reported (concomitant disease).

on morning after 2nd vaccination, 6/7/21, episode of acute hemorrhagic rectal bleeding. Presented to ED with hypotension requiring pressors, fluids, blood transfusion and ICU admission. Treated empirically for sepsis but more likely hemorrhagic vs hypovolemic shock and cardiogenic shock. Recovered quickly and discharged on 6/11/21

started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination; slept a lot after the shot; covid like flu symptoms; very weak/very weak feeling; terrible diarrhea; Zero appetite now for 3 days although eating once a day; no longer able to sleep at night; pain in my heart/pain moved from left side heart area and slid toward my left side; neck glands swelled last week/2swollen neck glands; very tired/very fatigue; Bad headache; chills (no fever); heart attack-like pain; lost 20 pounds of his body in the next 24 hours,weight was 184/185; sweat really bad/terrible night sweats; I had pain which I felt like was in the right kidney and lower right abdominal area; I had pain which I felt like was in the right kidney and lower right abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart attack-like pain) and POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after shingles vaccine. February 2020 second dose. October 2019 first dose.) on 24-Jun-2008. Previously administered products included for Shingles: Shingles vaccine in February 2020. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included HIV disease since 18-Feb-1988, Renal agenesis, Drug allergy (Allergy to Floriquins), Allergy to chemicals (Contrast dye allergy), Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhoea (Improved with daily morphine ER.) since 01-Oct-1996. Concomitant products included RITONAVIR, DOLUTEGRAVIR SODIUM (TIVICAY) and DARUNAVIR ETHANOLATE (PREZISTA) for HIV disease, AMLODIPINE BESYLATE, ACYCLOVIR [ACICLOVIR], PRAVASTATIN, FINASTERIDE, ABACAVIR SULFATE (ZIAGEN) and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185) and NIGHT SWEATS (sweat really bad/terrible night sweats). On 17-May-2021, the patient experienced ANGINA PECTORIS (heart attack-like pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area), ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)). The patient was hospitalized from 09-Apr-2021 to 14-Apr-2021 due to POLYURIA. On 10-Apr-2021, POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) had resolved. At the time of the report, ANGINA PECTORIS (heart attack-like pain) had not resolved, WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185), NIGHT SWEATS (sweat really bad/terrible night sweats), SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)) outcome was unknown and RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area) and ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. On an unknown date, Blood creatine: high (High) high. On an unknown date, Electrocardiogram: unknown (Inconclusive) unknown. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications included blood pressure medication. Follow-up received on 11-May-2021 included the completed ADR form with significant information about the patient's medical history and new events. Follow-up received on 12-May-2021 included additional details of lower abdominal pain experienced by the patient. The patient reported that he sought medical care from a doctor's office from 09-Apr-2021 to 15-Apr-2021. significant follow-up received on 03-june-2021 This is a report of a 61-years polymorbid male under multiple chronic therapies; who presented various adverse events after receiving the second dose of the product. For the event heart pain/angina pectoris, the patient was not hospitalized. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-073550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up included additional details about the adverse event reported in the initial SD of pain right side abdomen. On 03-Jun-2021: Significant follow-up added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

Fall due to weakness, severe myalgias, abdominal pain, elevated troponin, burning and pain in the lower legs and feet.

3 days after vaccine, patient started getting petechial rash to legs and then multiple bruises to thighs. Took him some time to seek care but was found to have thrombocytopenia. with Platelets as low as 20. Required admission to the hospital, platelet transfusions/IVIG/ and long term steroid course. Still undergoing treatment but is recovering.

Chest pain down right arm into right hand, radiating down into abdomen. Symptoms started 0800 hours 06/17/2021. Symptoms returned 06/18/2021 at 0600 hours. Emergency Department visit Dx: STEMI Treated with IV heparin and metoprolol

I had severe pain in my lower side of my sternum and my ribs and progressed to my spine. My blood was very low at the time.

On June 1, I was hospitalized for pancreatitis although I had none of the preexisting conditions for it such as a history of drinking alcohol or anything else that the hospital could find. Next on June 16, I began feeling lightheaded. I went to an internal medicine doctor who referred me to a specialist. After some testing, Doctor informed me that my heart was beating lower than the normal range. I just had a heart stress test done a few years earlier and my heart was more than fine. It is hard for me to understand how my heart health could have such a dramatic reversal so quickly.

Pt was vaccinated on 3/31/2021. His long time partner reported that he started feeling a little off 2 days post vaccination, he thought he had indigestion. Over the next few weeks he began feeling worse especially with exertion. While at work on 4/19/2021 he told his friend that he hadn't been feeling well for 3 weeks. Shortly after reporting this he went into Cardiac arrest. He was transported to Medical Center, where he was pronounced dead. His partner reports he was healthy with the exception of hypertension. She reports he was thin, never smoked, didn't drink alcohol and rarely used marijuana. She reports only a visual autopsy was performed and pt was cremated.

I had server chest pain. Slight SOB called 911 because of previous heart attack. They took me to the hospital. They did blood test, Chest x-ray, CT scan, Covid-19 (nasal and blood) and MRI. Covid-19 test came back negative. They told me it was not a heart attack. They said it might have been anxiety or tissue got stuck under rib. They did keep me overnight for observation.

developed afib after 2nd shot, treatment on going, doctor has prescribed metoprolol, and zeralta, still experiencing afib daily

Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few days of ok and then walking up my 3 stairs to my house, i got dizzy, my eyes went black and white abd squiggly, instantly massive headache, and stomach aches, my bones hurt thruout my torso... ongoing headaches, Tired all the time, my eyes are blurry alot, Very shaky all the time, loss of appitite, brain fog, back aches

My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila

rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; 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, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

Confirmed that pt passed away 3/13/21, 5 days after 1st covid vaccine. Per relative who rec'd the autopsy report, pt had no obvious health problems prior to death, was a smoker, but otherwise very fit and active, healthy eater. On day of death, pt had gone hiking for a few hours on a camping trip, they were sitting around eating dinner and pt said he had to go to the bathroom and never came out. Pt's family feel sure something was triggered by vaccine. Relative I spoke to retrieved the autopsy results during the call and read them on the phone as they were reported on paper. Final dx on autopsy was: I. atherosclerosis, generalized, severe. A. Atherosclerotic coronary artery disease i. atherosclerosis, coronary arteries w/ 75% occlusion of LAD, 90% occlusion of L obtuse marginal and 80% occlusion circumflex coronary artery. a. Ruptured acute myocardial infarction, transmural, posterior left ventricle i. cardiac tamponade ii. hemopericardium 350cc COD listed as: ruptured, acute MI d/t atherosclerotic coronary artery disease, tox report was clear.

61 yo man with HLD and a family history of premature CAD, who recently underwent a total knee replacement for osteoarthritis, and has been experiencing exertional chest pain with rehab. He was sent to the ED by his PCP, where he ruled in for an NSTEMI. An Echo demonstrated and LVEF of 40-45% and both anterior and apical hypokinesis. He underwent cardiac catheterization today and was found to have MV-CAD. An IABP was placed and he was referred for CABG. He is now symptoms free and stable hemodynamically.

Death caused by probable cardiac arrhythmia on May 10, 2021. No previous heart symptoms. Had the normal reaction to the second dose (body aches, chills, low grade fever), but was recovering as of April 19. First dose was administered 3/21/21. Second dose was administered 4/18/2021.

Chills, low fever for two days Episode of Tachycardia that required hospitalization; symptoms continued to persist for 4 months. Symptoms remain but at much lower intensity

Cerebral venous sinus thrombosis Symptoms - daily headache that started around 7/11/21 which is about 10 days after first dose of the vaccination

Intermittent HA x 1week- ER found extensive dural sinus thrombosis involving the superior sagittal sinus, torcula, and bilateral transverse sinuses, right cortical vein thrombosis overlying the frontal convexity on CT Head with Contrast seen 7/17/21 in hospital

PATIENT PASSED OUT IN THE ARMCHAIR IN THE OBSERVATION AREA OF THE PHARMACY A FEW MINUTES AFTER RECEIVING THE FIRST DOSE OF THE MODERNA VACCINE. 911 WAS CALLED IMMEDIATELY. PATIENT CAME ROUND AFTER A COUPLE OF MINUTES AND SAID HE FELT LIKE THROWING UP BUT HE DID NOT THROW UP. HE WAS SWEATING AND WAS GIVEN SOME TISSUES. HE SAID HE DID NOT NEED AN AMBULANCE AND LEFT JUST AS EMS ARRIVED.

Heart attack; Irregular heartbeat; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old male 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. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat). The patient was hospitalized on 24-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Beta blocker (unspecified) and statin (unspecified) for an unknown indication. Treatment included few stents inserted for the heart attack. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High. Concomitant medication and Treatment medication use was not provided by reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21. He is now a hemi-plegic with severe apraxia and aphasia, unable to work, communicate or care for himself. He had no health issues prior to the vaccination. He was in ICU, Intensive care and hospital for 2 months and rehab continues.

whole body muscle aches, chills, fever over 101, light headed/dizzy (fainted), fatique, some nausea. all disapated within 48 hours of getting shot

rib pain/shortness breath/Pulmonary Embolus and viral pneumonia Narrative: Development of symptoms beyond the 48-72 window. Tested at time of ER visit Negative for Covid. Repeated Covid NP swab on 01/05/2021. Was not hospitalized overnight discharge home on oral anticoagulant medications.

At work 24 hours after vaccine administration - Lip swelling, jaw swelling increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.

1/18/21 6 PM left arm soreness, took tylenol. Patient states that he started having chills, muscle aches, Patient states that he started having fever of 101 degrees Fahrenheit, dizziness, and tachycardia 1/19/21 at 8 am. Pt. states he took tylenol at 8 am and heart rate and tachycardia improved and dizziness improved as well. Pt. states that he feels good now, but feels like his covid symptoms are light with a cough. Pt. states that arm is still sore.

Systemic: Fainting-Medium, Systemic: Other- Pt felt sob and went to go get help, he fainted a while after. When EMS arrived he was feeling better, and was left at the facillity. Pt awaiting pacemaker, may have underlying condition. Symptoms lasted 1 day

Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.

Patient reported severe increase in blood pressure from evening following the vaccination (day1) through the day after (day 2). Blood pressure reading about 180/110. Upon following up with patient on day 3, patient stated blood pressure returned to relative normal reading.

a 62 y/o M who presents with concerns for an allergic reaction to the second dose of the Covid vaccine. According to him he got the vaccine around 8:45 AM. He has a history of anaphylactic type reactions with a swelling and urticaria in the past but has not had any symptoms in the last 5 years. He felt sudden onset pit in his stomach, tingling and warm sensations over his face and some chest tightness. He denies all the symptoms currently. He did get medications prior to arrival but states his symptoms were already getting better before he been given anything. He was given epinephrine as well as Benadryl beforehand. He denies any symptoms currently. Denies headache, change in vision, difficulty swallowing, lightheadedness or vertigo, chest pain, sore throat, wheezing, cough, nausea or vomiting, rash, falls or injuries. Denies any recent foreign travel or sick contacts. He did work a full shift yesterday and was coming off a 24-hour shift prior to getting his vaccination. He denies any significant reactions to the first vaccine. Medical Decision Making On initial presentation is an overall well-appearing 62-year-old male who has normal vital signs without fever or tachycardia. He is presenting with concern for allergic reaction of the field to a recent vaccination. The vaccine was given roughly 1 hour prior to arrival. He was given epinephrine intramuscularly as well as IV Benadryl. He states he is currently feeling mildly tired from the Benadryl. He denies any other recurrent symptomatology and feels better. Examination is not concerning for anaphylaxis at this time, no evidence of airway involvement or multisystem involvement. No evidence of local allergic reaction. Low clinical concern for occult infection, metabolic abnormality, ACS or arrhythmia for a cause of his symptoms. He is overall very well-appearing. Labs have been obtained as part of screening for reactions to the vaccination per CDC recommendations including a tryptase and C4 complement. They were drawn over an hour after the vaccine was administered. ECG was within normal limits. After observation patient remained asymptomatic. Did offer steroids, however he wanted to hold off on them as he just got his vaccination which seems appropriate at this time. He was sent home with a new EpiPen. We also gave him follow-up in the allergy clinic. He has any worsening symptoms we do recommend he use the EpiPen as well as call 911. He is understanding. At this point he stable for outpatient management. I did tell him he should expect to feel aches and potentially have inflammatory response to the vaccine, he is understanding of this. Pt was discharged home/self-care. Pt provided strict return precautions, including but not limited to, any worsening symptoms or any new concerning symptoms. Otherwise, Pt instructed to see PCP on an as needed basis.

Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable. CPR initiated, Ambulance summoned. Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired.

Patient has had numbness and tingling both arms, weakness of legs and fatigue since 2 days after his Covid Vaccine Jan 6th. Has had 2 syncopal episodes since then. Had a syncopal episode Feb 15 and again 2/26/21

Lt shoulder pain moves across chest , multiple joint pain, sensation he was dying, blood sugars 275-280

Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.

Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue

03/15/2021: Presented to the emergency department for atypical chest pain and GERD. Patient admitted for observation and discharged the next day. Troponin was negative three times, and heartburn resolved with GI cocktail.

Patient reports racing heartbeat, diaphoresis x 2 days, reported to hospital with a HR of 75, but was instructed by Hospital for patient to have VAERS filled out.

3/16/2021 - 6 PM lower left arm lite tingling, at 8 PM blood pressure dropped from 80 to 61 bpm (111/64), at 9 PM now left arm and left side of face lite tingling. 3/17/2021 - Still lower left arm and face has light tingling. 3/18/2021 - 3:40 AM felt nauseated. Took a Tum. Now at 1:40PM the tingle is stronger on lower left arm and left side of face is slightly numb.

Patient is a type 1 diabetic that went into diabetic ketoacidosis. Patient has never gone into DKA and is requiring hospitalization because of this. Patient possibly had an NSTEMI as well.

drive through setup, within minutes after injection, began to feel tingling in forehead which moved down my body. Between 5-10 minutes after injection, I just passed out (don't recall that happening). Woke to 2 EMT's by my side asking to check my blood pressure.. I don't recall the numbers however they stated I 'bottomed out'. shortly after gaining consciousness, I became nausea loosing contents of stomach twice. Remained under observation for 30+ minutes, then wife drove me home. Slept until 5:00 when I was steady enough to walk unaided, and finally eat some dinner.

Patient fainted about 5-10 minutes after receiving vaccine. EMS evaluated, patient left and drove home.

Pt developed a RT Leg DVT Deep Vein Thrombosis and Pulmonary emobolus. Started haveing symptoms of dyspnea. , low oxygen saturations in the 80s and RT pleuritic chest pains one week after getting the shot. He had never had a DVT or PE before. Was seen in Emergency on 03-23-2021 . He was admited on 02-23-2021. Started on anticoagulation and went to the cath lab to have intraarterial administration of TPA in pulmonary arteries.

contact dermatitis; significant rash which is very itchy; bruise; Afibrillation; A Spontaneous report was received from Consumer concerning 49-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and afibrillation, noticed a significant rash which was very itchy on his hips where he got a bruise, stated his wife thought it was contact dermatitis. The patient's medical history was not reported. The concomitant medication included Zoloft, Aspirin, Fish oil and Vitamins. On 11 Mar 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 038A21A, Expiration date: not provided) via intramuscular route in the right arm for prophylaxis of COVID-19 infection. On same day, patient experienced afibrillation which was resolved on 13 Mar 2021. On 15 Mar 2021 he noticed a significant rash which was very itchy on his hips where he got a bruise and he stated his wife thought it was contact dermatitis. Action taken was unknown with respect to events. The outcome of other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

3/25/21 developed chills, muscle aching, diarrhea evening of vaccination--symptoms continued for 48 hours with poor appetite/nausea. lost 4 pounds over the next few days. 3/28/21 c/o dizziness, heart fluttering/irregular. 3/30/21 saw dr, and EKG showed afib. medication changes. 3/31/2021 repeat EKG a flutter. admitted observation to hospital. NOTE: Does have a history of episodic afib/flutter--no episodes for the last few years

Fast heart beats in 2nd and 3 rd day afternoon around 2:00 PM and lasted 1-2 hours each afternoon. In 2nd afternoon, it was severe enough that I had to rest in bed due to precautionary measures.

Sudden onset of chest pressure with weakness and numbness in hands and legs. Systolic blood pressure on presentation to the ED was 235, indicating hypertensive emergency.

patient had a fever for 24 hours, increased heartrate for 24 hours and a tingling that started around the injection site and traveled to his elbow and down to his fingers. He also had a tingling on his left leg. This tingling started about 24 hours after the shot and is still continuing to occur. The tingling is only on his left side which is the side of his body that received the shot.

Patient reported feeling lightheaded and his ? heart felt like it was racing? Patient seen by medical team and provided water Patient?s symptoms resolved and refused medical transport and signed AMA form Patient will be driven home by spouse

Temperature 101, Shivers, headache, body ache. Lasted about 36 hours. It also spiked up my fasting sugar level in the 190 range for a few days and it is slowly coming down over a period of 2 weeks.

After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination . I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand. At that point, 7:00am 03/23/21, my wife drove me to the ER. I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.

I received my first dose on March 2nd and my second dose on March 30th of the Moderna vaccine. Both times about 7 days into each does I started noticing heart palpitations. I do not have any heart disease except controlled HBP. After the first dose, they started and were happening often and was concerning ? then they stopped after 5 days right before my scheduled second shot. Now after my second dose they have started again a week after the dose.

Chest pains, shortness of breath, started 24 hours after 2nd injection, has continued for past 5 days

Strong fatigue and accelerated heartbeat the evening of the shot. The following day, my pulse was racing at 153 BPM shine in the shower. After resting, laying down, the lowest it would go is 11 -107 BPM. We decided to go to the emergency office. I got an EKG, and by that time everything had slowed down and looked fine. A headache persisted. I've never had a resting pulse that high before. It was weird.

Dose was injected into left arm approx 1:30 on 4-8. Resumed normal daily activity including rigorous 1.5 hrs of tennis from 18:00-19:30. Left arm was a little sore, but no other adverse effects of vaccination. At approx. 01:00 on 4-9 I was awoken by what felt like severe chills with elevated heart rate. I tried to walk around my house to see if that would ease the symptoms, it did not. About 01:45 I started drinking a Brisk ice tea. That helped & allowed me to fall back asleep. Felt sluggish all day 4-9 with flu-like body aches & pains, so stayed in bed most of day. On 4-10 I resumed my normal activity level.

patient reported dizziness, near syncopal episode and body aches. Dizziness still present 6 days after administration.

Patient woke up the morning of 04/13/21 and explained to his wife that he felt "foggy" mentally. He went about his morning chores on the farm. He came inside to sit in his recliner with his feet elevated for almost an hour. At approximately 9:40 am, his wife observed that patient suddenly stiffened without warning and cried out. His arms stretched over his head in the chair and his legs stiffened like a board. His body was visibly contracted. He continued to cry out. His eyes were closed, he was salivating, and his forehead was sweating. His wife watched him move his arms suddenly to his lap, however, his fists were clenched tight. She tried to get his attention by calling to him. She noticed his lips were turning blue. She continued shaking him, shouting and then slapped him. Patient did not respond. She called 911. After 7 minutes, he finally relaxed some and started snoring loudly in the chair. He continued sleeping soundly for about 10 minutes while she waited for EMS to arrive. The wife did elevate his head , as she was told by 911 to do so. She was not able to wake him up during this time period. When the EMS arrived, he was just starting to move. They got him up to stand and he was able to verbalize his need to go to the restroom. They arrived at the hospital at approximately 10:25 am and was released after testing at approximately 2:30 pm.

death Narrative: Patient received Moderna Covid #1 on 3/11/21 in his home by nurse. On 3/25/21, a note was entered to indicate that is wife had called EMS the day before as "his heart stopped" and he passed en route to the hospital. No further details available. No autopsy results available. 13 days between date of vaccination and date of death.

I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce palpitations, the week prior and during the day of the stroke. I tried to take Flecainide twice before in the past few months, but I was unable to tolerate it. When I had the stroke, I didn't realize I was having one since I'm in very good health. I emailed my electro-cardiologist about my symptoms that day and found it difficult to use the appropriate words and reading the email later, I could see a number of mistakes. My ability to comprehend spoken language that day was impaired. I could only keep a few sentences in my head at a time and my attention span was poor as well, like having significant ADHD, which I don't have. I was unable to retain simple amounts of information the day of the stroke. I didn't seek treatment on the day of the stroke since I felt it was more of the side effects I had been experiencing from Flecainide. After going to the hospital I felt good and much improved, cognitively. An ER neurologist said that my stroke was a 2 on a scale of 1 to 42. Over the remainder of March and until this day (April 16, 2021), I have made steady and rapid improvement. I attribute my recovery to the lower level of stroke damage and the fact that I worked out every day with physical exercise and I worked out cognitively by doing a series of activities that I chose myself: reading out loud, reciting poetry and tongue twisters, playing logic and puzzle games on the PC, returning to my writing tasks for work, practicing grammar, and speaking at length with family and friends as a way to practice speaking. I had one appointment with an occupational therapist and two appointments with a speech therapist and have completed assessment. I now feel I am nearly completely recovered with an odd sense of some improvement in certain areas such as heightened mood and quicker connections for noticing practical matters.

major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse effect. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported. The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.

Within 5 to 10 minutes felt flushed, then a head rush. Got worse to the point where I was blacking out. Slumped in my chair grasping the sides holding on. Informed the person that gave injection that I might pass out, she said that I could sit there until I felt ready to go. Took deep yoga breaths while grasping on the chair hoping I would not pass out fall and crack my head. It slowly subsided. She kept saying I could go when I felt better. Really! I finally left after 30 minutes. Sat in my car with windows open for another half hour. Felt better as the day went on, slept well and felt better the next day.

On 4/6/2021 woke up with severe left muscle cramp in left leg. Next 3 to 5 days tried massage, ice, compression and Motrin - no relief. Did no treatment for the next couple of days. Went to primary care doctor and then got an ultra-sound on 4/14/2021 at clinic - by Doctor. Results showed had three blood clots in left leg. Started on Eliquis that day.

Extensive DVT requiring surgery. Received second Moderna vaccine approximately one week prior to admission, presented with acute onset of left leg swelling and pain. Left lower extremity ultrasound demonstrated an extensive deep venous thrombosis extending from the common femoral vein into the peritoneal and posterior tibial vein with a patent IVC. He was given a treatment dose of enoxaparin and admitted to the hospitalist service. Overnight he developed diminished sensation in his toes and vascular surgery was consulted. On 3/31/2021 he underwent mechanical thrombectomy of the left superficial femoral and common femoral veins as well as stenting of the left common iliac vein stent. Of note he was noted to have May Thurner physiology with compression of the left common iliac vein by the external iliac artery on the right. Post procedurally the patient's swelling and edema was significantly improved. He did not have any significant pain or difficulty ambulating. On postoperative day #1 he was evaluated and found to be hemodynamically stable with improvement of his symptoms and stable for discharge home. Prior to discharge it was discussed with the patient that he will need to be on a loading dose of Eliquis for 7 days, followed by a maintenance dose of 5 mg twice daily. No h/o COVID.

On 3/4/21 noticed my left calf was swollen. I did not think much of it at first. A week later the swelling had progressed to include my ankle. Saw Dr. and ordered an ultrasound on both of my legs. Right leg was normal & left lower leg had a clot(s) in it. Dr. ran blood work then prescribed Eliquis. Saw him in follow-up on April 14. Swelling down but not gone. Renewed the prescription for Eliquis and set a followup visit for Friday June 18. He ordered additional blood work to be drawn on Wednesday June 16 to have results at the next visit.

Vague RLE discomfort 3/16/21-4/4/21, DVT RLE greater saphenous vein discovered in the ER 4/9/21. He is on eliquis and may need to continue this for his lifetime given this is a second thrombotic event

62M with complex medical history incl IDDM, CVD, stroke and hx of allergies to oral meds and anaphylaxis to multiple foods (peanuts, monosodium glutamate) requiring evaluation for reaction to first dose of moderna vaccine. Does not carry epi pen with him though he has been prescribed one in past. Vaccine administered 10:02am. Immediately after vaccine patient reported dizziness that persisted for about 60 min. He reports similar if less severe dizziness after flu vaccine one month ago and that he often feels dizzy after taking his morning dose of nortryptiline which he took today. Symptoms evolved to include mild nausea, feeling that abdomen was "shaking", and headache. No SOB or chest pain, feeling of throat closing, or rash. Patient AO x 3 throughout evaluation and talking throughout. Fasting BG 234. Took basalglar 40u this AM and 5 of aspart. Drank 8oz chocolate milk 9:30am which is his typical breakfast. He notes that his home BP this past week was elevated into SBP 170s though typically is in the 120s/70s without antihypertensive medications. Prolonged dizziness and hyperglycemia (454). Regular insulin 5u SQ administered. Patient symptoms after 60 min. Repeat BG essentially unchanged but patient symptomatically back to prevaccine baseline. Discussed with ID on call. Plan for transport to SMMC lab for CH50 and tryptase with instructions to patient to repeat in more than 24 hours (to establish a baseline). Patient given strict ED precautions.

Initial presenting symptoms upon awakening four days after his shot were muscle spasms, "felt things in his chest," and dark urine. Within 48 he was confused and was unable to state his last name, which progressed to unresponsiveness by ~7 days after the vaccine. He has since become comatose and his brain MRI is notable for hyperintensity involving the deep gray nuclei as well as the periventricular and subcortical white matter diffusely, bilaterally. The etiology of his comatose state is still under investigation, but a detailed infectious, autoimmune, and malignancy work up at 2 different medical centers and have since been unrevealing as to alternate causes.

63-year-old male who complains of sudden mid upper back sharp tightness pain sensation worse with inspiration unlike pain ever felt before that occurred while he was exercising on the rowing machine earlier today. The patient denies any injury or fall and he does not take any anticoagulation therapy.

Second Dose Side Effects A fast heartbeat Dizziness and weakness Fatigue/tiredness Headache Muscle & Joint pain Chills Fever Nausea Vomitting Diarrhea Abdominal pain Lost OVER 20 lbs from starvation, inability to eat for 5 weeks, this skyrocketed ALT and AST.

I woke up at 3:10 am feeling cold and chilling. I took by temperature and it was 98.4. I normally have a temperature of 97.1 - 97.7. I take it daily multiple times. My hands were cold. When I got up and started moving around I didn't have any more chills. When I got up at 6:30 am. I just didn't feel well in general. Slight feeling of sniffles, congestion. I would get some aches that went away in a few seconds. They were at various points in my body, knee joints, muscles, and my head. They were simply a nuisance. I felt tired all day. My blood pressure was up 15-20 points on both numbers during the day. I've told my doctor when my blood pressure is higher, I'm having more aches and pains as though I'm fighting a virus. I tolerated the symptoms most of the day, letting my immune system try to work it out. My symptoms seemed worse at 5:45 pm, so I took two ibuprofen. My temperature was 98.9 at that point. The highest it's been. All my symptoms got better until 1:15 am. I woke up feeling like I was chilling, but not as bad as yesterday, so I took two more ibuprofen. I feel 50% better today and haven't taken any ibuprofen. Here is the really strange part. I had these exact symptoms and similar temperature ranges twic last year. In July and October I think. I didn't get tested last year because they were minor symptoms. They were just nuisance symptoms. I took ibuprofen right away last year. I followed the masking guidelines, social distancing, etc. So, is it just coincidence I had similar symptoms last year two times, that I had when I getting the inactive Moderna vaccine? I had no reaction to the first shot. I just wanted to provide the information in case it is helpful. Very strange. I expect no other symptoms in a couple of days.

The vaccine was given outside of the system (? county program). Patient's daughter thinks diffuse or migrating arthralgias started about 4 days after the vaccine was given. He visited ED on 3/09 complaining of pain in multiple joints for 3 weeks. No labs were done then. He returned 3/19 with difficulty walking and talking, was sent to SNF after MRI with diagnosis (probably incorrect) of acute cerebral infarct. He returned to the ED on 3/29 less alert, and no longer able to speak. LP showed 10 WBC (mostly lymphs) and protein 70. MRI was repeated, looked similar to previous scan , but reinterpreted as diffuse cerebritis, worst in basal ganglia. By 4/02 he was deeply obtunded ... (cont. on next page)

Red itchy "rash" on underside of right arm. 3 days after 2nd covid19 Moderna injection. Slightly elevated heart rate over normal?

I was typing in this section when I was timed out due to "inactivity". Pls change your definition of "inactivity". I do not believe that I will be able to duplicate what I previously wrote before being timed out. I will do the best I can. To the best of my recollection and ability. NOTE: Automatic Wrist BP readings (also takes pulse) closely follows manually-taken Stethoscope Sphygmomanometer readings. 4/22/21 Doing active range of motion pre and post injection. 7:45pm Signs & Symptoms (S/S) Mild - arm discomfort w/swelling, fatigue, lightheadedness, and body ache. Ice- alternating periods of 15 minutes on, then off - done several times. Lessen arm discomfort, no redness noted. Slow increase S/S through night. 4/23/21 mid afternoon- marked increase S/S plus start sporadic flush feeling, noted 1 x 1 inch oval red area over site. 8pm- Increased & more constant flushed. Temp 98.9 F. Noted marked increase body ache, first moving across chest, then descending to both toes/feet. 9pm- Temp 100.4 F. Monitoring temp, hoping peaked. 9:30pm 99.9 F- 9:50pm Felt very dizzy, self-palpated pulse- felt weaker than my normal, noted more distended veins on arms. Asked wife to get pulse oximeter- sat/pulse ranging 93-97, depending on finger, hand, how long on each; noted amplitude lower than my normal; 82-86 range pulse. 9:53pm Obtained BP R wrist supine 105/61 Pulse 82. Felt too dizzy for BP to be done in sitting. BP confirmed by second reading. BP wrist supine sys about 30 -35 & diastolic about 10-20 below baseline. 9:56pm Took 1000mg Acetaminophen. 11pm Temp less than 99, marked decrease head to toe pain, more towards my mild lightheadedness at times due to my mild TB baseline. Able to ambulate. 4/23/21 4-5 am Temp low 98 range (more my normal). 7am BP L wrist supine 135/70 Pulse 69. Sat 98 reading obtained very quickly, pulse amplitude more my normal. Feeling better but not to Pre-vax. Repeated BP & Sat readings twice during the rest of date. Don?t recall time of 1st BP 135/70 Pulse 70 & Sat 96/Pulse 69, noted injection site redness. 9:30pm- started having headaches, pain on L side head (near site of my head wound/mild TBI site), slight increase lightheadedness, injection site red area increased in pain & size to covering almost full deltoid area. BP 125/73 Pulse 65 Sat 97/ Pulse 65. Both Sat numbers obtained very quickly, as per my normal. Ice used. Alleviated pain to tolerable. Monitoring size of red area & intensity/duration of lightheadedness. Recall a strong tingling sensation going down my left arm once. Noted change in sensation afterwards. Slight increase lightheadedness felt due to what usually happens in change in weather, like rain coming. Rain occurred. 4/25/21- Basically the peripheral of deltoid showing redness with some scattered redness centrally. At 8pm redness fully covering deltoid area. Will continue to monitor ("Covid arm"). Other than fatigue thought due to vax, NO S/S of markedly reduce platelets. If need be, will contact Teledoc. Have prior training as a respiratory therapist & occupational therapist.

I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood pressure, a little dizziness and weakness.

On day 4 following dose 2 of Moderna series, pt developed fever, chills, fatigue, malaise and self-medicated with ibuprofen and acetaminophen. After a "few" days of feeling unwell despite treatment, presented to ER and was found to have AKI, hyponatremia, and thrombocytopenia. Over the course of several days rapidly deteriorated and developed MSOF, including liver failure, DIC, respiratory failure requiring intubation, and shock requiring pressors. Workup for VTE, including V/Q scan, LE dopplers, and head CT negative for thrombosis. Ferritin was found to be highly elevated (12,000) suggestive of hemophagocytic lymphohistiocytosis (HLH). Per ER report, marrow positive for hemophagocytosis on smear. At time of report, transferred to Cancer Center for HLH treatment, currently in ICU, intubated, sedated, and on pressors. PF4 antibody pending.

Heart arrhythmia; Blood Pressure went up to as high as 230-220 over 160-130.; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart arrhythmia) and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL, SOTALOL, POTASSIUM CHLORIDE (KLOR-CON), APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced ARRHYTHMIA (Heart arrhythmia) (seriousness criterion medically significant) and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart arrhythmia) outcome was unknown and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Blood pressure measurement: 220-230 over 130-160 (High) 220-230 over 130-160 and 111/60 (Inconclusive) 111/60. On 18-Apr-2021, Electrocardiogram ambulatory: abnormal (abnormal) showed premature ventricular contractions. Patient reported that his usual blood pressure was around 140/78-84". His doctor advised him to go to the hospital. He was given clonidine in the ER and his blood pressure dropped to 111/60. The caller was also hooked to a Holter monitor and it showed PVC. Once the blood pressure went down, he was sent home. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient reported to his primary care provider, Dr, on or about 4/2/21, that he was experiencing swelling in his left arm. He was advised that he could be seen in the office the following Monday, 4/5/21, or may report to the nearest emergency department. He opted to wait until 4/5/21, and was evaluated in the office. Dr's staff reported to the pharmacy that a Doppler was ordered for patient, which revealed an "acute DVT in the left proximal / mid-subclavian vein and axillary vein", and it was suspected that the Moderna 1st dose may have been related. Pharmacy was contacted by the County Health Department ( nurse), and staff from County Office of Epidemiology , and instructed to obtain further information from Dr's office to file this VAERS report. Pharmacy was NOT able to successfully contact patient for further clarification on medications/prior conditions/allergies, as calls were not returned prior to completing VAERS report.

Patient admitted with left sided weakness on 4/21/21. First covid-19 vaccine (Moderna) received on 3/23/21. MRI/MRA shows acute infarcts of the right caudate body and striatum. H/o HTN, hep C with cirrhosis, COPD, tobacco abuse, alcohol use disorder, GTC seizure disorder. ECHO on 4/21/21 which was normal. Patient thought to be actively overusing alcohol at home. Patient was treated for stroke and discharged on medications to help with alcohol withdrawal symptoms (clonidine, gabapentin) as well as aspirin, plavix, and atorvastatin for new stroke. Thrombocytopenia noted (platelets 50K), however patient?s platelets have historically been low likely related to alcohol use. Per hospitalist discharge summary, low suspicion for vaccine induced thrombocytopenia. HIT Ab test ordered on 4/21/21, resulted negative. It seems to be coincidental that stroke occurred about a month after patient?s first covid-19 vaccine but reported to VAERS for completeness. Did not add covid-19 vaccine to patient?s allergy list. Patient received second covid-19 vaccine (Moderna) on 4/28/21.

On Friday, April 9, 2021 PT received the second Covid shot. The shot was administered in the right arm. About 6:00 pm on that same day significant pain started, affecting his right arm, elbow, shoulder , and chest. By Monday 4/12/2021 the pain was so severe he went to a local clinic to get checked. He was prescribed Naproxen for pain. He was still in so much pain on Tuesday 4/13 /2021 he went to the ER . They took him immediately back to check for possible heart attack and blood clot. After a stay of 6 hours the tests came back that there was no heart attack or a blood clot. He was prescribed more pain medication. Still not getting any relief from pain and now PT's fingers are going numb, PT went to See Dr. on 4/15/2021. Dr. determined that the shot had somehow effected the nerve endings. He gave him a dose pack of steroids by pill. He told him to check back if not better in a while. The week of April 19 the pain eased up through the day to around a level 3, to only return at night to a level 10, resulting in more loss of sleep. PT went back to Dr. on Friday, 4/23/2021 and received a steroid shot in the hip and a prescription of Gabapentin. The Dr's opinion was that it could take weeks to get better, and discussed getting a referral to a neurologist. Today is Thursday, April 29 and PT's pain is still constant through the day at about a level 3-4 , but at night the pain level is severe.

Patient arrived to clinic in no acute distress for his scheduled vaccine. Shortly after receiving vaccine today he reported feeling faint, ERT was called and his BP was found to be low (90/60) all other vital signs were stable. No loss of consciousness, dizziness, fever, chest pain, sob, or rash. It was recommended by ERT MD that the patient go to ER, 911 call was offered by patient and family refused.

Bloody nose x 2, blood blisters inside mouth including tongue, cheek, and lip. These symptoms showed up on 04/23/21. Went to the dentist on 04/24/21 due to having tooth extraction on 03/18/21. Dentist confirmed that had healed completely and recommended getting blood work done. Went to Urgent Care had blood drawn, report showed ZERO platelets. I was sent to ER where they ran a blood test again, platelets were ONE. 2 bags of platelets were infused, that brought platelets to 5. I was then admitted to the hospital and four hours later platelets were down to 2. They infused another 2 bags of platelets. Blood test showed platelets at 10. Four hours later the platelets were down to 4. On 04/25/21 I was diagnosed with ITP and was given an infusion of IVIG, on 04/26/21 my platelets were up to 16. They infused another IVIG on 04/26/21 and on 04/27/21 platelets were at 41. I was discharged on 04/27/21. Went to clinic on 04/29/21 and platelets were at 130.

Patient developed left leg swelling and pain. Ultrasound performed showing superficial thrombophlebitis of L posterior tibial vein.

I cannot confirm the type of vaccine the pt received as it didn't occur in our health system. Pt experienced out of hospital cardiac arrest a few days after vaccination. Pt resuscitated; however never regained consciousness. Coronary angiogram revealed normal coronary arteries.

6 days later pain in chest, next day went to lung, called the Ambulance. Admitted to the hospital, on 2nd day transferred to another hospital 4th day, went to arm. Released from the hospital after 7 days in the hospital. Still have numbness tingling and pain in the right arm. Going to have EMG today.

On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21.

Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.

Recieved obituray on patient. Called pt. ER contact and she stated that she was unaware how patient died. Pt. died at home but states that pt. had been having flu-like symptoms in bed with chills after vaccination. Pt. ER contact is unaware of pt. medical history or current medications. Pt. ER contact that pt. PCP was not us but another medical facility. Called funeral home and spoke to employee and she stated that the coroner cause of death listed was acute MI. Employee stated that she does not have a certified copy of death certificate at this time.

Developed signs and symptoms of left posterior thalamic stroke with sensory loss and pain. Began approximately 10 hours post injection and has persisted since that time.

Persistent fever began on 4/6/21 and persisted until diagnosis of acute pericarditis with pericardial effusion on 4/24/21.

Began as low grade fever and night sweats on 4/5/21. After two weeks began having difficulty breathing, and fever reached 102°F and was more constant. Pulse rate increased by almost 50% over 2-1/2 weeks. On 4/23/21, after 2-1/2 weeks of increasing fever, pulse rate, and breathing difficulty, pulse rate shot up past 200 so I went to the ER. Kept in ER for 4 days, was on oxygen for first 3 days. Diagnosed with Pericardial Effusion caused by Viral Pericarditis. Treated with anti-inflammatory medications. Have had two more SVT (SupraVentricular Tachycardia) episodes since; had to go back to ER for one of them Slowly recovering over several weeks.

Patient c/o sudden onset of lightheadedness f/b syncopal episode 15 min pta. Rec'd Moderna COVID-19 vacc yesterday. Has h/o HTN but has been refusing meds and chronic clinics since 2018. C/o SOB and upper back tightness. Responding nurse indicates pt's HR was initally irregular. Peripheral pulses thready. Unable to obtain BP. 18g IVs were placed in bilat ACs w/NS running wide open. EMS was called. On arrival they attempted adenosine 16mg then 8 mg. Then patient was successfully cardioverted and taken to the hospital.

acute ischemic stroke left thalamus. Right sided numbness. Began hours after receiving second vaccination dose

severe syncope, pt was pale and sweaty and 'felt funny'...administered epipen and pt stated he felt better then lost consciousness again and thready pulse...called 911, EMT came, gave oxygen and started infusion, took him to hospital. Pt discharged after several hrs

10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy.

62 yo male with a past medical history of HTN, HLD, and obesity presented to the ED on 5/17/2021 with complaints of palpitations. The patient noticed his watch stated his HR was > 120bpm and his wife measured his HR at which time it was greater than 100bpm. He presented to the ED for further evaluation and his EKG was seen as new onset atrial flutter with RVR and HR's ranging from 115-150bpm. He was hemostable throughout his ED stay and given PO cardizem and IV boluses of cardizem which improved his HR into the 115 range with MAP's > 75. He converted to sinus rhythm overnight and discharged home 5/18/2021. He denies any hx of sleep apnea. The patient otherwise denies fevers, night sweats or shaking chills recently and denies any other complaints of chest pain, dyspnea or lightheadedness. He denies any alcohol use but, and is a past smoker. He has had no new prescriptions. He has no hx of thyroid disease. He has not been diagnosed with COPD. CT chest imaging which is negative for a PE. He had covid 19 infection in 12/2020 and was not not hospitalized and recovered at home. He received his 2nd covid vaccine 4/19/2021.

Presented to emergency department with complaints of passing out and black stool on 3/28/21. Was found to be COVID-19 positive during screening for admission. Did not have symptoms and was not treated for COVID-19 infection. Patient stated he had prior COVID-19 infection in December 2020. Patient was admitted for 4 days for treatment of acute upper GI bleed and anemia.

Patient developed sore arm and leg cramps that went away the next day but starting on 1900-2000 the same day as the 1st vaccine, patient became very nauseous and vomited. As of 3/12 patient can not eat properly. He is taking Zofran but symptoms are still persisiting. Patients stool is really runny and he can not get his blood sugar below 200.

Patient was provided with the COVID-19 vaccine outside of the hospital and begain having shortness of breath approximately 15-20 minutes after receiving the vaccination. In route home, the patient could not catch his breath. The patient was found slumped over at home. EMS arrived and the patient received ACLS and ROSC was achieved. Days later, the patient arrested again and passed away on 5/13/21.

Patient reported fatigue and progressive weakness since given vaccination. Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.

@1/31/2021 Pain started in left ankle Lasted @10 Days. Swollen joints and pain. Swollen joints continued and pain moved throughout different parts of the body. (Right knee, right ankle, etc..) Pain increased every day until he couldn't stand it anymore so on 2/23/2021 went to emergency room for the first time in his life as the patient. Doctor gave him predniSONE 10 mg Discharge Diagnosis: Inflammatory arthropathy; Left arm pain; Tendinitis. 2/26/21 went to PC doctor Diagnosis New onset Polyarthropathy Prescribed PredniSONE 10 mg for 5 days. 3/2/21 Received 2nd Covid Vaccine shot. 3/8/21 called PC doctor still in extreme pain. Doctor prescribed Diclofenac Sodium 50 mg. 1 tablet every 8 hours. 3/9-3/10 started slurred speech. 3/10/21 Emergency room. Discharged Diagnosis Polyarthralgia (Joint pain) Prescribed methLPREDNIsolone 10 mg for 5 days. 3/11/21 Dr. called telling him to stop taking the Diclofenac Sodium immediately. Continued taking PredniSONE until 3/18/21. 3/22/21 sent to Gastrologist noted to have progressive microcytic anemia without GI bleeding, B12, folate, iron panel, EGD and Colonoscopy ASAP, Joint Swelling, Rheumatology evaluation pending, slurred speech, consider neurology evaluation. 3/31/21 Colonoscopy and Endoscopy performed. 4/1/21 Rheumatologist Appointment - First Appointment with this doctor. 4/5/21 Gasterology doctor diagnosed him having H-Pylori infection. All of his biopsies came back negative."H-Pylori Diagnosis - Amoxicillin 500 MG 2 Capsules twice daily for 14 Days /Omeprazole 20 MG 1 capsule twice daily for 14 days/Clarithromycin 500 MG 1 tablet twice daily for 14 Days. 4/8/21-4/10/21 Hands started shaking. 4/29/21 PC doctor appointment. Still experiencing fatigue and very pale. Can't catch his breath and gets tired very easily. Doctor took him off of his blood pressure medicine. 4/30/2021-5/2/2021 Had a horrible weekend. Pain/Fatigue/Absolutely No Energy 5/3/2021 stopped at PC office to see doctor. Took blood for more tests. Still experiencing pain in his body and swollen joints. "Prescription for Iron Tablets Take 1 pill in the am and 1 pill in the pm for 1 month Ferrous Sulfate 325mg (5gr) 5/7/2021 patient looks horrible today. He looks almost yellow to me and 1 of his eyes is bloodshot He has no energy (ZERO) and is very tired. He has lost over 15 pounds. 5/7/2021 patient called PC Doctor and asked him to look at his lab work. Dr. called and told him he made arrangements for him to go and see Neuropathist ASAP. Patient met Dr that same day. Dr. sent patient over to Hospital. In the ER they took blood, EKG test, CT scan of his lower abdomen and pelvis. They took a Chest X-Ray. He was given 60 mg of Steriods and started on IV fluid. They also scanned his head. Acute renal failure. Transabdominal ultrasound of the kidneys obtained. Ultrasound retroperitoneal kidneys. Findings: The right kidney measures 10.8 x 6.8 X 7.1 cm The left kidney measures 11.8 X 7.3 x 6.2 cm. There is mild bilateral renal cortical atrophy. There is increased renal cortical echogenicity of both kidneys. There is no hydronephrosis or shadowing renal calcui. The bladder is partically distended and unremarkable. Medical renal disease. No hydronophrosis or shadowing renal calculi. Clincial Indication: ARF-Other Acute renal failure. 5/10/21 Kidney Biopsy. Prednisone 20 MG Tablets Take 3 Tablets by Mouth Daily for 10 Days. 5/13/2021 Dr. visit diagnosis Focal Necrotizing and Crescentic Glomerulonephritis, Pauci-Immune Nine 0f 25 (36%) nonglobally sclerotic glomeruli show necrosis and/or cellular/fibrocellular crescent formation. Correlation with ANCA serologies is recommended. 05/17/2021 Prednisone 20mg. Next doctor appointment scheduled Monday, May 24, 2021. I also have 9 different Blood Lab Test Reports if you need to see them. My husband went from running 3 miles a day with nothing wrong with him except reflex condition to not being able to move at all. I'm not sure if it is related to the vaccine or not but I wanted to submit this report just in case. Please let us know if you have any further questions or need any additional information. Thank you.

Stroke; Vertigo; Dizziness; High Blood Pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Treatment information provided included steroids. Patient stated he in now in a walker due to having a stroke. Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event fell diagnosed as stroke (Seriousness criteria - medically significant).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was subarachnoid hemorrhage.

Within less than 24 hours after the first injection, patient went into tachycardia with heart rate 117 -120 for 2 weeks. After the second dose which patient was encouraged to get from their clinic, his heart rate went in excess of 139 for 1.5 weeks and he ended up in hospital for one week. Per patient's report, despite all treatments, they were only able to get his heart rate back to around 117. He was discharged home in tachycardia. Then, without change, 6 weeks after his second dose and being perpetually in SVT, patient's heart rate dropped into the 50s and has remained bradycardic. These have been the first changes in patient's last 5 years of daily heart rate logs since being diagnosed with paroxysmal a-fib in 2016. This has been unlike patient's history and a frank change in his heart rate and lots. Patient also reports having multiple whelps all over his lower abdomen since the injections.

C/o chest pain with radiation up posterior neck and thoracic area. Mild SOB Sent to CTH 5/19/21 and returned 5/23/21 TTE shows reduced LV function with large apical aneurysm and a layered non-mobile LV thrombus. Additional medications added upon return- Coumadin 7.5mg, Losartan 25mg, Lasix 40mg, Lovenox 150 mc/ml, coreg 6.25mg, Lipitor 80mg, D/c'd amlodipine, ASA

Patient's wife reports a diabetic episode the morning after receiving the vaccine. The patient was fine going to bed the night before, but in the morning about 20 hours after receiving the shot the patient was unresponsive to wake up in the morning. He struggled to open his eyes, but was able to awake with some coaxing. His blood sugar was 175, but came down after taking measures to lower his sugar. He was able to get up and walk around, drive like normal within 2-3 hours after waking up. The patient's wife states the reaction was abnormal, nothing different occurred the night before, the only change was the vaccine administration.

faster/quicker heartbeat; my heart beating double what it was supposed to be; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (faster/quicker heartbeat) and TACHYCARDIA (my heart beating double what it was supposed to be) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination. No Medical History Reported. Concomitant products included METFORMIN, LISINOPRIL and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, LEVOTHYROXINE for Thyroid disorder, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (faster/quicker heartbeat) (seriousness criterion medically significant) and TACHYCARDIA (my heart beating double what it was supposed to be) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Anticoagulant therapy, at a dose of 20 mg once a day and METOPROLOL SUCCINATE ongoing since an unknown date for Heart disorder, at a dose of 25 mg once a day. At the time of the report, HEART RATE INCREASED (faster/quicker heartbeat) and TACHYCARDIA (my heart beating double what it was supposed to be) outcome was unknown. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

palpitations; atrial flutter with RVR; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and ATRIAL FLUTTER (atrial flutter with RVR) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination. The patient's past medical history included Ex-smoker and COVID-19 (was not hospitalized and got recovered at home) in December 2020. Concurrent medical conditions included Hypertension, Hyperlipidemia and Obesity. On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization) and ATRIAL FLUTTER (atrial flutter with RVR) (seriousness criterion hospitalization). The patient was hospitalized from 17-May-2021 to 18-May-2021 due to ATRIAL FLUTTER and PALPITATIONS. The patient was treated with DILTIAZEM (CARDIZEM [DILTIAZEM]) (oral) ongoing from 17-May-2021 for Palpitations and Atrial flutter with rapid ventricular response, at a dose of UNK dosage form and DILTIAZEM (CARDIZEM [DILTIAZEM]) (intravenous) ongoing from 17-May-2021 for Palpitations and Atrial flutter with rapid ventricular response, at a dose of UNK dosage form. On 18-May-2021, PALPITATIONS (palpitations) and ATRIAL FLUTTER (atrial flutter with RVR) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate: high heart beats per minute (High) > 120 bpm and high heart beats per minute (High) > 100 bpm. On 17-May-2021, Computerised tomogram thorax: negative (Negative) Negative for a pulmonary embolism (PE). On 17-May-2021, Electrocardiogram: inconclusive (Inconclusive) new onset atrial flutter with rapid ventricular response (RVR), no ST changes. On 17-May-2021, Full blood count: normal (normal) normal. On 17-May-2021, Heart rate: high heart beats per minute (High) 115-150 bpm. On 17-May-2021, Mean arterial pressure: inconclusive (Inconclusive) > 75. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient denied any history of sleep apnea. He denied fevers, night sweats, shaking, chills recently and denied any other complaints of chest pain, dyspnea or lightheadedness. He was not an alcohol user and had no new prescriptions. He had no history of thyroid disease and had not been diagnosed with chronic obstructive pulmonary disease. No concomitant medications were reported. Patient was hemostable throughout his emergency department stay. The patient got converted to sinus rhythm overnight and got discharged to home on 18-May-2021. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient´s cardiovascular risk factors are an important confounder for the event atrial flutter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient´s cardiovascular risk factors are an important confounder for the event atrial flutter.

Developed stomach cramps resulting in explosive, somewhat loose bowl movements that were unusually smelly. Had a scheduled physical exam on March 8 which recorded low platelet count. Platelet count was normal when retested in early April. Stomach condition returned on June 1, 2021 although with much less bloating/gaseous bowl movements; the cramps are less noticeable and last much less time during the day.

6/3 @ about 10:00Am felt warm sensation in my head then 3 bouts of disinyness in succession. I had to sit on the ground for a couple minutes because I felt I was at risk of passing out

Pt had second Moderna Covid shot. On May 18th, One day later started to become confused. I saw him on May 20. He was confused, no headache. He had a large acute left Cerebral ischemic infarct. Three was an overlying 2.6 X 2.2 CM hemorrhagic infarct. Blood pressure was elevated at 170/130, I controlled blood pressure with Cardene drip.

Date of Admission 05/28/2021 Date of Discharge 06/02/2021 Reason for Hospitalization - COVID with O2 requirement Hospital Course - 63yo male with PMH of HLD, hypothyroidism, T2DM, HTN, intellectual disability, OSA, asthma who presented to the ED due to hypoxia after having positive COVID test on 5/27, symptom onset 5/23. Patient required 2-3L to maintain saturations, vital signs otherwise stable. Labs significant for WBC 3.38, Hgb 13.1, normal renal and liver function, troponin 75 with 2 hour delta 66 and 6 hour of 55. EKG with new T wave inversions in II, III, aVF. Cardiology consulted and the recommend heparin drip for 48 hours and continuing daily ASA, no Plavix. Echo obtained 5/29 and shows preserved EF without significant valvular abnormality. Cardiology also recommended stress test, but unable to do over the weekend. Pharmacological stress test performed on 6/1 which noted findings consistent with fixed inferior wall defect, no reversible defects noted, and LV function 44. Cardiology fellow notified and no intervention needed at this time. Treated with remdesivir from 5/28-6/1 and dexamethasone 6 mg daily from 5/28 until discharge on 6/2. Prior to discharge patient was able to wean down to room air. 6-minute walk eval was performed and patient did not need any oxygen, however was unable complete full test due to fatigue.

06/03/2021 1800 - Headache duration 24 hours. 06/03/2021 1900 - Elevated blood pressure, mild hypertension continues. 06/03/2021 1900 - Pain at injection site rated 6/10, 24 hours duration. 06/04/2021 1500 - Severe flu like symptoms, 24 hours duration. 06/04/2021 2000 - Fever 101.00, 8 hours duration. 06/04/2021 2000 - Nausea 24 hours duration.

05/07/2021 1000 - Headache, slight numbness of left side of face, body aches continuous. 05/08/2021 0800 - Lower extremity aches 48 hours duration. 05/09/2021 0600 - Red non itching red rash noted on chest, 6 hours duration. 05/25/2021 1500 - Elevated blood pressure. Diagnosed with mild hypertension with no previous history of mild hypertension.

Fever highest 103F, head ache, body ache, chills, tired, unable to eat symptoms lasted 3 days and during that time my heart went back into atrial fibrillation

Patient presented to the ED and was subsequently hospitalized for atrial flutter within 6 weeks of receiving COVID vaccination.

After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.

Upon arrival to the ED, the patient reported symptoms starting on Sunday with exertional SOB. SOB was significant while laying flat and awakening at night SOB. Patient was admitted to the hospital and stayed in the ICU for a few days. Medications received during the patients stay included: APAP 650 mg, ASA 81 mg, Atorvastatin 40 mg, Colchicine 0.6 mg, diphenhydramine, enoxaparin 40 mg, fentanyl citrate, heparin. lidocaine hcl, metoprolol tartrate, midazolam hcl, ondansetron, miralax and NS. The patient was admitted 6/4/21 and discharged 6/10/21.

4 days after jab symptoms of nausea, headache, fever, deep lung congestion, hypoxia, fatigue. Study shows 10-20 fold antibody increase after jab one with prior covid vs no prior covid. I had covid in nov 2020. 10 fold increase in covid antibodies after jab 2 with prior covid vs no prior covid. WHY DID CDC WITHHOLD THIS CRITCAL INFO FROM PUBLIC? WHY CDC SO ANTI SCIENCE? THIS IS RECKLESS DISREGARD FOR PUBLIC SAFETY. STUDY SAYS OVERDOSE OF ANTIBODIES, A WASTE OF VACCINE. ALSO CDC WITHELD CRITCAL NO INFO ON - HOST - MICROBIOME AND COVID - COVID LIFE SAVING BREATHING EXERCISES BY PULMONOLOGITS AND LUNG THERAPISTS - NO INFO ON NUMBER ONE CRITCAL ISSUE OF COVID COMPLICATIONS OF OBESITY AND OVERWEIGHT - NO CDC INFO ON HOW TO DEAL WITH COVID OR HOW TO PREPARE WITH SIMPLE CRITICAL TIPS LIKE OTHER COUNTRIES GAVE. MICROBIOME AND COVID. CDC IS INTO SCIENCE OF LIES AND PROFITS FOR THEIR MASTERS, BIG CORRUPT PHARMA. HIIT, HIGH INTENSITY INTERVAL TRAINING ON EXERCISE BIKE, SAVED ME FROM GOING TO HOSPITAL WITH COVID FROM BREATHING PROBLEMS. iT SIMPLY MOVED THE DEEP LUNG PHLEM TO HIGHER PART OF LUNG WHERE IT COULD BE REMOVED WITH COUGHS AND OXYGEN EXCHANGE. NO INFO FROM CDC ON CYTOKINE STORM FROM OVRER ACTIVE IMMUNE SYSTEM. LUNG MICROBES CROSS TALK WITH GUT MICROBES, TURN ON A HUMAN GENE THAT MAKES INTERFERON IMMUNE PROTEIN THAT STARTS FIGHTING COVID VIA FULL 48 HOURS BEFORE OUR HUMAN IMMUNE SYSTEM IS AWARE. ROOT CAUSE = DISRUPTED MICROBIOME AND THUS DEADLY CYTOKINE STORM. THIS WEBSITE FORM, IT WIPED OUT MY PRIOR STATEMENTS. CDC IS A COMPLETE CORRUPTED DISGRACE CDC IS A LYING DISGRACE, NO EXCUSES.

62-year-old male with history of hypertension presented to the hospital with chest pain. Chest pain centrally located, pressure-like sensation radiating to the left upper extremity and left side of the jaw. Associated with sweating. He had difficulty breathing when he had the chest pain. Patient was nauseous. NSTEMI. Cardiac Catheterization performed.

I experienced immediate chest pain, chills, difficulty sleeping, numbness, dizziness when standing. Vomiting. Occasional elbow pain on left arm.

Had sweats within a few hours but seemed ok. Around 3AM had a seizure but just like a eyes open no one home which passed within 15 minutes. Got up and around 9 AM had a full blown seizure kicking, moaning, unconscious Fire dept responded to home we were staying at and so did fire truck. Patient was transported to the ER where he stayed a few hours . Given chest x ray, blood draw, and an IV bag . We went to his seizure Dr once back to report incident

Patient became disoriented incontinent extremely high blood pressure lethargic exhausted confused jumbled speech

1- Palpetations and Aflutter which was controlled prior to second shot was exacerbated and evolved into AFIB within 1-week of second shot. (26-March-2021) 2- Sought treatment subsequently and required cardioversion. (3-April-2021) 3- Another cardioversion was undertaken and finally, the installation of a pacemaker was completed to avoid total heart block condition which evolved. 4- Placed on maintenance dose of Amioderone beginning 2-April. Palpetations continue

This is my second report on this. The first report was more about the soreness, tiredness and feelings of lethargy. But approximately 2 weeks after the shot I suddenly had high BP. 165/110 taken by nurses where I work. Was taken to doctor. This continued on and off for about 5-7 days. During this time my blood pressure fluctuated for no reason, and i kept having a rapid pulse even after sitting for long time periods- sometimes reaching 90-100 BPM. Symptoms finally relaxed after a week and I felt normal again. I then received the 2nd Covid vaccination on 2/19/21. About 5 days after this the same symptoms occurred. It came on faster and lasted longer. Fluctuating BP again, and high heart rates. Sometimes associated with feelings of anxiety. I did a follow up Doctors appt. and told them what I thought happened, that it was all from the vaccine. It took about 2 weeks to get over this episode where my BP stabilized and my heart rate stay normal -around 70+ BPM. To this day I have sharp heart pains. First lot was Moderna #013L20A. Second Lot was not specified on my card

March/April 2021 began having palpitations and shortness of breath. EKG at PCP office confirmed new onset atrial fibrillation. Stress ECHO and Holter monitor confirmed a reduced ejection fraction and mild cardiomyopathy. Cardiac angiography confirmed suboptimal ejection fraction

Patient presented to the ED and was subsequently hospitalized for Atrial flutter with rapid ventricular response within 6 weeks of receiving COVID vaccination.

Patient states he passed out the evening after receiving his 2nd dose. He doesn't know how long he was out. the next day, he was fine.

Started experiencing ectopy sinus rhythm heart beats that continued on and off for 5 day. After second shot, the ectopy rhythm returned and I experience they constantly to this date.

APPROXIMATELY ONE MINUTE AFTER RECEIVING MODERNA, PT REPORTED FEELING DIZZY AND HOT. I APPLIED ICE PACK TO WRISTS AND A COOL CLOTH TO BACK OF PTS NECK. PT SAID HE COULD HEAR HIS HEART BEAT LOUDLY IN HIS EARS SO I THEN CHECKED PTS BLOOD PRESSURE , PULSE OX, AND PULSE RATE. PTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED BUT PULSE OX AND PULSE RATE WERE NORMAL. APPROXIMATELY 5-10 MINUTES LATER, I RECHECKED PTS BLOOD PRESSURE AND IT NORMAL. PT ASKED FOR AND DRANK A BOTTLE OF COLD WATER. AFTER 35 MINUTES PT SAID HE WAS FEELING BACK TO NORMAL.

As reported to me by Patient On 6-29-2021 patient had a stroke on 6-30-2021 sister came to get him and took him to Hospital in city Stroke on left and has affected his right side of body. He is still recovering. His Blood was very high. However, he has never been to see a physician so no baseline Blood Pressure.

Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.; his chest hurt so bad; he got sick very bad; He has elevated immunity; More than 35 days after the first dose without receiving the second dose; I felt like I was having a heart attack; my knees were aching; When I woke up the next day, felt like a truck ran me over; lost all appetite; it attacked both my knees so severely I could hardly walk; Couldn't get off my toilet seat; I can't sit in my couch; had all kind of symptoms; 101 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine) and INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) at an unspecified dose. On 22-Mar-2021, the patient experienced GENERAL SYMPTOM (had all kind of symptoms), PYREXIA (101 fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) (seriousness criterion hospitalization), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch) and ARTHRALGIA (my knees were aching). On 06-Apr-2021, the patient experienced CHEST PAIN (his chest hurt so bad) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (I felt like I was having a heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety directly related and due to the vaccine) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (he got sick very bad) and IMMUNE SYSTEM DISORDER (He has elevated immunity). The patient was hospitalized from 06-Apr-2021 to 07-Apr-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine), INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.), GENERAL SYMPTOM (had all kind of symptoms), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch), ILLNESS (he got sick very bad), IMMUNE SYSTEM DISORDER (He has elevated immunity), ARTHRALGIA (my knees were aching), PYREXIA (101 fever) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 101 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) was unknown. Patient reported that he wont get the second one, as he got sick very bad. He had elevated immunity, his antibodies level is off the charts, that was documented in his hospital. Concomitant medications was not reported . Treatment history was not reported . 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; 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.

Heart attack; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient received first dose of Moderna COVID-19 on 19-MAY-2021 with lot number 045b21a intramuscularly. No concomitant medications were provided. No lab data was provided. No treatment information was provided. Company comment: Based on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.

Patient informed me that 24 hours after he received his vaccination he was transported and admitted to the hospital. He was running a 104 degree fever and was suffering from a very erratic heath rhythm. It took them a significant amount of time to get his heart rhythm under control and or him to be discharged.

I had a pulmonary embolism that required hospitalization. I had blood clots in my lungs which traveled from my left calf. I noticed a shortness of breath when running 4 days after my first vaccination. Subsequent runs featured extremely elevated pulse rates, too high in my opinion given I was only running at a moderate pace. That led me to think there was something wrong. I went to the doctor who ordered tests for me. The tests confirmed that I had blood clots and I was told to go to the emergency room immediately. I was hospitalized for 2 days, and was prescribed Eliquis. I have to take Eliquis for 6 months. Bloodwork confirmed that I was not genetically predisposed to blood clotting. If I was not active, I would never had known a problem existed. I was told that I could have died if I did not go to the doctor to check this out.

Patient was given the vaccine at approximately 11:40 am by technician. The patient was advised to wait for 15 minutes in the waiting area after the vaccination was given. During the 15 minute waiting period the patient fainted in the waiting area of the pharmacy. The patient was immediately assisted. The technicians were told to call 911 and management. Upon encountering the patient, the patient was gently rubbed and asked if he could hear me. The patient was immediately responsive and told me his name and date of birth. The patient was asked if he had any health conditions or prior incidents of fainting after a vaccination and the patient stated "no". The patient was provided water and asked if he could sit up. The patient stated that he could. The patient sat on the floor in an upright position for approximately ten minutes. The patient was then asked if he felt that he could stand to get back into the chair. The patient sat back in the chair and continued to drink water and take deep breaths. The patient stated that he still felt dizzy and nauseous. The patient's emergency contact was contacted to inform of the situation. EMT arrived at approximately 12:15 pm. Patient was asked by EMT's if he wanted to go to the hospital. The patient responded "no". The patient was then asked if they could "check him out" and he agreed. After assessing the patient the patient was taken to the hospital by ambulance.

Cardiac Infraction; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac Infraction) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. No relevant medical history was provided. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN LOW) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Cardiac Infraction) (seriousness criteria medically significant and intervention required). At the time of the report, MYOCARDIAL INFARCTION (Cardiac Infraction) outcome was unknown. Patient stated that they put a stent in there. Company 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.; 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.

I had a slight sore throat on night of getting vaccine. On the day after, I had chills, body aches, chest tightness and pain, shortness of breath and Wheezing.

Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188. We had him lay down and about 10 minutes later his blood pressure was 140/70. After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.

increase temperature 99.6-103, elevated Blood Pressure 196/128, Heart Rate 115, mild light headedness, no shortness of breath, alert and oriented

Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia.

admitted to shady grove hospital for ITP(immune mediated thrombocytopenia) plts were 1 on admission have not responded to typical ITP therapies, platelets still 4 today after 4 days in hospital workup shows ITP no other risk factors or history of itp or autoimmunity

At the end of patient's monitoring after the covid-19 vaccine, patient said he felt like his heart rate was fast subjective feeling. Medical provider and nurse assessed patient. Patient had normal heart rate 60-64 rate, regular rate and rhythm on exam, normal sao2 94-95%, elevated blood pressure 153/103, 174/92, 160/109, 153/93, 170/86.

Patient sat down and alerted observation that he was experiencing feeling flushed and felt his pulse was faster than usual. He took off his jacket to cool down. As time progressed, he said he did not feel as dizzy. Patient was in observation for over thirty minutes. EMS arrived at scene to evaluated patient. Patient signed a refusal form to go to the hospital and to receive treatment. Pulse 76, pressure 121/83, oxygen was 96. Patient was instructed to download the app .

Thursday Nite starting at 11 PM: A warm feeling at the top of my head like a heat lamp. Lasted 15 Minutes. Then Left Leg, Two Toes start pulsating/shaking uncontrollably. I rubbed with the right foot...it would stop...then start back up. Lasted 30 Minutes. Then my chest started feeling like I had a bad sunburn on my skin. Lasted 30 Minutes...all the while these strange things were going on, I noticed I had asthma. I ONLY get asthma if I have a cold or flu. I thought to get up and take an inhaler but decided against it worried about an adverse reaction to the vaccination. I fell back to sleep and awoke with no asthma and all strange symptoms gone. Then Friday afternoon I developed chills and a queasy stomach (belching and gas and loose stools.) I checked my temperature (on multiple occasions) and it was normal. These two conditions lasted until Saturday. Also on Saturday, I developed aches in my neck. Then very late Saturday Night, I awoke to a sweat drenched tee shirt but chills were gone. Sunday...today....I feel perfect.

We were made aware that days after vaccination the patient suffered a "major brain hemorrhage" according to patient's wife. He is currently admitted at a different hospital. After vaccine administration on-site, the patient became unconscious for a few minutes. However, this is common for him - he informed us that he almost always "passes out" after vaccine administration. He slowly returned to consciousness without any issues. He was seen by an ED physician prior to leaving the facility. Deemed to be in good health, patient also stated that he felt fine and believed he was okay to leave as these episodes occur frequently following vaccination.

Bloody nose for 4 days usually in the evening around 7:00 pm. After tilting head back and using a tissue in the nose, bleeding stopped after 15 - 20 minutes.

Lightheaded and dizzy, and elevated BP 180-100 one hour after injection. Monitored on-site for another 1/2 hour and BP remained high. Transported by ambulance to Hospital for further observation. Head cleared and BP came down to acceptable level about 8:00 PM. Released.

I am being treated through medication for A-Fib of which I've had 0 episodes since August 9th, 2021. I received the Covid Moderna shot on 1/29/2021 at noon. That night and into the following morning I experienced 3 A-Fib episodes. . I have not had any since then.

My oxygen levels dropped below what they had been previously as I am recovering from Covid infection tested positive 20 October 2020. If I do anything at all other then set my oxygen levels would drop into the low 80's. I have also been monitoring my sugar levels. I am not diabetic but did so because in ICU was using steroids which elevated sugar levels. I continued to monitor it at home because I had to do injections for several weeks after leaving the hospital. Have not had to use insulin til the other day. Vision is very blurry. Had that problem in the hospital but it has gone away but since I had the first vaccine everything is now blurry. Left leg hurts to put weight on the heel. I have nerve damage to the left leg but this is a unique issue. I'm running a low grade fever 100.2 - in the morning it is normally 96.5-97.6 and this temperature was in the morning the day after the shot. Neck is very sore. I have rods from C3-C6 and the pain is in the muscle glands closer to the surface. It is almost like it is attacking all areas of the body I previously had issues. I spent October 25 - November 13 in Hospital, majority of time in ICU.

1/31 - received 2nd dose of Moderna vaccine at MD (where I work as M.D.) Approximately 8 hours later, experienced severe chills, fever 102, chest pain, and shortness of breath. Fever lasted two days, however ,still not feeling well then experienced palpitations, irregular heartbeat. Went to cardiologist on 2/8. Tests revealed pericardial effusion and pleural effusion.

2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on the signs of Stroke "FAST" Patient Issues: Physical shaking like Parkinsons , Heart Palpitations and rapid BPM, Chest Pressure, shallow breathing, stuttered speech, Slurred Speech, Headaches, Confusion and lack of short term recall, red flush face, difficulty in comprehending conversations, reading

Patient experienced Chest pain & was diaphoretic approx 5 minutes after vaccination. Onsite EMS was called vitals BP 168/107 HR 63 100% O2 room air. No past reaction to vaccine, last flu vaccine in September. Patient said he was feeling better after approx 10 minutes. Relased to home.

Got the 2nd dose of Corona Vaccine Moderna at 12:45pm yesterday - at 6p, started to feel weak/dizzy - then this am on 2/22/21 at approx 6:30, pt had a syncopal episode with preceding dizziness, denies cp/fever.

pt lost consciousness immediately after injection. Code blue team was called, provider assessed. Once pt regained consciousness he was transferred to hospital for f/u care.

Morning after shot was at church and all of a sudden got nauseous and very hot for a number of minutes, then passed out before leaving church. Had a cut lip, nose and have a stiff(sore) neck last day or so.

Cardiac arrest just stopped breathing fortunately at home wife called 911 within five minutes of noticing not breathing responders there in 3-5 minutes worked on him for 15 minutes at home before transporting to ER hospital. No heart beat pulse etc... used CPR machines and paddles Patient had walked 6 1/2 miles that morning no problems did about 50-60 miles weekly outside. This was sudden and me, his wife, say it was a reaction to something in shot that contributed to this event- there is absolutely nothing you could say to make believe differently. This happened 1 1/2 hours after getting shot.

Day #1-3-- >Sore arm, edema to the site (resolved after day #3) Day #5-- >Symptoms include fatigue and increased stomach upset. Routine labwork drawn on 2/19/21 (see results below). Will be having labs redrawn on 3/5/21 and will see the hematology oncologist on 3/16/21.

Patient was found on the ground sitting. Reported he was leaving after receiving 1st COVID-19 vaccine and "loss balance". Patient denies hitting head. Laceration to the elbow noted. Patient requested assistance to get up and still felt "dizzy". Patient assisted to wheelchair and recommended to go to ED via ambulance for evaluation. Patient then loss consciousness for 10 seconds. 911 was called. Patient refused all care by EMS. They called by EMS as they deemed patient was not safe to drive due to unsteady gait. It was advised patient to go to ED as instructed by EMS and The provider but refused. They also advised for patient to go to a hotel nearby to rest. Patient refused all recommendations and was escorted by EMS to his car.

patient passed out while waiting in the observation area after the vaccine administration. He passed out briefly about 1 minute then regained consciousness. He then responded to pharmacist questions. 911 arrived and took him to the hospital

About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to the top of my head. It almost like little shocks going thru my body. I had a video appointment with my Dr. and he prescribes doxycycline and prednisone. The next day the fever went away and started to feel better (48 hours later). I also tested positive for Covid on 12/24/20, I didn't wait 90 days before I got my vaccine. I felt awful with the second dose, almost worse than being in the midst of Covid. I'm currently on Workman's Comp. I'm constantly out of breathe and have no energy, I use to have tons of energy. From my atoms apple to my sternum I have tons of pain. My lungs feel like I'm smoking and have tons of pressure. My Dr. ran test because I have the worst head aches. I'm like slow motion.

Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134. MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93% and 97%. Client continued to be diaphoretic, pale, also shaky

Patient woke up at 4am with shortness of breath, pulse ox 75 on 3.5L oxygen. No improvement with increased oxygen so patient was transported by ambulance to the hospital. When patient arrived to hospital heart rate was over 200.

Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure. The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported. On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection. On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had received his first dose. On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.

Pt reported on 3/8/21 with concerns of chest pains r/t the covid immunization he had previously received. Pt had F/U apt to discuss this with PCP. Advised per DO to report the possible reaction.

Fatigue, nausea, vomiting and aches and pains in chest area similar to feeling when I had Covid19. This lasted for about 15 hours

intermittent headache and blood pressure is erratic sometimes going as high as 170/130. Eye floaters and eye flashes and high BP caused ER visit on Sunday 3/14/2021.

Wife reported symptoms of all-over tingling, increased heart rate , and increased BP. Patient took over-the-counter Benadryl and symptoms subsided.

Patient wife called clinic at 1156 am. Patient lethargic, too weak to stand or walk, dry heaves. Advised to call 911 and take to ER. Called patient 3/17 for details. States on 3/4/21 in the evening, he developed HA, chills, and body aches. 3/5/21 took a shower and became light-headed, near-syncope or syncopal episode reported by patient. Wife gave him a Zofran ODT, which relieved the dry heaves. He rested remainder of day. Felt mostly better by 3/7/21, with remaining fatigue until 3/9/21.

3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself. Pain is substernal, radiated to the left arm, associated with lightheadedness. Denies diaphoresis or nausea. Per EMS there were short runs of nonsustained ventricular tachycardia 3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia. He states he was lifting a couch yesterday and his heart started beating fast. He did not really have any chest pain, but felt a little bit lightheaded. He called an ambulance and they brought into the ER. In the emergency room his EKG did show some frequent PVCs. However, he did not really require any intervention. He was given 3 nitro, but it really did not make any difference in the way he was feeling. The patient denies multiple times that he actually had chest pain. He states he just felt like his heart was beating funny. The patient's most recent stress test was a nuclear stress test in May of 2019. Overnight, the patient has felt very well. He denies any significant chest pain. He denies any further heart palpitations. On the monitor he would occasionally going to bigeminy, which is not abnormal for him. EKG this morning was unremarkable. After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion. She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out. She states last night he was extremely diaphoretic and very nearly passed out.

Received call from his exwife that patient had passed away. Death Certificate states date of death as March 14, 2021. Causes of death are listed a. Cardiac Pulmonary Arrest. b. Myocardial Infarction

Patient reported "covid" rash that he had from previous infection last year that got worse after vaccine, patient reported chest tightness feeling like his sore arm made his chest hurt.

Pt received 1st moderna vaccine on 3/15/2021 and was admitted with sudden hypoxia , sob , low grade fever and pleuritic chest pain 10 days later. Pt is lifelong non smoker. no recent travel or recent illness. no new medications.

Started to feel a little different in the first 8 hours. Then the next 10 hours I got a headache in the front of my head & the back of my neck. Chest pain when I had to cough. My whole body ached & slept for the next 12-16 hours. I started to feel better after 48 hours from the shot. All I did was drink plenty of water & eat bananas & apples & blueberries, just like I did when I had Covid-19 back in first week of November 2020. The only difference between the shot & having Covid-19 is I slept for almost 96 hours with Covid-19.

Pt received first Moderna COVID-19 vaccine on 3/15/21. Starting 3/27, patient began to have acute onset dizziness, muffled hearing, loss of consciousness and sinus congestion. On 3/28, this dizziness lead to a fall in which he hit his head and was sent to the ED. Pt tested positive for COVID 19 while in the ED, and was admitted.

Patient reported pain in center of black and vision blurry approximately 10 -15 min. Patient with poor color and sweaty. Patient Pulse OX 77% , HR 50. 1555 - Epinephrine 0.3mg administered IM left thigh. Oxygen (full face mask) applied at 15L. Patient pulse ox 98%. Patient report still feeling poorly. 1402 - Benadryl 100 mg IM Right Deltoid administered. 1406 - B/P - 125/82 Pulse Ox 98% HR - 56 Oxygen slowly decreased to 5 L. EMS transported to ER

vaccine recieved 3/29/21, on 3/30/21 patient expired in his home. cause of death assumed to be cardiac related. Pt. was not feeling well after covid vaccination, therefore refused to go to dialysis (3/30/21). Collapsed in basement and was found by spouse 30 minutes later. Patient was DNR. spouse stated she feels death was not directly related to vaccine because he had several health conditions in which he has been noncompliant with and has not been following his medical providers treatment plans.

Right after 48 to 72 hours later when I was feeling fine - had BP shoot up and also had palpitations. The BP settled down after 6 hours to so (took a lot of water and did some breathing). I am not concerned about what happened in the three days or so of the vaccination. However, I am worried about the continuation of palpitations that seem to happen a few times a week.

Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection location soreness and pain. Cannot sleep at night. I thought to call 911.

Had a stroke Mar 16, 2021. 12 days after shot. This is nonsense adding all this data. It is as though you don't want to hear. Mistakes on pages are mot clear and easy to figure out. Such as no months if over 2 years of age. Idiotic.

Patient got 1st Moderna Covid vaccine on 3/24/21. On 3/29 patient started getting a runny nose. By 4/2 patient started getting fatigue with loss of appetite and on 4/3 started getting right sided abdominal pain with movement. Seen in the clinic on 4/5 with tachycardia 112 apical and temp 99.1, abdominal pain was feeling a little better and only reproducible with use of abdominal muscles. No resp symptoms except intermittent runny nose. Patient appeared very dehydrated on exam, IVF were offered but patient declined. Labs were done and patient was encouraged to aggressively hydrate at home. US abdomen was ordered STAT. Patient declined US on 4/6 because he was busy so it was scheduled 4/7. Covid test scheduled for next available apt. On 4/6: Labs showed mild increase in WBCs and dehydration but otherwise no major abnormalities. Patient reported new onset swelling, redness, and pain in his R leg and concern for DVT. He reports family history of DVT in his mother. US of the leg was added to his testing on 4/7. He also reported on and off chills. 4/7: Report called for US Abdomen was negative but patient did have extensive DVT in the right leg. Eliquis was called in and patient instructed to pick up and begin immediately. He denies any respiratory symptoms today but still intermittent chills. He reports that abdominal pain has resolved.

Patient came the the pharmacy for the Covid vaccination (Moderna). After Intra-muscular injection, Patient was asked to stay for 15 minutes in order to observe the side effects/Allergic reactions if any. After 5 minutes-Patient reported that he is feeling anxiety or numbness on his left hand and arm. Patient states his left hand grip was not as strong as before.-We checked blood pressure, Blood pressure came out to be 212/116. We called the management Pharmacy protocol-Code White- for injury), Management asked the patient if we need to 911?. He said yes and we called 911. Paramedics took him to the hospital.

PATIENT SAID HE WAS FEELING DIZZY ABOUT 10 MINUTES AFTER RECEIVING HIS VACCINE. RPH WAS IN THE PROCESS OF CHECKING HIS BP, WHEN HE FAINTED. 911 WAS CALLED . HE SHORTLEY GAINED BACK CONSCIOUSNESS AFTER EPI PEN WAS ADMINISTERED

Immediate excessive bleeding. Immediate pain compared to previous vaccinations. Arm and shoulder became increasingly more painful through out the next several hours. By evening I was unable to lift arm. Any movement resulting in extremely sharp pain. No movement and the arm and shoulder had high degree of aching. Next day same and stayed in bed for next 3 days due to pain. On 4th day some improvement and could move arm by lifting with other hand. 5the day slight improvement. 6 the day small improvement still can not lift objects or reach out without severe pain

Heavy nosebleed upon waking in the morning. First occurence ever. Blood pouring from nose, and down back of throat causing gagging. Duration 20 minutes or so. Applied pressure to nose, eventually stopped.

Patient received the 2nd dose of Moderna COVID Vaccine on Wednesday 4/7/2021. He called the office today 4/12/2021 at approximately 9:00AM. He stated that his left arm was swollen from the shoulder, down to the his fingers. He said that the swelling started on Thursday 4/8/2021, and has not improved. I scheduled him to come into the office for an appointment with PA, at 10:20AM today, 4/12/2021. Patient was sent him to have an ultrasound, which showed DVT in the left subclavian vein and internal jugular vein.

Pt complained of dizziness for 2 weeks prior to hospitalization 4/10/2021, and passed out 6 times in the 2 days prior to admission. Upon admission was found to have acute pulmonary embolism. Physician requested VAERS report.

Pulmonary embolism resulting in atrial fibrillation with rapid ventricular response. Hospital treatment included IV anticoagulation, IV anti arrhythmic medications, and subsequent cardioversion.

Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.

Blood clots in left leg, hip, bilateral lungs; treated with blood thinners; was admitted to hospital from 4/1-4/3; discharged to home, stable

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

Pt. reports immediately feeling tingling in both hands and some dizziness with mild nausea. Pt. denies ever having similar reaction to vaccines or blood draws. He reported he does have an allergy to "streptomycin mixed with penicillin". Pt's BP initially elevated in treatment room. EKG ordered and reviewed by physician. As time passed pt. reports symptoms "dissipating". Pt. evaluated for 30 minutes and sent home with ER precautions given.

Patient came to pharmacy today w/ his wife to pick up Rx for XARELTO. He has developed multiple DVT's in his leg. He reported symptoms started the day after (Saturday) his second dose of Moderna COVID 19 vaccine on Friday 4.9.21. His leg was swollen by Sunday 4.11.21. Symptoms would get worse and then get better. He finally went to see Dr. today 04.20.21. They found several blood clots in the leg via doppler. Patient was therefore prescribed Xarelto. Pt wife advised that Dr said clots were due to Moderna vaccine and they should let pharmacy know also. Their next appointment will be in 2 weeks.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: PATIENT DEVELOPED BLISTERS AND SORES IN MOUTH APPROXIMATELY 1 WEEK AFTER RECEIVING VACCINATION. WENT TO PRIMARY CARE DOCTOR WHO DID BLOOD WORK WHICH SHOWED A PLATELET LEVEL UNDER 2000. PATIENT WAS HOSPITALIZED AND GIVEN STEROIDS BUT HAS SINCE RECOVERED.

Vaccine on 04/10/21.Shortness of breath, dizziness, nausea 04/13/2021. Death on at hospital on 04/14/2021 Autopsy found Bilateral pulmonary thromboemnbolus

Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient complained of dizziness, confusion, fatigue, and mild SOB. He was evaluated by PCP and PA-C. BP 150/100 and glucose 156. EMS evaluated the patient and did not send to ED. Patient was observed for 30 min.

received the vaccine on Monday 4/19/21 into his left arm Tuesday 4/20/21 he went to work but after lunch became extremely fatigued and achy, went home to sleep it off Wednesday 4/21/21 he woke up with right UE/LE numbness and weakness which persisted until Thursday 4/22/21 so sought medical attention

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing

1st, after about 2 hours: sore shoulder 2nd, after about 5 hours: whole arm, chest, back and side pain. 3rd, next morning: all of the above, plus dizziness and nauseated, but no vomiting. Fever peaked at 101.4. This lasted all day. 4th, next morning: Fever, dizziness and nausea gone. Pain reduced. Sore arm remains.

3 weeks after Patient got this shot he got blood clots in his leg and amputated next week .The problem is he has ITP platelets were 12,000 He can't make blood clots!!!

Sudden, sever vomiting, chest & heart pain, mild fever, pain/discomfort in both shoulders, increased shakiness.

Developed right-sided headache with facial weakness and numbness on April 19. Blurred vision and ptosis, inability to hold liquids in right side of mouth, irregular smile, and nose bleeds. CT of head same day was negative for any acute findings. Evaluated by optometrist on April 22 and referred to other eye specialist. Evaluated on April 27 by specialist and diagnosed with Bell's palsy. Prescribed steroids and acyclovir. Family reports patient's facial weakness has improved significantly, smile is equalizing and patient is able to blink and move muscles in forehead. Still has some residual symptoms at this time.

COVID diagnosis; coughing; low oxygen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COUGH (coughing) (seriousness criterion hospitalization) and HYPOXIA (low oxygen) (seriousness criterion hospitalization). On 24-Feb-2021, the patient experienced COVID-19 (COVID diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Antibody test: negative (Negative) Negative. On 19-Feb-2021, Oxygen saturation: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not given. This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. 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 described a cold sweat and chills, then he lost consciousness and his neighbors called EMS. He was seen at Hospital. In the aftermath, the patient complains of hearing loss.

CHF (congestive heart failure) Pneumonia Respiratory distress Hypoxia Suspected COVID-19 virus infection

Tight sensation in neck and chest post vaccination (approximately 1 hour later) that came and went 3 times.

4/24/2021. Extensive bilateral pulmonary emboli with hypoxia: Uncertain of the cause of the emboli. Did have COVID-19 in January and also received his 1st COVID vaccine within the last week. No recent surgeries in no recent travel. CT chest PE protocol demonstrates extensive right more than left pulmonary emboli with evidence of right heart strain. Small pulmonary infarct in the right posterior lower lobe. Started on heparin drip with full bolus and will continue heparin drip per protocol.

I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir

Intestinal gurgling, heavy sweating, palor, general malaise occurred within 10 minutes of receiving vaccine. Symptoms persisted for 5 hours until bedtime. Next morning had fatigue, headache and feeling of scalp tingling but other symptoms had lessened or subsided.

This 63 year old male received the Moderna Covid shot on 3/26/21 and went to the ED on 4/5/21 and was admitted on 4/5/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident)

63 yo male received 1st dose of Moderna Vaccine on 3/31/21. Admitted to hospital on 4/6/21 then transferred to another Hospital on 4/12/21 for idiopathic pericardial effusion, acute kidney injury then released home on 4/23/21. He presented to hospital on 4/25/21 with acute respiratory failure, septic shock, cardiogenic shock, acute myocarditis and acute on chronic kidney injury. Transferred to different Hospital on 4/30/21

Patient passed out 30 minutes after getting the vaccine. He bumped his head and was transported via ambulance to hospital. He was kept overnight. All test results came back normal. Patient is currently wearing a heart monitor for 3 days.

Pt states that he woke up the next morning and his entire left arm was swollen and numb. The following day, two days after the vaccination, the entire left side of his body was swollen and numb. The patient went to the hospital on April 6, 2021, and was hospitalized for ten days. Upon admission, he had bloody urine, swelling and numbness on the left side of his body, and was short of breath and coughing up blood. Pt was diagnosed with pneumonia while admitted to hospital.

5-19-21 Patient self-reported to that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.

onset of respiratory failure on 05/14/2021 to be eventually diagnosed with pulmonary embolism. hospitalized at facility .

He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was that was for 2 days. Then his breathing starting getting worse. He started coughing, couldn't lay down, could not sleep due to that. He went to the ER and they told him that there was nothing wrong and that it was just allergies. They told him to go home and take some OTC cold medicine and that everything would be okay. A week later he went to another ER for the same thing as he continued not to be able to breath, they did a bunch of tests and said that nothing was wrong and that it was just a call. He then went to Hospital ER and they released him stating it had just a cold. He then called his cardiologist and they told him to go back to Hospital, was admitted on 5/11/21 and they did more tests and said that he had a blood clot in his left lung and said that it had nothing to do with the vaccine. He was discharged on 5/13/21. They put him on Heparin while in the hospital and sent him home as a disgruntled patient. They also told him that he had fluid around his heart and gave him medicine to get that taken away. They sent him home on Lasix and Eliquis. He then went to another hospital on Friday 5/14/21 as he was going crazy about the blood clot and went there and was kept there for 3 days and discharged on 5/16/21 with the same medications, Lasix and Eliquis. He was also told that he had fluid around his heart again. Before the vaccine he was very healthy, and was able to jog around his neighborhood and now he's not able to do so, and they told him that he was now having heart failure and is having trouble breathing because his heart is swelling up. He went to see his cardiologist last Friday and that's when she told him about his heart failure. ADMISSIONS: ADMITTED 5/11/21 TO 5/13/21; 5/14/21 to 5/16/21.

pt felt dizzy, like heart racing - pt had cold water & sat a few minutes longer then stated he was ok to leave. Pt has parkinsons & wife said he gets anxiety.

I recently had blood work done for an annual physical. The blood was drawn the same day I received the @nd dose of the vaccine.. I met with the Dr, 4 days later for my physical. He indicated my white blood cells were low and platelets were low. I did not have any adverse side effects other than a slightly sore arm. That particular blood test was accomplished, and the white cell count went back to normal and the platelets are improving, and I still feel no side effects. My primary care provider just wanted me to keep your company informed of the situation.

2/19/21- Patient presented with shortness of breath that appears to be chronic, but potentially worse (this was 5 days after 2nd Covid vaccine). Lab tests showed thrombocytopenia (unknown if this is new or old) as well as mild transaminitis (again, not known if new) 3/23/21- Patient presented with a stroke involving the R frontal and parietal lobe. Echo normal at that time 4/22/21- presented to urgent care again and was found to have elevated troponin (without associated chest pain or EKG changes). Echo was normal, but cardiac MRI showed evidence of myocarditis

Patient lost consciousness and was in and out for roughly 5 minutes. Clammy, sweaty, confused. EMS was called. vitals checked. patient cleared. pt went home from pharmacy with wife.

per patient: "On 5/26/21 received the 2nd dose of Moderna Vaccine. Around noon experienced headache, left earche and tingling to left foot. Around 1pm started having trouble breathing and later that evening felt like someone was standing on my chest. Took Excedrin EC for headaches. Headache lasted for a day or two. Felt like i was forcing myself to breathe instead of coming naturally".

After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Muscle close to hip that gave me a lot of pain; I had a short heart attack. It was a pretty severe pain.; mid chest, left side pain; Felt lousy; Had flu-like symptoms; Cough; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) in a 63-year-old male 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 Scarlet fever (Patient had as a child, about 13 or 14 yrs old.) since an unknown date. On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) (seriousness criterion medically significant) and CHEST PAIN (mid chest, left side pain). On 27-May-2021, the patient experienced MYALGIA (Muscle close to hip that gave me a lot of pain). At the time of the report, MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.), CHEST PAIN (mid chest, left side pain), MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle close to hip that gave me a lot of pain) had resolved. Concomitant medications were not provided.Treatment information was not reported. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Fainted and fell on the floor; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted and fell on the floor) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced SYNCOPE (Fainted and fell on the floor) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to SYNCOPE. At the time of the report, SYNCOPE (Fainted and fell on the floor) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medicines were reported. Treatment information included heart monitoring and head scan. 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.; 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.

left leg pain and swelling developed on 5/26/2021, did not seek treatment until 6/9/2021 as not resolving. Evaluated in ER 6/9/21, identified on ultrasound left popliteal and calf deep vein thrombosis. Started on anticoagulation therapy, Eliquis 10mg BID, ongoing treatment, reduced to 5mg BID after 7 days and will continue to monitor renal function.

Acute bilateral pulmonary embolus and right lower extremity DVT. No typical risk factors such as recent trauma or surgery and no personal history of DVT/PE. Received Moderna COVID-19 vaccination series in February and March of this year.

Pt received 2nd dose of Moderna COVID-19 vaccine 5/5/21. In mid June patient developed SOB symptoms, dyspnea on exertion, and upon CT imagining in ER found to have bilateral pulmonary emboli with evidence of right heart strain on CT and EKG.

The evening of his second shot, he collapsed. He said he became light headed, but I believe he may have lost consciousness briefly. He rand a low fever for 12 hours. Afterwards, he complained that he had "not felt right" since the second shot. He died of a heart attack on May 27, roughly one month after his second shot.

Heartbeat 110 at rest. Overall body aches. Extreme fatigue starting about 12 hrs after injection and lasting about 48 hrs. Passed out in shower about 29 hrs after injection. (Have no history of fainting.)

24-36 hours after second Moderna covid vaccine, patient began experiencing greying-out of the left superior quadrant of his vision in both eyes. He presented to care by 4 days after his vaccine date and was found to have right sided occipital lobe ischemic stroke.

Foot swelling due to Blood clot in left leg. Went to hospital ER on 2/22/21, received ultrasound showing clot. Prescribed Eliquis.

short of breath; Missed dose 2; heart rate dropped below 40; dizziness; "hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive); Pea Sized Nodes/nodes were tender; Sore Muscles; fatigue; fever; sore bones; patient felt like he was "hit by a bus"; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate dropped below 40) in a 63-year-old male 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. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever). On 16-Feb-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender). On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)). On 25-Feb-2021, the patient experienced DIZZINESS (dizziness). On 26-Feb-2021, the patient experienced BRADYCARDIA (heart rate dropped below 40) (seriousness criterion medically significant). On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose 2). On an unknown date, the patient experienced DYSPNOEA (short of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and Surgery (Pacemaker) for Bradycardia. On 19-Feb-2021, INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender) had resolved. On 21-Feb-2021, INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)) had resolved. At the time of the report, BRADYCARDIA (heart rate dropped below 40) was resolving and DIZZINESS (dizziness), DYSPNOEA (short of breath), BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), PRODUCT DOSE OMISSION ISSUE (Missed dose 2), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Heart rate: 40 bpm (Low) 40 BPM. It was reported that, in total the patient recorded 3 negative COVID tests. There was no history of cardiovascular disease in patient's family. The patient was advised by his doctor to not receive the second dose of the vaccine. Treatment medication include Advil. Company Comment : This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received and case was upgraded to serious, Height, age, race and Ethnicity updated in patient tab, Suspect product Batch number and route of administration updated in products tab, Updated events and event outcome in events tab.; Sender's Comments: This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable.

The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d post-COVID vaccine (2nd dose, Pfizer). He presented to our hospital on 6/18 with these complaints and was found to have significantly altered mentation, acute kidney injury, and profound thrombocytopenia. Workup was positive for TTP and he was started on PLEX therapy x 5d. Hematologic parameters, renal function, and mentation have improved with PLEX therapy. ADAMTS-13 activity <5% c/w acquired TTP.

blood clots in his right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was reported. Concomitant products included ENOXAPARIN for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROMBOSIS (blood clots in his right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) from 06-Apr-2021 to 24-May-2021 for Clot blood, at a dose of 10 milligram twice a day. At the time of the report, THROMBOSIS (blood clots in his right leg) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Ultrasound scan: confirmed blood clots (abnormal) confirmed blood clots in patient's in right leg. 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. Further information has been requested This case was linked to MOD-2021-220788 (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, a causal relationship cannot be excluded. Further information has been requested

Blood clots in his left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in his left leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included APIXABAN and ENOXAPARIN for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (Blood clots in his left leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in his left leg) 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. 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. Further information has been requested. This case was linked to MOD-2021-220804 (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, a causal relationship cannot be excluded. Further information has been requested.

Pt stated that he has had swelling, tingling, and pain up and down his arm. He is also reporting mild pain down one side of his chest which is not going away. The second shot of Moderna was give 05-03-2021.

Recurring bouts of fever, aches. Pain when taking deep breath. eventually shortness of breath and pressure high in chest. Diagnosis : Pericardial Effusion. Treatment : Surgery to drain fluid. install drain. install pericardial window. 5 days in hospital.

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

Systemic: Chest Tightness/ Heaviness/ Pain-Severe, Systemic: Flushed/ Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

Patient states he developed "seizure symptoms" four days after second dose of Moderna COVID vaccination. Patient described "seizure symptoms" as a headache and chest pain severe enough that he was not able to drive. He took an aspirin for his symptoms and symptoms were completely resolved in two hours. Similar episodes occurred Thursday, Friday, and Saturday. Writer advised patient to seek emergency medical care for symptoms on Saturday for further evaluation. Patient was resistant, and writer stressed importance of evaluation of chest pain. Unable to follow up further.

Admitted to the ER complaining of 103-104 fever, extreme fatigue, headache, weakness, and nausea. Initial diagnosis was inflammation and sepsis from unknown origin. Patient was slightly anemic and had borderline enlargement of the heart on Xray. Pulse Ox levels were 91-93 prior to giving 02. Patient had traces of blood and protein in urine. WBC levels were normal. Blood cultures failed to reveal a bacterial, viral, or fungal infection. IV Antibiotics were administered and patient was discharged with no fever after 5 days. However, patient began experiencing mild afib onn the 5th day. Metoprolol was prescribed and patient scheduled a follow up echocardiogram. No infection ever located.

Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.

Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving COVID vaccination.

After the vaccination my airway was tightening and chest tightness and coughing. When i coughed it was really bad i still have th ecoughing the doctor prescribed the medicine and steroids it is a little better but i still have the symptoms.

Massive PE with R heart strain. Possible RA thrombus. Duplex LE with extensive residual B/L lower extremity clot. Was given heparin and needed tPA due to high risk for decompensation. Transitioning to Eliquis

Fully vaccinated patient who tested positive for COVID upon admission screening to hospital. Admitted through ED for STEMI. No fever, cough, or loss of taste or smell. No s/s of COVID throughout stay. Discharged on 07/17/21. Of note - patient recovered from COVID in 11/2020.

Patient called this office 7/21/21 and stated that on 5/3/21 he was found unconscious by his son just days after his second dose of Moderna and was taken by ambulance to the nearest hospital facility where he was stabilized and then transferred to another hospital system for higher level of care. He stated he spent 3 days in ICU and 3 days on a stepdown unit. Patient reports that since then he has felt weak and had to undergo rehab. Would not provide more information to this writer,

husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred; can't drive anymore; first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) and CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee replacement and Carpal tunnel syndrome. Concurrent medical conditions included Overweight and High cholesterol. On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) (seriousness criterion medically significant). On 26-Jun-2021, the patient experienced FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (can't drive anymore). The patient was hospitalized for 2 days due to FALL. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 325 milligram once a day and ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred), CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) and IMPAIRED DRIVING ABILITY (can't drive anymore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.

2 hours after injection:- Sore arm. 12 hours-99 degree temp, elevated pulse, shivers. 14 hours-100 degree temp, elevated pulse (120 bpm), chills, persistent moderate headache, achy muscles, sore back. 24 hours-98 degree temp, head ache gone, just a worn out feeling, 36 hours-back to normal other than a very sore arm at injection site and a worn out feeling.

Patient began having headache and fatigue 12/29. Early morning of 12/30 patient reported severe chills. Felt better during the day of 12/30 with only a headache. Night of 12/30 patient reported severe chills again and wanted to call the doctor in the morning, but the felt better on 12/31. The night of 12/31 patient again had chills, but less severe (rated 3/10 on scale). Night of 1/1 patient reported slight hive like rash that went away with warm Epsom salt bath. 1/3 0100 patient woke up with severe hives down back of legs and lower back. Got into a hot tub to soak and once the patient got out he was standing at the sink and passed out. His wife got him back to bed. Around 0700 on 1/3 patient woke up to urinate and he passed out again. He states both times he passed out felt the same stating "I felt like I was going to vomit and then all of a sudden I couldn?t breath, almost like I was choked out."

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

Severe constant headache that has been lasting for 5 days so far along with nausea. Low body temperature in a range 94.5-97 degrees F. There has been unstable blood pressure.

Got the vaccine at curb side at a pharmacy. was ask to sit and wait incase of reaction in the vehicle I started feeling hot and Tingley like I need to go to the bathroom so I went inside and told the pharmacist so they sat me down and took my blood pressure and heart rate 168/108 HR 108 then they gave me some Benadryl and waited about 8 min. to retake my BP again and it about the same. They called my primary care provider and he said to go to the ER. Did not have problems with breathing and swalloning. The feeling was like a contracts for a dye to a CT warm and tingles. Pharmacy called for EMS and was transported. Hospital watched my BP and HR, gave me pepcide, and steroids. Arrived about 12:15 pm and left 3:30pm. 122/78 HR 73 (approx) now I am home just kinda tired.

Pt and other foster home residents and CGs received COVID shot #1 at 11:30 am within the foster home after POA consented to pt's vax. At ~9p, CG heard pt vocalize a loud sound, CG checked on him and entire body and stomach so rigid, lips were pressed together/pale and pale throughout. Stopped breathing for a few seconds. CG couldn't get BP or pulse initially. Say tears rolling down face. 87/45, 56, 97.2F, 91% on RA. After 10 mins was 129/53, 48, 91%. Called 911, 79/47, couldn't get pulse. Due to POLST comfort measures, EMS did not transfer pt to ER. After EMS left, pt "came to" again, pt signed EMS consent NOT to be transferred to ER. Pt's POA didn't pick up the phone. Current VS: 111/64, 69, afebrile. POA does not want pt to receive the second COVID shot.

Following vaccination, patient experienced lightheadedness, dizziness, headache and nausea. BP elevated. Blood sugar 315. Little improvement following rest in reclining position. Transferred to the hospital via ambulance. Next day, family reported patient was released from the hospital that evening and has resumed activity . No rash or wheezing noted during the episode. Telephone call to patient x2 for more information to complete VAERS but did not return my calls.

Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of appetite, chills, generalized discomfort, chest pain, difficulty breathing, and difficulty sleeping. All symptoms resolved with the exception of headache and difficulty sleeping until day 2 after receiving vaccination. Day 2 without symptoms

Staff member called to report an elevation in blood pressure (168/96) and pulse (103) with fever of 103.6F. Symptoms lasting into next day-was seen by his PCP with no additional follow-up needed.

Body felt normal with a little stiffness in neck. Felt tired and went to bed but in bed started experiencing chills. I put a heating pad on the bed and even though the bed and pad felt warm, the chills continued for about 10 minutes. Later in the night, my daughter came and checked my temperature. It was 105, even though I didn't feel like I had any fever. I took some Ibuprofen and my daughter put a cool damp cloth on my forehead. I never felt hot. In the morning, the area in the bed where I was sleeping was completely soaked! My temperature was normal.

Resident had chest pains and rapid heart rate and felt like he was going to have a seizure. Laid back down for a few hours, then EMT called at 6:19 am and transported to hospital. Hospital update that he does have a fever and have him on IV fluids. Tests came back that his cumin levels were high. Patient is back home.

After receiving Moderna vaccine, client became nauseous and diaphoretic. Laid down and lost consciousness. Came to within seconds. Denied any head injury or headaches. Complained of dizziness. O2 initiated 10L nonrebreather. Declined epinephrine. EMSA called. Client transported to hospital via EMSA for further evaluation.

Patient is currently hospitalized in Hospital with Covid. His Wife reported admission with O2 Sat at 48. He has Pneumonia, Ketones of 4, borderline ketoacidosis, and Fluid on his lungs,.

Narrative: Patient with history of seizures was given his 1st dose of Moderna COVID- 19 vaccine toward the end of a stable dialysis treatment. 15 minutes post immunization, patient experienced hypotension and grand mal seizures. Hypotension resolved with saline administration. Oxygen via NC administered. EMS called due to ongoing seizure activity. Transported to hospital where he was admitted for an undisclosed diagnosis.

Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620.

Patient experienced chest tightness and anxiety 5 minutes after vaccination. Onsite EMS was called vitals are HR 89 BP 160/79 99% O2 room air. Patient went home.

on 2/218/2021 the patient was at home and developed chest pain. Patient was transported by family to urgent care then to the ED where the patient later died.

PATIENT GOT THE VACCINE AND WAS TOLD TO SIT DOWN FOR 15 MINUTES . DURING THAT TIME PT FAINTED .CALLED 911 AND WAS TAKEN TO THE HOSPITAL

pt stated that evening after getting the covid vax he started getting a pain like a cramp that started in the left buttock and hip that went all of the way down the outside of his leg. Pt went to ER on 3/5/2021 in early am since was having problems breathing and very nauseated. His back and legs were still hurting. He was given something for pain and nausea. Blood Pressure was elevated. They did blood work and chest X-ray with normal results. He was observed for about an hour and then discharged since nothing was found and told him he had a reaction to the vaccine. Pt still has constant pain in left leg and has not been able to work. Pt has an appt w/ PCP on 3/12 for FU.

Severe shortness of breath. RR 50. Severe chest pain unable to take deep breath severe back pain unable to move.

First unusual symptom the day after vaccine - felt as though we were experiencing an earthquake. Unsteady balance since then. I had aches common with flu shots, which are now (3/9) gone - these are not a problem. Yesterday my apple watch said my heart beat was below 40 bpm for ten minutes a few times. I tend to have a low heart rate so not a major surprise. But last night when I got up, I lost balance and fell, hitting my head on a chest. No major damage. But feeling of dizziness is still a little present.

Patient received 1st COVID vaccine on 2.12.21. Reported to local ER with chest pain and increased ShOB on 2.22.21. Found to be positive for COVID, elevated troponin. Transferred to medical center. Patient was mildly hypoxic on the floor but never required more than 2L nasal prongs. Patient is currently on dialysis. Patient received dexamethasone therapy only while on the floor. Discharged home on 3.4.2021.

The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing.

Heavy chest pain, trouble breathing, fatigue on day following vaccine. Symptoms of chest pain remain but have lessened.

Started abnormal heart rhythm. 400-500 skipped beats per day. Mostly PVC. Not continuous but periodic over the course of the day . Symptoms have lasted 3 weeks. PET scan revealed no ischemia at this time .

I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion

On 3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital. ER dr name unknown so provided family dr nane

I normally have an a1c value of 5.9 My blood sugar went up to 275 and I had to take triple the amount of insulin to bring it down. My blood sugar is still elevated 1 week after the shot, although not at 275 now. Headaches and sleeplessness

Eight minutes after the shot, I started felling unwell so I started my Apple Watch to see my heart rate. It was at 86 and a minute later it was at 116 and a minute after that it peaked at 119. It fell to mid 90's a couple minutes later, then went up to 105 fell back to mid 90s, then rose to 117, fell back to 80, and kept rising and falling until about 3pm. The technician told me before my shot that it would be a few minutes as they had to do something the vaccine. I don't recall what she told me. I think she said they had to switch a vial or something. You'd have to ask her what happened before I had my shot. This morning I have tingling in my thumb, forefinger and middle finger in the arm I got the shot. I did sleep on the arm that had the shot .

Painful injection site, sick stomach, fever, earache, headache, After 24 hours from injection I developed a bloody taste in mouth, severe bloody nose.

High heart rate/panic attack. Patient reported feeling high blood pressure and panic after 10 minutes of administration. Upon talking to patient and monitoring patient for an additional 20 minutes heart rate was at 70 and patient was feeling better and felt good enough to leave with his adult children for lunch. Water, deep breathing, and time were the only treatments administered, no epinephrine or diphenhydramine were administered. Followed up with the patient later that day, approximately 4 hours later and he was felling better. During monitoring patient did mention that he had a similar reaction to Miralax in the past but not Go Litely. Upon looking at the screening form this was not noted in the allergy field. This patient may have a concentration dependent sensitivity to polyethylene glycol, suspending agent or major component in the moderna vaccine is not diluted in any volume. Talked to supervisor to add a potential field of propylene glycol for the screening from.

Elevated heart rate (76bpm) from normal resting heart rate of (49 bpm) consistently since afternoon of the injection...ongoing as of this morning.

Moderna COVID- 19 Vaccine EUA: patient presents to the emergency department (ED) with shortness of breath, dizziness, abdominal pain, nausea, cough, malaise, and headaches. Symptoms started four days prior to arriving in the ED when shoveling snow. Three days prior to arriving in the ED patient received vaccination and reports fever and persistent shortness of breath ever since. Seen by primary care provider one day before presenting to the ED and prescribed prednisone but did not take it. Initial vital signs showed tachycardia, fever, tachypnea, and decreased oxygen saturations on room air. Physical exam noted faint wheezing. Patient placed on oxygen, received albuterol, ipratropium, and steroids with improvement. Patient discharged to home with steroids, inhalers, and oxygen.

Vasal vagal response. Diaphoretic no SOB. Placed pt in Trendelenburg after BP stable patient able to stand and walk around. Wife states this happened before when the pt gave blood. Initial BP 61/43 , BP at D/C 121/60 D/C home stable

HEART ATTACK 14 HOURS AFTER VACCINE. EMS TOOK TO ER. TAKEN DIRECT TO OPERATING ROOM, FOUND ONE 95% BLOCKAGE AND STENT PUT IN. HAS HEART DAMAGE NOW

patient was anxious before the vaccination. after vaccination, he wanted walk around then sit. he sat on the floor and was stating that he had a phobia to needles/shots. he passed out briefly and came to shortly afterwards. 911 called, very low bp. patient and wife were moved to ambulance where patient eventually felt better and was able to walk. patient and wife did not want to go to hospital. we called him later to check on patient, he said he was feeling much better.

On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot. The site were I had to shot was burning like it had been branded. I had brain fog couldn't remember what i was doing up. Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area. the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch. Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.

More recently (around 2/1) he started having intermittent chest pressure again, then developed dyspnea, cough, intermittent mild fever ~ 101, and hypoxia noted on home monitor. Felt to have pneumonia and was placed on antibiotics 2/4/21 without improvement of symptoms. Seen by his PCP on the day of admission, he was much more dyspeptic and tachycardic with heart rates in the 150s. He was sent to the ER for further w/u and management.

Pressure in chest, rapid heart beat, skipping heart beat. shortness of breath, headache. Took Tylenol after 3 days which helped with headache, felt better after 1 week. heart skipping still although not nearly as often

Around 9:15pm while watching tv, I felt a quick kick in my chest. My heart rate increased to 153 bpm, according to my watch. My chest felt tight and heavy. I went to a Trauma Center around 10:30pm. I sat in the Waiting Room after triage until 6am Saturday 3/6/2021. I started to feel my pain subside, never saw a doctor and I left. Notified my Family Doctor and he referred me to see a Cardiologist. I have an appointment for 4/13/2021 at 8:30am.

Right Arm DVT and superficial venous thrombosis on ultrasound done on 3/30/2021-Pt noticed right arm soreness and discomfort then he started to have firmness which continued to get worse.

Patient sat in waiting area chair after receiving vaccine. I was notified by another customer that something appeared wrong with the patient. I went to the patient and found him unconscious and unresponsive. I told the technician to call 911 for EMS and I proceeded to remove the Epinephrine emergency pen from the emergency bag. The patient regained consciousness, I did not administer the epinephrine emergency pen. I remained with the patient. The patient complained of feeling hot, nausea and tired. Patient also appeared confused. Patient's head was cold to the touch. EMS arrived and took the patient's vital signs. The patient's awareness and tiredness appeared to vary from feeling fine and alert to confusion. After about 15 minutes with EMS the patient choose to go with EMS to the Hospital Emergency room for observation. The patient walked about 15 steps then chose to go on the gurney with EMS.

on 2/8 developed cough on 2/13 to Hospital Emergency Room, diagnosed viral pneumonia on 2/15 back to ER, admitted, diagnosed with pulmonary embolism on 2/20 to ICU, intubated and put on ventilator on 3/3 died from pneumonia due to COVID-19 per death certificate

patient called to cancel his second dose appointment reporting that 7 hours after he got his first dose he got a terrible headache and for the next 3 days his chest was pounding because his heart rate was so fast. He was about to call and make a doctors appointment if it didn't resolve but on the 3rd day it started to go back to normal. He wasn't sure how fast his heart rate was but his chest was "pounding non-stop day and night".

Day after the shot (March 3) he started having shortness of breath and then continued up until March 16 started running fever of 102.9 and still having difficulty breathing-went to ER and then diagnosed with blood clots in lung "acute pulmonary emboli" and pulmonary infarct and his heart was enlarged-by CAT scan. In ICU for 3 days and discharged at that time out of ICU to home.

Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.

14 days after 2nd dose severe shortness of breath, fatigue, lightheaded, near syncope. Diagnosed with bilateral DVT and bilateral PE

Right after I went to sleep around 12:30AM EST on 4/5 I noticed there was no feeling in my left leg - lasted 30 minutes - then I was able to walk on it but did not want to put full weight on it - went to urgent care clinic at 11:30 am est on 4/5 and they referred me to ER. Arrived at ER around 12:30 pm est on 4/5 (I walked into both places without assistance). They gave me Eloquis at hospital and I had slightly higher blood pressure than normal. Was discharged late in day on 4/6 around 5pm est. They gave me neuro eval every 2-3 hours and pulled blood constantly. They decided to start me on Crestor at hospital as well - was already on finofibrate, stopped fiofibrate aand fish oil and baby aspirin once I returned home

patient experienced onset of subjective and eventually objective fevers 4 days after receiving the second Moderna vaccination. He experienced malaise, and fatigue as well and some shortness of breath with chest tightness and was ultimately diagnosed with pericardial effusion and pericarditis.

PATIENT STATES: WITHIN FIVE MINUTES OF INJECTION MY FACE BEGAN TINGLING ON THE LEFT SIDE STARTING IN MY CHIN AND MOVING UPT O INCLUDE MY ENTIRE MOUTH, LIPS, UNDER MY LEFT EYE AND THE ENTIRE LEFT SIDE OF MY FACE AND HEAD. THE TINGLING BECAME NUMBNESS AND VISION ISSUES IN MY LEFT EYE. I STARTED EXPERIENCING HEART ARRHYTHMIAS DIZZINESS AND VERTIGO. I THINK IT WAS CAUSING ME SOME STRESS, WHICH CAUSED ME TO BE HYPERSENSITIVE TO EVERTHING. I WAS SITTING IN MY CAR FOR THEREQUIRED 15 MINUTES AND AT THAT TIME I WENT INTO THE PHARMACY TO REPORT IT BUT THERE WERE SO BUSY THAT I COULD NOT GET ANYONE'S ATTENTION TO ALERT THEM SO MY WIFE AND I LEFT. WE WENT TO A COFFEE SHOP, I HAD SOME CAFFEINE AND I FELT OK TO DRIVE BACK HOME TO REST.

Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER

pale, clammy, sweating, lightheadness, possible absence seizure after 2nd shot. He waited his 15 minutes, and was waiting on his wife's 15 minutes, when he started to feel badly. Ambulance came to make sure he didnt have a seizure and his vitals were okay. patient said he had not eaten before shot and walked to a nearby restaurant to eat.

patient reports he spent many days in hospital after 2nd Moderna vaccine wtih severe blood clots. Informed he did not tell hospital that he had the 2nd Moderna shot but informed the other hospital. It was the other hospital that instructed the patient to contact the Health Department to inform of the same

Developed a blood clot in his right leg, inner thigh, up toward groin area. ER diagnosis on 4/20/21 at healthcare facility.

1st moderna lot number 027A21A given 3/14/21. Pt woke up with right side weakness and aphasia. Still ambulating on his own. At 0800 he went with his wife to get his second Covid-19 vaccination. Symptoms progressed until he was unable to speak or move his right side at all. Family called 911. Pt admitted to hospital with Dx of Left MCA Stroke.

Patient reported to primary care office on 4/28/21 at 16:50 with chest pain, numbness in left arm(injection site) , jerking/spasms related to pain in chest; pain radiates from left chest to left scapula, down left arm. Per pt symptoms started after receiving COVID vaccine on 4/19/21 and have only become worse. Pt took tylenol at home with no relief. Pt did not go to the ER anytime after COVID vaccine for evaluation. Pt unsure if got Moderna or Pfizer. Lost his vaccination card. Pt sent to ER- Pt refused EMS stated would drive himself to hospital.

Severe pain to lower left leg without injury hx. Went to doctor on 3/17/21 and was examined and doppler to left leg showing no blockage. Dr prescribed nsaid as needed for pain and monitor. Monitored and pain continued until approx 4/9 and noticed swelling starting and some redness to skin slightly warm. Returned to dr on 4/13 and was placed on antibiotics. On 4/14 noticed slight shortness of breath on exertion and on 4/15 shortness of breath worsened and some irregular heartrate. I went to hospital. Bloodwork, EKG, Chest xray and CT showed multiple pulmonary embolisms and several DVTs in left leg. Admitted to hospital and placed on Heparin drip and monitored for three days. Released from hospital on 4/19 on Eliquis and advised to follow up with personal physician and report severe breathing problems or CP.

No effects on day of vaccination, nor into the evening. Morning of 27th woke with headache. Symptoms worsened as the day progressed. Body and muscle aches, extreme fatigue, sleepiness, some difficulty moving around, heart seemed to be pounding harder as I moved, so stayed put in my chair. About 8 o'clock I had a fever of 101. Drank lots of water. Took Tylenol. Fever faded away. In bed by 9pm. Alternately hot, then cold for several hours but did not have chills. Around 1am temperature stabilized and I slept well. Today, the29th, symptoms gone. Arm not even sore.

patient was found down on the ground. he was slow to respond but eventually came around. he had a syncopal event or seizure.

Sore arm for three days after shot. Cough increasingly more frequent w/ rib soreness at the intercostal anterior of primarily right side but occasionally left side as well. Increasing difficulty breathing on exertion, increase in altitudes over 8,000 feet, entering cold environments. Severity increased to point where entered ER on APR 26th. Massive PEs found in both lungs. D-Dimer score of 10,000.0 ng/mL. CTA Chest w/ contrast found multiple PEs. ALS transport transferred to Hospital for treatment. Released from the hospital APR 29.

Patient presented to the ED on 2/24/21 with STEMI and was subsequently hospitalized. He also presented to the ED on 3/18/21 with stable angina.

My Father received the first dose of CV19 on 03/02/21 and the second dose on 03/03/2021 in the morning, and at night he had a stroke, we called 911 they hospitalized him within a week he was out of danger and had physical therapies for a month at facility he got out on the 31st of March 2021 and on April 4th he once again went into the hospital for lack of oxygen, they detected blood clots in his legs and his lungs and also an aneurysm in his heart.

Patient noted with the following symptoms: Fever, decrease in Oxygen saturation (documented in 70's), chills and poor intake. Resident was taken to hospital. Patient indicated on VAR that he had not had any vaccinations in the last 14 days. When pharmacist entered moderna vaccine information into the vaccine reporting system, it was discovered that the patient received a pfizer COVID-19 vaccination on 4/16/2021.

Dizziness, palpitations and not feeling well followed by confusion/altered mental status, chills and weakness 4 days later. Presented to medical center with bacteremia & hypotension on 4/26 PM. Transferred to same medical center on 4/29 with concerns for myasthenia crisis.

20% overall energy reduction, abnormal sweating while walking in 60 degree weather, Abnormal Shortness of breath upon exertion , Tinnitus tone change, Intermittent occasional chest wall cramping that goes away

patient suffered significant heart attack (100% blockage right coronary artery) on 4/18/2021. He has NO risk factors for coronary artery disease (no HTN, DM, hyperlipidemia, smoking, obesity, family history of CAD). He exercises by swimming one hour 7 days per week.

Two days after receiving second Moderna vaccine, recipient experienced Bell's Palsy effecting right side of his face, right eye dry and unable to blink, droop and drooling right side of mouth. patient was evaluated by his primary physician and no other cause of for the palsy was determined.

Platelets dropped to 6. Oncologist stated not to proceed with second dose. treated, and plt count at 22 as of report.

Patient presented initially to his PCP on 4/24/21 for on going muscle aches after his COVID vaccine. Pain is on other arms, takes tylenol for treatment but no relief. Blood pressure elevated at the time of visit, no limited ROM, bruising present. Patient denies sx of cough, fever, SOB or chills, chest pain/pressure, GI or GU issues, HA. Patient provided prescription for celecoxib 200mg PO daily prn pain. Presented to hospital emergency room on 4/27/21 for chest pain, found to have anterior wall STEMI. The patient was started on IV heparin and medical therapy with intravenous beta-blocker before being transferred to another healthcare facility. His initial troponin was 0.2. His CBC with diff and electrolytes are all within normal limits. Patient was immediately taken to the cath lab for PCI. In route to hospital the patient was given 1 dose of nitroglycerin, aspirin, morphine for pain. Cardiac catheterization was performed with placement of drug-eluting stent into the Mid LAD. Patient started on aspirin and Brilinta. Echocardiogram showed mild left ventricular hypertrophy, severe mid to distal anterior septal hypokinesis, apical akinesis with an EF of 45 to 50% and grade 2 diastolic dysfunction. Patient has had no return of his symptoms since the PCI, tolerated p.o. intake without difficulty. No nausea/vomiting, or shortness of breath. Able to ambulate without difficulty.

MYSTERY "STROKE": The patient remembers receiving the MODERNA COVID vaccination and feeling nothing immediately after shot, took off work a few days later and then on following Monday remembered getting up and preparing for day with shave and shower. Remembers blood sugar being in normal range. Went to dress and collapsed. Could not move left side of body or cry out for help. Was found by a neighbor after two days of being face down on floor unable to reach phone drifting in an out of consciousness. Transported by EMT to hospital. MRI brain scan, ultrasound of legs including Doppler velocimetry conducted. Now at healthcare facility. Continued weakness left side.

Four days post vaccine, associate started to get a pulsating headache. Two days later while at work, started to get a pounding headache, by noon started to get chest pain and felt dizzy. Went to the ER, did an EKG and blood work to rule out a stroke. has an appointment with an allergist and a brain scan.

The patient is a 64 year old white male known with diabetes mellitus type II, hypertension, osteoarthritis of his knees, and abnormal liver enzymes. Patient is being seen today for a routine follow up appointment. Patient is experiencing no pain and expresses no new concerns. Patient denies SOB, NVD, cough, cold, etc. Recent labs reviewed A1c 6.9%, LDL 100, total chol 180, Trig 301, HDL 29, VLDL 51. TSH normal at 1.290, AST 39, ALT elevated at 52. alk phos 81 , bun 11, Cr 1.01, GFR 78 , WBC 5.4, Hgb 15.1, Plt 180 reviewed during visit. GM 5/19/21 Patient reports after second Covid-19 vaccine he had 3 weeks of diarrhea, got dehydrated and then had to pass 5 kidney stones. States several coworkers who also had Moderna had diarrhea but it did not last that long. He also had joint pain and headache. He states the headache was mild it was "not bad". He unfortunately did not seek care during this time. Headaches lasted 1.5-2 weeks. Did not hold him up. Had no other sick contacts. Diarrhea and headaches started the next day. He had diarrhea any time he ate anything "a straight shot". At times full watery diarrhea. No fatty or floating stools. He did feel a little warmer at times but when checked Temp was normal. We do have cases of Norovirus in community but symptoms lasted too long for that and no other sick contacts in household with similar symptoms. Did not have a COVID-19 test during that time. Did not notify our clinic. Had fecal urgency. Denies blood in stool.

Patient received vaccine on 4/26/21 and had mild fatigue and malaise, otherwise in his usual state of health. On 4/30/21 he was working in his barn and towards the end of his work he began to feel some palpitations and chest tightness. This did not go away despite resting causing him to come to the emergency department. No known history of cardiac arrhythmia, does not follow with cardiologist. No recent travel. No significant alcohol use. No new medications. No unusual events over the last few days. Found to have new-onset atrial fibrillation on EKG. He was given diltiazem to reduce rate.

He had a recent bout of chest pain (like a ligament tear, worse with lying down x 2 days)- which he dates to end of March/early April; he didn't seek care right away. He subsequently mentioned the episode to EP and was diagnosed with pericarditis with moderate pericardial effusion on 4/8/21. CRP 77. No viral symptoms. He received the Covid vaccine 2/12 and 3/12. Repeat echocardiogram on 5/3 showed resolution of pericardial effusion. He was prescribed colchicine but told to stop it after the echo showed resolution. He also had a stress SPECT which showed normal perfusion but severe calcification of LM and LAD. He has no symptoms of chest pain. Pericarditic chest pain completely resolved. LDL was 110 and atorvastatin was increased from 60mg to 80mg 2 months ago. He has no chest pain or shortness of breath. Takes lasix for LE edema. Very active. Walked 5 miles yesterday without issues. Occasionally gets short of breath climbing stairs.

blood pressure that was at 229/147; a terrible headache that continued to the next day to a migraine; terrible headache that continued to the next day to a migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure that was at 229/147) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine). On 31-Jan-2021, the patient experienced HYPERTENSION (blood pressure that was at 229/147) (seriousness criterion intervention required). On 31-Jan-2021, HYPERTENSION (blood pressure that was at 229/147) had resolved. At the time of the report, MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure abnormal: 229/147 (abnormal) 229/147. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. On 31-Jan-2021, the patient went to urgent care due headache changing into a migraine. The reporter stated, urgent care would not provide treatment due to how high the blood pressure was and advised the patient to go to the emergency department. The patient went to the emergency department around 6:00 pm and was treated for elevated blood pressure of 229/147. The patient was not admitted nut was advised to follow up with a primary care physician. Treatment details were not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-114821 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-114821:

This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and ATORVASTATIN. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria medically significant and life threatening), CHEST PAIN (Pain in the chest) (seriousness criterion life threatening), LETHARGY (Lethargic), DYSPEPSIA (Heart ache) and FATIGUE (Tired). On an unknown date, the patient experienced HEADACHE (Headache). On 14-Apr-2021, MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) outcome was unknown. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) had not resolved, DYSPEPSIA (Heart ache) was resolving and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: abnormal Showed mild Heart Attack. His doctor gave him nitroglycerin which he could not take due to headache and full aspirin. His cardiologist appointment is coming up on 25MAY2021. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-114362 (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, a causal relationship cannot be excluded. Further information has been requested.

My blood pressure has been under control for 44 years. I'm not overweight. My blood pressure has been all over the place. Up to 200/100, staying in the 150s to 170s/ 90s.

confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb brain fog memory issues. very very tired super weak ... second shot, same but with added lower back pain and leg cramps. massive headache, went to the doc, he told me that first event was a stroke. now i have a blockage carotid left side in my neck. sent me for ultra sound them ct scan. waiting to see vascular doc after discovery 80% blockage. sill very tired very weak. brain fog, hands going numb eye sight weaker. bad smell in my nose sometimes., not sleeping well. short of breathe.

Woke up the next morning after the shot with a terrible headache and heart palpitations. Went to the ER at the hospital . They said I had PVCs which I never had before until after the shot. Went for other tests in two weeks

Irregular heartbeat which has over the past many weeks become more normal but still causing me to pause on getting the second shot

The next day, I started to feel really weird. I had no energy and my head felt really strange. About a week and a half later, around 5am, the left side of my body started going numb. My wife took me to the ER. My BP was super high. About 6 hours later, the numbness started to go away. They performed various tests, but couldn't find anything wrong. They think I had a TIA, which is a blood clot that resolves itself. For the following month or so, I was just extremely tired and felt really crappy.

Arrived to ED complaining of increased work of breathing, black stool and chest pain. Vaccination prior day incidental to medical findings not suspected to be caused by vaccine. 64 years male with PMH of multiple upper GI bleed secondary, atrial fibrillation, CAD, HTN, HLD, COPD on 2L, morbid obesity, OSA on CPAP who presented to the ED with black stools. Has had multiple endoscopic clips and coils placed in the past. VSS; H/H 7.5/21 on admission. His troponin was elevated and peaked at 1.68. Cath in July 2019 showed 80% proximal LAD, difficult to image secondary to an obese patient, occluded nondominant RCA, moderate disease in a large OM (40% stenosis), large anterior apical wall motion. motion abnormality, EF of 45%. GI and cardiology were consulted in the ED. He was admitted for acute blood loss anemia secondary to GI bleed, likely AVM. While inpatient, he remained afebrile and hemodynamically stable. He required 6u RBC transfusion total during his admission (transfused for <8.0 given ischemic heart disease). GI performed upper endoscopy x2 and removed large amounts of blood clots and placed 4 additional hemoclips to stop the bleeding. Cardiology was also consulted due to elevated troponin in the setting of ischemia heart disease, and inability to have stent placement/antiplatelet therapy due to GI bleeds - recommended conservative treatment, likely type II demand ischemia. He received IV octreotide 50mcg/hr for 4 days, as well as IV PPI 40mg BID.

Severe chest and left shoulder pain, worse on breathing and leaning forward. Five physicians heard a rub. Responded to Motrin and Colchicine. Lasted two weeks.

Person experienced vertigo, vomiting, double vision, low body temp of 95*. Took him to the ED Hospital. It was determined that he had suffered a small Ischemic Stroke. He was given Asprin and Lipitor (Atorvastatin) and an anti nausea medication. Several tests were done as outlined in Item 19 below.

During the day of the vaccine, experienced 6 hours of a racing heart. He could feel his heartbeat. He has not seen his doctor for over a year and did not call them (or the pharmacy). He has high blood pressure. He laid down and slept all night and the next day and was well. Additionally, he experienced a covid infection 11/2020 and could hardly breathe and could not sleep. We discussed the risks and benefits and the patient decided to get the second shot because his employer required it. He was strongly urged to call his doctor or go to the ER urgent care if he experiences severe symptoms of pounding heart or increased blood pressure. He may need to adjust his meds and could be at risk for a vascular event.

6/14/21, admitted for shortness of breath, initially thought to be CHF exacerbation, persistent hypoxia, underwent V/Q scan 6/16, showing bilateral pulmonary embolism, starte don heparin and then lovenox, still with persistent hypoxemia

On 6/18/21 heart transitioned to AFIB state. Prior occurrences have all occurred due to ingest of caffeine and ended between 6 and 24 hours after start. No caffeine is known to have been ingested since September 2019 (last accidental ingestion). I have not sough medical assistance yet.

Patient was vaccinated on 3/18/21. 1 to 2 weeks later patient reported fatigue and general malaise. Reported to PCP. PCP obtained CMP, CBC with differential. Patient was found to be hyponatremic with a serum sodium level of 110. Patient was admitted to hospital on 4.12.21. Workup showed that patient was in AKI and had DVT. Patient was treated with 3% sodium chloride infusion and was given diuretics. AKI resolved through his course of admission. Patient was treated with enoxaparin for DVT.

no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE], CLONAZEPAM (CLONAPIN), TEMAZEPAM and OMEPRAZOLE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of UNK dosage form. On 02-Apr-2021 at 3:15 AM, LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) had resolved. At the time of the report, IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed) outcome was unknown. It was reported that after the 2nd dose, within 75 min, the patient passed out after going home until 3:15AM the next morning (02Apr2021). The patient reported that the nurse at the vaccinating facility, after checking with the Doctor gave the 2nd dose in spite of the patient's concern (he was feeling sick on that day) if he needs to wait for the 2nd shot. The patient stated he made a terrible mistake getting the 2nd shot while still sick from the 1st shot. He is going for lab tests the next Monday (14 Jun 2021). Other treatment information include more amount water. company comment:Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-218564 (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.

3/15- 16 - tightness across upper back/shoulders into upper arms in the morning, rested and took naproxen 3/19 - major symptoms, tightness across upper back/shoulders, tightness/pain across chest, extreme fatigue. This happened while grocery shopping mid-morning. Wondered if it was a mild heart attack. Nearly abandoned shopping cart, but checked out, went home and rested for several hours. 3/23-24 - woke up with similar symptoms as 3/19, though not as bad on 3/23, but worse on 3/24. Rested on 3/24 until appt with Primary Doctor.

Atrial fibrillation with RVR I woke up on 6/26/2021 in AFib. Went to the ER and they confirmed that I was in AFib. I was given Metoprolol through IV to lower my heart rate and they also doubled the Metoprolol prescription that I was taking. They added Eliquis to keep me from having blood clots and a stroke. I was admitted to the hospital overnight. The AFib began about 1:00 am on 6/26 and it went back to normal sinus rhythm about 10:00 pm on 6/26. I was released from the hospital the following day. I have an appointment with my cardiologist (listed above) on 7/9/21. I do not know if the AFib will return or how long I will need to remain on the new prescriptions.

I had brief episodes of atrial fibrillation lasting about 30 seconds; I woke up with tachycardia of a heart rate about 130 to 140 beats per minute; my arm had some swelling; I felt a little fatigue; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 250202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) (seriousness criterion medically significant), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue). On 28-Feb-2021, ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Patient received vaccine in left non-dominant deltoid. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Approximately 15 minutes after dose I experienced rapid and fluttering heart beat. I also expreienced fairly intense heat and forehead sweating. I notified the attending nurse and she said she would reccommend I stay in the lobby for an additional 15 minutes. She checked on me again, 15 minutes later, and my heart palpitations had slightly subsided. We agreed it was probably ok for me to go home. This also occurred on my later second dose one month later but to a lesser degree. In both vaccinations I had a fever for a few days and stayed in bed. No further complications continued.

The vaccine was recommended to the patient by his hematologist. After receiving the first dose the patient experienced fatigue, headache and his thrombocytes level dropped from 111,000 to to 91,000, then fro 91,000 to 61,000. At that point his doctor increase the prednisone from 10mg to 20mg daily. The patient will continue to be monitored closely by his doctor.

4-13,14,15,16 : Fever and sweats while sleeping. Palpitations / rapid heart rate prior to sleep. Upset stomach.

Beginning 1.5 hours after the 2nd Moderna dose, my hands began shaking, and my arm was sore. These symptoms continue today and have not gotten better. Beginning 2 days after the shot, my left foot from my toes to my ankle turned black and green. Beginning 1 week after the shot, my toes turned purple; this has continued on and off since May 5, 2021. Beginning 2 weeks after the shot, the lymph nodes in my neck, roof of my mouth, nose, and ears were swollen and tender. At random times, I would get hot and begin to sweat profusely 2-3 times per day, and my ears would get extremely red. At this time, my temperature would be between 100F and 101F, and my blood pressure was elevated. These symptoms lasted about 4 weeks. Beginning 3 weeks after the shot, I developed a walnut-sized, squishy knot on the inside of the joint of my left elbow. I also began losing the hair in my armpits and have since completely lost all the hair in my armpits and on my legs. Beginning 4 weeks after the shot, I developed a golf-ball-sized, squishy knot on the inside of my right knee, similar to the one that appeared on my elbow. I also developed a walnut-sized, squishy knot on my left knee just below the kneecap. Beginning 5 weeks after the shot, I developed shin splints but had not completed any running or other activities that could explain the tenderness in my shins. Beginning 6 weeks after the shot, I noticed a loss of muscle mass in my arms and legs. Beginning 7 weeks after the shot, I have had severe chest pain three times. Each felt like I was having a heart attack; 2 times were in the middle of the night and 1 time was early in the morning. Beginning 8 weeks after the shot, I began getting lightheaded at random which has caused me to fall multiple times. In addition, I have begun bruising very easily; the bruises take weeks to heal. My left eye is also extremely tender and waters more than normal. Beginning 9 weeks after the shot, I notice that I have begun drooling even though I have never drooled in the past. My gums occasionally feel tender when I brush my teeth.

Unable to Breath, Excessive pain, Pulmonary Embolism. Resulted in Hospitalization. No prior history of PE's.

Myocarditis; chest pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, 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 experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (chest pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. 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.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. 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.

Pt received dose #1 Moderna COVID19 Vaccine Observed x 15 mins Left and went to his office where he exhibited "pounding chest & cold hands" Came back to clinic about 30 minutes after vaccine BP increased 180/100 HR 145 EMS called

During the observation period, vaccine recipient began complaining of his heart racing. RN observed flushing to patient head and neck. HR of 64. Patient taken to the ED for further evaluation and monitoring.

Patient stated he felt tachycardic post vaccination. Vitals were done HR was 119 BPM, rested and HR was 110 BPM, Family stated he has cardiac history, he felt better and left with his family.

Patient complained he felt tachycardic (HR was 74 BPM) he stayed for enhanced observation and stated he felt better HR was 64 BPM

tingling, dizziness, lightheaded, vertigo; seen & cleared by EMS. B/P-193/112, blood glucose- 226. Client declined further evaluation @ emergency room as recommended by EMS.

My Blood Pressure's High and Low readings jumped up 20-30 points on 01/16/2021 to 01/22/2021 when my PCP ordered my Lisinopril 10mg increased to 20mg. and came down 20 points each that night and normalized on 01/23/2021.

Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing, muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine. On 1/22/21: patient was seen by medical provider for "altered behavior". Per medical provider's documentation: "Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit". We did MMSE today: 22/30 score "mild dementia" On 1/23/20: "Patient was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am."

Temperature increased to 100.1 F, blood pressure elevated 148/92, dizziness with fall, radial pulse rate increased to 120/min, shortness of breath, rash

I got my injcetion on the 'top' of my shoulder. I didn't see it go in, but noticed entry point at home. Into the evening I started getting beyond normal reaction. I had a very stiff shoulder joint with pain, beyond that of my existing condition. It was severe the next day. Saw my doctor, for the first time meet, and mentioned the reaction I got, but he said it will go away. During the doctor visit I had elevated BP identified, which wasn't normal for me either. That evening I had additional symptoms that included swelling at the proximal points on the thumb and index finger, this also included the wrist. All symptoms have since subsided to normal. No other symptoms.

Received Moderna Covid Vaccine #1 on 12/26/20 in left arm. Had arm pain first few days. On 12/28/20 he began having right calf pain that worsened over the next few days. Was evaluated in Urgent Care and diagnosed with an extensive DVT. No history of previous DVT or venous issues. Pt was on Plavix and ASA at the time for dx of CAD.

Flushing and pressure feeling in my head/face and ringing in my ears increased immediately after injection. Then proceeded to get a slight noticeable increase in heart rate. After setting for approximately 15 minutes I was released to leave. I mentioned to them that I just lived down the street and told them if I had any further issues or symptoms I would call them. Approximately 30 minutes later I was having a slight lightning of the throat or airway and some slight tightness in breathing. This tightness continued for approximately 2 hrs. I called the clinic and was attempting to get there recommendations but the nurse had left. I was told to get the ambulance personnel. As a prior EMT I felt that an ambulance was not needed at this time. I took 2 ea Benadryl tablets and those symptoms lessened. Some numbness in lips and face, and felt heart beating in lips. That all subsided as well after taking Benadryl. Still trying to get with a provider that could give me advise moving forward. The doctor was busy with an Emergency.

CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis

Chills, shakes, fever, badly aching muscle and joints, headache, soreness at injection site, raised BP and HR, 12 hour duration of symptoms

- sore shoulder at injection site for two days (mild); - red rash after 24 hours on arms, thighs (no pain or itching); - after 4th day, headache, swollen neck glands, chest pressure, dizziness, sore throat, fatigue - ongoing

Intermittent low spO2 ranging from 90-93. Normally lasts ~15min, then back to normal. No ill effects, my watch measures spO2 and let?s me know when low.

Family called informing RN that patient was rushed to the hospital on 2/6/21 at around 1:30am because the patient is having chills, fever and mild chest pain that time. At this time, patient is still currently admitted at the hospital.

Significant spike in blood sugar - 399 - within 20 hours of getting the shot. Self administered additional 5 units of Humulin 70/30 and the spike was lowered to 164. While it may not be related, I felt it should be reported as my numbers have been stable.

never symptoms of heart condition with no medication ,age 65, the day after shot, I had severe chest pains left side of chest. went to hospital and had 99% blockage widow maker and another blockage. 6 living siblings, no heart condition in family, neither parent with heart condition prior to mother at age 90. Not sure if its connected to vaccine, I would like to know others had same, hopefully help other people

History Chief Complaint Patient presents with ? Elevated Blood Pressure ? Dizziness multiple times a day Patient who presents to the emergency department today for evaluation of hypertension, head pain, blurry vision, and neck pain. He states about 6 months ago he had open heart surgery. Since that time he states that he has been having intermittent episodes of blurry vision usually lasts a few minutes and resolve on their own. Today however, he notes that the blurry vision lasted for greater than 5 minutes and he started to become concerned. During that time he also began to experience some pain in his neck and a headache in the back of his head. He took his blood pressure at that time and noted that his systolic blood pressure was in the 190s. This alarmed him and so they called EMS. When EMS arrived they rechecked his blood pressure again and his systolic blood pressure was over 200. Upon arrival here to the ER he states that he is feeling much better and his blood pressure appears to be better as well. At this time he states he still having some right shoulder pain and a little bit of right-sided neck pain but he does state that he had his Covid vaccine yesterday in his right arm. Currently patient states he still has a little bit of a posterior headache but it is much improved. He denies any fevers, body aches, chills, cough, chest pain, shortness of breath, palpitations, lightheadedness, nausea, vomiting, abdominal pain, diarrhea, constipation, dysuria, hematuria, or swelling of the lower extremities. He has no known drug allergies. ? ED Course: I discussed physical exam finding with patient. Apparently most of his symptoms have already resolved at this time. His blood pressure is back down to 142/98. I still advise since he was having some weird blurry vision I would like to get a CBC, CMP, troponin, EKG, and a chest x-ray. Patient agreeable to this plan of care. We will also continue to monitor his blood pressure to ensure that it does not spike back up. Patient's work-up was unremarkable. His blood pressures down to 123/60 and states he is feeling much better. This point time it sounds like what happened was a hypertensive urgency. I advised him he needs to contact his PCP and schedule close follow-up discuss if anything further needs to be done. At this time though he is safe to be discharged home with strict return precautions. ED Course Procedures Clinical Impressions as of Jan 20 2235 Hypertensive urgency Plan: New Prescriptions No Prescriptions at Discharge. Disposition: Discharge

Received my second shot on 2-08-21 at 12:30 am ,next morning my left hand on arm I received my shot all my finger were numb and cold to touch. Tips of my fingers were blue and tingly like they had no blood flow. As of 2-12-21 only slightly improved

I saw the patient in consultation during his hospitalization for pancytopenia which proved to be severe aplastic anemia after bone marrow biopsy. He has been a blood donor. 1/4 Moderna vaccine HGB 1/8 12.8 - blood bank refused him to be a donor due to the HGB being too low. Recommended to repeat CBC at his primary care office. 1/26 7.8 1/29 7.1 1/30 5.7 No reticulocytes

Began to experience UTI type symptoms, with uncharacteristically frequent urination, and some burning. Began to have a fever which over the 24 hour period went from my normal of 97.6 to 101.2 at 10:30pm the second night. Throughout the period I had a mild headache and significant fatigue. I woke up this morning at 12:30am with the sheets, pillow and pajamas very wet (from sweat). I checked my temperature and for the first time in 24 hours, it had dropped (to 99.2). When I got up at 6 this morning, my temperature was 98.6 (still a little elevated for me). My wife experienced practically the same thing 4 days earlier without the urinary symptoms and temp not quite a elevated. We had the vaccine at the same time(s). I'm still fairly fatigued at this time (and my wife a little).

I awoke at 3:00 a.m. this morning (Feb 16) with itching in my skin beginning to be felt. By 3:30 am it was widespread and developing a rash over much of my torso and arms. This appears now to have run its course. My nose and lips swelled. My nose became hard and numb. Both now less swollen than early on. My body temperature was 95.4 degrees. I felt dizzy when standing, and there were waves of mild nausea. I had major nasal congestion and could breathe only through my mouth. My CPAP machine (which I use all night every night) was on before the 3 am wakeup, and I donned it again when I returned to bed at around 4 am. Nasal congestion now has improved a lot. On two occasions (maybe around 4 am) I noticed a minor wheeze. On a couple of occasions I coughed lightly, and it was a sore one from the chest. I still have some dizziness, and now an intermittent headache. Before going to bed last night I took two Naproxen Sodium PM tablets for some neck pain.

unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "doesn't remember any of it", "unconscious", "near death experience", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; "difficulty breathing", "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "Moderna shot is killing him", and "he is dying". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". At an unknown time later he experienced "difficulty breathing", "lost consciousness" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "dying", unconscious for almost a week". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results "didn't find anything". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, "loss of consciousness", "headache", "feeling abnormal", "weakness" "decreased appetite", "insomnia", "amnesia", " aphasia", "dysarthria", "confusional state", "dyspnea", "fatigue", " myalgia", "arthralgia", "chills", "nausea", "vomiting", " pyrexia", "urinary incontinence", and "dizziness" were possibly related to mRNA-1273.

After waiting 15 minutes, I got in my car to return to work. Approximately 25 minutes after receiving the vaccination, I became flush, felt hot and had a red face and neck. I felt lethargic and a little dizzy. The redness diminished throughout the rest of the day and for the next day I felt a little lethargic, dizzy, and weak in the knees. I returned to the facility and EMTs took my vitals. My blood pressure was slightly elevated but, no other negative indications. They released me.

Approximately 16 minutes after receiving the vaccination, I began to get quite dizzy. The staff was notified by my wife; and, a Pharmacist responded immediately to check on me. As minutes passed, I became more dizzy and was experiencing a mild "out of body" type experience as though I was in some sort of a dream. Knowing in advance that many people had experienced adverse reactions from these vaccines, my wife and I had brought along an "eppie pen" in the event I might experience something similar. The problem was that my "pens" had expired in 2015. My condition improved when I lifted my facemask to get more air. While the Pharmacy was obtaining a new "Eppie pen" for me, the Pharmacist told me to take the mask off. This stabilized me until we left after 45 minutes. I did not need to use the new Eppie pen. Still dizzy, my wife helped me to my vehicle. Enroute, being somewhat weak, I clasped against a parked car and to the pavement. During the trip home, my muscles began to ache and my joints stiffen and hurt. A heaviness began to present on my upper chest.

experienced epistaxis 2-3 x daily for approx 3 weeks, self ordered platelet count and it dropped significantly since 12-31-2020 and last blood work. Currently the frequency has slowed down.

Went to pcp two hours after vaccine. EKG given and was told by my doctor I was in AFIB and needed to go to the ER immediately. Spent a couple hours in the ER and then admitted for six days. I am still in AFIB

Patient was given COVID vaccine shot #1 on 1/4/2021. As of 1/8/2021 he was prohibited from donating blood due to a hemoglobin of 12.8. 2 weeks later he presented to donate again on 1/26/2021 and his hemoglobin had dropped to 7.8 without evidence of bleeding. He was subsequently admitted to hospital on 1/29/2021 - where he was found to be severely leukopenic and thrombocytopenic. A bone marrow biopsy revealed a diagnosis of severe aplastic anemia. He remains hospitalized but is now at another location. This has also been reported through VAERS.

severe reaction within 48 hours of the vaccine , sent to the hospital with uncontrollable bleeding, in ICU with thrombocytopenia

within 10 minutes of vaccination (administered 11:50 AM) felt weak and tired, became pale and diaphoretic. Pulse weak, irregular. EMS promptly arrive (1 block away) and transported to Emergency Department (within 1 mile). Found to have new onset atrial flutter with rapid ventricular response and BP systolic 86. Improved with diltiazem. Also treated with diphenhydramine and methlyprednisolone

vomit, diarrhea, chills, lost consciousness, BP drop. Paramedics brought to ER. Given fluids, EKG, and lab tests to make sure it wasn't heart related. Tests came back normal.

Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient. Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD. There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.

Patient with h/o afib presented to ED on the next day with shortness of breath after having with full-body chills, associated diaphoresis, fever temp 100.6, HR 120 and palpitations after receiving the 1st dose of the Moderna Covid vaccine. Patient had Covid+ back on 12/21. Patient was given IV fluid bolus and Tylenol. Discharged after reassuring labs and imaging. Fever has resolved.

ER admission on February 27th, discharged with a diagnosis of Bilateral Pulmonary Embolism and DVT of lower limb

Patient started experiencing dizziness, blurred vision, a "rush", increased blood pressure, feeling hot, tingling in arms, and appeared flushed. Occurred approx. 15 minutes after vaccination. Patient was given water and a snack and was told to take deep breaths. Blood pressure was monitored and returned to normal before patient exit. Patient was assisted by wife. No medications were given.

5 days after injection woke up with severe vertig. Dizziness, night sweats, low blood pressure lated for a week. Still feeling occasional dizziness 4 weeks after first shot

Head aches , severe HTN BP 210/105 HR 60 , general fatique, Has required Losartin 100/25 daily. All labs CBC, CMP, TSH, VIt D, HEM A1C were all normal. I rarely have headaches and never for days, Headache persisted to a lesser degree even with BP now at 150/85 on medication. I am now 1 month pass my 2nd vaccine. I went to my MD and BP is new with no explination.

Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021. On the morning of March 4, 2021, I was still experiencing a right sided headache as well as double vision. I was no longer able to drive at that point. I took my blood pressure digitally at the local pharmacy twice where it was 200/104. I went home to call my physician and also have my wife take my blood pressure manually. My blood pressure at that time was 214/106. I went to the hospital where they examined me and then discharged me with a General Headache without a know cause. I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning. My visit the next day showed an elevated blood pressure, double vision, and a continuing headache. My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd. Later that day my blood pressure was down, but still not in the normal range. The following day, March 6, 2021, I was still having the same issues despite the changes in medication. I took my blood pressure at 6 pm and it was 199/104. I immediately went to another hospital where I was admitted as a "stroke alert" patient in hypertensive emergency. I am presently being followed as an inpatient in order to get these issues under control.

Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.

Extreme chills & trembling which caused muscle spasms and body being rigid to the point of being barely able to move; left shoulder pain radiating down left arm; heart palpitations; duration of these symptoms was 8-9 hours

Symptoms began 3/5/21 and resolved by 3/8/21, included headache, fever, sore throat, fatigue, turning pale, feeling 'woozy', body aches, sweating, nightmares, ear ache and nerve "jumping" bottom lip. Self treated OTC tylenol, ibuprofen, oral fluids.

On 03/11 I received 1st shot of Moderna COVID-19 Vaccine EUA, after about 8 mins I became very light headed and short of breath after about 10 mins. I felt a rush come over my body followed by rapid heart beat. These symptoms lasted about 2 mins then subsided. I really didn`t want panic everyone or go to the hospital all I wanted was fresh air so I left, admittedly not my smartest move but I knew my doctors office was right across the street. After 24 Hrs. still Light Headed, no breathing issues, heart rate normal sore arm no rash.

Superficial thrombophlebitis of the right Superficial Saphenous Vein in otherwise healthy and active patient

Presented to Emergency for ongoing Chest pain. Found triple coronary bypass grafting was needed with a 90% blocked left main artery

Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to septic shock and respiratory failure, and he was placed on a ventilator at Hospital. On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL. On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy. He remains there today. We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.

My husband had a stroke one week after his 2nd dose. The blood clot affected his occipital lobe. Ten years ago he had a stroke in the same area below this area. On that Monday around 7 PM, he took our refuse out to the curb in front of our home. When he came in he did not recognize me or his surroundings. I took him to the hospital by car as I was not sure what happened to him. After testing the doctors said he had a minor infarct. The stroke affected his memory. He was very confused and did not remember anything from the moment of the incident until moments before exiting the MRI machine, approximately 2 hours later. He still cannot recall anything surrounding the incident. We questioned if this was related to his recent vaccination and the doctors stated no, however, we believe it is something that should be reported since it occurred a week after the vaccination.

65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.

patient died at home. apparently he awoke in the middle of the night and asked for help, then collapsed. CPR failed. patient and family did not want an autopsy. suspect sudden cardiac death

Swollen right lower leg. Doppler study revealed multiple blood clots. Stared on Eliquis. Continues on Eliquis at this time and leg still swollen

Patient's wife states that he reported a bad headache about 3 hours after vaccination, that had improved by the next morning. The afternoon of 1/27/21, within 24 hours of receiving the vaccine, patient suffered from a stroke.

Haven't had afib in over two years. At about 9:30pm on March 18 while watching TV I had a severe afib event that lasted over an hour. This was followed by two hours of tachycardia. I finally got it under control by administering additional metoprolol tartrate. If this had continued I would have gone to the ER to have them cardiovert me.

Sudden onset of shortness of breath, chest tightness and coughing. His usual rescue inhaler didn't help symptoms. Up all night long. Unable to lay down as it made his breathing worse. The next day, he did a nebulizer treatment and that helped his symptoms. Unfortunately, he has had an acute asthma attacks nearly every day since. Starting 1 week ago, symptoms have gradually improved. He is still having to use his nebulizer, but not as often, as his usual inhalers have not been ineffective.

2/16/2021 He was transferred to the Regional Hospital of due to low pressure (systole), received CPR in the ambulance on the way to the hospital. He died on 2/19/2021 due to various complications, including pneumonia.

65 yr old male who took his meds this morning, Moderna vax given @ 0840; had reaction to vaccine with HA, change in mentation, and diaphoresis, EMS called and pt transferred to ER; pt has SOB with POX down to 94 percent; went to 91 percent; with epi pen given at 08:51 pt went to 100%; due to his symptoms, pt sent to ER;

Got the shot Saturday patients arm was hurting Saturday and the people at shot clinic told the patient to take Tylenol for pain, Sunday the patient was extremely tired and clammy told the daughter his joints and body was hurting so badly. Sunday the patient woke up with allergy symptoms so patient was waiting it out to see dr until his appointment. The patient finally woke up on 3-31-21 around 5 am and the patient had cold chills and clammy the patient put on his robe then told his wife that he was too hot shortly after. The wife was leaving for work at 6am and the patient was curled around toilet stating he felt nauseous, wife left for work around 6am and then she stated about 15-20 minutes later the husband called her asking her to come back home she stated he sounded very short of breath and just not right, she turned around and got home around 645am and found her husband pale and in his recliner with his mouth open and unresponsive. The wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium

Deep Venous Thrombosis, 5 days of calf/leg swelling, diagnosed 8 days later, treated with Xarelto. Currently being treated.

Fainting; Back Ache; Fever; A Spontaneous report was received from Consumer concerning 65-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting, fever, and back ache. The patient's medical history and concomitant medication was not reported. On 03 Feb 2021, 1 day prior to the onset of the events, the patient received their second dose of mRNA-1273 (Lot number: 029L20A, Expiration date: not provided) via intramuscular route in the in the deltoid muscle arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, after administration of vaccine, the patient experienced fever, back ache and fainting. The fainting was considered as medically significant. Treatment information was not provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome for all events was considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Since leaving the clinic, with use of my left shoulder I have had excruciating pain in and around the shoulder to the point I have considered going to the hospital thinking I?m having another heart attack. I have taken a boat load of Tylenol and it doesn?t touch it. Only thing that helps is to prop my arm on a pillow and not use it.

Pt had second Moderna vaccine around 1100. Because he had dizziness with the last vaccine it was requested that he wait 30 minutes. At the end of the 30 minutes the patient complained of severe dizziness. He also had nausea but stated that this was present prior to the vaccine. The patient was pale and sweaty. He denied any chest pain or difficulties breathing. Attempted to get vital signs. O2 was 96 on room air. HR was 52. Unable to get a blood pressure as the patient would not keep his arm straight. Rapid responders were called to assist and a wheelchair was brought over. When we were going to move the patient to the wheelchair he complained of even more dizziness so we did not move him. He declined any juice due to nausea. He was given a few sips of water and a cold pack was placed on his neck. Urgent triage responded and attempted to get vital signs as well. Manual blood pressure was 80/62, HR 47, O2 97% on room air, respiratory rate 14. Patient denied diabetes or blood sugar issues. He had eaten breakfast and took all of his normal medications. First responders then moved patient to the gurney to take him to ER.

Patient had covid vaccine and then 1 day later, developed worsening PVCs. Patient has a history of PVCs and Vtach for which he has a pacemaker. Patient is historically very symptomatic with his PVCs. These worsened over the course of a week which lead to worsening substernal chest pain and he presented to the ER on 3/15/2021 and due to his history of CAD, was hospitalized for observation, discharged on 3/16/2021. He had labs, echocardiogram while in the hospital. His metoprolol was increased to help decrease symptomatic PVCs. On 3/9/2021, patient developed chills, difficulty swallowing and the sensation of his throat and tongue being swollen, along with some generalized itching. He presented to the ER 3/9/2021 due to these symptoms and these symptoms resolved without interventions and he was discharged home. He then developed lower lip swelling on 3/15/2021.

pt states that the next day after taking the vax he felt like he had a severe flu. He was shaking badly, he had body aches, pains, chills and 101.4 fever. He had a rapid heart beat. His O2 level went down to 86. Today 4/6/2021 he is feeling exhausted and his back hurts. He is taking Tylenol for his symptoms.

I woke up at night and my heart was racing. I woke up from a dead sleep, I was not short of breath and no chest pain. I just feel my heart racing. I was observed for a 4 hours and discharged the next morning.. My blood Pressure was 158/96. I had had Covid-19 tested positive on 12/29/2021. I had the second dose, and I did not experience the same symptoms.

On March 18th I received the Moderna Vaccine #2 at approximately 11 am. A few days later I started to feel tired. Then as time progressed, I lost my libido, sex drive, this vaccine made my vertigo worse...I am dizzy...My heart rate went down 10 bpm and I feel like I have a virus in me. The longer I sleep the worse it feels...If I had to go back and do this again, the way I feel, I WOULD NOT. This vaccine messed up my RNA and the Cytosine's are making me feel ill and not 100%.

Patient presented to ED on 3/16/21 with cough and shortness of breath. He was found to be COVID-19 positive on 3/16/21 at PCP office. Was treated and admitted from 3/16/21 to 3/20/21. Returned to ED on 3/21/21 following a syncope and collapse episode at home that results in a head wound and suturing. Presented to ED on 3/24/21 with hypoxia and was transferred to medical facility where he was admitted from 3/24/21 to 4/1/21.

On March 30th started with headaches then progressed to shortness of breath while moving. Then on April 4th transport to hospital via EMT was tested for Covid 19 results was negative. It was determined that blood clots where found in Right leg & Left leg and both lungs and now blood clot was found in heart. PT has low platelets, low blood pressure. While in the hospital pt was given herapin . Patient has remained in ICU since the 4th to present time.

Swelling in lower right leg, ankle, foot; Venous Doppler ordered; blood clot detected; doctor examination; Eliquis prescribed.

Approx 10 minutes after receiving vaccine, pt called out for help from his car in the waiting area. Was monitoring the area and went to assess patient. He stated he felt faint. O2 sat 94%, pt diaphoretic, pale, drooling, tongue protruding from mouth, eyes open, but difficult to arouse, unable to respond. Epi administered and EMS contacted. Pt then lost consciousness. Grossly diaphoretic, clammy to touch, in and out of consciousness, pupils small but reactive, BP 84/48, R16, pulse 68. Unable to obtain O2 sat as monitor wouldn't register values. Lost consciousness again. Not responding to sternal rub. Gave 2nd dose of epi and maintained airway with jaw thrust. Pt regained consciousness

ten days after the second moderna shot I had a TIA event and was hospitalized. I am in general very healthy and since both JJ and astro- vaccines have had reports of clotting, I thought it appropriate to enter my event into the statistical analysis

Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist and reports he began training again for the spring season approx. 1 mo ago. He had L calf tightness present for a few weeks as well as slightly painful knees which he attributed to his age and mild deconditioning over the winter. He traveled with infrequent stops on 4/2/2021 to visit family. He continued to have discomfort and increasing ankle pain, thus presented to ER. LE ultrasound venous dopplers performed showing extensive DVT: L femoral, popliteal, posterior tibial and peroneal veins. CT also demonstrated acute PE w/in distal R and L main pulm artery and w/in bilateral segmental and subsegmental pulm arteries involving all the lobes. Patient had remote history of LE DVT in 2017 after mild bumping of leg and placed on Xarelto for 6 mo. Had genetic testing completed at that time which was negative. He has had no clotting issues since. ( Received Moderna COVID-19 vaccines on 2/3/21 and 3/3/21. Reports brain fog and fatigue approx. 20 hours after vaccination followed by the above.) Patient discharged on rivaroxaban.

Patient received first Moderna mRNA vaccine 2/20/2021, second Moderna vaccine 3/20/21. Severe flulike symptoms after Moderna vaccine intermittently over 1 day. 3/23/2021 chest pain hospitalized severe pericarditis 750 mL. Also cardiac Cath Lab one of his blood vessels 80% occluded (I do not currently have hospital report) coronary artery stented. Failed Plavix of in-stent thrombosis and myocardial infarction recatheterization fixed thrombotic stent. Following couple weeks has had recurrent pericarditis requiring several hospitalization recurrent chest pain including recently requiring pericardial window.

Diagnosed with pericarditis; Severe breathing problems; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Pericarditis (He also had history of pericarditis when he was 21 years of age (which is from bacteria).), Pacemaker insertion (cardiac) (Patient has 2 pacemakers) and Sepsis. On 30-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) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PERICARDITIS (Diagnosed with pericarditis) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Severe breathing problems) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to DYSPNOEA and PERICARDITIS. At the time of the report, PERICARDITIS (Diagnosed with pericarditis) and DYSPNOEA (Severe breathing problems) outcome was unknown. Concomitant medications were not reported. The patient was under doctor's care. Pericarditis came back after he took the second shot of the vaccine. 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.; 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.

The night after this second Moderna shot began to have headache and low grade fever. Had some mild residual myalgia following first shot Moderna Lot 027AA21A on 03/11/21 in left arm but resolved. Overnight began to develop severe morbilloform rash first in buttucks and legs, then posterior chest, then anterior chest, neck. About 80% of body involved. Then after about 30 hours after inject began to have difficulty with esophageal narrowing. Breathing was okay, Speech was okay. Decided to go to Emergency Room at Hospital when I could not swallow my saliva. In the Hospital seen by nurse practioner and ER physician. They started IV line and gave bolus of Dexamethazone 10 mg. Immediately had relief of swelling in esophagus and some improvement in urticaria. They discharged me with orders to take Prednisone 50mg po Qam for three days. I also took Benadril 25-50mg po Q6H to treat pruritus which worked well. By forth day had 90% resolution of uticaria and pruritus. I had cystic mass develop over right anterior tibial muscle which was red and warm about 5 cm in diameter. This has reduced in size post prednisone. Wearing support stocking and taking Ibuprofen 200mg po BID which as eliminated tenderness and it has shrunken in size. Waiting to see if it resolves or will get ultrasound

Moderna COVID19 EUA chest tightness and shortness of breath, covid negative per rapid test, tachycardia and HR in 180s-190s. elevated BP and hypoxic, narrow SVT found through EKG, adenosine ineffective, admitted for pneumonia later developed chest pain and transferred to Hospital

Pt presented with lingering mild cough and dyspnea after his home diagnosed COVID-19 from 2 mos prior, that seemed to improve with his Moderna vaccine series 2/23/21 and 3/23/21. But he also had new LUQ abdominal pain and painful breathing. On exam he had a firm tender enlarged spleen versus several cm abdominal mass. WBC was > 185, 000, peripheral smear (by lab director) was "full of blasts". I sent patient same day to ER, he was admitted, prelim diagnosis: CML, awaiting pathology results but has started chemortherap as of today (4/19/21).

stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) 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. Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose. Company comment: 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. This case was linked to MOD-2021-076248 (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 these events, a causal relationship cannot be excluded. .

Left lower leg swelling which onset Sunday morning after getting his 2nd COVID-19 Vaccine (MODERNA) on Saturday.

Bell"s palsy, followed by retractable hiccups, and AFib. Bell's palsy was treated with acyclovir and steroid. Still has symptoms, but beginning to resolve. Hiccups lasted 17 days. Two hospital stays for IV medications to try and stop hiccups and get AFib under control. Will begin physical therapy for Bell's palsy on April 29, 2021. Hospitalized at facility two times for total of 5 days

Patient developed sweilling his left calf about 10-14 days after second dose of his vaccine. He had an ultrasound which demonstrated deep venous thrombosis of the left calf.

Moderna COVID-19 Vaccine EUA: patient presents to emergency department one day after vaccination reporting shortness of breath and left flank radicular pain. Found to have widely metastatic urothelial cancer involing the chest, abdomen, and pelvis. Patient admitted to the hospital for medical management. Discharged to hospice care.

stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LOSARTAN, ATORVASTATIN, ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), COLECALCIFEROL (VIT D3), CLOPIDOGREL BISULFATE (PLAVIX), GARLIC [ALLIUM SATIVUM], LIDOCAINE, TIOTROPIUM and CYANOCOBALAMIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram head: abnormal (abnormal) CT scan of head and was told that he had a stroke. No treatment information was provided. Additional concomitant medications included Circulant for an unknown indication. Additional diagnostic tests included magnetic resonance imaging, results not provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

Less than 24 hours after getting his 2nd vaccine patients ICD went off and he went into Ventricular tachycardia and had to be admitted to the hospital for several days.

Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.

I had a syncope event while trimming tree limbs from a platform 8 feet off the ground. I suffered 3 compression fractured vertebrae when I blacked out getting ready to get off onto a ladder to get down. No advance warning, no dizziness, no vision impairment, nothing except a sore knee when I bent over to kneel on the platform in preparation to get on the ladder. It was like someone turned off a light switch and then turned it back on after I was on the ground. Don't remember even getting down or a fall, but I was down on the ground. When I went to get back on ladder to retrieve my equipment I could not lift my leg due to pain and felt like I had a pulled groin muscle. Laid down and could not get up.

hot flash followed by dizziness then fainting. These events occurred at 7:00 AM and again at 11:00 AM. No recurrence after these two episodes.

On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something was different. States he could not make works come out his mouth, make complete sentences. This lasted for 7 or 8 minutes, then cleared up. He called his PMD that morning and was told to go to ER. He went to Hosp. ER, but was then sent to another Hospital. Hospitalized from 04/20/21 and discharged late afternoon of 04/22/21. Extensive blood work done, CAT scan, MRI, Carotoid ultrasound, Echo cardiogram. No signs of A-fib, cholesteral slightly elevated. DX. with TIA. Referred back to his cardiologist Has been under care of his cardiologist for 7 plus years - Pt is an active runner - Runs approx. 6 days a week for 2 1/2 to 3 miles per day. For the past few months he has switched to interval walk/run. After 1st dose of Moderna 03/03/21 - Reports no issues expect slight injection site discomfort. After his second dose of Moderna 03/31/21 - Reports chills 12 hours after injection, low-grade fever (99.0 - 100.0) started 14 hours after the injection. All symptoms resolved 30 hours after injection date and time. Stated he kept notes of this.

Pt with longstanding co-morbidities. Had routine phlebotomy today. It was noted during phleb O2 sat low and BP was elevated. Pt was not wearing O2 and it is ordered for day and night use. He does not wear his O2 as ordered. O2 was placed during remainder of appt. Will f/u with provider.

First Moderna dose on 3/30/2021 had no apparent adverse effects. Patient has persistent low platelet count, which dropped then recovered after the first dose without causing ITP symptoms. Second dose on 4/27/2021: significant muscle pain at injection site starting 8 hours after injection, lasting for 12 hours then subsiding. Significant chills/shivering starting 12 hours after injection, then fever of 102 with body aches and unsteady movement rising and subsiding over 36 hours. Moderate throat irritation and productive cough for 4 hours. Fully recovered from all physical effects by 48 hours after injection. Platelet response similar to first dose, lowered count with no ITP symptoms.

Severe chills, Stiff arm muscles ,Tight Chest, Sweats, Headache, No fever. Any worse would go to E.R. Lasted 48 hours approx.

Patient states that the evening of the vaccine he started having tightness in his left arm and soreness as if he had worked out excessively. As the evening went on the tightness spread across left arm into chest and neck and over to right arm. Felt somewhat better in morning but still sore in both upper extremities. 2 days later (3rd day after shot) he went to use the restroom in his home and could not get himself off the toilet - he describes himself as having lost all strength in his legs and when he went to stand he fell right over. He could not get up and had to be helped to the bedroom. He rested for several hours and used a walker to ambulate around the house for the next several days. Now feels back to normal.

Arthralgia; Chills; Cold sweat; Dyspnoea; Fatigue; Feeling of body temperature change; Nausea; Pain; Pain in extremity; Pallor; Unresponsive to stimuli; This case was received via FDA VAERS (Reference number: 1150577) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Arthralgia), CHILLS (Chills), COLD SWEAT (Cold sweat), DYSPNOEA (Dyspnoea), FATIGUE (Fatigue), FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change), NAUSEA (Nausea), PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), PALLOR (Pallor) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Lactose intolerance. Concomitant products included DIPHENHYDRAMINE, VITAMIN D3 and ZINC. On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Arthralgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), COLD SWEAT (Cold sweat) (seriousness criterion death), DYSPNOEA (Dyspnoea) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), NAUSEA (Nausea) (seriousness criterion death), PAIN (Pain) (seriousness criterion death), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion death), PALLOR (Pallor) (seriousness criterion death) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion death). 27-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) (seriousness criterion death). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 31-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: 104 (Inconclusive) 104. On an unknown date, Blood creatinine: 1.4 (Inconclusive) 1.4. On an unknown date, Blood glucose: 421 (Inconclusive) 421. On an unknown date, Blood lactic acid: 9.7 (Inconclusive) 9.7. On an unknown date, Blood potassium: 4.1 (Inconclusive) 4.1. On an unknown date, Blood sodium: 139 (Inconclusive) 139. On an unknown date, Blood urea: 13 (Inconclusive) 13. On an unknown date, Calcium ionised: 1.18 (Inconclusive) 1.18. On an unknown date, Haematocrit: 42 (Inconclusive) 42. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Paracetamol was taken for the treatment of pain. Patient's wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR. Action taken with the mRNA-1273 in response to the event is not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Death

His oxygen dropped to 88%; Bronchitis, upper bronchitis infection; Meory issues, words wouldn't go together; Sleep apnea, snoring a lot; COPD; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMANTADINE for an unknown indication. The patient's past medical history included Dyskinesia. Concurrent medical conditions included Parkinson's disease. Concomitant products included RASAGILINE MESYLATE, PARACETAMOL (TYLENOL), CARBIDOPA, LEVODOPA (SINEMET), MIRABEGRON (MYRBETRIQ) and DESMOPRESSIN for an unknown indication. On 10-Jan-2018, the patient started AMANTADINE (unknown route) 68.5 mg once a day. On 17-Jan-2018, AMANTADINE (unknown route) dosage was changed to 137 mg once a day. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) (seriousness criterion hospitalization). On an unknown date, the patient experienced BRONCHITIS (Bronchitis, upper bronchitis infection), DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). The patient was hospitalized from 30-Mar-2021 to 04-Apr-2021 due to OXYGEN SATURATION DECREASED. At the time of the report, OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) and BRONCHITIS (Bronchitis, upper bronchitis infection) had resolved and DISORGANISED SPEECH (Meory issues, words wouldn't go together), SLEEP APNOEA SYNDROME (Sleep apnea, snoring a lot) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: Negative. On 24-Dec-2020, X-ray: (Inconclusive) Chest x-ray continued. On 31-Dec-2020, SARS-CoV-2 test: Negative. On 30-Mar-2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, X-ray: Result not provided. On an unknown date, Oxygen saturation: 98%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication also includes RYTARY (CARBIDOPA; LEVODOPA) Capsule, 95 mg. The patient was treated each time with unspecified steroids and antibiotics.The infection would seem to resolve then came right back. On a subsequent unspecified date, the patient visited a pulmonologist and was put on a different round of unspecified steroids, nebulizers and antibiotics and finally the bronchitis infection resolved 100%. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Severe inflammation and pain around heart and lungs, joint pain, nerve pain, vivid malar rash. Looked like a full blown Lupus flare up. I've never had that before.

I have experienced an increased amount of Afib following my Moderna covid-19 vaccinations. I used to be able to expect at least two weeks Afib free between episodes, but on the evening of my first shot on March 12th I had Afib only four days after a typical episode. Then again on March 22nd and 30th. On April 8th I had my second Moderna dose. On April 11th I had Afib again and didn't think that much of it being related to the shot as I had been fever free for over a day at that time. But with episodes on the 13th, 14th, 17th, 18th, 20th(3 episodes) of April that far surpass the frequency of Afib in my history, I have become quite suspicious of the shots as the trigger. The episodes have thankfully been shorter than in the past, some ending within 15 minutes and some as long as four hours. My historical events had often lasted 12 to 18 hours. The arrhythmia events have significantly subsided with only one three minute arrythmia (likely flutter) in the last 12 days and less short duration palpitations as well.

Extreme fatigue, weakness, dizziness, muscle soreness, profuse sweating-no fever detected, heart seemed to race at times, headaches. Started the morning after vaccine, and is still continuing today, 5th day, 5/18/2021. I had to see my doctor today due to symptoms continuing and not improving. Doctor did a Covid test to make sure I didn't now have Covid. Was advised to rest and drink fluids.

Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs Erratic heart rate Outcome: death 3 days after. Heart failure

A few hours after my second shot I got a mild headache, tired, and a bit blurry vision. The next day things got worse with high fever, bad headache, and very tired. The bad side effects went away after 4 days but since then I often feel tired with a mild headache and a little chest pain now and then. Before my vaccination, I played tennis 3 times a week, each time I played about 2 to 3 hours continuously without feeling tired. But after the vaccination, it takes only 15 to 30 minutes for me to run out of breath so I have to slow down to catch my breaths. My stamina is adversely effected after my vaccination . I'm afraid that I have a case of Myocarditis, a condition similar to Pericarditis, which is an inflammation of tissue surrounding the heart, that caused by the vaccine.

Patient received the Moderna mRNA COVID vaccine on 3/5/21. On 3/19/21, patient presented to the emergency department with chest pain starting the night prior to presentation. Patient admitted from 3/19/21-3/20/21 for possible pericarditis.

This is a Physician reporter who is willing to provide further information if needed. The day of the vaccine I started to have tightness like a Broncho Spasm in my chest 30 minutes after the vaccine.. My co-workers told me I was flushed. I was a little short of breath and my pulse was elevated. It seemed to improve after a little time. I started to feel worse on 01/12/2021. Ten days after the vaccine I tested positive on 01/14/2021for Covid-19. I had serious symptoms with the Covid-19. After five months I have been unable to work as a Physician and I am still having. I recently got tested for Polyethylene Glycol and I tested positive on a skin test. I am unsure whether to get the second dose. I also have headaches and memory defects muscle aches weakness and a weak left arm. My headaches happen daily and they vary in severity. I am scheduled to have a Bifrontal MRI tomorrow. I started to have problems with concentration within a week of the vaccine and I am still having problems with that. I experience muscle and body aches as well as neck and shoulder problems. My energy level is improved but still very low. I am scheduled to see a Neurologist. My left arm is very weak from the shoulder to the forearm since that time Radiculopathy.

He got his vaccine, and just didn't feel well, overall feeling like he had the flu, coughing. He had extreme fatigue and not able to assist his wife when she was sick as he was in excruciating pain and the fatigue. He is still having excruciating pain in his arm, shoulder, neck and chest area. He did not have this pain prior to the vaccine itself. The arm did itch like crazy. He did not anything for the symptoms as he is not able to. The itching has gone, but the shoulder and arm pain are still there on the left side only, and headache are still present.

03/30/2021 Chest tightness a few days after my last shot, no pain just tight. called my doctor, went to hospital, they ended up putting in 3 heart stints. doing ok now so far.

May 28, 2021, about 28 hours after receiving the second Moderna shot, began to feel light headed and almost passing out. Breathing became labored. 911 was called and the EMTS arrived. Blood pressure was very low below normal readings. Also did an EKG on site. Was transported via Ambulance to Hospital. IV fluids administered in the ambulance. More fluids were given by IV in Emergency room. Blood Pressure monitored at 152/82 in Emergency room, about 2 hours after admitted. EKG, Chest and Lung Xray, full blood work. Emergency Dr gave 2 mg of Doxazosin scheduled meds and was released. Blood pressure continued to elevate after released. BP meds were still taken as scheduled.

I have had mild AFIB for years, minor short term less than 4 days perhaps once a year. On February 28th I started a very symptomatic AFIB, breathless with little energy and stamina , it lasted 8 days which is double previous events. It then subsided and recurred about 2 weeks later for 11 days. Again a severe episode which prompted me to seek out medical help. I just finished a cardiac ablation because of these episodes. They were far more severe and persistent than previous events.

First symptoms were severe back pain bent over when walking. Later pain in left shoulder and shortness of breath climbing stairs with heartbeat racing. Later developed pain in right thigh and calf. On May 30 emergency room determine blood clots in right leg and both lungs. First Symptoms appeared about one week after second dose on April 19

Patient received his second dose of Moderna on 4/9/21. The evening following the second Moderna vaccine, he developed fever, chills and sweats. He started to develop chest pain in May 2021 that lead to an Emergency Department visit, in which he was treated and released. On May 25, 2021, he was hospitalized at Hospital due a Myocardial Infarction that lead to Cardiac Arrest. He was successfully resuscitated spent 5 days in the Intensive Care Unit. He was informed that he developed Kidney Damage as a result of this event.

1st Moderna vaccine 3/18/21, no symptoms/adverse events. 2nd moderna vaccine 4/14/21, no adverse events until 5/28/21 had lost ability to move left side, was found on floor in home 4 days later on 5/26. Taken to hospital and was diagnosed with stroke. I asked the physician to report this to VAERS and he wouldn't because he didn't believe the vaccine was the cause. CDC states healthcare providers are required by law to report any unplanned hospitalization, disability (no date limit) after covid-19 vaccination, but physician kept refusing to report this to VAERS. My husband was from home independently and is now disabled, unable to move his left side and is going to a facility for long term care.

heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Atrial fibrillation since 2017. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation. Treatment included rehabilitation and learning how to ambulate with a walker. Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. This case was linked to MOD-2021-008992 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.

1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired.

Atrial Fibrillation (4 days non-stop). Doctor administered 20mg Xarelto and 25mg Metoprolol day 3 with AF resolved within 24 hrs. Blood pressure within normal range during episode. Blood pressure has been resistant to treatment since AF resolved. Increased Metoprolol to 50mg approximately 5/6/21. Increased to 100mg 6/16/21. Blood pressure remains elevated at average 145/97.

Pt reported was diagnosed by ER and PCP that he had allergic reaction to Moderna. Pt reports was hallucinating and passed out in shower twice causing 2 ER visits. Previous VEARS report uncertain and felt information collected needed reporting

Patient dob 9/10/1955 walked in for a covid vaccine on 6/26/21. About 10 minutes after administering the 1st Moderna vaccine at 4:27pm the patient fainted on his chair. A man waiting in line for pickup noticed the patient and luckily supported the patient to prevent him from falling off the seat. We provided the patient with a cold compress, cold bottle of water, and some life saver candies as the wife stated he hadn't eaten anything since the morning. We instructed patient to lie down on the back with legs elevated, but the patient refused. Patient also refused calling for ambulance. A member of management was also notified. The blood pressure was monitored at 100/70, 118/78, then 126/84 all taken approximately 10 minutes apart. Patient initially looked pale and felt clammy. With his BP returning to normal, patient is looking more alert and color back. Patient authorized us to contact Dr. his PCP. Patient was with his wife who will be driving him home. Patient stayed for at least 45 minutes before leaving pharmacy.

Patient presented to the ED on 2/21/2021 and was subsequently hospitalized for atypical chest pain and shortness of breath. Patient presented to the ED on 04/12/2021 with Hypotension due to hypovolemia and was subsequently hospitalized. Both visits are within 6 weeks of receiving COVID vaccination.

Three months after I received a Covid-19 vaccine, I developed a urinary tract infection. I was admitted to the hospital with a fever and low blood pressure. Urine culture showed presence of E. coli. This was treated with IV fluids and antibiotics, followed by oral antibiotics. I am still taking Cefuroxime daily to prevent recurrence of the UTI. I had another UTI on March 18, 2021 - this was between my first and second Covid-19 vaccines. The first UTI happened one day after a cystoscopy. There is no evidence that either UTI was related to the Covid-19 vaccination.

passed out due to pain from the shingles; went blind for two weeks; neuropathy in left eye; Shingles progressive around his eyes/ shingles on his face and on his eye; tooth fracture; haemorrhoids; pain in right arm; calcium deposit build up; injuring neck; injuring back; still has pain above left eye; bad tooth ache; toothache and cavity on left side; teeth have become more brittle; fungal rash; low back pain on the right side; teeth have been a real problem; sleep all day; loosing teeth; constipation; gaining weight; muscle spasm; allergies; big knot over his eye; nerve damage above left eye; someimes breaks out in a rash with red spots; fell; rash on outer right leg that was painful; pain in my hips; tired, worn out , exhausted; fever for at least 2 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), NEUROPATHY PERIPHERAL (neuropathy in left eye) and OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera. Concurrent medical conditions included Kidney stones (Kidney stones), Blood uric acid increased, Myeloproliferative disorder, Postherpetic polyneuropathy, CML, Itching, Haemochromatosis and Polycythemia vera. Concomitant products included MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]), ATORVASTATIN CALCIUM (LIPITOR), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]), AMOXICILLIN, LORATADINE (CLARITIN [LORATADINE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ALLOPURINOL, OXYCODONE, PREGABALIN (LYRICA), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS, UBIDECARENONE and DOCUSATE SODIUM for an unknown indication. On 27-Mar-2017, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 15 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles) (seriousness criterion medically significant), BLINDNESS TRANSIENT (went blind for two weeks) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy in left eye) (seriousness criterion medically significant), OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) (seriousness criterion medically significant), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), PAIN IN EXTREMITY (pain in right arm), CALCINOSIS (calcium deposit build up), NECK INJURY (injuring neck), BACK INJURY (injuring back), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), TEETH BRITTLE (teeth have become more brittle), FUNGAL SKIN INFECTION (fungal rash), BACK PAIN (low back pain on the right side), TOOTH INFECTION (teeth have been a real problem), SOMNOLENCE (sleep all day), TOOTH LOSS (loosing teeth), CONSTIPATION (constipation), WEIGHT INCREASED (gaining weight), MUSCLE SPASMS (muscle spasm), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), NERVE INJURY (nerve damage above left eye), RASH MACULAR (someimes breaks out in a rash with red spots), FALL (fell), RASH (rash on outer right leg that was painful), ARTHRALGIA (pain in my hips), FATIGUE (tired, worn out , exhausted) and PYREXIA (fever for at least 2 hours). The patient was treated with TERBINAFINE HYDROCHLORIDE (TERFINABINE) for Fungal infection, at a dose of 250 mg. At the time of the report, LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), BACK PAIN (low back pain on the right side) and PYREXIA (fever for at least 2 hours) had resolved, NEUROPATHY PERIPHERAL (neuropathy in left eye), PAIN IN EXTREMITY (pain in right arm), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), FUNGAL SKIN INFECTION (fungal rash), SOMNOLENCE (sleep all day), MUSCLE SPASMS (muscle spasm), RASH MACULAR (someimes breaks out in a rash with red spots), RASH (rash on outer right leg that was painful) and ARTHRALGIA (pain in my hips) had not resolved, OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), CALCINOSIS (calcium deposit build up), BACK INJURY (injuring back), TEETH BRITTLE (teeth have become more brittle), TOOTH INFECTION (teeth have been a real problem), TOOTH LOSS (loosing teeth), WEIGHT INCREASED (gaining weight), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), FALL (fell) and FATIGUE (tired, worn out , exhausted) outcome was unknown and NECK INJURY (injuring neck), CONSTIPATION (constipation) and NERVE INJURY (nerve damage above left eye) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.

In May, I suffered transient ischemic attack TIA, as a result of that I started taking blood pressure medication. I was not taking blood pressure medication prior to the medication.

Chills, heart arrhythmia or PVC's, extreme weakness, slight fever. Admitted to hospital twice within a few days of each other. I've never experienced that level of weakness and heart PVC's before.

Diagnosed with high blood pressure after receiving vaccine, even though I have been treated by a cardiologist for close to 12 years and have never had high blood pressure. My primary care physician has since played down the idea that my condition is vaccine-related.

After my shot I thought I did really good. I did have soreness and sensitivity but if I touched my arm it was sore. No fever, aches, or pains. I didn't think anything of it. I've had breathing issues for 5 years and I kept telling the Doctor I cant breath and I can't mow my yard. I did a medical stress test and a nuclear imagining afterwards and I assumed everything was OK because they weren't worried about anything. I still had the problems though. 05/13/2021 after lunch my chest felt heavy and that afternoon I had a heart attack and went to ER and it turned out that I had a blockage and the next day on 05/14/2021 Dr. put in 2 stents. I have to carry a card now. First stents in the OM, second stent in RCA. I don't feel the shot caused this but you never know. Now I'm feeling really good. Dose 2 Lot # could be 00821A or 008Z1A

Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Heart attack; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided. Company comment: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Added new adverse event myocardial infarction and upgraded the case to serious.; Sender's Comments: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

high blood Pressure; fever 104F; right arm hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (high blood Pressure), PYREXIA (fever 104F) and VACCINATION SITE PAIN (right arm hurting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurting) (seriousness criterion hospitalization). On 10-Mar-2021, the patient experienced HYPERTENSION (high blood Pressure) (seriousness criterion hospitalization) and PYREXIA (fever 104F) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (high blood Pressure) and PYREXIA (fever 104F) outcome was unknown and VACCINATION SITE PAIN (right arm hurting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) high. On 10-Mar-2021, Body temperature: 104 (High) 104 F. On 10-Mar-2021, Oxygen saturation decreased: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant was provided. No treatment medications was provided. It was reported that patient got transferred to a big hospital within 3 days and was put on ventilator, patient was later transferred to another Rehab Centre. 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.