Moderna

Having Peeing / semi diarrhea problems. Lucky I had a catheter with me; first time needed in a year. Semi diarrhea was something new. Did not eat anything after breakfast, fruit as usual that morning. Bad Headache went away after 48 hours. Felt good after that. Had no fever, ever.

Fever, coughing, drowsiness, generalized weakness. Was found to be hypercalcemic (corrected calcium 14) and admitted 1/2-4. No prior history of hypercalcemia.

Headache, Dizziness, Nausea, Fainted and hit my head on tile floor. Started at 2:30 a.m. on 1/10/2021 and culminated with fainting on same day at 12:30 p.m. Have continued with weakness, tiredness and dizziness. Other reactions have subsided.

Pt complains of severe lethargy since injection (6 days). Severe enough that he is unable to leave the house as is his usual custom. Denies fever. Reports blood sugars lower than normal and he's had to adjust his insulin intake in response to this. Some nausea, but no vomiting. Denies fever.

9:30 client became lethargic, diaphoretic, pale and taken via w/c to triage area. Oriented x 4 - drowsy. States the symptoms occurred immediately, that he felt too warm, felt clammy and light headed. States he has problems with claustrophobia. Cooled area by opening doors, patient removed layers of shirts. EMT personal at vaccine site in attendance. BP 136/78; HR 79; O2 sat 99% on r/a. 9:32 EMS activated 9:36 EMS cancelled per patient request. 9:50 states he feels much better and wants to leave, ambulated down hall and turned back stating he still felt lightheaded. Sat back in chair. States he last ate last night. provided juice. declined cookies. 10:00 States he feels much better, trial ambulation tolerated will without lightheadedness, gait steady. Left with wife to personal vehicle.

Fever, fatigue, headache, muscle pain, chills, pain at the injection site. Still have some side effects 6 days later. Sleep for 10 to 13 hours each night. Totally exhausted.

WOKE UP AT 0700 THIS AM WITH BODY ACHES, NAUSEA/VOMITING, CHILLS, DIZZINESS, WEAK, TEMP 102. ADMITTED 1/21/2021 INPATIENT. IV NS @ 100ML/HOUR, ZOFRAN 4MG IV, LOVENOX 40MG, SOLUMEDROL 125MG IV.

Low grade temperature of 101.2 dealt with by taking aspirins. Overall body ache dealt with by aspirins. Extreme pain in area of left arm/shoulder where the vaccine was given. Arm severely ached for 48 hours in any position, was very tender/painful to touch, and difficult to use or move. I'm pretty tough where pain is concerned with past injuries (broken leg in 17 pieces, severely sprained ankles, broken ribs, broken tail bone from horse accident. This vaccination arm pain was right up there with the worst.

The patient tells me that he had Covid in December, received his Covid vaccine yesterday and felt fine all day yesterday. This morning he awoke with a fever and reportedly coughing a lot. He reports the cough is productive of some phlegm. No hemoptysis. He describes it as moderate to severe. Nothing specific seems to make it better. He does report that he commonly has a cough but that worsened

Pain in left shoulder, Sleeping for hours, Out of control shakes and chills, Hot face. High blood pressure, Temp 98.2

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

The patient reports that approximately 11 hours after receiving the vaccine he experienced chills and felt weak. Then 2 days after receiving the vaccine, he developed a red, itchy rash to his left side approximately 4 inches dixtal to his axilla. The rash is almost completely gone, and chills and weak feeling resolved when the patient woke the next day.

Mild Chest Pain Worse With Deep Breath/chest pain got worse; Felt warm and his temperature was 100 F; Now I have A-Fib; A spontaneous report was received from a consumer concerning a male 76-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, fever, and atrial fibrillation. The patient's medical history, as provided by the reporter, included coronary artery disease. Concomitant medications included carvedilol. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient experienced chest pain that got worse when he took a deep breath. He also felt warm, and his temperature was 100 degrees Fahrenheit. The patient visited the emergency room where an electrocardiogram (EKG) was normal and his COVID-19 test were negative. Because of his history of coronary artery disease, he stayed in the hospital overnight. On 01 Jan 2021, the hospital cardiologist called it a reaction the vaccine, and he was discharged. On 05 Jan 2021, on a follow-up visit with another cardiologist, another EKG was performed, and the patient was diagnosed with atrial fibrillation. The cardiologist increased his carvedilol dose to 6.25 milligram from 3.125 milligram and added apixaban, 5 milligram, twice daily. At the time of the report, he felt fine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, chest pain and fever, was considered recovered/resolved on 01 Jan 2021. The outcome of the event, atrial fibrillation, was considered recovering/resolving.; Reporter's Comments: This case concerns a 76-year-old male patient with medical history of coronary artery disease, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of chest pain and atrial fibrillation and the non-serious listed event of fever. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. However, the events of chest pain and atrial fibrillation may be explained by the patient's history of coronary artery disease.

Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.

1. OK day of innoculation 2. Next day 1/25/21, 7:30 am, Blood Pressure (BP) was 141/76. Temp 98.1, pulse 88. (note my normal temp is 95.5-96.5) 8:30 am BP dropped to 66/46, cold sweat, dizziness. Woozy, passed out, but woke when I hit the deck. 9:26 am, BP up to 85/50, 80 bps, 96.2 degrees. 10:08 am, BP 98/55, 82 pps, temp 96.1. 1:23 pm, BP 88/54, temp 96.1. 6:30 pm, BP 103/60, 82 bps. 8:19 pm, BP 156/72, 80 bps. Temp up to 100.4 degrees. 11:28 pm, BP 125/65, 68 bps, temp 98.4 degrees 1/26/2021: 5:15 am, BP 123/70, 71 bps, temp 99.7 degrees 8:14 am, BP 110/60, 64 bps, temp 97.4 8:02 pm, BP 124/70, 72 bps, temp 97.6 1/27/21: 1:06 am, BP 132/75, 62 bps, temp 97.6. 7:35 am, BP 123/75, 63 bps, temp 95.3 (back to normal range) 1/27/21

My husband had a 2nd series if symptoms beginning the night of the 26th. (4days) after first onset of diarrhea and vomiting the night of the vaccination. (01/22/2021. This required a trip to his primary care doctor on 01/28/2021. His vitals were good, no fever but low blood pressure. Doctor prescribed an anti nausea med. which stopped the vomiting. It is 2 days later and he has lethargic, no appetite, confusion and concerns about getting 2nd shot!

I began having chills, a low-grade fever, sore muscles and soreness at the point of injection at 9 PM on the day of the injection. All of the symptoms except soreness at the point of the injection wore off at about 6 AM the following day. The soreness at the point of injection wore off later the following day.

about 2hrs after shot got really tired, lasted about 2hrs. Next day Sat. in afternoon broke in rash on chest, shoulders, and back. On left arm about 3 inches below injection had a round spot (red) about the size of a tennis ball. Next day Sun. rash got better. Next day Mon. rash got worse. Next day Tues. got better, almost gone by Tues. night. Red spot on arm almost gone. Wed. morning a little rash on chest right below neck.

chills from neck to waist; received it up on my shoulder higher than normal; A spontaneous report was received from a consumer who was also a 76-years-old, white, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received it up on my shoulder higher than normal and experienced chills from the neck to waist. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, six days prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient received his vaccine and reported that he "received it up on my shoulder higher than normal". On 26 Jan 2021, the patient experienced chills from his neck to waist. He felt fine the next day. Treatment for the events, included 3 teapots of Earl Grey Tea, which did not help. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, received it up on my shoulder higher than normal, was not reported. The outcome of the event, chills from the neck to waist, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a white male patient who received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and received shot up on shoulder higher than normal and experienced non-serious listed event of chills from the neck to waist. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event of chills, a causal relationship cannot be excluded and the event of chills is possibly related to the vaccine.

Moderna COVID-19 vaccine EUA General side effects : fatigue, headache, muscle aches and pain, and chills.

Muscle and joint aches, shot site ache, headache, chills, fatigue, no appetite Treating with Tylenol. No abatement yet (9 hours later)

Don't know if related to shot or not. Friday night 11:50 pm woke up from sleep with upset stomach. Took two rolaids and set on toliet in case I needed to throw up or had dirarerra. Nothing happened so 30 minutes later took acid reducer pill and went back to bed. Saturday morning pooped and it was black. Extremely tired all day and about 11:00pm again got an upset stomach. Threw up dark red liquid and had dirarerra and it was black. Sunday again extremely tired and drank lots of water and avoided alcohol drinks. (Had drank some beer on Friday and Saturday.) Poop still black but no upset stomach. Monday felt much better and poop became more brown. By Tuesday I felt back to normal.

Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache and fatigue following receipt of the Moderna vaccine 10 days prior. Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.

1st vaccine mild headache began 3 days after shot and lasted about 24 hours 2nd vaccine severe chills, diarrhea, fatigue began about 24 hours after shot and lasted about 24 hours

About 4 or 5 hours after the shot I had mild discomfort at the injection site, mild chills followed. On February 6th today I had a runny nose like one would have with a mild cold, slight chills. As I type this report at 9:20 PM Feb 6th, my nose has stopped running, and I don't seem to be having any chills. Definitetly worth having the vaccine

Wed. evening and through the night he has a temp up to 102, his body was shaking, weak, sleepy, sore all over

Woke up the morning after my second injection feeling slightly ill, maybe 75% of what I normally feel like. Did a two mile walk instead of my 4 mile run and continued the day as usual although somewhat subdued. I did have chills off and on all day and a temperature of 99.2 which is high for me. Went to bed and slept 11 hours and I am back to 100% this morning.

pt states he developed itchy during the night in various locations on the body. Next day pt also had mild headache and congestion. Pt has not contacted his PCP at this time.

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

Slept all day on 2-5-2021 low grade fever. Very wobbly had to have help getting out of bed and to the bathroom. Was better on 2-6 but still wobbly but not as bad.

On the evening of January 30 I began having chills and shaking. I then went to bed and had difficulty moving in the bed. I went to sleep. When I awoke on the morning of January 31, I was unable to sit up in bed and had been incontinent during the night. My wife called the paramedics to help get me out of bed and to change my clothing. At this time I refused to go to the hospital. The paramedics wheeled me to my lounge chair in the living room. About 1:00 p.m. in the afternoon I asked my wife to help me get out of my chair so that I could take a shower. I was not able to get out of the chair, stand or walk. My wife again called the paramedics and I was transferred . I was in the emergency room until 10:00 p.m. that evening. I was given some fluids IV. The ER staff had me walk to be sure that I was mobile before discharging me. They could not say for certain if this was a reaction to the Moderna vaccination, but thought it could be. Within a few days I spoke with my primary care physician, who concluded that I did in fact have a reaction to the vaccine. She has recommended that I not get the second shot at this time.

fever, muscle and joint pain, significant high fever, severe sinus headache, exhaustion. Symptoms started about six hours after injection. I had a significant fever that lasted for 18 hours. The first night I was unable to sleep because the body soreness and pain would not allow me to get comfortable. I started taking Tylenol shortly after the symptoms started but it did little to mitigate the symptoms during the first 24 hours. By the end second day following vaccination, symptoms were beginning to subside. On the morning of the third day, I pretty much back to normal.

this morning, 2/11/ 21 was fatigued., then had dizziness when gettin up to urinate, had fever 101.8 , gave him 2 tylenol both shoulders hurting ( he has had some shoulder ache in right shoulder for some time)

Patient received Moderna COVID vaccine on 1/20/2021. Shortly after (with in 1 week) patient experienced addominal pain, diarrhea, loss of appetite, and chills.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized, Systemic: Fever, Systemic: Joint Pain

Slight fever; fatigue; On the second day; Symptoms were resolved by the third day; No treatment--just rest on Day 2.

About 1:35 am I was experiencing acid reflux, I prepared some alka-seltzer. As I was beginning to drink it I started to feel faint, My legs started to give out, my glass dropped into the sink, and a was flat on my back on the floor. I got up and went to bed. As I lay there uncovered I began to perspire, but that soon stopped. After 10 minutes I pulled the sheet over me and 30 minutes later I pulled the blanket over me. At about 2:30 am I was feeling normal except for the reflux. I took a full dose of alka-seltzer and have had no more problems since then. I believe the acid reflux was from eating and drinking wine that evening. I don't know of the fainting was from the vaccine or a touch of flu for one hour.

Veteran received vaccine 02/04/2021. He felt very tired/fatigued from Thursday (2/4) until Sunday (2/7). Veteran stated he felt much better on Monday. Then on Friday (2/12) he started having fatigue, diarrhea, headache, and rash from elbow to injection site. He went to a local Urgent Care (2/15), where he received flu and COVID testing (both negative) and steroids. He reported this information to me via phone in the vaccination clinic today (2/16).

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

Pt reported dizziness and disorientation the evening after vaccine. States he "got lost in my bathroom" and "felt like I was going to die". He did have body aches and headache

Injection site sore for two days, joints ached for two days, slightly elevated fever for two days, reduced energy for three days

First 24 hours had cold feet, cold hands sleepy hands and chills ..very fatigued, Within the next 6-hours developed fever---slight fever of 101 that was taken care of with Tylenol. Muscle- aches and slight redness at area of injection. After 48 Hours felt a lot better. No fever--nothing!

Only one incidence of severe dizziness for 10 minutes or so. Very tired for that day and following day.

Fever, achy all over, arm and shoulder pain, other pain consistent with joint inflammation, fatigue, headache. Concerning event was chest pain in the center and of my chest and a bit to each side.

patient was unresponsive for 2 minutes after vaccination. Reaction occurred 10 minutes after injection. Reports feeling sleepy. Difficult to arouse. Team alert was initiated. Patient's vital sign 100/55. HR 61. O2 99%. Patient then woke up and reports that he feel fine. Denies sob, chest discomfort, or difficulty breathing. He was sent to ED for further evaluation due to low BP.

Pt called to report having chills and diarrhea on 2/24/2021. Spoke to pt on 2/25/2021 and he only reported chills and he took some Tylenol and they subsided. Pt is having no issues reported on 2/25/2021.

pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.

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

Vomiting x3, chills, headache, sweats started 2/24/21 Denies fevers but also admits he has been on Abx and Motrin prior to taking vaccine for his tooth being pulled.

Moderate nausea, loss of appetite & mild fever with chills - all expected. Unusual/ Adverse effect was a significant change in heart rhythm. Patient is consistently in A-Fib post PaceMaker insertion (June 2020). He is paced at 70 bpm when in A-Fib. His hearth rhythm went into sinus ~2.5 days post vaccine, and has remained so since. Change is quite unusual and has only occurred once since pacemaker insertion (October 2020) when he had a significant flu/cold event. More relevant is the increase in systolic blood pressure by over 20 pts.

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

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

Day 1 2/22 ? 2/23 4:00pm-4:00pm 99.3-103.9 Day 2 2/23-2/24 4:00pm-4:00pm 97.5-105.1 Day 3 2/24-2/25 4:00pm-4:00pm 98.6-102.8 Day 4 2/25-2/26 4:00pm-4:00pm 97.9-99.8 Day 5 2/26-2/27 4:00pm-4:00pm 97.5-99.6 Day 6 2/27-2/28 4:00pm-4:00pm 97.3-99.7 Day 7 2/28-3/1 4:00pm-4:00pm 98.1-100.4 Day 8 3/1-3/2 4:00pm-4:00pm 99.1-103.8 Fever and chills that continue to the present day - day 8 after the vaccine

Pt developed severe fevers, myalgias, headache, inability to take PO day after vaccine, developed significant AKI and required hospitalization - overnight observation. Was hospitalized 2/23 - 2/24 and had resolution of symptoms, improvement in AKI and was stable for discharge home.

Initially night of the vaccine 3/2/2021 body felt hot, felt sweaty but temp was 98.0, unable to sleep through the night. just felt uncomfortable. Morning of 3/3/2021 woke up with extreme pain in injection sight, sweaty, but cold, dizzy and weak, no fever., Could not stand up. Was sat down on sofa for maybe 2 mins. all of a sudden shoulders drooped, head fell forward, I asked "dad are you ok" there was not a response, I walked closer to him and his head flew back, his eyes were slit open, and he started gasping for air 3 times then slumped forward and passed out. 911 was called paramedics checked all vitals including blood sugar, oxygen, heart rate etc everything registered as normal.

stiffness soreness across both shoulders, shoulder blades and base of neck - started about six hours after injection but worsened in bed overnight. Began to ease off after 26 hours. Awakened 20 hours after shot with sense of lassitude, sluggish thinking - like the drowsiness an antihistamine may cause. Just felt strange almost not really present in the moment sensation. This is still still ongoing after 30 hours but easing off significantly. no fevers, chills, myalgias or flu feeling. no local swelling or redness at injection site. This odd feeling did not interfere with daily 10000 step walk. Feel much improved after exercise.

Vaccinated at 11:00 a.m. Started adverse reactions at 3:00 a.m. Fever of 103 degrees, nausea, diarrhea. Overall tiredness.

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

Starting afternoon after vaccine, extreme fatigue, sore muscles, achy, fever 100%, oxygen level lower than norm (95%). No appetite.

Had bad chills and bad aches and pains that kept me on the couch for about 6 hours, unable to function normally. Not even able to watch tv

2 days of fatigue, 1 day diarrhea, 1 day mild fever and five days of a dry cough - all starting 3rd day after second vaccination

Feeling cold weak fatigue very slow gate tired sleepy beginning 5 days after vaccination with moderate improvement in next two weeks with above symptoms, but repeated drops in blood pressure starting around day 8 and persisting to present with episodes of a fib episodes 2 days later and brief leading to present prolonged episodes of irregular beats and prolonged a fib.

3 weeks after the inoculation I awoke and was sweaty I had on o and off fever all day, headache, aches pain. This lasted 1 day. The next day I awoke with a sweaty nightshirt, but feeling ok.

Saturday- Started to develope a fever 99 around 7 pm, increased to 100.5 by 10 pm -took 325 mg Tyelenol-slight chills and aches - fever increased to 103.7 by 3:30 am -took 650 tylenol - fever around 102.8 about 8 am- strong chills throughout Sunday - fever in the 102 range - aches - just closed my eyes and was semi asleep. - Monday the fever was now in the 100 range-chills were not as violent - I stopped feeling like a zombie - Tuesday -no fever/chills, feeling better. ps -had covid in Dec 2020

1st shot flu symptoms exactly 12 hours was feeling better 12 hrs later,,,,,, 2nd shot flu like symptoms 16 hours after shot , day 2 had weird headaches for 5days,had covid in october ,still no taste or smell

Presented to healthcare with c/o N/V throughout the night. VS show tachycardia and fever. 156/87, 108, 20, 101.3. IV fluid for hydration, Zofran for nausea and Tylenol for fever. Monitor

The morning after the second Covid 19 shot I woke up with soar joints, fatique,. dizzy. Throughout the day chills, then hot, no energy.

Moderna COVID-19 Vaccine EUA 0300 on the 10th, flu-like symptoms, headache, 100.8 fever, complete body ache, dizzy spells complete bed rest, hydrate, soup, TYLENOL 0900 on the 11th, fever has returned to normal, some body ache remains, dizzyness has subsided

3 - 4 hours after dose ( Dose approx 1030 am reaction 2-230 pm) Light headed then dizzy blood pressure dropped to As low as 85 over 48 then appeared to have a small seizure and passed out. He recovered before ambulance arrived and blood pressure returned to 112 over 68. Then higher when EMT took it after arrival. Today (1day later) he has a bit of a sore neck and is still a little tired. Blood pressure 133 over 70 which is slightly higher than is normal.

Started 5 days after vaccine with dizzyness, nausea, sever headache, stabbing pain in left thigh, and continued soreness left arm at injection site. Has doctors appointment on 03/15/2021

first day I had chills, tired day three I had a feeling that my herpes was acting up so I took 2 Valacyclovir tablets, and one each day for the next two days, I then noticed on day 4 that my left arm in the area of the shot was very red and very warm, then it has progressed in size down to my elbow and on day 7 it is still red and warm

Second injection at 1:00 PM- around 7:00 PM * 6 hours later ) Fever, chills, nausea, skin is sensitive, loss of appetite, and severe tiredness. As of 24 hours after injection, side effects remain the same or worse. Severe chills throughout the night, only waking to urinate. He did wake up, took a shower only to have alot of coughing and chest discomfort.If he is not better soon, we will take a trip to the ER.

Fever, chills, very tired, extensive redness and swelling at injection site, large fluctuations in blood pressure and heart rate for at least a week, requiring hospitalization

The first three day I felt achy all over, if the afternoon felt chilled. My right arm was sore to movement ,like triceps/bicep area. It was very sore when I moved them. I did have a stiff lower back, sore when I get up and down. I did see my PCP and she put me on a topical cream and arthritis medication, but doesn't believe it's related to the vaccine. It seems like it's getting better, but I will make a move and will hurt again.

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

Chills, Fever (between 101 - 102), Severe Aches, It took effort just to get up out of bed. A very miserable day and a half. It is a little over 2 days since the onset of symptoms and it seems pretty much over. I had mild side effects after the first dose.

The usual headache, nausea, fatigue, but the worst was and still is four days later extreme to the point of screaming with any kind of movement, pain in my left arm. I need help getting dressed and can't pull up my own pants without a little cussing and groaning.

Fever; A spontaneous report was received from a consumer concerning a 76-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever (pyrexia). The patient's medical history was not reported. Concomitant products included chemotherapy. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 002A21A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, next day of receiving vaccine, the patient developed fever and was taken to the emergency room and subsequently admitted on 02 Mar 21 for the fever. Treatment for the event included were antibiotics. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event is not applicable. The outcome of event, fever was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient states he had a fever "a day or two" after he received the 2nd Moderna vaccine. The fever reached 101.7 degree F and resolved within 24 hours. A few days after that the patient states he had a "minor stroke." Patient states the doctor told him that there was a small clot on the left side of his brain. Patient has resulting numbness of the right side of his body. Per the patient the doctor says the clot had nothing to do with the stroke. When asked if the doctor had thought that the vaccine had anything to do with either stroke or clot the patient said the doctor said he didn't think so but also kind of ignored the question.

Modern COVID-19 vaccine Patient collapsed on bathroom floor 20 hours post injection. Could not get up 911 summoned and taken to ER. Given fluids and Tylenol for excess immunologic response. Loss of fluids excessive about 12 hours post injection. Loss of taste 24 hours after injection. Dry cough 48 hours after injection. Long dormant herpes simplex eruption 72 hours injection. Fever continued for 48 hours after injection but controlled with tylenol.

Around 10:15 P.M. on 3-3-2021 my hands became very cold. When going to bed I had uncontrollable chills for around 20 minutes under a bedspread, quilt, and sheet. Around 2:30 A.M. on 3-4-2021 I woke up very hot. My fever was 103.2. Getting up at 8:30 A.M. my fever was 103.3. Around 2:30 P.M. I took two Ibuprofen capsules. My fever started coming down. I awoke at 8:00 A.M. on 3-5-2021 and my fever was 102.7. I took 500 mg of Acetaminophen and by 3:00 P.M. my temperature was back to normal. On 3-6-2021 my temperature was normal all day.

Symptoms: about 20 minutes after eating a headache in back of head and blood pressure drops. Some light-headiness also. After about 45 minutes the blood pressure stabilizes. Had routine Dr. appt. on 3/22 and Dr. suggested it could be an adverse effect from second dose of vaccine. Heart check was fine. It hasn't been quite as severe the last several days. Dr. said to report this to you.

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

Patient and caregiver report redness 7" x 4" around site, hardness, heat to left deltoid with tenderness that developed 3/18 accompanied with low appetite, muscle weakness, and fatigue. Arm symptoms were reported on 3/22 and improving by 3/23. Other symptoms reported on 3/23. They report that on 3/23 symptoms were still present but starting to improve.

Patient developed chest pain at 0500 on 3/26. He took 3 doses of Nitro without relief, mildly diaphoretic, left scapula pain. Emergency responders were called. EMTs performed EKG in ambulance and reported AFib. He arrived at hospital, and symptoms resolved prior to exam. EKG, Troponin checked twice, and patient discharge to home with recommendation to return if symptoms recur and to f/u with Cardiology.

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

Altered Mental state; Weakness, confusion, hospitalization by ambulance, fever 102 for 3 days; impaired speech, upper body shaking Reaction to 1st vaccine required hospitalization with similar symptoms but not as severe; Covid fog. He had similar symptoms to covid last summer with lingering problem. Hospital wanted to diagnose as Parkinsons Disease but he was cleared for Parkinsons last fall and last year. Hospital did not want to file an AE report and did not know the process.

A few hours after the second dose, the patient was so fatigued that he could not walk. He fell down trying to walk. He said his entire body hurt to the point that he could not move.

Caller stated that he developed a fever as from 11:30am of 99.7, 100.7 and last one at 02:30pm 101.7. Patient instructed to reach out to his PCP for further evaluation.

hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold). The patient's past medical history not provided. Concomitant product use was not provided by the reporter. On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021. The action taken with mRNA-1273 in response to the events was unknown. The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this 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. Further information has been requested.

COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction). The patient's medical history was not provided. Concomitant medications reported were metoprolol. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Light headed, assed out in hallway, wife called ambulance Still light headed, fatigued, loss of appetite

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

4/2/21- increased fatigue and right arm reddened and itching in right arm 4/3/21- Temp to 101.7, decreased appetite, worsening tremors and weakness. worsening Parkinson's symptoms that lasted 24 hours.

Sick; Cough; Chest pressure; A spontaneous report was received from a consumer concerning a 76- year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pressure/ chest discomfort, sick/ vaccination complication and cough. The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, vitamin d nos, famotidine, isosorbide mononitrate, levothyroxine, metoprolol, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc, fish oil, pantoprazole and simvastatin for unknown indication. On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, same day of receiving vaccine, the patient fell sick, has chest pressure and was taken to emergency room by ambulance on 19 Feb 2021. He is coughing and took cough medications that will not relief his cough. He was discharged 2 days later, on 21 Feb 2021. Treatment medication included Promethazine and Codeine 5mg: takes 5ml q6H, Benzonatate 100mg TID. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

a couple of days after the shot, I started getting muscle pain, a fever and chills that would come & go and headache with nausea. On april 8th, after lunch I had to lay down on the floor because I thought I was going to pass out. After about ten minutes & breaking out in a sweat, I was ok.On saturday the 10th, I sat down for supper & could only eat a few bites before I thought I was going to throw up.

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

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

Moderna COVID?19 Vaccine EUA After getting the 2nd Moderna COVID shot, the patient was ok for about 10-11 days. Then, suddenly on March 25, he started showing high levels of dizziness and increasing blood pressure. We didn't think much of it and thought it was fatigue and asked him to rest. But, by April 2nd, his blod pressure was around 200/110. We rushed to ER. They conducted all the necessary tests and released him with his blood pressure holding around 170/100 asking him to go to a general practitioner. Then, on Monday we visited Dr. who recommended we wait for 2 weeks to see if the effects will dissipate to determine if it is neurological or if it is vaccine effect. It has been a very very slow dissipation of the side effects. He still has to walk very carefully and feels dizzy all the time. The impact has diminished about 20-25% in about 10 days but 6 weeks after his vaccine, he is still in trouble and is worried.

Lethargy, widespread muscle soreness, nausea lasting 4 days. Signs slightly less severe each day until at day 5 (today) almost normal

Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021.

death Narrative: Patient received Moderna COVID #1 vaccine on 1/28/21. On 2/3/21, he was admitted to a facility for fever, weakness, chills and rigor. Noted history of B cell lymphoma not on chemotherapy at the time. He also had reports of productive cough with thick brown/green sputum. He was admitted to the hospital and given 1 round of methotrexate and Rituxan. Hospital course was complicated with bacteremia (given vancomycin and cefepime), A fib, AKI, HTN, neutropenia (received Neupogen), acute popliteal VT (unable to anticoagulated due to thrombocytopenia - platelets as low as 20). No bleeding issues noted. On 2/18/21, family opted to change his status to DNR with hospice/comfort care and he passed on 2/19/21. No autopsy results available. 22 days from date of vaccine to date of death.

on feb 21, 4 days after second dose, developed a chronic persistent headache in setting of no prior history of significant headaches. --headache: no change in vision or blindspots; blurry vision noted (just had an eye exam in early February - slight change in prescription), location frontal top of hairline, continuous - every waking minute since Feb 21, has surges of intensity (never crippling, but always there), seems to be worse in evening, able sleep, appetite has been down -- nothing improves the headache (meds have no effect), no photophobia, no phonophobia, temperature does not impact it

On 3/25/2021 POC alleges that the resident begin to develop fever and urine infection. He was transferred to the hospital on 3/26/2021 where he had white secretions in his mouth. On 3/28/2021 he died in the hospital from respiratory cardio failure.

STARTING ON THE THIRD WEEK: SEVERE PERPETUAL LEFT-SIDE HEADACHE WITH LEFT BRAIN MODERATE CONTRACTION. NOT SURE AT FIRST BECAUSE OF SLEEPLESSNESS PROBLEM. OVER THE COUNTER COMBO TYLENOL IBUPROFEN ASPIRIN, THEN ADVIL, NOTHING WORKS AS BEFORE AFTER SEVERAL ATTEMPS OVER SEVERAL DAYS. THEN OUT OF THE BLUE WHILE SITTING TWISTING MY BACK TO CHANGE POSTURE, SUDDEN SHARP PAIN AROUND THE WAIST ON THE BACK NEEDING HELP TO WALK UP TO LIE DOWN WHICH USUALLY WILL RECOVER SOON, BUT NOT THIS TIME. TRIED THAI ASAIN BALM[CREAM] RUBBING ON THE BACK WAIST PAIN AREA AND USUALLY THE BALM'S MEDICINAL HERBS SMELL WILL FILL THE AIR AROUND THE BODY, BREATHING IN THE BALM AROMA USUALLY HELP FASTEN THE RECOVERY, SOMEHOW ALL ACHE/PAIN JUST STOP. SOMEHOW PERHAPS COINCIDENTLY ALL ACHE/PAIN JUST STOP FOR SEVERAL HOURS, SO DID NOT THINK IT WAS FROM THE VACCINE. AT THE END OF THE THIRD WEEK HEADACHE CAME BACK THOUGH NOT SEVERE WITH MILD BRAIN CONTRACTION THIS TIME UNTIL NOW THE FOURTH WEEK APRIL 19, 2021 AND SEEM PERPETUAL AS NO PAIN MEDICINE CAN CURE IT, JUST REDUCE THE PAIN A BIT. THAT IS WHEN I THINK IT IS FROM THE SIDE-EFFECT OF THE VACCINE, HENCE THIS REPORT. THE SECOND SHOT WILL BE THIS SATURDAY APRIL 24,2021; SHOULD I DO THE 2ND VACCINATION? TASTE, SMELL NORMAL THROUGHOUT WITH MILD FEVER, NO ACCURATE THERMOMETER AT HOME, STILL SLEEPLESSNESS EVEN INCREASE DUE TO THE HEADACHE WITH FEW MINUTES SLEEP DURATION IN BETWEEN HERE AND THERE THROUGH DAY AND NIGHT. BY THE END OF THIS WRITING HEADACHE REDUCED MUCH MORE AND DO HOUSE CHORES FINE.

Woke up at approximately 4:00 am with headache and severe dizziness. It was so bad it forced me to go to Emergency Room at the Medical Center 3/7/21. They checked my eyes that were bouncing back and forth, gave me IV, did an EKG. Prescribed Meclizine 25 mg for the dizziness, three times a day. Absolutely no help. Went to Primary Care Physician, and he thought it might be an inner ear infection and gave me a prescription for progressive Steroid Treatment. No help. Got appointment for 4/9/21 with Ear, Nose and Throat specialist. At the same appointment was sent to see, an Audiologist in the same building. The two doctors determined it was not an inner ear problem. I was then advised to get a Cat Scan of my Brain and see my cardiologist. I am now in my 6th week of major dizziness which has affected all aspects of my life.

Patient had received second vaccine of Moderna on 4/8/21. Since getting the second vaccine, he had experienced fever and right arm pain. When he presented to Medical Center on 4/14/21, he was acutely confused and febrile (102.8 degrees Fahrenheit). He was empirically treated for meningitis with Vancomycin and Ceftriaxone. His CSF was unremarkable, so antibiotics were discontinued. Patient continued to be altered and required intubation. So far, our other workups have been negative and we are pending the NMDA antibodies. He was extubated 4/19/21 and mental status has returned back to normal and is afebrile.

I have pain in my knees, hips and shoulders. I also have pain in my legs and some time have cramping. I usually walk 2-3 miles per day and my legs never relax. They remain tight at all times. I have pain in my legs when sitting and arising from a chair. The aforementioned joints ache in bed to the point that I have to roll over constantly because of pain caused by pressure. I have tried to stretch daily to loosen the muscles and joints to no avail. I never had any of these problems before. I recognize that the symptoms arose a month after my 2nd shot. After the first dose, 2/8/2021, i had leg fatigue on the forth day only. The next day I had no symptoms and none until 4/10/2021.

patient stated that he had to call the ambulance because he couldn't move. He vomited, was nauseous and aspirated his vomit. He was in the hospital with pneumonia

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

This is a 76-year-old male with dementia who is well cared for at home by his wife who brought him in the the ER on 4/16/21 for for altered mental status and not acting right. Patient is wife states he had his second Moderna Covid vaccine 2 weeks ago and has been declining steadily ever since. She notes he has had brain "fog" with increased confusion weakness and fatigue where he is no longer doing his baseline activities. She has noticed him getting more winded and tired with routine activity and then sleeps a lot. she feels like his dementia suddenly went on a rapid escalation. The morning of his ER visit her concern was he was acting as if his blood sugar was low described him as being sweaty, he was shaking, he was very weak and lethargic. She noted his temp at that point was 92.5 his blood pressure was 139/70 his heart rate was 70 and his blood sugar sugar was over 200. Patient also has a history of diabetes in addition to the dementia and he had a history of alcohol use disorder until 4 years ago when he suddenly stopped drinking. Her main concern was the rapid change since his Covid vaccine and now he is not sleeping at night and he is sleeping more significantly during the day and she is nearing exhaustion at this point. She saw the PCP and they said there is nothing they can do and told her to bring him to the ER

Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.

SHIVERS, SHAKES, hot forehead, cold sweats, dizzyness, unbalance, mussel weakness, joint weakness, flu-like symptoms, bed-ridden, for 2 days,

Hand tremors; Chills; Pneumonia; Sore arm; Fever with fluctuation in temperatures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), MONTELUKAST SODIUM (SINGULAIR), PYRIDOSTIGMINE BROMIDE (MESTINON), MIRABEGRON, TAMSULOSIN HCL and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever with fluctuation in temperatures). On 04-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (Hand tremors) and CHILLS (Chills). At the time of the report, PNEUMONIA (Pneumonia), TREMOR (Hand tremors), PYREXIA (Fever with fluctuation in temperatures) and CHILLS (Chills) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.7 (Inconclusive) 101.7 degrees F.. On 24-Feb-2021, Body temperature: 101.7 to 103.9 degrees f (Inconclusive) 101.7 to 103.9 degrees F. On 26-Feb-2021, Body temperature: 97.9 to 99.8 degrees f (Inconclusive) 97.9 to 99.8 degrees F. On 27-Feb-2021, Body temperature: 97.5 - 99.6 degrees f (Inconclusive) 97.5 - 99.6 degrees F.. On 28-Feb-2021, Body temperature: 104.4 - 103.8 degrees f (Inconclusive) temperature range was 97.3 - 99.7 degrees F.. In 2021, Chest X-ray: pneumonia (abnormal) Pneumonia was confirmed. Treatment for the event included paracetamol. Pneumonia is of an infective origin, hence assessed as not causally associated with mRNA-1273 administration based on the known profile of the product. However, based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Pyrexia and chills are consistent with the product known safety profile. This case was linked to MOD-2021-031492 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Medically confirmed changed. Added Lab data.; Sender's Comments: Pneumonia is of an infective origin, hence assessed as not causally associated with mRNA-1273 administration based on the known profile of the product. However, based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Pyrexia and chills are consistent with the product known safety profile.

had severe headaches that started a week after his 2nd covid shot., he was seen by NP on 2/25/21, was instructed to take ibuprofen short term, labs were drawn and were normal. On 3/8/21 suffered tonic clonic seizures, was unresponsive and taken to ER by EMS. remained unresponsive following the seizures and was placed on hospice care and died on 3/12/21.

Moderna COVID-19 Vaccine EUA. The vaccine activated a latent Chronic Myelo Monocyte Leukemia (CMML) The evening of the vaccine I became very fatigued and was freezing. (A topcoat was donned and I went to bed early. ) By day three the freezing dissipated; however, the fatigue di not. After three weeks of fatigue my physician ordered several blood analyses. High monocytes counts (4.0) and low Platelet counts (105) were revealed. I was referred to a hematologist who ordered a bone marrow biopsy. It revealed CMML 1. A A review of 18 years of monocyte and platelet showed the monocyte counts were hovering at the maximum and platelet counts hovering at the minimum until 03/29/2021 when they escalated to the counts reported above.

On April 3rd after his second shot he felt headache and "fuzzy headed" continued to get worse until he suffered severe memory loss. Could not remember how to lock the front door or put on a seat belt. Went to Doctor who sent him immediately for a head scan. The scan showed a very large brain bleed and he was taken to the ED and they began reversal procedures to the Coumadin with platelets and injection of "K". He had brain surgery on April 23, Burr holes to relieve pressure. Returned home on April 26. On May 10th he was reading the paper and suddenly could not speak and did not have use of his arms or legs. Called 911 and he was rushed to the ED. They did a head scan and found that his brain had an additional bleed. He had brain surgery again on May 12th, Craniotomy. Returned home on May 16th and is still recovering.

Approximately 2 weeks after receiving vaccination, patient developed confusion and lethargy. He presented to the hospital where he was found to be febrile. Alteration mental status continued to worsen, and then had a generalized seizure. Patient was empirically treated for possible meningoencephalitis but diagnosis is not confirmed.

04/2021 Seen in ED for c/o left sided chest pain increased with deep inspiration. Blood work, chest a-ray and chest CT. DX with 2 blood clots left lung and pneumonia. COVID test done - Negative. Admitted to hospital and anticoagulated with Heparin. Numerous blood tests performed. Followed by Hospitalist and seen by Pulmonologist and Hematologist.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure

Copied from Database. Topic: Acute Illness >> Apr 28, 2021 1:30 PM: Patient calling and woule like an appt. He states he thinks he has a sinus infection. He has a runny nose that is clear, congestion, mild cough and a minor headache.He has no fever or SOB Clinical Support Open 4/30/2021 RN COVID-19 virus infection Dx Encounter Notes All notes Progress Notes from RN [Unsigned] Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team: Primary Care Physician: The physician that referred you for the infusion and who will conduct the follow-up appointments related to your infusion. COVID-19 Navigator: The person who will schedule you for your infusion, ensure your follow-up appointments are scheduled and that you have all the necessary tools to track your health. Infusion Follow-up Plan: Day of Infusion: o You will be discharged from the Infusion Center to home. o You will begin recording your temperature and oxygen levels (pulse ox). You will receive prompts from the monitoring program you selected. Follow the prompts for when to record your temperature and pulse ox. Day 2-3 after Infusion: o You will receive a follow-up call from the COVID-19 Navigator to schedule your 7-day follow-up video visit with your Primary Care Physician. Day 8-14 after Infusion: o You will receive a follow-up phone call to assess your overall health. Day 15 after Infusion: o You will receive your final call from the Navigator, and you will graduate from the Infusion Program. You will resume your routine appointments with your Primary Care Physician. When to call your Primary Care Physician: o Please call your Primary Care Physician if you have pre-existing health conditions that you feel need medical attention and are unrelated to your COVID-19 diagnosis and symptoms. o If you are experiencing non-life threatening COVID-19 symptoms and have additional questions. When to call the COVID-19 Navigator: o Please call the COVID-19 Navigator if you have general questions regarding the infusion you received today, questions concerning follow up appointments, or home monitoring procedures & equipment. o You should receive a follow-up phone call from the Navigator within 2-3 days of receiving your infusion. o If you do not receive a follow-up phone call, please call the Navigator When to call 911 or Proceed to the closest Emergency Department: If you are experiencing life threatening COVID-19 symptoms including but not limited to: high fever, trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake or stay awake, blueish lips or face. How to Improve Your Breathing with COVID-19 Try to spend as little time as possible flat on your back! The largest part of your lungs are in the back of your body. When you lay on your back this causes fluid to pool in those parts of your lungs making it harder to breathe. Laying in different positions or sitting up will allow all the different parts of your lung to expand properly. You may notice it is easier to breathe immediately or soon after changing positions. One of the best positions for this is called 'prone position' which is laying face down on your belly. This position makes it easiest for the biggest parts of your lungs to expand easily. This is called 'proning' and the more time spent proning the happier your lungs will be. Laying on your sides or sitting up in a chair is also helpful for breathing and changing positions helps keep your skin healthy. Tips to Help with Repositioning ? Try placing pillows under the chest, hips, and lower legs when lying face down ? Trying different arm and leg positions can assist with comfort ? Eat your meals sitting up in a chair when possible ? When laying on your side, a pillow behind you will help you not to roll on your back if you fall asleep ? If a position is too uncomfortable move on to another; comfort and rest are important parts of recovery ? Switch positions in a rotation to help all the areas of your lungs expand

For 2 days he felt very sick, low grade fever for short time, aches, pain, tired, flu like symptoms and then he was fine.

Received the first and second doses at Pharmacy. Second vaccine shot was on Friday, May 14, 2021, in the left arm. On Saturday, May 15, 2021, I wasn't feeling well. Then later in the evening I developed a bulge under the left arm. The lympth node increased in size; my left arm would ache, especially if I would stretch to reach for something. I have been applying cold packs. This situation has now continued for two weeks.

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

In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported by reporter. Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times. On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. 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. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

Initially - chest pain 10 on 1-10 scale, heart rate 145 BPM, headaches, paramedics said A-fib abnormal heart rhythm, converted as they were checking; went to ER, admitted patient, stayed 5/24-5/27, gave tests including cardiac catheterization, echocardiograms, C-T scans of chest & head - all negative. In ER also found elevated cardiac protein-enzyme. Also in ER, chest pain reduced to 3 on 1-10 scale. Repeated some of the tests next day.

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

One week after 1st shot came down with multiple symptoms excluding vomiting and fever. After 2nd shot at 9:30 AM at 12:oo noon came down with like symptoms that lasted in the neighborhood of 2 weeks. 2nd shot had a temperature rise to 100.3 from a normal of 67.00 to 97.0 Temperature was intermintent.

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

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

Upper respiratory congestion with cough and excess mucous. Treated with Z-pak of antibiotics and antihistamine. Lasted about 1 week

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

Achy and felt tired, so went to bed early. When patient stepped out of bed, he fainted twice within a short period of time. He was found on the floor by wife at one point and had passed out. He then fell down and passed out on the way back to bed. Patient took some Tylenol before bed. When patient awoke the next morning, no other issues occurred.

'lost feeling of the left side'; still has some shingles; laid on his floor and went to sleep/passed out for 2 hours; got a stroke within 9 hours; got really tired; a small clot in the right side; lost feeling of the left side, couldn't walk, and couldn't do anything; lost control of his bladder/urinated in his pants; left arm went numb; the muscle was sore for about a week; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side) and HEMIPARESIS ('lost feeling of the left side') in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Injury, Back surgery, Gallbladder operation, Heart valve replacement and Heart valve disorders. Concomitant products included METHYLSULFONYLMETHANE (MSM 1000) for Joint disorder, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), CALCIUM, ZINC, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D3), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 10-Jun-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HYPOAESTHESIA (left arm went numb) and MYALGIA (the muscle was sore for about a week). On 11-Jun-2021, the patient experienced THROMBOSIS (a small clot in the right side) (seriousness criterion medically significant), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants) and FATIGUE (got really tired). On 11-Jun-2021 at 2:00 AM, the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours) (seriousness criterion medically significant). On 11-Jun-2021 at 3:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours) (seriousness criterion medically significant). On 22-Jun-2021, the patient experienced HERPES ZOSTER (still has some shingles). On an unknown date, the patient experienced HEMIPARESIS ('lost feeling of the left side') (seriousness criterion medically significant). The patient was treated with GABAPENTIN at a dose of 100 mg three times a day and LORAZEPAM at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side), HEMIPARESIS ('lost feeling of the left side'), HERPES ZOSTER (still has some shingles), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants), HYPOAESTHESIA (left arm went numb), MYALGIA (the muscle was sore for about a week) and FATIGUE (got really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: didn't find anything wrong (Inconclusive) didn't find anything wrong and patient mentioned the small clot in the right side.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 72 hours after receiving the first dose of the Moderna COVID-19 vaccine, the patient got shingles. He still had some shingles, and stated "it is leaving but still numbness in a belt from the stomach center to the back of the left side, front side is well, and back is numb". He was taking Gabapentin 100 mg three times a day for the shingles, which was the only prescription medication he was currently taking then. He was also prescribed pain medicine for the shingles which he no longer took as the pain had left. One of the pain medications is lorazepam. The patient received the second dose, and he stated his left arm went numb. The injection was in the top part of the shoulder, and it did not hurt up there, but the muscle was sore for about a week. In addition, the patient stated he "got a stroke within 9 hours" at 2AM on 11 Jun 2021 and lost feeling of the left side, couldn't walk, and couldn't do anything. He went to the bathroom and lost control of his bladder. He urinated in his pants and got really tired, so he laid on his floor and went to sleep at 3AM. He also described this as "passed out for 2 hours". At 5AM in the morning, he woke up and was fine. He went to the doctor on 18 Jun 2021, who told him that he had a TIS or a small stroke. The MRI didn't find anything wrong, and patient mentioned the small clot in the right side. He was never hospitalized. Prior medical history included spine injury, 2 back surgeries, gallbladder surgery, an artificial valve in his heart, and a clogged aortic valve in the patient's heart. He has taken vitamins and supplements daily for the past 20 years. 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-2021-231546 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient is a 76-year-old male with a past medical history significant for dementia, CVA 5 years ago with right-sided hemiparesis, functional parapalegia/wheelchair bound, chronically aphasic, hypertension, type 2 diabetes which is diet controlled and history of BPH who presented to the emergency room on 1/26/2021 with diarrhea that began on jan 18th 2021 and was admitted to the hospital.. Patient spouse reported that the patient got his first dose of the Moderna vaccine on January 14 and then the patient began having a fever on January 18 of 103 degrees and then developed diarrhea which continued. He was started on Imodium by his PCP on 121 with minimal results and was encouraged to follow a brat diet. He was then encouraged by the PCP to come to the ER for further evaluation of dehydration or colitis. Patient was on trimethoprim 100 mg daily for chronic UTIs which was discontinued on admission and therafter. In the ER he tested positive for C. difficile and he was started on vancomycin p.o. 4 times daily. He was also noted to be hypotensive and dehydrated and was started on IV fluids. He remained in the hospital for 4 days and was discharged home on 1/30/21 on vancomycin orally for 10 days with improvement. . He returned back to the hospital on 3/17-3/19 for recurrent c difficile, sepsis and colitis and was discharged on a prolonged vancomycin taper with improvement. He returned back to the hospital from 6/26-7/2 for again c difficile colitis, ileus and sepsis and was seen by infectious disease and gastroenterology and was discharged home on vancomycin orally qid for a prolonged taper. If he again fails this treatment the plan will be for a fecal transplant. He was again admitted on 7/6/21 and remains hospitalized with severe c difficile colitis/diarrhea not responsive to treatment. Now having some streaks of blood in stool. Stool occult blood was neg on admission, however. Also now has concurrent Pseudomonas UTI. CT abd/pelvis 7/7 showed "Marked irregular thickening of the wall of the rectum demonstrating cystic changes. Findings extend into the distal sigmoid colon. Differential diagnosis includes severe protosigmoiditis and neoplasm." and "increased feces throughout the colon consistent with constipation." Pt has been having 2-3 watery BM's per day since admission. Infectious disease concerned about possible undiagnosed malignancy, which may be driving his clinical picture rather than C diff. Recommended colonoscopy and to continue PO vanc x 10 days then resume taper. -pt was transferred to hospital for GI involvement for a colonoscopy/sigmoidoscopy on 7/8/21 where he remains hospitalized awaiting further work up.

Not having control of their bowels; Completely confused; Constant itching; Very lethargic; Never slept past 9am but after receiving the second dose they could not get up before 11am; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL INCONTINENCE (Not having control of their bowels) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VALSARTAN, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METOPROLOL for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced BOWEL INCONTINENCE (Not having control of their bowels) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Completely confused) (seriousness criterion hospitalization) . On an unknown date, the patient experienced PRURITUS (Constant itching), LETHARGY (Very lethargic) and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am). At the time of the report, BOWEL INCONTINENCE (Not having control of their bowels), CONFUSIONAL STATE (Completely confused), and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am) outcome was unknown, and the events of PRURITUS (Constant itching), LETHARGY (Very lethargic) was not resolved. On 06July2021, the caller could not get a hold of the patient. The caller called 911 to check on the patient. The caller found the patient at home completely confused (not knowing themselves or recognizing any family members), the patient was in their underwear. The patient was admitted to the hospital and stayed for about 10 days. The health care providers have done every test possible according to the caller and tests have come back negative and the HCPs stating "the patient is 100% healthy. No treatment drug details was reported.; 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 FOLLOWING SYMPTONS BEGAN ON 5/19/2021 AND COME AND GO PERIODICALLY: GENERAL MALAISE, HEADACHE, FATIGUE, NUMBNESS IN LEFT ARM AND FACE, DIZZINESS, LOSS OF BALANCE. ON THE MORNING OF 6/8/2021 I WENT TO MY FAMILY PHYSICIAN AND THEY SENT ME TO THE ER FOR THE POSSIBILITY OF A STROKE. I WAS ADMITTED TO THE HOSPITAL AND AFTER NUMEROUS TESTS, A STROKE WAS RULED OUT. I WAS DISCHARGED THE EVENING OF 6/9/2021 WITH NO DIAGNOSIS. ALSO I WAS GIVEN A HEART MONITOR THAT I HAD TO WEAR FOR TWO WEEKS AND RESULTS WERE NEGATIVE.

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

3 or 4 days after shot he started getting a cough which caused chest pains, he started getting a tingling feeling in his right leg, heart rate went up and oxygen level dropped

low blood pressure; Central sleep apnea; passed out while on the toilet; chills; nausea; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out while on the toilet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sleep apnea (Recent change in status of chronic condition took place. On 8 Apr 2021 a sleep study found that the patient have Central apnea.) since 13-May-2009, Hypothyroidism since 01-Jul-1977 and Allergic reaction to analgesics (Hydrocodone). Concomitant products included ATORVASTATIN from 2000 to an unknown date for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) from 1977 to an unknown date for Hypothyroidism, VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out while on the toilet) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache). On 06-Apr-2021, the patient experienced SLEEP APNOEA SYNDROME (Central sleep apnea). On an unknown date, the patient experienced HYPOTENSION (low blood pressure). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Feb-2021, LOSS OF CONSCIOUSNESS (passed out while on the toilet) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Central sleep apnea) had not resolved and HYPOTENSION (low blood pressure), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown. Patient needed a machine for central sleep apnea. Concomitant medication also included Multivitamin daily for an unknown indication. For 10 years, the patient have been treated for obstructive sleep apnea with a dental appliance. At that time and on 03 Jug 2016, The Patient was diagnosed with obstructive sleep apnea. In order to get a new appliance the patient needed a recent sleep study. That sleep study on 08 Apr 2021 showed that the patient now have central sleep apnea. The patient have to use a CPAP machine. 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-2021-024979 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Reporters information was updated, Patients demographics and race was updated , Patients relevant historical condition was added, Vaccine facility information added, concomitant medications added, New events chills, nausea, tiredness, and headache was added and outcome of the events updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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

First COVID vaccine given 2/11/2021, second dose covid vaccine given 3/10/2021. Person was exposed to a COVID person. On 7/23/2021 experienced sinus congestion. Tested positive for COVID on 7/26/2021. Received Monoclonal antibody treatment on 7/26/2021.

Fever 99.6F on 12/29/20 @22:41 and on 12/31/20 @03:52 s/p COVID-19 vaccine received on 12/28/20 @13:39. Patient is on standing Acetaminophen 650mg q6h for pain/fever. Acetaminophen 650mg administered 12:29 @22:41 and 12/31 @06:02 with resolution of symptoms. Fever ACETAMINOPHEN 650 MG QID FOR PAIN/FEVER

Moderna COVID-19 Vaccine EUA. Fever of 102.8 after 24 hours. Fever reduced by Tylenol and ice packs. No fever after 12 hours.

Sweating 20 minutes-took temperatures and they were normal. Continued preparing dinner. Some discomfort at injection site for first 24 hours.

leg cramps, BL until 1/13/21, shoulder cramps BL, head felt like it was puffed up, rash started 1/11/21 which was was on the back on the neck, front side had rash but not itchy, rash still on neck, not itchy today 1/14

not much sore ness from the shot at all. on the 1-11-2021 I felt a little flue like symptoms. head ace, low temp 97degres, aches in shoulders, small lymph node under left arm solen , I went to bed and the next morning it was gone. Tonight I feel a little of the aches. not bad but wanted you to know. Im ready for the next shot on the 1-28-2021.

Given Moderna COvVID-19 vaccine during vaccine event at facility. EMS was called 24 hours later for patient c/o nausea, vomiting and headache. EMS note reports they were told patient vomited black tarry fluids yesterday and again that morning. Patient confused but has history of dementia. BP 127/88 126/88 Pulse 96-100 EMS placed patient on oxygen via nasal canula and monitor. Transported to ER. No further info on outcome available.

Have been running low grade fever accompanied with chills off and on since 1/13 noon. Up to now, today only normal fever. Had ingested 2 Extra strength Tylenol at 5:30 am and 11:30 am.

Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21

Don't know if these are adverse events -- they are described in take home information as "General side effects:" Chills, headache, joint ache, muscle ache, extreme fatigue -- lasted about 36 hours. No treatment required other than ibuprofen and sleep (lots of the latter).

Flu-like symptoms, full body aches, short episodes of afib. I had a cardiac ablation over 10 years ago for afib and take flecainide as a prophylactic. Normally I don't not have any afib and haven't had an episode in several years.

Right after receiving the vaccine had a headache in the front of the head which lasted for about 6 hours. About 24 hours later noticeable amount of dizziness making it difficulty walking. Has not decreased since first appearing. Left arm is sore. If it does not clear up in the next few days will seek medical attention.

Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL

Passed out cold around 8 a.m. when heading to bathroom. He doesn't remember anything; woke up at some point half in and half out of his closet; injured elbow. Other symptoms beginning during the night were dizziness, weakness, headache, nausea, fever of 101, chills, extreme fatigue.

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakenss, COVID like symptoms (PT tested positive for COVID 11/21/20, patinet had to take 2 asprinin to help with side effects. Present-sweating, chills, fever, ibuprofen/tylenol rotated as needed

Headache, chills and weakness. Fever.12 hours after vaccination. Extreme confusion, seeing something not there, total weakness, 36 hours after vaccination. All back to normal 24 hours after vaccination.

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakness, COVID like symptoms (PT tested positive for COVID 11/21/20, patient had to take 2 aspirin to help with side effects. Present-sweating, chills, fever, ibuprofen/Tylenol rotated as needed

Went to the ER at the Hospital the day after receiving the vaccination because I had zero energy, no strength in any limbs and could not get out of bed. Dehydrated and high fever were detected.

Chills fever rash on arm right below injection site, also itching on my back. The red rash on my arm is still there today 1/24/2021.

Noted at 5:37pm on 1/18/2021 with a temperature of 100.0 degrees Fahrenheit. Acetaminophen 650mg once administered. Temperature at 7:03pm on 1/18/2021 was 98.6 degrees Fahrenheit. No other side effects noted.

Felt well until later that night of the vaccination, Saturday. About 11 pm I began to have chills, fever, shoulder and back muscle pain and vomited. Slept through the night and felt relatively well the next day. Sunday, felt extremely fatigued but slept well. Monday felt better, less fatigued but at 4pm came down with the chills for 2 hours and then fever up to 102.7 and muscle pain in my hip muscles. Have been drinking electrolytes and water dur to vomiting. Tuesday awoke with minimal muscle pain and only 99.2 fever. Currently feel better had light breakfast and lunch and temperature is 98.9.

Next day diarrhea all morning, imodium , he was cold, clammy, wet with sweat, week pulse at 40 , in profound shock, Stimulated him by shaking and hitting and had him take deep breaths . Pulse was 120/82 pulse up to 60 20 minutes into the event he was stable and alert .

The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.

Pt complained of dizziness within 15 minutes of receiving Moderna COVID vaccine. Vitals were taken, pulse was in the 40's, pt alert and oriented, soda given to see if blood sugar dropped. Continued to monitor, pulse remained low and pt continued to complain of feeling dizzy. 911 was notified and EMS arrived by 12:35pm. EKG strip performed, along with vials from the EMT in the health department. Positive orthostatic hypotension found by paramedic. EMS notified ER doctor on call for recommendations. ER doctor said vitals were consistent with dehydration and could be admitted for IV fluids or return home and encouraged to increase fluids. Wife and pt declined ambulance ride and request to return home.

Began with extreme fatigue, some nausea and constipation that persisted and worsened to the point that patient saw PCP on Monday, January 25, 2021. Abdominal x-ray done on 1-25-21 showed stool in upper colon. Mag Citrate and Fleet's enema prescribed and administered on 1-25-21. Extreme fatigue and weakness continued. Patient called PCP on Tuesday, 1/26/21, but did not receive call back. Patient called PCP again on 1/27/21. Patient was told that abdominal x-ray done on 1/25/21, also showed possible left kidney stone on x-ray report that was read by radiologist. CT scan scheduled and completed on 1/28/21. PCP called patient and confirmed kidney stone lodged in lobe of left kidney that appeared spiked and possibly unable to pass. Presently unable to get immediate appointment with urologist, and pain medication prescribed. Please also not that patient has absolutely no prior history of any type of kidney stone. Still awaiting relief.

EXTREMELY DIZZY, SWEATING, LACK OF APATITE. I HAD TO HOLD ONTO THING WHEN WALKING. TODAY 1/ 28/2121 I AM BACK TO NORMAL. NO SIDE EFFECTS. JUST ONE DAY OF COMPILATIONS

Moderna COVID-19 Vaccine EUA; Experienced Malaise, Fatigue, Aches, Fever, Chills days 6 through 8 after vaccination; fatigue still exists.

WEAKNESS UNABLE TO WALK WITH OUR HELP CHILLS AND EXTREME HEADACHE...SECOND DAY ONLY INDICATION IS MY RED ARE SAME AAT THE FIRST INJECTION.

Moderna COVID-19 Vaccine EUA First Maderna COVID vaccine No Symptoms at all Second Maderna COVID vaccine on Monday Monday: 12 hours after: Headache Some soreness at injection site Could not sleep at all that night Muscle, joint soreness Chills Tuesday Headache Fever Muscle ache Nausea, little appetite Lethargy Napped in the afternoon for a few hours Could not sleep that night. Took 2 Advil at 10:30pm, then slept Wednesday Felt normal on awaking. No headache A few sweats, so probably some fever. Thursday Normal in every way.

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

First, immediately after receiving the vaccine, I cycled 25 miles. Almost immediatly thereafter, my arm got very sore, I had a dull headache, my resting pulse went up about 20 bpm, and my blood pressure dropped from about 120/70 to 102/60. I felt "rough". I played couch potato for the rest of th eday, and was fine the next morning.

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

Swelling and pain in arm for several days. About 1 week after the vaccination, I developed chills, headache, muscle aches,fatigue, swelling of the knees and difficulty walking. I began to improve after 2 days, but recovery was slow.

chills Narrative: When patient presented for covid vaccine dose #2, patient reported the day after covid vaccine dose #1 patient experienced extreme headaches, muscle aches and chills. Patient did not report taking any treatment medications.

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

Post Covid vaccination patient appeared to be starting to fall from chair. He appeared lethargic and unable to speak or hold himself upright. Vitals where taken and 2 liters Via mask administered. Increased to 4 liters after no improvement in pulse o2. wife who stated he was released from the ED yesterday and stated he needed a stent. Patient nodded that he was having substernal chest pain without radiation. four 81mg Asa given and nitro administered after verbally ordered. EMS arrived and transported patient.

Excruciating pain in shoulder . First night was unbearable. Still hurts after three days. Also had flue like condition for about thirty hours. I noticed that the injection was inserted in the top of my shoulder and not on the side. The injection hurt more than any shot I have ever had, and I have had many. I don't know if my shoulder pain was caused by the way the needle was inserted of because of some reaction. I am in excellent health and have the long term covid antibodies.

By 1:30 am on 2/4/2021; patient was shaking uncontrollably. This continued about 1 1/2 hrs. then he could not get out of bed to go to the bathroom; thus wetting himself multiple times during the night; Patient was restless for about 5 hrs. but still could not get up even with me (his spouse) trying to help. He also could not understand how to help move his body to keep from falling out of bed (never fell out but I could not get his entire body on the bed until our daughter arrived around 9:30 am. It took our grandson who is 6'5" tall & 275 lbs. to help get patient up and walked him into our sunroon. throughout the day, patient could not stand without help & continued to urinate on himself. He could, however, feed himself breakfast & lunch. At 7:30 pm grandson and daughter had to walk patient into bedroom. patient could not walk without us telling him how and pushing his feet forward. It took both grandson and daughter to pull him onto the bed as he collapsed when he got to the bed. Patient slept until approximately midnight. at that time our daughter helped him to the bathroom and helped to change his underwear and tshirt which was wet from having a fever. Afterward, patient was able to go to the bathroom by himself but was very tired. He was able to walk outside with the help of a cane on 2/5/21 2 pm. On 2/6/21, patient complained of his back hurting and itching. We discovered he had shingles! Not a full body rash but shingles on his left side around his waist.

Chills, headache, loss of appetite and loss of energy, and feeling like I am overly hot. Symptoms started within a few hours of having received the shot and have continued through today, 8 February 2021. Taking Advil seems to help somewhat but I still have no appetite and no energy.

Received vaccine at approximately 1430 at 2300 started having, fever highest 102.1 fever would return to 98.2 after taking Tylenol, aching in the whole body. The symptoms lasted until Friday morning at around 0900.

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

HEADACHES, ACHY BODY AND JOINTS, UNCONTROLABLE CHILLS AND SHAKING, ELEVATED BODY TEMPERATURES. SIDE EFFECTS HAVE PERSISTED FOR 6 DAYS

TODAY (7/10/2021 - VERY DIZZY FOR ALL DAYS AFTER SHOT, URINE BLOCKAGE, BEING SEEN ALSO BY DR , C FOR BLADDER CANCER, TREATMENT, CYTOLOGY, NURSE WEEKLY, CATHETER TREATMENT 9 WEEKS. TODAY 7/10/2021 AFTERNOON BECAME VERY DEPRESSED, SCARY, DRY MOUTH, SOME KIND OF 'HIGH SPEED HUMMING IN MY HEAD AFTER VACC, BALANCE PROBLEMS BUT A LITTLE UPLIFTED AFTER 2ND VACC, INSOMNIA, EVEN WITH OTC SLEEP AIDS, SUDDENLY, AROUND 7:00 PM PACIFIC, DEPRESSION 'FELL OFF' THANK GOD. VERY SELF-RELIANT, STRONG INDIVIDUA, NON-RELIGIOUS, EDUCATED, BA LITURATURE, AA COMPUTERS - PROFESSION NOW RETIRED

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

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

reported headache, low-grade fever, and chills began 02/05/2021 evening. Pt temp spiked at 99.1F and most recent temp is 98.2F. Pt took pseudoephedrine along with Tylenol 02/05/2021 evening. Low-grade fever and chills subsided 02/06/2021 morning, headache still persists Date and time of vaccination: (list both if they received both shots): 1st Dose- 01/07/2021 @ 11:30 Moderna 1st Dose- Lot# 0112L0A 2nd Dose- 02/05/2021 @ 09:30 2nd Dose- Lot# 012M20A

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

SEVERE MUSCLE ACHE, SEVERE BONE ACHES, HEADACHE, ENTIRE BODY HURTS...FEVER -100.8 HIGHEST, FEELS LIKE SEVERE FLU. PERSISTENT NOT RELENTING NOW ON SECOND FULL DAY.

diffuse fuzziness, tired, mild headache, some increase in blood pressure. Slept 12 hours second day of symptoms. Symptoms waxed and waned, worse in mornings. Finally cleared completely Jan 27(onset Jan 10) Treatment occasional acetaminophen although no fever.

Patient reports approximately 12 hours post vaccination, he woke up with fever, sweating and unaware of his surroundings x 3 days. Patient reports his wife helped him with cares. Pt reports he was "out of his mind" for 3 days and cannot remember anything during that time. Pt reports it was a total of 5 days before he was back to normal.

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

8 days following the first vaccine, extreme chills came on rapidly. Vomit. Unable to sit alone in bed. Paramedics called and to ER. Treatment included EKG, CTscan, antibiotics, etc. Sent home at 1:00am. Still too weak to stand and walk independently. 4:00am rolled off of bed onto floor; collapsed. Unable to raise his body. Paramedics called again. Hospital said being treated for vaccine reaction. Sent home again at 4:00 by ambulance. Continues to feel extremely fatigued and upset stomach. He is ambulatory. We are being told for him to get his next Covid Vac this Friday, the 2/19. Worried

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

Headache, Chills, Hot Flashes, Fatigue, Nauseous, Muscle and joint pain. No Fever. These symptoms have continued with no improvement for approx 20 hours since injection.

Pneumonia; A spontaneous report was received from a physician concerning a 78 years-old, male patient, who received Moderna's COVID-19 Vaccine and who experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis. Products known to have been used by the patient, within two weeks prior to the event, included umeclidinium bromide/ vilanterol trifenatate, irbesartan, amlodipine besilate, metoprolol, glipizide, metformin, omeprazole, magnesium, and omega 3. The patient received their first of two planned doses of mRNA-1273 intramuscularly on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 22 Jan 2021 within a few hours of first dose, the patient developed fever, chills, weakness, and productive cough. On 24 Jan 2021, the patient was admitted to hospital due to oxygen levels in the 60s with productive cough, yellow sputum, and short of breath. He was diagnosed with pneumonia. During hospitalization, the patient had two negative PCR COVID-19 tests. Treatment information was not provided. The second dose of mRNA-1273 was discontinued in response to the events. The outcome of event pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's medical history of COPD and pulmonary fibrosis may have been contributory.

Patient reports at least two falls following COVID vaccine. Requiring assistance to stand up. Legs reported as "giving out" resulting in falls. Reports being shaking within 24 hours following vaccination. Reports extreme weakness and needing to be lowered to the floor at least twice. This is new for him. Did not report feeling dizzy; blood sugar was reported as normal during the time. No confusion or feeling out of it reported at the time. Ended up with abrasions. Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday. Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030. Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved. Assessment 1. Fall from standing, initial encounter 2. Multiple abrasions 3. Adverse effect of vaccine, initial encounter 4. Generalized weakness PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility PT EVAL AND TREAT I suspect his falls and weakness are due to Covid-19 vaccine reaction. I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain. Feeling better overall today. Recommended getting up every 2 hours to walk around, use walker for now. Call if more falls or continued extreme weakness.

Patient received 1st dose of COVID vaccination on 2/17/2021 (lot: 031M20A exp 3/11/2021). Wife called today (2/19/2021) to report patient has been experiencing adverse drug reactions: tired, lack of appetite, temperature of 102.9 (eve of 2/18/2021) and 102.4 (am of 2/19/2021), vomiting (phlegm). Patient said he was feeling better this morning and is managing the temperature with acetaminophen. Of historical note, patient did test positive for COVID virus a few months ago. I instructed wife to continue monitoring side effects and encouraged use of acetaminophen to help with fever. I educated that the side effects are "expected" with the exception of vomiting. I also informed her that I would be filing a report with VAERS to report the adverse reaction. At this time, I do not believe these side effects exclude him from receiving the second dose, and I encourage him to still receive the 2nd dose when due (3/17/2021).

Next morning, after 2d dose, flu like feeling, mild aches etc. Late morning, noon, rested, fell asleep for about 2 hours, woke refreshed. Arm still a bit sore but feeling great.

1/23/21 First shot: sore arm only. 2/20/21 Second shot in afternoon. By evening, fever 102.8 (then took Tylenol and fever reduced to 101). Fever, nausea, severe leg pain, moderate low back pain, severe fatigue. 2/21 morning through evening: 101 to 102, nausea, fatigue. 2/22 fatigue, temp 100 to 101. 2/23 fatigue, low temp 99.0.

Moderna COVID-19 Vaccine EUA. Several hours later develop sweats, feeling hot and cold, felt like a fever but temperature was normal, severe muscle and joint pains, unable to sleep, very tired next two days. Most symptoms have resolved although joint pains persist.

FEBRILE - 101 (2200), TACHYCARDIA (100+ BPM), RAGING A-FIB (ARRHYTHMIA) & HYPOTENSION (75/50); SLEEP MEDICATION INEFFECTIVE. ALL SYMPTOMS PERSIST (NO DETECTABLE DEHYDRATION) , INTO 4 FEB 2021. NO PAIN OR FEVER ABATEMENT MEDICATIONS APPLIED. AT 1600, 4 FEB 2021, 10 MG ZALEPLON AND 5 MG AMBIEN ADMINISTERED. 75 MINUTES OF SLEEP, FOLLOWING WHICH SUB-LINGUAL TEMPERATURE WAS NORMAL, BUT OTHER SYMPTOMS PERSISTED. SLEEP IMPAIRMENT AND OTHER SYMPTOMS PERSISTED 4, 5 AND 6 FEB, BUT SLIGHTLY IMPROVING EFFICACY OF SLEEP MEDICATIONS AND OTHER SYMPTOMS. AT 2000, 6 FEB, 10 MG AMBIEN (SLEEP ONSET UNTIL 2130), 10 MG ZALEPLON AT 2200 (SLEEP UNTIL 0030, 7 FEB), 10 MG AMBIEN 0030 (SLEEP UNTIL 0430), 10 MG ZALEPLON 0430 (SLEEP UNTIL

morning after vaccine woke up with the worse headache and left are soreness. The following morning headache and body aches from the hips and both legs. In the following days pain got progressively worse until it was very difficult to walk. After a week of this the pain settled into my left hip. On the 9th day of pain and difficulty walking went to see my PCP. Treated me for bursitis of the left hip with a steroid injection to the left hip joint. Pain has gotten better but still painful. The vaccine was given at Urgent Care. Post vaccine visit was with PCP

sore injection site next day. 2 days later started feeling sick, headache, chills and upset stomach, patient has been feeling worse with fever and wanting to vomit and aching all over. Each day goes by he feels worse, Called Doctors office let the nurse know he is not feeling well, no response back yet.

felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more. The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction." The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.

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

Starting about 5 or 6 hours after the injection I became extremely tired and that persists through today, 7 days later. At times, I found even a small exertion like walking up a couple of flights of stairs to be exhausting. At times my head felt buzzy, although I haven't had a fever. At times I also felt fine but then would relapse. My sleep has also been erratic, although not very good normally. Arthritic joints are more painful.

Dramatic drop in %SpO2: from a range of 94 - 97, to 88 - 89, with occasional drops to 87. I checked it because I found, even on waking, that I needed to make an effort to breathe more deeply - which did make enough of a difference. In a setting where it would have been available, I am sure I would have received O2. I also had a fever of up to 101.3, and felt "rotten", but not dire. In 2017, I had some sort of incident - I was traveling at the time, and it was never "determined" - that may have been a "scatter" pulmonary embolism - where the clot breaks apart before distributing into the lung. Initially, I did have quite low %SpO2 readings, but over the years that has improved. But these readings were even lower than I had ever seen. I have two oximeters, to, um, verify each other, so I am reasonably confident of their readings. I have a background in physics so I have some experience with instrumentation. This situation continued for perhaps 6 hours, then the fever slowly went down and the %SpO2 increased to 90 ? 91, which was ?manageable?, then slowly higher. It is still lower than it had been, but feels normal enough. Since this dramatic drop in %SpO2 seemed a part of COVID-19 symptoms, I thought this might be significant, and that is why I am reporting it.

I had to sleep all day the day after the injection. I think more should be said that people may have to plan on not being able to go to work the day after.

Flu like symptoms, fever, chills, then a rash broke out all over his body. It didn't itch, it hurt when something was dragged over it, like a finger or clothing. It was deep, deep red and some parts of his body there was no regular skin showing. Took him to ER, where tests were run, showing his liver counts were way off. Biopsy was taken of the rash. It was determined that the rash was similar to Stevens-Johnson and he was admitted for 2.5 days. They put him on large doses of steroids, which helped the rash. All labs were headed in the right direction except his liver panel. He was sent home and returned to doctor in 3 days to run panels again. All were headed in right direction, even the liver. He will see his cardiologist to be put back on his heart medicines.

Fever as high as 101.8 on 02/28/2021 Fever 99.1 morning of 03/01/2021 severe headache (starting to subside as of this writing 4:30 PM 03/01/2021) nausea (starting to subside as of this writing 4:30 PM 03/01/2021) Tiredness

Reported via Nurse Triage / PCP: Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting. States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night. Symptoms worsened today and patient became weak and fainted. Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head. Is awake and alert now, but still weak and only able to take 1 or 2 steps. No chest pain or breathing difficulty and no fever. Feeling very nauseous. Caller requesting prescription for zofran. Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER. From Emergency Department: Patient presenting with chief complaint of syncopal episode which was witnessed by his wife. He reported the got dizzy and lightheaded and then passed out while seated. The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state. He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence. He has not been feeling well ever since receiving his 2nd COVID-19 vaccine. By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids. His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago. Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated. I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient. With negative testing and resolution of his symptoms he is stable for discharge home. Close return precautions were given.

Patient states that a day after having the vaccine, he developed severe stiffness in his hips and shoulders, muscle aches, had a headache on and off, chills, felt tired, had night sweats, lost his appetite, and taste was off. There symptoms lasted 10-12 days. He was tested for Covid 19 on 2/28 with an antigen test and was negative and tested again on 3/2 with a PCR and was negative . He is starting to feel better now. Called his physician who felt that these symptoms were due to the vaccine, encouraged him to go ahead and get second dose.

pt stated that he got chills the night after receiving the vax. Early hours in the morning his temp was 98.7 and reached 101.7. He was nauseated at this time. Next morning he woke up 99.4 temp but all other symptoms were gone. He contacted his PCP at the hospital and they instructed him to call us to file report.

The day after vaccination (4March21) pt. slept all day, and had the chills. Got up next morning (5March21) feeling better. By noon felt lethargic and slept the remainder of day. He experienced incontinence while sleeping. He had trouble walking, and could not make it to the bathroom without support. While in the bathroom he went to the floor, (did not fall), could not get up. I had him crawl on his hands and knees to the living room. It's a though his muscles went soft. Remained lethargic the remainder of the day. Did not see a doctor. Stayed at home and waited for symptoms to pass.

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Moderna COVID-19 Vaccine EUA Soreness at the injection site. Fever (101). Stiffness and pain in every joint in my body. Duration 24 hours.

Slightly elevated temperature, chills, felt like I was getting a cold. Resolved on its own without intervention.

Feeling of impending doom. Felt like I was going to die. Symptoms of Anaphylaxis but did know that was what it was. Failed to call paramedics which I should have . Kept getting worse all night and the onset of vomiting, diarrhea, fever, which lasted three days.

Severe Chills Fever Full body ache - joints/muscles Lost Balance - fell twice Incoherent Confusion ulcers in mouth and on tongue Swollen lips no strength - could not stand up on my own dehydration

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

Symptoms reported by patient when he came today, ie 3/10/2021 for his 2nd dose of Covid Vaccine. 2nd dose not given due to an allergic reaction to the 1st dose. Explained to him about the same. Pt was given the 1st dose, made to wait for 15 minutes , no reaction so was sent home. He apparently did not feel good the night of vaccination and subsequently developed rashes all over his torso, the next day. He had a lot of itching as well. He did not go to any facility for care. He said that he did some home remedies. Per pt, the rash lasted for 8 days. He is ok now.

Spouse reported that patient had been feeling achy, tired and fevered most of day and had spent day in bed. When he got up, he fainted face down on bed. EMT arrived and rolled him over. Oxygen level was at 88, fever of 99.9. Since a diabetic, finger stick done (171) Patient given oxygen and IV fluids before transport and he started to feel better. Transported to Hospital - unknown if admitted.

Had muscle and joint pain and low fever for 2 days after vaccination. Stayed in bed. 4 days after vaccination a bubble the size of 3/4 of a golf ball popped up on the tip of my left elbow, Olecranon Bursitis. The pain was minimal but I could not put the elbow on a table or the arm of a chair without sudden pain. Bubble stayed the same for 4 weeks and then slowly went down over 10 days. Elbow is still sore when hit or put on a table. Got vaccinated 2nd time in the right arm on 02/22/2021. Right knee started hurting after 4 days. Could only walk by keeping the leg straight. Went away as suddenly as it came after 4 days.

Heavy flu like...upset stomach...headache...cold and hot sweats...shivering almost uncontrollably...extreme tiredness.. Lastedv3 days...day 4 feeling 90 percent better

Body soreness, general malaise for 3 days - like I dad the flu. No treatment but resolved itself after the third day.

Malaise, muscle & joint aches, brain fog, unusual memory lapses, night sweats...the issues have been experienced since evening of the 2nd vaccination...the only side effects after 1st vaccination was a sore left arm.

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

Symptoms began the day after the patient received the second shot. He was very tired and weak. By the afternoon, he was so weak he could not lift himself out of the chair. Even with the help of another person, he was too weak to stand. I called for emergency help. He had a fever of 101, was vomiting, very disorientated, confused, could not understand what people were saying to him. At the hospital he continued to feel disorientated, had nausea, dizzyness, a headache, a fever of 104, was dehydrated. He was admitted to hospital and spent one night. Once home, he has begun to regain strength and other symptoms have diminished. Four days after coming home he is feeling stronger and more back to normal.

Patient awoke the morning of March 5th feeling weak, fatigued, and unsteady. He went to his primary care provider 5 days later on the 10th of March, as his symptoms were not improving. He told his PCP there that the past few days he was suffering from unsteady gait, walking around like hes "drunk", and bouncing off walls. It was thought his symptoms were caused by a low serum potassium value, so he was given a rx for potassium. 3 days later the patient presented to the emergency room where his problems persisted. He was still having trouble keeping balance when he walked around. One of the providers treating him reached out to neurology, who recommended that the patient be started on high dose steroids followed by a prednisone taper for tranverse myelitis, The patient was then admitted and treated at Hospital.

Patient presented to ED with complaints of severe fatigue and generalized weakness. He complains of chills as well. WBC found to be elevated. No electrolyte abnormalities found. Patient is suspected to have a urinary tract infection. Patient received ceftriaxone for UTI. Patient was admitted to the hospital.

Hallucinations; Dizziness; Fatigue; Nausea; Vomiting; A spontaneous report was received from a consumer, concerning her husband, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, dizziness, fatigue, nausea and vomiting. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, approximately three days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, after second dose of vaccine, the patient experienced nausea and vomiting, fatigue, dizziness, and hallucinations. The event hallucinations were considered to be medically significant. The patient was also not been out bed for seven days. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events, hallucinations, dizziness, fatigue, nausea and vomiting were considered as 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 (dizziness, fatigue, nausea, and vomiting), a causal relationship cannot be excluded. Very limited information regarding these event (hallucination) has been provided at this time. Medical history and concomitant medications are required for assessment. However, further information has been requested. However, fatigue, nausea, and vomiting are expected for mRNA1273.

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

#1 2/12/21 #2 3/12/21 - headache started noon 3/18/21, not much appetite, got worse throughout the day, went to ED, INR 16.7

blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased). The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride. On 29 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: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient felt kind of sleepy. On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site. On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90. He said his normal blood pressure was 20/70. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event of blood pressure was high at 160/90 was not resolved at the time of this report. The outcome of left eye blood covered inside, kind of sleepy, itching around injection site, and injection site reddish and oval shaped was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Day after the vaccination I had chills and was very lethargic. Persisted till next morning. On Thurs 18th my left arm was red from my left elbow almost to the top of the arm. Problem Still persists. Using cold compresses.

The first evening was a little uncomfortable. The next day was very uncomfortable--fever, shivers, body ache--no concentration possible; aspirin didn't seem to help; only a good night's sleep. The next morning was almost normal and by midday completely normal.

2nd dosage - 102 fever, delusional, migraines. Migraines have continued since 2nd shot , since 2/5/21. Dr. has now prescribed blood pressure medicine as well as preventative migraine meds.

Patient reported a generalized headache minutes after receiving the vaccine. Became diaphoretic, pale, nauseated immediately. Assisted him to a cot to lie down. Pulse weak and thready. B/P 90/60. HR=42. Resps=20. Pt. disoriented, lips slightly cyanotic. FSBS = 156. Pt. stated he had taken his insulin today and eaten prior to arrival. Continued observation for 15 min with vital signs improved but profuse diaphoresis continued. Denied SOA, O2 sats 99% on RA . Denied chest pain. Considering the history and ongoing symptoms, he desired to be evaluated. EMS notified and he was transferred to their care.

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

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

convulsions. I woke up at about 3:15 with my body shaking and i could not control it. this went on for about 1 hour. I have never had this experience. I literally could not function because of the shkes. the other reactions were, i slept from 4:30 +/- am till 5 pm, when i had Covid i slept for over 5 days. Other symptoms head ache, body aches, fatigue and lose of appetite. I write this at day 3 after the shot, and have tiredness and want to sleep It's like a compressed version of my Covid experience.

Patient became diaphoretic and felt like "I want to pass out" immediately after receiving vaccine and reports history of syncopal event. Patient unable to recall events that lead up to the previous syncopal event.

pneumonia; A spontaneous report was received from consumer, who is 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. The patient's medical history was not provided. No relevant Concomitant medications were reported. On 20-FEB-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15-mar-2021 the patient was diagnosed with pneumonia by primary physician. The event is considered as medically significant. Treatment medication included Levaquin. Action taken with mRNA-1273 in response to the events was unknown The event pneumonia was not recovered .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's advance age may remain a risk factor. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's advance age may remain a risk factor. Further information has been requested.

patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine

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

104 degree fever, disoriented, delirius (couldn't talk coherently, didn't know where was or what he was doing), achiness, couldn't walk, tired/fatigued. made an emergency room trip

Patient was admitted to hospital on 3/27/21. It was discovered he did not get his second Moderna Vaccine and it was beyond 42 days. since he had the vaccine. His first Moderna Vaccine was given on 2/11/21. On 3/30/21 the second dose of the Moderna Vaccine was given here at hospital. He began to have symptoms that at first seemed like a normal but severe reaction to the vaccine including, fever and myalgias. His labs showed neutropenia. He tested positive for COVID-19 on 4/3. It was determined he had Covid-19. While this is not truly a reaction to or caused by the second vaccine we considered this was good information to make known. Patient who had one dose of Moderna vaccine contracted Covid. His symptoms are mild and he is improving. He has several comorbidities that put him at risk. We moved him to an isolation negative pressure room and we continue to monitor.

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

Approximately 20 hours following the injection I was suffering from extreme fatigue and fever. Slept for twenty hours straight and then felt okay. Almost five years ago I was diagnosed with spinal stenosis and have been pain free during that period, almost five years. Following the second Moderna injection I experienced severe pain in my left hip and X-Ray showed acute right-sided low back pain due to spinal stenosis. It's interested that the flair up and pain was dormant until the second dose of vaccine was administered. I assume the vaccine triggered the flair up but it did occur quickly after the second injection.

Patient came to office for complaints of body aches, chills, hot flashes, sweating and lightheaded. Nausea and loss of appetite.

Hematologist/oncologist diagnosed patient on 4/12/21 with hemophagocytic lympohistiocytosis (HLH) with CNS involvement. Patient met 6/8 HLH-2004 diagnostic criteria. 6/8 results were able to be evaluated; awaiting 2/8 evaluable. Probability per provider of having HLH is greater than 99% using the validated H Score. The trigger for the HLH appears to be deranged immune activation by the COVID-19 vaccine within the setting of prolonged immunosuppression for transplanted heart. Due to presenting with severe headache and elevated protein in CSF = Intrathecal chemotherapy was initiated. Treatment: HLH-94 Regimen Dexamethasone Etoposide Possible Rituximab - will only start if EBV DNA is positive

Fever at 103; Heart rate at 140; Blood pressure at 81/41; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever at 103) (seriousness criterion hospitalization), HEART RATE INCREASED (Heart rate at 140) (seriousness criterion hospitalization) and HYPOTENSION (Blood pressure at 81/41) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 81/41 (Low) 81/41. On 10-Apr-2021, Body temperature: 103 (High) 103. On 10-Apr-2021, Heart rate: 140 (High) 140. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was currently in the ICU receiving 2 vasopressor Norepinephrine and Neosynephrine. 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 4/21/2021 became very lethargic with vital signs of BP 99/48, Pulse 112, Temp 101.8. Medical Director notified and patient was transferred to ER for evaluation via ambulance. Discharge summary from hospital shows acute encephalopathy suspect toxic effect from Moderna vaccine and fever after Moderna vaccination.

Started experiencing a bad headache behind the right eye on Wed 1/27 at night, and on Feb. 7th could not get out of bed, his left shoulder blade became so painful went to the ED Feb. 8. Sent home the next day. The pain was so bad he thought he was having a heart attack. Took NTG did not help. Returned to ED on the 10th - stayed in in hospital for 8 days. Specialists were seen and nothing could help with the pain. Consulted with cancer doctors, and neurologists, doing tests to diagnosis. Dr. gave a nerve block and a week later the pain started to get better a week later on a holiday. Pain still comes and goes. Pain Started getting worse today 4/23/21. Must lie down on right side to get any relief. Has lost 50 pounds is very weak and getting weaker every day. and it is very painful to walk 40 steps to the garage. The TENS unit is not helping with the pain. Getting a spinal test.

Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided Concomitant medication included unspecified statin for high cholesterol. The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins. Treatment medication included Seroto to treat the blood clots. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:

Was in good health. Received 2nd dose of COVID19 vaccine on 4/7 with progressive weakness and confusion following vaccination. Admitted to hospital on 4/18 with confusion, fevers, thrombocytopenia, mediastinal adenopathy and elevated LFTS and inflammatory markers. Workup has been negative but ongoing fevers and confusion. Labs have improved without treatment.

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

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

Information obtained from clients wife. patient received his first dose of Moderna 2/24/21 lot 024M20A with no reported issues except for a sore arm. patient received his second dose of Moderna on 3/24/21; Lot# 006B21A. No immediate effects from the vaccine. On day 2 post vaccination, patient became to have chills, per wife; did not check temperature and denied any symptoms such as flu-like symptoms. Day 3 post vaccination; patient began to have weakness in the legs. March 31st; patient was unable to stand and the rescue squad was called. patient was taken to the Hospital; where he was evaluated and released home. Pt collapsed at 1am 4/1/2021 and died 4/1/21.

Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)

Patient Experienced Temperature between 99.9 - 100 deg. cel., he complained of body aches, tiredness, and being sweaty. Symptoms lasted for 11 hours.

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

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

Fever, Passing Out, Loss of Apatite, elevated calcium levels, shakes, nausea, tired, chills, memory loss. Near death. Has been in the hospital for 7 days. Was released yesterday without notice to the family to a rehabilitation facility. Doctors have not released the results of test or diagnosis and resolution or time frame for recovery. Very little communication to my mom and zero communication to the family members who were visiting the hospital daily. I was present when nurse was giving a shot in the stomach as a blood thinner. Only other relevant communication was told to my mom that 4 other patients at the hospital had similar effects from the vaccine and were in the hospital. It is important to point out that after getting the first dose of the vaccine and falling deathly ill, Doctor told him to NOT get the second dose or he could die

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of 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.

He is falling asleep all the time and continues to get worse, not better; He is falling asleep all the time and continues to get worse, not better; Freezing cold all the time; feeling horrible; walking feebling at times; He has lost at least 10#, and lost three inches in waist,; stomach is bloated; he shuffles his feet-like his legs are stiff; balance is worse than ever; balance is worse than ever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Freezing cold all the time) in a 77-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. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Freezing cold all the time) (seriousness criterion medically significant), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite), SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better). At the time of the report, HYPOTHERMIA (Freezing cold all the time), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better) outcome was unknown and SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Stool analysis: negative negative (Negative) Stool sample was negative for blood. No concomitant medications were reported. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-125899 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Patient was hospitalized due to pneumonia; Urinary track infection; Patient tested positive for covid at the hospital with a rapid test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia) and URINARY TRACT INFECTION (Urinary track infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included TORASEMIDE (TORSEMIDE), METOPROLOL TARTRATE (METOPROLOL XL), LEVOTHYROXINE, TAMSULOSIN, APIXABAN (ELIQUIS), METFORMIN, FENOFIBRATE and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Urinary track infection) (seriousness criterion hospitalization). On 18-May-2021, the patient experienced COVID-19 (Patient tested positive for covid at the hospital with a rapid test). The patient was hospitalized on 30-Apr-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient was treated with TAZOBACTAM (intravenous) at a dose of UNK dosage form and PIPERACILLIN (intravenous) at a dose of UNK dosage form. At the time of the report, PNEUMONIA (Patient was hospitalized due to pneumonia), URINARY TRACT INFECTION (Urinary track infection) and COVID-19 (Patient tested positive for covid at the hospital with a rapid test) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID at the hospital with a rapid test. Description: The patient was hospitalized on 30 Apr 2021 due to pneumonia and urinary tract infection. The patient was still in the hospital. 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 report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional 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. This report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional information is requested.

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

Patient received first dose of vaccine 5/10, second dose administered 6/7. 6/8 patient presented to ER with complaints of Malaise and fatigue, found with mild altered mental status and eventually had to be intubated

Heart Rhythm problems increase infrequency after vaccination; Heart Rhythm problems increase infrequency after vaccination; Fever (Low grade); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia (treated with ramdesivir during which he was coughing up blood.) in November 2020. Concurrent medical conditions included Dysrhythmias (heart rhythm problem which he has had for 6 years). On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever (Low grade)) and FATIGUE (Tiredness). On 22-Feb-2021, the patient experienced ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Feb-2021, PYREXIA (Fever (Low grade)) had resolved. At the time of the report, ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination), CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination) and FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 pneumonia: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported that his heart rhythm problem which he has had for 6 years has gotten worse after vaccination. He used to have about 1 episode every month, it increased to about 1 episode every week after infection with COVID-19 and how now increase to about 1 episode every 2 to 3 days after the first dose of the Moderna vaccine. 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. No concomitant information was reported.; 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 is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

condition aggravated; attempt to rise from bed difficult and painful; attempts to walk were difficult; severe pain in body joints / in constant knee pain; Malaise; sleepiness; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (attempts to walk were difficult) and CONDITION AGGRAVATED (condition aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal stenosis (His Spinal Stenosis is worse.) since 1999, Osteoarthritis (He is scheduled for a right knee replacement on 04 Jun 2021. Both knees will have to be replaced.) since 1999 and Pollen allergy. Concomitant products included METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication. On 10-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Feb-2021, the patient experienced MALAISE (Malaise). 10-Feb-2021, the patient experienced SOMNOLENCE (sleepiness). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (attempts to walk were difficult) (seriousness criterion disability), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated) (seriousness criterion disability). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (attempts to walk were difficult), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain) had not resolved and CONDITION AGGRAVATED (condition aggravated), MALAISE (Malaise), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. 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 started experiencing nausea and vomiting per his appointment on 03/30/2021 since the day after vaccination. From the 03/30/2021 appointment, he continued to have more symptoms such as loss of appetite, fatigue, weakness, incontinence... Patient came in to see his provider on 06/07/2021 and informed him of his tremors, involuntary movements and jerking.

Two weeks after shot, patient reported severe head and neck pain resulting in ER visit. He underwent CAT scan , received pain meds for one week. Patient followed up with primary 5/3-recieved nasal spray. On 5/7, ER visit -head/neck pain-CT scan, xray, medication given-nothing found on tests. On 5/17, ER visit due to left eye lid unable to close and lip twitching-Xray and CAT scan diagnosed with Belle's Palsy, which has since resolved but patient continues to be in pain. Following up with neurologist in future

He then felt dizzines and a headache the following day. On 6/2/2021(4 days after vaccination) he had slurred speech which prompted his family to bring him to ER. CT brain negative for acute CVA. Pt was placed on DAPT (Plavix and ASA). On 6/25/2021-- pt was hospitalized again for severe mixed aphasia and dysarthria--- second stroke with hemorrhagic conversion.

Acute headache upon awakening the next morning. Initially treated with Prednisone 60 mg daily for approximately 2-3 weeks. Headaches continued, Prednisone decreased to 40mg daily, now down to 7.5mg daily based on CRP labs tested every 2 weeks. Referred to ENT, CT scans performed, found inflammation in sinus cavity. Daily chronic headaches persist.

Exhaustion and was given blood test, and given test for HIV, Eventually was told he had the Antibodies for HIV.

07/22- Patient is a very pleasant 78-year-old gentleman with a history of pancreatic cancer on chemotherapy who presents today for evaluation of fever and chills. Patient states he began feeling unwell overnight last night. He developed shaking and chills. He contacted the clinic and was referred to the emergency department. He states he has had a mild cough. He has had no abdominal pain. He has had diarrhea which is somewhat chronic. He has had no urinary symptoms.

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

Sore injection site, fever, chills,extreme muscle fatigue 24 hours after injection. Full ?recovery ? by 1/8(Friday)

on day of vaccination experienced "heavy duty shaking , HA, sore muscles, fever 101 - similar to symptoms of previous COVID+ event S/S lasted 1 day - Most concerning to patient is the insomnia and hallucinations he experienced the night of the vaccine, none since

9 hours after the injection, I developed chills, the inability to regulate my body temperature, shaking, cold, red in the face and a server head ache. Recovered the next day.

After 2+ days of pain, soreness, swelling at injection site this abated. Today, 4 days after dose I have cold-like symptoms ... runny nose, watery eyes and slight sore throat. Been outside twice and maintain social distancing, wear mask.

The patient was vaccinated at another facility, but presented to our Emergency Department with reported fever of 101 at home and malaise and weakness. Upon arrival, he was noted to be hypoxic at 91% on room air and tachycardic. His evaluation ruled out PE, PNA, ACS, sepsis. He was given oxygen therapy, nebulizer treatments and has been placed in observation.

Received my 1st Covid shot yesterday at 11:45. No problem. Went home and went for a 4 mile walk. Still no problem. At about 2:00 AM this morning I woke up shivering. Added another blanked and turned up the heat. No improvement. Finally got up and woke up my wife. Temperature was 101.7° F. Blood pressure was 149/90. Took some ibuprofen and sat on the sofa with a heating pad on my chest for about two hours. Blood Pressure dropped back to its normal 125/75 (may have been high because I took it the moment I got up) but temp was the same. However, shivering had stopped, so I went back to bed. When I woke up this morning (about 8:00) temperature was 99.1° F, blood pressure was normal (125/71) and no other symptoms. My arm isn't sore either. It appears that the elevated temperature was my only reaction from the shot. It's interesting because during the entire time I did have COVID symptoms, I never had any elevated temperature.

Patient is extremely comprised due to a kidney transplant 7.5 years ago. The first day patient just had a sore arm. The next the day the 14th had chills, shaking then to bone pain and muscle pain and headache over a period about 4 or 5 days. Then patient started with very bad diarrhea, it was uncontrolled multiple times a day, about 3 days, he was getting dehydrated and muscle weakness. Patient went to the hospital 1/20/2021 and was admitted and the doctors are still trying to determine the cause of the diarrhea. Patient is extremely dehydrated and is still has the diarrhea. Patient is right now is hallucinating due to being so dehydrated. A stool culture has been preformed.

Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours. Very weak and shaky for another 24 hours.

AROUND 9:30 PM I BECAME VERY WEAK AND FEVERISH. I HAD CHILLS AND I COULD NOT EAT OR DRINK. I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM. I THREW UP TWO DIFFERENT TIMES. THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE. THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS. I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE. ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN. I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER. BOTH OF FEET FLARED UP AND HURT ALL THE TIME.

Severe chills, extreme dizziness, faint, felt like the worst days of my Covid infection. Outcome, other than fatigue, fine within 24 hours. For your information, I have never had an adverse reaction to vaccines, including pneumonia, shingles,etc. I am filing this primarily because I know there isn't a great deal of information about adverse reactions of previously infected Covid patients.

Moderna COVID-19 Vaccine EUA; moderate fatigue, very mild fever, moderate sore arm centered on injection site, beginning about 18 hours post vaccination. Resolved spontaneously within a day and a half after onset of symptoms.

At 5:00 AM Sunday morning, extreme pain, achy all over, headache, aching all the way down legs, back, neck. Almost like having the COVID virus. Rolled out of bed, could not stand up or hardly walk to the bathroom. Felt very faint, had to hold onto wall. Was very sweaty, running temperature, cold sweats. Just kept getting worse and thought about going to the ER and then decided to put it off until talking to somebody. Called 2-1-1 and the lady told her that it was part of the side-effects to it. She told her to call her doctor, and they were not in on the weekend. This morning, the doctor called and asked if she had Corona, his other doctor retired and got this one the first of January. Took 3 months to recover from the COVID and was on antibiotics, and told her because he have antibodies. Feeling better, still having some achiness.

Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection

Symptoms started around 8:00 p.m. They were: Headache, Body aches, very tired. Went to bed by 9:00 p.m., Slept all night, Slept through the next day and night with just a few times awake to go to the bathroom. Monday not as tired, but still headache and body aches. Tuesday feeling a bit better.

Fever and sore arm at shot site. Ibuprofen took care of the fever that day. No fever the next day. Sore arm with some swelling persisted for 2 days thereafter and subsided.

LEFT HAND SWOLLEN, MILD BODY ACHES, FATIGUE, CHILLS, 99.5 TEMPERATURE. ALL OCCURRED ONE DAY AFTER SHOT AND ONLY LASTED FOR ONE DAY. EVERYTHING BACK TO NORMAL 2 DAYS AFTER SHOT.

One is as yesterday progressed I got more and more tired. I had trouble staying awake. I was extremely tired. I tried my hardest to stay up awake until bedtime to try and not mess up my sleep schedule. When I went to bed I slept for 10 hours which is unheard of for me. I am still tired this morning. The other thing is on my Eliquis I take it twice a day, I set my cell phone to go off. I apparently just turned my phone when it went off in the evening, I didn't remember to take my 2nd dose of my medication. I worried if the vaccine caused some confusion. I am going to call my Primary Care doctor today. I did call the VA as well and talk to a nurse who said that I should be feeling better today.

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

1/31/21 - Light Headed all day. Nausea at 7:00 pm. Slight temperature rise at 8:00 pm. Arm sore at vaccination site. 2/1/21 - Light headed all day til now. Arm sore at vaccination site.

Periodic low grade fever. Received Vaccine 1/22/21 1/25/21 had low grade fever (100.2) took ibuprofen. 1/31/21 had low grade fever (100.2) took ibuprofen 2/2/21 had low grade fever (101.4) took ibuprofen. Concern is the low grad fever coming and going.

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

Patient presented to hospital with 1 day of extreme lethargy 2 days after receiving the Moderna COVId-19 vaccine. Patient had Mohs surgery on a L forearm lesion with cryotherapy to scalp on 27 Jan. He went to daycare problem on 28 Jan, in normal state of health. upon return, patient felt warm and had difficulty standing out of car. Wife let him rest on a chair in the kitchen and found him on the floor in the morning, for a unknown amount of time, unwitnessed descent to floor.

Intermittent sharp pain in top of skull began yesterday and has moved to intermittent sharp pain in right ear. No treatment. Just waiting to see if it subsides

SEVERE headache, chills throughout night of inoculation and into 1/2 next day, with moderate temperature and muscle aches.

Pt received his first Moderna injection on 2/6/21. On 2/7/21 he developed chills and fever in the afternoon. Pt woke up on 2/8/21 and had pronounced weakness. Nursing Home/Assisted living reports falls x 2 this am. First at 4 am and the second at 6 am. Pt normally is ambulatory and still capable of driving a car. Reports today generalized weakness. He is having difficulty walking and lifting his extremities. He also is having difficulty lifting his head off the pillow. He reports generalized body aches and lower back pain. He presents to the ER with a rectal temp 100 degrees. His vital signs are normal otherwise. He had a septic work-up in the ER that included labs, urinalysis and imaging. Only abnormal lab was a elevated lactic acid. Pt received IV fluids and was admitted to the hospital for further monitoring. He is routinely tested for COVID in the NH. Last time was Friday 2/5 21 and was negative. The patient had rapid COVID testing repeated in the ER again the results were not detected. He has no swallowing issues and he is able to move extremities but again demonstrates pronounced weakness.

Late Friday evening, my upper front gums became extremely sensitive, to the point I could not brush my teeth that night. Saturday morning, the sensitivity spread to the back side of my upper teeth and it felt like I had small blisters on the roof of my mouth from drinking too hot a beverage. That evening I developed a deep cough, and I started taking Halls cough drops. Sunday I started taking a cough syrup and chest expecturant. Monday I call my dentist but his office was closed. My temperature was in 100.1 range. On Tuesday I saw my dentist and he was somewhat taken back. My temperature was in the 99.5 range. He mentioned COVID Tongue issues but had no data, and he put me on a fungal mouthwash.

Moderna COVID-19 EUA Severe fatigue, chills, lack of appetite, sore arm for 3 days, slight headache off and on Did not report to physician. Bed rest and as much fluids and food as could tolerate. 3 doses of ibuprofen Symptoms persisted with diminishing severity until February 1, 2021

About 4 hours after his vaccine, the injection site starting hurting, but not bad. He could not sleep on it at night as he felt like he was sleeping on a red hot pocker. On Saturday he was extremely tired in the afternoon. Had to come in from yard work as he could not function. He also had pain in his neck and shoulders. On Sunday he the feelings were going away, but his muscles started aching. On Monday he felt really strange, felt like he was in a fog, and his muscles ached. He could not get relaxed, did his normal Monday chores, laundry and house cleaning. He then tried to relax but his muscles and nerves were very tense. He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg. It was worse on the left side than the right arm. This went on every 10-15 minutes for about 3-4 hours. Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today. He hasn't had any more of the seizure type feelings in his arms or legs. He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.

Patient had a sore arm on the evening of vaccination. The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb. He was transported by ambulance to the ER and admitted. He received IV therapy and acetaminophen. He states he vomited February 4th. An X-ray was performed on his abdomen and he was given a diagnosis of Ileus. The next day, February 5th, he was able to have a BM and eat. After he was able to eat, he was released from the hospital. Shortly after being released from the hospital his lips started breaking out in fever blisters. He estimates he had 50 or so cold sores and his lips were extremely swollen and red. After seeing his regular health care provider, he started a round of Valcyclovir. On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.

muscle ache at injection site and fatigued and tired at the end of the 1st day and throughout the 2nd day. 3rd day i was fine

Sore and inflamed left arm and red rash. headache medium, fever 100.4 thru 100.8 for about 42 hours starting early Saturday morning after a Friday inoculation, and ending Sunday evening. Woke up Monday feeling well and no after-effects. Took some tylenol during the event.

Severe headaches, we went to the ER and they gave him tramadol and did a CAT scan. Headache is primarily on his temples on the middle of his forehead.

Upset stomach, no appetite, chills, headache, disorientated. Temp went as high as 104.6, given Tylenol and put cold rags on extremities, Pulse oximeter read as low as 85and varied to 90. Applied CPAP and pulse Oximeter began to register 91 Pulse was as high as 103 and blood pressure was 152/92. This occurred over a time from 4:30 P.M. to approximately 6:40 when temp dropped to 102.8, and 7:45 temp was 101.8, Pulse oximeter was 86-89. By 9:05 pm Pulse oximeter went to 90 and rose to 92 and then 93 in the next couple hours. Patient had aching all over and felt disorientated the next day.

Awoke at 0500 with lower back ache assuming it was associated with flu like symptoms. Had my usual two ups of coffee and small orange juice. Took my meds at approx 0730 with small glass of water. From 0800 until 1030 I had frequent visits to the bathroom to urinate. My backpain was more associated with my Kidneys as the frequent urinating was causing mild pain. After 1030 I had one at aprox 1230 and did not pass any urine until aprox 1830 that evening. I did hydrate with water during that time. After 1830 I had no issues.

7-hour duration of general lethargy, joint pain, chills, temperature of 101.2 Went to bed that evening and woke up just fine following morning........

Fever of 104.3. Legs heavy. Occasional cold chills until 10:00 PM. Drank fluids. Covered up with blanket

pt stated around midnight after getting the vax he had some GI issues, fever of 101, body aches, fatigue, felt like he had the flu. Said it hurt to touch the hair on his body. The left arm was sore around the injection site. After about 30 hours after his vax his symptoms subsided.

2nd shot 10th @ 1115 , 1st shot 1/13/2021 lymphedema, red, itchy, fatigue lump under arm that has moved to breast.

Developed a fever of 101, pain and swelling in my shoulder, sluggish feeling. Fever was gone the next day. The only residual was pain in the shoulder.

He developed a fever on 1/8, become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine.

Severe headache lasted three hours; pain in left arm where shot was given; body tiredness 12-hours. 36-hours later: chills, shaking, temperature 101-degrees - lasted 2.5 hours.

2/16 10PM felt soreness in neck and shoulder area. Soon developed chills. Had trouble sleeping. Took temperature at 2AM (2/17) - 100.4. Got out of bed 7AM - temperature 100.3. Took 2 full strength asperin. By noon on 2/17 temperature down to 98.8, still soreness neck and shoulders and very tired. Less discomfort at 10PM and got good night sleep. Still somewhat sore and tired 2/18 and 2/19. No ill effects at all by 8AM on 2/20

This is the eighth day of a headache. Actually, it's a skull ached. The painful points are on the skull right behind the middle of each ear. Occasionally, it seems like a regular headache--in the forehead--but most hours of the day and night, it's in the skull as described. Motrin 800 helps.

Nausea, vomiting, dizziness, distorted vision, sore arm, fever, injection site swelling, ambulatory deficiency. Admitted to Hospital

pt states that he started getting chills, fever, fatigue and headache that lasted around 24 hours. Pt no longer has these symptoms and has not contacted his PCP.

The following day after the vaccine at 5:00 AM he had joint and muscle pain and weakness, not able to move his legs. He would sit down in a chair and needed help to get back up. Headache, dizziness. He had a low grade fever of 100.1. This got progressively worse and then by evening got better. His wife called the visiting nurse that they had coming who she believes notified the doctor, and told them it would go away. By the next morning it was basically gone. He took Tylenol for the symptoms.

Got up to go to the bathroom in the middle of the night, was dizzy. Wife walked with him because of the dizziness. On way back to bed he passed out and I tried to help ease him down. Came back almost immediately. Got on hands and knees and crawled to bed. Ran a fever of 100.3 all Wednesday and stayed in bed because of dizziness. By Thursday he was fine again and started doing his normal activities.

Patient received 2nd covid-19 vaccine yesterday. Patient's wife called stating around 8:30pm yesterday he started to experience shaking, chills, and a fever of 100.6. Today he is feeling painful/sore all over his body and has a temperature of 99.1. He states he is still experiencing episodes of shaking that come and go throughout the day. He is helping manage fever and pain with Tylenol and taking it easy. They will call back with more updates if anything progresses.

arm became really itchy around injection site; thought it be cellulitis; whole arm around injection site was swollen up like a balloon; whole arm around injection site was red; doses given 14 days apart; very nervous; became nauseas; ended up throwing up; very low fever 100F; just tired; This spontaneous report was received 10FEB2021 from a consumer which refers to a 78-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced nausea, vomiting, tired, itchy around injection site, arm swelling at injection site, arm red around injection site, first and second dose were given 14 days apart. The patient's medical history included current cancer, dermatomyositis (autoimmune disease), Concomitant medications included chemotherapy (Keytruda infusion). On 15JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: 039K20A). On 29JAN2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (Lot number: 028L20A). Doses were given 14 days apart, out of window 15 days early. The event(s) were, " injection site soreness, fever he became nauseas, "I never get nauseas", ended up throwing up, very low fever 100F, tired, the arm became really itchy around injection site, whole arm around injection site was swollen "up like a balloon" whole arm around injection site was red, first and second dose were given 14 days apart". The action taken for Moderna COVID-19 Vaccine was reported as taking Tylenol after the first vaccine injection for fever and Amoxicilin after second shot, 1x1000mg. The outcome of the events was reported as Resolved.; Reporter's Comments: This report refers to a 78 Y/O male with Inappropriate schedule of vaccine administered (second dose at 2 week interval) for mRNA-1273 (lot # unknown) with serious unexpected cellulitis 5 days after second dose and NS Vaccination site pruritus, vaccination site erythema, vaccination site swelling, fatigue, fever, nausea, vomiting. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. Very limited information regarding these events has been provided at this time. Further information has been requested.

Pulse 70, 02 94, temp 98.3 With in 6 hours back to normal Pules 58, O2 97 but temp was 98.9. by 12 hours normal but a sick feeling lasted about 2 more days. no red rash like shot one.

I felt like I had a bowling ball inside my stomach that was being pushed up through my throat. Forced myself to throw up to relieve pressure and acid 4 different times. Unable to get comfortable enough to sleep until the next morning. Took Alka seltzer, drank water and club soda. 12 tough hours

Fever over 100 degrees with muscle aches. Took tylenol to treat the fever and aches. Both fever and aches persisted for 1 day. Next day I had no problems.

pt stated that after he got his covid vax he had no symptoms so had normal activities. Pt woke up feeling bad and was constipated on 2/26/2021. He has 101.6 fever. Pts wife called the PCP but wasnt able to speak to anyone. She asked them to call back but office closed for the day and they did not get a CB. She will try to call back. Pt has taken decalux for the constipation.

Around 6 pm last night he had 100.3 fever and it went up to 100.7 by 3 am. He had a lot of fatigue and his balance was off. I found him bent over a chair in the bedroom @ 3 am and he couldn't straighten himself out. He needed help to go to the bathroom. He was very off balance. He hit his head into a cabinet that is above the toilet. I had to hold him up as he used the toilet. He also had a problem getting back into the bed twice.

Approximately 15 hours after shot chills, aching body/joints, weak legs, headache. This lasted one day.

An in-home fall, dizziness, slurred speech, blurry vision, felt very ill. Did not lose consciousness. Was able to sleep. Day after event was okay. Two days after event, dizziness and loss of balance re-occurred twice during the day -- but did not precipitate a fall.

Chills, confusion, fevers, nausea, confusion Subsequent precipitous decline in kidney function, required a 4 day in-patient stay

Patient is a resident in a LTC facility. Patient was COVID positive in October. Patient received the 1st Moderna COVID 19 vaccine on 1/11/2021 lot # 027L204. Patient received the 2nd Moderna vaccine on 02/8/2021 with Lot # 037K20A. Abbot rapid COVID 19 anitigen test were performed on patient on 2/9/2021, 2/11/2021, 2/15/2021, 2/18/2021, & 2/22/2021 all with negative results. Res had a general decline of fatigue, decreased appetite and foley catheter complications and was sent to ER on 2/25/2021. It was reported to our facility on 2/26/2021 from a nurse contacting the Dr. about another resident that patient had a COVID 19 PCR obtained in the ER and was positive.

3/2 I got my first moderna shot yesterday. Last night I started developing chills, a couple degree fever, overall body aches much like the flu and persistent slight nausea. Did not throw up but was uncomfortable for sure. Slept in 2 to 2.5 hour shifts then up to pee and back to bed. Finally this morning I lslept from 10 am to 2 pm. 4 wonderful hours of blissful unconsciousness. My O2 this morning was 98/74 BP 135/81/69. I just took my bp 315 pm and it was running 141 high end. O2 was good at 97 but heartrate was 99 and temp was 99.7 to 99.1.

severe muscle and joint pains lasting up to the present and continuing indefinitely., fatigue, fever, and chills,

March 3, 2021 SUBJECT: Moderna COVID-19 Vaccine, Side Effects This letter/email is addressed to a number of individuals with a request that you seriously evaluate the below discussion, take action to alert medical staff of your respective agencies of these side effects, and work with the manufacturer, Moderna, to address them. As the recipient of them it has thus far been debilitating and interfered with my daily activities. It is my hope that the medical community can find ways to prevent or treat them such that daily activity can be unimpeded. I will first provide a chronology of my medical history and my Moderna vaccine experience. Then I will discuss my observations. My medical history: Age: 78 Gender: Male Pre-existing Conditions: Medications Hypertension: Blood pressure medication, 50 mg of Metoprolol Succinate ER daily Cholesterol: Atorvastatin, 40 mg daily Medical History 2018: Triple By-Pass Surgery 2019: Passed out, Hit head on falling, Brain bleed: Subdural Hematoma, Hospitalized: No surgery required and released. Subsequently, pacemaker installed. 2021: Moderna COVID-19 Vaccine administered. First Dose: Lot Number: 011J20A, Date: 01/08/2021, Clinic Site: Pharmacy Second Dose: Lot Number: 032L20A, Date: 02/05/2021, Clinic Site: Pharmacy Side Effects to Moderna Vaccine administration First Dose: Administration Site: Swelling, Site Redness and Fever. All dissipated within week after administration Second Dose: Fever and Chills day following administration. Lethargic for several days following administration. These symptoms disappeared. Observations February 24, 2021: Began to experience dizziness, symptoms progressed to mild vertigo. Based on history of presentation of these symptoms, assumed I had an inter-ear problem and began taking Zyrtec D, half a tablet. Experience with Zyrtec D has been that ear dries out and symptoms of dizziness and disorientation disappear. In this case the symptoms of vertigo progressed to the point of difficulty in walking and loss of balance. Stopped taking Zyrtec D on Friday, February 26th. February 26, 2021: Had more severe vomiting, walking difficulty and lose of balance. Used walker to stabilize walking. At approximately 7 to 7:30 PM, following consultation with wife and daughter, decided to go the emergency room of the Medical Center (MC). Was quickly seen by emergency room staff. Following questions on medical history, the ER doctor, based on head bleed history, I believe, had a CT conducted. I do not recall any questions about COVID-19, but do think we told them that both myself and my wife had been vaccinated for COVID-19. I specifically recall that prior to my transport, a nurse came in to do a nasal swab for COVID-19. I informed her that I had been vaccinated, but she said this was a requirement for admission to the location where I was being transported. Following the CT scan, the ER physician determined he believed there was a possibility of a small new brain bleed. At approximately 2 to 2:30 AM I was transported by ambulance to Health Center at approximately 5:00 AM. I am not certain about the exact times here. February 27, 2021: Health Center administered a number of tests including CT scan, EKG, and an echocardiogram. While there, physical therapists came to see me twice and exercised me to improve my balance and walking ability. The last one recommended exercises to help reset my vestibular system. Based on the administered CT scan there, the physicians saw no evidence of a new brain bleed and were prepared to release me. At the time of that discussion in my room, the attending nurse pointed out to the physician there that my blood pressure was elevated. He ordered a new EKG and deferred on releasing me until a cardiologist reviewed the results. Their concern was that I was experiencing episodes of atrial fibrillation (AFib). Subsequently, the cardiologist reviewed the new EKG and concluded the episodes were within the normal range, my understanding, but did note that my heart rate was elevated. At no time did the medical staff raise or question the possibility of COVID-19 side effects as being a possible explanation for my disorientation or heart rate problem. I was released later that day. February 28, 2021: While speaking to her sister, my wife shared with her my experience of dizziness and disorientation. Her sister related that her husband had and was experiencing a similar event. Further, her husband?s sister had experienced a similar event. Additionally, the husband?s sister had experienced vertigo. On further discussion it was determined all three of us had received the Moderna Vaccine, and approximately three to four weeks post second dose administration, developed these symptoms of vertigo. This prompted me to go to the internet for information on vaccine side effects. The Food and Drug Administration Fact Sheet, revised 12/2020 in the Section Titled: What are the risks of the Moderna COVID-19 vaccine? speaks of severe allergic reactions including: a fast heartbeat and dizziness and weakness. I believe that I have suffered these two reactions. March 1, 2021: Called both hospitals to alert them to inform their respective staffs of the need to question the possibility of these side effects should other patients present in their emergency rooms. In my case, it may have helped to alleviate my concerns had I been informed of these possible side effects. At MC I left a voice mail for the Chief Medical Officer and at Health Center I spoke to the Nursing Supervisor. The nursing supervisor advised me to report my side effects and directed me to call the entity who had administered the vaccine doses. I called the Pharmacist and spoke to her. She said she would report my concerns through her reporting system. Further she informed me that there was a medication my primary care provider could prescribe. I called my primary care provider, and he has prescribed Meclizine, 25 mg tablets. I am currently taking ½ tablet, three times per day. A whole tablet made me drowsy. As of today, March 3, 2021, I am still experiencing disorientation. Hopefully this will subside and disappear. The above discussion is provided to assist medical professionals to further assess the side effects of the Moderna COVID-19 Vaccine. I am glad that I received it. I have no complaint about the care I received at the two medical facilities referenced. In fact, I think it was excellent. However, it would have helped me to have raised by either or both of them that my symptoms may have been COVID-19 Vaccine related. Further, it may have changed how they proceeded in assessing my situation. As an industrial hygienist with statistical training, it seems to me somewhat unusual to have three members of my extended family experiencing similar dizziness and weakness side effects, and for us all to have similar time periods following the administration of the second dose. Perhaps, if related to the vaccine, this cluster would suggest that this side effect may be more common than a ?remote chance.? Should any of you have further questions or wish to speak to me, please do not hesitate to call. Since I get a lot of calls from numbers I do not recognize, I do not always answer, but a voice mail left with a return call number normally results in a return call. Today, I received a return call from the Chief Medical Director of MC and told her she would receive a copy of this document. Thank you for your attention to this matter.

On March 4th, the day after the vaccination I woke up at 6:30 AM with aches and pains all over. After walking the dog and eating some cereal I began to experience chills. I measured my body temperature - fluctuating up to 102 degrees F.

Saturday 02/27 thru this morning: Low pains in upper left chest / Low pains in middle of left side of back Tuesday 03/02/2021: Headache and pain in left eye / Sitting watching tv on Tuesday 3/2/2021 and almost passed out Have never experienced anything like this before so think it may be vaccine related. Then saw the news report about women getting false positive mammogram results only on the same side they had their vaccine in and that seems to be the case with my events - all on left side.

respiratory distress Narrative: Patient is a 77yo gentleman with medical comorbidities of Gold III COPD (FEV1/FVC 0.34 on 6/2017) on baseline 4L O2 NC, R MCA CVA in 1999 with residual L spastic hemiparesis, tobacco use disorder in remission, HTN, HLD, mild cognitive dysfunction, OSA (cpap noncompliant), GERD, Chronic Pain syndrome, and unspecified mood disorder who presented to facility ED with 1 day of generalized malaise, fatigue, and subjective fevers after being discharged 2 days PTA s/p L biceps and brachialis release (2/22/21) and s/p 2nd dose of COVID vaccine 2/25/21.

arm pain, fatigue, headache, muscle pain, fever 102.4, severe chills, nausea, dizziness, fast heartbeat

chills @ 24 hrs to 36 hrs; muscle pain @ 36 hrs to 72 hrs; redness of skin over muscle area @ 72 to present

Moderna COVID-19 Vaccine EUA. Day 1 after injection: fever (100.4), constant headache, very sore at injection site, general fatigue and muscle soreness. Day 2: woke at 3:00 am, all symptoms gone except sore arm. Day 3: mild tenderness at injection site.

2/27 Saturday - vomit and severe body tremors, upper and lower body 2/28 Sunday - body tremors and unaware of situations around him for less than 1 minute 3/6 & 3/7 &3/8- welts and itchy rash over both arms and entire both legs Fatigue and no appetite

Within 48 hours of receiving covid vaccine, patient started experiencing severe headaches, mild nausea, and moderate chills. patient had tried OTC medication to help with symptoms with little to no relief. Same reaction/symptoms happened after 2nd covid dose. Symptoms are still present as of 3/9/2021 and not getting any better. 2nd covid shot was 2/11/2021 LOT:016M20A

pt states on 2/27/2021 after he got the vax he had a high fever. On 2/28/2021 he was weak and was getting out of the shower when he fell. He was to weak to get up. He stayed on the floor for four hours before he was able to get to a phone to call 911. Paramedics took him to Medical Center he was directly admitted. His temp was 103. He stayed for four days before he was stabilized enough to be able to go home. They ran numerous test, CT, EKG, Labs, Covid (negative). He has a nurse and PT coming to his house 2 times weekly. He states he now how control over his bowels and bladder and can take short walks w/ walker. He has a FU apt w/his PCP on 3/29/2021. He is scheduled for his 2nd Covid dose on 3/25/2021.

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

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

Patient felt generally unwell, tired and unable to walk well. Said his feet felt numb. He could not get up and slid to the floor. He did not have the core strength to even help him sit up. Sometime after he was assisted back on the couch around 4:30 am he must of got back up and attempted to go to restroom because he was found on the floor with his arm and face resting on the love seat which looked as if he was trying to pull himself up. His wife found him in the morning around 11:00 am and he had been died for some time according to EMS. His death was unexpected. Even when contacting his doctors they were confused as to why he had passed away. No autopsy was done but as of this moment he has not been cremated yet and is at Funeral Home.

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

Day 1 totally exhausted and slept for 24 hrs. Day 2 totally exhausted. Day 3 felt better but tired. Day 4 woke up dizzy and exhausted. Day 5 dizzy and exhausted. Day 6 dizzy and exhausted. Day 7 dizzy and exhausted. Day 8 still dizzy and tired, but beginning to feel better. Slightly dizzy for days 9, 10, and 11. This affected my work where I couldn't work. I will not get the second shot.

Dizziness blood pressure increased, shot injection area swelled and was red the size of an orange. Light headed, stomach cramps, overall fatigue, not able to sleep.

Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying. Really bad. The arm is swollen up like a balloon, black and blue from the injection. Took aspirin, and still having the chills and he can hardly move his arm.

I experienced weakness in all of my muscles, chills, temperature was 100.4 Monday morning; dizziness; extreme fatigue. I am continuing to experience slight weakness, slight dizziness, and am still extremely tired as of Tuesday late morning, March 16th.

Pt presented to ED with c/o nausea, shaking, chills and loss of appetite with onset approximately 2-3 hours post vaccination

After vaccination that evening I started vomiting, the fatigue started the next day and it was mild. Day 6 or 7 in the middle of the night I had an itchy arm that woke me up,went back to sleep, woke up the next moring my arm was blown up like a balloon and I was worried about cellulitis, but this lasted about 4-5 days and I was back to normal.

After six (6) days of getting my 1st Muderna vaccination I'm still having bad headaches all day with chills on & off during the day. Also I seem to be in a fog at times & having trouble paying attention. I'm taking Tylenol Extra Strength medicine twice a day, not helping.

Temperature of 101 approximately 60 hours after injection with flu-like symptoms, gone after 24 hours

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

headache, fever, ad confusion since getting vaccine; worsening generalized weakness over the next 2-3 days causing inability to perform ADLs or ambulate

Patient reports chills, fatigue, aches, diarrhea, and dizziness/imbalance approximately 24 hours after vaccination. Patient advised to see primary care physician given his balance issues/concerns. Given that patient was referred to make an appointment to see PCP, I am submitting a VAERS report on that basis.

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

Dehydrated; Vomiting; Severe diarrhea; Didn't get out of bed; Wasn't feeling good; A spontaneous report was received from consumer, concerning himself, a 78-year-old, male patient, who received Modena's COVID-19 vaccine (mRNA-1273) and experienced a diarrhea, dehydration, vomiting, malaise, feeling abnormal. The patient's medical history included diabetic (insulin dependent) and rheumatoid arthritis. The concomitant medications included as otilimab and insulin. On 17 Mar 2021, he got the first of two planned doses of mRNA-1273 (lot 038A21A) in his left arm, intramuscularly for prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient experienced diarrhea, vomiting, malaise, feeling abnormal. On 19 Mar 2021, patient had dehydration. The patient was hospitalized for vomiting, diarrhea and dehydration. Treatment included treated for dehydration, monitoring his heart, and giving his insulin, Action taken with mRNA-1273 in response to events were not provided. The outcome of the events were unknown.; 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. Further information has been requested.

Got the vaccine, went home and didn't have any problems. He woke up this morning to use the bathroom and his legs were aching. His wife came in and said that he was warm with a fever, and also has a headache, no energy. He has not taken anything for the symptoms. He has not notified his doctor. The arm where the vaccine was given is a little sore, but not too bad, just the achiness and fatigue.

Feeling spacey; severe diarrhea; Sweats; severe body aches; Chills; A spontaneous report was received from a consumer concerning a 78 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe body aches, severe diarrhea, sweats, chills and feeling spacey. The patient's medical history was not reported. Current condition included lung cancer. Concomitant products included chemotherapy pill for lung cancer. On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Mar 2021, 3 hours after receiving vaccine, the patient developed severe body aches, severe diarrhea, sweats, chills and feeling spacey. Treatment information was unknown. The event of feeling spacey was considered to be serious with criteria of important medical event and the rest events were considered as non-serious. Action taken with mrna-1273 in response to the events was unknown. The outcome of event, feeling spacey was considered resolved on 08 Mar 2021 and the remaining events were considered resolved on 07 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

difficulty thinking "Spacey"; sweats; severe diarrhea; severe body ache; chills; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe body ache, severe diarrhea, sweats, chills and difficulty thinking. current condition of patient include lung cancer. No relevant concomitant medications were reported. On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 5 Mar 2021, the patient experienced the events, severe body ache. severe diarrhea, sweats, chills, difficulty thinking spacey. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. Seriousness of events not reported. Event difficulty thinking(mental impairment) upgraded to medically significant based on IME list. Events Pain, hyperhidrosis, chills, diarrhea was considered to be recovered/ resolved on 7 Mar 2021.The patient recovered from the event difficulty thinking (mental impairment) on 8 Mar 2021.; Reporter's Comments: This case concerns a 78-year-old male on chemotherapy for lung cancer, who had a serious unexpected event of mental impairment along with events of unexpected pain, diarrhea, hyperhidrosis and expected chills. Event onset occurred the same day after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

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

Extremem muscle weakness, especially in legs, unable to stand, low grade fever, disoriented, confused, no appetite. Had to have 2 people help me up off the floor.

Three days of flu-like symptoms then thought I had recovered. But it has been over a month since second vaccination and the deep fatigue continues. Any exertion is unforgiving.

Lost 50% of left hand and finger strength If I am cold while working outside or in garage, another 25% of strength is lost. And finger dexterity is greatly decreased. I have very light trembling or vibration from shoulder to tips of fingers. The above continue unchanged every day. Extreme fatigue all day on some days, moderate fatigue all other days

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

Eight days after the vaccine I got a rash and swelling and redness and itching in my arm around the vaccine site. I t was my whole upper arm from shoulder to elbow and it looked like cellulitis. There was no pain, so my doctor prescribed Benadryl and it went down after 48 hours. On the second dose I had a low-grade fever for 24 hours.

"On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-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 Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication. On 07-Mar-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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved. Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.

I experienced this rather immediate unexpected gradually increasing dizziness with impaired balance while walking at accustomed pace over approximately 12-15 minute time period. I was compelled to leave the track and lay down on an exercise mat where fortunately my wife came by t Within half hour of this attack i coiuld not stand and walk independently without support. My first time to a hospital ER in my 78 years of life. Recommended for observation and additional tests I stay overnight in observation unit. Diagnosis appeared to be perplexing for physicians. My wife came by to assist me in standing , walking to the car and driving me to nearby ER. What happened to me was a frightening, anxiety-producing and dangerous situation. I could have easily fallen with substantial head or other bodily injury. Being in excellent health and with nothing else unusual having occurred recently to affect my general health (no changes, no illnesses), I cannot help conclude this episode was a serious adverse reaction to my 2nd Moderna vaccination. I now consider what happened on 3/28/21 a "Vestibular Attack". I think possibly my body for some reason related to the vaccine might have been attacking itself, if that makes sense to scientists. I hope this doesn't happen to others. I am not anti-vaccination. But individuals should be warned about this possible dangerous reaction or adverse side effect, which in my case did not occur immediately after the 2nd Moderna dose. I've complained to the hospital that possibility of severe dizziness with extreme loss of balance being related to recent Moderna 2nd vaccination was NOT discussed or commented.

Pt was called 24 hr for f/u on vaccine, pt stated not doing to good this time, joints hurt, flu like symptoms, also stated having dizzy problems

My neuropathy consists of pins and needles in my feet and heat going down the back of my legs. On the first day of the reaction, there was a significant increase in both pins and needles and heat. Also, started to experience restless leg syndrome which I had never had before. The next day I suffered from nausea. The next night the pins and needles and heat was even greater and the restless leg syndrome continued. Eventually, I had what felt like a hot flash and I thought I was all sweaty. My wife felt my shirt and body and said I was not sweaty. Immediately, after the hot flash, the restless leg syndrome disappeared and the pins and needles feelings were greatly reduced. I have never experienced anything like the hot flash, before.

3 days after injection developed left arm pain, swelling. persisted when presenting for second injection 4 weeks later which was deferred. evaluated next day in clinic. reported feeling feverish, left arm pain weakness which was in a sling. noted have swelling with moderate edema in hand. tender left lateral shoulder, hand. decreased strength in arm, hand possibly due to pain. no lymphadenopathy. afebrile. WBC normal.

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

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

bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bladder cancer. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

First Night, High Fever had to take PJs off to get cool, Next day, Cold,very Cold.Arm ached, had red colot going from injection towards elbow on outside for 6 inches. about 1-12 inch wide. Tired and slept except to get up for bathroom, eat a little, go to bathroom. Kidneys hurt, could feel pulse in Kidneys. Was weak. Back and legs ached. Legs felt almost numb. Hard time walking from back pain and had to sit ina chair for about 30 minutes to get relief from kidney pain. This continued until the 9th @ noon. Arm stopped aching then. Kidneys still hurt. Back strain started getting better. Bak and kidneys still hurt hen I first get out of bed. Have to sit in chair till it goe away. If the Kidney pain continues, I will se

23 hours after receiving dose, Hives developed and by Noon I was experiencing heavy chills. Began taking Benadryl 4x/day and HydroCortison 1/2% cream. Stayed warm

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

the next day, dizzy , 2 days later sore throat pain, chest pain short lived ( not like when he has had heart attacks in past ) , fever 99.2, coughing Advised may want to talk to PMD about breathing treatments, if chest pain seek medical attention. Placed follow up call on 4/16/2021 at 11:17: Pt reported that he is feeling much better today. Pt reported that the ADEs he had occurred within couple of days of rcvding his 1st Moderna vaccine, by the 3rd day all the symptoms had cleared up, and on day 4 he reported still had some running nose (which he contribute to his allergies). Pt reported for his symptoms he did not try anything to help alleviate his symptoms, he stated he is already taking Tylenol daily.

Fatigue, Body aches, Headache, fever 1- 2 degrees Lasted 24 Hours. Took Tylenol but did not help much.

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

Muscle pain, weakness, headache, and fever x 4 weeks post vaccine. Unable to walk x 2 days post vaccine due to pain and weakness. This week patient is starting to feel "like himself" again.

Patient on 4/18/21 experienced "chicken wire" vision (never before an issue), after vision issues patient said he lost vision on and off for the next 24 hours, accompanied with mental confusion, and was unable to get out of bed on the morning of 4/19/21. Next two days a continued decline in in ability to ambulate and demonstrated neurological deficits on 4/20/21 of impaired vision, cognition and experienced difficulty in moving limbs. Patient was in a car accident on 4/21/21, is now hospitalized, unable to ambulate, and has further neurological deficits with impaired speech, cognition, and movement as well as pneumonia.

SPOUSE REPORTS THE FOLLOWING FOR PATIENT 4/21/2021 @ 9PM GENERAL MALAISE 4/22/2021 APPROX 4AM SEVERE HEADACHE TOOK IBUPROFEN 4/23/2021 AFTER LUNCH, PATIENT WAS UNABLE TO WALK AS PREVIOUS AND HAD 4 FALLS, ALSO COMPLAINED OF A SORE THROAT. 4/24/2021 DID NOT FEEL WELL, TEMP UP TO 100.4, NAUSEA AND VOMITTING X 1 AND CHEST PAIN, CALLED EMS AND WAS TRANSPORTED TO MEDICAL CENTER ER. 4/26/2021 PATIENT WAS DISCHAGED HOME AFTER TREATMENT FOR RHABDOMYOLYSIS AND RETURNED TO THE HOSTPITAL AGAIN ON 04/27/2021 WITH RHABDOMYOLYSIS AS PRIMARY DIAGNSOSIS. RESIDENT DISCHARGED TO SNF ON 04/28/2021.

Patient stated had some fever and other expected side effects after second shot. 3 days after shot started to have some eye itching and irritation. Was seen 5 days after the eye symptoms started and noted to have corneal dendrites right eye, herpes keratitis. No known previous episodes. Started treatment and will follow up.

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

79 years old male with history of COPD on home oxygen chronic kidney disease stage III vaccinated and now he comes in with COVID-19 infection positive. Chest x-ray showed bilateral pneumonia started on antibiotics bronchodilators and steroid. Infectious disease was called advised for dexamethasone for 7 days and Levaquin for 5 days 250 mg daily and patient should. Quarantine himself at least 10 days from the first positive test which was done on May 3, 2021. Patient is doing well vitally stable will be discharged home to follow-up with primary care physician in 3 days and infectious disease in 1 week Discharge Physical Exam:

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

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

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

Fri 04-16-2021 10:00 pm Bad Chills start. Sat 1:30 am woke with 100.6 fever. 3:30 am woke with 101.8 fever. 8:30 am 101.8 fever. 11:30 am 101.6 fever. 4:00 pm 103.3 fever, took 2 Excedrin. 5:00 pm 101.7 fever. 6:00 pm 99.6 fever. 9:00 pm 97.6 temp. 10:00 pm 99.0 fever. 10:45 pm 100.5 fever took 2 aspirin. 11:45 pm 101.7 fever. Sun 1:00 am 98.5 temp. 4:30 am 98.9 fever. 8:00 am 98.8 fever. 12 noon 99.5 fever took 2 aspirin. 2;00 pm temp normal. Felt 100 % OK from then on. No more problems

My uncle had a stroke almost exactly one month after second moderna shot. He is/was one of the most healthy older men I have ever known. Avid bike rider and exercise buff usually runs circles around guys half his age. I?m talking biking in the hills fit. He does have a pacemaker now and has to tame things done, but I think he got the pacemaker because he pumped so much blood through that thing doing all those hills for all those years. Not on any other meds expect whatever might be expected for the pacemaker. He was at the gym on May 1 working out and sitting down doing some arm curls when all of a sudden he passed out, he regained consciousness as a couple of guys were helping him to his feet, that?s all he could remember. He managed to drive himself home and then couldn?t shake the headaches and on coming symptoms, so one of his sons took him to the emergency room. Within 30 minutes it was already determined the doctors needed to operate fast. The stroke nightmare and recovery has process has been ongoing ever since. He was transferred to a rehab on May 19th where it looks like he will stay for at least a couple weeks, hopefully. He looks like he aged fifteen years, speech is ok, but he?s slow almost as if he is not hearing me? I think his hearing is fine but it seems like he works to formulate the thought of what he wants to say as I write this summary on May 23rd. He?s got two staples in his head, one pretty much top center and the other just a little off to his right. Drain blood I assume as I?ve never seen a post stroke victim up close like that. Our family do not get strokes! Maybe too much tequila and stuff like that, but my huge family usually all live into their 90?s and a few into their 100?s like my grandparents and my 104 year old great grandma. But of course they did not grow up with flu shots and vaccines. My grandparent grew a substance and stored in jars of olive oil or canola oil and rubbed that stuff on their our bodies if ailments go really bad. Other than that it?s highly concentrate oil of oregano. Couple drops on your tongue will set your mouth on fire. That?s the concentration we are talking about! Anyhow, my uncle hasn?t done vaccines or flu shots in the past, but all this gloom and doom from the mainstream media convinced him to get the shot. This now make the second person to stroke out after these unicorn shots. Yeah thanks big pharma and you scandalous mainstream media for just reading your script and following along. No thanks to all you physicians and nurses out there that also know better, but are keeping your fat traps shut and your hand out receiving your paycheck. We wonder why there is vaccine hesitancy? It?s not hesitancy, it actually watching family and friend bite the bullet right before our very eyes. You healthcare providers are going to have to pay pounds of flesh to our creator for propagating this mess we are in. Your stronger delusion excuse will only carry you so far, before it becomes unforgiveable. God Bless and let?s see how long this report really take to get published on vaers. The world see this one! You better WelcomeTheEagle!

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

Patient received his second dose of the Moderna vaccine on 5/21/21. On the morning of 5/22/21, patient started having issues with mobility, heavy sweats, body aches, and headache, although he had no fever and maintained his sense of smell and taste. Patient was later hospitalized and tested positive for COVID on Thursday, May 27, 2021. Patient passed away on Friday, May 28, 2021.

Oxygen level was dropping; Slight cough; He was very sleepy.; COVID-19 virus test positive; could not finish his sentences; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough) and SOMNOLENCE (He was very sleepy.) in a 78-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 Immunodeficiency (Common variable immune deficiency - Some doctors says he has it, some doctors says he does not have it.), Prostate cancer and COPD. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen level was dropping) (seriousness criterion hospitalization), COUGH (Slight cough) (seriousness criterion hospitalization), SOMNOLENCE (He was very sleepy.) (seriousness criterion hospitalization), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences). The patient was hospitalized on 15-Apr-2021 due to COUGH, OXYGEN SATURATION DECREASED and SOMNOLENCE. At the time of the report, OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough), SOMNOLENCE (He was very sleepy.), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test: positive (Positive) Positive and. On 15-Apr-2021, 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 concomitant medication was reported. No treatment was reported. On 15 Apr 2021, the patient developed a slight cough, had difficulty finishing his sentences, the patient's oxygen levels had dropped and was sleepy. The patient was admitted to the hospital and tested twice for COVID-19, both times were positive. 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 except for the event of SARS-CoV-2 test positive which is unlikely.; 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 except for the event of SARS-CoV-2 test positive which is unlikely.

Patient presented to the ED on 3/18/2021 with superficial venous thrombosis of left arm. Patient had second vaccination on 4/9/2021. on 4/27/2021 patient presented to the ED with myalgia. He was admitted on 4/28/2021 with fever and chills. These visits are within 6 weeks of receiving COVID vaccination.

states had no symptoms for first 24 hours, then developed expected side effects including headache, body aches, fatigue. then on day 4 or day 5, states he developed problems with his equilibrium(falling into walls) but catches self and has not actually fallen to floor/ground. states no really "dizziness, just problems with balance". has not seen doctor or had any follow up. states afraid of vaccine and will not receive dose 2.

Jab 5pm; 11pm brief dizziness, slight headache (rare for me); 5am diarrhea for 3 hours; very tired for two days, on/off headache; next four days woke before dawn to very strong heart palpitations... jumping heart... each time soon following with strong headache; I could at strongest beats see the beats through 'flashes' in my eyes; standing or walking to bathroom felt faint, sometimes wondering if will pass out; always begins while lying down; sleeping on both sides, on back the same; sitting in chair seemed to eventually help; once up and eventually more active palpitations have settled down to a few 'reminders' during the day and evening. Fear going to bed now., eleven days after 2nd Moderna.

- Developed heavy sweating and almost passed out, 3/30 @ 3:30am, recovered on own in 3 hrs - numerous periods of low energy days with slight temp - 6/20/21 developed A-Fib at 8:30am and brought to hospital - put on new meds, Metoprotol tartrate 12.5mg x2 per day, Rivaroxaban 20mg x1/day - presently under Cardo Phys care - before COVID 2 shot never had any cardio issues

Patient tested positive for COVID-19; Sore throat; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) in a 78-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. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). On 21-Feb-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19). At the time of the report, COVID-19 (Patient tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were provided. The patient was scheduled to receive his second dose on 13 March 2021. The patient received an antibody infusion on 23 February 2021. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.; 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. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.

Pt presented to the ED on 07/19/21 with complaints of nausea, vomiting, sore throat, and generalized weakness. Pt was found to be COVID positive that same day. Pt has been fully vaccinated.

Mild dementia; Tired and exhausted for a long while; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Mild dementia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypercholesteremia, Pain and BPH. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OXYBUTYNIN for BPH, PARACETAMOL (TYLENOL) and IBUPROFEN for Pain. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Mild dementia) (seriousness criterion medically significant) and FATIGUE (Tired and exhausted for a long while). At the time of the report, DEMENTIA (Mild dementia) and FATIGUE (Tired and exhausted for a long while) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included 11-12 unspecified medications. Treatment information was not mentioned by the reporter. The patient reportedly might have used lozenges after vaccination The patient went to his neurologist for mild dementia. On an unknown date, neurologist ran a battery of tests such as heart scans and blood tests to check for things such as Lyme disease and HIV. The results from his local physician showed it was positive for HIV and his second test showed HIV antibodies but no HIV in his blood. Very limited information regarding these events have been provided at this time. Further information has been requested. This case was linked to MOD-2021-262688 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

The next day, around noon time. reported increased malaise. That evening temp of 101.1 with increased fatigue.

Slight dizziness upon awakening in the morning around 7:00 AM. dizziness faded through the day, but mild headache developed around 1;00PM. Symptoms not severe or incapacitating. Patient took two Tylenol caplets.

Today ay 10:00am started feeling weak and tired. Also, my hands and body be an cold. I went to bed with very heavy covers and got re-warmed after about 2 hours. Feeling somewhat better this evening at 07:00 PM

L arm pain, fever, chills, muscle ache, weakness, No treatment other than Tylenol and bed rest. All symptoms began about 24 hrs after vaccine administered and less arm pain still exists 48 hrs later

New onset leukopenia/neutropenia with fever, unclear if related to vaccination, but temporally occurred the day after receiving 1st dose. No labs immediately prior to vaccination, so leukopenia may have preceded vaccine. No other new medications to explain neutropenia. Off chemotherapy since 8/2020. Possible relapsed disease though no other evidence in support of this as remainder of CBC stable.

Received vaccine on Wednesday, January 13, 2021, at 11:40 AM. Had severe, shaking chills at 2:30 AM Thursday Had elevated temperature all day Thursday (ranging from 100.4 to 99.8). Woke up Friday morning with normal temperature and feeling well. Have had no further events or ill feeling.

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

received moderna covid 19 1/14/21 12 noon. 1600 hours developed severe sharp 7/10 peri umbilical abdominal pain that did not radiate, no associated signs/symptoms. Pain persisted until 2300 hours, took one tab acetaminophen, went to sleep. Upon arising in AM pain resolved. Has not recurred. Upon arising did experiencing more typical side effects including fatigue and thought he had fever, no thermometer to check, these symptoms subsided over 1-2 days. No recurrence of any above symptoms.

PATIENT EXPERIENCED HEADACHE, MUSCLE ACHES, SWEATING, JOINT PAIN, LOSS OF BOFILY FUNCTION THAT REQUIRED EMT SERVICES.

a history of Parkinson's who presented with generalized weakness as well as urinary frequency. Patient had a history of prior COVID 19 infection in 10/2020, was hospitalized. He had the first dose of COVID vaccine 1/19 and after that, he developed fever, increasing weakness and was unable to get out of a chair and therefore presented to the ED.

Chills 6 hours Headache I4 hours Fever 100.8 4 hours Dizzyness 6 hours High Pulse 101 High blood pressure 164-89 6 hours

7 hours after the vaccine tiredness and mild nausea started. Approximately 26 hours after the vaccination extreme dizziness occurred and he lost consciousness for a few seconds. He was clay and completely lost his coloring . His son is a retired HCP and we took vitals and within 30 minutes after drinking electrolytes he was back to normal. We believe he was dehyrated. He has had vertigo in the past and has a pacemaker. His blood pressure was taken in 3 positions and within less than 30 minutes after having him hydrate all symptoms subsided. I emailed these symptoms to his Medical Doctor. We also had him use his pacemaker monitoring system to send a report to his healthcare specialist.

Generalized feeling of being ill. Greater sensitivity to pain in right index finger which is arthritic; Stomach upset. Oral body temp 97.3. Chills

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

Starting noticing at 4:00 PM noticing pain in the shoulder. The pain in the shoulder got worse to where he had tightness in his chest, but was shaking uncontrollably shivering sensation but was not cold that continued for several hours. Today is still having the pain in his shoulder, and while laying down has the neck stiffness. While sitting up has pain in the shoulder and is applying ice on it now. He took some Acetimenophen as he was told to wait 24 hours before taking anything. Has chronic back pain for which he takes that as well, but now for the shoulder pain as well.

BRAZO, HOMBRO, TOBILLO, PECHO, CUELLO, PARTE DE DONDE LA CABEZA SE JUNTA CON EL CUELLO UN DOLOR COMO CUANDO LE PONEN LAS INJECCIONES DE VITAMINAS. HE PERDIDO LA FUERZA. NO HE PERDIDO SENSIBILIDAD PERO NO HAY FUERZA MUSCULAR. CUANDO VIRO EL CUELLO ME DUELE. EL PIE SE HA MEJORADO, PERO EL TRONCO DEL MULO ME DUELE. EL PECHO ME DUELE CUANDO TOSO. NO TENGO NINGUNA FUERZA NI MOBILIDAD EN MI BRAZO IZQUIERDO Y UN DOLOR "CANSADO" EN EL CUELLO.

Chills and fevers (102), muscle weakness (needed assistance to stand and walk); Tylenol and Motrin. after a day the symptoms were gone.

1-On the second day late evening felt mild tenderness in my arm. 2- I developed mild intermittent headache.

The day after the second Moderna shot I had a fever of 100.8, aching bones throughout my body. Arms ,neck back, legs and feet. Headache and burning and stinging eyes. I called the hospital and they advised that I follow up if there was no improvement. I have very little energy and am resting.

Local pain level 3 to 4, that evening I started to feel weak and chills and shivering. Then I started to feel nausea and then I vomited. Day 2 stomach upset and diareahha, pain level diminished to 2 to 3 Day 3 pain level reduced to 2 and general feeling of weakness.

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

Exactly 12 hours after getting the shot he woke up with chills, fairly severe headache and bodyaches. He took two extra strength tylenol. The chills only lasted for about 20 minutes, but he was cold. All of that next day he was in a reclining chair, taking two extra strength tylenol every four hours for headaches and body aches. Yesterday he stopped the tylenol because the head ache was resolving.

Five hours after no reaction to the vaccine chills commenced, nausea, vomiting, loss of appetite and severe muscle weakness; unable to ambulate even with walker; lost control of bowels and bladder functions; fatigue. Was bedridden for 36 hours . At about 28 hours upon recommendation from oncologist, took one Benadryl and within 2 hours started to improve. Took 1 Benadryl every six hours for next 48 hours and was feeling better except for residual whole body weakness. Would have been helpful to know about Benadryl before hand. Will take Benadryl 30 minutes prior to getting 2nd shot on March 5. Thanks. Hope this information is helpful to others.

Patient began throwing up at 3:00 a.m. 2/12/2021, had severe chills, blacked out. Extreme fatigue, headache, joint pain. Patient has been sleeping for approximately 14 hours at this time (5:45 pm PST). He is able to slowly walk to bathroom, couch, bed. He is slurring his speech.

5 days after vaccine given , patients started having chills for very short time twice, some chest pain, extreme fatigue , loss of equilibrium

When I got the shot, It was painful but everything was fine. I was fatigued that evening and then when I went to bed I slept excessively. On a scale of 1-10 I was experiencing a 4 in pain. I took Extra Strength Tylenol and am still having pain. I feel tired.

Nausea first day Next morning chills and fever 103.4 Incoherent Couldn?t function, like pull self out of chair Nausea Wet chair Inflammation in lungs after being checked at hospital

Severe chills , no fever, body aches , brain fog,lack of appetite Had COVID diagnosed 10 - 27 - 2020. Should be told at time of injection possible worse side affects if had COVID previously also need to inform of possible brain fog

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

My arm got sore within an hour of me driving home and got progressively worse throughout the day, I took advil. The next day I had severe chills, and tired, fatigued, and then my body aches. I had a bit of a sore throat. I also had joint pain. I had symptoms for three to four days.

Very sore arm for two days, slight headache for 1 day, Upset stomach that comes and goes after waking in the morning and after meals. persistent and still ongoing after4 days

Extreme fatique and weakness, slight confusion, cough, severely decreased appetite, constipation lasting more than 2 weeks.

Had chills/shakes night of1/31st, on 2/1st, had fever that day plus dizziness and off balance. Next day was better but still kind of dizziy and off balance. The third day,2/2nd seem better.

Currently waiting for dental work (crown removal and replacement to treat cavity). 2/18/21 Started to experience toothache (R) which got worse as the day progressed. Tylenol didn't help. Took one tab of Percocet (5-325) to allow me to sleep. 2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm. 2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness, difficulty in standing. Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18: 2/20/21 Felt better when I woke up. Temp normal. Ate breakfast. Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100) 2/22/21 Fully recovered. No lingering issues. Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.

HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. . COULD NOT RAISE EITHER ARMS AND STATED THAT THE "BALL JOINTS" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS. BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21

Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration

The day after my second injection I developed a non itchy rash on my chest and arms. I also had fever and chills the first two days and fatigue.

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

Muscle aches to groin and knee, worsening muscle aches yesterday, fatigue and weakness. Referred to primary provider if symptoms worsen. Patient has appt with provider next Wednesday.

Moderna Dose #1: The only adverse event was a mild ache in my arm at the injection site. Moderna Dose #2: About 7 hours post-injection I experienced a temperature (101 F peak) and mild chills, a short-term mild headache, mild muscle /joint aches, and an ache at the injection site. These effects lasted for about 36 hours and then were gone. I would compare them to a mild 2-day case of the flu.

Flare up of all arthritis pain, fever , sweating, chills. Took normal medications , plus Tylenol, went to bed early, fatigue on Friday

Woke up with body aches, head ache and slight nausea. Symptoms lasted thru the day after the shot and into the following day. Still a little tiredness in to the second day after the shot.

Both knees hurt and had pain. Both wrist (back side of thumb) hurt /pain. Had fatigue for 3 days. Had the moderna vaccine. Felt strange for 3 days. No energy

Chills overnight starting 6:00 pm 26 February 2021 and lasting until midday on 27 February 2021. I put on extra blankets and slept okay in my own bed. Appetite remained good.

profuse sweating less than 2 hours after receiving the shot. swelling and tenderness at shot site 12 hours or so later continuing to 3/2/2021

During the early morning hours of Friday, February 19, approximately 12 hours after the vaccination, I awakened to a 102 degree temperature, chills, nausea (triggering dry heaves), strange dreams, and very weak legs. Over the course of the day I alternated taking Ibuprofen (200mg) and Acetaminophen (500mg) every two hours for eight hours to drive down the temperature. I also pushed water, and took naps. I continued this treatment throughout the day of Feb. 19, and once on Saturday, Feb. 20. I experienced a deep degree of lethargy beginning these days and continuing for several days later. I did not "feel like my old self" until Friday, Feb. 2, eight days following the vaccination.

Patient was given injection on 3/3/21, symptoms started in AM on 3/4/21 with dizziness and headache. Patient was given meclizine by one of our providers from our clinic to help with the dizziness since patient experienced this with the first vaccine. Patient will follow up with a clinic visit if symptoms do not improve.

Arm was a little sore after shot, but the next morning pt. wasn't able to walk when he tried to get out of bed. He fell on the floor and was unable to get up. His face was very flushed and he broke out in a sweat several times. We had to have fire dept come and pick him up off the floor. He was able to get around a little bit with a walker, but spent most of the day in bed and was transported to bathroom by wheelchair. He was also a bit confused. He had very little appetite and was unable to eat very much. At dinner time, he ate a little bit of soup and when he stood up at the table, fell again onto wood floor. We had to call fire dept to pick him up from floor and EMT's/ambulance to come out and check him over. VItals were all normal. He was just a little bit better on the next several days. We made an appointment for him to see Dr. on 3/3. Doctor did blood work which came back normal. Pt. is still not back to normal.

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

Symptoms: severe muscle spasms, fever, ached all over, extremely tired and weak. Began 4:30 a.m. March 3rd (14.5 hrs. after vaccine) and ended by 8:00 a.m. March 4th. Seems to be gone now. These were basically the ame symptons he had with Covid 19.

patient had to be hospitalized after getting chills, a fever, severe diarrhea and vomiting 3 hours after receiving vaccination. Patient did not report having adverse reactions to previous flue shots at the time of visit, but his wife did report that he has severe reactions to the flu shot each year.

patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

Extreme pain in the arm I received my covid shot in,had the chills fever of 99.3,sore all over and slight headache

Chill at the night of the second vaccine, that accompanied by fever that lasted to the second day after the vaccination day. After second day of the vaccination day every thing returned to normal (temperature)

Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful. Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.

3/6 at 8 AM collapsed to the floor with generalized weakness, headache (5/10), severe nausea with dry heaves, copious sweating & minor nosebleed. No loss of consciousness. Was able to get to sofa about 8:30 AM and vomited scant amount of whitish fluid. Temp at 5:30 PM 98.1. Slept all day and all night. On 3/7 felt fine and resumed all normal activities. On 3/8 felt extremely fatigued from awakening at 7:30 AM until 11:00 AM. Fatigue resolved midday on.

By 3:00 he had a whole body chill. He was then incoherent, lost all control of all body muscles and was incontinent both bladder and bowel. He continued as such when Dr. said to give him Prednisone along with the Benadryl he was receiving every six hours starting at 3:30 p.m. 3/8/2021. He was given a Prednisone at 4:00 p.m. 3/9/2021 and again at 8:00 p.m. on 3/9/2021 along with his Benadryl. He was unable to ambulate or even turn his body over in bed. He was able sip water and sports drink but ate nothing since noon on 3/8/2021. It wasn't until early Sunday morning that he was able to move his legs and get to a walker and use the toilet. He slow, very slowly has improved since then. Late Sunday he was able to get up, and sit in a chair. Later he was able to take a sit down shower and shampoo and be an to feel "nearly human" again. He has slowly progressed since then and Monday morning was able to navigate by himself and to descend and ascend a 13 stair step to the basement. In discussing the 24 hours he spent in bed he was unaware of any of the things going on such as not being able to move, but knew he was in pain if he moved his legs. He also had a temperature of 102.3 which rose to 102.9 and then with cold compress on his forehead and time his fever dropped to 95.4 and the back up to a normal of 97.5. These are similar symptoms he had after the first injection of the Covid 19 Moderna vaccine and he had had a similar reaction in 2017 from the first flu shot he ever had in his life. He felt he needed to take this vaccine in order to be able to "have a life" even though we assumed he would have such a bad reaction. He is slowly improving and if it is like the first injection it will take him nearly two weeks before he can ambulate at the level he was before the vaccination. Still, he is grateful to Center for being so proactive as to have available the vaccine and it being more convenient for cancer patients than waiting in line at a mass inoculation center. He would appreciate an acknowledgement that this information has been received and could possibly passed along to help others in his situation. Thanks.

Extreme shaking and chill. Disapated after getting under covers for 30 minutes. Next day felt tired and lack of energy.

Fever ( temp 100.5 ), chills and body shaking Legs very week, barely walk and legs collapsed twice so went to bed for most on day. Slight metal taste in mouth. Didn't want to eat. Shot on Sun., down for count on Mon.,felt better on Tues and Ok by Wed.

Fall occurred, patient had trembling of both legs and arms, garbled speech for about an hour; couldn't walk without assistance for about 6 hours ,extreme fatigue for the next 48 hours and tiredness for the remainder of the week (3 days)

Left eye blurred vision - persistent, worse at the end of the day. Difficulty focusing. Also general overall fatigue.

Within 4 hours of vaccination my arm swelled up noticeable, became very stiff and sore and made it painful to move my left arm. By 8:00pm I began to feel weak, tired and poorly. By 11:pm I had developed a fever and aches and pains in most joints and muscles which mimicked flu symptons. During the night I became chilled and found it hard to sleep from all of the discomfort. Most of these symptons were almost gone by the next night except for the swelling, which took another 2 days to go down. I have had no other symptons since then.

Wasn't feeling good due to other reasons; Its past 42days of 1st shot; A spontaneous report was received from a consumer concerning a 79 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wasn't feeling good due to other reasons and it's past 42 days of 1st shot. The patient's medical history included chronic obstructive pulmonary disease. Relevant concomitant medications included salbutamol, budesonide, formoterol fumarate and tiotropium bromide. On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23-Feb-2021, the patient was not feeling good due to other reasons as he has chronic obstructive pulmonary disease (COPD) and was hospitalized. The patient tested negative for COVID-19 on an unknown date. On 25-Feb-2021, the patient was discharged. No treatment information was provided. The outcome of the event, it's past 42 days of 1st shot, was resolved. The outcome of the event, wasn't feeling good due to other reasons, was unknown.; Reporter's Comments: This case concerns a 79-year-old, male patient with a medical history of chronic obstructive pulmonary disease who experienced unexpected event of past 42 days of 1st shot (inappropriate schedule of vaccine administration) and not feeling good. The event of not feeling good was attributed to the underlying COPD.as such, assessed s unlikely due to vaccine administration. Inappropriate schedule of vaccine administration is assessed as not applicable.

Moderna COVID-19 Vaccine EUA Severe chest congestion, coughed almost all day. very little actually coughed up day 2, only a very little congestion. which is normal for me.

Mild fever beginning sometime in the early morning of March 11 and mild acheyness in joints, which became noticeable by mid-morning. Temperature rose to 100.5 by noon. Took one Aleve gel tablet then slept for two-three hours. When I awoke, the fever and acheyness were both gone. No other side effects since then.

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

Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.

79 year old male here for evaluation of possible allergic reaction to Moderna COVID-19 vaccine. 1.Allergic reaction, Urticaria Pt received hist first dose of the Moderna vaccine on Tuesday, March 9th at 11am in his left arm. On Wednesday he began experiencing chills, felt cold and developed a fever of 101.9. Today his symptoms from yesterday resolved however he developed a pruritic urticarial rash on his upper thighs bilaterally, upper arms bilaterally, lower back and abdomen. He took one tablet of Benadryl this morning which did not improve his symptoms. He is not experiencing any shortness of breath, cough, sore throat, difficulty swallowing or wheezing. He has not tried applying any topical creams or ointments. No new medications, laundry detergents, body wash, perfumes or bedding. No history of allergies to food, environment or medications. He has a history of COVID-19 and was hospitalized 2nd to COVID-19 pneumonia for 25 days in 12/2020. - Take OTC Claritin during the day and OTC Benadryl at night for one week - Take 20 mg Pepcid once daily - Start medrol pack - Increase fluid intake - Apply moderate strength triamcinolone ointment to rash - Labs drawn today will call with results - Will report allergic reaction to public health department - VAERS - Reviewed previous labs, HGB low - ER/red flag precautions given. Followed up with patient today 3/12/2020 over the phone: Called pt to follow up. He reports the rash worsening this morning and spreading behind his knees, behind his thighs and behind his calves mostly on his left leg. He applied the steroid cream this morning and he reports the rash greatly improved afterward reducing to about 10-15% remaining. States his rash is almost gone. Patient has been taking all of his medications as prescribed: Medrol dose pack, steroid cream, Claritin, Benadryl, Pepcid. Advised pt to continue to finish full course of medications as prescribed. PT denies any wheezing, cough, SOB. Advised pt that if symptoms worsen or do not improve over the weekend to go to urgent care or ER if life threatening. Red flag signs and symptoms provided. Pt verbalized understanding.

On the fifth day after vaccination I found myself disorganized in routine, everyday activities, such as washing & dressing, preparing meals, etc.; for example, I omitted washing my ears and forgot to put the kettle on. In the afternoon I was troubled by a headache of a novel sort, not with indefinite perimeter, but more specifically delimited, with ragged edges. Then that evening after ascending a flight of stairs, I heard a loud thumping, then suddenly realized that it was my own heartbeat that I could hear in my head. These bizarre effects disappeared by the next day. On the seventh through fourteenth days after the vaccination, I experienced a soreness in my trunk below the rib-cage, at first toward the sides, but then becoming more insistent and less localized; this was accompanied by headache (normal dull sort), along with irritation at the back of my nasal passages, and a feeling of being tired already upon waking.

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

Chills 1:20 am Very stiff right arm 1:20 am Lethargy for 6 days Mild diarrhea days 1 and 2 Urine more frequently than usual

KEY POINTS Had the first dose of the Moderna vaccine on Mon. Jan 11. Symptoms started Tuesday, January 19, 2021 1st hospitalization, January 27, 2021 o Discharged, January 29, 2021 o Diagnosis: High leukocytes, inflammation. Diagnosis, acute pancreatitis. 2nd hospitalization, February 2, 2021. o Discharged February 4, 2021. o Diagnosis: Diagnosis, Deep vein thrombosis (DVT) of popliteal vein and pneumonia Details in notes section. NOTE This is an updated and correctly filed version of a form that I attempted to email to the regulatory authority. No evidence that it went through. Use this version if you have the earlier version. DETAILED DESCRIPTION OF EVENTS AFTER VACCINATION PROGRESSION OF SYMPTOMS TUES. JAN 19: At night, felt like hunger pangs – but not really relieved by eating. In the morning tried 2 Tums. Had temporary relief for about an hour. Had symptoms for the last three days. Chronic, varied between almost negligible to mildly annoying. Bowel habits usually very regular. WED. JAN 20. Had major bowel movements in the middle of the night THUR. JAN 21. Had major bowel movements in the middle of the night FRI. JAN 22. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SAT. JAN 23. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SUN. JAN 24. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) MON JAN 25. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) TUES. JAN 26. Problems persisted and got worse. On Jan 26, Daughter GP suggested getting blood analysis to test for inflammation. WEDS, JAN. 27. Hospitalized. Findings: High leukocytes, inflammation. Diagnosis, acute pancreatitis. THURS. FRI. JAN 28. Hospitalized. FRI. Jan 29. Discharged. Wt 193 lbs! Usual, ~176-183. MONDAY FEB 2. Readmitted to hospital. Felt feverish, easy fatigue, bilateral stiffening of the calves, some edema. Diagnosis, DVT of popliteal vein and pneumonia. Given an iv bolus of a broad spectrum antibiotic. Started on Eliquis two 5mg pills twice a day for one week and the one tablet am and one pm. Given Lasix bolus and then started on 5 mg Lasix/day. Swallowing tests more or less OK WEDNESDAY FEB. 4. Discharged. MONDAY, MARCH 8, Check up with GP, Blood pressure 127/76. Lasix discontinued. THURSDAY, MARCH 11, Check up with GI doctor, Blood pressure consistently 150/90. Sent to adjacent cardiologist's office (next door). High BP reading confirmed and reconfirmed the next day. Dose of Metropolol succinate increased to 5 mg 2xday. Note 1: Still have the DVT. Note 2: Received 2nd dose of Moderna vaccine on Feb 11. Note 3. All medical records available either through hospital, GP or by contacting me. Note 4: This is not a crank report. I have had 50 years teaching and doing funded research in 3 medical schools rising to the rank of full Professor in each.

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

headach and shivering after 2nd Moderna vaccine shot. Then several weeks of excessive tiredness, lasting about 4 hours during day

Weakness, Fall, Rhabdomyolysis Narrative: Patient presented following a fall at home within 24 hours of the second COVID vaccine. Pt reported chills, weakness leading to fall, subsequently developed rhabdomyolysis requiring hospitalization due to weakness/prolonged period down after fall.

belching queasiness slight vomitus, feeling cold no fever, nasal congestion and left lower back and hip pain.

An hour after injection, case was trying to speak but words were not clear and jumbled up, states "like a baby learning to talk", not able to understand what he was saying, this lasted for about 10 minutes. States that he had a little headache that had started yesterday morning as well. Went out to Dr. office, medical provider after that.

I had my 2nd Moderna Covid 19 vaccine on Thursday morning March 18, 2021 at the hospital. Everything went fine. At approximately 4.00am Friday morning. I was awakened and barely made it to the toilet where i vomited 3 times. Following that took my temperature and it was 102.5. I was shaking all over, ached all over as well as a headache. very similar to my 1st vaccine reaction only much worse. Again i was planning to play golf Friday and Saturday mornings but cancelled. Can't play golf when you can barely walk. I drank pedialyte and gatorade to rehydrate and basically had no energy to do anything but sleep off and on for the next 2 days. It wasn't until Tuesday that I began feeling normal. Temperature slowly went down and finally was normal Monday night.

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

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

Some soreness in left arm. Just after midnight, began experiencing flu-like symptoms (achy, felt feverish but no fever) and now feel the way I did when I last had influenza...lethargic and sleepy, and a bit achy.

Patient advised Health Dept. (at time of 2nd dose) that approximately 45 minutes after 1st Moderna vaccine that he began experiencing blood in his urine. Patient contacted PCP and was admited to for further evaluation and treatment. Pt developed pneumonia while in hospital and spent a total of 4 days inpatient. Treating physician at hospital unable to identify cause of blood in urine. DR ADVISED THAT HE TREATED ANOTHER PATIENT WITH SAME SYMPTOMS AFTER INITIAL COVID VACCINATION but could NOT specifically attribute cause of blood in urine to COVID vaccination.

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

Slightly feverish & tired. Second day left foot turned bright red, very warm & itchy. Gone by next morning. No other issues.

Pneumonia; A spontaneous report was received from a consumer concerning reporter's husband a 79-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, approximately 13 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 001A21A) via an unknown route for prophylaxis of COVID-19 infection. On 14 Mar 2021 the patient was hospitalized for pneumonia and was discharged on 16 Mar 2021. The reporter stated that her husband has "previously been prone to pneumonia". Treatment information included unspecified antibiotics. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event pneumonia was not reported.; 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 event, a causal relationship cannot be excluded.

3/24/21 -Evening after shot had fever 3/30/21- nausea (vomit, once) - evening 3/31/21/-fever and delirium - night 4/1/21- fever (101.5), sniffles, cough - night 4/2/21 - fever (101.5) in morning - given Advil, 11:00 a.m. fever reduced

Moderna COVID-19 Vaccine EUA Side-effect symptoms: vomiting (once), fatigue Recovery was complete by 4/5/2021, the next day.

pt states he had a sore left arm that hurt for about 3 days. Pt says his both ankles were swollen and as of today 4/7/2021 they are still this swollen. He has developed fatigue a couple of days later. He still has these symptoms and will reach out to his PCP for medical advice.

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

Tinnitus in both ears became severe after vaccination and after taking seven doses of Azelastine HCL and Fluticasone; also headaches around sinuses

About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.

started with chills and slight fever. Went to bed; however, wears a CPAP. At around 2am spouse awoke and heard strange gurgling sounds. Husband sleeps on back due to CPAP. Upon turning on light discovered he had thrown up and had regurgitated the vomit into his mask and back down throat. Very high fever, body hot all over, in state of confusion and slid off bed; tongue swollen and hard to understand him. Called paramedics and they took him to hospital immediately saying "he was in bad shape". Admitted to Hospital at around 6am after being in emergency room and treated with antibiotics and steroid. Stayed in hospital 4 days. Diagnosis: aspirated pneumonia. Home but with health care.

Twenty hrs after shot began to have fatigue, this increased. By 24 hr after shot body aches began. This continued worsening so had very little control of legs and body. At about 30 hrs after shot had to call 911. BP & pulse not extreme but much higher than normal. I, his wife, had to help hold him in upright position so EMS tech could get his vitals. They helped get him in bed (refused ride to hospital). Approx 36 hrs after shot began to see some control returning. Approx 40-42 hrs after shot most side effects gone, only a little tiredness remained. By day 3 all better.

stated that he had a reaction that started 13 days after his second dose of the moderna vaccine. She states he had fever, chills, headache, and could not get out of bed. The fever, chills and headache lasted about 4 days. She states his strength did not return for about a week.

Patients significant other states that patient had been in the bed since the vaccine on 4/8/21. He was told that he was positive for COVID. She advised the patient not to come in for vaccine. She reports that he had dizziness, chills, fever, and nausea along with lethargy. He was told by a physician that he was dehydrated. He has been resting since the last vaccine and drinking fluids. As of today, she states that the patient is out of the bed and improving.

79-year-old male with history of Parkinson's disease who has become extremely weak since his second Covid vaccination 2 days prior to admission. He has chronic gait instability from his Parkinson's and he had difficulties walking over the last couple days. He slid from the couch onto the floor and was brought into the ECC for further evaluation. He could have been down about 48 hours per his wife and daughter. He injured his buttocks. He has chronic peripheral edema and is not using his compression stockings because they are too difficult. In the ECC, his temperature was 99.2. He did fall to 89% on room air but improved with nasal cannula. Patient was treated for 4 days an

High fever for 2 days followed by chills and profuse sweating. Severe case of Shingles developed after 9 days.

Patient came for vaccination in the morning, then went out to breakfast. During breakfast, the patient slumped forward in his seat and was unresponsive for about a minute. There was no incontinence or seizure activity. On regaining consciousness, patient seemed to quickly get back to his usual level of mentation. He was diaphoretic and nauseous. He denies any preceding lightheadedness, nausea, visual changes, chest pain or palpitations. He presented to the emergency room, also had nosebleed and UTI. Was admitted for observation overnight and discharged the next day.

24 hrs of Flu like symtons. Sever joint pain that endures to this day 4/23/21. I can barely curl my fingers and pain in both elbows. wrists and shoulders I was given steroid shots and knock down the pain last given on 4/18 but pain is back. I am nearly a cripple

Ankle swelling with extreme foot pain(has neuropathy) No symptoms in 15 minutes after injection on both injections After the second injection had complaints of being shaky, not feeling well with generalized weakness

Fatigue lasting more than 24 hours. Diarrhea around 8:00 pm on 4/25 (took loperamide 4mg). At 8:33 pm, no more diarrhea.

101.5 Fever, chills, headache, lower back pain on April 25,2021. Received Covid Rapid test on 4/25/21 - Result was negative. Was advised to follow-up with Primary Care Doctor. Went to Primary Care FNP on 4/26/21 and was given blood test and scheduled CT ABD/PELVIS W/O IV No Oral Con (Stone Protocol)

The person who received the vaccine got very sick 5 days after the receiving the vaccine. The patient was talking at 2:00 pm on the 28th and he was on a ventilator a few hours later. The doctors were never able to determine why he got so sick suddenly. He passed away on April 6th.

Initially, had no strength to get out of bed (1 - 2 minutes) Long lasting / Persistent: Phlegm cough Loss of appetite Runny nose Fatigue / low energy Indigestion Feeling of weight / pressure around eyelids and head Low alcohol tolerance

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

Non-ST elevation (NSTEMI) myocardial infarction; Acute kidney failure, unspecified; Pneumonia, unspecified organism

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

Lost the function in right side/ could not write; Tremor; Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid; Hematoma on the left side of the brain/ slight hematoma on the right side of his brain; Could not hold anything at all in right hand even a spoon, almost like he had a stroke; Dragging right foot; Headache; Total fatigue; Totally wiped out, took everything out of him to go to the bathroom; Could hardly get up and had no control in his fett; He was not acting right; Something going on with his eye, movement to the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain), MOBILITY DECREASED (Lost the function in right side/ could not write), TREMOR (Tremor), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) and LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) in a 79-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 COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) (seriousness criteria hospitalization prolonged and medically significant), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) (seriousness criterion hospitalization prolonged) and EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (He was not acting right). On 22-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) (seriousness criterion medically significant) and ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom). On an unknown date, the patient experienced MOBILITY DECREASED (Lost the function in right side/ could not write) (seriousness criterion hospitalization prolonged), TREMOR (Tremor) (seriousness criterion hospitalization prolonged), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), GAIT DISTURBANCE (Dragging right foot), HEADACHE (Headache) and FATIGUE (Total fatigue). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy for Mobility decreased. At the time of the report, CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) and MOBILITY DECREASED (Lost the function in right side/ could not write) was resolving, TREMOR (Tremor) had resolved, CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid), LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes), FEELING ABNORMAL (He was not acting right), GAIT DISTURBANCE (Dragging right foot), ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom) and HEADACHE (Headache) outcome was unknown and FATIGUE (Total fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) Hematoma on the left side of the brain. On 20-Apr-2021, Scan: hematoma reduced in size No hematoma was present on the base of the spine. On 22-Apr-2021, Scan: improved Scan showed improvement. Patient stayed in the intensive care unit for 5 days then in critical care unit for 1 day and then sent home. On 20 Apr 2021 patient was again taken to Emergency Room. They gave him pain medicine which helped with the headache and send him home. On 22 Apr 2021 patient was again taken to hospital due to some conditions along with fatigue. and given medication for sleep. On 18 May 2021 the patient was seen by the neurosurgeon. Hematoma did not go away by now. Patient is in physical therapy to regain the use of his hand, can write now, sensory issues have cleared up. 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.

3/10/21 experienced fever, body aches, sore arm. 3/17/21 bilateral hand weakness 4/8/21 2nd injection. 4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire. 4/18/21 seen in local ER - joint pain over a month. given toradol and prednisone by PCP. 5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines. Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine. 6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.

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

On the next day, 06/02/2021 and lasting 4 days, I experienced the following: painful left shoulder/arm, headache, extremely tired, uncontrollable diarrhea. Note: Daughter living in another city also had trouble over 4 days with the second shot. My Mother had Guillen-Barre Syndrome over 40 years ago and was incapacitated for a year.

daily fatigue pain in the right leg from the thigh and knee Knee is swollen went to doctor and told to get sonogram on June 17 after results of sonogram doctor prescribed Xzrelto

Pt received initial dose of vaccine on March 16, 2021. Pt received the second dose on April 15, 2021. Pt had CVA on April 16, 2021 affecting right hand and lower arm with generalized weakness. Pt was fully cognizant at this time. Pt developed pneumonia and was hospitalized in ICU on April 29,2021, requiring ventilation support. Pt died May 6, 2021.

Has DLBCL; lymphoma had metastasized; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), SPLENOMEGALY (spleen was double in size) and METASTATIC LYMPHOMA (lymphoma had metastasized) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, SIMVASTATIN and TAMSULOSIN for an unknown indication. On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL) (seriousness criteria hospitalization and medically significant), METASTATIC LYMPHOMA (lymphoma had metastasized) (seriousness criteria hospitalization and medically significant), and MYALGIA (Sore arm). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to DIFFUSE LARGE B-CELL LYMPHOMA and METASTATIC LYMPHOMA. At the time of the report, DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), METASTATIC LYMPHOMA (lymphoma had metastasized), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood calcium: 10.6 (Inconclusive) Inconclusive. In January 2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 08-Apr-2021, Positron emission tomogram: abnormal (abnormal) Test show damage or stunning of kidneys. In 2021, Biopsy: abnormal (abnormal) Bone marrow and lymph nodes biopsy shows large B-cell lymphoma.. In 2021, Blood calcium: 14.4 (High) Calcium level high. In 2021, Platelet count: 81-82 (Low) low platelet level. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information was not provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. An alternative explanation is that the events were more consistent with the increased risk due to advanced age related factors. Further information has been requested.

TIA; Lost vision on the left side; lump in left leg; vasculitis in the varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient required on full anticoagulation due to events experienced. Lab details were 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.

Tested prior to hospital admission. Started with a cough on 7/17/21 and fell at home. Was brought to ER for evaluation. Per nurse on the floor, he was admitted for fall and COVID, and has no issues from fall so continued admission is due to COVID treatment. Currently receiving plasma treatment and oxygen.

Soon after 1sr injection, experienced dizziness, fatigue. Within hours of 2nd shot, experienced loss of appetite; Fatigue; Confusion; Nausea; he fell several times; lack of grooming was noted.

4-day history of fever, headache, congestion, cough productive of yellow sputum, weakness and body aches. Symptoms started on Sunday and he reached a T-max of 103. In the ED he tested positive for Covid PCR. Covid pneumonia

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

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

With in 10 min after shot I began to feel flush and my tee shirt became wet . Felt sweat heavily even wit car AC on. Felt out of sync. On-site nurse took me to emergency room and gave me a bed . Headaches starte. Nurse practice right stayed with me ,took vitals and said she heard heart murmer. Never been told I had a heart murmer by my heart doc. After an hour and a half I felt a little better. Drove home went to bed early - stil had headache and felt week. Sept well. Woke up in am with headaches and physically weak.Waiting on my doctor to call.

Patient received casirivimab instead of intended COVID vaccine. At 48-hour follow up, patient reported Soreness to arm, fever of 99.9 and high blood pressure. Wife thought he was anxious. Follow up 2 hrs later and next morning, he reported he was "fine". Received COVID vaccine on December 31

As a 1a health provider I received my vaccination a weekend half ago resulting in dizziness, difficult mentation eg, administering my clinic, headache, a firey, red, rash over 90% of my upper body and 30% of my lower body, joint pain and muscle ache, worsening So far all the medical help I have received advices cortisone for the itch but I am really trying to understand what I need for my immune system and should I, or should I not get the 2nd dose

Pt got home at 3pm. Pt passed out and fell down. Pt did not hit head, but did bite his tongue. Pt reported to feeling nauseated and tired the rest of the evening.

Saturday morning (30 hours after vaccination) onset of widespread abdominal pain and tenderness, extending all over the whole surface of the abdomen; tenderness to pressure over the same area; pressure accentuated the abdominal pain symptom. The pain was associated with mild nausea. These symptoms continued through Sunday and into Monday following vaccination. Moderate to severe lethargy, expected with COVID vaccination. On Monday, the symptoms stopped. No cramps, diarrhea, constipation, fever, cough, loss of smell or taste or other expected side effects of COVID or its vaccinations. No symptoms relative to an allergic reaction. No treatment was necessary, other than bedrest. I am a retired public health physician. My theory: peritoneal inflammation. Question: should I take the second dose?

Weak; Collapsed; Delirium; Night sweats; Chills; Discomfort; Did not sleep at all that night; A spontaneous report was received from a physician, who was also an 80-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and felt weak. The patient's medical history, as provided by the reporter, included type II diabetes, diabetic neuropathy, heart failure, acid reflux, and urinary retention. Concomitant medications included metformin, gabapentin, furosemide, spironolactone, omeprazole, and tamsulosin. On 06 Jan 2021, hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the evening of 06 Jan 2021, hours after vaccination, the patient began feeling chills and discomfort. Overnight he began to experience night sweats and did not sleep at all. During the night on 07 Jan 2021, the patient experienced night sweats and had delirium. When he tried to get out of bed, he collapsed. No treatment information was provided. On 11 Jan 2021 and 12 Jan 2021, the patient began to feel better. He no longer had night sweats or delirium. He returned to his exercise routine at about 50 percent of what he normally did although he continued to feel weak. Action taken with mRNA-1273 in response to the events was not provided, although the patient reported he was not sure if he would take the second dose. The outcome for the events, night sweats and delirium, was considered resolved. The outcome for the events, chills, discomfort, did not sleep at all, and collapsed, was considered resolving. The event, weak, was considered not resolved. The reporter assessed the events, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and weak, as related to Moderna's COVID-19 vaccine due to feeling well before the vaccine and feeling more or less disabled after receiving it.; Reporter's Comments: This case concerns a 80-year-old, male subject with medical history of type II diabetes and diabetic neuropathy, who experienced a serious unexpected event of delirium and non-serious unexpected event of asthenia, discomfort, insomnia, fall, and night sweats, and non-serious expected event of chills. The event of discomfort, insomnia, chills and night sweats occurred 1 day; the event of delirium, and fall occurred 2 days and asthenia occurred 6 days after mRNA-1273 administration. The subject was on metformin for diabetes ty II and gabapentin for diabetic neuropathy, Lasix and spironolactone for heart failure, omeprazole for acid reflux and Flomax for urinary retention. Treatment details not provided. 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.

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

My father received Moderna vaccine and next day morning he is got high temperature and body ache. He himself is doctor presently practicing

Racing heart rate >100 woke him up out of a sound sleep around 10pm on day of vaccine. (Vaccine was given approx 1:40pm) lasted about 30 minutes then it calmed down to more normal heart rate. Next morning bad headache 5-10am. Took Tylenol for it. Also, pain at injection site, across shoulder and lower neck for approx 24 hours after shot.

Patient never tested for covid-19 prior to vaccination. Symptoms of stuffed and running nose and small rash may be related to covid-19, cold or flu, or the vaccine. What affect the vaccination will have, if any, on the patient's condition is unknown.

Right after the injection had warmth around injection site. Around 12:00 on 1/27/21, he looked wilted. Wife checked his temp and it was 103.8. Was given Tylenol and temp went up to 104. She called the doctor at 2:00 PM, told her to see the doctor. Lethargy and weakness. Tested him for COVID and flu and still had fever. Was negative for both, told to alternate Tylenol and Ibuprofen, went down to 102. At 6:30 PM went up to 103.8, at that point she called the doctor, could not speak to him until 6:45 PM instructed to bath down with warm rag, and was told it was probably a reaction to the vaccine. Was called in a steroid pack. He went to bed running about 103.6 at 8:30 PM. Was able to get up, was given more Tylenol/Ibuprofen and his fever finally broke around 101 about 4:00 AM. Got up this morning and does feel better. Running around 100-101 temp. The vaccine is the only thing that has been different in his normal routine. Still has warmth to the injection site, red.

He had slight fever and chills, diarrhea, muscle weakness, arrhythmia asserted itself. Home health nurse came out and checked on him and put him on bed rest.

Patient received the vaccine on 12/29/20 and presented at the ER at the Hospital on 12/30/20 stating that he wasn't feeling well. It is stated that his health had declined over the past few weeks and currently on hospice. Visit was unremarkable. Patient stated that wanted to stop dialysis. Patient passed away on 01/02/2021.

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

no reaction until 30 hr after vaccination. Then had severe shivering lasting perhaps 2 hr followed by exhaustion and stiffness lasting through next day. Third day after vaccination, shivers returned, fever no higher than 101 degrees, followed by heavy perspiration. Not sure when it will stop.

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

wife called this morning at ~ 9:00 a.m. to report that he woke up with a fever of 101, has been throwing up, is dizzy and disoriented since he woke up this morning. I advised that he remain seated or lying down, to give Tylenol per dosage on pkg/bottle. To call 911 if symptoms worsen. Wife stated that did have COVID infection in Sept. 2020. He walks with walker. I called wife back at 1:50 pm. States took Tylenol, fever went down to 99, and he has been able to keep small amt of fluid down. He has remained seated to avoid risk of falling. Wife has him urinating in bucket. Re-emphasized calling PCP to consult, or 911 if symptoms worsen. To continue Tylenol per pkg instructions. Wife voiced understanding.

Had my second shot on Tues 2nd Feb. Had some discomfort during the night and took one Tylenol tablet. The next day around 11am, started to feel very achy, weak nauseous and a headache. Then had severe shakes and felt very cold had to put on a jacket. Lasted about 4 hrs then gradually diminished but not 100% Unable to eat. .Today.(Thurs )feeling much better 90% normal. I feel I could have been given a little more warning about the possible adverse effects. Thanks

Extreme fatigue with fever which lasted for about 24 hours. Nose runny until took Coricidin. Highest temp was 100 degrees. Took 1 Coricidin in evening then 2 Tylenol about midnight. After 24 hours was feeling fine.

Narrative: Veteran reports fatigue + injection site pain. Both resolved after 2 days Other relevant Hx: Symptoms: & fatigue at injection site pain Treatment:

Swelling and redness at site, nightmares several nights, fatigues, had labs done today and has appointment with MD 2/11.

Chills then fever and joint and muscle pain beginning about 12 hours post vaccination and lasting about 24 hours. Dr. said that this is a common side effect to Covid vaccinations

2 1/2 days after the shot - chills, low grade fever, muscle aches, head & chest congestion. Lasted overnight. Following day minor head & chest congestion remained.

Patient began feeling ill within 24 hours of getting second COVID19 vaccination. Presented to our hospital the evening of 1/28/21 with generalized weakness, fevers, near syncope. Extensive workup revealed likely hemophagocytic lymphohistiocytosis syndrome attributed to reaction to vaccine. Patient treated with blood transfusions, corticosteroid (dexamethasone 20mg) and folic acid 1mg daily. Patient also developed rectus sheath hematoma attributed to vaccine/reaction. Patient continues to remain hospitalized 15 days later. Clinically stable, yet critically ill with no significant / some worsening of laboratory results.

Headache, chills, vomiting started on the morning of February 12, 2021. The vomiting happened twice but the chills and headache lasted almost 24 hours. He felt much better on February 13, 2021.

I awoke with a slight headache and a stuffed nose. When I blew my nose and cleared my throat there was a dark brown, grainy substance in the nasal and throat mucus. this persisted for about 20 minutes and then cleared. I've not had any repetition of this since.

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

Was vacinnated with first shot on 01/17/2021 at 1:30 PM and had no side effects until the next morning and had some fatigue which passed after the first day. Had second shot on 02/14/20121 about 12:30 PM. No side effects the afternoon, and during the night. The next morning had fatigue and headache so rested and eventually by end of day went away, 1 day passed all OK but on 02/17/2021 had severe headache and loss of all balance, equilibrium, and was very dizzy and lasted all day. Standiing up I would have to prop myself or hold onto furniture, By next day, began to regain balance and by end of day, was able to walk balancing with cane. With the dizziness came halicunations at times, especially if laying down.

Basically I came after the shot, I drank about 6 beers and got something to eat. About 6 hours after receiving vaccine, I started to develop a chest cold, and started coughing a lot, I was coughing up phlegm and it had blood in it. Yesterday I had chills, my fingertips were kind of a white in color. My temperature was 99.7. I had like a rumbling feeling in my chest and it caused an urge to cough. It went through all the next the day and including all last night. This morning I feel fine.

Patient developed fever and severe weakness about 24 hours after second COVID-19 vaccine. Spouse called ambulance and taken to the ED. Patient unable to get out of bed by self due to weakness. Patient admitted to observation unit due to fever and fatique for PT and strengthening.

18 HOURS AFTER INJECTION: SLIGHT SWELLING AT BICEP , APPROXIMATELY TWO INCHES BELOW INJECTION SITE. ITCHING. 28 HOURS AFTER INJECTION: FEVER OF 102. BROKE AFTER 8 HOURS. 36 HOURS AFTER INJECTION: REDNESS PATCH ON BICEP APPROXIMATELY 3" X 3", CONTINUED ITCHING AND SENSITIVITY. 106 HOURS AFTER INJECTION FEELING WELL, SENSITIVITY, ITCHING AND SLIGHT REDNESS CONTINUES.

Muscle aches and pains, fever 100.4 few hours later atrial fib low blood pressure, fall, admit to ED then admit to hospital. Care continuing in hospital at this point.

Nausia, chills, fever, and taste modification. Modification in tongue sinsitivity. Soreness in arm of injection Taste and toungue sensitivity lingers. Fever and chills lasted one day .

Bad chills, slight fever that night for about 1 hour and moderate chills next morning for 15/20 minutes.

STARTED AROUND 630PM WITH NOT FEELING WELL; BY 900PM ACHES IN SHOULDERS AND BACK; ALL NIGHT LONG ACHES BECAME WORSE UNTIL AROUND 800AM; AROUND 300AM TEMP 100.6; STAYED LISTLESS UNTIL AROUND 400PM; WHILE FEELING "BETTER" AROUND 600PM. STILL TIRE EASILY.

The day after the shot, my husband fell asleep on the couch for several hours. He was freezing and had a fever of 100.5 taken orally (under tongue). I gave him Tylenol and water He perked up that evening. People say the second dose is worse and I am concerned about him having a worse reaction. He was in the hospital with COVID 19 last August and September and was very ill. He came home in a wheel chair and oxygen 24/7. He is walking with a cane now and only uses oxygen at night. I am wondering what you think about him getting the second dose of Moderna. .?.? Please let me know what your expert opinion is. Thank you very much.

Mild shoulder pain. Mild dizziness, not enough to cause staggering. Drowsiness and causing many naps. Unusual fatigue during ski training at 7200 ft.

Weakness; 80% blockage of the carotid artery; Could not walk; chills; A spontaneous report was received from a consumer regarding her spouse, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 80% blockage of the carotid artery/carotid artery occlusion, could not walk/gait disturbance. Weakness/asthenia and chills. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 20 January 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 January 2021, approximately ten days after the mRNA-1273 vaccine was given, the patient experienced 80% blockage of the carotid artery, he could not walk, weakness and chills. He was taken to the emergency room, where he was admitted for two weeks. During this time, he had carotid artery surgery. His primary care doctor could not confirm whether he had a TIA. The consulting neurologist thought the symptoms might be related to the vaccine. Action taken with mRNA-1273 was not reported. The outcome of the events, 80% blockage of the carotid artery, he could not walk, weakness and chills, were considered unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21.

Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506

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

Over the weekend 2/27/21, 15 days after vaccination, Patient Just experienced symptoms similar to those he initially experienced after receiving the immunization. Patient reported diarrhea, fever, body aches and pain and swelling at the injection site. The symptoms lasted about 48 hours.

headach, runny nose, orange/reddish coloring in 3" circle at injection site, 14 days after injection, lasted 6 hours.

fever 102 , chills , myalgias on day after vaccine symptoms persisted for 12 days CBC done on 3/3/21 shows PANCYTOPENIA referred to hematology and plan is for monitoring of CBC for now fever has improved

Chills and violent shaking at 7:30pm temp 99.0. Gave 2 Tylenol. At 10:00 temp 101.6 then went to 101.7 and gave Ibuprofen 400mg. At 11:00 pm temp down to 99.7 and fell asleep. 9:00 a temp 97.5. Had no appetite all day 2/26 injection site red, swollen and bad pain. When fever went high had no mobility and could not sit up to take meds. Next day tired and listless.

During post vaccination observation period c/o dizziness,, feeling weak, requesting to lay down. C/o mild acute headache. History of chronic Atrial fibrillation on Coumadin, allergic to IV dye. Transported to ED, EKG in atrial fibrillation, lab work within normal limits, Given Benadryl and Pepcid, symptoms resolved and discharged to home.

Acute onset of bilateral thigh (quadriceps) wealness resulting in lower extremity immobility for about 10 hrs.Assoc. with fevereishness.

Soreness at injection site, Muscular & joint soreness, extreme fatigue. Tylenol taken for 2 days. Slept 2 nights and next morning slight lingering of affects. All gone after 3rd day. NOTE: No adverse affects after injection 1.

A few days after vaccination patient had an unusual dry cough/ and then a pain in his chest, He called our Doctor she said call your cardiologist now, patient called Dr and told him he wanted to go to his office, explained the pain he was experiencing - the doctor told him said he couldn't see him wanted to do a telemed exam. and proceeded to tell patient to see an gastro entomologist, take Tums, no tomatoes, no coffee and a few other foods and that patient was suffering from Acid Reflux and to call him back net week.

Approximately 15 minutes after injection, patient developed a severe headache, dizziness and swelling of the face with red rash across cheeks and nose. Profound fatigue - needed to lay down rather than sit up. Was admitted to the Emergency Room for observation and benadryl IV was administered. Patient experienced the profound fatigue for seven days after the vaccine.

one episode of heavy sweating...followed by 5 days of not being able to walk in my home more than 10 feet without having to sit due to severe pain and cramping in upper part of both les. Also unable to lift either or both arms above my waist without sever pain or cramping. this lasted for 5 days before subsiding. three days later both ankles and my lower left leg became swollen. this has presisted for 10 days.

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

Day 1 following shot - slept all day Day 2 headache, chills, low grade fever 99.7, sharp pain on side of head every 20 seconds Day 3 headache, chills, sharp pain on side of head every 20 seconds; Significant upper lip swelling started at noon. Still swollen at same level at 7pm. No additional swelling .

My husband has kidney problems that have nothing to do with the vaccine; C-diff infection; My husband has a tube connected to his kidneys.; My husband had diarrhea not sure if it is due to the vaccine or not; My husband has had issues with hypertension; My husband has had dehydration; husband would be missing his scheduled 2nd dose; A spontaneous report was received from a consumer concerning her husband, an 80-year-old, male patient who missed their second scheduled dose of Moderna (mRNA-1273) vaccine. The patient was admitted into the hospital. The patient's medical history provided included the patient was diagnosed with urine cancer when the patient was 57-year-old, had ongoing Hypertension and Kidney issues. Concomitant products known to have been used by the patient was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On 10 Mar 2021, the patient missed his second scheduled dose of mRNA-1273. The patient was hospitalized due to the kidney problem, C-diff infection and had diarrhea and not sure if it is due to the vaccine or not. Patient had ongoing issues with hypertension. The reporter stated that the patient might have had dehydration and had diarrhea that also lead to having kidney issues, the patient's numbers went down due to dehydration. The Patient had a bag connected to his kidney and a tube, the patient had blockage and the bag was to clear out the patient's urine. Due to prolongation of hospitalization the patient missed the scheduled second dose of vaccine administration. The patient was still in hospital. No laboratory details were provided. Treatment information was unknown since the patient medical issues were still ongoing. Action taken with mRNA-1273 in response to the event(s) was unknown. On an unknown date, the outcome of the events were considered Not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Reporter stated that the events were not related to the vaccine and the patient has hx of hypertension and kidney issues Further information has been requested.

Adverse event occurred after 2nd dose. Rash developed under lower lip across middle of the face and a lump developed inside the left nostril. 5 days later, rash and lump in nose still present, mild pain in back right side of the head (behind the ear) developed. Pain behind the right ear grew more intense each day and on Thursday, March 11 was seen at Urgent Care with intense pain. Was diagnosed with Shingles and prescribed Valacyclovir and Prednisone, Acetaminophen-Codeine for pain. Saw Dr. on Monday, March 15. Pain is gradually reducing, but still present today, March 22, 2021.

received shot at 1130 am on 2/19. client developed chills/ fever that evening on 2/19. on 2/20, woke up feeling well, was getting dressed to go out to lunch at 12 when he had a seizure, as per his wife, it lasted for about 5 sec. then he recovered and states had lunch and took a nap. no other issues after that.

4 days after second dose patient has noted a feeling of heaviness and unsteadiness when walking. He also feels sweaty in the morning

About six and a half hours after receiving the second COVID-19 Vaccine EUA I became extremely tired. The extreme tiredness lasted 24 hours and then went away.

Got the vaccine, yesterday afternoon he went to the bathroom and felt a little light headed, and was not able to move, but did not collapse. He did not have any muscle control and not able to stand up. He then went down on the floor, not able to get up and called an ambulance and they took him to the hospital, had a temp of 101.4, after Tylenol went down to 99.4 and checked him out, and was having heart arrythemia. They then suspected the adverse reaction to the vaccine and he was checked out of the hospital. They told him to take Tylenol. Told him to FU with his PCP.

passed out; Golf ball sized knot from hitting head somehow, believes he passed out; Nauseous and sick; Dry heaves for 10-15 minutes; Nauseous and sick; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of loss of consciousness, haed injury,malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head. The patient's medical history was not provided. Concomitant medications reported were blood pressure meds for drug use for an unknown indication. On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot number: 031L20A) via unknown route for prophylaxis of COVID-19 infection. On 10 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot number: 011A21A) via unknown route for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient experienced the event(s)loss of consciousness, head injury, malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. On 12 Mar 2021 the outcome of event(s), nauseous and sick, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head was considered as recovered/resolved..; 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.

Pt came into Emergency Department with resuscitation efforts in progress. Patient spouse states no known health concerns but was feeling unwell after 2nd dose of vaccine on Monday.

Patient called the office stating that his arm is red and hot and his arm is swollen all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0. Patient was also having arm pain. Patient was advised to go into UC.

My father, who at 80 was walking 2 miles a day and had just had a check up within the month consisting of an MRI, cardiac monitor and lab work which gave him essentially a clean bill of health felt fatigued after his second Moderna shot. 11 days after his second dose he took an afternoon nap and was found dead by my mother and myself. We are devastated. The time frame so close to his second moderna shot can not be ignored. We want no one to suffer a loss such as this if the vaccine was a catalyst. Full autopsy is ongoing, no know cause with initial results.

Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ulcers aphthous oral and Hernia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. 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.

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

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

Patient became lethargic, increasingly suffered from delirium & hallucinations, leading to inability to walk. ER visit resulted in no explanation. Took him off meds, patient returned to normal, added them back one at a time. After adding Metformin, delirium began again so took him off medication again & he again returned to normal. Doctors didn't prescribe new meds for diabetes, so Metformin was again re-added to control blood sugar, & again delirium and hallucinations began. Patient had no issue with medication prior to 2nd dose of vaccine. This occurred between 2/9/21 to currently. He was recently in hospital after a car accident and was mistakenly given Metformin again, symptoms resumed and he's still recovering.

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

0200/02/26/2021 awakened by being EXTREMELY cold as if laying in snow - nude, Attempted to crawl to bathroom. Was not strong enough. Pulled my way up to a standing position and slowly and unsteadily got to bathroom for water, then to a mountaineering clothes storage closet and put on warmest down trousers and jacket. Stumbled back into bed and fell immediately asleep. Slept12 hours during daylight on 02/27/2021 0215/02/27/2021 Awakened by being EXTREMELY HOT and soaked in sweat. I was wearing normal bed clothes. Able to walk to bathroom for two glasses of water then returned back to bed, I could not get into bed, falling once even with wife assisting. Fell immediately asleep once comfortable in bed. Wife had changed sheet. It did not occur to us to take my blood pressure (we have a battery operated BP device) nor my temperature. Upon waking I was just a little weak and able to continue normal activities fully recovered.

Severe chills, fever (99.6+ F), lasted about 60 min., treated with 500ml APAP.. Accelerated heart rate (~105), ache at injection site persisted overnight. Difficulty sleeping. Mild cough from onset of symptoms until present.

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

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

Patient developed unspecified pneumonia which led to extremely high troponin levels. Patient died due to cardio pulmonary disease due to complications from COVID vaccine.

moderate (101-102deg. F) for 24 hrs. For first three hours strong chills. Considerable chills for 3-4 days.

Received #2 Moderna on 3/5/2021. Started to not feel well the next day. By 3/9/2021, he was too sick to get out of bed. Friends stayed with him the previous night and opted to call 911 for hospital transport on 3/9. He was admitted to a Medical Center and diagnosed with pneumonia. He died on 3/18/2021 in patient.

Pt reports continued fatigue and muscle aches sine day after vaccine given. Currently being followed by PCP Numerous scans, and blood work for work up by PCP

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

Hives began on day 9 post Monderna vaccination. Resemble chigger bites and has several with cause itching & discomfort. Also had fatigue and a low grade fever which resolved within 2 days but the hives/rash has persisted for 2 weeks.

? Patient never had a COVID positive test result ? The narrative seemed to shift over time, with the most recent hospital notes stating the headaches started after the vaccination, so I wanted to include a more in depth timeline on this ? General timeline gathered from notes o 01/11/2021: Constant headache ongoing for 3 weeks; discussed scheduling his COVID vaccine, directed to website o 02/02/2021: acknowledges patient has had first dose of COVID vaccine; denies ever being sick or around anyone with COVID o 03/01/2021: patient states he has had a headache since the COVID vaccine 1/19/2021 o 03/03/2021: patient has had both COVID vaccine shots o 03/12/2021: patient has had a headache for a couple months that waxes and wanes, no cause was identified. His headache first began at the end of January after his COVID vaccine

5 days following vaccine - fever/chills/complete loss of strength... 30 days following vaccine COMPLETE LOSS OF STRENGTH.. patient fell twice - no strength to get himself up ... sent to hospital ... then to rehab facility

Sudden Onset Atypical Parkinson's diagnosed by neurologist. Symptoms began in early to mid March and progressively got worse. Posture & Balance, Mental Confusion, Thinking difficulty, Dexterity, Speech changes, Writing changes, Tremor, Emotional changes, Swallowing problems, Fatigue.

Regularly get chills every day. Muscle soreness. Discomfort at injection site. Difficulty lifting right arm.

This is an 81-year-old male with a history of dementia also a history non traumatic SAH over the right cerebral convexity in 7/17 thought due to amyloid angiopathy , stroke and TIA who is brought by his wife for evaluation of changes that she noted last night around 9:00. She stated around 9 when she was getting ready for bed she thought his speech was a little bit thick but thought she had worn about since they were outside doing a lot of walking and had been to a picnic. The morning of the admission he has been more tired his tongue has been thick his speech is been a little bit slurred and his gait was slow with a shuffling gait. In the afternoon when visiting her son he recommended she bring him in immediately for evaluation.head CT showed small amount of bilateral subarachnoid hemorrhage Neurosurgery at Medical Center was consulted and no surgical intervention was recommended. He was transferred to Hospital for further evaluation treatment . repeat ct head was stable. He was discharged on 5/20/2021 and his aspirin was stopped. He also tested positive for covid 19 despite being fully vaccinated. ddimer was 1787- venous doppler was not done. he did not require oxygen. He was placed on quarantine on dc. Called wife on 5/22 and she reports he is complaining of fatigue but no cough or sob. He also has a history of covid 19 on 12/20 and was hospitalized and discharged on 1/6/21 and tested negative on 1/7/21. during that admission he was treated with remdesivir and decadron. He did not require oxygen. His hospital stay was protracted due to deconditioning and confusion but he was ultimately discharged home . the baby aspirin was added on dc. mri during that admission was normal with no acute abnl seen.

Reports soreness to injection site since 5/24/21 however developed increased swelling and warmth at the injection site on 5/26/2021. On 5/27/2021 the swelling and redness began to spread down his arm and he started to not feel well with chills and nausea. The patient was then seen by primary care this a.m. on 5/28/2021 who obtained blood work and an ultrasound. The patient was then instructed to present to the emergency department for IV antibiotics. He reports the arm is painful however declines need for pain medication. The patient does have a scabbed over area to the right hand which he reports is from his daughter's puppy that happened approximately 3 weeks ago. He has been applying bacitracin to this at home.

Patient received first dose of the Moderna Vaccine on 2/15/2021 and second dose on 3/15/21. He initially developed minor flu-like symptoms and then developed chest discomfort accompanied by chest pain. Patient has history of cardiac stent placement and DVT. Patient contacted cardiologist, they initially believed he developed angina. Patient had an ECHO that was normal. Chest pain continued and cardiologist brought patient in for cardiac catherization where 3 stents were placed on 4/9/21. Patient still experienced chest discomfort post-stent placement. Severe pain began to develop after catherization. Pericarditis was diagnosed by cardiologist 12 days after catherization. Patient has been taking colchicine and pain was fully alleviated.

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

Initially had fatigue, diarrhea, and loss of appetite. Tested positive for COVID 19 on 5/28/21 , during surveillance testing related to a facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness, high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia, treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On 6/12/2021, went to ED for ischemic stroke. Died 6/13/2021.

Symptoms start evening 2-1-2021 slight fever 2-2-2021 fever 99.6 muscle pain legs 2-3-2021 fever 99.7 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-3-2021 fever 99.9 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-4-2021 fever99.4 muscle pain whole body easing 2-4-2021 fever, pain gone called Urgent Care, told to take Tylenol did not see a doctor, under lock down in this state,

Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.). On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown. 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 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; 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 was feeling in good health prior to receipt of vaccination- Patient reported not feeling well right after receiving the dose; fainted the following day- sought medical care that same day- no issues detected; patient continued to say he did not feel like something was right. Patient died on June 4, 2021- brain bleed - transferred to different hospital-intraparenchymal bleed ---please note- there are NO LOT NUMBERS WRITTEN ON PT VACCINE RECORD!

Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pre-existing disease. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Stated that symptoms began with a cough around 6/12, and symptoms gradually got worse since then. Pt was tested first on 6/22 from their family doctor, and then was admitted to medical center on 6/24. Pt was diagnosed with bilateral pneumonia and is in the ICU currently because he is on oxygen (not mechanical ventilation). Pt has high blood pressure and history with kidney stones.

Patient received dose 1 3/5/21 and dose 2 4/2/2021. Became ill early July 2021 with a stuffy nose and sinus infection. On 7/3 returned to PCP and was diagnosed with Covid infection at a different facility per report. On 7/15/21, following admission to ICU on 7/14/21, patient tested positive for sars-cov2.

Tested prior to hospital admission. Started with a cough on 7/17/21 and fell at home. Was brought to ER for evaluation. Per nurse on the floor, he was admitted for fall and COVID, and has no issues from fall so continued admission is due to COVID treatment. Currently receiving plasma treatment and oxygen.

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

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

COUGH, RIGORS, NAUSEA, VOMITING, URINARY URGENCY/FREQUENCY, DYSURIA - FOUND TO HAVE LLL PNEUMONIA, CONCERNING FOR POSSIBLE CYRPTOGENIC ORGANIZING PNEUMONIA

Serious weakness, inability to get up from sofa, very shivery, had to get assistance from facility nurse to get to bed. Temp was 102, talked to doctor by phone and took Tylenol. Slept for 4 hours. Was able to navigate again.

VACCINE ADMINISTERED AROUND 11 AM. NURSE DISCOVERED A LARGE HOT RED 2 INCH PATCH ON HIS LEFT CHEEK (98.2 DEGREES). THERE WAS A OVER A DEGREE DIFFERENCE IN TEMPERATURE FROM RIGHT CHEEK TO LEFT CHEEK (97. - ISH DEGREES) THERE WAS ALSO A SMALL AREA ON THE LEFT SIDE OF FOREHEAD THAT WAS 100.2 DEGREES. THE REMAINDER OF THE FACE WAS UNCHANGED AND 97 ISH DEGREES. UPON INSPECTION THERE WAS NO RASH ON TORSO. WE DID NOT CHECK HIS LEGS.

Light headedness,Loss of balance, vomiting, sick feeling on 2nd day @ 12:00 pm recovered after laying down for 3 hrs.

Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.

About one hour after injection, patient experienced overwhelming fatigue such that he had to lie down in bed. He slept two hours. Upon awaking, he noticed soreness at the injection site, which has persisted the following day.

Twelve hours after I received the Moderna Covid-19 vaccine, I experienced sever shaking, tremors and chills.

Per MD & RN notes from Emergency Dept Records: "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls. Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.

Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue. The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue. On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included "significantly elevated" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and "slightly elevated" troponin of 0.079. On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care. Action taken with the second dose of mRNA-1273 in response to the event was not provided. The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021. The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin. Very limited information regarding these events has been provided at this time. Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.