Moderna

Blistering burning rash opposite arm of injection site spreading down arm. Time 1 day after injection 24 hours later

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.

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.

Began having a local reaction. Spread to current size of 6 in by 4 in. Warm to touch, area swollen. Has not progressed in size over past two day. Somewhat sore, very itchy. No other symptoms except for the local reaction.

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.

Patient Began experiencing shakiness, tremor, feeling of ?rush? approximately 15 minutes after the vaccination. He was immediately assessed by EMS crew. Blood pressure 156/72 initially. Pulse is 64, respirations 20. He said he had a tight feeling in the neck and felt flushed. Oxygen saturation was 99%. Patient was given 25 mg oral Benadryl after five minutes of symptoms. He continued to be monitored. His symptoms improved mildly, But he continued to complain of a rush like sensation. It was recommended that the patient be transported to the hospital for at least six hours of monitoring. The patient declined and signed an AMA form. Patient monitored for a total of 45 minutes before allowed to be escorted out of the building with his wife, with instructions to present to the ER mediately if any symptoms worsen or did not improve within the next five hours.

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

Unable to use legs, extreme pain on both hip joints, nausea, very sore left arm, very weak left arm, needed assistance in and out of bed

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.

Marked involuntary movements, of whole body and especially left arm and leg. Loss of ability to communicate and feed himself. Vomited medication.

Initially felt mild soreness to injection site, lasting <48 hr. After 2 days, felt increased whole arm soreness with numbness to fingers by day 5 with pain to finger by day 8. He saw a specialist by telehealth on January 21, suggesting neuropathy from inflammation around the ulnar nerve, anticipating recovery in 4 weeks. He was prescribed Meloxicam and Gabapentin and recommended to receive the 2nd COVID dose in opposite arm.

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

I am not sure if this is a reaction but 3 weeks after the first vaccination I developed painful spots in my fingers that now have continued for 10 days and some new have developed and the old ones have changed it seems to me as a vasculitis of some kind I will see my PCP on 2/19/21 but for now I am going to skip the second dosage

after 6-7 days of receiving the shot I have a sore arm and a rash from the point of the shot running down my arm about 3 inches, the concern is the reaction occurred 6-7 days after receiving the shot ,Will I be able to take the second shot on 2/17/21 . Have not gone to a doctor , realize this is a normal reaction ,but wonder way it occurred 6-7 days later, concerned about taking the second shot on 2/17/21

I woke in the night on Monday, Feb. 1 to use the bathroom and when I stepped out of bed I felt a sharp pain in the outside ball of my right foot. I thought I had stepped on a needle. I could not step on that side of the foot as I walked without sharp pain. I immediately searched for what might be in my foot and found nothing. The pain continued through the night and into the morning. My shot was in the left shoulder. I have concluded this is a neurological reaction (nerve pain) from the vaccine (Moderna). Never had this pain before.

Patient received first dose of Moderna vaccine at 11:11am. Patient then moved to observation area to be monitored and at 11:26 am he reported feeling dizzy and a slight flush. No redness or hives visible on patient. Continued to monitor patient, breathing was even and unlabored, O2 sat assessed at 98%, HR 61, patient sitting upright in chair. Patient had 3 sweaters on and 2 facemasks. Patient removed the second facemask. Patient refused to remove sweaters to assess BP. Patient reported he played tennis prior to his vaccine appointment and had diet coke and a bag of chips following. Patient given bottled water and monitored for additional 15 minutes. Patient reported feeling better and had a ride home. Patient in no signs/symptoms of distress or anaphylaxis, respirations even and unlabored, denied itching, swelling, shortness of breath. Patient left facility at 11:47, gait steady. Informed to f/u with his PCP and seek emergency medical attention if any signs of anaphylaxis develop.

day after vaccination pt experiencing leg severe muscle pains, pt is not able to move much without using a walking stick, and has to have assistance to get around

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

12:58 Pt c/o tingling to R forearm. Vitals assessed B/P 200/96, HR 65, O2 sat 96%. Approx.. 5 min later pt c/o heat/warm sensation to head. No other c/o, no SOB, no rash, no N/V. Pt has hx of HTN, he took his meds this am. Pt reported approx. 5 min later that heat/warm sensation is gone & the tingling to R forearm is decreasing. 13:08 BP 158/90, HR 68, O2 sat 96%. Pt is feeling better, very little tingling to R forearm. No other symptoms. 13:22 B/P 150/80, HR 63, O2 sat 96%, Pt is going home with wife. He was notified if any other symptoms occur. Pt did not called 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

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.

Early next morning he got in his vehicle and drove around (he does not know why).He ended up behind a shell gas station and police were called as a suspious person. His windows werte down and he could not remember how to close them. He had been there for hours and unrinated in his clothing. He told the police he was making sure the waitesses were doing there jobs correctly. Again this was a Shell gas staion and not a resterant. The police closed his windows and sent him home. He hit the side of the house with the truck. Then when he got to the garage he could not remember how to put it in park. He is still having memory issues today but he can carry a conversation. Tuesday he could not complete a sentance

Beginning 1/24/21 - legs began feeling heavy- unsteady gait - weakness - stiffness - confusion . Parkinson meds appears to be no longer working- symptoms worse.

Potential allergic reaction - epinephrine administered PT had seizure activity at 11:45am, within 30 minutes after administration of first COVID vaccine (Moderna) Epinephrine (0.3mg) administered by provider at 11:47am PT had audible and palpable pulse, approximately 180 bpm that declined to 107 at time of arrival of the fire/ambulance department, respirations and heart rate did not cease during event PT in postictal state after seizure however able to dictate to Fire Department his name, date of birth and his last seizure which he states was "a month ago" Patient was transported to Hospital in stable condition Fire Department

Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021

Patient called 2/17/2021 to report he had a very stiff arm (unable to lift arm) and arm was very painful after injection 2/16/2021. Patient took acetaminophen through the night and arm was still stiff and sore morning of 2/17/2021. He required assistance doing his farm chores/work.

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!

Patient had the Moderna vaccine 1st dose roughly 5 days ago. Overnight, his wife woke to him having an episode of what appeared to be a tonic clonic seizure around 5 am on 2/23/21, followed by a period of disorientation and unresponsiveness consistent with a post ictal state. The patient has no history of seizures. It is unclear if this had anything to do with the Moderna vaccine, but I am reporting it due to the timing of the episode in conjunction with the vaccine.

caller stated he developed neurological issues a week after receiving the covid vax. Pt became weak, confused, unable walk, hallucinating. He fell 3 times in that week. Symptoms got worse to the point that 911 was called and he was admitted to the Hospital. He had a MRI and CT of brain. MRI on spine. Both had abnormal results w/ no bleeding. Blood Work was normal. He was treated and will be released on Hospice 2/25/2021.

Several days after receiving my vaccination with the Moderna product I developed a significant rash of both hands on the dorsal side. It is non-blanching and it's only mildly tender and itchy. It was on my neck a little initially, but that has cleared.

2/19: left arm, red spot approximately 2" in diameter at site of shot; itchy 2/20: left arm, redness increased to 3-4" in diameter; itchy; by evening increase to approximately 5" in diameter 2/21: left arm, redness area no change; itchy; swelling increased after physical exertion; tender and warm to touch; 9:30pm took 1 tablet Benedryl; 11:00pm took 2nd tablet Benedryl 2/22: left arm, redness and swelling increased; approximately 5-6" in diameter11:00pm took 1 Benedryl tablet 2/23: left arm, redness and swelling diminish slightly, approximately 5" in diameter; 11:00pm took 1 Benedryl tablet 2/24: left arm, swelling diminished; red area unchanged; 11:00 pm took 1 Benedryl tablet 2/25: left arm, swelling further diminished; red area unchanged - 5" diameter 2/26: left arm; no swelling; red area smaller - color changed lighter, more pinkish, area 2-3" in diameter at shot site 2/27: left arm; pink at injection site; approximately 1-2" in diameter; slightly itchy

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.

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.

Patient states 10 days after his first injection, he experienced sore arm, muscle/joint aches and diarrhea x 3 days, and went to the ER.

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.

Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.

patient reported generalized weakness and fall at home which started shortly after receiving vaccine. progressed to the point of severe weakness causing him to fall and not be able to pick himself up from ground. reports that around 2 AM on Friday, 3/5 patient had gotten up to go to the bathroom, he felt very weak, was unable to successfully ambulate to and from the bathroom and had a fall without injury on his way back to the bed. His wife was able to assist him back into bed and he rested later in the morning he got up a second time to go to the bathroom he essentially crawled to the bathroom. he was unable to get back to bed his wife was able to help him to sofa in the living room which was nearby; states that he basically leaned against the sofa until this morning when family arrived and helped bring him to the hospital for evaluation. Patient denies shortness of breath but the patient is breathing approximately 34 times a minute on my physical examination. He denies pain. He has had no nausea or vomiting since his vaccination.

Near syncopal episode after COVID19 vaccination. On direct questioning patient does not recall the episode, he does remember receiving the vaccination, but has no recall of later events. Patient was being observed after administration of COVID19 vaccination, and while being observed, he became less responsive, and he was noted with a decrease in his heart rate, and decreased strength of pulsations, a rapid response was initiated and he was transported to the Emergency Department (ED).

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

After receiving vaccine patient became unresponsive and had ?posturing like behavior. After a minute or two patient responded to strong sternal rub and was transported to ER for further evaluation.

Approximately two weeks after receiving my first dose of the vaccine, I started experiencing upper body bilateral joint pain, primarily in shoulders and wrists. This pain has continued since then for approximately six weeks now. In addition, my right arm, hand, and fingers are swollen, and the tips of my fingers on the right hand feel slightly numb. I have been taking acetaminophen, ibuprofen, and naproxen, but still have the symptoms described above.

New onset Myasthenia gravis. Patient initially presented in the ED on 2/23/2021 with complaint of left facial droop, slurred speech and double vision. His stroke score was 2, for left facial droop. nAChR antibody test this test has come back positive, making it likely that this patients symptoms are due to acute myasthenia gravis. The patient continued to experience double vision and eye weakness associated with trouble swallowing that has continued to worsen and was brought the hospital for re-assessment at the request of his wife.

Moderna COVID-19 Vaccine EUA 3-March to 7-March: sore left arm, then later sore neck, chills, aches all over body and general blahs. Took Tylenol Extra Strength 500 MG as needed 8-March to 15 March : forehead and left side of upper face swollen, red and slightly itch . I Put some Polysporin ointment on and it seemed to help a little. Called my doctors office on 12-March, they these symptoms were due to the Moderna shot and that I should ride it out until they went away.

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.

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.

Involuntary and uncontrollable movements of entire body, mostly left side, Dramatic loss of coordination for two days. Dramatic loss of cognitive function for at least two days. After two days he seems to have improved although I was advised not to allow him to have a second dose, especially since he already had and survived well the Covid virus in 2020. His doctor feels the vaccine may have caused swelling in his brain which caused the side effects. The symptoms subsided after two days but no one could assure me that he could recover from a second dose of the vaccine. I have video of the behavior.

Moderate pain in joints over 3 week period. Pain in fingers, shoulders, elbows, wrists, Jaws, .... 2nd Moderna shot, one week of joint pain

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.

I received my 1st dose on 2/26, but I still have intermittent level 2-3 pain in the left upper arm where I was given the shot. I think eventually it will go away, but since my 2nd shot is coming up and it has been almost a month, I thought I should mention it to you and ask whether I should mention it to the CDC as a reaction. I think this is just a result of the injection itself and not of the vaccine. But I have never had such a lingering pain before from an injection and so I raise the question.

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.

SHORTNESS OF BREATH ISOLATION-INFECTIOUS DISEASE SIRS (systemic inflammatory response syndrome) Hypokalemia Hypomagnesemia Lactic acid acidosis Hypoxia Transaminasemia Generalized weakness Abdominal pain, unspecified abdominal location Suspected COVID-19 virus infection

Sharp pains in feet, cramping in feet and lower legs, involuntary spasms of feet and legs all night. Still have some pains in feet this morning, but not as severe as during the night. Injection site quite sore, but that was expected.

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.

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.

Wife said the patient felt "jittery and aggravated". This started the day after his second dose and lasted two days.

Patient received second dose too early. Due date was scheduled for 04/09/2021. Patient experienced no adverse reactions as a result of receiving the vaccine too soon. Stated only experienced soreness in the arm where vaccine was administered x 24 hours.

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.

Pt recieved 2nd Moderna Covid Shot, April 5. thirty min later, pt lowed to the ground with generalized Seizure lasting about one min. followed by post ictal confsuion. Pt remained confused, so brought to the emergency room on the 6th where I saw him. He was awake, but confused, knew his name, but that is about it. He was released from the hospital today. I speak with his daughter, he has been in a stupor, but today his mental status is improving..

swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) 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 information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details include prednisone, Benadryl and oxycontin. Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

Chief complaint : syncope, vomiting, and weakness. Assessed by on site Medical and transported to Hospital.

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.

Per patient and spouse: 2nd dose of Moderna received on 04/01/2021. (This facility does not have record of administration). Patient seen in ED 4/11 after 5 days of bilateral lower extremity weakness, gait problems and numbness. Patient admitted and evaluated. Neurology consulted and on 04/13/2021 diagnosed with likely acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barre syndrome.

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.

respiratory and cardiac arrest Narrative: Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.

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.

injection site reaction; sore arm Narrative: Patient is a 75 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination.------------------------------------------------------------------------ SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction Yes Other No If yes describe: sore arm x1 day

Stroke; Can not talk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and APHASIA (Can not talk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization) and APHASIA (Can not talk) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA and CEREBROVASCULAR ACCIDENT. On 13-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. At the time of the report, APHASIA (Can not talk) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The wife reported on behalf of her husband. On 13 Apr 2021, the patient was transported to another facility by ambulance. The wife had no information about the lot numbers and was not even and was not sure about the date of first vaccine however, she did mention it could be 03 Mar 21. No concomitant medications were reported. Treatment information was not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

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.

swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) 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 No adverse event (No medical history reported.). On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms. Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case

Complained arm with vaccine hurt. Went to bed. Made a large noise which woke me at around 1:30 am. I found him unresponsive with wound on his forehead. Called paramedics. Took to hospital and then to rehab.

Patient received vaccine on 04/17/2021. Reaction started on 04/30/2021. Came to pharmacy and showed left arm was covered sparsely but with red blisters located on left arm, arm pit, left chest, and a little bit on the back arm. Reported soreness and itchiness as well. Has not tried medication but has been putting on a warm washcloth over the area to ease the soreness. Spoke about using otc pain to help ease until seen on Tuesday by doctor as the doctor office is closed today (sunday 05/02/2021).

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

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

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.

Pt had a rash on his arm from the second shot, as well as the first. He also said he had nerve pain in feet and nerve pain in feet that increased during urination.

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.

Patient presented to hospital evening of 1/27/21 with acute onset weakness and buckling of knees, admitted to medicine service and neurology consulted. Patient diagnosed with acute motor axonal neuropathy, a variant of Guillain Barre Syndrome. Patient received IVIG 1/28-1/31. Despite IVIG treatment, patient with progressive worsening of motor weakness, resulting in diaphragmatic weakness requiring intubation on 1/29. Patient has remained ventilator dependent and is now s/p tracheostomy.

pt states his right leg had pain and tightness from the inner thigh to the knee. It was painful to touch. Pt went to his PCP Dr. on 2/22/2021. He had blood work and ordered a sonogram for legs to check for blood clot. He was told to use a topical cream Voltaren which did not help. The sonogram showed that he had multiple blood clots on this inside of this leg down to his calf and was prescribed Xarelto. The blood clots disappeared after a couple of weeks.

Very painful arm.........Very weak whole body next day......had to urinate 4 times at night. (usually I only go once) vision weakened for 24 hours

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.

Patient had 2nd met during a vaccine on 05/15/2021. That same evening into the next day noticed profound weakness with difficulty walking without assistance. Needed to be helped to bed last night. This morning woke up at baseline and feels completely normal with no weakness or fatigue. Never had any fevers, chills, nausea, vomiting, diarrhea. No dysphagia, aphasia, facial drooping noted.

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.

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.

within days the pain and weaknesses that were reported to be common became far worse and long lasting (now in my seventh week), affecting my neck, head, shoulders and legs, especially my quads. I could not turn my head left or right, I had pain shooting up the backsides of my neck into my head, had head pain, shoulder muscles pain, and severe leg pains. I initially was told by my doctor that it would go away, and it hasn't, although not as severe now in my neck or shoulders, and I have more, but limited neck turning movement. My legs are i terrible shape and cause me a LOT of pain, for which I went a couple of weeks ago to an Urgent Care place, who said I need to go to a specialist, but recommended I try taking a NASID for two weeks first regularly, to see what happens. I am nearing the end of that period, having taken ALEVE twice a day. It has helped cut down on the pain, but the basic problems still persist. I feel like I have aged 10 or more years, although I had been healthy and vigorous before taking the 2nd Moderna shot, and I am expecting that the "doctors" do not know how to handle this. I am frightened.

MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment Based on the current available information and temporal association between the use of the product and the start date of the 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 the 9th, my father suddenly froze while standing up by thekitchen sink and stopped talking. He looked as if he was losing consciousness and couldn't talk and wouldn't drink. He suddenly collapsed into my arms after i ran to get a chair so he wouldn't fall on the floor. He could barely Sir in the chair himself. He got up and tried to walk but collapsed into the chair that i had dragged over to his new spot. He say and suddenly began to faint and seemed to be dying. I called 911 and the paramedics arrived and took his vitals and said he was fine now. By the time they'd arrived, he was up and alert and able to walk and talk. This was extremely scary as i truly though my father was dying. He had the first dose in May and also had a reaction. His lips blew up to a very large size. I didn't agree that he should have taken the 1st nor 2nd dose.

The day after receiving the second dose he was working outside and after coming inside he started complaining of pain in his lower back and legs. He said the pain was not consistent at first. It would come and go. Over the next few weeks it progressively got worst. The pain had increased making it hard for him to walk, sit on lay to sleep. On 4/2 he went to the ER at Hospital because the pain was very bad. He was treated with IV muscle relaxers and steroids. He as discharged with diclodenac, methocarbamol and prednisone for Radicular pain. He has progressively gotten worst as he has lost over 50 pounds. He recently visited the ER at second Hospital where an extra showed diffusers increase bone density. He was discharged with 600mg IBprofen , Dexamethasone and prednisone. He continues to get worst. He is now hardly eating and in pain all the time. He is week and have trouble walking

Started feeling stiffness and pain in arms and legs. Then pain and stiffness moved throughout the body rendering almost immobile. As of June 13, 2021 has not fully recovered and is still under a doctors care. Diagnosed with Polymyalgia Rheymatica.

Worsening abdominal pain and distention on 3/2/21 which progressed to include shortness of breath for which he did not seek medical care. He was found unresponsive on the couch on 3/11/21 and resuscitation was unsuccessful.

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.

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.

'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.

2nd moderna vaccine given 7/12, that night developed some mild low back pain. The next morning the pain was more severe and associated with left leg pain (throbbing). He developed a rash as well (purpura with some bulla) on the buttocks which then traveled down his leg and into the left foot (not painful/pruritic). No fever, chills or other adverse SE.

Right elbow swole vup to two to three times its normal size. Both feet swole up and was so sensitive I could not touch the floor or stand. Was hospitalized for a total of eleven days.

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.

The first week he started getting sore, affected hand and arm, can't raise right arm completely, soreness and brown spot at injection site

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

Patient's spouse states that approximately 1.5 hours after receiving vaccine patient was at home and found to be confused and non- verbal. Unable to verbally express what was wrong. Spouse called into the clinic was triaged via phone and advised to go to the ER for further evaluation.

PATIENT A 77 Y.O MALE PATIENT, EXPERIENCED WHAT HE THOUGHT A REACTION TO COVID-19 VACCINE ON 01/12/21. DETAILS BELLOW: HE RECEIVED THE VACCINE AT 3:15PM ON 01/12/21 AND EXPERIENCE RED SPLOTCHES ON FACE WHICH WAS WARM AND WOMEWAHT TENDER TO TOUCH. PATIENT DENIED SWELLING OF THE FACE, MOUTH OR ANY DIFFICULTY BREATHING. HE WENT TO URGENT CARE AND WAS PRESCRIBED BENADRYL AND WAS INSTRUCTED TO TAKE BENADRYL PO EVERY 4-6 HRS AND WAS SENT HOME. AS OF 01/13/21 PATIENT TOLD ME OVER THE PHONE THAT HE IS GETTING BETTER. HE STILL HAS THE RE SPLOTCHES BUT ITS NOT WARM OR TENDER TO TOUCH AS OF TODAY. I WILL CONTINUE TO MONITOR STATUS. PRIOR TO THE EVENT. PATIENT REPORTED THAT ON 12/14/20, HE WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED WITH CLINDAMYCIN ANTIBIOTIC FOR SUPPOSEDLY 2 WEEKS, BUT ON JANUARY 2,2021, HE DEVELOPED THE SAME RED SPLOTCHES ON FACE AND WAS PRESCRIBED PREDNISONE TABLET AND WAS INSTRUCTED TO TAKE IT FOR A WEEK. PATIENT STATED THAT HE TOOK THE PREDNISONE UNTIL JANUARY 8,2021 AND IT RESOLVED THE ISSUE. STATES HE THEN GOT HIS COVID-19 VACCINE ON 01/12/21 AND DEVELOPED THE ABOVE MENTIONED SIGNS AND SYMPTOMS, ALTHOUGH THIS TIME HE WAS NOT PRESCRIBED WITH PREDNISONE, INSTEAD WAS DIRECTED TO TAKE BENADRYL TABLET.

Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.

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

leg cramps BL, shoulder cramps BL, head felt like it wa puffed up, rash started 1/11 around neck, back and front itchy

Patient had knot on right mandible mobile that came up 24-48 hours after shot it was tender. At 72 hours no longer tender but large >2cm.

Patient complained of Nausea and dizziness on following evening and and vomited few times after that and symptoms were relieved after that. on January 19th , about 80 hours after the vaccination patient complained of being very weak and lost strength to move which lasted for about 30 minutes and family called ambulance. They checked vitals. They were okay. After that patient felt better and went to rest.

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.

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

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, 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

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.

Severe pain in arm. Limited movement. Difficulty raising sideways after 3 days. Greenish streaks down arm (veins?).

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.

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 .

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

Noticed today that left arm is a bit swollen . Has a pinkish color and slightly warmer than corresponding area on right arm. Slight soreness when area pressed.

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.

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

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.

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.

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.

On 1/07/2021 approximately 11:30 am patient started experiencing weakness; by 1:30 p.m. patient couldn't get out of a chair or walk without assistance of cane and person. Patient became increasingly weak and by 4 pm could not walk nor understood how to walk without caregiver telling him. Patient's doctor was called and at 5:30 pm patient was told to go to the hospital. Doctor thought patient could have had a mini stroke. Patient arrived at hospital at approximately 6:30 pm and underwent stroke test, COVID test, blood work; chest xrays and brain scans. All were negative.

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.

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.

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

Trigeminal neuralgia has been totally under control using prescribed medications. Shortly after the first vaccination started having occasional episodes despite taking medications as prescribed. After second shot, INTENSE episodes that medication does not control. Losing work, cannot talk at times, excruciating electrical, jabbing pains in face. Definitely neurological issues exacerbated by the vaccine.

Moderna COVID- 19 Vaccine EUA: soon after vaccination patient reported feeling warm and naseated. Symptoms resolved within one day. Six days after vaccination patient developed an itchy rash on the face that is warm to the touch, stomach cramping, dizziness, and chest discomfort. Physical exam remarkable only for rash: patient presented alert and oriented, well-appearing. Patient prescribed hydrocortisone cream.

I had my (Moderna) first dose yesterday. Within ~6 hour the soreness level of the shoulder joint (but not especially the site of the jab) zoomed up to intense. So much so, that simply lifting my arm slow-motion to the level of my eyes caused intense pain spasms. Last night and this morning were equally severe. Within the last hour or so, the pain level has diminished a bit. NOTE: I know how people rate pain is super subjective. In my case working as a geologist in a quarry a number of years ago, I was struck and pinned by a large boulder. The ER crew would not give me a pain killer, so that they could monitor how the Jaw of Life was working (it broke, the boulder was too heavy), so I not surprisingly passed out several times from the pain level before being extricated. Needless to say, this compound fracture of the tibia and fibula accident was a 10 of 10 pain level. Yesterday's CV-19 jab pain level was an 8-9 of 10. Nothing I read before yesterday's jab, Fauci et al, prepared me for this pain level. So, is this normal??? My POV is, I think, atypical in this matter of pain. Should I be concerned about a return to normalcy right now (today / tomorrow) as well as for the second dose?? I HOPE THAT A MEDICAL PERSON WILL RESPOND TO THIS EMAIL - NOT SOME BOILER PLATE WORDS. If you want more details, feel free to phone me

RN gave IM injection too high on the arm resulting in severe pain and immobility x 5 days. Patient felt pain very soon after injection and circled the needle mark of the injection site. Patient reported to public health department on day 6 after injection to ask if this was an expected reaction after a vaccine or if it was because the injection was too high. The location that the patient marked was indeed over the shoulder and not in the deltoid muscle. The RN who gave the injection has not done patient care in 20+years. The injection was co-signed by public health department staff. Patient reports that on day 6 the pain had decreased a small amount and that strength is returning to his hand.

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

Morning after, left leg was partially paralized, for about 20 minutes. Left elbow was same way except didn't last but about 5 minutes. Under front of nose there was a weird sensation that lasted until the second day. Felt like something was messing with nose but nothing was there that could be seen. Now this is day 8 and there is swelling abouve my left ankle probably about 2 inches up. The leg and elbow and nose seem to be ok. I don't think I want to take vaccine #2 because of these effects that happened.

mild case of the shingles on right side of stomach area approx. 6 inches by 4 inches tender to the touch t-shirt hurts the area

I arose at 7, took a shower and felt fine. Then while making the bed with my wife I suddenly felt vey week, needed to sit on the side of the bed. My wife said my face was white. I had some mild intestinal cramping so went to the toilet. I was doubled over sitting on the toilet and in a cold sweat with diarrhea. There was no nausea. I felt weak afterwards and napped most of the morning with one more episode of diarrhea, very mild this time, at 10:45. I did not seek medical help, was able to eat lunch and dinner with no problem, but was very low on energy for the remainder of the day. I went to bed early with 2 Acetaminophen and slept 11 hours. Felt better the next day.

Woke up the next day, vomited, ate little balance of day, weak, could not crawl from floor to bed, slept on floor, next morning we called 911, he was taken to the Hospital, for Wed/Thurs/Fri/Sat/Sun, then transferred to a Rehab Facility for three weeks for therapy, still at rehab,

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.

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

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

I'm a 77 year old Male, I take no Meds. I do have Peripheral Neuropathy, I'm not a Diabetic. About 20-25 minutes after my shot on driving home my left leg started to go numb, time I got home both were feeling the same numbness. [takes about 15 minutes to get home] Here it is 4 days later still have the numbness, but not as bad. Then on 2/13 Saturday evening I was watching TV, my eyes I started to see colors floating around in them. About 20-25 minutes later it was gone. The biggest thing with my feet and is it OK to go with the second shot?

marked weakness and inability to walk without assistance. Very unstable. Has fallen several times. These symptoms are much more pronounced than before the vaccine was given.

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.

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.

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.

Pt presented on 2/22/21 reporting right sharp and stinging arm and shoulder pain for 3-4 days. Pain was worse with touch/pressure. On 2/21/21 he developed a lesion on his shoulder. Provider found 2 vesicular lesions concerning for shingles. She started pt on gabapentin an valcyclovir and will follow up as needed.

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.

seizure; hospital staff "couldn't wake him up"; 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 experienced a seizure. He was hospitalized for one night and the staff had a difficult time waking him up. The patient's medical history included prostate cancer last year. Patient provided that he takes 8 or 10 different medications daily but did not list them out. No other medical history was shared and patient has no known drug or food allergies. On 30-Jan-2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31-Jan-2021, the day after the mRNA-1273 vaccine was given, the patient had a seizure and was hospitalized for one night. He stated that the hospital staff had a hard time waking him up. He spent one night in the hospital and was released on 01-Feb-2021. It was not reported what caused the seizure and the patient was unsure if the hospital knew that he had the vaccination the day prior. He was discharged with Keppra. Consent to contact was given by the patient to contact him and the hospital. No further treatment information was not provided. Action taken with mRNA-1273 was not reported. The events, seizure and depressed consciousness level, were considered resolved on 01 Feb 2021.; Reporter's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

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.

Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr

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

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.

On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine. Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.

Developed Belle's Palsey on left side of face exactly one week after first shot. Doctor says it may or may not come from the vaccine.

Very sore left arm, About 9 hours after injection began to feel cold, shaky, leg muscle ache and increasing temperature.

Client received Pfizer for the first dose of the series. He reports only a minor sore arm after receiving Moderna for the second dose. Pfizer EN5318 IM on 1/29/2021

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.

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.

He received the vaccine and after 2 hours he went home and was paralyzed from the waist down. He tried to stand up and then he passed out on the floor for about 10-15 minutes. He went to sleep and woke up around 5 hours later. He then tried it again and urinated on himself and he fell down on the floor, passed out without getting up until the morning. He did call his doctor who was not available, spoke to the nurse and advised to go to the hospital. He is weak and cannot drive so he did not go to the hospital. He slept the rest of that day and the following day. Then when he saw his doctor about 2 days ago, he described his reaction and told to report the reaction and that he would report it himself. He was advised not to take the 2nd vaccination. He is no longer having the heavy reaction, his muscles are aching and his vision is blurred, especially on his back and the shoulder. His doctor did do blood work at the office visit.

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

After receiving the Moderna COVID-19 Vaccine EUA, my left arm from shoulder to wrist became very sore the next evening. It was very sore for about one week. The soreness gradually dissipated over the next week, but then began to get worse over several days. Beginning the third week after this dose, the soreness is mainly in my shoulder.

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

I'm still not sure which COVID19 vaccine my dad received (It made me fill it out--I'm not sure if he got Moderna or Pfizer). Nursing home would know. He received his 2nd shot on Jan 19. On Feb 17 all was fine and they were planning on getting him crowns at the dentist. On Feb. 19 everything went poorly. He started to suddenly have seizures and was not responsive. When I arrived on Feb 21 he didn't say much and had seizures that night. On Feb 22, he responded a little bit and had a big black eye from a seizure the night before. On Feb 22 he had at least 4 seizures and he passed that afternoon around 1:20 pm

Neurological, including trigeminal neuralgia and one Bell's Palsy symptoms. Tried to complete online at library on 2/24/2021 but timed out at 20 minutes. Item #18: CDC asked to report any Bell's Palsy symptoms (also trigeminal neuralgia is related to BP). 48 hrs post vax, mid-afternoon Sat, Feb 6th: Suddenly unable to comprehend book I was reading; and there was a physical sensation of irritation just inside my skull, wrapping around my brain (meninges?) - it did not intrude into brain. Felt lack of 'presence' in room. Slightly unstable on my feet. Believed these were related to vaccine, would soon abate, but, also, that this would be no way to go through life! These lasted 2-3 hours. (I neither drink alcohol or take recreational drugs.) About that time, a 'twinging' precursor to trigeminal neuralgia began – uncertain whether it was TN? Recurred every 3 hrs. But then awakened at 6:30 a.m. by two painful TN jabs, repeated more strongly at 9:40 a,m. At about 12:30 pm, return of light 'twinging' sensation, then nothing – no recurrence. 3rd TN episode in 3 years, the briefest, the only one not requiring oxcarbazepine. Checked for Bell's Palsy symptoms (which I've never had): The left side of my mouth wasn't producing any saliva at all – none. This improved very slowly, continuing for 5 or 6 days; by far the longest lasting symptom. About Monday, the 8th, experienced an expanded time warp driving to library – took forever to reach two roundabouts. Lucid, alert, vision & reactions normal. Speed was a mile or two above limit. No euphoria or nystagmus. At library, conversation and work seemed normal. Around the same time I had about an 18 hour complete memory loss with regard to medications. Two dose periods in succession. On Monday, Feb 8th, I called our 4 day a week neurologist. He said the symptoms were an immune response to the vaccine but that he's never seen them together before. It was scary. I'm not going to take the second dose at this time. And will depend upon PCP. Filling out this form because you've asked about any adverse reaction related to Bell's Palsy (which TN is closely related to). I wonder how many others have experienced trigeminal neuralgia symptoms following vaccination? It's a cumulative disease and devastating in advanced forms. :-(

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

I believe I reported adverse symptoms on the 11th March, but on 12 March I noticed my left upper lip "drooping", and my right eye blinking differently from my left one, so, fearing a stroke I went to the Hospital at approx. 2PM. They monitored my BP, took blood samples, then did a CT scan followed by an MRI. Then the doctor saw me and told me that my MRI was "clear", but that I had "Bell's Palsy".

I am a 77 year old male with peripheral polyneuropathy. I received my second dose on 3/13. No problems on 3/14. On 3/15, I awakened with extreme pain in my right leg from my hip joint, down my thigh, encompassing my knee and my calf was cramping. I have been experiencing neuropathic pain in these regions for several years, but, this morning the pain was excruciating to the point I could not stand on my left foot, and I had extreme difficulty trying to sit down because of the knee pain, it would not bend without serious pain spiking. Listed above, are the treatments I have been using to treat the neuropathy since 2017. Was getting better until now. Pain today is the worst I have experienced in years.

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.

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.

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.

since morning today all my fingertips felt numb and frozen. not able to button my shirt. went back to normal after 6 hours. very scary no treatment done-just warmed up with mittens and gloves, but why did this happen. what should i do if it happens again?

About 1-2 weeks after first COVID Vaccine, he started to experience breast and axillary tenderness + swelling which are still present.

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.

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.

Patient reporting tenderness when moving arm. Patient reports 0/10 at rest. 5/10 if raised above head. Patient states he feels weaker in that arm since the injection. Patient assessed in office and refused any imagining or treatment. Provider believes a nerve is affected/irritated after injection. there is no redness, no mass, no other symptoms besides pain and weakness, only in the affected arm. Patient contacted us to let us know.

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.

24 hours later lost all feeling in both arms and both legs. This sensation lasted 12 hours and than I was ok.

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.

stroke like symptoms: severe ataxia, left side flaccid, could not walk, could not understand spoken word, fever 100.2F, hands contracted, could only speak 2 or 3 words. symptoms lasted about 4-5 hours intensely, not recovered until next day.

started with just injection spot swelling and red bumps, after 2wks its full upper body. Including arms, elbows, back, groin area, buttocks, belt line/waist, down the tops of the legs.

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

Grand Mal Seizure, called 9ll, went to hospital,took mri and cat scan. Appointment with neurologist on going. Meds perscribed.

Pt ingested a single martini two hours after injection . He loss conciousness for several hours. When he awakended he was confused , speech was slurred and appeared severely intoxicated

sore arm for 3 days. I have a psoriasis flare up in areas I dont normally have flare ups in. I also have an arthritis flare up

Patient came to pharmacy to report adverse events following 2nd Moderna COVID19 dose. Unable to determine if this was related to vaccine or not, but reporting as patient perceived event. The day after vaccine administration, patient felt weak and fell to floor when getting out of bed. He stated he was so weak that he could not lift his body up until someone came to help lift him. He said he felt shaky and could not control his bladder/was urinating uncontrollably. Pt reports that he only has 1 kidney and doesn't know if this may be relevant. Counseled patient and recommended consulting his physician/nephrologist and would report to VAERS.

Patient presented to the ER with right sided extremity weakness. Initial CT showed no hemorrhagic stroke so patient was admitted for treatment of ischemic stroke. Was started on IV Heparin drip and condition improved greatly. Subsequent CT showed small ischemic stroke on left. Patient recovered and was sent home on Plavix, Aspirin and Atorvastatin.

Patient developed painful, non-itchy rash on R arm accompanied by clear fluid-filled blisters 3 days after receiving 2nd COVID vaccine. Arm became increasingly painful and blisters spread down entirety of arm over next 2 days. Patient diagnosed with shingles in Emergency Department.

Peripheral neuropathy; Neuropathic pain; Body ache; Stabbing pain in extremities (arm to fingertip) (knee to toe); Weakness; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Intervertebral disc protrusion. Concomitant products included FENTANYL for an unknown indication. On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), NEURALGIA (Neuropathic pain), PAIN (Body ache), PAIN IN EXTREMITY (Stabbing pain in extremities (arm to fingertip) (knee to toe)) and ASTHENIA (Weakness). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), NEURALGIA (Neuropathic pain), PAIN (Body ache), PAIN IN EXTREMITY (Stabbing pain in extremities (arm to fingertip) (knee to toe)) and ASTHENIA (Weakness) outcome was unknown. Concomitant product included oxy immediate release (5mg 3 times daily). Treatment medication included Chronic opioid medications. Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested. The neuropathic pain, peripheral neuropathy(exacerbation) and pain in extremities are possibly descriptions of the same event.; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested. The neuropathic pain, peripheral neuropathy(exacerbation) and pain in extremities are possibly descriptions of the same event.

He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb. He called his doctor and she told him to go to the ER, which he did at Hospital. They did a CAT scan of his brain. They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing. They had given him 2 narcotics for anxiety before the scan. He was then transferred to Hospital in . He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM. He was hospitalized for 7 days, and discharged him with instructions on what he is able to do. They started him on new blood pressure medicines for his kidney's. On 3/26/21, lot# 028A21A. He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.

Patient began to develop progressive weakness on the night he received his first vaccine dose. This continued to progress over the course of two days and included left sided numbness and left sided deficit, including facial droop. Patient presented to the emergency department and was admitted for an acute ischemic CVA.

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

Patient complained of intense abdominal burning sensation across abdomen followed by intense flushing redness of face and lightheadedness. Symptoms resolved within 5 minutes, cool wash cloth to face. Patient on home oxygen canula. BP 142/84. HR 64 and regular. Resp 20-22. Patient observed for 45 minutes after vaccination without further complaints or symptoms

Patient received second dose of COVID-19 vaccine on 3/22/2021. Patient presented to ED on 03/29/2021 at 7:45AM complaining of dyspnea on exertion for 1 week since COVID-19 vaccine. Patient also complains of R lower ribcage pain on inspiration for 3 days. Patient became unresponsive and was revived twice. Patient became unresponsive a third time and could not be revived.

Patient had COVID infection in 12/2020. Had 1st moderna vaccine 1/31/21. developed new headaches 2/12/21. 2nd dose of moderna COVID vaccine on 2/25/21. on 3/18/21 admitted to the hospital with right sided weakness, expressive aphasia, left gaze preference and right hemineglect found to have a left posterior parietal intracranial hemorrhage with vasogenic edema and extensive venous sinus clot involving the superior sagittal sinus, bilateral transvere sinsu and sigmoid sinus to the level of the jugular veins. He stabilized and was airlifted from one place to another to have hospice care.

Pt to ED on 3/1621 with : "pt c/o left sided chest and rib pain. pt states that other symptoms along with the pain started today. Pt is c/o SOB, numbness and tingling in bilateral upper extremities, bodyaches and "feeling cold." PT dx with PE of unknown origin

Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired.

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.

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)

Three days after vaccination, the patient was working outside when he suddenly died. Specific events are not known as he was alone at his work site. No bodily injuries were found. He was simply passed out and unresponsive when found. He had been deceased for hours upon his discovery.

45 minutes after administration patient developed signs of a stroke: inability to speak, facial paralysis, inability to move

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.

Patient was diagnosed with Guillain Barre Syndrome in late May. Symptoms began in early May. Lower extremity weakness and paresthesias. He did not have any other proceeding illness that might be expected to cause GBS. I do not necessarily believe the COVID vaccination he received in Jan and Feb caused his GBS. On the other hand I don't have another explanation and thought it should be reported to VAERS

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.

Joint pain in fingers legs knee, muscle weakness in calves for 3 to 4 days. Reappeared 3 weeks later with the muscle weakness.

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.

I took over the counter pain relief meds. Really bad neck ache all the way out to my shoulder. It was in my left arm and the pain was on the same side of the shot. It was the worst pain that I have ever had. It even went down into my back. I went back to where I got the vaccine and ask the nurse about my pain in my neck and she stated that she had the exact same symptoms. I ask her what did she do and she told me to take some over the counter pain aide. It's just the side effect. She told me that it will go away. It did go away after 3 days but than it return. The pain would leave but return again and again. The next thing I did, I call Moderna and I got a doctor and I explain to him what happen and he advise me that it is one of the side effect.

Developed numbness in lower extremities about 2-3 weeks following the second dose of the Moderna vaccine. Neurology work up in progress. Left leg is much worse than right leg. Doctor's working diagnosis is peripheral neuropathy, autoimmune - possible prediabetic

Received vaccine left deltoid has soft tender area 8 inches from injection site pain with palpation 4/10. No brusing or rash noted . Ice pack applied. Moderna information number given to client.

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

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.

Received Moderna vaccine on 05/21/2021. On 05/23/2021 upon awakening at 6 am both arms at the shoulder joints and upper arm muscles were extremely sore. I had limited movement in both arms although I received injection in left arm only. The soreness lasted for about 2 weeks and subsided entirely by the time I was to receive my second Injection. On 06/18/2021 I received my second Moderna Injection and on 06/19/2021 both of my upper arms ached severely and were immobile. I couldn't lift a fork to eat or a cup of coffee. It is now 06/23 and my upper arm muscles and shoulder joints are in excruciating pain and I still have limited movement due to sore muscles and joints. I have a Dr's. appointment tomorrow to get some relief.

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.

Family stated patient had been weaker since "last covid shot". Patient death 5-5-2021 - 1 week after vaccination

Breakthrough infection, includes hospital admission that appears unrelated to COVID 19. Patient reported to the hospital with right sided numbness of the face. Patient had an MRI that was negative for acute stroke.

I took my first shot 01/13/2021, second shot 02/11/2021 Moderna 029L20A Moderna 024M20A I had the standard sore arm about 4-5 inches below the site. This went on to be pain down my left arm extending to my left ring finger and middle finger. I have had cramps muscle pain over my chest left rib area. Pain down my left side ribs. pain down my back over my ribs. Neck pain muscle tightness left side. Pain on my left shoulder turned into a muscle pain/cramp shoulder down my back lasting 12 hours. The muscle was standing up over 1 inch. I called my doctor he wasn't available, went to the ER the next day. I saw Dr. 07/01/2021 he said he couldn't do anything for me. He said he could treat the symptom. He gave me

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.

I got lightheaded on the drive home. Since I got home I had cramps, gas and diarrhea. I've recovered some but not 100%. Ate no dinner last night. Its been 5 days with these symptoms.

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.

Rash at injection site, on lower back, left hip, chest, arms, inner thighs, armpits, Swelling, itching, burning on both hands and fingers. Itching and burning on lower back. These symptoms began a day following injection and grew much worse on the second day after injection. Prescribed a prednisone steroid, zertec, over the counter Benadryl, and an epipen

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.

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.

Patient had tingling in lips and fingers. Benadryl 25 mg po given at 1021. 1021: BP 144/74 HR 58 RR 12 O2 sat 100% 1038: BP 144/68 HR 58 RR 15 O2 sat 99% Pt released home.

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.

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.

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.

Pt developed a burning red rash on multiple parts of his body, feet, legs, back, arm, which was it extremely itchy and painful.

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.

Started at 8:30 pm on 1/28/21. Pain at the site of the shot. started mild grew to medium until about 03:30am on January 30, Woke up to a feeling of an entire body flush with the left arm hurting. I was afraid that this was the life ending adverse effect that I was hearing about. Took my temperature it was 98.5 degF. was able to get back to sleep. When I arose at 7:30am the pain in my left arm had diminished substantially.. Now I can only feel it if I push on the injection site.

Severe and rapid onset of two chronic conditions, sciatica pain in glutes and upper legs. As well at the same time a rather severe onset of GERD symptoms. Next day all day bad symptoms, 3rd day much improved, 4th day both almost all gone. Prior history of COVID-19 event for myself in March 2020.

Change in gait followed by seizure like bilateral movements. Transported to hospital and admitted. 2 days of testing and consults. Symptoms gradually decreased and released 2 days later.

Patient says that it felt like his pacemaker was shocking for roughly 20 minutes 5-6 hours after receiving the vaccine. Since then he says he has been fine.

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.

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.

weakness, clammy, low blood kpressure, treated with rest and hydration sudden wide spread red rash with severe itching on day 3 treated with steroid injection, Benadryl and steoid cream

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.

Within one minute of my injection l felt numbness surround my mouth. Three minutes later I felt flushed. I asked my wife if my face was red and she said, ?yes?. I felt somewhat weak and paramedic called the Dr over. We talked and he determined that I had not eaten. Walked me around car, put me in the passenger seat. My wife then drove. I was a little disoriented late but didn?t complain. Since then I have felt like I did in July 2019 when I had coronial virus. Felt bad, 93oxygen, 77 heart beat which is high for me. Friday I did not get out of bed nor went outside. Sat more of the SamE. Woke up at midnight sat and felt better. I?m better but weak.

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

Patient's wife called on 2/10/21 and stated about 30 minutes after receiving the vaccine on 2/5/21 that her husband stated the left side of his face and his forehead went numb. He stated it felt like when you get an injection in your gum before having a dental procedure. Patient's wife stated it has improved some, but the feeling still has not completely come back.

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.

Patient received dose #1 of the Moderna mRNA vaccine at 8:45 AM. MST. No reaction occurred immediately after injection. At 12:45 PM MST patient while driving and eating a sandwich patient suddenly dropped his sandwich and his wife noted new slurred speech and drooping of the lower right side of his face. They drove to the hospital. Patient was evaluated in the ER and was found to have a normal EKG, CT of the head and troponin which were normal. Facial drooping resolved prior to ER arrival but mild slurred speech persisted for 36 hours and then spontaneously resolved. MRI brain was done on 2/8/21 and was unremarkable.

On Thursday following shot. Legs of both legs became itchy. Felt like they were on fire. skin was still clear. . After applying a some steroid cream it settled dawn and I went to sleep. Next morning I awoke with spots on my legs, and over the last few days, there were deliniated spots everywhere on my body - front and back - with the exception of my face. I thought it was measle, though my temperature was nomal (no fever) . I've not been able to contact my doctor. The spots have becom less definite and delineated, have grown into one another.. In general they're not teribly itchy, but they're everywhere. I'll see my Doctor tomorrow. I have spent the days in bed, not feeling my usual self. I feel a little better today but the spts (rash are everywhere.

LEFT HAND BECAME WEAK. HARD TO GR1P OR HOLD THINGS. A BIT NUMB. COULDN'T SENSE BEING HIT. OTHER WISE,, JUST THE NORMAL ACHES AND PAINS IN THE NECK AND SHOULDERS AS NOTNONED IN FACT SHEET

PT WAS VACCINATED ON FRIDAY. ON SATURDAY HE HAD A SEIZURE. HE WAS HOSPITALIZED AND LATER PUT ON A VENTILATOR. PT WAS DISCHARGED SUNDAY

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.

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

I had an ocular migranes 2 hours, 5 hours and 20 hours after the injection. I usually have ocular migranes abour once per month.

Stroke and seizure ( In the past he had a stroke and seizure ) So this is not his first time and we are not sure if this is related to the vaccine.

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.

I noticed that the left side of my mouth was a little droopy around 10:00am on 2/14/2021 but didn?t think anything of it. Then around 4pm my daughter saw me and noticed it as well. We went to the ED immediately and got a stroke rule out work up. There were no other deficits besides the left sided facial palsy.

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.

Extreme weakness to the point of being unable to stand, lightheaded, numbness, bilateral limb weakness progressing to stroke-like symptoms which persisted for approximately one day; palpitations and frequent PAC and PVCs which have persisted past initial treatment to current date. Patient was treated in the ER and given steroids, anti-histamines, and possibly anticoagulants for stroke-like symptoms, however ER notes not available and going off patient's verbal report. He was sent home on steroids and antibiotics and diagnosed with Vaccine injury from Moderna COVID19 vaccination.

weakness Narrative: 77 y/o male patient with h/o Parkinson's disease, CAD (s/p stents), supraventricular tachycardia, received first dose of COVID19 (Moderna) vaccine on 02/11/21. On 02/12/21, legs were weak and shaky, had a fall. On 02/13/21, continued to feel weak. On 02/14/21, fell and felt chest pressure. Ambulance called and was taken to outside facility and found to be in afib RVR, treated with diltiazem. Had cardiac cath on 02/15/21 which showed NSTEMI due to extensive CAD, not a surgical candidate therefore medical management optimized. Started on amiodarone for afib. Discharged on 02/17/21. Has no prior ADRs to vaccines or anaphylactic reactions to medications. No prior COVID19 infection.

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.

Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.

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.

1/8 vaccination *1-8-1/11 I felt fine 1/12 7am, when i woke up my eye was goopy, sticky, L eye. I could not blink. I noticed more problems later in the day; my mouth wasn't working properly (couldn't eat properly). I tried to call and make appt with PCP. Informed to go smile in front of mirror, my smile was sagging on L side. Informed to call 911. TX to hospital, for possible stroke. Dr. ran tests Dr. audio / visual consult *diagnosed with Bells Palsy 1/21 started to feel better **2/5/2021 2nd vaccination

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.

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

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

The day after receiving his COVID vaccination, the patient was found unresponsive in his driveway in respiratory distress by his neighbors. EMSA was called and pt transported to ED, where he was intubated and placed on mechanical ventilation. Patient extubated 3/4, but remains critically ill at this time. Neurologic causes are being investigated.

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.

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.

Severe muscle spams in lower back, painful but not debilitating, took some Advil at noon and beginning to get around much better. Had trouble getting out of bed this AM but walking Ok with discomfort now.

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.

He could hardly walk, legs gave out and he fell and could not get up; Can't lift legs; No strength in the legs and arms; A spontaneous report, was received from a consumer (patient), a 78 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced he could hardly walk, legs gave out and he fell and could not get up (monoplegia), can't lift legs (muscular weakness), and no strength in the legs and arms (muscular weakness). The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient stated that the morning on 13 Feb 2021, after the vaccine was administered, the patient could hardly walk legs gave out and he fell and could not get up, no strength in the legs and arms, and can't lift legs. The patient was now able to feel everything normal as of this morning on 14 Feb 2021. No treatment details were provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events he could hardly walk, legs gave out and he fell and could not get up, can't lift legs, and no strength in the legs and arms were considered resolved on 14 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

caller states the pt started having trouble talking and reading the next day after taking the vax. He wasnt able to put a sentence together. Pt knew the word he wanted to use but couldnt get it out. On 3/12/2021 is better w/ speaking but still struggling to read. Pt has not been treated for his symptoms since he is out of town but will FU w/ PCP when he returns home.

Moderna COVID-19 Vaccine Vaccine injected in left arm. BURNING SENSATION IN LEFT UPPER ARM WHEN THE ARM IS STRETCHED..

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.

After severe confusion, delusion, and paranoia, he was taken to the er. Encephalopathy, autoimmune and antibody disorders

seizures; small stroke; A spontaneous report was received from a consumer (wife of patient) concerning a 78- year-old, male patient who developed seizure and a small stroke. The patient's medical history included seizure 4 years ago, stroke long time ago. Products known to have been used by the patient, within two weeks prior to the event, Cholesterol medicines, Blood pressure medicines and Aspirin. On 18 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the Right arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient developed seizure, small stroke . Treatment for the event was not reported. Doctors are not sure about the causality, but want to report it. They spoke to his doctor about not getting the second vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event's, seizure, stroke was considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of seizure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.

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

8 minutes after the vaccine was administered, he started to act funny. At first, he looked like he was having a vasovagal/ syncopal episode: he became non-responsive, stared straight ahead. then shortly thereafter he started to take be gasps for air, his lips turned blue. It soon became clear that he was having an anaphylactic reaction. we called for an ambulance, we administered one dose of an Epipen, and administered oxygen. His pulse ox was in the low 80's. within a minute or two, he started to react and started to moan, breathe more normally, then began to speak to us. His BP was checked and was 118/83. His oxygen sat went up to 100%. after a few minutes, We took the oxygen off and his sats dropped into the 80's so we restarted the oxygen. We are rural, so it took the ambulance 30 minutes to arrive. He was very stable at the time that he was taken to an emergency room for further evaluation.

On a scale of 1 to 10 with 10 being the most sever, I would estimate my shoulder/arm soreness to be 1 to 2 sore. Only reporting because it has been over 6 weeks since receiving shot. No side effect of 2nd dose, given in the right arm.

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

He developed very labored breathing on Tuesday night. By Wednesday morning , upon waking it was severly worse. I would have taken him to the ER had I been home. When I returned home around 11am, he was having a very hard time breathing. I got him a rescue inhaler to use. He had a dailysis treatment that day, during the treatment they kept him on oxygen. I called Dr office to inform them, they ordered a new inhaler and told me if the symptoms did not decrease by 72 hours to inform them. His breathing did get somewhat better but he did not have his enegry levels that he had previously or his appeatite. 12 days after his 2nd dose of the Moderna vaccine he went into cardiac arrest in the home with myself and husband present.

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.

extreme weakness, collapsed, ultimately patient was determined through repeated multiple blood tests excessively high inflammatory markers over a period of weeks, severe shortness of breath, confusion, fluid accumulation around the lungs. All is documented in Dr records as well as Hospital

8 days after the Covid 19 Moderna Vaccine #1 was received, I started having adverse symptoms: left side of mouth was numb, face got numb and then left eye would not close completely. After Emergency Room visit, I was given a Cat Scan and MRI and the neurologist diagnosed my condition as Bells Palsy.

Moderna Covid-19 shot given 1/3/21 in patient's left deltoid. On 01/24/21 patient came to the pharmacy stating that he has experienced numbness/tingling in his right fingers and thumb since he received his first dose. It started with numbness in his pinky finger and progressed over the course of several days to each finger and thumb. This occurred more than once since the first dose was given. However, patient states that this has not happened anymore within the last week. Patient denies any kind of injury, pinched nerve, etc in his right hand/fingers and states he never had this occur to him at any other time in his life. Patient was scheduled for some type of procedure, however the physician will not perform the procedure until the source of the numbness is discovered.

?Can?t get a full breath? Nauseated, Dizzy, balance was off. ?Thought I was having a heart attack. Couldn?t walk without a cane because of pain and weakness.?

This was second dose, exactly one month after first. Both at Pharmacy. Evening of 3/26 restless, little or no sleep. Morning of 27th seemed normal until about 11am when daughter tells me I was stumbling, sluring words which quickly got worse. Family tells me it got progressively worse and became like a daylong, staggering drunk completely unable to walk without assistance, showing some belligerance until finally asleep around midnight. This am (3/28) woke about 10am feeling normal except a bit weak and uncertain balance. After eating grew stronger with recovered balance.

Five days after shot I had rapid pulse (120) and felt weak. Ten days after shot I felt very weak in morning and couldn't stand long enough to shave. Rapid pulse again (120).

Day 1 after vaccine, patient experienced extreme weakness and confusion. Found on the floor. Admitted to hospital that day for two day admission. Day 2 after vaccine mild weakness persisted and confusion started to resolve. Day 3 after vaccine- confusion resolved, mild weakness persisted. Patient still in PT. Discharged from hospital.

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.

Severe pain in abdomen; pancreatitis; Swelling in gallbladder; Swelling in kidney; weakness; A Spontaneous report was received from a Consumer concerning a male patient of 78-year-old who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis. The patient's medical history included heart problems, 13 stents, high blood pressure, high cholesterol, borderline diabetic, thyroidectomy (28 years), bilateral knee replacement, and arthritis. Allergy history included sulfa. Concomitant medications included metformin, metoprolol, lisinopril, levothyroxine, clopidogrel for unknown indication. On 25 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023M20A) on left arm for prophylaxis of COVID-19 infection. The patient had experienced difficulty in exercise and weakness, after first dose of vaccination. On 17Mar2021 he had severe pain in abdomen and hospitalized for seven days until 23 MAR 2021. The patient was diagnosed with pancreatitis and the patient also had swelling in gallbladder and kidney. The patient was treated with intravenous fluids but other meds were not reported. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Began having paresthesias L forehead and periorbital area on 03/10/2021 (1 day after vaccine), then developed zoster rash in L Ophthalmic nerve distribution over the next couple of days

The patient had an ischemic stroke (confirmed by MRI) on Friday, 4/2, approximately 24 hours after the 2nd dose of the Moderna vaccine given on 4/1. The symptoms of the stroke began in the evening on 4/2 and consisted of left face, arm, and leg weakness.

very sore arm with a burning sensation in the muscle that is still present at this time. I will discuss it with my GP in my quarterly visit in May 2021

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.

worse with the second shot.; worsening tremors; weak and dizzy; weak and dizzy; extremely nervous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous) and FEELING ABNORMAL (worse with the second shot.) 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 No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, 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 ASTHENIA (weak and dizzy) (seriousness criterion intervention required), DIZZINESS (weak and dizzy) (seriousness criterion intervention required), NERVOUSNESS (extremely nervous) (seriousness criterion intervention required) and TREMOR (worsening tremors). On 03-Feb-2021, the patient experienced FEELING ABNORMAL (worse with the second shot.) (seriousness criterion intervention required). At the time of the report, ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous), FEELING ABNORMAL (worse with the second shot.) and TREMOR (worsening tremors) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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. This case was linked to MOD-2021-049775 (Linked Report). Reporter did not allow further contact; Sender's Comments: This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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. MOD-2021-049775:

Patient received 2nd dose of vaccination on 03/01/2021 and developed symptoms on 03/03/2021. He presented with bilateral numbness in feet ascending to his mid shins and weakness complicated with multiple falls due to severe ataxia. He did not report any head injury or loss of consciousness. He also reported mild dysphagia, changes in voice and left arm weakness. Neurological examination showed bilateral leg strength 4/5 and numbness. The patient was admitted to hospital and given IVIG for 7 days before transfer to an acute inpatient rehab facility. The patient was discharged from rehab facility on 04/05/2021 and still has some residual weakness and numbness.

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

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.

weak and dizzy; Worsening tremors; Extremely nervous; weak and dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, 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 ASTHENIA (weak and dizzy) (seriousness criterion medically significant), TREMOR (Worsening tremors) (seriousness criteria disability and medically significant), NERVOUSNESS (Extremely nervous) (seriousness criterion medically significant) and DIZZINESS (weak and dizzy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-049791 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-049791:

CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD.

Date and time adverse event started: 1st Moderna dose 1/6/2021 time unknown but ADEs occurred on 1/7/2021, and then 3 days it reoccured. 2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day. 1st Moderna dose 1/6/2021 time unknown, pt reported he experienced dizziness on 1/7/2021 (which went away), then 3 days later the dizziness came back and he also had weakness. 2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day, pt reports the second dose the dizziness and weakness is more pronounced than the from the 1st dose and he is feeling shaky. The dizziness, weakness and shakiness is still occurring; pt reports neck is hurting when turning his head, and get more dizzy with slight head movements. Pt has been seen by his PCP (did MRI - no findings of anything). Also seen by specialists (ENT, Cardiologist, Neurologist). Pt is scheduled for an inner ear exam on 5/10/2021. Pt advised no one was able to help him with his symptoms, more tests are ordered. Additionally, pt reported he had reached out to Moderna and they were unable to provide him with any assistance. Pt reports that he stays hydrated and tired vertigo exercises recommended by his chiropractor for the past 3 weeks. Nothing has helped. 4/18-Follow up call by JD- Patient continues with dizziness and weakness. Doctor has prescribed scopolamine patch but is has made dizziness worse. Advised to continue to stay hydrated, get up slowly when standing from sitting position. Will be following with ENT doctor on 5/10/21.

Patient called to say that his arm was still sore 5 weeks after receiving the second dose of the Moderna COVD 19 vaccine.

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.

My father experienced an acute stroke, 1month +7days after receiving his 2nd shot. We are reporting this because when we mentioned the stroke to members of our church, there were at least 2 others who knew of someone in my fathers age group who also had a stroke 1 month after their 2nd covid vaccine shot. My father is currently at hospital, and is being moved to Rehab Center today. (April 28, 2021) On Saturday, April 24th, he woke up with wobbly legs around 3am, accompanied with an odd sensation in one of his arms, and legs. He went on about his day, but felt off. He fell around 2:20pm, I was called by mom. My husband and I arrived about 10 minutes later. He was up, and walking at that point, but his speech was very slurred. We checked his blood levels (159), and went through the stroke symptoms, and drove him to Hospital, where they immediately took him in under stroke protocols. It was determined he had an acute stroke.

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.

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.

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.

Redness, bruising, rash and skin dryness and burning sensation on both full arms and lesser so on legs and lower back recurring since vaccination

Patient was admitted from ED due to feeling week for approximately 1 week prior. Has passed out 2-3 times a day over past week. Patient tested on admission for Covid with a positive diagnosis via POC Rapid SARS-COV-2 Antigen. Patient was treated with remdesivir, albuterol, ceftriaxone, dexamethasone. Patient discharged after 5 days with dexmethasone as new med.

Sudden onset of severe pain in the left mid-thigh, medial area. Felt like knife wounds. Each episode, lasted several minutes and was partially relieved by deep massage of the area. No abnormalities were palpated in this area. This repeated, several times, over the next month, in the exact same area and then disappeared. One month later, this exact same thing, happened on the medial part of my right mid-thigh. It responded to the same treatment and lasted for the same duration. This right side pain returned several times over the course of the month, then disappeared. So far, those have been the only episodes. More recently, (05/10/21), a small, firm bump appeared on my left forearm - that was very sensitive to lightest touch and was itchy but not painful. Thankfully, this has not grown and is less sensitive.

2 days after vaccination, patient developed 10/10 pain, and arm swelling. Entire hand and part of lower arm was also so swollen that he could not make a fist. Pain was worst in 3rd and 4th left fingers. Patient is a farmer and did use are for his normal heavy work after vaccination. Patient also developed numbness in 1st-4th fingers in hand, worse in 3rd-4th fingers most consistent with carpal tunnel

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 received second dose on 3/13/21. In mid-april, patient started experiencing numbness, tingling, parasthesias, and weakness in the lower extremity. This progressed upwards over a period of 2 months with worsening weakness. Due to the symptoms the patient fell and broke his ankle. The patient eventually could no longer walk as the weakness progressed. On MRI the patient was found to have an extensive transverse myelitis and was admitted to the hospital 06/18 for steroid treatment.

- 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

Diagnosed with Transverse myelitis; Numbness; Paresthesia; Progressed to a point that the patient can no longer walk and no is on wheel chair; Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]) and PANTOPRAZOLE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: abnormal (abnormal) Diagnosed with Transverse Myelitis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains Non-Significant information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.

My upper arm started hurting shortly after getting the first shot. It continues to hurt to this date. The pain has moved down my arm to just above the elbow. You will note the first shot was on 3/17/21, almost 4 months ago, and the pain persist. Can you advise me or my doctor, what type of treatment is suggested. I have discussed this with my doctor but he wasn't aware of what to do.

Patient has a red sore arm and loss of appetite still on 7/14/21 since the date of vaccinations. Patient was vomiting on 7/10/21 but has stopped

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.

Four months after the second injection I was awakened after midnight by a painful red rash from my neck to my feet that burned and itched for about 2 hours. I put a wet towel on my chest and neck, but it did not stop the pain and the redness. I began rubbing my body from my neck down to my waist. After about 20 minutes the pain and redness began to disappear very slowly. I then began to rub my chest and legs for another 20 to 45 minutes and the pain and redness begin to be releaved. Last night (7/23/2021) I awoke at 1:30 AM with a painful red rash on both legs that itched like mosquito bites. The rash was primarily on the inside of both legs and down to my feet. I started using Cortizone 10 (it did not help), then I switched to Triamcincolone Acetonide Cream USP, 0.1% (that did not help) and then Halonate .005% (that did not help). It took almost an hour of rubbing my legs before the itching and burning subsided.

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

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 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.

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.

My L4-L5 stenosis was completely healed after my Nero surgery in 2018. After the Vaccine I took on 1/12/2020 - my right leg pain has suddenly returned on 1/20/2020. It is worse. I will be seeing my primary care doctor on 1/25/2020. I have difficulty walking. The pain is severe. Is it due to COVID vaccine I took?

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.

After monitoring time was complete, client stood from sitting position and fell forward and sustained ecchymosis to forehead and nose. He became less alert with delayed response to verbal commands. VS measured; BP 78/50, Pulse 65, O2 Sat 96% Room Air, R 16. He became clammy with repeat of BP 161/60, Pulse 63, O2 Sat 91% Room Air. EMT summoned and client transferred to ER for further assessment and treatment. Call to local hospital confirmed ER visit and release same day.

On morniing of 1/30/11 patient presented with confusion, unilateral weakness - diagnosed and admitted with CVA - embolism of R middle cerebral artery per CT scan. Noted to be in atrial fibrillation during admission. Discharged to rehab center on 2/3/21.

48 hours after vaccination, patient developed right sided facial droop, excessive tearing in right eye, inability to close right eye fully, inability to raise right eyebrow. Patient advised to not take 2nd vaccine dose. He was given oral corticosteroid prescription and advised to use eye lubrication ointment frequently and wear eye patch at night. He was advised to see Ophthalmologist to make sure no injury to cornea since he is unable to fully close eye and potential for eye drying at night when sleeping.

Moderna COVID-19 Vaccine EUA. 02/04/2021: Patient called to report adverse side effects following receipt of Moderna COVID-19 vaccine on February 3, 2021, 9:05 AM. 02/03/2021, 1 hour after vaccine, patient stated left arm pain at site of injection. 02/04/2021: patient had worsening Left arm pain, vaccination site redness, inflammation, and skin warm to touch at vaccination site. Patient notified health department approximately 3 PM. Nurse provided assessment questions via phone. In addition to previous stated symptoms: client stated slight numbness and tingling at site of injection (denied radiation down arm and to fingers), and rated pain ?4 or 5? (according to 1-10 pain scale). He was advised to: use cool compress 10-15 minutes per hour (vaccination site on the arm), contact his PCP to determine for evaluation, and determine if able to take ibuprofen or acetaminophen. 02/05/2021: Patient notified by health department nurse (9:00 AM) for cont. evaluation: identical evaluation as provided on 02/04/2021. Client stated he had contacted PCP office this AM and spoke with receptionist/nurse. He stated he was waiting for return call. 02/05/2021 (2 PM). Client again contacted byRN. Client had message to NP and had not received return call. RN explained, from evaluation, arm soreness was localized. RN stated that RN would notify client on 02/06/2021 to review symptoms. It was explained to client that if there was an increase in pain severity, swelling, redness, or transmission of tingling or numbness extending to fingers that he should go to the nearest Emergency Dept. for evaluation. Client verbalized his understanding.

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

I had Moderna COVID-19 Vaccine on Wednesday February 3 at 11:30 AM . After the vaccine I went home and had virtually no pain. Around 10PM that night I felt some pain in the toes on my left foot. When I looked, I noticed that my toes were red and appeared slightly swollen. My big toe was the worst. It was sensitive to the touch and very red. I also felt a short intermittent sharp pain that would last a second or two. It would happen every 3-4 minutes. The next day the redness was gone on all but my big toe. As I write this today Saturday February 6 at at 11 AM. My big toe is still sore, but does appear a bit better. I have had gout once in the past. So, gout or Covid ? The people at were great.

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.

Patient 5 to 10 minutes after immunization became unresponsive, The rn helped check out patient with other nurse. Pt had low blood pressure, and was not diabetic. RN gave patient .3 mg epi and patient vitals improved and was observed for 30 minutes by nurse and RN. Nurse later told RN that patient had pacemaker and had similar episodes at least 2 to 4 times in the last 2 to 4 weeks. Patient was fine when we left clinic.

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.

Finger numbness (middle and ring finger)- happened right after vaccination was given. Said numbness goes up the arm close to the shoulder. Patient did say this happened with other vaccinations and went away after half a day or so. Patient was seen in emergency department in the past but Dr. could not find anything wrong.

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.

Pt developed pain and swelling in his leg on 2/8/21. Sent to the emergency room on 2/10/21 and found to have DVT. No history of clots in the past.

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.

maculopapular rash started after January 14th vaccine progressed became widespread after February 11th vaccine. Itchy uncomfortable but no dyspnea Fever or mucosal lesions. Predominantly trunk proximal arms and legs. No genitalia or mucosal surfaces involved. office visit February 16th. Oral antihistamines topical steroid cream prescribed.

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.

Patient's arm was sore for about 3 days. About 5-6 days after receiving the vaccine my husband had tingling and a prickly feeling that ran down from my arms down to my toes but mostly on left on the side. It felt like an electrical simulation this lasted for one night.

Bell's Palsy; .A spontaneous report was received from a consumer who was also a 79 years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced Bell's palsy (facial paralysis). The patient's medical history was not provided. Concomitant medication reported included metformin. On 29 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection. On 29 Jan 2021, after the administration of vaccine, the patient developed Bell's palsy. The patient went to the emergency room (ER) for treatment but was unable to get the condition resolved. The patient was referred to a neurologist, but the side effects were still present up to this point. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, Bell's palsy, was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

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.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe

Right arm and leg noted with continuous uncontrollable jerking movements of involuntary nature that are still persisting.

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

Extreme itching and red areas on torso. Stopped in 48 hours. Then 8 days after shot, flashes of nerve pain in left upper arm (like electric shock). Then 10 days after shot, this flash of "electric" pain has occurred across the top of left foot.

Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery

The next morning, I looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right. called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.

Patient experienced generalized weakness and inability to ambulate. He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2. He presented with a rash at site of vaccination on left arm over deltoid muscle. He had a red petechial rash on anterior chest and upper abdominal wall.

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

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.

Several neurological impacts, including slurred speech, leg pain, tremors, slowed comprehension, and as days went by leading up to hospitalization, loss of ability to speak in complete sentences.

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

Sore left arm Red raised rash about 2" by 4" inches appeared on the 11th day at site of injection for about 30 hours

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 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.

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 recieved 2nd dose COVID vaccine and had unresponsive episode in car after monitoring period, staff assessed in car and patient had recovered, staff encouraged family to take to ED for evaluation. From ER MDs note: EKG was normal sinus rhythm, narrow QRS, delayed transition, minimal lateral st depression V4. Patient IV access on arrival, would Brady down to the 40s 1 time as low as 27 but remained alert, blood pressure is not dip. Troponin was mildly elevated and decision was made to transfer the patient. Prior to transfer is necessary to rule out pulmonary embolism, intracranial injury Patient wished to proceed with CT angio chest and noncontrast CT of head which were without acute findings. Patient given aspirin 81 mg to supplement the 81 mg he had earlier today. Discussed with hospitalist, patient was accepted in transfer. Suspect this is combination of patient's beta blockade with underlying sinus node dysfunction. Patient does have prominent lower extremity swelling and suspect pulmonary hypertension despite treatment with CPAP but cannot exclude valvular heart disease. Patient was went to Hospital. Symptoms thought to be unlikely from seizure. Doubt CVA, ongoing cardiac ischemia.

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

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.

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.

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)

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.

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.

Patient is an 79 year old male who had his 2nd Moderna vaccination in his dominant right arm Thursday afternoon. Upon awakening Friday morning, he had difficulty walking. His legs were strong enough to hold him, but he was unstable. He also had some numbness on the palmar surfaces of some index and middle fingers of his left hand. His speech was somewhat garbled, but when his wife would encourage him to repeat himself, he could enunciate more clearly. He had some nonspecific difficulty swallowing. He attributed this all to adverse reaction to the vaccination, which would pass... Friday mid day his wife took him to the barber, and on return home he was briefly nauseated and vomited. Later in the day on Friday they went for car ride, and on return home he was briefly nauseated and vomited. He had no other episodes of nausea. He had no fevers or chills. He had no visual disturbances. He had no other numbness or paresthesias. He was aware of no clear weakness. Finally today, the gait instability persisted and the numbness in the left hand, so he came to the ER for evaluation. Patient is currently recovering in the hospital

Wife called clinic on 3/3/21. Said he had a serious reaction requiring EMS to be called twice. Was seen by PCP on 3/3/21. Chief complaint of recent falls, no appetite, and cognitive issues since 2/26/21. HPI Per PCP Note: 79 yo male with Celiac, mild type 2 DM and prostate cancer on Leuprolide and Xtandi here for f/u Diabetes and to get advice following adverse reation to first COVID vaccine received 2/25/21. He has chronic RUE tremor. He was diagnosed with a TIA from an endocardial lesion many years ago. No cardiovascular disease history. He experienced increased generalized weakness and poor balance following the vaccine. He felt restless for 4-5 hours. He fell to the floor twice and next morning and afternoon and EMS evaluated both times. Glucoses 140-150. No hypotension or tachycardia. No arrhythmia. No focal hemiplegia or slurred speech. Did have sluggish cognition but not obtunded and could communicate wishes to remain at home. Spouse feels he was 80% better on Saturday and is 95% better today (Tuesday). No low glucoses. Hydration and rest the first 48 hours seemed to help but he doesn't feel completely normal yet (still has fatigue and no appetite). He can walk but is not confident of his strength. He was anxious about getting the vaccine. No prior hx of COVID but spouse did have it in August. Spouse had localized reaction only. Patient weaning off Gabapentin taken for tremor and neuropathy.

Patient complain of left facial numbness. Reported history of sucrose and read the info on Moderna - ingredient of sucrose is listed. Vital signs collected - stable. Dr. notified. Completed assessment. Orders received to monitor patient for one hour. Symptoms lessened. Patient ambulated with walker out of office without distress noted.

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.

Patient became weak and unable to hold his head up one day following injection. Following day, low appetite. Day 2, had vomiting and unable to take in any PO. Day 3, was able to start eating. Day 4 and 5, he had improvement of neck pain. Day 5, had drop in blood pressure into the 70-80s systolic and 40-50s diastolic at home and then again in the clinic with no other signs of illness. Day 6, found to have Acute Kidney Injury on his CKD with creatinine rising into the 5's with baseline creatinine of 1.4-1.6. His liver function was abnormal also with elevated bilirubin to 6 (baseline normal 1), Alk Phos 522. He was hospitalized 2/25-2/28/2021 for these issues.

Severe night sweats, every night since first injection up until now. In beginning, enough sweat to wring out of an undershirt. Aching in previous areas affected by gout--wrist and foot.

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.

Got the vaccine, and yesterday 3/24/21 somewhere around 3:30 he started feeling weak, tried to walk and had weakness. By 6:30 he could not get up. He was on the floor as he slid off the bed and could not push himself up on his arms, and got worse and worse. He went up to bed, and his son had to come over and help him into bed as he was not even able to lift his legs to get into bed. Then at 3:00 AM this morning he could start walking again. Now this morning he is a little wobbly and otherwise getting better. He did take 2 Tylenol. No soreness around the injection site, just the extreme weakness.

Chief Complaints: Progressive weakness with respiratory difficulty and severe shortness of breath Diagnosis: Guillain-Barre supported by progressive weakness, albumincytologic dissociation of cerebral spinal fluid, vocal cord paralysis, speech apraxia resulting in aspiration pneumonia Treatment: Guilain-Barre: Plasmapheresis requiring critical care management Pneumonia: Antibiotics

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.

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.

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.

3 weeks after his 2nd shot, he was seen in the ER due to drooling, facial spasms, and facial paralysis. After many tests and MRI, they found a mass tumor on his brain, They transferred him to Med Center and they did more testing. On March 13th they preformed surgery to remove the mass tumor. After pathology reports were ran, it came back as a cancerous tumor know as a Glioblastoma or GBM. They were able to remove 80%. The remainder of the tumor was in a part of the brain that they would run the risk of permanent damage or paralysis. He will undergo Chemo and Radiation to treat the 20% left.

2/03/2021: Patient stated shortness of breath and generalized weakness on admission. Patient started on Azithromycin 500 mg every 24 hours for 2 days, Ceftriaxone 2g every 24 hours for 2 days, and Acetaminophen 1000 mg once followed by acetaminophen 650 mg for 2 days. 2/04/2021: Patient diagnosed with pneumonia attributed to aerobic bacteria although no cultures were obtained. COVID and Influenza PCR negative. 2/05/2021: Patient discharged with no new prescriptions.

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

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.

Approximately 3 hours after vaccine administration, patient experienced the following: Nausea, Vomiting, Abdominal pain, and the following day: Bloody Bowel Movements. Patient went to the emergency department the day after vaccine administration. Patient was made NPO, started on IVF and Zosyn. Patient was seen by GI who agreed with supportive management of ischemic colitis. Around 1730 on 2/6, patient unresponsive and rapid response was called. Patient responded to Narcan. On 2/8/2021, 0358, patient was seen as not breathing and code blue was called. Interventions were unsuccessful and patient was pronounced dead at 0439am.

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.

Severe Pain in left arm fro injection site down the forearm. Severe Pain radiating through the left chest and the left shoulder blade. Inability to sleep unable to find a comfortable position for my arm due to tingling, numbness and lack of ability to use my arm in greater than 70 % movement.

Patient describes extreme weakness and disorientation to time, describing the event as "losing one whole day"

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.

chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated. Concomitant product use was not provided.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.

Looked pale and no energy on day 4 after vaxx. Day 5 had stroke between 0700-1100. Thought he was sick with flu. Did not recover after Day 8 and called primary doctor.

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

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

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.

soreness of the arm, radiates to his elbow. the past 5 days patient reported that he developed muscle soreness in cheeks, knees, front leg, thigh, lump inside of the arm

missing of scheduled second dose of vaccine / dose omission; stroke; right side of his body paralyzed, from his face to his feet; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) 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 Stroke in October 2015. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown, HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) had not resolved and PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After hospitalization, patient was transferred to nursing home, then a rehabilitation facility. The second dose of the Moderna COVID-19 Vaccine was scheduled for an incorrect date of 04-Mar-2021;however the patient did not receive this dose due to hospitalization. Products known to have been used by the patient, within two weeks prior to the event, included unspecified 15 pills. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the events, a causal relationship cannot be excluded.

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

Wife states patient has had a headache/migraine every afternoon since the 2nd vaccine. Describes it as a "lingering" ache that does not go away but that worsens each afternoon. His Provider recommended Excedrin but only "eases" the pain and doesn't "take it away."

In March my husband started having left hand tremors. He is still having them. I noticed he was shaking and he said he's had it since he had his 2nd shot.

Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021.

Pt reports with the 1st dose he had little bit of pain in his arm which went away the next day. With 2nd dose the symptoms did not occur until March sometimes, pt. experienced pain the in right shoulder which then travels to the left shoulder, down his legs and groin area. Pt reports he cannot turn in bed bc everything was hurting especially his hip and arms. Pt reports it was hard to lift his arms "feels like someone was pulling out my arms", had difficulty tying his shoes or picking anything up. The pain run down his spine and radiate to his right leg "hurt to even talk about it". Currently he is experiencing very little muscle pain in his left shoulder. Pt reports he had tried Tylenol and Ibuprofen but that did not provide him with any relief. Pt had been seen by PCP

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.

I received my COVID vaccine on may 25 the next day i went for dialysis and had what they told me a seizure. So we stopped the treatment and continued it on Friday and literally 6 minutes into my treatment i went in to cardiac arrest. Was rushed to the hospital and they said my heart was not the problem and they don?t know what happened. So i am assuming its the vaccine because I?ve been downing dialysis now for 3 month and never had a problem.

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.

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

Patient received second COVID vaccine on 2/3/2021. Was admitted to Medical Center on 6/15/21 for generalized weakness and tested positive for COVID 19 on 6/15/2021. Patient was also positive for COVID 19 in November 2020. Patient expired on 6/26/2021 while hospitalized.

The next day after my second vaccination, my left arm was immobile and very sore. I couldn't move it -- it just hung by my side. After three day of the same, I started range-of-motion stretches. At first just moving it inches, then working up to full motion -- the progression was very slow, over a period of days. But throughout this ordeal the pain never stopped, it is worse on some days. This has been continuing for 97 days and nights with no end in sight. I was able to see my doctor (new to me) after about a month. He offered physical therapy, but I declined because of time and distance -- it would have been 145 mi round trip for 3 days a week. I have been working out at home daily. I have a background in athletics and have equipment at home. I have no strength or endurance because of this and suspect it is an injury for life. I do not trust Moderna anymore.

alphasia , ..March 4 March 18....MRI, CT SCAN, EKG.... brain tumors March 23....Crainiotomy Brain Cancer

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

11X6 cm mildly erythematous, slightly raised, warm ovoid lesion. Became apparent 6 days after vaccination, has been unchanged for past 2 days.

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.

Muscular and joint pain in shoulders and upper arms (bilateral). First observed about 36 hours after injection. Persists as of 1543 EST, 15 JAN 2021

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

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.

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.

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

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

Started shaking violently at 8 p.m., Cold but not feverish. Went to bed and slept for next 24 hours. Got up with help to go to bathroom. Very weak. Had bowl of soup next day at 8:00 p.m. and returned to bed. Slept another 12 hours. Felt better. Gradually regained strength. No further reaction.

Patient with symptoms of burning and tingling initially lasting 1-2 minutes 2-3 times per day about 4-5 days after first vaccination. On 2/11, concern for increase in symptoms - episode of 5 minutes of itching - spreading down arms and into stomach.

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.

MALE EXPERIENCE TINGLING IN HIS LEFT ________10 MINUTES AFTER VACCINATION. ONSITE EMS AND PHYSICIAN REQUESTED. NO OTHER ADVERSE EFFECTS REPORTED BP FLUCTUATED 121/93 TO 148/93 HR FLUCTUATED BETWEEN 100-130. SYMPTOMS HAD NOT RESOLVED AT 1036AM. ONSITE PHYSICIAL RECOMMENDED PATIENT BE TRANSPORTED TO E.R. FOR OBSERVATION DUE TO HISTORY OF A-FIB AND TIA'S. PATIENT REFUSED, SAID HE WOULD DRIVE HIMSELF AGAINST MEDICAL ADVISE. AFTER FURTHER DISCUSSION BETWEEN PATIENT AND SITE COMMANDER, PATIENT AGREED TO BE TRANSPORTED TO ER BY EMS. NO ADVERSE REACCTION REPORTED TO VACCINES, HE RECIEVED FLU, PNEUMONIA AND SHINGES VACCINE IN 2020

A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.

At second dose today, patient stated his opposite arm (right arm) was sore after his first dose of the vaccine. He said the soreness started the day of the vaccine and continued for four days.

had a sore arm, so sore that he ended in the hospital for 2 days; he couldn´t move his arm; it still hurts and goes into his neck; A spontaneous report was received from a consumer concerning, an 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sore arm, he couldn't move his arm, and it still hurts and goes into his neck. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# not provided]) intramuscularly for prophylaxis of COVID-19 infection. The patient's wife stated that the patient had the vaccine and then 5 days later he had a sore arm, so sore that he ended up in the hospital for 2 days (dates not provided). The patient couldn't move his arm and it still hurts and goes into his neck. The patient did not plan on receiving the 2nd dose of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of he ended in the hospital for 2 days, he couldn't move his arm and it still hurts and goes into his neck were not 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 event, a causal relationship cannot be excluded.

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.

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 .

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.

bilateral thigh pain, leg pain with whole body aches 10 days after vaccination follow by weakness of both lower limbs

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.

Next day confusion, problems with balance and inability to walk, mumbling speech, scattered thought, unable to follow or understand speech which lasted 24 hours and resolved spontaneously without medical intervention.

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.

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

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.

Rash/ hives on entire body from the neck down. Concentrating especially on the back and stomach completely encompassed in splotches and running down both legs. Swollen hands and sanative to the touch.

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.

Pt here with concerns of numbness and tingling of his body since his COVID vaccine. He had it on 2/3 in his R deltoid. He notes started to feel bad on 2/6. He went to urgent care and was told that he probably had TIA. He came into clinic that next week and I ordered an MRI of his brain. MRI brain showed senescent changes and mastoid congestion, but no evidence of stroke/acute event. His symptoms started with R hand numbness (R thumb and R index finger), then progressed to R leg and arm numbness, R facial numbness with trouble speaking, which he describes as feeling like he had a lidocaine shot at the dentist. He denies any acute illness at that time, but did sleep alot more. Currently the only symptom he has left is R index and thumb numbness as well as feeling like the R side of his face feels different than the L.

Patient went to ER on Saturday, March 20, 2021 complaining of stroke-like symptoms. Medical staff determined that patient was suffering from symptoms similar to Bells Palsy. Presently he still suffers from being unable to close left eye without also closing right eye and the right corner of his mouth droops downward.

1. Inability to sleep after doses of Xyrem. 2. Loss of Consciousness ×3. 3. Falls x3--injuries to RIGHT arm, and lower back. 4. Confusion 5. Loss of Time Awareness 6. Reduced breathing, alamingly, during sleep 7. Clamminess; cold extremities 8. Shortness of Breath Lasted approximately 12 hours into March 21, 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.

One day after the first Moderna vaccine, this gentleman developed hand and wrist pain. There was then hand numbness and swelling across the right wrist and MCP joints. He had pain in the hands, wrists, shoulders, and hips. He felt weak in hands and with rising from a chair or climbing stairs.

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

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.

about a week or so after I got a sever burning on my left rib gage that was very itchy, thought it might be Shingles but I've had the shot. I disappeared after a few days. Then I got s similar reaction after my second shot that was on my belly and it also went away in a few days.

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.

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

Right leg, calf, pain, moderate, persistent, extending upwards, preceded about 24 hours by cramp, same region.

Flu again after second vaccine dose; Pulse oxygen level dropped to 75 after second vaccine dose; Hard time breathing after second vaccine dose; Lungs had fluid after second vaccine dose; Horrible mouth sores after second vaccine dose; Very weak after second vaccine dose/No energy after second vaccine dose; Patient feels like he was hit by a big truck; Trouble sleeping at night; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose), STOMATITIS (Horrible mouth sores after second vaccine dose) and ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was provided.). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-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 INFLUENZA (Flu again after second vaccine dose) (seriousness criterion hospitalization), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose) (seriousness criterion hospitalization), DYSPNOEA (Hard time breathing after second vaccine dose) (seriousness criterion hospitalization), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) (seriousness criteria hospitalization and medically significant), STOMATITIS (Horrible mouth sores after second vaccine dose) (seriousness criterion hospitalization), ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) (seriousness criterion hospitalization) and INSOMNIA (Trouble sleeping at night). On an unknown date, the patient experienced FEELING ABNORMAL (Patient feels like he was hit by a big truck). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to ASTHENIA, DYSPNOEA, HEART RATE DECREASED, INFLUENZA, PULMONARY OEDEMA and STOMATITIS. At the time of the report, INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) and STOMATITIS (Horrible mouth sores after second vaccine dose) had resolved, ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) and FEELING ABNORMAL (Patient feels like he was hit by a big truck) outcome was unknown and INSOMNIA (Trouble sleeping at night) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) normal. No concomitant medications were provided. Treatment medications included anti-herpes and mouth wash for mouth sores. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-078124 (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, excluding other etiologies causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-078124:Case for patient 1

Left arm swelling, shortness of breath, leg pain, generalized discomfort 4/5/21 - was seen at Urgent Care - no orders 4/6/2021 - seen at Hospital ER - CT showed blood clots/pulmonary embolism of left arm and lungs and lymph nodes. Received IV fluids in ER. Kept overnight for observation and discharged from hospital next day. Sent home on Eliquis and Prednisone

stiffness; rigidity; swallowing disorder; freezing phenomenon; worsened blood pressure fluctuation; Dementia aggravated; wrong technique in product usage process; stoma site pain; Abdominal pain; complication associated with device; stoma site granulation; pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in an 80-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. Concurrent medical conditions included Weight loss in December 2019, Aspiration pneumonia since 06-Feb-2021, Stomach ulcer, Chronic pancreatitis, Anxiety, Arthritis, Dementia, Pulse pressure wide, Urination impaired, Parkinson's disease, Abdominal pain since 21-Jan-2021, Abdominal discomfort since 21-Jan-2021, Abdominal bloating since 21-Jan-2021, Device migration since 21-Jan-2021, Distended abdomen since 21-Jan-2021, Nausea since 21-Jan-2021, Dementia aggravated and Blood pressure fluctuation. Concomitant products included CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease, LINACLOTIDE (LINZESS), MACROGOL 3350 (MIRALAX) and ACETAMINOPHEN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and STOMA SITE PAIN (stoma site pain). On 10-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process). In March 2021, the patient experienced STOMA SITE HYPERGRANULATION (stoma site granulation). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated). On 10-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) and STOMA SITE PAIN (stoma site pain) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and PAIN IN EXTREMITY (pain in arm) had resolved, STOMA SITE HYPERGRANULATION (stoma site granulation) and DEMENTIA (Dementia aggravated) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon) and BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Computerised tomogram: abnormal Abdominal: Revealed the internal retention plate of the G tube was rubbing up against the abdominal wall causing the pain. On 08-Mar-2021, X-ray: abnormal Abdominal unclear; PEG J Placement was okay. On 10-Mar-2021, Computerised tomogram: abnormal Abdomen: Balloon was pushed up against the stoma. On 10-Mar-2021, X-ray: abnormal Abdomen: PEG J Placement was okay. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be probably related and ABDOMINAL PAIN (Abdominal pain), STOMA SITE HYPERGRANULATION (stoma site granulation), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process), STOMA SITE PAIN (stoma site pain), MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated) to be not related. Treatment: The patient's PEG tube was moved back in from position 2 to position 4. The patient received treatment with silver nitrate and trimethobenzamide (Tigan).

Had the COVID shot and two days later he can't use the arm. Right shoulder hurts very badly. Also the shoulder joint hurts. Top of shoulder can't use the arm. Painful, very sore.

The Patients leg gave out and he fell. Per doctors at hospital, he did not hit his head. He could not get up and he vomited. Ambulance was called and he was taken to the Hospital. The family was told that he had a brain bleed near the thalamus. A few hours later the patient was unresponsive. He was intubated and taken to neuro ICU. Within less then 24 hours from first symptom the patient died.

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

breaking hip; Consumer put pressure on the leg and it collapsed; right leg feel asleep; Patient missed his second dose because he had to get a surgery; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (breaking hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Overweight. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (breaking hip) (seriousness criteria hospitalization and medically significant), FALL (Consumer put pressure on the leg and it collapsed), HYPOAESTHESIA (right leg feel asleep) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery). The patient was treated with Surgery for Hip fracture. At the time of the report, HIP FRACTURE (breaking hip) had not resolved, FALL (Consumer put pressure on the leg and it collapsed) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery) had resolved and HYPOAESTHESIA (right leg feel asleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment reported was surgery for breaking his hip. No concomitant medication information was provided. Caregiver states the fall was not related to vaccine. Caregiver did not provided information whether consumer was hospitalized and what kind of care he got afterwards. He did not have much information since he was calling with a medical inquiry. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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.

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.

2 hours after 1st vaccine waist down to toes, wrist and hands have pain. Sharp pains, lasts about 2-6 hours. Rating a 9 on a scale 1-10.

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.

4/29/21 hpi admission to inpatient: 80 y.o. male with a past medical history notable for Diabetes, history of CVA, arthritis, reflux, BPH, hyperlipidemia, hypertension. The patient presents for evaluation of Worsening issues of weakness and hyperglycemia in addition to being worsening itchiness. Patient states he has had some issues with worsening reflux. Patient has not any emesis. Patient's wife thinks he may be slightly jaundiced. Upon further evaluation patient was found to have pancreatitis. Patient was placed in-patient will hold patient NPO and provide IV fluids. Patient has had pancreatitis previously. Patient's itchiness is probably due to elevated transaminases. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Transferred to hospital 5/1 HPI: 80 y.o. man with a history of type II DM, hypertension, and remote h/o CVA who presented to hospital following transfer from another hospital for acute pancreatitis. Patient was initially admitted to their facility on 4/29, treated for pancreatitis with IVF, pain medication, and antiemetics. He LFTs failed to improve. RUQ US with no evidence of gallstones. Transferred here for MRCP/ERCP. He currently denies any abdominal pain. No chest pain. Breathing stable. No fever or chills. He states he has been having some belching and acid reflux for the last 1-2 weeks, worsening after a trip 1 week ago. 5/17/21 radiology: Malignant neoplasm of pancreas Admitted 5/20 - 5/24: Open biopsy of liver/Pancreas, ECRP 6/14 Office Vist : oncology, pancreatic carcinoma metastatic to liver

Shortly after administration of injection, patient complained of tingling of left arm. Has had previous history of carpal tunnel surgery. VSS at 3:40 pm: 164/90-74-97% oximeter reading. After 30 minutes, resolution of complaint and was able to leave on own.

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.

Pt c/o rapid heart stated my heart beat is feeling very strong at this time which he stated unusual for him. Also pt c/o feeling very cold, body aches and muscle cramps. Pt stated feeling sick since he got his 2nd dose covid vaccine Moderna on 02/17/2021 and sx not getting better. Pt speech clear. AO X3. Answered Yes to emergency sx Rapid heart beat at this time. As per protocol advised pt to call 911 or immediately go to nearest ED for further evaluation and treatment.

Received dose 2 of Moderna vaccine on 3/11/21. Symptoms worse after 2nd dose, and on March 31, 2021 get worse. On April 4 at church, became very hot and weaker and weaker. Came home and put him to bed and slept some. At lunch time, ate a bite of jello and sipped 7 up and said he did not feel very good. Took an Alka Seltzer for heart burn, but it did not help. Went to sleep. Wife unable to waken him later that day. Died 4/4/21.

Chief Complaint ; Right ICA occlusion; History of Present Illness; Patient is an 80-year-old white male with a past medical history of HTN and gout brought to the ICU after undergoing R ICA angioplasty & stent placement with the NeuroIR team on 7/22/2021. The patient was admitted by the Stroke Service on 7/20/2021 after transfer from an OSH where he had presented earlier that day for aphasia and dysphagia. Of note, the patient was found to be COVID-positive at the OSH before his transfer to this facility for a higher level of care. The patient was diagnosed with R cerebral infarction (mechanism: atherothromboembolic) and found to have severe stenosis of the R ICA. He was started on dexamethasone and remdesivir on 7/20 by the stroke team.

Patient had progressive weakness since February 2021. Patient currently diagnosed with Myasthenia Gravis during hospital admission, he believes this to have an onset 1 week after receiving 2nd Moderna COVID vaccine. Patient later reported to neurologist that he "may have had some mild weakness issues prior to February of 2021, but they were very minor and he ignored them" Attending provider requested to submit case

Starting on 1/2/2021 patient started experiencing intermittent tremors of upper /lower extremities that have been impacting on his mobility including transfers, ADLs and eating. Staff has now given the resident cups with lids to decrease spilling with meals. Provider was updated on resident's condition on 1/5/2021. On interview on 1/6/2021 resident stated he was feeling better, less tremor. Still felt unstable with transfers. Was able to eat and drink normally 1/6 and 1/7/2021. On exam on 1/6/2021 no tremor seen with rest or movement. In update from nursing staff 1/7/2021 no tremor noted, back to baseline. Had been on Losartan K 25 mg daily which was d/c'd 1/6/2021

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.

Per RN- At 1350 client stated "Slight numbness and tingling in both arms". No redness or swelling at injection site. At 1355, a coke was provided and tolerated well. At 1359, BP in left arm was 176/94, HR- 74, Lungs clear, Respirations- 20. At 1415, Numbness decreased to only in hands. At 1418, BP- 173/89, HR-71, Respirations- 18, Lungs clear, Client escorted to car by EMT.

Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated

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

Patient came in to receive his first COVID-19 vaccination at 2:00pm on 1/25/2021. Patient received his vaccine at 2:08pm intramuscularly in his left arm. Patient was asked to remain in the waiting area to be observed. At around 2:34pm, patient started feeling light headed and started yawning. Patient's wife noticed the yawning and said that he does that before experiencing a seizure. After a couple minutes of slow steady breathing, patient started having a seizure and his eyes started rolling back. Patients pulse was steady at the time and soon came out of the seizure. About 45 seconds-1 minute later he started experiencing a second similar seizure that lasted roughly 15 seconds. EMS was called and they came to help him. Patient experienced 1 more quick seizure in the time it took the EMT to get to the store. Patient started having a stronger pulse, breathing better, and looked a lot better. Patient also is a diabetic at the time and his blood sugar was slightly low. EMT assisted patient the rest of the way and they patient and wife left the store to go home.

Muscle twitching, lost balance and fell in the bathroom and couldn't get up for 15 minutes, extremely dry mouth, stated he kept feeling like his body was "pulling to the right".

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.

(1) Noted vertigo approx 200AM - 1-9-21, & nausea, dizziness and weakness. Continued with improving after Day 7. Initial No pain or redness & injection site - (2) Noted -

1/21/20 ,6 p.m. Queasiness and elevated heart rate. Blood pressure 192/97. 10 pm BP 209/119 1/22/20 M.D consulted. Started 25 mg HCTZ. Stopped hydrocodone/acetaminophen. Severe malaise until 1/24. 1/23 Blood pressure in acceptable range. Mild soreness in arm when touched. 1/25/20 Symptoms resolved

T 99.8, R 44, O2 94%, Pulse 132, Bp 199/82. Patient lethargic, confused, weak. Sent to local ED, and ED reported resident had MI and was transferred to another hospital for further workup. Patient tested positive for Listeria in urine at local ED as well, which may have contributed to this reaction.

pt states after taking the vax he woke up with headache and sinus congestion. After getting up next morning he noticed a numbness on the left side of his face, mouth and teeth. He got a tingling sensation that moved from his arm down into his thumb and then spread into his other fingers. He shook his hand and it seemed to disappeared. Pt has not contacted his PCP with symptoms.

Nurse was summoned to the dining room @ 0910 and found resident to be sitting in his wheelchair in an upright position with his head down with chin to chest. Lips were noted to be blue, resident was not responding to verbal or painful stimuli. Sternal rub resulted no change but a few small and deep breaths. Resident was assisted back to room , still remained unresponsive, assisted with 4 staff and hoyer back to bed. Noted VS at 98.3-54-12-87/46 O2 stats @ 85% on RA. O2 was started and increased up to 4 liters. Noted O2 stats at 86% @ 10:30 . Repeated B/P after 30 minutes was noted @ 75/35. Vitals @ 12:25 101/64 - 98 -57-14-O2 87% with O2 on, blood sugar 171, verbal response to questions @ this time.

two days after vaccination shoulder ache, cough, 4 days after RT calf upper muscle pain which moved into RT ankle, 5 days later previous symptoms gone, 8 days later same calf pain again but in LT, pt also noticed heart arrhythmia's occurring, pt took a beta blocker and symptom subsided

Next morning after injection, woke up not feeling well. Temperature, shakes, internal quivering, chills, tired, aching joints. This went on for 2 more days. Temperature ranged from 100.2 to 101.6. Friday morning (2/5) woke with fever of 101 but soon dropped down to 99. As the day went on temperature became normal and has stayed that way. Lost 3 pounds and still feeling very tired. Arm at injection site was swollen and very hard.

Patient receives home health, the home health nurse came to patient's home and gave the vaccine. By the next morning he had sore arm and minor weakness. The Sunday 1/31/2021 he was fine till that evening around 6PM he became confused and experienced memory loss. That lasted all evening until he went to bed. The morning when he woke up he seemed okay.

SORE ARM AND SHOULDER, VERY LETHARGIC, CHEST CONGESTION, NO APPETITE, HEADACHE, UPSET STOMACH. DID NOT SEEK MEDICAL ATTENTION.. GETTING BETTER. ACCEPTED AS PART OF IT SINCE I HAD HEARD STORIES THAT THE SECOND VACINE WAS GOING TO BE WITH MORE SIDE EFFECTS.

total loss of strength. could not crawl on the floor, only roll at about 10:30pm on day of vaccination via ambulance to Hosp. ER

Patient started feeling very dizzy, sick like, and weak starting about 24 hours after getting the vaccine. He was taken by ambulance to the local hospital and treated with fluids I believe. After regaining strength, he went home and was given meclizine for nausea and dizziness. He was told to keep up fluids and rest.

The first day, he did not feel real good, felt weak. On Saturday had fever, no appetite. Sat down and couldn't get up, joint pain had no balance. The fever kept going and down. Felt weak, didn't feel like moving and slept most of the time. Felt better on Sunday, a little weak.

January 20 received first shot-Moderna 005J20-2A at the hospital. Arm sore for about a day c. January 22 onward-slight headaches January 26 began having severe chills. These lasted for about 4 days. They were most severe on January 29. Concurrent with chills was the onset of fatigue. c. January 29-severe pain in hips and shoulders rendering me almost immobile. It was very difficult to get out of bed and to walk. I used a cane for support. Also the onset of diarrhea and loss of appetite. Tried extra strength Tylenol, but it did not help. Never had a fever, respiratory symptoms, of loss of taste or smell. Had nasal Covid test of February 1 which was negative. Saw Doctor on February 4. He ordered blood tests, one of which was to check potential source of joint pain. The test was negative for that, but showed some lessening of kidney and liver function. February 8-blood test showed considerable improvement on kidney and liver function. All symptoms except the fatigue have gone away. I did lose about 5 pounds during this reaction period. The fatigue is improving.

Patient received vaccine on 2/8 at 2:50pm. On 2/9 at 10am, patient was found unresponsive. EMS noted R gaze preference and L sided contracture. Patient was intubated and symptoms resolved when given Versed. Concern for seizure activity.

10:45 pt reported not feeling well; He complained of feeling nauseas and weak. Assisted pt to lie down on cot; Nursing assessment done, vital signs taken, pt offered water, history taken from pt and wife; mental status assesed; 911 called;RN stayed with pt until EMS took pt to hospital via ambulance for further evaluation.

Developed weakness/numbness in the entire hand within 24 hours of being given the vaccine. Patient was seen on 2/19 and while some of the numbness had resolved, she did have findings consistent with ulnar neuropathy (weakness in hand and numbness in 4th/5th digits)

Shaking terrible for like 18 hrs about 24 hrs after shot, vomiting, diarrhea, disoriented. A week later he is very weak. Has decided not to do the 2nd shot

Got shot on 1-11-21 and on 1-13-21 am was totally unresponsive , oxygen level low and passed away on 1-14-21

Very cold, had chills and shakes, weak, dizzy, bad head ache trouble with balance, trouble walking and in bed Monday after noon all day Tuesday. Still weak today but doing better

Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included alprazolam and hydroxyzine. On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection. On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen. Action taken with mRNA-1273 in response to the events were not reported. The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Patient presented to ED due to AMS, syncope. Wife reported that he became confused with generalized weakness and dropped his food on the floor and became unresponsive with his eyes and mouth open. Patient was febrile to 103 on admission w/o leukocytosis. He was admitted to hospital medicine for acute encephalopathy with associated loss of consciousness. Neurosurgery consulted but no neurosurgical intervention needed. Patient improved & discharged home 2/24/21.

Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air." On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.

2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017. Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.

Extreme loss of strength and energy at 2pm followed by and hour long bout of chills and uncontrolled shaking starting at about 9:15pm. On the following day (2/24) I felt extremely weak and fainted at about 7:00am. So weak it took about 15 minutes before I could raise myself up from the floor. Felt weak and unsteady all day and had muscle aches all over. Slept on and off for most of the day.

Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died. Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal. On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection. On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick. On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided. Action taken with mRNA-1273 was not applicable. Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided. The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Shot taken 9:30AM 2/25/21 DaQuil taken around 3:30PM Chills, violent shakes. Around 6:00PM 911 called , EMT arrived I did not know birthdate, where I lived, date, or where I was. Transported to ER do not remember any part of the trip or arriving at the ER. Bright red circle around shot with fever still have 3/4/21 plus sore.

1st day severe headache, diarrhea, weak 2nd day " " " " needed help to get up. Then collasped 02/23/2021 in hallway couldn't move at all, heaving sweating, Temp 100 degrees shakes, irregular heart beat B.P. 101/84 before got him up, weak for several days

Developed soreness in left shoulder and chest area. On Mar 2, 2021 I measured my blood pressure at 5:00AM to be 163 over 99. My normal blood pressure is 130-135 over 71-75. Went to the emergency room where an EKG. chest ex-ray and blood work were performed. Doctor reported that all test were normal but blood pressure was still high at 146 over 89. I have continually monitored my blood pressure as follows: 3/2 @ 10:00 PM 144/73; 3/3 @ 7:00 AM 147/77; 3/3 @ 10:00PM; 165/83: 3/4 @ 7:00AM 165/83: 3/5 @8:00AM 157/77. The ER doctor Dr. indicated that the vaccine could have caused inflamation which caused the change in blood pressure

1100 Patient found unresponsive to verbal stimuli by RN, lips cyanotic, color pale, lowered carefully to ground. Pt then stated he could not breathe. 1105 epinephrine 0.5 mg IM administered to left vastus lateralis by EMT. Breath sounds clear in all fields per EMT. BP 124/70 per EMT. Pt began to report ease of breathing, alert and oriented to self. 1110 Benadryl 50 mg IM administered to right deltoid. Pt condition improving, color improving, alertness improving. 1115 Report given to responding ambulance crew and patient transported to higher level of care.

At 9:30 am Saturday morning client got light headed, dizziness, bright lights became bothersome, and experienced weakness all over body which lasted approximately 30 minutes. Client then became nauseous and threw up within 30 minutes of other symptoms. Once client got home he slept for approximatley 4-5 hours, woke up feeling 100 % better.

3/6/2021 9:30 AM: Client experienced dizziness, lightheadedness, all over body weakness, light sensitivity, nausea, and vomiting. Episode lasted for about 30 minutes, client was in a parked car at time of incident. Once client returned home he slept for 4-5 hours and woke up feeling "100% better."

Beginning eight hours after injection, severe flu-like symptoms - high fever, headache, chills, shakes, nausea and vomitting. Confined to bed for 24 hours. Fever broke the next evening, One additional day required to return to normal activity. Also, several hours following administering of vaccine, upper left arm was in extreme pain extending to the elbo. Continued to be very sore for 36 hours, and slightly bothersome for 72 hours.

Patient was vaccinated on 2/24/21. On evening of 2/25/21, patient began to experience balance problems. On 2/26/21, patient began to experience tingling and weakness in lower extremities. On 2/27/21, patient required walker to ambulate.

Patient went down in the parking lot while walking back to his vehicle with his wife. Pt was using a walker. When this nurse responded, the patient was on his side and responsive. Pt denied pain or injury. Upon assessment patient was responsive but had a left-sided facial droop, which his wife said was new. Checked grasps and left side was significantly weaker than the right. Unable to check the lower extremities as legs were under a vehicle. Blood sugar checked, which was 168. Pt is diabetic. 911 was called and patient was taken to hospital via ambulance. Pt was markedly improved at the time of transport but was still pale and ashen.

02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it. In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell. He felt like he was going to vomit too. He was so weak that he could not get up off the floor by himself. My son lifted him up. He also noticed Friday night that there was a bubble where the vaccine was given in his arm. 02/27/2021, the bubble had burst and liquid was coming out. It was an open wound which was sore and really red. He also had a headache and continued weakness. 02/28/2021, he still had a headache and the arm was sore. 03/01/2021, felt pretty good.

81 year old male with h/o M. Abscessus infection, glaucoma, HTN, HLD, BPH, TIA, who presents with 3-4 days of severe weakness and SOB found to have new bilateral upper lobe ground glass infiltrates;RPP negative, BAL gram stain negative . Per outpatient note: Started imipenem/cilastatin and tigecycline on 10/10/20 and on Arikayce and clofazimine 10/23/20. He was transitioned to omdacycline/clofazamine/arikayce 12/20/2020. Initially on the floor but now txf'ed to ICU for worsening respiratory distress. Relevant labs: His smears and cx have been negative since 11/23/2020 including 12/10/20, 12/11/20 2/8/2021. He was found to have new bilateral UL ground glass changes by CTA and underwent BAL 3/10 for possible atypical infection versus drug induced pneumonitis; covid 19 neg PCR What was used to treat this reaction? Held Arikayce. Gave Solumedrol. Unsure if his pneumonitis was caused by Arikayce or the Covid vaccine. ADR Prior to admission? Yes Severity: Severe Probability: Possible ADR Preventable: not preventable

Extreme somnolence, slept 18 hours the next day after shot, muscles hurt. Then over the next few days, developed gradually increasing intermittent pain and stiffness in both hands as well as intermittent paresthesias in finger tips. Also can't make a fist.

1hr after vaccine chills started. Within another 1 hr started achey. Cintinued to worsen At 1:30 am he was so weak could barely get to bathroom. Had to hug the walls to walk. Sever pain at this point. All his joints had shooting pain. Started getting better by morning but still very achy and very fatigued. Slept most of day. Ate very little. Probably didn?t drink enough water. Still weak on 3-10-2021. By evening of 10 th seemed normal. This man normally walks 5 miles a day, does 150 push-ups daily. Never sick. Very healthy. Then on 3-17-2021 during the night he got sick again. Joint pain, temperature at 100.4. Severe weakness. Wobbly when walking.

hypertensive ermergency/ encephalopathy causing acute confusion, Narrative: Admitted for acute confusion related to hypertensive emergency one day following second dose of COVID-19 vaccine. Hospital notes reviewed. No correlation with COVID vaccine noted as a concern per providers. Reported given timing of vaccine + hospitalization. History of HTN. Recent diagnosis of lacunar stroke (between COVID-19 vaccine dose 1 and 2).

my grandfather suffered a stroke affecting his left side. it took us over a day to conceive him to see a Dr. he was finally taken by ambulance to our local hospital and transferred to another hospital about an hour away. they did multiple tests to make sure he wasn't in further danger and released him to the care of my mother. it didn't damage his ability to think. he struggles to speak, swallow, and walk, and can't move his arm at all.

Pt was admitted on 3/25/2021 with a TIA and sudden word finding difficulty along with a headache and a sudden inability to make decisions

Diarrhea; Felt hot, but no temperature; Nausea; Vomiting; Appears the Botox did not work; Shaking from the Parkinson's is aggravated; He was not feeling well; A spontaneous report was received from a consumer concerning a 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work. The patient's medical history, as provided by the reporter included parkinson's. Concomitant medications reported included botox injection. On 08 Mar 2021 at 01:00 pm, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 003A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection. On the 09 Mar 2021, after receiving mRNA-1273, the patient experienced he was not feeling well, shaking from the parkinson's is aggravated and appears the botox did not work. On 10 Mar 2021, the patient experienced, diarrhea, nausea, vomiting, felt hot, but no temperature. Lab details was not provided by the reporter. Treatment for the events was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work 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

Patient was seen in Urgent Care on 3/24/21 for left sided facial drooping, symptoms began on 03/14/21, patient was diagnosed with Bell's palsy and was prescribed valacyclovir 1000 mg. Patient seen on 3/30/21 with pcp to follow up from urgent care. Provider added methylprednisone 4mg and ordered ct scan.

Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine. On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand. Treatment for the event included nausea medication. 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 outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. Fever, nausea and vomiting are consistent with the product safety profile.

stomach and colon pain, headache, weakness, a-fib, short of breath, loss of taste. All symptoms occurred subsequent to suspected COVID 2/15/2020 (was not tested at the time because there wasn't much COVID in Utah where I lived at that early date). Symptoms continued for a year, was getting better the last couple of weeks before the 2nd COVID shot and then relapsed (including had regained sense of taste for 2 weeks. then lost it again after the shot).

Developed general weakness, occational productive cough, diarrhea, and anorexia starting on 03/20/2021. Tested positive for COVID-19 on 03/25/2021.

EXTREME WEAKNESS (could not get out of bed in the morning even with assistance), shakiness, loss of appetite

nausea, vomiting, diarrhea, change in mental status, and generalized weakness about 36 hours from time of vaccine. Initially treated with supportive care. He returned 5 days later with continuing symptoms plus headache and was diagnosed with a intracerebral hemorrhage.

He had covid in November 2020 and was hospitalized and went to rehab to start walking again, after treatment walked out of rehab. After receiving the vaccine the next day couldn't get out of bed and was very weak and could not walk. Went to the hospital and was there 4-5 days and sent home for physical therapy at home and still cannot walk more than 4-5 feet with out a walker. All of this after 1st dose of Moderna, he can no longer walk.

Slight fever 1 point elevated. Muscle, body aches, fatigue, tiredness, slight headache, joint pain, sore Rt. arm, sore injection site. Side effects have subsided after approximately five (5) days. None of the side effects were considered severe!

He received the vaccine on 3/4/2021 and by Monday morning 3/15/2021 he was running a fever and not feeling well. Fever continued until Friday March 19 when he went to the dr. Dr did a lung xray and said he had cloudiness on his lungs so she started antibotics. On March 22 he was brought to the ER because he was too weak to walk and wasnt feeling well still had the fever. The switched his antibotics and he went home. On March 24 he was rushed back to the hospital via the ambulance and they admitted him. He stayed in the hospital until March 30 when they finally let him leave to a care center. He had finally not had a fever. Had confusion and weakness. The confusion comes and goes from day to day sometimes min to min.

Patient received the Moderna covid vaccine on 3/11/2021. Starting the day after that, the patient's wife reported that the patient began to display confusion, weakness, and fatigue. The patient also presented to the clinic on 4/2/2021 with complaint of "sinus pressure" and was prescribed an antibiotic. He progressively worsened to the point where he was only able to speak a few words, and presented to hospital on 4/7/2021. Given extremely low platelet count on presentation, a diagnostic workup for TTP vs. ITP was commenced. It was determined by the inpatient hematology/oncology service that the patient was likely experiencing alterations in mental status and weakness and thrombocytopenia due to TTP. Fresh frozen plasma was administered. Plasma exchange daily x 5 days and corticosteroids were initiated.

APRIL 9 EVENING LUMP IN RIGHT LEG, PAIN TENDERNESS AND REDNESS, SITE IS HOT AS WELL. SWELLED OUT, RUNS 2 INCHES, RIGHT ON INNER PART OF LEG, BELOW KNEE LEVEL, HAS HAD 2 NEW KNEE IMPLANTS ON RIGHT LEG.

4/14/2021 Two weeks after the 2nd Covid-19 vaccine,,about 11 PM. patient, developed a sudden numbness in his right are, hand & right side of the face. He had no sensation and could not feel anything. He immediately was taken to the emergency room at Hospital. They began testing and suspected a blood clot. They administered blood thinners, TPA by injection into the port, performed many tests including Ct scan, chest Xray, blood tests, EKG etc. He was being monitored & hooked up to various scanners. They decided to move him by Ambulance to the ICU Unit at Medical Center . He was in the neurology emergency room there for several hours & then moved the Neurology ICU. They kept him there, doing various testing, until Friday 4/16/2021 When they moved him to a regular Neurology floor. Staff neurologists continued to monitor his condition. On Saturday, 4/6/2021, an MRI showed a small blood clot in the Thalamus of the brain, which they believe caused the lack of sensation on the right arm, hand & face. He was discharged & went home on Monday 4/18/2021. New medication was prescribed, Physical therapy and was told to make an appointment with a Neurologist. On Thursday, 4/22/2021 patient had an appointment with his Cardiologist, Dr. the Dr gave him an examination & told him to proceed with the neurologist, etc. Patient has an appointment at PT in on Wed. April 28, 2021. He is waiting for an appointment with Dr. Neurologist at Neurology Group

right bell's palsy symptoms started on 3/17/2021, became severe on 3/18/2021, with severe right facial droop and inability to close right eye, minimal improvement over past 6 weeks. Younger sister also developed Bell's Palsy after her second Covid vaccination.

Severe headache from the evening of Feb 25, 2021 to Feb 28, 2021, followed by a stroke incident on Feb 28, 2021 with slurred speech and left-sided weakness. Spent 18 days at hospital. (Field 21 was found to be not editable so we placed that information here).

Persistent encephalopathy beginning 2 days after vaccine, with multiple hospital admissions, some clinical improvement after CSF drainage from VP shunt, then recurrence of encephalopathy with falls, lethargy. Treatment included intubation, CSF neg for infection, clinically diagnosed with autoimmune encephalitis, brisk response to steroids.

Vaccine was given on 4/1 and the next day nauseated, dry heaves, cannot eat and lives on protein shakes and he's lost 20lbs and he's weak and been in the hospital twice and the doctors cannot find why. He has passed out four times. He is a cancer surivor but nothing shows that the cancer has returned.

passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

81 year old male who presented to Medical ER 6/4/21 with possible seizure like activity at home after having his second dose of COVID vaccine on 6/3/21. His first dose of COVID vaccine was given on 5/4/21. After the patient arrived to the ED he was able so my questions. The patient had an EKG performed was not concerning for ACS. He was given a total of 1 mg of Ativan IV. CT head CTA head and neck were negative for any acute findings. He was started on IV lactated Ringer's. CBC was reassuring. CMP showed a sodium of 125 and potassium 3.3. The patient was started on a liter of NS. Magnesium was found to be 1.7 was given 2 g of magnesium IV. Ammonia level blood alcohol level were negative. Initial lactic acid level was 5.9. Repeat lactic acid level is down to 1.9. I had spoke with on-call neurology felt that seizure is most likely due to the patient's electrolyte abnormalities. Did not recommend antiepileptics at this time. I spoke with Dr. who is willing accept the patient for admission to the ICU. When Dr. came down and spoke with the patient he started having another seizure. After the seizure he continued to not breathe. The patient was bagged and started having some spontaneous respirations however continued to have a low O2 sat if he was not bagged. We were able to speak with the neurologist again who recommended giving Keppra 1500 mg IV. Dr. was able to speak with the patient's next of kin his son and the patient's brother who both recommend the patient not be intubated or any other life-saving measures. Would like the patient be kept comfortable. The patient passed away shortly thereafter time of death was 2044.

fever, lack of energy and queasy stomach (did not feel like eating which means I am sick). Slept 2 hours during day after 11am and then slept about 10 hours that night, Next morning I felt fine. I also had same reactions to both Shingrex vaccinations in the last 4 years but not as severe the reaction to Moderna. Also no reaction to first Moderna vaccination

Pt received his first and second COVID19 MRNA Vaccine on 2/4/21 and 3/4/21, respectively. Patient was admitted to our facility on 6/17/2021 w/ symptoms of generalized weakness that had been worsening over the past few days. His first symptoms began on 6/14/21 w/ nasal congestion. He began to have cough and weakness on 6/16/2021. Patient tested positive for COVID 19 on 6/17 via PCR on nasal specimen. As of this report, 6/23/21, pt is admitted to a step-down unit at our facility requiring supplemental oxygen via CPAP. His current O2 requirements are 100 fiO2 and 60lpm w/ 15 cmH20 of PEEP.

mild leg muscle pain; difficult to walk; legs feel heavy; stability problems; couldn't walk; leg pain has gotten worse over time; became a disability; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (became a disability) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee replacement (The patient underwent 2 knee replacements.). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain has gotten worse over time). 04-Mar-2021, the patient experienced DISABILITY (became a disability) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced WALKING DISABILITY (couldn't walk). On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy) and BALANCE DISORDER (stability problems). On an unknown date, the patient experienced MYALGIA (mild leg muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain has gotten worse over time), WALKING DISABILITY (couldn't walk), GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy), BALANCE DISORDER (stability problems), DISABILITY (became a disability) and MYALGIA (mild leg muscle pain) outcome was unknown. No concomitant medications were 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.

Shortness of Breath, Difficulty Breathing, Difficulty Swallowing, Extreme wait loss, Low energy level. Progress over 2 month period

Pain and skin sensitivity began in right arm on Feb. 1, 2021. On the evening of Feb. 8, a rash broke out on the arm. The next morning I set up a telemedicine visit with my doctor for that afternoon (Feb. 9). In that visit I described my symptoms and showed him the rash. He diagnosed shingles. That evening I started a course of the anti-viral drug Valacyclovir. It took approximately two weeks for the pain and rash to disappear. I got my second Moderna shot on Feb. 26.

about 3 days after shot, except sore arm. Then pain started in shoulder joint down through the muscle and side of the bone to the wrist. Both sides of my wrist hurt. The pain was constant and moving was unbearable. Tried to use heat, cold, and vibrator to relieve the pain. Pain in the morning started as bearable but it would get worse as the day went on.

12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.

Starting the day following vaccination, patient's vaccinated arm became extremely sore all the way down, rated 10/10 on pain scale. Patient has been taking Tylenol, ibuprofen, and Aleve for pain relief, pain is currently less than previous (about a 4/10).

Heart rate went from a normal rate to 144-150. At same time I took a serious cold and achy joints and muscles. Doctor has me taking Digoxin, Diltiazem and Eliquis to try and bring the heart rate down.

MODERNA COVID-19 VACCINE EUA Patient reports approximately 24 hours after receiving vaccine , he came in from a doctor's appointment and remembers opening the door and then woke up in the floor and there was blood on the floor. Patient had no other adverse reactions other than soreness in his arm. No follow-up treatment required per patient.

weakness, dizziness, and one day of diarrhea, onset 2 days after receiving covid vaccine, resulting in ER visit. (ER evaluatiion done, included labs, chest xray and EKG, reportedly normal)

My dad got the Moderna Vaccine on Tuesday, January 12, 2021 in his left arm at the Mall injection site for the Health Department. He was told that the side effects could mean his arm hurting, tiredness, headache, and even a low grade fever. Additionally, the site informed us both (as I was with him to get the injection) that this was all normal and not to seek medical attention unless these symptoms last longer than 72 hours. That evening, my dad was experiencing all of those symptoms, and went to bed at 7pm. A little after 10am on Wednesday, January 13, 2021, when he awoke, my dad went to the bathroom vomiting. This was where he collapsed and went into cardiac arrest. Fire/Rescue was dispatched about 10:30am after my mom started CPR. County Fire Rescue EMTs and Paramedics continued CPR and other attempts at reviving him all the way to Hospital Emergency Department. He was pronounced dead at 12:14pm on Wednesday, January 13, 2021. We have no doubt my dad, following the instructions of the injection facility, thought he was just experiencing the side effects of the vaccine. He had no chance. Had this injection been done in the RIGHT arm, perhaps he could have recognized the arm numbness being that of an impending heart attack. We really miss Dad. He served this country with distinction for over 50 years, and we believe his country failed him.

Pt uses a walker, upon moving to observation area, patient fell trying to sit down. Pt states he simply missed the chair. He has very thin skin and suffered several skin tears. We applied pressure and bandaged wounds and observed pt for 30 minutes. He did not hit his head. Followed up with pt's wife next day and she reported that his arm was sore, but no other complaints. I recommended they see a Dr. for his skin tears.

Very mild: headache, sore arm, fatigue All three so mild as to be almost not noticeable. No other effects from vaccination

Two hours after injection I got very cold and got uncontrollable trembles with total loss of muscle use .

Adverse Event - High temperature, too weak to stand and walk, confused Treatment - Taken to hospital by ambulance - hospital treatment unsure ( 1 over night stay) Outcomes - continued pain in his neck, ?fuzzy? head, and dizzy 11 days after vaccine

Woke up with Nausea and vomiting all day 4 days later. Took Zofran for the vomiting. Also had a migraine and fatigue. Resolved in approx 8 hours

Began experiencing cold sweats, felt awful, a bit sick to my stomach, slight headache. It lasted about 30 to 45 seconds.

constant dizziness and headache; pain and stiffness in arms, shoulders, and neck; occasional numbness in both arms; tightness in the chest, brain fog

Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.

Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.

WOKE UP THIS MORNING NOT FEELING WELL, MANAGED TO SLOWLY WALK INTO KITCHEN, FELT PROFOUNDLY WEAK, BECAME DIAPHORETIC, UNABLE TO SPEAK, SYMPTOMS LASTED FOR 10-15 MINUTES AND GRADUALLY RESOLVED OVER COURSE OF 1 HOUR.

I received my Moderna shot on Saturday 1/23/21 around 4PM. On Tuesday -- 1-26/21 -- AM I woke up with a slight pain on the side of my left foot. In the middle of the pain there was a small black dot . I am an unusually healthy 83 y.o. physical active, ex Marine, with a high tolerance to pain. So at first I paid no attention to this and went and played pickleball that very day. But the next day I awoke to find that the foot was not only bright red and swollen, but painful. I immediately called my doctor and the next morning I had a telephone conference with him. We discussed the possibility of what could have caused this problem. Although I am pre-diabetic (111) he ruled out diabetes. He also ruled out gout. This only left the possibility of an infection. But since I had not stepped on any nails, etc. the only possibility was a bug bite. So he prescribed an antibiotic, which I started taking that very day. After several days the foot got progressively worse and turned into a ulgy, oozing sore and redness grew to the whole left side of my foot. So I made an appointment with my doctor for a physical visit, however this was delayed until 2/5/21. By then the swelling and redness had subsided considerably and the wound was healing. He ordered lab tests to rule out the possibility of diabetes and gout. He also gave me a prescription for stronger antibiotic and antibiotic ointment. Unfortunately the lab was by appointment only and I did not get the tests done until 2/12/21.I would not even be writing this except for the fact that on 1/27/21 I also developed a rash all over on my back that was very itchy. This is when my attention turned back to my vaccine shot, and the reports that Maderna had a track record of rashes from their shots. So I thought I had better write to see if it would be safe for me to get my 2nd Maderna shot which is scheduled in just 6 days (2/20/21).I do have a history of occasional painful rashes since childhood and I am wondering if the Moderna shot could have possibly triggered one, or both, of these problems? If it will help I did have photos taken of my foot during this episode and will be happy to send them to you if you feel it necessary?Thank you for your immediate consideration and response.

Day after vaccination: sore arm, tingling all day in arm and fingers, light headedness and occasional dizziness. Second day after vaccination: sore left arm.

EXTREMELY extremely WEAK. - he had to use wheelchair to move, and fell off chair. nausea, insomnia. I could not move him and had to call fire deparment. They said his extreme weakness was concerning and took him by ambulance to hospital.

2/13 0800 Post second vaccine. Weak, dizzy, unable to walk per self as usually does. SBP 80 when getting up to use commode with diarrhea. Syncope lasting approx 15 seconds. Came to et was oriented X3 at that time but having times of confusion. Staff reports pt felt weak and same way after first Covid vaccine. Encouraged hydration, bed rest, use of stand aide for use of BR. Gave Claritin 24 hour tablet. Held lisinopril. 2/14 @ 10 am. Feeling some better, mostly oriented with episodes of intermittent confusion. Drank lots of fluids over past 24 hrs. SBP 99. Continued with some diarrhea. Held lisinopril et gave another Claritin 24 hr. Tablet and encouraged hydration. Monday 2/15. SBP. 114/51. Gave Claritin 24 hour tablet and held lisinopril. Encouraged fluids. Feeling some better. Not as weak. Denies dizziness. Able to walk some per self. In evening used stand aid. 2/16 dayshift. BP 123/47 et heart rate 78. lisinopril held. Able to ambulated in room with supervision. Mentation at baseline. 2/17 dayshift.: lisinopril held. Ambulation per self in room and hall with supervision. BP 114/59 with heart rate of 57. No confusion. Mentation at baseline.

Patient was found the next morning on the floor, disoriented and weak. Once he was found he became unresponsive. Ambulance was called, low blood pressure was noted. Taken to hospital emergency room from home. Patient recovered after about 2 days

A fast heartbeat; Dizziness and weakness. Went to ED - "Patient is an 82yo male with a history of chronic Afib on Eliquis, HTN, and bradykinesia (thought to be PD) who presented to the ED with a CC of weakness after receiving 2nd dose of COVID-19 vaccine. He also had low-grade fever and difficulties ambulating. In the ED he was febrile at 38.5C and HR 159bpm. EKG revealed Afib RVR. BP was stable. He was given Cardizem 10mg IV x1. Basic labs were unremarkable. COVID negative. CXR negative. He was given Tylenol for fever and admitted under observation. He remained afebrile and heart rate remained controlled with home Cardizem dosing. Cardiology was consulted who will refer him to their clinic to establish routine care with their service. PT/OT recommended home with home PT/OT. The patient overall felt much improved compared to admission and felt ready for discharge. He was discharged home in stable condition.

Severe neuropathy pain throughout day after. Gabapentin was ineffective, so took 800mg ibuprofen twice during the day. Back to normal the following day.

2/6 (vaccine given): No side effects. 2/7: mild fever and chills (expected), weakness, low appetite 2/8: Severe weakness and fatigue, subjective fever/chills, low appetite, nausea, in evening diarrhea started. 2/9: Symptoms not improved in the morning. Went to ED. Hospital stay: Dehydration, give IV fluids. Continued symptoms, plus vomit and diarrhea with blood. Placed on clear liquid diet. GI consult. Diagnosed with duodenitis and gastritis. Started on oral PPI, no improvement in symptoms, switched to IV PPI. Vomiting resolved after a few days. Stool cultures all negative. Onset sore throat (possible reflux/esophagitis). Confirmed gastritis, gastric erosions. Fevers recurred. Consult with ID, possible TB, placed on isolation. Blood cultures and stool cultures all negative. AFB negative x2 (results of 3rd AFB pending as of today). Rheumatology consult for continued fevers, weakness, fatigue. Started on prednisone ~2/15, fevers resolved soon after. Severe weakness (bed bound), fatigue, low appetite, and diarrhea throughout hospital stay. Started on Megace and Immodium with slight improvement in appetite and diarrhea, respectively. 2/19: ALT and ALT increased, prednisone was dc'd (received 4 of 5 day treatment of prednisone). Crestor held. Anticipate dc for PT/rehab once LFTs are back to baseline.

2/18/21 about 2:30 pm started to not feel well. By 3:30pm had extreme chills, aching all over, headache, loss of appetite but no fever temp was 98.5. By 7:30pm was feeling much better. 2/19/21 Just felt tired all day until 6pm when he started to feel very unwell, weak, aching and loss of appetite. This lasted a few hours. 2/20/21 Felt well until he got up at 7:30am, then felt weak, sick in his stomach, some chills and generally not feeling well. We are assuming these are all just normal reactions to his 2nd shot. We expect them to subside completely in a few days

Excessive sleeping, hand shakes and had trouble holding spoon and fork. Use walker and could not balance (very groggy). Kept wanting to fall. Had to have wife help to get into bed on Friday night. Saturday was better, but still needed help. Sunday better and today Monday doing better. If Moderna second shot is known to be much worse for side effects, should it be taken?

2/17 first occurrence: symptoms = confused speech, memory impairment diagnosis = TIA 2/20 second occurrence: symptoms = confused speech, memory impairment 2/21: symptoms = confused speech, memory impairment, cognitive difficulty understanding others 2/23: unusual behavior (perhaps due to confusion), difficulty driving (almost hit a parked vehicle and a mailbox; and ran off the right side of the road), agitation (upset, because he considered it a waste of time to visit the ER and have more tests run on 2/23; and also upset that people were "questioning his driving")

From around midnight the day of the shot until 6 pm the following day: Gallbladder spasms Heartburn Headache Fatigue

At 9:00 PM on 02-13-21 experienced extreme pain in the bones of the neck from head down to the shoulder blades and half way to both elbows. Could not tolerate the pain, called Ambulance and went to Health Center.

pt states after he got the covid vax he had pain in his right arm. Pt still has pain in left arm from 1st dose and now has pain in right arm from 2nd dose. Has had these symptoms since vaccinations. Pt has not contacted a doctor regarding this symptom at this time.

On Monday, 3 days after, just felt weak, like a zombie, but didn't have swelling or hurting at injection site or headache. But in the days following, felt whoozy, dizzy, and had low blood pressure, once took a nitro for my heart and then blood pressure went down to 68/36, another time 75/45, another time 90/55,

The night of the vaccine at 9:00 PM his right arm was totally numb. He got up and took magnesium maleate, and it started clearing up the numbness, and took a baby aspirin. His right eye went blurry as if he had a cataract in that eye. Part of the eye was different, crescent vision. He then took some vitamins for eye, and took an Astroxanthem and started to have some benefit. He then took Epicor and it cleared up. A couple of days later he then had some blurry vision again and took some more vitamins, and it cleared up. He did get some dry eye drops and is using them. All the symptoms have resolved now. He does have an appointment with his eye doctor next month. Has not seen a regular MD or PCP in over 10 years.

Patient presented to ER with complaints of facial droop that began on 3/8/2021. Work up for stroke negative. Dx with Bells Palsy

Client is elderly and has reduced mobility status. Client was ushered up into the bleacher seating at the vaccination site following the dose administration, and upon sitting down was experiencing shortness of breath (reported by the client to be from walking up the stairs). Client pulled out personal inhaler (albuterol) and self-administered a dose. Responder noted pallor and increased difficulty with speaking for the client, but client's breathing returned to a regular rate and rhythm in the minutes following albuterol administration. Client's pallor resolved. The client refused emergency medical services twice, and refused having his vitals taken. The client was monitored visually by responder until deemed appropriate for discharge from the observation area. When the client ambulated down the stairs, Responder noted unsteadiness in gait. Once the client was safely at the bottom of the stairs, a wheelchair was retrieved for the client so that the client could safely exit the facility. Client accepted the wheelchair at this time. Client refused a vitals check a second time at the checkout station, per responder.

NERVE TINGLING IN HANDS AND ARMS FOR SEVERAL DAYS, WEAKNESS IN LEGS, SEVERE DEBILITATING JOINT PAIN , SHOULDERS, ELBOWS, BACK, HIP, KNEES, THIGHS ,CALVES AND GROIN. CHILLS, SLIGHT HEADACHES AND SLEEP DISTURBANCE

After vaccine I woke up about 1am extremely cold, chills and shaking, I tried to go to the bathroom and really started shaking and couldn't sleep, had a headache and couldn't sleep. I had no appetite when I woke up at 6am, took my morning meds and went back to bed. Noon I felt a little better and it gradually went away and it seem to gradually go away. Because I have an auto-immune disease I seem to have had a reaction to the vaccine because it did not bother my wife, except for her being a little tired.

Excrutiating leg pain from knee to groin began on day after first shot 1/28/2021 then after 2nd dose was given on 2/24//2021 a massive stroke occured within 8 hours.

03/15/2021: Presented to the emergency department after an outpatient MRI showed a subdural hematoma and the patient has expressive and receptive aphasia. Patient admitted for a craniotomy with evacuation of chronic subdural hematoma. The patient remains admitted at this time.

pt started slurring his words and his face started drooping about 8 hours after taking the covid vax. pts wife took him to ER. They did a CT which did not show a hemorrhage. He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU. Next day he had an MRI which showed he had a stroke. The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding. Pt is awake and starting to move around some but unable to communicate which speech at this time.

45 minutes after the vaccine, daughter and pt. stopped at a restraint for breakfast. Pt. stated that he had to go to the bathroom and he felt limp and needed assistance with ambulation to the bathroom. Went home and sat in the recliner and said he felt like a limp noodle and was incontinent of urine. Pt. states that he had a fever (did not check it), brain fog and weakness.

On 3/04/2021, patient experienced a seizure. It was an isolated incident and lasted less than a minute. There did not seem to be any residual effects. This was the first and only incidence of a seizure in patient. On 2/27/21 patient experienced fever of 100.8 , exhaustion and delirium. On 2/28/21, temperature was 99.9 and patient slept most of the day. He was restless and cried out in his sleep, speaking to people who were not present. On 3/1/21 temperature was normal and patient was tired but otherwise non symptomatic.

LEG WEAKNESS, CHILLS, SHORTNESS OF BREATH Narrative: Patient reported after taking his second dose of Moderna vaccine on 2/25/2021 he developed extreme leg weakness, shortness of breath, fever, chills and elevated blood pressure. States the fever and chills lasted for 5 days and the chills were so bad he "shook all over". Patient states the leg weakness and SOB are not completely resolved yet. He completed a chest xray this week and the results are: streaky opacities at the lung bases, likely atelectasis and/or scarring. Patient to complete PFT soon. States his BP has been running 167/88 until 3/15. However patient reports he doesn't take his metoprolol all the time. Legs are still weak 3/15, but began using an exercise machine yesterday for his legs and "feels that may help". Patient also reports he had purchased a "so clean" device to keep his cpap machine clean. He received a letter from the Clinic stating those devices have been linked to asthma and lung problems so he stopped it.

3/29-Date and time of vaccination: (list both if they received both shots): Pfizer 1/12/2021, Moderna 3/21/2021 Brand and lot of vaccine: Moderna lot #048A21A, Pfizer at private nursing home, unknown lot number Fever, generalized weakness, chills, weakness. Received tylenol which helped with symptoms. Symptoms mostly resolved except for continued weakness. 3/30-is doing much better, symptoms resolved

82 year old male with history of hypertension, hyperlipidemia, mild dementia presented with progressive worsening weakness over the past 2-3 weeks. Patient reported that he has noticed whole body weakness that has progressively worsened over the past few days. Reported that he has noticed feeling weak, fatigue and requiring more energy to do his daily activities over the past few weeks. He went to his PCP's office yesterday and had laboratory tests for further evaluation. Initially his PCP thought he might have PMR since he had bilateral UE soreness. However, the labs returned reassuring and does not seem to suggest the diagnosis of PMR. Since yesterday, he has noticed worsening of his weakness. Reported that last week, he was still able to play golf. Today, he was unable to get out of his car or get up from a sitting position without help. Associated with unsteady and poor gait. And reported that he has numbness in both hands and feels like his grip is weak. Denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, headache, vision changes, no urinary/fecal retention or urinary/fecal incontinence. Primary Discharge Diagnoses 1. Guillain Barr syndrome., 03/16/2021 Secondary Diagnoses: Guillain Barre Syndrome (AIDP) Hypofibrinogenemia Thrombocytopenia and Anemia, have been fairly stable for more than a week Hypokalemia Hyperlipidemia Hypertension, BPs controlled Mild dementia

My Dad complained about dizziness, feeling unbearably cold and weak. There was also shaking of the extremities.

PATIENT RECEIVED INJECTION AND WAS WAITING FOR THE 15 MINUTES AFTER INJECTION. PATIETN HAD BEEN TALKING TO OTHER PATIENTS IN ROOM WHEN PATIENT APPEARED TO BE MOVING IN CHAIR AND THEN FELL. PATIENT WAS UNRESPONSIVE AND SHOWING SIGNS OF RIGHT SIDED NEGLECT. PATIENT WAS UNABLE TO COMMUNICATE OR SPEAK. PATIENT WAS IMMEDIATELY TAKEN TO THE EMERGENCY ROOM WHERE HE WAS EXAMINED AND WAS THEN TRANSFERED TO A HIGHER LEVEL OF CARE DUE TO STROKE.

Minor brain attack; Partial loss of speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor brain attack) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Minor brain attack) (seriousness criterion hospitalization) and APHASIA (Partial loss of speech). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Minor brain attack) and APHASIA (Partial loss of speech) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included unspecified diabetes and blood pressure medications. Treatment medications included unspecified blood pressure and blood thinner medications. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and comorbidities may be confounding factors for causality assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and comorbidities may be confounding factors for causality assessment.

water and blood coming out the legs; paralyzed feeling in my legs completely, cant even walk around the house; uncontrollable diarrhea; severely decreased appetite; severe bloating; high body temperature of 103; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (water and blood coming out the legs) and PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (water and blood coming out the legs) (seriousness criterion medically significant), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) (seriousness criterion medically significant), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103). At the time of the report, HAEMORRHAGE (water and blood coming out the legs), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was included TORSEMIDE, CEFUROXIME and MUPIROCIN cream. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

soreness at the site for about 2 days gout at the right toe, swelling, redness, burning, tenderness, pain. took (1) motrin every 4 hours four times. pain subsided by 75% in 2days.

very confused and didn't remember the first day, diarrhea, and nausea, couldn't move or walk; this was similar to when he had covid, chills, nausea and fever also. I was so weak I couldn't get into bed. I still have foggy thinking and blurry vision.

At 5 AM on 3/21/2021 my father was in bed sleeping and started to gurgle, he was unresponsive, 911 was called he was unresponsive and taken to the Hospital and died at 3:22 PM on 3/21/2021. from a C V A.

Spinal infarct @ T 10-12, resulting in paraplegia. Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.

Two weeks after receiving the vaccine my left shoulder, left thumb and lower back started hurting. It felt like a flare of arthritis though I've never had arthritis in these areas before. Pain is only with movement. At the beginning I would rate the pain as 7 out of 10. I have only used topical pain control. My back stopped hurting after about 1 month but my shoulder and thumb still ache. Pain is now 3 out of 10

progressive generalized weakness including of cranial nerves diagnosed as acute demyelinating encephalomyelitis (ADEM)

Developing flushing of face within 15 minutes of vaccination, upon getting home, noted full body rash - itchy bumps. Headache and lightheaded with a slight little cough and able to taste something in mouth immediate. then one week later, 1/18/21 developed stabbing chest pain, medivac'ed 1/19/ 21 to tertiary facility hospital. had 2 stents placed on 1/20/21. Received second dose of Moderna on 2/09/21, again having flushing, headache, taste, smell of medicine, rash, less severe than first dose. Took a nap following. Hurt all over all night 2/10/21. 2/11/21 felt somewhat better. one week later, again experienced shooting chest pain on 2/16/21 (pain 'down my breast bone'). Has not followed up with medical care. Has been 'living with it' due to expense of Medivac. Finally does have a follow up appointment with Dr. on June 7th.

a stroke paralyzing left side; located in medulla oblongata initial tingling on left side of body; In ER for 3 days. transferred to rehabilitation hospital for 3 wks for basic rehabilitation. Then transferred to nursing facility which is on going. No fever

Per daughter, patient, after uneventful vaccine administration and 15 minute observation period, returned home, and father had lunch with wife and daughter. At 1:30, father remained home while daughter and wife went grocery shopping. Upon return from grocery store, approximately 1 hr. 45 minutes later, daughter found father unresponsive in bathtub with small amount of water, faucet off, and father partially clothed. Per daughter, the shower chair had been removed from the tub by her father. Per daughter, an autopsy was planned. Results are pending.

My husband was living at home and able to perform normal daily activities until the morning of May 13th when he woke up in his bed at home. He got out of bed to go to bathroom and ended up on floor due to no use of left side. I called emergency services and they took him to hospital ER where he was diagnosed with a stroke. His left side is still not functioning and he was sent to rehab facility for after stroke rehab to relearn use of his left side. The stroke occurred within 20 days of his second dose of the Moderna vaccine.

Early morning day following 2nd shot. EXTREME/VIOLENT shaking/chills for 2 hours....very concerning---upset stomach =slight temperature. General sickness. Extremely sore arm/shoulder at injection location. 2nd day was bet ter. 3rd day most symptoms gone gone with exception of shoulder pain. In the last few weeks pror to this date the pain in the shoulder has increased SUBSTANTIALLY and migrated in the the lower area of the shoulder. It is now difficult to LIFT my arm and have use of it do the the pain and decreased ability to use it. Having had major joint surgeries in the past I know what pain and lack of function can be. This is something different and becoming worse quickly.

The first thing was I had no feeling in my arm, shoulder, and hand. Still have no feeling in my arm. Tremendous pain in my back, upper and lower back. Went to the hospital and thought I had a stroke. Went to see another doctor for it. Could not get rid of the pain and was given steroids' to help. The pain left after two weeks, but occasionally still appears. Still cannot use hand, arm, or shoulder.

Migraine headaches, extremely bad for six straight weeks. Did not see a doctor for it. Eventually they went away on their own.

Patient was hospitalized due to vomitus material in mouth, concerns for aspiration pneumonia, decreased alertness, unresponsive verbally, obtunded

Patient complained of feeling unwell and having headaches after his second dose of Moderna vaccine on 2/2/2021. He became increasingly confused, paranoid and started occasionally refusing medications. On early March 2021, he started refusing all medications. Around 3/17/21, his increasing confusion and paranoia prompted suspicion for UTI which was confirmed with a urinalsis. Unfortunately, he refused antibiotic treatment. On 3/20/2021, nursing staff noted that patients right lower extremity was purple from toes to mid-calf, cold to touch and pedal pulse were not present. He complained of right leg pain. He was evaluated and diagnosed with probable thromboembolic event, since patient refused his oral anticoagulant for weeks prior to these event. Patient was sent to the local Emergency Department (ED) and diagnosed with acute critical right limb ischemia. At the local ED, he had a CTA which showed as per radiology: "Occlusion of the right superficial femoral artery beginning just beyond the origin. Occluded right popliteal, anterior tibial, tibioperoneal, peroneal, and posterior tibial arteries without reconstitution on arterial and delayed phases. Patent right deep femoral artery with minimal luminal stenosis in the proximal segment. Patent mid and distal right external iliac artery with up to mild luminal stenosis." Per discharge summary, "vascular surgery evaluated patient in the ED and did not feel operative revascularization with fasciotomy would provide any benefit; recommended continued anticoagulation with amputation/palliative management." He was admitted to the general medicine service which consulted orthopedic, infectious diseases and palliative care. Medicine Service also contacted patient's daughter who is his next of kin who opted for comfort care. He was discharged to facility on 3/25/2021 and started in the Comfort Care Program. He was pronounced dead on March 27, 2021 at 0807 hours. His autopsy showed that he also had thrombi on: 1. Pulmonary embolism, Left pulmonary artery 2. Left renal infarct

rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel

Patient experienced normal immune related response after dose two (Friday afternoon)- chills beginning about 12 hours after vaccination (Saturday morning) and ending by Saturday at 4 pm. On Sunday morning, patient reported feeling as though something was in his eye. He went to the mirror and saw that his eyelid and mouth were drooping on one side of his face. He lives in an assisted living facility and immediately sought medical attention by the staff and was taken to the nearest emergency department to verify that this reaction was not a stroke. Emergency room physician determined that it was not a stroke and the patient was diagnosed with Bell's Palsy, potentially related to his recent vaccination. Patient was prescribed steroids and an eye lubricant drop. On Monday, the patient is still experiencing the facial drooping.

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-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. No medical history was provided by the reporter. Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included exercise nerve tests with electricity. The patient has been to his hospital and has not seen any success in his treatments. 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 is a surgeon, developed pain and swelling right palm and 5th finger with swelling, gradual development of pain and decreased ROM right shoulder and neck. He believes this is a manifestation of post vaccination arthropathy with tenosynovitis as reported.

Redness, bumps, minor burning pain limited to forehead and chin. Pt washed hair and applied lotion to mitigate the minor burning sensation. Pt advised he noticed onset at about 6 hours post injection on same day, Saturday, January 2, 2021. As of this date, burning and bumps have dissipated and redness is only minor. Photos from Sunday evening, Jan 3, 2021 and Tuesday evening, Jan 5, 2021 showing progression of symptoms, are available upon request.

I heard patient coughing about 10 minutes after his vaccination so I sent the staff member to check on him. I went to his room,I told the staff to call 911. He had started eating his lunch and felt that the food was stuck at the notch at the bottom of his neck. I prepared to give the EpiPen. He stopped coughing and said he was feeling better, but the staff member . said he didn't sound right. I decided not to give the EpiPen. The Depot Runner asked to see his throat and tongue and agreed that he didn't need the EpiPen. Several other staff members came. Asked a staff member to take his vitals. EMS arrived and took him to the ER.

Pt had the Moderna vaccine on 1/16/2021. called into the nurseline around 2000 on 1/17/2021 stating the pt had dizziness and shaking for about 15 mins around noon today and in the last 30 mins has vomited 3 times.

Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.

Sore arm, 2nd day tongue swelled huge went to ER got shot of Benadryl and steroid tired and some dizzy

These symptoms lasted 3-4 days: Extreme sleepiness; inability to open eyes; tremors; delusions/hallucinations; non-ambulatory; required assistance to sit, in and out of bed, in and out of chair, in and out of bathroom; tremors; anorexia; difficulty swallowing; slurred/difficult speech; hypotension; aches on right side hip, waist, leg, back; Required 24-hour supervision/caregiving. Marked improvement on Day 5; by Day 6, at 80% improvement. FOR ITEM 20 BELOW, we are indicating "unknown" as the patient is still not 100%. FOR ITEM 21 BELOW, we had a conference call with the primary physician, but not an in-person office visit.

reports blood sugars have been higher than normal. Usually morning blood sugar is 120 and it has been 160 since the day of vaccination. Rash on head has flared up and is more painful and hot than normal. Pain at injection site. No fever no rash on arm or near site of vaccination.

First Day: At first: Tense, Restless; Later off and on: Headache, Chills, Fever 98.2*, Hands Numb and Cold Took Tylenol with Codeine for Headache Second Day: Off and on: Headache, Chills, Fever <100*, Hands Numb and Cold Took Tylenol with Codeine for Headache Third Day: Off and on: Headache, Chills, Fever 100.2* Took Tylenol with Codeine for Headache

1406: After receiving COVID vaccine, pt c/o sudden lightheadedness, LE weakness, bilat ear pressure, tingling sensation to nose, HA pressure 1410: BP 118/78 HR 52 RR 16 SpO2 99% Add. RN called; head of car seat lowered; pt denied CP or SOB. 1417: HR 60 SpO2 98% Missed heart beats noted on auscultation by NP; pt denies cardiac hx; dizziness persisting 1430: HR 62 SpO2 97% Pt requested to stand; 3 RNs on standby to assist 1432: BP 117/70 HR 58 RR 16 SpO2 97% Pt states, "I feel totally normal." O2 1 L N/C 1450: O2 weaned; no missed beats noted; sxs resolved 1455: Emergency precautions given; pt verbalized understanding; released home

Patient received vaccine at clinic, waited the 15 minutes and was released. Passenger in car, wife driving shortly after departing from clinic - wife state he passed out in the car for approximately 10 seconds, no loss of bowel, or bladder control. Had some UE jerking movements, he was quite awake and alert once he woke up and did not exhibit and post-ictal symptoms. Synocpal episode at 1300 was in Vtac per Boston Scientific Reading.

Narrative: Patient is 82 years old with cardiovascular disease and fell when bending over to pick something up. Therefore, it is not clear if fall was caused by these risk factors or by the vaccine. However, he had complained of weakness prior to this episode.

Ischemic stroke 2 days following vaccine administration resulting in hospitalization. Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine.

Total body shaking with abrupt onset at about 9:30 pm, followed shortly by low-grade fever 100.5 (my normal temp. is 97.3). Took tylenol 1000mg. and Alprazolam 0.5 mg., drank some water, and immediately went to bed fully clothed. Awoke at 8:00 am, with mild skeletal aches, took tylenol 1000mg., and within 2 hrs. I was back to normal. No further symptoms. I am a physician and did not feel need to contact my family doctor.

Increased weakness, confusion. All occured after surgery but was doing well postoperatively until 2nd dose given 2/4/2021 Then became confused, weak and unable to care for self.

For approximately 30 hours I was extremely sleepy. I felt all right otherwise, but I slept about 20 hours in that period of time. I had very little soreness in my arm. After the first shot I had quite a bit of soreness. I feel normal today.

At 12:22 on Tuesday, February 9, the second day, I was awakened by violent shivering and shaking uncontrollably. This lasted for four hours, with concomitant loss of sleep throughout the night and, when up, walking like a drunken man. In the morning , no appetite (managed a cereal breakfast). Ibuprofen administered. A pronounced feeling of weakness and lassitude throughout the morning, with slow recovery until mid-evening. Now at February 10th, return to normal feeling and strength.

22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair. Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)

On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it. He got up and got dressed, went about his day. Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind. At that time, his speech became slurred. They got a neighbor, who is a nurse, to come over. She recommended medical attention. They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred. There were no cognitive issues. Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke. Bell's Palsy was diagnosed. He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home. As of today, Monday, February 22, his symptoms are improving.

He became very weak and kiss all strength and mobility in his legs. Increased confusion and inability to concentrate. This also happened after the first vaccine and went away the following day.

Profound weakness that occurred 14 hours after his 1st met during COVID vaccination. He had marked weakness and was not even able to stand or crawl on the floor. He does spend the night on the floor. He was better during the day. The following night, he had similar episodes when he got up in the middle the night. Again had to sleep on the floor but was able to get back to bed. Vaccine was 5 days ago. This happened over the 1st 2 nights. For the last 3 nights he has been find any feels back to his baseline. CPK, 3/2/21 was 427

weakness Pt states that he became so weak that he was unable to move and het OOB. When he did, he fell and hurt his head. Went to ER following day from Injection and has been in Rehab since.

Daughter calling to ask about side effects of COVID vaccine? She said her 83 yr old dad got the COVID- 19 yesterday and overnight he became confused, had severe weakness, couldn't get out of bed, and became feverish. She said mom said they both got first dose of COVID vaccine yesterday around noon- then last night he started to feel unwell. Around 2am- her mom said her dad- became very weak, couldn't get out of bed, confused, started coughing, he had chills, felt feverish. She said so concerning by 4am her mom called EMS who came and took him to the Medical Center. She said he had pretty severe case of COVID in December that he need hospitalized for-she said he as really weak, foggy headed at that time, kind of out of his mind- she said was told that is how he was acting last night. After being seen in ED and getting put on some fluids and then antibiotics he now seems to be acting more like himself. They hydrated- have some concerns about possible pneumonia dx so they started him on antibiotics- was told this might be due to his rxn post + COVID vaccine - which is what prompted her to call today. He is supposed to follow up with his PCP doctor. He seemed better when he got home this morning- she said just left him a little bit ago after eating early lunch with him. She is not sure if getting him hydrated & sent home with antibiotics is what helped or just time since now about 24 hours post vaccination dose. Confirmed he has had no prior rxn to any other vaccines in the past.

Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains

Patient's wife reports patient never reported feeling unwell. He had been working on painting the basement all week and on 02.12.2021 came in from outside, ate, and they sat down to watch TV. Around 9:30 patient reported being extremely tired and went to bed. Was found unresponsive the following morning, 02.13.2021. Patient's wife reports the doctor said it was a heart attack.

On day of Wednesday day of Moderna vaccine shot, felt good all day, got ready for bed at 9 PM. Felt very warm and took my temperature it was 99.7. Not too bad. My hands and feet were very cold. Put socks on my feet and climbed in bed. Feeling ok. Woke up around 4 AM my tee shirt is soaking wet, had to pee. Got out of bed and walked to bathroom no problem. Sat down and then my wife said she heard a loud noise in bathroom. She comes to check on me and I?m sitting on toilet passed out, I?m leaning to my right against the shower door. She?s hollering and talks to me to wake up and shakes me and eventually I wake up, get up and walk to the bed no problem. Then I feel the urge to vomit. Go through a series of dry heaves, lay on my back and feel urge to vomit again. Wife tells me to lay on my side, not on my back, that works and I fall asleep. Woke up Thursday at 8 AM, wife is in the kitchen, I make the bed get dressed and feel ok. Walk out to the kitchen and wife is amazed I?m OK. She proceeds to tell me about my passing out in the bath room. I have no recollection that occurred. Had some tea and toast, drinking water to rehydrate and felt better. Walked outside, got leaves out of the pool. Feeling better. No further reaction, just a little tired the rest of the day. Had light lunch, soup. Took a nap at 3 PM woke refreshed and had normal dinner with a glass of wine. Today Friday had normal breakfast and feel completely normal. All in all not a bad reaction.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

Patient's wife stated on 3/12 patient became extremely confused, weak and fell 3 times. She stated that they were having difficulty getting him up and her daughter called EMS. Patient was taken to hospital and admitted. Patient is still in hospital, she stated he is more lucid. Patient has history of Parkinson's

Chills, presenting discomfort . Then they give him a bath. When they went to report to the nurse of each of the residents, they found him without vital signs.

I lost the hearing in my left earon March 4 three days after receiving the 2nd shot of Moderna vaccine, See details below: Report of adverse reaction (hearing loss) following second injection of COVID-19 vaccine on March 1, 2021. I believe I have had a bad reaction from the second COVID-19 vaccination, which occurred on March 1 at Three days after the injection I could not hear through my left ear. The vaccine identification is: Moderna vaccine, 2nd dose, 3/01/21, Lot#: 006M20A The sequence of events to date (3/14/21) is as follows: Mar 1, Mon: I received the second Moderna vaccination at Retirement Community. No reaction. Ran 2 miles in the afternoon. Mar 2, Tues: Felt slightly ill. Headache. No energy. Vaccination arm very sore. Did not feel well enough to work at my desk or to run. Mar 3, Wed: Felt better. Worked as volunteer at vaccination clinic, but tired easily. Did not run afterwards. In the evening, noticed some hearing difficulties in left ear, including greatly increased tinnitus. Mar 4, Thur: Awakened in morning with no hearing in left ear, and growing diminishment of hearing in right ear. No running. Mar 5, Fri: No hearing in left ear and diminished hearing in right ear. Tinnitus level high. Called my otolaryngologist; doctor not available; scheduled appointment for March 16. Visited Urgent Care; physician assistant found no obvious problem. Visited Clinic; (my primary care physician) not available; nurse practitioner advised me to wait to see Dr. on Mar 8 at my scheduled annual wellness checkup. Ran 2 miles. Mar 6, Sat: No hearing in left ear. Right ear continues to lose hearing. Ran 2 miles. Mar 7, Sun: Left ear deaf. Right ear hearing is poor and distorted. No running Mar 8, Mon: Left ear deaf. Right ear hearing is deteriorating. Had difficulties understanding speech. Reported hearing problem to Dr. at my annual wellness exam. She said I should report it to FDA. I requested that she do so because I had some difficulty in trying to make the report. She prescribed Mirtazapine for several concurrent health issues. Ran 2 miles. Mar 9, Tue: Met with Dr. (otolaryngology) and Dr. (audiologist). A hearing test showed left ear functionally deaf and right ear poor as before. Given order for a head MRI and prescription for prednisone and instructed to return in two weeks. Dr. urged me to report problem to the CDC. Ran 2 miles. Mar 10, Wed: Hearing problems as before. Deaf in left ear and hear with difficulty in right ear. Tinnitus very loud. No running. Tried to send report to CDC/VAERS (email not successful). Mar 11, Thur: Started 20 mg of prednisone; within 6 hours hearing began to slowly return in left ear. Ran 2 miles. Mar 12, Fri: Hearing in left ear returned to 70-80% of normal and right ear improved also. Had head MRI in evening. No running. Mar 13, Sat: Hearing continued to improve in both ears. Tinnitus remained loud. Ran 3 miles. Mar 14, Sun: Hearing has plateaued in both ears, although TV audio seemed a bit muffled. No running. Mar 15 onwards: Awaiting lab results of head MRI. Next appointment with Dr. is March 23. (End of report)

tightening in his throat muscle; unable to move much; unstable blood pressure; unstable oxygen; bled due to blood thinner; weak in terms of walking; coughing; every joint and muscle from neck to toe in pain; every joint and muscle from neck to toe in pain; cold; entire body in excruciating pain; A bit off; Bruising in arm; A spontaneous report was received from a consumer concerning a 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following events: bruising in arm (contusion), a bit off (feeling abnormal), entire body in excruciating pain (pain), every joint and muscle from neck to toe in pain (arthralgia/myalgia), tightening in his throat muscle (throat tightness), unable to move much (hypokinesia), unstable blood pressure (blood pressure abnormal), unstable oxygen (oxygen saturation abnormal), bled due to blood thinner (haemorrhage), cold (feeling cold), weak in terms of walking (muscular weakness), and coughing (cough), The patient's medical history included small cancer treated last year with 38 radiation treatments. No concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031620A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced little bruising in the arm. On 12 Feb 2021, the patient was a bit off. On Sunday, 28 Feb 2021, in the evening, the patient got cold, and within minutes his entire whole body was in excruciating pain, every joint and muscle from neck to toe were in pain. It felt like it was invaded with COVID. He went to hospital and got tested for COVID, Strep throat and Flu, and all three test results were negative. On an unknown date, the patient experienced tightening in his throat muscle and he went to the hospital where he was admitted. While there, they did every possible test, chest MRI, Neck MRI, all possible viral tests, and rapid and full COVID test. The rapid and full COVID tests came back negative. Results for chest MRI, neck MRI and viral tests were not provided. The hospital also performed a blood culture for bacteria. Results were not provided. The patient was unable to move much, his blood pressure and oxygen were a little unstable. On 06 Mar 2021, the hospital did a major blood test which came back negative and the patient was released from a hospital. He stated that he was still weak in terms of walking and coughing. He stated that he recently bled due to taking blood thinner. Treatment included major antibiotic treatments and steroids for pain during the hospital stay. The patient was still taking prednisone at a tapering dose. Action taken with mRNA-1273 in response to the events was unknown. The events of weak in terms of walking, coughing were unresolved, while the outcome of the events of tightening in his throat muscle, unable to move much, unstable blood pressure, unstable oxygen, bled due to blood thinner, Bruising in arm, cold, entire body in excruciating pain, every joint and muscle from neck to toe in pain, every joint and muscle from neck to toe in pain was unknown.; Reporter's Comments: Based on a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Myalgia and arthralgia are consistent with the known safety profile of the vaccine

arm was sore for the first few days. 2-3 days later I broke out in a itchy rash on my upper arm near the injection site and then the itch went away and I had tiny scabby red bloody bumps on my arm. it is gradually going away.

After the patient received the 2nd vaccine dose on 03/17, he became weak and unable to walk. He also experienced headache, nausea, and diarrhea. On 03/18, he was sent to the emergency department where we received a diagnosis of acute on chronic hypoxia related to the 2nd dose of COVID-19 vaccine. He required up to 2 L of O2 during the night time. He was given his regular home medications and Lovenox 40 mg SQ QD for DVT prophylaxis. On 03/21 he was discharged as his SpO2 improved. His hypoxia returned to his baseline level upon discharge.

Stroke; Passed out; Was flailing like a fish; Could not walk; lost motor skills and had to be fed; Could not speak; Did not understand where he was; was in La La land; A spontaneous report was received from a consumer concerning his father a 83– years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke, passed out, was flailing like a fish, was in la la land for many day, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. The patient's medical history, as provided by the reporter, included blindness in one and lost some hearing. Concomitant medications reported included diazepam, bisacodyl and oxycodone. On 12 Feb 2021, approximately three days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (batch 013m20a) via unknown route for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. No tests were done, and it was previously agreed that he would not go to the hospital if anything should happen to him. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, he lost his motor skills and had to be fed, was considered resolving. The outcome of the events, stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he could not speak, did not understand where he was and he was wheelchair bound were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient called today to report that his arm muscle that he received his second vaccine dose in began hurting on 2/21/2021. 9 days after vaccination. He also says it has now began hurting in his "joint." Referred to his PCP.

Lethargy and "achy" the first day after the second injection. increase in symptoms through that day and overnight. The following day unable to get up out of chair/walk. Confused and disoriented. Wheezing and SOB. Had to call an ambulance for transport to ER. Admitted. Became completely unresponsive. Testing revealed Ammonia level of 104. Liver function studies/scans negative for liver problems. MICU for 10 days, rehab for 3 weeks.

Injection was given Sunday pm, he woke up at 2 am Monday vomitting. He vomitted until 5am. It is now 3pm on Tuesday and he is too weak to get out of bed.

Cannot control himself; Face feels hot; loss of control of legs/cannot control himself/gait inability; shaking with chills; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of cannot control himself (loss of control of legs), hard to walk (gait inability), shaking with chills (chills), face feels hot (hot flush). The patient's medical history and concomitant medications was not provided. On 17Feb2021, the day before the onset of the events, the patient received first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 18Feb2021, the patient experienced not controlling himself. He reported it was hard to walk, he was shaking with chills, had three coats on and his face felt hot. Additionally he reported he was on the floor because he was nervous he was going to fall. The patient's granddaughter came to his house and he tried to call his physician but was unsuccessful as his physician was not available. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.

stroke (left facial droop, left side of body weakness, slurred speach, confusion, inability to express self)

death Narrative: Patient received Moderna Covid vaccine #1 on 2/12/21. On 2/17/21, his son contacted the clinic social worker to inquire about home health services as he thought Patient had had a stroke (no longer able to walk and slurred speech). Patient refused to go to the hospital and son agreed to not have him admitted for fear that he would die alone in a hospital. Patient receives primary care from a provider and social worker suggested that he contact his PCP regarding home hospice services. No further notes of what occurred after that conversation and his date of death is reported as 3/21/21. No autopsy results available. 37 days from date vaccine to date of death.

Had difficulty speaking and forming words. Thought it might be a TIA but next day he still was having difficulty forming words so probably a stroke

March 30, Weakness, light headed , no energy, upset stomach. March 31 slept 24 hours could not wake up, April 1, weak, could not sit up, wanted food, too weak to eat. My brother , retired fire caption medic, called 911 to ha e my father transported to ER

My uncle started feeling unwell the evening he got his 2nd Covid 19 vaccine. By the next evening, he started vomiting violently, trembling and sweating. He lived in country and his caregiver didn't think to take him to the hospital. The symptoms calmed down after a while, but he was not able to hold any food or liquids down. Eventually, he fell asleep and his caregiver left for the night. He returned on Easter Sunday at 9:30 am and found my uncle deceased.

COVID-19 pneumonia; Weakness; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) and ASTHENIA (Weakness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The patient's past medical history included Artificial cardiac pacemaker user and COVID-19 on 01-Feb-2021. Concurrent medical conditions included Chronic kidney disease (20 years). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization prolonged and medically significant) and ASTHENIA (Weakness) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 05-Feb-2021 to 15-Feb-2021 due to ASTHENIA and COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) and ASTHENIA (Weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, COVID-19: positive (Positive) positive. On 01-Feb-2021, Oxygen consumption: low (Low) low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment information provided mentioned that patient was prescribed vitamin C, vitamin D zinc and steroid. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Healthcare professional was consulted on 05 Feb 2021. Patient was admitted on 05 Feb 2021 and discharged on 15 Feb2021. Patient received Nursing House rehab which included oxygen, steps and walking. Based on the current available information and temporal association between the use of the product and the start date of these event (asthenia), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. Further information has been requested. This case was linked to MOD-2021-037770 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event (asthenia), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. Further information has been requested. MOD-2021-037770:Same patient 2nd dose for the case MOD-2021-037770

moderate stroke in the front of his brain - complete loss of speech, disorientation Outcome - mild aphasia

Moderate Stroke in front of brain - unable to speak, disoriented. Went to ER. Treated and observed in the hospital for 2 days. Outcome - mild aphasia

Day one: Minor pain in upper arm; Day after for a week or two, loss of strength and unable to lift or exert use of arm above the shoulder. April: do not remember the first time for pain in upper arm. The pain usually would hurt at night at varies times. Pain continue to get worse day to day. April 30, 2921: Gone to bed @ 11:00 pm, At 1:30 am woke up with very severe pain in upper left arm, continued for 30-40 minutes. Took 1000 mg Acetaminophen, 100 Antihistamine, Minor pain continues through 3:00 am

The resident was administered his second COVID vaccine (Moderna) on 5/19/21 at 9:30am. Per nursing, the resident tolerated the vaccine well and no problems were documented throughout the day. At 10:00pm the nurse who administered the vaccine recorded the resident's vitals as follows: BP 118/68, HR 72, Respiration 18, Temperature 97.0 F. At 10:20am the resident's CNA discovered him lifeless with vomitus around his mouth and neck. The resident was not breathing, bluish in color, and cool to the touch. Vital signs were checked and no pulse was detected. CPR was attempted with not effect.

Pain in left arm between elbow and shoulder. Painful in the morning, then subsides. One week after injection pain was severe for three days. Now not severe but still painful in morning and evening. Usually pain-free during the day.

Within three days of shot started with blurred vision, swerving while driving, progressing rapidly to unable to hold fork, falling down. Hospitalized since. Lost all motor skills, unable to walk, stand, feed self, control urine, slurring speech. No stroke. MRI found "lesions" in brain, spine/neck area, lung and stomach. Four Neurologists examined. They still are perplexed. One said she has not seen anything like this in her 20 years. Spent week in hospital, now in rehab center Minor improvement in ability to feed self (still can not hold fork), Receiving physical therapy.

Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

"blood pressure went nuts"; "soreness only when you touched it"; "arrhythmia skipping beats 1234 skip 1234 skip"; "a bump like the muscle was puffy"; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ("blood pressure went nuts") and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included NADOLOL, CLONIDINE and FINASTERIDE (PROSCAR) for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING ("a bump like the muscle was puffy"). On 23-May-2021, the patient experienced BLOOD PRESSURE INCREASED ("blood pressure went nuts") (seriousness criteria hospitalization and intervention required) and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY ("soreness only when you touched it"). On 24-May-2021, PERIPHERAL SWELLING ("a bump like the muscle was puffy") had resolved. On 12-Jun-2021, ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") had resolved. At the time of the report, BLOOD PRESSURE INCREASED ("blood pressure went nuts") outcome was unknown and PAIN IN EXTREMITY ("soreness only when you touched it") had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: skipping beats 1234 skip. (Inconclusive) skipping beats 1234 skip.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Patient had call on 14Jun2021, with symptoms following his first dose of the Moderna COVID-19 Vaccine, which he received on 19May2021 in his left arm, lot#027C21A, expiration 10Oct21. He states that he had felt really good for a day or so and then he developed soreness on his arm only to the touch, "a bump like the muscle was puffy," and "blood pressure went nuts." He had states the puffy muscles and soreness on his arm lasted about 2-3 days. He also states he was hospitalized for his blood pressure and was told by the doctors in the hospital that he had "arrhythmia skipping beats 1234 skip 1234 skip" that was seen on an EKG they performed. At the hospital, doctor "loaded he up with meds and sent he home" and his arrhythmia went away around 12Jun2021 but he is still dealing with the blood pressure. He states he has been dealing with blood pressure issues since before his vaccine and has seen his cardiologist and primary care since hospitalization. Consents to follow up with Safety. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.

Increasing weakness, fatigue and shortness of breath. Went to MD. Lungs clear, no wheezing, pulse ox sats 95-100%. Nothing made sense, blood work done. Diagnosis autoimmune hemolytic anemia and ITP triggered by vaccine.

I was given my first moderna vaccination on April 26,2021 . on April 28 my hands were shaking making it very difficult to eat . I had difficulty walking . I became very weak . My hands stopped shaking in about one week . I am still very weak . I still use a cane or walker . I did my receive a second moderna vaccination . The second vaccination made no difference .

Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear

Heart beat 100-103, Headache, Temperature 102.3, Muscle aches, extremely weak, needed help walking, fell down and needed help getting up

Moderna COVID-19. Vaccine EUA Exactly 12 hours after my injection, 1:30 am, I awoke with a severe coughing attack. In addition, my chest was wheezing and felt as if "bubbles" were in my chest. My arm felt very hot and tender at the injection site. This attack lasted for half an hour. I went back to sleep and awoke the following morning feeling very weak and confused. Feeling extremely fatigued, all I wanted to do was sleep. I also lost my appetite. The next day, I had occasional coughing which subsided with my over the counter cough medicine.