Moderna

Awoke with nausea and myalgias. Nausea and myalgias progressed. Fever and chills within a few hours. Very weak and fatigued. Myalgias became severe. Severe rigors and fever >102 about 26 hours post vaccine. Fever, myalgias, anorexia, nausea lasted approximately 30 hours. I felt like I had COVID all over again (I had it in July).

Sore arm, fatigue,chills ,nauseousness ,vomiting on 12/292020 . Chills ,nausea, vomiting started around 6 pm

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

Woke up that night feeling achy and run down. Had a low grade fever, headache, nausea for most of the next day after the injection. Two days later developed swelling and lymphadenopathy on same side for several days treated with NSAID's to help with inflammatory response. It is better now but some minor swelling still present but mostly resolved.

Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative: employee was told to follow up with his physician and get tested for covid

Diarrhea Reports 6x/day watery bowel movements since the morning after vaccination. 6 days so far. Narrative:

Mild to moderate dizziness and nausea for three days starting 01/06/2021. Reported it to a advice nurse and a physician on 01/08/2021 . Meclizine and Ondansetron was used immediately. Scopolamine was prescribed by the physician on 01/08/2021, picked and used on 01/09/2021; felt better . Residual dizziness remains after use. P.S. I do have a medical history of BPPV for the last 2-3 years and have been treated for it. Generally speaking my BPPV symptoms resolve themselves quickly after treatment. This current episode has lasted forthree days.

Headache, Myalgia, Fever, Rash, NauseaVomiting, joint pain, chills, and swollen glands, increased hip pain in replaced joint Narrative: Employee had COVID in March of 2020. 24 hours after receiving the vaccination states he got tested for antibodies due to not feeling well and that he was still IGG positive. on 1/6 his temp was 102.7, rash, headache, myalgia, nausea, joint pain, chills, and swollen glands. He had a hip replacement in September of 2020 and now has increased pain in that joint.

Myalgia, Diarrhea 12/31 severe body aches (back,neck,hip aches), GI distress (diarrhea) 12/31 severe body aches (sometimes happens using laptop): back, neck, and hip aches, GI distress (diarrhea). 1/1 faded away. previous Covid positive 3/23/2020. Patient reports these were the symptoms he had when he had COVID

After monitoring patient for 15 mins he then returned to his office. Called around 30 mins or so later and stated he was experiencing itching all over body and extreme nausea. Employee health went to office to check on patient. Face did appear flushed, but no rash seen. Stayed with patient until he stated he felt better and no further issues.

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

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

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

Back and neck stiffness, trouble swallowing, tongue thickness, facial twitch, and shortness of breathe.

Chills, muscle ache, nausea, headache 1/21/21 took tylenol at 3:30am and again at noon. Most symptoms went away by morning. General muscle ache continued through out the day. Morning of 1/22/20, all symptoms gone except for a little ache in right arm.

Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise. Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained. Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours. Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms. I often work through illnesses like the flu. Couldn?t work through this.

Moderna COVID?19 Vaccine EUA. On the day after my shot, injection site muscle pain, nausea, flu-like symptoms throughout the day.

After second Moderna shot, Pt developed nausea, headache, extreme fatique, and bad back and leg cramps/spasms to the point where he couldn't walk. These symptoms lasted for 48 hours and gradually subsided. His wife (me) was so frightened that I will not be getting the Moderna series since it's so dangerous and will caution friends and family as well.

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

I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 hours afterwards) with severe chills, shoulder, knees & most joints aching badly, bones in both feet aching with any movements, both arms sore along with severe stomach cramps & nausea, these all lasted through the night and day with a fever of 101 at 7am but by 4pm all but the stomach cramps were replaced by just nausea but severe headache and weakness all over were felt. I remained in bed until about 4pm 2/5/21 & soaked in a hot bath which relieved the joint pains. Headache, nausea & weakness continued 2/6/2021 & 2/7/2021 with the headaches coming if any sudden movements such as coughing or standing up too fast & nausea irritated by eating anything but saltine crackers. Today is 2/7/2021, took sick days from work 2/5, 2/6 & 2/7.

Next day chills, body aches, headache, diarrhea, fatigue. These symptoms had resolved by the 2nd day post-injection.

Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint pain, fatigue, mild cough, temperature elevated but not high, about 99 degrees. Symptoms varied over about 24 hours then subsided. Injection was Friday morning, Friday night not much sleep due to symptoms, all day Saturday in bed, slept well Saturday night, and Sunday fatigue and achiness only.

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

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

Headache, fever, body aches, nausea, fatigue, lethargy, injection site pain over first 12-18 hours. Fluids only for treatment

Chills began approximately nine hours after injection; temperature normal; treated with ibuprofen and sleep. Following morning fever rose to 101 F, chills persisted, with widespread muscle aches and general torpor. Treated with acetominophen. Vomited once at approximately 9:30 a.m. Fever and chills ended approximately 26 hours after vaccination. Extreme fatigue/torpor persisted until roughly 52 hours post vaccine. Condition normal by 60 hours post vaccine.

Headache, nausea, muscle pain, dizziness, fatigue, cognitive issues, fever/chills I'm taking Tylenol but don't know if it's doing much. Symptoms are ongoing I may go into my doctor's office if symptoms persist.

muscle/body ache, bad headache, pain, redness, and swelling at injection site approximately the size of a grapefruit, nauseated, neck swelling.

Had bad abdominal pains and diarrhea for 3 Days afterward. But the real issue is that now for the past week I've had diarrhea, bloating, abdominal pain and cramping, and some mild nausea. I don't know if this is related to the vaccine. That is my concern.

102.4 fever, body aches from the back of my neck to the back of my ankles, fatigue, throbbing migraine, no appetite

-Severe soreness in injection area lasting 3-days -101 fever starting 18-hours after vaccination and lasting 10-hours -Fatigue of whole body lasting 3-days -Loss of appetite lasting 2-days -Acute soreness in both shoulders that have existing tendonitis and in right ankle that has existing arthritis lasting 2-days -Internal lower abdominal pain starting 2-days after shot and lasting 24-hours

Sore arm. Headache. Dizzy 7pm same night. Didn't sleep well. Achy especially in knees and back. 3/7 am slight fever 100. Headache all day. Still sore arm. Body ache, no appetite.

Uncontrollable shaking as from chills, fever up to 101.6 (possibly was higher before checking), fatigue, no interest in food or drink. Symptoms came on quickly, and subsided in 8-9 hours. (Almost exactly 24 hours after the shot.)

"Fever > 100.4:Y, 101.4evening past 3 nights. @ 8-9 pm. Subjective fever: Chills:Y Rigors:N Myalgias:N Headache:N Sore throat:N Diarrhea:N Nasal congestion/rhinorrhea:N Additional symptoms:No rash No fatigue no dysuria Onset and duration: 3/3/2021"

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

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

pt states he felt fine until about the 10th day 3/8/2021 he started getting flu like symptoms. He has SOB, diarrhea, headache, sweats, muscle pain, cough, chills, and fever. On 3/11/2021 pt is still having these symptoms but is feeling a little better. Pt is taking Robitussin, Aleve, Vicks Av.

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

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

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

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

Starting the morning after shot when I got up at 4.00am I was having reactions to the shot. Hot, Cold, Headache , muscle pain, tired, nausea, loss of appetite like a bad case of flu. also which has been the biggest most unexpected side effect is that my left testicle was swollen and painful. All my flu like systems continued as well thru Wednesday 03/10/2021. started feeling some better except for being tired and the swelling and pain in testicle. Thursday morning went to Urgent Care, did examination with urinalysis and thought possible infection. Recommended ultrasound and prescribed Doxycycline HYC 100MG, also Ibuprofen 800mg.

patient stated experienced "labored" breathing and he took himself to the ER. did not experience rash, itching, hives, swelling of mouth, lips, or throat. Pt is also experiencing severe nausea and headache. Patient was instructed if continued to experience labored breathing to reach out to his primary care provider or seek medical attention. Patient did not have any reaction to first dose in series.

THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE. THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK. HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE. PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021. HE WAS DISCHARGED HOME IN STABLE CONDITION .

Morning after injection. Severe flu like symptoms including nausea chills fever muscle/joint pain pain at injection site sore throat and runny nose. Took ibuprofen for fever and body pain. Next morning body aches runny nose sore throat and a full body rash that did not itch.

I?ve experienced severe fatigue, daily elevated temperatures, occasional nausea, headaches and muscle aches.

This is a 60-year-old male who comes in today (3/22). Patient states that he received a Covid shot 11 days ago since then he has had mild fevers. However 6 days after he received his Covid vaccine he developed a fever of 102 he has been alternating between Advil and Tylenol without any improvement of his symptoms. Patient states that he now is having a difficult time breathing he has some nausea without any vomiting but has had a difficult time eating without any abdominal pain no diarrhea. Has had generalized myalgias as well. He denies any large cough states that he is coughing a little bit. No chest pain. Patient tested positive for Covid 19. Is now admitted and on oxygen.

Felt like I had it again, was in bed pretty much for 30 HOURS headache, extreme fatigue, soreness and neausea.

Low fever, chills, fatigue, muscle soreness, vomiting, severe headache Started at 10:00 pm at night and ended at 4:00 am. The headache continued into the next day and lasted a total of 12 hours.

He has been sleeping all day and at 1:30 pm he has started throwing up and has a fever of 100.9. This is less than 24 hours after receiving his first dose of his vaccine.

General covid symptoms. Very tired, loss of appetite, muscular aches especially hip area, inflammation at injection site, mild nausea

I had my second Moderna Covid-19 vaccine at noon on Thursday, April 1. I felt lethargic evening of injection, and injection site was sore to touch for next few days with a mild case of diarrhea. Sunday, April 3 I noticed that there was a large red circle with a slight rash surrounding the injection site that hadn't been there the day before. It was gone by the next day. The only reaction I had to the first injection was a sore arm for two days.

Fever- 100.5 degrees , Chills, Headache, Muscle aches, Vomiting every 2 hours . Couldn't hold anything down for 32 + hours.

Chills and fever started within 4 hours of the shot, followed by a severe migraine headache lasting two days along with soreness and weakness in the arm that was vaccinated. Day 2 had a fever of 102.5 on and off throughout the entire day and night, along with nausea, vomiting, and some diarrhea. Dizzyness and fatigue lasted into the 3rd day.

Headache, mild Fever, mild Chills, mild Muscle and joint pain, mild Nausea, prevented normal activities All lasted about 30 hours

Overview of symptoms in order of occurrence: Pain in the arm; Dry eyes; Fatigue; Nausea; Headache; Chills; Joint pain; Muscle aches; Dizziness; Measured Fever; and Arm rash. Symptoms of greatest concern: Nausea, Headache, Chills for 1-2 days; and the ongoing Fatigue is now in its 4th day. Details of symptoms with time of onset, duration and severity are provided below (Note: Injection with 2nd dose of Moderna vaccine took place at 9:24AM on 07APR21): 07APR21, 10:30AM ? Arm Pain: Onset of mild pain in arm that was noticed when not touching the arm; Level of pain was a ?1? out of 10). An annoying level of pain where the pain ramped up to 3 or 4 on a scale of 10 when the arm was moved about began at 7:00PM on 07APR21 and lasted 12 hours until 7:00AM on 08APR21. The pain diminished to a mild ache for another 33 hours until it became insignificant by 4:00PM on 09APR21. 07APR21, 1:00PM ? Dry Eyes: Onset of an intermittent feeling of very dry eyes that lasted approximately 1-2 hours at a time and continued over a period of 9 hours until 10PM on 07APR21. 07APR21, 3:30PM - Fatigue: Onset of mild fatigue that steadily increased until bedtime at 10:00PM on 07APR21; and was significantly more pronounced at 1:00AM on 08APR21 (was difficult to stand and walk 20? to closet to obtain a thermometer; could not walk straight and bumped into hallway on left 4-5 times). Fatigue was rather frightening and severe from 3:00AM to 3:30AM on 08APR21 when I crawled to the bathroom, but could not get off my knees and collapsed on the floor until I could return to bed by crawling on the floor. Was able to stand again at 7:00AM on 08APR21 and walked (slowly) 30? to a sofa. Slept from 10PM on 07APR21 to 1:00AM on 08APR21; 4:00-7:30AM on 08APR21; 8:30-10:30AM on 08APR21; 11:00AM to 3:00PM on 08APR21; 7:00PM on 08APR21 to 3:00AM on 09APR21; 3:30AM to 7:30AM on 09APR21; 9:30PM on 09APR21 to 9:15AM on 10APR21; 6:40PM on 10APR21 to 7:00AM on 11APR21. Ongoing weariness continues as I write this at 11:00AM on 11APR21. 07APR21, 7:10PM - Nausea: Onset of continuous nausea that lasted 13 hours and 20 minutes until 08APR21, 8:30AM. Nausea was particularly bad with intermittent dry heaves for the 7.5 hours lasting from 1:00AM to 8:30AM on 08APR21; Nausea then came in waves for 23 more hours until 09Apr21, 7:30AM when it was finally gone. 07APR21, 7:10PM - Headache: Onset of headache that has lasted 4 days (as of 11APR21, 10:30AM). Finally gave in and took one extended release tablet of 650mg Acetaminophen tablet about 25 hours after the vaccination (i.e., took painkiller at 10:30AM on 08APR21). Took two Ibuprofen at 9:00AM on 11APR21. 07APR21, 7:15PM ? Chills: Onset of chills that increased to intermittent shivering by bedtime at 10PM on 07APR21. Awoke at 1:00AM on 08APR21 and could not get warm. Two hours later, at 3:00AM, I felt completely opposite and could not feel cool. These symptoms gradually subsided and were gone by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Joint Pain and Muscle Aches: Onset of joint pain and muscle aches that occasionally became annoying with twinges of pain. These symptoms subsided by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Dizziness: Onset of mild dizziness that lasted 12 hours until 7:15AM on 08APR21. 08APR21, 1:00AM ? Measured Fever: Decided to measure temperature due to significant chills and shivering and found temperature was 101.0 at 1:00AM on 08APR21. At 3:00PM on 08APR21, my temperature was 100.2 (this was 4.5 hours after taking one extended release tablet of 650mg acetaminophen). At 3:00AM on 09APR21, my temperature measured 98.6 degrees and has remained near there ever since. 09APR21, 4:00PM ? Arm Rash: First noticed presence of a rash measuring about 2? x 3? on upper arm near the area that received the injection. Mild itchiness was present about an hour later and a topical 2% diphenhydramine gel was applied. The rash had dissipated by 5PM on 10APR21.

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

severe debilitating tinnitus in my right ear started approximately 2 weeks after the 2nd moderna shot on March 17. 2021. Intermittent mild to severe headaches. Unable to sleep as the pitch in ear is constant.

mild fever cold sweats severe headaches nausea bad shaking dizziness severe fatigue achy joints severe pain at injection site loss of energy loss of appetite diarrheafelt just like covid 19 symptons lasted approx. 2.5 days

Slight body aches and headache day of second injection. Moderate body aches and headache the day after injection. Night after second day had severe headache, severe confusion, severe dizziness, severe nausea, unable to walk unassisted.

The day after the shot, I had upset stomach, stiff neck and shoulders, and chills in afternoon. 2nd day after the 1st shot, I came down with a severe case of a rash (similar to shingles) across my entire back, and left side mostly. After 2nd shot, the same symptoms as the first shot and 2 new areas of rash broke out again. Dr. put me on steroids. ( Methylprednisolone 4 mg)

Purpuric rash; Accelerated hypertension; Systolic congestive heart failure exacerbation; nausea; Generalized non-itchy, non-painful rash a day after receiving the vaccine; Thrombocytopenia; few loose stools; Fever; Chills; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) and NAUSEA (nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Purpuric Rash and Thrombocytopenia After the mRNA-1273 (Moderna) COVID-19 Vaccine. Cureus. 2021;13:4 Previously administered products included for Viral hepatitis C: Interferon. Concurrent medical conditions included Viral hepatitis C, Chronic kidney disease (Stage 4, with a baseline creatinine of 3 mg/dl.), Uncontrolled hypertension, Systolic heart failure (Ejection fraction of 35%.) and Liver cirrhosis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine) (seriousness criterion hospitalization), THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization prolonged and medically significant), PURPURA (Purpuric rash) (seriousness criterion hospitalization), ACCELERATED HYPERTENSION (Accelerated hypertension) (seriousness criterion hospitalization), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized for 3 days due to ACCELERATED HYPERTENSION, ACUTE LEFT VENTRICULAR FAILURE, NAUSEA, PURPURA, RASH and THROMBOCYTOPENIA. At the time of the report, RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. In March 2021, Alanine aminotransferase: 90 (abnormal) 90 U/L. In March 2021, Aspartate aminotransferase: 196 (abnormal) 196 U/L. In March 2021, Bilirubin conjugated: 5 (abnormal) 05 mg/dl. In March 2021, Blood albumin: 1.9 (abnormal) 1.9 gm/dl. In March 2021, Blood alkaline phosphatase: 216 (abnormal) 216 U/L. In March 2021, Blood creatinine: 3.2 (Inconclusive) 3.2 mg/dl. In March 2021, Blood lactate dehydrogenase (122-222): 381 (High) high. In March 2021, Chest X-ray: abnormal (abnormal) Findings consistent with pulmonary edema.. In March 2021, Glomerular filtration rate: 19 (Low) eGFR - 19. In March 2021, International normalised ratio: 1.13 (Inconclusive) INR - 1.13. In March 2021, Platelet count: 84000 (Low) 84000/uL. In March 2021, Serum ferritin (24-336): 2400 (High) 2400 mg/ml. In March 2021, Ultrasound liver: abnormal (abnormal) Ultrasound of the liver confirmed liver cirrhosis.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered THROMBOCYTOPENIA (Thrombocytopenia) and PURPURA (Purpuric rash) to be possibly related. No further causality assessments were provided for RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). Concomitant medications were not provided. Hepatitis panel showed a heavy viral load of more than 11 (no reference range was provided). Per reporter, on presentation to the emergency room the patient was afebrile, had a blood pressure 183/106 mmHg, pulse rate of 82 per minute and oxygen saturation of 96% on room air. Treatment included anti-hypertensives and intravenous diuretics. On day 3 of hospitalization, patient left the hospital against medical advice. Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.; Sender's Comments: Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.

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

12 hours after it woke me up, stomach hurting, chills, tired, diarrhea, this went on and off during the day but lasted seven days

Developed vomiting 04/20/21 in the evening. This a.m. 04/21/21 he was experiencing weakness and vomiting. He fell while in the bathroom, and states it was because he wad so weak. He seems to be doing better now, but due to the weakness writer opted to report to VAERS. He refused medical treatment.

Moderna COVID-19 Vaccine EUA Fever, shivering, sweating, nausea, headache, extreme fatigue, loss of appetite, and general malaise beginning approximately 12 hours after injection, and persisting for the next 24 hours. Swelling , soreness, and redness near injection site are still present at 40+ hours after injection. OTC cold medicine (Alka-Seltzer Plus Day and Night), and PLENTY of rest (I must have slept 24 out of the last 48 hours) were the only treatments used. Note: Adverse reactions to the first dose, on 3/25/2021, were limited to the symptoms at the injection site, as noted above.

loss of appetite, diarrhea, fatigue, chills and fever and sore arm. All but chills, fever, sore arm have lasted 5 days so far

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

1st day: Soreness in right arm. 28 hours later: all Joints very achy. Fever of 100.3 degrees. Chills Intestinal distress. diarrhea. gas. overall exhaustion.

Sore injection site, 102 fever, chills, diarrhea, vomiting. Most symptoms ended by 4/23. Lingering diarrhea.

Approximately 4 days after this second Moderna vaccine I began experiencing severe headaches, dizziness and nausea from the dizziness. This has been ongoing now for 6 days.

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

About 4 hours after vaccine administration patient reported fever chills muscle aches nausea fatigue lasted for 48 hours.

I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.

Vertigo for 5 days so far about 3 weeks after second shot. First day of vertigo was so bad I threw up twice and had to stay immobile to not throw up. Day 4 I had to take meclizine so I could return to work. Day 5 which is today still dizzy a little bit but not enough to make me sick to my stomach.

BLURRED VISION - I've perfect mid-range and long-distance vision and everything is now blurry. All the other side effects have subsided except the blurred vision. Other Symptoms that have since subsided: headache, chills, upset stomach, muscle aches

Debilitating pain in left arm, exceeding that of a broken limb. 101*F fever, chills, sweat spells, body ache, headache, mental fog, upset stomach. I've never felt more sick in my life. Would have gone to ER however my wife suffered the same vaccination reaction (was vaccinated at the same time/location) and was unable to drive.

This 60 year old black male received the Covid shot on 4/15/21 and went to the ED on 4/23/21 with the following diagnoses listed below and died on 4/27/21. K92.2 - Gastrointestinal hemorrhage, unspecified

Within 12 hours or so the following effects were noted. This was the second injection. Both injections had similar effects. 1. Injection site soreness/tenderness for up to 3 days. Note : Different arm this time. 2. General soreness throughout my body. 3. Intense and long headache that lasted for up to 36 hours. Acetominophen and ibuprophen taken in series after approximately 20 hours. 4. Fever up to 100.5 F & chills for up to 2 days. 5. Some nausea for 2 days. 6. General feeling of lack of concentration and being "hazy" in general condition.

(Moderna COVID?19 Vaccine EUA) Chills, sweats, nausea, and migraine headaches. Also, respiratory congestion and cough. Symptoms started 24 hours after vaccination (not all at once) and persisted for 9 days total. Loss of appetite and loss of taste for certain foods. I lost 8 lbs. during this period.

Fever, Sweats, Chills, Nausea, severely swollen lymph nodes with soreness under left arm, neck, and shoulder blade. Swollen nodule at base of neck near left shoulder. Achiness in knees and elbow joints.

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

Severe fatigue and weakness, headache, general muscle ache, fever, lack of appetite Unable to function - 5 days in duration

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

After first dose of vaccine on 4/23 complained of fatigue and tiredness. After second dose on 5/26 complained of fatigue, dizziness, nausea and body aches. Expired on 5/28.

Muscle aches, arm soreness, shoulder tightness, lightheadedness (better), decreased appetite. patient taking tylenol and aleve to help alleviate symptoms. Symptoms began 6/23/2021 at 6PM. lightheadedness recovered.

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

Horrible heart burn and GERD started the evening of my second Moderna shot- it has NOT stopped. Ive had to go on medicine - tried three different ones. I?m taking twice a day Omeprazole 20mg. Its very painful- Ive changed my diet, and still not helping.. Its Bad???..

Fully vaccinated patient admitted to hospital with diagnosis of COVID per PCR. Patient admitted to the hospital on 06/21/21 for left sided upped abdominal pain. Diagnosed with pancreatitis. During admission testing patient has a detected PCR test for COVID. Patient remained asymptomatic for COVID throughout his stay. Discharged on 06/23/2021.

Diarrhea started about 8 hours after injection - has been persistent for several days but calming down now

I suffered an incident of Vertigo (intense dizzyness and vomiting) lasting approximately 48 hours that required a trip to the ER. Physical Therpay was prescribed and done for a period of one week or until symptoms are no longer present. I feel fine now.

Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my entire body hurt and I was dizzy to the point that I could not stand up without holding onto something. Since the injection, I have felt nauseous everyday, I cannot concentrate, I become fatigued just standing up. It's been almost six weeks since the injection & I still do not feel right. I fall asleep whenever I sit down and I've fallen asleep while driving.

Had a seizure, 2 other reactions like seizures; Could not breathe, has breathing problems; Was really sick; could not get out of bed for 4 days; shoulder pain; muscle pain; Felt a little nauseated; Is really fatigued, tired; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure, 2 other reactions like seizures) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Diverticulitis, Narcolepsy and Vertigo. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (Had a seizure, 2 other reactions like seizures) (seriousness criterion medically significant), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired). At the time of the report, SEIZURE (Had a seizure, 2 other reactions like seizures), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired) outcome was unknown. The patient's medical history also included an unknown syndrome (could not understand the name). Concomitant product was not reported. The patient had experienced shoulder pain, muscle pain, fannnnd had elt a little nauseated. Three and a half weeks after having the second shot , he had a seizure, was really sick, could not breathe (started after he got the seizure), and it was horrible. At the time of the report, the patient continued to have muscle pain and everything, predominantly in his upper chest, and has breathing problems; he had never smoked or anything. He also had 2 other seizures like reactions. He was really fatigued and tired. He could not get out of bed for 4 days. He went to doctor but was given no aditional treatment. At some point after he had the seizure, the patient saw his doctor. Treatment was not reported. Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.

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

2:00 the afternoon of the day of the vaccine Pt started feeling bad and did not sleep much that night. Then about 7:00 the next morning he started vomiting and vomited all day until 3:00pm. He vomited so much he thought he was going to have a heart attack. Also, the gland in his underarm is very very swollen

within 24 hours, the patient developed diarrhea, fever, chills, dizziness, headaches, fatigue, muscle cramps, vomiting, aches, and pains throughout the entire body. Symptoms subsided after 48 hours after the shot was administered. Symptoms were most prevalent from 14-30 hours after initial vaccine. Hot showers alleviated pain, and aided vomiting Bed rest when possible. Oral medication to relieve fevers/chills were ineffective due to vomiting.

Previous Covid + physician with documented antibodies Symptoms started 17 hours post vaccine Fever x 36 hours Chills Rigors Malaise Myalgia Mild diarrhea, anorexia,

Fever, Chills, Nausea, body pains. all started 12 hours after the shot. Got better and went away the next day.

Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour

Headache, Diarrhea, chills Narrative: headache, tenderness on the left side of neck, mild chills, diarrhea

Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea Narrative: Employee received vaccine on 01/04/2021 and did not experience symptoms until the following day. On 01/05/2021, employee began experiencing fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of note, employee reports attended a football game on 12/26/2020. Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet resolved.

Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea Narrative: Employee received vaccine on 01/04/2021 and did not experience symptoms until the following day. On 01/05/2021, employee began experiencing fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of note, employee reports attended a football game on 12/26/2020. Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet resolved.

feverish, chills, shaking, 99.9 fever, extremely nauseous, Zofran did not work, nausea went away that night, fatigue, red square size of a stamp at injection site, size has increased in size, Dr rx Bactrim antibiotic

Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. Fever 102.9. Severe headache. Vomiting next morning. Bedridden 36 hours total.

At about 1am the night following receiving the vaccine, I started getting a headache and indigestion. At about 1:30 I had diarrhea for the next 3 hours until I took an anti-diarrheal medication. My wife and I ate the same food that day. She did not get sick. I haven't had diarrhea in years. I had a lingering headache the following day.

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

About 12 hours after receiving the vaccine I experienced severe stomach cramps, followed by diarrhea, and vomiting. The episode lasted for about 4 hours. After it was over I felt very weak and stayed home but no further symptoms arose.

Beginning on Day 2, nausea on and off sustained now through day 25 Today). Loss of appetite as a result. Extreme muscle pain on day 10 (just day 10). Extreme Fatigue now through day 25, with headache. Dizziness and head pain beginning week 3 after shot. Unable to function properly. Symptoms are not constant, come and go from mild to extreme.

Within 8 hours of the vaccine I was experiencing a right sided headache, sharp shooting; aches; fatigue and mucousy diarrhea. The right sided headache continued for days. On Saturday evening Jan 16th it became the worst headache of my life. Like a fool I didn't go to ER until Monday morning when I developed left handed weakness. I was visiting my son and presented to the Medical Center ER where I was diagnosed with an acute sub-dural brain bleed and airlifted to Specialized Hospital. Was admitted to the Neuro-Neurosurgery Unit.

After 12 + hours I felt a headache (like a sinus headache), In addition I experienced fatigue, light headedness, and mild sense of nausea. It felt like I had Covid again, but to a lesser degree.

patient sent home from work on the morning of 1/21/2021 due to muscle pain, weakness, nausea. Symptoms worsened including decrease in o2 sats 72% (compared to normal mid-90%), patient was unable to ambulate due to muscle weakness/pain, pulse elevated to greater than 100 bpm. Ambulance was called and arrived to the home where patient resides at 8:55 am on 1/22/2021. Home director emailed symptoms to the pharmacy after the patient left for the ER. Pharmacist called home director to get additional info. As of 1:03 pm on 1/22/2021 patient has returned home after ER staff determined his symptoms were an adverse reaction to Moderna. He was advised by the ER staff to rest and drink plenty of liquids. Pharmacy advised home director to contact patient primary provider to report ADR and determine if the 2nd dose of Moderna is advised by the primary provider. The pharmacist will follow-up with the house director status on 1/23/2020 before 3 pm and will have any additional ADR's reported to the pharmacy and the patients primary provider

Headache, head feeling very heavy and nausea; So far lasting for 4 days and not getting better; I took Tylenol but does not help. Last night was the worst couldn?t sleep all night

Slight headache for 3-4 days, overall muscle and joint fatigue for one day, loss of appetite from 20-36 hours after injection

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

Moderna COVID?19 Vaccine EUA Extreme fatigue, visual hallucinations, anorexia. Symptoms worse at ~12 hours, significantly improved by 72 hours but not resolved.

Fever, chills, nausea, vomiting, severe headache, severe muscle pain, joint pain, muscle weakness, extreme fatigue

Pt states he felt nauseous soon after vaccination. Pt has no other complaints. Pt educated on next course of action. Pt has not vomited in our presence. Pt released w/ all questions asked and answered. Pt states symptoms have become more manageable during observation period.

large red bright red bumps on forehead and top of skull that is painful/irritation to touch, off and on nausea , intermittent headache

Approximately 24 hours post injection-fever-102.4, and fatigue. Fever persisted for 24 hours then resolved. Fatigue persisted for 48 hours then resolved. Possible side effect-72 hours post injection-queasy stomach, malaise-Duration-approx. 6 hours all resolved. Also, cold sores erupted on lower lip for no reason. Being treated with Abreva.

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

19 hours after the injection there was fever, rigors, sweats, headache, nausea, myalgias. This lasted for approximately 30 hours then resolved. Tylenol 1000 mg q 6H and

after first injection I began having the worst G.I symptoms. Cramping/diarrhea abodemin pain . Symptoms like diverticulitis. Seconds injection same symptoms. 8 wks later still having symptoms.

Moderna COVID-19 - Symptoms included: headache, muscle pain, joint pain, chills, nausea, low grade fever 0f 100.0 F, and fatigue

Started feeling a bit dizzy Monday 22nd in the evening. Woke up Tuesday 23rd room was spinning (patient had labyrinthitis 18 years ago symptoms lasted 2-3 weeks) dizziness lasted throughout the day (Tuesday 23rd, 2021). Vomiting started late afternoon Tuesday. The symptoms were lessening Wednesday and Thursday.

Fatigue, nausea, fever 102. This was my first shot. I was given two shots because the first one didn't have the needle on all of the way and a lot ran down my arm. They decided to give a second one.

had lack of appetite before second dose. When received the second dose, he started vomiting on the way home. Was sick on and off for the next few days. Died suddenly on 2/23/2021

Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to lay down, stay home from work. Rested. Took Tylenol and slept throughout the day. Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature up. Jogged for 60 minutes, returned, ate and rested again. 4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level. 5th day back to normal.

abdominal pain diarrhea with constipation painful bowel movement chills muscle aches and headaches fatigue

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

Significant aches and pains all over my body, tired, loss of appetite, mild nausea. No fever. No respiratory problems. Subsided in about 36 hours. Back to normal in about 48 hours.

Upset stomach, severe chills, body aches lasting about 8 hours. Then, fatigue lasting through the following day.

RLQ abdominal pain; less intense now than when it began but it still persists. We recommend that they be evaluated in an ER because this a/e is not common with the vaccine and there is need to rule out other causes of patient's symptoms such as appendicitis or other abdominal emergencies. Pt went to see doctor today as we rec'd and MD thinks is gallstones and patient will be having an ultrasound tomorrow.

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

Stomach pain, diarrhea and vomiting for about 8 hours. Started feeling better at about 10:00 pm on March 9 and fully recovered by noon on March 10.

got dose Sat, was very sore/stiff Sunday, then late Thursday started getting nausea, Sat 3/13 called us to report vomiting now.

For about 48 hours I felt out of it--lethargic, chilled, lack of appetite, slight headache, drainage down back of throat. Last symptom still exists.

23 HOURS AFTER VACCINE DEVELOPED LIP SWELLING , BODY PRURITIS, AND BILATERAL BLOTCHY HANDS. ABDOMINAL PERIUMBILICAL PAIN. SYMPTOMS LASTED 12 HOURS. STARTED ON OZEMPIC 7 WEEKS AGO AND HAD SAME ABDOMINAL PAIN 3 WEEKS AGO BUT NONE OF THE OTHER SYMPTOMS. THIS ABDOMINAL PAIN MAY NOT BE RELATED. IMPRESSION: PROBABLE ALLERGY TO MODERNA. PCP WAS NOTIFIED BY VACCINE CLINC. PATIENT ADVISED TO SEE ALLERGIST IF HE CHOOSES TO PROCEED WITH SECOND DOSE OF MODERNA.

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

Exactly 32 hours after injection, both myself and a 41 year old friend who got the vaccine with me experienced the following: vomiting, incredible amounts of mucus coming from lungs, uncontrollable diarrhea, violent sweating and chills, extreme headache, bed-ridden for two days. Both the pharmacy and the health dept. refused to record our reactions, and the health dept. hung up when we tried to report this incident. The pharmacy would not call us back.

I had Covid in November and was told that there was a high probability that I would get sick but was not prepared for this. It is like I am sick all over. Fever, no taste (It all reminds me of cardboard), exhausted, sleeping, no appetite, mild nausea, headache, winded easily

Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache. These symptoms lasted all day and into the night with some minor relief. Following morning woke up to light-headed, headache, and some dizziness. Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around. Still feeling light-headed. The following days experience ligh headedness in the morning and serious dizziness when laying down for the night. After about an hour of getting up, feel almost normal but not fully.

Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.

Developed bad, itchy hive-like rash all over trunk of body front and back within 6-7 hours of injection. Treated with 25mg Benadryl for very little relief. By four days post vaccine it has spread to groin and head. Mild nausea and fatigue

do not know the lot number but this is what is on my woke up at about 3am 3/23/2021 with a horrific headache and way sick to my stomach and then severe low back pain in the afternoon of 3/23/2021; as I write this now my headache is not as severe, stomach is meh at best and low back is still very sore.

Shingles; Abdomen started to bloat and becamne incredibly swollen; Sore arm; A spontaneous report was received from a consumer concerning a 61-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles/ Herpes zoster, abdominal started to bloat and became incredibly swollen/abdominal distension and sore arm/injection site pain. The patient's medical history included hepatic cancer and unspecified liver procedure. Concomitant products known to have been used within two weeks prior to the vaccination included pembrolizumab. On 19 Feb 2021, the patient received her first dose of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 19FEB2021 the patient had a sore arm. On 24 Feb 2021, the patient developed shingles which broke out all over his face affecting his lips, ears, gums and inside of his mouth. His abdomen started to bloat and became incredibly swollen. It was unknown if he received any treatment in response to the events. Action taken with mRNA-1273 and pembrolizumab in the response to the events shingles, abdomen started to bloat and became incredibly swollen and sore arm was not known. The outcome of the events, herpes zoster, abdominal distention and injection site pain 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.

Chills sweating bad headache Throwing up stayed in bed for 36 hours when I stood up very dizzy 45 hours later I am feeling a lot better

Severe soreness at injection site. Fatigue Stomach cramps Joint and muscle aches Bad headache Diarrhea High fever chills severe sweating Dizziness

Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination

Lungs filling up with fluid; Cannot move; Uncontrolled diarrhea and uncontrolled bowel movements; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lungs filling up with fluid/pulmonary edema, uncontrolled diarrhea/diarrhea, vomiting, cannot move/mobility decreased, uncontrolled bowel movements/bowel movement irregularity. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 16 Mar 2021, prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection. On 16 Mar 2021, within 12 hours of vaccination, the patient experienced lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events, lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements, were unknown.; 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.

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

Severe vertigo, with cold sweat, extreme nausea-went to ER-given cardiac, blood and CT tests. Symptoms going away. Will follow up with ENT

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

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

Ringing in one ear a few minutes after injection. Fatigue and slight nausea first night and next day but is now gone. Tinnitus continued and is now a bit worse today.

After 5 minutes post vaccine, patient started vomiting and became dizzy. patient symptoms were not resolving so paramedics were called.

I woke at 4:30 AM and spent the next SEVEN HOURS explosively vomiting and diarrheic. Muscle pain and tightness spread from my left shoulder, across my back, to my right shoulder. Lying flat gave me dry heaves. Standing up made me dizzy. I?m coughing like there is fluid at the bottom of my lungs. The base of my skull felt like it was in a C-clamp. My temples felt like they were in a vise. I have a rash on my shoulder and arm. I smelled like rotting flesh. (To head off any concerns over lifestyle or hygiene, I have a BA, BFA, MBA, MSL, and completing my PhD.) After two days of exhaustion, vomiting, diarrhea, pain, etc. I took a shower at 11:58 PM Saturday. When I swiped my soapy face towel over my left should, I wiped away a layer of skin, like a burn victim. Be grateful I don?t have power. I would stop the Moderna injections until someone finds out what it is about my genetic makeup that might signal those with similar genetics to stay clear of Moderna.

I received my 1st shot on April 8, 2021, later that night I took a shower and went to bed. Around 0100AM on April 9, 2021, I started to have chills and a fever which lasted all night until around 10 am the next morning, after the chills and fever left I lost my appetite and my body ached all over. I had flu-like symptoms for 3 days and I was OK after that time period.

61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became. He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight". He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities. He had no trouble with his vision or cognition. He had no trouble with the previous vaccine. Presently the symptoms are resolving. Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23

pain in abdominal area right front next morning, skin extremely sensitive, pain also right back , rash started 4 days later, 5th day noticed blisters on rash, Doctor's appointment on 6th day confirmed Singles which I had as a teenager, Given a prescription for Valacyclovir Hcl 1 GM 3 times a day.

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

4/1/2021 Shivers/Shakes at about 10pm, Fever was high 102+, after midnight began vomiting for along period and until empty. Chills continued with fever thru the night. 04/02/2021: The next day had severe headache and fever all day. Went to bed at 10pm and woke the next day feeling much better. 04/03/2021 Weak all day but headach was gone. Had some shortness of breath for almost a week.

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

Vomiting, dehydration, nausea, fever, joint inflammation, muscle weakness, inability to ambulate, pain, soreness and decreased appetite.

Very sore arm for 1st week. Arm still sore after 2nd week. Flu like symptoms for 3 days. Observed "gray" stools (affecting my liver) after 3 days; diarrhea; Low grade flu continued for 4 weeks. Fatigue, mild body aches

Initial reaction in the first 48 hours was as expected (chills, sweats on the first night, sweats the second night). Starting starting 54 hours after the vaccine, chills began to recur, accompanied by severe indigestion and gas. In the evening of the third day after the vaccine, chills were extreme and excessive stomach gas and bloating was experienced, with occasional sharp gas pains in the abdomen. While the gas symptoms moderated overnight, they returned in the afternoon and overnight of day 4. Experiencing fatigue, but this could be related to lack of sleep due to the symptoms. This is day 5 and the gas and bloating remain but appear to be moderating.

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

patient c/o mouth dryness, slight headache, and slight upset stomach. Provided water to patient. patient seen by Dr. Monitored patient for additional 30 minutes. After 30 minute observation patient felt better and no longer had symptoms. Patient was sent home and was advised to eat breakfast. patient verbalized understood and agreed.

Had chills, slight fever, diarrheafor a few days. Then headaches set in . Have several headaches a day. 17 days since my vaccine and I've had several a day every day since. I WILL NOT BE TAKING A BOOSTER.

On 04/28/2021 - started feeling brain fog. Nausea. Several times I felt like I am having an out of body experience and I become easily agitated

Injection site redness...more than 5 days. Arm soreness has decreased daily. Initial noticed effect besides slight soreness in arm... Chills 10 to 11 hours after injection. These increased for next 12 hours. Weakness, moderate to severe nausea( vomiting).. lasted 2 days. Not able to keep food down. Headaches...slight to moderate migraine headache..3 days..in duration...decreasing in severity daily. On second night and third night.....profuse sweating on Second night....restless and little sleep. Third night slight sweats in early morning. After 4 days....eating and getting energy back from a really bad experience.

symptoms began at: April 28, 3pm No appetite, lethargy, nauseous, high fever (102 - 103+), sleeping for 16 hrs out of 24 hrs with highly disruptive sleep, interrupted by vomiting, dry heaving, delusional fever dreams, tiredness and low grade fever for another 12 hours No medical tests given No physician called

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

Headache, fatigue, chills with some shaking, slight nausea, soreness at injection site. Started in the afternoon and increased until about midnight. Took a normal ibuprofen dose. Slept and mostly resolved by morning. Mild symptoms today (May 4). Note: I had minimal symptoms with the first dose; less soreness at the injection site, which came on more gradually. Reporting this more for data purposes, not as a health problem.

Morning after vaccination, around 7am awoke feeling slightly unwell, worsened through the morning to slight fever, headache, nausea, chills, genera debilitating discomfort; began abating 8-10pm and returned to comfortable condition around midnight

3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down /or take any meds/had to miss work/ disoreinted/ just kept sleeping all day and night felt better the next morning... went to work on Thursday 05/ 06/ 2021 felt about 95 % better in about 24 hours......no food and no meds and very week....feeling better now, besides tender stomach from dry heeving

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

Severe flu like symptoms. Extreme body aches, nausea and fever. Felt like the worst flu I?ve ever had. Couldn?t eat for 40 hours.

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

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. 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-2021-141559 (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.

About 1month afterward starting having facial swelling and tingling from jaw/lips to eyeball on the right side, with eyeball pressue. I also have tingling, numbness, burning to both lower legs from the knee down to the feet. I can have burning and sometimes my feet are freezing at the same time. Lower back pain also. The burning and sensations have gone on for awhile now. Also tinnittis which is currently off the charts with pain, lost 30 lbs as I get so ill from the noise I cannot eat---have nausea when the symptoms are to bad.

Dizziness, lightheadedness, imbalance, ataxia Nausea, vomiting Hospitalized for extensive work-up, Possible diagnoses Guillain-Barre variant (Miller Fisher)

Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.

Sweating concurrent with extreme chills 7 hours duration. Headache. Fully body aching. Nausea no vomiting. Loss of appetite. Injection site rash/reaction 3 day duration. Muscle pain below the injection in left arm 4 day duration.

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

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

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

Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.

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

About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by severe sinus congestion which lasted for about 10 days. This has been followed by ongoing severe fatigue, inflammation of my joins, painful movement and walking, brain fog and inability to concentrate. i am still dealing with the debilitating effects 7 weeks out.

Patient states that he had "EXTREME whole body shakes( not chills), Nausea and vomited 1 small amount

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

Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-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 Bipolar disorder. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient reported that the adverse events started immediately after the first shot. Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered. This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.

Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site) and my wife had to call 9-1-1 and EMT's took me to hospital and I was hospitalized for four days. Hospital. I am recovering from the medications still but I have recovered from the health event from the vaccine.

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

That night started having pain below belly button, hurt all through the night. Below nipple on left side of chest started feeling like heartburn pains which went on for about 3 wks. Just started feeling the same pain on the right side. Drinks apple cider vinegar for pain his stomach.

After eating lunch on 12/29, he felt nauseated and dizzy, vomited within 10 mins and felt dizzy, there was some orthostatic BP changes clinically, he was at work in the hospital on that day, he was taken to ED, kept under observation for 24 hours, cardiac workup was done, non specific EKG abnormality was noted and he got a stress test on the 30th, which showed a normal stress perfusion study and normal cardiac function. He was discharged from observation status. No further dizziness.

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

Congestion like a head cold, raspy throat, nausea, headache, low grade fever 100. -Tylenol taken for fever

Headache, Myalgia, Diarrhea, NauseaVomiting, N/A Narrative: 1030hours received dose. 1130hours developed HA not alleviated with OTC Acetaminophen. 1200hours upset stomach, not alleviated with "jell-o" and clear soda, developed nausea. Had 4-5 bouts of BMs from time of dose to 1300hours.

Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee reported being off work since the day of her injection Narrative:

Patient experienced a headache, nausea, and loss of appetite the evening and day following his COVID vaccination. Patient stated he had previously had Covid several months before and had similar symptoms while he was Covid-positive.

Pt feeling very nauseous, throwing up, pain in his tummy. very uncomfortable, dry heaving, could not sleep. for 10 hours now

Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatigue, dizziness. Disturbed sleep. Joint pain overnight. Took advil during the night and helped immensely. Following day mild dizziness and fatigue, just feeling slightly unwell. Slept 9 hours that night where normally sleep 6-7. Thursday morning back to 85% and by end of day back to normal.

High temperature, difficulty breathing pain in abdomen and ribs. Shallow breathing to try and avoid cough as it hurts so much. Temp in the middle of the night reached 102.4F Chills and uncontrollable shaking.

nausea - 30-45 minutes shortly after injection 1/29/21 fatigue body aches - began shortly after injection, continuing but lessened muscle spasms - from 2/2/21 to 2/3/21

Patient did feel itchy all over and ached some after first shot, but didn't say anything about that. Morning after 2nd shot became nauseated; ran fever and ached all over. He felt this was for 2 -3 days, and also very tired. Still very tired on 4th day after shot, but no fever or aching. Patient did take Tylenol, didn't help so also 1 dose of Ibuprofen. Take Prasugrel, so Ibuprofen wasn't really an option for him.

Pain in upper left arm, approx 2 hrs after injection. Nausea, headache, light-headedness: approx 21.5 hours after injection

pain and soreness at injection site, chills, fever, muscle and joint pain, nausea, headache, fatigue "symptoms almost identical in type and order felt when I first experienced having COVID-19 in late November 2020, except of course; for the duration of each stage".

Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24 hours after vaccine was administered and still continues. Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue SOB started 24 hours after and continues slightly

severe weakness, nausea, extreme diarrhea, fever, muscle aches all over, headache, shakes, Chronic cough much worse than ever and still is.

Good night of the injection about 11 hours after I got the injection I started to feel very achy and very sore and then led to shiver passing and turning headache and all of the above the next morning I woke up feeling okay I ate a very small portion of yogurts and oatmeal took two sips of coffee and had to go to the bathroom it was very intense I would stuck in the bathroom for an hour intermittently going number 2 and vomiting very sick and scary the rest of the day I was weak and miserable with a temperature and the temperature lasted all the way until last night it range from one hundred and one point eight two last night at a hundred and 128 I had severe muscle aches after I tip my prod element injection yesterday it which is a Statin anyway that today I feel much better but it was very intense I also developed a swollen lymph node under my left armpit the same arm where they did the injection and it was hot and painful I'm afraid to take the second injection but I want to complete the process if possible

Extreme Sore Deltoid (1st sign progressed over day). The following symptoms started around 9 pm and increased through the night: severe headache, nausea, malaise, other joint pain - especially joints of previous injuries (lifetime), chills, hot flashes, tiredness - though inability to sleep. I needed to take Tylenol through the night which did help with headache. The symptoms were significantly decreased by 6 pm that day (Feb 24th).

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

3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen every 4 hours. Around 2:00pm, uncontrolled shivering due to chills started. By 3:30, had muscle\joint pain in back and began feeling lightheaded. At 5:30, was unsteady on feet, pounding headache, fever of 101.8F and no appetite for dinner. Fell asleep on couch, woke at 7:30 pm, discontinued ibuprofen and acetaminophen, took 500mg Excedrin, fever of 102.8F and went to bed. Uncontrolled shivering resumed around 8:30pm, woke up several times during the night drenched in sweat and took ibuprofen at 4:30 am. Awoke at 8:30 am on 3/4 drenched in sweat again, took hot shower, had light breakfast and took 500mg Excedrin. Temperature is currently 99.3F

Received vaccine in morning on 2/2/2021. No noted reaction. Next morning 2/3/2021, patient started vomiting blood/coffee ground emesis. Sent to ER. Hospitalized. Recovered and readmitted.

Approximately 12 hours after injection, had horrible chills off and on for several hours with fever. The following night, the fever spiked to 103.6 and stayed above 103 for several hours. Fever finally broke 3 days post injection. Injection site was very painful and is still somewhat painful after 4 days. Experienced body and muscle aches, nausea and headache. Still experiencing nausea and dizziness 4 days after the injection. Have been taking Tylenol on a regular basis and pushing fluids.

I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to ask if I should get the second one? I was able to get an appointment for a Covid vaccination thru store/pharmacy. I had the shot about 4:00 on Friday. On Saturday about noon I started not to feel right; head ache and stomach. About 4:00 I started to get an increase in my temperature. At 5:30 I started getting uncontrollable shaking. Over a span of about 30 minutes I had 4 or 5 episodes that lasted 30 - 45 seconds. I had a temperature at one point that reached 102.3 I took 200 mg of Ibuprofen every three hours before falling asleep for the night. On Sunday morning I still had a slight temperature (99.9), but it seemed like all my body joints ached. I ended up feeling better about 4:00 on Sunday. Reply

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

Approx 12 hours post injection woke in night with chills and fever. 101.5F fever persisted through the following morning until early afternoon. Flu-like symptoms; fever, body aches, low appetite, fatigue, chills. High fever reduced with acetaminophen. Bed rest through afternoon and fluids. Body aches and fever dissipated by 36 hours post injection. Return to normal health by 48 hours.

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

tingling in lower left arm; tingling in face; mild nausea -- tingling started in left arm about 8pm night of shot and has maintained since then. experienced tingling in face starting next day

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

On Friday (05.19.2021), fourteen days after receiving the first dose of the Moderna COVID-19 vaccine (on 03.05.2021) at pharmacy, I began experiencing body aches (mostly leg cramps) followed by nausea, headache, and fatigue. They continued through the next 36 hours. Today (Sunday, 03.21.2021) the headache subsided, but the nausea and fatigue remain, albeit less so than yesterday. I had similar symptoms in the first 24 hours of receiving the first dose but understand that to be a very common experience.

Serious Dizziness / Vertigo when moving from a laying down position to sitting or standing, and when moving from sitting or standing to laying down. Visual "room spinning" and some nausea as well. Symptoms began 3/17/2021. Still ongoing.

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

Itching in 10 minutes followed by reddening of skin and red splotches, extreme headaches, body aches, fever, sweats, chills, cough, nausau, swelling of lymphs nodes in chest and groin, shortness of breath, and light sensitivity.

Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,

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

Got the vaccine on 3/26/21 had no problems, and then Saturday morning at around 3:00-4:00 he had a sore arm, nauseous feeling and threw up water a couple of times, and did not eat. He finally ate something that evening, and started having left arm pain, aches and pains. He was having chills, and then fell asleep again and woke up in sweats. He also developed some diarrhea going into Sunday, and Sunday morning his temp went down, his blood oxygen went up and started feeling better. He also still had some chills, and very little sweats than before. On Monday he felt better, his blood oxygen was back to 100, temperature was better. On Tuesday he felt much better and by yesterday 3/31/21 he felt back to normal again. He did take some Tylenol and Ibuprofen for his symptoms during the course of the event.

Fairly severe nausea ? lasted about 8 days. Constantly felt like I was going to vomit, although I never did.

9-10 minutes after the injection the mucous membraines in my mouth (including tongue and lips) went totally dry and tonue and lips started tingling/buzzing and went numb. No productin of saliva was happening making swallowing difficult. Additionally eyes felt dry/itchy. Tongue and lips also felt swollen but didn't appear swollen. I was able to work up a slight amount of saliva after few minutes and swallow with moderate difficulty. Purchased a bottle of water and had no difficulty swallowing that. Did not seek assistance as my heart rate was normal, no difficulty breathing, no outbreak of hives or swolllen face/extremeities. Departed store at 25 min. as symptoms get worse. Symptoms gradually abated by 12 hour mark.

Awake 4am, and fell down (down to knees and hands) because I was really dizzy and nauseated. I couldn't walk (well, I could with great difficulty leaning on furniture) and was very dizzy and felt like I would throw-up. I moved to a reclining chair and stayed there 20+ hours (it's 20 now)... I got up to go to the bathroom and not much more. I had a difficult time even making it to the bathroom. Never had a fever (that I know of... I don't have a thermometer but didn't feel feverish or chilled), but I felt dizzy and nauseated all day and could hardly move from the recliner except for extreme need.

Fever, chills, nausea, headache, injection site pain on the first day after shot on March 26th. On day two after injection all the other symptoms subsided, but headache continued. On April 1st the fever, chills,and nausea returned and temperature had reached 100.8 degrees and headache intensified. On April 2nd I woke up feeling better but still had the headache, as the day progressed the chills and fever returned with temperatures up to 100°. On April 3rd I woke up with no temperature but the headache continued. On April 4th The headache finally went away. My treatment was plenty of water aspirin, ibuprofen, acetaminophen and bed rest.

About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up. Started seeing stars, vision narrowing. I laid down on the floor, and it seemed like I was having a hard time breathing. The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down. I felt like I was passing out. The pharmacist checked my BP and it was like 80 something. He felt I was having an allergic reaction so gave me a show with an Eppy pen. They called paramedics. I started feeling better but paramedics said I should still go to ER so ambulance took me to ER. They ran blood tests, EKG, and chest Xray. After a few hours they released me. They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it

Had worst headache I've ever had in my life. Arm was swollen and super sore. Joint aches everywhere and had diarrhea. It lasted 48 hours Took Tylenol every 4 hours.

Patient reported difficulty swallowing and stated he felt throat closing within 10 minutes of receiving vaccine.

When I woke up, my entire body felt really bloated and soar. Moderate headache. Dizzy, could not think. Walking very slow. No desire to do anything. Sat in my recliner most of the morning with body aches and sleeping. In the early afternoon, I decided to go lay down in my bed to get more comfortable. Continued drinking water throughout the day. Woke up about 7:00 PM. As I got out of bed, I immediately noticed that I was feeling about 80-90% better. The whole body bloating feeling was gone. Body aches were very reduced. Headache was very minor. I felt like a different person when I woke up (better). Very freaky feeling! I was also able to eat some good at this time.

Terrible stomach pain to point of not eating or drinking for two days, thought I was dying, almost went to hospital. Started Saturday at 4 and pain did not go away at all until Monday at noon then it got a little better. It stopped completely Tuesday. I didn?t poop at all while I was hurting.

Unable to sleep due to pain in right arm, chills, adjusted heat to try to sleep but that didn't work. Decided to take hot shower but that caused me to vomit several times. Once I stopped vomiting I started to feel better.

patient felt nauseous, dizzy, light-headed 15 minutes after shot. Patient threw up after a couple more minutes then his symptoms improved. He sat another 10 minutes before going home.

Approximately 36 hours after shot experienced dizziness and nauseousness. After throwing up, experienced tinnitus which has not subsided.

Shortly after receiving vaccination patient's wife began honking her car horn. This nurse went to vehicle, patient was clammy, cool to touch, diaphoretic. He was not verbal and had vomit coming out of his mouth. EMS contacted. Vital signs were within normal limits. EMS cleared patient. Wife attributes reaction to severe anxiety related to anything medical.

No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and went home, woke up around 2 am with sweats and nausea and headache which became progressively worse through the day prohibiting any activity. Dry heaves and severe headache with dizziness lasted until 4 pm or so. I did take Ondansetron at 12 noon to limit nausea. Worked the following day with few physical symptoms but very irritable. The next day (Saturday) woke with headache and slight nausea which became worse as the day wore on, limiting activity but I was able to get chores done, though I was very lethargic. The next day was much better. Worked on Monday the 12th of April and felt well. Fell ill again with similar but less severe symptoms, though marked nausea and dry heaving again. Slept until approximately 2pm and started writing this report. 4/13/2021

Slight Nausea 20 mins about 10:15 - 10:20 AM after injection vomiting about 5:00pm Nausea for about 2 hrs after vomiting. sore arm for a day after injection Small itchy Bumps/Rash, over entire back for two or three days after inection

I received the shot around 9:15 AM. Early afternoon started feeling tired and a general feeling of unwell. Went to bed around 9:00 PM. Woke up at 10:00 PM with real bad chills and headache. Got up at 1:00 AM 4/12/21 very hot and chills. Took my temp and it was 103 degrees. Felt dizzy and weak. Took two Acetaminophen and went back to bed. Got up around 4:00 AM still hot. Took temp and it was 101.6. Took two more Acetaminophen and went back to bed. Continued this type of treatment all day. Drank water and rested. All day had temp, headache, fatigue, and nausea. Went to bed at 7:00 PM after taking 2 Tylenol PM's. Upon getting up (4/14/21), took my temp 99.5 degrees. Still have slight headache and fatigue, but feeling better.

4/11/21 - extreme vertigo with nausea; Epley maneuver helped but took all day before I could walk. Continued to do Epley daily for both sides and only started to dissipate on late on 4/18/21.

Patient sitting in lobby for recommended 15 min observation time. He burped loudly, vomited (green/yellow vomitus), slumped to his right in the chair. Patient was diaphoretic and slow to respond to verbal stimuli.

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

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

1) After midnight, I began to get what felt like the shivers, but they were unlike anything I had ever seen or experienced, as I could not stop shaking, feeling like I had to try to get warm. I had a heat pack under my back, and no temperature, but for 25 minutes, kept shaking. 2) At 10am in the morning, I began hallucinating, which has never happened to me before, and I only recognize because when my Dad was dying of prostate cancer, they had him on morphine and he began to see things. It was a very specific hallucination, of being in a specific from in front of a specific computer talking to a person. I feel quite reluctant to share this. This lasted for somewhere between 30 and 45 minutes. 3) I've vomited once, and had diarrhea, drinking lots of water, and only using Tylenol. I did not take the Tylenol until after I stopped shivering.

He got the vaccine, had a little pinch, did not bother him. Then it got a little sore and went away. A day or two later things would show up, got fatigued, headache seemed to be the main thing, nausea without vomiting, chills and no fever. The symptoms are moving around the body with body aches. This morning when he got up he was very nauseated, and not feeling well. Did not go to work as not knowing if he had the flu or anything else.

Fever (100) for 10 hours; slight nausea; extreme fatigue (17 hours); extreme aches (17 hours) -- very much like having the flu.

Throat infection swollen lymph glands neck Shingles outbreak right ear Difficulty breathing and swallowing

4/18/2021 at 1:00 AM i woke up with extreme dizziness and was very unsteady while walking at 6:00 Am, the dizziness was worse, the unsteadiness was worse and I had vomited. Had a virtual visit with my doctor who said to take Dramamine for the dizziness. I was not feeling less dizzy until Wednesday afternoon (4/20/2021) - I am still slightly dizzy if I move my head too quickly. I have an appointment with my doctor for later this week.

Severe stabbing pain in the head ,jaws,teeth, dizziness, profuse sweating, feeling like your burning up,pain in the joints, toes,fingers,still having stabbing pain through the temples 10 days after the last vaccination, nausea,severe constipation,never before,pain in the spine, feel fine for 5 minutes then suddenly feel like you've been hit by a truck!feels like you can't think clearly!

Severe headache for 20 hrs. starting at 2am. Very weak and no apatite. Severe lower back pain for 30+ hrs. Slight fever for short period of time. (100.1) Sore arm at shot location.

Pt reported that he was vaccinated around 2:45 pm and at 6:45 pm the same day began to feel nauseous and light headed. He states he was so weak he had trouble getting into bed. He also experienced feeling cold and sweaty. He states he took his temperature and did not have a fever. He states he felt a little better around 8:30 pm and ate crackers and soup. He states he didn't sleep well and was still nauseous and felt like he had heartburn around 5 am. He states he was able to eat at 7 am the next morning (3/13) and took a shower around noon. Pt states he took his blood pressure on the morning of 3/13 and that it was low. He says he took his blood pressure daily until the 22nd, and it took about a week for it to return to normal for him. Pt reports that he saw his primary care provider on 3/18/21 and his EKG was normal but his BMP was elevated. PCP referred him to cardiologist.

12 hours later he felt nauseated and which he still is as of today. Then last night he threw up and felt shaky today. He is sipping on powerade. Not eating much. Drinks beer still.

Woke up this morning at 2:30 am with severe fatigue, muscle/joint aches, sore throat, feverish 99.6f, headache, nausea, and chills. Have not gone to hospital yet.

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

Patient received vaccination at 8:00 am and returned to work after finishing the 15 minute monitoring period. At approximately 0845 am the patient began to feel nauseas, tightness in throat, diaphoretic, short of breath. In the Emergency Department patient was given Epinephrine 0.3 mg intramuscularly and methylprednisolone 125 mg intramuscularly.

dizziness, nausea, light-headed, loss of appetite, general ache, low fever with chills lasting approximately 48 hours.

Severe vertigo with vomiting lasting several hours that occurred on the following dates: Shot was 4/7/21 Attack on 4/13/21 Attack on 4/15/21 Attack on 4/17/21 Attack on 4/24/21 Attack on 5/2/21

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

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

Approximately 20 hours after administration of the second dose, the following symptoms arose and subsided (except for pain at injection site) over approximately 48 hours, seemingly completely: pain at injection site; fatigue; heavy chills; and serious diarrhea.

first dose. Muscle soreness first 2 days joint pain next two days. Dose recieved 4/28/21 Second dose. Upset stomach then loss of appetite the first day. Got better on second day. Very tired on the second day Third day: Hacking cough and sore throat. Could eat, but when drinking caused me to cough. Then started to lose my voice. 6th day. Coughing better but still there voice still weak. Fluids do not make me cough anymore. 2nd vaccine date 5/26/21

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

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

Chills, fever, body aches, muscle aches, flu like symptoms, loss of apatite, extreme discomfort lasting ~ 2 days

Pt initially contacted clinic describing shortness of breath present the night before, and no other symptoms. Pt advised to go to ED or call 911. Pt contacted today and he described his symptoms differently, specifically as: aprox 5 hours after COVID immunization, developed fever 102, sweating, loss of small and taste, diarrhea, fatigue beginning noc of immunization and gradually fading over ~3.5 days. Only residual Sx pt endorses at this time are diarrhea and fatigue. Pt given advice directly from Provider to go to emergency dept/call 911. Pt cont. to decline to attend emergency dept /urgent care of get COVID test, saying "I'll ride it out."

Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-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 DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the vaccine was not the cause, he had other medical issues too. This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

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

Fatigue, 102 temp, headache, swelling at the injection site, pain behind my eyes, skin painful to the touch. sore body aches, cold and hot chills, appetite suppressed, lower abdominal pain and cramps, diarrhea, All events lasted 24 hours except: Headaches, skin pain, and body aches, and appetite suppression, which lasted another 24 hours. After 48 hours just appetite suppression.

Diarrhea everyday since vaccinated in Feb, but slowed down to just a little prior to 2nd dose. He didn't report the diarrhea to CDC or to family MD

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

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

Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication. Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication. On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Pt called on 5/23/21. Pt got Moderna vaccine 2nd dose on 5/21/21 at site. Pt complains of abdomen distension and excruciating pain at abdomen area onset 5/22/21. Pt reports he has history of chronic ab pain. Advised pt to go to ED immediately and pt stated he will go.

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

(02/08/2021)(102)Fever, Bone rattling chills, aches, nausea, 3-5in of major swelling at the injection site, Tylenol for fever, light clothing, bed rest and fluids. took about 4-5 days to come to normal

Transverse myelitis, with symptom onset around 6/22. Symptoms began with bilateral lower extremity weakness and pain, and then progressed to constipation and concomitant bandlike abdominal pain.

It's interesting as a non-medical person, the struggle I'm having, to get one person to just understand the period of time that I've seen different providers. Since my second injection I had suffered from ongoing problems, I have days where I can just hardly stay awake. I have never felt like there was a single medical professional who was trying to even find out what was going on with me. On May 28th I woke up in the morning at 2:30AM with an extreme case of dizziness and nausea. I got up and went to the bathroom and went back to the bed thinking I could go back to sleep. It was as if I had some type of horrible severe hangover or something, but I did not. About an hour later I got up, fell on the floor, then decided I had to go see somebody. I called the ambulance and was taken to the ER, where they ran lots of tests. The diagnosis was that I had severe peripheral vertigo. and prescribed medications for that. So in June 2021 I went to the DR for a stress test and echocardiogram and those came back fine. I get mild nausea and dizziness still but nothing like had happened originally. I had visited PCP, my DR, after my visit to the ER and she is the only one kind enough to me to care. I have had an ongoing effect on my ability to function so when I got the v-safe check in, of course I replied that I have had an event of course. Ondansetron 8MG as needed for nausea Meclizine 25MG as needed for dizziness, these are the medications they gave me at the ER by the way.

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

True vertigo - room spinning dizziness, perceived motion, made worse with changes in head position. Nausea and vomiting at extremes of vertiginous symptoms. Also generalized fatigue noted. No fever, chills, diaeresis, headache, hearing loss, loss of taste or smell, cough, or nasal congestion, muscle aches, body aches or myalgias.

True vertigo. Room spinning dizziness with perceived movement. Symptoms made worse by changes in head position. Nausea and vomiting with extremes of vertigo symptoms. NO fever, chills, cough, loss of taste or smell. No muscle aches, body aches, myalgias, nasal or sinus congestion.

RASH STARTED IN THE ANTERIOR WAIST , AND BIALTERAL LOWER LEGS ABOUT 30 HOURS AFTER VACCINATION. THE RASH EXTENDED TO THE ANTRIOR PELVIS, THIGH , UPPER ABDOMEN, ANTERIOR NECK AND FOREARM, AND EXTEND TO THE UPPER ARM IN 48 HOURS. THEN ABDOMINAL RASH DESAPPERED. NO-MINIMAL ITCHING, NO FIEVER , NAUSEA OR DIARRHEA. MINIMAL HEADACH AND ABDOMINAL PAIN. NO TREATMENT.

Myalgia & Diarrhea Narrative: Patient received the vaccine on January 4th 2021 and had body aches and diarrhea that night and following day. Symptoms have since resolved when self reported today.

Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, Fatigue Narrative: Lost time of work

Moderna COVID-19 Vaccine Extreme dizziness except when laying down since waking at 5am. Nausea with several episodes of vomiting earlier has subsided, but I'm afraid to eat or drink and get sick again. Severe fatigue and tiredness which are both unusual symptoms for me.

Moderna COVID-19 Vaccine Extreme dizziness since waking at 5am that persists still. Only goes away when lying down. Nausea with repeated vomiting earlier. Feeling somewhat better this evening, but afraid to eat or drink and get sick again. Extreme fatigue; unable to get out of bed.

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

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

Headaches, tiredness. Sunday still had headaches but worse after waking up. Started developing severe SOB, stomach ache. Early evening, had diarrhea until the next morning. Monday still had SOB, and headache. By Tuesday, SOB had kind of went away but still had headaches.

Saturday, headaches and tiredness. Sunday morning still had headache, later developed SOB, difficulty breathing, feeling sick, and diarrhea. Monday, headache and SOB throughout the day. Tuesday, SOB had gone away but still had headache.

Acute severe vertigo associated with nausea. Approximately 10 events each lasting 1-2 minutes. Treated with OTC meclizine and seems to have resolved. No associated headache. Only other symptoms was moderate pain at the injection site

Approximately 5 days after receiving 1st dose of vaccine, patient woke up from nighttime sleep feeling 'itchy' all over body. Found approximately 10 red, raised spots or 'welts' on skin that he had never seen before. They were sporadic, NOT clustered. He described as not quite hives. He checked bed for 'bugs' but didn't find anything. He had taken metaxolone for only the second time in his life before bed. Prior use did not elicit any type of 'rash' as described. He applied no topical nor ingested any oral medication at this time. He mentioned he has IBS and also had 1 instance of diarrhea. He then took 1 imodium. He was able to eventually fall back asleep. When he awoke the next morning, all but 1 spot were gone and no indication this had ever happened. He has experienced a mild headache off and off since injection, but nothing significant that keeps him from his normal business.

Symptoms of an enlarged spleen; Blood in stool that lasted 3 days; General tiredness; A spontaneous report was received from a dentist, a 63 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced general tiredness, blood in stool that lasted 3 days, and symptoms of an enlarged spleen. The patient's medical history, as provided by the reporter, included high blood pressure. No relevant concomitant medications were reported. On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 026L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis. On 04 Jan 2021, the patient had general tiredness. On 16 Jan 2021, the patient experienced blood in his stool. On 17 Jan 2021, the patient had symptoms of an enlarged spleen. He stated that he had intense pain on the side of the spleen. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, blood in stool that lasted 3 days, was considered resolved on 19 Jan 2021. The outcome of the event, symptoms of an enlarged spleen, was considered resolved on 19 Jan 2021. The outcome of the event, general tiredness, was considered unknown.; Reporter's Comments: This case concerns a 63-years-old male patient, who experienced a medically significant unexpected event of blood in his stool, and non-serious unexpected event of Symptoms of an enlarged spleen along with expected non-serious event of General tiredness. General tiredness occurred on the same date after the first dose of mRNA-1273, lot # 026L20A. The event of blood in his stool occurred approximately 12 days after first dose of mRNA-1273, lot # 026L20A. The event of Symptoms of an enlarged spleen occurred approximately 13 days after first dose of mRNA-1273, lot # 026L20A. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

12 hours after receiving my second moderna vaccination I started to get a fever of 101. Throughout the night I fought the fever with Tylenol. The following morning I still had a fever of 100, but also great fatigue, nausea, headache, and general body ache. From the on set of my first symptoms until they completed was 30 hours.

Muscle pain and cramp like symptoms mostly in legs over night for 6 days, fatigue, loss of weight and appetite

Day 1: sore arm, fatigue, headache Day 2: headache, fatigue, chills, mild nausea, body aches, joint stiffness Day 3: sore arm, fatigue, lower back pain, chills at night Day 4: sore arm, a period of body aches, a phase of fatigue, sudden lower back, neck, and knee pain Day 5: sore arm, fever, chills, lower back pain, stiff joints, neck pain, headache

2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence 2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise, cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement

Fever 100.1. Nausea. Joint pain. Fatigue. Chills. Pain redness rash swelling at injection site. Rash still on 2/14/2021.

Injection 1 - Slight headache. Appeared a couple hours after shot, went away about 4 hours after that. Injection 2 - Sore at injection sight. About 12 hours after injection, woke up with moderate chills and joint & muscle ache, diarrhea. Developed headache a few hours after this. All of these symptoms went away after 5 - 6 hours except for joint/muscle ache. Those took about a day to dissapear. On the 5th day after 2nd injection I developed a cough in the chest trying to expel phlem. Still have a little bit of chest cough (10th day) but very minor.

Severe Chills and High Fever 104 beginning 10 hours after injection, fever lasting 5 hours, return to normal range at 12 hours post onset, moderate headache with nausea and vomitting.

Severe muscle spasms in both shoulders extending down the arm where the vaccine was injected. Nausea, fever and servers soreness at site of injection

Developed chills, mild headache, mild upset stomach within twelve hours of vaccination. Persisted until the morning of the 24th.

I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs. I then tried to drink cranberry juice and eat 3 bites of a banana which I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days

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

Blood stain streaks bright red in feces; Nausea; fatigue; Headache; Diarrhoea; Feeling gassy; Fever; Vomiting yellow bile; A spontaneous report was received from a consumer regarding a 63-year-old male patient who received Moderna covid-19 vaccine and have experienced blood stain in faeces, vomiting, nausea, headache, flatulence, fatigue and fever. The patient's medical history was not provided. His concomitants include Baby aspirin (blood thinner),Potassium(for low potassium),Gabapentin(for pain),VitB12(for nerves),Duloxetine Hcl (Neuropathy),Doxazosin Mesylate ( for prostrate),Lisinopril(for hypertension),Simvastatin(for cholesterol) and Alprazolam(anti-anxiety).No information on allergies. On 10-FEB-2021, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine intramuscularly for the prophylaxis of covid-19 infection (Lot#015M20A). On 11-FEB-2021, he vomited yellow bile looking stuff, had diarrhea, fever and felt gassy. On 12-FEB-2021, he no longer felt vomiting, but felt nauseous, slight fever, fatigue and headache. On 13-FEB-2021, he felt nauseous and had blood stained faeces (bright red). Caller was informed to consult physician for treatment and her question regarding second dose for her husband. Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported. The outcome of the event vomiting is recovered, but other events are not recovered at the time of report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

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

Severe chills, shaking and fever lasting 6 hours. Fatigue lightheaded dizziness vomiting next 2 days +

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

Resident received 2nd dose of COVID vaccine 3/3/2021 at about 11:00am. At 18:08, primary care nurse at that time checked VS and noted resident's temp to be 100.2 with nausea and vomiting. by 18:15 resident temp was up to 102.1 and SaO2 83% and was placed on oxygen via nonrebreather mask. 911 was called and transported resident to hospital.

PER PT DAUGHTER. RECEIVED VACCINE AND HAD NORMAL SORENESS OF SITE. AFTER 5 DAYS, HAD SEVERE PAIN IN LOWER EXTREMITIES AND HAD TO GO TO HOSPITAL ER 3/5/21. WAS GIVEN STEROIDS AND NSAID AS WELL AS PAIN SHOT DURING VISIT BUT DIDN'T HELP PAIN MUCH. FELT A LITTLE BETTER NEXT DAY BUT WENT TO PRIMARY CARE AND WAS TOLD TO STOP MEDICATIONS FROM HOSPITAL. NOW WAITING FOR ULTRASOUND. DURING THE COURSE HAS EXPERIENCED SEVERE PAIN, SWELLING, HOT FLASHES, NAUSEA, AND LOSS OF APPETITE.

throat was swollen, difficult to swallow, no compromised airway, uvula swollen, TX: Patient given decadron IM and oral prednisone taper, patient responded to treatment and doing better

Mild headache and nausea about 30 minutes after injection. In middle of night had pain and swelling in left eye (same side of body as injection), left arm pain the next day.

sudden fever spike followed by intense vomiting/dry heaves which lasted most of the day but has eased in the day following...

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

During normal activity around 3pm 3/9/21, patient was overcome with nausea, vomited, and required assistance to his car and home. His symptoms persisted throughout the night into the next day (3/10/21), and he went to his primary care physician. He vomited multiple times in transport and at the physician's office. Due to the nature of his symptoms and his concurrent hypertension there was concern for stroke and he was taken to the emergency department at Medical Center for evaluation around 4pm. Stroke was ruled out, and he was sent home with a prescription for meclizine with a presumed diagnosis of vestibular neuritis. 3/11/21 patient did not leave the bed except to use the restroom, however vomiting controlled with meclizine. 3/12/21 symptoms persist and patient has not yet improved.

Severe arm pain at and around the injection site 6 hours after the injection. Nausea and slight headache during the night at about 3:00 AM that went away in a couple of hours. Arm pain persisted the next day. The following day the pain also involved the armpit, possibly lymph glands. Lesser pain at the injection site and arm pit areas the following day and was very slight the third day after the injection. Can?t wait for my second dose and despite the side affects will happily stand in line for my next dose.

Exstreme chills and body shaking for over 1 hour at 2 am next morning. Complete body ache all over. Headache and sick to stomach with no vomiting. Cold chills off and on for 2 days and very fatigue.

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

Fever of 102 all day. Nausea, but never vomited. Was in bed sleeping All day. Recovered the following day, 3-26-21

No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fatigue. No fever. Loss of appetite. Soreness at injection site which spread from shoulder to elbow of left arm. Chills. Poor night's sleep with most symptoms continuing in morning.

102 F temperature this morning. Taken with two different oral thermometers. Temp has now subsided to 99.5 F. Chills. headache, nausea, painful site injection arm, lethargy.

Chills fever for 36 hours. Sever sinus headache 36 hours. Flu-like body pain 36 hours. In-bed for 36 hours. Nausea, no appetite.

Body aches, strong head aches, heartburn, bloating, nausea, calmly, feel hot but no fever---for 3 days and counting

Started experience what can be described as cold like symptoms 12 hours after vaccination. Next morning had full cold-like symptoms (chills, muscle aches, stuffy head, dizziness). The second day felt better but became nauseous after physical exercise. The third day felt better in the AM but then started experiencing nausea and cold-like symptoms prior to bed. Today, the nausea continues when I eat.

30 minutes after Vaccine developed fatigue that persisted until hospital admission as below. 9 days after Vaccine developed acute onset nausea with vomiting and diarrhea. The following day developed abdominal pain. Ultimately 11 days after admission was admitted to the hospital with acute pancreatitis with workup neg for any other etiology or reason.

Shortly after the patient got his immunization, he felt nausea and like he was going to throw up and was sweaty. He was nervous and had thrown up before coming to the immunization appointment. He stated it is normal for him. He had to lay down and felt better after a couple minutes.

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

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

Soreness at injection site - prolonged. Extreme fatigue - chronic and ongoing. Loss of appetite Chills, fever elevated.

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

Moderna COVID?19 Vaccine EUA; moderate to severe headaches; fever up to 100.7 degrees; body chills; severe body aches; nausea; fatigue. If symptoms persist for two more days I will take my father to the emergency room. He is currently recovering at home.

runny nose - symptoms started approximately 8 p.m; diarrhea - symptoms started after 9:30 p.m. chills and fever - symptoms started after 10:00 p.m. used inhaler for breathing troubles - first known inhaler use 7:00 a.m. currently sleeping with bouts of chills and fever. time 8:45 a.m. has not gone to doctor or medical facility yet. Requesting to just get warm.

Patient received 2nd dose in series on 4/5/21. On 4/7/21 patient started to experience vertigo type symptoms including dizziness and occasional nausea. On 4/11/21 nausea became particularly worse and he also reported vomiting. Patient had an acute episode of dizziness in which he lowered himself down to the floor and remained there for 2-3 hours until his wife helped him up. On 4/12/21 he presented to the emergency department for ongoing nausea and dizziness. He denied other symptoms including fever, chest pain, shortness of breath, and abdominal pain. Patient reports having an appetite, but is unable to keep food/drink down due to nausea and vomiting. Upon exam patient had left-sided nystagmus, which worsened with head turning.

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

Headache, fever, nausea, chills, body aches, dizziness, tiredness, and ear ringing. All symptoms subsided accept for dizziness and ear ringing as of 4/18 6pm.

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

Per Spouse Client had the following symptoms after 2nc Covid vaccine Fatigue, vomitting, nausea and fever 101. Client also had fatigue and nausea with 1st dose of Covid vaccine. Client sees Dr. was notified of reaction via client. Spouse voiced client's symptoms improving today. No treatment. Client did have Covid illness last fall.

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

very sore arm, nausea, headaches, high temperature (99.4), felt like a zombie, felt sick, stayed in bed, unable to concentrate

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

Diarrhea in the form of very loose stools every day all the time since the moment of receiving the second shot.

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

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

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

swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment drugs were reported. 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 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; 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.

A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast

Sore arm below injection site, redness, swelling. Sore shoulders and lower back. 100.7 fever for 12-24 hrs after shot. Slight feeling of nausea. Fatigue for 48 hrs.

bleeding from rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from rectum) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding from rectum) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product use was not provided by the reporter. No treatment information was provided. The colonoscopy was scheduled for May. 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 reported soreness after 1st day of vaccination which went away within 24 hours. However, several after weeks after vaccination patient developed soreness at the injection site with a raised bump and redness surrounding the area on 4/28. There was no associated weakness in the arm except due to pain which prevented him from lifting his arm. The patient experienced diarrhea for about a week prior. He did not see a doctor for this and attributed this to a viral illness. The soreness and swelling resolved after 4 days. The patient reported the reaction on 4/28. He was given a prescription for PT, but as it resolved by the time of his appointment, he did not see PT. The patient reports that the injection was high on his shoulder, about 2.5 fingerwidths below the joint. He denies experiencing joint pain.

Muscle and Joint aches, upset stomach, mild loss of balance, temperature 102.4, Pain at injection site. Lasted for 48hrs

Severe diarrhea leading to a loss of 10 pounds over 24 hours. I went to an urgent care facility 36 hours after the diarrhea started and they sent me to the hospital emergency room for treatment. I was given 2 liters of fluids (lactated ringers & sodium chloride) and then sent home. The diarrhea finally stopped about 20 hours later.

Day 1: mild diarrhea; headache;muscle ache; mild fever Day 2: headache;muscle ache; mild fever Day 3: symptoms disappeared

Vaccine was administered at 9:30 AM 5/5/21 Aching muscles started 5:30 PM Fever and chills started 8:00 PM Severe nausea started 6:00 AM 5/6/21. Fever and chills continued. I was unable to keep down even water. I tried to stay hydrated, but vomiting continues throughout the day. Nausea stopped 8:00 PM 5/6/21. Fever and chills greatly reduced. symptoms reduced to mild muscle aches 6:00 AM 5/7/21 symptoms gone 6:00 AM 5/8/2021

patient died aprox 1 week after the 2nd dose . presumed cause of death stated by son was GI bleed. Not confirmed to be caused by the vaccine. Autopsy not performed according to the son.

Saturday 5/29/21 I experienced extreme fatigue, which kept me in bed all day. Sunday 5/30/21 I experienced nausea, vomiting and diarrhea beginning around 7:30 AM. Those symptoms had dissipated by around 8 PM Sunday 5/30/21.

hemolysis aggravated; dark urine; diarrhea; fevers; vomitting; severe fatigue; This literature-non-study case was reported in a literature article and describes the occurrence of HAEMOLYSIS (hemolysis aggravated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria (diagnosed with PNH 30 years ago), Blood transfusion dependent (Transfusion dependence) and Dystonia (smooth muscle dystonia). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (hemolysis aggravated) (seriousness criterion medically significant), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 26u/l (Inconclusive) Pre-vaccination and 22u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood bilirubin: 2.4 (Inconclusive) Pre-vaccination and 3 (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood lactate dehydrogenase: 305u/l (Inconclusive) Pre-vaccination and 342u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Haemoglobin: 11.9 g/dl (Inconclusive) Pre-vaccination and 7.1g/dl (Inconclusive) Post-vaccination (after dose 2). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue) to be possibly related. It was reported that the last dose of the concomitant medication ravulizumab, was given four weeks prior to dose 1 vaccination and seven weeks prior to dose 2 vaccination. PNH Clone was reported as 99% RBC, 99% granulocytes. A week following the second dose, labs showed >4 g/dL hemoglobin decrease from his baseline. No treatment medication reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's medical history and concomitant medications are required for further assessment. This case was linked to MOD-2021-151607, MOD-2021-151607 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's medical history and concomitant medications are required for further assessment.

Within 1 week, the following experienced severely inflamed: Colitis (Have had diarrahea for 5 weeks) Lower back (Received steroid shots) Prostrate (Was put on medication to reduce leaking and pain) Right risk (Received steroid shot)

24 hours after started with nausea, anorexia, diarrhea. Urging when nothing there. it went away after two weeks. after 2nd dose it came back and while it has gotten better, it remains with some nauseas (constant), anorexia, urges all the time.

Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.

Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea and teeth chattering, cold and could not move my left arm . Same arm as shot. I had a temperature of 101.2 Took tylenol, still sore and chills. Had to call in to work to say I was sick. Took naps mostly throughout the day, fever still persisting around 101. Took Tylenol, 2 hours later fever down to 99.1. Could not stay awake for long. Slept most of the day.

I started having gastrointestinal issues. I went to see Dr. after a week of taking Pepto-Bismol, antacid tablets and loperamide hydrochloride. He prescribed pantoprazole sodium 40 mg. After 2 weeks of using the medication, my problem didn't go away. After that I went to see Dr. he prescribed famotidine. I went back a third time and saw Dr. He ran some blood work and he told me to discontinue taking the famotidine and continue with pantoprazole. He told me that if it continues that he would refer me to a GI specialist. After a couple weeks, I was referred to a GI specialist. I am seeing Dr. I went and saw Dr. and he suggested an endoscopy. I had one done on 06/04/2021. He said it looked like there is an ulcer, but it did not perforate the stomach and he said that I have H-pylori. I had a follow-up appointment on 06/17 where Dr. prescribed me to take amoxicillin, omeprazole and clarithromycin. As of today, with the antibiotics it's causing me to have diarrhea several times a day. I am eating a lot of vegetables, fruits and only pork or beef. If I eat any fried foods or meat, it causes me to have black stools with blood in it. The doctor told me that it was my upper intestines that are affected. Dr. did advise me to not take my pravastatin while I'm taking my antibiotics. I was advised by all of the doctors to stop taking the ibuprofen and naproxen and switch to Tylenol. I am scheduled for a colonoscopy 07/19.

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

I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

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

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

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

Bedridden for 9 days. Chills high fever loss of appetite. Hospitalized for 10 days on oxygen remdesivir and antibiotics

Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.

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

Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain

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

The morning after the vaccination I woke up at around 5:30 am with severe diarrhea. One of the worst bouts of diarrhea in my life.

Day 1 headache progressing to migraine and nausea, injection site pain Day 2 - 3 continued migraine with aura, nausea worsening, runny nose Day 4 abdominal cramping , migraine subsided to dull headache Day 5 abdominal cramping worsening and muscle soreness (abdomen and lower back) hurt to urinate. Day 6 - 7 abdominal cramping subsided general soreness lessened Day 8 recovered

WITHIN 11 HOURS AFTER INJECTION - BEGAN EXPERIENCING SLIGHT RASH OVER MOST OF BODY- SORENESS AND INFLAMMATION AT INJECTION SIGHT (LEFT ARM), CHILLS, SHIVERING, ABDOMINAL PAIN, RISING TEMPERATURE (MAX 100.8) MUSCLE/JOINT PAIN, AND VERY SEVERE HEADACHES, LASTING NOW FOR THREE DAYS.

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

Severe pain in left arm now 48 hrs after shot. Fever on 2 consecutive nights - bedding and pillows soaking wet. No appetite - headaches.

Very drowsy 6 hours after injection until 48 hours after injection. Diarrhea 18-26 hours after injection. Feel normal48 hours after injection.

10:00 am - headache, pressure on frontal lobe 2:00 pm - headache excruciating, weakness in legs, nausea 2:35 pm - blood pressure 198/97 2:40 pm - severe headache 3:00 pm - muscular aches all over body, overwhelming weakness 3:40 pm - vomited, had to pull over while driving home 3:50 pm - somewhat relieved after vomiting, arrived home stayed in car (parked) for over one hour to allow headache and weakness to subside 5 pm - entered apartment, took blood pressure, 137/77 5 pm - temperature normal (98.0 F) 5-9 pm - muscle weakness, headache.

When given the first dose I had slight pricking when the needle went in and when they removed the needle. Otherwise no pain. Later that night my arm started hurting and I felt a sharp pain in my forearm, my fingers felt like millions of needles were picking them in both hands, and I had severe abdominal pain just below the belly button. The abdominal pain was so severe that I was screaming out in pain and my wife had to hold me. I took three ibuprofen, still have the pain, but fell asleep. The abdominal pain went away the next day. The other symptoms took a few days to get rid of.

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

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

I have had chronic diarrhea since receiving the Moderna vaccine. This is the third week experiencing the symptoms.

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

Sir are immediately for 30 seconds, then around bedtime, very sore arm all night and most of Wednesday 2/3 and minor pain on 2/4 2/3 morning unsteady and queezy for 1/2 day Irritated throat 2/3 and 2/4, throat still still raw

1045 Patient c/o nausea; he was encouraged to lay down on a cot, he however declined. Agreed to sit with RN in the Vaccine Administration room. He stated that he was nauseated prior to the vaccine because he had had coffee without eating breakfast. He was alert and actively interacting with this RN, while he waited to feel better. 1104 Patient stated he no longer felt nauseated. He walk out clinic stable.

Fever, shivering, temperature of 104, after taking 1000mg Tylenol, still had shaking/chills, headache, nausea temperature of 103. Took again 1000mg Tylenol. No information provided after Tylenol was taken.

36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection site, and severe diarrhea. The diarrhea lasted about 12 hours. I also felt general discomfort over entire body as if I had flu. This discomfort lasted for approximately 2 to 3 days. I was unable to perform normal activities during this time.

The day following vaccination, I started having lethargy, chills, lack of appetite, dull pain at injection site and sore neck and shoulders. by end of day, symptoms were as severe as when I had COVID last Nov. The next day, I felt fine, except for continuing site pain.

On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right arm., Unable to work. Seen by Concentra provider on 2/26/21. On 3/1/21, still feeling ill, unable to come to work.

Severe flu like symptoms, weakness, nausea, vomiting, muscle aches, dry throat, difficulty swallowing, 102 temperature

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

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

C/O abdominal fullness and unable to burp. C/O soreness in bilateral lymph nodes. EMS review, VSS, Patient burped and reported improvement in symptoms

arm was sore for 3 days. then a week later I had intense itching in my arm. It went away and then for a few weeks now I have had sudden onset of diarrhea. I have taken Imodium and it isn't working. I even tried eating a bunch of cheese.

Severe headache...nausea...dizziness..severe joint pain..uncontrollable body temps from cold to hot over and over

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

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

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

Relatively severe pain Rt. side lower back, side and moving to front intestine area. Persistent vomiting until 10:00 pm. Entire event from 12:15 pm until 10:00 pm. Mild pain and soreness all day next day (Sunday Feb. 28)

Severe vomiting, severe diarrhea, nausea, 99.1F temp. - started 03/11/2021 @ 09:00 - dissipated 03/11/2021 @ 16:00 Fatigue- started 03/11/2021 @ 09:00 Wife called primary doctor, doctor said if symptoms do not disappear in 12 hours go to emergency room. Since symptoms dissipated in 5 hours, pt did not go to emergency room.

Fever, chills, fatigue, nausea, diarrhea, itching all over (itching has resolved). All but chills and fatigue have resolved.

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

6 hours after injection had severe flushing of skin. Moderate to severe itching minor swelling of face and throat. Started to subside in 30 minutes or so. Went home took a Benadryl and slept for two hours. Had severe tiredness and some minor nausea.

Chills and feeling freezing; Vomitting; Abdominal pain; Difficulty breathing; Fever; A spontaneous report, was received from a consumer (patient's wife), concerning her husband, a 64 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chills and feeling freezing (chills), vomiting, abdominal pain, difficulty breathing (dyspnoea) and fever (pyrexia). The patient's medical history included history of congestive heart failure; triple bypass surgery done in 2017. The patient received dialysis on (Mon, Wed, & Fri), and was on oxygen 24 hours a day. The patient has allergy to valsartan and morphine. No Relevant concomitant medications were reported. On 11 Mar 2021, approximately within one hour prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, while at home, within an hour of receiving the vaccine, the patient started to experience chills and feeling freezing. The patient was taken to the hospital. The patient also experienced vomiting, complained of chills, developed abdominal pain, and had difficulty in breathing. The patient was currently in the intensive care unit. The patient's carbon level was high, needed a pit line and under bypap. The patient also had developed fever. Treatment medications included unspecified antibiotics and bilevel positive airway pressure (BiPAP) given to the patient at the hospital. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, chills and feeling freezing, vomiting, abdominal pain, difficulty breathing, fever were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

vomiting and diarrhea 4+ hours in duration fever of 99.7 extreme weakness and fatigue 16+ hours, (patient is still experiencing extreme weakness and fatigue at the time of this submission).

pt states he started getting nauseated, got the chills, sweating, body aches and pains. He says it made him very shaky and his teeth were chattering. He went to bed and suffered w/ his symptoms. On 3/25/2021 he says his symptoms seem to be improving. Pt sent his PCP a message about his symptoms.

Vaccine side effects included fever, headache, cough, dry throat, muscle pain, joint pain, gastrointestinal distress, abdominal pain, insomnia, arm pain, sweating, chills.

Within an hour I started getting a headache and felt nauseous. Very tired. Approximately 8hours later I had a 103 temperature and was vomiting most of the night and suffered the chills which made me shiver uncontrollably. I was feeling terrible the whole next day but the vomiting had stopped. The headache and fatigue along with more than usual muscle aches. The next day the headache stopped but the fatigue and muscle aches slowly diminished. Today I am back to about 80 percent of being normal still am a little fatigued.

dry cough, chills, and at that time he tested positive to COVID-19. symptoms have progressively worsened with diarrhea, fever with T-max of 101°, loss of taste and smell sensations

SINCE GETTING THE VACCINE ON 3/18/21 PT HAS BEEN EXPERIENCING NAUSEA, ,FATIGUE, AND CHILLS (NO FEVER) THAT HAVE NOT RESOLVED SINCE 3/18/21. SYMPTOMS ARE STILL ONGOING.

1.) Strong soreness in lower back and gut area. Hard to bend over. I don't typically suffer from back pain and didn't exert or do anything that might have strained muscles. Pain seems muscular in back and deep in lower gut/groin area in front. 2.) More concerning is the tinnitus or ear ringing I am experiencing. Very loud and unrelenting. Feels like ears need to be popped such as when air pressure changes. However, can't swallow hard or chew hard enough to clear ears. It's a bit flummoxing as it is unrelenting. Sounds like cicadas in my head.

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

First dose received 3/17/2021. First two days I had muscle aches. Third day, lack of coordination and fatigue. Fourth day also had chills, sneezing and runny nose. Brain fog, fatigue and lack of coordination improved over the following days. The second dose receive 4/13. First day fatigure, chills, lack of coordination and muscle aches along with a lot of soreness at the site of the injection. Second day also had dizziness, mild abdominal cramps and mild headache. Could not eat until midday. The third day dizziness, brain fog and lack of coordination continue. Close to a point of seeking medical care but probably worth filing a report.

Experienced nausea starting about 15 hours after the injection. Went home to rest. Started feeling fatigue, then temperature went up. At about 20 hours after injection, temperature peaked at 101 Fahrenheit. When I woke up the next morning, at about 34 hours after injection, most of the symptoms had disappeared or lessened. Three days later, I still occasionally experience mild nausea.

After first shot on 3/1/2021 all I had was a sore arm for a couple hours and nothing else a breeze but after 2nd shot on 3/29/2021 My arm was getting sore and sorer and by 6:00 p.m. I started to get hot sweats and chills for the next 24 hours. I became very weak and developed diarrhea badly running to the toilet all the time and that lasted for four days. I also developed on day two burning urination for 3 days like a bad UTI which I have experienced being a diabetic. On day four hot sweats and chills stopped but burning urination continued but I was able to get diarrhea under control using some very good medicine I had on hand - The light green anti diarrhea medicine in the bottle -can't remember name but I can get. I also got very bad headace and there is still some there to day on top of back of head

12 hours after my vaccination (first dose of Moderna covid vaccine) and while sleeping, I suddenly started having numerous muscle aches and a slight headache and fatigue that persisted for another 24 hours or so. I also has some intestinal trouble with pain and a bout of diarheea, which I haven't had in years. 48 hours later I feel back to normal with no pain or fatigue of any kind.

Sore arm at injection site within an hour or so. 4 days later fever 99.7, chills, body aches, abdominal pain

HEADACHE, STIFF NECK, CHILLS OF SHORT DURATION, LEADING TO IMBALANCE, FINE TREMORS, SEVERE "HEAD FOG", DYSPHAGIA,

He got the vaccine, by 6:00 he was running a little bit of fever, and took some Tylenol and took some more and went to bed with a little headache and a little fever. The next morning he woke up with a little headache, and by that evening his stomach started aching up, having diarrhea, throwing up and bones/joints and muscles were aching and felt tired. He continued to take the Tylenol. By dark Saturday evening he was getting better. By Sunday evening he was feeling pretty good again other than feeling a little weak, 3/28/21. He continued to feel week for 2-3 more days, but then was fine. He did call his doctor on Monday to let him know whether he should take the shot or not, which he did today, 4/23/21.

pt states today , april 27/2021 is the first day he has been able to get out of bed and dress for the day; symptoms started the morning after receiving shot which was april 14/2021, states body aches, chills and sweats (never took his temperature states he has not thermometer), no appetite but has been drinking, got up only to go to the bathroom; states he still feels lousy

I felt awful like never before in my life. This lasted 3 1/2 days. Joint pain, aches, fever, nausea, vomiting and extreme fatigue. My family thought I had actually gotten COVID. Still having reflux issues and not at 100% strength.

1st Dose: No reaction 2nd Dose (Booster): Nausea - Dizzy, could not stand for several hours. Severe Headache, Full body muscle pain. 3rd day symptoms cleared up 85%

Mil headache, muscle joint pain and Vertigo like symptoms that have lasted 1 week so far. The dizziness is coupled with nausea depending on my activity. I was unable to do much at all because of the severity of this. I will not take another vaccine no matter what. Being this sick is ridiculous, I will take my chances.

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

Since my husband has had the vaccine he constantly has bad headaches and nausea. NOT even a little bit had he anything close to this. We are worried about this and I've been thinking and thinking as at our age and his leukemia it is scary. He was worried enough that in the middle of moving to Fl from Ut he found a oncologist to make sure was not anything to do with cancer. We can get the medical information concerning that visit if necessary but really getting concerned this is a temporary illness as been to long

diverticulitis; sick in his stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (diverticulitis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DIVERTICULITIS (diverticulitis) (seriousness criteria hospitalization and medically significant). On 04-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick in his stomach). The patient was hospitalized for 3 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis) and ABDOMINAL DISCOMFORT (sick in his stomach) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient's diverticulitis did not have anything to do with the vaccine and he had no history of diverticulitis. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

The next morning (exact time was estimated) patient complained he didn't feel good. His symptoms increased to the point of his believing he has Covid again (with the exception of taste and smell); ie: restlessness; fever (off and on); extreme fatigue; coughing; labored breathing; loss of appetite; and difficulty sleeping. He already had Covid-19 and was hospilized over a week and returned home with oxygen and at-home treatment.

Fairly strong injection site pain for several days (unusual for me as I normally have no problems with past vaccines). 102.8 fever 12hrs after 2nd dose. Severe chills/shaking. Fever dropped to slightly over 100 from dose plus 17hrs through 63hrs, prior to dropping rapidly to normal. During duration of fever: headache, muscle aches, digestive tract gas and loose stools, weakness, lack of mental focus, tired, and general feeling of heaviness with some feeling of heart palpitations (not normal for me). Post fever, minor headache, weakness, and lack of mental focus continued through present (Dose plus 80hrs), but now almost totally gone. Appear to be starting Moderna/COVID arm with 4in diameter, round, itchy red spot on just at and below injection site on right bicep.

Headache, Nausea, Hot Temperature (sweating profusely), coughing (damage to chest), body aches, lethargic, sleeping 16 hours, blurriness, large amount of mucus. Tired, results similar to pnumonia.

I got my first shot actually felt better but the second shot my arm got very sore around the injection site and then I got deathly sick throwing up for around 8 to 12 hours got very week and dizzy headed and also messed my mind up to where I couldn't think right couldn't hardly walk had to hold onto the wall which I have some problems walking already but that made walking much much more difficult and after that started to feel better and so far I'm still feeling better just wanted to let you know how it done me to see if anyone else has or had any of these symptoms

3 weeks after injection: Sudden onset of hearing loss in one ear, feeling of fullness/congestion in ear. Absolutely not a bacterial ear infection - no soreness/pain, redness, or discharge. Visited an ENT Dr. and inner ear issue confirmed. Hearing test showed significant loss or hearing (loudness) and loss of word discrimination. Fri, 2-Apr: 1st COVID shot (Moderna). Slightly sore arm, no other symptoms/side-effects, all clear in 24 hrs. Fri, 23-Apr: Relatively rapid (over an hour or so) onset of hearing loss in left ear. Feeling of fullness in left ear, thought it might be congestion. Sat, 24-Apr: No change/improvement in hearing of feeling of fullness in left ear. Sun, 25-Apr: I started to feel dizzy. I developed vertigo, though I did not get nauseous. Slept it off. Mon, 26-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing or feeling of fullness in left ear. Dizziness returned after dinner. Vertigo followed, more severe than the previous night. Unable to walk without help. Vomited and the nausea passed. Vertigo abated a bit, though still present. Slept it off. Tue, 27-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing of feeling of fullness in left ear Wed, 28-Apr: Saw ENT. First hearing test. Test confirmed quite a bit of hearing loss in left ear and some in the right ear. Thu, 29-Apr: 2nd COVID shot (Moderna). No side-effects until evening. Slight body ache, mild headache, maybe a mild fever. Some dizziness after eating. Fri, 30-Apr: Continued mild side-effects from COVID shot. Some dizziness after eating Sat, 1-May: Side-effects from COVID shot completely gone. Left ear noticeably worse. Sounds more attenuated, speech sounded more distorted. Sun, 2-May: No improvement in hearing Mon, 3-May: 2nd hearing test. Test confirmed significantly reduced hearing (volume) and speech recognition in left ear. Agreed to steroid injections to try to clear the suspected fluid retention/swelling. Tue: 4-May: 1st eardrum injection (10 mg dexamethasone) at 11:00 AM. No noticeable effect through bedtime. Wed, 5-May: Woke up with notably improved hearing in left ear (now only 10 or 20% attenuated). However, felt dizzy as soon as I woke up. Dizziness persisted until late afternoon. Thu, 6-May: No dizziness Fri, 7-May: 2nd eardrum injection (10 mg dexamethasone) at 11:30 AM. No noticeable effect through bedtime. Sat, 8-May: No improvement in left ear hearing, mildly dizzy when I woke up, dizziness persisted until late afternoon. Hearing not great in right ear over the course of the day (maybe 20% attenuated) Sun, 9-May: Minimal improvement in left ear hearing, if any. Right ear still partially impaired. A little light headed at times, no real dizziness. Mon, 10-May: Not dizzy when I woke up at 5:30 AM. Made a cup of coffee and ate an oat bran muffin at 6:15. Felt mildly dizzy by 6:30, persisted through the day and started to abate by evening. Tue, 11-May: No dizziness when I woke up. Hearing in left ear marginally improved. 3rd eardrum injection at 4:30 PM. Wed, 12-May: Woke up with improved hearing in left ear, still some attenuation, almost no distortion, still some feeling of fullness in the ear. No dizziness. Thu, 13-May: Woke up with hearing unchanged from Wed (i.e. no back-sliding). No dizziness in AM, though slightly lightheaded. Hearing degraded as the day progressed. Fri: 14-May: Woke up with hearing worse as compared to Thursday. Feeling of congestion/fullness in ears (more on the left than the right). Slightly lightheaded, no dizziness.

Shot site pain, Low fever ,diarrhea, headache, shivering, bad general body aching, fatique All gone in about 24 hours

shot site pain, headache, shivering, diarrhea, fatigue, disyness, bad general body aching all the symptoms were gone in about 24 hours

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

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

Fatigue, nausea, and headache beginning day after the second vaccination shot (5/21/21). Treated by patient --- rest, fluids.

Shot hurt more than usual when administered. Experienced expected shoulder/arm pain, mild nausea and fatigue the day of and following day. Shoulder pain of varying degrees has persisted to this day - seems rotator cuff related, not debilitating but very uncomfortable at times.

Fever, chills (14 hours after vaccination), fatigue (0800 next morning, slept next 25 hours), mild lingering headache, nausea, loss of appetite (started 0800 next morning). No treatment, symptoms gradually receding.

The symptoms started 3 hours after the 2nd dose of COVID. I felt pain in my left arm ( the same arm where I was injected ), chills and fever across my body, sweating, numbness and electric tingling in head, dizziness and vertigo with sensation of wanting to vomit, a lot of pain in my joints, watery eyes and pain in my eyeballs, lack of equilibrium and orientation, and other symptoms.

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

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

Had 1st vaccine on 3/30/21started feeling ill on 4/2 on 4/5 went to hospital for fever, aches & pains, loss appetite shortness of breath, etc. Was back in hospital 4/9 ? 4/14 for weight loss, fever, aches & pains, headache high white count

Patient reported that he had the vaccine about two weeks ago and three days after the vaccine he started experiencing a very dry mouth, burning and discomfort. Pt also reported sores in the corners of his mouth that won't heal. Pt said that is has not gotten any better since the symptoms first appeared. He said that this has never happened before and nothing changed in his medical history except receiving the vaccine.

In March IBS started which I?ve never had before. Everything I ate turned into what felt like rocks , I got so constipated I couldn?t use the bathroom. I started to become nauseated every day. I was up every hour of the night. I tried drinking water to flush my body and stomach, I had trouble eating. I ended up losing 3lbs a week up to 20 lbs. total. I ended up in ER on March 17, 2021. I had to be wheeled in because I was so weak, I couldn?t walk. I had CT scans and bloodwork done. I was sent home after I had a bowel movement. I was also given laxative to take at home. I went to the ER again on 4/23/21 @ 5pm ( 2nd ER visit ) I had CT Scans with contrast, enema, and lab work. I was also hooked up to an IV. I had no blockages from CT Scan. The CT Scan showed impaction, I had to drink stuff in ER to flush system and was given another enema. Once I had a bowel movement I was released with laxative. I now take generic brand laxative and generic brand of medication every day. I was advised that it could take my intestines a long time to return to normal. After following up with doctor, he decided I needed to have a scope done on my lower GI. I am still having complications.

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

Swollen glands in neck, left side (fairly significant swelling) Extremely sore throat, difficult to swallow Fever around 100 - typical issues that with fever (tired, achy, etc.) Rash on chest

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

aneurysm; vomiting; greater than 35 days between doses of Moderna Covid-19 vaccine.; headache; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (aneurysm) and VOMITING (vomiting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0258218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 13-Mar-2021, the patient experienced VOMITING (vomiting) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANEURYSM (aneurysm) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.). The patient was hospitalized for 14 days due to ANEURYSM and VOMITING. The patient was treated with Surgery for Aneurysm. At the time of the report, ANEURYSM (aneurysm), VOMITING (vomiting), PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.) and HEADACHE (headache) 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 given by the reporter. No Treatment information were provided by the reporter. Patient received his first Moderna Covid-19 vaccine on 03 MAR 2021, the patient reports having a headache. On 13 MAR 2021, the patient experienced vomiting and went to the hospital. The patient was found to have an aneurysm and was admitted to the hospital for surgery. The patient was discharged from the hospital 2 weeks later. This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.

It started with diarrhea - after about three days a sore throat began on Sunday the 11th. The diarrhea continued - I emptied myself out and then it continued every three days for a good two weeks. By the following Wednesday, the 14th, I started contacting the doctors. They said it might be a viral infection. I went to Urgent Care Center on, (or it could have been Tuesday, the 13th) center. They gave me same diagnosis and they did a COVID test and that was negative. They gave me an oral lidocaine - whatever you gargle with for sore throat. My voice had been really bad. By Friday, my throat was better and a few days later the diarrhea stopped.

Extreme Pain in lower abdomen. CT Scan was performed. Results were diagnosed as Diverticulitis with Micro Perforations of the lower bowel. Strong antibiotics for 10 days. Follow up CT Scan showed the condition had healed.

Hide copied text Hover for details FINAL IMPRESSION 1. Adverse effect of COVID-19 vaccine 2. Hypokalemia 3. Acute alcoholic gastritis without hemorrhage PLAN New Prescriptions FAMOTIDINE (PEPCID) 20 MG TABLET Take 1 tablet by mouth 2 times daily. ONDANSETRON (ZOFRAN) 8 MG TABLET Take 1 tablet by mouth every 8 hours as needed for Nausea. Discharge Instructions I do suspect that part of your feeling poorly is from the Covid vaccine. However you are difficult situation also makes you quite vulnerable to feeling fatigued and worn out. The alcohol I am afraid is really bothering your stomach. Please cut down the wine as much as possible. I am afraid you are starting to irritate the lining of your stomach. I put you on an acid blocking medication given you something for nausea.

1. Sore arm started several hours later approximately 9 PM 12/29/2020 2. Chills started approximately 12:30 AM on the following day 12/30/2020 3. Severe myalgias and arthralgias with difficulty moving approximately 6 AM 12/30/2020 4. Fever starting approximately 6 AM starting 101.5-1 03 then later in the day 105. 5. Severe headache starting approximately 9 AM 12/30/2020 and persists but much less 6. Nausea starting approximately 9 AM 12/30/2020

Moderna COVID-19 Vaccine EUA Woke up at 1:30 AM to get drink of water, feeling somewhat lightheaded. Vomited and a few minutes later experienced diarrhea. Went back to sleep, woke up at 7:00 AM. Diarrhea again. Experienced slight headache and some lethargy. Can eat and drink but decided to fast for the day and just drink water. Went to work as usual. I believe I am recovered now.

Since date of vaccination (12/29/20), the adverse events, symptoms and side effects patient has experienced are the following: Pain, tenderness and swelling in the same arm of the injection. Fatigue, headache (on the second day only), muscle pain, chills. He is usually a very active person but now he has been sleeping a lot. He is also experiencing lack of appetite.

The next day I started to get the chills,fatigue,headache,muscle pain, nausea, fever. I came home and took 2 acetaminophen and went to bed. After I woke up the fever broke and I felt better.

01/16 Pt was called for status of vaccination. He reported fever, chills, body aches, nausea, diarrhea, temporary loss of taste and soreness at injection site. Pt did not call nor report to ER as advised when sx first occurred. He reported to RN during this call that symptoms resolved on 01/16.

Weakness upon waking 8am next day 1/17/2021, fever of 103.8 at 10AM. Administered tylenol, cold drink, temperature went down to 101.3 within the hour. Temperature varied between 99.8 and 101.5 most of the day. Vomited once after eating dairy. No fever today, 01/18/2021, experiencing tiredness and weakness.

Mild nausea beginning 15 minutes after injection and lasting around an hour, some fatigue a few hours later, and mild headache intermittently in first five hours

Patient received the Moderma Shot IM to L arm 0.5m CoVid Vaccine at 11:30am on 012220221 and then was taken to observation room and observed for 15 minutes. At 15 minutes the patient complained of Nausea and dizziness Blood Pressure was taken by 158/90 pulse 64 R 16 T 97.4 She noted no signs and symptoms of Distress Paramedics on the scene transported to ER at 12:00pm Paramedics reported diffuse rash all over body by the time the patient arrived at the hospital

24 hours later began feeling body aches, joint pain, headache, then suddenly 26 hrs later experienced extreme chills, pulse 125-160, fever 102.5, then vomiting. Paramedics called and administered zofran. Symptoms dissipated 2 hrs later but still existed. Next 24 hrs temp of 101.5 headache and body ache. 36 hours still fatigued but afebrile

Found dead at home slumped on the floor; Loss of appetite; Body aches; Feverish; A spontaneous report was received from a physician, concerning a 65-years-old male patient, who received Moderna's COVID-19 Vaccine and experienced feverish, body aches, loss of appetite, and death. The patient's medical history, as provided by the reporter, included diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia. Concomitant medications reported included metformin, glimepiride, lisinopril, atorvastatin, aspirin, methimazole, propranolol, and cilostazol. On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037k20a) for COVID-19 infection prophylaxis. On an unknown date in Jan 2021, some time after receiving the vaccine, the patient was feeling feverish with body aches and loss of appetite. On 09 Jan 2021 at approximately 21:30, the patient was found dead at home slumped on the floor. According to the paramedics, the patient was dead longer than when his wife found him, and no resuscitation was performed. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, feverish, body aches, loss of appetite, was considered resolved. The patient died on 09 Jan 2021. The cause of death was not reported. The reporter assessed the event, death, as not related to Moderna's COVID-19 Vaccine. The reporter did not provide assessment for the events, feverish and body aches, in relation to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 65 year old male patient with medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia, who experienced the serious unexpected event of death, non-serious unexpected event of loss of appetite, and non-serious expected events of fever and body pain. The event of death occurred 5 days after the first dose of mRNA-1273. The events of fever, body pain and loss of appetite occurred an unspecified period of time after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Definitive causal association is confounded by age and medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia.

Headache, Muscle aches, a "buzzy" feeling in the body, GI upset, brain fog, exhaustion upon arising and in the evenings. Soreness at injection site lasted 2 days, the other symptoms lasted four full days.

After about 3 days I developed a very dry mouth. It is like my salavery glands have stopped working. Very bad cotton mouth. Can not eat most foods, only those with high moister content. ****I AM NOT SURE THIS IS A VACCINE REACTION***** I am reporting it just in case others report similar symptoms.

After about 12 hours severe body aches started , then uncontrollable chills, and nausea. These lasted about 20 hours. Also very painful swollen testicle which lasted about 30 hours.

He got the vaccine yesterday, 2/10/21, and at 8:00 PM started getting chills. About 10:30 was getting joint aching with pain. Went to bed at 8:00 due to fatigue. Felt nauseated. Was hurting really bad with the joint pain that lasted until about 2:30 AM. He woke up this morning and is feeling much better. He did not take anything for the pain. It attacked his joints mainly his ankles and knees and was not able to move. His knees felt hot to the touch.

Minutes after shot felt woozy and light headed. As my fifteens was up , I started getting severe heightened sense of smell and could smell body odors from people all around me. Threw up before exiting building in rest room.Needed to get out of building ASAP fast for fresh air . Breathing-20 degree fresh air maskless helped but still felt weak so wife and medical aids brought me inside to isolated area on a cot to rest and take vitals . When I was sick with COVID-19 in September 2020 I had same issues with heightened smell and taste before I lost them for three months.

February 10,2021 (about 1030PM) Diarrhea, stomach ache/cramps last through the night and until the next morning. Thursday morning up about 05:00AM - sick at stomach, mild headache, body ached all over, freezing cold, temperature 98.3F, fatigued, slept most all day. Able to eat granola bar, hot tea-with sugar, (Normally do not take any thing in hot tea or coffee but was craving something sweet. Drank lot of cold water. Friday morning, sick at stomach, mild headache, body aches all over, freezing cold, Temperature 98.xF, fatigued, again slept a lot of the day. Ate a home made waffle for breakfast with syrup (Still Craving Sweets), black coffee, (continuation section),

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

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

RECEIVED VACCINE ON 2/9. FELT QUEASY BUT NOT BAD ON TUES PM AND WED. THEN FINE WED 2/10 NITE. ON THURSDAY 2/11 RASH STARTED ON LEFT ARM NEAR INJECTION SITE. TOOK OTC BENADRYL . STARTED SPREADING TO WHOLE ARM AND UPPER CHEST AND HEAD AND NECK. SEVERE SHEDDING OF SKIN. PAINFUL AND ITCHING. ON SUNDAY 2/14 WENT TO EMERGENCY ROOM AND WAS ADMITTED OVERNIGHT OBSERVATION. RECEIVED IV LIBRIUM, DIPHENHYDRAMINE, FAMOTIDINE, OLORAZEPAM, METHYLPREDNISOLONE SOD SUC (PF).

1. Upper shoulder achiness , increasing temperature ( peaked at 100.2 degrees F), body chills, slight nausea, overall body weakness. 2. Symptoms began decreasing Friday 19Feb21, disappearing by late afternoon, except for slight headache. 3. Symptoms almost gone as of this writing (9:30 P.M. 19Feb21).

Nausea, muscle ache, chills, arm soreness and head ache. I would describe my symptoms as serious, not mild or moderate. I felt that I was extremely ill for the first 45 hours. I ate very little and I could not bathe. I stayed in bed, leaving only to go to the restroom. On the 3rd day, I was much improved and I would characterize my symptoms as moderate. I was able to get up for short periods and I was also able to bathe. On the 4th day (today) I believe that I am symptom free with the exception of continued arm soreness at the injection sight.

Vaccine - Moderna COVID-19 EUA, dose 1. Patient received the first dose on 2/1 around 6PM PST in his left arm. By 2/2, the patient experienced arm soreness, and by 9PM, he felt pain in his right ear. On the morning of 2/3, the patient woke up with hearing loss in his right ear, slight dizziness and nausea, but was able to work and eat with normal appetite. On 2/4, the patient woke up with general malaise, dizziness, lightheaded feeling, GI discomfort (minor diarrhea and vomiting), sweating, and chills. The patient still experienced hearing loss. The patient was fatigued, and had no appetite; stayed hydrated and slept most of the day. The patient gradually became less fatigued and gained appetite from 2/5-2/8. On 2/8, the patient visited urgent care for his ear. The NP on site observed yellow fluid in the patient's right ear and prescribed amoxicillin and flonase generic. The patient took the amoxicillin for 10 days and flonase generic for 14 days. On 2/22 (D21 post vaccine), the patient saw his PCP, still reported hearing loss, but the doctor did not report any findings. The patient received a referral for the ear specialist. To date, 2/23, the patient has hearing loss in his right ear.

Severe uncontrolable shivering, fever, severe headache, 103 temperature, complete loss of appetite, loss of enengy

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

For 2-3 days after the 2nd dose (given on 2/10/21), I had a sore arm, aching and weakness all over my body, tired, nauseous and no appetite. I remaining in bed off and on for about 36 hours and then worked my way back to eliminate most of the symptoms. However, after that and continuing at this time, i continue to be achy, particularly in my joints and my hands, fingers and neck, and I find that my lower jaw seems to be moved forward when I awake in the morning. The achiness is particularly acute when waking in the morning, particularly in my fingers.. The pain is by no means debilitating, but it is noticeable. I would rate the pain 3 or 4 when waking and 2-3 throughout the rest of the day. I have not sought any treatment.

I developed a swollen lymph node in my right side neck just under lower jaw at rear. This presented itself as strong jaw pain like a bad cavity and soreness at the lymph node. I have a sore throat and have not been able to hardly chew or swallow without pain. This is still going on as of 3/3/21 but seems to be easing up a bit. I have a Dr. appointment on 2/9/21 to check it out.

Doubled over in pain in my stomach. Lasted for 5 hours add an excruciating level. Continued on for 24 to 48 hours at some degree. Still having some weird effects after reading at this point.

Mild dizziness onset approximately 10 minutes status post vaccine administration. Patient reports history of issues like this after blood draws, but improved due to frequent lab draws. Possibly "slight headache." Mild, intermittent nausea (unchanged from baseline that started this morning). Patient continually stated that he needed to get to a bathroom (not urgently), but it was quite a focus. He is having frequent diarrhea this morning after increasing Miralax dose last night for constipation. Patient with ulcerative colitis. Transferred via wheelchair to reclining chair and reclined to flat position approximately 10 minutes. Vitals stable. Positioning helped. Sat for approximately 20 minutes prior to leaving. Dizziness resolved prior to discharge. No concern about symptoms from patient or caregiver. Patient took diazepam yesterday and Celebrex yesterday (as needed medications).

STRONG SPASMS IN LOWER BACK. NOT NORMAL. NEEDED TO TAKE STRONG PAIN KILLER. ALSO, NEXT DAY - DIZZINESS AND NAUSEA.

On February 19th, one week after shot I woke up with severe dizziness and nausea. Room was spinning and would only stop by sitting up. Eventually dizziness subsided but had mild nausea all day. Dizziness returned each morning for following week but not as severe as on the 19th. Went to an urgent care where they gave me rapid and pcr covid tests. Both came back negative. Also checked heart and blood pressure multiple times. Everything was normal. Reported everything to my doctor. On March 6th, woke up at 7am with severe dizziness and nausea again. Dizziness is subsiding and nausea is gone. Seeing doctor on March 10th and will discuss then.

General body aches, tiredness, feverishness (but no actual fever) headaches, occasional nausea. Began +/- 5 hours after the shot, increased through the night and through the entire next day. Subsided the following night

Vaccine was at room temperature for>6 hours at time of administration. Weak, chills, very sore arm, and diarrhea.

Pain in my left arm where I received the shot, terrible Headache, internal fever, chills, tiredness, feeling of having a cold, feeling symtoms of vomiting, not wanted to eat.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: patient was very anxious prior to shot.

woke up 3/10/21 with 101.3° temp; temp was elevated between 99.7°-100.9° during 36-38 hours after injection; two times over the next day (3/10/21) between 12 noon and 6pm I experienced a very short dizzy in spell and felt nauseous ... felt "normal" the next morning (3/11/21) when i woke up

Started with bad headache, chills, 102 fever, then body aches, stomach ache, no appetite and fatigue.

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

Flu Like symptoms. Severe fatigue for full 24 hour period. Had nausea when trying to eat. I could not eat for over 24 hours. I had fever as high as 101.3F. Also, had chills. Symptoms better after 24 hours with loss of appetite still present. Temperature at 98.0F as of 3-22-21.

Stomach pain/abdominal pain started on March 4th, black stool started March 3rd (only lasted 4 days after the vaccine)-currently normal as of march 23rd and the patient states stomach pain is almost normal but not 100%, just an uncomfortable full feeling Patient didn't do anything and didn't see a PCP

Headache, extreme exhaustion, chills, 102.7 fever, nausea, body aches for 2 days and sore arm for 6 days!

Got his vaccine, stayed 30 minutes, had no problems. He went to bed, woke up and has mild persistent headache, mild persistent fever, achiness, body aches all over, flu-like symptoms, not much appetite. He did take Ibuprofen for the symptoms and is starting to feel a little better. The headache is gone, the arm is less sore.

Day 2, Wednesday 3/24 at 5 am body aches, headaches, weighted down feeling. Day 3, weighted down feeling, Day 4, nausea, vomiting, diarrhea. Day 5, weak and tired, Day 6, nausea vomiting, gassy, 102 temperature., Day 7 gassy, tired/rundown but feeling better.

I had moderate aches and pain. I had moderate to severe diarrhrea for 3 straight day. I had shortness of breath for 1 week.

Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29

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

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

6 hours after shot my throat closed a bit and had trouble swallowing. . . I took 2 benedryl and drove to ER at Hosp. . . They said it wasn't too bad. Observed me for 2 hours . . I went home . . I asked for Epipen script.

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

?Moderna COVID-19 Vaccine EUA administered at approx. 11:30 am Saturday morning. I woke up at 4:00 am Sunday morning (Easter) having aches. Throughout the day I have run a temperature of 99.5 to 99.7 degrees. I experienced some diarrhea at 5:00 pm.

Patient became nauseated and lightheaded after receiving vaccine, symptoms were resolved after 5 minutes with no known re-occurrence at this time

Vaccine received on Thursday at 3:08 pm. Headache, nausea, temperature (Tmax 101.7), extreme muscle pain and joint discomfort all day Friday. 2 Tylenol Extra strength taken at 10 pm on Friday evening and repeated at 10 am on Saturday morning (I don't like to take medicine and held off as long as I could). Temperature on Saturday in the 100.3 to 100.7 range down to the 99.1 - 99.5 range on Sunday. Intermittent muscle and joint pain that subsided by Sunday morning. Remain with occasional slight headaches and not feeling "normal"

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

diarrhea, nausea, feeling faint, exhaustion, headache, eventually congestion and cough initial symptoms cleared up by noon the next day, but the congestion and cough began the second day and have continued.

Approximately 12 hrs after the vaccine injection I experiences mild flu like symptoms. The flu like symptoms went away around 24 hrs after the injection. The following morning around 3:00 AM I woke up with severe lateral movement. I was not able to walk, experienced severe vertigo and nausea. These symptoms began to reduce 24 hrs later. At this point double vertical vision began and lasted for approximately one week. Currently I have mild vertigo 18 days after the injection. I am able to drive safely and the vertigo symptoms are reducing day by day.

blurred vision and sweats within 5 minutes of injection. +throat tightness. stomach cramping started several hours later.

Patient presented to local ED on 4/8 after having symptoms ~0400 with right sided numbness unable to move fingers on right hand. Patient also unable to use right leg properly to walk. Later ~0800 weakness, numbness progressed to left side and patient had worsening paralysis to all extremities, trunk, and to face. Patient was transferred to our facility for concern for guillain-barre syndrome. Once admitted, patient was intubated for airway protection and remains on ventilator receiving plasma exchange sessions for presumed diagnosis.

Stomach pain and cramps. Frequent loose bowel movements, 15-20 per day. Excessive gas (burping) and farting constantly. Fatigue and weak. Lack of sleep due to having to go to rest room frequently. Hemorrhoids pain and some bleeding due to frequent bowel movements. Functioning daily activities difficult due to having lack of sleep and frequent rest room visits. Symptoms still going-on as of 16 April 2021.

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

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

Chills, Nausea, Entire Body Aches, Fever, No Appetite, No Sleep, Headache for36 hours, starting 15 Hours after 2nd vaccine, Home location throughout. Urine discoloration.

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

On 3/8/21 65 y/o M received his first Covid-19 vaccine (Moderna) and states on 4/2/2021 he had a myocardial infarction with 2 stents placed. He discharged to home and was doing very well. Tuesday, 4/6/2021, he received the second Covid vaccine. The following morning, he had pain in his right ankle. It progressed and involved his left foot and ankle. Over the next few days his pain progressed to involve his legs, but stopped at the knees. He had leg weakness and associated diarrhea, fever and chills. He thought his symptoms would pass and tried to wait it out over the weekend. When he awoke on Monday morning, 4/12/21, he could not move his feed. He went to the ER and was diagnosed with Guillain Barre Syndrome.. He received 5 doses of IVIG with very good response. Patient states his leg strength is improving, but is not back to baseline. His arms are unaffected by his Guillain-Barre. He is in Rehabilitation now.

Woke up sweating dizzy, wanting to throw up (2 or 3 times to the point of dry heaving), arm sore Recommendation: Drink fluids/pedialyte to stay hydrated. Flu-like symptoms should resolve in 2-4 days, if longer than 4 days seek your PCP. You can take over the counter pain relievers/anti-fever medication such as ibuprofen, naproxen, or acetaminophen to treat your symptoms.

Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self

Pink round skin blotch outer thigh, not itchy. Flaking, very slowly diminishing. Abdominal pain, followed by chills then vomiting. This occurred 5 days after the shot. Subsided after about 24 hours.

Patient received 2 doses of Moderna vaccine: 1/18/2021 and 2/15/2021. Admitted to Hospital on 4/25/21 for blood in stool. Tested for COVID as part of routine admission testing for COVID-19 on 4/26/21. Patient asymptomatic for COVID-19.

Patient presents to a hospital with a complaint of weight loss with diarrhea. Onset was roughly 10 days prior to admission. Patient also reported shortness of breath with fatigue. In the ED, patient was found to be COVID positive.

The patient presented to the Emergency Department with shortness of breath, mild cough, fatigue, diarrhea, and weight loss. Upon presentation to the ED, the patient tested positive for COVID-19 (04/28/21). The patient is currently being treated with dexamethasone and remdesivir.

65-year old man with PMH notable for CAD s/p 3v CABG 2015, HFrEF (EF 54% 11/2020), CKD, T2DM (A1c 7.5% 9/2020), and OSA, presenting with 2 days of weakness, malaise, difficulties getting out of bed and walking. The patient was in his normal state of health until he got the 2nd dose of the moderna covid vaccine two days ago; since then he has been somnolent, weak, not eating or drink much, and slid out of his bed and woke up on the floor once. He came to the ED because he was so weak that he couldn't walk. He furthermore endorses suprapubic and generalized right-sided abdominal tenderness that started after two episodes of nonbloody emesis and chills while waiting in the ED. He denies fevers, chest pain, dyspnea, orthopnea, lower extremity swelling, palpitations, brbpr, melena, dysuria, rash, easy brusing/bleeeing, headache, vision changes, and sensory changes.

Very tired that afternoon later that night Chills, low fever, aches, nauseous ,headache ongoing Noticed burning spot on face above right eye Saturday 5-1-2021 then it spread to bigger area forehead and top of head it is a blistery burning rash , welts on face and head. Still ongoing 5/2/2021

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

Emergency room visit and subsequent Hospitalization x 3days for severe vertigo, nausea, and vomiting. Transferred to rehab hospital for therapy to treat vertigo.

NAUSEA, DIARRHEA, SEVERE COUGHING, MUSCLE/ BODY ACHES, SEVERE SHORTNESS OF BREATH, PAIN WHEN BREATHING, HEADACHE MY HUSBAND WAS PUT ON FULLTIME OXYGEN TODAY

About 2 weeks after the second Moderna shot, patient developed dry cough and noticed a weight loss. Patient went to Dr. to report condition. Dr. did bloodwork, chest x-ray, and abdominal ultrasound. All came back negative. Patient has subsequently started taking Ensure, which has stabilized weight, but continues to have digestive issues, which is mostly stomach gas that seems to come mostly severely when sitting down. Patient takes 1-3 Tums a day to deal with gas, but has not returned to Dr. as the situation seems manageable, though somewhat distressing as gas has never been a problem with patient before. The dry cough, the wet loss of about 10 pounds, and the stomach gas, all seemed to develop after the second Moderna shot. The patient did test positive to Covid in November, 2020, and had a mild case that did not require treatment.

Pt admitted hospital on 5/21/2021 for vaccine reaction, received first moderan vaccine 5/20/21, severe nausea, vomiting, weakness, falls, history of severe COVID-19 infection with pneumonia and resp. failure requiring hospitalization and 02 in October 2020, had been well after, feeling back to normal 5/21/2021 AM, discharged home, follow up in clinic 1 week, Dr followed in hospitalization.

Headache not relieved by Ibuprofen 800mg and BC powder, body achy and bones hurt, sick to his stomach (wanting to throw up), loss of appetite. Patient reports he has taken: Pain killers Ibuprofen 800mg TID, BC powder once or twice a day.

Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and have problems getting it down throat/Heimlich to get food out; Had problems breathing; can't think straight; Fever; Chills; Muscle soreness in back/Muscle soreness in legs; Muscle soreness in ankle; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Had problems with throat getting stuck/Heimlich to get food out) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle). On an unknown date, the patient experienced CHOKING (Had problems with throat getting stuck/Heimlich to get food out) (seriousness criterion medically significant). At the time of the report, CHOKING (Had problems with throat getting stuck/Heimlich to get food out), HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle) outcome was unknown. Concominant medications included unknown cancer medications. On an unknown date, treatment included the Heimlich maneuver. 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. 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.

Extreme dizziness, nausea, vomiting that started Saturday May 29th and has not subsided. Trip to the emergency room and appointment with provider.

Woke up the 2nd morning and tried to stand up, I immediately fell back onto bed and the room was uncontrollably spinning very badly. Tried to call out but was unable to due to the dizziness. after about 10 min the dizziness subside enough to call out and get help. was unable to lift my head off bed without uncontrollable dizziness. stayed in bed the entire day with 1 trip to bathroom. The trip to the bathroom I basically crawled since I was unable to stand up. The dizziness lasted for about 5 week. Unable to look up due to dizziness coming back. I lost 7 days of work and was extremely cautious of falling over going to work. Loss of appetite, balance, and a feeling of nervousness lasted for many weeks. Visited by family doctor and said it was nothing and not related to corvid injection. Visited neurologist and said it was not related to corvid injection. N one seemed to know what the problem was except I know it was caused by the injection.

03/20/2021- I went to fashion show and had a drink, I came home and had a meal, that next morning I woke up and felt like I had pancreatitis, in severe pain, I stopped eating and went to liquids only, sent message to Doctor, had complete blood work done, I also had prostate pain. I remained on liquids such as watermelon juice and coconut water, my pancreas is still bothering me, I still get occasional abdominal pain. Have not fully recovered, I see doctor in August.

The patient had a raised area where the vaccine was administered immediately following the injection. A few seconds later the patient reported not feeling well, claiming to be light-headed. He was light-headed for a few minutes and then reported feeling nauseas. A few moments later the patient vomited. He took a few sips of water and reported feeling much better after vomiting.

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

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

Patient became dizzy, weak and woozy/nauseous. He reported that he may have passed out for a quick moment.

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

extreme nausea, heart palpitations, sweating (first night). Weekly bouts of nausea, reduced appetite, weight loss, difficulty waking up, brain fog.

Moderna COVID-19Vaccine EUA Arm soreness, headaches, nausea, chills, fatigue, dizziness; started the morning after I received the injection and lasted 24 hours. 48 hours later I still have fatigue and headaches. (It is noteworthy that I had COVID in October, recovered at home, in bed for 3 weeks. This was very similar)

I developed a hive/rash below and above my waist line on my stomach area. I also felt bloated in my lower stomach. I noticed it when I was undressing for bed. It was a mild reaction that came and went quickly once I laid down to go to sleep. Some belching relieved the bloating in my stomach.

Moderate injection site pain, mild loss of appetite, mild headache, mild fatigue and mild nausea. No treatment.

18 hours after injection, patient described fever of 102.5 degrees, chills, shakes, and nausea. All symptoms resolved within 24 hours.

Vaccine given 1-7-21 @ 3 PM. On 1-8 around 10 AM started to feel hot, got chills around 1 Pm. Eyes felt hot with shaking. Subsided around 3 PM. Felt fine. On 1-9 while at home around 10 AM my stomach growled and I stood and had explosive uncontrolled diarrhea. One bout. Felt perfectly normal since.

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

After vaccination, pt. returned home and later had nausea and vomiting. The next evening he also had diarrhea. Pt. reported to hospital today and is currently being treated for n/v and diarrhea.

1/15/2021 Took 2 Tylenol Extra Strength 500 mg about 1:00 pm to prevent injection site pain. Chills began about 7:00 pm. Took 2 more Tylenol at 8:00 pm. 1/16/2021 Fever spike of 102.2 at 3:00 am. Took 2 Tylenol. 8:00 am headache and nausea and took 2 more Tylenol. 8:30 am fever down to 98.7. 9:30 took Nurtec ODT 75mg for severe headache. Extreme fatigue. Slept for several hours. Headache subsiding. 2:00 pm fever back at 99.2 6:00 pm temperature back to 98.3 Went to bed at 8:00 pm with 2 Tylenol and body aches. 1/17/2021 feeling back to normal. Patient was covid positive in July of 2020

Dizziness, nausea, headache. Nausea and dizziness began in a few minutes. Nausea very mild and sporadic thus far. Dizziness/lightheadedness more intense and lasting. Mostly gone after 4 hours. Headache briefly and mildly about 3 hours post injection

after 2 days in the evening was hit with a severe stomach pain, after 1 hour started getting heat flashes and chills, lasted untill I woke up on Sunday the next day. Feeling weak, but better so far.

5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9:00 am. - progression of previous symptoms with addition of discomfort on chest area, severe acid reflux. 1:00 pm. - further progression of previous symptoms with addition of pain in neck and jaw area and headache, occasional feeling of shortness of breath. 7:00 pm - all symptoms began to progressively decrease in mostly the same order of onset. 11:00 pm - Continued decrease in symptom severity. 1/24 @ 8:00 am - Symptoms subsided with exception of minor degree of swallowing difficulty and reflux.

Explosive diarrhea occurred four and one half hours after receiving 2nd vaccination. Single event (so far... its now 6 hours since vaccination). Diarrhea is not a common health event for me. It is not listed as one of the common side effects so I thought I should report it. I have not been been feeling ill. Event came on very sudden. I had eating lunch between vaccination and diarrhea. Only side effect from first shot was a sore shoulder for two days.

Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3-4 days after receiving the vaccine. Last phone call to daughter expressed extreme nausea and seemed to have altered mental status. Found dead by daughter on 01/04/2021.

Around 8:30PM started to feel bloated and the feeling of something out of the norm. Around 8:45PM-diarrhea. Then, nausea followed quickly. Stood up, felt light-headed, and vomited several times. Went to bed around 9:30PM. Got up 3 times during the night with diarrhea. Got up in the morning and felt fine. No headache or fever. But was feeling chilled when I went to bed.

8 hours after injection started with extreme fatigue, chills , sore arm. Over next 7 days experienced severe symptoms : fatigue, myalgias, chills, arm pain, nausea, vomiting , abdominal pain, mental fog, insomnia, anorexia, change smell.

Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021

On the way home from getting the vaccine I started feeling tired and I had to stop a few times on the way home, when I got home I just laid in bed. I took some ibuprofen for the headache and had no appetite. The next day I felt fine.

2-4, 11:00AM - Achy and blah. Very light 'flu-like' feelings. Some nausea, slight sinus pain / headache. Lasted throughout day and evening. Temp. 99. Some small shots of pain up neck and in right shoulder. Possibly not related. 2-5, 09:00AM - Temp. 96.3. Still some light nausea, etc. 10:30AM - Feeling basically OK. Shot site was sore with some slight under arm lymph tenderness. (2nd shot was very painful and burned, unlike 1st dose which was amazingly painless with very little shot site soreness, if any.) 04:00PM - Discovered rash around shot site. Rash was blotchy, somewhat and about 4-5 inches in circumference. Slightly itchy. Rash continued through 2-10-21 with a bit of remanent through 2-12-21.

Second day: sore arm and neck (over by next morning), dizzy spells and nausea (ended by evening), temp 100 (normal by next morning).

Terrible pain left shoulder (deltoid) terrible flu like symptoms, felt like throwing up. .. bad enough symptoms that I called 911 fever of 103.1 for a few hours. This woke me up at 2:30 am Now at about 12:30 pm arm still sore but most other symptoms gone away, but still feel like I got hit by a truck.

Diarrhea, fogginess, and large red, swollen, warm,painful area about 5 inches below injection site on left arm.

Patient received his injection at 12:20 pm. He was observed for 15 minutes and released. Almost an hour later he was still grocery shopping in the store he stated he very rapidly became dizzy almost like vertigo, began to feel shaky and sought a chair to sit down. He quickly became very nauseous and found a nearby trashcan to vomit but states he could only dry heave 3 or 4 times. He became quite pale and sweaty. He was observed by his wife accompanying him who is an RN. After appoximately 15 minutes the patient began to feel somewhat better. He was given a bottle of water to drink and he could sip it successfully . He was able to stand successfully and walked back to the pharmacy where I checked his blood pressure (136/86) and pulse (68). He refused a 911 call and said he felt about 95/100. Will check on patient again later this afternoon. Patient will check with his doctor before getting the second vaccine.

30 mins after vaccine was shopping at the store that administered the vaccine and had a severe dizzy/vertigo episode. Had to hold shopping cart and sit down. 3 mins into dizziness I became nauseated and had to find a garbage can to vomit into. I had 4 episodes of dry heaving and was diaphoretic and sat for 15 mins and slowly the dizziness subsided. Pharmacist asked me to return to pharmacy the gave me water and took my BP. 136/86 HR68. It is now 3 hours later and I feel much better. I just ate lunch. I'm very healthy with no issues and this literally floored me.

Severe arm pain at area of injection about 9 hours after shot (bedtime). Next morning very severe total arm, head and joint pains, total fatigue, mild fever, no appetite. Unable to get out of bed except once to urinate which was a painful struggle. Next morning most symptoms subsided greatly. Only a mild headache and moderate arm pain remained. As of this writing headache is gone but moderate arm pain at injection site continues.

He states that he began urinating every 2 hours at approximately 6 p.m. the day he received his second vaccine (approximately 4 hours after his vaccine) and this lasted until 8:00 a.m. the following morning (14 hours). He had no other urinary complaints to suggest an infection. He also had 3 episodes of diarrhea, fatigue, and joint pain following his second dose of vaccine.

About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like "in another world", feels weak at times. Feels dizzy. Has and "eerie" feeling. Feels "equilibrium is off". Took Benadryl on 2/20. Has some disorientation "forgot what he was doing" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2

Onset of chills after 20 hours of injection followed by nausea and lightheadedness as day progressed. Symptoms completely gone after twelve hours.

I started by getting a modest headache in the early afternoon. About 3 PM feeling fatigued. About 5 PM I began getting chills. By 7 PM headache became a bit stronger, and loss of appetite; becoming more fatigued; generally just feeling "crummy". About 8 PM I took prescribed amount of regular strength Tylenol, and went to bed, easily falling asleep. Woke about 7 AM next day feeling noticeably better. I took another dose of Tylenol, just as a precaution. I would say by 11 AM all illness was gone.

About six hours after receiving the Covid Moderna vaccine I quickly began constant tremors that was strong enough that I could not walk or stand. I did not have a thermometer but I?m certain I had a fever. This lasted throughout the night. The following morning I was bedridden, unable to eat and had flu like symptoms. This is continued for three days now. I am slowly Beginning to gain strength but I?m still bedridden.

19 days later (following first daytime cardio exercise in ages), chills, stomach pains, bad headache that evening. Okay next day and night but then next two evenings chills (not lasting as long) with eventual headache (more treatable). Okay again today, and will contact Clinic about it in case they want me to get a Covid test before the second vaccine. Concerned that the "reactions" have been so long after the vaccine, and that it was only the first vaccine. Can find no info matching this course of events....

Fairly strong headache in the middle of the night. Took 500mg acetaminophen, which worked well. Awakened Saturday morning to the call of diarrhea. After four additional visits to the toilet in the next two hours, I started keeping track of these episodes. Over a period of 24 hours (Sat 8am-Sun 8am) I HAD to visit the toilet 31 times. Each episode was accompanied by a serious need to evacuate my bowels. Lots of pressure and pain in my intestines, every time. The first 4-5 sessions had considerable content, but after that, the almost-liquid movements could have been captured in 2 tablespoons (not a lot of content). After about 12 visits, which required vigorous wiping to remove the gelatinous remains, my long-dormant hemorrhoids started bleeding bright red and rather profusely. By the 18th visit they had reduced to pinkish smears, and remained that way until the present. I also became very tired and sluggish after about 8 hours of repeated toilet visits. The diarrhea episodes continued all night, allowing me only short cat-naps in between episodes of gnashing pain. After 24 hours (Sunday morning), the diarrhea episodes reduced in intensity and frequency, but the near-liquid consistency has remained through till just now (Sunday evening) where the content is slowly growing (about 1/2 cup) and beginning to have a little more solid appearance. I have been napping all day.

Within 12 hours of my second shot I experienced the typical symptom cluster, headache, fever, aches, and fatigue. I then experience stomach cramps and a brief bout of diarrhea. All of the above symptoms resolved within three days, however the stomach discomfort and cramping persisted for more than a week. Upon going to my local ER I was subsequently diagnosed with appendicitis. I am suspicious that this was triggered by the vaccine, as there is growing evidence that the appendix plays a role in the immune system, the response of which was exploded by the second shot. I have never had stomach issues in the past, confirmed my medical exams and preventative colonoscopies. I am extremely healthy, eat well and my bowel habits are quite regular and reliable.

At 12:30 that night I woke and I felt like to throw up and diarrhea at the same time. I had a terrible headache, dizziness, nausea. I had chills. The next day I was still very, very sick and had a fever of a hundred degrees. And I was sick all day Saturday. Unable to hold down any water. Sunday morning it broke and I was starting to come out of it. Today I'm not feeling 100% but much, much better.

Patient has gastric cancer that was in remission. Within 48 hours of receiving the vaccine he noted abdominal discomfort and swelling which progressively increased and led to a diagnosis of malignant ascites within a week of the vaccine.

"Moderna COVID-19 Vaccine EUA temp of 101.6, extreme letheragy, dizzy, weak, cognitive impairment, body aches, chills, loss of appetite

for 48 hours following the shot the patient reported diarrhea, extreme nausea and no appetite then it went away.

Presented to the ED on 3/1/21 with progressively worsening SOB with cough for past 1.5 weeks. He also reported having bright red blood per rectum for the past 6 months. He denied fever, N/V, abdominal pain, etc. He reports that he stopped smoking ~2 weeks ago and this is when his symptoms started. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Saturday March 6th ~6:00am - Severe vomiting, sweats, chills lasting the whole day... Sunday March 7th ~ 3:00 - 4:00am - drenching sweat and dizziness preventing him from getting up. This is ongoing at this time. Sunday March 7th @ 1pm. Any movement of the head brings the dizziness back .

Approximately 5 hours after receiving my first Moderna vaccine I developed a cough, fever, chills, runny nose. I assumed these were some of the symptoms as a result of the vaccine. I monitored my fever for several hours. The cough persisted for the next 9 plus days and I didn't have any desire to eat or drink liquids. I lost my taste and smell during this 9 day period. On February 25 my wife and I took a Covid-19 self test at pharmacy. Also on this same date I went to urgent care My wife was concerned about my labored breathing. My vitals were checked and I requested a chest xray. I was given 2 prescriptions. 1 for Prednisone 20mg and Ventolin.

Vomit 2/18/21 12 hours Diarrhea 2/18/21 8 hours Sore muscles 2/18/21 - 2/19/21 48 hours, Advil Fatigue 2/18/21 - Current date Ache in the back of my head, lower right side 2/18/21 - Current date, Aleve helps it for short periods Bell's Palsy 2/25/21 - Current date, no medication

Flu-like symptoms -- chills, achy, tired, loss of appetite. Started 2nd day. Back to 100% normal by start of 3rd day.

Symptoms very similar to my shellfish allergy. Throat started to close up, hard to swallow. Note this was a mild reaction but a reaction all the same. A single dose of Benadryl was all that was required.

I had Chills, Felt Nauseated, Light Headedness, and a Slight Fever (100) approximately 24 hours after receiving my shot. It lasted overnight and I felt fine the next morning on 3-13-21. No Medical Treatment Required.

Fatigue, headache, muscle and joint ache, general malaise, chills, lack of appetite. Pain and slight swelling of injection site. Slept for 36 hours. Treated with 650 mg aspirin every 4 hours. Fully recovered in two days

03/13/2021: Presented to the emergency department for profuse diarrhea, tachycardia, and diffuse wheezing. Patient hypoxia was most likely secondary COPD exacerbation was started on IV steroids and transition to p.o. prednisone. Medication changes led to better heart rate control.

3-4 days after vaccine, developed asymmetric, localized edema in both ankles along with neuropathic-type pain in both lower extremities. Flare-up of epididymitis also with headaches. Nausea, malaise, which continues now, two weeks later. Started spiking high-grade temps every night up to 102.8 degrees. Weakness, fatigue. These symptoms are atypical for me!

Mild flu-like feeling, very tired, no appetite, only wanted to rest and sleep. I check my blood pressure often and during the day after my shot my pressure was high all day, at one point was 160 over 90. As of today, the 17th of March, my pressure has gone down to normal. My symptoms lasted just over 30 hours.

achyness, shaving fever and chills for 1st day diarrhea x 1 first day lesst fever and chills and achyness 2nd day small amount of achyness and fever 3rd day resolved by 4th day

In addition to the normal vaccine reaction such as Chills, heavy head, nausea, etc. I had severe diarrhea for 2 days. was able to resolve with 3 pills of imodium over a time period of 15 hours

Fever, chills, headache, diarrhea, shoulder ache, balance issue Tylenol for fever was resolved by 3/17/21 Still weak and diarrhea on 3/19/21

After experiencing chills, fever, hot flashes and stomach aching, extreme swelling around the left eye occurred to the point that there was no vision possible. This swelling lasted for more than 2 full days. Began to subside several hours after taking prednisone to reduce swelling.

Day after, extreme fatique. 3/20. Slight nausea. Ate cereal. Other food not appealing. 3/21. Injection area is hard, swollen. 6.5" x 3"

By 9:00 pm the evening of my vaccine I was having chills and a fever of 100 degrees. Not that high I know but for me it is and gave me a very bad headache and body aches. I did not feel good enough to try to sleep until about 1:00 am after using a heating pad and hot tea to try and chase the chills away and Ibuprofen for the aches. My shoulder was so sore from the shot that I could not lay on my left side. The following day I was about 50% better. No more chills but still slight fever and no appetite. Didn't feel good enough to do anything except take a nap. The following day I was pretty much back to normal.

Joint pain, body aches, loss of appetite, and sharp pain in left arm (could not lift arm for two days). Fever of 100 within 12 hours of injection. Fever went up to 102 and remained at that level for about 46 hours. Total recovery time was three days.

Pain in joints, body aches, and loss of appetite. Pain at injection site and could not lift left arm for over 24 hours. Fever of 101 started about 13 hours after the first vaccination. Fever went up to 103 and remained at that level for another 22 hours. Total recovery time was about 3 days.

Date and time adverse event started: 03/21/2021 Evening- Body aches, chills, nausea- Still occurring 03/21/2021 Evening- Diarrhea- Resolved 03/22/2021 Morning Date and time of vaccination: (list both if they received both shots): 1st Dose- 02/21/2021 @ 09:30 2nd Dose- 03/21/2021 @ 09:30 Brand and lot of vaccine: Moderna Lot # 00LA21A- 1st Dose 044A21A- 2nd Dose

Tiredness, Chills, Joint Pain, Mild Nausea. I started getting the chills during the night (night of receiving my second dose), and was cold most of the next day. I was very tired, slept most of the day, and felt some joint pain and mild nausea. I woke up today (second day after second shot) feeling a little tired, but basically fine, without symptoms.

Moderna COVID-19 Vaccine EUA. Approximately 16 hours after the injection, I felt tired. As the day progressed (within 2-3 hours), I experienced a feeling of malaise and body aches and no appetite and a slight runny nose. I took two (2) OTC Tylenol to relieve the pain (worked very well!) and consumed two (2) 12 oz cans of ginger ale over the next 8 hours. Upon waking up (about 40 hours after the injection), I felt rested, alert and about 95% of great. No symptoms or other side effects whatsoever since.

About 6 hours after injection, onset of headache, body ache, general overall lethargy. Then sleep interrupted by chills, and then sweats (so much so that had to lay down a towel and another towel for my pillow). The next day was dominated by body aches and headache (I rarely get headaches). Loss of appetite. This general condition of malaise lasted all day (the day after injection) and it was at times horrible. The symptoms started to subside by the evening hours and I was able to have a better night sleep. By the next morning I felt better.

Wheezing, tired, fever of 101.4, chills, muscle and joint pain, severe headaches, extreme nausea , swelling, itching and redness at injection site.

I had fever and chills starting about 12 hours after my vaccine. Plus, I had an upset stomach. These symptoms lasted for about 24 hours.

pt states that later that night he had a very sore arm, headache and dizziness that lasted about 24 hours then went away. About 10 later he developed diarrhea and this has lasted 3 days so far. He took Pepto Bismol for 2 days but this did not seem to help. He has an already scheduled appt w/ his Diabetic doctor and will discuss his symptoms with him to see what he suggest he should do about the diarrhea.

I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was having some joint and muscle pain, and stomach upset. I had no appetite and did not eat lunch. At supper I still did not want anything, so ate cereal instead. During the night I was restless, and expelled quite a bit of gas throughout the night. Stomach still uneasy. When I awoke, about 6:00 AM, I was hungry and attempted to pour a bowl of cereal but could not due to shaking. My wife found me in the middle of a grand mal seizure and called the ambulance. The ambulance, police, and fire company all responded. They provided medical care onsite and in route to Hospital. I had a fever of 102 degrees, had been biting my tongue raw, flailing arm and hyperventilating. I was somewhat disoriented and delusional. During my hospitalization the injection site was found to be very swollen and red. Ice was applied. An MRI was performed of the head and found to be normal. Several other blood tests were also completed. I remained inpatient from 3/25/21 through 3/21/21.

first night, chilled, heavy blanketing and slight headache. second day, headaches, fatigued, achy, nauseous. slept most of day. night heavy sweat out - wet tshirt, bedding. third day - continued headache, but feeling better.

he started with dizziness in early morning after the vaccine. As the day went on, it got worse. He is having nausea and severe dizziness. He will call his dr. tomorrow.

At about 11 pm on 3/26/21, patient experienced uncontrollable chills. He did not sleep well. On 3/27/21, he got a fever that ranged between 99.7 to 102.6. He could not eat and thinking about it made his stomach upset. Every bone and joint in his body ached, even his skin hurt and he had a bad headache. Tylenol did little to alleviate any of these symptoms. His fever broke on 3/27/21 about 11 pm. He still did not sleep well and slept until noon on 3/28/21. His symptoms persisted except for the fever, though he still had chills that night. He still did not feel well throughout 3/29/21 and 3/30/21 and he still ate very, very little until 3/31/21. On 3/31/21, he was able to eat and went to the grocery, but it wiped him out and he slept for a couple of hours in the afternoon. He still has a dull headache and very little energy that is keeping him from doing his daily activities.

Previously reported this last week Report #392105. Yesterday (4/1) had a 2nd episode of aching joints, chills and felt feverish (temp was 98.4). It seemed worse this week. Also, this week I had an added dose of mild diarrhea. Last week it started in the evening. Yesterday is started mid-afternoon, This morning I feel fine, just like last Friday.

Maderna vaccine. 13 days after 2nd shot my husband ran a high fever for 3 days, a 36 hour break then fever for 48 hours. Vomiting. Diarrhea . Has recovered. Did not go to hospital or covid screening location

"This is a 67y.o. male with a past medical history of ESRD on PD, undergoing eval for transplant HTN, Gout who presented to the ED with complaint of diarrhea. Patient states that started to develop mild diffuse abd pain with diarrhea 3 days ago. Has been going up to 20x a day. Denies fever, chills, loss of taste/smell, nausea, vomiting, chest pain, sob, cough. Denies sick contacts."

3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. felt he was getting very hot. itching down back of his head into his arms. reported pain in his throat, dificulty swallowing, felt like something was stuck in his throat. felt he had an upset stomach but did not think he was going to vomit. denied trouble breathing in his chest. no lip swelling, no eyelid swelling, no hives. pulse regular. 74. BP 150/70. O2 sat 98%. 0.3mg Epi given to right thigh at 1432. pt complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. BP 180/90 at 1435. reported "hammer to his head" headache at 1437. cotninued blurry vision and globus. BP 172/94 at 1438. 0.3mg Epi given to left thigh at 1438. 1440 pt getting very shaky, handoff given to ambulance.

1st dose: Swelling and redness on injection site (1st day). Chills, nausea on 2nd day. 2nd dose: Swelling, redness, nausea chills on 1st and 2nd day 10 days after 2nd dose: nausea, fever, headache, chills that lasted 3 days. Took Tylenol for three days.

Patient had syncopal episode, urinated, became nauseous upon rousing. Placed in trendelenburg, left side lying for nausea. Patient bp 85/52, HR 110. Patient sent to ER via medics

He got the vaccine and began with chills, body aches, joint aches, complete brain fog (out of it), fever to 100 (normal is 95.5), extreme fatigue (could not get out of bed) which lasted for 3 days. After 24 hours he continued with the nausea, body aches and cannot shake the brain fog feeling. Had lingering effects of nausea for 10 days, now being the 15th day he is still tired, still has body aches not his usual symptoms and feels a little out of it, brain fog. Not back to where he was before the vaccines. He took Tylenol for his symptoms. He did call his cardiologist who informed him that they would go away, which was over a week ago. He took a long bike ride 2 days ago, 4/7/21 but he was extremely fatigue other than his normal and not able to function the next day.

weakness; inability to rise; frequent urination; lack of taste for food/loss of sense of taste; inability to produce a bowel movement; inability to walk/inability to reach bathroom; blood sugar higher than normal; blood pressure higher than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (inability to walk/inability to reach bathroom), ASTHENIA (weakness), DYSSTASIA (inability to rise), POLLAKIURIA (frequent urination), AGEUSIA (lack of taste for food/loss of sense of taste) and CONSTIPATION (inability to produce a bowel movement) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (10 day hospitalization and administration of oxygen therapy) on 01-Nov-2020. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (inability to walk/inability to reach bathroom) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSSTASIA (inability to rise) (seriousness criterion hospitalization), POLLAKIURIA (frequent urination) (seriousness criterion hospitalization), AGEUSIA (lack of taste for food/loss of sense of taste) (seriousness criterion hospitalization) and CONSTIPATION (inability to produce a bowel movement) (seriousness criterion hospitalization). In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to AGEUSIA, CONSTIPATION, DYSSTASIA, GAIT DISTURBANCE and POLLAKIURIA, and then from 03-Mar-2021 to 06-Mar-2021 due to ASTHENIA. On 06-Mar-2021, GAIT DISTURBANCE (inability to walk/inability to reach bathroom) and CONSTIPATION (inability to produce a bowel movement) had resolved. On 24-Mar-2021, ASTHENIA (weakness), DYSSTASIA (inability to rise) and AGEUSIA (lack of taste for food/loss of sense of taste) had resolved. At the time of the report, POLLAKIURIA (frequent urination), BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment History includes ER visit, hospitalization, IV fluids, IV medications, "injections for blood sugar", EKG, scope to check for blood clots, physical therapy. Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus; Sender's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus

Severe hand tremors, weakness in legs, fatigue, irritability-ongoing since right after the second shot. 1 incident of vomiting.

Uncontrollable vomiting and diarrhea simultaneously; chills, Sweats, shaking,headache Beginning at Sunday,1:30AM, 04/11/2021 until 4:00 PM same day

Acute appendicitis with rupture. Was in hospital receiving IV antibiotics for 5 days. Woke wife at 3am and dressed and went to hospital with acute pain. Surgery at 6pm.

I received my 2nd Moderna vaccine shot on Wednesday at noon and wanting to report that starting about 11AM on Thursday I started experiencing fever type of feeling. By 3PM I was knocked out with a fever of 99.4 and felt generally lousy with no appetite. Had difficulty sleeping throughout late PM, evnening and overnight . up every 2.5 hours. Fever is normal this morning but lagging effect of fever and general weakness remains.

extreme fatigue (falling asleep in front of a meal for long periods can't arouse himself), severe frontal headache, loss of appetite, didn't eat for over 24 hours. Poor appetite for several days after this. The only symptom remaining was extreme fatigue that seemed sometimes to be improving and then return. Then woke up in middle of the night to go to the bathroom April 5th and couldn't coordinate his legs, they were numb. Equal in strength when checked in bed by me, but had to crawl back from bathroom in early morning. Since then the numbness comes and goes and balance issues come and goes, fatigue is getting worse again to the point where he is sleeping or too exhausted to move for most of the day. S

Patient reported to ED with severe dizziness, emesis and left arm heaviness that started at about noon on 4/1/21. Found to have a cerebral infarct.

deep vein thrombosis, blood clot in left leg and 2 clots in lung, pneumonia, in hospital 3 days, released 2 days and back in for 3 days with gastrointestinal hemorrhage with melena

dx VTE, observed on local imaging; abd pain Narrative: patient reports PE as diagnosed but local imaging did not appreciate same diagnosis. Abd pain continues despite 42 days removed from vaccine administration and other comorbidities present. Hospitalization prolonged for continued workup of reported symptoms

The patient woke up on 03/22/21 at 7:30 with multiple symptoms. He had a fever of 100.5, both hands were swollen to the point he couldn't make a fist, a rash from wrist to elbow on right arm, chills and overall hurting from head to toes. By the evening he had a rash on both legs from ankles to hips. He lost his appetite for two days. Also, for two days his glucose levels were between 300 and 408. Patient took acetaminophen but it didn't relieve his fever. His wife called his primary care provider, on 03/22/21. She was instructed to call a hot-line, which ended up being our county health department. She was told by them to contact his primary health provider. She didn't call the primary provider again. The patient's symptoms had resolved by 03/25/22 except for the rash on his right arm. The wife called Care physician on 04/09/2021 to talk abouth what happened to her husband. This time provider called the state hot-line. The state hot-line advised the patient not to take the second shot because the symptoms could be worse or fatal.

A few days after the normal second injection reactions of fever, chills, exhaustion, saw a rapid and extreme gastro disorder. Started with significant diarrhea for several weeks, and progressed to severe cramping and very odd lower abdominal pain, as well as generally mild nausea and lethargy. Family doctor ordered blood and stool analyses, which both came back negative. Doctor prescribed anti-diarrhea meds which worked within several days, and condition improved gradually until at this time am almost back to normal. Doc also recommended gastrointerologist(?) if conditions did not improve. Of course this entire sequence of events may have nothing to do at all with the vaccine, but it is unprecedented for me.

first shot, on and off dizzy, lightheaded, a bit nauseou 2nd shot, heart tightness, fullness, some tingling in fingers,

Fever, chills, body aches and headache beginning 11:00 pm the night of the injection. Tylenol did not help. Drinking water and cold compress on forehead finally helped enough to be able to go to bed at 3:30 am and sleep. The morning after vaccination fever gone but still had headache and some muscle aches, no appetite. The second day after vaccination I felt pretty much back to normal except for slight headache which is still present today which is the third day.

became hot, clammy, (nausea w/ results for over 15 hours), entire body aches, shortness of breath, it was like doing all over again, has been over 40 hours now better but not quite there