Moderna

101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, severe body aches,. tender nodes in neck, felt very ill, slept 24 hours, no appetite, itching.. I have improved but still itching and have hedache

Patient on evening of vaccine administration had low blood pressure, vomited, and had episode of loss of consciousness. Occurred in patient's home and spouse contact 911 after trying to communicate with her. EMS noted patient's blood low and transported to ER facility. Patient expresses she felt fine in ER and requested to discharge. No other issues after this episode and has follow-up appointment with physician given concomitant medical conditions.

12AM awoke with R arm in pain, nose congestion and pressure in sinus, occasional urge to vomit, nausea

Moderna COVID-19 Vaccine EUA administered at 10:59 am on 1/16/21. Felt ok for the remainder of the day. Awoke at 1:25 am ith severe pain in left arm injection site, headache, nausea, fatigue, muscle and joint pain throughout body, chills and low grade fever. these symptoms persisted until mid-afternoon on 1/17/21 and gradually subsided i took ibruprofen and drank water. Finally ate a slice of toast at 5 pm and noticed the pain at injection site was improving. 12 hours later, feeling ok but still fatigued.

Fever, sore muscles, sore joints, headache, fatique, nausea & chills. I had a positive Covid 19 test on September 9th. The symptoms I've had from the shot are pretty much the same as when I was sick. I was fortunate not to have any respiratory symptoms either time as confirmed by my oximeter. I had two Antibody tests. One on Nov. 23rd, which was positive for both IgG and IgM. I had my second anti-body test on 1/17/2021, the day of my injection which was positive for IgG and negative for IgM. I have not contacted my doctor concerning this and I am taking Advil for the fever and ached and pains. Today i feel better than yesterday.

On 1/17/21 staff reported that client had episodes of diarrhea x2. Client had extreme fatigue and was afebrile

Nausea and vomiting on 1/16/21 early morning and then noted at 9PM with hives to back and neck area-has been afebrile, 1/17/21 temp=99.7 continues with nausea and hives, 1/18/21 Hives continue.

Diarrhea 2-3 x daily > 7 days (+) Hx cholecystectomy (-) Risk or hospitalization (-) Abdominal pain Plan: Complete labs to assess for electrolyte abnormality ? CBC Brat Diet 12-14-2020 Covid positive

11:15 patient seated in observation area reported a "burning sensation in her stomach" and feeling hot Water given, encouraged to remove her coat RN offered to move to private observation area 1117 patient confirmed she was able to stand and ambulate independently. Patient walked with adult son to private observation area. Door opened for fresh air and patient seated next to door. EMT and RN assessing patient 11:18 VS: 150\88, HR 70, PO2 97% Patient stated she feeling better and shared she really thinks it was nerves Last blood sugar 142 taken at 8:30 before daily medications 11:22 apple juice offered and declined by patient. another water provided. patient stated she is feeling fine 100% better. 11:28 patient discharged from observation area. Self ambulated with adult son at side.

mild headache for 36 hours; exhaustion for 36 hours; sensitive to cold,unable to get warm for 36 hours, shivering a lot; vomited once after 22 hours after the injection. No fever.

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

Moderna COVID-19 vaccine EUA Headache, nausea, heart palpations, rapid heart beat, elevated blood pressure Trip to ER Heart was not impaired

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

strong headache , brain fog, chills, nausea, heavy chest, heart palpitations,dizziness hot red spot 3 inches on arm

Day 2 - Sore arm, fatigue Day 6 - fatigue Day 7 - extreme fatigue Day 8 - 100.2 temp, aches, chills, stomach ache, mild diarrhea Day 9 - fatigue, mild diarrhea, but no temp, aches, or chills

Evening: around 8:00 p.m. headache, arm sore, body aches, sleepy. I slept all night Saturday night, all day Sunday except for a few minutes three or four times, slept all night Sunday night. Monday I?m still tired and sleepy, now I?m nauseous..

VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early to bed. Tuesday AM awoke with severe 'bed-rocking' chills, nausea and fever 100-101 degrees. recommended I go to Hospital ER. At ER, temperature increased to 102 degrees. Covid test was negative, but cost X-ray showed reasons to suspect pneumonia. No one suggested I was just suffering acute reaction to vaccine. Returned home w/ prescription for doxycycline hyclate and request that I return to the ER the next day if I continued to feel ill. The next morning, 1/19/21, I again awoke with intense, somewhat frightening chills, vomiting and a mild fever. As instructed I returned to the ER. Assuming the COVID Test may have been a false negative, a second one was given; it too turned out to be negative, but I remained at the ER and then admitted to Hospital to remain under observation. Im the hospital the chills, nausea and fever came to an end, but acute headache and utter fatigue lasted until I was released on Jan 22. My discharge papers indicated no further signs of pneumonia or any other infection; my attending doctor, concluded that my experience was an unusually strong (and delayed) reaction to the 1st dose of the Moderna Vaccine.

A few hours after receiving the vaccine my arm was sore. It has stayed sore since then, Yesterday it was bothering me so I looked and noticed there was knot about the size bigger the a dime but smaller then a quarter. Slightly red area the injection site and has been itching. Feels warm to touch. I haven't really bad or anything. Since Saturday I have been trouble with my stomach which isn't anything unusual. It seems like it is upset.

shot 2:30 pm slept woke up got coffee, sat down felt dizzy sweating weak nausea high blood pressure 172/113

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

When I woke up to use the bathroom I was ataxic and had nystagmus. A while later I became nauseous. I took a baby aspirin because I was afraid I was having a stroke. This lasted about 5 hours. Then I developed a head ache just behind my nose. The headache subsided in the mid afternoon, but I was wiped out and slept most of the day. Today (the next morning) I feel fine, just a little tired.

Pt states she got her second Moderna COVID19 vaccine in her LUE yesterday 1/26/21. She developed a low grade fever and nausea last night. Today, 1/27/21, around 0800, pt states that she fainted, fell on her left side and injured her L elbow. She states that her husband found her and said it appeared as if she was having a "mini seizure". Husband states pts fainting/seizure episode lasted for 15-20 seconds. Pt states that her L elbow pain was 7/10, but is currently 2/10 and she is now experiencing some tingling in her L third and fourth fingers. Pt denies any hx of a seizure and is currently able to get up and walk around. Pt speaking in full and coherent sentences while on call. Pt advised by triage RN and PCP to go to ER for an evaluation

Very lethargic leading to flu type symptoms including achy muscles and joints, vomiting and very sleepy and tired

Patient came out of a sleep feeling numb all over and head felt empty. Thrashed about on floor with muscle spasms in both legs. Kept trying to hold onto head and not swallow the tongue. The attempt to swallow the tongue went on for one hour, if the patient was reclining on a bed. If standing, the tongue felt sore. The patient was still shaken, the next morning.

I slept for more than24 hours, getting up only 3 times to use the restroom and take Tylenal. I had headaches, body aches, dizziness and nausea. I will call my doctor tomorrow. I did not die.

Moderna COVID- 19 Vaccine EUA: one day after receiving vaccination patient presented to the emergency department with epigastric pain for three hours. Patient denies sweating, shortness of breath, nausea, vomiting, and diarrhea. Stated that soon after receiving vaccination experienced fever, chills, and myalgias. Initial vitals within normal ranges except for blood pressure of 158/77 mmHg. Patient administered antacids and lidocaine with symptom improvement. Repeat vital signs within normal ranges and patient discharged to home stable.

My arm wasn't sore right away but I think I laid on it and the next morning it was sore. It felt like a bee sting I took some medicine and it went away. On the 27th I had bad gas. I did try a new cereal and thought it was cereal. On the 28th I still gas and upset stomach like flu like symptoms and felt light headed but not bad. On the 29th still an upset stomach and had diarrhea, I was still light headed and really shaky. I was really weak. I was shaking a lot at arms (hands) and legs were both shaking and made it hard to walk. On the 30th I still really light headed and my legs and hands were still shaky, still having difficulty walking, still had an upset stomach and still felt weak. On the 31st my stomach was a lot better, I was still shaky and light headed, and I had a weak feeling. My head felt like when you feel like you have a head cold (pressure in my head). Today my stomach is better, I am still lightheaded and still shaky but not as bad. I still feel pressure in my head, but no runny nose or any other cold symptoms. These were symptoms I had in March when I was sick for 3 weeks. I was negative for COVID but didn't get back to my normal self until the June. Doctor was a private practice and recently closed so I do not see my new doctor till the 24th.

Headache, chills, fever, muscle pain, joint pain, nausea, vomiting, diarrhea, extreme fatigue, brain fog

Immediate swelling of tongue. Within 4 minutes of receiving shot. Slight nauseaness. Tongue returned to normal approx three hours later.

Diarrhea. Happened the first time on Friday 1/22/2021 , diarrhea 2 times then every other day once a day. Took Pepto Bismol 2 tablets.

Day 1 to Day 6: painful Left arm Day 3 to current Day 7: area red, hot, swollen and intense itching, w/redness increasing in diameter each day. Now the size of a baseball, and waking me frequently during the night w/ intense itching. Lethargy, nausea on Day 7

Muscle ache, right arm, 3first days; vomited dinner day 2 and occasional nausea 2 more days; joint pains off and on for first few days; "Covid Arm" day 8, ongoing: baseball sized 6" diameter hot red rash around injection site, and swollen finger joint opposite (left) hand. Ongoing, but pain and redness in arm is subsiding; finger joint remains swollen, stiff, and painful. Probably not related, 2 wks duration tendinitis left retro heel.

Tuesday after my injection I started getting nauseous, my right arm was very red and swollen along the injection site and overflowed into my upper arm. These symptoms lasted 7 days. When I went to bed on Tuesday night, I woke up early in the morning with palpitations, very nauseated, and light headed. The palpitations lasted about 2 hours, light headedness about 30 minutes. I had no further palpitations or light headedness after this.

Extreme pain and bruising in the left arm which lasted for 4 days, decreasing pain each day. I couldn't sleep lying on my left side. Very restless the first night with little sleep. Small bruise is still showing 7 days later. Mild headache, nausea, and dizziness for 4 days.

Injection Jan 19 - Jan 29 two red itching circles, one at injection site and one below. Grew together and formed large circle that was also slightly sore. Upset stomach. Both improving on Feb 5.

1. Very sore arm diminishing over 36 hours 2. diarrhea around 36 hours after 3. mildly lethargic for about 4-5 days 4. Mild headache for about a week. 5. after one week a large red, itchy, swollen area appeared at the injection sight (approx. 2" x 4") reduced over 12 hours to small area swollen and red at injection sight and that still exists 2 weeks later.

At 10:58 am patient stated "I feel like I'm going to pass out". EMS called. At 11:02 am patient stated "I feel faint" & c/o nausea and a "humming sensation" at bilateral ears. Applied cool compresses and monitored until EMS arrived at 11:14 am. Patient transported to local ER by EMS. Vital signs stable.

Woke up and started vomiting around 11:30 that night(2/5.) This lasted approximately 1-2 hours. Was unable to eat anything until late afternoon on Sat. the 6th. Had a bad headache throughout and bad soreness at the injection site. Still have headache (approx. 5pm on Mon. 2/8) but soreness at injection site has almost disappeared. I do not have a primary physician so have not called anyone. Am now taking Advil for headache which helps but it returns if I stop.

Patient presented with bright, flushed face; nausea; chest pressure; medic on-scene performed EKG; patient refused transport

Patient woke up this morning after a restless night and pain in the arm. She was nauseous more or less the whole day and now, 9pm on 2/11, her temperature is 101.4. She is taking tylenol regularly.

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

pt stated her left arm was sore and warm to the touch after getting the vax. On the next day she developed a fever of 101-102 along with fatigue, nausea, weakness, so she slept all day. Third day her fever was 99.8, she still had fatigue and arm was hot to the touch at the injection site. She now has a rash an inch below the injection site and is about 3x4 inches in size. Pt has not contacted her PCP at this time.

NO fever at all during this time or shortness of breath. Pain in the arm at injection site up into neck and top of head. (48 hours) Tylenol for pain. About 3pm Saturday 2/6: Concerning spike of blood pressure 154/92-resulted in urgent care visit. Covid test taken as precaution by MD. Mom not "feeling well" 0630 Sunday 2/7: BP spike to 166/109, Blurry vision, dizziness. EMS called to assess at home. followed up by ER visit. all tests resulted negative. BP dropped to 120/72. On discharge BP up to 162/92. Lisinopril prescribed for HBP. 1 dose given. Monday 2/8: Vomiting and diarrhea, lightheaded. EMS called for assessment, BP drop 100/70. Hydration, rest. Moderate/Severe fatigue and aches (6-7 days) Mild lethargy. (24-36 hrs)

Started to get achy later that night after shot. Achiness got worse as all joints and bones hurt. Got up next morning with a temp of 101* and still achy all over. Slept most of the day with same symptoms. Got up next morning (Feb 17) fever was gone, aches were gone, but very very tired all day. A little unsettled stomach. Everything improved as the day went on. There is a report # 269542 from the first shot reported by telephone.

Pain, swelling, tenderness at injection site. Muscle pain in body, headache and nausea started several hours after injection and lasted about 24 hours. Fatigue lasted into second day. Fever and chills started about 12 hours later for about 6 hours. (Some of symptoms at injection site may have been a result of the administration of the injection. There was some blood at the site and I still have a black and blue mark)

Injection site: pain, tenderness and swelling General side effects: fatigue, muscle pain, joint pain, nausea

Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive urination....for over a week

Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation. The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam. On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report. The second dose of mRNA-1273 was delayed in response to the events. The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

02/18/2021 I felt fine in the morning, but at about 11:30 a.m., I became extremely weak, nauseous. for the rest of the afternoon, I suffered diarrhea, dry heaves, and extreme weakness. I began feeling somewhat better at about 5:30 p.m. but still had diarrhea. By bedtime, I was able to go to bed, and I slept as usual with no interruptions. Today, I am feeling normal, had a normal breakfast at 9 a.m. I am still a little weak, but I feel like I am no longer ill.

Stomach pain , back pain, nausea, confusion, headache.. Started around 2pm in 02/20/2021. Ambulance was called, stated she felt like she was dying and was having severe pain

Loose bowels, cramping (Thursday); Diarrhea, cramping, vomiting (Friday); cramping (milder) and loose bowels (Saturday/today). Talked with nurse at doctors office, they pointed me to the COVID hotline.

Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appetite. All these symptoms lasted 8 hours and diarrhea continues for 48 hours. Took Tylenol and rested for first 12 hours, then continued normal daily routine. I had a severe bought of COVID 19 in March 2020, resulting in 3 weeks hospitalization. Exhaustion and pain in finger joints continue today.

When I woke on the 19th I was trying read my bible and I couldn't concentrate and I was really cold. I went to back to bed and slept most of the day. I was really cold and fatigued and didn't have an appetite. I took some Tylenol. I woke up about 3:30 AM Saturday and my back, arms and my head were all hurting and I took some Tylenol and went back to bed. I woke up about 6AM and was covered in sweat. I didn't want to do anything Saturday, I rested most of Saturday and Sunday. Today the 22nd I am back to my normal self.

This patient received dose one of Moderna covid19 vaccine on 2/10/21 at 110pm. At 330pm pt c/o sharp abdominal pain, nausea, vomiting, and diarrhea. She developed a rash to left deltoid area on 2/12/21. She continued to have these s/s. She was evaluated at Clinic by Dr on 2/16/21. He increased her Nexium to 40mg twice daily. Upon TC to patient on 2/23/21 she relates still having nausea, diarrhea, and occasional sharp abdominal pains.

light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least recovered after 24 hours

Had flu-like symptoms for 24 hours. Very tires, total body aches, appetite loss. Constant headache. Took Motrin as needed, and slept in naps. Took liquids. Temp 99 degrees.

I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had another onset of diarrhea. that evening I had chills so bad that I could not get warm. Left arm is sore and swollen but mobile.

pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, body aches and slightly nauseated. On 2/12/2021 she felt better, no fever, but noticed she had developed a slight rash around the injection site. On 2/14/2021 she noticed some red streaks moving down her left breast that disappeared fairly quickly. She had an apt w/ her Dermatologist on 2/15/2021 and the pt had a slight rash on her left arm. On 2/16/2021 she noticed she had a 'covid arm' rash that covered 3/4 of her left upper arm. On 2/18/2021 the rash was still noticeable and was itching so she took a Benadryl and then again on the 2/19/2021. She saw her Dermatologist again on 2/24/2021, her rash is less red and seems to be disappearing.

The day after sx developed; severe chills, some nausea, some body aches, headache. Rested all day and by the next day (day 2 after injection) I felt 95%. Took 2 Tylenol at bedtime on the day with the sx. No other OTC drugs. Did not contact my physician or felt the need to; really not bad sx.

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

Immediately after the injection and got a pounding headache behind her eyes. Then about 7:30 PM she started to ache all over and very tired. She went to bed around 8:00 PM and then she couldn't sleep all night. She kept trying to drink liquid, running fever, hot and opened a window with temp being 30 outside. She could hardly walk to the bathroom due to the muscle weakness and fear of falling. She tossed and turned all night long. She got up and her temp was 99.8, and she was told not to go to PT this morning. She is being treated for a frozen shoulder. She feels dehydrated and is drinking water, and going to drink Ginger ale and crackers due to the nausea.

I woke up Friday 2/12 morning very dizzy. The dizziness subsided. Later Friday afternoon, I had severe dizziness and was vomiting when I got up. I went to Clinic Saturday 2/13, for being unbalanced and weak, but not so dizzy. Sunday 2/14 I was extremely weak with low blood pressure and fast heart rate. Monday 2/15, in the morning, my left arm started hurting, swelling, was feverish, red, itchy and I had a rash at the injection site. I went to my doctor on 2/19 and he stated that maybe I should not get the 2nd vaccine shot. He stated that he was not certain that everything that happened was a result of the vaccine, but that he couldn't say that it wasn't.

Chills, fatigue, body aches, headache, fever, nausea Took Tylenol after 24 hours Helped lessen the symptoms. Took more Tylenol after 6 more hours. 48 hours later-am 70% improved.

After 10 days, noticed a large reddened area; painful; tenderness; heat; itchy; off-centered from injection hole in deltoid muscle; and swollen lymph nodes; with difficulty swallowing. This lasted for 2 days. Now on 14 days post first injection, site is still slightly red. No treatment was necessary

Sudden onset shaking chills , headache , body aches , joints pains , weakness. Chills relieved 30 minute after taking 500 mg Tylenal . No relief of headache , body aches and joint pains . IN pain , weak and losing balance at 7 am , temp 99 , mild nausea . Took 5/325 hydrocodone , paetial relief joint pains , headache persists .

24 hours after vaccination felt instant dizziness and nausea and fell against the wall. Crawled to the bed and collapsed. Stayed in bed with head flat for 2 days. Had to be helped to the bathroom. No walking capabilities. Gradually started coming out of it on the third day, still not able to have head up while trying to eat and drink. 4th day better in the morning with head up and walking. Seemingly gone by evening. Horrible episode.

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

The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I woke up and the rash was there, and spread over the different areas of body. I was sweating bad, muscle pain, joint pain, and nauseated for about 3 days. I had knots in my arms. I went to the doctor last week, and she gave me a shot in the hip, it helped with the swelling. Then I called her back and she called in a cream for me. The other symptom remaining is the rash at the injection site, I have been putting the cream on it twice a day, taking Benadryl and Tylenol for pain

feeling really nauseated; vomiting; Patient states when the vaccine was being administered, half the dose squirt out; another syringe was administered in addition to the previous dose; A spontaneous report was received from a consumer concerning a 76-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered). The patient's medical history was not provided. Concomitant product use was not provided. On 21-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 26-Jan-2021, the patient reported feeling really nauseated and vomiting. She stated that she was sick for ten days. Additionally, when the vaccine was administered, patient stated that half of the dose squirt out and another syringe was administered in addition to the first dose. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), was not reported. The outcome of the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), were recovered/resolved.; Reporter's Comments: This case concerns a 76 year old, female patient, who experienced a non-serious expected event of Nausea, vomiting, 7 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # unknown), with no associated AEs. Very limited information regarding this event has been provided at this time.

No discomfort with the shot itself, the reaction was the diarrhea that lasted 8-9 days and I tried over the counter things to help. I have an auto immune issue and the vaccine may have triggered what happened.

Diverticulitis; This spontaneous report was received from consumer on 18-FEB-2021, concerning a 76 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced diverticulitis. The patient's medical history was not provided. Concomitant medications included was blood thinners. The patient received suspect product mRNA-1273 on 23 JAN 2021 prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:030L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. On 4 FEB 2021, approximately within 24 hours of receiving shot, the patient experienced diverticulitis. Treatment history was not reported. Action taken with the dose of mRNA-1273 in response to the event was unknown. The outcome of the event, diverticulitis was considered as unknown.; Reporter's Comments: This case concerns a 76-year-old female who experienced Serious unexpected event of Diverticulitis. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

First: Vaccine was not given at Center. It was a drive-up at Drive Thru. Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021: fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite. Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.

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

Pt called triage line with c/o intermittent symptoms of feeling "feverish", chills, body aches, and diffuse ABD pain. Pt denies SOB, N/V/D, HA, sore throat, and/or CP at this time. In addition, pt reports a "period of delirium for less than 20 minutes yesterday...it has to be because of the vaccine...". Pt reports that she received her 2nd dose of the Moderna vaccine on 03/02/2021 to L deltoid. Pt advised to seek medical attention and/or evaluation with either their PCP and/or HCP with PMG IC for symptoms.

Over the course of five or six days: headache, severe body aches, chills, loss of appetite, swelling, pain and redness at the injection site, brain fog, unable to complete/execute daily chores. Weakness.

Moderna COVID-19 Vaccine EUA Interrupted sleep the first night with shakes. The next day I had chills, shakes, and muscle weakness. I had no appetite, slept most of the day, and had a full night's sleep. I felt better about 9:00 PM and am fine today Friday, the 5th

Within several hours after receiving injection, patient began feeling disoriented, confused and experiencing diarrhea. Patient does not recall the events - was told so by her husband. Resolved on it own.

Three days after second vaccination developed red, itchy rash covering large portion of outer upper arm,. Was swollen. Also, diarrhea that day. Later in day of shot was fatigued, during night chills and severe muscle aches. Aches and low fever the next day.

Chills, low grade fever, slight nausea, headache, body aches, fatigue. Fatigue lasted approximately 1 week; other side effects about 3 days. 2 days after injection, had a 3 by 6 inch red raised itchy welt appear about 2 inches from injection site. Gradually faded over a one week period. I had an allergy injection 2 weeks prior to Covid vaccine. Contacted allergy doctor and we agreed to postpone next allergy injection until after second Moderna vaccine, in case there was a connection.

18 hours after the shot - chills, severe stomach cramps, total body aches, left arm pain (severe), hot flashes, fever 100., sever headache. Felt bad through 48 hours post vaccination.

18 hours after the shot: Chills, Fever 100 Severe stomach cramps Severe headache Left arm ache - severe Total body aches

2 am (13 hrs after shot) the following day, i awoke with intermittent shooting type pain down my arm into my finger tips and a sore upper arm at injection site. 1:30 pm (24 hrs after shot) i had a bad headache and queasy stomach, approximately 1/2 hr later had the chills and a fever of 99.8. I slept for approximately 3 1/2 hrs. Upon awakening I still had chills but no fever 98.8 and all my joints ached. 6 pm I took 2 Ibuprofen and by 7:30pm I had warmed up but was extremely tired. 10 pm I took 2 more Ibuprofen and went to bed. I slept until 7 am and feel wonderful. My arm is a little tender yet but no trouble using it.

The patient developed severe arm pain, redness and swelling one week after the vaccine. She was treated with benadryl and steroid. Since that time she has continued with some arm pain, had new onset pain in her espohagus, rash and diarrhea.

Chills first 1 hr., body aches 8-9 hrs, nausea 1- 1-1/2 hrs., sinus drainage 2 hrs. ( had to sit up to keep from going to stomach), headache front and back. After 5-6 hours took Tylenol (no effect). Body aches start lessening about 7-71/2 hrs. Second Tylenol. Took excederin for headache after 10-11 hrs. And headaches ended after 12 hrs. Still didn?t feel good all day but couldn?t sleep. Second day softer shot not feeling well - stomach ache all day and belching all day. Next 5 days feeling ok, but not bad to normal. Did have injection sight soreness and mild itching for 9 days.

Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes. Next day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.

Patient is having severe lower abdominal pain and cramping that started on 3/4 2 days post vaccination. She is having trouble standing straight up due to the pain.

3 days after the 2nd dose I started to get intermittent diarrhea. I would get a loose movement but still formed. I would skip a day and then get a day with several more movements (usually in a.m.). I had C Diff a few years ago and was concerned. It gradually became more watery as time went on. It lasted for 8 days. No fever, didn't feel sick after the diarrhea passed. I've been fine for the last 2 days and tomorrow will be the 2 week mark after the 2nd injection.

?Patient came to pharmacy to get her 2nd dose of Moderna vaccine. During screening process patient disclosed she had injection site reaction on left arm including rash, redness, itching and swelling on her arm that had resolved. She also disclosed a similar area occurred occured on right side of abdomen that has somewhat resolved; however she still has sporadic occurences of redness and itching. Due to the patients reported adverse event; patient was advised to hold therapy of 2nd dose of Moderna vaccine; and if she needed to continue therapy the 2nd dose should be given under medical supervision.

Total weakness. Could not get out of bed without being lifted. After getting up was able to walk with assistance. No appetite or thirst. Could not stay awake. Slept most of a 36 hour period. No treatment given. After that was tired for another 2 days but able to maintain a schedule.

caller states the pt woke up on 3/10/2021 w/ tender arm, headache, nauseated, dry-heaving, very weak, diarrhea, slight fever, and chills. Pt will go to the ER if her symptoms do not improve.

Sudden significant nausea 7 hours after vaccine. Lasted an hour. Suddenly went away. Muscle and body aches and headaches, beginning about 5 hours after vaccine, lasting for 60 hours. Swollen lymph glands in neck and under jaw on both sides, 26 hours after vaccine. Significant fatigue, beginning about 6 hours after vaccine, ongoing at hour 52. LARGE RED HARD BLOTCH on vaccinated arm, one inch+ UNDER the vaccine site (which still has bandage on it), TENDER, ITCHY, ABOUT 32 HOURS AFTER VACCINE. ONGOING, although the hardness is decreasing, and the redness isn't as angry at hour 52.

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

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

Severe splitting headache (starting in left temple and proceeding to encircle my head). It felt like a vice tightening around my head. This was followed by nausea and eventually lead to projectile vomiting for about an hour. Extreme weakness.

Sore arm, fatigue, headache, muscle pain, joint pain, chills, fever all starting during the night. all next day no appetite, very tired, slept most of the afternoon and evening. Went to bed slept that night, fever gone. Just very tired the day after. Two days after almost back to normal. If booster needed in the future or another shot, I would try another brand.

The patient presented in the ED on 3/11/2021 with abdominal pain. She reported having diarrhea and increased number of bowel movements compared to her normal. Reason for admission: suspected acute diverticulitis at distal sigmoid.

Fatigue, headache, joint pain, chills, fever, slight nausea. Started Saturday day after vaccination with fatigue to the point couldn't stay awake and weak. Sunday woke with bad ache all over and harder to move along with fatigue. Small headache along with slight nausea in afternoon. Woke about 5 am Monday with total sweat, then chills and couldn't warm up. still had fatigue but not as much pain. Called Hospital Covid Hotline as directed by my Dr.s office (never talked to my Dr.) Nurse with Hotline discussed it with me and we determined it was probably side effects. Since I am aware of allergic reactions, I didn't feel threatened, only messed up. The fatigue and some aches lasted throughout the weak, and I am still fatigued and weak compared to normal.Aches seem better.

Patient was given immunization at 7:30am, at 7:50am she reported her hands were a little tingly. The patients blood pressure was taken 203/125. She then reported a dry mouth, feeling flush, and a little difficulty swallowing. 911 was called and her blood pressure was monitored. 7:56am 181/108 HR65, 7:59am 184/98 HR 57 8:03am 189/110 HR 62. EMS arrived and took over. EMS transported patient to the hospital to be monitored due to blood pressure.

2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx. Patient became lethargic. Patient condition worsened over the next few days. Patient decreased oral intakes, including medications. Care and comfort measures were in place. Patient expired on 2/4/2021.

2/27 Muscle aches,headache,nausea, lasting 2 weeks 3/6 Covid arm lasting 1 week 3/9 Jitteriness,dry heaves

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

March 11, at about an early 9 pm bedtime, heaviness in left shoulder, soon into both shoulders, and mild, intermittent ache in other limbs. Thereafter, through the night, a feeling of fever, back & forth: skin hot, then normal feeling. Some chills. Took my temperature several times and would only get a normal reading. Puzzled, because I thought I must have a fever.....the STRANGENESS of this was that my skin felt like it was BURNING UNDERNEATH my skin....not like any fever I might have ever had. Still normal temp readings. The next day...mostly in bed, tired, no appetite, continued fever feeling, but no fever temp reading. The second day, up and around, eating.

Patient received first dose of MODERNA COVID vaccination on 3/8/21. On 3/9/21 she developed chills, headache, dry heaves, and fatigue. This last 24 hours and resolved with rest.

72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part. 3/16 woke up feeling much better and able to eat, smell and taste about 75%. Spoke via text with doctors office personnel for advice 3/14 and 3/15...very supportive!

We are using the Drive thru. Client received COVID 19 vaccine and after getting it drove to Recovery Room. Client stated in Recovery Room she felt a little N/. She wanted to stand up, so she did and then drank some water. She felt better and we made her sit in the 30 minute line. After the 30 min were over, she felt better and went home. Told her if she had any other problems to call her Dr.

Woke up 3/13/21 with stomach ache, and feeling a little sickly, by next day , Sunday 3/14 stomach ache was stronger, loose bowels, feeling tired and general malaise , on Monday 3/15 stomach ache still there, and loose bowels and tiredness and by Tuesday the 16th felt like vomiting (though I never did) and also developed a headache and still had loose bowels and today wednesday the 16th am feeling somewhat better, headache is slight, stomach a lot better and on the 16 took Tylenol for headache and Loperamdie for bowels, all was improved. Lived on tea and toast and bananas and crackers. It asks if I have recovered as of 3/17 am improving but not like normal yet,

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

Sore/tender arm at injection site beginning in about 2hrs after injection. Entire upper arm hot, red, swollen about 10 hrs - very itchy at 24 hrs. Remained extremely tender and red, itchy for a week. Still slightly sore, tender at 9 days. Had a fever of almost 100 starting next day following injection and continued for a total of 3 days. Fever accompanied by chills. Decreased appetite and extremely fatigued. Appetite now back to normal but still somewhat fatigued.

soreness of arm, fatigue, loss of taste, loss of appetite, chills, pain in the back of head and neck, nausea and vomiting, right arm numb and tingling

Moderna COVID-19 Vaccine EUA 2 hour episode of diarrhea day of injection. Rash on upper biceps area appeared 1 week after vaccine.

Symptoms began Saturday afternoon: fatigue, nausea, headache, chills, muscles ache. Diarrhea began on Sunday around 3pm

Woke up about 12 hours later, teeth chattering, dizziness, nausea, arm extremely sore, chills and feeling really cold and couldn't get warm. She had diarrhea, lightheadedness, couldn't keep anything down. She tried drinking ginger ale. Lasted for about 20 hours. She started feeling better afterwards. Later she had no taste for food which lasted about 2 weeks. After 5 weeks, she has no taste for wine.

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

About 21 hours after receiving the vaccine, she developed a temp of 101.8, fatigue, headache, muscle aches and pain, chills and nausea, did not vomit. Back to normal today.

Rushed to hospital by ambulance with severe pain in my liver area (Oblique area), vomiting (no blood) severe pain crying in pain

I am allergic shellfish, the nurse ask me if I was allergic and I told her shellfish only. She gave me the shot anyway, that night I had chills, fever, and diarrhea. The next day I was ok but the following day I noticed my memory started to decline. It got worse where I develop a speech problem and my blood pressure was high. I also noticed that I had an unexpected limp. I went to urgent care and they performed a CT scan of my brain to see if I had a stroke. The results were negative. I wasn't getting better so they wanted me to go straight to the hospital to get an MRI. The hospital performed the MRI with contrast dye to get images of my brain (stroke). Results are neg,

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

The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a black eye and cheek bone swallon. extemely tired, light headed nausea .

The next day, I felt light headed and very tired. I felt that way for about three weeks. I had loose stool for those three weeks - it wasn't diarrhea but loose stool. And then 11 days after vaccine, I had a rash on my thighs and my lower torso. And that rash lasted for four days and it went away. Rash looked like measles or chicken pox - red dots. I went to the dermatologist as I have never had a rash in my life. Dermatologist did a Biopsy. The rash lasted for four days and cleared up.

brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog. The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported. On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired. On an unknown date patient experienced brain fog. On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The headache, tired and brain fog was ongoing and for other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

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

Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Oxygen drop) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOXIA (Oxygen drop) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was hospitalized on 20-Feb-2021 due to HYPOXIA. At the time of the report, HYPOXIA (Oxygen drop), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side extreme squeezing & twisting sensation of heart; intense bone pain in areas that were injured 15 years prior- neck, posterior thorax, sacral area- all on right side only- day 2; awoke day 3 drenched, extreme diaphoreses- loss of 4 lbs; others less intense- loss appetite & thirst, Rt side only parietal and also occipital headache; tired & weak. Ended in 7 days.

The day after the vaccine I started to feel nauseated, Chest pain, lower abdominal pain and back pain. My blood pressure was a little high. The following day I was feeling a little better, but the chest pain was worrisome. I went to Urgent care and they said my EKG was not normal. I was taken to the hospital which was also the vaccine site. I was treated in the ER and they ruled out a heart issue with a complete workup. I was admitted for an unexplained bowel obstruction and remained in the hospital for four days. I got the second dose of the vaccine and I did not have any significant problems. I may have Covid-19 in the spring of 2020.

She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a bit nauseous today), face red and swollen, jaw hurt, stomach pains-she couldn't eat.

On 03/20/21 a day after receiving 1st dose of Moderna, I woke up at around 8am with a dark bruise on the right outside corner of my bottom lip. I checked it in the mirror and noticed a dark bruise inside the same area. I also noticed some small boil like bumps on the same corner of my right bottom lip. Also some sort of lesions inside of my mouth on the right cheek and inside the right side of the bottom lip and inside the bottom of the skin between my gums and bottom of bottom lip. The next day 03/21/21 the bruises were gone, but the small bumps and lesions were still there and have been until the present. I did not call my doctor or go to urgent care, because I got very sick to my stomach like stomach flu, and it takes forever to get through to make an appointment with the clinic and urgent care. I was going to call for an appointment today, but have had diahrrea for the last week. I also don't know what type of doctor to call for oral type problems. I was going to call my insurance company to ask them. I have a great doctor, but I don't feel like waiting on the phone to get through to my doctor or urgent care. So haven't been seen by a doctor.

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

Awakened 5:30 AM with vomit in my throat. I could move my arms and legs but could not move my body and my bed was spinning wildly. I vomited continually. When I was able I called an ambulance from my bedside phone at around 7:30 AM. Vomited all the way to hospital. In hospital I was diagnosed with Vertigo.

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

Issues with her heart pushing fluid; Cellulitis collecting fluid; Missed 2nd Dose due to hospitalization; Did not feeling well; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Nausea; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis collecting fluid) and CARDIAC FAILURE (Issues with her heart pushing fluid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac catheterization. Concurrent medical conditions included Cellulitis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced CELLULITIS (Cellulitis collecting fluid) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC FAILURE (Issues with her heart pushing fluid) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea). The patient was hospitalized on 23-Mar-2021 due to CARDIAC FAILURE and CELLULITIS. At the time of the report, CELLULITIS (Cellulitis collecting fluid), CARDIAC FAILURE (Issues with her heart pushing fluid), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. patient missed second dose of vaccination due to hospitalization. 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. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.

Fever (went up to 102), aches, sore arm, diarehea, throwing up, tired, headache, dizziness (all lasted for several days). Felt like a very bad case of the flu. I also receive a flu shot each year and have almost the same reactions.

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

Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). In March 2021, the patient experienced PAIN IN EXTREMITY (minor sore left arm) and PYREXIA (fever). On 04-Mar-2021, PAIN IN EXTREMITY (minor sore left arm) had resolved. On 15-Mar-2021, PYREXIA (fever) had resolved. On 16-Mar-2021, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were 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 events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-075222 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-075222:crosslinked to Dose2

Consistent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Consistent diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 011a21a) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure pills.). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Consistent diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Consistent diarrhea) had not resolved. Action taken with mRNA-1273 was not applicable. Concomitant medications included high blood pressure pills. Treatment information was not provided.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of Diarrhea. Event onset 2 hours after second dose mRNA-1273. Event ongoing. 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.

12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures .

chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Polyethylene glycol.). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling). On 19-Mar-2021, CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Electrocardiogram: normal normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Continued, nonstop nausea/diarrhea, headache, joint pain (back, hips, knees), circulation issues (in mornings hands don't open and close well)

Pt received dose #1 Moderna COVID vaccine 1/19/21 @ LPH Vaccine clinic. Overnight some nausea, malaise. 1/20/21 experienced a syncopal episode at home and BIBA to PVH ED. Vomiting, incontinence in route. Workup negative, given IVF and zofran, discharged. Per ED provider "Likely vasovagal syncope. Possibly related to reaction to vaccine. No worrisome findings in the evaluation today."

By 11:30 AM headache starting, eyes burning By 12:30 could not get warm even with thermostat at 80°. Very bad gas. By 7PM temperature 101°. By 2:30 pm severe nausea. Began vomiting and then retching by 9:30 PM which was on and off for 5 hours. From about 11 PM through the night and into the next morning so hot could not use covers even as the temperature went down to 79°. Headache was extreme. Gradually began to subside throughout the afternoon. Days 3-4-5-6 after the vaccination bright pink full body rash. bright pink covered all the skin. Itching days 5-6.

Systemic: Vomiting-Mild, Additional Details: Vomited water according to daughter in law. Gave pt water and let them stay extra 15 minutes more. She was fine when she left.

Patient presented with abdominal pain, nausea and malaise. She was diagnosed with acute idiopathic pancreatitis 2 days after 1st moderna vaccination. Imaging of gall bladder is normal. Triglycerides are normal. No offending medications identified.

According to patient's daughter, patient only complained of nausea the day of the immunization. Patient received 2nd dose of Moderna vaccine at 4:05pm and passed away around 8:30pm that same day per daughter's account. She had no pulse upon arrival to hospital. Autopsy was not performed.

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

When I woke up I felt my legs wouldn't hold me up. I passed out in the bathroom. Finally managed to get up and walk with the aid of a walker. I have no more memory of that day. Except for meals and bathroom use I remained lying down all day. I was very nauseous and severely weak, light-headed, and had brain fog, Except for the nausea I felt that way for 10 days. On the 10th day I felt able to stand long enough to take a shower.

Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) 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 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown. Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-162182 (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.

I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.

Day 2 following second vaccine dose had onset of diarrhea. After several days of diarrhea, went on BRAT diet with no relief. Took Pepto-Bismol with no relief. Took Imodium with no relief. After two months of chronic diarrhea, discussed problem with NP. She prescribed CHOLESTYRAMINE with no relief. Diarrhea is not bloody and does not contain mucus. No pain but there is occasional cramping.

Patient described onset as 6/10/2021 into 6/11/2021 - rash on stomach, back and neck; nausea; tiredness; and chills

PT WITH ALLERGIC REACTIONS. SORE THROAT. IRRITATIONS. SKIN IRRITATIONS. RASH . MUSCLE ACHES. NASAL IRRITATION, LOOSE STOOL FOR 3 DAYS. FATIGUE . AT FIRST, ITCHING NOW AFTER 1 MONTH . AT TIMES., WITH IMPROVED SKIN IRRITATIONS. HAIR THINING PER PT.

Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night, nap in day. June 2 start of stomach or gut hurt, constipated, until June 9, June 2, beginning of all leg, ankle, knee, hip lower spine pain could barely walk. Lasted until June 10. June 15,soreness and roughness inside cheeks, June 16, Terrible pain in left knee ,the leg with varicose veins. Feels like nerve knee, up to hip. Leg swelling. Can only walk for a little. Still happening. Also, drinking water goes right through me, comes out almost clear.

This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) and GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 04-Nov-2020. Concurrent medical conditions included Hypertension since 2014 and Walker user. Concomitant products included LISINOPRIL for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021 at 1:45 PM, the patient experienced GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) (seriousness criterion medically significant), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), INSOMNIA (Difficulty sleeping turning in bed), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias). On 20-May-2021, the patient experienced POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) (seriousness criterion medically significant). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 220 mg twice a day; PREDNISONE ongoing since an unknown date at a dose of 15 mg once a day; PREDNISONE at a dose of 12 mg once a day; PREDNISONE at a dose of 10 mg once a day; MELOXICAM ongoing since an unknown date at a dose of 15 mg once a day and IBUPROFEN at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica), GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias) outcome was unknown and INSOMNIA (Difficulty sleeping turning in bed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 11.5 (Low) Decreased and 13.5 (Low) Decreased. On an unknown date, Rheumatoid factor: normal (normal) rheumatoid arthritis profile normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included small dose of unspecified of antihypertensive medication The patient had initial improvement in neck pain, and later bilateral hip pain began which was unrelated to any injury. There was a gradual onset of sciatic distribution which got worsened after inactivity. Also, the patient had difficulty in sleeping, sitting and walking which kept increasing over time. The patient had seen her physician on 30 Mar 2021 and was prescribed Aleve 220 mg, bid at its maximum dose for three days which helped with some improvement in symptoms which stopped after ten days and had rebound of symptoms within one week. The patient's rheumatoid arthritis profile was normal. Ten days after using Aleve, the symptoms soared. The patient also used Ibuprofen and had to return to use Aleve. On 01 May 2021, the patient could not climb steps. On 03 May 2021, the patient started prednisone and meloxicam. The symptoms improved within one day. The patient saw nurse practioner with rheumatologist on 20 May 2021. Later, prednisone was decreased to 12 mg, daily. The patent was diagnosed polymyalgia rheumatica. The patient saw rheumatologist on 03 Jun 2021, and prednisone was tapered beginning with 10 mg, daily. Later, it was tapered by 1 mg on a monthly basis for the next 10 months and also meloxicam was discontinued. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on on 09 Jun 2021: Patient demographics, reporter, relevant medical history, concomitant drug, events, event outcome and case seriousness were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Stages violent fever, chills, aches (2 days) next nausea , abdominal cramping, diarrhea, more new aches, weakness, exhaustion, loss of balance, another round of fever/chills and repeat again of abdominal distress. This has continued until today (Day 14 since the vaccination.)

I woke up feeling nauseous, dizziness and challenging to walk and a lot of coughing. I went to the dr and he gave me prednisone.

fatique, headaches (still have them. They go from one side of head to the other), swollen hands (continuing issue), bone spur on foot (7/10/21), sores in mouth (June 2021), bulging left eye ( June 2021). None of these issues have been resolved. Something new every week. Body's immune system is under attack. I had none of these issues prior to the 2nd vaccination. The first vaccination I got severe covid arm.

A few hours after receiving 2nd Covid vaccine patient began feeling nauseated then started vomiting. She denies blood in the emesis. She also endorses feeling "chilled to the bone." Triage temp is 103.1. Patient denies chest pain, shortness of breath, cough, numbness, tingling, falls, headache, abdominal pain, diarrhea, constipation, changes in diet, recent travel. No dysuria, hematuria, rashes, bruising or bleeding. She states she has had at least 6 or 7 episodes of emesis and is on her fourth emesis bag in the ER. She states she feels very dehydrated and week. I was informed that the patient was admitted and was under the care of a hospitalist who I could not reach.

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

hot, red, itchy and felt like bees stinging me 2nd day severe Vertigo and vomiting 3-4 days severe diarrhea (with nausea) 9 days later arm swelled and got very red and sore for over a week Still hurts 6 months later

Dizziness/light headed (almost passed out) Vomiting Diarrhea Exhaustion (slept for 5 hrs) High blood sugar (300)

Unusual Digestive upset?nausea, cramping and diarrhea lasting approximately 12 hours and weakness lasting 24 hours. Had no treatment and felt completely well in 48 hours.

Lightheaded nausea swelling headache chills itching. Swelling continues spreading around injection site and is hard as a tick. Sensation of stinging

Pain in arm ... moderate/sever nausea ... fatigue ... aches. The nausea came on within a few hours of the shot. I have just awakened the next day and am still nauseated. Hard to keep down required morning medication taken with water.

Dizziness starting early AM and progressing to virtigo and nausea with vomiting around 3 pm in the afternoon. Bed rest until 1/21. and able to get out of bed around 8 AM. Ate a small breakfast and returned to bed rest until later in the morning. Vertigo is still evident but not as severe. Vertigo is still present at 4 pm on 1/21 but able to move around slowly with assistance. Vertigo continues at the time of this report.

Wednesday and Thursday: headache, low grade fever, chills, fatigue, slight nausea, very sore arm. Arm still very sore and red today on Friday.

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

About 10 minutes after receiving the vaccine, I was sitting in a well organized waiting area I started feeling flames in my throat. My throat was literally on fire. I raised my hand as I was instructed to do. I asked for water, they brought me a bottle water, I started to drink it. My throat was having a difficult time swallowing. They brought me over to nursing area. I went into this area and the nurses were there. They made me take my mask off, they took my blood pressure was way lower then normal (110/30). Then they gave me 50MG Benadryl. They called EMS and I refused to go. I had to wait at the clinic until the Benadryl took effect. The "flame" feeling began to lessen. When I got home I took another dose of Benadryl. The "flame" feeling went away but then I was left with a sore throat for the rest of the night and the following morning. It felt like there was an actual fire in my throat that the Benadryl put out but then it felt as if the after effects of a burn in my throat. I do have a call in to my primary care provider and still waiting for a call back.

Pt was admitted to her local hospital for less than 7 hours for fever, chills, fatigue, intense body aches, nausea and vomiting.

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

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

Next morning 1/23 woke up with acute vertigo, dry heaves and chills. Next day only dizziness when raising or lowering head.

Moderna COVID-19 Vaccine EUA, first dose: Severe aching in both shoulders on evening/night of the vaccine; chills during the night; two days later had severe diarrhea and fatigue, causing me to be down all day. General fatigue for several days after

Moderna Covid-19 Vaccine EUA. 2:00 am 1/28/2021- woke up feeling queasy, joints in legs were achy. My left knee replacement felt like it was in a vise, This was a short lived event with some residual feeling in the knee in the morning. 3 days after injection 10:00 pm 1/30/2021- I noticed a small rash on my left abdomen near the navel, this rash moved quickly to the left and soon covered entire left abdomen, moving to the groin area then down left inner thigh. I took a Benazepril and went to bed. During the night I woke up several time with a strong pressure in left bowel area. Changing position seemed to help and went back to sleep. woke up about 5 am and checked the rash which was mostly gone except for the original spot where it began. The rash and pressure seemed to be restricted to front left side below waist area. It is now 11:00 am 1/31/2021 and I am feeling fine, very little residual rash at initial site. I had not read anything about delayed reactions as late as 3 1/2 days after the injection so wanted to report this event.

pain at injection site (beginning 4 hours after injection) sickness beginning at 3am (15 hours after injection and continues as this is being completed 9.5 hours later) fatigue, headache, muscle pain, pain in legs, chills, nausea and periodic vomiting, fever (100.6)

Her arm began to get very sore that night, then the next day it was swollen, she also had a horrible head ache for two days, the third day she slept most of the day in bed(highly unusual for her). She has experienced fatigue every since the shot. and she has had some digestion issues a couple of days; upset stomach and diarrhea.

My arm was a little sore and a little achy first day. Next morning, Body aches and chills all day long, had a funny taste in my mouth, no apatite as afternoon progressed developed diarrhea, nausea, was sitting on the toilet and fainted. Woke up and got up and went straight to bed and slept the entire night and got up the next morning, I was just tired and weak feeling, kind of dozing on and off. the next day Saturday i was feeling much better, and then Sunday i was perfectly fine.

Itchy and rash where vaccine was ministered. My husband age 80 who got the vaccine same time as I in left arm and has the same rash , No other symptoms

Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster outbreak on lips, low grade fever.

Approximately 1hr post injection pt rptd. N/V + D X3 episodes. Zofran 4mg po for nausea Imodium 1tab po for diarrhea F/U with Pt 01/29/2021 all symptoms resolved Pt. also had a salad which she attributes to the cause of symptoms, on her f/u appt on 01/29/2021.

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

Ran a fever of 102.1. Very weak. Dry heaves. I took Tylenol for the fever. The fever broke about 4:00 am.

Begining Around 9:00 PM on Fri 1/22/2021 started having chills and probably had fever and became nauseous. Was sick thru the night and most of day on 1/23/21.

Flushed warm face, chills, aches, nausea, headaches, overall weakness. Flu-like symptons. Lasted two days.

No reaction after first vaccine other than soreness in injection site. Day following second vaccine, had chills, fever up to 101, and slight nausea. Those symptoms were better the next day, but it is now day 3, and I still have redness, swelling, and redness around the injection site.

Got the shot on 1/26/21, the next day 1/27/21 her arm was a little red and sore and was nauseous. Then about 8 days later, just over a week she woke up and her arm was red again and more swollen and looked like a black and blue area where the needle went in. There was a red rash around that point. The rash was larger than the palm of her hand. She was tired that day and it did go away after 2-3 days. She took Tylenol one night due to the pain to help sleep. She did not call her doctor. It has now totally resolved as of today, 2/10/21.

Head ache Fatigue Joint ache: neck, lower back, knees Muscle ache: calves Loss of appetite Night sweats/fever Deep chills Redness and swelling at shot site

After patient was watched for 15 mins she was discharge with her son. Just prior to leaving the building she became pale, nauseated and started dry heaving. VS remained stable although she appeared tired. 20mg of pepcid given by mouth, 50mg of benadryl and 125mg of solumedrol given IM. Patient was then transferred to the ED via wheel chair for further monitoring and evaluation.

Woke up feeling poorly. Started with weakness, progressed to dizziness and nausea. Got worse as the day progressed. Has lasted all day at the time of this writing.

2/9/21 Day of injection feeling fine all day. That evening began to feel weak and a little dizzy. 2/10/21 feeling dizzy and weak. I was holding onto furniture and walls in order to move around. Some cramping in belly. 2/11/21 No longer dizzy but still feeling weak. No more cramping; 2/12/21 No longer dizzy. Moving around without feeling so weak. No cramping.

about 80 hours after receiving the shot, I experienced severe diarrhea , starting at about 10 PM. I spend most of the night sitting on the toilet. No vomiting. Some abdominal cramping, and my nose was very runny, altho not stuffy. By morning the diarrhea had stopped, but I felt awful. Did not know if I was mainly dehydrated, exhausted from no sleep, or sick. Ate nothing that day, but drank a lot of fizzy water and herbal tea with a little honey. Following day feeling OK, and by third day, fine. The experience felt like a really bad stomach flu or food poisoning, but I haven't had either of those for over 15 years (and that was from Erythromycin prescribed by my dentist when I didn't realize I am allergic to it).

After 24 hours plus, chills, loss Oscar appetite, no fever, body aches Went to bed and slept 14 hours. All is well now after breakfast and tea

Chills, headache for one day, achy feeling, blood pressure below 120 for 2 days, SpO2 between 92-94 for 2 days. Acetaminophen for 1 day at maximum dose for headache, reduced appetite for 2 days.

Pt developed chest pain (EKG shows she is back in AFIB), upper abdominal pain, jaundice (labs pending), and possibly enlarged liver and spleen (feel enlarged on exam, US ordered). Symptoms began about 28 hours after administration.

Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient developed pain, fever, nausea and chills. On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection. On an unknown date, the patient had mild diarrhea and fatigue. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

COVID-19 Vaccine EUA; chills, nausea, and fatigue, started about 4 hours after the vaccine. It was enough to have me stop and lay down. Lasted about 5 hours except the fatigue which lasted for a few days. The fatigue was more than my usual fatigue.

severe dizziness early next morning with nausea and slight headache. took medicine for dizziness and nausea but symptoms continued for two days still feel dizziness now and again

Feb 3 afternoon developed headache, began shaking all over, sleepy. During night vomiting 3 times. began to feel very weak. Fell in floor and had great difficulty getting up due to weakness. Slept all day Feb 4. Could not eat. Slept all day Feb 5. Could not eat. Very weak. Feb 6 mouth broke out with sores. Still shaking and headache. Began to feel better Feb 7. Felt fine Feb 8 except for mouth sores.

Fever started within a couple of hours the first night, didn't take temp during night but could feel that it was VERY hot. Extreme arm pain thru night and achy. Next day, fever of just under 100o (my normal is 97.6) all day (didn't take any pain relievers or fever reducer), exhaustion, achy, felt yucky. fever started to go down very slightly until normal by bedtime. Next morning: no appetite, fever gone, exhaustion and less arm discomfort. Today

Date and time of vaccination: (list both if they received both shots): 1-16-21 @ 12:00pm Moderna LOT # 013620A 2-13-21 @ 12:00pm Moderna LOT # 029K20A Date and time adverse event started: 2/13/21 fatigue, chills, cough with phlegm and a HA, 2-15-21 at approx 0800AM had a slight nose bleed, Tuesday 2/16/21 had a nose bleed along with 1 episode of loose stool, 2/17 2 episodes of loose stool.

I received the vaccine, and I don?t remember passing out, but I fell and hit my face and nose and its sore and bruised. I felt dizzy and felt like I had covid, my O2 level was at 80 and it?s usually at 92, I also threw up. Now I stay dizzy and shaky. I had covid in November and was in the hospital for 17 days.

"Moderna COVID-19 Vaccine EUA; second dose caused all COVID-19 symptoms (or so it seemed) within 12 hours of shot. Great discomfort for two days...and now diahrrea on the third day. Not able to eat but bits at a time. Coffee taste terrible. Fever is back to normal now.

low grade fever, nausea, headache, brain fog, fatigue for most of two days, diarrhea and slowness day 3 still tired Loss of appetite still an issue day 4...hard to stay hydrated but know I'm better than day 1 and 2.

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

On Wednesday afternoon she had a fever of 103, was very fatigued. Got up in the middle of the night and had dry heaves, went back to bed and was okay. Her arm got really red, hot and blisters all over it like a sunburn. It is down to about the size of a half dollar today. The blisters burst and have made places, is still warm and sore and looks like it is drying up. Did look like a severe sunburn. She ran a little fever until Thursday night 2/18/21. The arm is still sore to touch today, 2/22/21. She took some Tylenol the night her fever was 103, then it went to 101. The fatigue is diminishing, she has slept a lot, but wonders if her arm is ever going to be right.

patient reports swelling at vaccine site 1 week after vaccine administered. swelling accompanied by itching, headache and nausea x 1 day. redness remained for 4 days

First Day arm sore, fatigued and cough. Second day Chills and Fever, Body Aches, Headache, Nausous, couldn't eat or drink, Arm sore and swollen, very fatigued, slept all day. Third day a little better, Fourth day fine.

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

5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.

Pt received dose #2 Moderna COVID vaccine 2/2/21 Vaccine Clinic. 2/3/21 at 1815 presented to ED for workup. Reported myalgias, nausea, vomiting, arm soreness, fever, diarrhea. Taking OTC Tylenol. Given IVF, Zofran, Toradol with improvement of symptoms. Dx with immunization reaction. Able to discharge home without excalation of care.

At 8 PM last night, 2/25/2021 patient began to feel nauseous and fatigued. This morning the symtoms were more pronounced and at 8:45AM she had a temperature of 100.4. She ate a piece of buttered toast and was drinking water. Both stayed down.

Severe side effects including chills, fever, headache, fatigue, diarrhea, loss of appetite, runny nose

Feeling cold despite warm room and clothing starting about 10 hours after injection. Uncontrollable shivering starting about 12 hours after injection and lasting an hour, nausea, headache, weakness, passed out when I got out of bed the next morning, exhaustion and diarrhea lasting two days.

Started out with waking the next day a fullness in her head, but kind of a headache, and very tired. Then a couple of hours later she got a severe case of the chills. She laid down and slept on and off for about 5 hours. When she got up she took her temperature and it was 101. She also had body aches in her back and her legs felt very heavy. She then noticed a rash on her body from a line that went underneath her breast, and redness on the left side of her breast to her belly button, all red around the belly button. When she realized she had a fever she took Tylenol. The rash by Saturday was fading and she also had diarrhea on Saturday, persistent diarrhea. She felt almost normal except that she was tired. Today, 3/1/21 she has the returned diarrhea, doesn't k now if it was related to the vaccine. She spoke to a nurse yesterday, and she told that she had a typical side effect from the vaccine. She was not sure if the diarrhea was from the vaccine.

Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swelling starting soon after vaccination. Patient did not take diphenhydramine. During clinic visit seven days after vaccination patient reported chest burning, alternating hot/cold sensation, fever, facial erythema, and sensitivity to smell. No swelling or erythema noted on physical exam: findings include malaise/fatigue, tinnitus, constipation, back pain, nervousness, and insomnia. Vital signs all within normal ranges. Patient discharged home from clinic stable with prescription for hydroxyzine.

patient presents to the ER complaining of nausea, vomiting, diarrhea on 3/1 @ 0134 AM. She states the symptoms occurred gradually on 2/28. She is admitted to the hospital with a diagnosis of noninfective gastroenteritis. She states the symptoms are aggravated by food and alleviated by remaining still. She states she has not experienced similar symptoms in the past. The patient and the hospitalist, Dr., attributes her symptoms to the Moderna Vaccine. Patient is given IV fluids (NS), protonix, and Zofran for her symtpoms.

muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared excepto for swollen lymph nodes after 2 days

Chills, 2 degrees of fever, sore arm, whole body ache, disoriented when walking & (collapsing pain in left leg when trying to stand the next morning), slept for 30 hours except for necessaries, didn't eat for 1 1/2 days, all in all body felt like a bad case of the flu.

Vomited approximately 10 hours after the vaccine Diarrhea approximately 10 hours after the vaccine Malaise Cough Fatigued for 7+ days Headache for 4 days Slight Fever (around 99.0 for 2 days) Chills (extreme) Arm Sore Loss of appetite for 3+ days Confused Dizzy/equilibrium issues for 2+ days

Vomited approximately 10 hours after vaccine, but no memory of it Diarrhea approximately 10 hours after vaccine, but no memory of it Malaise for 3-4 days Fatigued for 3-4 days Headache for ~2 days Chills (extreme) Arm sore for ~3 days Loss of appetite for ~3 days Confused Dizzy/equilibrium issues for ~2 days

Severe nausea, vomited, extreme fatigue, dizziness/lightheaded disoriented. Yesterday and today. Stomach pains moderate

6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been applying ice, so I took 200 mg of Advil. At 9:15 pm, I had chills and fever for 3 hours and during that time, my right forearm, wrist and hand became very, very sore. I couldn't even flex my fingers the pain was so bad. Pain throughout my body continued during the night, including stomach cramps, back and leg pain and then I took another 200 mg of Advil at 9:15 am on 3/4. I feel I am 20% improved 25 hours after my second shot.

Symtoms are fever/chills, weakness, headache, muscle and joint pain, nauseous, loss of appetite, light headed/dizzy, lasting four days. I am still not 100 per cent recovered.

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

Early evening post injection sore arm. 9 pm onset of chills, fever, continuing through night and following day. Accompanied by severe fatigue, loss of appetite. Treated with acetaminophen. Fever and chills gone morning of 3/4, but severe fatigue persisted. Morning of 3/5 feeling better, but lightheaded. Improved throughout day and 3/5 evening pretty much back to normal. No medical attention required.

Extremely tired, disoriented to place, time, and family, loss of appetite, cold, left shoulder and neck pain, intermittent diarrhea that lasted for approximately 8 days before seeing improvement. Symptoms are now intermittently, states this has been the best days. continuation of medications Metoprolol, Digoxin, Diltiazem, Losartan Potassium, Chlorthalidone, Hydroxyzine, Benadryl and Tylenol as needed

Moderna COVID-19 vaccine EUA headache, chills, joint pain, nausea, body aches during the early morning of March 4 and throughout the rest of the day. Then symptoms eased and gradually went away throughout night of March 4 but then just tired for two more days.

41 hours after vaccine, diarrhea, vomiting for approx 12 hours, 49 hours after vaccine began severe hives and itching for about 15 hours

Chills and fever, beginning at app.15 hours later, around 9AM, intensifying over the course of the day, with severe aching, especially over the torso. Soreness at the injection site. Fever reaching peak of 101.8 by late evening. I took two Tylenol before retiring. I woke , self and gown drenched in sweat at 3AM on 3/6. Slight chills upon rising for about 3-4 more hours on 3/6. Upper injection arm itching continues to this day, 3/9 , which is relieved with cold compresses and a 25 mg Benadryl tab.

High fever of 102, dizziness, headache, pain in left side of jaw, neck , chest. Nausea, weakness, seizure.,( Never seized before) left eye burning high blood pressure. Symptoms started in bed while asleep 12 hrs after 2 nd vacccine

Rash fading but continuous Chills, aches, fatigue, lethargy, poor appetite for about 60 hours No fever

pt stated that became very ill when she went to bed. she woke up in a cold sweat, had vomiting and diarrhea that lasted an entire next day. she had headache and chills but no fever. pt had a phone visit w PCP and they told her to stay hydrated and get bed rest. Doctor will FU tomorrow 3/10/2021. Pt states she is feeling better at this time.

Saturday, 3/6 11:00 p.m. - Left arm began to hurt Sunday 3/7 - 3:00 a.m. - Woke with chills and body aches Entire day - Fever from 101 to 102.7, chills, body aches, headaches, nausea, diarrhea Monday - Temp 100.7. Felt much better. Diarrhea continued Tuesday - Much better.

Patient received Moderna Vaccine 1/21/2021. 2 days prior to vaccine administration patient had vertigo and sinus allergies that resolved. Patient canceled her 2nd dose appointment on 2/18/2021 reporting she had been sick. She rescheduled 2 times on 3/4/2021 and 3/11/2021 but canceled those appts as well reporting still not feeling well. She called 3/10/2021 and informed nurse of persistent symptoms that started 2 weeks after receiving her 1st dose of Moderna Vaccine. The symptoms reported throat burning, metallic taste in mouth, metallic smell in urine, body weakness, warm sensation over body, ear pressure and nausea. She reports she has been to an ENT doctor 2 times, her PCP 1 time and the ER 1 time. She and her doctor's are unsure if her symptoms are related to her first injection.

Sudden dizziness with some nausea and cold drenching sweat - no fever - extremely weak and fatigued and could barely stand and then severe headache came on about 10 minutes into episode. Dizziness lasted approximately 2 hours until I could safely move and then began to subside. I noticed my eyes did not want to focus well and was seeing spots when I tried writing down what happened. Chills began and I felt extremely cold, my head felt "foggy" and tight, ringing in ears started and headache moved to migraine level. Slight fever 99.8. Main dizziness did pass after about 2 hours but other things continue to linger on an off. I just feel "off". I have actually heard other seniors mention some of these very symptoms so am not super alarmed, however, I did not have any of these side effects before the vaccine for Covid-19. I did experience extreme fatigue and bad headaches since I received the first dose on January 27, 2021. I have not called my doctor regarding these side effects since I have heard many seniors complain of very similar reactions. I have rested as much as possible, tried to stay hydrated, and taken Tylenol when needed. For the dizziness I tried to stay as still as possible and put my head between my knees until it finally passed.

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

Patient experienced extreme nausea and vomiting and became dehydrated and had to go to urgent care. She also is experiencing mouth sores.

6 hours after injection total body muscle aches , tired, followed over next 24 hours by chilling, temp 100.6, nausea (vomited once), headache. Next 12 hours less ache, no fever, headache persists.

Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm.

"Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, increased swelling,

Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; Vaccine too high on her shoulder; A spontaneous report was received from a nurse concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine too high on her shoulder/product administered at inappropriate site, trouble lifting her arm/ movement disorder, nausea, fatigue and vaccination site pain. The patient's medical history and concomitant medications were not reported by the reporter. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A ) in the left shoulder for prophylaxis of COVID-19 infection. On 02 Feb 2021, patient believed the vaccine was given too high on her shoulder, and had nausea, fatigue and pain at the injection site (shoulder and arm) which increased with movements, radiating to the upper limb and had trouble sleeping, treated with Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

fever, nauseous, redness itch lower injection area, fatigue, headache, urinated 10 times that evening, tired, chills, itching, swollen arm

received shot at ll:45 am was fine went home. about 4:00 started to get cold. developed flu like symptoms, headache, fatigue little bit of fever, pain up back of neck and to my ears. was in bed all night on 3/12/21, stayed in bed all day 3/13/21. Had some oatmeal, gatorade, juice. Could not taste anything back to bed. Sunday got up thought I was good. But dizzy and lightheaded, little itching on my legs and a little nausea. Had tuna sandwich could not taste it, thought it was awful. Back to bed all day. Monday I am up but still dizzy when standing trying to stay up but just sitting. Taste has come back.

Body was extremely hot and red, and I also had chills. Arm was very hot and sore and swollen. Entire body ached (like I have never had before) , nausated, bad headache, very weak. My urine was a different color (kinda of peach/pink). I took Tylenol to help with fever etc., for a couple of days. I still fatigued from the ordeal.

Headache, SEVERE uncontrollable shaking (don't think it was due to being cold), nausea, fatigue, all over achey, hot/soreness at injection site. Severe symptoms lasted overnight, fatigue and aches lasted for three days. Could not function enough to get to the bathroom by myself during the night of shaking. Disoriented to the point of not knowing which direction I was going. Treated with liquids and Advil.

Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia

Email to COVID CARE - referred to PCP "I'm having side effects after the second shot. I'm having vomiting, diarrhea, can barely talk, balance problems, dizziness, and back pain. I'm very tired. I had a brain bleed six years ago."

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

Severe headache. Nausea. Diarrhea. Lasted 6 hours. Better next day. Scared for second dose. Do Zi need a small person dose? I am an older , small woman. Weight 110lbs.

day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intestinal tract upset slight nausea and diarrhea. Next day...arm better, lightheadedness better, very tired and slept a lot. Next day: not bad during day. in evening had shooting pains in calves, and sweated a lot at night. Arm much better. Today: arm almost painless, still a bit lightheaded, intestinal tract still "busy". no pains in legs.

At 11:50 pm on 1/26/2021, I could not swallow even a sip of water. My Esophagus appeared to have closed. I debated calling 911, but had sick animals I couldn't leave. Went to bed and when I woke, I could swallow again. However I had severe hives as well as debilitation itching and swelling of my fingers, hands and later, my toes and feet as well. These symptoms have continued in varying degrees ever since I received my first Moderna vaccination.

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

Painful R Deltoid x 2 days, followed by chills, fever, diarrhea evening of day 3. Malaise day4. Tight feeling (semi headache) from then on (probably related to Increased BP) culminating in BP of 202/102 and TIA day 10. Taken to ED. CT scan performed-no bleeding. Physicians assumed TIA caused heightened BP. Not so. BP decreasing graduallly, today, day 13 now around 135/80 (still elevated for me). semi-H/A resoluved.

Treatment: Tylenol Symptoms: chills, joint pain, muscle soreness, nausea, headache, extreme fatigue, fatigue lasting 5 days

Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep.

3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort. Patient reports a 2 day history of increasing cramping and pressure in the suprapubic area. Patient reports she felt this way when she had urinary tract infections. However, patient denies any current urinary frequency, dysuria, hematuria, or urgency. Patient does report some minor dribbling which she states is common for her. Patient denies any fevers but does report an occasional chill. Patient does report pain across her low back. Patient denies any nausea, vomiting, constipation, diarrhea, melena, hematochezia. Patient does have an extensive abdominal surgical history including colon resection, cholecystectomy, appendectomy, and hysterectomy

Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours. Had Temp 100.3. Headache, body aches, and no energy. Started feeling better on 4th day after Covid injection.

Sore muscles began soon after vaccination. In the night woke up dizzy. Then had intense chills and became nauseated. After several bouts of chills finally fell asleep again. Next morning woke up with fever of 101 F (usually body temp is around 97.5) and headache. Stayed in bed all day with fever and headache. In evening symptoms began to disappear.

Hallucinations; Could not eat for 2 days; On the floor for 2 days; Chills; Fever; A spontaneous report was received from a 77 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, could not eat for 2 days/decreased appetite, on the floor for 2 days/asthenia, chills and fever/pyrexia. The patient's medical history was not provided. The relevant concomitant medications were also not provided. On 10 Mar 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number: 001821A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced hallucinations, chills, fever, could not eat and was on the floor for 2 days. No laboratory data was provided. Patient took paracetamol and hydroxyzine as treatment. Action taken with mRNA-1273 in response to the events was not reported. The events could not eat and on the floor for two days were recovered on 12 Mar 2021. The outcome of hallucinations, chills and fever were not known.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

She got the vaccine and was sitting around that evening and discussing with the family over the phone and was explaining that everything was fine, could barely tell where the shot went in, and the next morning around 10:00 to 11:00 AM she got deathly ill. She had diarrhea but not too bad, and then started throwing up uncontrollably, violently, projectile. She goes to where she was disoriented and did not know where she was. She was reaching to touch things to figure out where she was. Her husband called the ambulance, and she went to the hospital and got her normalized but does not know how or what they did. A woman came in to register her and started talking to her and was not making any sense. They treated her in the ER, took a bunch of tests, and sent her home. They told her that she had food poisoning and hadn't had anything but some biscuit and gravy and had some crackers when she got the vaccine as she was weak. They gave her Ondansetron for her stomach to stop the diarrhea, but she is still having that. She is still having the weakness, and not back to her normal self.

Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise). The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication. On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant. On, the same day, the patient was discharged. The patient still was not feeling 100% still. No Treatment information were provided. Action taken with mRNA-1273 in response to the event(s) was Not applicable. On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; 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.

1st day after: fatigued. 2nd day after: nausea upon eating breakfast, tightness in neck, shoulders & headache. Take Tylenol. Symptoms lessen by mid-afternoon or dinner time. No symptoms first thing next day. The issue has happened for 5 days in a row. Eating oatmeal with no milk or sugar and hot tea. How long can this last???

extremely high blood pressure; entire body filled with heat during high blood pressure episodes; Sore arm; itch all over body; feels terrible; can't eat anything but ice chips; Headache; A spontaneous report was received from a consumer concerning a 77-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headache, itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. The patient's medical history was not provided. No relevant concomitant medications were reported. Additional suspected products included Prolia. On Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number not provided) intramuscularly for prophylaxis of COVID-19 infection. Patient received Prolia injection 2 weeks after 2nd dose of Moderna's COVID-19 vaccination. Patient side effects reported since Prolia injection are itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. Patient has been hospitalized twice over the past 2 weeks. Treatment for the events included steroids and amlodipine. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of the events were considered not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the Prolia injection received by the patient, which is known to cause these side effects.

Worst was nausea, vomiting and diarrhea for several hours; also tiredness, aches, chills and brain fog for several days

first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - sore arm, sore back of neck from headache (muscles seemed frozen for days), really cold from 8pm to 4am with debilitating headache. left side of body was without coordination, hip, knee, ankle didn't work. Went sideways with all joints when walking. 03/18/2021 - passed out in bathroom due to pain. Hit door frame and had large lump on forehead. Bowel mess to clean up. 03/21/2021 - didn't dress, still wobbly stomache upset, neck sore, dizzyness, ate squash and beans. 04/01/2021 - still have stomache upset and though day temperature is over 70 degrees, am very cold, tired as soon as do just one thing. continues

I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination. No medical advice was sought and acetaminophen was taken on an as-needed basis. What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first

The following started the morning after the shot: Achy, no desire for food, felt like I had a bad case of the flu, very tired and wanted to sleep all the time. The second day was the same, except that my Blood Pressure went up, and remains up. It currently( Day 3) registers at 153/99, with a pulse of 101.

Within 5-10 hours of the second dose: nausea, vomiting, chills, fever, fatigue. Chills, fatigue and nausea continued for 10 days until death

Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A spontaneous report was received from other concerning 77-year-old female patient who developed Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever. The patient's medical history included Cardiac issues in 2016 and 2018. Concomitant medication included Motoporal for heart issues. The patient received their first of two planned doses of mRNA-1273 (Batch number:001AZ10 ) on 26/2/2021 Intramuscularly and suppose to have second dose on 26/3/2021, for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient took the shot and experienced fever, chills, full body aches, nausea and headaches. The patient also had very fast heart rate that was pounding for hours, she had the fast heart rate for 24 to 30 hours. The patient also said that she had Covid in Dec 2020 and Jan 2021 for 6 weeks with the same symptoms. The patient was supposed to have her second dose on 26 Mar 2021. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever were resolved on 28 Feb 2021.; Reporter's Comments: This case concerns a 77 Y/O F with a serious unexpected event of tachycardia, and nonserious unexpected palpitations, and expected pyrexia, chills, headache, pain, and nausea. Event onset the same days as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

pt says her left arm was swollen and had fever in it for almost 2 weeks. The swelling has gone down now. She had fatigue that lasted almost 2 weeks. She developed diarrhea a couple of days after getting the vax and still has this today 4/7/2021. She says every time she eats she gets diarrhea. She has taken Pepto Bismol but it has not helped. Pt will contact her PCP regarding her symptoms.

chills, fatigue, upset stomach five days after vaccinations; same symptoms experienced day after vaccination

I have been experiencing symptoms for over a month now. Extreme fatigue, sometimes nausea and light headedness. The symptoms are better some days than others but never completely go away. Most of the shaking and shivering have gone away but still do not feel well.

Patient was seen at healthcare clinic 3/5/21 for complaints of abdominal pain and diarrhea x 1 week, no fevers. Admitted to the hospital for IV fluids and Zofran. Lab work shows elevated WBC and patient was given x1 dose of Metronidazole IV and discharged to home with appointment to f/u at healthcare clinic 3/6/21. On 3/6/21 patient was not improved and was sent back to hospital for IV fluids. Lab worked showed further elevated WBC, CRP and PCT so CT abdomen was done and found to have inflammation throughout the colonic wall. She is then admitted to for further evaluation and antibiotic treatment. Patient remained afebrile and WBC, CRP and PCT all trended downward. During hospital course she was also treated for hypokalemia due to diarrhea. She was started on Budesonide for colitis and was discharged on 3/11/21. On 3/25/21 patient is again seen at healthcare clinic for N/V/D with dehydration and is sent to hospital for IV fluids. Lab is again elevated and patient improves and is sent home with instructions for f/u at healthcare clinic on 3/26/21. On 3/26/21 patient is then admitted to hospital for N/V/D with dehydration and fatigue with headache. CT again shows pancolitis. On 3/26 patient then experiences A.FIB with RVR and is stable but as the day progresses becomes unstable with elevated heart rate and low BP. Due to patient?s unstable condition she is flown to another hospital for increased level of care.

5 th day after the second dose, I was awaken at midnight with severe vertigo, cold sweat, nausea and loose stools. I had no serious side effects after the first dose. Did not go to the emergency room. Today I feel better if I do not make sudden moves.

explosive loose bowel movements with burning anus for two weeks (burning elemenations continue still); head ache on top of head - several days; puffy face; Brief Chest pain on 4/4/21 with fatigue following for several hours and balance problems. pain in left plantar fascia and discomfort in right Siatic nerve area and upper thigh 4/13 Cough - productive; patient is mostly recovered from adverse reactions with exception of burning bowel movements

dizziness and concern for elevated blood pressure reading. This afternoon at around 12:00, the patient received her second dose of the Moderna COVID-19 vaccine at the clinic. She had no apparent complications with her first dose of the COVID vaccine. However, about 10 minutes post second vaccination, she suddenly began to feel dizzy, described as lightheadedness, with associated nausea, all of which were rated a 4/10 in severity. Staff there took her blood pressure, which was noted to be elevated, reportedly at 220/104. EMS was activated, and en route to the ED, the patient was given Zofran by paramedics. Currently the patient no longer has nausea and has not had any vomiting. She does have chills, but no measured fever.

Patient received the vaccine on 2/8/21. There was a continued gradual weight loss and decrease of appetite after vaccine. On 3/2, patient had unknown reason for elevated blood sugar of 303. On 3/4, patient had oxygen of 78% on room air, Pulse 127, RR 22, BS 158. Oxygen started. Lethargic, hypoxic, tachycardia. Transfer to hospital. Patient readmitted on 3/12/21 with community acquired pneumonia, bacteria in urine acute kidney injury. Treated with antibiotics and hydration.

PATIENT PRESENTED TO ER WITH COMPLAINT OF DIARRHEA SIN AM OF 4/14/21. ER WORKUP WAS UNREMARKABLE EXCEPT PT WAS HYPOXIC. HOSPATILIST CONSULTED AND PATIENT WAS ADMITTED FOR OBSERVATION DUE TO HYPOXIA

iST INJECTION WEAK NAUSEA RIDE CIRCLE UNDER INJECTION SITE LASTED ABOUT 4 DAYS TOOK WATER & TYLENOL 2ND INJECTION WEAK NAUSEA DRY HEAVES EXTREME PAIN IN ALL JOINTS CHILLS CIRCLE BELOW INJECTION SITE UNABLE TO FUNCTION ON MY OWN FOR 5 DAYS WEAK AND NSUSEA LASTED 4 DAYS MORE TOOK tYLENOL AS SUGGESTED BY STAFF WHEN RECEIVING INJECTION

6 days after the shot I got "Covid Arm" and reported it to you. Now 13 days out, I got REALLY sick! Chills, fever (102.4) nausea, sore throat, slight cough, loss of appetite and it has lasted until tonight 4/20/21/.. I am finally feeling a bit better BUT still not right. The idea of having a 2nd injection is off the table. They say you get sick with the 2nd. I surely don't want to get any sicker than I am.

Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9.

Laparoscopic Appendectomy 2/27/2021 (Miniperforation) Never had any previous trouble with appendix symptoms came on (mild) 1 week after first Moderna vaccination, to ER for CT scan following evening: surgery 1:30am. No idea I?d this is related. Only reaction to first vaccination was sore arm.

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

I fully support efforts to end this COVID-19 pandemic. That is why I took these vaccinations Over the last twenty years I have taken a number of vaccination including an annual seasonal flu shot. I have learned during these years that when I take such a vaccination I need to do it when my schedule is clear to allow for several days of down time. I usually need several days to recover from such a vaccination. I also take only one vaccination at a time to lessen any problems I may have with it. Sometimes I have had a large red spot on my vaccination arm, up to four inches wide, near or around the injection site. Continued:

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

Driving my car on route 50 in morning of the 6th, felt fine after getting up showering and getting ready for work. About 10 miles to my destination I felt naueous and completed fainted at the wheel. I then hit a guard rail on the right and I can only assume I pulled the wheel to the left and hit the guard rail there. I was very lucky I did't hit another car or I wasn't hit myself by another car. This road is very busy all the time. I then got myself together and pulled off to a place where I could evaluate my situation. Someone came to my aid as I tried to remove myself from the drivers side door, which was dented in. The called 911 and I was taken to the hospital. The did a number of tests and I was told that I was fine. I have had no re-occurrences and have no history of fainting. I did about 15,000 of damage to my car.

Foggy brain, dizziness, fatigue, weakness, loss of appetite, depression, nosebleeds. diarrhea, groin pain (left & right), Sciatica (left & right) headaches, head pain,

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

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

severe muscle spasms in back and shoulder on right side, severe pain in right arm, shooting pain and numbness in right arm finger pins and needles numb. Unable to stand without pain and spasms. symptoms started 2 days after first shot, went to urgent care since have seen 8 doctors, 2 trips to the ER, 2 MRI, CT scan and back and neck xrays.. Presently seeing a spine specialist and received a cortizone shot. Still can not stand witout pain and numb arm and hand.

According to the patient (my mother), and my father, the patient had her 2nd shot on 4/30/21 and within 2 days began having a 102 fever. She continued to have that high fever off & on every other day and spoke to her primary care physician who told her he didn't know why she had the fever, then finally advised her to go to the ER. She had already recovered from COVID prior to taking the 2nd shot, and tested negative for COVID by the time she went to the ER. She went to the ER on about 5/18/21, and in addition to fever, experienced sore throat, appetite loss and fatigue. She was admitted and the doctors told her they're unsure if it's related to the experimental shot, but they can't rule it out at this time. They continue to give her drugs and run tests, with no real answers to speak of and she believes it's likely an adverse reaction to the shot(s).

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

She received her vaccine. The next few days, she was extremely tired and slept a lot. A couple days after the vaccine, she complained that her stomach hurt slightly. Days went by and the pain slowly got worse. She didn't feel like eating. Then on 2/8/21 in the middle of the night, she woke up in excruciating pstomach pain and her husband called ambulance. They rushed her to ER. The determined that her colon had ruptured near her stomach and they took her in for emergency colonoscopy. The surgery was a success, but a couple days after, she was weak and said she didn't want to fight any longer. They put her on hospice measures and she died 2/15/21. We feel that she was doing fine before the vaccine, and then all of a sudden this occurred. Seems to be too much of a coincidence. Finally taking the time to report it, in case there are others having colon and or stomach issues.

Diverticulitis; cannot lift anything up or drive; painful arm between the elbow and shoulder; muscle spasms; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-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 MUSCLE SPASMS (muscle spasms) and ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) had resolved, MUSCLE SPASMS (muscle spasms), ABDOMINAL PAIN UPPER (stomach pain) and MUSCULAR WEAKNESS (cannot lift anything up or drive) outcome was unknown and MYALGIA (painful arm between the elbow and shoulder) had not resolved. No concomitant medication were 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. Action taken with mRNA-1273 Moderna vaccine was Not applicable Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up was accepted on 27-May-2021 On 26-May-2021: Non significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Night of second shot had low fever and diaphoresis lasting 3 nights. On 5th am post injection had severe upper abdominal pain. Upon arrival in ER had bloodwork, CT, and MRI (results below) Diagnosed as idiopathic pancreatitus since no reason could be found. No alcohol at all, no stones, and no routine meds known to cause this. Admitted NPO and on IV fluids. Discharged next evening after pain resolved and tolerating po fluids. Hospital physicians told me they did not think the vaccine could have been the issue but I still feel this was such a coincidence that it should be reported.

On March 6, 2021, three days after second Moderna vaccine, I had sudden onset deafness in my right ear and progressing dis equilibrium. Within a couple of hours I could barely walk. Extreme dizziness/vertigo, nausea. Went to ER next day, 3/7 and was transferred after about 5 hours to Medical Center. Was eventually diagnosed with Idiopathic Labyrinthitis. ER wanted to admit me at 11:30pm but I hadn't eaten or had any fluids and they don't feed people in the ER so I went home. Conditions worsened with walking like a very drunk person and brain fog, dizziness, vertigo. Went back to ER where they completed all kinds of tests and scans.

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

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

Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fainted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainted) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, LOSS OF CONSCIOUSNESS (Fainted), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting) had resolved. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 was not applicable. Company Comment: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second 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.; Sender's Comments: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second 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.

I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, nauseated, went into AFIB. Went to hospital.

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

Nine days after receiving first Moderna shot I broke out with rash on injection site. That evening I experienced extreme abdominal, back, underarm pain and bloating. It was enough to double over and almost pass out. Pain has continued on still. I called my gastroenterologist a few days after. We had a telehealth call. I?ve had ultrasounds, endoscopys, mris, ct scans, blood work. No diagnosis as yet. I have malnutrition and extreme weight loss.

12/31/20-pm upset stomach; 1/1 /21 woke up with diarrhea and mild headache thru the day. Around 7 pm felt like a dizzy spell loosing ability to move with like fog in my head and uncontrolled strong shaking and vomiting. 1/2/21 woke up with no symptoms and feeling fine.

DECEMBER 30 2020 BUMP , SWEELING AND ITCHING AT INJECTION SITE AND HALF DOWN MY ARM. USE SARNA AND FELT BETTER IN ABOUT A DAY JANUARY 4TH 2021 SWELLING AND INTENSE ITCHING ON MY RIGHT ARM AND CHEST ACCOMPANIED BY A RED RASH. USED SARNA AND ICE PACK. FELT BETTER AFTER A DAY OR TWO.

EXTREME LETHERGY, NAUSEA, FATIGUE, WEAKNESS, ELEVATED TEMP, ELEVATED HEARTRATE, SENT TO THE HOSPITAL FOR EVALUATION, FLUIDS ADMINISTERED AND MONITORED, THEN RETURNED TO FACILITY

Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sniffle. This morning woke up about 4:30 a.m., has some nausea but did not vomit. Had some lightheadedness. Has had vertigo in the past.

Diarrhea, sore arm, nausea, headache, and fatigue. Symptoms resolved within 24 hours except for arm soreness. Took Tylenol and rested.

Patient became unresponsive, did not eat, little fluid, slept nearly 24 hours per day, became weak, took to ER, no infections, no COVID, no pneumonia, no flu, no heart problems, no recommended further treatments

At 9:00 PM started with chills for about an hour, headache, stomach hurt, lost appetite and food and water did not taste good just like when she had COVID, which was 10/13/20. Couldn't sleep either. Just took OTC medicine. Now feeling better about 10:30-11:00 this morning, but still does not have an appetite.

Very bad back and stomach pain beginning 7:30 pm to 7:00 am the next morning when I called advice nurse, told to take Tylenol. pain got much better. Continued to take Tylenol every 6 hours, kept pain bearable, slept 12 hours the next night. Had a slight fever 100.5 the next day, still having some pain in my abdomen. Thursday night, pain in abdomen was bad again, but not as bad as the first night. Talked to my doctor on Friday about these effects. Friday night pain in my abdomen is much better but still there. No fever on Friday or today, Saturday

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

Very extreme pains throughout my whole body, extreme exhaustion, pain in lower part of stomach and pain when sitting. Lasted for 3 days. Headach.

patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a severe headache and fever, unknown exact temp, nausea and vomiting. Fever stopped on 1/20/21 per patient. She reports her eyes seemed blurry for several days, like haziness. States she felt like her heart was racing for a few days beginning on 1/18/21. She did have a routine doctors apt on 1/22/21 and her physician completed bloodwork, unsure of labs or results. Her physician said that she should report her symptoms after the vaccine. She also had swelling and redness to her left upper arm all the way down to her elbow area after the vaccine.

Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and joint pain, chills, nausea, dizziness (for about 18 hours) oxygen level: averaged 96 but dropped to 93 one time (but that might have been equipment error)

The morning after receiving the vaccine, I woke up and was pretty dizzy which made me nauseous. I had to try a few times to get out the bed. It went off and on on Sunday then it went away. (felt like I was suffering from vertigo) I do not think I have suffered from it since then.

Flushing 2-5 minutes after the injection; numbness in tongue and difficulty swallowing 20 - 25 minutes after infection

Redness, swelling, heat, mild itching, hardness at injection site Abdominal cramps, nausea, vomiting Mild fatigue

Patient presented with vomiting symptoms, fever, general weakness, high blood sugar, and loss of appetite. COVID19-IgG and IgM test were ordered and both were positive. PCR testing was also performed, with positive result. Case was consulted with the Infectious Disease clinician, who also recommended treatment with Bamlanivimab. Patient has not shared that he had recently traveled 7 days prior and that her grandchildren had also tested positive for COVID-19.

fatigue, headache, muscle pain, joint pain nausea. Slept most of the day. No appetite, very little food consumed.

Extreme pain in jaw. Lump tmj and in throat. Swollen glands on left side. Sharp pain when swallowing and ear ache.

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

1. Tendonitis of the left achilles. Began 29 hours after injection -- 5pm on Saturday, January 30th. 2. Nausea and vomiting: Began 40 hours after injection -- 3am on Sunday, January 31st.

Approx 8 hours after receiving injection headache began, went to bed. Woke up at 3 am aching muscles and head. Fell going to the bathroom. Able to get up and go to bed. Got up at 6 am, went to bathroom and fell in bathroom hitting doorframe causing black and blue bruise on right shoulder. Feeling very weak, sweaty, and shaky. Laid on floor x 15 min until able to get up and scooted over to sink and pulled self up and vomited x 1. Got back to bed. Felt weak, shaky and sweaty for the whole day. Feeling better after taking Tylenol for the achiness by the end of day. Felt weak and tired the following day but better.

Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain. The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid. On 04 Jan 2021, approximately 2.5 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain. The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown). Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to ‘possibly related' for all events.

pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appetite, dizzy, weak and felt like she needed to faint. She was experiencing angina type symptoms w/ short frequent episodes of AFIB. She went to bed and woke up around 11 PM on 1/31/2021 sweating and had a temp of 103. She took extra strength Tylenol and went back to bed. Next morning her temp 101.5. but had returned to normal during the day but had gone back up to 99 later that night. On 2/2/2021 states there was no temp but her arm is swollen, itchy and red with pain. She was able to eat and get hydrated. Pt is still dizzy and light headed at this point. On 2/3/2021 patient woke up feeling some better and able to focus but still has itchy, painful and pink arm that is hot to touch. She is going to call her PCP and Cardiologist today on 2/3/2021.

severe numbness and tingling of both lower limbs extending from the buttocks to the toes on 02/02/2021 to 02/3/2021 associated with lower limbs weakness. resolved with some residual right thigh muscle tenderness and sensitivity. chills low grade fever headache and severe nausea resolved by 02/03/2021

The day after the vaccine I woke with a sore arm. Similar to a tetnus shot. By afternoon I was nauseated, I took Pepto Bismo before bed. I woke up in the night with diahrea and severe vomiting, the vomiting was so severe that my stomach muscles were sore for three days after the episode. Sorry about the spelling errors.

awoke this morning and began with throwing up, not violent, but it would come back again and again. Since she got the covid shot yesterday, we assumed that wae the cause of it.

On the 4th hour I was sleepy and fatigue, 3pm, went to bed at 11pm, woke up at 2am extremely dizzy and the room was fiercely spinning and couldn?t get up. I tried going back to sleep and when trying to move the room spined drastically slowly sat up and went to the bathroom and laid back down and it started again, each duration lasted 10 seconds and it caused me to have 3 BMs in the next3 hours, couldn?t sleep but I have a tightness around my head and sleepiness and last event was 7am, when got up I had diarrhea and and had dry heaves that lasted 5 minutes and now fatigued and hot feeling around my eyes. My stomach feels stressed and tired and weak

per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff neck for a couple of hours that evening, unable to eat Tuesday, Wednesday, feverish, and shaking. Slowly recovering through week. As of today per pt. "feels perfectly line"

Diarrhea. Patient stated it started 2 days after vaccination and has been lasting everyday since then. Reported to me on 2/6/2021.

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

Injection 2 on 2/5/2021: small red rash around injection within 12 hours of injection nausea started at 4:00 PM NEXT DAY sore throat started the evening of 2/6/2021 by evening of 2/6/21 red rash grew to approx 2 inches all the way around the injection site and became more itchy

Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family. The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium. On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day. A few days later, the patient was not eating much and did not recognize her husband or family. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time. Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.

Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine. Told to go home and rest. Feb 10 at 9:00 am found dead on the floor in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug.

I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100. took a tylenol. I woke up at 5am the 10th and I was shaking and having chills and I was hot and cold... I was dizzy and my eyes hurt. My arm was hurting. I took another tylenol. at 6am I called my NP daughter for advice and she told her it was a reaction of the vaccine. my fever was 102.5. I was advised to take more tylenol and to rest. the fever broke later that morning but I was still experiencing those side effects. 3 days later I'm still not 100%.

pt stated within 30 minutes after taking the vax she had leg pain starting in the calf and moved all the way up to the thigh. This pain last for 2 days. On 2/12/2021 she woke up she was dizzy and nauseated. Pt has not contacted her PCP regarding her symptoms at this time.

Had no reaction during my 30 minute wait after the injection. That evening at 9:15 started feeling really tired and was chilled feeling which made me shake. Was nauseated all night long. I had dry heaves three times. Had a headache all night. These symptoms subsided later in the morning and by noon I was feeling fine except for being tired from the night's experiences. I feel fine now.

Pain and soreness in the arm, fever, headache, nausea, weakness, and body aches. Nausea, weakness and body aches lasted 3 days.

Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get warm

Entire body hurt,Weak, lathlathergic, stomach bloated, slept through only got up to use bathroom, drink tea and water. Next day awake 6 hours had 1 meal, cup tea and water. Slept 2 hours up til 10:30 back to sleep.

I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscle and body aches, bone and jaw pain, no appetite, nausea and diarrhea?all starting on the same day and rather severe by the next day.

Day after injection-Chills, headache, nausea, body aches, diarrhea, dizziness, fainting, temperature. 2nd - 3rd day- headache, fatigue, slight temperature, tightness in chest

extreme temperature drop; extreme fatigue; headache; joint pain; right side of face and ear painful; Next day - drenched, trouble controlling temperature, headache & joint pain and nausea

I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms On2/8 I had my second dose and the injection site got very sore. I experienced flu like symptoms of achiness, fever, chills. I also had diarrhea and I felt like my intestines were on fire. my arm turned red and was incredibly itchy

The patients daughter states that the patient woke up the morning after receiving the vaccine and does not recognize family members, stops eating in the middle of her meal and doesn't remember what she was doing, has a greatly decreased appetite. Daughter states she is declining quickly.

Lost muscle control, could not raise up out of bed, could not walk, lost bladder control, slept 24 hours, no appetite, weakness, headache, fatigue

ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED IN ICU PER DAUGHTER FOUND have 2 ANEURYSMS.

8-10 hrs post injection (this was the second dose) nausea, fever, chills, diarrhea, headache, weakness, dizziness, could not get out of bed or stand.

Pt began to complain of feeling dizzy. Initial BP was 130/80. Pt then began to complain of double vision and her head feeling "tight". BP at that time was 160/77. EMS called due to increasing BP, double vision and headache. BP when EMS arrived was systolic BP of 180. Pt also complained of nausea. EMS did not transport patient to ED per daughters request to wait at clinic under observation for 30 min in the quiet and then will go home. Pt observed for 30 min and all symptoms resolved within 30 min. Pt taken home by private care.

Nausea, Vertigo, mild headache. Vomiting for one and half days. Soreness at site of injection for one day

Did NOT occur until 1 week AFTER injection: pain, tenderness, swelling in upper arm & pain, hardness and redness; these were preceded by diarrhea and fatigue. Better in 2/3 days.

Experienced severe acid reflux with white, coated tongue for 3 days 4th and 5th days nausea, headache, chills aching joints from neck to feet on 2/19 left arm sore (it was not sore except for day after injection) and itchy

Sharp pain in knees and elbow, nausea ... took pain pill and pain was gone in am. Have been feeling bad (like I was hit by a Mack truck all day. (Flu like aches) nausea on and off but cant throw up. Feeling weak.

Potential Absence Seizure duration 5-10minutes, vomiting at conclusion. Episode occured roughly 40 minutes post vaccination. Patient returned to her baseline following episode. EMS called and patient evaluated in ED and returned to facility with no lasting effects.

Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post injection for observation. Patient reported that she felt her tongue swelling and had difficulty swallowing. Patient anxious, but in no respiratory distress. BP 130/72. Patient was instructed to take some slow deep breaths. Patient continued to c/o tongue feeling thick and she had hacking cough and c/o difficulty swallowing. Patient was given Epinephrine 0.3 auto injector to right thigh at 1:32 pm by RN. BP 150/92, P 90 R 20, Patient also given Diphenhydramine 50mg IM to left deltoid by RN, Supervisor. Patient remained alert and oriented. BP 176/92 at 1:37 pm. EMS arrived on site and monitored patient with EKG, Pulse oximeter, BP and pulse. Patient had some shaking. She remained alert and oriented. Patient refused transport by ambulance to ER. She did agree to go to ER by private car. Patient's husband resent and to transport patient by car to Medical Center. EMS followed patient to hospital. Confirmed that patient was taken to Medical Center ER, by RN.

Bad headache, dizziness, achy, vomiting (3x) Lasted until about midnight, Monday, Feb.22. Felt totally recovered by 9AM Tuesday.

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

After vaccine I was fine went home and took a nap, when I woke up at 2pm I was a little dizzy. By 7pm I was dizzy and nauseated, and it got worse, I got chills and shook and shook and shook, I had a fever and the next day I tried to get out of bed, and I fell to the floor and couldn?t stand up, I had no energy or appetite. I had covid in August 2020 and the wasn?t made aware of the possible side effects if you had covid. They didn?t ask if I had covid in the past and the pharmacist told me later that people who has had covid has reported having bad side effects. I had gone a couple weeks ago to see if I had the covid antibodies and I was positive for antibodies and the injection works against the antibiotics. This part of the procedure was overlooked. I have no one else to help me and going through this alone, it would have been better to have been made aware of this ahead of time.

Woken up at 0300 by severe headache along with body aches, fatigue, nausea and diarrhea. H/A and body aches lasted for aprox 8-10hrs., continued to have nausea, diarrhea and fatigue for about 24 hrs after initial incident. Symptoms have resolved as of today. Denies any other symptoms.

After Dose #2 Muscle swelled and red mark just below vaccination site same day. Next day fatigue, chills, sweats, diarrhea, low grade fever, burping Next day pain above stomach below breast bone, nauseau, vomiting, indigestion, burping. Next day arm still swollen, red spot much larger, itchy, hot.

My antidepressant, Sertraline has stopped working. After the shot, my eyes got blurry. About 5 days later I thought I had a headache from sinus. After medication and doctor visits, it is not sinus. No appetite. shaky, insomnia, no interest in ordinary activities. Constant headache. Feel very sick.

Evening of 1/28 I started feeling fatigue, muscle aching, stomach upset and headache which lasted till next day around noon. Then was fine for 7 days. On 2/5/2021, I went to get my B12 shot and asked the doctor to check left arm where Moderna shot was given as it was itching and a bit sore at the same time. He told me I was having reaction. By evening, a third of my arm around injected area was swollen an had red rash. Then same symptoms of fatigue, etc. came back and I was in and out of bed for the next three days....then at end had a bout of diarrhea.

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

My lips started to swell and got very red on Day #5. I started applying vaseline. By day #7, I called my dr who wasn't in and spoke to his associate. She said if it got worse to follow up with my dr. They continued to get worse and by Day #9, I called my doctor and sent him a photo. He told me to take benedryl and an antihistamine (zyrtec). By the next day, the lips were worse, sent another photo and he prescribed Prednisone 20 mg for 5 days. I had a lot of trouble eating and drinking. My lips also felt like pins were constantly being stuck in them. The prednisone helped but it took at least another week before my lips returned to normal. On the advice of my doctor, I did not get the second Moderna dose.

2/23/21:Headache, sore arm 2/24/21: High Fever 100 degrees: 8:00 p.m. Blurry eyes, Stuffy, runny nose. Sore arm. Sneezing. Felt ill. 2/25/21: Fever slowly came down during the day. Arm itchy and sore. Hot arm. 2/26/21: Hot, itchy, sore arm. Red area near injection site. 2/27/27: Arm still red, sore itchy. nausea.

On Saturday 02/20 twenty four hours after receiving the injection I felt fatigued with loss of appetite and some chills. At the same time I noticed a 2inch red ring around the injection site. The next day I felt fine ,but had a very sore arm with the red circle and a large pink blush running down to my elbow which never disappeared. The following week the red circle disappeared but the pink blush remained. On Sunday, 02/28 I noted that the blush disappeared but I now had a 3inch red circle around the injection site. On Monday 03/1, the red circle grew and spread, and by 03/2 it was no longer in circular form but spread down my arm to 3inches by 6inches. It remains the same 0n 0/3. It is not painful or itchy. I am worried. I know this is called covid arm but my reaction does seem extreme. I do have some photos beginning on 02/28

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

The first night she had the chills real bad. She got up to go to the bathroom and was so could she didn't think she was going to get back to bed. She took 2 Tylenol, and went back and laid down. She then awoke the next day starting to have some chills but not as bad as the night before. She covered up with an electric blanket in a chair and finally passed over. She noticed Saturday that she had nausea and dizziness. She then had tenderness in her mouth, used warm salty water which seems to be helping. She cannot eat any hard food on it due to the discomfort. She has continued nausea in the evenings. No problems with the arm where she got the vaccine. She feels it it getting some better, but the dizziness and nausea is the worst issue. She did call her doctor and they told her that they could not give her anything for the rash in her mouth, and the chills. They told her that it had to run it's course.

Mild nausea, mild headache on Feb. 24 plus extreme joint and whole-body muscular aches that continue a week and two days after the 2nd injection

chills & fever (101.7), nausea, dizziness, aches & pains, I felt out of reach with reality for about 24-36 hours. It never occurred to me to try to eat, drink or even to take my daily meds. I have never experienced that feeling before,

Pt had received dose 1 of COVID vaccine on 12/22/20. On 01/01/21 pt presented to the emergency department for intractable nausea, vomiting, cough, and non bloody diarrhea. Pt had tested positive for COVID 19 on 12/30/2020. Pt was spiking high fevers and was hypotensive. Pt was admitted to the hospital from 1/01-1/06 and treated with dexamethasone, remdesivir, and convalescent plasma.

About 9 days after my 1st dose of Moderna vaccine, I began to have itching on my right upper arm in the area of the injection. That continues today. Two days after I noticed the itching, the upper arm was hot to the touch, red, and swollen. The area is about 6" in diameter. I did not have an elevated temperature, but I felt slightly nauseous and light-headed on March 5. I had no reaction to the shot until a week and a half to two weeks after the injection. I still have a red, itchy area on my right arm. It seems to be slowly improving.

Cold during the night and today went to lunch and does not feel well at all and threw up and has a tempurature of 100.4

Within two to three hours, I reacted with chills, fever, weakness, fatigue, soreness at vaccination site, waves of nausea, joint soreness. I can only remember a couple of times in my life ever feeling so sick. Within 24 hours my side effects subsided. Ten days later I developed itching and burning on hands, arms, chest and neck which, when scratched, turned bright red. The rash lasted about three of days.

Dizziness and lightheadedness starting 3/3/21. Some nausea. No vomiting. Tiredness. Saw doctor 3/4/21. Physical examination and lab tests done. Will take Prometazine 12.5 mg , 1/2 to 1 tablet every 6 hours as needed for feeling of being lightheaded. No further dizziness after 3/6/21.

Day after vaccine, I was very sick as though I had the flu. Had a severe headache above both eyes, was nauseous and vomited, slightly off-balance, and tired.

Head ache, nausea, weakness to the point of near helplessness,. I couldn?t eat & just slept for approximately one day/night & into second day.

With the first shot, I experienced chills for a day and a half. Absolutely could not get warm. With the second shot, I experienced chills; was clammy at the same time as the chills; very fatigued and could not stay awake; my muscles, joints and my whole body ached; headache; sinus infection (for which I am currently on an antibiotic); nausea; loss of appetite (lost 5 pounds); loss of taste and smell for 2-3 days. Too weak to make it to the bathroom by myself. I felt like I was in a delirium but my husband said that I was not incoherent. Appetite is still not normal. Mouth was so dry that I was not able to feel any moisture at all which I feel led to my sinus infection.

Fatigue 8:30 pm, 2:30 am upset stomach, slight head ache, (unable to go back to sleep) 9:00 am extreme fatigue rash around the injection site (not sure when) Approximately 3pm (following day10th) upset stomach and head ache stopped. Fatigue diminished. Fatigue gone 6am on the 11th. Rash still visible and minor itch.

Left are was warm to the touch and slight sore, started throwing up around 5:45 pm and temperature was 102.3. Threw up again in the night and started having diarrhea. Still running 99.8 fever on 3/11/21

3/4 very sore arm. 3/6 arm soreness gone. 3/7 at 2:30am awoke with rapid heart rate. Continued to mid morning and developed chills, fatigue, slight fever, no appetite. By days end felt much better. However the very next day 3/8 woke up feeling fine but by days end lower abdomen painful. Pain continued into 3/9. I called my family Dr and went over systems on phone. Diagnoses, bout of Diverticulitis. Which I have had before. The times before required antibiotic etal, not this time. I writing this today 3/12 to say feeling much better. I?m on a light diet and this seems to have helped this time.

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

Nausea, diarrhea, slight headache, lightheadedness and discomfort at injection site. no muscle or joint pain but slight fatigue.

Fever, extreme back pain, nausea, lightheaded, headache, chills, redness, bruising and swollen arm where injection was given.

Thursday Morning had covid vaccine, felt tired, Friday night diarrhea, vomiting and stopped during the day, stayed in bed all day saturday, was able to eat saturday again, continues to have loose stools, is taking pepto bismol. There is not any data regarding this as a reaction however will file a VAERS report per pt request. Is pushing fluids and does not have any further concerns. Will call provider if symptoms continue.

Got the vaccine and was fine, on the 2nd day 3/12/21 she got so weak, was freezing, her legs and feet were cold. She turned the AC off and the temp in the house was 82 and she was still cold, had a headache and felt so bad. She took her temperature and it was 101.6, she felt nauseous. She had eaten a protein bar at 11:00 AM on then at 1:00 PM had the above symptoms. She continued to drink water and kept it down, took her temp about 2 hours later and it was 100.4. About 4 hours later she continued drinking water, and her temp had dropped to 99._. She was so weak that she could hardly get off the bed to go to the bathroom and urinated on herself trying to get up out of the bed. After her fever went down she was able to get up. Her husband was almost total care and she was not able to take care of him. She went to sleep and woke up at 3:00 AM and felt so much better, and ate some crackers and took some Tylenol for the headache and felt like she was OK. She did not eat anything on Friday and on Saturday ate lightly. The vaccine area is warm to touch, sore and swollen but not much.

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

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

low fever, up to 100.0, aches, nausea, fatigue, arm continues to be sore. Symptoms on and off since vaccination; worse today

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

About 36 hours after the injection, I became lightheaded, along with diarrhea, general feeling of being out of whack. It lasted about 20 hours.

Brain confusion (1 hour), headache (3 days), body aches (3 days), vomiting (2 days). weakness & tiredness (5 days). No treatment for any of above.

Patient reported a welt and itching on day 2, then very high blood pressure about 3 days after which she went to the ER to get evaluated and nothing determined to be for certain related and she was sent home . about a week after shot , she developed Covid Arm (rash and itching on arm and neck) and also had nausea.

6 hours after having shot it triggered PTSD because she couldn't lift her feet (like heavy rocks) staggering to lay down, diarrhea, nausea, poor appetite, headache, fatigue throughout body, aching bones/joints

joint ache, nausea, fatigue, no appetite, no taste, very weak, difficult swallowing, memory problems,. Start evening of 2/25 to present - 3/22/21 Emergency room treatment: blood profile, X-rays, Cat Scan, urine analysis, etc. All OK.

77 yr old caller got her vaccine on Tuesday march 16th her first vaccine at 230, moderna lot # 044 A GA or AUA woke up Wednesday with dizziness history corona virus in sept of 2020, asthma later on Wednesday she vomited one time feels fine today

3/10/21 5:00 p.m. extreme body/abdominal pain; 3/11/21 a.m. pain & abdominal and back (kidney area spasms) p.m. Fever of 101.2; . itchy rash started in arm pits 3/12-3/15 extreme body and internal back pain and itchy rash continue 3/16 p.m. doctor prescribed Simethicone 125 mg. (I added Acidophilus & Bifidus) one capsule each after each meal 3/25 Itchy rash gone; extreme pain gone, continued stomach tenderness and low inner back pain.

about one month after #2 shot in L arm, whole left side from toes toes to head affected. toes/left foot/side tingling, constant felt like foot asleep continuously even awakening in sleep at night L calf on outer side felt cramped occiput, left side of head achy some constipation tired every late afternoon

On 03/24/2021 around 10PM my left arm started to ache, was itching & stinging. On inspection, a red tender slightly swollen area where I had the injection. Also had more body aches than usual. On 03/25/2021 upper left arm showed more redness & swelling. Also had nasal congestion & an episode of diarrhea in the PM.

The arm was sore for 2 days. I have diverticulitis and it flared up a few days letter. my legs feel a little heavy. I don't think that a vaccine should be attacking my weaknesses or current health conditions. I eat very bland and I don't have issues but now I have terrible issues since the vaccine.

Both arms, and only the arms, became swollen, red with rash, itchy and painful. Other more common side effects included fatigue, chills, nausea, severe headache, which occurred in the evening of the day vaccine was administered

About 10 mintues after the vaccination while the patiet was waiting the 15 minute obvservation time, she complained about feeling nausea, and tingling and numbness running down her left arm. ( The left upper arm recieved the IM shot). Patient stated she was feeeling anxiety and was afraid her blood pressue was increasing. She took a read on the automated personal health station and got a reading of 178/99. Pulse 78 10mins later I took a reading using a hand held blood pressure reader and got 175/98 pulse 74, 10min later next reading was 176/89 pulse 68. At this time I called for EMS to come and evaluate the patient and her symptoms. About 10 minutes after the last reading the EMS tech took reading of 174/73 pulse unknown. After their assetment of the patient and talking with the her daughter the patient refuse transport to the ER and was taken home by her daughter

*Patient did not have exact dates/labs/detailed information* Patient stated the following: She had every side effect on VIS except nausea and vomiting and they started around 3 pm the next day. Within 2 weeks she developed a thrush like reaction on her tongue. When she recently had routine bloodwork it showed "increased liver" and issues with her pancreas. She stated her bloodwork was only ever elevated after the covid shot. Also states she has now developed an autoimmune disease (not documented, they are in the process of testing). Her doctor has not said it, but she feels this is all because of the vaccine.

Low grade fever (100), chills, slight sore throat, mild headache, eyes burning, lassitude, lack of appetite

diarrea, vomiting, cant walk, dizzy, chills, fever SICK SICK SICK SICK SSICK SICK SICK SICK HOW DO YOU EXPECT A SICK PERESON TO FILL OUT THIS long form????????????????????????? I AM STILL ALIVE BUT THE CHECK MARK WON'T LETY ME CHECK SOMETHING ELSE.

The day off there was alot of pain similar to a bruise, nauseous throughout day of and night, swelling in right hand,

Patient had 2nd dose of Moderna vaccine and within her 15 minute waiting period she became lethargic and had a decreased level of consciousness. She was lowered to the floor where she then vomited. She was placed in the recovery position and 911 was called. She was then transported vis EMS to the ER.

A Spontaneous report was received from a Consumer concerning a female patient of 77 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for COVID-19, diarrhea, decreased appetite. The patient's medical history included heart transplant and was on dialysis prior to the vaccination. No relevant concomitant medications were reported. On 10 Mar 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) on right arm , intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reports she was tested positive for COVID-19 and was hospitalized with symptoms of diarrhea, loss of appetite. The patient was discharged from the hospital on 19 March 2021 and was still in quarantine at the time of this report. Laboratory details were not provided. Treatment details included Remdesivir. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events of patient, positive for COVID-19, decreased appetite, diarrhea was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Date:3/13/21 820am Patient c/o feeling nauseous, vomited x1 small amount of yellow color emesis. Patient stated that she feels dizzy and lightheaded. VS 97.3,20,81,176/86 O2 sat @ 96% on Room air. Patient stated that she ate breakfast and took blood pressure medication this morning. Son stated that patient was nauseous while en route to get vaccination. patient awake, alert and verbally responsive. Resting in w/c. Close monitoring in progress. 835am Patient states that she feels a little better VS 97.6,18,70, 134/79. patient stated that she usually gets nervous when getting vaccinations. Encouraged to rest for 15 more minutes. 8:50 am patient stable. VS 97.5, 18, 131/80,72. Patient verbalize relief. left facility with son at side.

fever for 55 hours. 101.1 to 103.4,last temp 4pm Sunday 99.8. vomiting , severe body pain, chills, shaking, no taste, weak, sweating . took tylenol and advil. called my pcp she said it should last about 24 hours. As of tuesday 4/6/21 still very tired.

Chills started at 4:00 PM on 3/26/2021, I woke up at 1:30 AM, chills were gone but had a headache which lasted 2 days. Nausea started that morning and increased in intensity associated with dry mouth. The nausea was constant. I couldn't stand the smell of food. I drank lots of water, forced myself to eat some crackers, lay on the sofa all day for several days. On 3/29 I started taking Omeprazole. On 4/3 my nausea started improving and by 4/5 was gone.

Relaxing on couch-normal day. Suddenly felt very sweaty-hair wet - decided to wash face - went into bathroom- Quick reaction - Instant diarrhea and vomiting in bucket. Very scary - asked husband for more toilet paper. After cleaning up, I was extremely COLD. Put on extra clothes sweatshirt - got 3 blankets, by now it is 1:30 A.M. Slept in recliner. Next morning - felt weak, unsteady - afraid to eat anything but did drink lots of water. Today is Sunday April 11th, still very cautious about eating and still taking it easy. Seem to have a little discomfort in sternum area (thinking this could be my "years ago diagnosed hiatal hernia ??

SEVERE CHILLS - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) LOW GRADE FEVER - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) NAUSEA - NO TREATMENT BETTER (STARTED 8 HOURS AFTER AND LASTED 12 HOURS) PAIN IN ARM AND BELOW LEFT RIB CAGE - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) RED RASH AT INJECTION SITE - NO TREATMENT BUT NO PAIN (STARTED NEXT DAYS 4/10/21 STILL GOING AS OF 4/12/21 11:00AM CST) COLD SWEATS - NO TREATMENT (STARTED NEXT DAY 4/10/21 STILL GOING AS OF 4/12/21 11:00 AM CST) STIFFNESS IN NECK AND SHOULDERS - NO TREATMENT (STARTED NEXT DAY 4/10/21 AND ENDED 4/11/21 IN THE EVENING)

Approx. 11 am on 4/2- begin to unbearable chills, headache, lost appetite, sleeping, lost of energy . 4/4, starting having diaherra, lasting until 4/6. On 4/8, begin to start feeling better.

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

is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included paracetamol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient called pharmacy 4/14 stating that she experienced nausea, persistent fatigue when walking, and hyperphoresis the day of and the day after the immunization on 3/29.

Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol (Tressor for cholesterol), Stress (Takes "stress pills") and Drug allergy (azithromycin (Zithromax)). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 05-Mar-2021, LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10-Apr-2021, she experienced right-sided facial paralysis and was unable to keep her eyes closed. Her doctor subsequently diagnosed Bell's Palsy. The patient inquired if there were patients who have experienced the same thing. Action taken with mRNA in respect to the events was not applicable. Concomitant medications included stress pills and tressor for cholesterol. Treatment included prednisone, unspecified antiviral medication and eye drops for the right eye. 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.

Headache, pain in chest, increased blood pressure, systolic reading increased to 210 day of vaccination (unsure of diastolic reading). Today blood pressure 155/107. Patient went to healthcare facility on 4/12/21. was prescribed ASA, Xanax 0.25mg and Norvasc 2.5mg. Headache and chest pain resolved. Patient takes log of blood pressure readings daily. 4/16/21 Follow up: Patient stated as of this morning her BP is 140/109 , chest pain has subsided but she feels its related to gas, headache has also subsided. Advised her to continue with the meds she is taking and also advised her that she can take a gas-x otc to help to relieve some of the bloating and gas feeling she has. Will follow up on Monday 4/19/21.

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

on 9th started with a sore throat.running nose,coughing, by the 12th throat was so sore could hardly swallow. Went to urgent care .Was treated for just a sore throat. Wed 14th in the evening I went into a-fib and ambulance called and taken to hospital. They tried two different meds to get me back to normal sinus rhythm..They sent me home that evening the 15th.Today I`m starting to feel better.

Tiredness (sleep), loss of appetite (ate Jello), fever of 101 (Tylenol), = day after injection and next day Diarrhea/very loose bowels (Immodium) = second day after injection

vomiting, diarrhea, n/v, metallic taste in mouth, syncope, weakness, anorexia, abdominal cramping Drinking warm ginger-ale, dried cheerios, sips of water with some relief. Recommended Mylanta to help soothe stomach. 4/23-symptoms lasted 1 week; feels improved. Still fatigues easily.

Unable to move. Falling on the floor. Lying on back on floor and vomiting clear liquid for aprox. 3 hours . finally able to move after four hours.

COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID Diagnoses After Vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID Diagnoses After Vaccination) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID Diagnoses After Vaccination), NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Source of sample- Nasopharyngeal. 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. Relevant concomitant medications were not reported. Treatment information included Monoclonal antibody therapy as bamlanivimab infusion for the virus start on 19 Jan 2021. Company Comment: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information included adverse events (chills, cough, nausea, diarrhea, nasal congestion and loss of taste), hospitalization confirmation, laboratory exam performed date and treatment information as bamlanivimab infusion.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Late afternoon of 2/18/21 developed high fever, chills, nausea, headache, severe dizziness. I was literally unable to think or move. I was totally bedridden until the next day when I started to feel some better.

She got her vaccine, she had a different person than the first one and didn't even feel anything and was fine. With this one she felt when she was stuck with the needle. She got a flush of heat that went down to her elbow. She stayed there for the allotted time period and went home. She got up the next morning, the first she realized that she could hardly stand up due to the pain and aching everywhere. She then started getting chills, and went in to eat and not able to eat, but no appetite. She laid around all day and started taking her temperature and the last time she took it it was 100, then didn't take it after that. She had a massive headache, in fact that evening she put an ice pack on her head as was told not to take Tylenol. She states that this lasted all day, she went to bed early and the next day had exhaustion, unable to do anything, took it easy. She did have her appetite back, and was able to eat. By the 3rd day she was back to her normal self. She did call the paramedics to ask questions as they are around the corner, and they told her to wait 24 hours and see if it resolved, which she did.

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

Day one typical chills starting at 10 hours post-vaccine. By 16 hours she had all-over body aches and a migraine, treated with 4x Motrin 200 mg tabs with good improvement by 28 hours. Chills again at 36 hours and some shoulder and low back muscle aches, treated with 3 x Motrin 200 mg tabs. She did well the rest of day 2. Day 3 started by feeling well, but by 9 am she felt cold, weak, and nauseated. I covered her with multiple blankets and a heating pad and lay her in bed. About an hour later she felt less nauseated but still cold.

Patient stated next day after taking the vaccine, she had 102.7 temp, fatigue, nausea, chills, body aches and pains. Her legs hurt and she had trouble staying awake. She took Tylenol which helped bring down the temp but did not make it go away. On 5/14/2021, patient stated she still has 100.7 temp and is nauseated but the other symptoms have subsided. She had the COVID virus on January 23, 2021.

Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for 2 days,, sleep on and off for 3 days. Just starting to feel a little better. It was hell. 10 days.

She got her vaccine, and felt fine. She came home and did what she had to do and when she went to bed she felt fine. When she woke up yesterday she sat on the edge of the bed for a minute and then passed out and woke up on the floor. She called the manager of the apartments and asked if she would come and help her get up. She helped her and felt that she should call the paramedics, which she did, and they came out and checked her out and she was okay. Later in the day the dizziness hit her again and she passed out again. She finally managed to get to her phone again, she was not able to get up, and she called 9-1-1 and they came out and got her in the chair, but did not take her to the hospital. She has not passed out anymore but she feels very dizzy and woozy and does not move fast. She also had some nausea, but that is pretty much gone. She has not called her doctor as it was over the weekend.

GI bleeding; Walking with a walker; Not Able to Walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleeding) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleeding) (seriousness criteria hospitalization prolonged and medically significant). On 05-Apr-2021, the patient experienced GAIT INABILITY (Not Able to Walk). On 06-May-2021, the patient experienced WALKING AID USER (Walking with a walker). The patient was hospitalized from 15-Mar-2021 to 05-Apr-2021 due to GASTROINTESTINAL HAEMORRHAGE. The patient was treated with Rehabilitation therapy for Gait inability. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (GI bleeding) outcome was unknown and GAIT INABILITY (Not Able to Walk) and WALKING AID USER (Walking with a walker) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. On 14 Apr 2021, the patient was moved to Rehab, and after 3 weeks in rehab, she is now walking with a walker. It was reported that the patient has not received the second vaccine yet. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

shivering, general body pain, extreme weakness, severe sleepiness ( sleeping 24 hours ), nausea (unable to drink water or eat) , no fever

Chills, fever,,headache, vomiting stars headache apps 1 hr after shot, chills, vomiting started around 1:30 am and continued until 2:30 pm on the 21st

Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise, had second moderna covid vaccine 5/21, became ill 5/22 woke up with low grade fever, generalized weakness, malaise, no appetite, lightheaded, fall to ground stricking righ cheek, no LOC, baselilne memory losse, confusion improved, better on 5/22 morning, no need for follow up clinic visit. Can't get to fill in hospital information to unshade to fill in

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

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DESLORATADINE for Allergy, ASA and APIXABAN (ELIQUIS) for Anticoagulant therapy, LOSARTAN and METOPROLOL for Blood pressure, FUROSEMIDE for Diuretic effect, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye, FLECAINIDE from 14-May-2021 to an unknown date and CLONIDINE for Heart disorder. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) (seriousness criterion medically significant), HUNGER (Unusual hungry feeling) and BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings). On 15-May-2021, the patient experienced VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball). At the time of the report, ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).), HUNGER (Unusual hungry feeling), BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings), VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Blood pressure measurement: 104/54 (Inconclusive) At 6:50am, 97/62 (Inconclusive) At 11:40am, 110/62 (Inconclusive) At 2:50pm, 142/89 (Inconclusive) At 8:45pm and 119/69 (Inconclusive) At 10pm. On 12-May-2021, Heart rate: 74 (Inconclusive) At 6:50am, 73 (Inconclusive) At 11:40am, 62 (Inconclusive) At 2:50pm, 109 (Inconclusive) At 8:45pm, 103 (Inconclusive) At 10pm and 97 (Inconclusive) At 2:50pm. On 13-May-2021, Blood pressure measurement: 110/87 (Inconclusive) At 7:12am and 117/76 (Inconclusive) At 8:06am. On 13-May-2021, Heart rate: 104 (Inconclusive) At 7:12am and 101 (Inconclusive) At 8:06am. On 14-May-2021, Blood pressure measurement: 116/80 (Inconclusive) At 7:32am, 129/78 (Inconclusive) At 1:02pm and 169/97 (Inconclusive) At 8:32pm. On 14-May-2021, Heart rate: 99 (Inconclusive) At 7:32am, 102 (Inconclusive) At 1:02pm and 107 (Inconclusive) At 8:32pm. On 15-May-2021, Blood pressure measurement: 140/83 (Inconclusive) At 7:03am, 147/88 (Inconclusive) At 9:19am, 146/96 (Inconclusive) At 4:55pm, 161/95 (Inconclusive) At 8:20pm and 112/83 (Inconclusive) At 10:00pm. On 15-May-2021, Heart rate: 78 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:19am, 108 (Inconclusive) At 4:55pm, 109 (Inconclusive) At 8:20pm and 95 (Inconclusive) At 10:00pm. On 16-May-2021, Blood pressure measurement: 136/75 (Inconclusive) At 7:03am, 101/67 (Inconclusive) At 9:12am, 101/62 (Inconclusive) At 2:03pm and 127/75 (Inconclusive) At 10:00pm. On 16-May-2021, Heart rate: 101 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:12am, 90 (Inconclusive) At 2:03pm and 70 (Inconclusive) At 10:00pm. On 17-May-2021, Blood pressure measurement: 139/86 (Inconclusive) At 7:03am. On 17-May-2021, Heart rate: 73 (Inconclusive) At 7:03am. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.

Device connection fit issue; stomach pain; nausea; Infected sebaceous cyst; postoperative pain; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of INFECTED DERMAL CYST (Infected sebaceous cyst) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and DULAGLUTIDE (TRULICITY) for Blood sugar increased. The patient's past medical history included Thyroidectomy NOS in 1976, Total hip replacement in 2019, Hysterectomy, Gallbladder removal and Bladder repair. Previously administered products included for Plaque psoriasis: Aclovate, Clobetasol and Tacrolimus; for Product used for unknown indication: phenobarbital, Neosporin, Cardura, Vasotec, amlodipine, diovan, isoptin, Metformin, Carafate, januvia, CARDIZEM [DILTIAZEM] and ZITROMAX. Concurrent medical conditions included Sebaceous cyst since 2020, Denture wearer, Non-tobacco user, Abstains from alcohol, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Shellfish allergy. Concomitant products included METOPROLOL and NITRIC OXIDE for Blood pressure high, ACARBOSE and GLIMEPIRIDE for Diabetes, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, AMOXICILLIN for Prophylaxis, METHOTREXATE SODIUM (METHOTREXAT [METHOTREXATE SODIUM]) for Rheumatoid arthritis, FOLIC ACID and VITAMIN D3 for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder. On 30-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In February 2021, the patient started DULAGLUTIDE (TRULICITY) (Subcutaneous) 40 milligram. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, the patient experienced PROCEDURAL PAIN (postoperative pain) and BLOOD GLUCOSE INCREASED (blood sugar increased). On 23-Feb-2021, the patient experienced INFECTED DERMAL CYST (Infected sebaceous cyst) (seriousness criterion medically significant). In March 2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Device connection fit issue). The patient was treated with INSULIN GLARGINE (TOUJEO) on 26-Apr-2021 for Blood sugar abnormal, at an unspecified dose and frequency; GINGER ROOT [ZINGIBER OFFICINALE RHIZOME] for Nausea and Stomach pain, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CLINDAMYCIN at an unspecified dose and frequency. On 15-Mar-2021, INFECTED DERMAL CYST (Infected sebaceous cyst) had resolved. In April 2021, ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) had resolved. At the time of the report, PROCEDURAL PAIN (postoperative pain), DEVICE CONNECTION ISSUE (Device connection fit issue) and BLOOD GLUCOSE INCREASED (blood sugar increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pathology test: benign (Inconclusive) Benign sebaceous cyst. On an unknown date, Blood test: trouble with blood sugar (Inconclusive) trouble with blood sugar. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included a surgery for the removal of sebaceous cyst infection on patient's right breast in the dermatologist clinic on 15 Mar 2021. Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-131000 (Patient Link).; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.

Nausea; getting more and more sick, it is getting worse as the day goes; stomach problems; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C2HA) for COVID-19 vaccination. The patient's past medical history included Back surgery (2 back surgeries) since an unknown date. Concurrent medical conditions included Hypertension, Epilepsy, Spinal cord disorder (Spinal problem) and Seizures. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), ILLNESS (getting more and more sick, it is getting worse as the day goes) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (stomach problems) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) 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. Concomitant medication included unspecified seizure medication, blood pressure patch and pain medicine. No treatment products were reported. Patient had her first dose on 20 May 2021 in her right dominant arm. On 21 May 2021, patient experienced nausea, getting more sick and worse as the day goes stomach problems. Patient called her family doctor but doctor was left for the day. Patient wanted to knowwhat to do about her side effects. Patient provided her doctor's contact information and permission to contact her doctor. The patient had her first dose in her doctor's office. No treatment medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended; 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.

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

Started with heartburn which I never had. Took Prilosec. Covid tested negative on May 3 at the local urgent care clinic. On May 4 at 9 am went to the emergency room of hospital. Blood test and ultrasound done. I was low on sodium, but my organs around my stomach were fine. On May 7 at 2 am, woke up with 103 degree temerature, felt chilled and shaking/spasms violently which I had never experienced before. EMS came at about 3 am, and shaking subsided after drinking hot water. Had follow up visit with my primary care doctor on May 11 at 1 pm Still experience heartburn and am taking Sucralfate and Nexium.

I felt fine after my vaccination until about midnight. I felt weak, and generally sick - horrible. I felt like I had a fever and I felt like my heart was still thumping too hard. I felt nauseas and generally all over sick as a dog, weak as a kitten. And I was afraid as well, because it was midnight and I live alone. I thought about going to the ER due to my condition. I took my BP and it was 120/68 which is normal. I took my temperature and it was 96.7 and then I did my blood oxygen and it was 96 with a heart rate of 66 so all of my little at home tests were normal. I was no longer afraid. I took two baby aspirin and I drank a lot of water and I went to sleep. I did not feel good in the morning but due to my vitals being okay, I began to stop worrying. Around noon the day after my vaccine, I felt OK. I contacted my DR the next day and they called me back and I was fine at that point so said nevermind.

When I woke up 8 days later and left arm swollen at site with red bumps that were raised and itchy. Chest had red flat circles. Raised red bumps under bra line. Nausea.

tireness, no appetite, finds it difficult to converse These symptoms have gradually gotten worse since the second vaccination. She has been to ER and Prompt care.

sleep for 36 hours, then nauseas, headache, After that four 4 months no taste or smell Terrible taste in mouth

Pt states night of the 2nd vaccinations fever, chills lasted several days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing

Patient ran fever of up to 102, reports headache, fatigue, body aches, lack of appetite, redness, heat at site of injection. Patient used only Tylenol to treat. Patient states that 5 days later she is finally feeling a little better

nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. 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

Acute hepatitis; Fatigue; Diarrhea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEPATITIS ACUTE (Acute hepatitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS ACUTE (Acute hepatitis) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, HEPATITIS ACUTE (Acute hepatitis) was resolving, DIARRHOEA (Diarrhea) had resolved and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Alanine aminotransferase: 653 (Inconclusive) 653. On 29-Jun-2021, Aspartate aminotransferase: 283 (Inconclusive) 283. On 29-Jun-2021, Bilirubin conjugated: 0.3 (Inconclusive) 0.3. On 29-Jun-2021, Blood alkaline phosphatase: 90 (normal) 90. On 29-Jun-2021, Blood bilirubin: 1.3 (Inconclusive) Gilbert's. On 29-Jun-2021, International normalised ratio: 1.03 (Inconclusive) 1.03. On 29-Jun-2021, Ultrasound liver: abnormal (abnormal) +ANA chronic for years , low suspicion. On an unknown date, Alanine aminotransferase: high (High) 20 -> 250 -> 950. On an unknown date, Aspartate aminotransferase: high (High) 20 -> 147 -> 256. On an unknown date, Blood bilirubin: 1.2 (Inconclusive) 1.2. On an unknown date, International normalised ratio: <1.2 (Inconclusive) <1.2. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other laboratory included test for Acute hepatitis- Negative for Hep A/B/C , IgG Treatment information was not provided. The physician reported that previous labs suggest underlying Gilbert's 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

Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna

5/28/2021 Patient started experiencing sharp pain in her left ear. In May patient had stroke symptoms for about 15 mins. Speech was slurred and she could not remember people. In June stabbing pain and left feverish and had a episode of loose stool.

After about two days, began to experience diahhrea for three months. Consulted with Gastroenterologist who put me on CREON. I am still trying to get diaahrea under control.

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

Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76, 157/82 feeling better after 24 hours. Given Tylenol. Had refused medications while feeling ill after vaccination, medications taken next day with no problem.

The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vaccine yesterday. Now displaying increased weakness, blood in urine, increased confusion and urinated on herself today. Fever of 101.9 ) 79-year-old female presents to the emergency room with fatigue. The patient states yesterday she had the Moderna COVID-19 The patient states today she had a temperature 101.8° prior to arrival. Her son noted that she was having episodes of urinary frequency and also that she was profoundly weak and fatigued. They denied falling or hitting her head. The patient also states she been having nausea vomiting with diarrhea.

On the second day, I had to drive to get the car serviced. When I got home I was very dizzy, got out of the car took 12 steps backward I was so dizzy it did not end in a fall.. I went into my house and tried to eat and it turned my stomach just to look at food. I lay down and slept until 10 am the next day. Now when I get up in the morning I am too dizzy to walk to the bathroom. I must wait 5 minutes before getting on my feet.

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

January 13, 2021 - received injection and didn't feel it going in, shortly after got sore arm January 14 - 9:00am arm very sore and had diarrhea, clammy and very hot. Had diarrhea 3 more times until around 11;30. Nothing else until about 4:00 pm - had chills, didn't last very long after covering up. January 15th - just sore arm, no redness at injection shot. January 22 - noticed injection site had a 3" x 1 1/2" red place and warm to touch. Doctor said to ice it and take Zrytec and put Benadryl cream on it. January 23 - not as red, but a little sore. Had some diarrhea, but don't know if that is what it is from.

About 20 hours after receiving the COVID vaccine she was tired and lay down to nap. Shortly thereafter she became very dizzy even while lying down. As time went on she started burping loudly and developed nausea. She also has developed a headache and has a low fever of 101.5. This all continues until now, 48 hours after the injection and she is still dizzy in bed with the above symptoms.

feeling hot but no fever, slight headache, slight nausea, general tiredness . atypical for me. 36 hours

Severe, uncontrollable diarrhea 2 hours after vaccination. Indigestion 2 days later. Injection site continues to be red and sore.

Reaction started about 22 hours after the shot. Reaction included tenderness, swelling and redness ( 4 in. diameter ) at the injection site, chills, low grade fever, fatigue, nausea and vomiting. Symptoms, except fatigue, subsided in about 12 hours. It took about a week for the fatigue to subside

Next night vomited, fever, chills, back pain, extreme fatigue, inability to eat, lack of coordination in legs, confusion ...lasted for 4 days now. Worse symptoms when temperature is high.

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

Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination. Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)

Had Moderna Covid vaccine 1/21. 3 days later she had nausea and dry heaves, cough, & clear rhinorrhea. The next day she had a fever, Max 101, poor appetite and nausea. Fever last 3 days, then went away. Still having fatigue 1 week out

Rec'd vaccine at 1:30 pm on 02/03/21. Next morning, diarrhea, fever, and was unable to stand up, even with aid of a walker and my husband's help. Muscle weakness, which lasted about 24 hours. . After 24 hours, took 2 Tylenol, Next day problem was gone. And no further problem with muscle weakness. Did read CDC recommendations, not to take 2nd dose if there were problems. And I will not be t aking the second one on 03-03021. Did call Health Dept and reported it but not sure what staff member I visited with, but it was not the nurse who gave injection nor the Administrator.

Patient reported she had second dose of COVID vaccine (moderna) on 2/8. She states later that evening developed severe headache, and vomiting- which lasted 36 hours. Nausea and slight chills during that time. Injection sight sore but no redness, swelling, rashes. Today patient has been able to eat and drink fine, and feels much better.

Monday Eve.: Typical flu-like symptoms: Dizziness, Nausea, Headache, Bone Pain, sore arm Tuesday: Arm hard, warm, very sore --continued Wednesday: Black and Blue around injection site Thursday: Red rash that extended to elbow. Checked with NP who said could be cellulitis or inflammatory reaction --put topical Hydrocortisone on it and watch. It did shrink some, but still present through this evening.

NAUSEA, FEVER (100.3), CHILLS, HEADACHE, MUSCLE ACHES FOR 24 HOURS. EXTREME FATIGUE CONTINUEING FOR 3 DAYS.

COVID-19 Vaccine EUA-FDA/CDC Vaccine Adverse Event; Onset: 3:30 pm Headache, fatigue, dizziness, joint pain, muscle pain, chills, rapid heart, some GI distress. Duration: 28 hrs. Tylenol 500 mg. kept it under control.

A few hours later, my head and bones and muscled started hurting. I was hurting really badly when I woke up this morning. I had a little nausea and my hips felt like they were going to collapse. I started coughing and developed a fever. The muscle pain is very bad. my chest area is very uncomfortable. ( its not over my heart, its higher up) I took Tylenol that seems to be helping the muscle pain a little.

I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days. I had a headache for a few days. I had "covid arm". It was red, sore, it had some swelling, and intense itching. I am still tired. I have diarrhea as well.

Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The following morning she reported to her husband inability to taste food or drink. She developed nausea and vomiting which persisted from 1/30/21 through her death. She was found deceased in bed by her husband this morning.

Up to 72 hours after the shot: * Headache * Pain in the injection site (described as sharp pain) * Her face would get very bright, red and flushed; it would remain this way for about an hour, and then go back to normal. Then the cycle would repeat about 2 hours later. * Patient reports alternating between feeling "feverish" or "really hot" alternating with feeling "really cold" * Dizziness, and very unbalanced on her feet * She fell twice the first two days while trying to walk to the bathroom * Extreme fatigue - she slept most of the first 48 hours * Extreme confusion (more than what was presenting with the Alzheimer's prior to the shot) - she could not remember where she was Ever since the shot/still experiencing: * Persistent nausea * Constant "achy" feeling in her arms, legs and feet * Panic and anxiety (again, more than is common with her daily routine) * Severely decreased appetite - unable to finish more than half a meal or not being able to eat at all due to nausea/a feeling like she is going to vomit * Her arms and legs are visibly shaky * She is too weak often to lift herself out of her recliner (she was able to do this prior to the shot)

Extreme weakness leading to patient falling and unable to get up. Nausea, headache, large itchy welt on arm lasting 7 days.

Swelling, Redness, Rash on vaccination site, rash on back, stomach pains, diharrea, headache, fatique.

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

On the 19th by about 4 pm pain in both arms not just the pain in a left arm muscle which was expected Pins and needles and pain in both hands Neck and shoulder pain Later that night chills Stomach ache and constipation followed by loose bowel later These were milder versions of my reaction when I had Covid-19 in November except the pins and needles in hands. That came on after I got over Covid. These pains went away after a couple of courses of Tylenol extra strength. Except the chills and stomach ache recurred and my stomach is still a little achy

Symptoms: large red itchy spot on arm, chills, fatigue, slight nausea, mild general headache that became piercing,painful and intermittent for several hours Symptoms lasted for approximately 36 hours ,arm remains red and slighty itchy 4 days later, slight headache Treatment:tylenol,liquids,rest

Seven days after receiving the vaccine, the patient's right arm itched, and she reached up to scratch it, and noticed that the area around the deltoid was red. The area does not really itch, but is just red. For the first two days, the rash didn't move. Then over the next several days, the rash starting spreading down the upper arm. On February 18, the patient experienced bad diarrhea. On February 21, the patient put a cold damp cloth over the area to soothe the area. Some areas within the rash are improving, but the redness continues to spread down the arm. The area felt like a bad sunburn, and the patient put some salve on it one day, but did not notice a difference.

very bad pain from head to toe in every muscle, bone and joint, nausea, weakness, freezing cold and the worst was from about 10 pm feb 18 to about 11 am feb 19 but the weakness went on through feb 20. Felt pretty much over it by Feb 21 but still some weakness and fatigue. Also a very sore arm that turned pink and feb 22 is still sore and pink and itchy but not as bad as the previous days. I have always gotten a sore arm with flu shots but not as bad as this time so I didn't consider that a bad reaction.

Woke up Sunday morning 02/21/2021 with cold chills, quickly turning to hot flashes, continuing with a severe headache,vomiting,diarrhea ,and nausea. Continuing thru Monday 02/22/2021 and Tuesday 02/23/2021. Called my Dr?s office at 9:00;AM 02/23/2021. Have not heard back. There message recording asks not to duplicate calls, which I did not do.

Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.

Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my head hurts and my neck. I am still sick. I do not feel good. I am not getting the 2 shot.

Really tired on Monday the 22nd and I felt fatigued. I began to get nauseated and then I began to vomit. I vomited 5-6 times even though I had not eaten anything. I also had diarrhea. I had chills. Some point during the night I spiked a fever, I woke up and drenched. Yesterday the 23rd I had a fever, my stomach still does not feel settled. I have not ate much since Sunday but have been trying to stay hydrated with lots of water. I also developed a cough yesterday. Tuesday night my temperature 100.6 and I think it got higher because I woke up once again drenched in sweat. This morning my temperature was 99. I am achy today with muscle and joint pain, my stomach feels better but I still leery of eating. I did eat some Ginger ale and eat some saltine crackers. I also feel horse. I called my doctor yesterday and still have not heard back. I will call again today. It feels like I feel better in the morning but as the day goes on I get worse and start feeling worse. I have been resting a lot in bed.

REPORTED SLIGHT LIP SWELLING AND SOME DIFFICULTY SWALLOWING, PATIENT TOOK BENADRYL 25 MG ORAL DR OFFICE NOTIFIED, SPOKE TO EMPLOYEE

Tiredness, queasy, itching/rash, feeling of not being well. On days 9 & 10, arm was painfully itchy and a rash developed on my stomach and breasts. Exhaustion lasted 3 weeks.

Swollen, red, hard and feverish knot at injection site. Severe headache and slept for over 24 hours. Was unable to leave bed for 24 hours except for necessities and experienced dizziness and disorientation when trying to get up. Fever over 100 degrees and no appetite and no food taken. Still no appetite on 02/27/21.

Seizure on 02/19/2021 Narrative: Patient had a Seizure last Friday 02/19/2021. This is new-onset seizure activity started on Keppra. PMH of a Hemorrhagic stroke October 2020. Patient received the Moderna vaccine on 2/13 developed dizziness, headache and nausea all day on Monday then 4 days later had a seizure and ended up hospitalized so per hospital report may have been a combination of a weakened immune system and old stroke that included the seizure.

Nausea, vomiting, weakness, confusion, headache, body and joint pain, fever, tiredness, arm soreness,chills. started within 15 hours of injection. Uncontrolled vomiting and weakness necessitated going to emergency room. She had had severe covid 19 in 2020 and was hospitalized for 5 days. Received remesdivir and dexamethasone

"Moderna COVID-19 Vaccine EUA" Immediately felt routine pains in right arm at shot sight and just out of sorts. By 6 PM I felt nauceous , headache, pains in every joint of my old body , cough, chills, virgo, weakness , low grade fever, unsteady on my feet. Unable to sleep finally took Tylenol . This lasted 48 hours!

CHIEF COMPLAINT Chief Complaint Patient presents with ? Abdominal Pain ? Headache a 79 y.o. female who presents with chief complaint of not feeling well. Patient is unable to be any more specific about what it is that is wrong. She denies fever chills nausea vomiting abdominal pain diarrhea constipation or urinary tract symptoms. She does state that she has been feeling somewhat weak. Her appetite has been fine.

Severe Headache on February 5th and nausea, headache, and the feeling that I would faint if I stood on the 6th. I checked my BP and it was 128/70. My blood sugar was 80. The symptoms passed by the 7th of February (my 80th birthday).

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

CLIENT AWOKE 3/2 WITH SORENESS TO THE INJECTION SITE THAT EXTENDED ACROSS HER BACK AND SHOULDERS ACCOMPANIED BY INTERMITTENT NAUSEA. THIS MORNING (3/5) SHE WOKE UP TO THE LEFT HALF OF HER FACE SWOLLEN.

Swollen arm( 3 inch circle), red, painful, diarrhea, lethargy. Took Tylenol 1000mg prn for pain, Alternated heat & cold to arm for two days, Nothing for diarrhea

"Moderna COVID-19 Vaccine EUA" Severe chills, fever 100, nausea started at 2:00 AM. Threw up 3 times, fever and chills ended about 4:30 after hubby gave me Tylenol. Next day stayed in bed with weakness and achy body. 2nd day still weak but did move around with naps in-between. Sunday stayed up and feeling much better.

First 2-3 days felt normal discomfort at injection sit. It got progressively worse and began to feel like a torn rotator cuff. A lot of pain (7-8) unable to sleep on that side and unable to lift more than two pounds or drive or reach above my shoulder without pain of about a 10 on scale of 1-10. Saw orthapedic physician assistant on 03/26 who gave me a steroid shot in that shoulder with 75% relief by the next day. Still some minor residual discomfort at this writing. Also ran a fever with nausea and headache exactly two weeks after first shot.

Following the vaccine she noticed the same day fatigue. She was so tired that she didn't understand it. Then had headaches off and on, as well as muscle and joint pain everywhere, weakness all over her body. She also had a low grade fever Saturday and Sunday. She did have the Corona Virus in July of 2020. She is feeling better today as far as the weakness, just a little bit of muscle and joint pain. She did have a trace of nausea this morning, but took her medication and it subsided. The weakness was something like she had never had before. She took Tylenol for her symptoms. She did not call her doctor. Just has a small amount of symptoms, but still not feeling herself yet.

Patient begin to experience throat tightening, sensation of need to clear throat frequently, voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine. Patient took Benadryl 50 mg OTC and went to ED. Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid. Given script for epipen by ED provider, but has not needed to use.

heavy fatigue, mild nausea, loss of appetite, soreness in upper arm. was at worst from about 18-32 hours after getting the vaccine. took some aspirin for the soreness, slept much of the day.

Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, passed out, and a bit of an ache in her injection arm. The patient's medical history was not provided. No concomitant medications were reported. On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection. On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved. The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Headache the evening of the vaccination. The next day I had headache, chills, whole body ache, stomach upset. I took Tylenol, as directed, for two days.

PATIENT STARTING EXPERIENCING NAUSEA, VOMITING, AND CHILLS ALMOST 2 HOURS AFTER RECEIVING THE VACCINE. PATIENT WAS NOT EXPERIENCING AN ALLERGIC REACTION.

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

Moderna C19 Vaccine EUA Mar 5: 3:15 AM arm started hurting. 8:30AM chills, body ache. 11:40 temp 98.6. arm stopped hurting. 12:05 temp 99.5. slight headache. 12:25 temp 99.9. 1PM temp 101. 5PM temp 99.8. Mar 6: 12:30 PM feeling better. no fever, chills, body ache Mar 9 very difficult bowl movement. Mar 10/11 stomach problems diarrhea

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

Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on the right side radiating deep into the shoulder blade. It would last about 5 - 10 min., stop for the same amount of time, then start up again.... on & off until close to 11:00 pm. Since someone else I know had the same thing happen the day after her shot, I assumed I had the same symptom, tho' it was very frightening. A week later after going to bed on Friday night, I woke at 2:00 a.m. to the same pain only this time on my left side. Thinking I could be having a heart attack, I went to the hospital where I was admitted after having a series of tests. I was there for 2 days during which time I also began to have un-controllable diarrhea. Altho' they could find nothing wrong with my heart, after scans, x-rays, a stress test, numerous blood tests etc., they cannot say positively whether or not it was from the Covid vaccine. I tho't it best to report this in case others have similar events. I had the MODERNA vaccine

fever and chills, headache, nausea muscle aches, fatigue treated with tylenol felt fine after 24 hours

Diarrhea beginning early March 5th continuing through today, March 13 with only two diarrhea-free days in that time. Cramping, urgency and liquid or extremely soft stools. Diet(s): liquid only; jello, plain yogurt, saltines; BRAT diet; normal diet. Only difference in outcome is that I'm very hungry on any other than the normal diet. Imodium approximately 2x a day.

It started with a headache, and then i was shaky(but that went away) tired,chills, fever 101.6, blood pressure was really low (I typically have high blood pressure). Major loss of appetite. Vomited twice. Runny nose. Forgetfulness.

Every part of body hurt one day after the injection, didn't eat, Second day everything ran out of me until I pooped yellow liquid. Third day started to eat and be up more and moving around. Felt like flu. Day 4 checked weight and lost

I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOUND UP IN THE HOSPITAL ON FEB 8 WITH BLOOD CLOTS DOWN MY ENTIRE RIGHT LEG AND IN MY LUNGS. I NEED TO KNOW IF THE MODERNA CAUSED THESE OR MADE THEM WORSE. I HAD NO IDEA I HAD BLOOD CLOTS BUT MY FOOT, LEG WERE SWOLLEN AND I ACHED FROM MY HIP DOWN THAT LEG. I ACTUALLY THOUGHT IT WAS SIADACA.

Temperature elevation, chills, headache, joint pain nausea, dry heaves...I had COVID IN NOVEMBER, DIAGNOSED Nov.19, had double pneumonia , released from hospital Dec. 6....I waited over 90 days to have vaccine...adverse effects lasted around 48 hours, I?m still fatigued, no temperature elevation, but the whole episode was like my first stages of Covid. I do not want to get my second shot in April and go through this again..what are studies showing about vaccine given after having had Covid...have you learned anything from them yet? Will I be certified as being vaccinated with only the one shot?

1st day all joints stiff 2nd day chills head ache body pain coughing third day neck stiff backache and stomach pain fourth day coughing and generally body ACHES

Patient came to the pharmacy 3/20/21 complaining of Gas, uncontrollable diarrhea, fatigue and headache for the last 5 days. She stated that the symptoms started 3/16/21 the day after vaccination. Anti-diarrhea medication was unsuccessful at stopping the symptoms.

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

Approx. hour after injection started with a nagging headache for over a week, chills, muscle aches, joint pains, fatigue, tireness, and nausea all lasting for over a week. On 1/16/2021 vomited all day - no stomach cramps or any other indication of that being a "stomach virus". Continued nauseated feeling resulted in cancelling a dental appt on Tuesday after injection.

Approximately 24 hours after injection (March 20, 2021) I became nauseous and started vomiting. Then chills set.. Felt like I had COVID 19 all over again. I did not have fever. Did not start feeling until 12:00 P.M. March 21, 2021. I did have the Corona virus in December of 2020. Waited 90 days to get the first vaccine shot on March 18, 2021.

Pt received 1st Covid Shot Saturday 10:30am. Felt some abdominal cramping that evening, and when she woke up on Sunday, had abdominal pain, nausea, vomiting, and a small amount of diarrhea. She continued to vomit all day, and became weak/dizzy. Went to ER, where she was found to have Diverticulitis and Dehydration. She was given IV fluids and anti-nausea medicine and hasn't had any further vomiting over Sunday Night. Patient will continue oral antibiotic treatment for Diverticulitis at home.

Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST.

I felt very bad that evening. I couldn't eat. I felt a little nauseated. my arm was sore across my shoulders and down my left arm. I had fatigue, headache (I felt like my head was going to explode) , muscle pain and general pain all over. My heart rate was 96 and my BP was 62/36. I felt Dizzy, weak. 03/16/21 I went to the ER Still feel hazy and foggy. I feel like my limbs are disconnected and dont respond as easily as they should.

swelling of left arm and shoulder from shoulder to below elbow, extreme itching and rash, fatigue, headache, loss of appetite, low-grade fever. This has continued for two weeks.

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

After going to bed I woke up around 12:30 pm with itchy sensations on my hands, underarms and torso; also my tongue became swollen. I Felt weak and nauseous but did not vomit. After drinking a glass of water I went back to sleep. I awoke in the morning 3/28/21 @ 8am My itchy areas were gone. I did not feel weak, just tired. The swelling of my tongue gradually reduced during the day and now it is normal (7:30pm). There was no treatment.

Difficulty swallowing, swollen lips - benadryl Subsequently - Diarrhea, migraines and chest discomfort.

Severe vomiting, blood pressure spiked at172/157 pulse rate 148, then severe hot flushing sensation ending in being soaking wet and clammy feeling, dizziness and feeling like I was passing out. Sat down on toilet, called my daughter and all I could say was help, I think I'm passing out. She found me passed out on the toilet , got me to wake up but not coherent. She called 911 and I was checked and taken to emergency room with diagnosis of dehydration caused by the vomiting.

"Moderna EUA Requirement" Patient hospitalized for decreased responsiveness and vomiting x2days. Has had approximately a week or so of decline with increase seizures. Acute exacerbation of CHF

she got couple episodes of vomiting next day of vaccine and by the day after morning she became unresponsive and took to ER and found benign meningioma ( not known before ) and uncle herniation, thalamic infarct and followed by went for the decompressive surgery at the and brought home after 2 week and at the 3 rd week put on hospice and diet on 03/18/2021. She would be alive today if she hasn't received vaccine.

Pt admitted to the hospital with fever, cough, chills, diarrhea, and fatigue with an abnormal chest X-Ray.

Bloody diarrhea; A spontaneous report was received from a consumer concerning a 79-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea/diarrhoea haemorrhagic. The patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 01 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 030L20A) via unknown route in right arm for COVID-19 infection prophylaxis. On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 031M20A) via unknown route for prophylaxis of COVID-19 infection. On 05 Mar 2021, the patient experienced bloody diarrhea. The event was considered as medically significant. No treatment information was provided. 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. The outcome of the event, bloody diarrhea was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.

Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days of intense headaches, followed by two days of flu-like symptoms and 99.0 fever and heart palpitations, and for the next two weeks intense frequent diarrhea and continuing heart palpitations, which continue to current date.

Patient felt weak and dizzy, which started after receiving the shot and persisted a few weeks. Pt also reported pain swallowing or could not swallow. Patients have reached out to her provider.

My arm was sore to the touch and it was very big and the size of an Avocado. It was very hot to the touch. I had put some lotion on it and it did not itch. I was given antibiotics. The doctor thought it was moving down my arm. They drew a circle around it, and it did not grow. It slowly went down over the course of a week. I got the second dose, and I was poorly for two and a half days. My arm was not affected by the second dose. I did have a low appetite for a month after the second shot. LOT # 024M20A

fever, generalized muscle ache, diarrhea, loss of appetite, weakness - lasted for three days - took 1 1/2 week to fully recover

Slight cellulitis at the injection site; Sore arm; Fever of about 102.4°; Nausea; A spontaneous report was received from a consumer who is a 79-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) vaccine and experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia, nausea. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 05-FEB-2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly on arm for prophylaxis of COVID-19 infection. On an unknown date, after receiving the first dose of vaccine, patient experienced feeling a sore arm, like a slight cellulitis at injection site, fever of 102.4 and nausea. The event injection site cellulitis was considered as serious (Medically Significant). Treatment medication included alcohol which was used at the injection site. Laboratory tests were not reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia and nausea 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.

Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke during the night. Sunday & Monday still feel out of sorts. Temp normal but blood pressure on lower side. Reports today still feel unwell; injection site slightly warm, feeling light-headed, slightly nauseous, headache, again lower BP. Took 2 Tylenol @ 4pm.

3/21/2021 Husband , reported that wife attended the Covid clinic 2/13/2021 and received #1 covid vaccine about 11:30 AM Soon after she complained of Discomfort at site on right arm with area from shoulder to elbow swollen extremely tight, red, and had rash by evening. Generalized side effects of nausea and weakness with the inability to ambulate unassisted. She did have Covid #2 3/13/2021 with somewhat similar response but not as severe.

pt began coughing, complaining of scratchy throat, tongue became swollen and pt had difficulty swallowing

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

Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.

Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out. These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms. Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center. I also experienced some post-op Afib in first 2 weeks following the procedure.

Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days; then Diarrhea & bloating for 24 hrs; then prior symptoms gone but very weak & tired - for 4 days (the first day had low blood pressure); then general malaise for 1 week

Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbalize thoughts with clarity without tremendous concentration.

Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into afib.

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

STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HEART. PRESENTLY AM GOING THUR EXPECTED EFFECTS OF BACK TO SLEEP 14/16 HRS DAILY, SWOLLEN LYMPHS UNDER LEFT ARM ONLY, BACK HEAD PAIN WHEN RESTING, PAIN, PALMS HANDS, SAME PAIN, LEFT AREA ABOVE EAR, INTERMITTENT HEADPAIN DIFFERENT AREAS OF SKULL...

First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, headache. 3rd day, same, but no heart pain. By 5th day all okay, except some cognitive issues (slower thinking, searching for words, poor memory) still with me on May 3, these are subtle changes, but it's obvious to me they began after this vaccine shot. SERIOUS REACTIONS BEGAN AFTER 2ND COVID SHOT ON 2/26/2021: Pain in neck, hips, head, down left leg. Diagnosed as inflammation and bursitis in left hip, which still remains in May and limits my life in the extreme.

Very tired prior to bed. Woke up in the night with bad headache followed by body aches. On Tuesday the 4th, I had fever (highest 101.3) couldn't eat, headache continued all day and into the night. I felt very ill as if I had Covid again. I slept on and off all day and felt too weak to do anything. Wed, the 5th, I still had the headache which wore off around 10 or 11. I felt stronger as the day progressed I was able to eat and do some activities. Now, Wed evening, I feel fine and no more side effects.

Nausea and vomiting, which I have not done since chemo in 2015. Atrial fibrillation occurring most of the time for four days afterwards. I usually only get a short episode once every two or three weeks. Feeling very weak and sick.

Patient presented the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was hyponatremia and intractable vomiting.

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

Symptoms onset 1 day after vaccination. Symptoms include: nausea, lethargy, sore throat that has not resolved since onset on 4/22.

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

Inflammation of mouth and gums started on 2nd day after 1st vaccination. Mouth inflammation cleared in about 8 days. Inflammation returned in May and has worsened. Gums and front teeth are very sensitive. Some days are worse than others. Front center right tooth feels loose off and on during the day.

Around 02/05/2021-02/06/2021 she started having a cough, upset stomach, and a fever. On 02/09/2021 we both got the Covid antibodies but they did not work for her. It ended up going into Covid pneumonia and she was treated for that and once she got over that she got bacterial pneumonia and we have been going through that since (still ongoing). She has seen specialists and had a hospital stay for 9 days. She has had all kinds of blood tests. She just had a test on 06/16/2021 to see if she has an immunity to Covid. She has had overall weakness and when we took her to hospital she fainted.

CYCLONE OF DIAREAH, ER VISITS AND BEING ADMITTED FOR 3 DAYS HISTAMENE ISSUES, HISTEMENE INTOLLERANCE

I woke up 3:00AM, and was very nauseated. I wanted to throw up. I had really bad stomach cramp. I called the doctor's office in the morning because of the bad stomach pain. It just had to work itself out. It lasted most of that next day 12-14 hours. I felt fine after that.

Hearing loss; Vestibulocochlear-neuritis; Tinnitus; Traumatic situation; Vertigo; Dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form; LORAZEPAM (ATIVAN) at a dose of 1 dosage form; PREDNISONE at a dose of 40 mg once a day; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at a dose of 1 dosage form and METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) at a dose of 1 dosage form. At the time of the report, DEAFNESS (Hearing loss), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Patient has through three emergency room visits and two hospitalizations because of her symptoms Patient has been going to balance therapy once a week. Lab details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-219233 (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.

prednisone worsened her symptoms; Hearing loss; manstasis; Tinnitus; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of METASTASIS (Metastasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Co-suspect product included non-company product PREDNISONE for an unknown indication. No medical history reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PREDNISONE (unknown route) 40 mg once a day. On 25JAN2021 and she was experiencing hearing loss, tinnitus, menstasis, and vomiting. During the time when her symptoms started happening, she had no idea what was going on. Patient has through three emergency room visits and two hospitalizations because of her symptoms. Her doctor prescribed her medications to treat her vomiting. She reported that prednisone worsened her symptoms.On 26-Jan-2021, the patient experienced ILL-DEFINED DISORDER (Manstasis) (seriousness criteria hospitalization and medically significant), DEAFNESS (Hearing loss) (seriousness criteria hospitalization and medically significant), TINNITUS (Tinnitus) (seriousness criterion hospitalization), and VOMITING (Vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (prednisone worsened her symptoms) (seriousness criterion hospitalization). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Adverse event, at a dose of 1 dosage form; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Adverse event, at a dose of 1 dosage form; LORAZEPAM (ATIVAN) for Adverse event, at a dose of 1 dosage form; Physical therapy for Metastasis; Physical therapy for Deafness; Physical therapy for Tinnitus and Physical therapy (Therapy helping her with her balance) for Vestibular neuronitis. At the time of the report, ILL-DEFINED DISORDER (Manstasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had through three emergency room visits and two hospitalizations because of her symptoms. The patient stopped taking Ativan because she heard the medication can worsen her symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Patient medical history may provide alterative justification for the vents occurrence.

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

Severe diarrhea and destruction of part of her intestine and subsequent sepsis. ER doctors "could not rule out the vaccine as a contributing factor." It was suggested she have a portion of her intestines removed. She refused and went on a high dose of antibiotics. She was hospitalized in the ICU and eventually released to a nursing home when stabilized. She never regained control of her bowels or had a solid bowel movement. Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis. She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed. She elected to go home on hospice, where she died. Her kidney doctor also relayed to her family that this reaction was a direct result of the vaccine. When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report.

After April 7th shot, the arm was so for a few weeks. Received the second shot on May 5th. The pain lasted a long time - 3 or 4 weeks. Reports starting to lose her appetite and she was losing weight during the middle of June. This continued on. The weekend of July 4th, she reports knowing something was wrong. On July 8th, she reports not being able to sleep and her right arm started to bother her a great deal. On July 9th, July 10th and July 11th, the pain in the right arm was unbearable according to individual. There is also swelling in the arm. On July 12th, she went to the Walk-in center. Doctor felt lymph nodes under the right arm that were swollen. Individual had an ultrasound which showed swollen lymph nodes and fluid in that area. She was given a prescription for Keflex and Naprosyn.

interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; shaking and teeth chattering; impossible to eat w/out vomiting / She couldn't eat or; she had all over excruciating pain; UTI; extreme back pain; weak legs and unsteady/ very unsteady; arm was sore at the site; aching head to feet, body that had ever been in pain was more painful; rigor chills, teeth chattering; Nauseated; cytokine reaction; headache; sick to her stomach; dizziness/; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (cytokine reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cystitis interstitial from 1996 to 1999. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (cytokine reaction) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), HEADACHE (headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), MYALGIA (aching head to feet, body that had ever been in pain was more painful) and CHILLS (rigor chills, teeth chattering). At the time of the report, CYTOKINE STORM (cytokine reaction), CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), HEADACHE (headache), MYALGIA (aching head to feet, body that had ever been in pain was more painful), CHILLS (rigor chills, teeth chattering) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 degree Celsius (High) 100.6 and 99.1 degree Celsius (High) 99.1. Relevant concomitant medications were not reported. Treatment information was not provided. Patient visited her cardiologist and primary care doctors and they reported good strong immune response. Patient also visited oncologist; he reported cytokine reaction. Patient also had a medical history of interstitial cystitis for 3 years but again she developed interstitial cystitis after the 2nd dose. 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 11-Jul-2021: Additional information received on 10-JUL-2021 regarding the 2nd Dose events and lab data. On 12-Jul-2021: Follow-up information received on 12-JUL-2021 contains updated event onset date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient stood up and blood pressure dropped and started to faint and nursing staff was with her. Her blood pressure was 85/45 and pulse of 60. Patient got nauseated and vomited. Nursing staff contacted MD and they decided to have her checked out at the ER.

12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt "wired and worked up". Noises made her anxious. Patient states "everything smelled bad". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped 12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.

rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm. Symptoms gone by about 10 pm. She took her heart medication as ordered and felt better by bedtime.

nausea, dizzy, loss of balance ,small amount of vomiting: for most of the day (approximately 12 hours) no treatment: subsided the following day, 1/13/2021

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

At 7 pm arm began hurting, by 11 pm was vomiting then passed out, vomited 4 more times during the night and passed out each time very briefly, for a total of 5 times. Stopped by 6 a.m. Did not vomit or pass out any more after 6 a.m. Next day (1/19/21) stayed in bed and slept most of day, started eating again normally 1/20/21. Feels much more normal 1/21/20 other than sore arm.

middle of the night awakened by terrible shakes, uncontrollable, feeling very cold. fever of 101.2, brain fog, severe body aches, every joint unable to eat forced myself to drink fluids; anxious and depressed, felt weak and unable to assist my husband who was having adverse effects as well(mobility issues: he fell on the floor and was unable to get up. I had to call fire department to get him back to be. Later on he could not reposition himself in bed and I had to do my best to help him. hydration, Tylenol x2 q6 hours, bed rest

Redness swelling extreme pain at vaccination site -48 hours following vaccination Nausea, diarrhea, fever, light headed -48 hours following vaccinations

Swelling of lips and face; and rawness inside of mouth after approximately 3 days. lasted approx 3 days with swelling gone completely after 7 days. Rawness and blisters in mouth are still active.

12 hours after receiving first dose of Moderna, Chills, temp of 103, intractable nausea and vomiting and severe headache lasting for 30 hours.

10 days after injection, 01/25/2021, left arm became itchy at injection site. When I looked at arm, it has a large pink oval spot, warm to the touch, under the injection site. Itching stopped overnight. Woke up next day 01/26/2021, with headache, very tired and nausea and gagging. This is my third day feeling sick. Not as bad but still turned from eating.

Client called 1/22/2021 to report that she woke around 3AM with severe stomach cramps and the start of flu symptoms "feeling yucky". Reported she took a Benadryl and went back to sleep. Said when she woke up the cramps were gone but now her B/P was elevated. Denies any other c/o.

Severe, painful leg cramps- entire leg, but more intense in the upper thighs - lasting the night into morning/ time ( now 12:30 pm and still have mild cramps)- disrupted sleep. During evening took quick-dissolving tables of Hylands Leg Cramps PM. Fell asleep about 7:30 am till 11:30 am. Last night also early evening mildly nauseated. Either the 26th or 27th felt slightly nauseated, had some diarrhea and mild stomach cramps.

Felt fine at first then everything started spinning and I started vomiting that lasted 2 hours, I was dizzy and my daughter call the ambulance and they gave me meds for nausea and started IV and at hospital they did the same and gave me something for nausea which helped.

swelling from elbow to chest and upper shoulder. hurts to touch it. skin hurts all over. Sore neck. feels like she is drunk. thursday and friday had staggering. Took conafec for pain in arm. poor appetite, not wanting to cook

Sudden short episodes (less than 5 minutes) of excessive salivation followed by nausea. Hours later it morphed into continual nausea and vomiting not related to food intake or any illness - continued for 36 hours.

20 mins after vaccine became nauseated, light headed and chest pain, tightness in central to epigastric area. VS found she was Orthostatic - BP dropped to 99/55 while standing. Diabetic. Chest pain persisted. Sent to ED

80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining her first dose of the Moderna COVID-19 vaccine today, and about 10 minutes afterwards began feeling warm and diaphoretic and developing left chest pains and nausea, at approximately 11 AM. This lasted about 5 minutes and then subsequently resolved. She then got up to leave and again began feeling the left chest pain, diaphoresis, and again lasting about 5 to 6 minutes and then subsequently resolving. She does state a history of anxiety but did take Xanax this morning preventatively. However, she states she has had similar pains in her chest over the past month. She states these are not necessarily associated with any exertion and seemed to be somewhat better after antacids. She notes she has not had anything to eat or drink this morning which is not unusual for her and her blood sugar was 117 this morning.

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

Extreme fatigue, had trouble getting out of bed and needed help. Slept most of the 24 hours after the adverse even started. Diarrhea upon getting up and lasted approximately 6 hours. Soreness in left arm.

Daughter reported that beginning 1-23-2021 after vaccine, patient experienced a red, swollen arm. Swelling present down to elbow of right arm. From 1-24-2021 to 2-6-2021, patient experienced diarrhea and fever. Daughter was concerned that patient was becoming dehydrated so patient was given IV fluids for replenishment. Facility where fluids received and length of stay in facility are unknown at this time.

Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognition, unsteady gate, loss of appetite. Weird feeling in head to the point of losing focus and almost passing out. Severe symptoms lasted for five days until 2/6/21. Currently limited fatigue, slight cough.

Shaking with chills. Could not warm up. Nausea. Pain in chest. Temperature of 99.9, lasted about 7 hours and then I felt fine, but tired. The next day felt normal, except for arm being slightly sore. The worse part was the severe shaking from chills and nausea. I did take a Tylenol before going to bed.

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

Severe Chills Fever 102 Hot burning whole body Dry Heaves Weakness Took Tylenol, pushed fluids--lasted 24 hours

Moderna COVID 19 Vaccine EUA Very sore arm, queasiness, chills. Next day, threw up cere all, had many bowel movements.

Six to Seven days of moderate to severe body aches: back shoulders hips with heavy fatigue; loss of appetite and total exhaustion inhibiting ability to perform ADLs (generally very high functioning). Ibuprofen for several days and in bed for nearly a week and after that time symptoms improved. delayed response. only sore arm until about 72 hours. now, 14 days later near resolution of all symptoms.

Please see details on previous page regarding itching and mild diarrhea. I also had a slightly sore arm at the injection site, but not until 9 hours after the injection at 11 PM. Itching may be due to my occasional eczema--I still have it, or it may have been triggered by the gel used for my heart echocardiogram on 2/12/21 or possibly by the vaccine. The mild diarrhea was only on 2/14/21 and resolved with OTC medication.

Fever, Headache, Nausea, Whole Body Ache, Weakness Inability To Sit Up In Bed, 40 Hours, Have developed red spots on arms several days later, which now seem to be fading

PT HAD CHILLS, NAUSEA AND VOMITING. STOMACH UPSET, HEADACHE, FOR 6 DAYS, TOOK TYLENOL. ONDANSETRON

next day woke up with fever 104 headache diaherra tickle or cough arm site red and sore no apperite and wanted to just sleep temp all day run between 101 to 104

pt stated that her left leg around the groin area in the muscles started to hurt. She had severe pain in the left lower back. She also had muscle spasms in the top part of her back then got nausea and vomited. No fever. Pt will call her PCP for medical advice.

Developed 4 inch red band around arm under injection site. Extremely itchy. Took topical and oral Benedryl (Note: Patient was extremely nauseated and tired with sore arm for 24 hours after vaccination, but got better then on day three, rash appeared.)

Patient reported not feeling well at 3:50pm. Stated she was lightheaded and nauseous. Informed patient to stay for further evaluation and monitoring. At 4:15pm, patient vomited x1 with continued nausea and feeling lightheaded. RRT was called at this time. RRT arrived at 4:20pm to assess patient when patient stated she was no longer lightheaded or nauseous. At 4:35pm patient was taken to ER for further evaluation. Vital signs at 3:50pm: BP 107/59, HR 74, SPO2 96%. Vital signs at 4:05pm: BP 110/52, HR 72, SPO2 96%. Vital signs at 4:20pm: BP 131/82, HR 82, SPO2 95%. Patient was discharged same day on 02/17/21. Follow up today 02/18/21: Patient stated she was feeling better as time goes by. States her only symptom now is an upset stomach. No other side effects noted.

Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up to 95 degrees; went to bed with several blankets; temp went up to 100 degrees about 11pm with stomach ache, horrible headache, & loose stool; lasted all night all next day; day 3 Saturday 4am got up to pee dizzy & faint & fell into glass closet doors then into wooden door then to floor & broke nose & bruised several other areas besides face. Now 11am still dizzy & sick to stomach & loose stool so called CDC but no help so took meds on hand. Zofran 4mg & Loperamide 2mg.

Arm pain, swelling, red rash around injection site. a bit queasy initially., tired. Queasiness started Sunday - first full day of side effect. lasted maybe 24 hours. arm pain worse first day or so, slowly decreased. rash slowly went away - took at least a week. swelling also slow to go down.. only minimal issue with itchiness. used topical Avena twice.

approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of bed safely. I have never experienced a chill like this before. 3-4am I was shivering and shaking and so very cold again. this lasted until at least 4-5pm. I was shaky and my voice was shaky. no appetite.

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

pt stated that the day after the covid vax she had the dry heaves and body aches and pains. The second day she shaking and jerking, couldn't hold on to anything. Her blood pressure was up and down that day. She said she felt like she was dying and then she vomiting where she bruised both elbows on the toilet bowl due to the jerking movement she was experiencing. She took a nap and woke up confused. She was hallucinating saying she felt like she went from a small box to a blue box to red box and didnt recognize her room. Her sitter said her eyes were glazed but was able to recognize her sitter at that time. Blood pressure dropped so the sitter then called EMTs where they checked her out. Vital signs were good but she declined to be transported to the hospital via ambulance. The third day she was feeling some better where she was able to eat and get a sponge bath. Fourth day she was better so was able to shower. She states she is better now with just a little soreness and redness around the injection site. Pt has contacted her PCP and spoke with the nurse about her symptoms.

Patient said she felt "unwell" day following vaccine, but that passed the following day. Her symptoms fell within the typical expected side effects post-vaccination. However, Friday 2/26 (9 days after 2nd dose) she said she woke up around midnight with chills, vomiting, and diarrhea. This lasted 5-6 hours and then stopped. She hasn't had any problems since and was encouraged to report this event via. She was advised to contact her doctor is symptoms reappear/persist.

02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night, same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care

After 20 hours of receiving vaccine, I had chills, fever, sweats, dizziness, & nausea feeling. Returned to bed; slept 4 hours; & then ate & began to feel better.

the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell, 2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today

Headache (severe), chills, fever, fatigue (severe), injection site pain, lethargy, loss of appetite. Most of these lasted at least 3 days, up to 5.

PATIENT REPORTS T-SHAPED, HARD, BLUE, SORE SPOT ON LEFT HAND NEAR THUMB BEGINNING 3 DAYS AFTER VACCINATION AND STILL CONTINUING TO PRESENT (5 DAYS POST-VACCINATION). SHE ALSO REPORTS THAT HER LEFT THUMB ACHES. SHE ALSO REPORTS A BLACK AND BLUE, SORE SPOT AT INJECTION SITE AND INTERMITTENT NAUSEA STILL CONTINUING 5 DAYS POST VACCINATION.

NAUSEA, WEAKNESS, NO APPETITE, THIS STARTED ON 2/26. ON 2/23 2 HOURS AFTER INJECTION SHE HAD ITCHING AND RED DOWN TO ELBOW.

Started with chills, Dizziness. weakness, mild headache, injection site soreness & stiffness, nausea, vomiting, dry heaves,, fever 101.3. and fatigue. Was transported to Emergency Department via ambulance. At ER given saline IV, ran chest xrays, blood test and observation. Transported around 11:00-11:30, discharged 4:45 pm.

2 weeks after Moderna vaccine for COVID. Low fever 99.7, Chills, headache, Joint/muscle body Aches, Fatigue, no appetite, and abdominal pain. Duration was 24 hours. Took Tylenol.

Exhaustion, quisiness, headache - first through third day after injection. Took extra strength tylenol, and slept most of two days.

Stabbing abdominal pain for a week that was diagnosed as shingles 3/15/21. Recurrence of trigeminal ear pain 2 days after shot. 102 fever the whole day after the shot

Out of the blue, I got nausea and diarrhea the most severe in my whole life. I was vomiting and periodically having diarrhea for four hours. I felt faint. Had a hard time standing. I have never had anything like that in my whole life and I have had food poisoning in the past. This was worse, much worse. Afterwards, for days, I was weak and now three days later still have some nausea although I am not throwing up. I do have loose bowels though.

pain, tenderness, fatigue, headache, chills, nausea and fever. No treatment. Symptoms gone by the following day. First shot experienced rash in left arm after 10 days. This disappeared in about 6 days. It did not itch and did not bother me.

The administration of the vaccine was extremely painful. Began to feel hot flashes about a half hour after the vaccine was administered, nausea and feverish symptoms. The site of injection began to swell to the size of a half dollar; the next day she could not move her arm. Describes pain from the site of injection all the way down to her wrist. The symptoms have persisted for two weeks, headache, exhaustion, and aching at the site of injection.

Severe headaches, nausea, unsteady, restricted diet (crackers, potatoes, farina, oatmeal, bananas), fatigue

After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95.

A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm. On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon. On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date. The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was considered 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.

As requested, "Moderna COVID-19 Vaccine EUA" to be included in the first line of box #18 of the report form. Monday, 3/15/2021: 6 hours post-injection tenderness began at injection site continuing throughout entire upper arm; greater than usual fatigue. Tuesday, 3/16/2021: woke up with a headache (which she doesn't commonly get); extremely fatigued; continued pain at injection site and throughout entire upper arm, worse than day of vaccination; exertion from activity greater than normal; nausea and dry heave vomiting around 6:30pm; felt very shaky and cold sweats; recovered from episode of nausea and weakness after an hour, but remained extremely fatigued and low on energy. Wednesday, 3/17/2021: injection site and upper arm pain continued Thursday, 3/18/2021: less pain in arm, but still at injection site

Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely weak with chills, fever, vomiting and diarrhea and headache and was found on the floor by family at 2:30 pm. She reported she was so weak she lowered herself to the floor around 7:30and lie there till she was found in the afternoon. She was given IVF and admitted to the hospital for further work up and physical therapy.

I had all symptoms ofcovid except arm pain and diarreha fever. I had Extreme fatigue, nausea, headache, balance was off, muscle and nerve and back pain. Just took covid test and just got results--Negative. (3-19-21) The symptoms subsided March 12. Still vaguely experiencing all of them. Should I take the 2nd shot. Feel those results would return at an even heightend level. Pharmacist said I was probably 85 % covered now with these effects from the 1st shot and should not take the 2nd. My Dr. said the 2nd shot was my call to make and that I should report it to CDC.

102.5 temp., off balance and brain fog. Fine two days, then down again with same symptoms and 99 temp. Have had no temp since, but brain fog and off balance like having gotten off a boat and sea legs, occasional nausea. All lab tests fine.

- Started with weakness and ?feeling bad? 03/16/2021 at 4pm. Stated she developed nausea but no vomiting and severe, jerking chills overnight. C/o leg weakness that caused her to need assistance of cane to ambulate that night and next day. 3/19 patient saw her PCP and the PCP suggested she report her symptoms to the HCHD. Patient stated the weakness to her legs is slightly better, but not 100% resolved.

pt had pain in arm iced and took tylenol --- orginally -- late rin day pt experienced chills/ hot flash diarrhea / vomitting and headache lasted 2 days/ symptoms had resolved today 3/22 -- same day as reported to us.

Chills, extreme soreness on left arm where I got the 2nd vaccine. Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite. Extreme fatique. was up all night

The morning after the 2nd dose, I got up to make coffee. I had just started and felt a bit light-headed. I was going to go sit down, but I passed out and fell onto the kitchen floor for a few seconds. I have never passed out before or felt such light-headedness. I went to lay down. I vomited a bit of liquid. I lay down and several hours later my husband drove me to the emergency room. After many tests they said I had suffered a Syncope and had a slight concussion.

After my mother took the first vaccine shot on March 4th 2021, I noticed the changes 2 weeks later. Her handwriting became more disoriented in her checkbook. She said she had trouble remembering which week days to write in her checkbook. I noticed incomplete transaction lines. She forgot to take medications for the first time in years. She used to be an early riser. She started to get up late in the mornings between 8 am and 9 am. She does not eat as much as she should. She drank coffee more frequently all day daily. She hardly drank enough water to avoid her chronic consciptation problem in the bathroom. She has not been herself lately since her first shot. So I have a good reason to be concerned. I think a 2nd vaccine shot is not really a good idea.

Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, headache, pain at injection site, fatigue, nausea and dizziness. Retired early and got up during night with GI distress. Before getting back to bed passed out hitting my head and lower back on a metal door frame. I did not recall this but found myself back in bed partially dressed. Husband found a hallway Persian rug (heavy) displaced in AM. Slept until 3PM following day and awoke with lg. bump on head and pain in sacral area. Self treated with ice to painful areas plus Tylenol 500 mg. After 6 days with no relief saw orthopedist who took x-rays and diagnosed bruise to sacrum and post-concussive syndrome. Offered visit to neurologist which was declined as cognitive ability seemed intact, Treated with ice to sacrum 20 min. x 5 daily, Tylenol 1000 mg. and Aleve 1 q 12h x 5 days. Sx continued for 8 days requiring Tylenol, Aleve, iceand/or heat. Feeling less pain by Day 20 post vaccine.

3/31/21 To er for eval of dizziness. States she was at the hairdresser when she became very dizzy and had to lay In the floor, was nauseated but no vomiting. Incident happened approximately 10am.

Almost passed out; Vomiting; Heat on side of head; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/loss of consciousness, heat in head/feeling hot and vomiting. The patient's medical history was not provided. Concomitant medications included inhaler and statin. On 22 Feb 2021, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 031L20A) for prophylaxis of COVID-19 infection. On 22 Feb 2021, three hours later, the patient experienced heat on side of head and almost passed out a medically significant event. On 26 Feb 2021, the patient had heat in head again and did pass out and vomited. The patient was hospitalized when passed out and did tests and everything was ok. Treatment details included anti-nausea medication. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events almost passed out, heat in head and vomiting was resolved on 27 Feb 2021.; Reporter's Comments: This case concerns an 80-year-old female who had a serious unexpected event of loss of consciousness along with NS events of unexpected feeling hot and expected vomiting. Event onset the same day as the first dose of mRNA-1273. Treatment with anti-nausea medication. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Client developed a cough on approximately 3/23. She also has been experiencing diarrhea, nausea, weakness, and confusion. Diagnosed with possible Covid-pneumonia. Client also states that she has been having various symptoms for the previous 4 months. She had been seen by her outpatient primary care doctor and gastroenterology for abdominal pain symptoms, ultimately found to have C. difficile and treated for this.

Throwing up; Colds; Bowel movement was not going anywhere; A spontaneous report was received from a consumer concerning an 80-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced cold/nasopharyngitis, throwing up/vomiting and bowel movement was not going anywhere/constipation. The patient's medical history was not provided. No Relevant concomitant medications were reported. On 23 Feb 2021, approximately two weeks prior to the onset of symptoms, the patient received their first of the two planned vaccine doses of mRNA-1273 (Lot number: 010T00A21A), on an unspecified arm with unknown dose and route of administration, for prophylaxis of COVID-19 infection. On 9 March 2021, the patient was hospitalized for colds. On 12 Mar 2021, the patient was discharged. On 13 Mar 2021, the patient was throwing up and was again brought back to the hospital. The patient was told that their "bowel movement was not going anywhere." On 17 Mar 2021, Diagnostic procedure, Endoscopy was performed on the patient and the result was normal. No Treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was unknown. On 12 March 2021, the outcome of the event, cold was considered resolved. On an unknown date, the outcome of the events, throwing up and bowel movement was not going anywhere were considered 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, Constipation and vomiting, a causal relationship cannot be excluded. The event of Nasopharyngitis was assessed as Unlikely Related to study drug, as this could be due to spread of virus droplets.

3/27/21: Patient presented and was admitted through ED for epigastric abdominal pain, nausea, and vomiting. Patient was discharged on POD#2 after recent surgery of laparoscopic periesophageal hernia repair on 3/23/21. Imaging performed at admission showed ongoing versus recurrent hiatal hernia. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.

Vertigo, nausea, dizzyness, vomitting, hearing loss. All symptoms lasted 48 hours. Went to Urgent care and was givenMeclizine 12.5mg and Ondansetron 4mg. Dizziness and nausea lessened over the next 3 days. Went to ENT doctor - Hearing test on 3/29/21 revealed total loss of hearing in right ear. Hearing in left ear was diminished before vaccination and that was about the same after the vaccination. ENT injected steriod into right ear on 3/31/21. Second steriod injection on 4/2/21. No improvement in hearing so far. Dizziness continues off and on. Still unstable and needs to use a walker.

18 days after vaccination in which I only had soreness at the injection site. Anxiousness, followed by dizziness and later nausea.

Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown. Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief. 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.

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

States she had the shot in the morning, states in the evening she had a stiff neck that radiated down into her R side (the side she got her shot on). States she went to bed and woke up at about 3 a.m. and she was so sick vomiting/dry heaves (2-3) and having diarrhea (approx 3). She also had chills. States she could hardly use her R hand. States her wrist is just now getting better. She notes she was able to walk but she was very careful. She did not try to speak. She does not have residual symptoms other than some residual stiffness. She had to use her rescue inhaler the morning prior to the vaccine, and again in the evening after the vaccine.

Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 AM had severe pain in left arm, could not move it. Experienced light-headedness, all over body ache. Arm pain was so bad i didn't want to move. couldn't sleep all night. tried to eat breakfast but got dizzy, cold and clammy, couldnt eat. Stayed in bed until around 5 PM because of arm pain and general malaise Was finally able to eat and took a tylenol and fell asleep as light-headedness abated and arm pain was better. Next day was better but couldn't lift arm well until 15th still some pain to this day

Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine

Day 1-3 Left upper shoulder pain from injection. Day 4-8 Headache, tiredness, fatique, nausea, vomit (1), knees joint pain. Day 4 to present - some tiredness, continued severe knee joint pain (left and right)

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

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

my left arm developed a rash and a red bruise the size of a dime.local pharmacist recommend a cortizone ointment [2nd injection] had loose bowel movements with 2nd dose.

Patient came to the pharmacy to inform us that she had side effects following the administration of her COVID vaccine. She stated she was clammy, her body was hot and cold. She experienced nausea and vomiting. She took a a shower to cool off. She was dizzy and had the sore arm.

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

A few hours after vaccine, right arm started to get red and swell. Patient had chills, fever, headache. Feeling unwell. Two to three days later she felt like she had Covid-19 again. Right Arm continued to swell from shoulder to elbow for 3 weeks. The arm was hot to the touch. Fever, headache, chills, diarrhea for 3 days. Had Covid-19 feeling all over again. Poor taste and sense of dread. Did not seek medical treatment for swelling in arm or symptoms.

She got her 2nd vaccine, they kept her 30 minutes as she had problems with the 1st one, her BP was okay and that she could drive home and was told to drink a lot of water. She went home and after every bottle of water she had 3-4 episodes of diarrhea and kept drinking water all day and after 3-4 she did not have any more diarrhea. She had some pain in her arm. She started having visions of chicken scratches/white lines across her eyebrows from the left to the right across her whole forehead. She always has this vision discrepancy all day long inside the house and outside when she goes and gets the mail. She first went to the eye doctor as she was having floaters, white lines visually appearing but have not had them for a long time, and these did not go away and they were not the usual floaters like she had before. They got her in the office immediately and that doctor said that he did not have an answer for her and he didn't find anything wrong with her eyes. She told him that she was worried about what happened after the vaccine. She went to her PCP and she ended up in the hospital as she has a problem with her left rotator cuff and needs surgery on that but is waiting for her leg to heal from total knee surgery. When she lays down at night she has chest pains, and didn't know what it was and was told that there is a nerve that runs down from the shoulder and crosses over to the heart and gives the feeling of chest pains. She had tests done and they did not give her any answers to what the pains were. She then went to her PCP again and told her about the vision issues and she didn't have an answer to her issues either. Her daughter suggested that perhaps her BP was an issue and she brought that to her attention and she told her to document it and to FU this week with her nurse to see that everything was working okay. She states that her BP has never been the same, she has never had a BP problem before. She takes it every morning between 9-10 AM. 131/86, 139/80, at 5:00 132/74, 148/88, 133/84, 139/92, yesterday was 137/83, today 132/84. She has been placed on BP medicine, Cardizem 30 mg.

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

Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High. Concomitantly the patient was receiving unspecified medication for hypertension . Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.

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

I had some diarrhea - but I do get that quite often even before the shot. Noticed blood in the Urine at home and I called for an appt. Doctor at Kaiser.

really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment information was not provided Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-248557 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved. It was reported that the blood pressure intervals were high mainly during the day time. The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out. Treatment information was not 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. This case was linked to MOD-2021-023313 (Patient Link).

Syncope within 48 hr of vaccination and persisting lightheadedness, palpitations, then hypertensive urgency

Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm. Nausea but it passed; feels weak and slept 6 extra hours today. Joint pain in shoulders and legs. No fever.

Pt received dose #1 Moderna COVID Vaccine 1/15/21 Clinic. Experienced nausea which resolved on it's own. No interventions or escalation of care. Entered for tracking.

Over the course of about 12 hours I experienced extreme fatigue (sleepy state), muscular pain at the site of the injection, chills, nausea and vomiting, fever and lingering headache.

the night of vaccine Started feeling bad all over about 7 pm aching and chills all over. went to bed early because i felt so bad a little nauseous. about an hr later i got up and threw up. i took 1 tsp of pepto, before i threw up and after. I only weight 89 pounds so i feel like it affected me differently. the next day (today) had nausea when i woke up but am starting to feel a little better. able to keep down a little yogart.

Patient had vaccine on 01/06/2021 and reported she woke up early in the am on 01/07/2021. She wanted to go to the bathroom but had severe dizziness and needed help from her husband to get back in bed. She also experienced nausea and vomited 3 times. Also had extreme soreness. Was followed up in office on 01/08/2021 when she continued to report severe pain in L arm where she had the injection. No nausea or vomiting for past 24 hours.

On the first day, my arm was sore and I was a little tired. I had some abdominal pains on the day after the vaccine with diarrhea. After 24 hours of that pain, I could get up and move around. About a week I felt better.

Pt complained of feeling flushed and tightness in her chest. Pt face was visibly red and she began to have blotches down her back. BP 170/84 at 1:30. Benadryl 50mg given IM at 1:40pm. 2 L of O2 via nasal cannula at 1:42pm. On call physician assessed pt at 1:42 at which time pt started complaining of nausea. BP 132/76 @ 1:45pm.

Patient's tongue and lips started swelling and she was having problems swallowing and talking. These were primary symptoms she experienced while at the site. Emergency services were called and she was taken to the hospital.

Vomiting and diarrhea at the same time/ then chills and extreme fatigue then diarrhea continued for two days this began at about 8 pm the day of the shot.1/27 lasted until 1/30/2021. Sunday am of 1/31 mild fatigue fading away.