Moderna

Tingling of tongue, lips, nose and cheeks lasted 5 hours . No swelling Unusual taste in mouth lasted only 5 hours

Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00. Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.

Very sore arm, low grade fever, fatigue, red rash at injection site and down the left arm to just above the elbow. Took a Tylenol for fever, lots of water and an anti-itch cream for the rash. No fever after 2 days, arm is still tender, but the rash and itching remains. The rash and itching did not occur until the third day after the injection.

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

Within about 2 days a round red sore appeared on my left arm just below my elbow. Each day it became more sore and inflamed. Within one week it became filled with puss, erupted, bled and now seems to be filling with puss again. Now, within the last 2-3 days the injection site has suddenly developed a large red patch of mildly itchy irritation surrounding the site, with one or two other small patches starting to appear nearby. During the last few days I have also notice a dull pain coming and going in my left arm. Using my cell phone, I have taken photos of the sore in 3 stages and of the red injection area. Those photos could be submitted to my doctor or this office, via text, if helpful.

Felt fatigued and weak while taking routine daily walk (cold, clear, sunny weather). Had to stop once to rest (almost never happens). Then nearing end of 2-mile walk, knees buckled and fell down on sidewalk. (Did not trip). Hurt arm, scraped face. Went home, put ice on face, laid down, rested.

Day 1-3: Sore arm, fatigue Day 4-6: Normal Day 7-present: Injection site is red, swollen and hot, fatigue, dizziness, vertigo, weakness

Patient states that she started experiencing symptoms on 1/16/21 morning. Patient notes that she had a fever of 103.9. She notes weakness and wasn't able to get out of bed. Fever, weakness, chills, fatigue, unresponsiveness. Patient states at one point she became unresponsive per her daughter. EMS was called to patient's home and patient appeared not alert and wasn't able to answer EMS questions. Patient states that her fever has since broke and denies any current fevers. Patient states that she continues to feel very weak. Patient states that she has been resting in bed and increased her water intake. Patient did test positive for COVID on 10/20/20. Patient inquiring if she should receive second COVID vaccine due to symptoms she experienced with first vaccine.

Day 1-3: Fatigue, sore arm Day 4-6: None Day 7-9: Injection site red, swollen and hot, fatigue, vertigo, dizziness, weakness, facial swelling---experiencing now.

Arm went stiff for two or three days and it was very painful and ache , bruise at injection site for weeks no rash.

Extreme pain in arm (not just sore) and body aches, as if run over by a truck, chills (could not get warm), worst headache I can ever remember having, felt like ice picks thru my head, sensitive to light and noise, lasted from 2:00am until approx. 9:00pm on 1/19.

Immediate burning sensation in arm and lightheadedness, lasting 10 minutes. Felt weak for another 1/2 hour. Red blotch on arm lasted 5 days, went away but came back a couple days later. This time was very itchy, swollen and hot. Size was about 3 inches down my arm from the injection site.. Lasted about 4 days. Two weeks from shot, arm once again was itchy, with red dots near injection shot and down the arm.

On date of vacation 1/14/21, I had no reaction other than a slightly sore left arm which was better the next day and I had no other symptoms until today. Today 1/22/21, 8 days later, I woke up with my left arm sore at the vaccine site and when I looked, I found a bright red circle about 2" in diameter around the site. It is not hot to touch or sore - just a little itchy. Since the vaccination I have used no ointments or lotions on my arm, have done the same exercise each day, and have had no bump or accident to my arm.

Client received the vaccine on 1/8/21. The arm was sore until 1/16/21 when it became red and tender to touch. Was still red and tender when she reported the reaction to the health department.

COVID-19 Vaccine EUA Ten days after the injection of Covid 19 injection my arm swelled up, and became very red and itchy at the site of the injection. It just came up out of nowhere it seems as I had no reaction at all to the vaccine during the prior 10 days since the vaccination. This continued for two days. The first day after it happened I felt tired and weak in the morning. I got into work here at the house and the weakness went away. I treated the itchy situation with Clobetasol Propionate Cream which I had here and was prescribed by my dermatologist for poison ivy. That took away the itchy situation that was very annoying. Two days into it the swelling began to go down. Today is the 4th day since the problem occurred and there is no swelling and only a slight redness. I am assuming that I can take injection #2 on February 9 as scheduled.

Sore left arm, day 2. Swelling, redness, inflamation (heat), itching on day 8- a week after the injection. This required Acetaminophen and cortisone cream. Surface area (4" by 6") still red on day 10.

At 1038 Client started with flushing of the face and started feeling as though her throat was swelling. She took an allergy pill that she had brought with her in case of a reaction. She carries an epi pen but stated that she has never had to use it. She stated that she had a similar reaction to receiving a flu vaccine 25 years ago (flushing, itching and swelling). She was assessed by EMS staff that was on site.

Patient was complaining of eye issue on Thursday 01/21 and new medication was ordered. Received vaccine Friday 01/22 and had no other complaints other than facial twitching. Primary MD was contacted and patient was transferred to hospital for evaluation due to facial dropping.

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..

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

patient was going in and out of consciousness/clammy skin; color returned and condition improved once supine with legs elevated

temporary loss of consciousness few second every few minutes; clammy skin, color improved once supine with legs elevated

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.

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

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.

Approx 15 min after reciving injection pt states her left hand felt tingling. Sensation good to touch, pulse present and strong, color good and equal to right. C/O flush feeling down lower arm following. No obvious swelling. Movement intact. Flushing resolved after approx 5 min. Pt waited 30 min prior to leaving.

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.

On 1-23-21, left arm became sore area of injection site; hurt to lie on left side to sleep. On 1-24-21, in am, upper arm very sore and red area, 3? X 1 1/2? at site. By evening it was more red and sore. Morning of 1-25-21, red area was more diffuse. Same evening, redness started to fade in center, creating a ?figure 8? appearance, with faded area in centers of figure 8 circles. Morning of 1-26-21, redness nearly gone, much less soreness. Today, 1-27-21, no redness but arm slightly sore to touch. Note, arm was sore for only three days after vaccination given.

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

initially with redness and itching on chest and neck, elevated BP to 190/100, but otherwise normal 02 , HR, RR. Symptoms developed within 20 ish minutes of receiving vaccine. Hives developed on neck and near ear, then patient reported perioral sensations. Patient was non-verbal and communicating using texting so communication was challenging. Patient was initially given benadryl, but with the additional perioral sensations Epi was given. Patient transported to ER via rapid response team where additional benadryl and steriods were given.

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.

States that the day after vaccination her arm was sore. Three days ago, patient noticed a large rash under right breast then she noticed small rash at injection site. Recommended for patient to follow up with primary care doctor- patient agreed. Will also discuss with doctor if she should receive second dose.

Patient started to experience increased heart rate, tingling of the tongue (possibly swelling) patient just said it felt weird, feeling flushed or feeling hot, back of neck seemed warm. Shot was given 12pm (noon) 15 minutes later patient started to experience these symptoms. Blood pressure was checked initially (147/78).

Flushed after 20 minutes blood pressure spiked to 205/105. Waited additional half hour went home. Blood pressure at home 225/125 called doctor who sent me to ER Remained at the hospital 5 hours and was released with pressure 187/80 Went to the hospital Jan 24 with pressure 205/95 released 4 hours later Pressure still out of control Jan 29 Never had pressure so high normally on meds 110/60

1/28/21 vaccine received; couple mins after receiving numbing, tingling in arms, flush feeling, stabbing pain in chest area/back for about an hour, arm sore, lightheaded. PT has had to take Tylenol as needed

Started Itching PM on 1/28/21. Next morning a tiny bit sore and red. Four hours later still red but hasn't increased.

After shot my arm was a little sore, but by the following afternoon (Jan 28)it really hurt. When I actually looked at it,the area around the site was very, hot, swollen. That evening I took two Advil and used ice. The next day it was still quite uncomfortable and iced the area and had Advil again. The 30th was still swollen and red.and itchy/stingy. Used ice and Advil. Today it is not as red but still some swelling and a little itchy and minimal discomfort.

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.

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

Patient had vaccine given at her senior living apartment by staff. She reported to her PCP today that she has upper back and neck pain, left arm pain, and headache. This started one week after the vaccination. She has had to use biofreeze, ice packs, and Tylenol to treat the discomfort. She did state that it is slowly letting up.

Moderna COVID-19 Vaccine EUA Severe rash, welts, burning, chills; occurred 1 week after injection. Visited Clinic; placed on Prednisone, Hydrocortisone, & Benadryl. Next day rash spreading & worse, again visited clinic & prescribed Famotidine 20 mg; Zyrtec - 10 mg; Hydrocortisone

Patient reported being flushed, dizzy, and having blurred vision. We gave her water and kept monitoring her to evaluate for 30 minutes to see if she needed to get checked out in the adjacent urgent care. She felt better after waiting for 30 minutes and did not need to seek treatment.

Sore arm for 2 days which I think is normal. On day 2, I started having back pain running down my left side and around the side to my left breast.

Fever, chills., muscle achyness in my back at base of lungs (hurts when I walk) area, knee joint pain

Client stated on 1/30/21 she started to have pain in her left arm. Pain continued and on 2/2/21 she visited the Emergency Room. At the ER she was given a splint for her left arm and instructed to take ibuprofen. She stated she is feeling better today and her left arm is still a "little weak (2/3/21)..

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.

About a week after receiving the vaccine soreness in my arm which lasted for about 3 days. About 5 days after the soreness went away I developed a rash on my arm. My arm was hot and swollen. I went to an urgent care the same day I noticed the rash, they put me on steroid and antibiotic Cephalexin. They also sent me to the ER for an ultrasound to make sure I didn't have a blood clot. It is normal now. Besides the rash I felt fine otherwise.

About 8 hours after vaccine began to feel flu like symptoms. By next am had chills, sore arm, generalized aches and pains, fever 101.4 and generally felt "awful".

Rash with hives on left arm. Spread to face, neck , chest. Burning and itchy. I took Bendryl. Applied Triamcinolobe cream with cold damp cloth to all effected areas. Did go to urgent care. Was told it was a reaction. Take Bendryl every 6 hours.

About 10-11 days after vaccine, my arm was sore again and I broke out with a red, angry, splotchy, patch. A little itchy, a little sore, about 3" in diameter. Did some internet searching and saw it might be "Covid Arm", no reason to worry, and no reason not to get second shot which I'm scheduled for on the 18th. Might use the right arm though since it's still a little warm and sore.

Fever up to 101 degrees 4 hr after the injection followed by chills and a headache, followed the next day by a sore throat and then by 3rd day by swelling and pain of left side of the face

The next day after I was so weak and fatigued I couldnt get out of bed. I was literally stayed in bed for 36hr because I was so weak and tired. My arm swole up just as bad as from the previous arm did from the 1st vaccination but this time when healing it was like red and pink streaks were up and down my arm.

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

Later on after getting the shot I noticed that my arm was starting to feel sore, and I got real tired so I went to bed at around 11, and I woke up a few times because I couldn't get comfortable on that sore arm. When i woke up this morning I just felt yucky and I took my temperature and I was running a fever, 101.4

Patient reported symptoms started on 2/11/21 with low grade fever, "fuzzy head", sore arm and body aches. Patient will take tylenol or ibuprofen as needed.

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.

When I woke up the next morning my arm was super red and itchy, throughout the day it got swoller, redder and developed a fever. About 12n my daughter took the temp of my arm and it was 102 so we made ice packs to help with the pain and swelling. Later she went an bought Cortisone and used the ice packs and Cortisone for about 3 or 4 days when the arm finally begin to get better. My arm was so painful it was almost unbareable to touch.

Unknown onset of altered mental status. Last time known well was day of vaccination 2/3/2021. Found altered on 2/9/2021. Working diagnosis is encephalopathy: MRI unrevealing. CVA vs other etiology

7 days out from first vaccine I had extreme pain in my neck, shoulders and upper back. Could not turn my head left or right because the 6 Scalene Muscles in the neck were so tight. The pain also went up the right side of my face & skull affecting my TMJ and eating. The Scalene Muscles are on the side and front of a person's neck so I looked on the web as to how to release them. I gently used my knuckles, fingers and a tennis ball for 4 days on these 6 muscles while someone used a large 2 ball massager on my spine from my bra line and up my neck, and I laid on a heating pad but the stiffness and pain remained. Pain last 2 weeks, first week the worst. Extreme fatigue for a week . I believe I might have some arthritis in my neck and I frequently have minor aches and pain in my upper back, shoulders, & neck. So this area is venerable so maybe that's why it happened. I hope my 2nd shot won't be worse.

I woke up with severe Number 10 pain in my right knee, front , back and side. It was red, tender and swollen. The pain moved down to my right ankle and foot with severe muscle spasms pulling my right foot inwards toward my left foot. I could not walk to bathroom without screeming. Then it moved to my right hip area with muscle spasms across my lower back. I am still experiencing pain and muscle spasms (not as severe) today at this writing. It seems to be attacking my body where I have old injuries.

Immediately once the vaccine was injected, patient felt a tingling sensation rush through her body. She also experienced a taste in her mouth within 5 minutes of the vaccine and lasted for about 30-60 minutes after the vaccine.

Started feeling pain in right side (opposite side of shot) about 2 am on 2/9/21. Got worse during day and no sleep at all 2/9/21. Called Dr. 2/10/21 for appt next day. Severe pain on right side under armpit, shoulder and neck. Very painful to lay down (would get spasms), could not lift right arm at all and extremely painful to bend over. At 2/11/21 appt, was prescribed 10 mg Zyrtec twice daily, Aleve every 10 hours and Hydrocodone 5-325 mg at bedtime. Was able to get a little sleep 2/11/21 but pain back with a vengeance 2/12/21. On the morning of 2/13/21, the pain was less on right side but now also on left side in same areas.

I was vaccinated with Moderna in the right arm. Immediately afterwards, I felt a searing pain in my right index and middle fingers. This pain last several minutes, and has recurred several times over the last 3 days.

approx 22 hours: Extreme arm pain; acute headache; chills; sweats; fatigue; slept almost entire time, then dissipated except for extreme sore arm.

less than 24 hours after shot was given, started to feel "crummy" and got worse as the day progressed. Right arm got very sore, to the point of not being able to move it for a day; fever of 101.2, chills, sweats, stayed in bed most of Tuesday (the day after the shot was given), and then symptoms subsided Wednesday, but was weak and fatigued enough to stay in bed all day. Thursday, tried a little physical activity, and after 30 minutes playing croquet, had to stop and sit down. Went hon=me and napped again. Friday, napped most of day, as on Saturday, and yesterday, Sunday. Today is one week after the shot and I'm still feeling weak - not my normal self.

My second Covid Vaccine was 2/4/2021 and then on 2/11/2021 I was diagnosed with Shingles. Also started with symptoms of Sciatica on 2/13/2021

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.

Per Client received COVID 19 Vaccine in left arm on 02/9/2021 at 4:00 PM and by 2/11/2021 at 2:00 PM started having symptoms: Right arm painful, sore and left sided trapezius musle sore, achy and tender to touch. Per Client taking over the counter Aleve by mouth, applying ice and heat to site. per Client symptoms are still present in areas listed above and Client has already placed a telephone call to PCP for further follow up.

2 weeks and 2 days after injection of first dose of covid vaccine I noticed a rash and itching on left side of torso. Included achy pain and sharp, stabbing pin-prick pain. It spread to my back. Went to Urgent Care 4 days later and it was diagnosed as shingles by Dr. He prescribed 7 days of valacyclovir and Advil and Tylenol for pain. Was told it will take weeks to clear up. I had the Shingrex vaccine (both doses) 18 months ago and am not supposed to be able to get shingles. I had chemotherapy for lymphoma 6 years ago and I believe it adversely affected my immune system. I'm reporting this in hopes you could ask people if they've had chemotherapy in the past, which may lead to adverse side effects such as shingles. I also had severe nausea 36 hours after the covid first dose, which I have previously reported. The sore arm was to be expected and I ignored it.

Arm was moderately sore for first two days. After approximately 2 weeks, a large area around the injection site became red and intensely itchy. This continued for a full week or more. The point of the injection was clearly visible with a whitish area around it.

Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tired but on day two, felt so much better. Noticed that now her arm w as itchy and had a small round circle. Notice that the red circle was getting bigger and felt hot.

Felt fatigued the day of the shot. Arm pain came on gradually and worsened by evening, even though I was moving my arm a lot. Had trouble sleeping due to arm pain. Next day slightly better. Second day much better. Third day pain completely gone.

Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot Chest pains New left axillary Adenopsthy -CT scan 2/11/21

Raised Rash/welts/hives at injection site and down the entire left arm/forearm.Itchy, and hot arm.. started day after injection and is still ongoing now 6 days later. Now also spreading to the right upper arm( 6 days later). Headache beginning directly after injection and lasting 3 days. Extreme fatigue evening of injection and lasting foe 2.5 days

2:00 A.M. 2/18/2021 I awoke with muscle pain in left arm and left side of body. I arose to use the bathroom and when standing at the sink experienced the room beginning to spin and darken. I steadied myself at the sink; the dizziness passed; I returned to bed after taking two Tylenol tablets to relieve the pain. My husband, who also received the Covid Moderna vaccine yesterday 2/17/2021 at 10:55 a.m. , was also awakened at 2:00 a.m. 2/18/20121 with the same muscle pains. 6:30 a.m. 2/18/2021 we were both feeling much better and able to carry on usual life activities (such as they are...) [note 1: I walked 3 miles yesterday afternoon after receiving the vaccine and feeling perfectly fine.] [note 2: we both are enormously grateful for the vaccine!]

Vaccine Clinic: Patient (10/29/44) received her 2nd dose of the Moderna Vaccine today. She and her son waited in the observation area for 15 minutes and when they getting ready to leave, Patient stood up and felt weak and dizzy. Son sat her back down in the chair and the nursing student called out for my attention. I went over and assessed the patient. MA went and got a manual BP cuff. Patient reported weakness and dizziness. I asked a team member to get Dr. and he quickly came over and assessed the patient. He advised that the patient stay in observation another 20-30 minutes and report any changes. I offered water and a snack, but patient refused. We had the patient and son stay as instructed. About 25 minutes later, the patient was more alert and reported feeling better. I offered to wheel her out in a wheelchair and she refused. Son also stated that she is doing better. Patient and son, were escorted out the vaccine clinic. No other issues reported.

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.

About 22 hours after the vaccination I became very weak, could not get up from the floor, was very fatigued, disoriented, and could not walk without being held up. I went home, and slept most of the rest of the day. The following day I was listless with very little energy. I took several naps. Late in the day, the second day after vaccination, I ate food and am feeling a little better.

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.

Arm was sore day after shot and remained so....then last night it started itching and there was a slight rash above. It is now aching enough that I have tried putting ice on it and taking Tylenol and Advil. It is somewhat swollen and red with slight rash. Red at the spot of injection. It did bleed when shot was given. I would have thought by now it should be clear.

Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's Palsey right side of face, along with headache, herpes on left corner of mouth, fatigue and ?Epstein-Barr. I was exposed to the virus by my hairdresser on 2-11-21 and she developed symptoms and tested positive 4 days later

Pain to neck, shoulder joint, front snd back of arm. Severely limited range of motion and unable to Lift arm.

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.

Sore injection site first two days (slight difficulty laying on that side), then Day 9 developed a rash and itching close to injection site, Day 11 noticed swelling on the upper arm and tenderness in armpit; Day 13 rash about doubled in size and some itching returned Applied Cortizone-10 to relieve itching - it helped

Patient said the day of the vaccination she developed a red patch about 1/2 inch in diameter that was red and swollen and a little tender. Patient reported that it was periodically itchy and she has been scratching it. She stated that yesterday (day 9 after vaccination) that she noticed the size of the redness had increased. She said it was still periodically itchy and only slightly tender to the touch. She said she felt otherwise fine no systemic effects reported. Patient had not taken anything. Recommended benadryl and icing the area. Treatment outcome unknown at this time.

Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home. No accute pathology but hyperinflated WBC was 19. Sent home with oxygen

LEFT ANKLE APPROX 10 DAYS AFTER INJECTION: BUMPY RED RASH, ITCHING, BURNING EVENUALLYSPREAD TO COVER APPROX 4.5" IN DIAMETER . NOW NO MORE ITCHING OR PAIN BUT LIGHTER RED ANDDRY FLAKY SKIN. BASE OF LEFT THUMB AND RIGHT THUMB" APPROX 14 DAYS AFTER INJECTION. SAME SYMPTOMS AND CURRENT STATUS. SITE OF INJECTION ON UPPER RIGHT ARM:

I got extremely hot. I undressed quickly and got into my bed. My head moved from side to side with out my control. I was swallowing rapidly. I was awake and knew what was happening. I don?t know how long it lasted. When the episode was over, I went to sleep. I awakened in about 3 hours, went to the rest room, and returned to bed. I was uneasy and thought I might fall. I slept another three hours and went to the bathroom again. I felt a little better. I got up in about two more hours and felt a little better. Didn?t feel good all day and my arm was really sore.

2/11 -13/21 Sore arm first 2 days. Then I felt fine with no effects until the following week. On 2/18 my arm begin to itch at site of injection. 2/21 itching subsided but I noticed a red circular area around injection site. The area also feels warm. I feel okay physically. Today 2/24, the red circular area is still present.

The day of the vaccine she had no problems. Then 9 days later on 2/20/21, her arm started itching, she scratched it, it swelled up, hot to the touch and sore. It is getting better, but still has some color in it, reddish, and does not itch as bad. It looks like the picture on the website. She took some Tylenol, but nothing else.

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.

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.

On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.

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 .

Rec'd first dose on January 18, 2021, and three days following the first dose (January 21, 2021), severe arm pain in both arms (entire arm) at 2:30 P.M., accompanied with a few light chills. No fever. Pain remained for approximately 3 hours. Took 1 Advil which relieved pain. On February 23, 2021, following the second vaccine dose (administered on February 16, 2021) I experienced same arm pain in both arms at 5:30 A.M. The pain was less severe and felt in upper arms only. Duration approximately 1 hour. Took 1 Advil which relieved pain. Two days later (February 25, 2021) at 6:30 A.M., slight upper arm pain returned and remained 30-60 minutes. Took one Tylenol which relieved pain.

02/25/21: Slightly accelerated heart rate; sore arm, tender nodule above left clavicle. 12/26/21: severe chills, heart face and head, stiff neck, general weakness, sore arm. Severe symptoms lasted approximately four hours but continue to a lesser degree for several more hours. Throughout the day, weakness, feeling cold, sore arm and nodule is still there and still tender.

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.

Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard. Hairstylist removed her mask and she then passed out. Called 911. They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy. After several minutes she came out of it. Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am. Her color was still pale and she was still incoherent. While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled. I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75. She stayed with me for the rest of Saturday. Her sugar was still high Saturday evening and Sunday morning. Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.

Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow.

Chills, 101 fever , headache, body aches, swollen arm at injection site Symptoms present for 16 hours Tylenol taken - 2x500mg twice at 6-hr. intervals Sore arm lasted 5 days

2-3 days after 2nd Moderna vaccination a 10 inch area around injection site swelled and became hot, painful and hard, and a large bright red rash appeared . It persists without improvement today. I also had pain in the joints in my feet and ankles, hands. Some fatigue. No fever, no chills. I had NO reaction after 1st vaccination, although injection site was hot and very tender for days. Used left arm both times. I saw an online photo of "COVID arm" hypersensitivity reaction and looks exactly like mine. Really quite uncomfortable.

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"

Tiredness that night and the next morning i felt like i had not slept and continued over 5 days. i was so sleepy. legs were very shaky and i was very nervous inside. I had shortness of breath and i still have it. I road a bike 4 to 6 miles every day and now i cant. i had chills and body pain, i feel like i had the flu. dizziness, just just random spouts of sleepiness and it would last for about an 1 hr and half. My muscle in my chest just tightens and is hard as a rock. and then it goes away.

Patient states left hand has been having intermittent throbbing pain up to wrist starting 2 days after receiving second Moderna dose.

Having itching red swallowed arm cant stop itching to the point i want to take my skin off.. took so many antihistamines, rash medication nothing is calming it down... my both arms are having fever it's red and sever discomfort.... it's been over a week I still have the same symptoms

Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10). About 10 minutes (12:20) letter started feeling "Chest tightening". She denied not shortness of breath, and no other symptoms. About 2 minutes after that all symptoms were resolved. She denied BP check, & EMS. Reports when she got home felt yucky & whoozy but was still able to do chores. Around 9:00 pm started feeling short of breath and real tight chest. She put vicks vapor rub on chest and in nose and about 20-30 minutes felt a little better. She was able to sleep her normal amount. She reports she is back to her baseline this morning.

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 02/18/21 - achy back and neck (beyond ?normal? for me) - left arm sore 3/10 - pink rash near injection site - temp: 100.3 (normal 98 or below); Tylenol was not strong enough to relieve discomfort - took Aleve; improved on Friday 02/19/21; much better on Saturday 02/20/21; back to my ?normal? Sunday 02/21/21

Headache, Body Aches, Fatigue. Began the morning following vaccine injection and lasted approximately 24 hours. Left arm sore. All side effects much milder than those following first Moderna injection. Forgot to say on report of first injection that I tested positive for Covid on December 7, 2020 and had a mild case of Covid not requiring medical treatment.

In the evening lots of pain in left arm. during night chills including teeth chattering, pain all over, no sleep but slept through most of the next day, ate nothing. Was quite concerning but did not call doctor although I sure thought about it. I was wondering if I was actually infected with Covid- 19. Shot was Tuesday 2: 30 PM, felt a bit better by Thursday but arm still hurt even on Friday arm was red and swollen down to my elbow. Saturday fine. I thought someone should know about this as lost of my friends also had difficult reactions. But this was the first time I saw an opportunity to respond.

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

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.

Instantly felt shot material go through veins on L side of chest, 15 minutes later extremely light headed, 10 min later L side of face become numb, headache, 30 min later L arm swelled to side of 1/2 of baseball, lymph nodes under L arm and on L collar bone became enlarged. Arm swelling lasted 4 weeks, Lymph nodes have not gone down and it has been 5 wks, Advised by Nurse Practioner at Pharmacy advised me not to get 2nd shot. I am extremely healthy and work 5 days/wk, workout at gym 3x /wk Weights and Total Body Lift classes. Sided effects were a major surprise!

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.

Aside from the expected sore right arm, I developed painful welling of underarm glands (right side) which I've NEVER had before even as a child; also developed itching and some redness and swelling at injection site,. These occurred in late afternoon on 3/5/2021 - a day after 2nd Moderna vaccine injection. I also developed a low fever for part of the same afternoon (3/5) into early eve. I also had some ache in center chest (gone now) which I never had before (angina?). It is now 3/6/2021 and I still have swollen underarm glands (right arm), right arm soreness at injection site, and some itching there as well. But no fever just now. I'm VERY CONCERNED the swollen glands will not go away in time for my aortic valve replacement surgery on 3/15/2021.

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

The day after the vaccination, I started having a very bad dizziness, and vertigo, and they are ongoing up to today. I went to the doctor and she prescribed some pills called LOSARTAN 25 mg. but they have not done anything, and on the contrary they gave me very bad leg cramps, and a bad pain on my right leg.

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.

I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.

During post vaccination observation period, reported feeling flushed & was hypertensive 220/90, no hives, facial swelling or difficulty breathing. Pt did not take her antihypertensive for 2 days. Transferred to ED, 1 dose of antihypertensive med (Toprol XL) given and discharged to home.

sore arm, chills, feverish The sore arm developed around 5 o'clock on Feb. 27 and lasted until March 1. Chills started and ended on Feb. 28. Slight fever started and ended on Mar. 1. I took Tylenol.

FELT COMPLETELY FINE THE DAY OF THE SHOT. WOKE UP THE NEXT MORNING AND COULD BARELY WALK. MY BUTTOCK AREA WAS EXTREMELY TENSE AND HURT TO STAND OR WALK. THE PAIN WENT DOWN BOTH OF MY LEGS, MORE PROMINENT ON THE LEFT SIDE. I HAD BEEN FEELING THAT PAIN FOR A FEW WEEKS, BUT IT WAS A DULL ACHE, NOTHING DEBILITATING. I HAVE BACK PAIN, BUT THIS WAS INTENSE AND NOT A PAIN I'VE FELT BEFORE. AS THE DAY WENT ON, IT EVENTUALLY GOT A LITTLE BETTER. WHEN I AWOKE THE NEXT DAY, I COULD BARELY GET OUT OF BED. MY DAUGHTER HAD TO TAKE ME TO THE ER BECAUSE THE PAIN WAS SO INTENSE.

Patient reported (upon returning for second dose on 3/8/21) feeling a tingling sensation around her face and down her arm in the 15 minutes after vaccination the first time, it went away within 15 minutes and she had no other signs of reaction. She had the same sensation on 3/8/21 after her 2nd shot, it presented in the first 5 minutes and it was only her face that was tingling. I sat with her for the full 15 minutes and she was chatting with me the whole time with no other symptoms or signs of a reaction. By the time her 15 minute observation time was over, she said the tingling was gone.

swelling of L arm's inner aspect; tenderness in entire arm especially around the inside elbow; some red areas that have diminished; fatigue. continues.

Left sided facial paralysis (Bell's palsy) began on 3/7/21 and was still present when I contacted the patient by phone one 3/9/21. Problem has so far not resolved. Seen at urgent care and diagnosed as Bell's palsy.

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.

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.

Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25.

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.

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.

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.

Arm is red, aching, circular, raised, hard, growing slightly, warm, and itches. Also feels itching in her throat, and allergies are acting up. Patient took benadryl cream along with antihistamine she usually takes.Continue using cream for symptomatic relief, if symptoms worsen feel free to call back or see your PCP. We will follow up in 2 days at around the same time.

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.

Slight soreness on left arm. On 3/11/2021 I experienced extreme RIGHT arm pain - upper arm/elbow/to my hand. It was 95% gone on 3/12 and 99% gone on 3/13.

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.

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

03/12/2021 sore arm and fatigue 03/13/2021 chills, low grade fever (100f), aches, fatigue 03/14/2021 fatigue but no other symptoms

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.

Red, burning, itching rash with welts left arm, that spread just above elbow. No longer spreading, somewhat better each day

Fell; Severe Stiffening and Cramping up of all muscles for hours; Worse Severe Unbearable pain in body ever felt; Stiffening of muscles; Worse pain in neck and head ever. Went to the ER twice and finally got an appt at primary care, now seeking another primary care Dr.

Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed assistance. chills shortness of breath excessive thirst

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!

Had severe headache, chills with body shakes, fever, body aches, dizziness, fatigue, and painful arm at injection site that lasted for 24 hours after second vaccine on the 13nth of March, 2021.

pt stated that she had bad pain in her left arm, shoulder, and breast. This pain lasted about 3-4 days. Pt stated she developed a burning, sore rash over a week after taking the vax. The rash is underneath her left arm pit, back, and chest. She says her muscles feel very sore. Pt has only taken Tylenol, Ibuprofen, and using an allergy cream. Pt will call PCP regarding her symptoms.

Swollen upper arm, redness, very warm to the touch , itching, sore arm muscles (difficulty holding anything using left arm. Pain extends to the wrist.

Pt experienced soreness immediately after administration, which subsided 03/12/2021. On 03/14/2021 pt started experiencing redness, itchiness, soreness, and warmth at the injection site, which is still occurring. Pt denies fever and denies fatigue.Pt was advised to take Benedryl and Tylenol, and if the symptoms worsen or do not improve in 1-2 days to contact primary doctor and seek medical care. SPI was consulted and Dr. was notified.

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

1st Day after injection ran a lower grade fever (100.2), injection site itching & turning red with moderate pain . Started taking Benedryl 10 mg and applying 1% cortisone creme ,I buprophen. Day 2 red rash spreading down arm 5" and about 4" wide. No fever but site still itiching & tender. Continued to treat the discomfort. The red rash finally fade after 9 days (3/19/2021). I had delayed reaction to the first injection of Moderna that did not start until 8 days post injection. Not as sever as the second one.

Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vaccine; extreme chills for hours so hard to sleep, because whole body shaking; arm sore to raise and lower, all joints ache, especially knees and neck; fatigue and little energy; runny nose. Feeling better next day, but tinnitus noise still strong, left arm and joints hurt, and low energy.

Migraine type headache, dry mouth, achy arms (both arms not just at injection site), heaviness in lower extremities (inability to get out of bed for several hours).

Developed a reddish pink rash that lasted about 3 days and itched really bad. Left a slight soreness for a couple days after.

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.

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

Headache 10 mins after shot, muscle spasm in left arm & left shoulder 15 mins after shot, pain lower back, weakness in both legs, aching all over, tired, started about 20 mins after shot, large raised area, red, itch, slight soreness shortly after shot

Patient was in the office on 3/19/21 for her first dose of Moderna COVID vaccine. 15 minutes after administration of vaccine, patient expressed she was feeling hypertensive and her hands were feeling cold. Patient was taken to an exam room for evaluation with assistance of language interpreter and RN. BP of 220/120 with symptoms of headache and blurry vision. No chest pain. No signs of anaphylaxis. Patient stated she was feeling slightly better after 3 minutes. Repeat vitals of BP 180/94, pulse 80, RR 32, O2 sat 98%. Patient did take BP meds as prescribed. Plan to go to the ED was communicated to patient and her brother in law to which they agreed. Patient requested that her brother-in-law drive her to the ED instead of activated EMS. Report was called to the hospital ED recieving provider by myself with diagnosis of hypertensive emergency.

The evening of the first shot on February 5, I had a strong headache, muscle aches and was extremely tired for the next two days. I had brain fog for the next 2 weeks. Tylenol and Advil mostly relieved physical discomfort. I had the second shot March 16. The next day I had a severe headache, no energy, achy body, chills and fever and on the second day after the shot my temperature was 101.4 - 101.8. Tylenol and Advil relieved the symptoms. Today, one week after the second shot I developed a pungent chemical taste in my mouth and a similar sense of smell. The tip of my tongue is tingling, and while I can breathe in deeply, my chest feels heavy, like I'm not getting enough oxygen.

Pt. received her first dose of Moderna vaccine in her left arm on 3/11/21 and began having symptoms on 3/13/21. She noticed a heaviness feeling in her right shoulder extending to her elbow with her right arm feeling limp and her right hand cold. She spoke with her doctor's office on 3/17/21. Her symptoms have continued.

Arms, legs and body was paralyzed; Nerve pain that travel from her head to the back; Excruciating pain,Pain is still remaining; Not being able to get up from bed; Lightning pain in the back; A spontaneous report was received from a 76 year old female patient concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain and the feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and patient had lightning pain in the back. The patient's medical history was not provided. Concomitant medications were not reported. On 26 Feb 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly on left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, after receiving the first dose of the mRNA-1273, the patient experienced excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed (Other Important Medically Significant). This pain was still remained, kind of nerve pain that travel from her head to the back and also the patient had lightning pain in the back. Laboratory investigation details was not provided. Treatment details included Tylenol for pain. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and lightning pain in the back was not recovered/not resolved at the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pt received the Moderna vaccine 2/28 at 4 pm (per her) and on awakening on Monday am her entire left arm was numb. continued monitoring and conservative treatment failed and paresthesia persists in left arm even w/addition of muscle relaxer, NSAID, B complex, magnesium, heat, ice, massage. EMG ordered with repeat imaging of cervical spine,

Second day, redness and swelling below injection site. Started size of quarter, grew to size of $.50. Tender, especially to the touch Warm to touch.

I had a severe migraine - and I don't have headaches. My whole face hurt. (I have two optic aneurisms and I was afraid they were starting to bleed out.) My eye was running water even more at that point and I also had some mucus in my eye. I went to ER. January 8 and they did a CT scan - and they gave me something IV for pain. They told me to take extra strength Tylenol every four hours and that didn't help. After one hour, I was in severe pain again. At that point, both eyes were tearing. I went to the dentist (Monday) -and they did x-rays - ( to see if I had a tooth issue and I went to my ENT doctor (Tuesday)- and he said it didn't appear that I had a major infection. still in severe pain - she gave me a prescription to get rid of infection in my eyes. She gave me a steroid shot - which stopped the pain. The following week, I had an appt with an ophthalmologist- I was not in pain any more and my eyes had pretty much cleared up. He said I probably had a viral or bacterial infection prior and when I got the vaccine then that was why I got a migraine. 2nd vaccine - 30th of January (8:30) - I slept all that day - I was sleepy the whole day and the Sunday, I had flu like symptoms and after that I was fine. This week, I have the infection in my eyes again. I went back to the Dr yesterday to get an antibiotic because I was having the same kind of infections. This time - infection in my left eye, with tearing and mucus. They had me do the eye drops again and nasal spray I've been using.

Troponin over 4000; Blood pressure over 300; Flushing beet red/erythema; Feeling groggy; Difficulty with cognition; Arm swelling; feeling hot/overheating; A spontaneous report was received from a consumer who is a 76-year-old, female patient who experienced blood pressure over 300 (blood pressure increased), troponin over 4,000 (troponin increased), flushing beet red (flushing), overheating (body temperature increased), grogginess (somnolence), difficulty with her cognition (cognitive impairment) and arm was swollen (peripheral swelling). The patient's medical history included breast cancer in the right breast. Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication and once weekly Fosamax with calcium and vitamin D. On 10-MAR-2021, the patient received a dose of mRNA-1273 (Batch number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Mar 2021, immediately following the vaccination, the patient reported she experienced overheating, became beet red and her blood pressure was over 300. An ambulance took her to the emergency room. She had her troponin levels checked which were over 4000 that lead to a hospital admission and required a unspecified catherization. The patient was discharged home on unspecified date. She reported still feeling groggy and having difficulty with her cognition but it was improving throughout the day. The patient also reported her arm was still swollen, but improving. Treatment for the event included diphenhydramine and other unspecified medications and treatments. Action taken with mRNA-1273 in response to the events was unknown. The events, blood pressure over 300 and troponin over 4,000, were considered recovering. The events, flushing beet red, overheating, and grogginess were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

02/25 I had my first dose- within the 15 minutes after I felt dizzy and lightheaded. it subsided enough for me to drive home. I was tired for a few days. injection was very high up in my shoulder and about 3 weeks after I had tenderness in my elbow. My physical therapist said it was due to the injection being too high. 03/25- halfway home I had a significant headache. It diminished but I then got very very sleepy. I napped and then made dinner. 03/26 I was doing normal things and I felt cold, then my hands were very cold. I ate lunch but was very sleepy just before lunch. I then had a fever, My temp is 101.1. I have had a little drainage from one side of my nose.

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,

Patient reports tingling and numbness down whole arm after receiving vaccine; could feel and move hands after 20 minutes but could not lift arm without assistance. Refused EMS transport; mother of patient opted to take her mother to urgent care.

Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jerks, headache, irregular heart beat, joint pain, muscle pain, itchy area under the shot, swelling of upper arm, red rash under shot-4"X6", continued "brain fog"

Got the vaccine, had no reactions. Then on 3/8/21 woke up with a stiff neck, muscle cramps and then broke out into a rash. She went to her PCP, and it had just come out and was right where you would wear a necklace and diagnosed her with an allergy, but did not take the medicine he prescribed as she felt his diagnosis was wrong. A couple of days later it was hurting and bother her and went to a dermatologist who diagnosed her with shingles which came out on her neck and her shoulder, and typical shingles reactions with stinging, hurting, itching, etc. Her dermatologist put you on Acyclovir, which is helping a lot, fading reaction, and help with the pain. She does still have some sensitivity around her neck but the rash is fading. She also had pains in her ears at the same time.

Patient received 1st vaccine on 3/24 with no issues reported. Patient returned on FRiday for routine treatment and was afebrile, BP within normal limits and no compliants. Left the unit stable post treatment. Patient passed away on Saturday morning. There was no hospitalization. Patient went straight from home to the funeral home. Daughter states that patient had been feeling warm since Wednesday.

With the first dose about 12 hours later I experienced some numbness of my face. The next day I had a measles-like rash which went away in a few hours. Pain in my arm went away in 2 days. With the second dose on the third day after the injection I developed severe itching and noticed a red spreading rash in the area of the injection, just a little below the injection site. This is very red, sore and feels somewhat warm to the touch. The area is about 5 inches in size and is still painful. I have also noticed some shortness of breath but minor. Some numbness and itching around my face.

Presented like a stroke approximately 22 hours later - slouched, leaning sideways, breathing, but unresponsive. Called EMTs who transported her to ER where tests showed slight fever and minor dehydration

Patient received the first moderna vaccine. She was waiting the 15 minutes after the vaccine, at about 8 minutes I checked up on her again and asked if she was doing okay. her eyes were open but she was not responding. I ran over there and tried to get her to respond to my touch and voice. She was breathing but was non responsive. She also had incontinence and when she came to she stated that she was asleep. We called 911 at this time and the paramedics came and took all her vitals, all of which were within range. The paramedics came within 10 minutes and at this time she was already responsive. She kept stating she was just asleep and told us she does sometimes have incontinence and has to wear pads. She refused further medical care and I contacted her when she was at home, where she stated that she would rest up but overall feels fine.

Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness). The consumer's medical history was not provided. No relevant concomitant medications were reported. On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.

Fevers to 103 degrees, lethargy, weakness, myalgia in neck and shoulders severe. Poor exercise tolerance. Oxygen desaturation with walking. Symptoms of severe neck and shoulder pain persisted greater than 3 weeks. PT required. Still ongoing. Then 2nd vaccine on March 12th. Symptoms of high fevers, weakness, myalgia this time in low back and hips.

76 yo female with c/o numbness and tingling to finger tips s/p receiving second dose of Moderna COVID vaccine in left shoulder. Fingers remained warm and well perfused, grip strength normal. Pt rested, had water, and gentle ROM exercises. Symptoms fully resolved in ~30 minutes. Pt was d/c'ed home with friend/driver.

2/1 midnight woke up with fever, chills 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. Husband could hear better than me without his hearing aids.) 3/18 went to doctor. He thought I had fluid in my ears. Put me on fluticasonne Propionate Nasal spray, stopped meloxicam Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. on 3/1 at 11:45 am had 2nd moderna vaccine shot. By midnight I had fever, chills 3/2 fever, chills am, very tired.

2/1 midnight woke up with fever, chills. 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam. Began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. (Husband could hear better than me without his hearing aids.) (3/18 went to doctor ). He thought I had fluid in my ears. Put me on fluticasone Propionate Nasal spray, stopped meloxicam. Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. On 3/1 at 11:45 am had 2nd Moderna vaccine shot. By midnight I had fever, chills. 3/2 fever, chills am, very tired. 3/2 in the evening I thought I would watch tv. I turned it on and the mouths were moving but I couldn't understand anything they were saying. 3/8 Went to ENT and had a hearing test. I still had tinnitus. Test results showed that I have a moderate to severe hearing loss in conversation area in both ears. 3/9 Went to ENT who prescribed prednisone beginning with 60 mg. 3/30 Had another hearing test at ENT. Test results showed no improvement, hearing still as on 3/8. So end results I have tinnitus all the time and a hearing loss that I did not have before taking the vaccine.

Had kidney stone problem; Urine test showed bacteria; Sore arm; A spontaneous report was received from a consumer concerning a 76-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm / pain in extremity, had kidney stone problem / nephrolithiasis and urine test showed bacteria / urinary tract infection bacterial. The patient's medical history was not provided. Concomitant medications reported included potassium and nebivolol hydrochloride administered half a pill. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient experienced sore arm. On 13 Mar 2021, the patient had kidney stone problem and urine test showed bacteria. The event kidney stone was found to be medically significant. Treatment drug administered was amoxicillin and clavulanate potassium on 18 Mar 2021 and on 19 Mar 2021. On an unspecified date, treatment drug was switched to ciprofloxacin. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, sore arm, had kidney stone problem and urine test showed bacteria was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of sore arm, a causal relationship cannot be excluded. Very limited information regarding the events of nephrolithiasis and urinary tract infection bacterial has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Acute-onset vertical binocular diplopia found on 2/19/21 exam by me to be a left fourth nerve palsy. By follow up on 3/19/21 the diplopia has essentially resolved and the left fourth nerve palsy was measured to be nearly resolved as well.

patient got vaccine on Thursday evening. She came in to store on Saturday morning and said her are was very sore. The soreness started on Friday and she still had soreness on Saturday. It was hard sleeping on her arm at night. She told me the pain was not getting worse. I told her if the pain continues or gets worse she should call her doctor immediately

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.

DIARRHEA 3 TIMES IN 5 HOURS AND NAUSEA, EYES BURNING, HEADACHE, TIREDNESS, VACCINATION SITE VERY SORE WHICH LASTED 2-3 DAYS. THE TIREDNESS AND GENERAL NOT FEELING WELL RETURNED SEVERAL TIMES DURING THE NEXT 3 WEEKS. AFTER THE SECOND SHOT ON 3/31/21 AT A VACCINATION SITE. THE SIDE EFFECTS STARTED AFTER 20 HOURS AS FOLLOWS: ACHY ALL OVER, HEADACHE, CHILLS, BURNING EYES, HOT FLASHES, TIREDNESS WHICH HAS BEEN HAPPENING OFF AND ON SINCE 3/31/21. FEEL I MAY NEED BLOOD WORK TO SEE WHAT IS GOING ON. I HAVE HAD EPSTEIN BARR VIRUS AND WONDER IF THIS HAS BEEN REACTIVATED.

passed out; she fell down; bruised her lower back; her back is killing her; she felt cold inside; really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), FALL (she fell down), CONTUSION (bruised her lower back), BACK PAIN (her back is killing her), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed). On 26-Mar-2021, SYNCOPE (passed out), FALL (she fell down), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed) had resolved. At the time of the report, CONTUSION (bruised her lower back) and BACK PAIN (her back is killing her) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive. Concomitant medications taken by the patient were not provided. Treatment activities was done with paracetamol, ibuprofen, a shot and pill. This case was linked to MOD21-064155 (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. Further information has been requested

This was my 2nd shot of the Moderna COVID-19 Vaccine EUA. The morning after day of shot I had a sore arm and felt tired through the day, I slept most of the day. These symptoms went away quickly from the following day.

All the normal side effects, and 3 electrical charges to my body muscles that were shocking and a swelling and rash around my injection site.

After first Moderna vaccine had several migraines with the Z's but they were unusual. Usually I have a path of Z's going left to right and then at my age I had a very slight headache. These looked different with broken up lights. and I woke up with them.Then on Feb 24 :1t 1:15 I had my second. The next morning I woke up with a hazy eyesight but I thought it might be a migraine. I somehow knew it wasn't but didn't go to a doctor. The next morning definitely knew. Saw 2 doctors one in emergency situation he placed me on steroids but I had lost part of my eye sight.

Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tonsils starting around March 21. Had to go to urgent care on March 28. Strange headache on left side. Finger tips and toes went numb. Covid vaccine related illness(chills, body aches, shallow breathing) started 1 week after 2nd vaccine. Ongoing shortness of breathe.

RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21. SHE HAD NO SIDE EFFECTS OTHER THAN SLIGHTLY SORE ARM UP TO THAT POINT. ED MD FELT SHE HAD SIGNIFICANT CARDIAC HISTORY AND LIKELY HAD MI. MEDICAL EXAMINER DID NOT ORDER AN AUTOPSY AND SHE WAS CREMATED. I FELT THAT I SHOULD JUST REPORT IT SINCE IT WAS SO CLOSE TO RECIVING THE VACCINE.

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.

3/18/21 admitted via ER for Transient cerebral ischemia (left sided weakness/paralysis primarily left arm)- discharged 3/19/21 3/19/21 Acute Stroke (progression of symptoms, involving left arm and leg/foot drop)- transported via ambulance to ER and admitted again, then transferred to inpatient rehab ~3/23/21 and discharged to home 3/31/21

Chest and back pain, legs weak since COVID shot 10 days prior; Feet feel like "pins and needles". Lower extremity weakness and paresthesia's and low back pain which now extend to her hands. Unsteady gait. No urinary or vowel incontinence. No similar reports from other vaccinations

complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,

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.

Pt woke up on 4/9 (the day after immunization) and left leg was very sore from the hip down. She is needing to use a walker to get around. Has hx of arthritis, but usually only her knees bother her. Some OTC pain medicine will lesson the pain, but overall it has stayed the same since 4/9.

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.

Patient received the COVID-19 shot (Moderna) on 03/23/21 and has been having a severe arm pain from the site of injection. She was checked by her Dr and was told that she is having a nerve pain as a result of the vaccination. She just called the pharmacy today on 04/16/2021 to report the adverse events as advised by her Doctor. According to the patient she is taking the Gabapentin 300 mg prescribed by her Dr and it is helping her with the pain.

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

Initially had headache, sore arm, chills, but on 4/1/21 had to go to ER with a stroke, and then on 4/5/21 had a TIA

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 .

pain in right lower extremity few hours after first and second vaccine. pain then returned and was diagnosed with Right lower extremity DVT

Stiffness and increasing pain in shoulder, arm. Inability to sleep due to pain. Unable to rollover at night, and loss of use of arm. Saw 2 doctors, neither of which could identify the source of the pain. Inability to rise from bed or couch without assistance. Both doctors recommended physical therapy. I waited to visit a doctor for a week, then another week to see a specialist. I started physical about 3 weeks after the vaccine was admiistered.

after 3 minutes of getting shot, patient developed headache, labored breathing, tongue swelling, burning sensation in the chest, and was flushed. she was at a drive through administration facility run by Hospital Systems. she was given benadryl and epinephrine and then was driven to the ED, where she was given IV steroids. she also developed flu like symptoms which she is still having now.

patient had covid shot given to her at drive up. she states immediately she started having a headache, labored breathing, tongue swelling and burning in her chest along with being flushed. the physician on site gave her benadryl and epinephrine, and she was then driven to another ED where she was given IV steroids. she states the vaccine adverse event was not reported by any of the facilities that took care of her that day. she also has had flu like symptoms since she got her shot and she is still recovering.

Traverse myelitis. Extremely painful neck and back in joints which moved outwards to arms and legs. Started on about day 4. Could no walk to toilet. Pain moved out from joints to muscles in arms and legs. It is improving but after 30 days! Also my tinnitis got worse. I have never had a vaccine or a flu shot in my 76 yr life.

Approximately 2 hours after 1st dose Moderna, developed right sided facial numbness and tingling and right sided headache. Symptoms lasted approximately 2 hours, then disappeared.

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.

I awoke at 1:30am 0n Tuesday April 27th shaking with chills, headache and fever that went up to 100.7. I had received the second Moderna shot 16 hours before at 9:30am the previous morning (Monday April 26th 2021). I had chills and shaking until noon but had the headache and some aches in my arms and legs until about midnight when I fell asleep for the night. I woke up on Wednesday April 28th at 5am exhausted but no aches, headachce or chills. I am just taking it easy today and try and recoup my strength.

1st dose...only right arm (shot spot) sore and it's still sore today, but no other side effects at all 2nd dose...arm not sore, BUT I was so out of it the next day 1. Major headache...no relief with acetaminophen & didn't try anything else 2. Minor temperature...99.8 most of the day 3. Every muscle, every joint and every bone in my body ached...perhaps my skin & hair also :-) 4. Nausea...without vomiting 5. Dizziness upon standing and intermittent lying down 6. Lethargic...probably due to all the above Stayed prone all day and night except to get water and go to the bathroom Drank lots of water and hot tea with saltines Day 2: 1. Headache...gone 2. Temperature...back to normal 3. Aching...subsided, but not totally gone 4. Nausea...gone 5. Dizziness...subsided but not totally gone 6. Lethargy...hung in there, but not nearly as profound Made myself get up, eat and do minor household chores to gain better equilibrium and feel more productive plus work out the muscle tightness from being inactive

Cellulitis; Arm started swelling; Arm was red; Arm was tingling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling). On 22-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 16 Jan 2021, the patient's arm started swelling, and it was red and tingling. The redness started traveling down her arm. On 22 Jan 2021, the patient went to urgent care and was told she had cellulitis. She was told it was bacteria getting into the skin from the way it was administered. She stated the physician who gave her the injection, cleaned the area before the shot was given. She reported that she was to pick-up antibiotics that day (22-Jan-2021). The patient states she definitely has an infection in the arm. 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.

Five minutes after shot, got a numbness feeling from above my arm to neck and up to left side of head. Then down from arm and shoulder to left leg. It lasted about a half hour, then started lessening. It was better after a half hr. I was moving my arm out and back as pharmacist suggested. After an hr of shopping in store, it was a lot better. Went home, in two hours it quit. Haven't had any more numbness since then. Its only been two days though.

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.

Patient had the second COVID vaccine and the next day she was not able to lift or move her arms. She has been having body aches and is barely able to move her neck. She reports she is feeling better today than yesterday. The red area and tenderness have decreased in her arm.

Two weeks after second shot, I experienced all over body myalgia, chills, extremely fatigue and weakness. It lasted for ten days. Extra strength Tylenol, 2 every 8 hours helped. Then the symptoms would return. This lasted off and on for weeks. Gradually feeling better but still taking some Tylenol now and then. Had blood work and my sed rate which is usually 5 was 67 and showed positive antibodies for Covid. I have not had Covid 19.

Pt came into our pharmacy complaining of her arm still hurting after receiving vaccine more than 15 days ago. The pt's right arm was red and irritated in a large 2 inch circle around her whole arm. Pt complained of arm itching, warm to touch, swollen and inflamed.

I had my first vaccine in February and got along fine. My second shot was in March and the first thing I noticed was the shot hurt so bad, and I am not a whiner. The second day my arm hurt so bad i couldn't even lift it and could not use it for almost a week. The second day after the vaccine, I had a massive headache. The third day was Sunday and I was so sick with body aches, fatigue, the arm, and headache I couldn't go to church. For days and days I would wake up thinking I was better but by noon.I was a mess. A church friend mentioned she thought I had Covid bc my symptoms were so much like hers when she had the virus. Both my daughter and stepdaughter noticed how I was struggling with my speech, which has

Pain in face; Ophthalmic herpes zoster; Eye inflammation; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) 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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1. On 02-Feb-2021, the patient experienced EYE INFLAMMATION (Eye inflammation). In February 2021, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) (seriousness criterion medically significant). On an unknown date, the patient experienced FACIAL PAIN (Pain in face). At the time of the report, OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster), EYE INFLAMMATION (Eye inflammation), FACIAL PAIN (Pain in face) and HERPES ZOSTER (Shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included prednisone. Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.

I could not get out of bed for 3 days terrible chills weakness whole body aches crushing fatigue very bad headache . Worst symptoms abated but I still do not feel good have crippling fatigue unusual headaches & unexplained leg pains & unprededictable cold sweats & odd temperature sensitivity

O2 levels where they'd be mid 90s and would walk a little and go down to 79%; weakness; shaking; shortness of breath; unable to get out bed; heart rate would go into the 100s with minimal exertion; myalgia in neck and shoulder; chills; 103F fever; This spontaneous case was reported by a physician and describes the occurrence of HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) 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 COVID-19 (had COVID19 at the end of October) in October 2020, Fever (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020, Myalgia (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020 and Appetite lost (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020.Concurrent medical conditions included Hypertension (for which she takes a small dose of an antihypertensive medication). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) (seriousness criterion medically significant), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever). At the time of the report, HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram: negative (Negative) Negative. In 2021, COVID-19: negative (Negative) Negative. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Electrocardiogram ambulatory: negative (Negative) Negative.NThe action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included ANTIHYPERTENSIVES for Hypertension.BHer neck and shoulder pain persisted so she used Lidoderm topical and muscle relaxers which seemed to help as well as resting. Her doctor also advised she go to physical therapy to help.NBased 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.NThis case was linked to MOD-2021-103020 (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,s a causal relationship cannot be excluded.

Patient's arm started involuntarily shaking about 17 hours after vaccine administration. Patient states it continued for an hour then gradually subsided. She would also like to report severe headache beginning at the same time.

Awoke the next morning with upper arm muscle pain bilaterally. The left arm was NOT worse than the right. Pain spread across the neck and shoulders over the following two weeks, with increase in intensity. No treatment given, physical therapy referral made. As of today pain persists in arms and hands, worse in the morning.

A few days before she had trouble breathing, wheezing and then she got the vaccine and it got worse. Also had pains in her legs and chest. She gets weak and would have to lay down a walk and when she goes up and down the steps had to huff and puff, which she had not have this type of trouble in the past. She went to her cardiologist who took blood work, and he also did a chest x-ray. She then went to her PCP last week, who said he would check with her cardiologist and see the results of his tests. She is also a little light headed, but the breathing and wheezing is what is most bothersome.

Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to other joints and muscles. Intensity varied. Applied ice to back of knees and legs when movement was affected. As the weeks progressed, fatigue, weakness and pain became more intense. It became difficult to stand from a sit position, walk, turnover in a lying position, bend-over and sit-down. PCP ordered labs on 3/08, which resulted in ESR and CRP showing elevated, inflamed condition. Referred to rheumatology. Diagnosed on 4/21 with polymyalgia rheumatica. Prescribed prednisone 15mg/day. Symptoms relieved and strength returned. Gradual tapering off of prednisone is planned.

Soreness started in fingers and elbow joints and then to hip, knee and foot joints about one month after second shot - I walk 2 miles every day and play golf - was unable to walk or play golf for 4 weeks - slowly getting better - joint pain mostly subsided and have started a slow walk and up to over 1/2 mile ? just reporting for data purposes.

To begin, I cannot sit or rise easily because I do not seem to have the use of my legs. I have to push myself up with my arm when I am trying to stand. When I am standing and walking, I cannot straighten up completely and I seem to loose my balance. This problem seems to only be below the waist. The tops of my legs attaching to my buttocks are a constant soreness. Below my knee on the left side of my left leg, there is constant soreness. My legs are continually throbbing down to the ankles. Just now as I writing this sitting at the computer, my legs are throbbing. When I am lying in bed, there is constant throbbing and soreness. This morning when I awoke, it seemed as if there were needles pushing into my left heel while lying in bed. I have been taking a 500mg Tylenol in the a.m. and before going to bed but it doesn't give relief. This doesn't appear to be a problem with my joints but rather a stinging sensation in both legs. When I am driving, my right leg will begin to have a severe cramp which is very painful until I can stretch. I can bend over but with great difficulty. I cannot step up on a curb without great difficulty. I have a general overall feeling of weakness and instability. I did cease using pravastatin. I have been feeling these issues for about 1 month and they seem to worsen. My first Covid vaccine was January 25th. My second Covid vaccine was last Thursday, February 18th. Thank you for brainstorming this for me. I am a very active person so this is a puzzle for me.

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.

After second Moderna vaccine I could not walk; the pain is excruciating on my ankles and heels. I have not walked since March 5, 2021.

Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history

Starting 6/2/21, pt felt like her kidneys "were not working properly." She states she isn't urinating much and when she does urinate, her arms tingle. Symptoms have persisted throughout yesterday and today 6/3/21.

Fever ,chills,headache,unable to sleep 2 wks due to tartness of both leg muscles,lose of balance & leg strength, extremely tired loss of energy.

Severe nerve muscle attack almost paralyzed; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; arms Pain; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed), PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) and MYALGIA (arms Pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. 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 an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed) (seriousness criterion disability). an unknown date, the patient experienced PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability) and MYALGIA (arms Pain) (seriousness criterion disability). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of 300 mg three times a day; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed), PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) and MYALGIA (arms Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Inflammation scan: extremely high (High) extremely high. In 2021, White blood cell count: extremely high (High) extremely high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. As reported primary healthcare provider, increased the Gabapentin to 200 mg for a couple of week since pain is not going away. Currently patient is on 300 mg of Gabapentin 3x a day. Velocity test from another Dr., result shows it was not Guillain Barre Syndrome. Onset of events began exactly two weeks after the shot. Concomitant medications were not reported. Second dose was given on 18Feb2021 administered on same arm. No adverse reactions were noted (Lot number: 041L70A) Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; 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. No further information is expected at this time

On April 18 I developed a headache and fever (101), fatigue, tightness/pressure in my throat/esophagus. Continued through April 20, when I called my GI physician to describe symptoms. Doctor recommended going to Urgent Care to be tested for COVID 19. Within an hour or two I went for the test, which was negative. The attending doctor then ordered EKG, blood tests, and CT scan to see what was going on. Found high white blood cell count and Pericardial Effusion. Sent me to hospital, where I was admitted and spent 6 days. The diagnosis was that the Pericardial Effusion was caused by inflammation, not infection, and I was started on a combination of drugs to eliminate the fluid. I was released on April 26 with only trace fluid around my heart.

The patient presented to our pharmacy on 6/12/21 to pick up a prescription for Ketoconazole 2% topical cream. At the consultation window the patient mentioned that this was to treat a rash on her neck that she believes was caused by the Moderna vaccine. She received her first dose on 1/29/21 and reported that two days later she had a rash on her neck. She stated that the rash burned and was itchy, and that it gradually spread to her inner left forearm and face. At the pharmacy on 6/12/21, her neck was visibly red, along with her face and left forearm. The patient saw her primary care doctor in Februrary, but she states that she was not given any thing for the rash and was told by her doctor to monitor the rash. The patient saw Doctor again in May and was prescribed a cream for the rash, but the patient does not recall the name of the cream and there is no history of that prescription at our pharmacy. The patient reports that the cream did not help, so she saw her allergist in June. She saw Provider and was prescribed ketoconazole 2%.

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.

Attempted to get out of bed to go potty and slid to floor unable to stand on legs, daughter and grandson had to help put me back to bed, went to emergency room and they couldn't figure out what was wrong but with assistance from nursing was able to walk. I came home and pretty much slept all day. The next day was weak, sore all over and had a headache

Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.

Patient received the second moderna covid-19 vaccine on 4/1/21. 2 days later she developed a painful itchy rash at injection site that traveled down her whole arm to her hand. Over the next few days she began to feel dizzy and weak. She had an episode where she was parked in her driveway and felt she could not get out of the car due to feeling dizzy, weak, and faint. She was able to get out of her car and to her bed were she remained for the next 8 hours. She felt she could not get our of bed due to feeling so weak and faint and she feared she would fall. She woke up the next morning able to get out of bed. She then began to develop pain and weakness in both shoulders, both arms, both hands, both knees, and both ankles. We ordered blood test on 5/11/21 including a CBC, CMP, CRP, urinalysis, ESR Wes+Fer, Rheumatoid arthritis factor, and ANA all blood test came back within normal limits. Patient was seen in the office on 5/24/21 for a physical exam and was found to have loss of range on motion in both shoulders and arms, pain and swelling at both elbows, both hands, and both knees. Patient also complained of general weakness, fatigue and a fullness or swelling in both ankles. She has been doing physical therapy, is taking tylenol for the pain, and has been on 2 rounds of steroid medrol dose packs. Patients continues to suffer with weakness, fatigue, muscle, joint pain in whole body. We have also contacted the moderna company and was told they could not help us and hand no treatment or other advise for us. We have referred our patient to a Rheumatologist.

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.

Tingling in feet and hands, numbness in feet, loss of balance 2-3 weeks prior to ER visit on 6/12, was admitted to hospital Guillame Barre Syndrome was diagnosis MRI of brain and lumbar Lumbar puncture to confirm high protein IVIG infusion for 5 days

Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel flu-like though. and within the first few hours I had "Moderna arm" - right near the injection site - big red splotch and the arm was sore. The redness in the arm lasted a good week. It was a red blotch but not itchy or swollen. I didn't feel well for a few days after the vaccine. The symptoms came and went as far as how I felt - chills, weak, not feeling terrific for those first few days or so. A month after the second shot, I had a rash on my neck. It came and went - a little itchy and then not itchy. (This happened for a month.) And then at the same time, I felt the same original symptoms - chills and not feeling good. It lasted about three days - the chills and weakness. And then it went away. Even since, April, I get this periodically - I feel weak in the knees, I get the chills and I have to take a Tylenol or something. The middle of May, I was taking off my makeup and I felt a burning on my face (same stuff I've been using for 20 years on my face) red splotch from top of nose and all around and on cheekbones and down the face - it was puffy, swollen, red and caused bags under my eyes and redness under my eyes- and it still is. He gave me a cortisone lotion (my dermatologist) - It's not as red as it was but if I press on it the redness comes back. I have not changed anything with make-up; lotion or food. I have photos of it that I can send of my face. It's still here - maybe not as bright - and I'm not sure that I notice difference using the cortisone cream. It's been a good six weeks since it started on the face.

Hospital Course: In summary this is a 76-year-old female with past medical history significant for hypertension, CKD stage III, chronic dizziness, and glaucoma, who presented to the emergency department on 3/11/2021 due to generalized weakness, slurred speech, and confusion. Patient lives alone and there is no last known well time. Of note patient had reportedly received the Madera COVID-19 vaccine in the days leading up to her presentation. History was limited due to the patient's altered mental status. I was later informed by the patient's son via phone that she just recently received her first Covid vaccination here at Hospital earlier this week. Additional information for Item 18: Due to concern for stroke stroke alert was activated and CT imaging of the head was ordered. However due to patient's agitation this is not able to be performed despite giving a total of 4 mg of IV Ativan. As of this point the decision was made to intubate the patient in the emergency department for imaging and further work-up of her encephalopathy could be performed. Patient was subsequently extubated on 3/12/2021 at which point she was able to report her symptoms started as numbness in her feet and the inability to walk followed by no further recollection until being in the ICU. She reports similar episode on a trip for which no cause was identified. The results of her testing remain inconclusive and did not identify any acute cause for her presentation and therefore working diagnosis was possible TIA versus conversion disorder. Patient was subsequently transferred to the general medical floor on 3/13/2021. Patient seen by me on: 3/11/2021 Assessment: 76-year-old female with a history of hypertension and CKD 3 presents to the ED with altered mental status, apparent time of onset approximately 7:15 PM, unable to answer questions or follow commands Differential diagnosis: CVA, TIA, ACS, electrolyte abnormality, occult infection, metabolic encephalopathy Encephalopaty requiring intubation and intensive care.

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.)

My right leg, hip and groin all hurt all the time, it is very bad pain all the way down that leg. This has been going on since May 23rd, 2021 and is till happening. My dr is having me go to PT soon. Also about three weeks ago I am now having hot flashes.

On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchiness, and muscle pain in both legs starting on 7/6/21, Tuesday night. She took Tylenol around 8pm, which helped. The next day the chills resolved, but she is still experiencing itchy and swollen legs. She tried Cortizone 10 cream and Bactine Max spray, but neither helped. She received her 2nd COVID-19 vaccine on 6/28/21, and she has experienced an allergic reaction when taking Tylenol previously.

on the the day right arm warm was itching, large knot on arm, red and raised up and hot, continued to spread down her arm for the next 7 days, became very weak, unable to eat and very sick for the next 6wks. very weak couldn't get out of bed.

March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital

feels terribly weak; hurt really bad; her arms don't work and hands don't work; hands are tingly and don't work; Inappropriate schedule of vaccine administered; Arm on the injection site was hard; Arm on the injection site was red; Arm on the injection site was swelling; Arm on the injection site hurts and feels like it was hit by a baseball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels terribly weak), PAIN (hurt really bad), HYPOKINESIA (her arms don't work and hands don't work) and PARAESTHESIA (hands are tingly and don't work) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 038B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Arm on the injection site was hard), VACCINATION SITE ERYTHEMA (Arm on the injection site was red), VACCINATION SITE SWELLING (Arm on the injection site was swelling) and VACCINATION SITE PAIN (Arm on the injection site hurts and feels like it was hit by a baseball). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (feels terribly weak) (seriousness criterion hospitalization), PAIN (hurt really bad) (seriousness criterion hospitalization), HYPOKINESIA (her arms don't work and hands don't work) (seriousness criterion hospitalization) and PARAESTHESIA (hands are tingly and don't work) (seriousness criterion hospitalization). The patient was hospitalized from 24-Jun-2021 to 28-Jun-2021 due to ASTHENIA, HYPOKINESIA, PAIN and PARAESTHESIA. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (feels terribly weak), PAIN (hurt really bad), HYPOKINESIA (her arms don't work and hands don't work), PARAESTHESIA (hands are tingly and don't work), VACCINATION SITE INDURATION (Arm on the injection site was hard), VACCINATION SITE ERYTHEMA (Arm on the injection site was red), VACCINATION SITE SWELLING (Arm on the injection site was swelling) and VACCINATION SITE PAIN (Arm on the injection site hurts and feels like it was hit by a baseball) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. During the hospitalization the patient had a MRI, CAT scans, X-rays and sonograms, results were not provided. Patient was discharge to rest at home without an official diagnosis. No concomitant products reported. No treatment medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant follow up appended to AER; document contains new events, hospitalization dates, and lot numbers for suspect product.; 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.

It just seemed like a little soreness in my arm, and then it became bigger like 4 days after, I put a circle on it to keep an eye on it, it kept getting bigger, so I went to the urgent care. They put me on Bactrim twice a day for 10 days.

on 1/22 left arm hurt really bad . Went to doctor because she could not use arm . Had to hold arm in place. Had surgery April 2nd .

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.

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

waited 15 minutes after shot and went Home, next morning got out of bed, legs VERY week from knee to foot , both legs, I always had strong legs.

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

In july 2021 I got the shingles, the pain felt like a short on the right and along the back of neck and on my shoulder like I got a shot on my right arm. It start on my back on the right and rubs and breast . I went to the urgent care twice

My right eye became very painful, hurt and felt scratchy until 12/31/2020. My arm still aches and it is 1/2/2021. I also ache everywhere and still do. I am extrememy tired all the time and at times have to lie down. On going.

Starting same day sore arm, by Tuesday late/Wednesday sore shoulder and knife like pains under left shoulder blade. Pain bad enough Wednesday night/Thursday early morning to contact Dr. Thursday. He determined my pain was muscle pain. Suggested Aleve (as Tylenol and Advil weren't working) and heating pad (which I had used on Wednesday during day). Aleve helped a lot. Pain by today (Sunday) is minimal but still some minimal discomfort.

Within about 10 minutes experienced heart thumping and light headedness. Felt overall as though I was hyperventilating, but breathing was normal. By that evening, I was feeling "not right". By the next morning, started chilling, temp was elevated, over all "sick" feeling. Experienced that until the next afternoon. Arm was very sore (still is, but better). Please note that I had Covid starting November 8, was very ill 2 weeks and continued feeling extreme weakness and fatigue for several weeks after.

Tingling began at 11:12am, one hour after injection. Tingling in both lips. Tingling continued on right side from bottom lip to chin. Tingling not severe, but quite noticeable. Initial sensation lasted ten minutes, then continued for 4 hours slowly dissipating and ending about 3pm.

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.

A lot of pain and redness in arm day of vaccine. It subsided 2 days later. 6 days after vaccine redness and itchiness returned.

Chills, shaking so badly could not stand up to drive home from office, headache, ache over entire body. In bed for 2 days.

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.

chills, fever (more than 24 hours, 100.5-101.5F, ) body pain, weakness, fast pulse Feel very sick. No treatment.

The morning of 1/20/21, I awoke with a very itchy, moderately reddened upper left arm. Reddened, itchy area 3 inches X 5 inches, on outer aspect of L arm in Deltoid area. I was given the vaccination injection within this same area. The symptoms were worse Th. 1/21. Called Dr. He believes it is an allergic reaction. Discomfort continues. Only relieved by cold compress, ice pack.

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

pts daughter states she has severe confusion with slow speech with difficulty speaking and slow movement Also has extreme muscle pain and double vision. Pt had urge to urinate but could not. Pts daughter states she is still having some symptoms but is improving and will see her doctor next week for a regular scheduled appt. Pt started the medicine Cymbalta in November 2020 for her Fibromyalgia but had developed confusion from it so the doctor took her off of it on January 11th 2021 and was doing well until the day of the vaccination.

First covid given 12/23/20 side effects were sore arm. Second Covid given 1/20/21, approx. 18 hrs. after shot: chills, fever 100 degrees. Fever through 1/22.

On 1/24/2021 I noticed that the site of the injection looked bruised and had some red rash around it. The site was warm. By the morning of 1/25/2021, the rash around the site has increased considerably and the site remains warm to touch. I feel slightly clammy but have no fever.

Redness and swelling in site of injection still present 10 days after shot. My arm was sore for a couple of days as expected, no other symptoms following the shot. I began experiencing a headache January 24th and woke during the night sweating. No temperature last night or today.

Symptoms started to show after 6 hours from having vaccine administered. Patient had stiffness (unable to sit back down from standing position), blank stare, depressed breathing and fever. Transferred to ER, seizures were witnessed. IV Keppra was initiated. Patient was discharged after 2 days and followed up with primary care provider in clinic. Primary provider documented that cellulitis is noted in right arm and antibiotic has been initiated.

One week later she woke up with an itchy, sore & red arm. Took Benadryl and the itchiness went away by the next day. The red area is now fading.

Patient reported generalized warmth five minutes after vaccine administration that resolved within 2 minutes. She reported R finger paresthesias about 7 minutes after vaccine administration that resolved within 2 minutes. Patient did not develop any worsening symptoms throughout 15 minute observation period. She remained well appearing throughout and was reportedly asymptomatic upon leaving.

Patient had onset of LEFT arm nodule over her subacromial bursa, associated w/ tenderness, w/ limited active range of motion. This is the contralateral arm to her vaccine administration site.

I received my injection on 1/25/2021 I had my second COVID shot, everything went well, I just had a little pain and swelling and was fine. About 7 hours later i got up from chair and i was dizzy and my balance was off and i almost fell into table. I didn't feel right. I went and sat back down and i was very tired and i started getting headache. I called my daughter and a nurse she knows told me to take extra strength Tylenol 500 mg take 2 every 6 hours. I started at 730 and went until 130. I slept on and off and got up Tuesday and my arm was still hurting. I was very tired and had no energy. When i got up later in the afternoon i had extreme chills. It was 83 degrees in Florida nd i turned heat up to 84 and i was still shaking. I got under covers and had a fever it was 100.8. Went to sleep that night and fever broke. Got up Wednesday and felt a little better, still had headache and tired. Decided to take a shower. I noticed my left arm where the injection was was all red. 6-7 inches long and about 5 inches wide which i never saw before. after shower I called my PCP I contacted the nurse said she thought it was normal and if there was no change to call her back on Friday. my arm is still red and warm i went to sleep but couldn't sleep. I saw an article about COVID arm rash seen after Modern vaccine and now i know that's what I had. I feel better after I read it in the magazine today and it said it will only last a week. This should be listed as a side effect so nobody else wonders what it is. I drank so much water because it said to drink plenty of water and i tried to use arm as much as possible.

After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up and my balance was completely off and I almost fell into glass table. I felt very foggy and my head wasn't right. I had to hold on to things and I sat down and I kept saying I just didn't feel right. I called my daughter and my arm was hurting and I figure that's what happens, I was getting so tired and really bad headaches. My daughter asked somebody and they told me to take extra strength Tylenol (500 mg ) 2 at a time 6 hour intervals. Which i did i got up the next morning and i had to go back to bed i had no energy. I felt horrible. When i did get up in the afternoon all of a sudden i had horrible chills and that day in Florida it was 82 degrees and i put the heat on 84 and i was extremely shaky and cold. I went back to bed and later i did have a fever, not highs, it only went to 100.8 but during the evening it did break because my sheets were almost saturated. Yesterday morning 1/27 Wednesday i felt better, fever had gone down, pain was still there in my arm and swelling. I thought that was natural. In the afternoon i decided to take a shower and i noticed my left arm around the injection site was a red rash about 7inches long and 4-5 inches wide which i had to seen before i called my primary doctor just to make sure this was normal around injection site and talked to the nurse and she thought it was normal. But if there was no changes to call her back on Friday. Last night not able to sleep i saw an article that said COVID arm rash seen after Moderna vaccine, annoying but harmless it was a large article and it made me feel better but there were only 14 examples but they believe there were more because they were younger people with the health dept. that received this vaccine. It said in 1week it should go away. I still have it, its still red and sometimes itchy and i am happy to say now that i know it will be a week i feel better. it should be on the list of side effects for all.

Had Covid vaccine Friday morning, Saturday morning at breakfast started shaking, couldn't talk. Called 911 and treated for TIA. Received blood thinners, had CT scan . MRI, and echo gram on heart. Released from hospital Monday morning, no after effects.

Pt reported feeling like she was going to pass out at around 10pm on 1/26/21 and lowered herself to the floor in her bathroom. Was discovered on the floor around noon, 14 hours later, by staff after noticing her food tray was untouched . Arrived in ED via EMS. Pt was febrile with rectal temp 100.7 c/o weakness. Pt had a WBC count of 11.2, absolute neutrophil 9.9, and creatine kinase 3214. Pt was alert and oriented and reported having been hospitalized for a few weeks in November 2020 with Covid-19 and having received her first dose of covid vaccine at approximately 11:30 on 1/26/21. Hospitalist voiced concerns that this may be a reaction to covid vaccination.

On day 10 arm started turning very red and painful. Redness continues spreading up and down arm until up above shoulder and almost to elbow. To ER on Sunday. Said use Tylenol and cold packs. By next Friday almost all redness gone but upper arm and shoulder are now very painful. No issues with arm until day 10

Large 3? diameter rash, very red, itchy, tiredness - it is now 3 days later rash is lighter in color, arm tender, not itchy, still feeling tired.

Within 2 hours of receiving vaccine I began feeling achy and cold; within the next two hours was experiencing hard chills, fever of 101.7; muscle aches and pain. This lasted 33 hours; chills stopped, aches lessened and fever began dropping. By 40 hours after shot temp was normal, no chills or body aches. At 44 hours after event, am back to normal.

Slight sore arm for 3 days, but then on the 8th day intense itching and very hot. It is now Jan 30, 2021 and the area is still itching, tho less, and is still hot. There is a 1/4" wide reddish ring in a circle of about a 3" diameter around the shot site. Today I put a cold compress on it and was surprised that as soon as I took it off after about 10 minutes it was still hot. I am worried about having the 2nd shot in the same place.

Flat red rash developed around vaccination site 8 days after inoculation. Not itchy or painful at this point, feels warm. After inoculation only minor arm soreness for 2 days. Putting Aquaphor Healing Ointment on. Already take nightly small dosage of Atarax generic.

Day 1 and 2 ...sore arm. Nothing until Day 8. On Day 8 a light pink splotch ( 3inX2in) at site if injection. VERY itchy and a bit swollen.

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)

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.

Patient felt weak, dizzy, and faint. EMS was contacted. EMS transported patient in stable condition to the ED for further evaluation and treatment. No airway or other life threats were identified.

Upper right arm became swollen, red and painfull 10 days after the shot was given. Went to urgent care doctor and was told there was an infection from the shot or a reaction from the shot. Doctor gave my an injection of Rocephin 1g IM. I was prescribed 500MG of Keflex PO 3 times per day. Symtoms got worce and went back to primary care doctor. Doctor stated that I should continue with the same treatment and return for further tests if the condition did not get better.

Erythematous rash with mild pain and itching developed to upper arm, vaccinated arm, starting one week after vaccination.

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.

Patient arrived at shot table in TCPH w/c, short of breath. Taken straight back to private observation from shot table. EMT on site in attendance. Upon assessment; patient having suprasternal, substernal, intercostal retractions. Patient on home O2 at 2 L/M per NC. Per EMT auscultation patient has inspiratory and expiratory wheezing. Patient has a loose congested cough. Pt's nail beds dusky, no blanching. Hands are cold. Unable to initially obtain O2 sat reading. Patient does not have inhalers with her. Pt. can't recall names of meds. 9:30 BP 132/62; HR 68 strong and regular per palpation. RR 30. 9:40 O2 sat 82% after hands warmed. Patient increased her own O2 to 3 L/m . EMS activated 9:45 O2 sat 84% with 3 L/m per NC. Still having deep retractions. 9:50 EMS arrived along with FWFD. Patient alert/oriented x 4, still labored breathing. Patient denies feeling badly. Med star team evaluating. 0957 O2 97% on 3 l/m per nc. HR 72; BP 104/58; ETCO2 41 1007 O2 97% on 3 L/m per NC; ETCO2 43; HR 112; BP 96/56. EMS recommends transport. Patient refused. Pt. states she will go home and take her own nebulizer treatment. Patient called brother for ride Patient left AMA, patient remains A/O x 4, taken via w/c to brother's car for transport home.

A few hours after receiving the vaccine my arm started to become sore. On 01/28/2021 my arm started to become pink and very itchy. The next couple of days it remained very itchy, started light pink and got pinker never got really red color. On Sunday 31st in the morning it looked normal but later in the day it got pink again. Yesterday and today it is fine besides it is itchy. I have not been scratching it. One day I put some Benadryl cream on it one time.

Sudden onset in the evening of Feb 1 (17 days after initial dose)--chills, fever, headache, muscle ache, discomfort in upper chest and jaw. Temperature 100.1 which is about three degrees above my normal temp. Night sweats. Following day, malaise, headache, and discomfort when inhaling a full breath. Night sweats again. Today, much better. Able to breath fully without discomfort, not muscle aches or headache, but tired feeling.

No problem with discomfort after shot, just a little sore arm for a day. No flu symptoms. Eight days after the shot, however, my right arm started to itch in the morning, and by nighttime, the shot site was no longer itchy but swollen, red, and hot. I applied ice treatment which helped relieve the heat and swelling. Today, my arm is much better. I still have a slight swelling with a light redness around the shot site, but no discomfort, no heat. I reported this delayed reaction to the shot to my doctor?s office, and they referred me to you to report my experience since they thought it was an unusual reaction.

Pt. rptd. on 02/01/2021 having severe body aches, fatigue, inability to taste, (R) arm achy swollen & red "looked like bite mark", & itchy rash allover body Pt. declined injection of solumedrol benadryl or treatment. Wrote script for hydroxyzine 10mg tab, po, 1tab TID, prn. Tylenol (acetaminophen) 500mg 2tab po q8hrs prn. for body aches. Called 02/02/2021 to check on pt and no answer. Left vm.

Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pressure spike, dizziness, heart palpations, ear ringing, dry mouth, weakness and trembly, visual aura with eyes closed of red ball in field of vision, some pain at temple as if migraine tho I only have had migraines in first trimesters of pregnancy, adolescence and at time of diagnosis of hyperthyroidism. Have had blood pressure brief spikes in past (possible tyramine sensitivity) but this persisted rather than momentary. Live alone and was at home so called Ambulance. Took over 12 minutes for ER to come after called when symptoms did not quickly resolve. Was still having symptoms though blood pressure had dropped to

On January 29, my arm swelled, turned red, was hot and sore. Lasted till February 2. Took photos. Patch was 4" long and 1-1/2" wide

2/1/21 sore arm 2/2/21 sore arm and itchy rash at site 2/3/21 sore arm and very itchy rash at site that became raised and redder 2/4/21 still have rash and soreness

Pt has a hx of seizure disorder. Vaccine given at 0942. Seizure started at approximately 0944 and lasted until 0948. Patient was unable to converse- was attempting. It lasted approximately 4-5 minutes. Her partner was with us and assured us she was okay and did not need medical tx. She states vaccines can "sometimes shock system" but it had been a long time since she had a seizure. Second seizure occurred at 10:10 and occurred for approximately 3 minutes. Patient states she took her medication: Lamictal 150mg BID for her seizures. Partner states that seizures can be normal for her and declined need for ambulance.

unknown if it was moderna or pfizer. Vaccine administered elsewhere so details are not known to me. Pt received vaccine on Friday and was admitted to hospital Sunday 1/17 with CVA, right sided weakness.

an extremely itchy, red, sore, slightly swollen patch on my upper left arm (but not the exact site of the injection) about 2" x 1". So far, symptoms have subsided after 22 hours except for redness.

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

flushing, lightheadedness, increased confusion, significant increase in weakness resulting in a fall twice.

Pt received 1st dose of moderna covid vaccine at 0942. At 0953, pt reported feeling hot and eyes feeling funny. Moved to exam room. BP185/82, pulse 70, o2 94% on 4l/nc (pt on home o2 at same flowrate). Reported "spots" in eyes. Spots and hot feeling resolved by 1008. Pt reported jaw stiffness at 1008, states feels similar to when she sits for a long time. Dr notified and benadryl given per order. Continued to monitor patient. At 1047, pt reported that jaw felt "tired", no other c/o. 1101-Dr updated on pt condition, Dr stated that patient may be discharged to home with husband and may receive 2nd dose of vaccine, but should take benadryl prior to appointment. Vital signs remained stable, bp 173/73, pulse 71, SpO2 91% on 4l/nc at discharge.

Left arm pain starting the day after administration, progressed to redness and swelling and has continued to worsen over 10 days. No improvement over that time. Has no fever or oozing at site. Has not had any treatments.

Numbness, facial paralysis- Diagnosed with Bell?s Palsy. Treatment Oral Steroids, Eye drops, Speech Therapy, Accupuncture.

patient arm was red, swollen, and warm to the touch. Injection site was hard to the touch. Symptoms started the evening of shot and continued the next few days. As of today, (2-9-21), she still had symptoms as stated above but stated she was improving. She also stated that she was going to the Dr. today for an unrelated issue and would get them to look at her arm.

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

Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and soreness of whole left side of body. Body aches and tiredness

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.

Minimal soreness in arm; nothing more immediately after vaccination Day 5: rash on right leg below knee, no itchiness. Day 8: injection arm red very, very, itchy rash; also rash om left leg below knee, not itchy

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.

I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.

On 01-25-2021, I started to experience left arm soreness. I felt like my left arm was going to "drop-off" with extremely pain. I also had a high fever, was extreme cold, was disoriented, felt my brain foggy and these symptoms lasted up until 3AM. I also felt extremely fatigued. By Friday 01-29-2021, I was getting back to normal.

Patient stated she was having some flushness in the face and some itching. No swelling, tongue swelling, fever, or headaches. No trouble breathing. Patient has had anaphylactic reactions before and stated this was not a repeat of that. Just mainly the itching and she described it as a "cortisol flush".

I was sleeping, then woke up and my whole body felt numb. I got up to go to the bathroom and fainted. I fell on the floor and got a bloody nose, cut lip and cut and bump on my head. I had stiff neck for a week afterward.

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

Tingling in the tip of my tongue as well as in all fingertips. Took two Benadryl within a half-hour of the injection. The tingling disappeared in the fingertips, but my tongue, although no longer tingling, still feels sore and irritated almost two weeks after the injection. As far as I can tell, no swelling involved. Also still experiencing tiredness.

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.

weak arm/pain/couldn't move, chills, fever, headache, lips swollen, face pain when touching, huge pouch under eyes/cheeks sore, hoarse

Pain in left shoulder, then pain moved to include muscle from shoulder to near the base of my neck. As of this date, the pain is somewhat less but still is painful enough that I am taking Ibuprofen several times each day.

Patient received vaccine on 2/5. We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit. She was sent home. Daughter found her on 2/6 or 2/ 7 unresponsive and she died.

Caller states she had her covid vaccine at 11:30 am, this morning. Approx 4:00 pm , noted a small burning area on left side of her chin. Denies any respiratory distress or swelling. Instructed to put cold compreses to face and call PCP if condition worsens. RN

This event , because so many elderly people have the fillers in their knees should be widely publicized! We have fillers that help so much to be able to walk without pain, but this vaccine has caused me to have extreme pain and burning and not be able to walk without pain for 4 days now. NO ONE has said anything about how this Moderna vaccine would affect us because of the Hyaronolic Acid injections to our knees. We should have been allowed to get Pfizer!!!! I am so upset about this and extremely disappointed in our government's lack of disclosure.

Because of reaction on the first shot, when I got home after getting second shot I took a Benadryl. In the early afternoon I began to feel shortness of breath, breathing not normal and it steadily increased towards early evening when I took 2 more Benadryl which then quieted down the breathing reaction. Also that day I experienced a sore arm. The next day, breathing problems were almost all gone but decided to take 1 more Benadryl. During the day I felt flu like symptoms. The third day I feel like myself again.

The evening of the vaccine started with fast heart beat, was unable to get to sleep as her heart was beating fast and she was breathing fast. She has a sore arm with a slight redness. They lasted over night and then resolved. All these symptoms have resolved.

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.

Patient received her second dose of the COVID-19 vaccine from Moderna. Patient tolerated the first dose well, but her second dose on 02/12/2021 caused some adverse reactions. She experienced injection site pain, itching along her upper arm, fatigue, a low-grade fever, and facial flushing that lasted about 4 days with only mild relief from OTC ibuprofen. Recommended OTC acetaminophen to the patient and to report to her PCP for follow-up.

pain in left arm same day and a week later on Feb 11, 2021 during the evening an itchy rash on the left side of her neck . The itchiness last 3 days but the rash still minimally presents.

summary of her symptoms: 1 hr post vaccination - feeling tired and sneezing excessively for a couple of days. 3rd day post vaccination-skin tingling sensation all over that resolved with oatmeal bath. 5th day post vaccination-was seen by pcp who told she was fine. received a call from pa from office to inform her she had an allergic rxn and was not to receive the second vaccine. today-she is asymptomatic.

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.

1st reaction was sore arm for 2 days. Sire to touch and achy. Week later. Arm red and hot for a few days. Next week arm sore and burning. Tingling, pins and needles, burning in random parts of body Arm, leg, face , back. Head. Every part was hit. The last two have continues through today almost 5 weeks after my shot. Went for second shot and they suggested I wait a little longer. Right now I am afraid to have second shot.

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

Patient received vaccine @ 1315. At approx 1325 patient showed signs of seizure activity and possible anaph. Patient was laid down flat At 1335 patient was given Epi in (L) thigh and 911 was called. Ambulance showed up at 1345 and patient was taken to hospital. Epi lot# 0FM498 Exp. 05/2022

PATIENT STARTED TO HAVE SEIZURE WHILE SHE WAS IN HER WHEELCHAIR ABOUT 10 MINUTES AFTER HER VACCINATION. PATIENT'S DAUGHTER AND I WERE WITH HER WHILE SHE WAS HAVING SEIZURE. SHE WAS AWARE WHAT WAS GOING ON BUT HER BODY WAS SPASMING. SHE DID NOT HIT HER HEAD AS SHE WAS IN HER CHAIR AND DAUGHTER ASKED US NOT TO CALL AMBULENCE (OFFERED TO CALL RIGHT AWAY) AS HER SEIZURES USUALLY PASS AFTER A FEW MINUTES. AFTER A FEW MINUTES (PATIENT WAS SITTING WHOLE TIME), SEIZURE PASSED AND HER BODY WAS NOT SPASMING, PATIENT STAYED FOR ADDITIONAL 20 MINUTES TO BE MONITORED IN CASE ANYTHING HAPPENED. NO TREATMENT WAS GIVEN EXCEPT GIVING PATIENT WATER (PATIENT HAS HISTORY OF LYMPHOMA, SEIZURES (ON MEDICATION FOR IT PER DAUGHTER)). AFTER 30 MINUTES, PATIENT RECOVERED AND WAS BACK TO NON-SEIZURE STATE. DAUGHTER STATED IT WAS FINE TO LEAVE AND NO ADDITIONAL HELP WAS NEEDED AND PATIENT WITH DAUGHTER LEFT.

Initially, chills which has resolved. Now experiencing sensation, warm to touch, redness and inflammation to injection site (right arm)

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.

COVID-19 VACCINE EUA; MY ARM SWELLED REAL BAD TURNED A DEEP RED, VERY PAINFUL, AND AS OF YESTERDAY 02/16/2021 HAD PURPLE SPOTS.

The following day she was sitting on her loveseat and she just slid down to the floor, and could not get up. She had no strength at all in any of her extremities which lasted all day, from 10:00 AM to 6:00 PM. Her daughter called and she informed her that she could not get up, and wiggled herself through the house and pulled herself up by the hand of her granddaughter to help her. It then resolved and she has not had any other problems. Her arm did hurt for about a week and sore to the touch, but wanted to report that she had the extreme weakness. She did not consult her doctor, cannot get through to them, been trying for 3 days.

I received my injection on Thursday at 2:00 PM. Upon waking the next day, around 8AM, Friday, I had a bad headache, body aches, weakness, could not get warm. I laid on the couch all day and didn't eat anything until 4 in the afternoon, a little soup. Later in the day I got a fever and was so weak I could barely walk, I fell when trying to get up, fortunately I fell onto the couch, I made it to the bed and didn't get up until about 8 the next day. Saturday. I felt much better then but am still weak.

2/19/2021 - 8:50AM - severe PAIN IN Back OF NECK AND ACROSS SHOLDERS, SHORTNeSS of BREATH.CHCKED B/P - 85/67. DRANK COLD WATER + LAID on COUCH - subsided in about 10min. 9:00AM - SEVeRe PAIN + MUSCLE CRAMPS, BOTH Legs, fROM knees to toes, couldn't stand up, crying with pain, leaned on walls to get to where husband was, He massaged it with Theraworx ~ 15min, got to wALK then. Exhausted NOW, Drinking a lot of fluids. 8:00am earlier syMPTOMS = Headache, PAiN IN LefT ARM, SLuggish

She developed arm pain, redness & swelling at injection site which lasted for 5 days. 5 inches across area. Pain intense. It reoccurred again at day 10 with more redness, swelling & pain for 4 more days. Went away after about 3 days. Reoccurred with soreness on 22nd day, but this time with some soreness also in right inner wrist. No fever, headaches, or chills. Synopsis- arm pain soreness, redness & swelling off & on for over 3 weeks post vaccination

I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back of the head. My head and neck and mouth and face were in excruciating pain.

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.

Acute nontraumatic pain in neck, left side, and upper left extemity(shoulder). Acute left cervical lymphadenitis. Still have discomfort in shoulder blade, some swelling yet of lymph node. Tingling in two fingers on left arm, had swelling over same two knuckles but that has receded just have like my hand is asleep, more at night time. Fullness feeling inside of arm at bend, vein area. Injection site is high - about 1 1/2 fingers down. Have had no x-rays or tests. Went to Urgent Care - prescribed Predisone for 5 days - no help. Nec k, now, has less swelling. Mom

bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken

Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on 2/24/2021

Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; 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 shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later. On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion. On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.

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.

Patient had swollen injection arm, red rash and chills for 7 days following administration. Also had pain in calves and ankles

pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200

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.

Moderna COVID19 Vaccine EUA I received the first injection on Feb. 13, 11:00. Because I am very thin, I wasn't too worried when my arm was sore for a couple of days, but on the 6th day, I was awakened at night with an intense itch at the injection site, and in the morning I saw an egg-shaped and egg-sized bright red area and it was swollen. I contacted my doctor on line, and she recommended hydrocortisone cream and Benadryl, which I have been doing for three days. The red patch has calmed down to light pink, but it's still sore and a bit swollen. It's been two weeks since the injection and I'm scheduled for the second injection on March 13. I'm concerned that the reaction will be worse next time.

Normal redness and soreness at vaccination site for the first few days then a 3? circle appeared at the site on the 7th day and caused itch and soreness. It is now fading away with no after effects

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.

11 hours after the vaccination I felt achy all over, my legs felt limp and lump on my arm was sore. Temperature measured 98.6. I took two Tylenol and went to bed. I got up two times during the night to go to bathroom. I felt more achy all over and unsteady on my feet. Did not want to get out of bed next day, so slept until noon. At noon my temperature was 100.4. I took 2 Tylenol every 6 hours. Had a very achy, miserable day and just rested. Was somewhat better by bedtime and had a better next night of sleep. Next day am still achy but much better.

Very Sore arm, Bad headache, Muscle Soreness, especially in right hip and right shoulder. Arm better in the morning after, but headache lingers. Muscle pain a little less by 11:00 a.m.

Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain.

4x4" area increasing to 3x6" red with circle changing to mostly red. Warm. Swollen. From slightly painful first 2 days to just a little itchy by 5 day- today. Painful arm a few hours after injection, which mostly ebbed, with the redness starting about 7-8 days after injection, becoming somewhat tender, with that ebbing by 5 day. On third day ( 8 days after vaccine) Urgent care diagnosed it as a seondary infection and prescribed doxycycline. Dr. said had never seen anything like it. Took the antibiotic for 2 days and stopped. Med seemed to make no difference.

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.

3 days after vaccine i got a Horrible rash from my neck all the way down to my thighs, and its red with fire. its covers my back and arms, everywhere. Went to Patient First and was given prednisone and told to take Benadryl but not helping .

Chills, fever, weakness, aching for about 36 hours, Sore, painful arm, then 3 days post injection, swollen area covering a 2-3 inch on arm with severe itching, redness lasted about 2 days.

Client reported "weird" taste in mouth, Tingling lips & Rt. hand tingling @ 1215 pm. BP 162/78 @ 1225 pm. BP @ 1235 pm 168/78 @ 1245 pm 166/78, @ 1255 pm 158/70, @ 105 pm 155/70. Monitored client for worsening symptoms. Symptoms remain unchanged. Team lead called FNP. Verbal order for Benadryl 50mg IM. Benadryl 50mg given in Lt. thigh. Symptoms subsided. Continued

c/o lower bilateral arm pain and shaking of arms. Arms did not shake when on her lap. Denied chest pain or SOB .

I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to the point that all I wanted to do was sleep. So I went to bed, but just as I would be close to falling asleep I'd have to get up to empty my bladder. This was happening almost every 15 minutes for a few hours. I knew I probably should hydrate, but I chose not to because I wanted to get some uninterrupted sleep which I finally did at about 4:00am which only lasted a couple of hours. Then up at about 6:30am when I took some acetaminophin and went back to sleep. I was in bed all day, sleeping most of the time. When I'd wake up I'd take my temperature and most of the time I'd hydrate. I haven't had anything to eat because I wasn't feeling strong enough to even heat water for soup. My normal temperature is about 97.6 give or take. The highest temperature I had was 100 when I took another dose of acetaminophin. But one time it was 94.3!!! I started feeling better at about 8:30pm (3/1/21) and was able to make myself some chicken noodle soup and had some cereal and cottage cheese with it. I finally felt "normal" on Tuesday morning (3/2/21) after getting a good night's sleep.

6 inch red raised red patch that itched and pained so far for 5 days. It is not at site of injection but in the inner crease of my elbow. I used ice and benydrel.

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.

soarness of arm and discoloration at injection site, pain radiating through back of shoulder/neck to elbow. Self care at home

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

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

Patient presented to ED after ground-level fall. Patient appears to have not lost consciousness or pulses. PT/OT attributed fall to generalized weakness and ambulation due to chronic deconditioning. Patient to follow up with neurology for further management of severe dementia. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

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.

Patient during routine observation a flag for 30 minutes began to feel sweaty, hot flash sensation and began tohyperventilate. Patient was identified by observation staff as follows: Awake x3, no chest pain, slight SOB, increased work of breathing without rales, rhonchi or wheeze. Pulses strong, capillary refill at 2 seconds, warm and dry. Patient is hyperventilation state without carpal spasms. Patient placed on pulse ox at 98% room air, pulse 88 and BP 174/84. No rash or hives, - supportive treatment - Refused additional treatment

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.

Received vaccine on 2/17/2021 at the healthcare facility. States about 6 days later on 2/23/21, her L arm became extremely sore, itchy and swollen. Also, looked severely bruised from just above the site the vaccine was given down below the elbow. Saw MD on 2/24/21. Reports taking Plavix and doctor told her the Plavix could be a contributing factor to the severity of the bruising. MD advised pt. that the pain to the L arm and the bruising was likely related to the COVID-19 vaccine.

Pain tenderness swelling Left ankle(fasciitis) Unable to walk for one month bec of pain on stretching ankle. Other :muscle aches , joint pains for 48 hours

On 3/1/21 at 11:00 AM I received my second dose of the vaccine Moderna. I was fine all throughout the rest of the day. Upon awakening early on the morning of the second, I had moderate aching in all joints, headache, weakness and fatigue. I stayed quiet for day. Upon getting ready to shower on the morning of the 3rd I found I was covered with an angry bright red rash from my neck down to my knees both front and back. Because I did not shower on the 2nd of March I have no idea when it began. On Thursday my head still felt pressure but felt a little stronger and that evening I again showered and the rash looked less angry and bright. Waking this morning on Friday the 5th the rash is gone and I am feeling much better except for soreness in the armpit of the right arm that received the injection.

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

2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of face; 2-21 - tired, tingling along jaw line; 2-24-21 - sniffles,intense tingliness on and under tongue, feeling of numb lips; 2-25-21 numb lips - called Facility, talked with advise nurse: 2-26-21 swollen gland, slight headache. Video visit with Dr,; She said if symptoms continued for another week to call back and that an MRI might be considered. . Symptoms of tingling, sense of numb lips primarily on left side have continued daily through today 3-5-21. Called advise nurse today and am waiting for a call back from Facility.

Approximately 10 minutes after second dose injection client experienced weakness in both arms and light headed in the 30 minute monitoring lot. The EMT on site was summoned to car: B/P 189/86, HR 80, SPo2 100%. Client reported to EMT, tingling hands, and chest pressure. No respiratory symptoms reported. Client was transferred to local hospital to monitor for symptom. No medications were administered in ambulance nor at the hospital ER per client report

After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd dose on 2/25/21, pain at shot site, redness & swelling. On 2/26/21, heavy chills, short of breath, face flushed, temp 98. Pain in low back & right upper arm (torn ligaments). Pain more severe than previously. 2/27/21 Shot site sore, itchy, red, swollen, short of breath, headache. Heavy chills towards evening. 2/28/21, Light pain at shot site, site swollen, warm to touch, labored breathing. Shakey, anxious, doom & gloom, food seems tasteless. Evening feeling better, swelling down, flashes if left eye. 3/1/21 arm itchy, no swelling, arm aches slightly. Pain in low back severe, right arm pain. There was only 26 days between the two doses. The pain in back may be from scoliosis. Pain in right arm, torn ligaments. But after receiving vaccine, these pains increased tremendously, as well as the shortness of breath and extreme groin pain (maybe from fibroids?).

Moderna COVID-19 Vaccine EUA Freezing cold, headache, arm swollen & hurt, fever, dizzy, Memory loss, chest pain, fatigue. No treatment. These symptoms lasted 4 days. (not all at once)

IMMUNIZATION CLINIC NOTES: 77 y.o. female presented to Elementary School for second dose of COVID-19 vaccine. No known allergies. Patient reports history of hypertension, being treated with amlodipine. No history of asthma, COPD, use of inhaler for any conditions, or recent respiratory illness. Patient is a non-smoker. First dose of vaccine, Lot # 039K20A, administered on 2/6/2021 and patient reported no immediate symptoms during observation period after first dose. Second dose of vaccine, Lot# 013A21A, was administered on 3/5/2021 at 10:52AM to the left deltoid. Approximately 5 minutes after receiving second dose, patient reported feeling anxious and feeling like her blood pressure was increasing. Patient taken to EMS observation area. Patient observed by EMS. Nurse assessed patient at 11:23AM. Patient was alert and oriented x 4. Manual blood pressure was 196/86. Pulse, manually palpated, was 86 and strong. SpO2 99% on room air. Patient with flushing. No generalized hives. No itching. No swelling of face, lips, or eyes. Left deltoid injection site without erythema or swelling. Skin warm and dry. Lungs auscultated and inspiratory wheeze noted in all lung fields. No shortness of breath. No cough. No nasal congestion. No change in voice. No sensation of throat closing. No stridor. No dizziness or syncope. No GI symptoms. Patient experiencing skin and respiratory symptoms. RN was asked to assess patient?s respiratory symptoms and also noted bilateral wheeze. Patient?s symptoms post-vaccination involved more than one body system, skin and respiratory. Reviewed symptoms and standing order procedures with patient. Standing order for Medical Management of Vaccine Reactions in Adults in a Community Setting was followed. Patient was assisted to stretcher by EMS. 0.3mg epinephrine auto injector, Lot # G191202X Exp. 4/2021, was administered to the right outer thigh on 3/5/2021 at 11:39AM by RN. Patient was then transported by EMS to Medical Center. EMERGENCY DEPARTMENT COURSE AND TREATMENT NOTE: Patient's condition remained stable during Emergency Department evaluation. Decision made to obtain prior medical records. (+)Prior records reviewed. There is low suspicion for an allergic reaction given symptoms. Patient is well appearing with a normal exam. Plan to monitor. 03/05/2021 13:13 Patient remains well appearing will discharge home.

After receiving the 2nd dose of COVID vaccine become very tired, exhausted, low energy and soreness in the left arm, even a month later.

Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21; used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.

red hurting itch rash on L arm of vaccination site, changed to triangle shape day and 2 weeks after, still having pain and lost range of motion in that arm, ongoing 1 week red hurting itchy rash on R butt cheek, then on both butt cheeks 2 weeks after, took Zyrtec 3 day and tar cream RX by Dermatologist, clearing up

lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bigeminy, atrial tachycardia, fever 101, chills, myalgias, arthralgias, headache, right arm pain

My reaction was very mild. I received my shot at 1:30. By late afternoon I felt a little wimpy - maybe like I might be catching something. The feeling continued through the evening. I took an Aleve before going to bed. The next couple days my arm was slightly sore, but no other reminders of having received the vaccination.

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

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.

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.

I am starting this report with the current status of my, nearly, 6-week ordeal of agonizing pain, doctor appts. debilitation, pain meds, a blood test and the final MRI — this past Saturday, 3/6. Finally, an MRI has confirmed physician's recent suspicion that my second Moderna vaccination was improperly administered. In fact, it tore a tendon in my right shoulder. I knew something was wrong when I saw how high the needle was injected into my arm/shoulder. I just didn't know what the ramifications would be. I have been referred to a surgeon, and my appt. is 3/16). Summary of Events: On 2/1/21, I received my second dose of the Moderna vaccine and had 2 days of moderate pain and soreness. But about 3 days later, 2/4, I awoke to excruciating shoulder/arm pain that had me sobbing out loud. I took Tylenol and waited. Nothing. I took more Tylenol and slowly the pain diminished. For an hour or so. All I could do was lie on the couch, literally, groaning and unable to lift my arm By evening, the only relief I could get was from an old (hip surgery) Oxycodone pill. I took 1/4 piece and slept the night. Friday and Saturday I was totally debilitated. I couldn't lift my arm, care for my dog or do anything but lie on the couch, still sobbing, until small pieces of the Oxy set in again. It was the weekend, and I didn't want to bother anyone but I never felt such pain for such an extended time or survived so long on meds. Monday morning, 2/8/21, I called my Doctor. I was very concerned and really wanted to make sure this pain was still from the vaccine and not some "weird" condition that might have hit me. The office told me the pain was probably from the vaccine and advised me to keep taking Tylenol. So it continued, on and off, relief and agony. I was sure it would stop. It didn't. Thursday, 2/11, I saw the Doctor, in person. Physician did not have an answer for the pain but gave me a prescription for Celebrex and did a blood test to see if there was a bacteria infection that might have invaded the area. We would wait for results. Another weekend of pain but lessened a bit. Around 2/13, a neighbor called me with an article he found about the SAME situation MANY people were suffering (thousands) and LAWSUITS pending!! I didn't know what was happening to me but the Gov't did. The article was found on internet, 2/12, and printed an article from news paper, 2/12 No other reports appeared anywhere. The pertinent findings of the article: thousands of vaccinated people (Covid and flu) have reported similar pain and debilitation. The previous gov't has introduced a law prohibiting lawsuits (l think against the pharmas but not the administering agencies. Not sure.) that was to go into effect, 2/23. Again, not sure of details. But no one knows about this - people NEED to know. I immediately notified my family and close friend about my situation. While the cause is not certain, it is suspected that improper injection technique/training/experience is to blame. To get the word out, I posted on social media, wrote representatives, etc. And now I found you. The information must be made available; not to stop vaccinations but to alert the public if they occur.

patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.

First 6 hours post injection: localized redness RT. deltoid. Next 25 hours: febrile 101.2 to 102.6, joint pain knees & hips, muscle pain, extreme fatigued. On Day 2: same symptoms for next 10 hours. Very similar to full-blown flu symptomatology. This event was followed 18 hours later by a sore throat & signs/symptoms of a head-cold & sinusitis, thought to be viral (clear mucous from nasopharyngeal area. Weakness & significant fatigue continues; saw my physician?s Nurse-Practitioner: mow on Ampicillin/ clavulanate 825/125 mg.

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.

I was extremely tired the day after, and continued to be tired with gradual improvement over a few days. But I have not recovered my previous level of energy, which was already very, very low because of longstanding chronic fatigue syndrome. My persistent vertigo (since 1989) is also worse than it was, and continues so after 2 weeks from date of first shot.

chills alternating with hot spells at night painful injection site headache for several days generalize fatigue

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

Immediately, sharp shooting pain from injection site ( the back of my arm, not the middle) when all the way down my arm and was severe in my pulse side of my wrist. I reported it. The pain resolve mostly after 30 minutes. Either Feb. 28 or March 1 woke up with my left eye being red from broken blood vessel. March 3, slight burning with urination. 1X March 4 no burning until about 4:30 pm, and then also much blood. 15 minutes later, the same.

chills, fever, headache, joint pain all over, red swollen arm with severe pain starting morning after injection and continuing for 2 day. Arm still red swolen, sor to the touch and hot to the touch

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.

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.

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.

Ache in back of left leg. Thought it was a muscle strain from working in yard. Did not go away so went to Clinic February 2nd, 2021. They asked me my symptoms and then sent me for a Sonagram and discovered a DVT and later a Pulmonary Embolism in my right lower lung. I am now on Eliquis.

Patient developd worsening congestion and new weakness, fatigue, shakiness days 1-6 after vaccine administration. Patient was evaluated at healthcare facility on 3/15/21 with elevated blood pressure of 200-246/80-90 and sent to emergency room via 911/EMS activation. HR 99-108, Pulse ox 94-97% room air. BP 200-246/80-90

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.

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."

Patient states that she experienced pain in her left arm within hours of the injection; she went to bed that evening with increased arm pain and generalized body aches; patient denies taking any pain meds or any type of treatment for the pain. Patient states she slept well but 'knew her arm was in pain. The morning of 02/23/2021 patient awoke as usual but said she was still in extreme pain and felt her vertigo beginning. She did not take any of her vertigo medication. The last memory she has at home that morning was walking into the bathroom. her next memory was being in a helicopter. Patient reports that when she lost consciousness in the bathroom, she fell and sustained a head trauma. her husband called an ambulance that transported her to Medical Center; she was then air lifted to Hospital. Patient states she spent 10 days in ICU to treat an intracranial bleed. She is now in a rehab facility and expects to be there for 2 weeks before being discharged to home.

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.

13 min post vaccine pt became unresponsive to verbal and uncomfortable stimuli. Pt slumping in chair with right side facial drooping . Pt began to respond in approx 3 minutes with confusion and not recalling events of prior 3 min. Pt with max assist placed in wheelchair and paramedics called. RR. Low teens B/P 150/88 Per family pt had same episode yesterday

She started with left leg jerking. then it was right arm jerking. Then all legs and arms jerking for about 10 seconds She said her eyes felt like a bright light

One week after injection, my arm was swollen with a rash and pain up to my shoulder. It is still painful to use my arm and shoulder. I have had Rotator Cuff repair twice on Rt. Shoulder and the pain I feel there is like it is in my rotator cuff. I cannot lift my arm up above my waist without feeling the pain. When I do not use my arm, there is not pain. I do not have a rash any longer but feel there must be swelling in the shoulder. Ocassionally I have some itching in injection area but try not to scratch at all.

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.

One of her eyes and mouth were dropping a little bit/Bell's palsy; Broken out with fever blisters; Rash and itching all over the trunk; Itching all over the trunk; A spontaneous report was received from a patient's spouse in the concerning a 77-year-old female patient who experienced one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus and broke out with fever blisters/database: oral herpes. The patient's medical history was not reported. Concomitant medications included metoprolol, lisinopril, acetylsalicylic acid, omeprazole rabeprazole sodium, vitamin D, duloxetine, folic acid, vitamin A, balofloxacin, vitamin B12 and amlodipine. On 25-Feb-2021, one day before the start of symptoms, this patient received the planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 012A21A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection. On 26-Feb-2021, the patient developed a rash and itching all over the trunk. The events resolved on 27-Feb-2021. On 28-Feb-2021 the husband noticed one of the patient's eyes and her mouth were drooping a little bit. He took her to the ER (Emergency Room) because he thought she was having a stoke. She had also broken out with fever blisters. They ran tests NOS and everything was normal. The treating Physician said it was Bell's palsy and it was due to the vaccination. The events were treated with prednisone 15 mg and valacyclovir 1 gram. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the events, one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis and broke out with fever blisters/database: oral herpes is unknown. The outcome for the events, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus is recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

After receiving her second vaccine shot, while in the observation area approximately 20 minutes after recieving the shot, patient became light headed and dizzy. Firefighter / EMT assessed vitals and reported that pt had high blood pressure and a rapid pulse. Chief / Paramedic spoke with pt also. Based upon her continued symptoms and no resolution of the dizzy feeling, an ambulance was summoned and pt was moved to a less crowded location for further observation. She walked with assistance to the kitchen in the fire station due to her dizziness. Lt. completed patient assessment while FF gathered vitals. EMS personnel recorded that pt had no medical history, no medications, and was allergic to penicillin. Patient continued to feel cold and light headed. Ambulance arrived and patient care was transferred to the medics. Medics then transported the female to hospital.

Allergic reaction with bright redness and swelling of face, tingling, itching and swelling of tongue, mouth, gums, tingling, heat and itching in hands and fingers, feet,insoles, between toes, in crook of arms, behind knees, itchy eyes, ears, scalp, increased itching throughout body

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.

extreme pain under arm the night of shot lasting 12 hours itchy rash on same arm 2 days later bruising(red discoloration) on same side of body 4 days after shot additional bruising approaching area of breast 5 days after shot sore nipple on breast 5 days after shot

2-3 WEEKs after receiving vaccine...pain in right foot (rheumatoid arthritis) sore and weak all over, tired-lethargic on 3/19- woke up, sat at edge of bed to text daughter, got up walking to bathroom, got dizzy and collapsed = passed out. Got up and again collapsed passed out =don't remember it happening .... Went to ER for fall and analysis as to what , why, etc. I would be having this acute autoimmune reaction... blood work etc. you can contact the LWRM and Dr for details.

orbital swelling; redness; itchy in her face; urticaria; prickly feeling; 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 started to feel itchy in her face (pruritis), orbital swelling (orbital oedema), urticaria (urticaria), redness (erythema) and prickly feeling (paraesthesia). The patient's medical history was not reported. Current conditions included seasonal and environmental allergy and was allergic to ibuprofen and aspirin. Concomitant product use was not reported. On 06 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. On 06 Mar 2021, an hour after receiving vaccine, patient started to feel itchy in her face, orbital swelling, urticaria, redness and prickly feeling. After taking diphenhydramine hydrochloride, symptoms were slowly abating. 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 outcome of events, started to feel itchy in her face, orbital swelling, urticaria, redness and prickly feeling were considered resolving.; 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.

Date and time of vaccination: (list both if they received both shots): First dose: 02/20/2021 @01130, second dose: 03/19/2021 @01130 Brand and lot of vaccine: Moderna LOT(M030M20A) (048A21A) patient reported that she developed a fever and arm sorness today (03/20/2021) @730. instructed to take tylenol to help with the fever. patient was instructed to apply cold compress to help with the arm sorness. patient was instructed to seek medical attention if the symptoms got worse.

Extreme pain in left arm which lasted 12 hours - from 3 am to 3 pm on March 20, 17 days after injection. Pain disappeared as quickly as it started. I did not seek treatment.

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.

2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia

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

Respiratory. Labored breathing, felt strange, little tingling in hands, tongue felt thick a little layet

Pt became mostly unconscious/unresponsive for approximately 24 hours after vaccine and very pale. Hospice nurse called to facility. Pt vital signs stable and pt on hospice, so family did not elect to go to hospital. Pt did eventually start arousing the next day but was lethargic . Pt started eating and drinking normally after approximately 2 days.

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.

Extreme dizziness the day after, weakness, fatigue. Symptoms of rapid heartbeat, fatigue and weakness have continued - this is day 15 of the effects. Some days better than others.

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.

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.

On the 6th day I got a quarter size red spot with blisters on my back.Another one on the 7th day.Also nerve pain front and back

Intense arm pain during the night after vaccine. Next day my arms and body and thighs were covered in deep red hives. Hives still on arms after 10 days

Red, itchy raised area below injection site; pain in joints and muscles all over body (arms, legs, back, knee joints, elbows, wrists, ankles, calves), short of breath, weakness. Severest late Saturday and through night of March 27th and March 28th. Still feeling restrictions in back, lung area on Monday, March 29th.

severe pain in right scapular radiating to left scapular, right shoulder and right arm. still have pain never dissipated. Constant had x-ray of only right shoulder by orthopedic doctor, negative results. Pain now chronic constant. Never had this prior to vaccine, could it be related. ,over four weeks still have his pain. I would appreciate a reply. Thank you

states that approximately a week after her 2nd covid vaccine she has been having sudden episodes of fatigue, brain fog, aches in arms and memory changes where she cannot remember specific details in the afternoon that she knew in the morning such as what she paid for something. She states she has always been good with numbers, the next morning she can remember again and the next afternoon won't be able to. Family h/o dementia. She had no difficulty answering questions for this form.

Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain radiated to her right arm and had significant shortness of breath. Symptoms started one week prior to seeking emergency care.

30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT LIKE THERE WERE LITTLE SWORDS, MY BREATHNG BECAME A LITTLED LABORED. WHEN I GOT OUR OF MY CAR AND WAS ALKING INTO Y HOME I FELT VERY WEAK. I WAS VERY AFRAID! I CALLED 911, EMT'S DID MY VITALS, BLOOD PRESSURE HIGH, OXYGEN 95 WHICH IS NOT Y NORM(99). AFTER MUCH DISCUSSION THEY WERE WORRIED I WAS HAVING A STROKE, THE AMBULANCE TOOK ME TO THE HOSPITAL. DID CAT SCAN. BLOOD TESTS. WATCHED ME. I WAS THERE ALL DAY. SENT HOME AT ABOUT 5:30PM HOSPITAL.

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.

High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth 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 these events, a causal relationship cannot be excluded.

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

Began having ever increasing visual /ocular migraines with very slight headache after first injection on February 1, 2021. After second injection, March 1, 2021 began having very frequent visual migraines and light headaches and went to emergency room. 7 days later I had an occipital stroke and was hospitalized for several days. I am slowly recovering. Symptoms were only visual but quite severe for a short time.

Pt presented to observation post 2nd Moderna vaccine- had been advised to remain in observation for 30 minutes. @6:00 PM pt walked up to observation RN to express "something is not right, I dont feel right and my teeth are chattering and my hands are tremoring" Pt was able to walk back to sit in a chair Initial BP was 225/205 and pt began to c/o feeling "I feel faint, very tired all of a sudden" RN advised CNA to alert staff for help Pt then began to wheeze and cough. Per adverse drug reaction kit IM Epinephrine 0.3 mg administered @ 6:05 pm 911 called. Within 2 minutes pt expressed "I feel better now" teeth chattering, fatigue and cough resolved. EMS arrived, son arrived Pt w/s/s similar to arrival at time of transport but lessened, pt left via stretcher to Hospital@6 bp recheck at time of discharge 169/64 Staff RN

Following the vaccine, my day progressed normally. Started feeling a bit tired and dizzy in the evening. Next morning, upon rising became very dizzy. Sat in my chair and promptly passed out. Eyes rolled to back of head. Husband could not rouse me for several minutes. Following that experience, became very tired. Returned to bed. Was dizzy, fever of 100.2, headache for a few days. Minor arm pain.

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.

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.

Within hours patient began studdering, slurring and became unable to form a sentence. She had difficulty doing regular tasks such as drive a car., she was tired and went to bed early. The next morning she complained of a headache, pain in her right arm at the insertion site, and could not walk without holding on to walls, speaking was difficult the same as above. She went to the ER by 1 pm where they found that she was having a double brain bleed. With a cat scan with contrast. They send her to a near by hospital with a Neurosurgeon on staff, Medical Center. They administer Vitamin K and Platelets and monitored her. At the first Hospital. She is presently being admitted to a Rehabilitation unit. She continued with difficulty with speaking, difficulty with simple tasks such as using the phone and the nurse reported that she is weaker today than yesterday.

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

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

She got the vaccine, was fine and went to bed. She sleeps in a fetal position with her legs curled and when she woke up she was not able to get up and was stuck in the fetal position. She was in excruciating pain, and had a dog to let out as she lives by herself. This went on for about 3 days. Then she went back to work and worked 2 days and then she woke up the next morning 3/28/21 and every joint in her body including her toes was throbbing and aching like she had arthritis. Since then she has continued with these symptoms, and aching all the time in her feet, shoulders and other areas. She saw her stomach doctor who she told him about her side effects and he advised her not to take the 2nd vaccine. She took her normal pills and Tylenol arthritis. She did notify her regular provider of her reaction as well. She went and got x-rays of her knees and legs at healthcare facility that said that they did not find anything other than some arthritis. It also affected her arms, legs and feet and had x-rays again and showed nothing but some arthritis in her hips. She still continues with the same symptoms. It will ease up, she will go about her business and then will wake up with throbbing pains.

Approx 10 days after shot - severe pain in muscle part of arm, neck gland protruding , swelled, neck pain going all way to ear- previous to this time could not lift arm above waist- not concerned at first but kept getting worse and extending to neck, shoulder, upper arm. Some swelling in hand as well numbness - fullness feeling in inside of arm especially at bend and hard lump in muscle of arm. I had this w first shot, filled report, met w 3 doctors, each prescribed different rememdoes. First time went to UC - prescription for steroids & ice. Family dr back from seminar visit - said should never have prescribed steroids -- prescribed heat, topical cream. 2nd shot effects mush later showing - this time dr prescribed xtra strength Tylenol, ot ibuprofen. Do not want to talk meds, want to know why this is happening. Since last major surgery, 2019, after 2 others in 6 years, only take low dose aspirin & vitamins pills.

Patient developed severe leg pain and increased shortness of breath 2 days after the vaccine. She was seen by her PCP and diagnosed with A COPD exacerbation, thought to be caused by the vaccine.

next day she had a fever the next day after taking the vax. 2 days later she had a 101 fever and she had severe pain shooting through her lower extremities. she contacted a physician that is a friend and asked to for an order to start therapy. On the 3rd day she started physical therapy. She started getting worse so she contacted her surgeon that ordered an MRI. DX is stenosis and bulging disc which she has had for years but has never been laid up because of it. She went to her PCP. They feel like she developed inflammation of the nerves for the weak parts of her body after taking the vax. The pain is in the nerve from her waist down to her ankle. She is still doing the physical therapy. She is scheduled to see an Orthopedic Doctor on 4/23/2021.

04/11/21 stroke event --unable to speak and not consistent with actions, CT 04/11/21 L MCA infarct no midline shift

Client started to c/o symptoms approximately 10 minutes after vaccination. She c/o numbness in her fingers, feet, and lips. Stated that she had heaviness in her chest and a pain that shot from her chest to her back lasting only a few seconds. She c/o dizziness. Client reported her BS was 140 this AM, B/P was 136/82, pulse regular and steady. EMS called to evaluate the client at 0930. EMS checked her BS which was 324, and her B/P was increasing. Client was transported to the hospital for further evaluation.

Rash began in center of chest, below neckline; slowly spreading toward neck and rest of chest. It presented as a red breakout ontop and under skin, with itching, pinching/pricking feeling. Over the counter topical creams were ineffective. Dermatologist prescribed Triamcinolone Acetonide Cream 0.1%, which calmed the itching/pinching/pricking, but hasn't resolved the rash.

Reports she was exhausted and weak for a few days after the shot. on 4/20 she went to the ER to receive treatment for a blood clot in her right leg. Reports she had been having trouble with her leg for 5 days before going to the ER. She has started taking Xarelto. She went for treatment. She was not admitted.

Sore arm after initial shot on 3/15. Pain in groins started 3/17 making walking painful and slow. Getting on and off commode I sometimes need help. Pains in muscle area of arms has subsided. Called PCP to document how I felt on 3/19. They returned call on 3/22 - said to take B12,Zinc,and Vit. C because I had questions about 2nd. shot. Got 2nd. shot on 4/12 - seems like I'm back to square 1. Taking Tylenol - 2 tabs every 6 hours. Helps but I need to get back to normal.

Had second COVID vaccine 03/26/2021. States that she had no itching or severe symptoms after 2nd vaccine. She had some shaking. She did fall on the following day. She went to sit on a desk chair which rolled out from under her and she fell to floor.

Case noted with increasing difficulty walking and writing. Once case noted with difficulty speaking s/o transported to hospital. Hospital dx CVA. Case now resides at LTC permanently.

1st dose pain in right side near small intestine 4 days after vaccine, doctor did blood work, ct scan 2nd dose sharp pain in left lower back morning after, chills same day as vaccine - ER gave muscle relaxers, did blood work, urine test taking advil have continued warm/inflammatory feeling in abdomen 4 days after 2nd shot

"Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21. She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.

Received 2nd moderna vaccine 2/12/21. Left arm a bit sore that night at injection site. Woke up 2am with chills, whole arm and left shoulder blade very painful, fatigue. Sunday felt a bit better. Monday improved. Now use arm to hold the phone. Would just hang at the side, very painful. Laryngitis started yesterday, has chronic PND and allergies. Still have some chills, fatigue overall improved. Took tylenol, mindful of transaminitis

Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injection site; Itchy at the injection site; Extreme fatigue / Could not get up for 2 days / Lay down for 2 days; Headache with flashing light; Broke her L2 vertebra; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis, Blood pressure high and Migraine. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light). At the time of the report, LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra), PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light) outcome was unknown. Not Provided No concomitant medications were reported. No treatment information was provided. 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 for all events except Lumbar vertebral fracture which is unlikely. This case was linked to MOD-2021-092132 (Patient Link).; 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 for all events except Lumbar vertebral fracture which is unlikely.

presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/21 with severe frontal headache and increasing lethargy throughout the day. Admitted to hospital with suspected subacute stroke. Overnight developed LT sided weakness and RT gaze. Transferred to another healthcare facility on 5/3/21 with suspected seizure / encephalitis.

arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-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 22-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) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved. No concomitant medications provided. Treatment included doxycycline and prednisone. 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.

Woke up on Sunday May 9th with Bell's Palsey; classic symptoms of drooping on LEFT side of face. Has seen 2 doctors; one says vaccine is to blame other Dr says stress is to blame. She was under extreme stress the 2 days before symptoms began. Symptoms still persist on Tuesday, May 11, 2021

pt states her left arm was sore about 6 hours after taking the vax but about 5 days later she woke up with a red shiny rash around the dorsal surface of her left arm. It was about 4 x 6 inches in size, extremely itchy and warm to the touch. She applied ice to it for about 4 days and took Benadryl which seems to help. She says it is still pink but no longer is itching or hurting.

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

Only a sore arm, but about a week after the first dose I had sensitivity in my front teeth that progressively got more sensitive. I took some Aleve to help with the sensitivity.

1020: Patient was complaining of dizziness. When transporting patient to stretcher she was having weakness and shaking. Onsite NP and EMT assessed patient immediately. First BG reading read low, second reading read 29. Patient was immediately given a breakfast bar. Vitals were taken. BP 171/96, HR 116, 02 98%. EKG showed sinus tach. Patient stated she had not eaten this morning and she is a diabetic. Fire rescue was called. 1035: Second set of vitals were taken BG 89, BP 177/96, HR 120, O2 98%. 1045: Fire rescue arrived, assessed patient. BG was 179. Patient refused to be transported to the hospital. 1100:, Patient agreed to no further medical intervention on our end.

Injection site bled and was swollen. Arm was very sore from April 1 through April 5, 2021. Became sore again April 8, 2021. Injection site became sore at point of injection around April 22, 2021 and is still sore. Especially after using the arm in tight parking or shopping. Reported the incident to Moderna on April 29, 2021. Case # MOD 21-083927

05/07/2021 from 12:30 am - 6:30 am experienced painful crushing viselike pressure on left torso area behind left breast down to left waist in front and back lasting for several hours making it impossible to sleep. 0/5/15/2021 from 3:30 am - 6:30 am again experienced this pain but not as crushing making it impossible to sleep. Pain also occurred in right upper arm and shoulder area at that time. Due to uncertain origin of this pain, I am seeing cardiologist and having Left Diagnostic Breast Mammogram and ultrasound on 05/17/2021, followed by Covid Test on 05/19/2021 and Stress Test on 05/21/2021.

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)

She got her vaccine, about a day and a half her arm was sore and itchy. Then later on it was red, splotchy kind of redness, but not at the point of the injection, just a couple of inches below towards the elbow. This lasted for about a week. The soreness went away but could see redness in the area, which took about 4 weeks for this to disappear completely. She had a headache which lasted for a short period of time, and disappeared. She also had a swollen lymph node along her waste that were sore about 2 days after the vaccine, which also disappeared and had it only for a day or two. She started noticing a sound, thinking it was in her old house the 2nd week of April, but moved to a quieter neighborhood and still noticed it. She was reading an article this morning in the paper and realized the sound that she was hearing was tinnitus. She was only born with one ear and it sounds more like a beeping sound than a ringing, but it continues to bother her. She does not notice it when she's out driving around from the other noises in the environment but when it's quiet due to the one ear she can hear it. With only one ear she cannot determine the direction of where the sound is coming from, but does notice it during quietness. She puts her ear up to the wall to determine where the sound is coming from and plugged her ear, and determine it was from the ear itself. She is worried about it getting worse or not getting any better with only having the one ear.

heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Cardiac catheterization on 17-Mar-2021. Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable

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.

Pain in area of where the lower buttocks meet the upper leg. Pain radiating down and across upper leg. I wouldn't have even thought about this being related to the vaccine, but 2 other acquaintences have mentioned the same problems coming up since the last vaccine. There has been no injury or event to explain this pain.

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.

Patient started having stroke like symptoms at approximately 1145am on May 30th. Pt was having difficulty dressing and generalized feeling of being paralyzed for a brief moment or two. Pt was also having trouble getting out her words/thoughts. Pt never had loss of function of her limbs, No weakness, No facial droop, No loss of bowel or bladder control. Once in ER at Hospital, pt was found to have irregular heart rhythm e on EKG (Sinus Tachycardia with possible AFib with rate in the 100's up to 130's) - CT Scan of Head was negative for bleed or acute ischemia. By 8pm the same day the pt had improvement of speech and getting out words/thoughts better and by the next day at 10am sounded back to normal self and still with no other neurological deficits. During that next day we learned that the patient had been to her Primary Care Dr on 5/24/2021 for routine visit when they did an EKG in the office and pt was thought to have an "irregular Heart rhythm" and referred to see a cardiologist. During course of hospital stay the patient was treated with heart rhythm medications and Eliquis for Diagnosis of Afib/TIA.

She got her vaccine, her left arm hurt as it does with her regular flu shot and normally goes away after a week. The next day she read what to do, but she moved her arm slowly around to exercise it to get rid of the soreness. On the 2nd day the pain went away. By the 3rd day it was back with a vengeance, and stayed there and never got better. Her joint and everything started to hurt. It felt like she had to have rotator cuff surgery again, and it still feels that way. She went to her doctor who gave her a steroid shot which helped but then it came back again. Within a week she could move her arm, but in a certain position it hurts her extremely badly. If she raises her arm it "bites" her and the pain does not cease. Her groin area also she is having pain there as well that radiates to her knee. The front top side is burning and sore all of the time, and does not want to quit. She takes baby aspirin and was given Norco but she did not like how it made her feel and doesn't take that. The 800 of Ibuprofen did not help with the pain, neither does Tylenol or Advil. She states that the medicines make her muscles sting and burn and feel worse. She feels that the vaccine got to her vulnerable places of pain from before that have healed and feels that it has reactivated that pain and the pain won't go away. Her arm did not hurt her for years, and her leg pain had been gone for a long time, but since the vaccine she has had nothing but pain. She got her 2nd vaccine on 3/25/21, she did not have any adverse reaction, just the reaction from the 1st one did not go away and it did not go away after the 2nd one and still has the same pain. It did not bother the bladder where she had surgery, just the joints of her body where she had previous problems. Her back has been out of place and could not walk for a year and a half, but this has not bothered her back.

I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness

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.

Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and knife-like sharp pains in legs 5- 7 days heavy nasal mucus discharge painful muscles and joints; fatigue, unstable balance, sensitivity to light lasted 3-4 days 3rd day sore upper left arm with rash from injection site to elbow lasted 3-4 days Symptoms generally cleared up by June 16. Treatment: bed rest, fluids and 1000 mg Tylenol every 6 hrs over 4 days

seizures lasting 10-12 minutes, hospitalized since May 16, 2021. Transferred to hospital on May 28, Expected to be transferred to long term care on June 14, 2021 .

I was having shooting pains through my head which were severe and in my right ear was soar as well (tender to touch with shooting pain). I did not have any energy and couldn't concentrate since the pains were happening all the time. My doctor treated me with Valtrex and a topical pain killer (Lidocaine). I was diagnosed with Shingles but did not break out. It took about a month to recover from the Shingles and then my ear continued to hurt for another two to three weeks. Now, everything seems to be fine.

can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) in a 77-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot. 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.

Patient became lethargic, weak and generally debilitated with tremors and inability to complete ADLs without assistance, beginning on 4/7/21 (date of second dose of vaccine). She was taken to see a neurologist on 4/12/21. She showed some improvement by 5/5/21 but then had a recurrence of generalized decline and on 5/28/21 she became weak and fell while ambulating. On 5/29/21, she had another event with weakness and fall and was taken to the hospital and admitted.

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.

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

2 days after first injection I could not turn my head, neck pain, shoulder and arm pain. went to urgent care, symptoms got progressively worse, numbness in my arm and severe spasms in my back, after 2nd injection I could not function or go to work. I have seen 8 doctors, 2 trips the ER 2 MRI and CT scan. 3 cortisone injections and i still have pain in my shoulder and numbness in my arm and hand. Pins and needles if I try to use my arm. I am still out of work and very painful. A surgeon has been recommended to relieve the nerve pain I am experiencing.

I got home and immediately felt awful. I felt so bad that even though the roof was being done over my head and the workers were banging above me, I went right to sleep. I was back to sleeping for long periods of time. This lasted 2 1/2 weeks. I took Tylenol which helped some. I also had a sore arm. After the 2 1/2 weeks, my symptoms went away.

Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls.

Patient stated 2 weeks after receiving the 2nd dose, left breast was tender (tissue-pressure). Arm soreness and breast tenderness still continuing. Primary recommended mammogram and lymphoid exam.

PAIN AND SLIGHT SWELLING IN INJECTION ARM. NO REDNESS, NO RASH. STARTED IN AFTERNOON AFTER 1ST DOSE OF MODERNA. CONTINUED TO TODAY (6/29/2021) AND PATIENT STATED THEY WERE ON THEIR WAY TO THE PHYSICIAN TO BE EVALUATED. PATIENT WAS AMBULATORY AND, OTHER THAN PAIN AT INJECTION SITE, SEEMED TO BE IN GOOD HEALTH.

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.

left knee warmth; left knee swelling; woke up/collapsed after trying to get out of bed; felt fluish; felt weak/got weaken as day went on; fall; could not walk; joint infection; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (woke up/collapsed after trying to get out of bed), GAIT INABILITY (could not walk), INFLUENZA LIKE ILLNESS (felt fluish), JOINT WARMTH (left knee warmth), JOINT SWELLING (left knee swelling), ASTHENIA (felt weak/got weaken as day went on), FALL (fall) and ARTHRITIS INFECTIVE (joint infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Knee replacement (LEFT) in 2013. Previously administered products included for Hives: Amoxicillin. Past adverse reactions to the above products included Rash with Amoxicillin. Concurrent medical conditions included Tobacco user (30 TO 40 CIGARETTE STICKS A DAY) since 1962, Drug allergy (AMOXICILLIN-RASH AND HIVES), Abstains from alcohol, Diabetes, Blood pressure high, High cholesterol, Water retention and Rheumatoid arthritis. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Water retention and Blood pressure high, AMOXICILLIN for an unknown indication. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. In February 2021, the patient experienced FALL (fall) (seriousness criteria hospitalization and medically significant). On 22-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt fluish) (seriousness criteria hospitalization and medically significant) and ASTHENIA (felt weak/got weaken as day went on) (seriousness criteria hospitalization and medically significant). On 23-Feb-2021, the patient experienced SYNCOPE (woke up/collapsed after trying to get out of bed) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (could not walk) (seriousness criteria hospitalization and medically significant). On 25-Feb-2021, the patient experienced JOINT WARMTH (left knee warmth) (seriousness criteria hospitalization and medically significant) and JOINT SWELLING (left knee swelling) (seriousness criteria hospitalization and medically significant). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (joint infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 1 dosage form. In February 2021, SYNCOPE (woke up/collapsed after trying to get out of bed), JOINT WARMTH (left knee warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (could not walk) and JOINT SWELLING (left knee swelling) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt fluish) had not resolved and ASTHENIA (felt weak/got weaken as day went on) and ARTHRITIS INFECTIVE (joint infection) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Laboratory test: left knee infection (abnormal) Left Knee Infection. On an unknown date, Culture: unspecified (Inconclusive) unspecified. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke and unrecalled results (Inconclusive) Unrecalled results. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. Patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021. Patient stated that she was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. It was reported that the patient had a culture test and unspecified laboratory test on an unknown date; results were not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events. This case was linked to MOD-2021-234196 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events.

Swelling of L knee; infection of the stryker knee/ left kneee replacement surgery; Joint infection; joint warmth; Orthostatic collapse; weak; Flu-like symptoms; fall; unable to walk; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), SYNCOPE (Orthostatic collapse), ARTHRITIS INFECTIVE (Joint infection), ASTHENIA (weak), GAIT INABILITY (unable to walk), INFLUENZA LIKE ILLNESS (Flu-like symptoms), JOINT WARMTH (joint warmth), JOINT SWELLING (Swelling of L knee) and FALL (fall) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2114) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Knee replacement (left knee replacement.) in 2013. Concurrent medical conditions included Tobacco user (TOBACCO USER:30 TO 40 CIGARETTE STICKS A DAY) since 1962, Allergy to antibiotic (AMOXICILLIN DRUG ALLERGY MANIFESTED BY RASHES/HIVES), Abstains from alcohol, Diabetes, High cholesterol, Water retention and Blood pressure high. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Hypertension and Water retention. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. In February 2021, the patient experienced FALL (fall) (seriousness criterion hospitalization). On 22-Feb-2021, the patient experienced ASTHENIA (weak) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion hospitalization). On 23-Feb-2021, the patient experienced SYNCOPE (Orthostatic collapse) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (unable to walk) (seriousness criterion hospitalization). On 25-Feb-2021, the patient experienced JOINT WARMTH (joint warmth) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery) (seriousness criteria hospitalization and medically significant) and ARTHRITIS INFECTIVE (Joint infection) (seriousness criteria hospitalization and medically significant). On 25-Apr-2021, the patient experienced JOINT SWELLING (Swelling of L knee) (seriousness criterion hospitalization). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at an unspecified dose and frequency. In February 2021, SYNCOPE (Orthostatic collapse), JOINT WARMTH (joint warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (unable to walk) and JOINT SWELLING (Swelling of L knee) had resolved. At the time of the report, ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), ARTHRITIS INFECTIVE (Joint infection) and ASTHENIA (weak) was resolving and INFLUENZA LIKE ILLNESS (Flu-like symptoms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body fluid analysis: left knee infection (abnormal) Left Knee Infection. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021.Patient stated that She was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. On an unknown date, it was reported that the patient had an unspecified laboratory test; results 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. However, multiple underlying co-morbidities may remain as confounding factors. This case was linked to MOD-2021-234158 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.However, multiple underlying co-morbidities may remain as confounding factors.

Neuropathy in her feet (like pins and needles) and in her muscles from the waist down; Floppy ankles; she could not complete "stair climber" exercises up until a month ago; Can wiggle toes, but even though functioning they are numb; still suffering from long term effects (neuropathy); Caller stated her balance is off as well.; still feels exhausted.; Neck pain; Couldn't sleep; Headache; Chills; Fever; Muscle Achiness; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Muscle Achiness). On 22-Mar-2021, the patient experienced NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) (seriousness criterion medically significant), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb) and FATIGUE (still feels exhausted.). On 25-Mar-2021, NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. At the time of the report, NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb), MYALGIA (Muscle Achiness) and FATIGUE (still feels exhausted.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No adverse events reported after first dose on 20 January 2021. No concomitant medications reported. Patient reported she had a COVID test on 27 March 2021 but no results were provided. Patient reported elevated blood pressure and heart rate that persisted for weeks but has since resolved. Patient reported an electrocardiogram was performed on an unknown date with a normal result. No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

I had a regular appointment with my doctor and that?s when I told him that my arm was hurting, and he said that I had to go to physical therapy. He did not prescribed any medications or do any tests

1205p back to clinic c/o "whoozie" and hands tingling, water given, cool cloth to forehead, BP 147/84 P 73 R 18 SpO2 95% RA, 12:16p pt reports "better" denies any s/s, BP 135/78 P69 R 18 SpO2 96% RA, ambulated with RN to valet parking

weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chills, was losing her balance, headaches, temporal artery on right side of her head is bothering her, diagnosed with gastroparesis, right arm/near breast is sore, developed tremors

7/8/21 0430: Resident sitting on floor in room. Staff assisted back up, resident noted to have fever of 103 degrees. Shaking movements of extremities, weakness in legs, and confusion noted. Resident sent to local ER. Ct of head showed no acute process, CXR showed no acute process, and urinalysis did not indicate a UTI. Resident returned to facility after about 2 hours in the emergency room. At time of return was coherent and no longer confused.

Patient received Moderna COVID-19 vaccine Dose #1 on 3/15 and Dose #2 on 4/12, unsure where patient received vaccine. Admitted to hospital for syncopal episode at a store on 7/8. The ED provider note does mention that the patient reports increased weakness and fatigue over the last month with heart rates in the 40-50s. She had bleeding head laceration on admission. New Afib noted this admission. Platelets low on admission (9) with no prior CBC's in the chart. Three units of platelets were ordered to be transfused. Low platelets are an incidental finding.

Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.

fever (103.9) one day after last vaccination. 10 days after vaccination, visit to cardiologist who had precribed verampamil for palpitations a few days before my vaccination - my legs and feet were swollen. She told me I had mild purpura and edema from the verampamil, and she discontinued it. I told her I suspected it was from the vaccine. I quit taking verampamil, and I still have the rashes and edema in my legs and feet, and also on my arms. I had to go to the ER for severe leg pain, I believe in March orApril, where they tested me for a blood clot, which was negative, and went away a few days later. I still have the swelling and edema and rashes. I do not have a doctor's appointment until September with the cardiologist NP, and in October with my PCP. I am sure my situation is from the vaccine.

After the second Moderna dose, a day later I exhibited severe neck pain - this lasted for 2 one-half weeks before it subsided. I did not go to the doctor but was very worried about it. I am 5'2" tall, weigh 100 lbs. and in excellent health. I am very active, ride my bike, go to water aerobics, and walk - this reaction was very debilitating; I am concerned about taking a booster shot and feel that the dosage should be adjusted based on weight as I had the same dosage a much heavier person would receive. Please consider this issue in the future if a booster is needed. Thank you.

didn't get the second dose; Blood pressure High; Heart beat raised up to 110 bpm; Throat raspy; Throat dry; Knees swollen,knuckles swollen; Knees red, knuckles red, face red; Knees hot, knuckles hot; A little bit of fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure High) (seriousness criterion medically significant), TACHYCARDIA (Heart beat raised up to 110 bpm) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat raspy) (seriousness criterion medically significant), DRY THROAT (Throat dry) (seriousness criterion medically significant), JOINT SWELLING (Knees swollen,knuckles swollen) (seriousness criterion medically significant), ERYTHEMA (Knees red, knuckles red, face red) (seriousness criterion medically significant), FEELING HOT (Knees hot, knuckles hot) (seriousness criterion medically significant), PYREXIA (A little bit of fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't get the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form; ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form and AMLODIPINE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 210/110 mmhg (High) Blood pressure went up very high. On 04-Feb-2021, Heart rate: 110 bpm (High) Heart beat was raised all day. 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 reported. Patient went to the Emergency Room and diagnosed for allergic reaction. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Patient stated that about 6 hours after getting her 2nd dose of her Moderna vaccine, she started to feel a tingling, shaking feeling in the arm where she received her vaccine, then her arm goes numb for about 2-3 minutes. Patient also stated that her legs start to shake, she will get dizzy. Patient has been to doctor to for Adverse Event and wasn't prescribed any medication. Patient stated that this happens at least 6-8 times a day, she's only had 2 days since she was vaccinated that this hasn't happened.

2 days after vaccination: Muscle pain in both thighs - difficult to sit, squat, get out of a chair, difficulty climbing stairs Hip, pelvis, and butt pain in the muscles, hip bones as well Right arm, shoulder, back, neck pain Swollen joints in hands, stiffness especially in the morning Prescribed Prednisone for pain, 30 MG gradually weaned over 5 months. Still extreme pain and difficulty performing daily tasks - weaned due to it being only a short term solution. Overall arthritis-like symptoms in joints that never experienced arthritis before, either from age or injury.

Her ALT was 101,JUL2021 her ALT (83); AST was 70,and AST (66) rose again; she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off; she has been having is a backache on her right side above her waist possibly by her kidney; had an unusual need of staying alert and trying not to fall asleep while texting because her texts; unusual need of staying alert and trying not to fall asleep while texting; On 30APR2021, she experienced the shaking again from her hips to her shoulders; it was my body shaking,her body was shaking again at night but not as violently as the1st time.; had an occasion to be awakened at night,the following night, I had an awakening again; tremor; passed out after turning on television; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out after turning on television) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is provided by the reporter. Concomitant products included Vitamin B, Vitamin C, COLECALCIFEROL (VITAMIN D3), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]) for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out after turning on television) (seriousness criterion medically significant). On 27-Apr-2021, the patient experienced TREMOR (tremor). On 28-Apr-2021, the patient experienced SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again). On 29-Apr-2021, the patient experienced TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.). On 30-Apr-2021, the patient experienced TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders). On an unknown date, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts) and FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting). At the time of the report, LOSS OF CONSCIOUSNESS (passed out after turning on television), SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again), ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts), FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting), TREMOR (tremor), TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.) and TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drug was provided by the reporter. On 28APR2021, she was able to sleep well through the night. 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-2021-262809 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow Up appended. On 22-Jul-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.

Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Superficial bleeding left leg) in a 77-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 Rheumatoid arthritis (gradual improvement) since 1996 and Hypertension (stable) since 2018. Concomitant products included METOPROLOL from 2018 to an unknown date for Hypertension, METHOTREXATE from 1996 to an unknown date and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 1996 to an unknown date for Rheumatoid arthritis. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in l. arm). On 16-Jun-2021, the patient experienced HAEMORRHAGE (Superficial bleeding left leg) (seriousness criterion medically significant). On 05-Jul-2021, HYPOAESTHESIA (Numbness in l. arm) had resolved. At the time of the report, HAEMORRHAGE (Superficial bleeding left leg) had resolved with sequelae. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: elevated (High) Elevated. In 2021, Ultrasound scan: normal (normal) Normal. The patient reported that signs of bleeding were still present .Ten days later bleeding in left leg, area 4 in. x 8 in. 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-2021-163325 (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.

My arm started feeling sore the evening of the injection day. I di not sleep well that night as slight chills and general achiness began. When I got of bed the following morning I felt so weak, woozy and light headed that I was afraid I would fall. I slept all day but by that evening I began feeling better and by the following day (day 2 after the shot) I felt normal except that my arm was still sore. It is now day 3 and my arm is still slightly sore but not limiting my use and is steadily getting better.

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.

Patient received Moderna vaccine on 12/29/2020. Minimal discomfort the day after. Patient called today to report on 1/6/2021 she developed red, raised area at injection site. Warm to the touch and itchy. Today symptoms have improved. Patient reports she applied ice to injection site.

Electric like jolt continuous from shoulder to hand. Later DX as a injury to the nerve at the site of the vaccination. Sent to urgent care told to take Tylenol, and ice the area. They referred to physical therapy.

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

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

6:00PM R arm very sore, soreness progressed to R side of body, began to feel very weak, unable to lift leg to bed, malaise 24-36 hrs, exhaustion, wanting to sleep all the time, extremely weak next day

Two days after my wife received the moderna vaccine she showered significant cognitive impairment and memory loss . She cannot recall words and is experiencing delirium. Both her internist and her neurologist are convinced it was the result of the vaccine e. She had a complete Nueromosych evaluation done two months ago snd the results were completed normal. I want you to be aware of this snd if it does not resolve I may sue the federal government and moderna. Thanks a llot

Patients left arm is slightly swollen and red-warm to the touch. Patient received vaccine on 1/8/21. Symptoms started on 1/15/21. Reported to pharmacy on 1/19/21. States antibiotic cream has been helping.

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

Extremely sore arm - much more than flu shots and STILL very sore. Ice and Ibuprophen 400 did not help. Chills and shaking so much I put on flannel pj's. Very tired next day. Did almost nothing and took 2 naps. Was still some tired today but better

Received injection on 1.12. Felt fine. On Jan. 18 my left arm began to throb and a painful rash appeared. 2 days later it is still there. Concerned about taking 2nd injection.

fatigued and tired, sore arm within a day. On day 8-9 very large red area and swelling from below injection site to elbow, itching and very uncomfortable.

Following vaccination patient reported "shakiness all over" and general weakness. VS 122/88, 75, 94% saturation. After 15 minutes symptoms resolved

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

Chills, fever of 101.3 and then cough with wheezing And bad headache. Don't know if this is all related to the vaccination.

pt received the moderna COVID-19 vaccine. Approximately 10 minutes later she experienced dizziness and lightheadness and weakness. She was evaluated in urgent care, found to have severe hypertension 230/120 (no h/o htn). Hypertension remained present for 2 hours and troponin returned indeterminate. She was transferred to ED for further evaluation and management. See note for details of care.

1/21 Significant itching at injection site. Refrained from touching. By evening progressed to small area of redness and swelling. 1/22 Much larger area, rosy red, swelling and felt hot. Applied ice. Area affected continued to spread. 1/25 Presently extends from shoulder to arm pit, but not under arm. About size of very large orange. Tender, but not painful. Very itchy, still red, hot feeling, and puffy. Hopeful it is safe to receive 2nd dose around 2/14/2021

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)

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

Deep muscle pain and joint pain on hips, knees and ankles. No joint pain above the waist. No pain in a sitting or standing position. the pain happens at night when lying down often followed by cramping and "charlie horse" symptoms. This has lessened somewhat after 2 weeks, but it does still happens. Really considering declining the second vaccine as that is reported to be much more likely to have side effects.

Patient had small localized reaction for 2 days after injection that cleared. At approximately 7 days post injection she began to have another localized reaction that included reddness, swelling, pain, heat, and a dry skin tecture that progressed to cover the lateral aspect of upper left arm from shoulder to elbow. At time of examination by RN, the patient reports that size and intensity have been increasing for about 7 days. Patient finds relief in hot shower. No other treatments attempted at time of exam. Patient reported area may be improving, but she is unsure. Area was outlined with marker by RN and patient was advised to see PCP for treatment if area increased in size and was not continuing to improve. Counseled on using OTC benadryl cream if there was itching.

Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home. Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.

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.

Sore throat - 1/28/21 woke up Arm pain - 1/28/21 woke up Itchy eyes - 1/28/21 evening and currently Itchy ears - 1/28/21 evening and currently Itchy in the arm of vaccine - 1/28/21 evening and currently

The patient received the vaccine on January 20, 2021 uneventfully. She did not develop soreness at the site. Approximately 3 days later, she noted a bump that was sore to touch and slightly itchy. It slowly got better. She did apply clobetasol ointment on January 24 and 25. It seemed better. On January 28 the evening and 8 noticed some redness. She saw me, her doctor, on January 29. She had a 7 x 7 cm round pink area that was slightly warm and minimally tender. This was at the site of injection. It was slightly swollen. I did not give her the vaccine. She got it through the health Department.

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.

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.

Upon going to bed, within a matter of a few minutes, I started to get the chills real bad. Then my muscles and joints started to hurt. I could not even turn over in bed without my whole body hurting. I don?t know if I had a fever or not. I was so tired, but shaking with chills and body hurting I couldn?t go to sleep. Put more blankets on and took 2 Tylenol. I was able to eventually go to sleep. I felt better in the morning but was very tired during the day. It felt like I had covid again. I had the same symptoms then. I tested positive for covid November 27 at a rehab/nursing home where I was sent after foot surgery.

Rash as blisters on joint areas of the wrist, fingers, elbows, knees, ankles, toes. Extremely itchy with burning. Triamcinolone Acetonide cream, Zyrtek, Benadryl, Helps some but still breaking out

After administration of the Covid-19 vaccine I had 2-3 days of chills, muscle aches, fatigue, sore arm. Symptoms gradually went away. Then about the 7th day I started experiencing an itchy arm and a 6 inch circle of intense red at the injection site, with a wide band of white surrounding it, that itched unbelievably, was hot and swollen. That lasted for several days, then began to subside and now is only slightly red, itches some and is no longer swollen or hot. My question is: Is it safe for me to get the 2nd dose, after experiencing this kind of reaction?

C/O OF DIZZINESS A MINUTE AFTER RECIEVING VACCINE. UPPER EXTREMETIES COLD TO TOUCH, AWAKE AND ALERT X4 TOLERATED ORANGE JUICE SYMPTOMS IMPROVED.

Blister formed in vaginal area. Broke open. Rash developed along right buttock. Burning. Slightly itchy. Symptoms started on 1/25/21. Used Calamine lotion. Presented to clinic on 2/1/21. Diagnosed with Shingles. Started on Valtrex 1gram.three times a day x 7 days

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

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.

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.

Got the vaccine, had sore arm immediately. Thought she was fine. Husband had the same vaccine, and had the splotch and soreness, but then around 1/23/21. The shoulder started to hurt after about 3 days, and put a heating pad on it, and finally the pain and discomfort gradually subsided. She is not having any problems now.

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

24 hours following vaccine arm very sore and red. Beginning 24 hours later arm continued to swell to size of tangerine, very red, hot to touch. Unable to sleep or lay on side. No lymph node swelling. Unable to use. arm. Took Tylenol first day only. Took Ibuprofen for arthritis but not for arm. Did find some relief from the over the counter meds. Seen by private doctor who diagnosed cellulitis. Told to take second dose but in different arm.

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"

Woke next day with sore arm, chills and temp 99.6. Tired and chill all day. Took tylenol. Much better today.

Extreme weakness, chills, mild fever, body & joint aches, headache, coughing, one episode of chest pain! Trying to recover by resting and staying in. I will be contacting the my doctor, just as soon as I finish this inquiry!

Pt called 02/08/2021 at 12:00 PM detailing possible adverse reaction to vaccine. Pt received COVID-19 Dose #1 on 02/05/2021 at 4:20 PM through the Health Department. Around 10:50 AM 02/06/2021, pt stated she began to feel lightheaded, and jittery. Pt is a Type II diabetic. Pt took her blood glucose level which was initially 193. Pt waited 10 minutes and retook her blood glucose which was 230. Pt waited 30 minutes and retook her blood glucose which was 174. At 2:40 PM blood glucose was 157. At 5:00 PM blood glucose was 120.

within a minute, electrical like vibration and then tingling pains & needles, left side of tongue, then left mouth, face and down left side of body to foot. Strong tingling, but no numbness - continued ver 1 and 1/2 hrs - never had that before followed by sore arm Day 2-3, then gone Since then have had 5-6 much milder, shorter episodes of vibrational electric impulses mostly left side, and mostly left neck to shoulder and legs. Odd. Will fu with PCP02/12/21

Late Saturday I noticed my lip dropping to the right and by morning my right eye was dropping. On the way to theER my eye felt like it had sand in it and I had to hold my hand over it and my mouth and lips felt like I had a shot of novicane and it was hard to pronounce certain words. I have to eat small things because it is difficult puttinng food in my mouth and I can not feel the food in my mouth on the right side and if food gets over there it gets between my gums and my cheek, to drink I have to position a straw in my mouth on a certain point and some goes back down in the straw.

Began having seizures on 2/6/2021 a day after having vaccination. Husband of patient reports patient having 2 seizures on 2/6/2021. Pt transported to ER for testing. Husband denies pt receiving any treatments. Pt underwent various tests. Pt sent home. Husband reported pt having altered mental status from seizures. Pt then had 4 more seizures on 2/7/2021. Husband states pt had altered mental status but her condition began improving after seizures. Pt has not returned to baseline cognitive function as stated by husband. Husband states pt has a history of seizures and is prone to having seizures. Pt also in early stages of dementia.

Aproximately 15 minutes after receiving the dose (and while being observed for 30 minutes for past allergic reaction history), the patient stated that her Parkinson's tremors had suddenly become more severe. Prior to the injection, she would have small tremors in hands and legs on occasion but not as severe as she was experiencing afterwards. Patient was examined and had normal vital signs, O2 saturations of 93% on room air (hx of Copd), and was negative for stroke evaluation. We placed her on her own 02 which she generally has on when short of breath, and ECG showed a sinus rhythm with a bundle branch block. We continued to monitor the patient which she stated her symptoms where "better" but continued to have sporadic Parkinson's like tremors which facility stated was more significant than normal. It was decided that the patient would be warrant an emergency room evaluation. The patient was transported to hospital.

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.

Fever and chills (severe shaking) starting around 5 p.m. on the day of the vaccination (Feb. 10). Took 2 Tylenol around 9:30 p.m. and went to bed. Had a temperature of 100.2 on Feb. 11; no chills. Stayed in bed the whole day. By about 5 p.m. the fever was gone and I was feeling much better. Today (Feb. 12) pretty much back to normal.

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.

Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheeks. . Took Benadryl and 16 ounces of water around 1hour 15 minutes after shot Two hours after shot experience slight sore throat lightheadedness head cold symptoms Symptoms lasted another six hours took a second then a drill. Rank another three bottles of water Symptoms became lighter with a little bit of a headache After 20 hours everything went away except tiredness and light headaches

Severe leg cramps. It felt like many muscles in my legs and toes were cramping at once. Legs were painfully bending and twisting Could barely walk. Very difficult to try to relieve them as motion to relieve one cramp made others worse. Lasted about 45 minutes. After about 15 minutes I took a cyclobenziprene I'd had for a back spasm about a year ago. After seeing a report of a woman with severe seizure-like leg spasms I decided to report my experience. I am concerned about taking dose #2 scheduled for March 4.

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

low grade fever, fatigue, headache, muscle aches, chills, pain at injection site these symptoms started around 9:00am 24 hours after injection of second dose.

BELL'S PALSY. PATIENT WENT TO ER ON 2/13/21 AND WAS DIAGNOSED. FOLLOWED UP WITH PRIMARY CARE DOCTOR 2/15/2021. 2/13/21 PREDNISONE 10MG TAPER: 50MGX4DAY, 40MGX2 DAY, 30MGX2DAY, 20MGX2DAY, 10MGX2DAY 2/15/21 ACYCLOVIR 800MG 1 FIVE TIMES A DAY FOR 7 DAYS, BACITRACIN OPTHAMIC OINT AT BEDTIME.

30 Hours after the shot without any warning or ill effects, I suddenly collapsed from my chair at the dining room table. Fell on the floor unconscious and ended up in the Emergency room with a broken nose ,concussion, and no memory of the episode. Hospital did a CAT scan which did not show indication of a stroke but did verify concussion and broken nose. Later saw personal physician and heart monitor was placed on my body, and echo cardiogram scheduled. Echo cardiogram did not indicate any blockage. Results from heart monitor not available at this time. I am a perfectly healthy individual - walk 3-4 miles every day, swim, play golf, eat a keto diet and have never had an episode like this. An hour before it oc Apple watch 6 texted a message that read: "are you okay or should we call 911". I was perfectly fine and just thought the message was a fluke - replied I am fine. An hour later the episode occured. I am not used to taking vaccines - no flu shots, no shingles shots - only keep up my tetanus. The only vaccine I have had recently was in 2009 - yellow fever shot so I could travel to. I have never had a reaction like the one after the Moderna vaccine.

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.

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 second Maderna shot at 10:30 am. No problem with my first one three weeks ago. At 10:00 pm I started to get extremely cold and could not get warm. At 10:45 my upper body started shaking very, very bad. I couldn't control the shaking and my teeth were chattering. I had to lay down and put my arms under my body to keep them from shaking and I was so cold even though I was wearing warm things and under a comforter. The shaking lasted an hour and a half. I took my temperature during the night and it was 102. I am very week this morning, temp. is 99.9. I was expecting the temperature and pain in the injection site but I can't find out anywhere on line whether the uncontrollable shaking was normal for the second shot. .

Viral encephalitis; Short term memory loss; Combative behavior; Significant cognitive deficit; Not remembering words; Completely incoherent; A spontaneous report was received from a consumer concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent. The patient's medical history, as provided by the reporter, included an unspecified thyroid disorder. Concomitant medications reported included levothyroxine and levothyroxine sodium. On 09 Jan 2021, approximately two days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient began exhibiting short term memory loss and combative behavior. She was completely incoherent, not remembering words, could not name colors or shapes, and her short term memory was gone. On 15 Jan 2021, the patient saw a neurologist and tests ordered included a doppler and air being blown into her ear. On 18 Jan 2021, the patient had unspecified bloodwork done. No results were provided. On 21 Jan 2021, three magnetic resonance imaging (MRI) exams were conducted as well. No results were reported. On 21 Jan 2021, it was reported the patient's symptoms had not resolved and the patient had since been hospitalized. Her doctors believed she developed viral encephalitis brought on by the COVID vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent, were considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

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

I had Soreness on the arm the same day of vaccination, redness, achy in the muscle area on my arm. I think the injection was administrated to high in my arm. The within the next 24-48 hours I had a headache and was tired. About the 4th-5th day I had tingling, prickly feeling across right shoulder, down both arms down to my fingers and down my legs down to my toes. This lasted about 5-10 minutes. Then on the 16th it happened again but this time it was my whole body the torso area and my limbs. I also had weakness, I felt like I needed to hold onto to someone to be able to stand. I had an unstable feeling while standing. The headache has occurred on and off since time of vaccination about 4-5 times. I went doctor on Tuesday 2/16/2021, I did not see my doctor this time I see a different it was a lady doctor. She wasn't aware of this being one of the side effects and just to monitor myself and return if the symptoms worsen. She thought it was safe to get the 2nd dose. I have a virtual visit scheduled with Dr. on 2/23/2023

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.

My arm was sore. there was a little itching. It was later in the evening that I felt very tired. I felt warm but I didn't have a fever. I developed chills. it lasted for several hours.

Chills, muscle aches throughout body, headache and pain in left arm that made it too painful to move or use it. All symptoms except arm pain resolved within 24 hours. Pain in arm lessened to tenderness on touch and slight pain on movement within 48 hours. All arm pain symptoms were gone by 6th day after injection.

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.

Arm pain and fatigue from the first shot Arm pain, fatigue, burning breast shortly after receiving second shot and arm was painful and weak and unable to be lifted one week after second shot

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.

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

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.

I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and because of the myesthenia my breathing was compromised. On the oxymeter it showed 92 and 93 at times. Today, the 22nd February l feel better but weak and tired and my head feels funny Hard to describe. I still feel it's difficult to take a deep breath

Sore arm day of injection. No problem after. Eighth day following injection experienced redness, hard lump in arm 2-3 in diameter around site of injection, warm to touch and itchy.

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.

Patient reports that starting Wednesday afternoon she felt "yuck". Continues to state that from Wednesday afternoon until approximately Saturday afternoon she had flu like symptoms, consisting of fever, chills, aches, muscle cramps in her legs.

Had vaccine on Feb 19. On 22nd my arm became sore and itchy and developed a red rash. Up until then my arm had not been itchy, only slightly sore. The area is very warm and itching became worse on the 23. On the 24 the redness is worse and the level of itching has not changed. The red rash is about 3 inches long and from 1? to 2? wide.

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.

PATIENT C/O CHEEK BURNING AND PRURITIS. SYMMETRICAL SMILE, NO REDNESS NOTED TO SITE, NO DROOPING OF FACE NOTED. PT STATED "IT FEELS LIKE IT DID WHEN I HAD SHINGLES. HELD 30 MIN FOR OBSERVATION AT CLINIC SITE. INSTRUCTED TO NOTIFY PCP IF CONDITION PERSISTED OR WORSENED. FOLLOW UP CALL TO HER AFTER 24 HOURS-BURNING SENSATION RELEIVED ABOUT 4-5PM AND BUMPY FEELING ON CHEEK RESOLVED ABOUT 10 PM. SHE STATES THERE WERE NO VISIBLE BUMPS BUT "IT'S LIKE IT WAS UNDER THE SKIN". NO FURTHER ISSUES.

Four days after injection right foot became inflamed and hugely swollen. Top of foot and all along the outside side of it both on top and at bottom of foot all very painful. Ankle and leg very swollen and painful. Can't walk on foot. As of 2/26/2021 swelling is not as bad and not so discolored but still some swelling and redness burning and very painful and still cannot use the foot. Also have noticed places where I have had surgery or injuries is hurting and being stiff. Am questioning whether or not I should get the 2nd shot. Concerned it will make situation even worse.

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.

Upper arm became somewhat sore by later afternoon, became excruciatingly painful by later evening. Did not feel well by bedtime, and a bit fuzzy-headed. Next day, I was fuzzy-headed, body stiff and achy, very tired, upper arm excruciatingly painful. All symptoms began to clear significantly by evening, and back to normal by the following morning (2/10).

Client reports that at 1500 on 2/24/21 (same day as vaccination) she noted her lips were swelling and "tingly feeling." Client denies rash, difficulty breathing, dizziness, or other symptoms. Client advised to try Benadryl and check in with physician if needed. Client reports she has not had anything new to eat, but did have a yogurt with fruit from the local senior center and she does have a soy allergy. Follow up on 2/26/21 client explains that she took benedryl at 1600 on 2/24/21, again at 2000, went to bed, and woke on 2/25/21 and took a 3rd dose. Client reports that at that time the swelling was improved and she has not had any symptoms since.

in the middle of the night my toes turned beat red/purplish color and numb and cold started to form blisters took almost a week to get over it still have rough spots where the blisters were. Went to the dr. took my blood pressure and it was high. went for several test at the Cardiologist my blood pressure was still high and i was also having some discomfort and chest pain

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.

About 45 minutes after injection, funny feeling in face (can?t explain, maybe tingly, puffy), muscles in throat tightening. Both of these were fleeting. Following two mornings had no voice (laryngitis) first thing in the morning. Voice came back as day went on. No further issues

Patient started to feel flush in the face. She also reported a headache. She was seen by the EMS on the premises today and they obtained vital signs. Patient had elevated blood pressure but reports this is normal. After being evaluated for 30 minutes her blood pressure did improve and she reports feeling better. Nurse assisted patient to the car. Patient ambulated well to her car with no symptoms noted of change.

After the second shot, I expected mild side effects and experienced some: mild headache, sore left arm around injection site, fatigue, brain fog. I was walking to my garage with a small package of papers when suddenly my lower back spasmed sharply. The pain was intense. I thought it would subside so I managed, with difficulty, to make it into my car. When I was seated in the car, the spasms subsided. I considered not driving to my two errands but decided that I felt well enough seated in the car to drive and deliver the papers to my tax preparer and the carful of donations to Goodwill. At the tax office, I called an assistant to come to the parking lot to pick up the papers, which she did. At Goodwill, one of the attendants emptied my car. When I got home at about 10:50, I had to call my husband to help me into the house. I spent the next several hours in agony (11 on a scale of 1-10) with spasms, punctuated by absolutly not moving. The spasms were so bad I could not breathe. My doc prescribed a muscle relaxer, then the next day prednisone, which has helped. Today I will have an mri to determine if the spasms herniated a disc.

0854: Rec'd Covid vaccine 0859: About 5 min after rec'ing vaccine, pt c/o itchy throat; had previous reaction to Moderna vaccine & PNA vaccine 0903: BP 120/70 HR 62 RR 20 SpO2 98% 0904: Benadryl 25 mg po given 0908: Pt c/o sl more itchy throat & tongue swelling 0914: Itching resolved 0916: BP 122/72 HR 62 RR 20 SpO2 99% 0926: BP 121/74 HR 56 RR 18 Sp)2 100% Right arm tingling/itchy, tongue tingling/itchy again; breathing feels "ok" 0927: Benadryl 25 mg po repeated 0929: Feeling "a little bit more labored breathing"; clear lungs 0934: Feeling better 0939: Itchy throat resolving; breathing better

12 hours after 1st covid vaccine she began having swelling of the left side of her face, cheek, eyelid. She also noticed tender lymph notes in her neck on the left side. Denied any recent illness, no rash/hives. Denies problems breathing, no swelling of tongue. Seen on 2/25/21 at PCP office. Assessment by Dr. on 2/25: "mild residual soft tissue swelling noted in the cheek laterally and into the chin and skin above the left eye. There is tenderness to palpation along the left side of her neck with mild fullness of the lymph nodes.

Triggered arthritic flareup. . It caused inflamed right hip enough to jam the nerves in the right leg. Taking 2 anti-inflamatory drugs and treating for pain.

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

Ran a fever at night the first 2 days, the second day my arm started getting red, swollen and painful

3 days after I took my first Moderna vaccine on 2/4/2021,I had a reaction on Sunday, 2/7/21. The reaction was at 5:00 p.m. on 2/7, I did not feel well and my legs felt shaky and my blood pressures which are always in the 120 or 110 range over 70s or 60s were 164/86, 141/96, 199/79 and 156/132. The paramedics were called and they said it was the vaccine and my blood pressure was 151/70 at 6:15 pm.. I started to feel better but at 8 pm the same day, 2/7 m pressures from 8 pm to 11:30 pm were 158/83, 191/87, 146/106 and 144/74 and 130/67 and I was feeling better. On Monday 2/8 my blood pressure readings were normal. On Tuesday, 2/9/2021 I did not feel well at 5:00 a.m. At 5:55 a.m. my blood pressure was 188/85, 137/100, 169/89 and then was normal. The last time it happened was on Saturday, 2/13 and my pressures were 160/127 at 3:20 a.m. and 138/97. My pulse was always normal.

right after receiving covid vaccine-19 second dose , pt started having audible wheezes, can only speak 1-2 sentences, grasping for air, cold clammy perspiration, pale. Pt states she has asthma and wheezing before she came in but worse after the covid vaccine dose. pt vital signs taken . Pt restless and asking for an injection to help her breath, Sats 96% RA. Pt had 2 puffs of albuterol and with slight relief. Pt was taken to Urgent care in stable condition ( same building) for an evaluation.

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.

Arm very sore for 2 days. Third day a rash on both arms. Very itchy so I took Benadryl and it subsided. On the third day the chills started around 2:00 in the afternoon. Went to bed with pajamas ,socks ,and a robe in order to keep warm because of the chills. Woke up this morning and the chills were gone and I feel great.

pt stated that both arms and legs started tingling and aching. She stated she would would drop anything she tried to pick up or hold. Pt states her hands are still weak uncontrollable but no longer tingling and her legs are still aching but no longer tingling. Pt has not contacted her PCP at this time.

For 8 days following the injection I had a sore arm, on the 9th day the area became bright red about the size of a drinking glass lid, was warm to the touch, hurt and itched. and was hard maybe slightly swollen.. It remains that way.

March 3, 2021 Arm started itching, Arm has been sore for 3 days, warm to touch and swollen. Rash appeared around injection site and below. Size of rash 6" long x 3" across. Applied ice throughout day and evening. Found information online regarding COVID Arm reactions and pictures which looked like my rash. March 5, 2021 - rash is less but arm still swollen

12 hours after injection had tremors in extremities, especially arms and hands, lasted 45 minutes then went away. 1/2 hour later tremors got worse but only in arms and hands - went to bed and woke up fine. Today, 3/5, very dizzy, went to bed that way and still can't walk without feeing I am going to fall down.

Patient states arm was black-and-blue after the shot. Which began several days (at least 3) after the shot was given and was persistent over the course of 2 weeks. Did not have pain, but had soreness the day after the shot.

Fever as high as 101.4; Chills; Whole body aches; Whole body soreness; Weakness; Fatigue Took Tylenol Extra Strength every four hours; Increased water intake; Stayed in bed Lasted for approximately 48 hours

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.

About 4-5 hours after receiving vaccine: Severe Chills- Arms shaking, freezing, hands like ice, Temp 99.6; Tylenol, to bed sleep 4-5 hrs, Temp 100.??; sleep; awoke middle of night Temp 107.2, legs very warm to touch; into shower; Temp came down to 99.??; sleep, Temp OK. Later in day Temp 100.4. Some muscle pain but not too bad. Didn't feel good rest of day/night. Next day felt OK. All lasted about 36 hours. After 1st vaccine, I felt somewhat same as above - except Temp 104 and lower; Very sever muscle pain initially- hard to get out of bed and walk. Started 4-5 hours after injection and lasted about 36 hours. severe chills but not freezing. Taste and smell were not affected either time.

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

Began with feeling exhausted and sleepy within a few hours. Progressed to aching throughout body, painful L arm and stiff neck. By 9pm unable to elevate L arm, unable to turn head and blazing headache. Symptoms continued for 24 hours. Began to decrease and bu the 36th hour was nearly normal. It has now been 4 days since vaccination and I?ve resumed normal lifestyle......but have residual ?fatigue? in late afternoon.

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.

On day 3 there was slight swelling, tenderness and heat at injection site. On the fourth and subsequent days there has been a red rash. It is about 2+ inches wide and 3+inches long. Still quite red and tender to touch. Muscle underneath the injection site is still tender. It has been eight days since the injection. I also experienced some lethargy for the first two or three days.

Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation). The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

daily migraine headache which does not respond to medication. Initially a constant migraine type headache for 1 1/2 weeks. Then 1 day headache free. Followed by headache, followed by 4-5 days being headache free. Since then a migraine type headache daily or every other day. Sumatripin orally has no effect, tramadol decreases pain slightly, Lortab takes away pain, but head pressure still here. Just started on a decreasing doses (day two) of steroid, with no effect.

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

fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.

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.

The following day she was at the clinic (she said to make sure you knew she was a cancer patient) and experienced uncontrollable cold & shaking, they took her temperature at clinic which registered 101 degrees, and she was disoriented and unable to move to get out of her vehicle. She then reported the day after the side effects she woke up and was fine.

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.

About six hours after the second vaccine my whole body began shaking that lasted several hours. At the same time I had general malaise. By morning the tremors were gone but malaise and profound fatigue lasted through the day. By morning of the third day I was feeling better, just still a bit tired. I did not seek any treatment.

Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced of feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. Treatment information for event unconsciousness included resuscitate via cardiopulmonary resuscitation with no success. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event unconsciousness was fatal and patient died.; Reporter's Comments: This is a case of death of a 78-year-old, female patient who experienced within a few minutes of product use who experienced feeling of discomfort and became unconscious and subsequently expired. Based on the current available information, a strong temporal association between the product use and onset of the events, a causal relationship with the events cannot be excluded. However, critical details such as the patient's medical history and actual cause of death is lacking.; Reported Cause(s) of Death: Unknown cause of death

couldn't move her body at all; lay there unable to move or crawl or even pull herself up for 6-7 hours before she was discovered; no recollection of this episode of what happened to her or what she was doing at the time it occurred; she fell to her garage floor; speech was gargled; brain fog and difficulty; residual confusion; local reaction limited arm movement; local reactions such as pain; 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 local reactions such as pain and limited arm movement (vaccination site movement impairment/vaccination site pain), fell to garage floor (fall), couldn't move body at all (paralysis), lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital (paralysis), brain fog and difficulty (feeling abnormal), no recollection of this episode of what happened or what she was doing at the time it occurred (amnesia), speech was gargled (dysarthria), and brain fog is improved now but still has some residual confusion (delirium). The patient's medical history was not provided. Relevant concomitant medications were not reported. On 27 FEB 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 FEB 2021, the patient experienced vaccination site movement impairment and vaccination site pain. On 28 FEB 2021, the patient experienced paralysis, amnesia, fall, dysarthria, and feeling abnormal and due to these events hospitalization was required. On 04 MAR 2021, the patient experienced Delirium. Laboratory details was provided as CT Scan on 28 FEB 2021 and the result was normal. Treatment information was not 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. At the time of this report, the outcome of the event's, local reactions such as pain and limited arm movement,fell to garage floor, couldn't move body at all , lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital, brain fog and difficulty, no recollection of this episode of what happened or what she was doing at the time it occurred, speech was gargled, and brain fog is improved now but still has some residual confusion, 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, a causal relationship cannot be excluded.

Admitted to hospital 3/13 with encephalopathy for monitoring. Discharged 3/14. At the beginning of ED visit, Patient did not know her daughter's name. She was unable to lift her legs at home when daughter tried to help patient to dress. At ED patient was given Tylenol and fluid. Patient now recognizes her daughter and was able to get up to the bathroom with only minor assistance. During encounter, patient is awake and able to follow directions. Patient is not oriented to time, though she know she is in the hospital. Patient states that she had COVID this morning and that is the reason why she was in the hospital. Daughter at bedside helped history. Patient received 2nd Moderna COVID 19 vaccination yesterday. Daughter called but patient did not respond at noon. daughter went over to see the patient. Patient could not finish the sentence to questions. Patient could not get her dressed up by herself. Patient went to bathroom for urination but she wiped the toilet, and folded the towel. But she did not do what she was there for. Also she could not life her legs to get helped to get dressed to come to the hospital. Now patient is able to shuffle to the toilet. Now she is able to answer her name and birthday. But still patient looks confused and not her baseline. Patient has difficulty remembering her medications. Patient does remember her children's name and home address. Patient lives alone at home and daughter wishes patient to be monitored as she has not recovered completely. Hospital Course/Treatment Rendered 78/F, CC : altered mental status PMHx Endometrioid adenocarcinoma stage IA, grade 2, status post hysterectomy and BSO on 04/06/2015. Diabetes type 2. HTN. HLD. Altered mental status, Encephalopathy, metabolic, likely related to COVID 19 vaccination. Neuro status as well as hemodynamics been monitored. Fall precaution. PT/OT was consulted for home safety evaluation as patient lives alone. Neurology, Dr. was consulted. Patient refused lumber puncture in ED. CT chest - no pneumonia or Pulmonary embolism. UA - ketone positive and dehydrated but no UTI. In the morning of 3/14/2021, patient has improved and mental status back to baseline. PT deemed patient able to go home safe. Uncontrolled hypertension at ED. Gentle hydration as patient has dehydration(urine specific gravity 1.026) and continue antihypertensives such as losartan. SBP 145-165mmHg, Asymptomatic. Will continue home medication. High D-dimer. CTA chest - excluded DVT. Venous duplex US of Both Lower extremity in AM done and no evidence of DVT. Type 2 Diabetes Mellitus. continue to monitor blood glucose and continue glipizide. controlled with blood glucose 188-135.

blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm. The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism. On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin. On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient had a sore arm for about a day after the vaccination. Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound. The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate 5 milligrams AM and PM and apxaban two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week. There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021. The outcome of the events were considered as unknown. Follow up: No follow up information received.; 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.

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.

Patient visited pharmacy a few days after administration to report slight redness and irritation. Pharmacist informed patient to apply ice and take Tylenol or Ibuprofen to help with redness/swelling. Patient called today 03/16/2021 to state that the redness spread to the upper and under arm. Patient is still experiencing pain/discomfort from vaccine. Pharmacist suggested patient to seek medication attention and to inform us of outcome.

Pt. came for her second Moderna COVID vaccine shot. After 15 minutes, noted flushing and tongue swollen and shortness of breathe. Tingling in her hands and lower legs. Shaking. Pt. was transported to our ED department.

2/22 right hip spasm 2/25 right shoulder blade pain 2/30 right hip socket very painful 3/1-3/15 pain in right knee 3/15 pain now in left knee 3/16 extreme pain at 3AM in BOTH knees, thought might go to Emergency

She had her second Dose of COVID-19 vaccine in the afternoon. The next morning, she was confused, had tremors in all 4 extremities, was weak, unable to bear weight, and unable to walk. She remained in this state and bedbound for 3 days. Her husband considered taking her to the ER but was concerned that she would be alone and unable to advocate for herself due to severe confusion. She gradually regained strength and tremors resolved after 1-2 weeks.

2-3 days after vaccine pts voice changed. "I'm losing my voice." No other complaints. Denies sore throat

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

pt states that about 30 minutes after getting the vax her heart started racing and fluttering so she took her bayer aspirin and went to bed. This lasted about 30 minutes total. Next day she had a headache and sore arm. She no longer has any symptoms. Pt wanted to make a note of her size since she only 4'11" and weighs 97 lbs and doesnt do well taking any medication.

Just like what she felt during her first dose of moderna covid-19 vaccine, she had a seizure about 10-15 minutes after the vaccine was administered. The pt's episode lasted for about 5 min. She was sitting on her wheelchair and her daughter was speaking to her and holding her hand and head. Patient was responding to her daughter when daughter ask if pt can hear her. Patient did say she saw wavy lines while she was having an episode. They left after she felt fine and I spoke to daughter later that evening and daughter said that patient didn't feel tired after they got home and was eating her dinner. Daughter did speak to her mom's neurologist about the seizure that happened with the first shot and md recommended pt get second dose and not sure why she had a seizure.

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

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.

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.

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

very cold the night after shot. very tired the next day. a few days later had blood pressure and heart rate fluctuating. sore red swollen arm. md says infected.

The following Monday ,in the evening ,my arm began to hurt and itch. It has a bumpy rash around it. Its Tuesday now,and hard at the injection site. Like something is stuck inside.

@ 6:50 pm- Resident lying in bed with signs of apnea also has o2 in progress per Nasal cannula. Call bell in reach. v/s 53/20, 12, 101.5, o2 is 92%. Family choice not to send out to hospital bc resident had HX of periods of apnea @ 9:30 pm- resident had no means of life, vitals wasnt reading at this time.

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

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.

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

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.

I have had a continual burning in my right breast. I have reported this earlier and also reported it to my internist. I don?t know how to treat the burning. Please let me know

complaints of generalized weakness. Patient states she was sitting at home when she developed sudden weakness throughout her body. She states she walked to the bathroom and felt as though she was going to fall down. She reports feeling sweaty as if she was having a hot flash. She states her symptoms lasted approximately 45 minutes and resolved after arriving to the ER. She denies feeling dizzy, lightheaded, no visual disturbances, paresthesia or headache. She denies any chest pain or shortness of breath. No recent fever, cough or chills.

Heart pain immediately after the shot which lasted ~6 hours (9:15 am to ~4 pm). Nex day, 3/24/2021, right arm pain and red spots on the chest.

Burning sensation; Itching; Cellulitis; A spontaneous report was received from a consumer concerning a 79-year-old, female patient, who burning sensation, itching/ Injection site pruritis, and cellulitis. The patient's medical history was not provided. Concomitant products known to have bee used by the patient, within two weeks prior to the event, included Synthroid and Metoprolol. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 006M20A) via unknown route for COVID-19 infection prophylaxis. The patient experienced bump like a hard ball, burning sensation, redness, itching, and pain at the injection site after the first dose of vaccine. On 24 Feb 2021, the patient was referred to a doctor and was diagnosed with cellulitis. Treatment medication was reported as Antibiotics for eight days. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, burning sensation, itching, and cellulitis were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

passed out; feeling strange; started sweating; sore arm; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and tender right arm, feeling strange, started sweating and passed out. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 16-MAR-2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 16-MAR-2021 patient had a sore and tender right arm. On 19-MAR-2021, she started feeling strange, started sweating and passed out. The adverse event of passed out was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not applicable. Outcome of the events of sore and tender right arm, feeling strange, started sweating and passed out 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.

Covid Arm. Large red area appeared at injection site 7 days after second shot was administered. (Second Covid shot administered on March 24. Sore arm and some fatigue the next day. Covid Arm appeared on March 31). Slight soreness. This is the second day and it is still there. I understand that it will fade and isn't dangerous.

Told her not get the second dose of the vaccine; Doctor told her she had a bad reaction to the first dose; Partially paralyzed for about 4/5 hours on her bottom half; Little bit itchy – hair, ears, and eyes; A spontaneous report was received from a consumer concerning a 78-year-old, female patient, who experienced partial paralysis on her bottom half/paralysis, bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus. The patient's medical history included COVID-19 in Dec 2020 and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event included high blood pressure pills. On 09 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient was partially paralyzed for 4-5hrs on her bottom half. The patient had same symptoms when prior exposed to COVID-19 in Dec 2020 and experienced little itchy- hair, ears and eyes. Brain scan, lungs, heart, blood tests and neurological functions were tested when patient consulted a health care provider (HCP) hence was advised not to take second dose. Treatment for the event included Benadryl. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, partial Paralysis on her bottom half/Paralysis was recovered. The outcome of the events,bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus 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, a causal relationship cannot be excluded.

29 days after patient's second Moderna dose, she had sudden onset significant pain where she couldn't stand or walk, her left leg became swollen twice it's size, and blue. She went to the ER with no treatment. About 5-6 hours after discharged she returned with her leg turning purple and uncontrollable pain. She was diagnosed with venous thromboembolis and transferred to a larger facility where she underwent lytic therapy and venous angioplasty. She is having to go for venous stenting in the next two weeks. She continues to have pain in her leg, chronic fatigue and weakness, as well as being lightheaded with a stable BP (no orthostasis). She has been diagnosed with anemia since vaccination and is being worked up for that.

Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. 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. This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. 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.

Friday, April 2nd, in the late afternoon, I began to feel very weak . I had difficulty breathing throughout the night. Saturday, April 3rd, from the moment I woke, I had difficulty focusing due to severe dizziness and extreme weakness, unable to function normally. Shortness of breath continued and I remained in bed throughout the day. Today, April 4th, I am stronger, but unable to physically do more than necessary because of tiring easily with the weakness.

Pt stated she was unable to walk and had dizziness. She had to be assisted to chair. BP was 170/60 and a pulse was 60 bpm. Pt stated that she was breathing but felt unable to take a deep breath. Pt stated that she had problems opening eyes and leaving them open. also reported headache . Pt reported chilling and was having tremors possibly related to being cold.

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.

Pt developed stroke like sx the morning after second COVID vaccine including weakness and numbness of R extremities. PCP ordered MRI the following Monday that showed an acute lacunar infart of the L periventricular white matter between the caudate nucleus and thalamus, likely embolic from untreated afib and CHADS-VASC 4.

Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemic crash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and VACCINATION SITE PAIN (Arm soreness). On 21-Mar-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic crash) (seriousness criterion hospitalization), MUSCLE SPASMS (Feet cramping), HYPERHIDROSIS (Sweating) and FEELING COLD (Feeling cold). The patient was hospitalized on 21-Mar-2021 due to HYPOGLYCAEMIA. At the time of the report, HYPOGLYCAEMIA (Hypoglycemic crash), MUSCLE SPASMS (Feet cramping), FEELING ABNORMAL (Brain fog), HYPERHIDROSIS (Sweating), FEELING COLD (Feeling cold) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

First on 4/5, and again on 4/8, patient reports blood coming from the "hole in my arm from the vaccine." It stopped after applying pressure. The arm was "really sore" initially after injection, but she did not not bleeding at the time of injection. She noted a scab had formed, but no rash. When bleeding started, she did not feel the scab had just been rubbed off. "There's only the hole there." She describes a very tiny hole, not a scar or sore. Among her chronic medications are a baby aspirin daily, and a generous dose of fish oil: 2,000mg BID. Her last platelet count was 185,000 / uL on 2/11/21

Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. Pt went to the hospital and was later called to come back to the hospital because she had a blood clot. Pt was sent to clinic and had a procedure by to remove clots. Pt states that the clot was "2/3 size of thigh." Pt states that she is scheduled to have a second procedure in May to remove blockages from iliacs.

High blood pressure 170s-200 approximately one week after receiving the vaccine; Dizziness; Difficulty speaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) 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. The patient's past medical history included No adverse event (Medical history was not provided). On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) and APHASIA (difficulty speaking). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to HYPERTENSIVE CRISIS. At the time of the report, HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine), DIZZINESS (dizziness) and APHASIA (difficulty speaking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided The patient's wife began experiencing dizziness, high blood pressure that ranged from 170s to 200, and difficulty speaking approximately one week after receiving the vaccine. Treatment for the events, 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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

The day following the injection, the patient experienced fever, chills, fatigue, aches. She began wheezing significantly and had tremors. Oxygen levels dropped to 82-84% which persisted following two albuterol nebulizer treatments. She was taken to the emergency department and was admitted for 2 days for oxygen and steroid treatment.

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 ??

She got her vaccine, and within a couple of hours had fever, cold chills, achy body, fatigue. The following week she lost her taste, and ever since she has cold chills constantly, is weak, cannot do anything. She is light headed, her vision is sometimes blurred and will not go away. She has been taking Tylenol for fever. She went to the ER because it was so bad, and they did a CT scan, EKG, chest x-ray for pneumonia, and did blood work. They could not find anything wrong with her. She has also been to her doctor who checked her over and could not find anything wrong either.

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.

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.

Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh. The patient scheduled to have a second procedure in May to remove blockages from iliac. Action taken with mRNA-1273 was not applicable. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.

Fatigue for 2-3 weeks. Sore arm for 10 days. Shortness of breath for 2 weeks. All symptoms have resolved.

10 minutes after receiving the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.

Came to see PCP on 4/8/21: Left Shoulder pain- she had a steroid injection in this shoulder years ago for pain, but the pain returned after she received her first COVID vaccine in that arm. Referred to Physical Therapy. Patient also c/o "hot flashes in her back" She was rx Lyrica.

About 10 p.m. on 2-22, sore arm. About 2 a.m. on 2-23, very dizzy During the day on 2-23, headaches, muscle aches, fatigue About 7:30 p.m. on 2-23, chills and fever

Diagnosed with rhabdomyolysis; Found on floor with knee in an awkward position; Strength has not come back in legs and now needs a walker; Did not have strength to lift legs to go to bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) and JOINT DISLOCATION (Found on floor with knee in an awkward position) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol. Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Did not have strength to lift legs to go to bed). On 12-Mar-2021, the patient experienced RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) (seriousness criteria hospitalization and medically significant), JOINT DISLOCATION (Found on floor with knee in an awkward position) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker). The patient was hospitalized from 12-Mar-2021 to 18-Mar-2021 due to JOINT DISLOCATION and RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis), JOINT DISLOCATION (Found on floor with knee in an awkward position) and ASTHENIA (Did not have strength to lift legs to go to bed) outcome was unknown and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker) had not resolved. Treatment for events included fluids and shots in knee. 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.; 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.

collagenos colitis; Migraine; the arm starting hurting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (collagenos colitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer, Chronic pain (left arm), Colitis collagenous and Mastectomy bilateral on 20-Oct-2011. Concurrent medical conditions included Headache. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye, COLECALCIFEROL (VITAMIN D 3) for Nutritional supplement, LORAZEPAM for Sleep disorder NOS. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COLITIS MICROSCOPIC (collagenos colitis) (seriousness criterion medically significant), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting). At the time of the report, COLITIS MICROSCOPIC (collagenos colitis), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had previous health issues and these problems returned with vengeance. The patient had a history of headaches but mild she started having migraines. The patient had breast surgery and had previously had problems in her left arm because of infections and had 12 surgeries. The arm got better and haven't had any pain in years. The arm was started hurting again. The patient was diagnosed with collagenous colitis. It hasn't bothered her in many years. It was back and worse than ever. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and non-serious unexpected migraine and pain in extremity. Event onset 12 days 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. This case was linked to MOD-2021-075459 (Patient Link).; Sender's Comments: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and nonserious unexpected migraine and pain in extremity. Event onset 12 days 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.

she has a bruise about the size of a quarter around the injection site. It is red and hot to the touch that goes from the injection site down her left arm about 4 inches. her arm was sore for about 3 days but now it is itching. Pt still has these symptoms today and are not improving.

When she stands up it still hurts; large broken vessel about the size of a nickle; leg was itching; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of VASCULAR RUPTURE (large broken vessel about the size of a Nickle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure, Thyroid disorder NOS and Cholesterol. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (leg was itching). On 08-Apr-2021, the patient experienced VASCULAR RUPTURE (large broken vessel about the size of a Nickle) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (When she stands up it still hurts). At the time of the report, VASCULAR RUPTURE (large broken vessel about the size of a Nickle) and PRURITUS (leg was itching) outcome was unknown and PAIN IN EXTREMITY (When she stands up it still hurts) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Ultrasound scan: abnormal abnormal (abnormal) a large broken vessel about the size of a Nickle. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included acetaminophen. Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; 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.

Tingling in arm, anxiety , refused to fo with EMT. We gave her Benadryl and monitored for 45 minutes, she got better and went home

I had tender areas on the inside of my left leg starting about mid or late March in the upper thigh region and some aching in the inner aspect of the calf portion of the leg. This became worse over the Easter weekend and I went to clinic on April 6, 2021. I had a superficial blood clot just above the knee on the inner aspect of my left leg. After that appointment the redness and soreness and very hard feeling of the veins extended up my leg 8 to 10 inches. I did not have a blood clots in the deep veins. I have had some varicose vein?s and surgery for such about five years ago. The clinic did not say the clot was due to the vaccine but I had no injuries, no recent surgeries and nothing unusual that would have caused the clot other than the vaccine

Was given shot very high up right below my shoulder. Am still in a lot of pain. Am now able to use that hand but unable to sleep in bed. And unable to lift my arm above shoulder height without experiencing extreme pain. This is 2 weeks after receiving the shot.

Early morning after 2nd vaccination, 2/19/21), patient was what is best described as in a comatose type state. Symptoms where unresponsiveness, fever (101 degrees), unable to eat, drink or open eyes. Was able to suck on a washcloth. The following day, 2/20/21, same symptoms as day before but fever went down. Took blood sugar in the morning and it was good. Was able to give minimal liquids by a bottle. Got about 4 ounces of water in about 2 days. On 2/21/21 around midday patient was able to get out of bed and was on way to recovery.

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.

Within about 45 mins . after I received the shot (and had left the facility), I was driving home and began to feel the left side of my mouth (my lips) swell up (as if I had been give novacane at the dentist), then the area under my left cheek bone began to swell up as well; nothing hurt, I had no chest/back pains (had a double by-pass 16 yrs. ago, no further heart problems), no pain, tingling, in arms, legs; my doctor's office is closed Friday afternoons, so went to Emergency Medical office where was diagnosed with Bell's Palsy; went to my own doctor following Tuesday; swelling had decreased, on and off; by Saturday (i.e. one week after the shot) I also had a red very itchy rash on my left arm at the vaccination site; swelling still not gone by third week after shot, so went to my ENT (allergist) who said it was not Bell's P., recommended not getting 2nd shot; then (4th week after the shot and still some swelling around the cheek) went to my Cardiologist, did EKG, all OK, but he said both the rash and swelling were allergic reactions and I should not get the second shot - so I will not get the second shot. Now (7 weeks from shot, am still "aware" of lips and cheeks - not exactly swollen, but like an injury that is not completely healed - this occurs when I am "tensed up" about something (l trying to get to an appointment on time :)

Patient had eyes closed and was not responsive 10 minutes after getting vaccine,. Pharmacist checked breathing and pulse which were ok. 911 was called to check out the patient. She did not go to the hospital.

Severe exacerbation of autoimmune symptoms. Ten weeks after shot, still mostly bedridden with very low energy and flu-like symptoms. Increased MCAS symptoms. CCI worse.

After first shot, only side effect was a very sore arm, could hardly raise it for a few days. Did not affect life. Same after second shot until 5 weeks later. Woke to being VERY dizzy! This did, and has continued to, affect my life. I am walking with a cane, using a grabber, can't bend over to anything below table height. I didn't drive for 2 weeks, now afraid to leave town. on my own. Since I am prone to these episodes, I wasn't too concerned, because they do pass, BUT I am still having the issue, daily. I understand that so many unknowns are with the Covid-19 vaccination. My hope is that this DOES pass and I don't have to live with it the rest of my life! Thank you for taking my symptoms.

Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot; Woke up shaking; Eyesight effected; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot) (seriousness criteria hospitalization prolonged, disability and life threatening), TREMOR (Woke up shaking) (seriousness criterion hospitalization prolonged) and VISUAL IMPAIRMENT (Eyesight effected) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in March 2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by the patient, within two weeks prior to the event, included seizure medication. Treatment for the event included intensive care and stroke unit. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event 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. However, Very limited information regarding this event has been provided at this time. Further information has been requested.

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.

woke up and had chills and shaking then a very bad headache until about 5am i got up and took some tylenol slept about an hour then got up and felt bad the rest of the day slept off and on all day

Admitted with generalized weakness, lethargy, and muscle aches for a couple weeks (since receiving vaccine). Planned to rule out atypical PNA. Blood cultures positive for bacteroides, likely abdominal source. Abdominal CT scan showed portal vein thrombosis, confirmed on MRI.