Moderna

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.

Pt c/o having 'weird feeling/not feeling good' and increase heart rate about 7-8 minutes after receiving vaccine. Pt denied any shortness of breath at the time, no swelling of face, BBS clear and equal with equal rise and fall of the chest wall, alert and oriented X 4, able to speak in complete sentences. Progressed to report 'lips feeling like they are swelling approximately 18 minutes after the vaccine was administered. 911 was activated. Epinephrine 0.3 mg IM via epi autoinjector was administered to left thigh. Pt still c/o feeling that her lips were swelling 8 minutes after first dose of Epinephrine; therefore, another dose of 0.3 mg Epinephrine IM via epi autoinjector was administered to left thigh. Diphenhydramine 25 mg IV was administered 2 minutes after second dose of Epinephrine. IV fluids administered as well, while awaiting arrive of EMS. EMS arrived on scene approximately 30 minutes after called. Blood glucose was 120 mg/dl approximately 25 minutes after vaccine administration. Pt report feeling better after the 2nd dose of Epinephrine and Diphendydramine and 500 ml of Normal saline IV. Pt was transported via EMS to the ER for further evaluation and treatment.

3:45 AM awoke with dizziness and loss of balance. 4:57AM awoke again with more intense dizziness and loss of balance; stubbled, fell in bathroom. Symptoms have persisted of state of drunkenness' when walking and head is feeling "weird".

One week after receiving the vaccine shot, my left upper arm from should down began to itch. Slight red, under the skin 'rash' could barely be seen. The individual spots did not seem to be the specific irritant. The arm around the shoulder was somewhat achy and tight feeling. I was able to sleep through the night after rubbing on Sarno-anti itch lotion. Could not get comfortable on my left side, with the shoulder area hurting.

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

Received the second dose of Moderna on Friday afternoon at 3 p.m., Awakened in the middle of the night with significant muscle pain. Unable to sleep. Was unable to stay awake on Saturday. Slept almost all day. I took no medication. Did not seek medical care. Used my Series E Apple watch to monitor my heart rate: 80 bpm average. Side effects were gone by the next day, Sunday.

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.

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.

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.

Began to have slight wheezing and coughing on Wed afternoon, the day after getting the shot. Thursday wheezing and coughing increased and woke me up during the night several times. Cough was productive with clear sputum. Friday felt very tired all day and coughing and wheezing increased substantially, producing shortness of breath upon any exertion, like going up and down the stairs. Very tired. Began to think I'd have to go to see the Dr. because wheezing was significant with every breath. Cough was racking, increasing through the day into the evening. At 10 p.m. I began to wonder if I'd make it through the night without calling the rescue squad. Couldn't take a deep breath or speak a whole sentence with out a coughing jag. Then, suddenly about 11:30, it just ceased. The tightness in my chest went away, the coughing with every inhalation stopped and I could take a deep breath. It was a bit stunning. Because I had pulmonary embollisms about ten years ago, my lungs have been a weak spot in my body with bronchitis occurring frequently. I hadn't seen reports of this side effect of the vaccine, so I thought I'd report it. This morning, Saturday four days after the shot, I am breathing much better, not coughing, and do not have any wheezing.

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

Starting on 1/31/21 patient was very fatigued and continued to worsen until today (2/3/21) where the patient's son called 911. The patient was in a complete haze and very foggy. The pt would not open her eyes or respond when her son would ask her any questions. EMS arrived and did not take her to hospital. Stayed with her in the home for awhile and waited for recovery. EMS had her eating and drinking until she would open her eyes. They advised son to continue to give her liquids to continue recovery.

Evening of vaccine patient felt chills that lasted through out the night. Patient got up Sunday morning and passed out, fell to floor. Patient reports that once she woke up it was about 15 mins before she could get off the floor. All day Sunday felt very fatigued and rested. Then felt "foggy" on Monday.

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

Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar. The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported. On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.

About 3:00 p.m. of day of injection, head felt "fuzzy" and I felt somewhat unsteady upon standing and walking. Today, next day, I feel a little better.

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".

About 9:00 pm in the evening I first noticed an unusual racing of the heart while watching television. It subsided and I proceeded to bed. About 10:30 while in bed and reading it occurred again and continued for a few minutes. It continued to wake me a couple of times in the night before stopping about 4:00 am. No further occurrence so have not sought medical assistance.

tested positive for Covid 19 on 1/17/2021 - fever, chills, slight cold - no problems after 5 days, returned to work after 10 days quarantine with no symptoms. Hospital decline to give me second dose on 2/3/2021 as scheduled, stating I would have to start over in 90 days.

Emergency Medical Technician was on-site during clinic performing medical observation of vaccine recipients. Patient complained of feeling light-headed and general uneasiness. BP taken by EMT was 170/90 and pulse 72. Patient was aware and able to walk on her own. Patient walked to her vehicle, assisted by EMT, but she returned to the building because she still wasn't feeling well. EMT contacted emergency services for transport of the patient to Hospital ED.

Approximately 9:00 PM, experienced severe chills, after having zero side effects all day. She went to bed, and could not get warm. She was unable to use body muscles, could not stand without help, and was conscious, but was unaware of her surroundings. She started regaining muscle control about 12:30 AM, but still no awareness of things around her. Next morning, she was fine, with no remaining side effects. It should be noted that she had a small glass of red wine about 30 minutes before experiencing chills.

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.

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 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.

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

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.

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.

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

Approximately 10 minutes after receiving 2nd dose of Covid-19 Moderna vaccine, patient began to have difficulty breathing. Husband reported that she has a history of panic attacks. No swelling in throat was noted. Instructed patient to take slow deep breaths. 911 was called. Vitals obtained with blood pressure 118/80, respirations 30-35 per minute, SP02 at 97% on room air. Patient was transported via ambulance to Hospital. Spoke with the ER and she reports that patient is doing fine, they diagnosed as anxiety and gave her Ativan . Patient discharged back home.

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.

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!]

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

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

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.

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.

The following day after my injection, I had bright RED hives all over my body except for my face and hands. It was very uncomfortable. I tried to calm my skin with lotions. As the days progressed, the color receded and all of my skin started to peel. It was terrib ly itchy and difficult to wear clothing. It took about a week for it to calm down, and the peeling continued for another week.

Initially, itching at injection site. Five hours later, swelling at injection site with itching spreading down arm to above elbow. Difficulty sleeping. Next day, lethargic with other symptoms continuing. Next day, swelling decreasing but itching continuing. Noticed a small cyst in upper arm the size of a small pea. Energy has returned.

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

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.

Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results normal. On the day I write this (March 1) continue to have shorter periods of rise in blood pressure and heart rate, diaphragm tightness, insomnia and lethargy.

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.

moderna COVID-19 vaccine EUA mental fogginess. no physical symptoms. not tired. for example, I usually update my financial records to the nearest dollar. I left the information several dollars out of balance. I lost interest in personal phone calls after 10 minutes.

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

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.

Patient presented to ED with altered mental status and leg weakness at home causing fall. Ammonia 89, being treated with lactulose for hepatic encephalopathy. Patient currently admitted.

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

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.

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

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!

Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.

sx APPROXIMATELY 20-30MINS AFTER: Facility nurse reported feeling light headed, heart rate was 44 bpm, feeling cloudy, fatigued

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.

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

Second Covid Response to Moderna I had a very severe reaction to she second Moderna shot (3/4/2. I went grocery shopping the afternoon after I had my shot at about 11am. Everything seemed normal, but after 20 minutes I was in an episode of the Twilight Zone . I bought the wrong products, I also bought several of the same thing. I bought products I never would have bought and had never purchased before. Then I got home and was feeling still like I was in the Twilight Zone. (nothing seemed real). Soon after I fell on the floor and could not get up. My leg and back would not work. Then I started to urinate and could not stop. Buckets came out and every time I tried to get up, I fell completely flat again. The urination lasted from early afternoon till about 6:30 pm. Then I went to bed and stayed there till morning when I could get up and walk. Meantime I had to wash my bedding, 3 pairs of pajamas and seven pairs of under pants. One of the times I fell, my foot (which was recovering from a burn across my toes) and I jammed it between the wall and the bed, causing a break. Also the first night I took the shot, I could not get to sleep until 4am (my cat and I were stuck watching Robo Cop till it ended at 4am. I?m now in a boot-cast, and will get an x ray tomorrow. I should let you know I take Sartaline HC, 100 mg once a day and Clonazepan, 1 mg 3 times a day.

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!

extreme tiredness, brain fog and memory lapses, redness and blister on arm , NOTE: After a week, still very tired

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.

fine for first few hours then some swelling at shot site the need to lay down hit and I as out for 35 hours. Ended with flu like symptoms. Had covid in Dec 2020 with a 5 day hospital stay. The 35 hours was unnatural and mentally fuzzy. Very concerned about a second shot.

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.

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,

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"

Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21. On 3/16/21 She developed symptoms of fatigue, chills, body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest. In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE. patient did not have previous pulmonary disease. Additional information for Item 19: studies: PO Chest Final Result Stable chest. No new opacities are identified in this patient with known extensive bilateral pulmonary embolus. US Venous Duplex Lower Extremity Bilateral Final Result 1. Acute DVT involving the right popliteal and posterior tibial veins. 2. No acute DVT involving the left lower extremity. CT PE Protocol WITHOUT legs Final Result 1. Positive exam: Large-volume central pulmonary emboli seen in both main pulmonary arteries with extension bilaterally into all lobes. Dilated right heart chambers suggesting acute right heart strain. 2. Peripheral groundglass opacities in the right upper lobe may represent small area of pulmonary hemorrhage or developing infarct. Red Level 1 findings were entered into the system. | Actionable Findings system for documentation and communications on 3/22/2021 4:31 PM, Message ID 191499. 3. Pulmonary nodules in the right lower lobe measure up to 4 mm maximally. See below consensus guidelines. TTE - INTERPRETATION SUMMARY: Left ventricle is normal in size. There is normal left ventricular systolic function. The quantitative LVEF based on modified Simpson's method is 62%. There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm. There is mild (grade I) diastolic dysfunction with normal left atrial pressure. Right ventricle is normal in size. There is normal right ventricular systolic function. No previous echocardiogram in Froedtert Health system for comparison.

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.

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

Woke up in middle of night to use bathroom. Experienced severe dizziness, felt like brain was sloshing around inside my skull. Had trouble keeping balance. Returned to bed, slept, experienced same dizziness in the morning when I woke up. Felt better after having breakfast but very tired throughout day. I took it easy and dizziness cleared up about mid day. fortunately my husband was here to help. I would have gone to clinic if symptoms had continued. It is now 4/3/21 and I am not experiencing anything but slightly sore arm where vaccination was.

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

feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99). On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering. On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache. Event onset on Day 4 after first dose mRNA-1273. Main 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.

Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking cough, rapid heartbeat, miscellaneous pangs around body, earaches, edginess, swollen feet and face. Started about 4/06/21 and beginning to subside around 04/11/21

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.

Within one hour pt began feeling "weird" and developed right sided pain. Went to local fire department and was transferred to hospital with severe right side pain. On 3/26 underwent removal of galbladder. Discharged to home 3/27 Has since consulted her liver sp3cialist regarding the galbladder attach and her liver failure and the effect of the vaccine on her condition

Had a spike in blood pressure (194/100); Increased heart rate; Toe injury/Minor bruising; Trouble sleeping; Sleeping pattern has changed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) 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 Insomnia. Concurrent medical conditions included White coat hypertension. Concomitant products included CALCIUM for Calcium supplementation, MELATONIN for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) (seriousness criterion medically significant), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed). At the time of the report, HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 194/100 (High) High. Two weeks after receiving the vaccine the patient had trouble sleeping and sleeping pattern was changed. The patient reported that she had a spike in blood pressure (194/100) and increased heart rate when she went for doctor's appointment. She has white coat syndrome. The patient was prescribed Ativan 1-2 times a week as needed (after sleeping pattern changed). The patient consumed a cup of wine to help her fall asleep. On 06-Apr-2021 or 07-Apr-2021, the patient had a toe injury which caused minor bruising and sleep problems started around that time. 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, 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, Further information has been requested.

shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment include Benadryl and Tylenol.. Event Start date and stop date updated. 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 28-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: 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.

I have Tinnitus. All tests have been performed and I have been "living with it" for almost 20 years. After my secon shot it's been getting increasingly louder. I have been waking up in the night due to the intensity. I did not consult my doctor because I thought it was part of my usual Tinnitus which they always say cannot be cured.

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

Has felt run down and not right since second shot on 4/22/2021, then started with TIA like symptoms 6/2/2021, and found to be bacteremic.

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.

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

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.

On 04/01/21 patient presented to Emergency Department with altered mental status and fever. Husband stated that at baseline patient has no dementia and speaks and interacts normally. He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified). He said beginning 04/01 in the morning she was not acting like normal self. She was not speaking as much as she normally does. He stated she did fall on 03/31, but does not believe she struck her head. He said her behavior was normal yesterday. She does not walk since a seizure 3 months ago. No shortness of breath or cough was reported. He stated her chest seemed red earlier but that has resolved. The patient was unable to give history and not responding to questions. Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.

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.

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.

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

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.

12 hours after receiving vaccination, became "delirious" temp rose to 103.+ with chills malaise, joint pain, "head hurt worse than did during active Covid + HA lasted 2 days". Temp gradually decreased to 100 over 2 days. Injection site had "fever" for 3 days still sore 5 days later PCP ordered prednisone and z-pak for symptoms

5 minutes after vaccination started to feel "Funny" and "Distant". Treated with PO juice. Feeling continued x30 minutes, sent to Urgent Care and diagnosed with anxiety

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.

1/16 injection site was extremely sore and disturbed my sleep. 1/17 the soreness was improving. There was a small rash 1/21. 1/23 the rash got heated and very itchy and I could not sleep. I applied Biofreeze. The rash is the same but irritation has calmed down.

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.

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.

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.

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

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.

Pt. C/o pain onset in Left arm, about an hour after receiving shot. Said pain was severe and requested pain medication. No redness or warmth noted, pt. unable to complete ROM with left arm and pain radiated from shoulder to elbow. Pain persisted through night and the next few days after disrupting her sleep and ranged from mild to severe. Continued to tx with Tylenol and ice packs. Res. does not want second dose.

started hurting same day of shot. i cried. i cant lift my arm at all. i cant dress or bath or anything. my shoulder is swollen. I can only lift it with my other arm. pain goes up my shoulder to the back of my neck and up my head. The shot was given in the muscle and joint. It was am immediate pain.

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

Within approx 12-15 minutes of injection, I began to feel slightly light-headed. I didn't say anything at the time, because it was so slight, and I attributed it to being a little nervous. It continued, for perhaps hours 3 or so hours, getting slightly worse before subsiding. I had eaten my usual breakfast in the am before I went for my injection.

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.

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.

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

Her vaccine was in the afternoon on 2/11. She had no adverse effects for the rest of the day. Today, 2/12, she woke up and did not know where she was and she could not speak in complete sentences. She was unable to dress herself or bath herself. This has persisted throughout the entire day. She has a temp of 101.5 F. She did likely have Covid (undiagnosed) in December and had the same symptoms for about one week. They had since resolved and she has had no other issues since then until today.

c/o dizziness Patient disoriented to name and year for about 3min when medical and EMS arrived. Mental status back to normal after 3min. Reports anxiety, denies chest pain, SOB, palpitation, dizziness, headache. BP: 117/65 ( sitting), 147/71 ( standing) HR: 94 Sp02: 98% No acute distress, seen and cleared by EMS

Severe left shoulder pain, awakened from sleep at approximately 1:45 AM, 9 hours post injection. Unable to return to sleep secondary to pain.

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.

77 YEAR OLD FEMALE COMPLAINED OF A FUNNY BACK AND NECK AFTER SHE RECEIVED THE VACCINE. ONSITE EMS AND PHYSICIAN RESPONDED. IT WAS RECOMMENDED THAT SHE GO TO THE E.R AND SHE REFUSED AND WENT HOME

Got the vaccine, went home and got home around 3:00, and all of a sudden she was extremely cold, put another blanket on, and got a heating pad and put it on her feet. She was lying in bed, her heart was hurting to the point that she could not move it. Around 8:00 she put the electric blanket on, got warm but she would still get a cold chill like she had ice water in her veins. Was this way all night. She had a fever, the swelling on her arm. She did not throw up but just the chills, fever. She tossed and turned all night until about 3:30 this morning. She then took 1/2 of Tylenol, dozed off. She is still cold, not as cold as she was. The arm is also still sore.

"brain Fog", anterograde amnesia to the events of the day. lost track of what she was doing and where she was for brief moments. Noted leg weakness on the right.

Three hours (9:00pm) after receiving the shot in Left Deltoid muscle pain started. Getting progressively worse it radiated from neck under Left ear to end of fingers in Left hand Pain was so extreme that I took 2 - 500mg tylenol at 10:30pm. Pain evident without even moving. At 3:30am (2/17) I took 2 - 200mg Ibuprophin. Unable to sleep. At 9:30am took 2 - 500mg tylenol. Called pharmacist explained to him the pain. He said he probably hit a nerve upon injection. Take tylenol and ice it 20 min on and off. Today Friday 2/19 I am still in pain even with meds. Not as severe but still have limited motion. Scale of 1-10 with out motion about 2-3, on motion 9-10. Is there anything else I can do?

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

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

Four days after the 2nd dose, my blood pressure became elevated to 140/80. I went to the Emergency Room where the following tests were performed: BMP, CBC with Differential, Flu/RSV//Covid PCR, Troponin Ohr (initial), Urinalysis reflex Microscopy/Culture, CT HEAD BRAIN WITHOUT CONTRAST. Findings: No evidence of intra- or esttraaxial hemorrhage, mass effect, midline shift, hydrocephalus or acute transcortial infarct, No acute intracranial pathology. Cardiac silhouette and pulmonary vesselas are within normal range. No infiltrate, pleural effusion or pneumothorax. Impression: No acute disease. There were no other event occurences in my life to generate anxiety. Also General muscle

fever: 102.8, chills, muscles aches, "fuzzy" head, took 2 advil, fever broke after few hours, aches remained for 42 hours, repeated advil twice during that time. much better now (vaccination was working)

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

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

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.

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

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

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

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

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

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?).

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.

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.

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

Body aches and sore at injection site night of second injection. Morning after, fever at 101.4, body aches, extreme fatigue. By afternoon, temp had dropped to 100.3. Still very tired, aches diminishing. Slept poorly that night. Temperature normal on second day, still a little tired. Back to "normal" on third day.

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.

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

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.

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

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.

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

C/o dizzy, lightheaded, shaky. Assess: - LOC, - NIV. VS 132/86, HR 96 Reg, + SOB, Resp 22 reg nonlabored. Within 5 min PT state I feel much better. Only had a muffin earlier. Encourage hydration & nutrition. Resp came down to 16 reg non labored. Daughter with her provided encouragement. Anxious about getting vaccine. Refused to wait 30 min. OK'd to exit. RN

Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; 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 vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19. The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided. On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up. On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic. On an unknown date post hospitalization, the patient tested positive for Covid-19. Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test 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 event, a causal relationship cannot be excluded except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-033912:

Patient sitting in recovery post vaccination. She began crying and complaining of a severe headache. EMS over to assist and evaluate patient. Workup completed. 20 mg of Labetalol given IV by EMS. Patient taken to local Emergency Room for further evaluation. Son contacted by phone to inform of situation. Son to meet patient at Emergency Room.

Vaccine hit me so hard; Couldnt move any part of my body; Brain fog; This spontaneous report from was received from a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine hit me so hard/vaccination complication, couldn't move any part of my body/ hypokinesia and brain fog/feeling abnormal. The patient's medical history and concomitant medications were not reported. On 28 Feb 2021 the patient received her second dose of mRNA-1273 (Lot number: 012A21A) solution for injection intramuscularly prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient experienced a strong reaction and couldn't move any parts of body. She said the vaccine hit so hard. She had brain fog. She's never experienced anything like that. She got stuck on the garage floor for so long until her daughter and son in law came to rescue her. She was taken to the emergency room Sunday evening (28 Feb 2021). On the night of 03 Mar 2021, the patient was released from the hospital. As of 04 Mar 2021, the patient felt better. The hospital performed CT scans and she was hydrated with IV fluids. The outcome of all events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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.

Started with headache and mental confusion within a hour of first injection. Right eye was becoming blurry by day 3 and loss of vision apx 6 days after first injection.

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

Within 8 hours of receiving the Moderna vaccination (dose 1), I could not raise my left arm parallel to the floor, extend my arm or lie on my left arm/shoulder. It has been 6 days, and it is somewhat better, but still quite limiting in what I can do. I sure wish I was told that this could happen. I have osteoarthritis, and i rely on my left arm/shoulder when I take the stairs and do daily activities. I am in a lot of discomfort and my activities have had to be quite limited.

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.

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.

Pt explained that she was sleeping and her cat woke her up, she said her heart was pounding and it wouldn't stop so she drove herself to the hospital thinking it was an anxiety attack. Upon arrival pt was examined and told it was likely a myocardial infarction and transferred to another hospital for higher level of care per pt.

Too ill to get out of bed for about 24 hours. I was not this sick when I actually had COVID in November. Feeling a little fearful about getting shot #2 since I hear the reactions with shot #2 are often worse than with #1.

Mom became agitated. Would not sleep. Stayed continuously awake for approximately 40 hours. Could not be redirected. So tired she was swaying on her feet, but could not be convinced to lay down. After 2 days we were able to get 50 mg Trazadone from our doctor. After sleeping for 6-8 hours she then did another 24 hours awake. We upped the dose to 100 mg. By this point the event had started to pass. During this time we also noticed mom was running a low fever in the morning. 99.5 - 100.5. It would go away in the afternoon. During this time mom was hallucinating - having conversations with people who were not there. Mom's hearing declined during the event as well. As of 2 days ago mom's temperature seems to be back to normal in the morning. This "event" has impacted mom's mental and physical decline. She seemingly overnight now needs help showering and toileting, and sometimes dressing. (This kind of decline is common for dementia. Each time over the past 5 years that mom has had some physically stressful even such as hurting her foot or getting a bad stomach virus, she has come out the other side degraded) The reason I'm reporting this is that the behavior changes were sudden, seemed to peak, and then subside. There is a correlation with the second moderna shot, and so I though it was important to report.

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.

She got moderna vaccine at 9:30 AM. She started to get itchy lips and fuzzy tongue shortly after immunization given. This is a similar reaction as when she has had carbocaine and novacaine. She is having no breathing issues. No facial swelling. She got benadryll at 10:04 AM. She notes that has helped - the burning in her throat is better now after the benadryl. She is currently feeling like she still something in her throat, wants to clear it. Were better then throat scratchiness occurred and same throat burning and foreign body feeling returned. Epi pen given in office and patient was sent to the ER. Her vitals were stable and she had her son here who felt comfortable transporting her to the ER.

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.

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

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

Owner emailed the following message on 03/23/2021, "Patient was feeling not good after the vaccinations and we call 911. She refused to go to hospital . Today she did do good and we call 911 and they took her because her oxygen dropped down . As of now she passed away"

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.

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 was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) 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. The patient's past medical history included No adverse event (No reported medical history). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome 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.; 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.

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

balance was weird; left side of head, above my ear felt like something inside my head popped and liquid drained; felt really terrible; she thought that maybe she was hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (she thought that maybe she was hallucinating) in a 77-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 Dyslexia and Thyroid associated orbitopathy (Unspecified Allergies). On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible). On an unknown date, the patient experienced HALLUCINATION (she thought that maybe she was hallucinating) (seriousness criterion medically significant). On 12-Feb-2021, HALLUCINATION (she thought that maybe she was hallucinating), BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible) had resolved. No treatment medications were provided. Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.

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

pt developed acute confusional state w paranoia, delusiona, AMS. irrational behaviour w outbursts, required hospital security team to hold pt for nurse to administer Haldol shot

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.

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

palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my heart was skipping beats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Contrast media allergy and Drug allergy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ROPINIROLE, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN CALCIUM (ATORVASTIN), FAMOTIDINE, LORATADINE and PANTOPRAZOLE MAGNESIUM (PANTOPRAX) for an unknown indication. On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization), DIZZINESS (light headed), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats). On 13-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). The patient was hospitalized on 19-Feb-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (palpitations), HEART RATE IRREGULAR (irregular heartbeat), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats) outcome was unknown and DIZZINESS (light headed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 13-Feb-2021, Heart rate: irregular (abnormal) Irregular. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. About 9 days later she experienced irregular heartbeat. She was seen by a physician and treated with Metoprolol. Upon receiving at first she felt weird, light headed and that night she starting heart palpitations. It felt like her heart was skipping beats. She called doctor and had an electrocardiogram (EKG), and then she went home. The heart palpitations continued to get worse and she went back to doctor and was admitted in the hospital on 19-Feb-2021. She was continually working with her doctor. 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-Apr-2021: added patient contact details (address, email ID, phone number), patient demographics (height, weight, race), added patient's allergies, concomitant drugs and events (palpitation, weird feeling, dizziness, heartbeats skipped); 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.

Congestion, stuffy sinuses fill up drain and repeat. Feels like lump in throat and cannot get deep breath in for 8 weeks. Anti histamines no help. Anxiety after 4-5 weeks. Lack of sleep due to drainage and asthma.

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

Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mild Brain pause) 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 report provided by the reporter. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Mild Brain pause) (seriousness criterion medically significant), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head). At the time of the report, MENTAL IMPAIRMENT (Mild Brain pause), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The rechallenge was positive. This case was linked to MOD-2021-114463 (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.

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

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.

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.

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

Starting one day after vaccine patient began to feel funny in her legs, that progressed to not being able to walk well. She stayed a few days in hospital and by discharge had improved but not recovered to baseline.

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.

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

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.

5/23/chest discomfort. Hiked pain going uphill. went to Clinic care. They did ekg -negaitve. Dx me as Costa Chondritis and rx prednisone 6 -1st day to 1- 6th day Pain abated somewhat at first by 6th day could not sleep from the pain. Admitted into hospital 5/31 for stress test 5/31. Negative discharged. Returned 6/4 admitted second time in hospital. Placed on iv antbiotics . 5/7 83 cc removed from cardiac sack and 6/6 6oocc removed from left lung sack. Pain abated. all lab tests negative no cause found for this strange event. I am a daily workout person. I do hike and yoga and taichi.

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.

Within 3 hours, I had aches and pains and fatigue that lasted 3 1/2 weeks. A week later, I came down with bronchitis. I was on antibiotics for 7 days. The bronchitis got better but the pains and fatigue did not. That lasted another 2 1/2 weeks. I was sleeping 11-12 hours a day because of the fatigue. I felt better in 3 1/2 weeks and three days later received the second shot.

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.

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.

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.

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.

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.

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

I DON'T KNOW if this was a reaction to vaccine: I felt "weird" for a few seconds, so I decided to take my blood pressure and heart rate. HR 185, BP 90/57. I continued to monitor and over next 90 minutes my HR went to 165 then 175, back to 165, and my BP got as low as 57/37 and everything in between that low and 90/57. After about 90 minutes both HR and BP stabelized to 112/90. I have never had any heart issues. I have felt fine since then.

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

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

Approx 3 hrs after the injection, I felt tightness in my throat like a lump, then noticed a blotchy vibrant red rash over both arms, legs, neck and shoulders. I took Benadryl, Claritin and Pepcid ( these were meds previously recommended for my daughters allergies). It took about 30 mins after the meds to be able to swallow comfortably without coughing. The rash however lasted three weeks. I has a telemedicine consult with my allergist who was hesitant to advise the second shot.

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

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

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.

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.

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.

Patient complained of headache, lightheadedness and anxiety. Observation awake, alert and anxious. No wheezing. Initial blood pressure was 190/100 pulse 92 . Lungs clear. After 5 minutes of observation symptoms unchanged. 170/90 pulse 90 . Extra systoles on pulse palpation. Administered 12.5 mgs Benadryl p.o.. No change in symptoms, no further improvement in blood pressure and pulse. Patient remained anxious, lives alone, transported patient to emergency room.

12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID test; Positive Bamlanivimab; treatment/infusion; 3 hours 15 days isolation 1/18/2021

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.

Area around injection site got very itchy, sore with a bump in it and a rash formed. Happened before I went to bed and I had a restless sleep. No fever in morning and symptoms disappeared as day went on. Rash lasted two days

Experienced non-serious but severe side effect (pain). Unusual fatigue 7 hrs after injection. Awakened at about 10:30 p.m. (12 hrs after injection) with extreme pain at/around injection site. Very extreme pain. Had me yelling ow!ow!ow! Pain seemed to become generalized across shoulders and to right arm. Most acute phase lasted about 30 minutes. Fatigue and pain gone by next morning. All seemed normal. But every night since (including last night, 2/6/21), in the middle of the night, I have again been awakened by serious (but not nearly as extreme) pain at/around the injection site. Always gone by morning, although slight ache remains.

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.

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

Patient received Moderna COVID 19 vaccine EUA. Patient reported to nurse that she was "feeling weird" along with chest tightness at 10:30 am. Patient placed on non-rebreather and oxygen a 100% wide open. Vitals taken every minutes. EMS called at 10:36 am. Patient declined EMS. Patient monitored for one hours. Patient left clinic with her daughter.

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

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.

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

2/9/12-1st lightheaded, metallic taste in mouth, dizzyness, high systolic BP x3, q5 min: 186/80, 180/80, 153/83, normal systolic 120, HR WNL. Ct feels reaction r/t anxiousness prior to vaccination, 'I don't like shots' , Ref to PCP, appt w/ ENT on 03/02/21.

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.

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

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.

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

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).

Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.

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.

I got the shot in the afternoon of 2/24. I went home and had dinner and went directly to bed about 6. I didn't wake up until 3 am on 2/26.

Moderna rec'd last Thursday, the injection was pushed in deep and by the evening the pain at the injection site was unbearable, she injected pretty high in my arm and it started to sting. After 4 hours the pain was unbearable and my range of motion was limited and the it feels very hot. I cant sleep because of the pain and have to take Motrin to even function.

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

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.

Patient had COVID-19 with pneumonia at the end of December 2020 and recovered. Received vaccine in mid February and 2nd dose of vaccine on March 3rd. Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.

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.

Experienced Shortness of Breath about 3 minutes after the vaccine was admistered. BP 168/80 - O2 sats 99. STated feeling better and slight notice of breathing. Shortly thereafter HR 34-40 briefly and not feeling right. EMS called. HR quickly returned to baseline in the 80s. BP 173/80. Patient has a history of HTN and did not take BP meds that Am. Given a lighter surgical mask as patient's mask felt "thicker than normal". EMS arrived, vitals were stable. Patient was feeling better, no more SOB. Patient cleared and released.

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

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.

Patient presents today with complaints of probably shingles under her right axilla area extending inward over the right breast somewhat as well as around to the upper portion of the back along the bra line. She started with pain in the area about 3 days after receiving her 2nd Covid Vaccine and the rash developed a few days after that. Terribly painful and she is finding it hard to be comfortable. She is having issues sleeping due to the discomfort. She has no fever. No other symptoms. Wounds do not appear infected.

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.

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.

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.

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.

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

9:35 am Daughter stated "she spoke to her mother and she didn't answer her she had a blank stare like she was out for a second then she answered me" Mother pt c/o of "feeling whoozy" Assess: When nurse arrived to vehicle pt AAO no SOB, no LOC - N/V VS taken 168/94, HR 80 reg, strong, Resps 18 reg non labored, SpO2 96%. daughter stated "it wasn't like a seizure, her mother doesn't take her medications correctly" No list of meds. Changed monitor to 30 min. gave water for hydration. Pt stated anxious about getting vac. L del vac site benign. - red, - swelling. - facial swelling. Provided reassurance Monitored VS BP elevated 178/96, 80. Advised to call primary to update, V-safe . pt stated "I feel good now, not dizzy" after 30 min OK'd to exit.

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

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.

3ays after shot massive depressive episode, suicidal. 4 days after, exhaustion, muscle weakness (I normally walk 2 - 4 miles daily)- this continued for almost two weeks. Along with weakness, extraordinary "brain fog", vertigo, loud tinnitus (buzzing). 2 1/2 weeks in I found an elliptical itching rash at the vaccine site. almost a month later I'm still suffering from dizziness, brain fog, and exhaustion. 2nd dose due 26th March and I'm scared to proceed.

Additional side affect on Saturday night episode where my lips became numb, my balance was unsteady, and I had difficulty walking, my head was foggy-- and additionally I felt shaky inside. Just as if you have the shivers. This is in addition to my events with the headaches. I am very worried about the second shot in the vaccine.

Headache and loss of balance within 1 .5 hrs. after vaccine, recurring, at 8:30 pm. Recurring next day at noon and then at 12:00 am. My lips became numb( like I had a nova cane shot) upon standing I had difficulty with balance and walking and my head felt foggy until 3 A.M. I almost called 911. I took Tylenol, Claritin and Pepsid and finally felt better. On Sunday my head felt foggy and my balance was not good. Then again on Tuesday, I had intermitent episodes.

Patient has a history of anaphylaxsis. Vaccine was administered at 9:46am to right deltoid. At 10:15, patient described feeling a little bit funny. The patient complained of tongue swelling at 10:20am. Vitals signs Heart Rate 61 BP 152/62 spo2 was 97%. At 10:25, the patient was assessed by an on site APN and was administered Benedryl 50mg IM. She was placed in a supine position. At 10;52am, the patient reported feeling better and was discharge to home setting.

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

I ended up passing out while driving home, hitting a fence and totaling out my car. For about 4 days after was very depressed and would randomly start to cry multiple times during the day.

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.

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.

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.

Noted change of consciousness in evening following vaccination. She had a tonic gaze to the right when EMS 1st arrived at the scene. She was not having any overt epileptic activity. She is normally very debilitated and moderately demented but conversational and jovial according to the daughter. She is normally able to be fed, taken to the toilet, and has no trouble with day-to-day living. She was brought to this hospital day after vaccination. She was alert at the time of the vaccination. She had COVID in August of this last year. In ED, she was given a very small dose of Ativan. She had immediate effect from this with resolution of the tonic gaze, developed a voluntary gaze and had minimal but clear-cut purposeful conversation. She was also able to move her extremities after the Ativan. Prior to that she was fairly rigid in her extremities. She did not have any obvious seizure activity however. She was transferred to another hospital for higher level of care and continued management.

Respiratory arrest and was out; Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen; Cough that felt like coming from another human being; Felt crappy; Covid red arm; Intermittent Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy), ERYTHEMA (Covid red arm) and CHILLS (Intermittent Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029120A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (patient reported hypertension as one of the health issues that she has.). On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY ARREST (Respiratory arrest and was out) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen) (seriousness criterion hospitalization), COUGH (Cough that felt like coming from another human being) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt crappy) (seriousness criterion hospitalization), ERYTHEMA (Covid red arm) (seriousness criterion hospitalization) and CHILLS (Intermittent Chills) (seriousness criterion hospitalization). At the time of the report, RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy) and ERYTHEMA (Covid red arm) outcome was unknown and CHILLS (Intermittent Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Erythema: (abnormal) (big - diameter 3.5 X 6 inches). In February 2021, White blood cell count: 15.5 (High) Her white blood cells were 15.5. In February 2021, X-ray abnormal: (abnormal) lung X-rays were horrible and was "tanked" due to all the diaphragmatic breathing (could not breathe). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received treatment with 3 antibiotics, steroids and oxygen. Patient reported that they wanted to intubate her and ativan was pushed by RN. Patient was on "vent mask" that delivered oxygen and was in cardiac intensive unit for 4 days and then the doctor decided it was not covid or pneumonia and were looking at cardiac issues.They had to give Narcan to reverse the effects of Ativan. Patient stated in the call that Moderna pushed her off the end of the cliff and reports that prior to this she was healthy and walked daily on regular basis. Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder. This case was linked to MOD-2021-065711 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder.

pt had 2nd dose of covid vaccine on 03/16 went home got something to eat laid down- does not remember anything else for 2 days was found on the floor by her bed must have fell off of the bed has lost urine neighbor found her- call paramedics declined to go to hosp thinks she passed out for 1.5-2 days daughter came to take care of her had to drink from straw couldn't eat brain fog feeling better now

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

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

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.

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 :)

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.

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

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

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

hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic lymphocytic leukemia. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Concomitant medication was not reported. Treatment of these events were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described This case was linked to MOD-2021-104070 (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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described

My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later. She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th with an other doctor and when she asked if she had any other issues, pt. showed her her leg. The eye doctor immediately told her to go to urgent care. When she did she received blood thinners and started injections in her stomach for 5 days. Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room. She was transferred over to another facility in the afternoon and kept overnight. She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks. She also had a check up about her leg, which was still swollen. On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after. By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital. She was monitored and kept over night, but during the early morning she suffered a stroke and a heart attack and passed way the next day.

Pt c/o headache, muscle weakness, anxiety, flushing/sweating. Pt indicates that they have a hx of adverse rxn reported w/ first vaccine dose but no VAERS was submitted by clinic staff at that time. Clinical review cleared patient for second dose. Pt assisted to bed. Abnormal vitals. BP 251/91 (133), HR 82, RR 21 -- > 237/84 (120), 70, 17. Pt denies hx of HTN, NKA. Physician advised patient to go to urgent care d/t elevated BP; pt verbalized understanding. After 5 mins pt denies and HA, verbalizes feeling calm, muscle weakness resolved. Pt ambulating w/o c/o dizziness. Patient taken to Urgent Care/ER by private car.

Felt lightheaded; Neurologic event; left cheek, arm and leg on the left side felt numb; can't stand on the left leg; falling; fell in the bathroom and cut eye and got black and blue, knocked head; pain; fever of 99 and something, which is high for her, usually her temperature is around 97; aches; sleeping a lot; weak, could not get up, right hand is weak, progressive weakness; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak, could not get up, right hand is weak, progressive weakness), HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020621A and 003AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes, Hypertension and COPD. Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, SERTRALINE for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) (seriousness criteria medically significant and intervention required), HYPERSOMNIA (sleeping a lot), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches). On 29-Apr-2021, the patient experienced HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb) (seriousness criteria medically significant and intervention required), DYSSTASIA (can't stand on the left leg) (seriousness criteria medically significant and intervention required), FALL (falling) (seriousness criteria medically significant and intervention required) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) (seriousness criteria medically significant and intervention required). On 30-Apr-2021, the patient experienced NERVOUS SYSTEM DISORDER (Neurologic event) and DIZZINESS (Felt lightheaded). The patient was treated with Rehabilitation therapy for Asthenia; Rehabilitation therapy for Hypoaesthesia; Rehabilitation therapy for Dysstasia; Rehabilitation therapy for Fall; Rehabilitation therapy for Injury; Rehabilitation therapy for Nervous system disorder and Rehabilitation therapy for Hypersomnia. At the time of the report, ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) and NERVOUS SYSTEM DISORDER (Neurologic event) had not resolved and HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling), INJURY (fell in the bathroom and cut eye and got black and blue, knocked head), HYPERSOMNIA (sleeping a lot), DIZZINESS (Felt lightheaded), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches) outcome was unknown. Events began after second dose of vaccine. Treatment included ibuprofen. Patient was taken to an emergency room on 30-Apr-2021. CT scan (computed tomography) and blood tests performed. Patient was not admitted to the hospital, but was transferred to a rehabilitation center. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded.; 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.

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

Severe weakness in both legs. I couldn?t walk. Dizziness and mental confusion. I was taken to the ER. Blood and urine samples taken, chest X-ray, ECG, and was told I had a UTI and was prescribed a course of antibiotics for 10 days and discharged.

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

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

Muscle joint aches, terrible headache, 106 fever and slept for 36 hours. I had hives spots again and i grabbed the leftover predinione and took them. I went to the doctor and she gave me another prescription of predinisone.

She got her vaccine, she was fine, drove herself home 5-10 minutes, felt fine until her arm started to feel hot and a rash broke out. There was lump at the injection site. Then she felt like she had a lightening strike through her body, and felt like she had the flu the next day. She could not move and it lasted only a day and she stayed in the bed, and it went away. She had a low grade temp of 100, normal temp 97. She then woke up on Wednesday with a rash at the injection site to the elbow but used hydrocortisone cream which did not release the pain and used a cold compress to remove the heat from her arm. The cortisone cream did not work and she called the doctor who prescribed Benadryl cream and Benadryl to take (allergic to). Cream worked, Benadryl made her sick so now lists that as an allergy. She then took Claritin and it worked, but the rash remained. She got a rash then on the back of her right thigh, and she had hives on both knees (one on each knee and on the elbows). The rash on her arm was there and had to use cold compresses and eventually by Friday of that week it subsided . Annoying due to the itching, but not painful. The rash on the thigh went away the next day. Also had rash on her buttocks, which went away the next day as well. Has been fine since the Friday after the vaccine. She saw her doctor who told her to take the shot, her son is a Dr. and they told her to take it. All of her family members and friends had no reactions.

developed anxiety; Chest tightness/chest congestion; shortness of breath; it felt like she had asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (atropine- high fever and vomiting) since 1952. Concomitant products included GEMFIBROZIL and AMLODIPINE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), ASTHMA (it felt like she had asthma) (seriousness criterion hospitalization) and CHEST DISCOMFORT (Chest tightness/chest congestion) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (developed anxiety) (seriousness criterion hospitalization). The patient was hospitalized on 10-Mar-2021 due to ANXIETY, ASTHMA, CHEST DISCOMFORT and DYSPNOEA. The patient was treated with GUAIFENESIN (MUCINEX) for Asthma and Dyspnoea, at an unspecified dose and frequency; LORAZEPAM at a dose of 1 dosage form; SALBUTAMOL SULFATE (VENTOLIN RESPIRATOR) for Asthma, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) on 04-May-2021 for Asthma, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal. On an unknown date, Troponin: negative (Negative) negative. Patient height was 5 inches. Action taken with mRNA-1273 in response to the events were 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. This case was linked to MOD21-032955 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow Up information was received on 01-Jul-2021 Patient demographics updated. patient medical history updated. Concomitant medications provided. Treatment medication was provided Start date for the events updated. Case is upgraded to serious and seriousness criteria included hospitalization. Outcome of the events updated ( from unknown to not resolved).; 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.

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

Two days following Covid vaccine2,I woke up with severly painful red left eye. I went to opthamologist on emergency. Treated for split/cornea above above the pupil, then covered with contact patch & given antibiotic & drops for redness; returned for several follow up visits w/associate, Dr. who continued treating me even with oral antibiotics to try to treat the severe redness now in both eyes. He also prescribed Rx for dry eyes. I was referred to eye specialist. Dr. diagnosed as immune reaction to Covid vaccine. I saw all Drs. still visual impairment persists!

Polymyalgia rheumatica; Pain interfered with sleep; Pain in buttocks 2nd dose; pain in trapezius muscle 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cervical spinal stenosis (The stenosis was treated) in November 2020, Arthritis of neck (The Arthritis neck was treated.) in November 2020 and Parathyroidectomy. Concurrent medical conditions included Latex allergy and Hypothyroidism since 07-Mar-2003. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 26-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 5:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). an unknown date, the patient experienced INSOMNIA (Pain interfered with sleep). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 200 milligram and PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), INSOMNIA (Pain interfered with sleep), ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Basophil count: 0.05 (Inconclusive) The value was 0.05 10E3/uL (reference range: 0.01 to 0.08 10E3/uL). and 0.4 (normal) The value was 0.4 percent (reference range: 0.0 to 1.0 percent).. On 16-Apr-2021, Blood alkaline phosphatase: 127 (High) The value was 127 (high).. On 16-Apr-2021, C-reactive protein: 28.60 (High) The value was 28.60 (units was not mentioned).. On 16-Apr-2021, Eosinophil count: 0.15 (normal) The value was 0.15 10E3/uL (reference number: 0.03 to 0.51 10E3/uL). and 1.3 % (normal) The value was 1.3 percent (reference range: 1.0 to 9.0 percent).. On 16-Apr-2021, Haematocrit: 38.3 % (normal) The value was 38.3 percent (Reference range: 34.1 to 44.7 percent).. On 16-Apr-2021, Haemoglobin: 12.2 (normal) The value was 12.2 g/dL.. On 16-Apr-2021, Lymphocyte count: 11.4 (Low) The value was 11.4 percent (reference range: 18.0 to 51.0 percent). and 1.30 (Inconclusive) The value was 1.30 10E3/uL (reference range: 1.02 to 3.25 10E3/uL).. On 16-Apr-2021, Mean cell haemoglobin: 28.6 (normal) The value was 28.6 picogram (reference range: 23.5 to 32.6 picogram).. On 16-Apr-2021, Mean cell haemoglobin concentration: 31.9 (normal) The value was 31.9 g/dL (reference range: 31.4 to 35.2 g/dL).. On 16-Apr-2021, Mean cell volume: 90 (normal) The value was 90 fL (reference range: 76 to 98 fL).. On 16-Apr-2021, Monocyte count: 0.77 (Inconclusive) The value was 0.77 10E3/uL (Reference range: 0.23 to 0.70 10E3/uL). and 6.7 (normal) The value was 6.7 percent (reference range: 4.0 to 12.0 percent).. On 16-Apr-2021, Neutrophil count: 79.9 (High) The value was 79.9 percent (reference range: 37.0 to 73.0 percent). and 9.14 (High) The value was 9.14 10E3/uL (high) ( Reference range: 1.43 to 6.19 10E3/uL).. On 16-Apr-2021, Platelet count: 315 (normal) The value was 315 10E3/uL (Reference range was 158 to 384 10E3/uL).. On 16-Apr-2021, Red blood cell count: 4.27 (normal) The value was 4.27 10E6/uL (reference range: 3.67 to 5.15 10E6/uL).. On 16-Apr-2021, White blood cell count: 11.5 (High) The value of white blood cell count was 11.5 10E3/uL (Reference range: 3.3 to 9.4 10E3/uL).. On 12-May-2021, Albumin globulin ratio: 0.88 (Low) The value was 0.88 (low).. On 12-May-2021, Anion gap: 2 (Low) The value of Anion gap was 2mmol/L .. On 12-May-2021, C-reactive protein: 9.4 (High) The C-reactive protein value was 9.4 mg/L (reference range: 0.0 to 9.0 mg/L).. On 12-May-2021, Light chain analysis: 2.56 (High) The value was 2.56 mg/dL (Reference range: 0.33 to 1.94 mg/dL)., 1.74 (High) The value was 1.74 (high). and 1.47 (normal) The value was 1.47 mg/dL( Reference range: 0.57 to 2.63 mg/dL).. On 12-May-2021, Protein urine: 5.0 (Low) The value was 5.0 mg/dL.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other relevant concomitant medication included multiviamins. Treatment information included Acupuncture. On 12-May-2021, the patient was referred to a rheumatologist with various x-rays and blood work. On an unknown date, the patient was diagnosed with polymyalgia rheumatica. The pain interfered with patient's sleep. On 15-May-2021, the patient underwent the following laboratory tests with no result. The laboratory tests were as follows: foot complete bilateral, hand bilateral, chest two view, wrist complete bilateral, glomerular filtration rate, creatinine comment, ana screen with reflex, component four complement, component three complement, comprehensive metabolic panel, c-reactive protein, creatine kinase, sedimentation rate and hepatitis C antibody. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended On 08-Jul-2021: Additional significant Follow-up was received on 08-Jul-2021: Patient details, suspect product details, medical history, event details and lab tests 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.

Increased problems with speech, finding words, and confusion. Cannot answer the phone anymore. She seems to be more needy, shuffles (new onset), and incontinence problem has returned. Did not have an office visit as a result of adverse event.

Two weeks after 2nd dose of Moderna developed upper lip swelling and all over red, blotchy, itchy rash. This continued after decreasing dose of Prednisone and prescription antihistamine. Second dosing (increased time) of Presdnisone taken with no relief. Continued with increased itch, Started Allegra 180 mg daily and prescription cream to be applied twice a day. Also prescribed Hydroxyzine to be taken at night to control itch and help me sleep. Now 3 months later, starting to see rash greatly decrease. Stopped "green" pill, changed laundry products to all -clear and changed shampoo and conditioner, All had no effect on decrease in problem.

Pt reports the day after vaccine feeling chills, slept all day, felt "out of it.". 7/28 she noticed her arm was red and swollen. advised these would all be considered normal side effects. Need to monitor arm. If size increasing please notify dr. If getting smaller should resolve on its own. All other symptoms other than arm have since resolved.

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

This vaccine was administered on 12/23/2020. On 12/30/2020 I experienced intermittent headaches (waking me during the night), very heavy pressure between the breasts, fatigue and extreme redness, swelling, itching at injection site. I went to emergency clinic on 1/1/2021. The performed blood work, EKG, Chest X -Ray, took vital signs and all were normal. All symptoms have disappeared as of today, 1/2/2021, except the redness and extreme tenderness at injection site.

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

1/19/21: ER visit for evaluation 1/20/21: Hospital admit due to increased confusion and possible sepsis. Principle Problem listed: Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction; Acute encephalopathy SIRS likely due to COVID-19 vaccine but no current evidence of acute infection. Her acute encephalopathy is likely due to her SIRS response in the elderly and does not require acute intervention other than support.

Day of injection arm a little sore. Next day (Friday) felt perfectly fine and spent the day at home doing usual house cleaning and laundry. Felt fine in the evening and Saturday morning was extremely fatigued, loss of equilibrium, and elevated blood pressure. This condition remained for a few days and on Tuesday my pressure was somewhat down and I saw my doctor. He suggested that since I was doing a little better had NO other symptoms such as fever or chills or muscle aches I would be better in time. It was a rough week feeling so unlike my self but I pushed through. I see the doctor again on Tuesday the 26th. I have never had any reaction to any other vaccine such as flu or shingles vaccine at any time. I am an active woman who exercises and walks to the beach near my home frequently every week. I am anxious about the second dose of the vaccine. I have an appointment on Thursday, February 4th. Hopefully all my strength will have returned by then. I feel like I'm still only 80% back to normal. I have spoken to a young woman who called me back. I would like very much to speak with a medical person who can give me some feedback on my response to the vaccine. That would be reassuring that I am not alone with these side effects. Thank you.

Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78. Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.

Patient called over nurse and stated she felt like her heart was racing. Vitals taken and pulse 64-72 and regular. Patient states she is feeling very emotional and she states she thinks this is anxiety. Patient reassured and monitored until 2 :20. All symptoms resolved and patient states she felt fine prior to discharge

SYMPTOMS: SEVERE, SORE/STIFF LEFT ARM - COULD NOT RAISE MY ARM TO TAKE MY SHIRT OFF AT NIGHT - HAD NO MOBILITY. SUBSIDED OVER A PERIOD OF 72+ HOURS. 1 WEEK LATER THE SEVERE SORE/STIFF SITUATION REAPPEARED, COULD NOT TAKE MY NIGHTGOWN OFF THE NEXT MORNING AND COULD NOT PUT A SEATBELT ON OR DRIVE, DRY MYSELF AFTER A SHOWER, ETC.... THIS CONDITION, WHILE IT HAS DIMINISHED TO A POINT, BUT NOT COMPLETELY HAS BEEN PRESENT FOR 3 WEEKS. 1/25/21 I RECEIVED MY SECOND VACCINE IN MY RIGHT ARM. WITHIN 3-5 MINUTES I HAD A BURNING SENSATION AT THE SITE OF THE LEFT INJECTION, I AM WRITING TO YOU ALMOST A WEEK AFTER THE SHOT AND THE SORENESS STILL PERSISTS. THE RIGHT ARM WAS SORE AT THE INJECTION SITE ONLY LIMITED AFFECT ON MY ARM MOVEMENT. THAT HAS SUBSIDED A BIT. BUT MY LEFT ARM IS STILL A PROBLEM. I HAVE BEEN IN TOUCH WITH BOTH MY DOCTOR AND MODERNA. IN EACH CASE THEY BOTH RECOMMENDED ADVIL AND THAT I SHARE MY REACTION WITH ALL OF YOU. THIS HAS BEEN A VERY LONG A DIFFICULT REACTION TO THESE 2 VACCINES. I RECOGNIZE THAT ANY REACTION IS BETTER THAN COVID BUT THIS SERIOUS REACTION IS UNEXPECTED. THE DOCTOR'S ASSESSMENT BOTH TELEPHONE AND IN-PERSON VISIT, ASSURED ME THAT IT WAS NOT HEART, ROTATOR CUFF OR BURSITIS RELATED. THE DOCTOR SUGGESTED IT WAS MOST LIKELY A VACCINE RELATED EVENT.

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

Had reaction in November to tetanus vaccine. Had flu vaccine with no reaction. Then had this vaccine, no reaction initially, came home, feeling fine but an hour later had flushing in her left ear, just creeping over to her eye and the side of her face. This lasted for about 15 minutes and left the feeling of something not quite right around her eye. Nothing compared to her reaction in November from a tetanus booster. Still has the feeling but not an adverse reaction. Then at 10:00 PM all of a sudden her face went really hot, and presumed she had a fever, started feeling badly. Started walking around the house, took Tylenol. That feeling lasted for about 30 minutes and resolved. Went to bed and did not feel anything but a funny feeling. All symptoms have subsided except for a weird feeling around her eye.

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

Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @ 0732 for workup. "Patient states that she got her Covid vaccine 3 days ago, had 1 day of myalgias, flulike symptoms, yesterday she felt much better however she felt that her heart was beating irregularly and she was feeling anxious. This persisted through the night. She denies any chest pain, shortness of breath. Patient is scheduled for follow-up with her cardiologist later next week." Afib, tachycardia, palpitations. Rhythm self converted. Given NS bolus and discharged home without further escalation of care. Entered by PSS for tracking.

(1) fatigue beginning at 7pm, (2) from 2am until about 2pm the next day: headache, body aches (arms, legs, back, neck), chills, fever 101°, heavy fatigue, sleeplessness, (3) high blood glucose levels all the next day. (4) At this time injection arm still sore, somewhat lightheaded,.

Felt very nervous , jittery and shaky approx. 45 min after injection and lasted approx. 60 minutes. It went away and did not return.

Awoke on 1/10/2021 with severe arm pain in left arm. Unable to lift arm. Thought odd that it hurt in arm opposite injection site. on 1/12/2021 pain extended to right arm, next, down towards elbows. Acitivities of daily living difficult. Pain severe in morning, better throughout day, but still painful. Unable to lift arms, pick up items. Hips begain hurting within a week. Started prednisone 2/2/2021 with very significant relief of pain. Weaned every 3 days until 20 mg - continue to take 20 mg until seen by rhuematologist. Continues to have morning bilateral arm and shoulder pain, improving throughout day, although not always complete relief. In addition, vertigo started on 1/8/2021 and continues.

Moderna COVID-19 Vaccine EUA On Jan. 28th my knees and hips began to hurt. I have osteoarthritis in my left knee and right hip as well as a left hip replacement and right knee replacement I thought perhaps the pain I experienced was weather related as I had not experience pain in these joints like this before. I went to bed that night about 9 p.m. and was experiencing more pain in my legs. The pain kept me awake most of the night and I got up about 4:30 a.m. By then I could barely walk. The pain was not only in my joints but felt like it was in my bones as well. My skin on the lower leg felt tight, almost like my legs were swollen, but they did not appear to be. My right leg hurt the worst. I still have a discolored spot on my arm where I had the shot. It is about a 1/2" diameter. It does not hurt.

At 1:30 a.m. on Tuesday, February 2, 2021 (88 hours after my vaccination) I I was awaken with horrific itching on both hands and wrists, I was scratching so hard I thought I would tear my skin. At times it went up my arms and there were red blotches on my wrists and arms. After a shower at 3:00 a.m. I went on the couch until 8:00 when I awoke in a complete fog with itching that was subsiding and gone by noon. I was just 'slow' the rest of the afternoon.

She was in bed after her vaccine, she had to go to her sisters to get her to sign a will. She actually slept for 4 days. Tuesday was the worst day, it got slightly better. She was just feeling lousy. She felt fuzzy and weak. On 2/8/21 her temp was 97.3, she felt well. On 2/14/21 and it was 97.5, before that she had been in bed and did not take her temperature. Today she is feeling like a human being, but does not feel as though she is functioning normally mentally. She is upset about her sister who is dying and plays a large part in how she feels mentally.

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

Within 15 minutes of the vaccination, the patient reported scratchiness in her throat to an RN. I was notified and immediately went over to the patient. She did not have any chest tightness, chest itchiness, or swelling of the throat, mouth, tongue, or facial areas. No visible rashes. Patient then reported the scratchiness in the throat to me and seemed to be panicked. I recommended one dose of 25 mg diphenhydramine. Roughly 15 minutes after the dose, the patient told me the scratchiness went away. She was given a glass of water with the dose of Benadryl and had another full glass as well. She was continuously monitored throughout the process.

with first injection muscle was toxic for 36 hours, T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours as couldn't lift head even to drink water. Second injection was toxic for 36 hours , T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours,also temp of 100.4. When I could drink I took a tylenol. questionaire did not ask, but I had covid in mid August

2nd dose lot #042L20A. Had not reaction the 1st shot. 2nd shot (Tuesday) within few hours was cold and tired. Next morning (Wednesday) temp which is normally 96.9 was 100 in am and 102 in pm. Was extremely exhausted. Oxygen sat which is normally 99 was running around 92. Next morning (Thursday) temp 99.9 and was exhausted all day. I can not say if aches was from COVID as I am always somewhat achy. Friday woke up feeling great but with a few hours started to feel strange - took blood pressure and was 102/56 in am. Later in afternoon was at 136/90. Oxygen sat back to 99 all day. Blood pressure been running high since.

Patient received her Covid 19 Vaccination on 2-11-21. I counselled her about side effects and asked her to wait 15 minutes. She waited and as she was leaving she fell to the floor and hit her head. The other patients around her said it looked like she slipped, but when speaking to her it seemed that she had become dizzy and fell. I spoke with her after she fell, she did not loose conscienceness, but was disoriented. She did know what day it was, who she was and where she was. She said her head hurt and she could move all her limbs. I asked the store director, to call for an ambulance. I sit with her for a few minutes and talked to her, then asked store director to stay with her until the ambulance arrived. They arrived and spoke with her and decided to transport her to the hospital. Later that day, her sister in law came by and said she was doing fine and had been released. The doctors indicated they thought she because dizzy due to dehydration

Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3 Red rash over both arm pitts, below breasts, upper thighs, Rapid heart pulse, irregular pulse, called and visited Cardiology Clinic for Ekg confirmed PVCs Day 4 Light headed, dizziness affecting gait, forced lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5

She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth. Her cheeks were swollen, she felt that maybe her tongue was as well. She got the liquid Benadryl and let it stay there and it helps that feeling. She had taken the Zyrtec and Singulair the night before. She did the inhaler puff in the morning, the feeling did not go away. She then took the Ventolin and it seemed to calm down. The symptoms then went away and didn't come back, and thought that she was ok. She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do. She is fine now.

On Feb 21, fever of 101 discomfort in arm, extreme tiredness. Difficulty sleeping. On February 22, fever of 99.1 , increased redness, heat, and swelling at site (about the size of my palm). Iced site for about an hour and took citirezine antihistamine. Feb 23, today AM temp 98.6, perhaps size of swelling has decreased. Still painful to raise arm there. Can do all household activities.

Pt felt "off" some minutes after receiving vaccine. reported to staff and fainted upon standing. eased her to floor and elevated legs. regained consciousness immediately. called 911. heart rate low blood pressure normal. clammy before faint quickly regained color. EMS took over and transported pt to hospital

Started 5 hours after shot severe arm swelling and redness and confusion. Arm pain and mental fog for 3 days and then started to improve. Still 10 days out and feels like extra effort to concentrate and started had busted blood vessels on vaccine arm and back. swelling and tenderness almost resolved.

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

It has been exactly 2 weeks since the shot was given of Maderna. I still have a red rash that itches and burns on my arm. Hard to sleep at night. It seems to be getting worse.I will visit my general practice physician tomorrow.

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

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

This woman had her first Moderna Covid 19 vaccine on 3-2-21 around 9:30am. Nothing significant or different occurred in this woman's day after her vaccine. Her husband had to wake her up for an appointment around 7:00am, which is unusual for her. She usually wakes on her own around 6:00am. She was moderately confused, unable to dress herself, or care for herself to get ready for the day or her appointment. She did not remember that she had an appointment for an MRI this morning. Her MRI appointment was scheduled for 9:30am and he did take her for that appiontment. He was not allowed to go back with her. He did call Dr. office. She is out of the office and they referred her to the Clinic. He stated he would not take her there. I referred him to take her to the Emergency room, which is just down the hall from where she was having her MRI. He isn't sure how well she will do without him and she is not able to care for herself or understand basic instructions to undress, lie down, etc. He stated that he will likely take her to the Emergency room since her doctor is not available to see her.

When patient returned to the Covid Vaccine clinic for her second Covid vaccine on 3-1-2021, she stated after receiving her first Covid Vaccine on 1-25-2021 she experienced a vivid dream/nightmare that night. She stated she does not have a history of nightmares. Patient woke up crying she stated. Also stated had mildly sore arm for one day after vaccine. It was suggested to her she sign up for V-Safe after receiving her second vaccine.

Dizziness and trembling following shot. Slight sinus inflammation. Steroids prescribed. Dizziness and head disorientation continued after prescription over. Took blood. Everything including thyroid and electrolytes were normal. Dizziness and unsteadiness left after 19 days.

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

About a week after I got the shot my whole upper arm was red and itchy. I had fever and chills, that didn't last long- 2-3 hours maybe. A week after I got a not in my throat. I went to my Dr he did an ultrasound and sent me to an ENT. The ENT did an ultrasound as well and said he would follow up with me in 3 months, but everything looked fine. The lump went away.

Received the vaccine, came home and both of her cheeks were bright well, as well as her forehead. Her tongue is real sore and feels as if she burnt her tongue. The top of her gums in her mouth were all red and hurting as well. She got real nervous and antsy. She had this for a few days, then about 4 days later called the doctor and went to the clinic and she has canker sores in her mouth. They told her they would probably go away in a week or two, and it was 2 weeks yesterday from her vaccine. They have gotten better but they are not totally gone, and her mouth still does not feel right, but does not feel as bad as it did, does not feel normal. The tip still feels like she burnt it. He wants to check her again around the 17th, did not give her any treatment for it. The pharmacy wants her to recheck with her doctor in regard to getting the 2nd vaccine or not, or to get it at a doctors office to watch her more closely.

The patient stated that she gets paralyzed after getting vaccines. I asked her if she had someone in the pharmacy to help her. She said she came alone. I told her I would have her wait 30mins after dose to make sure there were no issues. After I gave her the shot, she looked at me and said that didn't hurt at all. Then she looked and said my neck hurts. So I had her take deep breaths with me to get her to calm down as she appeared anxious. She was doing great then she went limp. I held her head up and asked her is she was ok. She said she was, but then her breathing become shallow. She was un responsive at this time with her tongue pushing her mask off her mouth. So I lowered her mask and her tongue appeared to be enlarged. I had my technician call 911 and I gave her a dose of epinephrine 0.3 mg. She was unresponsive, but breathing on her own. The paramedics came and got her vitals, placed her on stretcher, and put in a medicine line to give her medications if need be. She left somewhat unresponsive. They said she should be fine and took her to ER.

3/12 (day of #2 vaccine) typical warm, slightly swollen injection site on RIGHT deltoid. 3/14 LEFT arm had shooting pains from deltoid to fingers that would clench involuntarily (similar symptom as with #1 vaccine) Intensely itchy skin developed over entire body late in day. Intensity increased to burning sensation, extreme fatigue, mental fog, and inability to fall sleep. This lasted all night until about mid-day 3/15. 3/16 Symptoms began to subside. 3/17 Close to normal .... I hope!

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

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

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

Felt very cold on first day of vaccination. Insomnia. Soreness. Fever of 101 24hr after injection. Slight headache. Fatigue.

Patient reportedly recevied COVID vaccine on 2/25/21 but unsure of manufacterer or lot number. Patient admitted to hospital on 3/17 for altered mental status and suspected UTI. COVID screen test on 3/17 resulted positive. Patient was asymptomatic for COVID. Patient was discharged on 3/21/21 with no clinical deterioration from COVID.

Patient states that later in the evening (approximately 6 hours) after getting immunization on March 24th she started feeling muscle aches and itching. Thursday March 25th, in the morning, she was having trouble standing and could not walk, plus confusion understanding husband when he talked to her about her problems. They went to hospital and she was admitted. Do not know what tests or treatment patient got at hospital, but she was released to go home on Saturday March 27, 2021.

similar reaction to first dose 1 month ago increasing altered mental status and generalized weakness with decreased mentation and talking starting one day after vaccine and requiring hospitalization 1 week later

Received vaccine on 01/26/2021 and unknowingly experienced event. Early morning of 01/28/2021 had fainting spell and thought it was caused by low blood pressure. Felt fine for remainder of day. On evening of 01/29/2021 I started having strange symptoms. Could not concentrate, vision impaired and couldn?t figure out what evening meds I needed to take. Decided to go? to hospital on 01/30/2021. Getting ready, I passed out and husband called emergency services. Husband learned later in the day that I had a stroke. Doctors i;nfo?rmed that had blood clots in heart and lungs. Doctors advi;se not to get second vaccine shot.

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

Beginning the day after the shot, I started having chills in the afternoon and then would get a fever. Also had a sore throat, cough got worse. I was tired and didn't sleep well. Fevers were as high as 101. 5 and my body temperature is usually lower than 98.6. This continued for over a week and on the 28th, I went to hospital for a covid test, chest x-ray and blood work. All tests were negative and blood work was find. About two weeks after I received the vaccine, the symptoms stopped.

can't sleep; muscle aches ("I can't walk , I can't sleep, it hurts so bad"); crippling; A spontaneous report was received from a 79-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches (i can't walk , i can't sleep, it hurts so bad), insomnia, and crippling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, ten days after the vaccination, the patient experienced the events muscle aches (i can't walk , i can't sleep, it hurts so bad) and crippling. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, muscle aches (i can't walk, i can't sleep, it hurts so bad), insomnia, and crippling was not recovered / not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; A spontaneous report was received from a consumer concerning a 79-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea). The patient's medical history was not provided. Concomitant medications were not provided. On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported. Action taken with response to mRNA-1273 was not reported. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergic reaction; mucus in her nose,terrible back drip; Tickle in her chest,tickle in her throat; heaviness in her chest; hoarseness; cough; lost her voice; described her symptoms as bronchitis like; described her symptoms as laryngitis; felt like she had an entire respiratory infection; A spontaneous report was received from a consumer concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 7 minutes after first dose immediate allergic reaction(hypersensitivity), mucus in her nose and terrible back drip(secretion discharge), tickle in her chest and tickle in her throat(general discomfort), heaviness in her chest(chest discomfort) choking on the mucus(choking), hoarseness(Dysphonia), cough, lost her voice(aphonia), described her symptoms as bronchitis like(bronchitis), described her symptoms as laryngitis(laryngitis), felt like she had an entire respiratory infection,(respiratory infection) feels like she is still not okay(feeling abnormal). The patient's medical history was not provided. Concomitant medications reported were Claritin, Vit D, Calcium Pills, Mirtazapine, antidepressants, multivitamins for drug use for unknown indication. On 16 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004MZ0A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event(s) 7 minutes after first dose immediate allergic reaction , mucus in her nose , terrible back drip , tickle in her chest, tickle in her throat , heaviness in her chest ,choking on the mucus, hoarseness, cough , lost her voice ,described her symptoms as bronchitis like, described her symptoms as laryngitis, felt like she had an entire respiratory infection . Event choking on the mucus was considered medically significant. On 24 Feb 2021, the patient experienced the event(s) feels like she is still not okay. Treatment details included Robitussin and Honey, she has taken Tylenol for symptoms with only 20% relief. Her doctor states that if she does not, improve he will give her prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), 7 minutes after first dose immediate allergic reaction, mucus in her nose,terrible back drip, tickle in her chest, tickle in her throat, heaviness in her chest, choking on the mucus, hoarseness, cough, lost her voice, described her symptoms as bronchitis like, described her symptoms a laryngitis, felt like she had an entire respiratory infection, feels like she is still not okay was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected choking and NS unexpected hypersensitivity, rhinorrhea, discomfort, chest discomfort, dysphonia, cough, aphonia, bronchitis, laryngitis, respiratory tract infection, feeling abnormal. Event onset 7 minutes after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration about 8 hours

Out-of-sorts feeling, lethargic, achy, tired, sore arm, itchy eyes This continued for 4-5 days but the out-of-sorts, zoomed out feeling returned yesterday. The itchy, runny eyes has been constant

Tiredness, extreme emotion - tears out of proportion to stimulus, inability to focus following one of sleeplessness

Day after 2nd shot had pain in arm. 3 weeks after shot still have pain. It comes and goes but is particularly bad at night. To such an extent that it wakes me up. Originally used ice, then switched to heat. Not doing either now. Taking extra strength Tylenol for pain. No reaction after first shot.

head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown. No treatment medication was included. 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-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (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. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose

Date and time adverse event started: 3/18/21 - 1PM Adverse events experienced and are they still occurring now: 3 HOURS POST MODERNA VACCINE ON 3/18/21 PATIENT BEGIN FEELING TINGLING/NUMB IN HER LIPS AND A HOT "WEIRD SENSATION THROUGH THE BODY" THAT RESOLVED WITHIN 3 MINUTES. What happened as a result of the adverse event? RESOLVED SPONTANEOUSLY

3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.

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

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

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

STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HAS NOT FELT WELL SINCE THEN. MADE AN APPT WITH HER HEART DOCTOR FOR FOLLOW UP TO TRY AND SEE IF THEIR WAS ANYTHING SHE COULD FIND TO HELP IMPROVE HER FEELING. WENT ON 4/22 FOR APPT AND MD SENT HER STRAIGHT TO THE HOSPITAL. WAS ADMITTED THAT NIGHT WITH FINDING OF BLOOD CLOT IN HER LUNG. CLIENT REPORTS AFTER EACH VACCINE SHE HAS SEVERE WEAKNESS WITH CHILLS AND FEVER OF 99-100. FEVER CHILLS RESOLVED WITHIN 1-2 DAYS BUT WEAKNESS JUST PROGRESIVLY GOT WORSE.

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

Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.

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

Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST segment elevation. Patient was transferred to hospital ED and admitted

very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.

Patient reports fatigue and arm soreness that started immediately after second Moderna shot and have not improved (currently > 7 weeks post-vaccination). Additionally, she experienced a fever for about 2 days, as well as "terrible" fatigue and "odd thoughts" for about 24 hours,.

Patient said that got Moderna vaccine on Thursday in her left arm and that on Sunday night she started have pain on the left side of her head. She described the pain as a throbbing pain with a "boom" that would come every few seconds. It was painful to touch that side of her head. The discomfort kept the patient disoriented for a few days where she was only just today (05/12/21) able to report the pain. She said as time has passed that the duration between the throbbing (or "booming") seemed to get longer and she thinks it is getting better. Tylenol has provided some relief.

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

14 day after the vaccine had worsening of arthritis, before patient could walk and performed daily activities of living. Now patient needs walker and cannot shower on her own. Increase join pain in hands not able to knit anymore.

Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for more than 2 hours and resistent to regular strength acetimeniphan. Over the same two months, continuous low level headaches, chills, disrupted sleep.

Patient Summary: Patient is a 79-year-old female with a past medical history significant for hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypothyroidism and previous stroke versus TIA in 2016 who presented to the emergency department at Hospital on April 27 after receiving her second Covid vaccination and developing altered mental status. She was evaluated in the emergency department by the neurology service and there was no evidence of stroke on imaging. She was admitted to family medicine for continued monitoring and evaluation for infection. Extensive work-up including echocardiogram, chest x-ray, MRI of the brain, blood cultures and all of her labs were nonrevealing. Her cognition returned to baseline but she was noted to have weakness and unsteadiness. Physical and Occupational Therapy evaluated the patient and recommended postacute rehabilitation in a skilled nursing facility.

Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; 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.

5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.

pt felt strange followed 5 min later by feeling short of breath and severe pain in head, mild wheezing auscultated

I had a slight headache immediately after vaccine, I had a tennis ball sized red area where I received the vaccination. My joints started to really bother me about 2-3 weeks after vaccination. It started in my knees and went to my wrists and hips. It was extremely painful, I couldn't walk and couldn't sleep.

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

I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the night three days after the vaccine. My lips were swelling up and I had a tickling feeling at the back of my throat. My lips were getting bigger and bigger. I went to the ER and I was given prednisone and Benadryl. My symptoms subsided a little but when the prednisone wore off, I started to have lingering symptoms. The symptoms returned and I had another course of prednisone. I still have permanent swelling in my hands five months later which started about two weeks after the vaccine. My fingers are puffy and swollen in both hands. My index fingers are the worst. I have white knuckles.

septic; did not know who she was or where she was; missed second dose; acting like she had a stroke; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (septic) and DISORIENTATION (did not know who she was or where she was) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), PREDNISONE and VITAMINS NOS for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DISORIENTATION (did not know who she was or where she was) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (feeling ill). On 25-Jan-2021, the patient experienced ABNORMAL BEHAVIOUR (acting like she had a stroke). On an unknown date, the patient experienced SEPSIS (septic) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was hospitalized on 25-Jan-2021 due to DISORIENTATION and SEPSIS. At the time of the report, SEPSIS (septic), DISORIENTATION (did not know who she was or where she was), PRODUCT DOSE OMISSION ISSUE (missed second dose), VACCINATION COMPLICATION (feeling ill) and ABNORMAL BEHAVIOUR (acting like she had a stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. 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.; 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.

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

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

Patient presented to urgent care clinic approximately 24 hours after receiving the Moderna Covid-19 vaccine with complaints of fever and myalgia. She had mild confusion with the fever which resolved after acetaminophen. However, due to the confusion, she received an extensive work-up in clinic for other causes of altered mental status.

PT became dizzy, short of breath, and nervous . IV started at site. PT transported to facility and given IV diphenhydramine and solumedrol.

Left deltoid began turning blue evening of 01/13/2021. After awakening on 01/14/2021, left upper arm was blue and red to elbow. Voices that "head felt like it did when I had covid, light-headed, dizziness", hallucinations, urinary incontinence, weakness, memory loss.

Morning after receiving vaccine (01/14/2021), woke up and was having chills, weakness, "head felt like it did when having covid, dizziness, light-headed". Urinary incontinence and memory loss, and hallucinations on 01/14/2021. Blue color to left deltoid started 01/13/2021 in PM and on 01/14/2021 when waking up, left upper arm was blue and redness noted down to elbow. "I have laid on the couch and that's basically all I've done since getting the shot."

Starting around 6 pm the following day, awoke with fever of 103 degrees. Significantly compromised muscle weakness and gross motor coordination. Had difficulty sitting up and walking. Compromised speech and altered mental status. Took Tylenol at advice of GP administered by husband. By 10 pm fever down to about 99 degrees. Speech and mental status recovering. By the next day, still felt quite weak and shaky, but fever 99, speech and mental status basically recovered. A week later, still feel slightly weak and shaky

Starting the following evening around 6 pm, upon waking up from a nap, spiked a fever of 103 degrees. Experienced significant muscle weakness with gross motor coordination compromised. Could not sit up. Had to rock back and forth to try to sit up. Difficulty walking. Difficulty speaking and altered mental status. Speech not clear. Took Tylenol on advice of GP administered by husband. Temperature fell to 101, then 99 degrees by 10 pm. By 4 am Sunday morning, temperature was 99 degrees, speech had returned to normal. Sunday 8 am, sleeping normally. Sunday during the day, felt shaky and weak, still slight fever of 99 degrees but normal mental status and speech. Continued taking Tylenol periodically. By Sunday evening, felt mostly back to normal, but have continued to feel somewhat weak/shaky for the last week.

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

Pt came up to medical staff in observation room after waiting 15 minutes. Pt stated she felt heart palpitations. This RN brought her and her son back to the resting area and started collecting information. Upon auscultation, pt's heart rate was 86. The first BP collected was 168/89. After talking to the pt, she stated she was "nervous". This RN guided her in some deep breathing, calming conversation, and gave her some water. After five minutes, this RN rechecked her vitals and her heart rate was 82 and blood pressure was 136/85. Pt stated she was feeling better. Her son stated she would rest at his house for a couple hours. This RN directed them to contact her PCP if she were to have further concerns.

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

Starting on 1/22/21 her arm started to itch, got red circle around injection site about a quarter size, warm and hard in that area. On 1/23/21, started to put warm compresses x 3, Sunday the same thing and by Monday it had dissipated and was fine. Then last night 1/29/21, about 1:30 AM got up as she was not sleeping well, took two Aleve. Woke up this morning with arm itching, red again and kind of warm. Feels fine but that location has reappeared from the initial injection. Pink in color and warm to touch.

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

8 days after the first dose, my Mom developed a rash at the site of the injection. It lasted for about 6 days and it was the size of the palm of a hand. She saw her primary care Doctor on 1/25/21 for a regular physical. He saw the rash (which had subsided) and advised her to take one Benadryl 30 minutes before she has the second dose of the Moderna vaccine on 2/10/21. On 1/30/21 she had an episode where her face was tingling and she was not feeling well and a somewhat out of it. Today, 1/31/21, she is feeling better but still has tingling in her face.

Client complained of "feeling odd" during the nite and slightly disoriented in the morning. Had somewhat strange behavior in the morning of confusion and chills.

DISORIENTED AND SLOW IN MOVEMENTS DIFFICULTY IN GETTING DRSS DIFICULT IN COORDINATION CHANGE IN PERSONALITY ,AND NOT HERSELF. ALL THIS AFTER THE VACCINE . SHE IS NOT HERSELF

An hour after vaccine I felt lightheadedness, some fogginess, a slow wave of weakness flowed from my face down to the neck, shoulders, arms, torso, thighs, knees, legs, feet. Although my entire body experienced weakness, I tried & was able to stand and walk cautiously, ate a little bit of chicken, had tea but I had to sit. The weakness remained for about an hour. After which my strength was returning slowly. It took 30min more for the strength in my legs & feet to fully return.

After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like electrical discharges between ears and sharp pain in joints.. In morning chills, sharp pain in joints that made walking difficult, fever of 100.1. Felt miserable all day. Second night: slept well and felt much better in morning and almost myself again. Still some muscle pain in injection arm. No adverse effect after first dose on January 10.

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

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

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

constant headache, pain throughout my body, mild temperature (99.3) with chills off and on, restless sleep. Symptoms gradually declined and disappeared within 24 hours. No reoccurrence.

Pt awoke early the morning following vaccine with overall shaking, dizziness, and increased confusion and somnolence. Evaluated in ER; Back to baseline at end of ER visit.

Day 1: sore arm. Day 2: severe bladder pain with chemical smell to urine ( 6 hours), mild headache resolved with APAP, fatigue, mild stiffness. Day 3: bladder pain gone but mild chemical smell to urine, increasing stiffness and joint pain, mild muscle pain. Day 4: chemical smell in urine slight but still present, severe joint pain and swelling requiring narcotics, mild muscle pain, moderate stiffness, moderate fatigue. Day 5: chemical smell gone, severe joint pain and swelling requiring narcotics, drenching sweats, significant stiffness, fatigue with 12-14 hours sleep, inability to manage ADL w/o help; Days6-8 same as Day 5; Day 9-10 mod fatigue, less jt pain, no narcotics, able to do ADL's w/o help;

Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but nothing like the initial one. Started to get dizzy and felt weird on the ride home from the vaccine. The headache lasted a fairly long time and got tired by the evening and the next morning. The headache has still continued a little off and on until now, 2/17/21. The dizziness has gone away, the feeling "out of it" feeling has gone away, does not feel well about the concentration. The tiredness and fatigue started the day after the vaccine and has gotten worse, has to drag herself through the day and by 1:00 PM is done through the day due to the fatigue. Some days can go to 4:00 but most days only lasts until 1:00. She gets up at 7:30 and today at 10:37 has the feeling of tiredness. The gland under her arm a couple of weeks ago was swollen, which is still sensitive but not as bad as it was. The fatigue is the main thing that continues to bother her. She has not taken anything for these reactions. She has seen her doctor, and is supposed to get some blood tests today, 2/17/21.

Chills all day, confusion beginning early. light headache. Next day low grade fever for half day. Confusion gone. Noticed two days ago left arm very red and blotchey from injection site to elbow..

10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme the next day and Saturday. I found myself looking up at the ceiling 4 times during the night after fainting dead away. Frightening as that has never happened to me before. It was the weekend; I was unable to reach any doctor for advice. Plus with a major snow storm we were snowed in and I couldn't get out. This was the sickest I've ever been in my life!

Client stated she "felt odd/disoriented" and exhibited strange behavior, unaware of surroundings. Had chills/headache.

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

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

My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital. All tests showed no acute signs of stroke, etc.

Received the vaccine at 1:45 AM. At 9 PM I became very cold. The following 2 days I had fever (100.4 and 99.9), aches and was feeling lousy. My right arm was very red, warm and itchy. (Ten days after receiving my first vaccine my left arm became warm, red and itchy for about several days). On the 3rd day the discomfort began to diminish. Today I am fine.

Woke up at 2:30 am and was incoherant, difficulty walking and was assisted to bathroom, chills, headache. Next morning had soaked through pajamas with sweating.

I had the vaccine at 1:00 PM, and that same night I attended the wake of a family member, and I wasn't feeling well and I was feeling itchy and burning. That night I didn't sleep at all. So that night I called the doctor and I went to the doctor Friday morning, and was diagnosed with the worst case of Shingles she had ever seen. She prescribed prednisone on a taper, Valtrex (generic) 1 gram tablet 3x daily for one week, and topical ointment (flutisone propionate) .005 strength twice daily, and 500 mg tylenol every six hours.

FEVER AND SWELLING AT INJECTION SITE. BODY ACHE, FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF NITE BETTER ON 3/3/21

My mom was difficult to awaken and took 35 minutes for her to respond. Increased confusion (did not know me, nor did she know her own name). Extremely unsteady on feet. She had slept from 5pm to 9am. After breakfast and an hour she regained her knowledge of her name and mine and could correctly recite her DOB. She continues to have difficulty ambulating complaining her legs ache. She is also extremely tired.

By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morning to go to the restroom and my dog needed to go out. I felt light headed as soon as she was back in the house. I felt things going dark and I passed out in the hallway. I don't know how long I was out but when I came to, I felt like I couldn't move. I laid there for a while and finally crawled back to my bed. I was able to get back in bed. By then it was 3:00am. The next night I woke in the night and had an irregular heartbeat. I could not get back to sleep until it finally went away. For several days after the vaccination, I had very little energy.

Husband called our clinic on Saturday, March 6th at approximately 10:15 to report that on 3-5-21, this patient seemed confused, was not responsive to questions he asked her, and did not make any meals. He does report that she was oriented to person, place and time, but did not eat any food, would not shower and could not use the phone. Her temperature at bedtime was 101 degrees. The husband was offered an office visit for evaluation of symptoms, but he declined stating that she seemed to be coming around on Saturday 3-6-21. The husband was advised that pt. could take Tylenol for fever. Husband was advised that if symptoms worsened over the weekend that she should be evaluated by the nearest ER.

Beginning about 4 hours after receiving shot, muscle aches in arm, from elbow radiating up the arm, over the shoulder thru collarbone & up the side of the neck to the ear. By 6 hours after the shot, pain was excruciating and I was in literal Agony for the next 8 hours. It felt like a hot poker was being pushed along that pathway. Tylenol & ibuprofen had no effect. I could not sleep & could barely move the arm at all. (I am Not a pain Wimp) I would say this was the longest lasting without relief/strongest pain I have ever experienced and I have had one child;+ hip & shoulder surgery which required almost no after surgery medication at all. By 5 a.m. I was able to sleep a bit & most of the extreme pain was gone by 8 a.m. I had some headache the following day and was barely able to function (I live alone) just from all over tiredness. About 36 hours after injection, I was back to normal.

Patient reports going home the day of the shot and went to take a nap and had a hallucination about her friends bringing bugs to her house and cooking in her house. She also started itching later that week and has continued to itch for the last month. She has not had any rashes or difficulty breathing or swelling only itching throughout her body. Her primary care doctor recommended she take antihistamines and use hydrocortisone cream which she is still using 1 month later.

Patient presented to ED with AMS, GCS 8, elevated troponin within 48hrs of receiving vaccination. Initial dx NSTEMI

Patient received 2nd dose of Moderna COVID-19 vaccination on 3/10. Husband reported AMS and temp starting 3/11 at 0530 and that she was in a daze and staring into space. Husband also reported that her temperature was elevated to 105F while at home. She was brought in by EMS and had a temperature of 101.5F and a BP of162/75.

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

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

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

Patient started experiencing shallow breathing and had a hard time breathing two days after vaccination. She said her ankles were swollen and hurting and she could not sleep for three days after these symptoms started. She did not seek medical attention and the symptoms resolved on their own without treatment.

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

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

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

No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia. The patient's medical history was not provided. concomitant product used not provided by reporter. On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak). On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body). On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs). The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported. The action taken with mRNA-1273 in response to the event was not reported.; 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

Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 10 Days went to Yavapai Regional Medical Center ER and was admitted with high blood pressure 225/97.

Upon waking the morning of 3/24/2021, client experienced confusionMRI did show punctate acute/subacute infarct identified within the pons in the cortex of the left temporal/left parietal lobe. She was also noted to have stable moderate chronic ischemic microvascular changes and a stable old lacunar infarct, as well as a 8 x 6 x 6 mm meningioma arising from the right lateral anterior falx.

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

Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excellent state of health until about 2 weeks after vaccine. Pt started exhibiting spontaneous bruising and petechia without external causes of trauma. Days later patient started exhibiting signs of confusion and sluggishness and complaining of headache. On post vaccination day 21 patient taken to ER where platelets found to be 18 and CT scan showed a subdural hematoma. patient continues to be hospitalized and workup is underway to determine cause. My belief is the severe thrombocytopenia is related to the vaccine.

Received second dose of Covid-19 Moderna vaccine on 2/8/21. On 3/10/2021 she went to ophthalmologist for normal checkup. Did have her eyes dilated (Tropi-Phen). 3/14/21 started having what she thought was floaters in her left eye, has a history of floaters. Then 3/16/21 got worse with blurred vision in both eyes. 3/22/21 Retinal specialist diagnosis of panuveitis with significant vitritis and retinal vasculitis on angiogram. On 3/24/2021 she was started on 60 mg of prednisone daily along with Prednisolone acetate eye drops. Vision beginning to improve. Due to ADRs from steroids (SOB, insomnia, hyperglycemia, myopathy) , started on Humira 4/27/21 with goal to taper steroids. Patient has been unable to work due to vision issues.

3-4 hr onset fatigue. for 3 days confined to bed from fatigue. Has slowly remitted. - Now - 8 weeks after second shot still daily fatigue, pedal edema with activity. Nap required daily. Occasional episodes of sleep disruption. 2-4 days severe arthritis flare with rheumatoid joints swelling as well as mild swelling in OA joints: fingers, wrists, elbows, neck, back, hips, knees and ankles. deformity of dips, not previously present. Now, 8 weeks later, swelling resolved but arthritis still worse than prior to 2nd immunization. Severe bruising in R upper arm. 8 weeks later still have brown discoloration over6 inch area - INR increased to 5.4 3-4 hour mild headache lasted 2 days reoccurred 2 or 3 times over the week

couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think of words) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CR1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and LATANOPROST for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MENTAL IMPAIRMENT (couldn't think of words) (seriousness criterion medically significant), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills). On 28-Apr-2021, MENTAL IMPAIRMENT (couldn't think of words), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory details was given. No treatment information was given. Patient stated two occurrences of this type of episode on 27 Apr 2021 and 28 Apr 2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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. Further information has been requested

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

within 2 days of the vaccine. Patient fell a couple times and lost the ability to walk or use her hands. She was admitted on 3/6 for a 2 week course. She has yet to regain full function of her hands and feet. She was unable to move the other day so they referred her to a neurologist after and MRI. She has had mild confusion at times. The neurologist wanted to do a DAT scan to look for possible Parkinson. She is having Parkinson disease type symptoms post vaccine. Today she is being transferred 911 to the hospital again because she is unable to get out of bed and use her arms or legs. Baseline before she was completely self sufficient living at home my herself.

pt became very sleepy immediately after taking the vax. She got home and was so fatigued and in so much pain she went to bed and slept for almost 2 days. She says she has severe body aches and pains and is having major problems with both hands going numb, tingling, and hurting. On 4/20/21 she went to her PCP, Dr. and she was told to take Ibuprofen for her pain. On 5/6/21 she went to Dr. He did blood work. No Arthritis or other problems were found. CRP was elevated at 14. She has been to her Chiropractor on 2 different occasions to help with pain. She has had this pain going on 2 months and will see her PCP again at the end of the May.

Extreme fatigue, Bad body aches, mild headache. From about 1Am on Wed. May 19 , Very restless all night, not able to sleep. Fatigued all day. Took two 2Hr. naps, then slept from 9PM to 8:40AM. May 20th feeling pretty normal now.

Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob

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

Patient feeling weak And was acting confused per husband today. She has a chronic cough- no change. Received second dose of Moderna Covid vaccine yesterday. Denies headache, chest pain, shortness of breath, nausea, vomiting, diarrhea, fever, chills or dysuria. Has not taken anything for her temperature today. Denies recent illness.

The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a headache for 3 days. Additionally, she has been experiencing a stiff neck, has been passing out, her toes have been turning blood red, and she feels like she has not been able to function during the past 3 months. She reported that she went to the hospital to have multiple tests ran, and no unusual lab values were noted. The patient went to the hospital due to the adverse effects she experienced from the vaccine. Upon speaking to the patient it was not noted how long the patient remained in the hospital.

Patient complained of "burning in her throat" immediately after receiving the vaccine. I gave her a bottle of water to drink. She then complained of a lump in her throat. I gave her a dose of benadryl, and I monitored her for over 30 minutes. She said she did not feel any better and went to the ER where they monitored her for several hours, sent her home, and told her to take more benadry.

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

I waited 15 minutes and I left we shopped a little bit. About an hour after on the way home I got confused. By the time I got home I could not speak. My words would not come out. It happened for 30 minutes and I walked around the yard for a while then I was okay. I was really frightened. When I told my doctor what happened, he advised me he did not feel it was related to the vaccine. He advised me to start taking Baby Aspirin. The doctor did not tell me I had a mild stroke but, I feel that I did.

Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter 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, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (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. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.

Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion. Temp. 99.6 FBS 114. Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.

Pt was accompanied by daughter, who drove pt to clinic. Pt was correctly identified, screened, given vaccine, monitored for appropriate time. Pt left clinic as passenger of vehicle and was being driven by daughter. Pt started complainingg of Shortness of breath and not feeling right.. Daughter brought pt to local emergency room, Pt was later transferred to higher care hospital. Information regarding symptoms and further medical care was relayed to clinic by family member.

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

1/22 day of vaccination pt started experiencing extreme tiredness, pain in right arm/tender, low grade fever, headache, sluggish, trouble sleeping, runny nose, sneezing, fever 100 after a couple days. PT is still experiencing tired, headache, extreme sluggish.

1/27/21 - Woke up at 5 am, and felt awful, it was dark outside. Symptoms included; Difficulty walking Felt Shaky Feverish and hot Very confused, could not tell if it was day or night Did not take any medication that day Slept all day, and woke up several times At 5 pm, ate sandwich (but was not hungry) drank water Went back to bed and slept until the next day 1/28/21 Woke up 1/28/21 and felt fine

Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams waking me up with a rapid heart beat and fast pressured breathing, and vivid dreams continued for approximately 10 -12 nights had 2 nights with vivid dreams. On 2/5/21, woke at about 4:50 am with rapid heart beat that changed into AFib and elevated blood pressure. Heart beat reached 151 bpm and subsided about 30 minutes after getting out of bed.

Day 1: 01/07/21 Moderna Vaccine Dose #1 was given in left arm. No side effects noticed. Day 2: 01/08/21 No side effects noticed. Day 3: 01/09/21 Left arm slightly sore (no action taken). Days 4-9: 01/10/21 to 01/15/21 No side effects noted. Day 10: 01/16/21 (T:98.0) Woke up to a large welt, hot to the touch, no pain on upper left arm - below injection site. Began 25mg Benadryl (25 mg) 2 doses taken. Day 11: 01/17/21 (T:98.2) Welt increasing, hot to the touch, slight burning on back of neck also. Took Benadryl (25mg) twice during the day and Tylenol (650 mg) twice during the day. Day 12: 01/18/21 (T:98.0) Rash seems to be flattening out spreading a little, neck rash seems slightly worse. Burns. Day 13: 01/19/21 (T:98.6) No change in symptoms Took Benadryl (25mg) twice Day 14: 01/20/21 (T:98.3) Rash seems to be spreading into the armpit area. Neck area is larger and burning. Took three Benadryl (25mg) during the day-Tylenol 2 tabs (650 mg) at bedtime. Day 15: 01/21/21 (T:98.3) feeling tired. Rash is spreading under both armpits and neck. Back seems to be itching a lot too. Took Benadryl (25mg) three times. Day 16: 01/22/21 (T:98.6) Rash is really bad! Area of original welt is slightly larger. Took Benadryl (25mg) 6 am, 12pm, 6pm 10, pm and 3am. Will call MD on Monday. Used Shea Butter lotion (little help). Day 17: 01/23/21 (T:98.0) Rash is worse, both arms and larger neck areas hot to the touch burning sensation. Benadryl (25mg) 6:30 am. (37.5mg)10:30sm, (37.5 mg) 3:30 pm, (25mg.) 8:30 pm. 2 Tylenol (650 mg.) 9:00 pm. Day 18: 01/24/21 (T:98.8) Rash is still worse and spreading (will call MD tomorrow). Benadryl (25 mg) 6:30 am and 11: 45 am, 2 tabs of Tylenol (650 mg) noon and 4:00 pm. Shea butter lotion not helping. Applied ice, seemed to ease burning sensation but still miserable. Day 19: 01/25/21 (T:98.4) Saw Dr. who prescribed RX: Prednisone 60 mg daily for 5 days, Benadryl 25-50 mg for itching, oatmeal baths, cortisone 1% cream or lotion, I picked up my RX and a new package of Benadryl/Banophen. Went home and took Benadryl (50 mg) 2 tablets at 9:30 am,1:30 pm and 5:15 pm, mistakenly believing they were 25mg tabs because of packaging change and miniscule text on bottle and difficult to find directions. Also Prednisone 60 mg, 10:00 am. Took 2 Tylenol (650 mg) 12:45pm and5:20 pm. I did not realize that the Benadryl dosage was different! Actually double! So I took 300 mgs of Benadryl. Took an oatmeal bath at 5:30 pm. Around 6:30pm I felt a little dizzy. So I went to bed because I did not feel right. I was not making any sense. When my daughter FaceTime?d me and realized I was slurring my words. She phoned her sister to do a wellness check. 2021 Covid Vaccine They found me still incoherent and unsteady. I did not realize that the bottle of Benadryl was a different dosage! Dr. office and spoke to doctor on call. They suspected steroid psychosis. We had not yet puzzled out the exceeded dose of Benadryl/Banophen. Used oximeter during night to monitor breathing, which was normal. Day 20: 01/26/21 (T:98.2) Prednisone dosage was decreased to 40 mg daily (due to question of psychosis). No cortisone cream or lotion. The dosage of Benadryl was discovered and resolved. Rash is still spreading over body. Now on lower stomach. Benadryl (25 mg), one tablet at 9:30am, Benadryl (12.5mg) at 2:00 pm, 9:30 pm. 2 Tylenol (650 mg) at 1:20 am, Pepcid AC (new addition at 10:00 am, Prednisone (40 mg) noon. Trying aloe and calamine. Day 21: 01/27/21 (T:98.4) Rash on neck and underarms spreading, also back is now raw. Feeling less fidgety. Pain slightly better. Benadryl (25mg) 7:30 am, 3:30 pm, 10:00 pm, Prednisone (40 mg.) 9:00 am, Pepcid AC, 2:00 pm. Day 22: 01/28/21 Feeling slightly better, Benadryl (25 mg) 6:50 am,1:00 pm, 7:30 pm. Prednisone (40 mg.) 6:15 am. Pepcid AC, 1:00 pm. Day 23: 01/29/21 (T:98.6) Rash is still spreading. Benadryl (25mg.) 3:30 am, 9:00 am, 2:30 pm, 8 ;38 pm, Prednisone 7:30 am, Pepcid AC 2:00 pm. Day 24: 01/30/ 21 really itching, neck burning, Benadryl (25mg) 2:05 am,8:00 am, 2:30 pm, 8:30 pm, 1:30 am. Prednisone (30 mg) 8:00 am, Pepcid AC 3:30 pm Day 25: 01/31/21 Oatmeal bath at 1:30 am. Benadryl (25 mg) 7:35 am,1:45 pm, 7:10 pm, Prednisone (20 mg.) 7:30 am & 1:00 pm total 40 mg. Pepcid AC 5:00 pm. 2 Tylenol (650 mg) 6:00 pm. Neck bright red again and rash worse on forearms and hands. Wearing gloves in effort not to scratch. Misery continues. 2021 Covid Vaccine Day 26: 02/01/21 (T:98.6) Benadryl (25 mg.) 2:30 am, 7:50am, very itchy, did not use ice for last 12 hours. Rash is now in the groin area. 20mg prednisone at 9:55am. 2 Tylenol (650mg) 11:45am. 12:10pm Pepcid AC. Saw new dermatologist who prescribed Rx strength steroid cream.

Woke up Friday with terrific headache, darts shooting through head, sore neck, sore back, sore arm, pretty much sore all over, had temp of 101 in afternoon, felt weak and very, very bad, did not visit dr. felt really bad for 1 day and 1 night, am a bit afraid to take second dose, was much better on Saturday

7-10 days after vaccine head was itchy, enough to wake client up at night. Scratching. Started at crown of head and approximately half of clients hair fell out.

on the 8th i had an itching rash all over my body. I had not eaten or taken anything out of the normal.. Called 911 and they sent EMA to come out and they gave me a shot of Benadryl 50 mg . I stayed awake all night. after a while the itching did stop. When i got up the next morning the rash was gone.

Felt like I had the flu. All I wonted to do was sleep For 3 days. The first day I felt a little sick , then mostly Felt real bad.

Pt described the feeling as a lump in her throat when swallowing. "feels like something's there". Pt denied any SOB, tightness in her chest, difficulty breathing, swelling of her tongue or throat. 0929 Pt denied any contraindications to benadryl or Pepcid. Pt gave verbal consent to administer medication. Benadryl and Pepcid administered per COVID vaccine standing order for adverse reactions. 02 98-99% Pulse 86 Pt was monitored for an additional 30 minutes after medication. She gradually felt like the lump in her throat was getting better. She again denied any difficulty with breathing.

the injection site is very red and I have a big rash about 3 inches around the injection site. feeling a little spacey in my head.

My entire body really ached. I was freezing. I was feeling absolutely miserable. Very physically uncomfortable. No appetite whatsoever. I was feeling close nauseated. I almost felt shaky. I took an Advil about four hours later and I felt a little better. I had diarrhea that afternoon. I turned up the heat and started drinking chamomile tea to warm up. I didn't eat anything anything until about 6:00, when I had toast and banana. Feelin 95% better by Monday.

pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chills, nausea, constant dizziness, has a rash around her neck, has fatigue and weakness. Pt also has had pain in her right knee the night of the vax. Pt just feels bad, raised blood pressure, has numbness in both hands and is very uncomfortable. Pt called her PCP and was told to her to take an extra HBP pill. Since pt is still having most of these symptoms she will call her PCP back for more medical advice.

Rash on left arm noticed about 10 days after first shot of 2. Also felt a lump in throat right under jar bone. Consulted by phone with primary care giver's office and got a return call from nurse relaying conversation with Dr. Described as minor reaction and go ahead with planned second shot. Rash slowly disappeared. 2nd shot on 01/13/2021 and rash began appearing by end of next day. Rash area continued to enlarge and no lump in throat this time. Very itchy and rash on larger area than with 1st shot and is more solidly red. Plan on continuing to watch but no medical attention seems necessary at this time.

Rash on left arm noticed about 10 days after first shot of 2. Also felt a lump in throat right under jar bone. Consulted by phone with primary care giver's office and got a return call from nurse relaying conversation with Dr. Described as minor reaction and go ahead with planned second shot. Rash slowly disappeared. 2nd shot on 01/13/2021 and rash began appearing by end of next day. Rash area continued to enlarge and no lump in throat this time. Very itchy and rash on larger area than with 1st shot and is more solidly red. Plan on continuing to watch but no medical attention seems necessary at this time.

1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DEVIATING TO RIGHT SIDE, BLURRED VISION, DIZZINESS, FEELING OF MAJOR DISTRESS 2-, MUSCLE SORENESS STARTED TO INCREASE AFTER ONE WEEK AND HAS CONTINUED TO INCREASE OVER TIME, BECOMING WORSE AT 4 WEEKS, AND LIMITING EXERCISE: CANNOT RAISE ARM, OR DO ANY MOVEMENT THAT REQUIRES MUSCLE FLEXION OR EXTENSION.

Per patient's daughter: around 1 pm patient started acting confused. At one point, patient thought it was Valentine's Day. Daughter also stated that patient ate a Kleenex. Patient was treated with 2 L of fluids and cardiac monitoring. Patient's AMS resolved by next morning. Patient returned to baseline and was discharged after 36 hours of observation.

Patient c/o feeling dizzy/lightheaded and her face was warm. Reported feeling anxious. Facial flushing noted. Patient taken to private room for further observation via w/c. Patient reports SOB and chest pressure 9/10 BP 204/85 hr 71 spo2 99%. Nitroglycerin 0.4 mg SL given. Pt continues to appear flushed, and c/o h/a and chest pressureEKG completed and handed to doctor at bedside. FM replaced with O2 2LNC. Patient's facial flushing, redness to upper extremities and tremors, has subsided notably and pt is reports feeling better. Continues to deny chest pain. Pt's affect improving and she is able to smile when she answers questions. BP 144/53 HR 88 Spo2 100%. Pt discharged via w/c with family in stable condition as per doctor. Patient aware allergy department will be following up on her reaction and she will be provided with further instructions regarding second dose of moderna covid vaccine.

Patient's daugher-in-law called. She reported that the patient cannot remember anything that happened 02/28/2021, the day after she received vaccine. 03/01/2021, patient is still having difficulty remembering and not behaving "normal". Family is taking patient to primary care provider now (03/01/2021 4:00pm). Family is to call me when they have information.

Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swelling, hard lump, redness near injection site - began on day February 15. Hardness lasted five days, redness lasted 13 days Sleep disturbances - difficulty getting to sleep, waking in middle of night with feeling of disorientation - began on February 15 and lasted for four nights. Eye pain with feeling of object in eye and red, itchy eyelids. Began February 17 and recurred intermittently for six days.

Covid arm. Red, swelling, large bump., hot, sore. Called clinic told it was probably nothing. CDC website said go to dr or ER. Dr there glanced at my arm and said it was an infection and gave me antibiotic, Cephalexin 500mg, 10 days. Feel really bad but maybe better today and that is after tramadol and tylenol. Headaches. Tylenol helps.. now afraid to take 2nd shot.

approximately 8 hours after the injection a sudden case of chattering chills come on - temperature checked soon after was 103 - followed approx. an your later by vomiting and then restless night of sleep due to body aches and stiffness in trying to get out of bed. Following day improved but no appetite or energy and mild headache. Well by 32+ hours after incident

During post vaccination observation period reported feeling hot and nauseous. Was hypertensive 214/102 and couldn't recall if she took her antihypertension medicine that day. BP decreased to 187/86, pt anxious and felt tingling sensation and tightness in face and gums. Transported to ED, no difficulty breathing, no facial swelling and no hives. Given diphenhydramine and d/c to home.

On 3/7/2021 the patient presented to the ED with generalized weakness and altered mental status. She was admitted for hyponatremia and found to have a UTI. Per EUA, all hospitalization must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.

Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia. The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific. On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia. Treatment for the event included ice on the area 3 times a day, 15 minutes at a time. Action taken with mRNA-1273 in response to the events was not provided. The events, soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of the event leukemia is unknown. Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

redness with warmth and tenderness approximately 3"x3" area, over 3 days and current. also causing numbness to arm and hand at night interrupting sleep .

I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was very quiet. When we were going home they told me I was swerving, all over the road and they told me to stop, they would drive, I said no, i don't trust anyone with my car. We got home, I remember changing into my nightgown and was texting someone and I suddenly I stopped. After that I was unresponsive. I would not answer anyone, they said I looked pale and stared into the air. They called my children and they came and emergency personnel was called. I was taken to a hospital and they transferred me to another hospital. I stayed there for 3-4 days. After going home it took me some days to be able to walk without assistance. I wanted to say I had covid in May (1st time) and September (2nd time) . I still do not have taste or smell back from the covid. I can only eat 3 or 4 bites and then I am done.

Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spontaneous report was received on 10 Mar 2021 from a consumer concerning a 81-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spasms like seizures/ seizure, fidgeting non-stop/restlessness, barring their teeth like a grimace/bruxism and low-grade fever/pyrexia. The patient's medical history included COVID-19 and severe Alzheimer's disease. Concomitant product use was not provided. On 09 Mar 2021, approximately 1 day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced low-grade fever, spasms like seizures, fidgeting non-stop and barring their teeth like a grimace. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, spasms like seizures, fidgeting non-stop, barring their teeth like a grimace, and low-grade fever, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Since A week or so after second shot I have been fatigue, feverish, brain fog, cough, achy Have been to doctors on antibiotics Still not feeling up to par

On the date of first occurance March 10, felt fatigue and muscle ache in groin and legs, on first night felt restless, and sleepless with pain occuring in more joints. Next morning March 11, could not get up out of bed without assistance. Excruitiating joint and muscle pain . Sleeping 10-12 hours during day. Could barely walk pain persisting. Foggy brain, unable to consentrate. Feeling depressed. This last through weekend, subsiding some on Sunday March 14. Visited family physician, Dr. on Monday. Diagnosed with Serum Sickness. It has been a gradual decrease in joint pain, but still persists in my hips and legs as I write this on March 22.

I got the "Covid arm" twice, after first and second injection. First did not come on until day #11 after vaccination, second only after 3 days. Besides this were chills, extreme tiredness, a sort of "brain fog," general aches and pains with the second shot and knees weak and feeling like a rag doll which lasted a couple days. Several episodes of urgent diarrhea with the first dose. First "Covid arm" lasted 8 days, the second just 4. With both, there was an almost constant feeling of queasiness.

On that Friday, I had a fever and started shaking. I took my temperature the next morning, it was 100.7 and my normal temp is 97.7. I felt bad all day. I took some Tylenol, my temperature came down, I started feeling better and haven't had a temp since. Didn't seek treatment because I had already been warned about the side effects.

2/1/2021 4" bright red splotch on shot arm, no pain, no fever faded away in two days 2/20 12:20PM #2 shot 1PM Tylenol 2 pm Fatigue+ feeling strange Restless night 2/21 tired + a bit unsteady 2/22 Redness starting on shot arm 02/25 Redness faded away. Rock-hard bowel movement. 03/1 shot arm almost itchy, almost burning tiredness linger

Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment 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. 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. Further information has been requested.

Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node. This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks. Then patient received Moderna Dose #2 on 2/8/21. By 2/11/21, patient had some intermittent confusion noted. Vitals were mostly WNL. On 3/4, patient observed with SOB and restlessness. SPO2 was 86%, Temp 98.4, HR 59, BP 136/59. Oxygen started. Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen. Transferred to hospital. Patient was admitted to hospital on 3/4/21. She was readmitted to nursing home on 3/12/21. Discharge diagnosis included: altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.

4:00a.m., next morning,chills (couldn't get warm), fever ( temp 102.8) , difficult to stand, no appetite, very sleepy all day. Had to hold onto walls just to walk felt dizzy, weak, aching and confused. Right shoulder swollen, not red. No desire to eat,and forced myself to take fluids. Lasted 4 days.

Patient is a 81-year-old woman who last Tuesday received her second vaccination shot in her left arm. Several hours after the procedure she developed pain and discomfort in her left arm. The left arm discomfort gradually increased over the past 3 to 4 days and she began to experience symptoms of claudication in her left forearm and hand. She had a difficult time performing her daily tasks. The pain significantly worsened today to the point that she had constant pain in her hand and developed numbness in her fingers. She presented to the urgent care clinic and was subsequently transferred to the emergency room where CT angiogram demonstrates thrombus in her left brachial artery. She denies a history of heart palpitations. She has no history of hypercoagulable state. She has no history of blood clots or easy bleeding. She has no history of infection and denies fevers chills or night sweats. She has no significant history of peripheral vascular disease and can walk over a mile without difficulty. She denies symptoms of transient ischemic attacks. Left brachial ulnar and radial artery thrombectomy due to inflammation of the brachial artery and thrombus in the brachial artery extending into the origin of the radial and ulnar arteries done on 3/22/2021. Discharged on aspirin 81 mg daily and Lovenox. Has transitioned to Eliquis now. Complication of left arm wound dehiscence. Debrided by wound clinic on 4/9/2021. Taken for washout/wound closure on 4/13/2021. Continues to f/u in our clinic.

chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.

I have horrible ringing buzzingin my ears. Started first with buzzing in ears just at night for about two weeks. After two weeks it is all the time buzzing. Seems to be louder in the evening and night. It is causing anxiety.

As per patient's daughter, her mother's blood pressure became uncontrollable 96 hours after 1st vaccine. it lasted about 3 days and was stabilized with medication management. Also as per daughter, her mother's memory got worse

As per patient's daughter, her mother started to have sever memory problems about 7 days after 2nd vaccine. Her mother would not remember what happened earlier and would repeat herself over and over.

I began feeling dizzy, nauseous, weak in legs, blurred vision in early May which continued throughout the month. On June 3 I experienced an event like no other. My legs felt like rubber and tried but could not speak. My husband carried me to the sofa, when I sat down I felt disoriented, and saw a circle in front of my eyes. I felt as if I was about to pass out. I saw my cardiologist a week later. He is concerned that the neurological symptoms are new. He suspects I had a mini stroke despite being on blood thinner for my CHF and referred me to a neurologist. He suggested I report this sudden change to VAERS.

pt says she developed a rash and has progressively gotten worse since then. The rash is red, with little pea shaped pimples that are burning and spreading all over her body. The skin is prickly and very sensitive. She still cannot think clearly and still has fatigue. Her legs are bothering her know as well. She saw PCP Dr on 2/19/21 and told to take Claritin which did not help. On 2/26/21 she saw Dermatologist PA. She was given a skin biopsy. She was diagnosed w/ spongiotic and interfaced dermatitis w/ rare eosinophils. She was prescribed triamcinolone. She has since developed nose bleeds that would come every couple of days then started happening daily. She has had blood test which white blood count cells were up, the doctor thinks the steroid cream may have caused this so she is no longer using it. She has been to the doctors several times due to the skin rash and nose bleeds and nothing the doctors have done for her has helped with her symptoms thus far. She goes back to the doctors in a couple of weeks for another biopsy. These has had these symptoms for months.

Ok I went to bed in the evening of the shot and it wasn't long before I was very uncomfortable and feeling aches all over. This went on all throughout the night and when I got up I was faint and nauseas a few times through the night. I did not sleep at all. And late morning/mid day I took something like an Advil/ibuprofen and some tums and felt better the next evening.

Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood clot in the vein running along shin bone; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed a small blood clot in the vein running along shin bone) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Throbbing pain in leg right next to my shin bone), INSOMNIA (Kept me awake at night) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) (seriousness criterion medically significant). At the time of the report, PAIN (Throbbing pain in leg right next to my shin bone) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) had resolved and INSOMNIA (Kept me awake at night) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-017541 (Patient Link).

Flashing light hallucinations; Pain in joints; Numbing of toes both sides; Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands; Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night; Pain in hips and legs up to knees/ Pain in legs feet and fingers; Bone pain; Sleep seven hours in raw; "could not drive"; Body pain/ Constant pain in body; Tiredness/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Flashing light hallucinations) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Macrobid allergy), Fibromyalgia (Fibromyalgia was under control. Unbearable now.), Arthritis (Arthritis was under control. Unbearable now.) and Myalgia. Concomitant products included DOXYCYCLINE, VITAMIN A [RETINOL], VITAMIN B NOS, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue). 06-Mar-2021, the patient experienced HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive"). On 22-Mar-2021, the patient experienced HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night) and PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers). On an unknown date, the patient experienced HALLUCINATION, VISUAL (Flashing light hallucinations) (seriousness criterion medically significant) and ARTHRALGIA (Pain in joints). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Myalgia, at a dose of 2 dosage form. On 08-Mar-2021, HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive") had resolved. At the time of the report, HALLUCINATION, VISUAL (Flashing light hallucinations) and ARTHRALGIA (Pain in joints) outcome was unknown and HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night), PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers), BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue) had not resolved. The patient had implant dental work near 2 weeks ago around 10-Apr-2021 and received Doxycycline. The patient reported that the doctor won't return the call. 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 20-Jun-2021: Additional information received included patient demographics race, relevant history details including Macrobid allergy, current condition fibromyalgia and arthritis; new concomitant medications added; Treatment medicines were added . Added New adverse event Flashing light hallucinations.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

1. She was found with her skirt up around her neck and normally is oriented 2. Speech slightly off 3. Left sided facial drooping 4. At time of EMS transfer BP 156/22, P 118, R 18, Temp 104

Altered mental status and seizure like tremors, slurring her speech, could not state day, time, place, or situation, salad like statements, increased weakness.

Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.

After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitation felt cold and shaky. After about an hr and half i started to get back to normal. When i got up i started to walk funny. I was able to drive home. took Tylenol when i got home. ate a little soup. laid down and fell asleep. when i woke up a couple hrs later i still had a headache. took another tylenol.

Called at 8 am this morning to inform me of a reaction to her COVID vaccine. She received the vaccine on Tuesday, 1/19/21. The next day she noted the back of her tongue on the R side was swollen. On Thurs, 1/21/21, she reports she woke up with the back of her tongue swollen on both sides such that she had some trouble speaking and needed to be very careful with chewing so she would not bite her tongue. She stated she also had drippy sinuses and an earache which then woke her up several times during the night last night. Today she reports the tongue swelling is only to the back R side of her tongue. She continues to have ear pain. She states she had not reported the symptoms to anyone before her call because she had not felt the symptoms were life-threatening. I asked her if she had taken any benedryl, and she stated the only medication she had taken was her analgesic herbal supplement. She states she has never had a vaccination reaction in the past. I advised her to call her PCP and be seen, which she was able to do. After she was seen, she called and stated while the clinician was looking at her tongue, it started to have shooting pains when she moved it to the right. The clinician stated her tongue and throat were not visibly swollen, noted no swollen lymph nodes, and noted no ear abnormalities.

Pt. stated "my head feels funny". Blood pressure was high. @ 9:58 am 188/90, @ 10:02 - 176/84. consulted with APRN on call & was informed to monitor BP & observe pt. for 20 more minutes. AT 10:10, BP was 180/88, @ 10:20 - 190/98. Pt continued expressing head feeling funny & stated she had a mini stroke in February 2020. Nurse again consulted with APRN & was informed to offer to call an ambulance for pt. Patient initially refused ambulance, but eventually decided to accept. Ambulance was called & transported pt. to hospital at 10:45 am.

Pain upper rt. Lateral back, side, chest- unable to sleep because of pain-tender to touch-reflux with no relief from antacids

Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.

Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself and walk, intermittent dry cough, decreased oxygen level

Major fatigue (can't awaken), Mass confusion (doesn't know what she is doing. Not eating or drinking. Can't get dressed.)

Moderna COVID-19 Baccine EUA Unable to fall asleep from 9PM-12PM, slept for 3 hours, awake for rest of night and all of the following day. Second night was normal. No pain but felt wide awake and alert. Almost like I had a small dose of adrenaline. No high or nervousness. Quite normal except for the fact that it wasn't daytime! Check online and saw that Pfizer had sleeplessness as a side effect but not Moderna. It was not an "adverse" event for me...rather fascinating since I've never had anything like that before.

Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via EMS due to confusion and memory loss. Pt's son states that pt was diagnosed with "TIA" and stayed in the hospital x 3 days. Pt states that the physicians at facility was not sure if TIA was related to vaccine but encouraged him to report adverse event. Pt's son states that pt has short term memory loss and has since moved in with him after this event happened.

Moderna COVID-19 Vaccine EUA First day, Jan. 28, head felt funny and went to bed at 6:30 pm and by 9:30 pm when I work up, I felt fine. Day 8: felt itchy on left arm where vaccine took place and pink. Same thing this morning.

Patient reported having diarrhea throughout the night and insomnia. Patient states symptoms resolved by 6:00 AM on 02/09/2021.

chills started about 4:00 pm ABOUT HOUR LATER EXTREME BODY ACHES MUCH MORE THAN NORMAL, TIRED AND SLEPT A LOT. ARM WAS SORE FROM THE TIME OF THE SHOT AND KEPT GETTING WORST AS TIME, DAYS WENT ON MY ARM WAS BRUISED WHERE THE SHOT WAS GIVEN AND JUST BELOW THAT IT WAS SWOLLEN - RED - SORE. THE REDNESS WAS ABOUT THE SIZE OF A SMALL SAUCER, EXTENDING ALMOST TO MY ELBOW AREA. COULD NOT LAY ON MY RIGHT SIDE WHEN SLEEPING AND IF I DID IN MY SLEEP IT WOULD AWAKE ME RIGHT AWAY ON SATURDAY MY ARM ITCHED IN THE RED AREA UP TILL ABOUT MONDAY - MY ARM HURT EVERY TIME I MOVED IT OR USED IT - BUT EACH DAY IT WAS LESS TODAY 2-9-21 MY ARM IS NOT SWOLLEN OR RED ANYMORE BUT SLIGHTLY SORE TO THE TOUCH

I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.

Vaccine #1 had no issues. Vaccine # 2 had the following: Site of shot was hot, large, inflamed 4 days/ started to imrove on day 5 Day #1 Woke up at midnight with severe shooting pain in neck and went straght up head/followed by inability to move legs/eased off and the next morning could use legs and pain gone, but arm had started to swell at site of shot Day #2 Very sick, flu like symptoms, sleepy, no headache, chills Day #3 same as day 2 Day #4 Same as day 2 and arm easing off Days 5-9 severe fatigue , abnormally tired and unable to function normally Day nine severe dizziness started and has continued to day 13. Cannot drive, wobbly

Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.

The patient started running a fever of 101 within 12-24 hours of receiving her second covid vaccine and was suffering from altered mental status. She was transported via EMS where she was admitted until her d/c home on 2/20/21.

2/28/2021 about 9 am. Unable to get out full words or sentences, says she felt like she had marbles in her mouth. No other symptoms and it is slowly improving. 3/1/2021 my mother called me at 1:38. She speaks very slowly, has a difficult time getting certain words out and definitely has a problem completing thoughts and sentences. Her speech is somewhat slurred. She seems "out of it." Her primary care doctor encouraged her to go to urgent care. My father is taking her there now. It is currently 3:07 pm.

The day after the injection I felt "puny" and by that early afternoon I noticed a red, raised 3 -inch diameter circle surrounding the injection site on my left arm. The red site itched and hurt a bit when touched. (Note: I took a Benedryl pill and put some Cortozone-10 ointment on the circle the second day after the injection when the circle appeared.) That day and the next the tissue within the red, 3-inch diameter circle got progressively harder - it felt as firm/hard as a golf ball. (I took another Benedryl pill the third day after the injection, but switched to Benedryl ointment, which worked better for the itch than the Cortizon had.)

Patient reported on 2/27/21 she woke up at 4AM feeling "dizzy, disoriented, nauseous, and weak." She stated the symptoms have been slowly getting better as the week progresses but that she continues to feel weak. She stated she also noticed her left arm was red, swollen, and sore/achy on approximately 2/27/21. She stated the redness was on her upper arm and progressed from just at the injection site to her shoulder down to her elbow. Patient saw a provider on 3/2/21 who described the redness as "erythema, swelling and tenderness noted on the left arm. The area was marked with a marker today." The provider diagnosed the patient with left arm cellulitis and prescribed doxycycline 100 mg twice daily for 7 days. Today 3/4/21, patient stated the redness has not spread outside the marked area but has not significantly improved.

Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in fainting and falling, proceeded to faint multiple times - lost all bodily functions, eyes rolled in back of head multiple times and 911. Did get back to ability to get home but now repeats herself more than before and seemed to have lost some mental capacity till Wednesday March 10 / she now is better but scared to do anything on her own as fearing issues again

Several days after receiving the 2nd Moderna vaccine for COVID 19, I began have pain in all the joints in my hands, shoulder. Unable to use my hands due to excruciating pain. The pain began 3-4 days after the 2nd shot, starting in 2 of my fingers and progressively moved to all the joints in all of my fingers, wrists and my shoulders. In addition there is swelling. I have very little use of my hands, requiring assistance to care for myself. I have never had joint pain in my hands before. The pain has continued for 2 weeks non-stop. At the doctors recommendation I have been taking Tylenol for Arthritis, however this does not alleviate the pain, only reduces some of the discomfort.

Patient said she was fatigued and had to sleep all day. She was also confused and disorient. She could not remember where she was and forgot to take her medications. Her family almost called 911 because they were very concerned. She said her experience lasted for 24 hours.

x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2/16/21; admitted 3/18 swg bed for physical deconditioniong. 3/18/21 Swg Bed admission HPI: 82 y.o. female presents for direct admission to swing bed. Back in the middle of February the patient had a high-grade small-bowel obstruction ended up with laparotomy and lysis of adhesions. She was extremely deconditioned. She came to swing bed here and states here for about 2 weeks. She thought she was ready to go home and be successful at that time. Unfortunately, she has gotten home and found that she can barely take care of herself. She is extremely deconditioned. She thinks she just needs to be built up for another week or 2 and then could be very successful at home. She does have a friend that is helping her, but is worried about getting so weak that she end up hurting herself. I saw her yesterday in the office and thought that another swing bed stay a might be in order.

Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Tired alot; A spontaneous report was received from a consumer concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced feeling bad/feeling abnormal, had similar symptoms of those of heart failure/cardiac failure, coughing a lot/cough ,congestion/nasal congestion and tired a lot/fatigue. The patient's medical history included heart failure and hypothyroidism. Concomitant medications reported included medication for heart failure and hypothyroidism. On 19-JAN-2021, approximately three weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient reported that three weeks after receiving the vaccine she started feeling bad, had similar symptoms of those of heart failure (which he has had), cough/coughing a lot, congestion and tired a lot. The event similar symptoms of those of heart failure is considered as medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events feeling bad, similar symptoms of those of heart failure, cough (coughing a lot),congestion and tired a lot, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Chills 1 hour after injection, tightness and aching in upper arm just below injection site and radiating down arm to hand, sleepless night, took two oxycodone during night to alleviate pain

Pain and swelling commenced on day 6 as reported to V-Safe- itchiness rash and frequent urination....unable to sleep throughout night on day 7 and an ER visit confirmed shingles.

Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that "this ain't good" or "this ain't right". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral

Headache began around 8:30 PM and went from my temples and forehead to the base of my neck, followed a while later by pain in both arms between my shoulders and elbows. Knowing sleep would be difficult, I stayed up until 2:00 AM and fell asleep about 3:00 AM. I awoke at 3:20 AM trembling so badly that I couldn't hold a thermometer in my mouth. So, it was time for "chills and fever" and I put sweat pants and a sweat shirt over my flannel Pjs, heavy socks on my feet, and socks on my hands. My entire body felt ice cold. Back under the covers, I finally warmed up and slept off and on for almost eight hours.Woke up around noon on Saturday, feverish, feeling nauseous, exhausted, and still feeling the headache and arm pains. My "normal" temperature runs from 97.1 to 97.6, but ranged from 100.2 to 100.5 for two days after the vaccine. Slept off and on around the clock on Saturday and Sunday, and by Monday the headache, pain, and fever were gone. Slight nausea remained as well as the fatigue on Monday. On Tuesday, my legs felt wobbly, like "sea legs." By Wednesday, I was back to normal catching up on email and reading my books, and on Thursday drove out to the county to bring food to my sister and fix her PC. I understand that seniors do not usually get the side effects as I did, because the immune system declines with age. Apparently, my immune system is not aware of my birth date. Can't help but wonder if taking Co-Q-10, as I've done for almost twenty-four years, has anything to do with it.

struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt miserable; Felt knocked out; Short term memory feels affected more once again; A spontaneous report was received from a consumer concerning 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt knocked out/ loss of consciousness, felt miserable/ feeling abnormal, struggled to get out of bed and stayed in bed all day / bedridden, short term memory feels affected more once again/ amnesia, no appetite/ decreased appetite. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included lisinopril, levothyroxine sodium, omeprazole. On 22 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 001A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, patient experienced arm sore for a few days. On 25 Feb 2021, patient had experienced hurting all over body and couldn't do anything for 5 days (very painful). Short term feels affected. On 22 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 037A21A) through unknown route at right arm for prophylaxis of COVID-19 infection. On 22 Mar 2021 in the evening after second dose, patient felt knocked out and miserable and struggled to get out of bed. She had short term memory feels affected more once again. On 23 Mar 2021 patient stayed in bed all day and had no appetite. On 24 Mar 2021, patient was feeling a lot better. The event patient felt knocked out was a medically significant condition. Treatment activities for event was done with paracetamol. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event, felt knocked out, felt miserable, struggled to get out of bed and stayed in bed all day, short term memory feels affected more once again, no appetite was recovering/resolving.; 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.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-056390:Dose 1

Confusion to the point of hospitalization; A spontaneous report was received from a consumer concerning her mother, an 82 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Confusion to the point of hospitalization/Confusional state. The patient's current condition includes Blood pressure, Arrhythmia, Arthritis pain. Concomitant medications includes water pills, Blood pressure pills, Heart medicines for Arrhythmia, Arthritis pain pills. On 18 Mar 2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (batch number: 006B21A) via unknown route for prophylaxis of COVID-19 infection. On 19 Mar 2021, the patient developed extreme confusion to the point where she was admitted. She was still in the hospital on Admission today 23Mar2021. No Treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, confusion to the point of hospitalization was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

"Patient was admitted to hospital service with confusion post her second coronavirus vaccination. The symptoms started about 3 hours after she received the vaccination. She felt weak and very restless. Her family noted her to have global confusion. She had no focal neurologic deficits. She was brought to the emergency department. Head CT did not reveal any acute findings. Her generalized weakness and restlessness slowly resolved and she felt back to her normal state by the date of discharge on March 30. She was not noted to have an infectious process. Coronavirus testing was negative. Of note patient with a chronic normocytic anemia. Iron studies were sent and iron and ferritin were within normal limits with a low percent saturation of 11. Folic acid and B12 were within normal limits."

hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-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. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.

Fatigue the day after increased and progressed to weakness and confusion for the week following the vaccine, culminating in Emergency Department visit with hypercalcemia and acute kidney failure and subsequent 9 day hospitalization.

Pt c/o feeling lightheaded s/p 2nd moderna vaccine. Vital signs stable BP 140/70, HR 58, RR 14. Exam provided. Pt reported feeling "off-balance and unsteady" when standing. Provider recommended that she go to ER immediately with ambulance. Pt and daughter refused.

For about 30 minutes, couldn't remember where she was or how she got there, confusion, memory loss. All memory returned after about 30 minutes.

Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia

Client reported felt fine after 2nd dose Moderna on 4-8-21, until the next morning. Daughter tried to call & could not get her to answer. A son checked on her & found her half on & half off the couch disorient forgetful, could not finish sentences, did not know recent events or year, B/P was 179/129-ambulance called & transported to Hospital. Client was admitted, CT scan, UA, chest x-ray & MRI with no results or evidence. Client did have low grade fever- was kept in hospital 3days Client home, doing better & daughter staying with her

On April 22, 2021, around 2:30 AM, my mother woke up vomiting and diarrhea, and was weak, she wasn?t able to keep anything down, stayed in bed all day.

My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. She fell sick the day after the injection and suffered with brain fog, memory issues, lethargy from that day forward. On day 36 after the 2nd dose she developed a debilitating stomach issue that cause explosive diarrhea that lasted 4 days/nights. This bout with stomach issues left her extremely weak and exhausted. On the 4th night of the diarrhea she got up in the middle of the night to go to the bathroom and couldn't lift herself off of the commode. It took two hours for her to call for help. Once admitted to the ER the stroke was confirmed. Because they could not pinpoint the first stroke symptom she was not eligible for the life saving blood thinning meds and suffered complete paralysis of her right side.

Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome - Memory loss

Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory loss.

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist, which helped relieve it; then for 4 weeks was extremely fatigued....I am healthy and exercise regularly and I could not do anything like shop, cook, except briefly....less than 2 hours and then would need to lay down to recoup.....no energy at all...the stress and not knowing what was happening increased my blood pressure and my anxiety greatly. After 4 weeks, energy began to come back gradually over the next two weeks. Am now fine.

Patient called the pharmacy to report that she was having leg cramps/aches, no bowel movement since vaccine yesterday, is very tired, and generally "feels bad". Advised her to stay hydrated and make sure she is eating to keep strength up. Get plenty of rest and contact us if any further or worsening symptoms develop.

1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.

started running temp and had pain in the left side of her neck and head. Next day left jaw and lips were numb so could barely talk. Pt saw her PCP Dr. and was told it was a side effect from the vax. Left eye started swelling so went to eye Dr. on 4/14/21. She was prescribed eye drops but continued to use her regular eye drops. At times her eye continues to feel hard and that the vision has been impaired and jaws feels funny.

ER HPI: 82 y.o. female who presents with altered mental status. Patient is transported to ED via EMS from local nursing home because of increased confusion. Patient is unable to give any pertinent history. DX: Cerebral infarction due to embolism of cerebral artery

Client stated that night after receiving the vaccine she became dizzy, had chills, had vision issues where her eyes could not focus, and her vision was blurry. Client stated that she felt like she was doomed, and maybe having a stroke. Said her symptoms lasted about 2-3 days.

Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism. On 24-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. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment medication included an unspecified cream for an unknown indication. A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-248016 (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.

Resident vomited several times throughout the night, started running a fever as high as 102.3, developed a cough, c/o dizziness and increased confusion. Went out EMS, BP was low, will be kept for obs at hospital.

The injection did sting, but didn't think anything about it. For the first 30 minutes I did seem to be fine, so I was released, but my shoulder was not looked at. It was itching some. About an hour later I started getting a headache, some nasal congestion and a sore throat. I took a couple of Tylenol and went to bed early. Day 2 I felt sluggish and achy and my stomach was bothering me some. Day three my chilling was worse, but after Tylenol I began feeling better around 6:00 pm. The rest of the week I felt sleepy and achy. My shoulder was feeling sore. I am the type of person that tries to push through when I feel bad because I live a very busy life. On day 5 I finally looked at my left. It had a large red area beginning at the injection site. I got a tape measure and found it was 10 inches long and 3 inches wide. Today is day 6. I have finally admitted I feel bad and will rest a few days. I am wondering if I should skip taking the 2nd vaccination? . I am also taking some 60mgjAllegra on ce a day.

Pt reports that the day after she had her vaccine she started having some pain where she had shingles before. That evening she started feeling really bad and knew she was having a shingles flair again. Reports she was nave able to finish her shingles vaccine series because she developed shingles a week after her first vaccination. She was still within the 6 month period to wait to get the second dose when this occurred. She called her doctor who advised her it was ok to take her antiviral for the shingles and that she could still get her second injection for the COVID vaccine.

Few hrs after getting shot at mid day, lower back started aching. By 10:00 p.m. my lower back, sides were in pain and abdominal muscles and stomach were like frozen in place. Couldn't move anything and the area seemed to be swollen. Had lost appetite in late afternoon so had not eaten dinner, only liquids since figured I needed something. Couldn't sleep, aspirin didn't help. Next day around noon my abdominal area was better and pain decreasing on sides. Still no desire to eat. Trouble sleeping, 2nd day after shot, still lower back pain, feel bloated, no desire to eat. Very little side pain. Had slight headache This third night after shot I could finally sleep. This fourth day I felt back to normal. During all this time, the arm that had the shot never really bothered me

Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pain in knee worsened, very tired. had to take half of a perkaset. and did not help. could not sleep because of the pain. the next day. felt really horrible, bad body aches. Could not stay awake. no apatite, eating made stomach upset Went to bed early about 9:00 and slept all night and all that day. just felt like fighting the flu. Had no energy. Felt better on the third day.

1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on

6 days following the vaccine (1/22), extreme itching and redness around the injection site. Next day, it got (1/23) it got redder and itchier. It looked like there were 2 giant hives on my my arm (bigger than a nickel). Took 1 Benedryl (25mg), which didn't help. Hardly slept due to itching, and soreness to the touch. I can't wear a blouse with a sleeve. Today (Sunday 1/24), the redness came together into 1 big red blotch, measuring 2"x3.5". Hot to the touch, and very sensitive. I feel pain into my shoulder blade area and where my arm meets my body in the front. Also, pain going towards my elbow. Ice / cold packs make it feel better. I will call for Dr. appointment tomorrow (Monday morning).

She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increased confusion. Patient also developed a junctional heart rhythm on night of admission.

Patient was seated in observation area and RN noted she was crying. Caregiver accompanied patient stated she was upset because she was separated from her son. Caregiver also reported the patient was experiencing nausea. 11:33 patient taken via personal wheelchair to observation area with son, caregiver, RN & EMT patient encouraged to take off her mask, face shield and take some deep breaths; door opened for fresh air & waste basket provided; caregiver & son reported that patient frequently has nausea, and also got car sick on the drive to vaccine clinic 11:35 VS 169\94 | HR 94 | PO2 97% water provided to patient and son gave her an aspirin (brought from home) 11:37 son gave patient alcohol based hand sanitizer and stated she often smells this to help with her nausea 11:40 patient reported she felt better, nausea passed, and had calmed down 11:43 VS 140\78 11:45 patient discharged via personal wheelchair to home with caregiver & son

About 2 hours started to feel sick to her stomach. All of a sudden felt heart pounding and racing. Could hear her heart pounding and racing really fast. Laid down and after 45 minutes to an hour was still racing, so laid back down and when got up the 2nd time her heart was still beating fast but not as bad as when it first happened. Gradually the symptoms subsided. Not having problems now. Did not feel very good Saturday or Sunday, but today is feeling fine. The first day was the worst.

She noticed a rash on Sunday morning, January 24, 2021. It was suspected that it was shingles. On Monday she became ill throwing up and diarrhea. on Tuesday had telephonic appointment with Dr who confirmed shingles and prescribed valacyclovir and tramadol. She throwing up returned about noon on Wednesday. Took first valacyclovir. By evening she was confused and couldn't form words. Was somewhat better on Thursday but had diarrhea. Did not take valacyclovir. Another appointment is schedule with Dr. for Friday, January 29, 2021. The shingles continue to spread.

Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low dose benedryl from 1/13 - 1/25. Second adverse event on Jan 25; began sudden onset of dizziness, weakness, nausea, vomiting and unusual blood pressure elevation. Went to ER @4 pm.. Released after 6 hours. Same occurrence next day, similar symptoms. Began to feel 'bad'; BP still elevated. Went to closest ER at 3 pm. Discharged after 5 hours with clonidine. Skipped a day, but could not resume normal activities. On Jan 29 returned to ER early afternoon, admitted for observation. Discharged ~6:30 pm on Jan 30. Currently only on higher dose of losinipryl. Rash bumps persist as 'red streaks', elevated BP and not feeling well. Streak is inner right arm above elbow. Rash streaks continue but are not bother some. Including morning of 1:30 after night in hospital. Rash usually appears after sleeping and early a.m. No medication. Still unable to resume normal activities. "feel terrible".

Hallucinations Sunday while watching TV Thought she saw mice running across the corner of the TV Hallucinations only on Sunday approximately 48 hours after vaccine

PATIENT RECEIVED COVID-19 VACCINE AND WAS TAKEN BY WHEELCHAIR TO THE OBSERVATION AREA WHERE A PROVIDER AND NURSE WERE OBSERVING FOR ANY ADVERSE REACTIONS. THE PATIENT WAS ADVISED TO WAIT 15 MINUTES BEFORE LEAVING THE FACILITY. THE PROVIDER NOTICED THE PATIENT LEANING FORWARD IN HER WHEEL CHAIR. SHE TRIED TO ENGAGE HER AND SHE WAS UNRESPONSIVE. SHE TRIED TO ALERT HER AND SHE WAS AGAIN UNRESPONSIVE. THE PROVIDER ADVISED NEARBY STAFF TO CALL 911 AND FOR THE NURSE TO BRING THE CRASH CART AND OXYGEN AS SHE ASSESSED THE PATIENT FOR A RADIAL PULSE. NO PULSE WAS PALPABLE. SHE THEN ASSESSED FOR A CAROTID PULSE AND NO PULSE WAS PALPABLE. ANOTHER PROVIDER ARRIVED AND THEY QUICKLY PUSHED THE PATIENT TO THE CLOSEST EXAM ROOM FOR FURTHER ASSESSMENT AND POSSIBLE CPR. VITAL SIGNS WERE BEING OTAINED WHICH REVEALED HYPOTENSIVE. BLOOD GLUCOSE TAKEN AND WAS WITHIN NORMAL LIMITS. AS THEY STARTED TO REMOVE HER CLOTHING TO PREPARE FOR RESUCCITATION SHE BECAME ALERT AND APPEARED ANGRY AND CONFUSED. SHE QUICKLY BECAME ALERT AND ORIENTED. EMT'S ARRIVED AND COLLECTED THE INFORMATION NEEDED TO TRANSPORT THE INDIVIDUAL TO THE NEAR BY EMERGNECY ROOM FOR FURHTER EVALUATION.

My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th. On Friday, Jan 29th, she started having diarrhea and continues to experience the same. She feels bad all over, can't get up and move around. When she stands and walks, she said she feels pain in the back of her neck and head. She is out of breath and generally laid in bed all day today. She is not eating much on a daily basis, today just some cheese and crackers and orange juice.

fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day), but very tired and sleepy.

didn't sleep well the night of injection, about an hr ago my stomach started cramping and it went to my throat like i was gaging and it went through your arms and into your head.

Filing this additional report because I neglected to report all of possible side effects. In addition to the fast and hard heartbeating for 20 minutes in the evening, I should tell you that I decided to take my Blood Pressure before retiring. I usually have low BP at about 125/68 or so. That night I took it and it was 182/160. I decided that HAD to be wrong so I took it immediately again and the next time it was 165/82. I decided that this must be anxiety and went to bed. My son suggested that I should report all this to you anyway.

pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.

Aching, listless,couldn't sleep, not hungry, but NO temperature. Lasted about 30 hours, then feeling o.k.Required no treatment.

Since around the 10th, not quite sure, but around that time, I have been feeling very, very tired and weak and slight headache. It did not occur to me until about 1/2 hour ago that these feelings could be related to the 2/5 shot. Not bad enough to go to the doctor, just not feeling normal. Blamed it on the lack of sun (SADS). I have a special light that I just started to use 3 days ago. Therefore, I am now reporting my feelings.

Chills, shaking, fever and body aches. Lasted from Wednesday evening to Thursday evening. Still feeling lifeless on Friday no appetite. Saturday feeling weak. Arm is bruised and itches terrible.

One hour after second injection on 2/17, felt a little 'out of it', then redness at injection site. 3" by 4" area of redness, warmth, stiffness and soreness at shoulder.

Sudden onset of low grade fever at 100.1 F, decreased verbal responsiveness with mild confusion, generalized weakness, and unsteadiness 18 hours after getting the second covid vaccine. Recent strong smell in urine. Numbness on left arm and left leg

Five days ago, patient received her 2nd COVID vaccination. Following that she had myalgias and some sedation/confusion. She apparently stumbled and struck her head. She did not lose consciousness. She did recover from her symptoms by the next day. She has some soreness on her scalp in the scratch but no significant hematoma. However, she then developed some swelling and redness beneath her eyes. She is here to evaluate that. She she is back to her normal self. Comments: Patient has ecchymosis in swelling beneath both eyes and the bridge of her nose. It is nontender. Scalp-minor area of tenderness in the right vertex. There is a slight abrasion on the skin. No signs of hematoma. Assessment / Plan: 1. Contusion of scalp, initial encounter Contusion right scalp-I suspect patient's lungs are delicate skin informed a small hematoma. The swelling and bruising and 5th settle down into her eye sockets. I reassured patient that this will resolve the next 1-2 weeks. I believe patient had some severe myalgias and fatigue after a COVID shot. I do not think this is a longstanding problem. Expect her to get back to her normal self. Patient did have COVID-19 approximately 3 and half months ago. I told her that people have more significant reaction to the COVID vaccine after having had the illness. At this point, I do not agree need further workup.

Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited. The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream. On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating. On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home. On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital. Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms. Treatment information included Benadryl and Cortisone Cream for the indication hives. Action taken with mRNA-1273 in response to the events was not reported. The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021. The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.

Red, swollen, itchy, painful arm from shot site to elbow and under arm. Started evening of shot, became worse, hindered sleep, etc. Called Nurse Line on Sunday (injection was Friday) and given information about icing area. Continued icing 4 or 5 times a day until symptoms eased on day 6 (Wednesday).

Day 1 No adverse affect. Day 2 about 7:15 pm suddenly pounding heart and panting to breath. Fitbit showed HR of 134. Weak. Layed down. Took extra Propanolol. Stopped after 5-10 minutes. Scary. Took BP and it was 175/89. Felt warm while sleeping poorly. Got up and BP was 105/40. Temp was 99. Fell asleep. Felt poorly all day but fine on Day 3

Pt. reports waking around 6am on Saturday, March 6th with a temperature, headache, body aches and nausea. She reports that this lasted all day on Sunday, March 7th as well. Woke Monday, March 8th and Tuesday March 9th fatigued and rested or slept most of the day. Pt. was advised that she could use Tylenol for fever and generalized achiness. Pt. woke today, Wednesday, March 10th with no symptoms and felt "like her normal self".

My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th.

Upon walking onto the tennis court and the open space all of a sudden I felt that if I took one more step I would fall off a precipice. There was no dizziness - nothing seemed spinning around. This has continued since then whenever I am in a large open space.

Groggy, sweating, has trouble concentrating and talking, dizzy, trouble sleeping, and confused. Pt thought was in Mexico. Symptoms are normal, if they do not subside within a few days seek medical help.

Day 2 severe pain in upper arms and shoulders (both). Same pain as I experience after a nuclear stress. test. Vaccine site was badly inflamed and itchy for next 4-5 days.. Also noticed a scale-y patch at the injection site. Use Cortizone on it and it made the pain in my left arm and shoulder really hurt. Severe diarrhea all day the 18th. No known reason for it. 19th very tired. 20th unable to go to sleep all night. Body aches travelled up and down my body. 3/21, up at 1:30, took shower and started to fix breakfast. Suddenly felt like I was going to vomit. Very sweaty and dizzy on the way to the bathroom. Threw up, no diarrhea. Vomit was yellow, foamy liquid. 3/22 left shoulder much pain at bedtime. Took tramadol and applied heat pad to shoulder. Shoulder still has issues.

severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; nausea; disoriented; cramping; A spontaneous report was received from a consumer who was also an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dehydration/Dehydration, cramping in lower abdomen/ abdominal pain lower, fever/pyrexia, nausea, headache, disorientation, flu like symptoms/ Influenza like illness, intense vomiting/ vomiting and cramping/ muscle spasms. Patient's medical history was not provided, and concomitant medicines were not reported. On 25 Jan 2021, the same day as the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient reported that she initially had an "extreme reaction" with severe, flu-like symptoms, headache, fever, disorientation, nausea and dehydration. She reported that she had a fever within three hours of receiving the vaccination. She stated that she suffered extreme vomiting for three and a half weeks along with ongoing headache, fever and cramping. On an unknown date, she was in the hospital, or ER, where she received medication for nausea and intravenous medication for dehydration (unknown if hospitalized}. She reported eight hours of pain/cramping in her lower abdomen, and again, stated that she was severely dehydrated. (The duration of hospitalization or ER visit was not reported). At the time of reporting, she said that her symptoms were ongoing, however, much less severe. Treatment included was nausea medication (patient did not remember the drug's name), intravenous (IV) medication for dehydration, IV antibiotics and dicycloverine. Action taken with mRNA-1273 was not reported. The outcomes of the events, dehydration, cramping in lower abdomen, fever, nausea, headache, disorientation, flu like symptoms, intense vomiting and cramping, were considered recovering/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.

fatigue, arm soreness down to fingers, decreased appetite, head feeling "foggy" and high blood pressure

Stroke occurred on 3/6/2021, seen in ED at healthcare facility. Transferred to another healthcare facility. Right sided weakness/paralysis, altered mental status, dysphagia, slurred speech. Rehab at another healthcare facility. Now at home cared for by family.

Pt suffered diarrhea for two days prior to collapsing . she could not move that morning to get out of bed and could barely talk. She mentioned chest pain and an ambulance was called. Following her vaccinations she was very confused and had fallen in the kitchen the Thursday (22nd) prior to her heart attack. They took her to ER noted she was in shock and had very low blood pressure enroute to hospital. Her pulse was very low. She was life flighted to the medical center. It was determined a blood clot had blocked a major artery into the right side of her heart and it was removed and a stent was placed. She remained at hospital 3 nights and was transferred to nursing home for recovery and therapy where she currently is being assessed for mental issues and is on 4 different heart medications to control blood pressure and prevent future heart attacks. There is not a family history of heart issues. Pt was very healthy in spite of being 83 years old.

overall itching of the skin, internal like going to get hives, but NO rash or hives. No try skin, as already treated by both general physician and demitologist with various locations, creams and steroids. Very difficult to wear clothing and sleep at night. Sometimes hands get red and feel like on fire. No break out at injection site.

About 24 hrs after 1st Moderna shot, patient presented with fever to 38.9, confusion , lethargy. Negative infectious workup. Defervesced and mental status returned to baseline after another 48 hours.

2 WEEKS AFTER THE INJECTION i DEVELOPED SEVERE TREMORS IN RIGHT AND LEFT HANDS, CAUSING THE DROPPING OF ITEMS, DIFFICULTY CARRYING LIQUIDS, PLACING ITEMS IN MICROWAVE, HANDLING KNIVES DISHES, APPLYING MAKEUP, STYLYNG HAIR AND ANYTHING ELSE INVOLVING MY HANDS. I know how I functioned before this vaccine, and I know darn well how what a diffcult time I am having now. I also know who is at fault at pushing the vaccine! Dr. lied about the safety, and that is what I believe and no one can change that. I will never be the same, this will never go away and shame on the drug companies for doing sloppy work. That's my true outcome and I stand on it!!!!!!

sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. 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: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; 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.

was seated and waiting for her 1:12 appointment. We administered the vaccine and approximately 2-3 minutes later she was turning red and calling me for help. I asked her what was going on and she said to help her, that she can't breathe, and that she thinks she is going to die. We administered a dose of Epinephrine and shortly after she said she was feeling better but she was shaky/jittery. EMS was called simultaneously and they arrived shortly after.

Given shot on Monday, January 11, 2021 at 10:15 am . Was fine until 7:30 pm that night. Felt like I was drugged and couldn't keep my eyes open. Slept (except for bathroom stops) until 7:30 pm on Tuesday night. Very red and large knot on shot arm. Lasted many days. Very sleepy for days, Dull headaches. Stomach upset. Very foggy thought processes for more than a week. Blurry vision for a few days. Joint pain. Spoke with Moderna and they suggested I talk to my doctor. Doctor told me the side effects would go away within ten days. Most of they did.

Got sick to her stomach, very weak with dizziness and disoriented like in a fog. No headache, fatigue. Not as sick to her stomach, but the weakness is still there and not getting better. Shaking hands. Not able to talk right now due to weakness.

throat felt funny, she said it felt strange to swallow and that her head felt funny. Administered 25mg Benadryl and gave patient water.

Patient was dizzy and slight disorientation after getting vaccine and was observed on site until 1/22 then she was sent to hospital for stroke like symptoms and is scheduled to return to facility on 1/23.

Exactly 12 hours after receiving my vaccination, at 1:30 am, I had a horrific coughing spell that lasted for half an hour. In addition, I had wheezing and a feeling of "bubbles" in my chest. My arm was very hot and tender at the injection site. I slept through the rest of the night but awoke feeling extremely weak and confused. As a result, I spent the day in bed. I had no appetite, as well. The next day, I had coughing bouts off and on and still don't feel myself.

Moderna COVID-19 Vaccine EUA Inability to eat (nausea), unpleasant taste, extreme weakness, inability to think appropriately (unable to recall words, slow thought process), diarrhea -- all occurred for two days and have resolved themselves without treatment; still weak but am increasing liquids, salts, immodium (not today), frequent rests, cancelling Physical Therapy and private clarinet instruction

no treatments at present Insomnia, weakness, muscle aches all over, discomfort in left side of chest, just did not feel well, all happened within 48 hours

I was very weak and I nervous like shaking and very sleepy it just lasted about 1 day. When I woke up this morning I was feeling okay.

CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURATION, HIGH BLOOD PRESSURE

some bruising near my eye; area was a little tender; Afib started to act up; blacked out; Hit forehead on the door jamb; A spontaneous report was received from a consumer who was a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced area was a little tender, Afib started to act up, blacked out, hit forehead on the door jamb and had some bruising near eye. The patient's medical history, as provided by the reporter, included atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, after receiving the vaccine, the patient had no pain or soreness, but the area was a little tender if you pushed, and she waited one hour in the hospital afterwards. As the patient was getting ready to leave, she felt a little lightheaded. She was driven home, she ate lunch and then worked in the yard for a little bit. As she came inside, her Afib started to act up, she took an extra half of metoprolol, and had supper. She took half an alprazolam before going to bed. That night, as she got up to use the restroom, she had a strange feeling in her head like everything was going away. As she walked into the hallway, she blacked out and hit her forehead on the door jamb. Her forehead was all right but there was some bruising near her eye. She went back to bed and fell asleep. On 15 Jan 2021, when the patient woke up in the morning, her rate was still acting up. At about 9:30am to 10:00am, everything improved, and her heart felt normal. Everything seemed to resolve in approximately 25 hours. Treatment also included acetaminophen/diphenhydramine (no details when it was taken). She contacted her cardiologist since receiving the first dose of the vaccine. The cardiologist encouraged her to take the second dose of vaccine with diphenhydramine and have someone stay with her that night in case something happened again. Consent given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Afib started to act up, blacked out and hit forehead on the door jamb, were resolved on 15 Jan 2021. The outcome of the events, area was a little tender and had some bruising near eye, were not provided.; Reporter's Comments: This case concerns a 84 year old female patient with medical history including atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. She experienced serious unexpected events of Atrial fibrillation and Loss of consciousness and NS unexpected events of Contusion, Head injery and Vaccination site pain. The events occurred after first dose of the study medication administration after she went back home. 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, her medical history of heart condition and medication she took could remain a confounder.

Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,, headache, just didn't feel right. Went to primary doctor office on 29th. Ran every blood test, ekg and chest xray-mostly normal except orthostatic hypertension. Told to increase fluids. Felt a little better over the next week then same symptoms again Feb 4 and 5th. Took to ER had a seizure and vomiting. CT showed a Stoke and am currently in hospital.

Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 12-30-2020 11AM Moderna LOT # 025120A 1-26-2021 11AM Moderna LOT # : didnt have a LOT # written in Pain in arm 1-26-2021 pain at injection site immediately and now achy . pi point prick like pain that wakes her up while sleeping/laying down. used cold compresses and warm compresses. took OTC pain reliever and states that helped. also reports a possible lymph node swollen above/anterior the collar bone

Waited the required 15 minutes. got to my car and drove one block. suddenly confused so stopped vehicle along a side street (I believe I had a TIA.) and didn't know my way home for only a couple of minutes. Within minutes recovered and drove on home. Not sure if this vaccine was the cause ( I have had a couple of TIAs many years ago) Not sure if I should get a second shot, it it is safe for me

Patient reports her symptoms started on 2/16/2021 with fevers, generalized weakness, mild disorientation, and dizziness when she presented to the ER.

Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fatigue. Bizarre dreams

Swollen, Itchy arm for three days, first night I kept getting up to Pee and the next day I slept the entire day. My second shot, same reaction, but still do not feel well. Also had temperature of 100 both shots

The day following Moderna #2 (on 2/17/21) she had sudden onset of confusion. She thought the remote control was the telephone and speech was confused. No motor deficits. Was taken to ER and then admitted to Medical Center for stroke-like symptoms. Admitted 2/18/21, discharged 2/20/21 with diagnosis of Acute Encephalopathy (possible TIA) and Accelerated hypertension.

Extreme fatigue, spinal joint pain, muscle aches, foggy brain and chills but no fever. The spinal joint pain began in my sacral area and over the next 4 days migrated up to the low back, then to the rib cage, then to the neck. Muscle relaxants were ineffective. Oral steroid decreased the joint pain over a 5 day period.

Son/caregiver called to report patient was experiencing a decreased mental acuity accompanied with fatigue and loss of appetite after receiving her 2nd dose of Moderna Covid 19 vaccine since Febuary 27th, 2021. Son describer the symptoms as progressive starting after receiving the vaccine. It was recommend the patient's primary care provider be contacted to receive further advice.

Woke up at 1:30am feeling weird. Experienced Weakness, body shakiness, inability to move lower extremities (legs), super weak as in can?t put one leg in front of the other, headache from 1:30am- 11pm on 3/4/21. ?Feels like a spike being driven into the heels of my feet up to my knees where my legs would jump?, pain persisted off and on for entirety of the night. Loss of appetite. Still experiencing some weakness and shakiness.

Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of consciousness, vomiting, feeling abnormal. The patient's medical history included thyroid disorder and hypertension. Concomitant medications used by the patient were thyroid medication and blood pressure medication. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced passing out and falling, vomiting and feeling strange. She was taken to the emergency room and was administered IV and had some tests done. The patient was not admitted. The event passing out and falling (loss of consciousness) was considered as medically significant . No Laboratory details were provided. Action taken with mRNA-1273 in response to the events was not reported. On 13 Feb 2021, the outcome of the events, loss of consciousness, vomiting, feeling abnormal were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

84 yo woman here to follow up from recent episode of vasculitis. She started getting a rash - started 7 days after 2nd dose of vaccine At last visit, we did testing for vasculitis after the rash looked more vasculitic to me; ANCA testing was positive, as was ANA. - 17 days after 2nd vaccine She was given prednisone 20 mg taper over the last 8 days. She is feeling much better in terms of her rash and swelling. She is having surgery on the 29th for her BCC on the left eyelid. She is noticing blurred vision in both eyes since this all started and she is mentioning this to the eye doctor when she sees them. She says her head was fuzzy when this started and this is better but is still "fuzzy sometimes" Her renal function was normal. Her CBC was mildly elevated WBC but otherwise normal. She denies any breathing problems, blood in stools or blood in urine, or neurologic symptoms other than the fuzzy head.

pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4 red, hot, itchy hives arounds the injection site. She stated she had an AFIB event that started up this same day. She has had this before but has not been a problem until this day. Pt is using Goldbond itching cream and Benadryl. Pt will contact her PCP about the AFIB event. Pt still has some redness and itchiness of the arm. The brain fog and fatigue is gone but she still has some AFIB going on.

Received 2nd COVID vaccine 3/7/21. Suffered syncopal episode on 3/8/21 resulting in fall, hit head, ambulance transfer to ER. Non-contrast CT head negative, discharged from ER. Another ER visit on 3/13/21 due to chest, shoulder and back pain, was found to have fractured ribs and discharged to care of child. Pt was taken to ER on 3/14/21 as woke up unable to ambulate without 2 person assist. CT chest revealed 3 fractured ribs, magnesium level low and replaced in ER. Pt was eventually admitted to the hospital, 2 night stay and transferred to an extended care facility where she remains. Pt is still unable to ambulate without 1-2 person assist, has suffered confusion and occasional hallucinations. Awaiting results of 2nd CT of head obtained on 3/18/21.

about an hr or so after inj.....severe hand/arm tremors followed by complete incoherence,,, muscles like jelly, no use of anything. this total out of it occurence lasted about 12 hrs followed by days of weakness, achy, sleepiness, off and on foggy. general blah feeling

CLIENT HAD SEVERE TREMORS FOLLOWED BY TOTAL DISORENTATION, COULDN'T STAND OR WALK. UNRESPONSIVE FOR ABOUT 12 HOURS. FOLLOWED UP 3/23/2021 WITH PRIMARY DOCTOR. DR FELT SHE HAD AN EXTREME AUTO IMMUNE RESPONSE. WILL RECHECK ON 4/08/2021

Having prolonged pain in neck- Left- with vertigo whenever I get up falling to the left. Very unstable. Chills every day beginning around noon, lasting until around 5pm. whole body shakes. Wondering if this is going to be lasting for a short time?

Diarrhea, fatigue, and confusion starting 3/24/21 with normal blood sugar levels (132). Morning of 3/25/21 pt disoriented, confused, fatigued (can't stay awake), dizzy, and has vomiting and diarrhea. No fever.

Morning after 2nd shot felt great deal of fatigue, to the point of returning to bed. Spent rest of day on couch with no strength. Beginning of front of head headache. This headache has continued to this day, also some visual blurring. Fuzzy head thinking feeling. These conditions are on going as of today 03/25/2021.

I noticed significant swelling and increased pain at the injection site when I went to bed. (The deltoid area had swollen a bit by the first night after injection, so this was the second night. ) I took an OTC sleep aid (50 mg diphenhydramine) and drifted off by 1 am. At 3 am I awoke, whether due to my usual polynocturia or the vaccination reaction I can't say. My upper body, especially my arms and hands, was violently shaking and I had a blinding headache--and likely a fever, too. After that, I awoke at 4, 5, 7 and 8 am, during which time the shaking and headache subsided. I was very tired and my whole body was sore, so I went back to bed and slept until 10 am. By midafternoon, I was back to normal.

on and off dizziness, brainfog and nausea, continuous weakness and fatigue, sometimes incapacitating, varying in duration and severity, continuing to present, 3/29/21

dementia was exaggerated; Confused/mentally unwell; A spontaneous report was received from a consumer concerning an 84-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, dementia was exaggerated (Dementia), confused/mentally unwell (Confusional state). The patient's medical history included Covid-19 after first dose. Current conditions included underlying dementia. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, after receiving her second dose of vaccine, the patient was confused and mentally unwell. It was reported that after the vaccine, it seemed that her dementia was exaggerated. Treatment for the events was not provided by the reporter. 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, dementia was exaggerated and confused/mentally unwell was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. However, patient's elderly age along with underlying dementia may have been contributory.

the next day after vaccine I felt sick, then I had a TIA mini-stroke, I've recovered but I still have memory loss, I forget everything now.

Could not get comfortable; Could not function; Rash all over her body; Intense neuropathy; Pain in her back to the point she; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Intense neuropathy) in an 84-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 Neuropathy and Broken hand. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Intense neuropathy) (seriousness criterion medically significant), BACK PAIN (Pain in her back to the point she) and RASH (Rash all over her body). On an unknown date, the patient experienced FEELING ABNORMAL (Could not get comfortable) and IMPAIRED WORK ABILITY (Could not function). At the time of the report, NEUROPATHY PERIPHERAL (Intense neuropathy), BACK PAIN (Pain in her back to the point she), FEELING ABNORMAL (Could not get comfortable), IMPAIRED WORK ABILITY (Could not function) and RASH (Rash all over her body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment details included generic Claritin and oxycodone. 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.

Day aftrer second shot, temp went to 102.5, used cold compresses on forehead and throat to reduce fever. Few days later, developed shoulder pain. Harsh "hot" pain in shoulder joint, radiating across shoulder blade and up neck to base of skull. Have not reported to doctor, for why bother??? Only pain med I can use is tylenol, and it helps some. Also use ice pax wrapped around neck. Pain at times is disabling. Will not take a booster. Also will not advertise this side effect. But have a friend who is also suffering same pain.

Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown. 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.

Altered Mental Status. Confusion. Lasted about 12-24 hours. Occurred about 24h after vaccination. Pt found by daughter speaking gibberish and acting oddly.

Patient called today and said her arm really hurts and kept her up at night. It is also swollen , red and hot to touch.

I developed a severe case of hives at the vaccine site 5 days after the inoculation. I also had arm pain. Then I developed brain fog, hallucinations, shortness of breath, worse a-fib, body pain , deep depression.

Patient received both doses of COVID Moderna vaccine (2/13/21 and 3/13/21). She presented to the ER on 7/7/21 after a fall at home. She was noted to have altered mental status/confusion and claimed she was dizzy. CT brain was negative, as well as chest X-ray and pelvic X-rays (also negative). Pt was tested for COVID per protocol, and was found to be positive on 7/7/21, despite being fully vaccinated and being asymptomatic. Patient was admitted for Neuro work-up and was started on ceftriaxone for presumed UTI. COVID treatment has not bee started since pt is asymptomatic and is not hypoxic.

Don't remember the whole next day with the exception of a minute in the morning when my husband was stepping on my left arm and I was on the floor beside the bed, telling me to get up and take care of him ( he has dementia) and then in the late afternoon and I'm on the floor in the living room and my husband is stepping on my left hand and is telling me to get up and take care of him. I remember nothing until the next morning when I got up and was normal. Took my blood pressure and it was 97/50. I have high blood pressure. I have no idea of how I functioned.

The patient's son said his mother complained of dizziness, headache, confusion and very high blood pressure. He brought her to the emergency room where her blood pressure was found to be extremely high. The staff told him she was reacting to the Moderna Vaccine.

Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine. She has red and itchy bumps. She saw a primary care doctor who diagnosed scabies. She was treated medically and it did not work. She saw a dermatologist who twice biopsied. A skin inflammation was diagnosed and Sarna was advised. Her primary care doctor prescribed prednisone: it made her puffy but did not help much. Her primary care doctor gave her a sulfa antibiotic and she completed it without benefit. She has an ointment to mix with Sarna and it helps. She cannot sleep. She has used Zyrtec: it does help her to sleep but nothing else. Allegra did not help. Individual lesions can last a week at a time. She has a history of ?swellings? of her bones. She has had problems of her knees and heels. She has had injections of her knees, shoulders and heels. Her fingers sometimes hurt, and they have been injected. She denies any other swellings. She started Edarbyclor and Bystolic last year. She started Diltiazem in March or May. Baby aspirin was started in the early 2000s. Simvastatin in about 2003. She recently completed a week of sulfamethoxazole-trimethoprim.

In the early morning of Monday, January 11th the patient developed a significant headache with neck pain. She also reported parathesia and tingling in bilateral upper extremities with weakness of the right upper extremity. She reported feeling very anxious and "wound up". Patient presented to the Emergency Department 3 hours later. CT of the head/brain, EKG, CBC,CMP, Magnesium and Cardiac profile were performed with no significant findings. Ativan 0.5mg was administered orally. Patient was admitted to the facility for observation. Symptoms gradually resolved with no additional treatment.

She awakened in the middle of the night feeling much pain in arm where injection was. Felt like she would throw up but couldn't move from the bed. Felt like her face was drawn and tight. This morning, she has been very shaky, sounds like some congestion in her chest (cough), very tired, very dry mouth. She is never sick, so this is alarming to her and to me.

The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.

Patient reported sore arm shortly after vaccination. Later in the evening a feeling of disorientation and dizziness. Overnight experienced extreme nausea, headache, fever, chills, body aches, severe weakness and mental disorientation. On the next day, patient was still unable to eat and was extremely weak with continued nausea and severe headache which was aided by Tylenol. 2/11 patient is still very weak and no appetite and a general feeling of malaise.

This case experienced facial flushing just after receiving the vaccination; "Felt funny"; BP values initially normal, ( 120-130/80-90) became elevated 200/100.

During the night became almost paralytic (whole body - which lasted two hours), fever 102.7, no energy, nausea, no appetite. Second day, slight fever, slight appetite, more energy.

24 hrs after injection i was hot hot, started getting weak, body weird, , feeling nauseous, went tto bed and woke up feeling sick, unsteady on my feet, hard time breathing. Went to the ER on the 10th but was not able to treat you. im getting better but slight nauseous still

paralysis, hallucinations, lack of speech, no bowel control, slept for 2 days straight, no mental reasoning or control of bodily functions

Patient was very fatigued and incoherent the entire day. She does have some short term memory loss normally but yesterday she was not able to track simple commands, she could not complete a sentence, she thought people who had dies years ago where living, she was unable to identify her daughter on the telephone etc. None of these examples are typical for her it was very alarming and I was unable to find anything like this listed in side effects. After a night of sleep last night she woke up "normal" this morning and she is not able to recall any of what happened yesterday.

Patient called and stated she could not sleep last night due to severe "unbearable" itching on her back. She stated initially no rash, but later said there were a few small red dots on her back. She denied having a fever, difficulty breathing, itching in other areas of her body, or any other rash. She stated possible stomach discomfort, but was not sure if this was related to the vaccine.

My mom had a fever, chills, aches all over, sore arm, and had 2 days of memory loss/crazy behavior. It was almost as if she had dementia - she repeatedly called myself and my daughter claiming that her phone didn't work and she needed help. She was trying to tell me a phone number but kept giving me random words instead. She doesn't remember talking to any one of us who spoke to her Saturday and Sunday. She was repeatedly asking what a specific button did on her TV remote, and would then ask again a few minutes later the exact same question. This went on for 2 days.

Monday, four days after vaccination, Awoke feeling "off" and about noon after Physical therapy treatment felt worse, really tired, went home to bed, slept, no appetite; 1:00 PM fever 99.9 about 3:00 PM fever 100.9; general body aches, ate a small supper. Went to bed, Slept well, awoke feeling good. No more problems.

Moderna COVID-19 Vaccine 15 hours after I received the vaccination (3 AM of the morning of February 24) I went to the bathroom to take two Tylenol for a headache. I then used the toilet and started walking back to bed (less than 20 feet away). About halfway there, I I realized something was wrong. The next thing I knew I was lying on the ground right next to my bed. On the way down I think I heard crashing into wood furniture. I don?t know how long I was blacked out; it might have been 10 minutes. I managed to get up onto the bed and felt something wet on my pillow case. It was blood coming from a deep laceration on my chin. My doctor told me to go to urgent care. They sent me to the emergency room. I was kept overnight for observation and give three stitches in my chin. I have felt woozy ever since, but all the tests administered in the hospital showed no damage.

The day after the vaccine chronic nausea, feeling passing out, disorientation. overall weakness for ten days. Including hot flashes... Called doctor and was advised not to take 2nd shot. Called pharm and tried to cancel the next shot without success. Now reporting it here. Mom does not want 2nd shot

pt states that on 2/27/2021 she started getting nervous and dizzy. She fell on 2/27/2021 and 2/28/2021. On 2/28/2021 she started coughing and having trouble breathing so she went to Urgent Care. She was tested for flu and covid and then told she needed an EKG so was told to go to the ER. She did not go to the ER but went to a Cardiologist Dr. next morning on 3/1/2021. They took chest XRAY, EKG, Blood Work, and covid test. Dr. changed her prescription Carvedilol 6.25 mg x 2 daily and Furosemide 20mg once a day. Pt is expecting them to call her today w/ test results and will FU w/ regular Cardiologist.

in evening headache nausea overall sick feeling weak had to get in bed no sleep during night sick all night unable to get out of bed till noon felt better ate drank around 2 pm today

pt stated that the next day after getting the vax she started feeling foggy so went back to bed. Pt had to take Aleve because she was feeling cruddy and couldn't see straight. Had headache, low fever and body aches. Pt drank some water but it came back up as soon as she drank it. Pt states she feels some better today.

At first, slight headache,that progressed to mild, joint ache, fever of 101.1, fatigue. Took 1 Advill at 11:10 P.M. Felt better next morning until 1hr. 30 min after arising. Sudden heavy fatigue. Couldn't finish fixing breakfast. Slept 3 hours, did 1 load of laundry, slept 3hr. 30 min.. No appitite, Did another load of laundry, slept 3 hours. Ate fruit and a sandwich about 6:30 P.M Took 4 Low dose aspirin then,, Took a bath and in bed at 10:25.Headache gone then. Slept til 6:00 Sun. felt fine except for fatigue which lasted into Monday,. Also sore right arm at injection site.

Within the first 24 hours she showed a look of serious aging, and then the following day extreme pain in the mid and left side back making it difficult to walk or move. Severe pain. The pain seem to shift around like more nerve pain showing in the muscle . Started on the left side but moved around. This was initially helped with some strong curcummin/boswella (inflammation pain formula at our health food store) and a homeopathic remedy. But the symptoms came back and kept going . She is very active and was unable to do her regular routine. She was sleeping more and in considerable pain. After several days, we tried what another country recommends for reactions to vaccines and it seemed to help her within a very short time. There is still now residual pain but she is better. We have GREAT concern over what a second dose could do and do not feel that with such a strong reaction the second dose safe. Also a great concern that the same amount of vaccine for a 250 pound person and a 100 pound elder. She is very tiny bones and weighs around 100 pounds are less. Very concerning as no medicine is usually the same for everyone. Also a concern of why just one month from second dose when it takes a known 6 weeks for blood to change. A high chance of severe reaction can happen with such a close proximity and a second dose. We would like to see advise of no second shot or considerable less for small people. CDC person recommended she switch vaccines? That seems risky and there is no studies of adverse reaction to combining two different vaccines. She would like to be comfortable moving around in public and is of great health for her age so this reaction was very concerning. If she had such a reaction on FIRST DOSE....wouldnt that be a indication that her body reacted and a second dose not necessary advisable. Please advise. This is of great concern to all of us who love her and of great concern for the general public who may be at risk for such adverse effects. I put unknown below because she still feels some pain even though it is less.

At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aphasia, her daughter called 911. The ambulance delivered her to Hospital by 2:20. She presented with a brain hemoragh. Hospital called for medivac which took her to another Hospital. The bleeding continued and the docs ruled out surgery. They were unable to slow the bleed. Patient was put on a ventilor shortly after arriving at hospital. Patient passed at 6:55 PM March 13.

Patient reported feeling fine after vaccinatoin up until 7 days post Moderna vaccine. She reported her arm started to itch and hurt terribly. She reported a rash that grew to 6 inches long and is starting to show improvement today after 3 days. She reports the itching was much worse than the pain and bothered her so terribly she had difficulty sleeping.

Eleven days after the first shot, I developed shingles. The day after the second shot, I developed fever, severe headache, vomitine, diarrhea which has lasted four days. I could neither eat nor sleep. It felt like I had been poisoned. This is not a small reaction!

RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021. ON 3/14/2021 SHE STARTED TO BECOME DIZZY, CONFUSED AND DEVELOPED MALAISE AND EVENTUALLY BECAME SO WEAK SHE COULD NOT MOVE. PRIOR TO THIS SHE WAS VERY ACTIVE AND WAS WALKING AROUND FINE AND EVEN CLEANS HORSE STALLS AT HER HORSE BOARDING STABLES. SHE WAS PHYSICALLY VERY ACTIVE PRIOR RECEIVING THIS 2ND VACCINATION. SHE IS CURRENTLY ADMITTED. SHE IS STILL CONFUSED AND AGITATED SHE CONTINUES TO BE WEAK AND CANNOT AMBULATE AT THIS TIME.

headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around that time. was found 4 days afterwards by home health aid in bed, with bowel incontinence, disoriented, weak and unable to speak. Pt states also had diminished sight and hearing. pt is diabetic and had elevated blood glucose readings that have persisted almost a month following the vaccine, per pt report

Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday for bronchiolitis. Covid test was done, no results yet. Pt daughter stated got better yesterday today confused. 85-year-old woman who presented with 2 days history of cough, chest discomfort and shortness of breath. She reports insidious onset of symptoms 2 days ago cough which was initially dry, then productive of scanty whitish sputum. She also reported associated shortness of breath and pleuritic mid chest discomfort. She denies any fever, chills, nausea or vomiting. She denies any known contact with individual diagnosed with been tested with COVID-19 infection, reports compliance with masking directives. She is up-to-date with her COVID-19 vaccination, 2nd short of COVID-19 vaccine was administered last Saturday. Chest in her primary care physician yesterday and been diagnosed with bronchiolitis, prescribed oral Augmentin and Medrol Dosepak without any improvement in symptoms. She presented to emergency department today and was found to be hypoxic to 82% on room air. At present she has required supplemental oxygen at 5-8 liters/minute. She will be admitted to the hospitalist service for further treatment and evaluation. 3/20/21: She is s/p plasma, antibiotics (aztreonam, vancomycin), no remdesivir due to poor renal function. She has been on decadron 3/12 to date (to complete 10 day course) She was able to be weaned down to 1 L NC oxygen while on admission with improved symptoms. Plan is to discharge to rehab today.

Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental status. Sent to ER. Had elevated cardiac enzymes. Admitted to hospital and treated for sepsis and altered mental status.

23 hours after vaccination I just had to lie down and was what I call delirious, not knowing anything except kicking the covers freezing, then hot. First reaction was nausea and couldn't eat anything. It lasted from 10AM on 03/12/2021 until 10AM on 03/13/2021 I had the Corona 19 virus the last two weeks of November, 2020. Emergency room at Hospital afte I had been sick for the 2 weeks, the doctor at the hospital thought I was practically over it so released me.

a week after injection she gained 10 lb water weight, then over the next 2 weeks an additional 20 lb of water weight. She had decrease in activity, anorexia, and was found to have multiple bilateral pulmonary emboli.

Red, swollen and itchy arm, fever and chills. For several days. In the beginning. After about 2 weeks very weak and shaky legs. Varicose veins became very painful/. Blood tests show high amount of inflammation

About 18 days after shot, I noticed pain on my left side in evening after sitting in bed two hours watching TV. Turning or changing position hurt but passed if I held the position. It affected my sleep a bit more as the days past. But during the day, I could dance, move with no or sometimes, a tiny bit of pain in my side or back. Because it got more painful at night and early mornings when I got up I decided I better contact you and delay the second dose which is scheduled for Friday, 4/23/2021 at l:00 pm. Should I take Tylenol in the meantime at night. Again I feel fine during the day when I am moving around. But there is a reminder from time to time.

After shot no problem, then 3 weeks broke out with rash that itches all over my body left arm and back of neck most severe. Cannot sleep for itching have sprayed with anti itch medicine used creams, lotions anything to keep skin moistened but still persisted Finally on April 24 I was so miserable I went to Urgent care and received a steriod shot which helped for a wee then itching returned and I went back and thy said no more steriods and tried a benedry shot which put me to sleep until the itching woke me up. My friend was having the same problem but went on and took her second shot and ended up in ICU in town and they have recently moved her to hospital. I did not take the second shot and want to know what to do for relief.

Chronic Pain med requirements increased after the second dose of the vaccine. 1 week after vaccination previous dose quit working.

Individual reports about 14 hours after receiving vaccine at 2 a.m. she started to get a severe zinging followed by a pop in her head. She also reports hallucinations at this time of a cat running around her legs with a dogs head. She reports these things lasted for a couple of days. Denies any dizziness or being light headed. She reports she was so frightened she did not want to leave her home to seek medical attention. She reports after a couple of days the symptoms went away. Her friend recently told her she should have reported the symptoms so she made a call into us today.

Feeling unwell; Shoulder pain; Joint pain; Unresponsive to stimuli; Could not speak; Felt very shaky internally; Leg tightening; Burning sensation; Pain in neck; Unable to sleep; Tiredness; Severe head discomfort; Arm hurt after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after the injection), FATIGUE (Tiredness) and HEADACHE (Severe head discomfort ). On 13-Mar-2021, the patient experienced INSOMNIA (Unable to sleep). On 15-Mar-2021, the patient experienced NECK PAIN (Pain in neck). On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation) and LIMB DISCOMFORT (Leg tightening). On 18-Mar-2021, the patient experienced NERVOUSNESS (Felt very shaky internally). On 20-Mar-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant) and SPEECH DISORDER (Could not speak). On an unknown date, the patient experienced MALAISE (Feeling unwell), ARTHRALGIA (Shoulder pain) and ARTHRALGIA (Joint pain). At the time of the report, UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), SPEECH DISORDER (Could not speak), BURNING SENSATION (Burning sensation), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Arm hurt after the injection), NERVOUSNESS (Felt very shaky internally), LIMB DISCOMFORT (Leg tightening), INSOMNIA (Unable to sleep), MALAISE (Feeling unwell), FATIGUE (Tiredness), HEADACHE (Severe head discomfort ) and ARTHRALGIA (Shoulder pain) had resolved and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 203 (Inconclusive) 203. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up included updated height, weight and race of patient, outcome, additional lab information, and additional events. Case was upgraded to serious.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273.

Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy. within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's. Performance status declined. Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.

Massive headache. Began forgetting things. She was asking the same questions over, and over. She never showed signs of concern over her memory.

Patient with fevers, myalgias, and delirium. Required hospitalization for infectious work up which has been negative to date. Now improving and still hospitalized.

Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real real dizzy; I didn't feel sick, but I didn't feel right; I slept most of the day; I didn't have appetite; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib wt RVR) and TACHYCARDIA (Tachycardia) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis in 2010. Concurrent medical conditions included Drug allergy (aspirin), Drug allergy (Avelox), Drug allergy (morphine), Hypertension since 12-Dec-2011 and Hypothyroidism since 24-Sep-2014. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 24-Sep-2014 to an unknown date, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 12-Dec-2011 to an unknown date and LOSARTAN from 17-Mar-2021 to an unknown date for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Afib wt RVR) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite). On an unknown date, the patient experienced MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue). The patient was hospitalized from 15-Mar-2021 to 18-Mar-2021 due to ATRIAL FIBRILLATION and TACHYCARDIA. The patient was treated with CARVEDILOL at a dose of 6.25 mg. On 20-Mar-2021, DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite) had resolved. On 01-Jun-2021, ATRIAL FIBRILLATION (Afib wt RVR) had resolved. At the time of the report, TACHYCARDIA (Tachycardia), MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: high (High) high. On 15-Mar-2021, Heart rate: high (High) 150. On 20-Mar-2021, Blood pressure measurement: 139/79 (normal) 139/79. On 20-Mar-2021, Heart rate: low (Low) 53. 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 treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received included: Added medical history, concomitant medications and added new event of Atrial Fib with RVR.; 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

She had generalized weakness so severe her son had to pick her up and carry her up the steps she was hallucinating a "little person" and carrying on a conversation with him. She was extremely confused. She had diarrhea We ran bloodwork /testing everything was fine except for some hypokalemia likely from the diarrhea. She recovered on her own within the week.

1/26/21 Stiff neck on left side that awoke me in middle of night - Took tylenol approx. 10 am 1/26/21 - most pain gone by 1 pm

Pt received Moderna covid vaccine. Vaccine Placed into Left deltoid. During vaccine administration, pulse ox was placed to Pt's right index finger, HR showed 122-156, 98% RA. Pt stated she was nervous and anxious and was noted to be diaphoretic. Pt stated she got the vaccine because her spouse wanted her to. At approximately 1646 Pt's HR 138. Pt denies chest pain and sob and stated she was feeling anxious because of all the attention she was getting. O2 at 2 lpm placed via nasal cannula. At 1649 HR 141, O2 at 99% @ 2/LPM. 1653- Pt's HR 120, O2 sat 99% @ 2 lpm. At 1655- HR 126, O2 sat 99% @ 2 lpm. 1700-HR 147, 98% O2 @ 2/LPM. BP 138/89, HR 142 at 1704. BP 137/90 HR 142 at 1710. Pt advised that Paramedics will be called. Pt upset and stated she was fine and declined to have paramedics called. Pt signed AMA at left clinic at 1714 with husband. Advised Pt and spouse to call paramedics if Pt becomes SOB, difficulty breathing and/or having CP. Pt and Spouse verbalized understanding.

10days after shot, my arm got hot the spot got swollen. it was about 5 inches in diameter and it was hot red and swollen. Physically i had all the chronic fatigue attack where my mind is not sharp, I was depressed, and tired, and i was hurting. My hips were hurting, i have paraphasia in my right foot but it went from my toe to my knee and it was painful. lasted for 10days. I woke up Saturday and everything was fine and i was back happy. I am still stressed

Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe shortness of breath and felt as if she had a cement brick on her chest. She struggled to breath all night, and paced the house. Patient states she felt as if she was going to die. Patient did not wake anyone up or tell anyone, so vitals or other information could not be obtained during the reaction. Patient felt better Saturday morning, but still very fatigued and very fearful.

Was wandering around the house in the middle of the night, after midnight. Went to the kitchen to eat and fell, had to have help getting up. She was too weak to get up on her own. Had no recollection of falling. She went back upstairs to her room and eventually continued wandering around. At 7:15 am she didn?t know if it was morning or night. Shortly after eating she had no recollection of eating. All of this sounds like it would be her normal with Alzheimer?s but she is not at this stage yet. She acted as she did when she had a TIA several years ago.

02/04/2021 I began to get an itchy arm and I developed a rash. my arm was sore. the rash covered my upper arm down to my elbow. today 02/08/2021 the rash is mostly gone but still noticeable and very itchy but much improved. I was very miserable and I am unsure if I should get the second.

Top of head to bottom of feet for itching. difficulty breathing, lung pain, headache, dizziness, disoriented-unable to maintain balance, growly voice, body aches

That night, after the vaccine, I had severe lower back spasms, really painful, but each did not last but a few seconds. There were probably 3 or 4 of them, in succession. Other than sleeping for 48+ hours (except to eat) and a very sore arm vaccine site, and swollen (and still so, but improving), but no other events. No treatment except as given (Tylenol & ibuprofen), no other symptoms, etc.

Woke up to red arm at injection site. I am due to get my second shot on February 19 and my arm is still a little red, smaller than before and does not itch or hurt .

overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg weakness, nausea, dizziness, mouth ulcers outbreak, face flushing , this happened during the week following the Monday vaccination...?.still have some mouth sores and face flushing

Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital. No autopsy was done.

HAD SHOT IN LEFT ARM - AT 6:00PM LEFT HAND WENT NUMB. AT 8:00 HAD SEVERE CHILLS & HIGH TEMPERATURE WHICH LASTED FOR 24 HOURS. HUGE BODY PAIN & COULD NOT MOVE ANYTHING. NECK & HEAD HURT SO BAD I COULDN'T STAND TO MOVE. I COULDN'T LIFT ARMS TO DRINK WATER. SON TOOK CARE OF ME ALL DAY THE DAY AFTER THE SHOT. HAD BRAIN FOG. COULDN'T THINK WHAT I WANTED TO DO OR WHAT I WAS DOING. LASTED FOR A WEEK. AFTER A WEEK I TRIED TO DO MY USUAL WORKING OUT ROUTINE, BUT WHEN I TRIED TO RIDE THE ELLIPTICAL I BROKE OUT IN A HUGE SWEAT AN ALMOST PASSED OUT. THAT LASTED UNTIL 2/22/21, WHICH WAS YESTERDAY, WHEN I WAS FINALLY ABLE TO RIDE ELLIPTICAL WITHOUT ANY ADVERSE REACTIONS. (I'M 86, BUT A VERY ACTIVE 86. I PLAY TENNIS 2 TIMES A WEEK & WHEN WEATHER IS NICE I RIDE MY BIKE FOR 15 MILES A COUPLE TIMES A WEEK.) LIFT WEIGHTS 3 TIMES A WEEK AFTER RIDING ELLIPTICAL FOR 45 MINUTES. NOT A TYPICAL 86 YEAR OLD PERSON.

2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme confusion and weakness in arms and legs. unable to do usual daily activities. unable to self-transfer. Taken to ER and diagnosed with UTI. 2.18 - resident complained of headache and being unable to sleep previous night. VS: temp 101.8; BP:135/63; P:93; R:20; SP02:79-80%; HOB elevated. Resident send to ER via ambulance. Diagnosed with pneumonia. hospitalized for 5 days.

Received vaccine on Feb 25. One Feb 28 started feeling like coming down with cold with runny nose and by evening mouth was beginning to feel strange. Monday through Wed with sores on lips, gums, tongue. roof of mouth. Sores were red inside and not raised on lips sores were blister like, raised and sore. Sore on tongue also blister like. All sores were painful. Had difficulty eating especially sour things. Gums were very sore. Today, is feeling a little better. Issue not yet resolved. Tried salt water mouth rinse with fair results to decrease pain. Used OTC meds for pain relief.

Got the vaccine, and later noticed pain in her neck, knees, head. She had dizziness, chills, shakes, nausea and a slight fever. She went to bed that evening and everything was hurting, and felt very nauseous. She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97. She did take her morning meds and an extra-strength Tylenol and went back to bed. She took Tylenol, was feeling better, but still the chills and fatigue and was better. The problem with the headache continued and her temp was about 99. On 2/12/21 had temp over 100 again, no energy, slept a lot. Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking. On Monday felt shaky, chills and difficulty sleeping. On Tuesday she was having headache, not sleeping well and no energy. She also was not sleeping well, had a headache. By 2/17/21 was feeling better, not great as she was still not sleeping well. She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20. When she had the covid test she was inconclusive and that's why she could not see her doctor. Her doctor did the antibody test that showed she had antibodies. She is feeling back to normal as of today, 3/8/21. She had the malaise from COVID after she got the 1st vaccine. Feels that they should ask people before getting the vaccine if they had COVID.

Two days after her second Moderna vaccination (administered on 2/25/2021) she developed lesions on her neck. We took her to an urgent care clinic on 3/2/2021 and they diagnosed her with a shingles outbreak more than likely as a result of her vaccination. She did not have any reaction to her first Moderna vaccination four weeks earlier. She was prescribed an anti-viral. She is more comfortable now but her cognitive and physical abilities have declined significantly. She is also having significant sleep issues which have also contributed to her cognitive and physical problems.

Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.

The second dose was administered, in error, on day 22 (rather than day 28) therefore, given too early. This individual began to experience severe body aches, fatigue and reported having chills on day 2 following the vaccination and lasting 3 days. She remained in bed most of day 2, only getting up to the bathroom. After day 2, she was able to get out of bed with assistance for meals, however, continued to complain of fatigue and some body aches. At this time, symptoms have resolved with exception of still experiencing some body aches in the mornings, making it difficult for her to her out of bed and to breakfast.

Extreme long standing arm pain with inability to raise arm, progressed to other arm. Diagnosed with Subacromial bursitis, shoulder capsulitis, SIRVA

On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor. She had fatigue, headache, and generalize pain, her BP was low 100/44. All she could do was sleep and had no appetite, on the 20th she felt well enough to go for a car ride, her husband drove. She did see her PCP on the 18th who thought she was depressed, seemed unconcerned that she fell to the floor, her Bp was low this day as well, all labs were normal. This was her 2nd Covid-19 Moderna vaccine, she had no symptoms with the first injection. She has never before experienced disorientation, that she did on 3/14/21 @ 3 am.

pt states by noon after taking 2nd dose she had developed itching, chills, headache, body pain, and head was foggy. Pt had very odd body aches and pains, itching, and headaches that would come and go for weeks. These symptoms lasted at least 22 days before subsiding. Pt contacted her PCP and was told to take Claritin. Pt also had an annual appt w/ PCP where she did blood work but pt has not received any results. Pt no longer has these symptoms.

A day after vaccination the recipient became disoriented, had memory issues, developed a rash and was extremely fatigued. This persisted for "several days."

About a week and a half after the vaccine, I came down with shingles and I'm so tired and have terrible brain fog and I can't function well.

Fatigue, hypersomnolence, gait instability, anorexia, apathy, urinary urgency/incontinence, "brain fog"

Extreme fatigue and weakness, swelling of injection site (left arm), elevated temperature, mental confusion, complete loss of appetite ,cold sore

Stomach pain which ended in diverticulitis attack; Cold; Sweating; Nausea; Stomach pain which ended in diverticulitis attack; COVID arm; COVID Flu Symptoms; Right arm tender; Fever; Body aches/ Achy flu system; Splitting headache; Chills; Doesn't felt great; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Stomach pain which ended in diverticulitis attack) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diverticulitis since 15-Jul-2018, Drug allergy (Allergy to Flagyl (metronidazole).) and Drug allergy (Allergy to Sulfa). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (Doesn't felt great). On 09-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Splitting headache) and MYALGIA (Body aches/ Achy flu system). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm tender). 10-Mar-2021, the patient experienced PYREXIA (Fever). On 10-Mar-2021 at 8:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (COVID Flu Symptoms). In March 2021, the patient experienced CHILLS (Chills). On 19-Mar-2021 at 9:00 AM, the patient experienced VACCINATION SITE REACTION (COVID arm). On 12-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain which ended in diverticulitis attack). On 15-Apr-2021 at 10:00 AM, the patient experienced DIVERTICULITIS (Stomach pain which ended in diverticulitis attack) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). The patient was hospitalized from 15-Apr-2021 to 18-Apr-2021 due to DIVERTICULITIS. The patient was treated with Surgery (On 18-may-2021, patient underwent intestinal surgery to remove diseased section.) for Diverticulitis. On 12-Mar-2021, HEADACHE (Splitting headache) and MYALGIA (Body aches/ Achy flu system) had resolved. At the time of the report, DIVERTICULITIS (Stomach pain which ended in diverticulitis attack), PAIN IN EXTREMITY (Right arm tender) and ABDOMINAL PAIN UPPER (Stomach pain which ended in diverticulitis attack) had not resolved, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (Doesn't felt great), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown, INFLUENZA LIKE ILLNESS (COVID Flu Symptoms) had resolved with sequelae and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: increased (High) increased. No concomitant medications were reported. Patient reported to have no health issues for the past 18 months, before administration of mRNA-1273. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. This case was linked to MOD-2021-023857 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional info:updated events after second dose of scheduled two doses of mRNA-1273 - chills, fever, achy flu, tenderness of right arm, hives, stomach pain. Updated Serious event - Diverticulitis, which required hospitalization. Updated No prior history and no treatment received to events - COVID arm and COVID flu. Updated medical history to Allergy to Sulfa and Flaquil, Diverticulitis on 15-7-2018. On 11-May-2021: Additional info:Updated events - cold, sweating, nausea.AE information(merged with other case); Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. MOD-2021-023857:Patient's first dose

An avid crossword puzzle worker for 50 yrs, suddenly doesn't work them anymore. Short-term memory is worse than before. Left side of the mouth droops. Weight loss. Confused. Complained about leg weakness, legs and knees hurt, hard to walk, being tired, drooling, dry mouth, mind not right.

Covid-19 vaccine administrations (Moderna) 3/23/21 lot# 013A21A 4/20/21 lot# 013A21A Admission to Hospital (5/2/21 ? 5/10/21) for hypertension and acute on chronic back pain requiring ICU admission, hyponatremia thought to be due to SIADH. CT of abdomen done at hospital noting no significant lumbar abnormalities and a plain film of her lumbar spine with no obvious compression fracture. Outside hospital notes do not further outline why she could no longer ambulate. Brain MRI done and negative during that admission. Discharged to a rehab facility for ongoing weakness. On 5/13/21, patient?s son requested admission to hospital for further evaluation. She states that she feels confused and her legs are very heavy and she can barely move them. Notably she lives alone in her own home, used to drive, did not use any assistive device to walk, and paid her own bills until 2 weeks ago. The symptoms did occur approximately a week after receiving her last Covid vaccine. Pt also notes around April 1, 2021 having taken an engorged deer tick off her head. 5/14/21 Lyme serology IgM & IgG = negative. Neurology was consulted. She had an MRI of her thoracic and lumbar spine, as well as an LP. She had had an MRI brain at a hospital. Her MRIs did not reveal a source of her weakness and pain. Her CSF revealed albuminocytologic dissociation. Given this finding and the constellation of symptoms and LP findings, it was thought she had Guillain Barre Syndrome, presumably due to her COVID vaccine. She was given IVIG for 5 days. She improved with this. As above, she had a recent admission for hyponatremia and hypertensive urgency. Here, her blood pressure was somewhat labile, but at times was low. She was started back on amlodipine and carvedilol, but at much lower doses with plan for ongoing monitoring. In terms of her hyponatremia, her salt tabs were stopped, and eventually her fluid restriction was able to be lifted. Her sodium was 136 at discharge.

Severe anemia, low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abnormal. Meningitis due to varicella zoster virus. Died on June 13 2021

Early April 2021, my mother said she was experiencing pins, needles, numbness and pain in right leg (mild in left leg), her hands, severe back pain, and extreme fatigue. She soon lost the ability to hold items in her left hand. On May 10th she was in extreme pain, barely able to walk or hold herself up, making her mostly immobile up to the present day. She has experienced repeated intense "shock" sensations down her right leg, and localized areas of intense pain in different parts of her body such as the hip bone, wrists, collarbone, and left side of temple that come and go. In recent weeks, she's lost function of two fingers on the right hand. For the past several weeks, she's had an intense itchy scalp.

Hemorageic stroke, died next day on 03/12/21 My mother became noticeably and increasing confused, quiet and forgetful after the first dose. Immediately after the second dose, she became confused and shakey. On the third day after the second shot, she was disoriented and unable to communicate sufficiently. She was rushed to a local hospital, where she was diagnosed with a brain bleed. She was transported immediately to a hospital, where she was given a catscan and it showed unreparable damage to the right side of her brain, she never regained consciousness and died the next day.

Encephalopathy; Non-convulsive focal status epilepticus; visual hallucinations; acute confusion; left frontal headache; urinary tract infection; This case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) in an 86-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 Diastolic dysfunction, Type 2 diabetes mellitus, Phacoemulsification and Lens implant. Concurrent medical conditions included Chronic kidney disease stage 3, Glaucoma and Cataracts. Concomitant products included PREDNISOLONE for an unknown indication. On an unknown date, the patient received first 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization prolonged and medically significant), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus) (seriousness criteria hospitalization prolonged and medically significant), HALLUCINATION, VISUAL (visual hallucinations) (seriousness criteria hospitalization prolonged and medically significant), CONFUSIONAL STATE (acute confusion) (seriousness criterion hospitalization prolonged), HEADACHE (left frontal headache) (seriousness criterion hospitalization prolonged) and URINARY TRACT INFECTION (urinary tract infection). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CONFUSIONAL STATE, ENCEPHALOPATHY, HALLUCINATION, VISUAL, HEADACHE and STATUS EPILEPTICUS. The patient was treated with CEFALEXIN MONOHYDRATE (CEPHALEXIN [CEFALEXIN MONOHYDRATE]) for Urinary tract infection, at an unspecified dose and frequency; CEFTRIAXONE for Adverse event, at an unspecified dose and frequency; LORAZEPAM for Adverse event, at an unspecified dose and frequency and FOSPHENYTOIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion), HEADACHE (left frontal headache) and URINARY TRACT INFECTION (urinary tract infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: negative (Negative) Negative. In 2021, Blood folate: normal (normal) normal. In 2021, Blood gases: normal (normal) unremarkable. In 2021, Blood glucose: high (High) 394 mg/dL with an osmolality of 308 mOsm/kg.. In 2021, Blood thyroid stimulating hormone: normal (normal) normal. In 2021, C-reactive protein: borderline (Borderline) 1.2 mg/dL and high (High) 4.0 mg/dL. In 2021, CSF culture: negative (Negative) Negative. In 2021, CSF test: negative (Negative) meningitis/encephalitis panel NAAT, oligoclonal bands and Lyme antibody were negative except for West Nile virus IgG but no IgM antibodies with minimal protein elevation. In 2021, Chest X-ray: normal (normal) unremarkable. In 2021, Computerised tomogram: normal (normal) no acute findings. In 2021, Culture urine: negative (Negative) Negative. In 2021, Electroencephalogram: abnormal (abnormal) non-convulsive focal status epilepticus. In 2021, Magnetic resonance imaging head: normal (normal) with and without contrast showed no acute findings.. In 2021, Metabolic function test: normal (normal) normal. In 2021, Physical examination: abnormal (abnormal) Word finding difficulties and slow mentation. however, no focal neurological deficits noted. No suprapubic, abdominal nor costovertebral pain was noted.. In 2021, Procalcitonin: borderline (Borderline) 0.14 ng/ml. In 2021, Red blood cell sedimentation rate: high (High) 107 mm/hr. In 2021, Respiratory tract infection: normal (normal) normal. In 2021, SARS-CoV-2 test: normal (normal) normal. In 2021, Treponema test: negative (Negative) Negative. In 2021, Urine analysis: negative (Negative) Negative. In 2021, Vital signs measurement: borderline (Borderline) Body temperature: afebrile, Pulse 61, respiratory rate 20, oxygen saturation 99% on room air Blood pressure 150-170/66-75. In 2021, Vitamin B1: normal (normal) normal. In 2021, Vitamin B12: elevated (High) above 2000 pg/mL. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) to be possibly related. No further causality assessment was provided for URINARY TRACT INFECTION (urinary tract infection). Patient was at baseline neurological function. Patient had no evidence of cognitive dysfunction at baseline and no known neurological or psychiatric history. Patient had never used tobacco, alcohol nor any other illicit drugs. Their was no evidence of giant cell arteritis. Patient had no family history of seizures. Patient was seen in outpatient neurology clinic one month post hospitalization with baseline neurological status. Patient also reported she received 2nd Moderna vaccine 2 weeks post hospitalization and only experienced local injection soreness. 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 is a literature case. This case was linked to MOD-2021-256855, MOD-2021-256858 (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. This is a literature case.

Stroke, unable to know name, where she was, date, time of year, misusing words, speaking incoherently word finding, memory issues, etc. Permanent memory/word finding disability Note: 7 days at Hospital, 7 days at Rehabilitation Hospital

heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved. Treatment medication were not reported. Concomitant products were not provided. After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down. These symptoms lasted for about five weeks. 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.; 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.

Resident reported shortness of breath, severe fatigue/weakness, new onset confusion, sore throat, body aches, runny nose

ON JANUARY 19, 2021 THE RESIDENT WOKE FEELING "ACHES AND PAINS ALL OVER HER BODY" . SHE DID NOT TAKE HER TEMPERATURE SO SHE'S NOT SURE SHE HAS A FEVER. RESIDENT STATES THAT SHE CONTINUED TO WORSEN THROUGH OUT THE DAY AND FELT "REALLY BAD" LAST NIGHT. THIS MORNING, JANUARY 20,2021 SHE WOKE FEELING "A LITTLE BETTER". HER PULSE OX WAS 94 ON ROOM AIR, PULSE 71 BPM, TEMP 98.3. SHE WAS ALERT AND COULD ANSWER ALL MY QUESTIONS. SHE DID STATE THAT SINCE THIS MORNING SHE WAS "FEELING BETTER AS THE DAY GOES ON" SHE HAS OXYGEN IN HER APARTMENT FOR HER COPD SO SHE STARTED USING THAT SINCE HER O2 LEVEL WAS LOW.. I WILL CONTINUE TO FOLLOW UP WITH HER THIS AFTERNOON. ON A SIDE NOTE SHE STATED THAT HER ARM WAS SORE FROM THE INJECTION.

Patient reports tingling in the tip of her tongue since getting the vaccine (for the past 3 days). She also reported extreme fatigue once she got home (felt fine at the pharmacy during the observation period). She also states she was so fatigued she didn't remember driving home and had to crawl from her front door to her bed and that she was in bed fatigued for 2 days. She has recovered from the fatigue but is still experiencing tingling in the tip of her tongue, which she hasn't experienced before receiving the vaccine.

Low grade fever, chills, body aches, nausea, abdominal pain, diarrhea, confsion, weakness. Unable to get out of bed, stand or walk independently per baseline. Onset within 11 hours of dose with resolution except for leg pain 48 hours after administration

temp of 102.4 for two days, sevee headache for three days, vomiting and diarrhea for two days, confusion, aches all over

Injection given Friday morning. On Saturday she was very tired all day. Sunday she was very tired and became light-headed around noon. By Sunday evening she was lethargic. Monday morning, still lethargic and light-headedness has increased. Feeling somewhat disoriented. No fever, blood oxygen at 93.

1545 PATEINT TOLD DAUGHTER SHE "FEELS LIKE SOMETHING IS IN HER THROAT" PATIENT IS SUCKING ON COUGH DROP AND IS ABLE TO SWALLOW. PATIENT IS ALERT AND ORIENTED X3. SPEAKING. 1610 PATIENT TOLD DAUGHTER SHE WAS OK TO GO HOME. PARAMEDIC INSTRUCTED DAUGHTER TO CALL 911 IF PATIENT STARTS FEELING SHORT OF BREATH OR IS UNABLE TO SWALLOW. PATIENT CONTI ES TO BE ALERT WITH ON DISTRESS NOTED

Confusion on room location and got pretty angry with redirection, which is not normal for her. She was noted to have hallucinations last night, had a fall out of bed and stated she was trying to lift her mattress up.

Moderna COVID 19 vaccine #1 given 2/4/21 at 130pm. Patient had malaise, confusion on 2/5. She then had 3 generalized seizures- status epilepticus- on 2/5 around 4-5pm. MRI brain and labs unremarkable. She recovered 36 hr later - on Keppra.

VACCINE GIVEN AT APPROXIMATELY 12:40. AFTER 15 MINUTE MONITORING PERIOD, PATIENT WAS ASKED BY MONITOR IF SHE WAS FEELING OKAY. PATIENT REPORTS SHE DOES NOT FEEL THE SAME AS BEFORE THE VACCINE. MONITOR STATES PATIENT WAS SHAKING AND HAD NOT PLACED ARM BACK IN SLEEVE FROM INJECTION 15 MINUTES PRIOR. MONITOR IMMEDIATELY GETS NURSE TO ASSESS PATIENT. AT 1257 BLOOD PRESSURE IS 122/62 AND HEART RATE IS 62. PATIENT REPORTS TO NURSE THAT HER HEAD FEELS FULL AND HER EYES ARE HEAVY. DENIES ANY OTHER SIGNS OR SYMPTOMS. PATIENT STATES SHE IS READY TO LEAVE. NURSES ADVISE PATIENT RECOMMENDATIONS TO BE EVALUATED BY EMS. PATIENT REFUSES STATING SHE WILL NOT WAIT. SHE STATES SHE IS READY TO GO HOME AND IF SHE FEELS BAD WHILE DRIVING SHE WILL PULL OVER. RISKS OF LEAVING AGAIN DISCUSSED WITH PATIENT. SHE ONCE AGAIN REFUSES TO WAIT ANY LONGER AND LEAVES.

TUES: Approximately 8 hours after the Covid shot, patient developed violent shaking, extreme pain throughout her body and became disoriented & confused. She did not have a fever. At 9:30 pm the home health nurse said to give Pt Tylenol which we didn't have so she said give her 2 Advil. At 11:30 pm Patient fell asleep. WEDS: Patient awoke 1:30 am. Her pain was still very bad and she was confused. She was given 2 advil. At 3:30 am she fell asleep. At 8:30 am she awoke and couldn't recall anything that had happened. Her mental state appeared to be better, however, the situation quickly deteriorated. She became agitated, began hallucinating and repeating what said to her, and started calling objects by the wrong names. The overall body pain seemed to have subsided. At 4:00 pm the home health nurse came by to take her vitals, which were all normal. At 7:00 pm Dr. prescribed an anxiety medication. THURS: Patient awoke at 12:30 am. She was confused, combative and unable to follow instructions. The paramedics were called and she was taken to hospital. She remained in the hospital through Sunday and was transferred to a Board & Care facility because she currently needs 24 hour care. MON: Mental state appears to be improving however, she has tactile sensitivity (painful to the touch) throughout her body.

The night she received the shot she developed pain, tenderness, redness and swelling at the injection site. The next morning had headache, chills, heart felt loud and fast, could not think, could not remember even normal things like how to turn on TV, insomnia. Went to store and became weak and breathing hard with minimal activity, had to sit down and rest before leaving. Symptoms lasted about 3-4 days and at this point have resolved.

pt stated that about 2 days after getting the covid vax her upper left arm was sore and she developed a dry cough. She lost her voice since her throat was hoarse. She had alot of mucus and nasal congestion. On 1/29/2021 pt stated she was very very weak and could hardly function. On 2/1/2021 she was worse and started running 101 temperature. She contacted her PCP where he recommended for her not to take her 2nd covid vax dose but did not give her any medical advice. She is still having periods of weakness at this time.

Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy no health issues or symptoms of this nature until after receiving the Moderna COVID vaccination (1st dose). 26 Feb 2021 (Friday) 3:00 PM First dose Moderna vaccine given - no issues at time of vaccination. At approximately 7 hours post-dose ? severe whole body shaking, weakness, racing accelerated heart rate, difficulty walking- lasted throughout the night. 27 FEB 2021 (Saturday) Morning ? brain fog- very confused ? NO FEVER or shaking- however weak, unbalanced on her feet and confused in the afternoon we went about normal activities during the day so we thought she made it thru some acute reaction. Evening ? At approximately 9 PM ? whole body shaking, chills, weak, unbalanced. Her heart rate was not as accelerated (serious) as Friday night 28 FEB 2021 (Sunday) -seemed better but still brain fog (confusion), - by afternoon did normal things did a walk to get fresh air but she seemed to have labored breathing ? ?Huffing? and slow-she seemed better after the walk. 5 PM ? sudden and unexpectedly- she started whole body shaking, chills, difficulty walking, unsteady ? lasted about 1 hour ? unsteady on her feet needed assistance to walk. I put her to bed at 7:30 pm to rest and I was afraid she would fall because unsteady and shaking legs ? she had intermittent whole body shaking, chills, weakness 1March 2021 (Monday) ? around 10 am another episode - intermittent whole body shaking & chills, generalized weakness? developed respiratory symptoms, wheezing, deep croup- like coughing, weakness 2 March 2021 (Tuesday) ? respiratory symptoms seemed to be progressing. 3 March 2021 ( Wednesday) 3 PM Doctor evaluation ? fluid in lungs ? tested for Covid & prescribed antibiotics for lungs- 250 mg AZ ( 5 day treatment)

2/15/2021 -8pm - fever, body aches, weakness and fatigue, seemed o resolve after 24 hours, but during that following week, had forgetfulness, second week, forgetting was more frequent, by third week, daily and repetitive , can remember meds, Dr. names, whereimportant papers are , why we were going to the Dr. or where his office is.......etc She says she knows something is wrong, id fearful to walk the dog "I might get lost", she cant remember how to lay cards or marjong, which she did weekly for years. Saw PCP 3/10, went to hospital had CBC, CMP,, lipids, CXR, CAT head, UA, EKG, discharged on aricept and told to make an Neuro appt for eval,, First available was mid April, went back to ER next day 3/11, condition worse, "keep an eye on

Patient had been slowly declining over the past year due to dementia and age. On the date of her second vaccination, Feb. 17, she was getting around with her walker. On Friday, Feb. 19, she was so weak she was no longer able to walk with her walker, and she declined every day thereafter. On Monday, Feb. 22 she began crying and saying "help me". That lasted approximately a week. her health declined every day until Saturday, March 6, when she passed away at 6:15a.

Patient was confused and was not able to move her feet and could not ambulate, was brought to the ED.

*Orthostatic hypotension [I95.1] Yes ? Generalized weakness [R53.1] Yes ? Chronic diastolic heart failure (HCC) [I50.32] Yes ? Sleep apnea in adult [G47.30] Yes ? Type 2 diabetes mellitus with both eyes affected by mild nonproliferative retinopathy without macular edema, without long-term current use of insulin (HCC) [E11.3293] Yes ? Essential hypertension, benign [I10] Yes Patient woke in middle of the nigh with confusion and tripped over furniture. Was having orthstatic S/S. Went to hospital for evaluation.

patient complained of feeling unwell after second covid vaccine (which happened after first one as well)- dizzy, shaky, chest pressure, nausea, resolved with time in clinc

With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take Tylenol, on second vaccine 2-6-21 I had a very bad headache that went down my neck and right shoulder, and lower back, NP said it was arthritis, go to sports med. since that time the pain has covered all my joints, muscle spasms to the point of not being able to walk, completely bedridden at this time, severe pain, headache, insomnia

urinary tract infection; passed out; foggy; missed her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 87-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 Urinary tract infection (She was given some medication and has significantly improved with her urinary tract infection.) on 05-Apr-2021. Concurrent medical conditions included Stomach cancer. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (foggy) and PRODUCT DOSE OMISSION ISSUE (missed her second dose). On 05-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed her second dose) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) was resolving and FEELING ABNORMAL (foggy) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Her doctor and oncologist have told her to get the vaccine 1 week from today. 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.

Became very dizzy with loss of balance. Sight in left eye became very blurry. Significant difficulty walking. Significant cognitive impairment including loss of memory and not understanding what was being said to her. Fell over and broke her left arm that required surgery.

didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. On 03-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 MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient was concomitantly taking blood pressure medications. Patient received IV fluids as corrective treatment. Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine

Moderna COVID-19 Vaccine EUA Day1 after injection - soreness & slight swelling at injection site on right arm Day 2 - ? Day 3 - Right shoulder became sore & had twinges of pain Day 4 - ? + hard to raise right arm - very painful every time it was moved. Unable to undress without help. Extremely painful. Took Tylenol & used heating pad. Day 5 - unable to move right arm at all without extreme pain. Taking Tylenol. Right rotator cuff was previously repaired surgically in 2005. No issues in 15 years until now.

Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it.

large rash on right upper arm around injection site that has now covered most of upper arm starting on 2/7/21; although tired day after, extreme fatigue starting on 2/8/21 and sleeping almost all day, every day including today 2/12/21; all over body pain, especially in upper body and arms; None have resolved as of today 2/12/21, 7 days after 2nd dose date

c/o epigastric pain and nervousness. Denies chest pain, SOB. Denies history of heartburn BP: 135/50 HR: 98 Sp02: 99% RA

Awful rash and itching over entire body starting on day 7. Unable to sleep or even wear much clothing.

Delirium, started 2-1/2 hours after injection, admitted to the hospital, required IV sedation, Then, 20 hours after vaccine developed fever up to 100.9, and patient developed somnolence but no longer combative, then about 32 hours after vaccine improved to 50% of normal status, 48 hours after vaccine was 90% normal, and then slowly returned to normal over the next 2 weeks

She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, emesis,and fatigue. She was sent to ER @ Hospital. Continues with confusion and weakness as of 3/4/2021.

The day after her second dose she became very confused. Tried to make a phone call with the tv remote and couldn't remember how to turn on tv. (Prior to this, neither of these have been a problem). She thought her recliner was the toilet, pulled her pants down and urinated. She tried to do this again later that night. Next morning she had no recollection of doing this and seemed much less confused.

02/25/2021 by 12:30 feeling very tired , did not sleep well as right arm was painful and hot to touch. 02/26/2021 weak, lethargic, pain right arm , redness, swelling and warmth 1" x2", Temp 101.7, Tylenol at 12 noon and temp 100.7 @ 6PM Tylenol given, did not get out of bed till 8PM, only drank water during day, finally Jello around 8 PM. 02/27/2021 still lethargic, resting in bed, right arm red 3"x 3" and warm, itchy, took Claritin and did cool compresses and hydrocortisone cream as had been directed by Dr. after first vaccine . On 2/28/2021redness 3"x4" with two painful bright red itchy spots near inside of right arm continued with treatment. On 02/29/2021 area 4x4 but less redness, still sore and itchy. By 03/01/2021 redness , itching, swelling, pain gone.

Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore; Left leg very swollen; Chills; Had fever; Inconsistencies to remember; Not feel well; Delirious; A spontaneous report was received from a consumer concerning 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, began to not feel well, had fever, was delirious, inconsistencies with speech, problems with the left leg, left leg was very sore, very swollen, could not get up, had chills, couldn't sit in the bathroom, overreaction and activated a Baker's cyst The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, approximately three hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced to not feel well, had fever, was delirious(considered medically significant event), inconsistencies to remember, problems with the left leg. On Wednesday 17 Feb 2021, the patient experienced left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills. On Thursday 18 Feb 2021, the patient experienced could not sit in the bathroom. On Friday 19 Feb 2021, the patient was still very swollen. On an unknown date, the patient experienced activated a BAKERS SYSTS Laboratory details included, on Saturday 20 Feb 2021, the patient went to the hospital and got an ECO DOPPLER. Treatment for the event included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bad reaction, began to not feel well, she had a fever, she was delirious, said inconsistencies, problems with the left leg, left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills, couldn't sit in the bathroom, overreaction and activated a BAKERS SYSTS was considered recovering(getting better every day).; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship cannot be excluded.

Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for about a week. Then on 2/11/21 she had an ocular migraine, and as that ended she was hit with an intense pain in her head that she had never experienced before. It lasted for hours, for the rest of the day. She took Ibuprofen which did not do anything. She looked up online and the clinic had a report on what to do for the migraines, and she took Ibuprofen and strong coffee. She does that and was able to ward it off and stop it some. Then it continued to happen during the day and the pain is so intense. The day before yesterday, 3/9/21 the regimen of coffee and ibuprofen did not improve. It goes from the top of her head, down to her neck and sore to touch behind her ears. It is now a dull headache around her whole upper skull. She lives alone and her children do not live anywhere close to her. She is also having horrendous fatigue and is not able to get much done such as shopping, also shortness of breath and pounding heart beat generally is very active and some days she is not able to get dressed due to the symptoms. She went to UC and she had them do a COVID test, which was negative and sent to the ER at and her BP was 191/75, and was told to FU with her neurologist and internist and had no answers for her headaches.

Complained of "lump in her throat"; History of "lump in throat feeling"; Took 2 puffs of inhaler and said she felt fine after using inhaler; she used her own inhaler; symptom subsided after 30 minute wait in recovery-observation.

Patient presented to the ED on 4/11/21, which was 4 days after her 2nd Moderna COVID-19 Vaccine, with bilateral hip pain that patient reports started after getting the vaccine. The bilateral hip and thigh pain was very severe and she was unable to ambulate and perform her ADLs like usual. Vaccine received on 4/7/21.

Later on the day of the vaccine, I developed difficulty speaking and walking. My son brought me to the ER the following day. They ran tests and ruled out stroke and other known causes of my neurological problems. I showed improvement the next day so they sent me home. My symptoms continued and worsened over a few weeks. My children called the ambulance on March 17. My body temp was 88 when I arrived at the ER and heartrate in 30s. I stayed in the hospital for 7 days but have no memory of that or the week before. As the Drs could not find a cause or remedy to symptoms, I was discharged to hospice care. I have improved at home with a lot of assistance but am not back to my pre-vaccine strength, energy, or coordination.

pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes. She had trouble swallowing, no appetite, and had severe chills w/ no fever. She had trouble sleeping and eating. She could only drink water. She said she could only get a couple of hours of sleep a night. Pt developed thrush. She went to her PCP on 3/18/21. She was prescribed meds to take. Pt went to Dr. on 4/2/21 since she was not feeling any better. She was prescribed more medicine. She went to PCP on 4/19/2021 he gave her valium so she could some sleep. He ordered a sleep study. Pt says she is just starting to get her appetite back but is still having trouble sleeping.

Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.

Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-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 DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

upper arm red swollen hot itchy, resident states has felt terrible since receiving the vaccine will not get the 2nd dose, has had chills, body aches, headache, backache, was in bed for days states she would rather die than have the second vaccine still not feeling "right" to this day

VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after receiving COVID-19 vaccine. Seen resident immediately in apartment around 1310 accompanied by CM sitting in chair. Alert and oriented to person, place, time, and situation. Verbal and able to make needs known. Speech clear and coherent. No slurred speech or facial drooping noted. Resident received the 1st dose of Moderna COVID-19 vaccine around 1200. She was observed for 30 min by ARR staff immediately after vaccine was administered. She then went to grab coffee and went to her apartment. She did not yet eat lunch. Resident c/o feeling "woozy" and eyes feeling heavy/"uncomfortable". Continued from above: Resident has a history of anaphylaxis and several allergies. Called EMS around 1320. While waiting for EMS rechecked BP several times with SBP between 200-215. She denies any SOB, numbness, tingling, or indigestion. SpO2: 97-98%RA. Resident then stated she has slight tightness/discomfort to her left chest. EMS arrived and left ARR at 1414 and sent to Medical Center.

Pt sat down after vaccination and within about 5 minutes she alerted the observer that she felt like she was "floating," dizzy, hot, racing pulse, light headed. EMS and paramedic alerted. took pt's VS. HR 80 BP 111/65 96% RR 18 . EMS arrived, they did their evaluation. Pt reported she was feeling better, wanted a coca cola. Pt waited in observation for an addition 30 minutes with no other symptoms noted. Pt signed refusal with EMS to be transported to the ED. Pt's daughter was present and suspects the pt had not felt well due to wearing a mask. Pt was given precautions to return to the ED by EMS.

RED, FEVERISH, AND ITCHING FROM SHOULDER TO ELBOW. SOLID RED AND ITCHED. HAD PROBLEMS SLEEPING. HYDROCORTISONE CREAM OTC DID NOT HELP. RUBBING ALCOHOL APPLIED TO AREA PROVIDED RELIEF. PATIENT APPEARED TO SHOW ME AND HER ARM AND ITLOOKED FINE AND SHE SAID SHE WAS NOT HAVING ANY ISSUES AS OF 01/22/21. PATIENT DID NOT SEE A PHYSICIAN.

Client received dose #1 of Moderna COVID19 vaccine at the Health Center on January 14, 2021 at approximately 1530. Client was observed for 15 minutes by RN following vaccination and was found to be WNL and was permitted to leave post vaccination. Client reports that she noted her arm to have a reddened area around the injection site approximately 2 inches by 2 inches that evening, site was otherwise WNL per client. Arm remained reddened remainder of week getting larger in size again otherwise WNL. On Thursday January 21, 2021 client was awoken to her arm very extremely pruritic. Per client, she did not scratch her arm however it keep her awake. CHN spoke with clients daughter

Had vaccine, didn't feel much at all. Came home, did not feel bad, day and half later started feeling bad, as well as kind of like a cold with drainage to her throat, a little coughing. Has had diarrhea for the last 3 days, nausea and generally feeling bad. The first week had a lot of drowsiness, had fogginess as far as thinking. The first few days took Tylenol and did not take anymore as her daughter said it contained aspirin for the pain. Still having the headache, feeling like she is not thinking real good. About a month ago had blood work and everything was perfect, no problems. Due to the fact that she is still having these reactions 2 weeks from the injections wanted to report it.

Patient started to feel dizzy/lightheaded about 10-15 minutes after vaccine. She was nervous before the vaccine. Had her sit in waiting area and gave her a bottle of water. She had not eaten since a small breakfast earlier in the day, gave her crackers and continued to have her sit. She stated that the shaky/nervous feeling started to get better. After about 45 minutes her and her husband left the pharmacy. Called patient on 2/1/2021 and she stated that she is feeling fine today except for a sore arm.

1/21/2021 started feeling achy joints and restless at HS, reported feeling chilled 1/22/2021 Reports fatigue, states "slept all day" 1/23/2021- 1/26/2021 reports face "puffy", continues with muscle aches Reports used Tylenol to treat symptoms. Not able to recall date/time of initial dose.

began seeing hallucinations; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and began seeing hallucinations. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, about 4 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, about 4 hours after receiving the vaccine, the patient began seeing hallucinations. She was seeing moss grow on the walls and real bright turquoise colors that turn pink. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event began seeing hallucinations was unknown.; Reporter's Comments: This case concerns a 89 year-old, female patient, who experienced event of hallucinations. The event occurred 4 hours after the first and last dose of mRNA-1273 vaccine administration. 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 and the event is assessed as possibly related.

One hour after vaccination, pt reports "feeling out of it" and confused. Diarrhea began the following day. ON day 3, Monday, pt to ED c/o focal tremors intermittently in each arm and leg. Pt has no history of seizure disorder. On arrival to ED, pt having tremors in right arm, improved after benzodiazepine administration (ativan IV 1mg once). CT head negative for acute illness.

One week later it started itching and the next day it was red and hard. i was hurting on my neck and felt bad and couldn't stay away. I think I had a fever because I was sweating but started feeling better by Sunday

Pt's daughter states that after each COVID19 vaccine her mother is "confused and paranoid usually around the 5th day after injection". This confusion lasted for 2 weeks after first vaccine and then patient returned to baseline. After second vaccine confusion and paranoia resumed and was still present at time of call on 3/2/2021.

She was vaccinated on 2/2/21 and started feeling bad on 2/4/21. She was treated by her doctor, improved somewhat, got worse, then went to the hospital on 2/16/21. She died on 2/20/21.

My mother has experienced a severe reaction to her vaccine. Diagnosed with brain encephalopathy probably caused by molecular mimicry in response to the Covid vaccine, she is now being treated as an inpatient at the Clinic. She was fully independent- living alone, mobile, with excellent cognitive function. On January 21, 2021 she received her 1st Moderna vaccine. Subsequently family noticed small balance changes, slight fine motor coordination changes (handwriting, etc) and a little forgetfulness not previously seen. Everything was chalked up to her being 89 years old. She remained independent and relatively fully functional. Patient is now unable to stand without assistance, leans backward when trying to stand, has developed a spastic tremor bilaterally in her arms, and her cognition is completely altered. Hallucinations, memory loss, can follow some directions but not all, speech clear but inappropriate. This declines DAILY. As of March 7th, she could not identify immediate family members in a photo. These changes have all occurred within the past few weeks and appear to have an acute underlying cause not related to age. Medical staff are looking at an autoimmune encephalitis picture based on the antibodies developed from the vaccine attacking the tissue in the brain and spinal cord that resembles the small piece of the vaccine. She is currently at the Clinic affiliated hospital. At this time, family is contacting Clinic main campus to request further investigation. Photographic evidence of rapid decline available, but not able to attach to this form: Available are three pictures of a log patient keeps with her vitals that she was doing every day. 1. Personal log of vital signs– pre Covid vaccine/dose 1 - you can see the handwriting is concise, clear, and orderly. 2. Personal log of vitals after Covid dose 1 on Jan. 21 - slight changes in the handwriting and orderliness but still ok. 3. Personal log of vitals after Covid vaccine dose 2 – Feb. 17 - note the illegible handwriting, missing entries, and no spatial awareness of line alignment. Available are three photos of crossword puzzles she does every day. 1. Puzzle dated Feb.12. Demonstrates her ability to accurately fill most answers with clear writing. 2. Puzzle dated Feb.19 shows an ability to fill in only a couple answers with obvious handwriting changes. 3. Puzzle dated Feb. 21 shows inability to complete, and a strange discrepancy between ability and inability- note 29 across and 18 down. Patients outcome is undetermined as diagnosis/treatment and prognosis are ongoing.

Patient's daughter states worsening dementia and bladder control. Patient can normally care for herself, but peed her pants more than once between 3/13 and 3/15. Unable to remember to take her medications by herself. Unable to cook for herself. Seems to be letting up as time has passed. Patient's daughter is taking her to see her primary care provider.

Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, and blurred vision. She was taken to the ER, but refused a CT scan. She was given a saline bolus. As of 03/19/21 her vision is still blurred and she is more disoriented than her baseline.

Patient received her second coronavirus vaccination on March 18, 2021. Shortly thereafter she became confused. Patient developed anorexia and weakness after the second coronavirus vaccination. Patient presented to the emergency department 3/21/21 with confusion and hyponatremia and was discharged home. She represented to ED on 3/24/21 for altered mental status and was admitted with encephalopathy and hyponatremia after several days of confusion. Patient required Haldol as well as lorazepam and received 3% saline. She had an MRI of the brain showing no acute intracranial process and radiograph of the chest showing no acute findings. She was discharged home 3/26/21 but then returned to the ED 3/29/21 for altered mental status, confusion and dehydration and was admitted with toxic metabolic encephalopathy. MD feels toxic metabolic encephalopathy related to second coronavirus vaccination.

On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/2021 refused medications; 3/16/2021 became constipated; 3/20/2021 gait unsteady and reported feeling as though she'd fall; more fatigued; 3/20/2021 refused medications and slept excessively; 3/20/21 vomited in bed; 3/22/2021 restless and exit seeking; 3/25/2021 packed belongings and exhibited exit seeking; 3/26/2021 transported to hospital 5:15 am due to falling while attempting to pick up something off of the floor; 3/29/2021 hospital reported she had a brain bleed and had chosen hospice care at her daughter's home; resident passed away on 3/30/2021.

Pt admitted on 04/05/20 with SOB and altered mental status. Was given steroids and supportive care throughout admission and transitioned to comfort care on 04/09/2021 and passed away the next day. Patient had received both doses of COVID vaccine and tested positive for COVID 41 days later

First Day complaint of aching arms, light head ache. on the 19th second day she said she did not feel very well, tired, by the evening noticed she was a little disoriented, by 10pm she was in bed my sister checked on her as she got worst called ambulance and she had a stroke right before paramedics got there.

Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high