Moderna

Patient had an asthma attack about 10 minutes after the dose was given while waiting in the post-vaccination area.

After about 24 hours: muscle and joint pain; After about 48 hours: intense muscle and joint pain back pain, fever of 101.7, shortness of breath Following day: weakness, extreme fatigue, tachypnea, shortness of breath on exertion Shortness of breath and cough persisted for several days, finally resolved day 6 post vaccine

Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husband, stated that she got a few miles down the road and starting experiencing tightness in her chest and flushing. She took 50 mg of Benadryl, 30mg of prednisone and two puffs on her inhaler. She returned to the clinic, upon assessment from nursing she looked extremely flushed and anxious, she stated that she still felt tightness and that she had a history of anaphylaxis once before and had used an epi pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse was normal, respirations normal, she continued to experience tightness and "not able to catch my breath", encouraged to use epi pen. She administered epi pen to right thigh at approximately 4:45PM, 911 called. Within a few minutes, she stated she was feeling better, less tightness in the chest, flushing was subsiding. BP at 190/70 at 4:52. EMS on scene at 5:03pm. Vitals normal , EKG normal. Client decided not to transport with EMS.

"Hot, flushing. took Benadryl liquid several doses, chest tightness and shortness of breath, resolved by next morning"

Vaccine on December 30th @ 8:30 am. Fine all day until 1:00am next morning 12/31 it woke me up with fever, bad body aches hurt to touch me, left arm I couldn't move painful, nausea and bad headache this went on for 2 days(12/31 & 01/01). Next 2 days (1/02 & 1/03) was recovering with just soreness, anxiety and headache(Migraine Med help), tired and shortness of breath9inhaler0. Was like having Covied again.

"Hot, flushing, took Benadryl liquid po several doses, i had chest tightness and could not take a full breath until the next morning"

RespDepression, CoughWheeze & Syncope Narrative: Patient started having shortness of breath about 20 minutes after injection. First reported as a cough then asked for water and was having difficulty breathing.

First, let me say that I had a diagnosed case of Coronavirus in April of 2020 last year. I woke up about 12 hours - at about 3 or 3:30am - after receiving the vaccine to my teeth chattering and feeling like I was freezing. It felt about the same as it did when I have Coronavirus before. My head was hurting like a tension headache, I had a slight buzz in my ears, my neck, shoulders, back all hurt (body aches). I felt pressure in my chest but unlike when I had the virus, I could still breathe. Eventually instead of freezing, I got hot and my temperature went to 101.9. I checked it several times with 3 different thermometers. I became dehydrated quickly which I realized because I kept going to the bathroom. My niece brought me Gatorade which helped. I also took Naprxin 500mg. On Thursday morning I felt better. Now what remains to oday, Friday, 1/8 is a sore arm that feels HOT to the touch at the injection site. I admit I am not looking forward to Moderna shot #2. It gave me flashbacks of the Virus I suffered through for a month before being able to get a test and another month afterward from March 6 when I think I contracted it through May 15 when I tested negative. I wish I understood why this happened to me and if it will happen again. I am reporting this because my Test was arraigned via my job and my CIO said I should. A friend who I happened to see at the test site who tested a few patients after me has zero negative effects.

Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential frontline healthcare worker in a skilled nursing LTC facility on January 6 2021. The day after receiving the vaccine (1-7-21), she started to feel increased shortness of breath (she has shortness of breath at baseline due to chronic health conditions- CHF, asthma), a heavy feeling in her chest/lungs, sweating and fatigue. She contacted the pharmacy on January 8th, as we were the entity that vaccinated her to ask about vaccine reaction. Due to her medical history of MI and CHF, pharmacist did not want to dismiss this as a reaction to the vaccine, and recommended that she contact her doctor for further guidance. She did reach out to her care team, and ended up going to the emergency room for testing due to cardiac history and presentation of symptoms. She had diagnostic testing done (see item 19) and the ER doctor attributed her symptoms to an exacerbation of CHF and asthma, noting that vaccine involvement in the worsening of her symptoms can not be ruled out. Treatment/discharge instructions include: follow up with cardiology/pulmonology, furosemide dose was increased, potassium supplement restarted, and instructed to use inhalers already on hand when needed. As of time of report on January 9 2021, the patient was resting at home, doing well except still having symptoms upon exertion.

Cough, shortness of breath, SPO2 decreased to 88-90% 24-36 hours after vaccine administration. Normal vital signs on 1/9/21 at time of urgent care visit

Tachycardia c/o "SOB, heart racing, HR increases with exertion. HR @ 104. Narrative: Staff was instructed to monitor HR and if symptoms persisted or worsen staff was instructed to go to nearest ER. Staff member was instructed may leave work if unable to perform duties due to elevated HR. Staff stated," I have one more patient to see now then one after that. I will see if i need to go home and let you know if i leave work. I will go to the ER if my heart rate gets higher or if i get chest pain." Instructed staff member I would await her decision.

1-8-2021: 9:25 body shaking, nostrils constricting, throat tightening and legs weak. Happen while I was heading home. Returned to HD. EMT administered 50ml benedryl and pushed 125ml saline. No response. Throat felt tight, not closed but tight. Offered EpiPen .3 agreed. Body reaction - shaking. Went to Hospital ER via ambulance (~11am). ER administered 50mg steroid and had 2 puffs of albuterol inhaler twice. Became very tired but felt heart raced - assumed reaction to steroid/albuterol. 2:30pm started to finally feel relief. Discharged 4pm with rx for prednisone 50mg 1/day-10 days and benedryl 25mg for that night and am/pm next day. O2 dropped to 94 that evening. Administered 3 rounds of 2 liters/minute before saturation held at 97. 1-9-2021: 9am took benedryl and prednisone doses. 10am both nostrils still feel "swollen," legs are weak and very tired (benedryl?). Oxygen saturation is good - 97. Starting to feel slight sensitivity at injection site. 4pm able to shower and move around. Breathing is better. Elected not to take benedryl as I'm not getting an positive response from it, only fatigue. Nostrils still feel swollen - tried lubricated nasal spray, not much help. 1-10-2021: 8:30 prednisone dose Oxygen saturation good - 98% pulse 72. Nostrils still feel swollen. Injected site sore, Started around 4pm (similar to shingles vaccine - expected).

Started with a headache and elevated temp the next day with temp peaking at 102 degree. Progressed to brain feeling swollen and to large for head with ringing in head with every step or movement - Squeaking in ears when swallowing - Eyes hot and burning - Extremely dizzy and off balance - Chills- Body aches - Tired - Shortness of breath like with the Covid - Injection site swollen, hot, red and itchy still at 6 days out.

Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl. Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21. Was diagnosed with allergic reaction.

This patient received her first dose of Moderna vaccine and was then sent to the observation area. Within 10 minutes of vaccine receipt, she began complaining of a fast heart beat and some tightness in the throat. Emergency services was called immediately and she was placed supine in a stretcher. Her initial vitals were: heart rate of 130 beats/minute and oxygen saturation of 95%. Repeated vitals were as follows: 11:25- BP 162/94,HR 123, SO2- 98% 11:30- BP 161/81 HR 101, SO2- 96% 11:35- BP 160/106 HR 95, SO2- 96% 11:35 - BP 157/96 HR 96, SO2- 95% complaining of tingling in fingers. 11:40- BP 162/79 HR 91, SO2- 96% 11:45- BP 152/84HR 92, SO2- 95% denies chest pain, shortness of breath, or throat tightness at this time. Patient felt better within 20 minutes and was taken to the emergency department for evaluation. In the emergency department, she was encouraged to obtain the remainder of the work up but declined and elected to go home. She denied rashes, respiratory distress, or itching at the time of discharge from the emergence department. She planned to follow up with her outpatient primary care provider.

Patient being observed for 30 minutes due to hx of anaphylaxis to bee's. 15 minutes post vaccine patient stated SOB and throat tight. HR 77, O2 94%, wheezy, alert. administered 0.3ml epi in left thigh. transferred to ER

at 3 am I started to feel muscle ache, headache, weakness, i felt as if i couldn't breath for a little bit, my chest felt tight for about 5 minutes, I could not breath . The next day i couldn't go to work due to heavy weakness, still had muscle ache. I also had mucus coming of my nose for 2 days as if i had rhinitis.

I am experiencing a severe case of Cholecystitis and can barely move or inhale deeply without sharp, stabbing pain. It is severe enough to go to the emergency room, but I don't have health insurance and cannot afford to go to the hospital.

swelling in throat and sob after receiving C19 vaccine. Epi x 1 at vax site with relief, required Epi x 1 en route to ED, pt remain stable, no report of urticaria, angioedema or any other complications during transport

Patient was a 30 minute observation due to hx of anaphylaxis with bee's. 15 min post vaccination, patient stated "Short of breath and my throat is tight". HR 77, O2 94%, wheezy. gave 0.3 ml epi in left thigh, immediately transferred to ER

I had the vaccine and shortly after my left arm was very sore, tender to the touch. The pain was from my elbow radiating up into my neck and head causing a severe headache on my left side of my head. I had chills with no fever and felt nauseated. I went to work the following morning, I still had soreness in my left arm, headache and some chills, even after Tylenol. About two hours into my work my chills went to sweating Perfusely, the pain in my arm was increased from the elbow into my neck and head. My headache made me feel nauseated and light headed. My heart started beat harder and I had a hard time breathing. My BP was 164/122 and my pulse was 190. I was checked by a PA and my supervisor. I was sent home. At home I had to monitor my BP and felt fatigued The Who,e day along with my other symptoms. They lasted for 24-26 hours.

Patient stated she was having heart palpitations and SOB. She was taken to the ED and all tests were normal, no palpitations and oxygen sats were in the normal range. Anxiety attack.

1 week after first Moderna covid 19 dose she had sudden onset of shortness of breath and subsequently some chest pain, She was seen in ER, had elevated D dimer. She had negative CTA for pulmonary embolism and negative cardiac workup that included ekg and cardiac enzymes. She was dishcharged home and returned in 2 days with similar symptoms and no cause found . She has had recurrent chest heaviness lasting about 1 hour episodically since that time, about 3 times, and has cardiology follow up scheduled.

Onset of sharp chest pain that worsened very quickly. Patient also experienced SOB and dizziness. HR 96, regular on initial check, 5 minutes later, 80, regular. Skin cool to touch. Placed patient in wheelchair and transported to the ER in the facility. Placed on monitor immediately, EKG completed, Chest x-ray, nitro, and baby aspirin administered. Zofran for nausea.

Whole body itching Nausea Slight swelling of airway and lower lip Feeling of anxiety Above symptoms started w/I 20 min of injection, still itchy and taking Benadryl at 2300 Swelling at site of injection about the size of a small orange

Anaphylaxis within 15 minutes. Throat tightened wheezing began given Benadryl at clinic then taken to ER downstair at Hospital. Given more benadryl, then epinephrine, Decadron, then breathing treatment. once undercontrol sent home and then recommended seen by own doctor. I saw doctor on the 21st.

While patient was waiting her 15 minutes after receiving the Moderna vaccine (1/21/2021), she complained of a bad pain in the left side of her neck & that it was hard for her to breathe. She was assisted by EMS (who was on site). Her blood pressure was 249/149 per the patient. She also experienced some lightheadedness. It was strongly suggested by EMS & nursing staff that she be transported to the ER but she refused stating she had to work the next day. She continued to be monitored by EMS until her blood pressure stabilized & she felt better. She continued to refuse ER. She was driven home by her companion. On 1/28/2021 she sent an email to the health department showing a picture of her left arm showing redness from the injection site down to above the bend in her left arm. She reported that on 1/26/2021 her physician recommended that she not receive the second dose of Moderna. She continues to complain of high blood pressure. It is unkown if she takes medication for high blood pressure.

FEELING OF LUMP AND TIGHTNESS OF THROAT 1007 PATIENT STATES FEELING OF LUMP IN THROAT AND MILD DISCOMFORT. DENIES SHORTNESS OF BREATH, CHEST DISCOMFORT, OR PAIN 1012 PATE STATES THIS FEELING IS BETTER AND IS DRINKING TEA 1020 PATIENT FEELING NOT GETTING ANY WORSE, DENIES ANY DIFFICULTY BREATHING OR SWALLOWING. 1030 PATIENT IS FEELING BETTER, NO PROBLEMS BREATHING OR SWALLOWING. NO HIVES OBSERVED, PATIENT SKIN IS PINK AND WARM TO TOUCH. AND SHE IS TOLERATING TEA 1042 PATIENT INSTRUCTED TO CALL EMERGENCY MEDICAL SERVICES IF ANY SHORTBESS OF BREATH OR CHEST DISCOMFORT WHILE AT HOME. PATIENT VERBALIZES UNDERSTANDING. PATIENT STATES SHE IS FEELING BETTER AND WITH TAKE HER ALLERGY MEDICATION WHEN SHE GETS HOME. PATIENT DROVE HOME

chills, shortness of breath, new onset a-fib, overall ache, extreme fatigue Still in a-fib w/ shortness of breath

Flu like symptoms, fatigue (lack of energy to do daily activities), disorientation, inability to breath, headaches, sleeping up to 15 hours a day. Lived on over the counter medicine (Musinex), nasal spray, albuterol inhaler, aspirin and alka selter. Started feeling better on February 1st. Scared to take the second round, which is due to be taken on February 16th.

About 3 PM she received her second vaccination for Covid. She states that she has a history of adverse reactions to flu vaccines that are anaphylactic like in the past. She usually premedicates with Benadryl and steroids. Today she did take 100 mg of Benadryl prior to her vaccination. Shortly after receiving the vaccine, she did feel like her throat was getting a little bit tight but she did not feel like it was true anaphylaxis. However she then felt very off. After this vaccine her throat started to feel tight, and she stated she did not feel well overall. She did have some tunnel vision and was shaky. At about 1730 her heart rate drops to the 30s, she started feeling itchy, and then she went into a coughing fit and started to feel her throat close. She received 0.3 mg IM epinephrine, 20 mg IV famotidine, 125 mg IV methylprednisone, 0.5 mL of nebulized racepinephrine, and 500 mL NS bolus. She has since recovered and is stable on room air.

Fever, lethargic, Headache 6 days later, swelling and large red rash on arm and face. Mild throat swelling or irritation

Patient stated that she had a tight and tingly throat. Patient was evaluated. Was in no respiratory distress and vital signs were stable. Patient had no skin rash and no evidence of anaphylaxis except for subjective tightness of throat and hoarseness of throat. Patient evaluated by EMS. She was given IM diphenhydramine and was told to go to ER for further evaluation. Patient refused ambulance transport and said she would be taken by her husband.

Received shot around 7 am by 6 pm chills aches fever fatigue throbbing headache. Took 400 mg of ibuprophen drank water slept. 2/6 woke thought felt better went to bathroom throbbing headache started chills body aches and with activity shortness of breath . In bed all day took 800 mg of ibuprophen every 6 hours drank water slept . Injection site tender no redness or swelling. Till Sunday 2/7 . On 2/7 slight headache no body aches or chills felt better but arm rash started slight tenderness to arm but increase swelling redness warmth. Monday 2/8 redness expanding on arm with increase swelling slight tenderness and warmth no body aches chills or headache. Tuesday 2/9 redness /swelling decreasing to arm no warmth. Intermittent headache took ibuprofen x1. As far as fever goes it fluctuated from like grade to 102.3 2/5 to 2/6.

Last Moderna vaccine taken at about 1015 am Friday, 02/05/21. Later in the day, left upper arm sore, itchy as expected and started breathing faster, tired, laid down in bed about 8pm. About 1030pm, that Friday night 02/05/21 woke up stretching alot, was weak, had major aches, lots of stretching, fever 102.5, headache, shivering, very thirsty, was delirious for a couple hours, no appetite. I took tylenol a couple times during the reaction, started to break the fever early Sunday morning 02/06/21 about 1am. My clothes, sheets and blankets, even my pillow was soaked where my head and neck laid. I was so startled, I thought I peed on myself in bed at first, got up and changed clothes. Then just just laid a big towel on the mattress and got another blanket fell asleep again. About 2 hours later, I woke up shivering, was soaked again. I changed clothes once again and laid on the couch, had a terrible headache but fever went down. Headache was worse than earlier. Suddenly woke up and felt fine breathed better in months even, no fever. Got up, tried to work in the yard the last couple days but was too weak, just laid around, finally ate, found I had a mild fever of 99.9. It's normally like a 96.4. But Tuesday the 02/09 but went back to work 02/09/21 still had mild fever. I feel tons better today 02/10/21. No fever this am 97.1

Approx 1 hour after receiving vaccine, I began to have stomach or abdominal pain, followed by nausea (did not vomit), light-headedness, headache, very noticeable sweats, & overall discomfort. The symptoms were bad enough I went to lie down, but the discomfort was bad enough that it was difficult to find a position to lie down in. I had some shortness of breath but I believe that was caused by discomfort (& possibly also worry). I did not experience difficulty getting breath in or out. I had pain in my neck & stiffness (& mild numbness) in my arms. My son (11 years old) said I felt hot but I did not feel hot myself. No fever found with thermometer. About 1 & 1/4 hours later the symptoms went away leaving me fatigued & light-headed, & a little uncomfortable but nothing I would remark upon. The following day I was fatigued, & got light-headed as I got more tired. This continued but also lessened the two days thereafter.

First dose vaccine on 2/5/2021 developed a cough that never resolved. Second dose woke up at 11:00 pm with fever chills, blinding headache, nausea, sever coughing, SOB and chest tightness. Called caregiver hotline the next day and they sent me to the Care where it was found my BP to be 225/120 and pulse 100. They sent me to the emergency department at Hospital where I was treated for hypertensive urgency and immunization reaction. Still suffering from elevated BP and pulse beyond what was normal prior to vaccine. Still experiencing fatigue and weakness that was not present prior to vaccine.

15 minutes after vaccination mouth numbness, tip of tongue swelling, some fullness in throat. Person took 50 mg diphenhydramine 20 minutes after symptoms began approximately and symptoms began improving within 5 minutes. Patient observed for one hour and minimal symptoms present at time of discharge from vaccine POD.

A few minutes after vaccine administered, shortness of breath and weakness started. Because of my ALS, I have spasms at night. I also had involuntary contractions (spasms) in arms (forearms moved repeatedly and violently). These never happen during the day like this but can at night. Between contractions and early in the event,DR took vitals. Blood pressure 160/96 (usually 100/60) and heart rate 102 (usually 60?s). I felt odd before the contractions started that I attribute to the elevated blood pressure and heart rate. Entire episode lasted 30 minutes (estimate).

Communication Comment: "Patient present in clinic for COVID-19 vaccine. Patient reported feeling something" going up and down her neck" about 15 mins after vaccines was administered. Blood pressure reading was obtained, elevated at 188/100, HR 100. She reported new symptoms of dry throat causing tightness sensation and numbness in tongue. Patient was given Benadryl 25mg PO and water and observed for an additional 40minutes. Her symptoms resolved including throat dryness, tongue tingling, throat tightness. Denies dizziness, rash, difficulty swallowing, hoarseness, chest pain. Vital signs improved. She reports she has blood pressure medicine at home that she was advised to take only when needed. She did not take medication today. She does not know the name of medication. Declined prescription of blood pressure medication today, agreed to take medicine she has at home and return to clinic for appointment Friday, 2/12/2021. Patient given strict ER precautions if her symptoms continue, worsen or if she develops new symptoms."

I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got a real bad headache, was very dizzy and felt very hot all inside my body. I reported it to the nurse and she told me it was a normal reaction to the vaccine and to wait a little longer than the 15 minutes to see if it would go away. She gave me water and I did fell better and we left medical center. At around 5:30 pm that same day I started to get cold chills and body aches especially on my right side. my lower back and my right hip were hurting a lot and I was having trouble walking.at around 8:00 pm my husband notice my right foot was very swollen and I notice by breast, my arm and hand, my underarm and leg were extremely swollen and painful. I did take a Tylenol because that is what they told me to take. I was freezing cold by the time I went to bed during the night I was sweating a lot. As of that day my symptoms were: Swelling on my right side Body aches, Headaches Fever Difficulty breathing/Shortness of Breath Rapid heart rate ranging from 100-125 w/o doing anything My neck and throat were very swollen around my thyroid area Blurring vision Chills and hot flashes Fatigue/Malaise Big round red welt around my injection site about 4 inches wide and hot to the touch I finally called medical center on 2/18/21 because I still had right leg, hip pain and swelling. I had a tele-med appointment with one of their doctors and she told me I had to first get a Covid-19 test to see if I didn't have Covid. Which the test did come out negative. She also told me that maybe the vaccine triggered something in my body that was causing all the swelling. I do have an appointment for chest, hip spine x-ray and lab work for 3/22/21. I still have the hip pain but not as bad. The person who gave me my Covid test results said I should report my symptoms.

Patient reported feeling throat closure feeling, throat scratchiness, tingling, and mild shortness of breath 12 minutes after vaccine. Patient chair also beside table with wrapped muffins containing nuts, doctor discussed possibility of peanut particles around but more likely a vaccine effects.

Patient began to feel Sort of Breath, Warm to the touch, and have a headache during the 30 minute wait time after receiving her vaccine. She has had a previous reaction to flu so the nurses were already checking on her periodically. She was given some water, something cool to put on the injection site, and then asked to wait a little longer to see if she felt better. After about 20 minutes she was feeling well enough that everyone felt comfortable letting her go. We saw her later that day and she was completely fine.

Patient reported that 8 days after vaccination, she started feeling "hot under the skin, like menopause." (Patient vaccinated 2/11/21, adverse effect reportedly started 2/19/21). She did not have a fever. These "hot flashes" would come and go, and were still occurring when she called me on 2/23/21. The patient reported feeling more short of breath than usual, although she also reported a history of COPD. Patient also reported she takes clozapine and the dose had been reduced by her psychiatrist between 2/8/21 and 2/15/21 due to "low blood count." The patient did report these adverse effects to both her primary physician and psychiatrist.

About an hour after receiving the vaccine my arm was very sore, it felt like someone punched me in my arm. That night I couldn't lift my arm. I took Tylenol and put on ice on it. The next morning, I was going to the bathroom and I almost passed out. I was able to catch myself before I passed out. I felt nauseous and dizzy, I felt like I was going to throw up but I couldn't. I had chills. I went downstairs to try and drink some orange juice, I seat here and was gasping to catch my breathe. I kept thinking it was just my anxiety and kept trying to catch my breathe. I kept drinking the orange juice and the dizziness seemed to go away. I went to work, I was tired, chills and this lasted for 2 days. on Friday the 12th the rash (the rash which I developed from the 1st dose) seemed to get worse, when I took a shower, the heat from the water seemed to make the rash redder. I continued Hydrocortisone cream and then switched to Lubiderm. Neither seemed to help much so I kept switching between the two, eventually the rash did get lighter, it went away under my breast area but it is still there on my stomach. I filed a VAERS report for the first dose as well. About 8 days after receiving the vaccine, I have a tattoo on my right thigh and a red bump appeared on my tattoo, it was hurt. It was a bump and the next day the bump burst, it was hard and crusty. Then a rash developed around the tattoo. I have also had on and off fluttering of my eyelid since receiving the vaccine. I had made a dermatology appointment but I canceled it because it seems like the rash is going away and my deductible is to high. 2/26/2021 My right arm from the shoulder from down to fingers, is numb and hurting. Yesterday 02/28/2021, I got up in the morning and felt like I was going to pass out, I came downstairs and I got some orange juice. I got dizzy and couldn't catch my breathe, I told my husband to call 911,because I thought I was having a stroke. My husband said I passed out, my eye and my mouth were open, he shook my shoulders and called my name no response this lasted for about 3-5 seconds, then I take a deep gasp and came back. I was sweating profusely and pale. EMS arrived, transported me to hospital. My blood pressure was high while I was sitting and it was low when I tried to stand. I went to hospital 02/28/2021. The ER diagnosed with my syncope and wanted me to follow with a cardiologist. They believe since it was 2 weeks out since the vaccine, they do not believe it was the vaccine.

1030am, 10 minutes after vaccine; Patient states "feeling hot", feeling a 'rush" through chest, lips felt tingling sensation, and had burping. Also felt like she needed some air. 10:45am vital signs taken. Temp-97.7, BP- 138/90 ( elevated, states normal for her and has not taken blood pressure medication today) , Pulse- 72. Patient observed in my office for another 15 minutes. 10:55 Patient states feeling better and symptoms have subsided. 11:00 am Pt states ready to go home. States will self- monitor for post- immunization symptoms. ER precautions given and confirmed verbal understanding. Released home.

On Saturday February 6 2021, I experienced some some mild shortness of breath and a cough for approximately 3 hours after receiving Moderna vaccine Thursday February 4. Cough, SOB completely resolved after approximately 3 hours. Looking over vaccination information, this is not an expected side effect.

Nausea, muscle weakness, dizzy, hives, throat swelling, heightened blood pressure. Started within 5 minutes of vaccine. Lasted about an hour

15 minutes after the patient received the vaccine she began feeling light headed. She experienced leg numbness. She said that she felt that if she had to stand up that she would fall over. patient has felt this prior when she over took her seizure medication or when she takes her medication early in the morning. We gave the patient orange juice and water. We checked her blood pressure, oxygen, and heart rate. Patient then stated her throat felt like it was getting tight. We then gave the patient 25 mg of chewable benadryl. Patient did not have difficulty breathing. Patient was monitored for over an hour after vaccine administration

PATIENT WAS BROUGHT IN BY EMS AND GIVEN AN ADULT EPIPEN IN ROUTE. COMPLAINED OF SEVERE ITCHING AND FELT LIKE THROAT WAS GETTING TIGHT. ALSO COMPLAINTS OF INCREASE SOB. UPON ARRIVAL TO ER, WAS GIVEN SOLUMEDROL 125 MG AND BENADRYL 50MG . ALSO TREATED FOR HTN IN THIS VISIT. PATIENT WAS GIVEN A PRESCRIPTION FOR A MEDROL DOSE PACK AND TOLD TO CONTINUE BENADRYL Q6-8H FOR NEXT 48 HOURS. GIVEN FAMOTIDINE

7 days after; vaccine rash 1 inch diameter, 9 days after; rash 2-1/2 inch diameter, 10 days after; rash not grown but experiencing extreme fatigue, body aches, brain fog, body jerking, heavy breathing. I am reporting this on day 10

Modern a COVID-19 Vaccine EUA. First 24 hours- mild soreness not at injection site but 2-3 inches below injection site. Days 2, 3, 4 muscle fatigue and sensation of unusually elevated heart rate during stenuous exercise significant enough for me to take ?breathing breaks? to allow my heart to slow - like enforced interval training. Days 5, 6, 7, 8 no noticeable side effects. Day 9 slightly stiff sensation and itching at injection site, no rash, no swelling. Day 10 (today) itching at injection site significant enough for me to stretch in my sleep. Injection site visably swollen, warmer to the touch than surrounding area, no rash.

Respiratory congestion; stuffy, runny nose; cough (coughed up a lot of mucus), congested lungs, muscle & joint aches; no energy. This started the day after the vaccine, had all the above symptoms for 7 days. Today is day 21, I still have a cough (coughing up mucous), sinuses still not completely clear (still have occasional runny nose) - those are getting better. The sore nut& joints are still an issue.

Vaccine received Friday afternoon around 4:00 pm. I was fine all evening. I slept well, THEN... Saturday: headache, body aches, fever, deep chills (despite the house being 70 degrees and me in a jacket and a blanket), shortness of breath (blood oxygen 90), and extreme tiredness (slept 5 hours during the day, then 14 hours at night). Sunday: headache gone, body aches partly gone, fever gone, chills better but not gone, shortness of breath better (blood oxygen 94), and still very tired (slept 2 hours during the day, and 8 at night). Monday (today): still tired. Blood oxygen 96. everything else normal.

No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiety from the tingling]; @ 15 min had some SOB and knew this was not just anxiety. Had zero intention of being taken to ER as I could easily tx myself. Took inhalers, extra cetirizine. Did not take epi, though have several pens. @4 hour started feeling weak, severe arm pain. At 6 hours, unbearable arm pain, extreme weakness [did not take BP or pulse ox--though I can and wish I had]. Exceeding thirst, could not get water down fast enough. Reactivation of arachnoiditis symptoms. Started unusual muscle fasciculations in arms, leg, and face [face not normal for me]-took valium and baclofen. Next 36 hours unable Additional information for Item 18: next 48 hours, unable to get out of bed other than to get water. Severe HA upon waking [@16 H post injection]. Severe myalgias, but in areas of known arachnoiditis that have been quiescent for quite some time. Forgot to mention, as I find this strange: prior to going to sleep I had left eye conjunctivitis. Left eye only that still is slightly persistent and doesn't require any care [for me at least] I am currently 72 hours post. Still with HA and some fatigue, though worked today [I WAH for a population health company]. L arm is not as painful as the excruciating pain @ hour 4-16, and no need for additional acetaminophen. I have an exceedingly high pain tolerance due to the arachnoiditis, but this was the first time I took a narcotic in 5 years. 2 .5 mg oxycodone x1, then 600 mg ibuprofen x1, then 1 gm acetaminophen 2 over next 24 hours and nothing since, but it is still quite painful today. Different today than yesterday is the development of what feels like left shoulder bursitis. We'll have to see how this goes over time. There is extensive edema at the site, but not clear erythema [I'm dark skinned]. Still just can't seem to get enough water. Had my first meal last night [made chicken soup]. It's still pretty early on. I'm not even at the 72 hour mark yet, so hopefully things will settle down over the next weeks. I checked the box as life threatening because that was likely early anaphylaxis -- though at first I seriously thought at first I was just anxious because of the lip tingling. This is in defense of the fact I did not self administer epi when I became SOB. I likely should have, but know myself well and did fine without it and with asthma and allergy care. I didn't need extra albuterol after the first 24 hours [though writing this makes me feel SOB just from reliving it]. This second dose is a doozy. Hope this was helpful. I provided you guys with my cell but if you want to follow up, I use my phone for work so if you text first I cant tell you availability.

Within 24 hours of Shot, I started to feel chills, also achy, slight heaviness in breathing, slightly runny nose. headache, and slight dizziness. Lasted approximately 1 week. And now I have tested positive to Covid as of 03/04/2021.

60 year old female experienced increasednheart rate and SOB 8 minute after receiving vaccine, Patient is on 4 liters of 02. History of COPD & pulmonary hypertension, on list for lung transplant. EMS called

On Friday, March 12th, 2021 approximately 10:35 am, 60-year-old female received her first dose of Moderna Vaccine (Lot Number: 003A21A) in her left deltoid at the facility. Patient received the Moderna Vaccine. After which she sat in the designated medical observation area for her allotted 15 minutes. Approximately nine minutes post-injection around 10:44 am, she felt a bit ?wobbly? when standing up. A medical assistant called Emergency Medical Services (EMS) immediately and the Physicians Assistant went over to assess patient's symptoms. During the wait time for EMS?s arrival, the physicians assistant performed an assessment. Patient states to have experienced lightheaded-ness, mouth/tongue tingling, shortness of breath and palpitations. She denied throat constriction, denied itching, redness or pain at the site of injection. She said the tingling she did experience resolved around 20 mins post-injection. During the assessment, the physicians assistant noted clear breath sounds, irregular health rhythm, increased heart rate, extra-ocular movements intact with no nystagmus, no redness or swelling on the injection site and good grip strength. Upon EMS arrival at approximately 10:48 pm, the firefighters triaged as per their assessment. She expressed that she is taking ?Lexapro? and allergic to sulfa-drugs. She claims to be ?borderline diabetic? and that the lightheaded-ness has ?never happened before? The EMS took her to a separate room in the building and assessed her further. After approximately 20 minutes she left and did not leave in an ambulance against medical advice. She left with her husband and went home. She was made aware that she should go to the hospital immediately if she felt her health was compromised.

As a brick it came on. Throat started to swell up, and dry, very nauseous, shaking while no fever, eliminated all stools, and my heart staryed to beat fast mixed up with irregularity. It settled a bit after 1 hour after i did Therapy, a tapping method to support the immune system and help with adverse reactions. Stayed nauseous for days, and as of today 3/14/2021 i still don't feel like myself yet. Still tired, weak, a bit shaky, just off.

Got her vaccine with no problem, got her vaccine and felt dazed as she was going to the waiting area. She was anxious and then started feeling heaviness in her chest. She felt dazed, nothing registered and was not focused on anything, and sat for 25 minutes. She then got up and walked to the car, felt like she was in the clouds and her right lung was really, really bothering her by the time she got home and tired. Her heart rate was 140 and very fast. She didn't feel as if she was anxious but just blaise. She was really winded and exhausted by the time she got home. She had not eaten before she got the vaccine, made herself a sandwich and fell asleep and slept for about 3 hours. When she woke up she had a very, very sore arm. Then on Saturday, she woke up around 3:00 AM, and could not go back to sleep as she was wide awake. Then every task that she did just exhausted her and still felt heaviness in her chest and back and the right lung was really bothering her like she had worked like an animal for a period of time. She has a small apartment and it doesn't take any energy to walk to the kitchen. Saturday she felt fine, was cleaning and felt good. Sunday she slept all day and her right lung was still hurting her. Yesterday was still exhausted and winded feeling. Today, 3/16/21 she is still feeling the same way and exhausted doing simple tasks. She has a nodule in her right lung and several spots in her left lung but nothing is being done for them. The vaccine seems to have exacerbated the symptoms and made them worse. The injection site is a little sore but nothing out of the ordinary for a vaccine. She took two Advil for her symptoms which did help as she had pain in her head with this which will last for 5-10 minutes and then goes away. She has notified her doctor and she has an appointment on Friday at 11:00 AM.

Pt received 1st dose of Moderna at community pharmacy, within 7 minutes developed dyspnea with stridor. Received epinephrine, methylprednisolone, and diphenhydramine by EMS then transported to MMC emergency department for additional treatment.

Moderna shot at 5:30 pm on 3/14/2021. 3/15/2021 Body aches started, even nail beds hurt unable to sleep, difficulty breathing, cough. Took 2 Extra Strength Tylenol at 4 pm, 10 pm and 3/16/21 at 5:30 AM.

I was feeling very flush and couldn't get cooled down when all of a sudden I got very light headed, couldn't breath very good. Then the pounding in my chest started with pressure in my neck and head. After an hour I ended up in the ER with SVT. My heart was beating close to 200 beats a minute. My heart slowed down on its own to 114 beats a minute.

Pt was doing fine after receiving the vaccine. That following day, she reported having flu-like symptoms. She had covid-19 about 9 months prior and knew that she may have more severe symptoms. Later that day, she reported having shortness of breath and could not talk without taking breaks in-between. She also had a difficult time walking. Pt was seen and treated in the emergency department. I feel this was more patient issues since she has had a history rather than direct effect of the vaccine.

3/12/21 5 AM strong pain in arm when moved 7:30 AM lower abdominal let side aching on and off for several hours 8:00 AM Dull Pain behind eyes for 10 minutes Mid abdominal slight aching -comes and goes for the day 8:15 AM general aches-with pins and needles like fleeting prickling in left finger, mid abdomen 8:51 AM lower back pain fleeting Cramping in right hand fleeting 9:08 AM lungs feel tender breathing in-for rest of day 10:45 AM flu like achy 6 on scale 1-10 Feeling feverish 98.7 temp After doing some housework and having one client session 11:18 AM more light housework, getting dressed and feeling exhausted 7 rating on scale 1-10 And achy 6 rating , over more parts Of body?hips deep aching 12:50 PM Ate 1:30 PM amys squash soup, 1/4 c low fat cottage cheese and about 10 red grapes Its 1:40..PM caved in and took one Tylenol 50mg As all over aching is so strong- rated 8 I am in bed feel feverish Temp is 100.1 2:28 PM achy 4 rating..fleeting prickly sensations on back of calves Very tired -hard to stay awake Dull pains 4 rating running from inner right side of head, starting deep Inside near center of head and radiating out on right side of head just in front of right ear and up closer towards temple too Fell asleep 2:55 PM achy still rate 4 no headache now 4:41 PM searing fleeting pains in hands and feet ..achy bones increasing to 5 rating Lower ab left side faint aching comes and goes in and out 3 Rating In bed resting 3:51 PM sharp pains lower abdomen 5 rating 5:02 PM Joints hurting in feet -dull, continuing 4 rating 6:10 PM overall aching 7 rating Wirh headache.. Tylenol seems to be wearing off.. going to try not to take another .. feet aching rating 4 but not hands anymore 6:25 PM Chills 7:25 PM chills, stabbing pain lower left abdomen All over very achy rate 8 & Headache Hard to focus Slept 5:15 AM 3/13/21 Rough night Jabbing ear pain, rated 5 on and off thru night Loud Ringing in ears that is now a barely audible humming Lower L abdomen-nearly constant ache rates 4 -7 aaa night progressed Awoke to find both arms swollen and shot arm completely numb-couldn?t move fingers. Got up, walked around...feeling came back-but no pins and needles sensation as the feeling returned to my arm and fingers...as i expected 7:00 AM just very tired No more symptoms except exhaustion -maybe from bad night sleep Sunday-tired but nothing else Now its Monday and I feel slight chills today and still very tired .

Sharp, stabbing pain in middle of chest with every breath. The deeper the breath, the sharper the pain. Pain was severe in morning, first noticed around 4 a.m. and continued to be severe throughout the morning but very gradually eased up to moderate pain by afternoon. Now at 7 p.m., the pain is very slight, barely noticeable. I will call my doctor tomorrow to get it checked since I'm concerned about my heart, or it may or may not be related.

initially, chills, muscle ache, nausea; next day: cough, shortness of breath; 5 days later diagnosed with bacterial pneumonia; two negative COVID tests

1. 2/20 sharp rib pain. Predominantly right hand side 2. 2/23 Covid 19 shot /Headache/ Tightness in lungs afterwards 3. 2/24/21 shortness of breath, struggled with getting sentences out, rib pain, raspy voice 4. 2/25 called pulmonary. Said if not better by tomorrow call. 5. 2/26 Pain in ribs worse, struggled with breathing, short of breath. Prednisone prescribed & X-ray 6. Lungs eased, rib pain remained, sweaty, pounding in heart 7. 3/3 called pulmonary. Very winded, fatigue & rib pain. Dr. thought pleurisy & upped prednisone & antibiotic 8. 3/10 Sought out Pulmonary again. Short of breath, rib pain tolerable w/800 mg Tylenol. Extreme fatigue. Cat scan & blood work ordered 9. 3/11 note Cymbalta not renewed (cold turkey w/d) until ordered 3/12. Arrival expected Monday. 10. Fast forward lungs better, winded easily. Rib pain intermittently, extreme fatigue Fatigue - No reprieve, when move, get easily dizzy, feel like going to faint, feels like I?m tanking. Light headed goes away, fatigue seems to be getting worse. Dr. upped Losartin due to BP has changed since this event. No one is saying this is related. I go to a heart specialist next.

Presents to ED after receiving 1st covid vaccine the day prior, now with SOB, nausea, emesis, fever, diaphoresis, "shakiness", "darkness on hands", cough, congestion, abdominal pain, anxiety. Normal immune response, d/c'd home in stable condition.

Swollen and reddened face, headache, tingling lips, a little difficulty in breathing shortly after the injection. The injection site on my left arm later bruised and was painful to the point of interfering with sleep. One week later, a painful red rash developed and spread on my left arm. I again began to experience slight difficulty in breathing.

Patient reports her throat was starting to close and was feeling dizzy after 15-20 minutes of receiving vaccine. Cleared by EMS

Pt had single episode of extreme shortness of breathe lasting only a few minutes. This was accompanied with nausea and pain starting center back and wrapping around. Episode resolved itself in less then 5 minutes, Pt states reaction atarted approx 25min after vaccination.

Administered Moderna COVID Vaccine at 10:39, patient reported headache and difficulty breathing at 10:49. Patient's vitals taken and observed by myself as well as provider. BP 155/74 patient reported they did not take their blood pressure medication today. O2 97 % on room air with 95 HR. Patient reported they needed to go to the bathroom, escorted patient to the bathroom, upon exiting the bathroom the patient reported she could not breathe. Placed patient on 2 L NC, and Provider administered Epi pen as recorded in previous append. EMS activated at 10:55 and patient vitals retaken. O2 100%, Blood Pressure 171/106, HR 98. Patient denied any change in the shortness to the shortness of breath, patient still reports they can not breath, patient used rescue inhaler at 10:59 two puffs, denies any releif from the shortness of breath. EMS arrived at 11:05 and took the patient to DVH at 11:10.

Pt. states she developed fever, chills, headache and felt as if her throat was closing. She started to feel progressively better but 3 days after shot still had headache. Pt. states she already had COVID disease and this felt very similar to actual disease. Pt. able to speak but due to feeling as if her throat was closing, her doctor recommended she NOT get second vaccine.

Patient received the Covid-19 vaccine. She reports symptoms of Anaphylaxis Patient was dizzy, light-headed, and BUE tingling @1111. At this time denies shortness of breath and difficulty breathing. Patient was given juice, water, and granola bar. No difficulty swallowing noted. 1116: Patient noted that she was feeling worse with throat tightness without difficulty breathing. Vital signs stable with 100% O2 saturation. 1118: Rapid response called. Patient reports throat feels tighter and difficulty swallowing noted. Lungs clear, HR regular both radial and apical. I have observed for 40 minutes. Treatment/intervention: Patient observed. Taking given water, juice, and granola bar. Vital signs taken every 5 minutes per protocol. 1120: rapid response team arrived. 1111 98.9 82 128/73 16-18/100% 1116 93 148/86 16-18/100% 1120 95 164/95 16-18/100% Patient took 2 puffs of her personal albuterol inhaler 1127 Care transferred to rapid response team. Patient transported to ER via cart.

All symptoms started 2 hours after 1st dose of Moderna Shortness of Breath Difficulty swallowing (Benadryl 25mg Oral One Time Dose) Throat tightness Palpitations

When I arrived at work I was fine with in minutes my whole body felt as though it was spinning and I went to the ground, I began to sweat and got sick. I laid on the floor for about 15min they symptoms got somewhat better enough to sit up. I was sent home by my boss who also offered me a ride because I looked so awful. At home I went to bed but continued to throw up and have chills. I slept the rest of the next 2 days. I have continued to not feel well since the body aches and nausea as well as short of breath being the worst at this point. I felt in the beginning I was going to die it was so bad. I'm not one to just go to the doctors so I went home to bed. I have been short of breath

Client called 3/25/21 and reports experiencing swelling to her left arm and face starting approximately an hour after receiving the vaccine. She states she also felt difficulty with breathing as if she could not take a full breath. Client states that this lasted through the night, but is moderately improved today 3/25/212 at 1145. Client states that she felt improvement in airway with a hot steam shower. Client states she is now feeling headache and body aches. Client was instructed to immediately seek medical attention via physicians office or emergency room if she is having difficulty breathing. Client stated it is okay to follow up with her.

The patient received a moderna vaccination (unsure if this was her first or second dose) today at the vaccination site at a Stadium. She went back to her car and became very short of breath, confused, and became minimally responsive. 911 was called. Upon EMS arrival the patient was agitated and combative. She received 10 mg of versed. An OPA was inserted (sating at 98% on OPA) as she was unable to tolerate CPAP. Transported to Hospital. Given ketamine. Placed on BIPAP. ICU admit. History of CHF, COPD

She developed dyspnea while out of state the day after vaccine administration. She went to the ER, was observed, not felt to have anaphylaxis, administered oxygen, then released. She was told to get her second vaccine.

7 days after my first shot of maderma,bad congestion, headache fever a very bad cough.drainage is green and when I go into a coughing spell,it hard to breathe.i still continue having all of this even though I went to the doctor the other day.and fatigue is so terrible with a sore throat and ear hurting.

Extreme muscle pain, fatigue, headache, low grade fever (100.7), sore throat, loss of appetite, difficulty breathing (cannot take deep breaths because my chest and throat hurt so much )

Not being able to breathe; Could not smell; Positive covid test; A spontaneous report was received from a consumer concerning a 60 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and could not smell, positive COVID test, and not being able to breathe. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinner. On 4 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 002a21a) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On 6 Mar 2021, the patient was tested positive for COVID and could not smell. On 9 Mar 2021, the patient was hospitalized because of her not being able to breathe. On 15 Mar 2021, patient was released from the hospital. Treatment activities for event was done with regeneron, dexamethasone, remdesivir. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event could not smell, positive COVID test, not being able to breathe was unknown.; Reporter's Comments: COVID-19 In this patient is unlikely to be due to Moderna's mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.

She got her vaccine and within 15 minutes she was having a hard time breathing. She told her husband that she needed to go to the bathroom and see if she could get the feeling to stop. She went into the bathroom and she was gasping and choking for breathe. They got her into the ambulance and her BP was extremely high 128/90 and her BP normally is 98/60. They started an IV, breathing treatments and oxygen. She was gagging up saliva and having a hard time breathing. They got her to where she was calm. Her body when it is under extreme amounts of stress goes into seizures, which it did. She then was transferred to in for observation. By the time she arrived her BP had come down and was starting to stabilize. She was given steroids, discharged home. She has had problems breathing, extreme/sharp pain on the left side of her head behind the eye, which has been going on for over a week. By the end of the day she is exhausted. She has never had a hard time breathing at high altitudes and now she can walk up the stairs and be winded. This has all happened since receiving the vaccine. She sent a message to her doctor who did seem concerned. The pharmacist at the facility at the time said that she was fine, to leave her alone. The EMT's said that there was something wrong with her and took her to the hospital. The hospital did not give her any long-term medications to take. She does have a routine APT with her PCP on 4/6/21. On Thursday she woke up and asked her husband if her face was swollen, and he asked why, she stated that her face was numb, and some spots so sensitive that she could not brush her hair. This was on the left side. The sensitivity is still there, but not as intense.

Monday: sore arm after vaccination (high on left arm). Very sleepy about 10:30 pm. Difficulty sleeping when rolled onto left arm/shoulder. Tuesday: Arm looks fine, can't tell if any swelling, but I have headaches, shortness of breath, dizziness while driving. No fever. Wednesday: Felt worse than Tuesday, hard to get out of bed. More dizziness and headaches. Hard to concentrate on work. No fever. Thursday: Felt better than Wednesday but still wobbly. Occasional headache. Runny nose. Some nausea. Emailed my doctor to ask if I should get a covid test. She said to wait a day or two as my symptoms were probably just a bad reaction. Friday: feel better today but still thought I should document this when I saw there was a place to do so.

pt came to clinic in w/c 1155am c/o dizziness, SOB, SpO2 RA 96%, BP176/98 P76 1200 drinking water 1206 BP 147/80 P67 - better 1208 pt and husband, walked with staff (RN) to car

chest pain beginning 11:00pm after vaccine given at 9:30am with subsequently confirmed cardiac ischemia. There was associated shortness of breath and fatigue. Patient waited to call on 4/2/2021 and was seen in the office and subsequently sent to the ER after electrocardiogram was abnormal.

At 3:44pm, writer was paged to tend to patient who per monitor began having sudden hiccups. On writer's arrival to room, patient observed to have sudden onset abnormal breathing pattern and intermittent spasmodic hiccups. Writer called for additional assistance, oxygen and crash cart. Patient denied headache, dizziness, rash, throat discomfort, hoarseness, nausea, or chest pain. Patient was alert and verbal in between spasmodic hiccups with appropriate coloring; and she voiced that the active abnormal breathing happens when she gets an asthma attack. She simultaneously was reaching in her purse and worded "my pump". Oxygen via NC at 2Lpm provided to patient. Patient self-administered 2 puffs of her Ventolin rescue inhaler, though observed patient's inability to hold breath adequately after each puff. BP: 150/70 P: 98bpm RR: 22 Pulse oximetry 100% on 2LPM via NC. Dr. reached via telephone who ordered for patient to be sent out via 911 to hospital. Lungs and Heart auscultated by RN – no abnormal findings. At 3:55pm patient noted to have shallow rapid breathing, and voiced she felt lightheaded, weak and feeling a burning sensation in chest, and writer noted patient appeared to lose control over her head and neck. Patient repositioned to supine in recliner. Writer coached patient to control breathing with pursed-lip breathing technique and switched oxygen via NC to face mask, patient was able to follow commands well and remain alert. Dr. ordered Diphenhydramine HCl 25mg IM STAT. RN administered Diphenhydramine HCl per order at 4:00pm to right deltoid without incident. EMS arrived and assumed care at 4:00pm. Patient transferred self from recliner to stretcher with EMS assist. Patient left facility via stretcher and 3 EMS attendants at approximately 4:15pm, verbally responsive and oriented x 4 without supplemental oxygen and in adequate control of her head and neck muscles. VS: 170/60 P: 88 O2 Sat: 100% on room air.

PATIENT RECEIVED 1ST DOSE 3/18/2021. On 03/20/2021 patient states she had an allergic reaction where her throat was very tight and had some difficulty breathing and swallowing. Two days later on 03/24/2021 she had huge blisters on both lips and her nose. Patient states her nose and lips felt numb. She states lips were three times the size. Last week on 03/28/2021 her whole body started itching from head to toe. The vaccine site was very inflamed and she had huge welts on her chest area and belly and lots of burning. Patient has a tele visit with Dr. on 3/30/2021 and was prescribed prednisone and benadryl. Patient states she has no history of any allergies whatsoever.

Heart racing could feel heart beat in my head. Face ears and lips turned read. Labored breathing. Light headed. Fatigue. Itchy all over.

1/2 hr after vaccine, pt c/o some shortness of breath and difficulty breathing" like she normally gets pt rested X 1/2 hour plus with no change in symptoms Pt transported to ER via Amb

pt says on 3/27/2021 she started to get warm, clammy and damp. On 3/28/2021 she had SOB. She had swelling and pain in her lower stomach that was persistent and would not go away. Her temp was climbing reaching 99.9 . She did not eat but only drank water. She was feeling uncomfortable. She started sweating. Next morning 3/29/2021 she woke up w/ chills and vomiting. She vomited liquid only. She took Ibuprofen which helped w/ the chills and stomach pain. On 3/31/2021 her left shoulder started hurting once again like it did right after taking the shot. BP was 151/95 and pulse was 127. She still has all the other symptoms at this time with additional pain on her left side. She started feeling more like herself by 4/4/2021. Today 4/7/2021 pulse is 82. BP is 130/83. Pt will see her PCP and discuss getting the 2nd dose.

ADV EFFECTS: HEADACHE, EXTREME FATIGUE, TINGLING ON ARM/SHOULDER/LEG/FEET, BUTTERFLY RASH ON FACE,HOT FLASH, WHEEZING, CHILL. PATIENT WAS ON TYLENOL AND IT HELPED WITH THE SYMPTOMS

Patient presented to ED due to sudden onset of chest pain and dyspnea. Symptoms worsened with exertion and relieved with rest. She received 2nd dose of Moderna Covid-19 vaccine on 4/4/21 and began having left calf pain on 4/5/21. She was mildly hypoxic on room air with ambulation and tachycardic. Prior COVID 19 infection in December 2020. CTA showed bilateral moderate burden of disease and was found to have developed bilateral pulmonary emboli.

Pt arrived to vaccination clinic stating she had multiple allergies and after her shingles vaccination she had an allergic reaction. 3 RN's present in room during this time. Vaccination given and patient ambulated to observation location. Within 30 seconds patient started complaining of feeling dizzy, SOB, and passed out. Patient assisted to floor by 2 RN's while 3rd RN called RRT. Patient not responded to verbal commands. Pt with pulse and respiratory effort. Patient began shaking in seizure like activity. Oxygen applied at 4 L NC. Unable to get B/P or SPO2 due to shaking. Epi 0.3 mg administered SQ by RN. Patient began to mumble words and laughed at husband. RRT present and patient accompanied to stretcher and transferred to ER for evaluation. Report given to ED RN by Primary RN.

I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though I was tired, would get out of breath easily, and had chills. After 24 hours I just felt run down for the next 24 hours.

Nearly fainted twice on the bathroom floor; Postural hypotension; Left lower quadrant abdominal pain which continued for 24 hours; Dumping water from her rectum for approximately 24 hours; swelling of the lymph nodes on right side that increased to the size of a foot ball; Unable to move arm due to swelling in the lymph nodes; stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track; Throat was swelling with irregular heart beats; full compensatory pause when the patient was listening to heartbeat with her stethoscope; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Nearly fainted twice on the bathroom floor) and ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope) (seriousness criterion medically significant), CHEST PAIN (stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track) and PHARYNGEAL SWELLING (Throat was swelling with irregular heart beats). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph nodes on right side that increased to the size of a foot ball) and HYPOKINESIA (Unable to move arm due to swelling in the lymph nodes). On 04-Apr-2021, the patient experienced ORTHOSTATIC HYPOTENSION (Postural hypotension), ABDOMINAL PAIN (Left lower quadrant abdominal pain which continued for 24 hours) and DIARRHOEA (Dumping water from her rectum for approximately 24 hours). On 05-Apr-2021, the patient experienced SYNCOPE (Nearly fainted twice on the bathroom floor) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Nearly fainted twice on the bathroom floor), ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope), ORTHOSTATIC HYPOTENSION (Postural hypotension), CHEST PAIN (stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track), PHARYNGEAL SWELLING (Throat was swelling with irregular heart beats), LYMPHADENOPATHY (swelling of the lymph nodes on right side that increased to the size of a foot ball), HYPOKINESIA (Unable to move arm due to swelling in the lymph nodes), ABDOMINAL PAIN (Left lower quadrant abdominal pain which continued for 24 hours) and DIARRHOEA (Dumping water from her rectum for approximately 24 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment was not reported/ unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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.

admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged home. passed away at home after discharge.

On February 5th, I received my second Moderna vaccine. Monday the 8th, I was working from home and wasn?t feeling well. I went to lay down and was not able to. It was hard to breath. I got up, went to another room where there was a recliner and sat in it trying to catch my breath. It got harder to breathe. I had my husband call 911. I went to the ER, had a CT scan of my chest and was found to have ?extensive PE?s?, ground glass and signs of pneumonitis. I was admitted to the CICU for two days and was transferred for two days. I was told by my orthopedic surgeon that there was a high unlikelihood of PE?s developing from my ankle fracture 3 months later. I had home health care for approximately one month.

Fever, Headache, Rashes, Extreme Fatigue and Extreme low blood pressure. 77/44. Heart palpatations, coughing, Purple eyes, Swollen eyes, throat and lymph nodes. Sore throat. My HRT pellets migrated around my body that were inserted in my buns.

1st evening fever 103, shortness of breath, heaviness in chest. 2nd day nausea and fatigue and body aches, 3rd day diarrhea extreme fatigue, red rash, swelling, itching , hot to touch at injection site. 4th day chills, night sweats arm still the same, 5th day dizziness, vertigo and head ache. Body aches continuing and extreme fatigue, 8th day body tingling, my skin feels weird that's all I can say. It is hard to describe. Two weeks later I'm still extremely fatigued, dizzy especially bending over and moving head, General malaise feeling and shortness of breath upon exertion like exercising.

Patient had normal side effects (vaccine on 4/7/2021) Wednesday and Thursday with fever and aches. Woke up Friday morning with fatigue and over the course of the next days developed shortness of breath, severe fatigue, and palpitations. Came into the ER a week later (4/14/2021) found to have significant anemia. Coombs test positive. Seen by hematology suspect autoimmune hemolytic anemia. Started on prednisone 1mg/kg. Will need at least weeks of treatment then tapering of steroids. Outpatient follow-up with hematology.

About an hour after receiving the vaccine I started having difficulty breathing and it went into an asthma attack. I used my rescue inhaler which I keep on hand due to allergies. I used it 3 times that afternoon and evening. I felt nauseated but did not vomit. I had watery diarrhea twice. Nausea continued for 24 hours with loss of appetite. That has now abated. The injection site did not hurt until the next day when it started with tenderness then quickly turned red and painful and hot to the touch. Wednesday and Thursday the arm started getting a rash and it has spread up to the neck and face. Headache started the night of the injection and became intense (near migraine level) and stayed painful for 24+ hours. Fatigue began the night of the injection and has gradually gotten better over Wednesday and Thursday. Treated with Tylenol, rescue inhaler, Benadryl and hydrocortisone creams, rest, drinking lots of water, and notified my family doctor. Although I still have a rash and the injection site is hot and sore, I am considering myself recovered from the side effects.

BEGAN WITH BURNING AND TINGLING IN LEFT ARM BELOW INJ. SITE TO WRIST. PROGRESSED TO CHILLS, SWEATS, DIZZINESS, DIFFICULTY BREATHING ONSET NEXT FEW DAYS. MALAR LUPUS RASH BECAME SERVERE WITH HOT FLUSHING. SINCE I HAVE HAD SLE ONGOING, I WENT TO NEAREST ER, THEY MONITORED AND RELEASED WITHOUT ANY ADVICE. TWO DAYS LATER SWORSENING S.O.B, TAKEN BY AMBULANCE TO HOSPITAL BY AMBULANCE DX. LUPUS PNEUMONITIS, REQUIRES HIGH DOSE STEROIDS AND MULTIPLE NEBULLIZER TREATMENTS BACK TO BACK. ON ORAL HIGH DOSE STEROIDS NOW.

Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.

pt received vaccine. waited at pharmacy for 15 min. then went shopping. she returned to pharmacy with complaint of shortness of breath about 25 min after receiving vaccine. i sat her down and as i was talking to her about how she was feeling and she began to have convulsions. i laid her on ground and made sure she had an airway and pulse . pt was unresponsive for approx. 5 min. she regained consciousness and ems took over and took her to er

Trouble breathing. Peak flow at 150. Started at 14 Apr, 9:00 PM and continued until 9:00 AM 15 Apr. Treated with rescue inhaler and monitored with peak flow meter. Fever, dizziness, and fatigue occurred at the same time. Arm soreness and swelling also at height during this time.

anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure; lightheadedness; throat closure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites). 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) (seriousness criterion medically significant), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Tryptase: elevated (High) Elevation persisted 3 weeks. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Before her 2nd dose, she pre-treated with Motrin and Claritin. Concomitant product use was not provided by the reporter. Treatment for the event anaphylactic reaction included EpiPen and intravenous Benadryl. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-073832 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Patient received her vaccination at 9:30. At 9:45 she was dismissed as her observation time was over and she was feeling fine. At the exit of the clinic staff noticed she was staggering her walk. Staff braced her against the wall until a chair was brought to her. Patient reported feeling "lightheaded, faint and dizzy". After a few minutes patient stated she felt better. She was brought back to the observation area for direct observation of vitals and assessment of on site RN staff. Patient went in and out of being oriented to person, place and time. On site DO came to assess patient and 911 was called. Her BP briefly dropped to 98/54 before rebounding to 198/102. She had rapid, shallow breathing, moans of distress and body shaking. No medications were administered. No suspicion of airway obstruction. Time was approximately 9:45am-10:15 from symptom start and being transported by EMS.

While getting the vaccine I felt like an electric thing coming from back to head. Immediately felt dizzy. Got a benedril at pharmacy at 10:30. 10:45 I stand and still dizzy and lips were swelling, could not talk, and throat hurts.. pharmacy called rescue. Rescue arrives At 11:10am, all vitals fine, couldn?t see throat, for it was Swollen. Took me to Hospital. 12pm I got epipen and other medicines. Start Getting better. 2:35 couldn?t talk again got benedril, then again at 7:15. Stay overnight under observation. Got a shot on the belly at 5:30am to avoid blood clothes. And benedril at 7:15am. Got medrol for 6 days. After that.

Went into the er because I was shaking like I was having a seizure and I was delirious. During the testing they found a blood clot in my lung. I am being treated with anti biotics and blood thinners

One hour after became dizzy, weak, blurred vision,one hour later developed swelling in throat,proceed to hospital admitted at 2:19 pm and treated for allergic reaction. I was given 60 mg of Prednisone and zantac. Was given Rx for 3 days off prednisone

Extremity swelling, throat tight, anxiety, rash, fever, headache, short of breath, oxygen saturations at 86%, edema, took benadryl and no relief so went to the ER

Hospitalized: 3/13-3/22/21. Pericardial effusion, pleural effusion. Have had 3 thoracentesis as outpatient since release from hospital: 4/8/21 (removed 800ccs fluid), 4/19/21 (removed 1400ccs fluid), 4/26/21 (removed 1500ccs fluid). Scheduled 4th thoracentesis for 5/3/21 - have appt with thoracic surgeon on 5/13/21.

Patient stated she had an asthma attack after she got home from her vaccination. She used a rescue inhaler and the symptoms subsided. Her doctor advised for her to receive the second dose.

16 hours after receiving the vaccination, I experienced: 1) severe body tremors/shakes - lasted 20 mins, the slowly calmed down to sight muscle/body turbulence . Whole event lasted about 30-40mins 2) extreme muscle tightness/stiffness in neck, shoulders, chest, arms and legs while shaking uncontrollably and vigorously 3) breathing was also turbulent due to shaking; labored, rapid, short breathing (lime during child birth). I have asthma, also. (took my inhaler) 5) afterwards, quite strong headache, back of my head (occipital area) and on my temporalis (both sides) 6) afterwards muscle weakness in arms and legs Called my Primary care Doctor at 8am on 4/28/21 foe phone consultation. Doctor reported some patients having had similar side effects after the second Covid vaccine dose. He recommended resting and staking Advil 3x/day. Recovered, otherwise, but still have headaches and weakness in limbs.

Patient called nurse triage on 4/26 received the Madura vaccine on 4/22 and approximately 24 hours later pt developed tightness in pt's chest and difficulty breathing; pt did have an allergic reaction to a pneumonia vaccine the past; pt currently on 2 L of O2 at HS ; pt woke up with sob and breathing difficulties that improved dramatically once pt used her nebulizer treatment. Patient is inpatient at Hospital. Patient called nurse triage 4/27/21 States she has had a bad headache. States she had moderna shot and has had a bad headache. She is currently at hospital and was somehow sent to triage incorrectly

Developed chest pain within 18 hours of vaccine. Diagnosed with pleurisy, and treated with 16 day prednisone course. Symptoms subsided within 14 days.

3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed. The next day I still had the same symptoms so I described them to my doctor. She recommended going to a urgent care facility. I was diagnosed with 2 small blood clots - one in each lung. I'm on anti-coagulants for the next 6 months.

Asthma; Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds); Weird noises in her left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Weird noises in her left ear). On 15-Mar-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHMA (Asthma). On 22-Mar-2021, DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) had resolved. At the time of the report, TINNITUS (Weird noises in her left ear) and ASTHMA (Asthma) outcome was unknown. Concomitant information not provided On 14/Mar/2021, she had weird noises in her left ear. The next day she had hearing loss (felt clogged, electronic vibration, white noise, crackling sounds). On 17/Mar/2021 she went to ENT who told her she was not the first patient of the day that came in with hearing loss due to vaccination. She was diagnosed with hearing loss of 60 percent in left ear for word recognition. Her speech reception threshold in left ear was AIR 30 decibels (dB), pure tone average left Air 28 decibels Hearing Level (dB HL), bone 25 dB HL. Her right ear was normal at Air 17 dB HL. She saw a specialist the same day and was examined. He gave her 60 mg/day of prednisone for 7 days. She went back a week later, and her results were word recognition at 100%, but she still has clicking and white noise in the ear. Speech recognition air 20dB pure tone average air was 18 dB HL, bone 17 dB HL. Tympanogram diagnostics done on 17/Mar/2021 showed ear canal volume left 1.25, right 2.27. A week later it was 1.66 in left, right was 1.43. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD21-082695, MOD21-082690, US-MODERNATX, INC.-MOD-2021-092733, US-MODERNATX, INC.-MOD-2021-092583 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD21-082695: MOD21-082690: US-MODERNATX, INC.-MOD-2021-092733: US-MODERNATX, INC.-MOD-2021-092583:Crosslinked (MOD21-082668)

Became SOB 2-3 days after COVID shot, left shoulder pain, went to ER, treated with blood thinner x3days, untrasound done, placed on O2

9:10AM - 2nd dose of Moderna given, reviewed common s/sx and signs of severe reaction, advised to do 30 min observation, pt agreed to plan. 9:20AM - Complaints of severe bilateral arm itching. VS taken. BP 150/92, HR 66, O2 95% RA, RR 20. 9:25AM - Diphenhydramine 25mg PO given. 9:30AM - Developed severe coughing, shortness of breath, throat swelling. O2 Sat 92% RA. Lungs sounds - clear inspiration with expiratory wheezing. Pt refused epi-pen, symptoms continued to worsen, pt agreed to receive an injection of epi. 9:37AM - Epinephrine IM 0.3mg to the right thigh given. O2 given, non-rebreather with 8L/min. 9:45AM - Pt symptoms improved, breathing easily and talking. O2 Sat 99% on O2 8L/min. 09:50AM - Paramedics arrived. 10:00AM - Paramedics took a new set of VS. BP 188/94, HR 76, RR 20, O2 Sat 99% RA. No SOB, No itching. 10:15AM - Pt left via ambulance to Hospital.

Patient presented to the ED on 3/6/21. Patient presented to the ED on 3/9/21 and was subsequently hospitalized for 5 days. Prinicpal problem was syncope and collapse. He was diagnosed with elevated brain natriuretic peptide and pleural effusion. These visits are within 6 weeks of receiving COVID vaccination.

Had mild myalgias for 3 days then started with SOB, fatigue, sweating and lightheadedness w/ activity which is still occurring as of today 5/11/21. No hypoxia, normal EKG. Recent cholecystectomy 4/29/21.

Woke up at 6 AM, got into shower.. passed out, woke up then called out for my boyfriend to help. He ran into the bath to assist me and said that I passed out again and had no breath. I do remember having a difficult time breathing before I went down. He proceeded to call an ambulance which brought me to the ER. All which resulted in a reaction from the Modern shot. I felt perfectly fine after the shot the day of but not the following morning and the day after that as well. In my 60 years I don't remember ever passing out. Ironically the morning I passed out I was to go and have blood work done for my annual physical which is tomorrow 5/13/21. We shall see what the results are...

chills, headache, nausea, chest pain, shortness of breath,, cough, loss of smell, dizziness, blurry vision

She feels that vaccine had done permanent damage to her heart; constantly dizzy; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (She feels that vaccine had done permanent damage to her heart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE/SALMETEROL) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEART INJURY (She feels that vaccine had done permanent damage to her heart) (seriousness criterion medically significant) and DIZZINESS (constantly dizzy). At the time of the report, HEART INJURY (She feels that vaccine had done permanent damage to her heart), DYSPNOEA (shortness of breath) and DIZZINESS (constantly dizzy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood pressure measurement: 177/107 mmhg (abnormal) blood pressure increased. On 08-May-2021, Troponin: increased (abnormal) troponin level raised. 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 given with Prednisone tablets for 5 days and Doxycycline. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: added with new event information and reporter details; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.

She got her vaccine, had no reaction. Then two days later she had low grade fevers that do not go back to normal, upset stomach, headaches, sometimes muscle aches, fatigue, sometimes gets out of breath when she's doing something. She is still having these symptoms every day. She has contacted her doctor who said that there was nothing that they can do to continue taking the fever reducers and let it run it's course. It's been 5 weeks right now, and she's not able to do things like go places or see people due to these symptoms.

Sudden episode of afib with rvr needing to go to the ER. Passing out, confusion, shortness of breath. Resolved on own approximately 2 hrs followed by extreme fatigue and headache for 2 days. Still experiencing moderate to heavy fatigue and heavy sleepiness throughout the day.

Anaphylaxis 2 minutes after administration; gagging and heaving; throat swelling until she couldn't breathe; 0.3 mg EPIPEN administered into left thigh; EPIPEN relieved acute throat swelling so that patient was able to breathe; blood pressure 182/127 and pounding headache; transported to hospital by EMS.

Patient c/o shortness of breath and dizziness at 1145, patient transported to ED at 1150 via w/c. VS stable.

Cough, went to the Dr. for breathing trouble. I have not been able to walk with out sitting down to get so I can breath, I was told that I now have fluid with my heart. My feet have been swealing up so bad, I feel sick all the time now.. If I knew this would happen i would not have gotten the vaccines.

Fever (101) 2 week Aches 4 weeks Chills 2 week Nausea 2 week Sleep paralysis 2 nights Chilblains ongoing Breathlessness ongoing Tremors/ticks 2 weeks Psychosis 3 weeks Visual and auditory hallucinations 2 weeks Delirium 3 weeks Confusion 3 weeks Unable to track time 3 weeks Lethargy 4 weeks Weakness 4 weeks Nightmares 3 weeks

After arriving at our clinic for her second Moderna COVID vaccine, patient reports being allergic to her first dose of Moderna COVID vaccine. Patient reports going to the emergency room later that same day, 4/20/21, for swelling of her throat and "all of her insides." Additionally, she had trouble breathing. Patient was denied her second dose of Moderna COVID vaccine at this time.

Admission to hospital with pericardial effusion and pleural effusions on 4/10/2021. Also with chest pain. The patient was having some subacute systemic symptoms of fatigue, chest pain, dyspnea that predated the vaccine by more than a month.

When patient came in for 2nd shot, she said after the 1st shot , 2-3 weeks later, she had severe chest tightness and difficulty breathing, she also had fever, chills, body aches. Due to the severity of the breathing and chest tightness she explained, the 2nd shot was denied.

After the first dose of the vaccine I was very tired. After the second dose I was extremely tired. I started to have trouble breathing at night and I developed a cough one week after the second dose. After two weeks I went to an Urgent Care and they did not find anything on X-Ray. Two weeks later I was not improving so I went back because my breathing was worse. X-Ray showed Pneumonia in both lower lungs. I recovered a little over two weeks after antibiotics. I had Covid-19 in July of 2020 and I had not felt well since then. I was only working two days a week up until the time of the first dose of the vaccine. I was originally given a Benzoate capsules but those did not help. My breathing seems to better than it was for the time period since I got the Covid-19 last year. I still have a dry cough and I get short of breath on occasion. I use Flonase currently and I am able to work more now.

4/14/21 12 hours post shot extreme dyspnea lasting 7 weeks now. Dizzy light headed.Emergency room visit 4/17/21 blood work indicated increase troponin and potential blood clot in lung. Heart attack 4- 27-21. Second ER visit 5/8/21 which showed additional increase in troponin levels. Second heart attack on 5/22/21. Intense back pain between shoulder blades over shoulders and on chest. Additional squeezing in chest and neck pain.

Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath became increasingly worse throughout the month of April. Could not breathe at night. Went to emergency room May 5. Diagnosed heart failure 30% function. No known medical issues before vaccination. Currently wearing defibrillator. Kidney function stage three. Had a very active busy lifestyle, upstairs apartment Before vaccination. Now fighting for my life.

Day one thru three pain at injection site and swelling. Painful arm and shoulder and could not sleep on that side for two nights. After pain and swelling subsided, had heart palpitations, and some shortness of breath on evening of night four. Event lasted about 15 minutes. Was sitting up in chair so stayed put until breathing normalized and palpitations diminished and heartbeat normalized. No history of heart palpitations before.

Acute bilateral pulmonary emboli - onset of shortness of breath 1 day prior to diagnosis on 6/14/2021

Problems breathing. I had to be prescribe medications to get my lungs working normally. Still having issues with lungs and breathing.

Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is sitting on my chest; Shortness of breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney function and platelets low) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included LOSARTAN, ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath). On 27-May-2021, the patient experienced RENAL IMPAIRMENT (Kidney function and platelets low) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function and platelets low), CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Oxygen saturation decreased: low (Low) low. On 27-May-2021, Platelet count decreased: low (Low) low. On 27-May-2021, Renal function test: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The labs include blood tests, chest scans, x-ray, CT scans, and echocardiogram whose results are not provided. Treatment information not given. The patient visited an urgent care, followed by Emergency department for the events and discharged on same day. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

On May 14th her bronchitis and asthma flared up. Had a tight chest and using her inhaler every four hours. Couldn't sleep because she was coughing so much felt fatigue so much. After the second vaccination which was June 18th she went to see Dr. because the symptoms got worse and she didn't feel any better. Doctor prescribe azithromycin 250mg for five days and stated it help with the cough. Also prescribe dueler twice a day and a cough medicine benzoate 200mg three times a day. Have been using a vaporizer and a steam medication. She also got prescribed Mucinex 1200 ml 2 times a day.

Woke up in morning to get ready for work. Went into the bathroom to urinate, had crushing chest pain, got back to bed. Subsided after after a couple minutes. Very scary, took my breath away. I cried and called into work to say I wouldn't be in. Called MD clinic when they opened and got seen. As an RN, I knew the serious nature of heat pain.

couldn't breath; head started spinning where she saw white spots; passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing; Pasty and sweating; Patient was white; developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm; rash got redder on the stomach area/rash on stomach would not go away; couldn't hear; swelling; Very sore left arm/right arm hurt; could not get out of bed; redness; brain fog; Nauseated; Chills all day; Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it; Dizzy; Out of breath; passed out; Felt tired all day/very tired; Hard to lift her arm; Felt like she was "punched in the arm"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient had history of high cholesterol. Concurrent medical conditions included Drug allergy. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm"). On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DYSPNOEA (Out of breath), DIZZINESS (Dizzy) and FATIGUE (Felt tired all day/very tired). On 17-Feb-2021, the patient experienced ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it). On an unknown date, the patient experienced DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; PARAFFIN (LUBRIDERM [PARAFFIN]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (Out of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm") and DIZZINESS (Dizzy) had resolved. At the time of the report, DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day) outcome was unknown and ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it) and FATIGUE (Felt tired all day/very tired) had resolved. Concomitant medication included unknown cholesterol medication. Treatment for the event included ice and orange juice. It was reported that the red bump went away on an unknown date. On an unknown date, blood pressure measurement was high; CT scan, blood work, and electrocardiogram were normal. 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 MOD21-035540, MOD-2021-021611 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Added lab data and new events. Case upgraded to serious.; 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.

Sweaty; tongue feel raw and sore; feels feverish; Anaphylactic reaction; Heart rate more than 100 beats per min; Blood pressure which was 188/143.; Systolic blood pressure <90 mmHg; throat started to swell; Abdominal cramping; Feeling hot; her face became red and than blue; Started to gag/gagging sensation; Flushing; nausea; tongue felt huge; couldn't breathe; Mouth pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: DIPHTHERIA TETANUS PERTUSSIS VACCINE on 29-Jan-2021. Concurrent medical conditions included Sulfonamide allergy (FACE SWELLING HALF OF TONGUE SWELLED WHEEZING HARD TIME BREATHING) since 2016 and Blood pressure high on 30-Jun-2020. Concomitant products included LISINOPRIL from 30-Jun-2021 to an unknown date for Blood pressure, ATORVASTATIN from 01-Feb-2021 to an unknown date for Cholesterol, GABAPENTIN from 04-Feb-2021 to an unknown date for Nerve pain, DULOXETINE, MELOXICAM and VITAMIN D NOS for an unknown indication. On 22-Apr-2021 at 2:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore) and PYREXIA (feels feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, DIMETICONE, MAGNESIUM HYDROXIDE (ANTACID [ALUMINIUM HYDROXIDE;DIMETICONE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency and DULOXETINE HYDROCHLORIDE (CYMBALTA) ongoing from 29-Jan-2021 for Pain, at a dose of 60 mg twice a day. On 20-May-2021, BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) had resolved. On 20-May-2021 at 8:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. On 21-May-2021, GLOSSODYNIA (tongue feel raw and sore) and ORAL PAIN (Mouth pain) had resolved with sequelae. At the time of the report, HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), FLUSHING (Flushing), DYSPNOEA (couldn't breathe), VOMITING (vomiting) and NAUSEA (nausea) had resolved and ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty) and PYREXIA (feels feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement: 188/143 (High) high. On 20-May-2021, Blood pressure systolic: less than 90 mmhg (abnormal) abnormal. On 20-May-2021, Heart rate: 100 breaths per minute (High) high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No further causality assessments were provided for HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting), PYREXIA (feels feverish) and NAUSEA (nausea). It was reported that patient called in after receiving her 2nd dose of the Moderna covid vaccine on 20-May-2021. After receiving her vaccine approximately within 2 minutes, she started to gag, throat started to swell, and she was told by the staff members that her face became red and than blue. The pharmacist immediately administered an epi-pen and she slowly was able to stop gagging. The pharmacy dialed 9-1-1 and the EMS came. They took her blood pressure which was 188/143. They took her to the hospital and about 10 minutes in the ambulance she experienced the gagging sensation and her tongue felt huge. They administered the epi-pen again along with Benadryl and an antacid. She was monitored at the hospital for four hours and discharged. While at the hospital she had the gagging experience again and tongue felt huge. They administered the epi-pen again and she remained on IV which she believes contained Benadryl and an antacid. She is contacting the hospital to find out exactly what she was prescribed there. Today, 21may2021 she has to clear her throat a lot, feels feverish, sweaty, tongue feel raw and sore. She is highly allergic to sulfa. She wanted to know if these symptoms have been reported before and if the medications, she was administered at the hospital are going to effect the vaccine efficiency. She was wondering if Moderna could provide any compensation for her medical costs. 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 24-Jun-2021: Follow up information received on 24-Jun-2021 and included New reporter details were added, Suspect vaccine dosing details were updated, Patient demographics (race) was updated, new medical history was added, concomitant drugs indications, dosing and start dates were added, new concomitant drug Cymbalta was added, New historical vaccine was added, New serious event anaphylactic event was added, New non serious events were added, New lab tests were added. Suspect vaccine Batch number was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

After 2 nd dose?..8 hours after receiving, slept for 24 hours straight. Awoke with a huge red warm area hard to touch and painful on my left arm. Not at the injection site ? just below and a bow the elbow. I have photos and reported to pharmacy. The unable to arouse for about 6 days. Continues to give time to recover?yet intense head, neck, Rt shoulder pain with no sleep, nausea vomiting. May 7 th, contacted my PCP. Referrals made?unable to see ortho until 7/14. Pain increases, lethargy,extreme fatigue, disorientation to time, dizziness with right sided weakness falling. Systemic joint pain , SOB . Took my own driving privileges away. Sought tx at Er on 6/27?no relief Again, ER visit on July 6th dx of cytokine storm is a cascade of exaggerated immune responses that can cause serious problems. The immune system contains many different components that help you battle infections. It includes many different types of cells that communicate with each other via signaling molecules, known as cytokines. Might have been life saving for me. Thank God I do not live where I would have been canceled, and piled in the back of a U Haul??how did that happen ?

Patient was felling anxious; heart was racing, and she felt dizzy. She said her throat felt tight, but she has Eagle syndrome that causes this normally. She felt it was her syndrome was causing the symptoms, but we proceeded with caution. I administered 50mg (20ml) of oral diphenhydramine. She declined laying down but advised her to put her head between her legs for the dizziness. She stated she was better and calmer. After approximately 10 minutes she said her throat was returning to normal and she was able to calm down. After the full 30-minute wait she stated she was fine, her throat was how it was before she got her shot, and her dizziness was better, and she felt safe to leave with her husband. I advised her to take diphenhydramine in 4-6 hours if needed and not to hesitate to call 911 if her symptoms worsen at home.

Patient received Moderna COVID vaccine on 3/27/21 and 4/24/21. Patient states that she had a large gathering of family and friends on 7/4/21. Since then some people at the gathering had developed mild fevers and cough. Most however doing fine and have no acute symptoms. Patient however states that beginning 7/10/21, she began to have horrible asthma exacerbation, patient on prednisone 10 mg daily at this time but states she took 40 mg of prednisone secondary to concern for asthma exacerbation. On 7/11/21, patient again took 40 mg of prednisone, multiple rounds of her beta agonist without symptom relief. Patient noted that her home oxygen saturations on home pulse oximeter 85%. Patient is brought to ED for evaluation and eventually admitted. On 7/12/21, patient had respiratory decompensation failing HFNC and BiPAP, O2 desaturation in the 60's, and was extremely short of breath. FiO2 was increased to 100% without recovery. Patient was intubated and transferred to CCU on 7/12/21. This event is being reported due to COVID cases resulting in hospitalization even though patient was fully vaccinated.

Itching throat; Light headed; Felt throat closing/Sensation of throat closing; Coughing; Abdominal cramping; Red/itchy eyes; Red/itchy eyes; Nausea; Chills; Vomiting; Feel like crap; Left arm weakness; Hypersersitiver to other allergies; Still feel tired and rundown; had an allergic reaction; Weird feeling in throat; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat) and DIZZINESS (Light headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Bipolar disorder since October 2002, Thyroid disorder NOS, Premature ventricular contractions, Allergy to vaccine (Extensive history of allergic reactions to vaccines: flu vaccine, pneumonia shot, and tetanus shot (about 1993), Rash, cough gets really bad, itching, Have tried nasal shots .), Hypersensitivity reaction (Very long history), Hives and Anaphylaxis. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE and TOPIRAMATE for Bipolar disorder, METOPROLOL for Premature ventricular contractions, LEVOTHYROXINE for Thyroid disorder NOS, CLONAZEPAM and BUPROPION HCL for an unknown indication. On 18-May-2021 at 1:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-May-2021, the patient experienced THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing) (seriousness criterion hospitalization), COUGH (Coughing) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal cramping) (seriousness criterion hospitalization), EYE PRURITUS (Red/itchy eyes) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red/itchy eyes) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIZZINESS (Light headed) (seriousness criterion hospitalization) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat). On 18-May-2021 at 2:00 PM, the patient experienced THROAT IRRITATION (Itching throat) (seriousness criterion hospitalization) and ALLERGY TO VACCINE (had an allergic reaction). On an unknown date, the patient experienced FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness), HYPERSENSITIVITY (Hypersersitiver to other allergies) and FATIGUE (Still feel tired and rundown). The patient was hospitalized from 18-May-2021 to 18-May-2021 due to ABDOMINAL PAIN, CHILLS, COUGH, DIZZINESS, EYE PRURITUS, NAUSEA, OCULAR HYPERAEMIA, THROAT IRRITATION, THROAT TIGHTNESS and VOMITING. The patient was treated with EPINEPHRINE 18-May-2021 for Adverse event, at a dose of 0.3 milligram, right upper leg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 18-May-2021 for Adverse event, at a dose of 25 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 18-May-2021 for Adverse event, at a dose of 50 milligram and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intravenous) 18-May-2021 for Adverse event, at a dose of Long acting. On 18-May-2021, THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), DIZZINESS (Light headed) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat) had resolved with sequelae. On 18-May-2021 at 4:25 PM, THROAT IRRITATION (Itching throat) and ALLERGY TO VACCINE (had an allergic reaction) had resolved with sequelae. At the time of the report, FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and HYPERSENSITIVITY (Hypersersitiver to other allergies) outcome was unknown and FATIGUE (Still feel tired and rundown) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat), DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Weird feeling in throat), ALLERGY TO VACCINE (had an allergic reaction) and HYPERSENSITIVITY (Hypersersitiver to other allergies) to be possibly related. No further causality assessments were provided for FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and FATIGUE (Still feel tired and rundown). The patient had additional events to Flu and pneumonia vaccine like itching, the patient also tried nasal, shots. The residual effects included left arm weakness, continued Premature ventricular contractions (PVCs) for four days and still had hypersensitivity to other allergies 29 Jun 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It was reported since patient won't be getting the second shot, or one for the variant If there is one. She kept wearing mask and had never stop. But she also did not know abut the protection at all. 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 01-Jul-2021: Follow-up received on 01 JUL 2021. Patient demographic (pregnancy, height, weight, race), Allergic history (Hypersensitivity reaction, Hives, Anaphylactic reaction.), Concomitant medication(Bupropion, Clonazepam), Event details ( Throat tightness, Vomiting, Chills, Nausea, Fatigue, Intentional product use issue, Feeling abnormal, Dizziness, Ocular hyperaemia, Eye pruritus, Abdominal pain, Cough), Hospitalization details, event outcome were updated. On 13-Jul-2021: Live follow up received on 13 JUL 2021. no new information was 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.

exacerbation of Celiac disease; Bubble floating in eye/eyes had a bubble floating there for a week; Difficulty focusing eye; Elevation of blood pressure; Stomach Pain/severe stomach pain for about 3 weeks; Lying in bed for 3 days; Difficult to breathe; Extremely scary heartbeat at night while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (exacerbation of Celiac disease) in a 60-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 Celiac disease (worsening symptoms) since 1995. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping). On an unknown date, the patient experienced COELIAC DISEASE (exacerbation of Celiac disease) (seriousness criterion medically significant), VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye), BLOOD PRESSURE INCREASED (Elevation of blood pressure), ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe). On 20-Feb-2021, VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye) and HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping) had resolved. At the time of the report, COELIAC DISEASE (exacerbation of Celiac disease) and BLOOD PRESSURE INCREASED (Elevation of blood pressure) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: rapid (High) rapid. On 19-Feb-2021, Heart rate: rapid (High) rapid. In 2021, Blood pressure measurement: elevated (High) elevated. Concomitant product use was not provided by the reporter. The patient had severe stomach pain for about 3 weeks after the vaccine, extremely scary heartbeat at night while sleeping. It woke her up because it was difficult to breathe. It settled within a few minutes both times but was very disturbing. One of the eyes had a bubble floating there for a week and she had difficulty focusing it. The patient went to see doctors for all of these. Eventually they resolved themselves, but the fear of breathing issues at night remained. 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. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-jun-2021. No new information. On 23-Jul-2021: Significant Follow up received on 23Jul2021 contains events updated breathing difficult and Difficulty focusing eyes and fear of breathing issues at night relevant history celiac as current condition and suspect dose date detail.; 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.

Chills,low grade fever, fatigue,body ache,generalized body malaise,sore throat,severe headache,nausea,difficulty of breathing,shortness of breath,congestion,runny nose and severe headache.

Fever, Diarrhea, throat tightness, dyspepsia, injection site pain Narrative: Experienced throat tightness immediately after the vaccination. Observed by occupational health. Recovered with rest.

Dizziness THROAT FELT TIGHT Narrative: Anaphylactic reaction to injectable medication in past (gadolinium contrast)

Patient was brought to the ED after receiving the Moderna vaccine for difficulty breathing. Per RN progress note: "Pt arrived via wheelchair from auditorium, pt had received her first COVID vaccine left deltoid, approx. 10 minutes later pt appeared to have an anaphylactic reaction, pt arrives wheezing and tachypneic, labored breathing with accessory muscle use." The patient was placed on supp oxygen and received epinephrine 0.5mg IM x1, Benadryl 50mg IV x1, hydrocortisone 200mg IV x1, lorazepam 1mg IV x1. Pt discharged after 6 hour observation with Rx's for EpiPen, prednison, Benadryl, and famotidine.

severe chills, fever to 101.9 (for 24hr), fatigue, next day diarrhea, nausea (no vomitting), diarrhea lasted over 24 hr. Day 3 lost voice, day 4 seen by medical provider for shortness of breath with activity (covid-19 swab done at that visit; no results as of this report)

25 minutes after shot started having tightness in my throat, then heart pounding. Pulled into ER on my drive home. Received medications, prednisone, benadryl and pepcid and was observed a few hours. Ok now. Still glad I got vaccine since I am in health care.

started with metallic taste in mouth, progressed rapidly to clammy, light headed, elevated BP and HR. All of these progressed within minutes starting at 8:20 AM. Treated by drinking water, relaxation breathing, sitting for a half hour. Left the facility at approx 9:15 AM, but stayed close as requested and was told not to drive as still not feeling right, but better. As the day progressed, developed chills, fatigue, nausea, some shortness of breath, mild exacerbation of asthma- cough, then mild fever, runny nose, severe pain left arm. Symptoms finally moderated to just fatigue and body aches by the evening. Took 2 puff sof albuterol inhaler and 2 advil in the afternoon. Woke the next day with left arm pain, fatigue and continued to treat with advil through the day. Woke today, Jan 9 feeling normal. I did decline suggestion of going to the ER or my PCP when BP remained elevated at 11:30 AM on date of vaccination, chose to go home to self monitor.

Headache SORE ARM Narrative: headache the evening and next day that went away (12/29). I had arm soreness a day following the vaccination (12/29) that also went away. Sunday 1/3 flu symptoms (Diarrhea, fatigue, coughing and chest congestion). Today 1/5 USING inhaler due to cough, and SOB. 1/6 very fatigues and dizzy at times. Not feeling very well at all and uncertain if this is related to the vaccine.

I received the vaccine in my right arm about 10 AM on 1/11/2021 I felt a sharp muscular pain in my back near the base of my right shoulder. It was difficult to take deep breath?s. It felt like I had pulled a muscle there. Moving positions from sitting to standing or raising my right arm to scratch or reach for something caused the muscle pain to occur. After taking ibuprofen, water and rest the pain subsided a lot, but still continues. There was no increase in my temperature.

Patient stated that she went to the observation area and started to have difficulty breathing, the emergency squad went to the patient and advised her to get out of car and go into the squad to get evaluated and the patient refused because did not want to go to the local hospital here. They observed the patient for 30 more minutes and determined that she needed her inhaler. but, she had forgotten it they advised again to go to hospital and patient refused. she stated that she was fine and decided to drive to the hospital in her home town. when she arrived they gave her a nebulizer treatment as she had wheezing and high blood pressure when arrived at hospital. The patient stated that the physician told her that she was fine and that she just had a histamine reaction. He stated that the blood pressure that was 179/99 prior to her leaving would go down as she was not relaxed and over excited. Patient stated that she did take her blood pressure when she got home and it was normal. and she felt better. she stated that if she was by herself that day, she would have never reported it, because she has had worst Asthma attack's In the past. The patient also stated that her doctor advised her to get the second shot in the series and to make sure she carries her inhaler with her when she goes.

Patient arrived at drive thru clinic, received injection along with other co-workers, she pulled to our waiting area where a emergency squad had been, a coworker acknowledged that she was having difficulty breathing, patient states they (squad) wanted to bring her to the hospital and that she refused, she was fine, again they asked her multiple times and she did not want to go to the local hospital here. she stated that she drove herself to her local ED and was taken care of there. Patient states that they gave her a nebulizer treatment and advised her to continue to get the series of shots and to make sure she has her inhaler with her the next time. Patient did report that when she left the hospital that her BP was 179/99 and the doctor advised her that it would go down, she stated it did return to normal that night as she has a bp cuff at home and she took it several times. Patient stated that doctor told her that she had a histamine reaction to the vaccine and he has seen this several times this week.

Chest tightness and throat tightness 1 hour following vaccination along with itching and rash at injections site. Zyrtec was taken along with use of Albuterol inhaler.

Severe headaches, vomiting, dehydration, shortness of breath ... led to trip to Emergency Room at Hospital on 1/16/21 at 10:45 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and electrolyte imbalances , headaches, body aches, dehydration, nausea, shortness of breath. DKA is medical emergency.

Swelling in throat itching on my cheek and hand swelling on my left lymph gland in neck. everything was on my left side, Developed an inch round spot close to my eye showed up on Sunday and its red. Did run a slight fever went up to 100.1 and chills. arm pain that lasted a couple of days. Everything has been on the left side.

Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing. The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride. On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing. The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.

Pt reported she had a Moderna Covid -19 vaccine on 01/09/21 at Hospital at 2: 40 pm. Pt is c/o her eyelids swelling in the last 3 days, sob this morning. Pt has ST pain constantly today that is not worse with swallowing. + fatigue since yesterday.

Throat felt tight with blood pressure and pulse elevated about 15 minutes after giving vaccine. 30 mins after vaccine was given blood pressure and pulse still elevated. 45mins after vaccine was given throat was no longer tight but patient reported lower gums felt swollen. No swelling visable. Blood pressure and pulse remained elevated. Approximately 1 hour after vaccine was administered the patient reported that her gums no longer felt swollen but her blood pressure and pulse remained elevated although had decreased some since initial readings. Decision was made for her to go to the emergency department. Called the patient later in the afternoon on 1/13. She was still in the emergency room. Her blood pressure was still elevated and they were planning on giving her an intravenous medication to try to lower it.

FEVER, CHILLS, LUNGS HURT, MUSCLE ACHES, SNIFFLES, COUGHING. TOOK ACETAMINOPHEN FOR PAIN AND FEVER. FEELING BETTER DAY 2 AFTER VACCINE (1/21/21)

c/o dizziness, throat feels funny. Denies SOB, Chest pain, headache. Patient performed her fingerstick 143 BP: 164/86, 134/90 ( RECHECK); Sp02: 100 RA; HR 86 Seen and cleared by EMS

She experienced a noxious smell (ammonia) in the right nostril on the evening of her 1st COVID vaccine on 1/5/2020. It was so strong she could hardly breathe. Associated symptoms included nausea and watering of the right eye.

after vaccination, pt left pharmacy fine with no immediate AE, but on 1/28/21 she reported that at on 1/26th midnight she experienced body ache, swelling of face and puffy eyes, but not lips, or tongue. Pt stated she had mild difficulty breathing but she is smoker and had breathing problem before. Pt did not receive any medical treatment, and stated that after 15 hrs (next day) she felt normal and much better.

Patient itching of body and throat and asthma triggered. Transported to hospital for further observation. Patient did not stay the night in hospital. She is home tonight with her husband and will return to the hospital if symptoms worsen.

Pt received Moderna COVID-19 Vaccine Dose 1 at 0837. At 0843 pt started to complain of numbness and tingling in bilateral hands, right worse than left. Shaky feeling. Lightheadedness. Slight nausea. No dyspnea or numbness/tingling in face, neck, or throat. HR: 84 BP: 147/78 SP02: 95%-96%. At 0845, pt given apple juice and saltine crackers. Cool rags applied to neck. Stayed in room with pt to monitor. At 0900 pt laying back in chair, states she is feeling a bit better. HR: 74 BP: 128/73 SP02: 99%. At 0910, pt states that she is starting to feel like her throat is swelling and Convenient Care staff present by 0911. At 0913, pt was taken over to Convenient Care via wheelchair. At convenient care, pt presented with possible allergic reaction where she reported an allergy to peanuts and that she "has had reactions to other things". She had an injection site reaction to her first influenza vaccine (unknown year), but now receives them annually without issue. Pt reports she feels her hands are swelling, as her rings feel tight and that is not usually the case. Pt given diphenhydramine 50 mg IM x 1 and BP improved from 175/84 to 154/90. At 0940, pt reported she felt the lump in her throat was better and the rings on her fingers are looser. Pt spent about 1 hour at convenient care before pt was discharged to home. Pt diagnosed with allergic reaction to COVID-19 vaccine.

On 1/29/2021 at 10:10 am about 40 minute period of breathlessness/shortness of breath as if asthma attack were coming on. Have not had asthma in 15 years. Later, around 12 noon large red, hot, painful swollen rash came up around 3 inches injection site. Called primary Dr, and allergist, who said to take antihistamine and pain reliever. Took Claritin and Tylenol. 1/30/2021 awoke and rash was more red, painful, and swollen, and had spread to 6 inches in diameter. Returned to Vaccination Center, saw Dr on duty who looked at rash and recommended I call my primary for an antibiotic for a skin infection. My primary, prescribed Clindamycin began prescription on 1/31/2021. Night of 1/31/2021 awoke to pain on inner side of left arm, and intense itching in left underarm left chest, and left breast. Took Benadryl. I am still taking clindamycin for 10 days. Redness, swelling, pain reduce each day.

Soreness at end of first day, Next day arm pain mild, mild headache, fatigue and nasea, 1/29/2021 mild pain , headache .moderate fatigue, with mild nasea. 1/30t/2021 wheezing, low grade fever of 100.8., moderate pain., headache , redness and swelling in arm. Severe fatigue, moderate body aches ,mild abdominal pain and diarrhea. stuffy sinuses, 1/31/2021 no fever, arm pain, redness and swelling mild .Headache mild, fatigue moderate, 02/01/2021 no fever. pain ,redness or swelling in arm,.milf headache and fatigue.

Had moderna vaccine 1/9/21 at 2pm. Around 3pm started getting chills/low grade fever /headache/swollen right armpit node. Called supervisor and was told i could not come in with these symptoms. I was out of work for 2 days. Went back to work. Developed a non-productive cough/severe headaches lasting all day. Even if i took tylenol. Week of 1/18/21 Still had severe headaches/ cough/ chills/ no fever/ but started having a bad sorethroat/ chills and difficulty talking and swallowing. My throat lymph nodes were swollen. couldn't even swallow water but breathing was okay. Was sent to an ENT that same day. Had nasopharynscopy. Had slight swelling inside throat.

employee presented to Covid Vaccine Clinic for 2nd Moderna vaccine. Following administration sx onset began at 0845: dizziness, a feeling of a "headrush", feeling faint. 0846, BP 100/70, HR 85, shaky. "I just don't feel right, I can't describe it. I feel like my heart is racing, My head feels really weird. My throat feels like it has a little tickle but I can't be sure." NO h/o anxiety, panic, anaphylaxis. 900 am "my throat feels like it is swelling on the inside"

Pt described tight throat, tingling mouth, and swelling lower lip. Upper and lower lips bright pink on observation. 25mg PO benadryl administered to good effect, pt reported symptoms resolved within 5 minutes of administration. pt completed observation time and safely exited the facility.

Swelling in throat started within 5 minutes of receiving the vaccine followed by tingling and numbness in lips, increased heart rate and shaking limbs. Received 25mg of liquid Benadryl within 5 minutes of onset of symptoms. Symptoms completely resolved about 15minutes after taking Benadryl.

Within minutes of receiving the Moderna vaccine, I experienced an odd sensation in my stomach increased breathing, HR, lightheadedness, and dizziness. (I experienced a similar reaction years ago but more severe, after having a breast MRI with Gadolinium . I will consult my primary physician by email today. Per consult with a family physician, the recommendation has been advised for possible prophylactic treatment prior to obtaining the second Moderna vaccine. On rereading the composition of the Pfizer/Moderna vaccines, I noted that polyethylene glycol(PEG) is a component in both the Pzifer and Moderna vaccines. I also discovered that PEG is also used with Gadolinium particles in contrast dye. Gadolinium-containing copolymeric chelates. A new potential MR contrast agent. Solvothermal synthesis and functionalization of polyethylene glycol. It leads me to consider whether contrast dye should now be listed as one of the allergens on the vaccination registration forms, in order for persons with this allergy to report this information to their primary physicians prior to obtaining this vaccine.

I woke up and I couldn't take a deep breathe as the day went on It was harder and harder to breath. It felt like a stabbing pain in my back by my kidney. I hadn't done activity that day. I toughed it out till Monday and went to the walk in clinic. I was given anti-inflammatory and muscle relaxers. Symptoms went away in 24 hours.

Resident had fever of 102.9, decreased appetite, body aches, fatigue, and mild shortness of breath. Her injection site, left deltoid, was reddened, swollen, painful, and warm to touch.

Heart pulse goes from 83 to 170 several time in the past 20 hours. At least 7 or 8 times we know about. Tightness in the throat and chest. Slight headaches. Fatigue.

Fever, headache, muscle aches, skin sensitivity It seemed that every injury I had sustained in a lifetime had its ?pain receptors activated?. Triggered mild asthma which I controlled with an inhaler. For example: sites of broken bone or injury had increased sensitivity and felt it was on fire.

Pt received vaccine in left deltoid 12:09 p.m. @ 12;25 pt reported feeling nauseated. Given water and pt started coughing. Reported feeling slightly SOB. B/P 142/90. HR 87. Breath sounds slightly decreased on expiration. Reports mild headache. Positive rhinorrhea. Given 50 mg Benadryl PO once @ 12:35 p.m. No angioedema. 12:47 p.m. breath sounds clear. Reports symptoms seem to be resolving. Cough resolved. Continued to monitor. 1300 much improved. Denies any symptoms. HR 68; B/P 122/80. Instructed to f/u with PCP. # 21 Below: Evaluated by NP @ Vaccine Site

10 minutes after dose the patient started having dyspnea, lightheadedness, chest pain, weakness, and headache. Epinephrine 0.3 mg IM was administered prior to transport to the ED. Ipratropium-albuterol 0.5-2.5 mg/3 mL nebulizer solution, dexamethasone 10 mg IV and Diphenhydramine 50 mg IV were administered in ED. Patient was discharged after resolution of symptoms (2.5 hours after administration of vaccine).

"Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain, skin extremely sensitive to the touch, and fatigue. This resolved about 36 hours after the injection. Was feeling fine until today 2/3/21 (one week after injection) . New symptoms developed as I am now feeling like I have tightness in my lungs when I breathe with mild difficulty. (kind of like when I have a chest cold). Also my throat feels funny like my trachea hurts.I have been reporting daily with the CDC app as suggested and have reported these symptoms as well."

11 hours after injection I woke up (2/11/2021 @ 1:45 AM) with severe chills. Shaking uncontolably -legs and head. Than came body aches, especially my arthritic hand and ankle. Weakness, fatigue, SOB just walking to the bathroom. My temperature during the chills was 99.2, and after the chills subsided, about 3 hours, my temperature went up to 100.6 but never got higher than that. Taking 650MG Tylenol helped ease the discomfort. Was not hungry nor thirsty , did not watch TV, all I could do was lay in bed. Symptoms completely subsided by 8:00AM 2/12/2021.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: 5 minutes after taking the vaccine pt stated that she felt dizzy and lighheaded. After about 10minutes later she started grabbing her throat indicating she cannot breath. we gave her 2 epipens 5 minutes after the 1st dose and called the ambulance

on 2/16/21 PM home health nurse administered 1st COVID vaccine Moderna dose to the patient - patient had no immediate reaction in the first 30 minutes after the vaccination. on 2/17/21 AM visit (about 8:50am) - same nurse - patient was found confused, unable to speak in full sentences, repeating herself , "really off". Patient had tremors throughout her body, had abnormal vital signs - temp 98.8, HR 112, RR 24 and labored breathing, BP 88/42, O2 saturation variating constantly between 88-96% on 4 liters O2. Patient initially refused to have 911 called. Nurse has called patient's PCP and PCP spoke with patient who then agreed to call 911 to go to a hospital. 911 was called, report given to paramedics, the patient taken to local ER. Per patient and family - some tests were done in ER (?including CT of head from patient's description). Patient's cognitive status and vital signs have improved and patient was sent home. Per ER, they think this was a reaction to the COVID vaccine. Today 2/18/21 AM visit, same nurse - patient's cognition is at baseline. Patient seems very tired but vital signs are better.

woke with unusual itching all over scalp in middle of the night. two hours later, awoke again shaking uncontrollably. no fever. shortness of breath. heart pounding 180 beats/min this continued for 45 minutes. shortness of breath continued 10 days. feeling fatigued since then. unsure if I should take second dose of vaccine in a week.

AFTER RECEIVING THE VACCINE, SHE STARTED HAVING DIFFICULTY BREATHING. ONSITE EMS/PHYSICIAN RESPONDED. VITALS ARE BELOW. EMS WANTED TO TRANSFER HER TO EMERGENCY ROOM BUT SHE REFUSED AND WENT HOME AGAINST MEDICAL ADVICE.

On the date of vaccine, had no markings. 3 days later the size of a pencil eraser, dark blue/reddish with a black dot in the middle of it on her arm at the vaccine site. Then on Thursday, every joint in her body hurt and this continued until Saturday. On Saturday she had a big red whelt on the arm that progressively got larger. She still has some aches in her joints, but not as severe. The rash is deep red today, swollen with hard ridges, very itchy and very hot to touch. She has not taken anything for it. She has been having a harder time than usual breathing, but not sure if it's related to the vaccine or not. She has less than 20% of her lungs.

25 minutes after the vaccine was given I noticed hives on my arms and chest and my throat was tight. I went to urgent care, they administered iv Benadryl and pepcid. this did not stop the reaction, so they gave me an EpiPen IM and sent me to the hospital by ambulance. At the hospital, I was given Solu-Medrol IV, observed for about 4 hours, and sent home with prescriptions for 10 days of pepcid and Claritin and 4 days of prednisone. The allergic symptoms have not come back as of this reporting.

At vaccination site 30 minutes after 2nd dose vaccination I started having numbness in my front teeth then quickly went to nose, lips, roof of mouth and throat. Honked horn physician came over, performed simple neurologic test and advised allergic reaction. Had me roll down windows and sip water and to wait another 10-15 minutes. After 5 minutes throat and nose felt like they were closing. Paramedics came over and checked BP, which was elevated, and blood sugar which was very low. They continued to monitor me until symptoms started subsiding. Asked if I wanted to go to ER, declined. They recommended me to take 50 mg of Benadryl and to go to ER or call 911 if symptoms persisted or worsened. Took Benadryl within 15 minutes of leaving and about 10 minutes afterwards all symptoms were gone.

Shortly after my arm was very sore for a few days. A few couple weeks later I noticed a rash on the inner left arm which by the next morning afte had spread all over my entire body and was very itchy. On 1/13 my PCP diagnosed it as ezema and prescribed cortosone cream. I began experiencing Asthma issues so my PCP prescibed prednisone to help with that and the rash cleared up about 4 days later

Pt received vaccine at 10:52am and at 11:03 reported slight difficulty to breath and tingles throughout body. EMS took over with patient at 11:04 blood pressure 138/67. Pt received Benadryl IM at 11:10am on right deltoid. Pt released by EMS at 11:25am.

After 45 minutes of receiving vaccination , the knuckles in my left hand, the arm I received the shot in, began to hurt very badly. Before I was able to get home, 7 minutes away, both hands hurt so bad I couldn't hole the steering wheel and I was having cramps in my legs. I could hardly walk up the steps to my house because my ankle joints hurt so badly. I went to bed right away and slept . My hands hurt really badly, but I knew the vaccination caused an inflammatory response so I figured just rest. By the end of the day Tuesday, I couldn't type and could not hold the steering wheel to drive home. I felt out of breath, I hurt all over, my muscles ached and were cramping. I was nauseated, very emotional. I had a fever that spiked at over 101 degrees. I was so chilled that I was shaking violently. I hurt in every joint, my lymph nodes were painfully swollen, my heart was racing, normal pulse for me is 68 to 72, it was 88 to 90. Halfway up our stairs, I just stopped, couldn't make my legs work. Day 3 I called my doctor, had a virtual appointment I knew I couldn't drive or ride 45 minutes away. I missed 3 days of work, stayed home all weekend and was better by Monday. It was 3 weeks before my hands quit aching. The pain came and went in my ankles, wrist, knuckles, hips and knees. Food still nauseates me.

Pt was vaccinated on 1/14/2021 and presented with diabetic ketoacidosis on 1/16/2021. In addition to DKA she developed bilateral pleural effusions. She had previously well-controlled DM with no prior history of DKA. She has no cardiac issues to explain her pleural effusions.

Acute anaphylactic reaction. Presented with dyspnea, wheeze and chest tightness. Received IM epi 0.4mg x 2 - 20 minutes apart, IV Benadryl (50mg) and solumedrol IV 125, continuous albuterol med x 1 hr.

The patient received her second Moderna inoculation January 20, 2021 at 8 a.m. At around 7:30 p.m., she had a sudden onset of myalgias and chills. Within 30 minutes, she had a fever at 99.9° F. She went to bed without taking acetaminophen or NSAIDs based on new CDC recommendations of how to treat symptoms due to the COVID-19 vaccine. The patient hydrated and went to bed around 9 p.m. By 11 p.m., the patient?s fever was 100.4° F., accompanied by intense myalgias, chills and a migraine headache. She woke again at 1 a.m. with a fever of 101° F. At 2 a.m., she woke with right-sided pleuritic chest pain (severe pain with inspiration, some pain with expiration and no pain with holding of the breath), with her fever persisting at 101° F. And tachycardia to 109. By 7:30 a.m., her fever dropped to 100.4° F. But still tachycardia at 101. At this time, she took ubrogepant 50 mg, with resolution of her headache within about 30 minutes. Because she had rhinorrhea at this time, she decided to get tested for COVID-19 that day.

Lip/tongue/facial numbness, headache, throat tightness, shortness of breath. I started taking prednisone, claritan and benadryl 1 hour after injection. The symptoms kept getting worse so I went to urgent care and received an inhaler. I'm one week out and all but the SOB have resoled. The SOB seems to be improving but I feel like I'm still somewhat in a fog. I had lesions in my mouth for 5 days. I developed left sided enlarged lymph nodes, TMJ and ear pain for 2 days with discomfort in the left breast and axillary. This has resolved. I had a follow up appt today (3/3/21) and was prescribed an Epi-Pen.

Severe malaise for 5 days, fever with chills 48 hours, headache for 36 hours, shortness of breath 4 days, hard grapefruit size lump on injection site, generalized muscular pain x e days

Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild

shortness of breath, erythema to forearms, itching to palmar surfaces and perioral Tx: 50mg diphenhydramine IM, transfer to ED, predisone, solu-medrol, & Pepcid IV Discharged to home with instructions to return if sxs recur

PT PRESENTED WITH HYPERVENTILATION, TINGLING AND BENIGN TREMORS IN HANDS AND FEET. TACHYCARDIA, NAUSEA. VITALS: BP 126/85 AND 132/78; REPEAT 102/68 AND 112/68 AT 2:58 HR 97 RR 20 O2 98% THE ABOVE CONDITIONS RESOLVED ON THEIR OWN WITHOUT MEDICATION GIVEN. PT DRUNK GATORADE AND STATED THAT SHE FELT BETTER. AFTER 10 MINUTES OF OBSERVATION, SHE LEFT WITH HER HUSBAND DRIVING THE CAR.

Tuesday March 2nd, Swollen arm with a raised rash (my arm was the size of a softball) rash went almost the to my elbow. I had cold chills (ran no fever), dizzy, light headed, woozy, runny nose, eyes ached, head ached, muscle on left side of my neck sore also my gland under my jaw hurt, I was so tired and as the day went on I felt worse . When I went to bed, it felt like I had a softball size knot under my skim in between my arm pit and under arm (left side). There was a short time with my asthma, used my inhaler and it seemed to help. Wednesday March 3rd, Woke up and I was woozy all day and just didn't feel right. I did not feel as bad as the day or evening before, just tired. My left arm still swollen and rash. Not at all the systems the day before. Thursday March 4th, I just didn't feel right. My left arm still swollen with the rash. I felt so much better than the 2 days before. Friday March 5th back to almost normal. Swelling had went down some but still had the rash. Saturday March 6th I felt normal, My left arm swelling went back down and still had a rash. Sunday March 7th swelling gone and I just have a small amount of rash on the sides of my left arm.

Swelling of face, and throat, have difficulty breathing, and itchy inside of throat, and vaginal area, chills, itchy all over, but no rash on body.

Received vaccine at 2:15pm on Friday 3/5/21. At 7:15pm on Friday 3/5/21, began feeling slight throat tightness then Tingling sensation in Lips, Numb Nose, Rapid and Heavy Pounding Heartbeat, Tingling in front half of Tongue. Went outside to take breaths of cool air twice and then took 2 Bayer aspirin. Event lasted for about 30 minutes. After the issues passed, continued to have slight tingling in tongue and metallic taste in mouth until Tuesday morning 3/10/21.

30 minutes after the shot I felt an allergic reaction happening, My lips began itch, the lips and surrounding skin area and tip of tongue began to swell. I felt lightheaded and weak, my heart began to race. I had a small amount of difficulty breathing. 45 minutes after shot I took 2 Benadryl. The symptoms began to come and go. I then bean to feel the rush of the reaction making feel if as I needed to vomit and evacuate my bowels luckily it stopped before that happened. I took 2 Pepcid which seemed to keep it in check. The reaction completely subsided about 28-30 hrs. after starting. (also Pepcid the next morning, Xyzal in the evening and morning.

Patient, reported to EMT #1 tingling in hands and nausea at 0949. EMT #1 reported. At 0950, PHN began to assess patient. Patient started seizing at 0950. Patient observed breathing with minimal shaking and no jerking movements. Patient's family member supported patient in chair and stated she has a history of seizures, takes unknown medication for seizures, and did not have a seizure immediately following the 1st dose of Moderna. Seizure ended at 0953. Patient observed breathing, speaking, and appeared sleepy. Patient advised to wait for further observation. Patient offered 911. Patient declined 911. Patient vitals taken at 0956 by EMT. Blood pressure 100/60 mmHG and pulse 76 beats per minute. Patient and patient's family member reported to PHN wanting to leave facility. Patient offered 911. Patient refused. Patient left facility with family member at 1015 with unlabored breathing. Patient escorted by family member, 2 EMTs and PHN.

Patient stated difficulty breathing, facial tightness, skin tingling 30 minutes after receiving the vaccine

patient bring observed for 30 minutes post vaccine. hx of seizures and has service dog hx of anaphylaxis to bee stings and antibiotics. uses epi pen ,not available with patient 10 minutes post vaccine sudden onset cough and c/o itching throat, followed by wheezing nurse stat called. patient stated feels like passing out, within 1 minute started having seizures. was conscious but not responding patient lowered to floor stat team present eejrosepatient lifted to stretched, 100% NRB applied. patient taken to ER. patient conscious and responding

Systemic: Patient started with a fever overnight beginning at 9pm, got up and went to work and started developing shortness f breath and chest pain. She worked for 6 hours and went to the ER. She was diagnosed with a UTI and elevated troponin levels-Severe, Additional Details: Her BP on admission was 178/100, troponin levels went down, she was NPO the next day and then went home.

Choking Post nasal drip Severe headache Fatigue GI disturbance Nausea Frequent bowel movements Profound Bloating and gas for 6 days

THE FIRST EVENING AND THROUGH OUT THE NIGHT I WAS EXPERIENCING A TIGHTNESS IN MY CHEST BUT THE NEXT MORNING IT SUBSIDED. THEN THE NEXT MORNING AND FOR TWO WEEKS I WAS UNABLE TO BREATHE DEEPLY SINCE I WOULD ERUPT IN A COUGHING FIT AS IF I WAS EXPERIENCING AN ASTHMA ATTACK-BUT NEVER HAS ONE. MY INJECTED ARM WAS VERY SORE FOR 10 DAYS.

After 15minute observation after Moderna vaccine #1. waited15minutes after the Covid 19 vaccine - I had shortness of breath, great difficulty breathing, and had to stop and lean on cart, as I was breathing very hard, and nearly couldn't breathe. I had confusion, reporting? Epipen? Tell anyone. I was not aware of my surroundings otherwise during the episode. Afterwards, I was breathing ok? and went home. I later called Moderna, and reported this issue. I called the pharmacist, and reported the problem. I called many other pharmacies, asking for advise - ranging from NO do not take the 2nd vaccine (matter of life/death) due to serious reaction to take it & wait longer.

Tingling and numbness in left shoulder and left side of neck for four days post first vaccine. Patient reports some pain at injection site on day of vaccination. Patient also reports some shortness of breath for the four days post vaccine.

Chills fever diarrhea in the evening, short of breath next day with exertions, continued decreased activity tolerance until unable to go up one flight of stairs without fatigue and SOB, after 1 week slight foot swelling, 2 weeks, swelling of left foot and leg (pitting). Increased weight gain on 5 pounds, abdominal bloating. Had cardiac blood test come back abnormal showing heart failure, DVT ruled out, echo showed LA enlargement mitral tricuspid prolapse, increase RA pressure. While scheduling abdominal scan swelling went away. Repeated bloodwork and it came back normal. Stress test 3 weeks later normal. Plan to repeat echo in 6 months

Fever Weak Difficulty Breathing Difficulty Swallowing Unable to eat Stomach heavy as thou a lot has been eaten

5:13pm- Patient complained of burning, itchy, scratchy throat. NO breathing issues stated or observed; 05:15 pm- B/P 176/102, HR 101 pulse ox 98% on RA, RR-22; 05:18 pm- 25 mg Benadryl given PO; 05:42 pm-B/P 142/86, HR 79, 98% on RA, RR 22, patient stated choking sensation starting in upper throat. 05:43 pm- patient states less burning, itchy, scratchy throat, but throat "tightness"; 05:34- 25 mg Benadryl given PO; 05:42 pm- B/P 142/86, HR 79, pulse ox 98% on RA, RR 22; 05:56 pm- patient reports decreased amount of burning sensation, itchiness, scratchy throat symptoms, but denies completed relief of those symptoms, still throat "tightness"? 18:02 pm- B/P 152/92, HR 91, 98% on RA, RR 22; After showing signs of some relief from Benadryl, instructed patient to be seen by a doctor since patient?s reaction could possibly continue. Patient and husband agreed to head to urgent care. Husband verbalized understanding of signs and symptoms of increasing reaction and stated that he would pull over to side of road and call 911 if airway compromise became present. Patient report called to Urgent Care.

Patient received COVID19 vaccine @ 1411. Pt was waiting in biosafety area when she began complaining of discomfort. Pt. felt "nervous, dizzy, and shaky". Pt. could neither confirm nor deny difficulty breathing, but expressed a tightness in the throat. Epinephrine IM was administered at 1433. 911 was called. Pt remained responsive. BP 186/98, 99% on RA, RR increased, EMS assumed care of pt who remained conversational and was transported w/ family (sister) present.

Extreme Fatigue, shortness of breath, chills, redness and pain on site of shot, generalized body ache and joints, low grade

APPROXIMATELY 5 MINUTES AFTER VACCINE ADMINISTERED PATIENT DESCRIBED OR WAS OBSERVED EXPERIENCING THE FOLLOWING: COUGHING, FLUSHING, SOB, SWELLING OF THROAT OR TONGUE. Patient denied wanting a epi-pen administered, denied EMS being called. After pt reported feeling better and being able to swallow, she was given 1 dose of famotidine with a small amount of water. Pt was monitored for greater than 30 minutes and stated she was no longer experiencing the symptoms and returned to work. She was checked on an hour later and stated to be doing fine.

I started to feel unwell soon after receiving the vaccination. I was tired and had a sore arm the first day. By the second day, I began having heart arrhythmia and shortness of breath, which was confirmed at my physician's office by EKG. I was referred to a cardiologist. Today (day three), I am still feeling less energetic and have a higher than usual amount of skipped beats. I get short of breath easily. This afternoon I have a bad headache. My cardiologist has ordered heart ultrasound and monitoring out of an abundance of caution. He says it could be that the inflammation from the vaccine might be causing heart irritation.

An immediate funny taste in my mouth but so I left after sitting for 20 minutes. About 5 min later, my voice started to get hoarse like it does when I'm having an allergic reaction, began coughing and trying to clear throat. I pulled over and used my inhaler as first line of defense before trying epi pen. The inhaler got me home, I continued to have the build up in my lungs and breathing issues, wheezing. I continued to use my inhaler and gave myself a neb treatment. My arm got hot and it was swollen with bumps and very itchy. I treated with cool compress, cream and took Benadryl. I took Benadryl and Loratadine the remainder of that day/evening and into Saturday evening. Saturday evening, I used my inhaler 1 more time because I felt my lungs filling with phlegm (all clear) and was still coughing. This last use made me throw up all the clear fluid that was gathering in my lungs and I felt much better and breathing went back to normal. I used my inhaler once on Sunday and Monday and I haven't needed it since. Funny thing, my right arm began to itch and got red and hot in the same area as my left but I got the injection in my left not my right arm.

03/26/21 11:30am patient reported dizziness. patient was brought back to exam room. Vital signs were obtained and patient was seen by our PA. 11:40 patient c/o of throat feeling tight. over the course of 15min patient was given benadryl, epi, decadron then epi again. Ambulance was called and patient transported to hospital. patient left our office at 12:05pm

Patient called the pharmacy two hours after receiving the vaccine saying she couldn?t breathe and called the EMT to her house.

Today is beginning of week 4. Multiple issues main ones were/are Burning/itching at site, Red warm to the touch, knot under injection site, Swollen lymph nodes under arm (still). 2nd day I was wheezing, freezing but no fever, exhausted, palpations. It got worse the 1st week then went away. 2nd week seemed to be all good. middle of the 3r week red again, pain lymph nodes enlaged etc

Last week I had a mild sore throat for a few days, then on Friday, the day before my second Moderna shot (ie one month after the first) I went to bed and turned to my right side. My right ear made a strange pop sound and then my left ear began to ring. The ringing was pretty loud at first and then settled into a steady low ringing. I have had occurrences over the past couple of years of one ear ringing for a few seconds and then it going away, but never has the ringing kept going 24/7 as it has now. My left ear (where the ringing is) feels full and my right ear drum hurts. My head feels clogged, but I have no symptoms of a cold.

First day around bedtime 11:00pm sever body ache especially upper middle back, hands and feet. Heart rate high 90's. Felt better next day. 2 days later body ache again day and night, middle upper back, feet and hand, under arms. Shortness of breath especially at bedtime, heart rate has been dropping from 80's to low 60's. blood pressure a little high 130's/80's. Feel lump in throat, like choking sensation on and off. Severe weakness-tiredness. I wake up light headed and shortness of breath in the morning. Big bruise on left leg 2 inch long by 1.2 wide. My oxygen usually is between 98-100, last night dropped to 94-95. Doctor told me to report reaction. Feel a bit better today. Took today 2 Advils.

1:12pm - called to parking lot for this patient c/o rash and hot. When arrived at patients vehicle, patient is alert and oriented. States that she is having an itchy rash on chest and feels like she is burning up. No distress noted at this time. Patient reports that she spoke with her allergist and she was recommended to take a benadryl and xanax before vaccine, which she reports she took right before she came to park. 1:15pm BP 200/90, Pulse 100. Patient reports she has high blood pressure and did take BP med this am. Patient then reports that her throat is feeling tight and burning. Patient is talking fine and no distress noted. Patient reports she has her own epi pen but doesn't feel like she needs to use it at this point. 1:17pm - called 911. 1:20pm - patient still feels the same, but doesn't feel like she needs her epi pen. 1:29pm - ambulance arrived. All info given to EMT. Patient requesting that she wants to go to ER to be evaluated. Patient walked to ambulance and left to go to ER.

Malaise, auto immune reaction where I developed a rash over body, headache, arthritis in all all joints. Congestion in chest.

1:50 pm: chest pressure, a bit of breathing difficulty tingling in mouth and odd taste in mouth. Tingling in mouth stopped within an hour or so. Chest issue and breathing problem lasted about 3-4 hours. Early evening, about 20 minutes of constant diarrhea. Late evening, inside bottom lip a bit swollen and outside bottom lip a bit itchy around the edges.

Approximately 36 hours after vaccine: very dizzy, lightheaded, nauseated, hot/cold, achy, labored breathing. Took meclizine, pepto tablets, benadryl. Eased up a tiny after about an hour. Was somewhat better in the morning. It has now been 3 days and 4 hours. Not quite back to normal yet.

Patient reported feeling tightening in the throat about 5 minutes after sitting down to be monitored. She did not report difficulty breathing or other symptoms and she reported having a history of having this happening before so was not sure if she was having a reaction or just having an episode what she has had happen before. We monitored her for 15 more minutes and her husband asked us to call 911. she was breathing and awake but not very alert or responsive. When EMTs arrived she was checked out and they decided to bring her to the emergency department.

40 minutes after the vaccine I had itchy throat & I had trouble breathing. I had to go to the Emergency room & they gave me an IV with Benadryl & a steroid I was there for about 2 hours then I was cleared to go home.

40 minutes after the vaccine I started having itchy throat & trouble breathing. I had to go to the Emergency Room they put me an IV with Benadryl & a steroid then I was cleared to go home after 2 hours.

breathing altered; throat tightened; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; intermittently could not breath and swallow, could not speak; tongue proceeded to swell; tongue started to tingle; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak) and SWOLLEN TONGUE (tongue proceeded to swell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007BZ1A) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced IRREGULAR BREATHING (breathing altered) (seriousness criterion life threatening), THROAT TIGHTNESS (throat tightened) (seriousness criterion life threatening), SWOLLEN TONGUE (tongue proceeded to swell) (seriousness criterion life threatening), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell). On an unknown date, the patient experienced DYSPNOEA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening), SPEECH DISORDER (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening) and DYSPHAGIA (intermittently could not breath and swallow, could not speak) (seriousness criterion life threatening). At the time of the report, IRREGULAR BREATHING (breathing altered), THROAT TIGHTNESS (throat tightened), DYSPNOEA (intermittently could not breath and swallow, could not speak), SPEECH DISORDER (intermittently could not breath and swallow, could not speak), DYSPHAGIA (intermittently could not breath and swallow, could not speak), SWOLLEN TONGUE (tongue proceeded to swell), PARAESTHESIA ORAL (tongue started to tingle) and LIP SWELLING (lips started to swell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded

She got the vaccine she was fine, sat for 30 minutes. Then around 7:00 PM she got nauseated, small amount of vomiting. Then she started aching, joint pain, muscle pain, chills, fever. Friday she started wheezing, and sat in the bed sleeping sitting up. The highest the fever went was 102. She took Tylenol, Benadryl sinus congestion, Tylenol cold/flu. Also had coughing with a lot of mucous thinking she was having a cold. Fatigue as well. She did have a flu shot in October, and then diagnosed with the COVID virus on 10/14/20, tested negative on 10/30/20, she got the COVID rash in November that did not go away. She had similar symptoms to when she had the virus. Believes she may have had the virus in December 2019 as well as she was in the bed for 22 days. She feels that she is now completely recovered from the vaccine.

Swelling in ankles and feet, Muscle aches and pain, Shortness of breath Fatigue, Headache, and Blood Blisters on legs, arms and tops and bottoms of feet. All started around 12am 04/02/21 and have improved only slightly. Patient reported symptoms 04/06/2021 said that she was going to her doctor and that she still had shortness of breath and the blisters all over.

Severe fatigue, couldn?t draw a deep breath, had pain in my right groin, belching and reflux. But this all occurred 12 days after my second shot. I am wondering if this was a delayed immune response.

a 61 yo female who presents today for her first Moderna vaccination. Vaccine was administered at 1312 in the left deltoid. After receiving the vaccine, the patient was sent to the observation area where she reports that she, ?began to feel her throat closing.? At 1315, she was brought to the medical tent area with worsening complaints of ?throat closing? and ?difficulty breathing.? EMT's immediately placed the patient on the monitor for vital signs monitoring. Patient denies feeling lightheaded, dizzy, confusion, loss of consciousness, shallow breathing, wheezing, increased heart rate, swelling to the tongue, n/v/d or clammy skin. Provider administered 50 mg of PO Benadryl at 1318, with water. Medications tolerated well. Patient also self-administered own albuterol MDI, as directed and prescribed. EMS notified at 1305 and at bedside by 1315. Patient transferred to Hospital for further evaluation. Patient left with all personal belongings and medications.

Within an hour started getting heated and tired. 1:00 am started shacking uncontrollably bone pain sever headache hurt to breathe. Could not stay awake. Finally started coming around at 5. 04/07 still had soreness in lungs. Dr. advised me not to get second vaccine.

ITCHING TO THROAT, HANDS, AND "ALL OVER", REDNESS AND SWELLING TO PALMS OF HANDS, STATES THROAT "FEELS LIKE IT MAY CLOSE". GIVEN IM SOLU-MEDROL AND IM DIPHENHYDROMINE PER CRNP ORDERS. PT REQUESTED & GIVEN ICE. PT OBSERVED AND NO SYMPTOMS NOTED. ADVISED TO GO TO HOSPITAL IF SYMPTOMS RETURN.

Pt. developed difficulty breathing and dizziness 10 min after receiving the vaccine. 1 dose of EpiPen 0.3mg auto-injector was administered by the pharmacist. 911 was called and pt. transferred to hospital for treatment. we checked on the pt. she was discharged from the hospital, she stated that she received IV antihistamine and steroids.

One week after receiving the Moderna COVID-19 Vaccine EUA, I experienced a raised 2" circular area surrounding the vaccination site which was itchy and red in color. I took Benadryl for 2 days and it was gone in 2 to 3 days. Then, exactly 2 weeks following the vaccine, I experienced a severe asthma attack at 4:00 am in the morning. This was extremely unusual, and has not occurred since childhood. My usual meds, ProAir RespiClick & Adair did not appear to work as they normally do and gave me little relief. I saw my doctor the next day and he prescribed ZPAC & Prednisone which improved my breathing within a couple days.

The day after the shot: Fatigue, shortness of breath, pain at injection site, dizziness, foggy brain.

most severe: -headache-sharp and painful off and on -very red hot face along with cold hands -sever joint pain in hips and knees -loss of feeling in my legs, tried to walk to the bathroom and had a hard time, looked down and my legs were not working right and they were crossed and i was loosing control of them -fever, chills -sharp chest pains -pressure in the chest -shoulder and across the back pain -exhaustion -trouble breathing -nausea -foggy thinking -swollen glands

Weakness Confusion Falling down Vision impairment Legs really weak All of the above symptoms started on March 14, 2021 On March 18,2021 she was not out of bed except for just a few minutes. On March 19, 2021 she was on the floor laying beside of the bed and my father noticed blood looking stuff on her shirt and bed covers. She was really confused and lethargic. She was really weak and could not stand. She was extremely fatigued. At around 10:30 she fell again on the floor and my father and sister in law was able to get her back up and put her in a chair and she went to sleep. At 12:55 my father noticed she was not breathing and called 911. When they did CPR blood was coming from her mouth and nose. When the ambulance arrived they immediately took her to the hospital where she was pronounced dead at around 3:30 pm.

Fever; chills; Hyperexpanded lungs; Inflamed lungs; Pleural Effusion; Trouble breathing; Pain in her chest when taking deep breath; Liver numbers elevated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion), DYSPNOEA (Trouble breathing) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypertension and Cholesterol (Takes cholesterol medicine.). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LUNG HYPERINFLATION (Hyperexpanded lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflamed lungs) (seriousness criterion medically significant), PLEURAL EFFUSION (Pleural Effusion) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing) (seriousness criterion medically significant), NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) (seriousness criterion medically significant) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated). On 18-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 20-Mar-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) had resolved and DYSPNOEA (Trouble breathing) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: pleural effusion, inflamed and hyperexpanded lungs (abnormal) Pleural effusion, inflamed and hyperexpanded lungs. In March 2021, Liver function test: increased (Inconclusive) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products known to have been used by the patient, within two weeks prior to the event included high blood pressure medication and cholesterol medication. Treatment for the events included acetaminophen. 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.

In addition to major pain in left arm (shot arm), overall sick feeling, lethargy, couldn't read anything without head pain. Worsened, so went to lie down, whole-body chills every few minutes; sharp, sudden, intense stabbing pains in head, as if a sharp large knife was jammed into my head, at left temple, and behind my right lower ear - super intense pain, repeatedly. Occasional shortness of breath and difficulty breathing. All Sunday day and night. Since I couldn't even fall asleep due to the sharp, sudden stabs of pain, I tried a naproxen (Aleve). By Monday, the sudden sharp stabs in Head had lessened, (less frequent, and not as painful), and a deeper, constant headache filled the whole left side of my head. Whole left arm still very painful, and super sensitive to touch. Deep, sometimes throbbing, constant headache on left side, arm pain, and occasional difficulty breathing continue this whole week. (Today, Saturday, is Day 8 from first vaccine shot. ). Still. Also note: I have no smell or taste, since Jan.1,2021.

61 y.o. female who presents with chest pain and syncope. Patient reports she began feeling ill around 6:00 p.m. last night. Patient reports she was having nausea, vomiting, and diarrhea. She denies any hematemesis or hematochezia. Patient states she awoke around 11:00 p.m. and felt like she was needing to vomit so she went to the bathroom. Patient reports that upon getting up she noticed pain across her chest. She described her pain as a midsternal pain with radiation across the chest. She described as a dull pressure. She currently reports no chest pain upon arrival to ER. Patient reports associated shortness of breath, lightheadedness, nausea, vomiting, and diaphoresis with the pain. Patient's cardiac risk factors include hypertension, smoking, age, obesity, and family history. Once patient was in to bathroom, she states she began having nausea, vomiting, and diarrhea. Patient subsequently passed out and hit her head on the bathtub. Patient had slight nose bleed. Patient's family found her lying in the floor and call 911. Patient was unsure of how long she was out during her syncopal episode. admitted to hospital Observation dx chst pain, vasovagal syncope

This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evaluation of cardiac arrest prior to arrival. Patient's husband came from anouther [sic] room and found patient take a big gasp then suddenly became unresponsive. EMS gave patient a total of 4 rounds of Epi, 1 Narcan, and 2 shocks en route. EMS reports with glucose level of 92. Unknown if patient is on any anticoagulation. Patient presents in asystole. Epi and bicarb given. Compressions performed. Lungs equal with bagging. Bedside US performed which did not reveal any meaningful cardiac activity. Code called. Discussed with family, they state she had been having some cardiac issues and her daughter died of cardiac problems in her 30s.

Patient developed chest pain, palpitations, SOB and "feeling like throat closing" approximately 10 minutes after receiving vaccine. Hx of anaphylaxis from penicillin and cipro. Pt was given oxygen via non rebreather mask, Epipen and transported to ED via paramedics.

Tasted the vaccine in my mouth - 2 hours smelled the vaccine in my nasal passages - 2 hours Felt odd just strange euphoric/weird - 6 hours Jitters - 2 days face felt swollen and puffy - 1 1/2 hours throat swelled but not closed I could still swallow but it was tight - 1 1/2 hours racing heartbeat - 3 hours off balance - vertigo - 6 hours

2 days after receiving the 1st dose of Moderna Covid vaccine patient began having diarrhea, shortness of breath, feeling tired, muscle aches, sore throat, diminished taste. These side effects have continued for over 2 weeks after dose given. We have referred patient to her primary care provider for follow up since the duration of symptoms has been longer than expected and not improving.

Metallic taste , cold sensation. 5 mins later tongue and throat swelling, face and chest hot and tingling, shortness of breath

Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Additional Details: RPH Omorho Obogaimhe gave vaccine at 10:39am. Pt waited for 30 minutes, then left. She got in car to leave and started feeling itchy. Pt returned to immunization area and took a 25mg benadryl at 11:35am. her temp was 97.0 f. after sitting for a few minutes she reported her throat felt \"sore and tight\" An Epipen was administered at 11:43am and the rph on duty called 911. Paramedics came and checked her out and conveyed her to the hospital at about 12pm.

on Saturday, March 27th, patient noticed swelling in left lower leg with Shortness of breath, and heart racing. on 3/39, the patient presented to the ED and was admitted and diagnosed with a blood clot from left groin to left ankle, with "clot in heart and lungs". heparinized and discharged home on Coumadin currently taking 5 mg on Sunday, Monday, Wednesday, and Saturday and 2.5 mg on Tuesday and Friday each week.

Two days after taking the 1st vaccination, I developed a cough. As the days have passed, the cough got worse and has leveled off to a lingering productive cough with a dull ache on the left side of my back. I have suffered from pneumonia several times in my life and this feels similar to the early stages, however, I have no other symptoms and have nor felt as though I had an elevated temperature. I work as a technical support rep and have to talk on the phone eight hours a day and I have found it difficult over the last three days to talk for extended periods of time. I get mild shortness of breath and as the day progresses, the coughing gets worse and I am awakened several times during the night coughing.

8:48 AM- Patient complains of dizziness/chest tightness and SOB after second dose of moderna covid vaccine. States she experiences SOB sometimes but this time feels different. States she takes BP medication and has a hx of high bp. Denies throat swelling, assessed and all appeared normal. Vital signs at 8:51 AM- 118/88, 98%, 60. Assisted patient and husband to private room and assessed stomach, back and arm for rash and/or hives; none apparent. Patient states she is feeling better and not having difficulty breathing. Vital signs at 9:00 AM- 108/82, 96%, 58. Assessed throat for swelling, none apparent. Vital signs at 0905- 118/79, 98%, 60. Patient states she is feeling completely better and sob and chest tightness went away. Also had patient walk in hallway and states she is no longer dizzy. Advised patient and husband that all vital signs are normal and no other apparent signs of anaphylaxis, however if she still felt dizzy or any other symptoms she could stay as long as needed. Patient denies having any remaining symptoms and states she is ready to go home. Advised patient that if she experienced any other symptoms after leaving clinic such as sob, chest pain, rash/hives to contact emergency services. Patient and husband verbalize understanding. RN

Patient called 4/15/2021, states had first dose 3/17/2021 and approximately 1 hour after injection developed chest pain, had extreme sweating, became short of breath and experienced nausea. States went to bed and continued with these symptoms for 36 hours. Took nitroglycerin to relieve chest pain. Saw heart doctor today who told her to call us to report adverse reaction and advised to not take second dose.

Almost immediately yesterday post inoculation, I experienced shooting pain in my left temple (initially not so severe that I couldn't drive, but the sharp pains still make me wince). It has migrated to include my right side today. Other effects: lower back pain, chills, fatigue, slight breath shortness, neck lymph nodes feel swollen and slightly sore, and my skin and eyes are much more sensitive than normal. Hopefully tomorrow will be a brand new healthy day, and I can run in the morning.

Felt sick next day. Had sore throat, runny nose 99.8 temp, cough, chest and head congestion tired. Felt better the next morning but by mid afternoon I felt bad all over again. Fever broke three days after that but cough and congestion and headache still continued. It?s been a week now

within 15 min of injection, my throat got itchy and tight. difficult to swallow. I got dizzy and my face and chest felt like sunburn. The EMT on duty took my vitals with extremely high BP. he had another EMT confirm. They transferred me via ambulance to hospital ER for anaphalaxis. I was given benedryl on the way in iv. At the hospital, dr gave steroid and epinepherine in iv port. this helped me swallow and my vitals stabilized and i was released hours later with scrips for prednisone, pepsid and benedryl. Follow up with my primary care dr.

COVID-19 2nd dose given at 1240. Patient sat in the monitoring area for 15 minutes following injection without incident. She left clinic and returned at 1330. At this time she stated she felt "itchy". Red patchy areas noted to mid chest and forehead. Patient denies shortness of breath and no swelling to tongue and throat stated or noted upon inspection. Patient also denies shortness of breath. patient advised to come back to our first aid monitoring area. At 1345 patient noted to begin clearing her throat and was asked again if she felt short of breath-patient stated "yes a bit". EMS was dispatched and patient was transported to ED.

Patient had prior positive test for Covid-19 September 1st, 2020 Headaches & Fatigue for 3 months Dose #1: Patient self reports: Mild Sore arm at site, Nausea & Headache - 1st night Mild Sore arm at site, nausea, headache, jount aches, fatigue, shortness of breath, chills - Day 2 Moderate Sore arm at site, nausea, headache, joint aches, fatigue, chills, fever, depression - Day 3 Moderate Fatigue, Depression, Irritability, right eye pain & redness - Day 4 Moderate Fatigue, Irritability, right eye pain & redness - Day 5 Moderate Fatigue, Irritability, right eye pain & redness - Day 6 to Day 14 Mild Fatigue, Irritability, right eye redness persists (only eye pain subsided day 20, (+L-Lysine supplement) Item #22

C/o tightness in chest, slight diff. Breathing. VSS. ABLE TO SPEAK . Code Green called, paramedics on site to assess. feels better after 15min.

Nausea, horrible headache, chills, weakness turning to severe weakness, shortness of breath, fatigue, heart beating very hard. Today is 3rd day of symptoms. Still experiencing fatigue, headache, fatigue.

Patient received her first dose of the Covid-19 Moderna Vaccine. After about 5 minutes, she experienced a mild headache that then became sharp and severe. It quickly went away. She described no other symptoms. The pharmacist counseled the patient to watch and wait and that if her symptoms came back, did not improve, or worsen, that she should go to an urgent care. The patient left the pharmacy. A few hours later, the patient called the pharmacist and informed him that she went to the emergency room because she felt that her throat was closing. They administered a diphenhydramine drip and treated the patient's allergic reaction. The ER doctor stated to the patient that she had an allergy to come component of the Moderna and advised her not to receive the second dose. The patient was discharged.

Patient called nurse triage line to report the following symptoms: Intermittent chest pressure, symptomatic bradycardia, shortness of breath, dizziness, headache, body aches.

Within 5-7 minutes after injection, throat started to close up and heart started to race (elevated from upper 60?s to about 135-140 - checked on Apple Watch). Having reaction Reported to pharmacist who offered ambulance and inquired if I was anxious (wasn?t until my throat started to close). It didn?t close further but stayed very scratchy and uncomfortable, HR remained elevated 90?s ish). Finally one hour after shot, I purchased and took a dose of Benadryl which helped; at 530 PM took another dose of Benadryl as throat became increasingly scratchy /uncomfortable which again helped. Woke at 230 am finally feeling that reaction had passed. Pharmacist encouraged returning for next shot despite reaction. I participated in V-safe and reported reaction same day as vaccine. Researched on own to try and figure out 2nd dose or no as did not feel pharmacy was equipped for anaphylaxis. Finally called and spoke with Moderna on 4/5/21 and they indicated this was definitely an acute allergic reaction and should be reported to VAERS and 2nd dose was contraindicated Spoke with pharmacist on 4/6 (date scheduled for 2nd dose - my husband was getting his 2nd dose) and she did not discourage 2nd dose but I elected to follow up with my allergy testing as recommended by CDC which is now pending

Pain started on the upper thigh in left leg, caused staying in bed for three days. Tried to stretch out the legs, but had pain every time. ON 4/11/21 had difficulty breathing, so called 911 and was taken to the ER. Diagnosed with pulmonary embolism/

Patient was receiving second moderna covid vaccination when her tongue felt tingly and started to swell. She waiting 15 minutes and then brought the reaction up to the pharmacist. The pt was brought into the immunization room and monitored by. With no improvement 5ml of 12.5mg/5ml benadryl was given to the patient at 345pm. Patient bp and pulse was taken. Blood pressure was 154/94 which was typical for her and pulse was 69. Patient then started to complain of her throat feeling tight and having difficulty breathing. Pt had albuterol inhaler on her due to history of copd. She took two puffs of albuterol at 353pm. Patient had audible wheezing and was still having difficulty breathing. A 0.3mg epi pen was administered to her right thigh at 354pm. Code white was called and as we were calling 911 she adamantly refused medical attention and did not want the paramedics to come. , a co manager came back to check on the pt and she was still refusing medical attention. Pt was continually monitored as her pcp was called. called the pt to urge her to go to the ER to be monitored but she again refused. At this time I had a pulse oximeter measuring her blood oxygen level which was at 96%. The patients symptoms were improving. The patient stated she did not have an epi pen at home so sent an epi pen script to the pharmacy which was filled and sold to the patient. Pt was thoroughly counseled on the how to use the epi pen and was told by the dr and the pharmacist if she had to use the epi pen again she needed to head straight to the er. Patient was monitored from 3:20pm roughly the time of injection until around 4:50pm. Pt was contacted at 630pm to check up and she stated she was feeling much better and all symptoms had improved.

Guillain Barre syndrome; shortness of breath; tingling in her hands; legs were numb and tingling; feet were swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported). Concomitant products included AMLODIPINE and BISACODYL (LAXATIVE [BISACODYL]) for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet were swollen). On 01-Apr-2021, the patient experienced HYPOAESTHESIA (legs were numb and tingling). On 02-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and PARAESTHESIA (tingling in her hands). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (feet were swollen), HYPOAESTHESIA (legs were numb and tingling) and PARAESTHESIA (tingling in her hands) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. treatment information not provided Additional information:by 02Apr2021 she was admitted to the hospital and was diagnosed with GBS (Guillain Barre syndrome) She stayed in the hospital for 5 days. 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.

received the vac on 4/6, starting aprox 8th -9th I start to not feel good... just thought is was a mild reaction to the shot... by the 12th I felt terrible, very short of breath and unable to walk with out thinking I was going to die...... waiting as long as I could then I went to urgent care on the 14th and was told I probably have asthma and was given a few medications... on the 18th things were not any better and I no longer could take the pain and not being able to breathe... so I went to the hospital and was admitted to the PPC floor of the hospital after being in the ER. the next morning I had to have a procedure to break up BLOOD CLOTS in my lungs... I spent 4 days in the PPC ward and now home trying to recover from this... I was told my condition was very serious and was lucky I came in... Of course the doctors will not say this was a direct link to the shot ... i never had any problems before and never any blood clots. The doctor who did the procedure told me to make sure I REPORTED IT.... I was released from the hospital on the afternoon of the 21st.. 4 days!

Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 03-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL), MAGNESIUM and VITAMIN B3 for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized for 2 days due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved. Not Provided The patient received Xarelto and IV blood thinner at hospital. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MOD-2021-083811 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded

could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043021A and 037A21B) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COMA (in induced coma) (seriousness criterion hospitalization) and CARDIAC ARREST (went into cardiac arrest) (seriousness criterion hospitalization). On 19-Apr-2021 at 1:00 AM, the patient experienced DYSPNOEA (could not breath) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2020 due to COMA, then on 19-Apr-2021 due to CARDIAC ARREST and DYSPNOEA. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Manual therapy (CPR) for Dyspnoea. At the time of the report, COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) outcome was unknown. No concomitant medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient is a 61 year old female who has completed a 60 mins-minute observation period with the following signs and symptoms of an adverse reaction: other - Pt. c/o flushing. Noted tremors, eye rolling and hyperventilation. Moderna COVID-19 vaccine# 1 in series administered.

Moderna COVID-19 Vaccine EUA approx. 1 AM: felt fast heartbeat and extreme aches and pain all over body (this continued for 10 hours) approx. 2:30 AM: felt my throat swell/close up and could not swallow (lasted only about 20 min.) approx. 11 AM - 7 PM dizziness and fatigue whenever I stand up, pain at the injection site

mouth burning; face burning; hot and cold issues with nerves; she gets burning hot and heat waves come up; chills; metallic taste in mouth; difficulty in breathing\ntermittent difficulty in breathing; hives rash around throat and face; chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face; throat burning; throat closing; chest wall burning; chest wall closing; light-headed; anaphylactic reaction; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included TAFLUPROST (ZIOPTAN) for Glaucoma, LIOTHYRONINE SODIUM and LEVOTHYROXINE for Thyroid disorder. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing) and DIZZINESS (light-headed). On 05-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in mouth). On an unknown date, the patient experienced ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills). On 05-Feb-2021, ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved. At the time of the report, DYSGEUSIA (metallic taste in mouth), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing), DIZZINESS (light-headed), ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19: positive (Positive) Positive. On 31-Jan-2021, COVID-19: negative (Negative) Negative. On 02-Feb-2021, COVID-19: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. She was not admitted to the hospital. She stated she had to go back to the emergency room a few times since then for symptoms of burning and tingling in her arms, legs, mouth, face, as well as hot and cold issues with her nerves, and tightening of her throat and chest. She immediately treated with Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg, ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily. Company comment: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-087026, US-MODERNATX, INC.-MOD-2021-087026 (E2B Linked Report).; Sender's Comments: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. 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. US-MODERNATX, INC.-MOD-2021-087026:Case for dose 1 US-MODERNATX, INC.-MOD-2021-087026:case for dose 2

Positive COVID test and symptomatic infection Client began feeling ill on 4/23/21 with a sore throat and some shortness of breath. Other symptoms include dry mouth, congestion, loss of taste and smell, and nausea. I spoke with the client on 5/1/21, she was still having slight symptoms, but over the worst of her illness. She did not need to seek medical care at any point in her illness.

Became acutely ill early morning of 12-30. I was then seen in ER by DNP with diagnosis of covid pneumonia, UTI, high CRP and shortness of breath.

3-17-21 Shortness of breathe, intermittent fever, intermittent sore throat, fast heart rate, itching, intermittent dizziness, weakness. Second COVID Moderna vaccine given on 4/13/2021. Worsened side effects stated above plus headache and states "both legs feel heavy".

Had right chest and lower back pain and sweating during night of April 15, 2021. Also had unexplained cough for one month prior to vaccine. Pain was gone by morning. Did regular exercise of walking 4 miles in morning. Same pains came back afternoon of April 16. Went to ER at 4pm on 4/16. D-Dimer and Troponin were elevated and CT scan showed pulmonary embolism in right lung. Was given Lovenox and was admitted to hospital for 2 days. Was released on Eliquis 2x per day for at least 3 months. Had two plane rides lasting for 2 hours each on 3/21 and 3/31 where I walked to bathroom once so it is unlikely these plane rides caused embolism. I am active and walk about 20 miles per week. Doctors so far have not found likely cause for this event.

Dyspnea on exertion, orthopnea, SOB - diagnosed with possible myocarditis, myositis and pneumonitis along with diaphragm weakness potentially related to immune checkpoint inhibitor toxicity

Woke up freezing and felt like someone was crushing me bones. Had troubles breathing and very nauseous. This lasted 6 days. Blood pressure went sky high and had heart palpitations. Worst reaction I have ever had to anything. Almost felt need to call squad

the pt got the covid vaccine and felt light headed and short of breath. I asked the pt if she wanted me to give her the epipen and she said no. So I paged a code white over the intercom so a manager would come to the pharmacy and he called 911 immediately. After the paramedics came to the pharmacy and tended to the pt they connected her to the machine and all her vitals were normal. she wanted to be taken to the hospital so she was.

Approximately 60 hours after my second Moderna shot, I woke up at 7am with extreme dizziness and sweating. I couldn't walk to the bathroom by myself. I had nausea and vomiting, severe sweating, chills and LOW body temperature (around 91 degrees) for 5 hours. Rapid breathing also....so much so that my ribs and abdomen were sore for the next several days. Around noon, I went to sleep in bed - I was exhausted - and when I woke up, I wasn't dizzy any longer. Mostly only chills after that and fatigue that lasted a couple weeks. Entire event seemed to be around 5 hours. My doctor only told me that he has "heard of many different types of reactions"....but I hadn't heard of any other people with these side effects.

chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.

Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling tired; Oxygen saturation decreased; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation decreased), CONDITION AGGRAVATED (Condition aggravated) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension. The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL, AMLODIPINE, SELEXIPAG (UPTRAVI) and OXYGEN for an unknown indication. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg. In March 2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criteria medically significant and intervention required), DYSPNOEA (Shortness of breath) (seriousness criteria medically significant and intervention required), NASOPHARYNGITIS (Cold symptoms), MUSCLE TIGHTNESS (neck tighing), ARTHRALGIA (pain in her knee) and FATIGUE (Feeling tired). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen saturation decreased) was resolving, CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Shortness of breath), MUSCLE TIGHTNESS (neck tighing) and FATIGUE (Feeling tired) outcome was unknown and NASOPHARYNGITIS (Cold symptoms) and ARTHRALGIA (pain in her knee) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 71 % (Low) 71%. On an unknown date, Oxygen saturation: 96 % (Inconclusive) improved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient stated that the night after the vaccination the oxygen saturation decreased to 71% on oxygen 10 liters per minute. Treatment for the event included a non-invasive ventilator device (trilogy machine) with improvement of oxygen saturation to 96%. 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.

Day 1: injection site soreness, headache, fever, chills, body aches, air hunger, O2sat = 91. Day 2: extreme fatigue, headache, fever, chills, body aches, unable to eat (food revulsion), unable to concentrate, word loss, blurry vision, eye pain, moderate air hunger, O2 sat = 94. Day 3: fever, headache, eye pain, swollen lymph glands left side, dizzy, chills, body aches, loss of appetite, fatigue, mild sob, O2 sat = 97. Day 4: fatigue, body aches, eye pain, left side lymph gland swelling., O2 sat 97.

Pt received 1st dose Moderna @ 13:56, pt c/o "throat itchy & I'm going to be sick" @ 14:03. Pt has hx of allergies and brought own EpiPen. Administered pt's EpiPen at 14:05. After administration I noticed pt's EpiPen was expired. Notified NP and RN. 14:06 BP 158/83, HR 93, NP auscultated lung fields CTA. 14:10 pt c/o throat swelling, audible horseness, gave another EpiPen. Pt reported improvement in throat swelling and nausea. 14:26 EMS arrived and assessed pt. Pt refused EMS transport at 14:33. Pt called mother to come pick her up. 14:45 pt c/o itching to back and arms. BP 149/81, HR 88, SPO2 94%. RN gave pt 25mg x2 Benadryl PO. Pt's mother arrived to take pt to ER. Pt left @ 15:00.

Could not breathe, chills, entire body aches, headache, congestion in head, could not lay down due to breathing, lasted 12 hours with bad breathing, have never experienced a flu like this. Felt bad up to 3 weeks, still not breathing like before, also high blood pressure for a week until I took additional medication.

heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of breath; Athma exacerbations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (heart palpitations) and PRURITUS (itching all over the body) in a 61-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 Gastric bypass. Concurrent medical conditions included Asthma. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant) and ASTHMA (Athma exacerbations). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) (seriousness criterion medically significant), PRURITUS (itching all over the body) (seriousness criterion medically significant) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.). At the time of the report, DYSPNOEA (short of breath) and ASTHMA (Athma exacerbations) had not resolved and PALPITATIONS (heart palpitations), PRURITUS (itching all over the body) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patients treatment medication information included oxygen treatment, Benadryl, and prednisone. 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. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional Information Was received. Updated the reporters information and added events(Palpitations , Pruritus, Gait Disturbance); 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.

Immediately felt a sting when injected, within 10 minutes had a metallic taste in mouth lasted until April 30th. As of April 14th walking was exhausting with labored breathing, felt as if my muscles were being attacked. April 21st started experiencing similiar symptoms not as intense that I experienced 3 years ago with the drugs I discovered thay I am deathly allergic to. Since April 21st I have had a sharp pain in my right achilles and on May 9th I popped my right knee. These symptoms are the same symptoms I experienced within a month of taking Levaquin.

Client (DOB:10/11/1959) received the 2nd dose of Moderna COVID vaccine lot # 021C21A and expiration date 5/26/21 at 2:45pm. Client reports to patient having an asthma attack at 3pm and using her albuterol inhaler. At 3:05pm healthcare provider arrives and sees client sitting in wheelchair, alert and oriented. Client reports she is feeling better but that "mask makes breathing harder". Client reports no symptoms at this time. Vitals at 3:05pm: blood pressure:140/90, pulse:80 and oxygen:97%. Client reports that after she was intubated she now has some issues with her breathing. Client reports she will be getting dialysis tomorrow. At 3:10pm client reports she feels "fine" and that she is "sure this is not from the vaccine and that this has happened before." At 3:15pm vitals: blood pressure:140/90, pulse:78, and oxygen:98%. Healthcare provider recommends client stay until 3:30pm but since client has already been waiting 30 minutes, client reports she is ready to leave. Healthcare provider reviewed ER precautions. Client was wheeled out at 3:17PM by healthcare provider. Client is being driven home by daughter.

Seizure; Dyspnoea; Nausea; Paraesthesia; Somnolence; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seizure. On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence). At the time of the report, SEIZURE (Seizure), DYSPNOEA (Dyspnoea), NAUSEA (Nausea), PARAESTHESIA (Paraesthesia) and SOMNOLENCE (Somnolence) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 100/60 mmHg (Inconclusive) decreased. On an unknown date, Heart rate: 76 (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient is taking unknown medicines for the seizures.; 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.

DIZZINESS FOLLOWED BY ITCHY THROAT, COUGH AND DIFFICULTY BREATHING. EPINEPHRINE 0.3MG WAS ADMINISTERED INTRAMUSCULARLY WITH IMPROVMENT BREATHING AND DIPHENHYDRAMINE 25MG WAS GIVEN ORALLY. AFTER 15 MINUTES, EMT'S ARRIVED AND TOOK OVER. HOSPITAL PRESCRIBER DID NOT BELIEVE REACTION WAS ANAPHYLACTIC AFTER SEVERAL HOURS OF MONITORING.

Dizziness, rapid heart rate, high blood pressure; throat ?burning?; intense coughing, lessened ability to breathe.

I had the COVID vaccine on 3/4/21 was sick beginning the next morning. on 3/6/21 began having difficulty with breathing. went to urgent care on 3/7/21 due to difficulty breathing.

She had the shot on March 17,2021 and not even a week later on March 22,2021 she was having difficulty breathing so we took her to the emergency room and they couldn?t tell us what was wrong with her ..she ended up on the ventilator till April 26,2021 and then they performed what they call tracheotomy to wing her off the trach and now she?s in a rehab facility trying to relearn everything

My symptoms are shortness of breath which may mirror symptoms of Myocarditis or Pericarditis...not every day, but sporadic and gets worse at night in bed.

Pulmonary embolism in Right lung. Subsequent finding was multiple blood clots throughout both lungs. Gave blood 3 weeks after second Moderna injection, blood clotting would not allow a full donation (right arm). Upon checking in to the ER for chest pain on April 17, blood clotting would not allow IV hook up in right arm.

Patient received 1st dose 2/10/21, 2nd dose on 3/10/2021 She presented to the ED on 4/27 with dyspnea and found to have large pericardial effusion with early tamponade. Was transferred to hospital and on 4/28 had therapeutic pericardiocentesis. Started on colchicine for presumed viral/immune pericarditis. Seen in cardiologist office on 6/9/2021. Doing wqell with resolution of effusion.

Second does received 5-13-21 10:15 a.m. symptoms after first shot: shortness of breath, chest pain, chest tightness, extreme fatigue, lack of appetite. After 2nd vaccine the symptoms got 200% worse about 3 days after the 2nd vaccine. Lingering symptoms still continue today.

I started getting dizzy and then heart palpitations, shortness of breath, chest pains, sharp shooting pains on left side of neck by my ear. All but chest pains continue. Legs are swollen. Will be seeing clinic on July 7th at 2pm.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

Dizziness, headache, intramuscular pain where the vaccine was given, shortness of breath and listlessness in the body

Day after vaccine had extreme version of usual vaccine reactions, took Tylenol, still lingering effects the next day, extremely winded while trying to walk, several weeks later symptoms worsened. Extreme fatigue. 2 weeks after shot, was at elevation and extremely winded (usually not someone with respiratory issues). Missed work, drove to ER, lungs clotted. Doctor did not find any clot in legs, assumed it was Covid but did not have any other symptoms of Covid and negative covid test. 6 month recovery expected. Taking Xarelto coagulant, initially was on Eliquis, but responded poorly now on Xarelto.

The patient complained of some shortness of breath and dizziness beginning approximately 2 weeks after receiving the second Moderna Covid vaccine (first dose April 2, 2021, second dose May 5, 2021)

Patient developed chest pains and shortness of breath that has persisted for a couple of months and is gradually resolving. She had presented to the ER after a couple of weeks and had negative cardiac troponins and normal EKG but had notable low platelet counts. Subsequent follow-up primary care with persistent symptoms her D-dimer was negative in platelets had returned normal but patient continued to have symptoms. Symptoms have gradually improved.

So, around 8:00PM that evening I had body aches, chills, severe headache and did not even want my clothes touching my body it hurt so bad. I was extremely tired. That lasted for two and half days and following that my asthma really started to bother me, really, big time. The asthma problem lasted a couple weeks to fully recover, I was put on a course of steroids and a nebulizer and took my Symbicort. I had contacted my doctor on Monday following my vaccine, the 8th, that's when it really got bad. I had a telehealth appointment due to COVID protocol. The other symptoms were gone at that point, it was the asthma that was lingering. It was difficult to just talk and breath or walk.

Pt received vaccination at pharmacy at approx 9:25am. Waited 15 minutes at pharmacy without incident. At about 1:00pm same day pt reports began itching on arms, neck and face. Eyes and mouth soon began to itch and hives developed over arms, neck, face and chest. Eyes also swelled. When throat began swelling pt went to the ER at approx 3:00pm. Pt was treated with Solu-Medrol and given prescriptions for Prednisone and Famotidine to take upon discharge.

Symptoms starting and worsening over 3 days: Fatigue, chills, cough, sore throat, sinus drainage, low-grade fever, nasal and chest congestion, muscle aches, extreme sleepiness. I have *not* visited my doctor nor any clinic. On Day 3, I got a Covid-19 test at my local pharmacy, which came back NEGATIVE. I self-treated with Mucinex DM, cough drops, and NSAIDS. After 7 days, I switched to regular Mucinex tablets (without DM) and the sleepiness went away. (I had discovered that dextromethorphan reacts with my Fluoxetine, so discontinued it). It is now Day 16 and I am still suffering chest congestion, nasal drainage, and severe coughing fits. On about Day 10 or 11, I had a coughing fit so severe it caused a sudden extreme headache and vomiting. Since that night, I sleep sitting up to relieve the chest coughs.

Felt a flush of heat, and then HR elevated for a few minutes, making it hard to catch my breath for a brief amount of time.

Patient complained of left lower lobe of lung pain, which she stated has been causing her symptoms prior to Moderna vaccine administration. Asked patient if she needed treatment and she stated no and she just wanted to let us know.

Patient left building and started to walk to car and turned around with c/o "lump in throat. She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80.

Patient left building and started to walk to car and turned around with c/o "lump in throat". She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80

Sore arm beginning in the evening which got progressively worse for a couple of days then subsided completely. Some heart fluttering and some slight shortness of breath beginning a couple of days after. More a nuisance. No other symptoms I'm aware of although every little thing I feel now I think may or may not be a symptom like slight head throb but not consistent pain. Not sure because of vaccine.

Within 30 seconds to 1 minute, I had a strange taste in my mouth. It was neither pleasant nor unpleasant, just different. Following this I began to feel bad. It felt as if my blood pressure dropped. I became dizzy and had to hold my head up with my hands. Thank God, I was in my car when I got this injection, or I would have fainted. I felt my temp increase, and my breathing and heart rate became rapid. I used meditation to get my breathing under control, and within a few minutes, I broke out in a cold sweat all over. Then these symptoms subsided and I felt much better. This entire reaction was under 5 minutes. 15 minutes after the injection, a nurse returned to my car and I told her that the vaccine triggered a hot flash or something. My arm became very sore, and that night I felt a goose-egg lump, very warm at the injection site. Also, the left side of my throat felt tight, and it hurt. This morning my arm is still very sore, but no lump, and my throat feels better.

Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel throat tightness -upper pharynx/larynx region - like something was stuck or like I swallowed something - no difficulty breathing, just constant throat clearing like something was stuck on both sides of my upper pharynx/larynx region. I was monitored by EMS and given 50 mg IM Benadryl. After 30 - 40 min. symptoms cleared.

Approximately 25-30 minutes after administration of vaccine, patient complained of a soreness of her right throat and felt a sensation of swelling. Clinical exam revealed a small area of erythema on right side of posterior pharynx. No edema was noted. No skin rash or changes. No soft tissue and no facial/throat swelling. Lungs were CTA bilaterally. VS remained stable. Treated with Benadryl 25mg capsule PO x1. Symptoms resolved within 20 minutes. Patient remained in observation for an additional hour. Discharged home in stable condition, symptoms completely resolved. Given PO Benadryl to take home use prn.

SkinRash & CoughWheeze Narrative: Patient with small rash on neck, Dr. in to evaluate, patient given 17:00 Benadryl 50mg PO , patient at 1730 having wheezing, congestion take to ER by nurse pules ox 97% breathing unlabored

Pain mind swelling st injection site for 5 days, went away then on 7th day started wheezing felt warm and saw arm.had a deck of cards size welt where injection was.Took two benadryl the next day was in bed most of the time fever 100.6 headaches, body aches, reddnes and swelling at injection site

Patient reports a rash at injection site that was first noticed today. Reports tender to touch and mild pruritus. Reports rash is localized to right upper arm and extends about 1 inch from injection site. Reports she felt a little "agitated" a couple of days post vaccination but cut down on coffee and issue resolved. Patient stated 2 days ago on Tuesday started feeling tired with cough and wheezing (denies asthma history). RN informed patient that respiratory symptoms are not a side effect of the vaccine and she should call her primary care doctor for an evaluation and testing for COVID-19 infection.

Patient developed a fever starting 01/07/2021 and progressed to eventual decrease in condition overall. By 01/09/2021 she was bed bound, NPO, consistent fever, gurgling, hypoxic requiring 2-4 L of oxygen via nasal canula, and significant secretions requiring glycopyrrolate and suction. This progressed for the next days with decreasing condition and increase of above symptoms. Patient eventually could not swallow and developed rhonchi in lungs.

numbing of tongue, numbing of face, swelling of throat, body weakness, lack of oxygen short period of insomnia lasting two night. body ache, smelling of injection site along with redness.

Received vaccine at 9:45 AM and advised due to anaphylactic reaction in the past due to bee stings, advised to stay 30 minutes. At 10:03 AM husband stated wife was not feeling well. 10"05 called EMS. Blood pressure 197/88, chills, heart racing, and SOB. 10:10 ambulance here. Checked out patient and at 10:22 EMS dismissed patient. Vitals 140/98, HR 88, and Pulse Ox 97%.

Pt reported ~ 30 minutes after vaccine that she had a funny feeling in her throat, felt like throat was swelling and tightness in her chest. She was given 0.3mg epi via epi pen, 50mg benadryl IM, 8mg dexamethasone IM, albuterol neb and O2 via nasal cannula. Pt reported improving sx. and was transported to local ER via EMS. She was monitored and released later that evening

Cough, short of breath, headache that started on the 14th of January and continued during doctor visit.

I woke up at 1AM and had fever. 101.4 or around that range, it was the the same the next day. It came down on the 3rd day. I also had itching and redness around the injection site for about 10 days. It was about 5 to 6 inches around in diameter. Lots of lung pain which I have had which is my chronic situation from COVID (lung pain and SOB). I had much more of a cough. I just messaged my infectious disease doctor.

Patients daughter reported that the patient had a swollen tongue, swollen throat, swelling in her face and fainted. This was after treatment at home - unknown how much time had passed after vaccination. Patient received a dose of their own Epipen. Patient had consented to the vaccination and had received the VIS

Fever started and went up to 101.7. Dizziness, muscle soreness, nausea, shortness of breath. Extreme headache for days. Finally went to Med-One walk-in-clinic on Saturday, January 30th (only one nearby with rapid response) and got and rapid response test for both COVID and the FLU. Results were negative. The APRN, at the clinic, asked me to report these symptoms to you. I have no other health issues that could have caused this abnormality, as I am normally quite healthy.

Day 1 (1/19/2021) First symptom was vomiting at 12:30 p.m. then more symptoms developed after vomiting including chills, headache, achy from head to toes, pain radiated from injection site to fingers after vomiting episode. At 2:30 p.m., event of diarrhea. At 3:30 p.m. 100.2F temperature recorded Severe tiredness and increased thirst which led to increased urination Fever broke at 8:00 p.m. and temperature recording was 98.5F Next morning: symptoms of swollen face, difficulty breathing (band around chest feeling), post nasal drip, body aches After 3 days, symptoms gradually went away.

At 18:20 on 02/03/2021 Patient received Moderna Vaccine 0.5ml in Right Deltoid. At approximately 18:23 patient began complaining of shortness of breath and chest tightness. Assessment of patient showed a heart rate of 116 and SPO2 reading of 89. Patient was place on 2L/hr of oxygen via nasal cannula and encouraged to take deep breaths. Patient stated that " she felt like her throat was closing and she was going to pass out". After noting hoarseness in her voice LPN administered 0.3 Epinephrine via auto-injector and 911 was dialed. Patient was transported by ambulance at 18:35 hrs to Hospital.

Had the second Moderna injected placed on 2/2/2021 in the late morning, and within 2 hours started feeling sore and achy. By 5:00, my eyes were itchy and burning like they were on fire, then my throat, nose, ears, and then my hands swelled up and itched and felt like they were on fire. I also had chills. I took Tylenol and Benadryl and also felt the need to increased my Flovent HFA 220 mcg from once a day to twice a day on Tuesday and Wednesday. I continued to take Tylenol and Benadryl when and as the symptoms reappeared. I only needed Benadryl Wednesday night and woke up this morning with a bit of a headache. Took Tylenol and went to work today. I feel tired and my hands still hurt this afternoon(Thursday 2/4/2021) .

Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. 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.

On 1/29/2021 Patient noticed a fine raised rash on arms, trunk, body. Felt like she needed to "catch my breath". Had fever of 102.7 F , achiness, fatigue. States felt itchy, even her toes itched.

My right arm was painful at the injection site for 3 days after the vaccination. Then on Wednesday, February 3, 2021 about 3:45pm I experienced shortness of breath and some chest discomfort. At approximately 6:00pm, I felt a strong pulsating at my left temple which continued through the night. I took my blood pressure and it was 150/90 and pulse was 103 which is the highest reading I have ever had because I am on blood pressure medication. I took 2 aspirin, my Proventil Inhaler, and another Losartan 50 mg even though I had already taken my daily dose in the morning. I rested and continued to monitor my vitals. At about 11:30pm, I took my blood pressure and it was 160/110 and pulse was 109. I then took 2 more aspirin and my Clonazapem and fell asleep. In the morning on February 4, 2021, I tried to get in to see my doctor, but she advised to go to the emergency room. I went to an Urgent Care facility and the checked me and did an EKG and that was normal. But they also advised me to go to the emergency room. So I did go and they did another EKG, chest x-ray, and several blood tests. They came back normal but they wanted me to stay overnight for observation. On February 5, 2021 they did an echocardiogram and a stress test, which were normal. I was released from the hospital that afternoon. I have a follow up appointment with my Primary Care Physician on February 12, 2021. My blood pressure and pulse continue to be a little higher than normal. At this point, the pulsating, shortness of breath, and chest discomfort have improved. On Saturday, February 6, 2021, I noticed felt itchiness, redness and swelling at the injection site on my right arm. It is still itchy, red and swollen as of February 8, 2021. I am putting hydrocortisone cream on it.

initial symptoms started at ~ 8-12 hr post inj on FRI: fever, chills, fatigue, muscle pain (generalized), back pain from sacrum to occiput, through cranium to behind eyes, nausea, loose stools, exhaustion, arm swelling (6" diameter) with bandaid indented becoming hard (feeling a little like cellulitis). routinely measure pO2 and body temp--both spiked; resp rate went from normal pattern of 10-12 to 25; night time HR went from low 60's to the 100's; pO2 went from 96-98 to 89-91 (Innovo PulseOx)Treated with sleep (slept from 8PM night of shot until 48 hours after the shot), fluids, hot water bottles, arnica (I can't take NSAIDS), vit C, zinc megadoses; by ~36 hours post injection I started wheezing and coughing deeply but non productive, both nasal passages were/are open, feels as though phlegm is stuck at bronchi. By 48 hours, I was feeling better except chest, ribs, head, and neck and was experiencing 1-3" episodes of spasmodic coughing, wheezing, SOB; Occurred every 20-30 minutes and leaving me physically exhausted. Sunday night slept with 4 pillows; went to see acute respiratory care clinic, evaluated, COVID-PCR was negative, temperature was normal by statistics (I tend to be colder; baseline temps between 32-33oC and over past week has ranged between 35-39oC). Sent home with albuterol inhaler, mucinex (which I take at night), and flonase (my nostrils remain clear). Current status: extreme fatigue, high resting HR, minimal activity (walking) increases it to the 100s--not normal for me), and continued episodic bronchospasm (uncontrolled) with SOB and diaphragmatic, skeletal pain. Deep diaphragmatic breaths also trigger. Am also treating with hot water bottles to anterior and posterior chest walls, and nebulizer treatments with eucalyptus, thyme, and rosemary. Still megadosing on C and Zinc. Expect to return to work tomorrow (missed 2 days) as neurologic and orthopedic physical therapist /exercise physiologist.

She called the health department with questions about receiving the 2nd dose. The initial reaction occurred during monitoring after the vaccine, her heart was racing and she had a hard time catching her breath. After nourishment and the end of the monitoring she felt better and was able to drive home. On 1/11/2021, 4 days later, she was sitting and started feeling hot inside. Her left chest and left arm became numb and tingly. She went to the ER within 30 minutes of onset. After the examination she was told the reaction was likely a side effect from the vaccine. The numbness and tingling remained most of the day and she felt better the next morning and has had no other episodes.

4 1/2 hours after the vaccine my arm got red, hot and felt a little swollen, the band aid placed got really tight. I got the chills and started shaking, I developed a fever of 102, chills and fever broke in 36 hours. I developed a cough, congestion and wheeze, had aches and pains all over, rolled around in bed for 36 hours. The fever broke by 7am on Sunday morning the aches and pains especially lower back still continue. I took Acetaminophen 1000mg twice during my 36 hours .Severe symptoms appear to be over.

Swelling of tongue, medicinal taste, burning in nostrils following the vaccination. Next day headache, confusion in speech and thinking, constricted breathing in throat and chest, fatigue.

1st shot days after got rash from head to toe. 2nd shot 16 hrs after vaccine got severely ill. Fatigued, Nausea, & Vomiting, fever 100.6, headache, chills body aches, wheezing, heart rate rapid. Day after better but still nausea and fatigued for the 3 days, mild headache.

Approximately 6 hours after receiving the injection I started running a temperature of 102.7 and feeling absolutely terrible all over. Shortly there after I was having such sharp pains in my joints (pretty much all over) that I couldn't get out of a chair without much assistance. Then I couldn't walk only barely shuffle y feet with my husband holding onto me. I was very short of breath at this point with a pulse ox reading starting at 76 and finally reaching 88, but would not climb any higher. I was very nauseous and unable to eat or drink. The following day my temperature was still running 101, but not continuously. I still felt bad, but could shuffle walking without assistance and was still nauseous. I pretty much stayed in a recliner chair all that day, except to try to take a shower, which I really had a feeling I wasn't going to survive. I went to bed without dressing, because felt so bad. The next day I felt better, but was so short of breath I had to have a rolling chair to sit in to try to do something in the kitchen. By afternoon February 15, 2021 I was feeling better, Only shortness of breath when walking and my pulse ox was 92. Should I take the second Moderna vaccine?

PATIENT RECEIVED DOSE AND ABOUT 30 MINUTES POST VACCINATION, PATIENT COMPLAINED OF THROAT SWELLING AND TROUBLE SWALLOWING. 911 WAS CALLED, PAIENT REFUSED EPI-PEN, WAS GIVEN 20 ML OF LIQUID BENADRYL AND PICKED UP BY AMBULANCE

SEVERE weakness in legs and arms. SOB, headache, neck weakness, twitching, jerking, uncoordinated, dizzy, hardly able to walk, mind fog, chest pain.

5 minutes - severe flushing on face/chest and headache, 45 mins - sneezing, 1 hour - itching, chills, 2 hours to 24 hours - continued headache, chills, high fever (102), body aches, nausea, fatigue, stiff joints, tingling lips and tongue, difficulty swallowing, wheezing, MS symptoms, very high sugar levels (450 - out of normal range), began to subside in severity after 24 hours but was out flat for 4 days before feeling better, occassional bouts of chills and itching as well as ongoing need to sleep continued for over a week, huge raised swollen area appeared at injection site - from shoulder to elbow, very hot - used a cold pack to help reduce swelling. Throughout all of this, used large amounts of Benadryl, Advil, Albuterol, drank lots of fluids, used emergency insulin, and had Epi-Pen on hand.

Could not inhale air and only could exhale through mouth and lasted around 45 seconds to 1 minute. She slowly was able to inhale and increased a little over 1 minute before full breathes were obtained. Total time course approximately 2 minutes.

Systemic: see below-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Additional Details: prior to vax, voiced anxiety re: coming outside house for vax (reports not having left home since 3/2020). Reported h/o severe cardiac palpitations & possible swelling w/lidocaine, so instructed to wait 30 min obs post-vax (vs standard 15 min). Recieved vax w/o issue. Around 20 min into obs time, reported heart racing, anxiety w/ shakiness in arms. Eval'd by in-store NP; paramedics contacted. Fully cleared; normal BP, HR 100, clear lungs. Pt declined transport to hosp & left w/daughter

PATIENT REPORTS HAVING SWELLING AT THE SITE OF INJECTION ALONG WITH TIGHTNESS/SWELLING IN THE THROAT AND TROUBLE BREATHING WHEN LAYING DOWN AFTER HAVING INJECTION EARLIER IN THE DAY.

About 40 minutes after receiving the vaccine, I experienced shortness of breath for about 2 minutes, followed by flushing at which time the breathing returned to normal and has not reoccurred. No other symptoms have been experienced at this time.

Within 5 minutes of injection my tongue felt odd and I started to salivate. Shortly after, I found it difficult to swallow (as if throat) was closing up, numbness in lips, flush face, tingling in fingers. Liquid Benadryl (1 capful) was administered by mouth and within 10 minutes swallowing difficulty was less but still difficult. Within 30 minutes all symptoms subsided. At no time did I have difficulty breathing, chest tightness, wheezing or any other anaphylaxis symptoms other than the ones described.

5 minutes after the injection I got hot and my heart started racing. My throat felt tight. This feeling dissipated after 5 minutes.

following the Moderna COVID-19 Vaccine EUA: at around 6:00 PM I began experiencing a headache and some soreness in my left arm around the shot site and became very tired, then around 10:00 pm nearly half my joints began aching. After waking, I still had a headache and body aches, but felt somewhat better. by 1:00 pm, became very achy in my joints again and tired. I had 2 times during that evening lasting about 5 to 10 minutes each of difficulty breathing and a slight tightness in my chest. This passed and I did sleep better the night of 3/5/21.

Fast pounding heartbeat for 12 hours, left leg calf felt tingly, felt like someone was squeezing my throat briefly twice. That Went away within 2 minutes

Client started experiencing difficulty breathing and racing heart beat on 03/03/21 and lasted for 2 days. Client is diagnosed with carpal tunnel on both hands and is receiving cortisone injection. Currently, right hand is throbbing and left hand is partially numb. Client plans on following up with provider regarding symptoms.

Patient reported arm soreness, throbbing and pain for about 4.5 days, pain in left hip, and shortness of breath

Woke up at 2 a.m. felt tightness in throat went bathroom right side of face was drooping by mouth and speech was very slurred went to hospital an had various tests done

Moderna COVID-19 Vaccine EUA Within minutes of receiving vaccine, I developed itchiness at injection site. Within 5 minutes, developed itchy lips and scalp, and my asthma cough. No rash or shortness of breath. Went home after the 15 minute waiting/observation period. Developed nasal congestion when arrived home (5 min). Took 25 mg benadryl and my albuterol inhaler. All symptoms resolved in 90 minutes.

PATIENT STATED SHE FELT LIGHT HEADED ALMOST IMMEDIATELY AFTER THE IMMUNIZATION. SHE DIDN'T REPORT THAT TO ANYONE AT THE TIME AND SHE SAID IT GOT BETTER BEFORE SHE LEFT THE IMMUNZATION AREA. SHE SAID THE NEXT EVENING (3/3/21) AROUND 6PM SHE STARTED TO EXPERIENCE SHORTNESS OF BREATH AND LOOKED AT HER THROAT AND SAID IT SEEMED SWOLLEN, SHE TOOK BENADRYL AND STATED THE SHORTNESS OF BREATH DIDN'T GET WORSE AND RESOLVED WITHIN ABOUT 2 HOURS. SHE ALSO STATED SHE FELT ACHY AND FLULIKE WITH CHILLS AND FEELING FEVERISH BUT WITH NO FEVER. SHE FELT PRETTY ACHY AND TIRED FOR A COUPLE OF DAYS AND THEN EVERY THING RESOLVED.

Patient received her 1st dose of the COVID vaccine and during the observation she began to feel throat swelling and tongue swelling. She also noticed some pressure in her chest with shortness of breath. She was assessed by staff in the area and was given IM epinephrine 0.3mg for an allergic reaction and was transported to the emergency room for further treatment and observation. given diphenhydramine 50mg IV, famotidine 20mg IV, methylprednisolone 125mg IV.

Pt. experienced flushing, itching, throat tightness, increased B/P and heart palpitations. Given 50 mg. Benadryl IM. Sent to ED for observation.

Patient was vaccinated on 3/9/21 at facility in the morning. She developed a headache later that day. She woke up on 3/10/21 around 1145 with facial/neck swelling, urticaria, and shortness of breath and presented to the ER at 1250. Upon arrival she was given 50mg benadryl IVP, 20mg Pepcid IVP, and 125mg Solu-medrol IVP. Soft tissue neck xray showed subglottic narrowing and thickened epiglottis. She had some improvement after IV medications but was admitted to ICU for observation overnight. She was discharged 3/12/2021 in stable conditions on steroids and antihistamines. Pt's vaccine card did not list vaccine lot number. I reached out to facility for the lot number and have not heard back.

AT 1:40PM CLIENT C/O SWELLING OF RIGHT NECK- ENLARGED AND TINGLING ON RIGHT SIDE OF FACE. THATS BECOMING WORSE SHORT OF BREATH. STATES SHE HASNT BEEN TAKING HER SYNTHROID MEDICATONS IN A LONG TIME, FOR HER THYROIDS. RN NOTICED NECK ENLARGMENT TO THE RIGHT SIDE. NURSE IMMEDIATELY ASSESSED AIRWAY SPO2 @ 97% ON ROOM AIR. NURSE ADMINISTERED 1ML BENADRYL IM XS 1. NURSE STAYED WITH CLIENT UNTIL SYMPTOMS RESOLVED, CLIENT STATES FEELING MUCH BETTER THANKING STAFF FOR SUPPORT THEN APPROXIMATELY 40 MIN LATER CLIENT ATTEMPT TO STAND UP AND FELT DIZZY AND HUSBAND LOWERED HER TO THE FLOOR. ASSESSMENT BP 174/88 HR68 RR20 PUPILS EQUAL REACTANT TO LIGHT. HAND GRIP EQUAL NO SLURRED SPEECH NOTED A&0 XS 3. AMBULANCE CALLED AWAITING ARRIVAL BP NOW 220/130 AT 1;50PM

ASTHMA FLARED UP A LITTLE AND PROGRESSIVELY WORSENED IN THE NEXT 24-48 HRS. THE NEXT DAY, MONDAY, I CONTACTED MY ALLERGIST AND WAS TOLD TO START 4 BREATHING TREATMENTS DAILY. THE ASTHMA SYMPTOMS LESSENED OVER THE NEXT SEVERAL DAYS. I ALSO EXPERIENCED THE EXPECTED SYMPTOMS FROM THE SHOT, SUCH AS CHILLS WITH SEVERE SHAKING, FEVER 101.7, HEADACHE, MUSCLE ACHES, AND THE INJECTION SITE WAS RED AND SWOLLEN FOR A WEEK IN ADDITION TO 17 DAYS LATER THE INJECTION SITE IS LIGHTLY DISCOLORED. IN OCT 2020, I WAS HOSPITALIZED WITH COVID FOR 2 WEEKS WITH ASTHMA, PNEUMONIA, AND ON OXYGEN.

3/19/2021 horrible chest pains hard to breath Itching all over my body Right eye lid red and swollen 3/20 4-5:00 am up sitting in the side of the bed . Very uncomfortable to lay down can?t breathe properly Taking pantoprazole again 3/19- 9:00 pm 3/20- 9:05 am 3/20 - 9:04 blood pressure 130/87 9:15 am extreme itching and rash on both arms Took a warm bath felt horrible. Took temperature 100.5 Main concern is breathing

Started 3:00pm Saturday 3/20/21. Shortness of breath after two days taking vaccine - rest and vapor rub

Patient received her 1st dose of the Moderna vaccine and during the observation. She began to feel throat swelling and tongue swelling. She also noticed some pressure in her chest with shortness of breath. She was assessed by staff in the area and was given IM epinephrine for an allergic reaction. treated with methylprednisolone 125mg, famotidine 20mg, diphenhydramine 50mg. sent home with RX for prednisone 40mg daily for 5 days

About 12 hours in: strong metallic taste About 20 hours in: itchy throat and neck About 24 hours in: difficulty taking a deep breath with minor wheezing

allergic reaction, immediate report to injector of having "Halo effect". was told to be observed for 30 minutes. Started having itching on her neck before 30 minutes had passed. By the time she got home she had swollen tongue, slight SOB, rash over more of her neck and body. fatigue, swelling near left eye. She called her primary and they started her on steroids.

30minutes after injection: Swelling lips, eyes, face , throat red face fast heartbeat dizziness fatigue and headache next morning

It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest.

Within 45 minutes, I got dizzy, then 2 hours later I got a severe splitting Headache (migraine type without the aura) , fatigue, and nausea lasting 8-10 hours. Fatigue and Headaches continue daily in the afternoons and evenings. Then 2 days later my lips started to swell, which progressed in intensity for 3 more days until my lips and tongue split, blistered, developed more asthma and difficulty breathing but not enough to use EpiPen or go to ER, and also my tongue felt thicker. Called Immunologist on day 6 (Monday morning). He ordered blood work. The symptoms started to decrease on day 10 -16 but continue to have to use Symbicort 2x/day vs 1x/day and still get very fatigued as the day progresses and daily headaches. My lips will swell easily with allergens and an increase in asthma.

While staffing observation, I (EMT) observed the patient to appear to be short of breath. The patient had removed her mask and was breathing rapidly with accessory muscle usage. I escorted the patient to the EMS Exam Room and called for my partner ( Paramedic) to assist me. While in the exam room we obtained a set of vitals. The patients vitals at 1545 were P:132, BP:160/90, Resp: 20, SpO2 91% on RA. After examining the patient, she stated that she had a history of MACs and was being treated for that at Clinic. The patent also stated that she had a history of cardiac problems but was unable to elaborate on what they were. After 15 minutes the patient was evaluated---

9:20 am Patient was kept under observation for 30 min after the administration of the vaccine. 9:45 am Patient notifies the nurse in charge of the area that he feels itchy forearm, she proceeds to notify the staff, vitals are measured B / P 159/88, P. 68, T. 36.1, R. 21, S. 97 %, Dextrox 91mg / dl. Patient is channeled with .9NS. Starts with rash on both arms and back Dr. of the clinic orders to administer Benadryl 50 mg IV. Patient verbalizes having a heavy tongue and numb left arm and indicates that he cannot breathe. Benadryl discontinued O2 cannula is placed. Indicates feeling better. Solumedol IV 125 mg was placed, after the administration began with involuntary movements in the arms and legs. The drug is discontinued. Involuntary movements decreased. She is transported by ambulance by calling 911 to the nearest hospital.

face turned red, hard time swolling, 15 min after shot. took a benedryl and went to bed. next day really tired, wheezing, and coughing alot since.

Shot given March 25, 2021. Next day: March 26, 2021 - Cold-like symptoms nasal congestion, runny nose, tired. Following day: March 27, 2021 - Allergic reaction increased to itching palate, nasal passages, slight asthma, congestion, runny nose. Treatment: Self administered OTC allergy medication Zyrtec. One dose 10mg. Allergy symptoms subsided in two hours except nasal congestion.

Patient arrived to clinic for Covid immunization, received vaccine at 9:39 am in right Deltoid. Called to observation area 9:56 am by clinic case manager for patient report of "feeling funny" post immunization. Patient sitting upright with eye closed at table. Responsive to verbal stimuli and oriented to place and time. Patient complained of the following symptoms: trouble swallowing and "head rush" sensation. Patient was assisted back to exam room with bilateral two person support due to unsteady and slow gait. Eyes remained closed and patient required assistance to lay supine on the exam table. Speech slow and reported extreme feeling of fatigued. Vital signs at 9:58 B/P 118/72 left arm laying, HR 80. Blood Glucose 218. Patient is diabetic and reports she did take morning medications: Victoza 1.8mg, Lantus 60 units and Metformin 1 tab. Pulse ox 96%. 10:03 vital sign recheck 120/70 right arm (supine) with regular pulse in the 90's Complaints of feeling a burning sensation in body and reports very dry mouth with and jaw feeling strange (sensation much like before she has a seizure). 10:15 12-Lead EKG completed and reviewed by Dr who was present in room, no acute changes noted. Dr discussed need for patient to be sent to ER via EMS for further evaluation of vaccine reaction. EMS notified. 10:24 resting with eyes closed, reports ongoing fatigue and dry mouth. States that her "kidney's feel warm" and it "feels like my head is on fire", also states that her tongue has a burning sensation. Reports feeling like throat is "thick" 10:25 clear bilateral lung sounds,oral pharynx with no evidence of swelling. 10:32 Mild non-productive cough, remains with clear lung sounds bilaterally throughout, oral pharynx without swelling. 10:37: continues to report "burning sensation to back of head and neck", lips moistened with wash cloth for ongoing complaints of extremely dry mouth. 10:41: Resting with eyes closed, recheck vital signs, 116/72 right arm (supine), HR 95, 96%. EMS arrival, transported to hospital via EMS for further evaluation.

Patient had Trouble Breathing, EpiPen administered on site. Patient transferred to ER where she was given one dose of Prednisone PO 60mg and Atarax PO 25MG. Patient discharged home by 15:30

Started with severe headache and sinus congestion. Progressed to SOB. Patient took cold medicine to help with headache and congestion and that seemed to improve the SOB. No Medical treatment was sought.

Patient made staff aware that she was having difficulty breathing. The staff provided patient with 1 dose of Benadryl. EMS was contacted at that time approx 1037. Patient remained stable until EMS arrived. Patient left training facility via stretcher approx 1045 to local ER.

3/23 normal fatigue and arm pain, 3/24 woke up with body aches, 99 fever and it hurt to breath, between this day to the 27 there was an increase in pain in breathing, every breath it hurt. and still having pain breathing; I'm on a high dose of Prednisone

3/16/21-Obtained vaccine at 0800. At 1pm same day, began with cough then an asthma attack, chest tights, couldn't catch breath. Required rescue inhaler and Advair inhalers. by 3pm same day, fever 100.3 po, severe body aches, horrible neck pain, extreme fatigue, ringing in ears, 'brain fog'. Went to bed 5pm- slept 7 hours. Woke up midnight, fever broke, still horrible aches and extreme fatigue. Slept another 7 hours. 0730 on 3/17 woke up face was "red" like a sunburn- no fever, very weak, no appetite. called primary, told to rest, tylenol, fluids and go to ED if worse symptoms. revisit in person 4/19. From 3/17-3/26 fatigue, brain fog- had eye exam for employment on 3/26 and vision in left eye had changed- could not see the chart. By today 3/31, still poor vision right eye- will see physician 4/2- less fatigue and improving brain fog, occasional tinnitus. This was my 1ST in the series of Moderna vaccines. Concern- should I get the 2nd on 4/13?

Tingling tongue, swollen tongue, swollen lips, small rash on upper arm near injection site and opposite forearm, tightening in throat, inability to swallow, difficulty breathing, unable to breathe, Inability to talk, pale, hoarse voice, intermittent cough,

Shortness of breath; A spontaneous report was received from a consumer concerning for herself, a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath/dyspnoea. The patient's medical history included Covid-19 in an unknown date in Dec 2020 and current condition includes lung disease since birth, belly pain, arm and shoulder pain. Concomitant medications includes levothyroxine and vitamins. On 11 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient experienced shortness of breath for which patient was admitted to hospital and was given oxygen. The patient stated that symptoms resolved. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the event, shortness of breath was resolved on an unknown date 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 onset date of the event of shortness of breath, a causal relationship cannot be excluded. Patient's underlying lung disease may have been contributory.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: 5 minutes post vaccination, pt's husband stated that the pt wasn't feeling well. She complained of being dizzy and not being able to breathe. 911 was called at this point. Put pulse ox on her finger and her O2% never went below 98 during the entire episode. We laid pt on the floor and we were prepared to give an EpiPen if needed. EMS arrived, she stated she was feeling a little better. F/u w/husband at 7pm. He said she was fine and no treatment was given at hospital. No allergic reaction.

Worst headache ever in my entire life, it felt like my head was going to blow up. Coughing and wheezing started evening of 2nd dose, oxygen level dropped to 93%. Nausea started during the night and then followed by extreme vomiting the next day. I was unable to eat anything and was sensitive to light and felt unable to support my own head.

Exactly 8 hours after I received my vaccine, I had bad shaking for approximately 2 hrs and I had periodic trouble breathing during the evening and early hours of the morning. I has a 101F fever. Today is day#3 after the vaccine and I still have nauseousness and no appetite.

throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood pressure was elevated to 185/Unknown; pulse was 131bpm; aching and pain in throat area; shortness of breath; felt like the lymph nodes in her throat were achy; felt like the lymph nodes in her throat were swelling; chills; tiredness; This spontaneous case was reported by a consumer, who is a 62 year old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced throat was swelling, felt like the lymph nodes in her throat were swelling,felt like the lymph nodes in her throat were achy (Lymph node pain), pain in jaw to ear (Pain in jaw), tongue was numb (Hypoaesthesia oral), could not feel her swallow reflex (Hyporeflexia), blood pressure was elevated to 185/ unknown (Blood pressure increased), pulse was 131 bpm (Heart rate increased), aching and pain in throat area (Oropharyngeal pain), shortness of breath (Dyspnoea), chills (Chills) and tiredness (Fatigue). The patient's past medical history included No adverse event (No medical history reported). On 17 Mar 2021, 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 047A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Mar 2021, the patient experienced felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, and chills. The patient went to the emergency room. While there, the patient's tongue was numb and she could not feel her swallow reflex, her blood pressure was elevated to 185/ unknown, pulse was 131 bpm. The patient was at the emergency room for 4 hours before the symptoms subsided. Treatment medications included prednisone for 3 days and Benadryl 50 mg every 6 hours. Since then, the patient was feeling shortness of breath and tiredness. The outcome of the events of felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, chills, tongue was numb, could not feel her swallow reflex, blood pressure was elevated to 185/ unknown and pulse was 131 bpm was resolved on 17 Mar 2021. The outcome of shortness of breath and tiredness was unknown. Action taken with mRNA-1273 in response to the events was unknown.; Sender's Comments: This case concerns a 62 Y/O F with serious unexpected pharyngeal swelling and NS unexpected oropharyngeal pain, jaw pain, hypoaesthesia oral, hyporeflexia, blood pressure increased, heart rate increased, dyspnea, and expected lymphadenopathy, lymph node pain, chills, fatigue. Event onset day 1 after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.

swelling of throat from tonsils down to airway to collar bone, across bottom of chin, from ear to ear, affecting swallowing, breathing and hearing. took Benadryl every 4 hours. called pharmacy next day, they said to report to doctor. take a prednsone as well. the benadryl only took it down to halfway, the prenisone reduced it significantly. as soon as the benadryl wore off, it began to tighten again. severe gag feeling. contacted doctor to get appointment asap. will take another prednisone if needed.

Right after immunization patient alert APN monitoring are "Tickle" in her throat and "taste of metal". Then patient started experiencing tachycardia, shortness of breath , and continuously clearing her throat. 02:03pm- BP 130/100, pulse of 96, O2 88%. 2:04 pm--patient experiencing "hot potato voice" and sensation of back of tongue. EPI pen was administered at 2:05 pm. 911 called. 2:08 pm- Benadryl 50 mg IM given. 2:09pm- patient reported some improvement, feeling like she could breathe easier. BP 140/110, pulse 85, O2 93%. 2:11pm- patient transferred to ER via EMS. Later EMS reported had give patient a 2nd dose of EPI due to SOB and wheezing.

Metallic taste within 5-7 minutes, within 10 minutes redness in face, feeling of warmth, coughing, within 20 minutes more coughing and shortness of breath, wheezing increasingly getting worse. Taken to ER. Seen immediately. Received medications via IV and oxygen. Followed up with primary doctor. Scheduled to see doctor again on 4/10.

pt developed symptoms of: weakness (to the point of difficulty walking), pounding headache with vision changes, shortness of breath with exersion, upper abdominal pain, nausea, vomiting, rash on her legs, back and arms, heart pounding

PATIENT CAME IN ON 04/05/21 STATED THEY HAD AN ADVERSE REACTION THAT STARTED 2 DAYS AFTER VACCINATION THAT MADE THEM HAVE SWELLING OF THROAT AND TROUBLE BREATHING. PATIENT STATED IT LASTED 2 DAYS.

Difficulty breathing, body hurting head to toe, coughing hard, sore neck, extremely tired, weakness, headache

Female smoker w/ obesity, insomnia, HL, anxiety, bronchitis, diverticulitis, GERD, OA, COPD, MIx2 and HTN was given her 1st dose of Moderna Covid19 vaccine (lot # 046B21A) at 1310 4/13/21. Patient had hot flash and was fanning herself within 5 minutes of 15 minute observation time. After 15-20 more minutes, patient developed mild chest pain, nausea, diaphoresis and shortness of breath. Patient reported feeling light headed. Patient was moved to the recliner and her legs elevated. Patient found to be hypertensive. Initial BP 162/106. At 1346, BP 180/84. At 1352, NIBP 186/93, pulse 80's and regular. Per NP, bilateral diminished breath sound with wheezes. SaO2 on room air 97-99%, with the labored breathing and chest pain. Placed on oxygen 2L pm via NC. EMS notified for transport to ED. Chest pain increased 8/10. Patient refused nitroglycerin but accepted ondansetron 4mg po for nausea. Also given 324mg aspirin. In ED, EKG and Chest XR obtained. Both were normal. BP still elevated at 1442 171/83. Patient stable.

She got the vaccine and her pulse was high, her BP went up to 164/98, pulse was over 100 and her throat was tight, numb feeling in her throat. She was jittery and did not know why it was so jittery. They told her to FU with her PCP. She also had a low grade temp of 99.3. They told her to go to the UC which was downstairs and they started her on Benadryl and Pepcid. They sent her home and told her to get Pepcid and Benadryl to take at home and take it for the rest of the weekend. Her arm was sore, which they felt as normal. She then continued to get better and after 4 days the symptoms were gone.

Patient says that 2 days post vaccination that she was having difficulty breathing. They admitted her in the hospital and she said she had inflammation around her heart.

Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of nausea with vomiting, and had difficulty driving. On 03/27/2021, her nausea continued and she complained of shortness of breath while walking. On 03/28/2021, she was short of breath before vomiting a small amount. She then became unresponsive. Death was pronounced a short time later. Per her treating physician who signed the death certificate, the cause of death is felt to be probable myocardial infarction due to electrolyte abnormalities due to complications of her diabetes mellitus.

As soon as I got the vaccine my arm was swollen up and started itching and I walked around the store 15 minutes. I told them that it was mildly itching after 30 minutes, they said it would go away. The itch progressively got worse and started itching in different places, by Sunday it was really worse and the hives started breaking out on me. I went back to the pharmacy and they told me to take some Benadryl and the bumps went away but the itching didn't stop. On Monday I went to the doctor and he gave me a shot of steroids in right hip and after a while it stopped and I got a prescription for the itching. The pharmacist said they would not give me the next dose because of the reaction. I am short of breath as well and will see the doctor on Friday for the SOB

Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset of generalized muscles aches and weakness. She started feeling some pain in her back, which then spread to arms and legs. She is now beginning to feel weakness in her core and extremities. Having difficulty lifting arms above head. She is still able to walk without difficulty but legs do feel weak. Increase in SOB as well. Myalgias and chest pain resolved within a week, however she continued to feel weak, tired, and had DOE. She developed "brain fog" and talked to her boss about taking short-term disability as it had been hard to work. No appetite. On 4/1/21, she presented to the ED with 2 weeks of worsening generalized weakness, SOB, lightheadedness, dizziness and found to have acute anemia. Was admitted for further workup. Hgb at admission was 5.4. This admission diagnosed her with a new warm autoantibody hemolytic anemia. This is new since the COVID vaccine was administered. Upon admission there was no thrombocytopenia, so there was low suspicion for microangiopathic hemolytic anemia, TTP/HUS, or DIC. Peripheral blood smear at that time suggested a leukoerythroblastic blood picture (could be Bone Marrow recovery post chemo) but with marked normocytic, normochromic anemia, and with increased circulating erythroid precursors and increased red blood cell regeneration; spherocytes and fragments are present supporting hemolysis. DAT positive (both IgG and C3) along with other hemolysis lab including elevated LDH, Bilirubin, haptoglobin 3, and PBS c/w hemolysis; no evidence of MAHA. So warm autoantibody hemolytic anemia is the most likely explanation. She had negative cold agglutinin antibodies <1:32 on 4/9. Started on methylprednisolone on 4/2/21, but Hgb continued to steadily decline despite treatment. Continued on methylprednisolone 87.5mg daily. Rituxan 375mg/m2 was started on 4/6/21 with plans for weekly infusions for a total of 4 weeks. there was concern for a GI bleed on 4/10-4/11 due to bright red fluid appearing like blood in the toilet after a stool. This led to her receiving roughly 5 units of pRBCs. After these 5 units she started urinating red urine and we became highly concerned for hyperhemolysis. She did not have any further stools so we did not think a GI bleed was likely. She was given 1 dose of Eculizumab (Soliris) (4/12). This treatment is for complement mediated intravascular hyperhemolysis. Unfortunately it did not appear to help her. On 4/14, we were thinking TTP could be contributory with numerous schistocytes on peripheral smear. Her T bili was up to 7.8, and her hemoglobin plasma was trending up, in the 380 -- > 610 and in the 800s today. Cr was worsening. Platelet count was dropping. With her worsening condition and concern for both hyperhemolysis and possible TTP, we decided to start her plasma exchange followed by her second dose of Rituximab. Unfortunately she became disoriented/confused following line placement and while receiving plasmaphoresis. CT head returned without acute findings. She then had an allergic reaction with a rash during PLEX which was stopped (4L completed with a goal of 5L). Improved with benadryl. She was then administered rituximab. Then she developed worsening sinus tachycardia and HTN. Her respiratory status deteriorated and she eventually required high-flow oxygen to maintain saturations > 90%. CXR showed bilateral opacities, not drastically changed from previous films. Rituximab was stopped halfway through its infusion in case this was an adverse effect to the drug. She was given 20 mg IV Lasix per the nighttime sign-out. She was initially given ceftriaxone and azithromycin IV to cover CAP but later ABx were broadened to vanc and Zosyn with rising lactate of unknown source. Ultimately she had acute respiratory failure with hypoxia and need BiPAP. She was eventually intubated and a code blue was called. She unfortunately died shortly after intubation.

Approximately 2 hours after the injection I experienced breathing issues that lasted through the evening and into the nest day. The morning after the injection I awoke with an itchy rash covering my entire legs - I took a Zyrtec which eliminated the itch. I was also running a temperature of 101.

Was given in outside clinic, pt sent to ED, do not have other details at this time. Pt states approximately 10 min after receiving vaccine, she started to have throat tightening and started to become very anxious. Clinic gave patient one dose of epipen and benadryl 50mg IM and sent pt to ED. Upon ED arrival, throat is improved, pt still very anxious. Throat feels dry. Exam unremarkable

2/17/2021 4:20pm Tongue thickened 2/17/2021 5:50pm Both nostrils burning 2/17/2021 6:09pm Called Moderna and left voice message 2/17/2021 6:50pm Entire body felt horrible and went to bed 2/18/2021 6:30am Woke with sore throat 2/18/2021 9:01am Received call back from Moderna, stated that I was having an allergic reation, advised against 2nd vaccine and was directed to my Physician or ER 2/18/2021 10:00am Constriction in throat and upper respiratory area, confusion 2/18/2021 1:39pm Went to ER. Dr. confirmed allergic reaction, advised against 2nd vaccination, prescribed Cetirizine 10mg and Diphenhydramine 25mg

March 22, 2021 ? 1st shot of Moderna (was a bit shaky just after and mentioned it to the person but subsided later) March 23 ? heat and pain in upper arm, took Tylenol, better the next day April 1 ? extreme heat and pain in upper and lower left arm, came on suddenly April 2 ? extreme heat and pain in upper and lower left arm, weak in both arms and legs, called my Dr ? went to ER April 2 - Could not stand or hold anything; ER checked for stroke or heart attack first with CT and chest X-ray; then suspected Guillain-Barre Syndrome (GBS); neurologist consulted, ER doctor attempted a lumbar puncture twice that he could not perform. Admitted to hospital. Next two days, needed assistance walking to restroom, weak; April 4 ? Physical Therapist evaluated me, said there was a slight delay when I took steps; improving with strength in my arms and legs, just winded April 5 ? MRI, lumbar puncture, blood work, CT ? all tests were clear; did not need the walker to restroom, took little steps April 6 ? discharged with excruciating headache, could not lift head for one week (told it was from lumbar puncture) April 13 ? Head pain finally subsided but still pressure in my head I noticed when I coughed or sneezed. Slowly gained strength. April 15 ? Able to walk and drove car to the store. Still tired each day but getting much better. Dr. advised: No 2nd Moderna shot.

Symptoms started developing shortly after receiving first dose of Moderna COVID-19 vaccine including cough, myalgia, and body aches. She was experiencing worsening shortness of breath and presented to the emergency department on 4/18/21. She was found to have COVID-19 and was admitted to the hospital for further management.

At the time of first vaccination shot, I experienced an anaphylaxis reaction including constriction of throat, difficulty swallowing, inside of cheeks swelling, lips numb and inability to take a deep breath. I waited at the vaccination site for 30 minutes. No treatment was requested since I began to feel a little bit better after 30 minutes. It took approximately 4-1/2 hours to 5 hours to completely be able to swallow without difficulty and feel that I could actually take a deep breath. I contacted my Primary Care Physician and she advised that she is "not comfortable with my receiving the second shot" and told me to cancel my second shot.

found several blood clots in her lungs; it (difficulty breathing) became worse; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (found several blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (it (difficulty breathing) became worse). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (found several blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 11-Apr-2021 due to PULMONARY EMBOLISM. On 15-Apr-2021, DYSPNOEA (difficulty breathing) and CONDITION AGGRAVATED (it (difficulty breathing) became worse) had resolved. At the time of the report, PULMONARY EMBOLISM (found several blood clots in her lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: negative (Negative) Test results came back negative on 06Apr2021. On 07-Apr-2021, X-ray: abnormal (abnormal) Blood clots in lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After x-ray at urgent care on 07-Apr-2021 showed several blood clots in lungs, the patient was taken to the ER (emergency room) and was subsequently admitted to the hospital. Treatment information was not provided. On 12-Apr-2021 the patient went to their PCP (primary care physician) who stated that the clots most likely were not due to the vaccination and that the 2nd dose was safe for her to receive. At the time of this report on 15-Apr-2021, the patient reported feeling fine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.

After eight hours after receiving the second dose, the normal sx of the COVID vaccine occurred (muscle aches, fatigue). On the morning of 04/23/21, the patient completely lost consciousness and was not breathing. The caregiver (son) performed CPR and the patient regained consciousness. Paramedics were called and performed and EKG, blood glucose, and BP/HR - all were normal. Pt is resting but still in pain.

I received my second dose of the Modern vaccine about 3:15 pm on April 22. That night I went to bed experiencing the same symptoms as I had after my first dose of the vaccine: soreness in vaccine site, stiffness in my arm, headache, stiff neck, body aches and feeling lethargic. At about 5:30 am, I was awaken with a strange, unexplainable heaviness in my muscles and chest, my breathing felt shallow and I had a strong urge for a bowel movement. I got up, had a bowel movement (not diarrhea), began to sweat and shake, and then began to have the dry heaves, but did not expel any fluid, not even bile. At this point my husband said he heard strange sounds coming out of the bathroom and came to check on me. He found me passed out and said I was making strange snoring sounds and thought I was having difficulty breathing. The next thing I remember is him calling my name and struggling to gain consciousness. At this point, I was very dizzy and nauseous and lay down on the floor. My legs starting shaking sporadically and my breathing felt shallow. When I felt stable enough, my husband helped me back to bed and I fell asleep immediately and slept for about an hour and half. I was awakened by the same symptoms and proceeded to repeat the previous episode. After I passed out for the second time, my husband insisted that I go to the emergency room. In the emergency room, I underwent bloodwork, an EKG and they began administering IV fluids and 4 mg of Zoran. All test results came back normal. I was discharged and went home. After being released, I did not have any further episodes. The only symptoms I experienced after the episodes were a headache and backache, which were not relieved by Tylenol, lethargic and slept for the better part of the next two days. I did not at any time during these episodes or after or prior to the vaccine experience a fever, sore throat, cough, vomiting or diarrhea. I am not at this time, nor have I for many years been on any medication. In the past, I have been highly sensitive to medications and anesthesia and have experienced adverse reactions, even to some over-the-counter medications.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: \"weird taste\" in throat-Mild, Additional Details: Vaccine Admin at roughly 10:18 am. Patient waited 15 min in store, then left. Returned reporting a slight tightness in throat and a 'weird taste\" in her mouth. when questioned further, reported slight itchiness on arm. Called EMS, they examined patient. Per EMS, appears to have aggrevated patient's asthma. patient declined to be taken to hospital for further care.

AFTER RECEIVING FIRST DOSE MODERNA, PATIENT REPORTS FEELING DIZZY AND JULD SHORTNESS OF BREATH, , PT HAS ALLERGIES TO TO GENERAL ANASTHESIA, BENADRYL AND SEASONAL ALLERGIES UPON AMBULATION PATIENT REPORTS FEELING NAUSEOUS, DIZZY, WEAKNESS OF BILATERAL LEGS.

Fatigue started 4/20, then fever and chills and shaking, cough 4/21-24 with runny nose, nausea and ice pick head aches, shortness of breath and wheezing. Rapid Covid test negative on 4/23. Continued coughing and after 4 days of ice pick head aches almost constantly, went to ER on 4/25 at 9:30 am. IV pain meds stopped ice pick headaches after 40 minutes. Meds for cough and urinary tract infection. Discharged from ER after 5 hours. Continue to have fatigue, sleeping most of the day, low grade head ache, nausea, shaking, and one episode of vertical nystagmus.C

The patient presented with pleuritic chest pain and shortness of breath. Was diagnosed with Acute Myopericarditis with a Cardiac MRI and Echocardiography. Was started on Colchicine and Ibuprofen. The patient was readmitted within 2 weeks with a large pericardial effusion with early tamponade physiology

Intermittent Temperature Lightheaded/brain fog Extreme extreme fatigue/exhaustion Queasy Shortness of breath- intermittent Joint pain Dry mouth Since 3/26/21 There is no treatment

Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot distal to calf with pain. Admission date 4/23, vaccinated with second moderna dose on 4/12 Two clots identified: right lower extremity DVT "Positive study for acute DVT in the right lower extremity, extending from the calf veins up through the right external iliac vein. Positive study for acute superficial thrombophlebitis involving the imaged lesser saphenous vein." and PE: "Acute pulmonary embolism involving the main pulmonary arteries (saddle pulmonary embolism) and extending to the lobar, segmental branches bilaterally with some extension of the subsegmental branches in the right lower lobe, overall worse in the right lower lobe with occlusive segmental branches. " Was initially started on lovenox when admitted, switched to Eliquis, no IVC filter was placed discharged in stable condition on 4/26, Of note: Patient had bone marrow biopsy of right iliac crest of April 15th 2021 - carries diagnosis of chronic lymphocytic leukemia but is currently in remission

Approx couple weeks after vaccination hands started to swell, followed by cough, fatigue, low grade fever, shortness of breath. Blood test indicates now positive for auto immune disorder. Still being evaluated

Patient had an allergic reaction to moderna vaccine dose 2. Pt started having tightness of chest and hyperventilation. BP was 159/80 hr 117 o2 100%. Pt given benadryl IM 50mg. Pt started complaining of shaking and progessively got worse. Epipen was administered. 911 was called. Ambulance came within 5 mins of epipen administration

Pt reported having dizziness, light headedness, and shortness of breath. Patient was brought in to the exam room. Vitals obtained, patient assessed by doctor, and observed by nurse. After approximately 30 minutes symptoms improved and the doctor discharged patient to home.

3 days after receiving vaccine dose, patient experienced an asthma attack. Patient self-administered rescue inhaler and EMS was called. Patient has had persistent headaches ever since, taking acetaminophen daily to treat.

2nd Moderna vaccine administered at 1:29 pm. - Patient has anaphlaxis with ibuprofen. Due to patient's allergies, she was observed for 30 minutes. - When patient was called to leave at 1:59, she complained of dizziness and nausea. - She admitted to not eating anything or drinking any water today. - Patient was given cold water and ice applied to back of patient's neck. - She was also food. Patient refused food and refused to drink water - Reports that she feels like she is going to pass out. - Patient requested that her son be called. Her son was called as requested and he came to clinic. - Patient refused to elevate her feet and kept trying to stand up. - Denies hx of DM or cardiac hx. - Vitals were taken stable. - She then began to complain of worsening dizziness, nausea. Followed by abdominal pain, midsternal CP, SOB, and feeling as her throat is closing. - At 2:09pm, Epipen was ordered and administered to L thigh. - Reports that CP, SOB, and throat swelling resolved after epinephrine. - Patient was placed on 2L of O2. - Fire rescue arrived. Started IV and gave patient Zofran , checked blood glucose: 141, BP: 128/101, while waiting for ambulance to arrive. - Patient was transported via ambulance to Medical Center.

I received the vaccine on 1/8/21, I was tired, dizzy, and had diarrhea, I went snowshoeing on 1/10/21 and was tired and had diarrhea, I went snowshoeing on 1/11/21 and almost turned around (which I never do) as I was super tired, had diarrhea, and dizzy, I slept half the day 1/13/21 and was tired and congested in my nose and lungs (I thought it was bronchitis which I usually get this time of year), I missed work 1/16/21 being super tired and congested in my nose and lungs, I went for a Covid test 1/21/21, I was diagnosed with Covid 1/23/21. I went snowshoeing 3/1/21 and landed in the ED for 2 days with post-Covid breathing trouble. I still have a productive cough and will go to healthcare facility 5/24/21

She reports at first she had a low grade fever , headache, and body aches. Later on that day she felt like she was going to faint. Her blood pressure was 79/58 and heart rate was 104. She had shortness of breath, anxeity, depression, and just felt "odd". She said now she gets short of breath and has a heartburn like pain in the middle of her chest.

Patient returned to clinic at 4:20pm - 2hr after receiving vaccine - reporting of difficulty breathing and dizziness (both 7/10). Patient reports unable to work. HR=74, RR=16, SP02=98% on room air. Received liquid benadryl 30mL/75mg PO. Symptoms improved following administration and was able to speak without gasping per clinic staff. Patient was released to home and transported there via the company vehicle following resolution of symptoms at 4:40pm.

severe sore throat, persistent cough, respiratory/chest discomfort, chills, itchyness on my face and neck. Tireness, Weakness.

Patient experienced an allergic reaction approximately 10 minutes after receiving her second dose of the moderna vaccine. The individual presented with labored breathing, complaining of a feeling of "her throat closing" and had a decreased level of consciousness, she was lowered to the ground by 2 nurses then became responsive only to painful stimuli. The individuals personal epinephrine was administered in her right thigh with minimal response, vitals were obtained and an albuterol nebulizer was then administered with marked improvement in her breathing. After about five minutes a second dose .33ml epinephrine was administered in her right deltoid. After approximately one minute she began answering questions.

Trouble breathing, tightness chest - Blood pressure 200/100. Called EMS, EKG . Blood pressure rose 215/100. Sent to ER ER Record The patient presents with chest pain and shortness of breath. She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath. An ambulance was summoned to the store where she was getting the immunization. They gave her 4 baby aspirin and evaluated her. She opted to come by private vehicle. The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.

Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination, Shortness of breath worsened 6 days after vaccination, lasting 1 week until presentation to hospital ED. Was found with severe hypoxemia, and bilateral PE and right heart strain requiring interventional radiology procedure and catheter directed thrombolytic therapy, subsequent treatment and follow-up in the ICU Initial Moderna vaccine given 04/12/2021: Vial number 0 3 0 B21A Second Moderna vaccine given 05/10/2021 file number 031 B 21A Patient described mild shortness of breath beginning 1 month prior to 1st vaccine, but significant and severe shortness of breath developing less than 1 week after 2nd vaccine

Date of shot-May 20, 2021 (Thurs) injection site right arm slightly sore. Had chemical taste in mouth within 30 minutes after shot; urine had chemical odor after shot. May 21, 2021 (Fri) injection site right arm more sore and could not turn my head to the right as my right neck (lymph nodes) were all swollen. Had chills, headache, fatigued and threw up after eating light breakfast. I iced and took Advil. PM/Bedtime-could not get deep breaths through nose breathing/had to mouth breath-hardly slept. May 22, 2021 (Sat) called emergency room and Pharmacist (primary Pharmacist still on vacation) was told to switch to HEAT pad on my neck, take Advil. Right arm injection site, up the arm, across collar bone, up the right neck to ear lobe all swollen and painful since Friday-hardly any change. May 23, 2021 (Sun) so tired from not sleeping well (could not lay on right side since the shot) and slept mostly all day. May 24, 2021 (Mon) feel a little better but neck is still swollen and sore. 50% motion back to turn my head to the right. Breathing better when laying down through my nose as well. I would like to talk with a Doctor at the CDC as I do not have a Primary Doctor, and was just referred to one, but cannot schedule to see him until mid June. I am nervous if the 1st Moderna shot is causing internal swelling, bleeding, etc. ? And I am not planning on getting a 2nd Moderna shot after this severe reaction caused by the 1st shot. I am healthy, never take drugs, get flu shots, etc. and my body felt like it was fighting a battle...and I am not 100% myself. I want to know WHEN my neck will heal, WHEN my motion will be back to 100% as it is making driving challenging, and what next steps you recommend. Please advise.

25 minutes after injection, pt felt flushed, developed sinus/eye pain, difficulty breathing 7 hours later, at midnight, pt woke up with above sx again. Next morning, pt had a fever, continued sinus pressure, in the forehead, and more difficulty breathing

She got her vaccine, it was more painful, she had fever, she spent 2 days just sleeping due to being tired. She felt as if she was "out of it". She was not focused to work on the computer, to do school work and decided to not do that. She is a multitasker and was hard for her to get on her treadmill as she was off balanced and could not do that. She just had a brain fog, memory problems, was off doing her homework and reading things, but the clarity and focus was not there. She knew the answers to her tests, but when she was writing down it was not being written down as the answers in her head and was scoring low on her tests. She was also not sleeping. She has a fit-bit and averaging between 3-1/2 to 4 1/2 hours of sleep. She just felt out of it and this was through the month of April. Then on 5/8/21 she felt like something was in her eye, she had dyed her hair and put eye drops in her eye. She did correlate anything with the vaccine yet. Then Sunday morning (Mother's day), she observed something and was so tired and decided to go back to sleep. Then she woke up and the eye and the face started twisting and was paralyzed on the left side. Her speech was not clear and the automatic thing was to speak slower and it would fix itself, and what was going on. (She had a prior TIA). She thought of a stroke coming to mind, and decided she needed to take action and went to the ER by ambulance. Once she was in the ER, they did an EKG, did CT scan and an MRI to see if there was anything going on for a stroke or sign of a stroke, which there was not according to the paperwork and results. Not felt to be related to her heart either. They diagnosed her with Bell's palsy and sent her results to a neurologist for them to do their assessment. They were relieved that it was not a stroke. She went to the neurologist the following week and felt that there seemed to be some white matter on her CT. She finished the medication that she was given, and was told that he was going to do a phone appointment, and she refused to have that and said that he could not see the differences in her face and the progress over the phone. She was not able to breath out of her left nostril and was getting worse, having pain and wanted to find answers and they did see her in the office. They did EMG's, checked her eyes and said that she was fine, and asked why did it seem that it was getting worse. She felt like her skin was coming off her spine, and feels a pull. He suggested doing an MRI of her spine and her face, and suggested an EMI to see if there was damage to her nerves. She had shingles in the past and was already having difficulties lifting her arm and had suggestions. She also saw her acupuncturist who did not touch her face and did needling on her body and she was able to swallow better, and was informed not to do them on her face. She also had a telemed APT and was OK'd to have acupuncture on her head but again not her face. She was still on the steroids, and had information and paperwork that she had researched and asked him questions to educate her and help her. Her daughters have been doing research and told her that maybe she needed a different neurologist. She called the nurse line at the clinic who advised her to stay where she was and see what he had to offer. She is doing warm towels in the morning and evening and she?s able to get some relief and sleep. She finds that her brain is working better and that it is going to take some time for this to heal. She had testing for AVM?s during her chemo and she had no indication for that. In November and December 2019, she was really sick with URI and was on breathing treatments and was one step away from pneumonia and was not able to work. She took an antibodies test in March and had antibodies. She then had COVID in her household in December of 2019, but was tested several times and tested negative for that. She was diagnosed with cancer when she hit her head on a cabinet at work, and noticed that she had scarring, which she thought was from chicken pox and shingles. Her chicken pox left scars on her lungs and she did not take medication for that due to driving her kids back and forth to school and not wanting to be under medication effects. The ER followed up with her after telling her that she needed to see a doctor. She went to a cancer center and had biopsies and they lost her specimens at the hospital. She ended up having to get another test and was diagnosed with a very aggressive cancer, and told her she needed surgery. She had laparoscopic thoracic surgery and they removed 3/4 of her lung. She had chemo for 5-6 months, and was antibiotics the entire time due to infections. At one point she was excreting skin from the chemo. They inadvertently found out that a nurse had given other patient's wrong chemo and was fired from being a chemo nurse. She has been under a great deal of stress. Now since doing the warm towels her symptoms are better, the nerve is not as tight. It goes from the top of her brow all the way to her chin on the left side, it goes in sections. It was in the middle first, from there it goes up above and bulges on the top of her brow, and then with warm towels it progresses to a bulge on her face. She can't breath out of her left nostril and uses saline to keep it moisturized. She can blow her nose if she pulls her nose towards the left. She uses the salt water rinses in her mouth as she feels everything is pulling to the right including her neck. She was given a salve from her acupuncturist that has helped as well. She does self pictures throughout the day to see her progress of this process.

Woke in a.m. with heavy pressure pain mid chest and struggling to breathe, massive headache, could barely walk. Got up and thought I'd better sleep somehow so tried to find best position to allow me to breathe with less pain. Up/down several times, finally got to sleep.

Magnets stuck to her arm; Worse chills; Arm still hurts; 2 inches below the injection site there was a red spot which had since turned into a scar; Her arm swelled up; 104.3 degree F fever; Low pulse oxygen level of 77%/Breathing was worse than before the vaccination; Didn't feel good all weekend until Sunday; 2 inches below the injection site there was a red spot which had since turned into a scar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (104.3 degree F fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (5 years ago) in 2016, COVID-19 (hospitalized 01-Nov-2020) on 28-Oct-2020 and Pneumonia (almost died from pneumonia complications from COVID-19) on 01-Nov-2020. Concurrent medical conditions included Total lung capacity decreased (was left with 55% lung capacity after the pneumonia) since November 2020. Concomitant products included ALBUTEROL SULFATE for an unknown indication. On 29-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (104.3 degree F fever) (seriousness criterion medically significant), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination), VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), CHILLS (Worse chills), VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) and VACCINATION SITE SWELLING (Her arm swelled up). 29-Apr-2021, the patient experienced FEELING ABNORMAL (Didn't feel good all weekend until Sunday). 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm still hurts). On 22-May-2021, the patient experienced VACCINATION SITE REACTION (Magnets stuck to her arm). On 30-Apr-2021, PYREXIA (104.3 degree F fever), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination) and CHILLS (Worse chills) had resolved. On 02-May-2021, FEELING ABNORMAL (Didn't feel good all weekend until Sunday) had resolved. On 20-May-2021, VACCINATION SITE SWELLING (Her arm swelled up) had resolved. At the time of the report, VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), VACCINATION SITE REACTION (Magnets stuck to her arm) and VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) outcome was unknown and VACCINATION SITE PAIN (Arm still hurts) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Oxygen saturation: 77 (Low) 77%. On 29-Apr-2021, Pyrexia: 104.3 degree f (High) 104.3 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment provided were Tylenol. Follow-up received on 25MAY2021 included no new information. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.

Patient developed sudden onset SOB and chest pain within 12 hours of s\p vaccination. Her son called 911- she was in ER for 4-5hrs and ER staff told her this was vaccine related. Patient will not receive dose #2

Experienced vomiting, shortness of breath and trouble breathing for a short period of time. The next morning, my face was swollen but eventually subsided by the next day. I'm making this report after the nurse (who gave my daughter her second shot) suggested I make this report.

headache 10 min after injection-tired and heavy chest within 2 hrs of injection-unable to sit up due to lack of energy-slept through the night-next day I was dizzy, and exhausted with difficulty in breathing-chills and fever-all my joints ached-slept all day and night-third day was able to walk around the block-still sluggish-no chills or fever or aching on third day-fourth day after vaccination (vaccine admin on Monday @ 1:15-Friday morning back to normal) 100% back to normal

I received Moderna shots as follows: o March 18, 2021 - Dose #1 o April 15, 2021 - Dose #2 o COVID-19, Moderna dose #1 (lot 045A21A) was administered as in injection in my Right arm on 03/18/21 at. o The next morning (3/19/21), I experienced tremor/pulling type sensation in my right lower lip / jaw area that lasted a few seconds, then subsided. o COVID-19, Moderna dose #2 (lot 022B21A) administered as in injection in my Right arm on 04/15/21 at. o The next morning (4/16/21), I woke up to Left side jaw pain that lasted several hours, then subsided. Mid-morning of that same day, I experienced a strong spasm type pain in my Left leg (inner groin area to knee area), lasting a few seconds, then subsided. That same day I felt tired and experienced a loss of appetite. o Over the next few weeks, I felt an unusual lack of energy and little appetite, resulting in weight loss.

Right after dose I became nauseated and had to sit with a nurse for a half hour. An hour later I had to go to the ER because I was having shortness of breathe, it felt like something was on my lungs. I developed Hives which lasted for 5 days.

Swelling, redness, pain at injection site, warm to touch, extremely tender and sore. Increased breathing difficulty, fever, fatigue,

I received the first Moderna vaccine on March 15, left arm hurt to touch, couldn't lift it overhead, had sound halucinations and fatigue. On the eleventh day things got ugly. Sharp chest pain and jaw pain, blood pressure 130/104 (my normal is 125/60), for four days couldn't eliminate but a small amount of urine, dizzy spell-almost passed out, vitreous detachment in eye, lost taste and smell 24 hrs (test for covid-19 was negative), blood pressure jumped to 180/112, temp 94.4, TMJ/node pain and swelling three weeks, teeth didn't occlude four days and couldn't get floss between any teeth for a day (so weird), severe shooting wrist pain, couldn't hold a pen or type for 24 hrs, hand tremors, sound halucinations of metal scrapping, hammering, thumping when laid down, super itchy rash under armpit one week, occipital node swollen, top of head painful to touch, ankle swollen, pounding heart beat, dry cough, oxygen readings of 88, sub- normal temperature 94.8 to 95.8 for several days and a month of very high blood pressure readings with tinnitus, fatigue, cloudy thinking and speech. Most reactions lasted a day up four days, all were on the right side of my body, most resolved before the next started. The longest ongoing issue is high blood pressure. Finally went down to 124/66 but not consistently. Spent three weeks around 138/104 and when walking uphill, heart would start pounding, felt faint, nauseated, head ached and had difficulty breathing. Alcohol and salt triggered a reaction or made blood pressure jump to 180/104. Leaning forward to do yard work or and strenuous activity like walking made heart pound violently, head ache, and blood pressure go up. Laying down makes heart flutter. Most of the symptoms listed are for myocarditis. Once the CDC reported that kids were having these issues I reduced activity and and more bed rest and am feeling slightly better.

Dx of concern: New diagnosis of adrenal insufficiency with symptom onset 1 day after second COVID19 vaccination. Onset Nausea, vomiting, diarrhea , weakness within 24 hours of second COVID19 vaccination. Seen ER 4/21/2021 with temp 100.4, BP 144//92, HR 122. Treated with ondansetron and phenobarbital and d/c'd home. Office visit 4/27/21, pt reported weakness 10lb wt loss, poor appetite, exam notable for orthostatic hypotension. Office visit 5/7/2021, only symtom of weakness, again orthostatic.

30-40min after 2nd Moderna Vaccination I became lightheaded, rapid HR, intense chest pain in center of chest, SOB, light headed, cotton mouth, and extreme fatigue. Went to outpatient Surgery center next to where I got the vaccine. Dr checked my O2 sats which were 85%, listened to lungs and heart and heard no problems, BP Normal, HR fast but regular. I immediately could not stay awake due to extreme fatigue and slept for 2 hrs, then was better for 1 hr with minimal chest pain. Then got muscle/body aches & fatigue continued & slept another 3 hrs. Through night a lot of muscle/body aches, & severe headache. Continued chest pain in middle of chest (2-3 hr duration relieved by Aleve & Hydrocodone), also SOB with minimal exertion & fatigue continued.

I received the vaccine in the afternoon and did fine in the evening aside from a low grade fever. The next morning at 10:30 AM I experienced severe nausea and my BP was dropping. I was taking care of a patient at work at the time. I went ahead and got the nurses to take care of my patient. I laid down for a little until the nausea passed The entire time I was very fatigued. I slept for an hour in my car. Then went back to work. I went home at 1:30PM because I felt so bad. I slept when I got home and into the next day. I had nausea, vomiting and diarrhea. I called in sick on Thursday and Friday and stayed in bed the whole time. I also had a swollen lymph node in my right clavicle area. I was still sick in bed all weekend all through Tuesday. The entire time I also experienced shortness of breath. I still experience the shortness of breath. The shortness of breath was so bad I couldn't go a few feet to grab something with out having to take a rest. The shortness of breath has gotten me to a point where wearing a mask is difficult for me which was never the case. After having surgery, My stats kept dropping which is unusual for me. I also experienced pain in my shoulders. It feels like I am carrying a heavyweight backpack on my shoulder. I also am now experiencing chest wall pain. If I move around, I feel pain. It got to a point where I had to take a pain pill from my surgery and that did not help. I am scheduled for a echo on Thursday.

Three weeks and one day following my second vaccine, I had three episodes of disequilibrium followed by a drop in body temperature. I went to the ER and was admitted for a day for tests. CTs, MRIs, echocardiogram, PT consult, neurology consult showed nothing. I believe it may be vaccine related because the exact same thing happened to a friend across the country 3 weeks after her vaccine. We have been gone since.

She got her shot on June 2nd. Started itching on the 5th. Had a rash on her neck. The rash kept increasing so she called the ER on the 9th. The rash made her face swell and she had shortness of breath. She had to call an ambulance and was taken to the hospital. They prescribed her a steroid for 5 days. Gave her an injection of famotidine. Was at the hospital for about 4 hours. She is still having some itching on top of her head.

Per pt's agent, Pt had arm pain going down her Right arm (vaccine given in Right deltoid) within 15 minutes of receiving vaccine. Pt left after 15 minutes (pt did not notify us of anything wrong, and went straight to her PCP). Pt's agent said within 1 hour of the vaccine, pt was experiencing arm pain that radiated to neck, shaking, headache, heavy feeling of chest accompanied by shortness of breath, general muscle pain, and worsening of her carpal tunnel. pt agent said PCP gave pt benadryl shot, and prescribed pt hydroxyzine and diazepam (which were promptly picked up by pt agent to be delivered to the pt). Pt relayed all the above information to us as she was on the phone with the pt during this whole conversation. We will follow up with pt today.

Shortness of breath and dizziness with normal activity and at rest Persistent dry cough Recurring rapid heartbeat, weighty feeling in chest Fatigue. Needing to rest every few minutes Bubbling feeling/sound in upper chest

per discharge summary pt given covid vaccine 6/21/21. experienced nausea, vomiting, diarrhea, fever,. These symptoms went away within a day then on 6/25/21 pt was at work and experienced sharp chest pain, shortness of breath, and dizziness. Positive troponin mildy elevated. Discharged at stable condition 25 hours later. Followed up with PCP (MD.) Pt diagnosed with myocarditis.

2 stents were put in; Tender arm; Tired; Difficulty breathing/trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination. The patient's past medical history included Stent replacement (2 stents were put in) on 19-May-2021. Concomitant products included LOSARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol, PRASUGREL and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/trouble breathing) (seriousness criterion medically significant) and FATIGUE (Tired) (seriousness criterion medically significant). On 19-May-2021, the patient experienced STENT PLACEMENT (2 stents were put in) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TENDERNESS (Tender arm) (seriousness criterion medically significant). At the time of the report, STENT PLACEMENT (2 stents were put in), DYSPNOEA (Difficulty breathing/trouble breathing), TENDERNESS (Tender arm) and FATIGUE (Tired) outcome was unknown. Patient received the 2nd dose of vaccination on 21MAY202, she felt tired, had trouble breathing when going upstairs. The day after 22Apr2021, it increased, but was not gasping for air. She contacted to the doctor who told her to wait 2-3 days to see if her breathing improved. Patient reported that she made an appointment with her doctor and then Saw cardiologist on an unknown date. Patient reported that her breathing was better after the stents placements, but not perfect. On unknown date, Lab tests included stress test and ultrasound and heart test on 19-May-21 with outcome unknown. Patient reported that she is in cardiac rehab. Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

auto immune disorder; suspected reaction from covid vaccine; felt it was a dermatitis; intermittent numbness in fingers; difficulty breathing, winded; both hands are weak; Redness of both hands; Dry persistent cough/ cough; both hands are painful; interstitial lung disease; Pneumonia suspect; low grade fever; swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed; swelling in her hands equally on the right and left with tingling/prickling/ tingling; had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease) and PNEUMONIA (Pneumonia suspect) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 021L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (mild), Penicillin allergy (rash and chills), Osteopenia and Contrast media allergy (Rash). Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21). On 13-Mar-2021, the patient experienced PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling) and PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed). On 18-Apr-2021, the patient experienced PYREXIA (low grade fever). On 27-Apr-2021, the patient experienced PNEUMONIA (Pneumonia suspect) (seriousness criterion medically significant). On 24-Jun-2021, the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease) (seriousness criterion medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), HYPOAESTHESIA (intermittent numbness in fingers), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), ERYTHEMA (Redness of both hands), COUGH (Dry persistent cough/ cough) and PAIN IN EXTREMITY (both hands are painful). The patient was treated with PREDNISONE at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and AZITHROMYCIN on 18-Apr-2021 for Bronchitis, at an unspecified dose and frequency. On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21) had resolved. At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease), PNEUMONIA (Pneumonia suspect), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed), COUGH (Dry persistent cough/ cough) and PYREXIA (low grade fever) outcome was unknown and HYPOAESTHESIA (intermittent numbness in fingers), ERYTHEMA (Redness of both hands) and PAIN IN EXTREMITY (both hands are painful) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Apr-2021, Chest X-ray: pulmonary infiltrates at base of lungs. Pneumonia suspect. On 12-May-2021, Chest X-ray: pulmonary infiltrates still present but improved. On 26-May-2021, Chest X-ray: pulmonary infiltrates unchanged. On 08-Jun-2021, Antinuclear antibody: inconclusive (Inconclusive) inconclusive. On 08-Jun-2021, Computerised tomogram: pulmonary infiltrates present. On an unknown date, Antinuclear antibody: positive (Positive) positive Suspect reaction from covid vaccine.. On an unknown date, Blood pressure measurement: inconclusive (Inconclusive) inconclusive. On an unknown date, Body temperature: inconclusive (Inconclusive) inconclusive. On an unknown date, Heart rate: inconclusive (Inconclusive) inconclusive. On an unknown date, Respiratory rate: inconclusive (Inconclusive) inconclusive. Patient allergic to contrast results in delayed while body rash Treatment for the events included Zpak for bronchitis and nebulizer .Action taken with mRNA-1273 in response to the events was not Applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-065219 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Patient demographics, medical history, laboratory data, concomitant medications, treatment medications were updated. Additional serious and non serious events and reporter details were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-065219:Dose 1

Onset of sharp, shooting chest pains at anterior left upper chest and anterior right lower chest as well as mild wheezing within 1 hour of vaccine administration on 2/17/21. This continued daily until an episode of hemoptysis on 5/11/21, for which she was admitted for inpatient management.

On May 19th, approximately 6:00pm, I collapsed while out walking with my husband. He said I was unresponsive, my eyes rolled back in my head, my skin color turned gray and he could not detect a pulse or respiration. He and a neighbor called 911 and started CPR on me. I came to as the rescue unit arrived. Transported to Hospital via rescue unit where they started and IV.

Started having worsening shortness of breath, exertional dyspnea, paroxysmal nocturnal dyspnea 3 days after 2nd dose of COVID 19 modern a vaccine. transthoracic echocardiogram showed heart failure with reduced EF of 20-25%.

Breakthrough case after full vaccination. Patient developed symptoms 7/19/21 including fever, chest tightness, cough, SOA, nausea, loss of taste/smell, nasal burning, head congestion, sneezing, and rash to trunk

Itching, throat tightness. Pt was evaluated by Provider, VS monitored, benadryl 25mg PO X1 dose. Pt full recover within 30min and monitored for another 30 min, discharged to home with husband who is a PA-C.

Grade 3 local reaction - > 10 cm induration at injection site within 12 hours then gradual resolution over several days. Delayed Reaction: 7 days later > 10 cm erythema developed surrounding injection site with minimal induration. Did not appear infected. Photos taken of both events.

low blood pressure 85/52 pulse 102 continued to be low in the 80/55 the 1st day, 2nd day was 81/59 to 96/62 finally normal on the 12th. also, flared up asthma.

? injection site pain ? tiredness ? headache ? muscle pain ? chills ? joint pain ? fever ? injection site swelling ? injection site redness ? nausea ? feeling unwell A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions i.e. slept 2 days straight, missed work Increased asthma medication used rescue inhalers

4 hours after inj, achy at inj site.18 hour after inj, pain mark increase in deltoid, fatigue, malaise,, general body aches, felt chilly, sob ( PO 98%,HR 90), mild nausea, loss of appetite. side effects ended 48 hours after inj. of note: i had covid illness 3-20-20.covid test positive 3-24-20. antibody positive 2 months later

CoughWheeze fatigue, rhinorrhea Narrative: Received vaccine on 12-29-20. States on 12-31-20 started having fatigue, runny nose and some coughing with congestion. Thirteen days later c/o rash, itching and warmth to site of injection. States no pain unless applying pressure to site.

difficulty breathing post vax, self administered own inhaler, pt called PCP who advised ER, paramedic administered albuterol breathing tx, pt transported by ambulance to Hospital

When I got home from my hike the next day of vaccination I felt my heart going crazy I had high blood pressure 160/100 it stayed like that for the next 3 days but the next day I felt my whole body pounding I was shaky I had to go to urgent care. Then for the next week I was feeling very fatigue & short of breath lasted for about a week.

12:17 felt heart racing, face flushes, SOB with speaking. States she feels like she is going to pass out. Taken to private observation via w/c area with EMT on site in attendance. BP 180/120; HR 100; 02 99% on room air.. States she also feels lightheaded, is having generalized shaking, especially hands trembling. No redness or swelling noted at injection site. States she did eat yogurt and granola bar at 10 am. 12:29 - drank about 2 oz water without difficulty. Denies itching, states she feels better, but is still shaking vigorously all over upper body. Denies being cold. Denies chest pain. just feels like she can't catch her breath. Still flushed in cheeks and forehead. 12:34 BP 158/100; HR 82; O2 96% on r/a. Still shaking. Covered with her sweater. 12:36 Doesn't feel like she is going to pass out anymore. Still having tremors, shaking. Unable to completely catch her breath 12:40 EMS activated. 12:42 HR 77; O2 99% on r/a . Still shaking. States Bactrim sometimes sends her sideways. States she does have a history of hypoglycemic events. 12:55 arrived. Patient still shaking and feels lightheaded again. 12:58 BP 168/90; HR 91; O2 98% r/a. POC glucose check per EMT - glucose - 85 Gave patient juice 1306 Shaking subsided. She thinks the juice helped. BP 156/86; HR 78: 99% r/a 13:07 released patient she states her SOB is gone. No more tremors. Denies lightheadedness. 13:13 Patient taken to private vehicle driven by husband.

Patient age 63 presented for her second dose of moderna vaccine. She reports after 1st dose several hours after injection she had fatigue and some swelling in her throat with a palpable lump and difficulty swallowing. The morning after woke up with dizziness and abdominal pain and passed out. She reported itching about 3-4 days after dose

Pt presented to clinic and reports 3-4 hours after receiving first injection she felt fatigue and noticed some swelling in her throat and a noticeable palpable lump with some difficult swallowing. This went away after a few hours. Pt woke up the next morning with abdominal pain and reports standing up and passing out. Pt states she had diarrhea throughout the day also with dizziness.

Had tingling, hypertension, and hyperventilating 5 minutes after injection. Was place on a table in a supine position. BP was monitored and was down to 165/86 at 45 minutes after injection. Heart rate = 67 O2 Stat = 100. indicative of a vasovagal reaction. Was able to leave clinic after 1 hour and did not work the rest of the day

The of the shot I had no reaction, the day after the shot I felt a small tickle in my throat and the arm I got the shot in hurt a bit, this day I took a benadryl before bed that night and felt fine no issues till the 13th of January I woke with my left arm sore, and at the shot area my arm was noticeably swollen, hot to the touch, my throat was closing and I was itchy all over my entire body. I called the ER at the hospital and explained what my systeoms were and the person I spoke with said it was my choice to either come to the ER or if I wanted to try benadryl again. I opted to take the benadryl at the time then I took a 2nd Benadryl at bed time. Since then I have a little bit of a sore throat.

Allergic reaction within 10 sec. Tongue swelled, lips swelled, tingly tightness in throat and down center of chest/digestive, tingly tightness across my shoulders. 1 Hour. Per the Center, they phoned Moderna and Benedryl 25 mg was taken. I took another 25 mg a few hours later. In addition, I went to my immunologist for follow up (9 days after Moderna Vaccine 1 reaction on 01/16/2021). He cleared my taking my monthly allergy injections. I had a worse reaction to that and never do. The Moderna Vaccine was in my system. Same symptoms but my lips swelled further, broke out in hives on chest, oxygen level fell to 91.

got up in the night and stated that she couldn't breath, ambulance was called, pt expired in route to hospital. *relayed to me by Facility staff RN.

Developed hives within 2 hrs/took Benadryl that night; swelling that traveled up the arm and neck in the morning with shortness of breath/used rescue inhaler at 0400 and then again at 0800; and then anaphylaxis by 0900. Treated in ED with EpiPen then IV Solumedrol, Benadryl and Famotidine. Recovered and started on prednisone taper pack starting at 6 tabs for 3 days etc. Suggested to make follow up Dr appt for one week following incident/set for Feb 8

Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable. Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.

Left lower lid eye edema,itching and hives on body. Slight wheeze. Took a 25mg Benadryl p.o. Used my Proventyl inhaler. Relief within 30-45 minutes. NOTE; I had been to my beauty salon to have highlight treatments to my hair that day also. (2/02/21.)I have had this reaction in the past after my salon treatment but not the hives before. I strongly feel this was related to the chemicals used on my hair but felt I needed to report it.

Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection site

Moderna vaccine #2 was given on Friday, January 29 at 1 PM. She had no side effects that day. On Saturday she felt mildly achy and had a headache and stayed in bed. Sunday her heart was flip-flopping with palpitations. She noticed new dyspnea on exertion with just a short distance as well as feeling panicky. On Monday she went to work and continued to have the same symptoms. Two colleagues were vaccinated at the same time she was also reported the same symptoms of palpitations, dyspnea and new onset anxiety. Yesterday the symptoms were even worse, "really bad'. Her vital signs were checked at work and were all normal. Today she is not feeling as bad but still feels very anxious. She woke up with a headache again. She is taking ibuprofen for the HA which helps.

Shortness of Breath, Headache, Dizziness, Chills in upper body and feet, Pain on left side of head, coughing one day, heart pounding.

I was woken up from sleep at 11:30 with swelling of my tongue. It was getting hard to breath, so I got ice and sucked on it for awhile, then I put a cold cloth on my face, tried to relax and the swelling seemed ok. I stayed up all night because I was afraid that it would get worse, At about 9:30a.m. it seemed to be getting back to normal with just a little swelling in the back of my tongue. I felt terrible for the next three days and still don't feel great. Sore joints, got chills, headache. I am not going in for the second shot.

1-20-2021 8:30PM - sore arm 1-21-2021 8:00AM temp 98.1 sore arm only 2:25PM temp 99.8 Headache, cold, skin sensitive to touch, fatigue, weak 4:30PM temp 101.3 Nurse checked: BP 120/80 O2 - 98 4:50PM Took 2 Reg. Tylenol Temp went down to 98.1 by 98.1 but started going up to 98.8 by 10:30PM when took 2 reg. tylenol early evening started having heart palpitations Jan. 22 and 23rd, 2021 Temp gradually going back to normal without Tylenol. Still having fatigue, weak, heart frequently skipping beats, feeling short of breath with activity Jan. 27, 2021 saw family doctor because of continued heart palpitations and shortness of breath with activity.

Patient Had 2nd Covid shot on Friday Feb 5th started having diarrhea on 2/7/21 and then on 2/8/21 continued dairrhea. in am and then 2/8 pm patient began getting short of breath, low grade fever, cough and wheezing

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild

15 minutes after receiving vaccination, pt reported it feels like "my throat is closing up", left sioded neck, arm, and chest pressure, and nausea. Pt does report she has had chest pressure intermittently for past 2 weeks but throat closing feeling began after vaccination. Pt received aspirin 324 mg po x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, Solu-Medrol 125 mg IV x1, morphine 2 mg IV x1, and nitroglycerin 0.4 mg SL x1. Following treatment, pt reports she is free of chest pain and throat symptoms have improved.

two hours after injection I ran across a road and my heart began to race and I felt like I couldn't breathe. I slowly went into the post office and was offered a chair. It was over as fast as it hit me and everything was fine after that. No other adverse effects since then

Throat swelling and tongue felt raw was given Benedryl (2) by Dr. in attendance and observed for around 45 minutes. Later that evening (about 4 hours later) heart had a series of strong, short, contractions. Continued for the next few day but less each day. Followed up with cardiologist and was in regular rhythm but show him my left arm where I had a red circle (3 inches or so) around injection site. Referred to PCP and they suggested no 2nd vaccination. If deemed in need of another Covid vaccination allergist should be consulted first.

Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she developed significant shortness of breath and was seen in the ER where she was diagnosed with bilateral pulmonary embolism.

2 days after my first Moderna covid 19 vaccine, I developed a temp of 101, mild wheezing, headache and severe dizziness/vertigo which lasted for 6 days.

About 20 min after my arm started burning - like someone was holding a match to it. And that stopped. And then I got a shooting pain up from neck to ear; shortness of breath; lips were tingling and mouth was going numb (like a was getting Novocain) and I got a headache and then I got an earache too; I started to feel itchy - all within a short time. I was given Benadryl. It was enough to get my home. I took another Benadryl and I was okay from all my symptoms except the itching (like I was in an ant next) that itching lasted for three days even with taking Benadryl.

All three reactions were the same. I woke up feeling like my throat had a flap that was not allowing me to inhale. I had been snoring and work up abruptly because I couldn't breathe at that moment. If I inhaled sharply or sniffed hard to try and clear my throat, my airway blocked. I had a fever and also swollen glands in my neck and under my jaw. Once I got out of bed, I drank a glass of cold water and walked outside in the cold. I felt like it was an allergic reaction; so I took a Benadryl and I tried to go back to bed, but when I laid down it seemed worse, so I spent the night in my recliner. The first reaction was the worst in severity and happened about two weeks after my first injection. The second reaction was less than two weeks later, the last one happened 4 days after my second injection. All three incidents lasted about 12 hours, but I still feel like my glands are a bit swollen, and I have a hesitation when I swallow. I talked to my doctor today 3/1, he ordered a COVID test and ordered me to quarantine until I get the results.

3/4/21 1005am pt started complaining of feeling flush, restless, and anxious. pt states that she does not feel right and that there is something wrong. then pt reported that her legs felt numb.First RN and Second, RN was present to assist pt. pt was put on 4L of O2 by mask. Dr was called to assist. pt was moved from sitting in chair to laying on floor with legs elevated. pt reporting that her hands and legs were feeling numb. per Dr pts lungs were clear with good air exchange. pt alert and oriented to self, place, and time. 1012am BP 141/81 P 71 SaO2- 100% BS 99 pt still feeling flush and restless with anxiousness increasing. upper lip swelling. questionable tongue swelling. hand and feet numbness. pt states does not feel right. V.O. Dr 25mg Benadryl IM now administered to the right deltoid IM, RN 1020am BP- 162/100 P- 72 SaO2- 100% pt still feeling flush and restless with anxiousness. still with some upper lip swelling. questionable tongue swelling. hand and feet numbness is still reported. pt states she still does not feel right. husband is now with pt at her side and trying to calm her. pt is c/o some SOB, per Dr pts lungs are still clear. pt remained alert to self, time, and place. V.O. Dr. Albuterol neb treatment now attempted to start neb treatment however pt was not tolerating neb. ok by Dr to stop neb treatment. 1025am called AMR V.O. Dr 1mg Epinephrine now administered 1mg Epinephrine IM right deltoid. P. , RN 1027am pt wanting to sit up. states cannot get comfortable laying down. assisted pt to sit up. pt is less anxious. reports to feel less restless. decrease upper lip swelling and tongue swelling. pt reports that she is starting to feel a little better. pt is feeling less numbness in hands and feet. BP-141/58 P-99 SaO2-100% 1037am pt starting to complain of feeling flush, restless, and anxious again pt states that she does not feel right and that there is something wrong again. pt again reporting that her hands and feet felt numb. per Dr - pts lungs still clear with good air exchange. pt remains alert to self, place, and time. per Dr draw up another dose of Epi while waiting for AMR, AMR arrived prior to drawing up second dose of Epi. 1039am AMR arrived. transferd pt from floor to gurney and trnsported pt to ER. ................................................................... RN March 4, 2021 3:20 PM

Pt started feeling SOB about 15 minutes after vaccination, feeling tingling in arms/hands. She then reported it was harder to breathe and throat was feeling weird. She was lightheaded. EPI 0.3mg administered by autoinjector, then 50mg Benadryl administered. Shortness of breathe continued and chest pain developed. Another dose of EPI administered 5 min later. EMS arrived and transported pt. to ER.

Modern Vaccine I felt a little nervous but I?m not afraid of vaccines. Arm hurt, got home was more shaken inside. Took Ibprophen for pain. I continued to feel hyper, then tired, repeatedly all day long. At some point I remember feeling like my breathing was way too fast. The nervousness became fretfulness. At bedtime, I took my normal medicine and 3 mg of Melatonin as usual. I could not stay rested. My body would do one jerk and wake me. I finally got up to read and took .025 mg of Clazonapem . I have that for flying, etc. Today, March 11, 2021 I awoke at 6:30 am feeling much better but then as the day has continued I am out of sorts. Everything is very difficult to think about doing. My brain is getting stopped from simple writing ABC?s on index cards. Questions are overwhelming me. I?m not sure if I should even consider the second vaccine. This is very unsettling as I am normally very functioning as a teacher, artist, homemaker. Caring on a conversation is troubling.

Slight headache 1 day, extreme fatigue 2nd day, arm pain 10 days and arm had a circular red circle around the injection sight for 10 days, some shortness of breath. Had Covid-19 virus 12/17/2020.

shortly after receiving vaccine patient stated she felt like her throat was tight and there was something in it

Tightening in my throat, that was eased with Benadryl. Shot area swollen large lump for 3 days. Light-headed. Felt lethargic for Friday, Saturday and Sunday, following the shot on Thursday.

Presents to urgent care day after 1st moderna vaccine with chills, SOB, body aches, headache - normal immune response, d/c'd home in stable condition

MODERNA COVID-19 VACCINE EUA: Patient received Moderna vaccine dose on 031121 then reported shortness of breath, narrowing of airway shortly afterward during the observation period. The code team was summoned. She remained communicative during the event. Oxygen saturation initially measured was 99% and remained stable throughout. She received 1 dose of epinephrine SQ (right thigh). The patient remained onsite for continued vital sign monitoring for 1 hour then was released to home.

I have not had a asthma attack this severe in several years and actually have not had an attack of any kind in a year. I woke up at 2:30 in the morning literally unable to get any oxygen into my lungs. My wheeze was so loud it woke my husband who rushed to get my emergency inhaler. It was so bad that if any more time had passed he would have called 911 but eventually the inhaler did help me. I ams concerned if this was a result of the Vaccine or a coincidence but people kept telling me I needed to notify CDC...so here I am.

Around 15 minutes after the shot, began to feel some tongue swelling. Progressed to some throat swelling, breathing not compromised. Pulled over and called Dr office prescribed Benadryl wh/I took upon arriving home.

Pt had flushing and pt stated that she had chest pain. Pt was provided oxygen to ease breathing. EMS was called.

I was exposed to Covid-19 in September, but my tests were negative. I had the same chest pain as when I thought I had Covid-19 on the third morning after vaccination. Started in the back with trouble breathing. I was lethargic and tired but I had a lot of trouble breathing for a week. I also took a course of Zithromax and the symptoms resolved after eight days but the tiredness persisted. I gave blood on the day of vaccination after the shot and it may have some effect.

Experienced shortness of breath, nausea Provided epinephrine IM per protocol at ~11:14 am and also Pepcid 10mg po dose. Symptoms improved. 911 called, patient was transported to ED

Dizziness, light headed, and throat started feeling a slight constriction. They gave me Benadryl and after about 20 minutes my throat felt better

I had the typical side effects but I also had swelling in my neck and throat and I could feel my throat tightening up. the right side swelling went down overnight and then another day went by before the left side swelling went down.

Hurt to even swallow water. I have GERD and Shotsky?s ring. Ended up taking 100mg if Omeprozole during the entire day (then Gaviscon Extra Strength. I had to talk to the on call Dr. 2x. After taking the Gaviscon, I burped and had excruciating pain at the base of my esophagus, broke out in sweat and almost passed out. I had to breathe as if I?m labor. It happened again about an hour later. The Dr. said it could be a cardiac issue and go to the ER. I ended up with normal EKG?S and normal bloodwork during the time I spent the nite for observation. The cardiologist said I had no heart issues and to go home. I can only come to the conclusion that the inflammatory response from the vaccine was the culprit.

I was achy and my arm was sore that night. I was fine until I started experiencing symptoms on the 1/5. So that night, I checked my temperature and had a low grade fever. I took a COVID test on 1/6 and was positive and I got treatment on 1/7. I ended up being out of work for two months due to a sinus infection and pneumonia. I'm still experiencing symptoms such as lung inflammation and SOB, so I'm on an inhaler, nasal spray, allergy meds and I did a sputum test today. I'm also scheduled to see a pulmonologist, who I also saw prior to COVID for breathing issues. I've had to do 3 rounds of antibiotics to resolve my pneumonia.

I sat in the facility for the 15 minutes or so required, then in about 1/2 hour later I had like a had time breathing, something like labored and my vision was very blurry for about 30 minutes or so, I went back to work and a co worker asked if I was ok, she said my eyes looked weird and within the hour I was seeing fine again, was very tired but that I thought was normal,.

Congestion in lungs - coughed up blood , brown, green and yellow mucus; stopped up; Loss sense of taste and smell; Loss sense of taste and smell; Headache; Fever; Very tired; Chills; A spontaneous report was received from a consumer, who is a 63-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion in lungs- coughed up blood , brown, green and yellow mucus/ pulmonary congestion, stopped up/ nasal cavity packing, headache, fever/ pyrexia, very tired/ fatigue, chills, loss sense of taste/ ageusia and smell/ anosmia. The patient's medical history included injuries in right arm. Concomitant medications included clonazepam, potassium, magnesium, fluticasone propionate, salmeterol xinafoate, dexamethasone, metformin, sumatriptan, bupropion and cyclobenzaprine. On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, approximately 4 days after receiving vaccine, the patient experienced congestion in lungs- coughed up blood , brown, green and yellow mucus (medically significant), stopped up, headache, fever, very tired, chills, loss sense of taste and smell. Treatment medication was reported as paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, congestion in lungs- coughed up blood , brown, green and yellow mucus stopped up, headache, fever, very tired, chills, loss sense of taste and smell was considered as resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Approximately 8-10 minutes after receiving the vaccine, another recipient of the vaccine said that a woman in the observation area felt like she was going to pass out. Ten seconds later, her husband said that she felt like she was going to pass out. Upon getting to the patient, I felt for a pulse and observed mild breathing. The patient was unconscious and did not awaken with a sternum rub. The patient's husband helped me lower her to the ground, and I administered one dose of Epipen to the patient's lateral left thigh. She awakened and was able to state where she was, the year, and the president. EMT arrived later, and the patient refused further medical treatment.

Head and chest swelled due to arthritis in these areas. Had trouble breathing until I took a puff of inhaler. Also took an arthritis tylenol when I got home and that helped relieve my tight chest from arthritis. The next day my head hurt all over and arthritis tylenol helped but I also iced my head and slept most of the day. The second day after I was much better but I needed tylenol for my aching arms and legs.

Very hard to breath for few minutes; Swollen arm; Nausea; Headaches; Blood clogging; A spontaneous report was received from a consumer concerning a 63 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis, headaches, nausea, swollen arm/peripheral swelling. The patient's medical history included high blood pressure. Concomitant product use was not provided by the reporter. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 027L20A) for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 0101M20A) for prophylaxis of COVID-19 infection. The first dose of vaccine was taken in non dominant arm and second dose was taken in right dominant arm. On an unknown date, the patient experienced swollen arm. In between the two doses she felt very hard to breath for few minutes and when she took a deep breath it was fine. She had tylenol for the headaches after the second dose on 08 February 2021. She also had nausea along with headaches. She had blood clogging when she was in a blood donation camp. The event very hard to breath for few minutes and blood clogging were considered as medically significant. Thiamine was provided as medication 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. Follow-up received on 17 Mar 2021 included updated date for first dose of vaccine, and the events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Nausea and headache are consistent with the safety profile of the product

Took the shot at noon, and by midnight it caused copd exacerbation. It dropped my oxygen in the 80s. I am now on oxygen daily since taking this vaccine. My doctor advised me to fill this out. I am scared to get the second dose.

Shortness of breath, tingling in both arms to chest area, felt faint, dizziness, weak 20 minutes after the shot. Then for a week felt tired, head fog, headache, stomach bloating and diarrhea.

customer went out to her vehicle and started experiencing heart palpitations and feeling dizzy and lightheaded. customer had shortness of breath and started feeling tightness in throat and chest. customer drove home and had flu like symptoms the rest of the evening. She began having shooting pains and her sciatica was acting up and she was unable to sleep. felt better in the morning, but not at all 100%.

Severe itching on vaccinated are, chest , stomach and back. Rashes and hives, Burning skin, Sneezing, over active sinuses, Nausea, swelling in neck glands and ear glands, facial swelling at mouth and eyes, tightness in chest and difficulty breathing. The symptoms got worse each day and I went to Urgent Care on the 6 th day when the swelling started. I was given a Steroid shot and a prescription for Predizone for 10 days. The shot helped within a hour or two but the symptoms are still there but not as severe. All these symptoms have happened to me before when I have accidentally injested Gluten or Wheat. Is there Wheat in the fillers? I am very nervous about having the 2nd shot !!!!!!!

A half hour after I got the shot my lips went numb (like I had a shot of Novocaine at the dentist). Then about a half hour after that, the tip of my tongue started tingling. Then a little bit after that my throat got a little tiny bit tight and dry. Then by 2:00 in the afternoon all the symptoms disappeared. Then the next day, I felt just a little bit nauseous. Then the next day the numb lips and tingling tongue returned, except that only the left side of my lips felt numb, and only the left front quadrant of my tongue was tingling.the right side of my lips were fine and the right side of my tongue was fine. Today is April 2nd, and I still feel the tingling on the left side of the front of my tongue. That is constant. The numbness in my lips has faded, but it's still there.

On Mar 31, low grade fever and chills began at 10:30 pm. Weakness began at 11:30 p.m. to the point that I could barely stand and couldn't walk without assistance. Also experienced headache and quick and shallow breathing. Extreme fatigue lasted until Apr 2.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium

went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest tightness; did not feel like she could breathe; did not feel well; her face was flushed like she was on fire; A Spontaneous report was received from a physcian concerning a 63 Year old Female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dysgeusia/Felt like metallic taste, Dizziness/Dizzy, Presyncope/ Near fainting, Gait Disturbance /Walking difficulty, Chest discomfort/ Chest tightness, Dyspnoea/ Breathing difficult, Malaise/ Feeling unwell, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing. The patient's medical history included Asthma. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination. On 9 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via intramuscular route and unknown location for prophylaxis of COVID-19 infection. had chest tightness and she is an asthma patient. She did not feel like she could breathe and did not feel well. She went back to the pharmacy and they did not want to give her EpiPen. She went into seizure because she already had seizure disorder. Her blood pressure went to 162/80 and her blood sugar went to 152 when she was on her way to the hospital and her face was flushed like she was on fire. She took Zofran during her 5 hours of hospitalization and got a CT scan. They diagnosed her with a post vaccination reaction but she still wants to get the second dose. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event Dysgeusia, Dizziness, Presyncope, Walking difficulty, Chest discomforts, Dyspnoea, Malaise, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing was considered unknown.; 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 events, and excluding other etiologies but for history of asthma, causal relationship cannot be excluded.

Rec'd injection on 3/19/2021 in the afternoon. By that night, patient reports she started to run fever and had a sore arm. Reports she also developed a rash from the injection site that went up to her shoulder. Reports rash was very warm to touch and "splotchy" looking and very red. Prior to injection she was having issues with bradycardia. After injection she began to have palpitations and her heart rate increased with noted chest discomfort and dyspnea on exertion.

See patient's account of the event below. Patient is not an established patient and did not receive care for her symptoms at our facility: On March 18th I received my 2nd Moderna vaccination. On Friday the 19th at approximately 4 pm I began to have the symptoms of an immune response in my body. Sat the 20th was spent in bed with chills, body aches, fever, stiff neck, and bad headache. On Sunday I was having pain on inhalation along with everything else. Monday the pain resolved into left side lung pain on inhalation. Tuesday the 23rd I called my provider who directed me to go to the Emergency Dept. I drove to Superior Hospital. After being accessed I was transported; with pericarditis and the additional mentioned immune response symptoms, and a pronounced heart murmur. On Wednesday the 24 I shook uncontrollably with chills for 4 hours and 2 min and went into atrial fib for about 12 minutes, resolved with medication. Thursday the 25th I woke to all symptoms being gone. I was released on Friday the 26th with the statement my issues had resolved themselves. I was told to report this to where I got my vaccine so it could be passed along.

Faltigue, headache?, nausea, diarrhea, shortness of breath on exertion ( no difficulty breathing), dizziness.

After receiving Moderna vaccine patient c/o shortness of breath, lightheadedness, throat swelling and and feeling faint. Patient received Epi pen 0.3 mg IM, placed on O2 and given 2 puffs of Albuterol inhaler while calling 911. Patient was taken to hospital by 911.

Patient described feeling weak and out of breath (heavy feeling in chest) on Wednesday, April 7, 2021. On the morning of 4/8/2021, patient noticed a small nodule on right elbow (has a sore appearance to it). As the morning continued, she noticed raised red/purple bruising on right anterior forearm. When she presented to the pharmacy, she also had what appeared to be erythema spreading to posterior right forearm. She describes the "rash" as being itchy.

After the first injection arm was sore for three days. Second shot started with fever of 102.7. Extremely cold with chills. Headache. Muscle and joint pain. Very tired. Second day fever went down to 101 with Advil. Day 3 developed hives in my mouth and my throat started to feel as it was closing up. The throat was better the second day but the mouth hives stayed until about day 6 or 7. Last night my arm was still sore to sleep on at the injection site. Today it is still tender but better.

Felt short of breath shortly after receiving shot. Have asthma so thought it was just an asthma reaction vs. an anaphylactic reaction since there were no other symptoms. However, have been having at least one asthma attack each day since receiving the shot and Ventolin is not clearing things up. Not sure how much longer to expect this to go on.

I have no idea if all this is correct as I did not write dates time or whatever down. I am not trying to deceive you or what ever but I will not take the second dose. Many medical things happened this week and I cannot remember who what or each thing was discussed but I WAS NOT told it was a reaction but that it could be and the 2nd could be worse. I sat here at home coughing so hard I could not catch a breath for over two hours before calling the squad. All tests, including chest xrays came back normal, I am not sure it was because of the covid vaccine and I am not sure it was not. I will not be getting the second dose and taking another chance. If you want pacifics my medical record is there.

Patient called pharmacy 10 days after receiving vaccine to report that on her way home from clinic she experienced breathing difficulties, including in throat, pain on inspiration, and increasing feeling "whoozy". Arm also became swollen and painful Patient did not seek medical attention but instead called a friend and remained on the phone with her through the night, until symptoms resolved.

Starting 2 days after shot heart palpitations at random times of the day and that went on for two weeks. They became worse during sleeping hours so I was awake a lot of the night. Episodes of vertigo with shortness of breath when walking or rising from sleeping. Still suffering from daily headaches.

Tightness in throat, headache, dizziness, numb in arm, tingling in throat. BP 145/76, HR 84. Recovered and released in stable condition

While patient was waiting in observation after the vaccination, she complaint of having rash in the arm and that her body and throat were itching. She did not have Benadryl on her, that is why they injected Diphenhydramine 50mg from an emergency car since the itching on the throat gave her coughing and difficulty breathing. Patient also inhaled two pumps of Albuterol HFA. After two minutes of receiving Diphenhydramine, the itching and coughing alleviated.

Pt started to have tight throat, lips tingling and numb and numbness tingling at end of tongue within 15 minutes of getting vaccine and had left facility before 15 minutes as wanted to eat... went home and took 2 benadryl from home supply and that helped though continued to have some throat tightness next day for which she continued to take benadryl. Woke up the next day w severely red face and neck, over the course of the next day developed a bright red punctate rash, "like roseola" over chest, abdomen and arms which was severely itchy and which is getting slightly better w continued benadryl and the fluocinide she uses for psoriasis

paralysis of legs; feeling like tongue, lips, and throat were beginning to swell; feeling like tongue, lips, and throat were beginning to swell; feeling like tongue, lips, and throat were beginning to swell; hot and cold body temperature; burning eyes, eyes on fire as if someone poured acid in them; Red eyes; peppery hot taste in mouth, empty bland taste in her mouth; body aches; lower back pain; itching in upper torso; itching at injection site; fever of 103; throbbing headache; fatigue; body chills; muscle aches / body aches; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIPLEGIA (paralysis of legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included No adverse drug reaction (No medical history reported.). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DIPLEGIA (paralysis of legs) (seriousness criterion medically significant), PHARYNGEAL SWELLING (feeling like tongue, lips, and throat were beginning to swell), LIP SWELLING (feeling like tongue, lips, and throat were beginning to swell), SWOLLEN TONGUE (feeling like tongue, lips, and throat were beginning to swell), FEELING OF BODY TEMPERATURE CHANGE (hot and cold body temperature), EYE IRRITATION (burning eyes, eyes on fire as if someone poured acid in them), OCULAR HYPERAEMIA (Red eyes), TASTE DISORDER (peppery hot taste in mouth, empty bland taste in her mouth), PAIN (body aches), BACK PAIN (lower back pain), PRURITUS (itching in upper torso), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (fever of 103), HEADACHE (throbbing headache), FATIGUE (fatigue), CHILLS (body chills) and MYALGIA (muscle aches / body aches). On 04-Apr-2021, DIPLEGIA (paralysis of legs), PHARYNGEAL SWELLING (feeling like tongue, lips, and throat were beginning to swell), LIP SWELLING (feeling like tongue, lips, and throat were beginning to swell), SWOLLEN TONGUE (feeling like tongue, lips, and throat were beginning to swell), FEELING OF BODY TEMPERATURE CHANGE (hot and cold body temperature), PAIN (body aches), BACK PAIN (lower back pain), PYREXIA (fever of 103), FATIGUE (fatigue), CHILLS (body chills) and MYALGIA (muscle aches / body aches) had resolved. At the time of the report, EYE IRRITATION (burning eyes, eyes on fire as if someone poured acid in them), TASTE DISORDER (peppery hot taste in mouth, empty bland taste in her mouth), PRURITUS (itching in upper torso), VACCINATION SITE PRURITUS (itching at injection site) and HEADACHE (throbbing headache) had not resolved and OCULAR HYPERAEMIA (Red eyes) had resolved. Patient had no concomitant medications on file. The patient took acetaminophen as advised by her healthcare provider to help alleviate the symptoms, but the symptoms were not relieved. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-073883:Dose 1

WITHIN 20 MINUTES PATIENT FELT DIFFICULTY BREATHING, LIPS ALMOST TINGLING, LIGHT-HEADEDNESS, COULD NOT BREATHE THROUGH NOSE

Pt was in her usual state of health. Denied any past hx heart problems, works full time past medical hx sign for dm-2, obesity, htn and crohns disease. lifelong non smoker, no etoh use. received her 2nd covid 19 vaccination on 3/24/2021 then began having progressive sob starting on 3/28/2021. presented to the emergency room on 4/11/2021 with sign sob. cxr showing b/l pulmonary edema. pt admitted to the hospital with new onset heart failure. She ultimately underwent an angiogram which showed minimal non obstructive coronary artery disease after echocardiogram showed severe global hypokinesia and ejection fraction of 15%. She was diagnosed with idiopathic non ischemic cardiomyopathy. CT scan of the chest also showed new medistinal lymphadenopathy.

After 2 hours, lips and tongue started tingling and swelling. Took Claritin. 4 hours after that, got very dizzy and unwell. Had trouble breathing. Went to nearest Emergency room, about 8 minutes away. Breathing became very labored and noisy. Treated with oxygen, prednisone, and Benedryl. After about 1 hour, was stabilized and sent home with a quick taper course of prednisone, rx for Epi pen.

Major flu symptoms. Fingers and toes ached. Headache. Nauseous. Weakness. Felt generally ill all over, like the flu. Rapid heartbeat. Shortness of breath. No fever. Felt better on 4/18/21.

pt says she woke up w/ a horrific headache. She got up vomiting, SOB, lung pain, 101.3 fever, chills, sweats. These symptoms lasted for a couple of days. She says she has diarhea now, feels like she has a fever but does not. She has tingling in both hands and has a very hot swollen left arm around the injection site. The knot is about the size of the palm of her hand. Patient says she feels a little better but still has the symptoms.

heart beating fast; chest pain; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beating fast), CHEST PAIN (chest pain) and DYSPNOEA (difficulty of breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. On 06-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 5:00 PM, the patient experienced HEART RATE INCREASED (heart beating fast) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant). On 06-Apr-2021, HEART RATE INCREASED (heart beating fast) and DYSPNOEA (difficulty of breathing) had resolved. On 07-Apr-2021, CHEST PAIN (chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: abnormal (abnormal) She took an electrocardiogram (ECG) with her home cardio machine and reported that her heart was beating extremely bad. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment included for the events were metoprolol 75mg that night, 25mg in the morning of the next day (07 Apr2021) and 50mg that night. The patient reported that she was now feeling fine. 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. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.

Nauseated, pounding headache; severe chest pain; trouble breathing; sharp quick repeated pain in my fingers, wrists, and feet; 100 degree temp; pelvic pain much more severe than I have ever had with Interstitial Cystitis = EIGHT HOURS

Patient developed muscle weakness, dizziness, wheezing/shortness of breath, rapid heart beat several hours after immunization. Patient has been resting.

Immediately after receiving vaccine, patient felt light-headed and short of breath. After lying recumbent for 5 minutes and then sitting up to drink water, the patient stated that she felt better. She was no longer dizzy. Patient stated that the shortness of breath she experienced was brief and that she has episodes of light-headedness and shortness of breath sometimes. Patient stated that she felt anxious and that she took all of her normal morning medications, but forgot her blood sugar med. Patient was monitored for 35 minutes then released to her ex-husband for a ride home.

Delayed severe allergic reaction: hives to R neck, R axillary, needle type rash to torso, severe burning and itching. Both hand swollen and red, angioedema to R face and lips, SOB lasting 7 days.

Where I got my shot in right arm I have never recover from severe pain, it hurts to touch both my arms , can hardly lift the right arm. Noticed the night I got the shot the bottom of my feet were beet red and still are. Went to ER with breathing problems. Had a meeting with My lung specialist and we both decided no 2nd Moderna Vaccine. I have been to my family Doctor and she gave me prednisone and told me to take Tylenol for pain.

Injection at 9:10am. Ten minutes after injection, severe swelling in left arm. Informed nurse. She stated to remove watch band that was cutting into left arm - the swelling was normal. Ten minutes after noticed arm swelling. Pressure on left and front of side of throat with difficulty breathing. Informed nurse. We talked and she suggested I get out of the car walk around and take deep breaths. After doing so I informed nurse my breathing wasn't any better. She took me inside one of the buildings and found someone to use a pulse ox to test blood oxygen level. She said it was fine and I was good to go when 30 minutes was up. Husband drove me home, I laid down for a nap at 2:30 pm and got up at 4:45 pm. I woke several times during nap due to pain in lower left arm and upper left chest. When I got up I had difficulty breathing, talking and walking. I called on nurse. She asked questions and told me to call 911. My husband drove me to hospital in because it was faster than getting an ambulance. On the way to hospital swelling increased to left jaw and left ear. At Hospital I was seen by many nurses, I received 2 Pepcid, a Benadryl shot and a steroid shot. Due to the location of pain they were concerned they were concerned that something was wrong with my heart or I was having a heart attack. They took blood tests and chest xrays and did an EKG. Then they had me wait for a long time then did another EKG because they didn't like the results of first EKG. No changes in EKG's. They prescribed Pepcid 20 mg BID and Prednisone 2 20 mg tablets once a day. RX for Epi-pen 2 pack. Started with medications on Monday 4/12/21 morning and took for 5 days as prescribed. Also called primary care on 4/12/21 to inform them of situation. Also called hospital on 4/12/21 asking how to get records and get information

Patient reported to Pharmacist after 5 minutes after having Moderna Injection she was not feeling well. She looked very panic I sat with her and she explained she was having numbness in hands and chest . She was not having difficulty breathing so I did not give her an epi pen injection. WE talked and after 5 minutes I asked if she would like a benadryl 50mg injection She said yes because she was not getting better. She was getting very anxious 5 minutes later I asked her if she wanted to call 911 The staff did so . Paramedics arrived in 10 minutes lThey gave her oxygen and started an IV Her blood pressure was elevated . She was taken to nearby hospital . Paramedic stated I did the right thing by calling and that she had been hyperventalating which can cause numbness in chest and hands

Muscle and Joint pain 3 + days, Headache 3 days, dizziness 3+ days. Shortness of breath still 6 days later. This was way worse than having the COVID.

a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse and on April 23, 21 was admitted into Hospital with blood clots to the left leg and to my lungs.

Tuesday, 4/27, had extreme fatigue In the middle of the night, woke up ad she could not breath. Eventually went back to sleep 4/27 in afternoon, had another instance where could not breath, then sat up and felt better. Almost went to ED, but it resolved. Then 4/29, in AM, was taking grandchildren to school and started to feel squeezing both sides of lungs. When she takes a deep breath she has pain. She feels the pain is worsening and her SOB is worsening.

Approximately 8 hours after receiving the vaccine I started to feel ill . My symptoms were chills that felt like continuous seizure activity, fever highest temp was 103.6 , severe muscle aches which I could barely walk needing assistance, nausea ,dizziness , difficulty breathing with congestion and lightheadedness. Symptoms were severe for 24 hours then gradually started to taper . Temperature still at 99.8 .

~20-30 minutes during monitor period, pt developed mild chest tightness and SOB, both partially but not totally reliveved by rescue inhaler. Pt requested to be placed on O2 and then transported to the hospital.

1ST dose: 3/2/21 5 pm headache sore left arm 4 days. benadryl/tylenol ok on 3/7/21. mild anxiety short of breath. general allergy. 2nd dose 3/30/21 : 4 PM 3/31/21: severe migraine -r hydroxyzine/tylenol hydrated ok. vitamins zinc, probiotics some cough - nose allergy seasonal. 5TH APRIL :itchy hands, arms, some pain on right hand. mild headache. 14TH APRIL 2021: woke up noon : severe headache, blurred vision, malaise, right hand frozen, pain, burning sensation upto upper right arm. itch. Cold pack treatment, numb pain on left finger tips. contact welts, red patches, hair nose eyes blurry dbl vision watery itchy - bitter taste in mouth. lower right leg toe nerve pain burn on toe. pinched nerves. upper arm.

after 2nd shot felt like throat was closing, (has had reaction before with food allergies)EMT assessed and released

metallic taste in mouth within 5 tingling in lips, face and mouth followed by tightening of the throat in 20 minutes. Symptoms subsided and return over a two hour time peroid. Treated with 50mg Benadryl. Felt general weakness, fatigue and mild tingling in face for three days

Patient presented for her 2nd Covid-19 Vaccine today and when screened with the question if she experienced an anaphylactic reaction to a vaccine or injectable medication she stated that she had itchy throat, throat closing off, hives on neck and chest after her last dose. She gave herself "Benadryl and drank lots of water" and tried to relax to ease symptoms. She has had severe reactions before and says she knows how to handle them. She did state her second exposure to things that make her have a reaction usually double. For this reason we declined to give her a 2nd dose of the vaccine today.

Left upper arm swollen, hard, extremely sore, large red rash Fatigue, chills, nausea After 6 days still suffer from chills and fatigue During routine exercise shortness of breath and dizziness

Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia. Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021 with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal. Client died 5/5/2021.

Acute hypoxic respiratory insufficiency secondary to Covid pneumonia with concerns for possible superimposed bacterial pneumonia. feeling increasingly sick, with fevers, nausea, chills, shortness of breath, loss of taste, and poor appetite. Please take Augmentin 1 g twice daily for 1 day. Please continue taking dexamethasone 6 mg once daily for the next 5 days. Please start taking Lipitor 40 mg once daily.

Shortness of breath, severe; heart palpitations; uncontrollable dry cough, gagging; hot flashes, chills, slight fever, sore throat, fatigue.

Patient started with some rashing on her arms, but waited for the post administration time. She then stated she was okay and went shopping. Approximately an hour later she came back to the pharmacy reporting she was having a hard time breathing and she felt like her throat was closing. She was seated in a chair. BP at 4:58pm was 173/104; at 504pm was 133/86; and then 152/90 at 513pm. She as given 10ml (25mg) of liquid Benadryl at 458pm. One dose of 0.3mg epinephrine auto injector was administered at 459pm. A code white was called for store management and 911 was called. EMS arrived shortly after around 510pm to take of patient who reported continued trouble breathing.

Approximately 30 minutes after receiving the vaccine, I felt a numbness and tingling sensation in my left lower lip. Pain at the injection site increased throughout the next 48 hours. Numbness and tingling spread to the left side of my face and left hand, in the first 24 hours. I was unable to reach a health care professional at the clinic, but left several messages that were not responded to. By the eve of the following day, I experienced increased swelling of my lower lip, tongue, throat, and left eye, at which point I consulted with a relative in the health care profession who suggested I try an oral dose of ibuprofen. It was nearing 9 pm and we started to drive to the nearest emergency medical location, in the event that the ibuprofen did not help. I took two 25ml capsules at that time. After about 30 minutes, I felt some relief. I took one more 25ml capsule before going to bed. The next day, symptoms began to disappear by midday.

Pt w/hx of COPD/current smoker presented to ED w/2 week episode of dizziness, syncopy, poor appetite, chills, N/V/D with no SOB or fevers. Pt stated that she may have had COVID infxn months ago prior to receiving Moderna vaccines on 2/25 & 3/25. CXR impression consistent w/known COVID-19 infection upon workup and subsequent positive COVID test (5/8). Admitted on 5/5 for additional management of acute hypoxic respiratory failure d/t bilat PNA. Pt received dexamethasone, convalescent plasma, and tocizumab and is still in hospital requiring 9L of O2.

4/23/21 at 1435: Pt. has h/o allergic reactions to Codeine & most antibiotic Does not carry an Epi-pen. No other significant Med. Hx 1315: Covid vaccine #2 given. Pt. instructed to wait 30 minutes d/t allergy history. 1340: Pt. c/o rapid pulse. HR - 124. 1343: VS: BP - 183/102 - LA (reg. cuff) HR - 109 R - 22 1345: VS: BP - 174/85 - RA (Lg. cuff) HR - 94 Pt. denies any tingling in lips 1350: VS: BP - 174-93 HR - 94 R - 18 1400: Pt. states still 0 feeling well, likeheart racing again. VS: BP - 164/97 HR - 101 Given 50mg liquid Benadryl PO - Husband arrived 1401: Pt. states she is having difficulty breathing. Called emergency number - Epinephrine drawn up & ready 1405: VS BP-171/89 HR -102 EMS arrived Pt. began feeling better upon EMS arrival. VS improving. EMS stayed ~15-20min. & pt. feeling well, deciding 0 ambulance ride to hospital. Husband took pt. home ~1425 & will monitor wife for any s/s resp. distress. Couple lives 2 blocks from EMS headquarters. Instructed to call office if any ?s, & call emergency number if any respiratory distress.

DVT of bilateral lower extremities and bilateral pulmonary edema. Treated with apixaban 5 mg per standard dosing. Hospitalized 4/27/2021 and discharged 5/4/2021. Patient convalescing at home. Tentative return to work date 5/24/2021. Follow-up hematologist consult due on 5/10/2021 and follow-up pulmonary consult due on 5/19/2021.

On 5/12/2021 developed burning and tingling right breast and rheumatologist told her to restart Enbrel and methotrexate that evening; and next day developed classic shingles blisters; restarted her acyclovir that she has on hand for herpes simplex outbreaks; on 5/14/2021 developed URI symptoms with fever 99-100 with mild SOB; today 5/18/2021 gabapentin and albuterol sulfate inhaler rxs are sent

63 yof c/o dizziness, throat warmness/tightness s/p Moderna # 2 Pt in observation period for 15 min Left clinic And came back inside d/t SXs Pt in no resp distress Pt speaking in clear and complete sentences Pt A&O x 4 Denies CP, SOB, difficulty breathing, feeling faint, vision changes, HA, nausea, weakness 2:58 PM: BP 172/73 R arm, large cuff, sitting HR 82 O2 98% on RA T 97.3 tympanic Pain 0/10 8/10 dizziness 9/10 throat warm/tight Pt in no resp distress Pt speaking in clear and complete sentences Pt A&O x 4 Denies CP, SOB, difficulty breathing, inability to swallow, feeling faint 3:02 PM: BP 166/77 R arm, large cuff, sitting HR 72 O2 99% on RA LVN went to consult with provider Stayed with pt 3:10 PM: 6/10 dizziness 8/10 throat warm/tight 3:16 PM LVN: R arm benadryl 50 mg IM x 1 per verbal order, PA 3:22 PM: 5/10 dizziness 5/10 throat warm/tight States her dtr is here and is the one who brought her to appt 3:36 PM: Feeling sleepy PA saw pt: Pt to be monitored for 15 min and then pt should be ok to go home Stated this is something that can happen but normally goes away on its own 3:54 PM: BP 150/73 R arm, large cuff, sitting HR 61 O2 99% on RA 0/10 dizziness 0/10 throat warm/tight Home care instructions and ER precautions provided Instructed pt to advise if SXs worsen or new SXs arise Pt verbalized understanding and had no further questions Pt left clinic in stable and ambulatory condition 5/18/2021 called pt to f/u Pt states Fri 5/14/21 4:30 PM felt room spinning, closed eyes and started praying, resolved in 10 min Fri 5/14/21 5:30 PM ball the size of lemon behind R ear close to hairline, painful, swollen, hard; was massaging area; today issue has resolved; denies pain, drainage, redness, warmth Fri 5/14/21 10 PM on and off CP; 15 min episodes; pressure/poking-like; resolved Mon 5/17/21 in early areas Denies going to UC, ER Denies dizziness, CP, SOB, difficulty breathing Denies concerns or complaints Pt scheduled for f/u appt with PCP Home care instructions and ER precautions provided Instructed pt advise if SXs worsen or new SXs arise Pt verbalized understanding and had no further questions

Pt developed wheezing and coughing due to wheezing, pt attempted puffs from her personal albuterol inhaler with no relief, an albuterol neb was administered and 50mg benadryl given IM, pts symptoms resolved with this treatment, total time was approximately 15-20 minutes.

In March, these symptoms lasted 8-10 days- Fever of 100-102, chills, aches, significant headache, heavy fatigue, itching, tightness of breath, upset stomach, skin and joint tenderness, rash on neck/ upper chest, visibly swollen joints where I have arthritis. Since March, I have had 3 additional bouts of these symptoms that have lasted 3-5 days each. Each time my allergies and asthma symptoms increase dramatically (must use emergency inhaler, take maximum antihistamines around the clock, sleep 12-15 hours/ day)

Chills, muscle ache, new loss of taste, shortness of breath, fatigue and nausea. Abdominal pain and diarrhea Hospitalization

Patient presents with 7 day history of shortness of breath. Ct angiogram showed multiple pulmonary emoblism with ventricular strain. Patient required EKOS procedure for clot dissolution and bridging from Lovenox to warfarin.

The morning after I received my second vaccine I began feeling nauseated, then I started sweating profusely, and as I started to get a wash cloth to try to cool myself, I passed out. I came to shortly thereafter, but was weak the rest of that day. The second day after the vaccine I did go to work, but I battled my asthma all day. I had to use my emergency inhaler twice, and at one point thought I was going to have to go to the ER before getting it under control, but I did not have to.

Fever, pain throughout body, chills, extremly tired, headache, body aches. no appetite. Asthma flared up with cough, tight chest, hard to breathe .went to Dr next day was put on prednsione as all other aliments went away except asthma. Have been using symbicort, prednisone, 3 seperate prescriptions , Z Pack, albuterol. cough medicine DM , claritin, nebulizer and nothing is clearing up the breathing or coughing spells.

Coldness in my chest, heart. I had coldness in my right lung and the P.A. thought I might have pneumonia so I was given ZPAC. It did nothing. She then told me I had inflamation in my lung and it would go away in weeks .I kept having a hard time breathing which finally stopped on the 18th day. I did have a covid test which said negative. When I got the first Moderna shot the coldness transferred and went straight to my heart area from my lung. It started getting better in the first 3 weeks but by the 4th week it was feeling stronger. The 2nd dose has helped a lot but the coldness inflamation in my heart comes and goes all day. It is very slowly improving. The inflamation and hard time breathing actually started on Dec. 31, 2020. The inflamation in my heart started April 6, 2021 and as of today May 26, 2021 I still have it.

After second vaccination: Initially: Sudden experience of very low BP - 91/41 - fatigue, shortness of breath, dizziness, unable to go to work. Vertigo. One week later and continuing: heart palpitations, a fib, fluttering, shortness of breath, dizziness, fatigue, nausea, low BP, and unable to go to work.

05/20/21 Approximately 5:30 pm, during meal, consumed steak, rice, corn. Felt like "air bubbles" in throat; felt like "throat was closing", patient coughed. Symptoms resolved in "maybe" 3 to 4 minutes.

Woke to a pounding in my chest heart, very high blood pressure and heart rate. Have never had any of those symptoms before. High heard rate and shortness of breath lasted three weeks blood pressure became normal again in a week. Resting heart rate 107 Blood tests normal EKG Normal so no obvious cause or reason why this was happeneing. Any movement made me winded.

Within 15min of her shot, patient had tingling inside her mouth & her tongue, her lips were numb, and maybe had some tongue swelling; her breathing was labored (short of breath); her skin was flushed like a sunburn, starting at her head and moving down to her chest. Patient said she didn't mention anything to us (the pharmacy) because she is allergic to other things and didn't think much of her reaction. By 30min after her shot, the reaction was fully formed; all her symptoms went away within an hour without any treatment. Patient spoke with her PCP who told her to not take the second dose.

Two days after I had my second Moderna shot, I began having severe shortness of breath, no appetite and chest pain. On the 2nd day after my flu-like symptoms had disappeared, I woke up feeling like someone was sitting on the middle of my chest. I have never in my life experienced that before and it scared me to death! I was also have sporadic shortness of breath over the silliest of things - like vacuuming, walking up a few stairs, washing dishes, etc. Keep in mind - I have exercised all my life so this was very unusual for me. The tightness in my chest happened several times over the next few weeks - at different times of day and night - and even in bed. All those symptoms disappeared about 2 months after the second shot. After reading some people had heart inflmation after the second dose, I Googled it and alot of those symptoms were the same ones I had.

nephrotic syndrome; minimal change disease; focal acute interstitial nephritis; mild acute tubular injury; uncontrolled hypertension; foamy urine; Hypoalbuminemia; proteinuria; hyperlipidemia; Product dose omission; fatigue; dyspnea; progressive anasarca; periorbital edema; This literature-non-study case was reported in a literature article and describes the occurrence of NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury) and DYSPNOEA (dyspnea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Tobacco use disorder (dependence). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea) (seriousness criterion medically significant) and FATIGUE (fatigue). On an unknown date, the patient experienced NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease) (seriousness criterion medically significant), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis) (seriousness criterion medically significant), RENAL TUBULAR INJURY (mild acute tubular injury) (seriousness criterion medically significant), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with VALSARTAN (oral) for Renin-angiotensin system inhibition, at a dose of 80 mg twice a day; DIURETICS for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (METHYLPREDNISOLON [METHYLPREDNISOLONE]) (intravenous) for Adverse event, at a dose of 500 mg, pulse, for 3 days and PREDNISONE (oral) for Adverse event, at a dose of 1 mg/kg,unk. At the time of the report, NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia), PRODUCT DOSE OMISSION ISSUE (Product dose omission) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Biopsy kidney: minimum change disease (abnormal) pathology confirmed minimal change disease with mild acute tubular injury and a focal acute interstitial nephritis was also present. Four of 69 sampled glomeruli were globally sclerosed. There was 10% tubulointerstitial fibrosis. The glomeruli were found to have 100% foot process effacement. In April 2021, Blood albumin: 0.7 g/dl (abnormal) 0.7 g/dl. In April 2021, Blood cholesterol: 450 mg/dl mg/dl (abnormal) 450 mg/dl. In April 2021, Blood creatinine: 1.48 mg/dl mg/dl (abnormal) 1.48 mg/dl baseline was 0.7mg/dl. In April 2021, Blood pressure measurement: 181/82 mmhg mmHg (abnormal) 181/82 mmHg. In April 2021, Blood triglycerides: 221 mg/dl mg/dl (abnormal) hyperlipidemia. In April 2021, Creatinine renal clearance: 13.4 g g (abnormal) 13.4 g. In April 2021, Urine analysis: 3+ proteinuria (abnormal) 3+ proteinuria (without microscopic hematuria). mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and FATIGUE (fatigue) to be possibly related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Product dose omission). No prior history of renal failure. No concomitant medications reported. Patient advised to forgo the second dose of mRNA-1273 vaccination. The authors believe further rechallenges or boosters of this particular vaccine in this patient would be unwise until this potential relationship is more clear. 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, for the event Intentional Dose Omission of mRNA-1273, causality 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, for the event Intentional Dose Omission of mRNA-1273, causality is not applicable.

chest pain, difficulty breathing, day following shot. ER hospital, admitted, pericarditis, discharged 05/04/2021

Two hours after receiving the vaccine I started having heart palpitations and SOB that lasted until 09:00PM that night. On Friday, I experienced the same thing. Saturday, it started earlier in the day and it lasted until I went to bed at 11:00PM. On Sunday morning, when I woke, I still had the palpitations and the they were worse. All of the testing that they performed came back normal. They ruled out a heart attack and assumed I was having a panic attack. I went to see my PCP on Friday and everything checked out fine. My cousin had the same exact symptoms and she was told the same thing. I have not had any more palpitations since the last time and my breathing is good too.

redness, swelling left upper arm, pain decreased ROM left shoulder, fever, chills, muscle pains, weakness, tiredness, (slept over 10 hours) joint pains. with first dose, took allergy medicines, anti inflammatory medicines, . Second dose 02/11/2021 noticed more weakness, SOB, tiredness, joint pains mainly hand pains. Episode of palpitations lasting several hours 4/11/2021. Took more allergy and anti inflammatory medicines.

Dose 1 Palpitations, increased heart rate. Shortness of breath. Heart rate in the hundreds even on meds. Struggle to work everyday. Dose-2 01/27/2021, at 9 PM my heart rate raised, vomiting, off work for 4 days. Lethargy, loss of appetite. End of Feb, contacted PCP, I was exhausted and fatigued and struggled with any activities. Thyroid test Graves disease diagnosed. I never had issues with thyroid, no family history of thyroid problems. My levels were extremely elevated. The only treatment was surgery to remove thyroid. Third week from thyroid surgery, went back to work on 4th week, I now have to be on thyroid medication for the rest of life. Hair was thinning and nails were brittle, still going on. Discontinued all medication except for new medication of Synthroid.

Joint pain; Chills; Congested chest; So bad COVID-19 infection after the 2nd dose; Very sick; A lot of phlegm; Lots of coughing; Congested head/ Sinus infection; Dizziness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY CONGESTION (Congested chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PULMONARY CONGESTION (Congested chest) (seriousness criterion medically significant), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, PULMONARY CONGESTION (Congested chest), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient took Aleve, Mucinex DM to breakup the phlegm, Tylenol, and Pain pill as a treatment medications. Company Comment : For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events: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 verbalized that she has been SOB since her last COVID vaccine and was unable to lift left arm up to normal height and still has left arm pain. Patient verbalized that this has all been since her 2nd COVID 19 Vaccine. She received her 2nd Moderna COVID 19 vaccine on 05/10/2021. According to the VIS system it was a Pharmacy Store per VIS

This was my second covid vaccine, 2-3 days after receiving this dose I started experiencing chest pain, and pressure neck throbbing, blood pressure extremely high, severe headache in the back of my head and neck, short of breath, leg pain and weakness. Prescribed an additional medication for my blood pressure

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Severe, Additional Details: After administration, patient was flushed red in the face and her friend (who was translating) said that the patient's throat was closing up and she was having difficulty breathing. The patient fell off the chair and I instructed the friend to elevate her head from the ground to keep the airway open. Patient was screaming and complained of pain radiating from the back of the neck to the lower back. Epipen injection was administered, and 911 was called. Patient could breathe and no longer flushed

Symptoms: short of breath & heart palpitations after very little exertion, occasional dizziness or light-headedness. Treatments: (cardiologist) states he will try to get me into the heart rehab facility for monitored exercise. I am thinking I may need to get my lungs checked.

After the 4th day of the shot I wasn't feeling good, I was always dizzy, Short of Breath, Exhausted where it was hard to even get out of bed. Even trying to clean my house made it worse where I could not catch my breath. I could not drive do to my condition my Husband had to take off of work to take me to my Doctors Office

Three days (03/06) I had go to the emergency room. I was diagnosed with a Pulmonary embolism. I couldn't breathe good.

As soon as she got the shot she got immediately sick to her stomach, started itching and broke out in a cold sweat. Took Benadryl when she got home and by that evening her tongue and throat started swelling, heart palpitations and couldn't breathe. Went to the ER blood pressure started going up, heart started racing and was having spasms. When released from ER started getting blisters. Went to Hospital ER.

Caught COVID virus after being fully vaccinated. Fever, cough, congestion, no taste, no smell, can't breathe and shortness of breathe.

On April 27th participant stated she woke up with a congested chest and shortness of breath. Called her doctor and she scheduled an appointment on the 5th of May and put her on antibiotics because her doctor said her heart didn't sound right did an x-ray on her chest and sent her to a heart doctor. Seen Dr. on May 17th and he did an ultrasound and an acro-cardiogram. Got her test results back on June 7th and everything tuned out fine.

The evening of the vaccine I was having a tingling sensation in my legs where I get Cellulitis. The next day my legs were painful and it got worse. I got Cellulitis in both legs and it normally only happens in one leg. I also had a rash on my right arm. It was a red swelled spot. By the time I was in the hospital the swelling was all the way above my knee. I was also wheezing but it was identified as long Covid-19 symptoms. I had Covid-19 in March of 2020. I was sent home after two days and prescribed Keflex. I was referred to a Pulmonologist.

10:03Throat felt like going to closing like after other reaction to rocephin. 10:05Swallowing ability felt like going to be difficult. 10:06 Immediately to ER from vaccination area at hospital. 10:10 Then coughing from bronchospasm lasting over a minute repeating until ER meds kicked in . Meds- solumedrol 125 mg IV , Benadryl 50 mg IV , xophenex 1.25 nebulizer

About 5 minutes after receiving the vaccine, she began to experience a dry cough and tickling in the back of her throat. Also reported some shortness of breath. 25 mg of Benadryl was given IM in the R deltoid. Her symptoms subsided after approximately 15 minutes and she was able to return home.

body aches, fever 1st 24 hrs, diahrea, headache 48 hrs and swelling of eyes, nasal passages and shortness of breath at 50hrs. Treated with antihistines and steroids for a week .Feeling better now but have been extra tired.

Woke morning after, 1/4/21 with nausea and headache; by 10:30 a.m. body aches, chills and temp 100.3; Tylenol at that time; To bed at 11:30 a.m. Woke at 5pm with body aches, chills and fever 102.4; Motrin at that time; Morning of 1/5/21 temp 100 most of date with headache, body aches and fatigue; Afebrile by that evening; Morning of 1/6 woke with headache and fatigue; shortness of breath and tachycardia with exertion. Normal HR w/rest. Morning of 1/7 woke with headache that resolved w/Motrin - worked all day

Patient felt cold, lightheaded and had tingling sensation. Followed by chest pain and shortness of breath. Patient was transferred to stretcher for monitoring. Dose of Solumedrol 125mg was given at 13:42. Dose of Benadryl was given at 13:45. Dose of Epi-pen was given at 14:06 and patient showed some improvement. Then ambulance arrived and patient was taken to hospital.

Sensation in throat, followed by mild SOB, and seemingly troubles ?clearing? throat. Took a Claritin about 45 mins after injection with complete symptom relief

Difficulty breathing and swallowing, dry mouth Narrative: Employee vaccinated in COVID Vaccine Clinic, within 10 minutes developed throat tightness and difficulty swallowing with a dry mouth.

1/6/21 Developed fever, chills, headache & respiratory cough. Fever lasted 2 days (101.7). Chest congestion continued to 1/10/21. On 1/9/21 lost sense of smell and taste and is still ongoing as of 1/11/21.

I had a Covid test on the 1/4/21 thinking I might have covid. I am negative. So concerned had a 1/12/21 EKG all was fine. I have had shortness of breath and very rapid heart beat. I had a bruise on my right arm the size of a desert plate. It is finally gone after 12 days. I never bruise from any kind of an injection, My blood pressure was up. 135/80 . I am usually 106/68.. 1/12/21 Had temp 99. On the 9th day.. Very tired slept the day away. I am a person that requires about 6 hrs a night I am fine. My pulse had been around 88 it is usually 68-70. Oxygen is 98.

On Saturday 1/16/21 at approximately 4:15 pm my husband and I received the Moderna vaccine, lot number 041L20A . We waited the required 15 minutes to see if we had any reaction, we did not. After checking out we drove directly home. At approximately 5:10 pm, while driving to our home, about 45 minutes after receiving the injection, we both noticed that we were having difficulty swallowing and felt a swelling in the back of our throats. My husband experienced a metallic taste. The feeling of the swelling in our throats was similar to when a dentist uses a topical numbing gel prior to a dental procedure. The difficulty swallowing and the thickness in our throats lasted about 30 - 45 minutes. We monitored ourselves at home and did not feel that we needed medical attention. Because of my angioedema I had 2 Epipens at the ready. We both experienced soreness at the injection site (left arm), my husband's sorer than mine. The swollen throat and difficulty swallowing is the only reaction I had. My husband woke on Sunday morning and his arm was very sore, more so than what he has experienced with a flu shot. At approximately 12:15 pm on Sunday, 1/17/21, and about 21 hours after the vaccine was administered, my husband began to feel achy, like he was getting a cold. He took a nap and upon waking did not feel any better. His temperature was 97.6. He felt lethargic the rest of the day and went to bed early and sleep ok but woke up not feeling any better. I used a finger pulse oximeter and it registered 94/94. His temperature remains normal. I am registering these reactions after reading about the adverse and severe reactions of persons at who received the same Moderna lot 041L201 as we did.

Pressing on chest causing shortness of breath; extreme fatigue; stomach discomfort; nausea, headaches, no appetite; chills; diarrhea, 2 days later false positive for Covid. Three days later for next 4 days, tested negative each time for Covid. Since vaccine 1 to 3 weeks later fatigue, no appetite, suicidal thoughts as if my endorphins were temporarily deleted but endorphins returned 24 hours later. Due to the extreme side affects, 1/22/21, I will not receive my 2nd Moderna vaccine.

Shortness of breath - 7days and counting. Doctor and Urgent Care refused to treat due to ignorance about vaccine reactions. Exacerbated inflammation left shoulder joint

She experienced headache, dizziness and SOB. Later she developed diarrhea, then swelling in her both feet and right knee. She was admitted to the hospital for tests last Friday night and was discharged with gout. They drew fluid from her knee and left ankle. She is in a wheelchair at home.

30-45 minutes post injection experience severe dizziness and tingling of lips and mouth along with mild SOB. This lasted about 20 minutes and slowly subsided. That evening experienced moderately severe headache along with nausea, diarrhea, which lasted about 4 days. Have felt lethargic since vaccine but as of 1-26-2021 this is improving.

Asthma exacerbation treated with prednisone and (2) DUONEB with improvement in the ED. Discharged home with (5) day course of prednisone.

I already had a mouth sore about a week before the vaccine. The very next day that I received the vaccine started getting worse. The very day I did not notice anything but then 24-48 hours after the vaccine it started being pretty bad and it got a point where it got so bad the whole left side of my face swollen up, my tonsils, my neck, down the throat, only on the left side of my face. At one point it was hard to swallow (NY Eve), it was hard to swallow and breathe. I had just started taking the medication my DDS prescribed and it was not really helping yet. On New Years day when I woke up a little better. It took about 4-5 days for the swelling to go down. After 2 doses of the medication prescribed the pain was much more bearable and the swelling started going down. On 01/02/2021 my dentist cauterized some of the sores in my mouth,

While being observed for 15 minutes post COVID 19 vaccination, pt complained of shakiness, swelling throat, flushing in chest and voice became hoarse. Upon assessment, pulse was 110, respirations 12, BP 176/98, SP02, 97% Client reported Hx of asthma and chemical allergies (non-anaphylactic). Client administered albuterol to self, was given 12 ml oral diphenhydramine, and was actively monitored for 30 minutes. Ending VS: P 91, R 12 BP 168/82, SPO2 on room air 97%. Client reported feeling much improved; was taken home by spouse.

FIRST NIGHT- 1/23/ 21- RIGHT ARM PAIN, OVER 12 HOURS; NEXT DAY- 1/24/21- GENERAL FATIGUE , MALAISE , NAUSEA OVER NEXT FEW DAYS- AT NIGHT, "HOT", LIKE HOT FLASH, AND NIGHT SWEATS (NOT SURE IF RELATED, JUST FELT WORSE THAN USUAL. (JAN 31, HUSBAND STATED THAT I FELT "HOTTER THAN NORMAL" TO HIM DURING NIGHT. CONTINUE TO HAVE LOW ENERGY . URI SYMPTOMS, RUNNY NOSE AND SNEEZING. POSSIBLY RESPIRATORY - SENSATION - HAVING TO TAKE A DEEP BREATH, BUT NOT ACTUALLY SHORTNESS OF BREATH.

Headache, Chills, 101 fever, weakness, muscle aches, intense burning sensation in both arms, nausea, shortness of breath for 48 hours. One incident of irregular pulse that lasted 45 minutes .

1st Vaccine 1/6/2021; 2nd Vaccine 2/3/2021 in the am; developed SOA, fever, and cough 2/3/2021 night; seen at ED 2/4/2021 for reported symptoms and d/c' home same day.

had sudden worsening of sinus congestion for about an hour, also tightness of throat for about 3 hours, then rash on upper body for about 3 days, head felt tingly and dizzy. some redness and swelling of the injection site.

1/22/2021 - One & one-half hour after shot, little finger on left hand was extremely painful and hot; painful to grip hand. Took Tylenol & resolved in 4-5 hours. Eight-12 hours after shot - extremely sore arm; took Tylenol & resolved. 1/23/2021 - Latent asthma (no episode for over 2 years) started 24 hours after shot, continued for three days. 1/26/2021 - First-ever episode of Raynaud's syndrome - left hand -occurred during 15 minute walk in 40 degree weather while wearing sheepskin-lined suede gloves. 1/28/2021 - Minor arthritis in hip flared up to very painful & lasted about 8 days.

Fevers to 103 Rigors for 3-4 hours Headache the next day Fatigue Diarrhea/abdominal pain Shortness of breath x 3 weeks now.

Within seconds after receiving the vaccine my nose started drying up and I couldn't catch my breath. The nurse gave me shot of Benadryl. Since then my tongue and throat feel like they are trying to swell. I took some Benadryl. I feel like bronchitis and it is like I get winded easy. I have a crawfish allergy and my throat feels the same as when I eat crawfish. I called my doctor today and she did video visit with me at 11:30 and said if I keep feeling like this to go to the ER.

Patient's face was flushed and c/o "crawling things" on her face and itching and started coughing. Pt stated her throat was "closing up" but was able to speak and breathe. Pt's legs were raised, cold packs applied and Benadryl was given (per standing orders 25mg, PO). 0922 BP was 170/104, HR 61, Alert and oriented X4, hoarse voice and cough persist, no signs of labored breathing, able to complete sentences. Pt stated she had an EPI pen " just in case." At 0929 EMS arrived VS: 165/98, 88, 90%, at 0933 VS: 151/88, 86, 98% still alert and awake, no difficulty breathing noted. Patient declined to be transported to ED and stated "something similar happened when I got my flu shot " and when she received a "shot of antibiotics." VS at 0937: 128/76, 74, 98-99% Patient was assisted to car and she and Spouse drove away. No s/s of distress noted; pt was able to walk to her vehicle, denied other symptoms and stated she was "feeling better."

within 10 hours I had chills which I had for about 3-4 days. then I developed "Covid Arm". the injection site was 3x3 red, hot, swollen, rash on my arm. I had nausea and vomiting. my asthma also flared up. I also had joint pain. On Saturday the 13th I started having some weird things going on. I had mild paralysis and I was diagnosed with Bells Palsy in the right side of my face. (notably the same side as the shot was administered)

Throat and tongue tingling and sensation of swelling, diarrhea and took benadryl. At 8 hrs post vaccine got dizziness, throat swelling, anxiety, and had to use epipen. Went to hospital by ambulance and was further treated with prednisone and benadryl and Zofran.

pt presented approx. 25 mins after receiving Moderna vaccine in which she complained of throat tightness she remained upright and talking during event and was immediately pulled back for tx. Code team called to assess allergist on call during team who tx pt for sx at the time of event in clinic. epi pen administered in clinic, EMS called for pt transport. Pt stable upon leaving and oxygen remained 99% both before and after the administration of epi-pen.

Throat began to swell and I felt like I was going to pass out. Alerted the desk, brought to treatment room and given a very delayed epi-pen injection 42 minutes after. Transported via ambulance to Hospital to monitor effects of epi-pen and period of time once the administered medication wore off. Given 40mg of Prednisone and 40 mg Pepcid by mouth. Severe bouts of virtigo with vomiting and chills which continue one week later. Pain at injection site.

Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127

2/14: The day after receiving the vaccine, she noticed a rash on her chest and legs. She felt nauseous and endorsed vomiting, body aches, and fever. 2/16: Saw PCP and was found hypotensive. Was sent to ED and received 2L fluids, IM steroids, and PO ondansetron. She was discharged because she was feeling better. 2/17: Returned to hospital due to pleuritic chest pain and hemoptysis and was noted to have an elevated lactate (received 3L fluids) and was admitted to the hospital. SpO2 was in the 70s on presentation and she was placed on BiPAP (O2 improved to 100%). Per note: patient presented to the ED with hypoxia, tachycardia, tachypnea, and leukocytosis. Patient received dexamethasone 6mg, vancomycin, cefepime, azithromycin, furosemide, and ipratropium/albuterol. Patient is currently receiving the following medications: budesonide, ipratropium/albuterol, cefepime, acetaminophen, atorvastatin, benzonatate, enoxaparin, escitalopram, ferrous sulfate, guaifenesin, hydrocodone/acetaminophen, methylprednisolone, methylprednisolone, Montelukast, morphine, ondansetron, pantoprazole. Patient has been hospitalized since 2/17

Patient states that she was not feeling right, stated could have been blood pressure, blood pressure was with in normal limits, patient stated that she was having shortness of breath and chest tightness, offered to call ems client refused stated that she had family here with her and that she would have them take her to the ER advised against offered to call ems again client still refused and left with family in private vehicle .

Moderna COVID-19 Vaccine EUA adverse event. Approximately 7 hours after the 1st COVID vaccination on 2/22/2021, patient developed symptoms of fatigue, aches, chills & fever. Her symptoms worsened into 2/23/21 with increasing shortness of breath. On arrival in the emergency center on 2/23/21, she was hypoxic with SpO2 81% on room air. Oxygen supplement via nasal cannula was given which improved her oxygenation. Covid 19 test negative. Chest Xray shows pulmonary edema and CTA chest shows no PE. She was admitted to the hospital and provided supportive care. Pulmonary Edema and inflammatory process is likely associated with the vaccine. Patient appeared to be improving, however, on 2/26/21, she was working with Physical Therapy/Occupational Therapy and had a pulse ox reading of 75% on room air. She was on 10 Liters of oxygen via nasal cannula by the time she make it back to bed and her pulse ox was 89%. Neurology exam shortly afterward the above event demonstrated an NIHSS of 21. Patient became non-verbal and stat imaging revealed an acute hemorrhage in the left occipatal lobe likely representing a SAH. Patient then transferred to another hospital that could provide neurosurgical intervention.

The usual arm soreness. Then, 24 hours after shot began being nauseated, dizzy, headache, and with chills. Then, 48 hours additionally had slight loss of taste (most things tasting very flat, but could taste salt well). Third day still dizzy, especially upon standing (no blood pressure drop), and having some dyspnea. Walked out of house to get something from car (hot & sunny), legs got weak, had shortness of breath, and pulse 104, but with 97% pulse ox.

64 YO AA FEMALE PRESENTED WITH ACTIVE VOMITING. PT STATES SHE FELT FINE IMMEDIATELY AFTER RECEIVING THE VACCINE. AFTER WAITING IN OBSERVATION FOR 10 MIN, SHE STARTED TO FEEL A HOT FLASH (CEPHLAD TO CAUDAD), NUMBNESS IN HER JAW; SWELLING IN HER THROAT AND COULD NOT SWALLOW WATER/ KEEP IT DOWN. SHE ADMITS HAVING A DULL FRONTAL HEADACHE. DENIES CHANGES IN VISION, CHEST PAIN OR PRESSURE. BP 150/84 HR 83 SpO2 96% PT APPEARED ALERT AND ORIENTED X 3 WITHOUT VISIBLE NERVE DEFICITS. NO FACIAL SWELLING, LYMPHADENOPATHY, OR DIFFICULTY SWALLING ON EXAMINATION. SMALL ERYTHEMATOUS HIVE NOTED ON PTS' RT BRACHIAL AND CERVICAL REGION. AFTER 15 MINUTES OF MONITORING, PT SYMPTOMS RESOLVED AND VOMITTING CEASED. PT WAS INSTRUCTED TO REHYDRATE WITH ELECTROLYTE FLUIDS AND RESUME EATING PROGRESSIVELY. NO BENADRYL OR STEROIDS REQUIRED. PT LEFT IN STABLE CONDITION WITH HUSBAND. PT ADVISED TO F/U WITH PCP.

Pt reports cough, SOB with coughing and laying flat, congestion, runny nose, sore throat, and sensation that "throat is closing" when laying flat. No lip swelling, throat swelling, or rash. States she did not have symptoms prior to vaccine and noticed them this am, the day after. No other symptoms. Does admit that in the past when she had allergies act up, that she felt similar. She has not tried taking any medications to treat these current symptoms.

About 4 hours after shot I became short of breath just like when I had Covid-19 this summer. It has gotten better but I am 9 days out and still have to stop occasionally to get my breath. Tiredness.

The evening after the injection chills, fever and fatigue for 48 hours.. Fatigue continued for a week then the following Wednesday after the vaccination on March 3rd. Chest pains began with shortness of breath at about 6pm. Went to the hospital that evening and had xrays and echo which showed signs of fluid and inflammation in the pleural sac. Diagnosis Plurisy. Patient had no history of lung issues or recent sickness other that the vaccination.

Day 4 became short of breath and continued to increase each day until hospitalized on March 3, 2021. Wheezing, poor response to home meds. Oxygen sat was lowest 88. Dr thought this reaction was due to prior lung infection 2018 (ARDS - staph pneumonia).

The injection was my second shot of the moderna vaccine. My first shot was on 2/13/21 and I told the facility it was only 21 days but they said it was okay. When I gave my card to them they stamped it, and continued to send me to get my other shot. Later that same evening my fever started fising and lowering non-stop through out the night into the next day and still today I am running fever. It has gone anywhere from normal to 101.5 and 15 min later it can drop to 99 and a hour later back up,. It has been like this for 48 hours now. I am having a very hard time with my breathing but I am a copd patient and cannot tell if it is my disease or the shot.

Numbness to left side of face, heaviness on left side of face, with tightness to left jaw. Difficulty breathing - given albuterol 2 puffs. Sitting BP 111/71; standing BP 96/73.

At approximately 30 minutes after the shot, I experienced a tightness in the back of my throat. It lasted for approximately one hour and subsided without any interventions.

Pressure moving across chest from left to right, rapid heartbeat, swollen throat and out of breath. I also had arm pain and confusion

Awaken around 2:00 am with mild asthma symptoms wheezing and tight chest. Haven't been waken before at night and thought it was unusual. Around 5:00pm that same day I noticed itchiness near the injection site and around the neck. Around 6:00pm I noticed a muscle twitch around the elbow on the right arm. By 7:00 pm my back, chest, and both arms were extremely itching. I took a generic Benadryl and a puff of my Proventil inhaler. This helped a little but I took another Benadryl an hour later. I was able to sleep several hours later. Next morning sill have itchiness but less and asthma symptoms seem better.

general severe inflamation for 5 days. Could not climb stairs, could not walk more than 4 steps without wheezing, asthmatic cough, migraine, physical exhaustion, Extended asthmatic episode for 3 weeks so far, is being treated. NOTE: My mother was one of two people in 1959 who had Gulliane Barre after a flu vaccine. The other person who had it died. My mother was hospitalized for several months but survived. Dr. at CDC has details of case.

Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.

Became incredibly ill on March 4, 2021, still sick, fluctuating fevers 100-104, body aches, dizzyness, weakness, unbalanced, sweating, unable to get out of bed to days, almost passed out on March 6th. Day 7, dizzy head, dry mouth, recent tickle cough at back of tongue making it hard to breathe or talk without coughing spasm, slightly more strength today, but still feel incredibly weak and don't know how long to get back my normal self. No congestion or lung problems.

Was in 30 minute monitoring d/t hx of anaphylaxis to wasp sting. At 20 minutes post injection, developed tight cough and wheezing. States it felt like a film in her throat and her tongue felt "weird." Placed on O2, administered 0.3 mg Epi pen to right VL and 50 mg Benadryl IM to RD. Began improving immediately. States she always has a low BP and pulse. Medical hx includes liver disease, bipolar, dementia, arthritis. Accompanied by son.

THIS IS A SECOND ADVERSE REACTION EXPERIENCED FROM THE 2-26-21 vaccination...1ST ADVERSE REACTION ALREADY REPORTED.....was sick approximately 4 days with 1st reaction (reported) 5 days passed and 2nd adverse reaction: extreme flu-like symptoms and, in addition, extremely sore left side along my ribcage (received vaccine in left arm), fever, nausea, fatigue, chills, burning in legs, feet and toes, short, but extreme pain/sensitivity where spleen/pancreas are, extreme trouble breathing and seemed to bereft lung...the symptoms seemed to morph occasionally...I could almost feel it move upwards and, ultimately, extreme headache...symptoms lasted approximately 4 days...still very tenderlogwer left ribcage...

Fever up to 101.2. Headaches. Body Aches. Increased resting heart rate. Shortness of breath on any exertion (i.e. walk 20'..) Increased heart rate to 110's with minimal exertion

Within 30 minutes numbness and tightening of left side of face and throat. After an hour a headache set on and then neck pain usually associated when my blood pressure goes high. Upon taking blood pressure 3 hours after vaccine. blood pressure registered 107/190. I felt nauseated with head ache.

Complained of "arms, mouth tingle and metal taste in mouth"; Heart Rate increase to 126; Respiratory Rate increase to 26; Symptoms subsided after 30 minute wait in recovery observation: Heart Rate 80, Respiratory Rate 16.

Hives, extreme dizziness, weakness, headache, hives, nausea, rapid hearbeat, chest pressure, shortness of breath, sweating, throat tightness. Admitted to emergency room at Hospital.

Patient complaint of throat tightness starting 10-12 minutes after injection. Patient did have a non-productive frequent cough during my time of observation. States history of "being sick for 2-3 days" whenever she gets the flu shot but no symptoms like this. RRR, CTAB, patient had her albuterol inhaler with her and she self-administered 2 puffs inhaled. BP elevated at 182/120, pulse 114. oxygen saturation maintained over multiple checks above 95%. BP well controlled at last office visit in October. With patient's persistent throat tightness, elevated pulse and BP, EMSA was called and will be transporting her to hospital for further evaluation and treatment.

Shortly after the first dose I experienced chest pressure for approx. 10 minutes and slight difficulty breathing.

Two days after the vaccine I couldn?t breathe, and I had a cough. I consulted a telehealth service 01/19/2021. My Lymph nodes were swollen in my neck on both sides and they are still like that after 10 weeks. I have Asthma but I had pain in the upper lobes of my lungs and then I became congested. I was diagnosed with walking pneumonia on 01/21/2021. I was prescribed Doxycycline and the infection subsided. I had the second dose of the vaccine Prednisone and Allergy Meds added since second dose for exacerbation of Asthma condition that started two hours after second dose.

The day I got the vaccine I felt nothing at the injection site and I felt absolutely fine. But at about 9:00 PM on 3/17/2021, I immediately started feeling very ill. I was freezing cold and it felt like ice was flowing through my veins; my breathing became much more rapid and deep (no congestion) and I felt weak and achy. Then my teeth started to chatter. I took 1 Aleve , which did nothing (after 90 minutes) and then took 2 packets of Emergen-C Immune system defense (an OTC vitamin supplement) in a small glass of water. I started to warm up and feel much better at about 1:00 AM. At this time I took my temp which was 100 degrees. I have felt fine since this strange episode, except I still feel a little bit fatigued.

I got the shot in my left arm at about 3 PM on March 18th. I did not have any side effects within the 15 minute waiting time. After 2 hours my arm became very sore and throbbing. I took 1 regular aspirin and 1 extra strength Tylenol. I went to bed at around 10 PM. I woke up at 3:30AM on March 19 gasping. My upper throat was tight and seemed to be spasmodic. Suspecting that it was an allergic reaction, I took 1 Benadryl tablet. I had difficulty swallowing the medication. After about 1 hour, where I was not seeing any improvement, I decided to go to ER . They took two Soft tissue X-rays of my throat. They gave me a nebulizer treatment with a bronchodilator racepinephrine at 7:05AM March 19. At about 8:15AM they gave me a steroid pill and I left the ER at 8:21AM.

Please stated that she felt hot, short of breath, and her tongue was tingling. Epinephrine given to Right outer thigh @ 1445 and Pt. sent down to Emergency Dept.

5 minutes after shot shoulder pain then down to forearm. 10 minutes after shot, fast heartbeat and a little trouble breathing, headache, feel cold, stomach ache, belly ache, wanted to throw up, muscles shaking, throat sore. Drank vitamin C 1000mg. After 15 minutes I felt better. About every 15 minutes there would be another wave of the same pains. Then I would feel better and then another wave. There were five waves. After 1 1/2 hours, it stopped and I went home. Later that night, I was very thirty, couldn't sleep and my kidneys were sore. Next morning, I could not raise my arm from the pain. Every day since, I have had another wave of the same pains once in the morning and then again in the evening. Each wave lasted 1 to 2 hours. I would sleep and afterwards felt better. Saturday March 20th, the wave at night was the worst one and it lasted 3 hours. The wave today March 21st, the wave was smaller and then I could sleep. Today my arm is better, I could move it normally.

The same day my heart rate increased. Had an asthma attack. Brain fog. Chills. Both legs hurt (front). Fatigue to point of exhaustion, sleep long hours. No energy at all. Made my chronic illnesses much worse

350pm pt with a history of COPD/emphysema uncontrolled, on oxygen and nebs at home. about 15 minutes after recieving covid vaccine #1 pt began c/o sob and chest tightness. stated was having a hard time breathing.pt appeared to be having a hard time breathing and catching breath. RNs asisting pt. BP 110/88 P 110 SA O2 95% Called for Dr. per Dr-pt was tight with decreased air exchange. pt with increased work of breathing 353pm V.O Dr epi 1mg IM now Solumedrol 125mg/2ml IM now Albuterol neb 2.5mg/ml now 354pm gave Epi 1mg IM R arm. ................................................................... RN March 22, 2021 5:10 PM 355pm started Albuterol neb 2.5mg/3ml PO ................................................................... RN March 22, 2021 5:10 PM 358pm gave Solumedrol 125mg/2ml IM R arm ................................................................... RN March 22, 2021 5:11 PM pt states she is starting to feel better. not havign as much sob breath. is not having to work as much to breathe. 407pm P 107 SA O2 95% pt states she is feeling alot better. feels a little shaky however denies sob and states can breath alot easier now. albuterol neb is still running. Pt appears to be more comfortable. 410pm albuterol neb is complete BP136/84 P 106 SA O2- 95% PT states feels alot bettter. denies sob, dizziness, swelling of throat or tongue, itchiness or rash, dizziness, hand/fett tinglling or numbness. pt states that she is much more comfortable now and her breathing is alot more easire now. pt appears to be more comfortable now. per Dr- pt has better air exchange now with no wheezing. pt advised to use rescure inhaler and nebs at home. given ER precautions. Pt verbalized understanding. Walked out of clinic on own will to dial a ride. ...................................................................RN March 22, 2021 5:17 PM

Burning in my chest, Immediately throat tightness, episodes of shortness of breathe lasting for hours about about 4 hours after receiving Moderna my breathing pattern was so bad I considered ER. Also I developed a cough about 20 minutes after the vaccine. In fact it has been a week later and I still have coughing.

swelling, redness and hive reaction about 5 by 4 cm at vaccination site, new systemic pruritis, itching, wheezing sensation without asthma

3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started vomiting- Zofran 4 mg given- Positive outcomes. 03/21/2021- 0430 Resident found unresponsive on morning rounds- w/ weak pulse, shallow breathing. O2 via NC increased to 5 L, NP, Family ( Code Status DNR)- Power of attorney ordered to send out- MR notified- Upon arrival no rhythm detected- Death pronounced at 0445

Pt states her tongue was tingling, brought to medical evaluation. Redness at neck, blotchy skin noted both arms 09:40 BP 194/78 pulse ox 98 Denies SOB 09:42 BP 191/83 pulse ox 96 HR 75 lungs clear to auscultation 09:48 BP 164/71 Pulse ox 95 HR 71 10:00 BP 174/73 Pulse ox 99 HR 66 C/o throat swelling 10:07 BP 170/78 Pulse ox 97 HR 64 10 :11 ell Epi pen 0.3 mg given L thigh 10:14 BP 180/80 pulse ox 97 HR 66 10:18 throat feels better , tongue still "a little numb" BP 179/76 Pulse ox 97 HR 74 Daughter to bedside 10:22 EMS arrrived BP 139/67 Pulse ox 97 HR 68 10:27 50 mg Benadryl given IM by EMS 10:30 via ambulance in stable condition

No treatments initially. Big chills in the evening of March 20 and difficulty breathing, 100.7 F fever by morning, inability to even sit on March 21 so I stayed mostly in bed, nausea, headache, sore throat, altered taste (things tasted bitter and as chalk), strong body aches. I understand that the fever was not high, so my extreme weakness and exhaustion were not really related to the fever. Fever subsided by March 22, but numbness on the whole left side of head and body appeared for about 2 hours in the evening - unpleasant and scary, but I did not seek intervention. Headache and nausea on March 23 and 24. Total inability to sleep on the night of March 23/24 (stabbing headache and nausea contributed to a lot of anxiety). Finally took Xanax in the morning of March 24, so I finally slept between 7:30 and 10:30am. I am writing this at 3:30 pm on March 24. I am much better compared with March 21, but still with a significant headache and some nausea. I had Covid-19 in the first half of November. Post-vaccine symptoms were similar to my covid symptoms, but quick. In December I got post-covid a-fib and was diagnosed with heart failure. Improved on medication, awaiting heart ablation in May 2021. I am concerned that with the strong reaction I felt after the first dose, my reaction after the second dose may be even worse than that on March 21.

Throat closure; loss of feeling in left hand; loss of feeling in right foot; low grade fever; inability to lift arms; All joints were swollen and unbendable; eyes swelled up and were burning unbearably; loss of taste;

Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection. At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.

Fever, sore swollen arm, aches/pains, chills, cough, headache, fatigue, lethargic, stomachache, sharp pains in arm. Feeling better on third day, fever continues, sore arm. Day 4, pain in arm, lethargic, upset stomach, fever, asthmatic. Day 5, same symptoms. Today is day 12, I'm continuing to spike fevers, low grade up to 100, but I run a low body temp, usually 96-97. General feeling of being ill, upset stomach continues, fatigue. Been staying down as much as possible last few days, still not feeling well along with fever.

SOB and difficulty breathing 10 minutes after injection given. Epi was given and was transported to ER was given IV Benadryl and diagnosed with bronchial Spasm

Heart racing for 1 hour chest felt heavy 2 hours hard to swallow 15 minutes labored breathing 15 minutes weakness 2-3 hours severe headache for 3 days I took extra Metoprolol for heart racing and tightness in chest I took Tylenol and Advil for headaches each day together

swollen neck, tongue was swollen and patient was having difficulty phonating and felt short of breath

AT 109 PM C/O TIGHTENING OF THROAT, EPI X 3 SEPERATED BY 5 MINUTES ADM IM. BENADRYL 50 MG IM ADMINISTERED ALSO. EMS TRANSPORTED TO ER AT 1:24 PM.

After 5 min of receiving shot, in right arm, my right lung began to feel painful. When I am in an environment (house) with someone that has dogs/cats, I will have this same feeling.. allergic reaction to the animal dander. This happens if I am in the environment more than 2 hours, and after leaving the environment, the reaction dissipates from 2 to 6 hours later. The reaction I had after receiving the shot was the same as above. Also, during sleep, my Left lung at times feels a crushing sensation.. it dissipates once I lay flat on bed for a minute or two. The sensations continue to this day, the pain if felt from front to the back of my lungs.

My immediate reaction was blurred vision, then pain down my right arm. Next my pulse rapidly increased, and my breathing was labored. My finger tips of both hands felt almost numb, and my hands turned red. I became very lethargic, and both legs became very weak. I remained in the facility for 1.5 hours under the care of a RN. I went home and it took approximately 4 hours for me to recover. 3 days later I woke up with a metallic taste in my mouth that lasted 2 days.

3/26/21: patient presented and was admitted through ED for Shortness of breath for past 3 days. Patient also complains of worsening lower extremity edema. Stated being non adherent to Lasix which was prescribed for lower extremity edema. Patient was last admitted in May 2020 for COPD exacerbation. She left facility Against medical advice. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.

Dizzy right after shot. 24 hours after shot I got an asthma attack (lasted 1 hr). Have extreme chills. 104 temp. Couldn't raise left arm and leg for about an hour. Applied heat pad to myself to deal with chills. Had winter coat on as well.

1234-Vaccinated 1258-C/O Throat itching and Shortness of breath Pulse 106,BP within normal, O2 sat 100. 1302- Epi Pen given 1308- Patient transferred to ER

On 4 - 2-21, I had chills, swollen glands, and felt tired. On 4-3-21, at night, for about 2 hours or so I felt like it was difficult to breath. It felt like what I had when I had covid the year before. I went to bed and it eventually resolved and has not happened again. I just thought that I should report it because I have not heard of anyone else having this reaction. I did not seek any medical help, as it did not seem life threatening, but I was scared.

Patient received 1st dose Moderna vaccine. After vaccination found to have white nodules on posterior tongue/mouth. Patient described increased difficulty breathing and chest pressure. Patient stated has history of asthma. Physical exam and vital signs completed by RN and NP. Pt. A&O X 3, GCS 15, RR 18, BP 107/58 HR 60, no other findings on exam. Patient received benadryl 25mg PO. EMS called at this time. Upon arrival of EMS transfer of care without incident.

Diarrea, fever, troubled breathing, chills, shaking, dehydration Tylenol and limited monitoring. Patient was concerned that they nearly died due to not having proper care

Tingling and itchiness of mouth starting shortly after administration which then spread to entire body. Shortness of breath, felt body inflamed. Took Benedryl and symptoms subsided.

Tasted vaccine in throat, throat closed briefly, ringing in ears began immediately, hearing loss/stuffiness in right ear occurred immediately, foggy brain occurred immediately. The tinnitus is constant and persists along with the hearing loss .

Developed asthma approx 5 days after vaccine. I don't normally get asthma unless I have had the flu. Have had asthma for 2 weeks now. Using an inhaler to treat symptoms.

Patient started to feel shaky, hot and had trouble breathing about 10 minutes after receiving the vaccine. Patient was given 50mg of diphenhydramine and one epi-pen and 911 was called. EMS arrived about 15 minutes after the reaction began. They monitored the patient, checked her blood pressure, heart rate and pulse ox. The patient has began to recover at this time and EMS released her. The patient's son was present the entire time.

Shortness of breath , extreme pain 3 hospital visits until blood clot was detected,now on blood thinner Eliquis

Caller stated that she received her first vaccine on 04/10/2021 and a few minutes later she had tingling sensation to her tongue and lips and SOB. She took benadryl and it went away. After hours later she experienced SOB, itchyness and redness all over her body. She took bedaryl again and this time she felt fullness and swelling in her body felt like she had gained 5 pounds. But has not had any symptoms since yesterday just tired.

The following day after vaccine, patient had chills, fever, vomiting, body aches, and fatigue. Most of symptoms went away, except fatigue, and body aches. Today the day of scheduled dose she contacts us about difficulty breathing, both arms hurting, and severe headache. We are having patient go to urgent care and postponing her 2nd dose appointment until tomorrow and until Dr. says it's ok to receive 2nd dose.

immune mediated thrombocytopenia, anemia, pulmonary embolism, pulmonary infiltrates. treated with IVIG x 2 days and prednisone 120 mg daily. started on heparin drip.

Extreme SOB with exertion 1 \week after each injection. Continued SOB with activity such as walking, cooking, ALD's. 2-9-21 admitted to hospital extreme SOB, Tachycardia- r/o PE. Negative US, and CT. 2-12-21- to Cardiologist- not heart failure causing SOB, recommend course of steroids 2-24-21 to PCP short course of steroids, relieved SOB. but SOB returned after weaned off. 4-16-21 going to pulmonologist

Patient received Moderna vaccine prime dose on 4/1/21. Rash on the left upper arm appeared on 4/11/21. Patient went to the ER and was prescribed prednisone for 5 days and mupirocin. Patient seen for f/u on 4/15/21. Rash improving, but not completely gone. Patient also reports dizziness, bilat knee pain, nausea and some shortness of breath on 4/11/21 when she was seen in the ER. She reports those symptoms are gone now.

After waiting for 20 minutes at the parking lot, I drove home and started to have symptoms that included throat closing, a lot of congestion. This subsided after taking Benadryl. Dull headache for a couple of days; only slight pain at injection site. On 4/4, I began feeling sick with headache, weakness, nausea. On 4/6, the symptoms were worse and finally dissipated later that day enough to work. These symptoms continued for several more days and now feel better.

Patient began having nausea, itching and tachycardia approximately 15 min after injection. Symptoms progressed to feeling of tightness of the throat, diaphoresis, swelling of the eyelids and worsening nausea and itching.

Pt with wheezing, coughing, tongue swelling and shortness of breath immediately after receiving second covid vaccine. Seen in holding bay and oxygen noted to be 97-99. Audible wheezing, tripoding, throat itching, mucosal swelling (tongue throat). Albuterol given x 4 Given epi injection 0913. EMS arrival 0919 and given neb albuterol and taken to ER. bp 138/78, HR 80's, o2 sats remained high 90s

Aside from the usual, I had sudden weight loss, intense itching, and was out f breath easily and sometimes dizzy. It now has been diagnosed as hyperthyroid. I am undergoing more diagnosis now.

About 2 hours after the 3:30 pm injection, around 5:30-6:00 pm, I began feeling nauseous followed almost immediately by tingling in my mouth and tightness in a band circling my upper abdomen and back. I also felt tightness in my upper back. I felt it was challenging to draw breath, though I had no swelling in my face or throat. The symptoms got worse for about an hour and then began to fade. I went to bed about six hours after the injection and by then I had milder nausea and much less tightness.

Moderna COVID?19 Vaccine EUA Also had similar adverse reaction to first shot. second shot reaction 4/15 insomnia due to pain in arm and overall body pain, fatigue, chills, malaise, headache On 4/16 during the daylight hours -awake 5 hours sleep 1 hour on and off, chills, low normal blood pressure, high normal heart rate, freezing, dizzy, loss appetite, headache, sinus pain, small amount of blood from nose, food smelled terrible, sweating, malaise body pain, muscle pain overall pain and in arms and joints pain. 4/17 slept 6 hours awoke with headache, left knee muscles did not want to work (painful would not take weight, food smells bad, shortness of breath. still small amount of blood from nose, arm pain greatly reduced

Patient started having trouble breathing. She went to the ER at She was there about 3 1/2 hours while they gave her diphenhydramine and performed a chest x-ray. Chest x-ray was normal. Diphenhydramine helped patient and was able to go home. Her husband was able to call us the next day and said she was just fine.

Took Naproxen at 1:30 p.m. day after 2nd vaccine. Had taken Naproxen prior to getting vaccinated without side effects. This time had severe allergic event after taking Naproxen 20 or so minutes later. Had to call 911 an ambulance administered Benadryl an steroids' to help with skin reaction and closed larynx

Five minutes after receiving vaccine I experienced a tightness in my throat. I did not have any difficulty breathing and did not mention this reaction to the vaccine administrator. The feeling lasted the remainder of the day.

1. Fatigue, extreme, lasted for 6 days. 2. Wheezing/asthmatic response. Started Dulera. Wheezing eased but Dulera continues to be needed. Appointment to talk to doc about that and possible need for steroid treatment is set.

Started with sore arm where I could not raise it. (12pm) Headache, fever, chills (2pm) Light headed, fatigued, swollen joints in fingers (I have arthritis), could make a fist (6pm) called off from work at 8pm Had very vivid weird dreams, breathing somewhat labored, woke up every hour. I took Excedrine Severe Headache every 4 to 6 hours, drank lots of fluids Woke up in a pool of sweat, showered, changed went back to bed. Friday same thing, I pretty much stayed in bed all day. I did not start to feel better until late Saturday afternoon around 2pm and then I developed a rash on my left inside of arm and left side of my waist. It is very itchy and I have been putting hydrocortisone on as needed. I still have the rash, and feel pretty good. Will be contacting my Drs. office today.

about 10 hours later increased sob and chest tightness and then hypoxia and hospitalization x 4 days and IV steroids Patient is a 64 y.o. female with PMH notable for von Willebrand disease, asthma, OSA on CPAP, DMT2, HLD, lumbar stenosis, chronic opioid use, GERD, PUD, and anxiety who presents with SOB, weakness, fever. Patient with history asthma, controlled on symbicort and PRN albuterol, now with progressive worsening SOB since the day prior to admission, patient received 2nd dose of Moderna COVID-19 vaccine on 03/10/21. Also, with chest tightness, body aches, headache and chills. Was up last night with fever 101F, took ibuprofen. She had worsening wheezing and SOB while bring dog to dog groomer and had groomer call ambulance. EMS called, received albuterol nebs in route with some improvement in symptoms. Chest tightness has improved. SOB improved now at rest but still winded when up to bathroom. Vitals on arrival notable for BP 144/55, HR 125 (sinus tach on EKG), temp 102.1F, RR 22, 92% on RA. Labs notable for WBC 8.6, CR 0.54. Normal LFTs. Lactate 3.3. D-dimer 0.9. pBNP 56, troponin <0.012. COVID-19 PCR panel negative. CXR with Chronic linear atelectasis or scarring at the lung bases, unchanged. CT PE study negative for PE, possibly some mild pulm congestion, increased interstitial markings. Patient given 2L NS in ED as well as ceftriaxone 2g and doxycycline 100mg. Patient will be admitted to inpatient for further evaluation and management of sepsis. Met sepsis criteria given fever, tachycardia, elevated lactate. Infectious source most likely pneumonia (though only slight increase interstitial markings on CT). Could be atypical or viral pneumonia. However, timing of symptoms could also fit with reaction to COVID-19 vaccine and asthma exacerbation. COVID-19 negative and influenza negative. Was treated with abx for CAP and prednisone + albuterol for asthma exacerbation. Lactate normalized with IVFs, fevers and tachycardia resolved. Patient able to wean to RA, dyspnea and wheezing slowly improved. Abx narrowed to cefzil, doxycycline. 1/2 admission blood cultures positive for streptococcuss. Patient was febrile and septic on admission. Subsequent blood culture without growth to date. Abx returned to IV ceftriaxone given strep + BCx.. Low blood cultures x2 were negative at 48 hours. Dr. was consulted over the phone and he recommended 5 days of oral amoxicillin on discharge. Chronic medical conditions were stable while hospitalized. No medication changes were made.

Reports heart palpitations, SOB started 4/20/18 Headache, fevers-temp max 100.9 started the day of vaccine within a hour Taken Advil Of note: have had palpitations in the past.

Patient claims to have experienced muscle pain (sore arm), arm swelling and redness, fever (102.5 -103 F), rash, shaking, atrophy, altered mental status, shortness of breath, nausea, vomiting, diarrhea, and altered taste.

Within the 15 minutes patient received her second dose, we checked in on her. She stated she was flushing (no redness was showing), had difficulty breathing, developed a rash, and her face was numb (she said paralyzed, but no dropping or anything noticeable). Patient is allergic to Benadryl so the pharmacist administered an EpiPen and called 911. The ambulance came in and took her to nearby emergency room.

Presented to the ED on 4/18/21 with tachycardia and shortness of breath. Found to have bilateral DVTs and bilateral pulmonary emboli - confirmed with imaging. As a result, was found to have obstructive shock with presumed right heart failure. She received 50mg of systemic TPA along with catheter directed thrombolysis. Remains critically ill in the ICU.

Left arm very swollen, sore and warm to touch. Pain in left arm pit. Headache and general fogginess, fever +4 degrees from normal baseline temp. Pain in upper chest, breathing deeply brought on more discomfort. Stomach pain upon eating anything. Pain in eyes, hard to describe. Swollen glands in neck. Body aches and extreme fatigue. Took 1000 mg Tylenol with no symptom relief. Severe and acute adverse reactions including fever severe pain in left arm and acute chest pain lasted for 48 hours. Other symptoms continued as noted. 3rd day after vaccine, still had some fatigue, left arm (injection sight) pain still very sore and swollen, chest pain was diminished, armpit pain still present, throat pain/swollen still present, no fever or headache. took 1000mg Tylenol to no avail. No noticeable relief. 4th day after vaccine, left arm still swollen-somewhat painful to touch, swollen throat and pain still present, chest pain-deep breathing still present, arm pit pain still present, fatigue still present.

Have been having shortness of breath heart palpitations on annoy limp notes swollen on the left arm slight upper chest pain and under the arm and back headaches My stress anxiety has increased....

Patient was admitted to Hospital on 4/12 with shortness of breath and diagnosed with Acute Pulmonary Embolism .

She had the vaccine, felt shortness of breath and fever and chills on 4/16/21. On 4/18/21 she felt pain and discomfort on the left leg, and she had left leg DVT and bilateral pulmonary embolisms. Left leg was found on US, and pulmonary embolism was found on 4/22/21 on CT. She has been given Heparin drip and he does not know when she will be released. She is having difficulty breathing, shortness of breath mainly with activity.

Patient complained of shortness of breath, dry mouth, & dry throat a few minutes after receiving her 1st dose of Moderna. Patient states symptoms only lasted a few minutes and she recovered quickly. She states her symptoms could have been related to her anxiety or asthma.

anaphylactic shock; difficulty breathing; faced was paralyzed; rash on arms and chest; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing) and FACIAL PARALYSIS (faced was paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic shock) (seriousness criterion life threatening), DYSPNOEA (difficulty breathing) (seriousness criterion medically significant), FACIAL PARALYSIS (faced was paralyzed) (seriousness criterion medically significant) and RASH (rash on arms and chest). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic shock), DYSPNOEA (difficulty breathing), FACIAL PARALYSIS (faced was paralyzed) and RASH (rash on arms and chest) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included epinephrine injection. Company comment: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-081859 (E2B Linked Report).; Sender's Comments: based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-081859:Crossed linked

4 days of a stiff and immovable neck, sore lymph nodes in neck, base of skull & clavicle bone, swollen throat with difficulty swallowing, unable to sleep for 3 nights!

MULTIPLE BILATERAL PULMONARY EMBOLI NONOCCLUSIVE RIGHT POPLITEAL DVT OCCLUSIVE RIGHT POSTERIOR TIBIAL VEIN AND RIGHT SMALL SAPHENEOUS VEIN THROMBOSIS PATIENT BEGAN TO DEVELOP LEFT FLANK PAIN FOUR DAYS FOLLOWING VACCINATION FOLLOWED BY SEVERE SHORTNESS OF BREATH WITHIN THE FOLLOWING DAYS

After the vaccine was administered to me, I felt dizzy and weak, difficulty breathing, my body swells up, my pressure went up to 215/190. On site ambulance on site was called to monitor my pressure. I took Amlodipine. I stayed on the site for 2 hours and when my pressure went down to 195/185, I left the site and went home. At home I felt weak and dizzy the entire day and night. The doctor at the vaccination site called my home and spoke to me to make sure I got home safe.

4/14/21 received COVID vaccine and Thursday morning began with a sore arm and muscle aches no treatment done at this time. 4/19/21 Monday woke up at 6:00 am with chills, aches, headaches and extreme fatigue (Temperature was normal). On Friday 4/23/21 case spoke to PCP and PCP advised case to get a COVID test. Case went to urgent care and test result was negative 4/23/21, treatment on Monday night Tylenol extra strength 2 tab every 6 hours around the clock ever since 4/19/21. 4/27/21 9:00 am began coughing and short of breath called PCP and waiting for PCP response.

On Monday January 18th, I woke up grapping for air, unable to breathe. Was taken to the ER at hospital and admitted with blood clots in my lungs.

Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness

Pt vaccinated with Moderna (first dose) and was awaiting alongside the booth standing up and within a minute felt dizzy and was short of breath. Son at her side and assisted her to walk over to observation and felt weak all over, extremities and assisted in the wheelchair. Complained of chest pain/pressure. EMS called and brought to ED. In ED, EKG normal. Trops 0.1, 0.04 then 0.01. Exercise Stress test normal Discharged to home with PCP followup.

Patient reports about 30 seconds after receiving vaccine her throat felt dry and small. Tongue felt numb. These symptoms resolved by the next morning. Patient did not tell vaccinator about her symptoms and just went home. She reports not taking any medicine i.e. benedryl for symptoms (although she takes zyrtec regularly).

little Sore Arm; Pressure on the Chest; could not breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (could not breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (Patient is feeling fatigue and tired due to allergies.). On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DYSPNOEA (could not breath) (seriousness criterion medically significant) and CHEST DISCOMFORT (Pressure on the Chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (little Sore Arm). On 31-Mar-2021, DYSPNOEA (could not breath) and CHEST DISCOMFORT (Pressure on the Chest) had resolved. At the time of the report, PAIN IN EXTREMITY (little Sore Arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

Three to four hours after the 1st dose of the Covid 19 Vaccine, administered on 2/16/21, I was wheezing heavily. I wheezed for a couple of weeks, it dissipated somewhat until I saw the doctor on 3/4/21. I was given a course of treatment of inhalers and a week on steroids to help . I received the 2nd dose of Covid 19 Vaccine on 3/16/21. Three to four hours later that day, I again began to wheeze. I continued with my inhalers. After a week the wheezing disipated. I went to see a pulmonologist at the end of March, and had a breathing test. I was still wheezing and had difficulty breathing . He prescribed an additional inhaler, and I am improving gradually. I do have a history of asthma.

had difficulty breathing from day 2 to 5, lump appeared day 2 at injection site and got increasingly larger and harder until went to clinic after two weeks after, still very sore, They prescribed steroids, will start on 5-9-21

fever 104 degree, trouble breathing, swelling on arm ,upper neck, chest, feeling weak and dizzy , fast heartbeat, blood pressure 200/110 lasted for 24 hours

patient awoke in the middle of the night with breathing difficulty, loss of taste and smell, headache, dizziness and extremely fatigued

Patient called on 5/12/21 stating that she has been feeling extreme fatigue and shortness of breath since she received the 2nd dose of the Moderna vaccine. Also reported that her arm was red and feverish for about 2 weeks post injection but stated that her arm has cleared up now, but she is still bothered with fatigue and shortness of breath.

Patient presented to ED on 5/3/21 for shortness of breath, diarrhea, and bloody bowel movements, Patient does not occasional cough. Patient diagnosed with COVID -19 infection and GI bleed. Patient did have elevated troponins on admission attributed to demand ischemia from COVID-19 pneumonia and acute GI bleed. COVID-19 infection was treated with remdesivir, oxygen and steroids. Patient improved and was later discharged to home.

Passing Out, Loss Of Voice, Throat Closing Up, Can Not Breath, Chess and Body Pains, Headaches, Face Swelling, Face Red

64 y.o. female who presented with SOB. She has a history of CAD, diabetes, CHF, CKD and DVT presents to the ED in respiratory distress. Patient was brought in by EMS from nursing home. Patient had reported onset of shortness of breath and respiratory distress over the last 6-7 hours. Patient has O2 sat of 90% on 6 L. Patient only uses 2 L nasal cannula oxygen all day long. Patient is coherent and initially was placed on BIPAP but then stated she wanted to go back, now after ER doc spoke to her she is ok with being admitted but does not want BIPAP or to be placed in the ICU. She is DNR/DNI. She is working hard to breathe currently. Patient is unsure if she is making urine at this time. Workup in the ER revealed AKI on CKD and covid + pneumonia. Patient elected hospice and expired 5/20/2021. It was reported that patient had received vaccines at Walmart.

Needle separated from the syringe upon delivering the shot. So, I received some of the dose, was given a full second dose immediately afterwards. (Not known the amount of vaccine I received, most likely 1.5 doses). For 2 nights, Very bad arthritis pain and stomach pains. Disturbing dreams nearly every night, since the 2nd shot(s)--nightmares continue..they have not subsided. Two days ago, woke up gasping for air. No idea why. Felt as though I was choking on something..it could only have been my saliva, or a spasm in my throat. It eased up after about 30 seconds...and I was able to catch a breath again. Right lung continues to have pain..from first shot..mild, but, it's there.

Possible pericarditis; Tight chest; Sore throat; Chest pain; Sinus bradycardia; Laryngitis; Hypertension; Hoarseness/Hoarse voice/Loss of voice; Throat swelling; Palpitation; Shortness of breath; Burning sensation; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Possible pericarditis) in a 64-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 Gastritis on 17-Apr-2020, Trigeminal neuralgia and Obstructive sleep apnea syndrome. Concurrent medical conditions included Hypertension, Hyperlipidemia since 21-Jul-2015, GERD since 31-Mar-2020 and Drug allergy (History of intolerance to multiple medications. Blood pressure test kit-adult extra large cuff.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), LORATADINE (CLARITIN [LORATADINE]), COLCHICINE (MITIGARE) and OSELTAMIVIR PHOSPHATE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and BURNING SENSATION (Burning sensation). On 21-Jan-2021, the patient experienced DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice). In February 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced PERICARDITIS (Possible pericarditis) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest). In February 2021, PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Electrocardiogram: normal (normal) normal. In January 2021, Oxygen saturation: 98-99 (normal) 98-99. In January 2021, Physical examination: normal (normal) normal. On 17-Feb-2021, Blood pressure measurement: 149/62. On 17-Feb-2021, Chest X-ray: normal. On 17-Feb-2021, Electrocardiogram: Showed sinus bradycardia. On 17-Feb-2021, Heart rate: 59 (Inconclusive) 59. On 17-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 17-Feb-2021, Physical examination: normal (normal) normal. On 24-Feb-2021, Blood pressure measurement: 130/58. On 24-Feb-2021, Heart rate: 53 (Inconclusive) 53. On 24-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 03-Mar-2021, Blood pressure measurement: 133/54. On 03-Mar-2021, Heart rate: 61 (Inconclusive) 61. On 03-Mar-2021, Heart sounds: Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) to be probably related. Treatment for the event included antibiotics, prednisone and colchicine. Medical Clinic Coordinator provided events were resolved in mid Feb 2021 with residual effects of hoarseness and tightness of chest. Company comment Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required. This case was linked to MOD-2021-046995 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Vaccine adverse event reporting form and medical records received. Multiple fields updated.; 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, further information required.

After receiving the 1st vaccine symptoms experienced were numbness of mouth/tounge, severe shortness of breath, fatigue, and rapid heart rate. A couple of days later she experienced headache, soar muscles. About a week later, she was not able to walk properly, trouble breathing, coughing, and rapid heart rate. About half an hour later after receiving the 2nd vaccine on 04/30/2021 patient began experiencing rapid heart rate, severe shortness of breath and fatigue.

feels like had seizure; delirious; head swelled up like a pumpkin/face, neck, hand swelling; Bloated; migraine headache in half of head; injection site hot, hard, pink, swollen bigger than a deck of cards; brain fog; GI system feels like 100 bottles of hot sauce; GI system felt like 100 bottles of hot sauce; No appetite; shortness of breath; fast heartbeat; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site very red; nausea; fatigue; face, upper chest, and arms turned pinkish; fever; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (feels like had seizure) and DELIRIUM (delirious) in a 64-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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (feels like had seizure) (seriousness criterion medically significant), DELIRIUM (delirious) (seriousness criterion medically significant), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever). At the time of the report, SEIZURE (feels like had seizure), DELIRIUM (delirious), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not given. Action taken was not applicable as patient completed both the doses. 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.

2 days after vaccination, had fatique, A few days later, body tremors and shortness of breath. A few weeks later, after sinus surgery, had 12 pound weight loss, rash, palpitations, tremors . Had abnormal bloodwork, was ordered by dermatologist for rash, then referred me to my internist, who tested thyroid and diagnosed with hyperthyroidism. He referred me to endocrinologist who ran more tests and diagnosed me with Graves Disease. Am on Propranolol and Tapazole and am being monitored by endo