Moderna

Starting on day 3 after vaccination, developed a burning feeling near tip of tongue, as if I?d burned it with hot coffee. Area of tongue affected increased each day until today entire tongue is burning. Fissures are present, but no white coating. Today, two separate small blisters are present on lateral edge of tongue near tip.

When given shot I immediately had a hot lightning pain shoot all the way to my elbow. It went away quickly. About an hour after my lips and face felt like it was tingling. The following day I felt severe body ache, low grade fever, and headache. At times my face still feels funny and I have had a headache every day for the past 6 days.

Severe chills, mild body aches, excessive thirst for very cold drinks, temp 100.4. Rest and Advil

2 hours after my vaccine. My right side of my neck became stiff from the back of my head all the way to right shoulder. Lasted for 24 hours. Then I slept for 17 hours straight and had malaise and fatigue for 6 days after that. I am still with low energy level and my mood I'd irritatabl. Now with a small amount of swelling on left side of lip which is not getting bigger but lip feels thick. Bilateral cheeks slight swollen.

Migraine numbness of lips tingling in right foot and right leg Chills sweating memory issues hard to think of words granddaughter sad she thought I slurred some words

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.

Fever, UrticariaPruritus, extreme soreness,itching, warmth, redness, swelling at site; right jawline sensation; loss taste/smell; fatigue; T100.4

1300 Patient reports tingling throat and tongue 1315 Patient administered 50mg Benadryl PO 1400 Patient released; reports symptoms remain mild

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.

Came to Emergency Department on 1/8/2021 and was assessed at 5:21 pm. Symptoms of hives, and upper lip swelling. Complaint of fever, nausea and headache. No airway issues. No shortness of breath. Mild hives improved with diphenhydramine. Patient self treated with diphenhydramine at 3:00 pm on 1/8/2021. No fever found on assessment. Medications given: diphenhydramine, decadron and pepcid. Discharged from facility at 7:30 pm.

Patient experienced a reaction approximately 10min after vaccination, and reported a tingling sensation of the lips and tongue. Began monitoring vitals. Approximately 17min from time of vaccination, gave 50mg Benadryl PO. 39min after medication, patient reports symptoms resolved completely.

Patient came into Health Clinic for 1st dose of COVID-19 Vaccine. Patient completed COVID-19 vaccine screening checklist for contraindications. Patient checked that she is allergic to peanuts with a reaction of mouth swelling and rash. Patient reports she takes gabapentin for neuropathy. Medical provider MD onsite, reviewed risks with patient, she made an educated decision to receive the vaccine. Patient received Moderna Lot # O11J20A in left deltoid administered by, RN at 0935. Patient observed in clinic for 15 minutes after vaccine given. No reactions reported at that time. Patient left clinic with husband but returned to clinic at 1030, reporting she had a hoarse cough and her throat felt tingly. MD assessed patient?s airway, and lung sounds. RN obtained vital signs at 1045: temp 99.1 tympanic, BP 147/87, respiratory rate of 23, heart rate 72, O2 sats 100% on RA. Per MD verbal order with supervision and guidance from pharmacist, RN administered diphenhydramine 50mg/ml 1 ml in L. deltoid at 1050. Patient takes carvedilol for hypertension, reports she did not take this medication today. Pharmacist, RN, and MD in agreement to give medication closest to region of where reaction may have started from. Vital signs at 1103: 98.9F, 142/93, heart rate 72, O2 sats 100% and resp rate 22, slightly shallow breaths, though patient reports she is feeling some slight relief. 1109 per pharmacist request and with Drs approval/agreement, RN gave patient famotidine 20 mg tabs (2 tabs) oral. Patient tolerated well. 1120 vitals signs: 98.6F tympanic, BP 138/76, heart rate 74, O2 sats 98% and Respiratory rate 19. Patient reports she is feeling better at that time, RN observed patient?s shallow breathing getting to be less frequent and seemingly patient looked more comfortable. Patient having a conversation with pharmacist, no difficulty speaking, breathing, but voice does sound hoarse. Vital signs at 1140: 21 respiratory rate, 99.1 F tympanic, BP 123/88, 72 heart rate, and 98% O2 on RA. PHN listened to lungs and assessed breathing, lung sounds clear, patient reports she feels better though not completely back to normal. MD came in to assess patient, reports her exam is normal, cleared patient to go home and rest with strict instructions to go to the ER if symptoms of allergic reaction come back, get worse, or change. MD encouraged patient to reach out to allergist for further guidance on getting the 2nd dose of the vaccine. Patient escorted out of clinic by husband and RN.

angioedema within 15' : tongue swelling, difficulty talking, increased BP : transferred to ED & tx with H1, H2 with sx resolution . Observed 6 hrs and d/c to home

I had the vaccine on January 5 and I was fine the whole day. For the next two days my arm was sore from my elbow to my shoulder. the third day my whole upper right side was crippled were as my shoulder neck and arm was almost paralyzed and I couldn't really move without severe pain. A few hours later, my legs felt like noodles like I would fall over; I ended up leaving work early that day incase I couldn't get home. The next morning I went to work. the pain moved to my left side, same areas and creeped around my left rib cage. This has been going on since. I had off January 11 and 12 for my weekend. I haven't been back to work since January 13. I have had severe pain in my left neck, shoulder, rib cage, elbow, and now my left wrist and at times, my left hand feels numb. Also, the within the last 24-48 hours my breasts have been tender. I've been lethargic since yesterday and now my vision is blurry. My nurse keeps telling me to rotate between ibuprofen and tylenol, it's not helping at all, I am extremely uncomfortable and in pain. In fact, when I take the ibuprofen, it causes more pain. I've been trying to reach the on call doctor for pain medication and no one is calling me back. The only relief I have is when i hold my arm above my head. I am groggy and I am feeling emotional. I've missed a week of work and I'm nervous about getting my second vaccine, but I will get it. Oh, and I'm not sleeping well.

Called to see pt in drive up lane 4 min post vaccination. She immediately felt after the vaccination, numbness and tingling of face, tongue, throat. Past med history of rheumatoid arthritis and HTN. Possible allergy to Benadryl and Demoral. Initial examination lungs CTA, regular tachycardia. Swelling of lips, and tongue, uvula midplane, not deviated. Pt moved to observation area. Initial vitals: BP: 185/87, HR 128, RR 20, 100% O2 at 10:25 EMS notified and first injection 3mg Epi pen injection given at 10:23am; 911 called. BP: 185/87, HR 128, RR 20, 100% O2 at 10:25. Second epinephrine 3mg injection given at 10:26am. BP 185/87, HR 134, O2 sat 100% at 10:29am. Benadryl 50 mg po given at 10:29am. Next dose of epi given at 10:34 failed, 4th dose given at 10:35am. EMS arrived and she was taken to hospital at 10:45.

?Moderna COVID-19 Vaccine EUA - approximately 45 minutes after taking vaccine had a metallic taste in my mouth and a headache located at lower back of head/upper neck area. Also, blood pressure was taken with reading of 161/121 and within a couple of minutes BP was down to 104/74. Taste and headache lasted about 20 minutes or so. Felt fine after BP returned to normal and felt a little fatigue the next day. Thursday felt great.

Tues 1100 injection. 20 hours after: temp 100.6, all over body muscle aches, bone aches, ( duration of 24 hours), redness 1" diameter warm and soreness to injection site, and fatigue, (duration of 3 days). Starting 28 hours after: lymph edema and pain under arm of injected arm (duration Wed PM-Sat.PM). Thursday AM woke with eyeball pain and headache. (lasted 2 hours).

Moderna COVID-19 Vaccine: Instant headache Developed severe puritis approxamately 2 hours post vaccination that continued x 4 days. This required dosing with Benedryl q 4 hours. Developed fatigue post vaccination that continues at the time of thisd writing only not a severe. Developed sore throat and ear pain post vaccination day 5 which lead to seeing my PCP for an inner ear infection.(this is common when I get a sore throat as I have Eustachian tube dysfunction and have multiple

5 days post injection noticed heaviness of her left jaw, quivering of her left jaw, discomfort and pain around her left ear (in front of her ear) and droopiness of the face in general with difficulties closing left eyelid. The symptoms were familiar to her from her previous attacks. She denies double vision, swallowing difficulties, confusion, or focal weakness otherwise. She denies lesions involving vesicles or herpetic lesions (she sometimes has a cold sore on the other side of the mouth but not now) The patient visited the emergency room on 15 January 2021 and was diagnosed with recurrent Bell's palsy, given a pulse steroid treatment for 5 days which she completed yesterday. The patient reports no significant alleviation of the symptoms which are persisting more than a week now. A similar pattern occurred in her previous attack years ago. Her main discomfort is that of pain in general discomfort on the left side of the face, triggered by brushing her teeth and other activities There has been no recent brain imaging The patient did not develop chills, fever, or other viral-like syndrome after the injection

Within a few minutes of injection had tingling sensation in tongue, followed by a couple days of increased stomach gas, tons of burping, some reflux, took Prevacid. Tongue seemed to affected during the first several days, especially along the sides, red. Didn't get concerned at first. The common sore arm, cleared up within a few days. On about day 10 noticed large area on arm where injection given, warm red area about 4 inches by 3 inches, itchy, resolved on own by day 14 or 15. The next week (third week) mouth seemed to be getting more sore, swallowing harder, took prevacid. Today, day 27, mouth is sore, especially noticeable along sides where there are circle looking ulcerations where surface tissue seems to be missing. Very discouraged. Doubt I feel able to receive second dose which has been postponed, by myself, until day 30. Seeing primary doctor on day 30.

After sitting for about 10 minutes, I noticed my tongue was swelling up in the back of my throat. I noticed my airway was narrowed and tongue felt very tight, but I was still able to breath. I told the man at the doorway assigned to help people find a seat after their shots. He said, "We all have different reactions," brought me water, and I drank it. After another 10 minutes, the symptoms were the same, not better not worse. After 10 more minutes the symptoms were better. And after another 10 minutes, I left. When I made it back to my car, I noticed tightening across my forehead. This developed into a frontal lobe headache which continued off and on for the next 3 days. Also noted for the next 2 days was waking with swollen lips, face and extremities, and occasional ringing in the ears lasting 1-2 hours.

Within 3 min of injection - lightheaded, racing heart beat. Increased PAC sensation. Strong metallic taste.. HR/PACs resolved mainly within 10-15 min. Lightheaded, extreme fatigue and metallic taste eased after about 45 min.

Received vaccine 1/6/2021; immediate redness and pain in injection site. Continued, along with itching, for 2-3 days, then was mostly gone except a warmth and slight discoloration (pink, not red). Began to feel fatigue within the next week. Then, around 1/17 or 18, the heat, pain, itching, and redness returned, along with a painful swelling on the left side bottom of my mouth, and on the left side bottom of my tongue. I'd been told someone I knew had pain as well, and was prescribed Benadryl, so I took the over-the-counter type as directed, and within the second dose (after 4 hours), the pain and swelling receded in my mouth and on my arm. Within a day, I had no more mouth pain, and the arm feels better, although it's still pink, itchy, and warm.

Numbness in throat, tongue, gums and lips. No difficulty breathing (no wheezing, SOB etc.). Tongue still numb today, >24 hours after administration

dose one 12/31/2020 - developed headache, swollen hands and red palms, puffy eye 24-48 hours after dose. Took Tylenol. dose two 1/25/2021- developed continuous headache 8 hours after dose into day 2. Developed chills, sweats, body aches and burning sensation of eczema site on right foot 17 hours after vaccine administration. Took Tylenol and airborne without relief.

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

I have been having left arm pain every since having the vaccine. I thought it would go away but the discomfort is now when I have Range of Motion upward and the discomfort is in my shoulder, arm area and a little below the injection site. I still am having that discomfort and in addition to that, that past 7 days I have been having neck and jaw pain like in the node areas front and back of my next. As well as my lower lip has has two episodes of swelling but it goes down and then it feels ok. I generally overall just don?t feel well. Eye and head pain as well. I thought it was best that this be reported cause I just don?t know what is going on. I have made an appointment with my doctor which is on Feb 5.

After the 1st dose, two days later I had an infected tooth. After 2nd dose of Moderna vaccine, I woke up the 2nd day with my neck lymph glands completely swollen, my jaw hurt really bad, and every tooth in my mouth hurt, and I had another infected tooth on the other side of my mouth. I had to take an antibiotic for both tooth infections. Teeth were not infected prior. By the end of day 2, my lymph nodes were back to normal using Advil for swelling.

2:00am. Chills started first. Then chills got so bad I started shaking uncontrollably almost like seizures. I used slow breathing methods to try to reduce my shaking. I used an extra large heating pad with 4 blankets but could not get my body warm. I felt like i was suffering from hypothermia. I moved my heating pad around to large body parts to try to warm individual body parts to slow my severe shaking. My severe shaking and extreme chills went on for at least 4 hours. I felt nauseous and felt like I might vomit. I got in shower at 6;30 am to get into a hot shower. I could not lift my left leg without extreme pain in my lower left back. The pain in my back then moved to my hips, then my upper right side. I had diarrhea for 2 days and indigestion after eating small bits of food. I took Tylenol gel caps on Sunday morning with a full glass of water and went to sleep at 10:00 am. I woke up with my hip joints and left ear pain.

fever up to 102.4 day following vaccine for approx. 28 hours, joint pain, severe headache with the fever. On the 30th 3 days after vaccine 4 large fever blisters appeared. On the 31st sores inside mouth and on tongue, feels like I burned my mouth. On 2/1 my lips started peeling as if they had been burned. Today my lips are still peeling and the fever blisters have started to crust over.

Saturday Jan 30, 2021. In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches, arm pain and redness, warmth and edema at the injection site. Alternate between chills and sweating most of the day. Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F. Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening. Body aches cont tiredness. Arm had worsening redness, edema, warmth, some pain and itching. Tuesday Feb, 2 . Arm cont to worsen. I went to my physician's office and saw a PA who examined my arm. Started on antibiotics. Continue with some body aches and tired.

Approx 38min after injection pt c/o feeling lightheaded and that her throat was dry with "a lump." Rec'd Benadryl 25mg PO at 0754. Vitals at 0755 160/74, 70, 98% on room air, Vitals at 0800 260/94, 74, 98% on room air. At 0801 pt c/o having slight difficulty swallowing, denies respiratory complaints. EMS called. EMS on scene at 0807. Pt talking normally with no s/s of distress. Pt transported to ED with EMS.

Severe Chills, fever 102.2 degrees, muscle pain, headache, extreme thirst and fatigue for first 24 hours. Next day fever down to 100.1 degrees, fatigue, some muscle pain, dry cough and scratchy throat , lasted 24 hours. Was feeling fine by next morning.

Tingling in tongue, feet, fingers approx 5-10 immediately after injection. The day after injection. Feelings of Adrenaline rush, increase heart rate. Waking many times at night with same episodes. PCP Prescribed Predisone and Benadryl . some symptoms still remain 3 weeks out.

Day 2 had fever of 101.9, chills nauseated Since getting 2nd shot both eye are itchy and sight seems blurry. My eyes were check in December

Patient states felt skin was burning on eczema rash. She had a previous ruptured aneurysm in brain, and she stated she felt piercing pain in her ears for a few hours. She also experienced back pain. She has called her physician and is waiting for a return call. She stated she felt better today.

Right after the 2ND vaccine was administered I felt a warm feeling all over my body which resolved in a few minutes . Then that night my arm was very sore and warm where the injection was given. It was difficult to lift my arm. Also severe body aches and fatigue. Then I started to have a severe headache, head pressure and ringing in my ears . Took my blood pressure and it was 145/98, 155/101 and 160/100. I am monitoring it daily and it has not been below 147/92 and as high as 163/97. I have never had a problem with my blood pressure before.

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.

The next morning I started having a burning sensation that has irritated my face and left eye.Since years ago in 1990 got yellow fever vaccine had similar burning sensation in my face and left eye. Also exp pain in my right foot lasting week causing me to slow down in my daily walk. I was concerned about my foot went to see my PCP was told it could be my ligaments. The foot pain has gone since 2nd dose vaccine. I'm still exp symptoms as of 2/5 is still there in my face and left eye.

swelling pain in right arm at injection site, headache, severe fatigue, swelling in lips (Bottom inparticular)

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.

MODERNA -028L20A 45 minutes after the vaccine: nose starting itching, lips feel like they are swelling, ears feel full, neck itches. 2 hours -slight head ache, 5 hours later -Lips feel like a bad sunburn - feel slightly dizzy No rash, no shortness of breath the first shot I had nose itching an lips feel swelling but it didn't last only an hour or two

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

immediate LUE localized injection site discomfort. Status post 1.5 hours - head ache. Approximately 10 hours status post vaccination administration - chills, decreased and loss of taste & smell. PMD notified, ER visit recommended. Patient developing increased chills and diarrhea. ER unable to assist, recommending home discharge with increased fluids and OTC Tylenol. Signs and symptoms continuing x5 days. Chronic dry, non-productive cough continued.

Body/joint aches, fatigue, headache, chills, labile blood sugar for 2 days. Pain to left arm for 1 week, limited ROM. Lip ulcer (canker sore) 1 week after vaccination (last time I had one was in my 20's)

At 9pm, I started to experience headaches, dizziness and nauseated. The headaches are to my temples and to the back of my head with inflammation on my head. The next day I went to see my PCP in the early afternoon because my blood pressure. My blood pressure readings 140/70, 166/76, 144/80 and 161/89. My doctor put me on BP medication, Metoprolol to take for a few days. I also experienced jaw pain and I went to the dentist where an x-ray was done, which was negative. I was also put on antibiotics due to a suspected middle ear infection. I felt like I had a spiral headache. I saw my PCP, nurse practitioner who gave me a steroid injection which helped. I have cancelled my second dose injection. I have been sick for 4 weeks. I still have the jaw pain with a ringing sensation to my left ear. Tomorrow I will go get more tests done. I am also having swollen neck with lymph nodes swollen.

Day of second dose mouth started feeling funny. Woke up the next morning with blisters on her tongue. She reports extremely bad headache, body aches, extreme fatigue. Overall feeling a bit better but tongue sores are still very painful. Notes headache and body aches are more mild.

Awakened from sleep Fri. night with fever, chills, muscle spasms of jaw and feet, dizziness, nausea. Only able to doze off and on rest of the night d/t symptoms. Foot muscle spasms occurred approximately every 2 hours and lasted 5-10 minutes each time. Muscle spasms of jaw only occurred initially and lasted approximately 5 minutes. Spent Saturday going from couch to bed as symptoms continued along with feeling unable to function mentally & extreme fatigue. Tried to drink fluids, took Tylenol, ate only 6 crackers all day. Fever broke the following night and other symptoms gradually dissapated by Sunday evening. Still felt fatigued for 4 more days. Noted cellulitis on left arm 2 inches below injection site on Monday which lasted 1 week (redness approximately 3 x 4 inches with hardened area approximately 1/2-3/4 inch with itching/soreness).

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.

Patient had received her Covid vaccine 15 min later she reported feelingi a scratch throat and tongue starting to swell. Vital signs taken, pt reported she has had h/o allergic reactions to some antibiotics and foods. Pt assessed no signs of tongue swelling pt stated she gets white coat syndrome. given 25 mg of Benedryl and remained on site for 45 min at which time she declined to stay longer. advised to call 911 if problems occured

Burning on my skin and itching, not at the site of injection but my whole body. you couldn't see anything . temp was the highest 99.7. we saw regular dr. and then to a rumatologist and he told them that the vaccine caused issue with her RNA. He advised waiting 11 days after the 2nd vaccination to start on prednisone which they will start on Monday. The burning goes away for a few days and then comes back up again all over her body. when her skin touches something it hurts. She describes the feeling lik a very bad sunburn.

Left eye pain developed in afternoon along with left injection site pain (expected.) Later on I had a bad headache, fever, chills, all expected. When all other symptoms were resolved 2 days later eye pain persisted. Still present today even though milder .

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."

pain at injection starting overnight. It was worse with the first vaccine. Pain in right lower mandible on both vaccines started the day after the vaccine. This pain was 5 on a scale of 10. Lymphedema after 2nd vaccine only on the same side as the vaccine was given so only in the right axillary LN, began the 2nd day and lasted about 4 days. Tired more after 2nd vaccine. Continued to work, no time off taken.

Feeling flush, dryness in throat, tongue feeling thick. Dr. evaluated client. Assessed and noted lungs to be clear. No medication additionally given. Client observed for extra 30 minutes. Patient was noted to feel better and released out to family.

FEELING FLUSH IN FACE FEELING DRYNESS IN MOOUTH AND THROAT FEELING THICKNESS IN THROAT ( CLIENT EVALUATED BY CLINIC DOCTOR AND SYMPTOMS SUDSIDED IN 15 MINUTES)

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.

pt states that the day after receiving the covid vax she was having flu like symptoms. She had itchy hives on her head that seam to come and go. On 2/18/2021 to 2/22/2021 she had a solid red itchy burning rash on both ears. On 2/23/2021 the rash on the ears moved to her face. On 2/22/2021 she had a virtual doctor appt. She was told to take antihistamine and hydrocortisone. On 2/24/2021 the rash was getting worse so she visited her PCP thought she was having an allergic reaction to the vax and was told to continue the hydrocortisone cream and to come back if it didnt get better. Pt still today 2/25/2021 has the rash on her face and some on her neck that she has aggravated it by scratching it in her sleep.

Immediately after the injection - fever within 24 hours, chills, achy, fatigue. Fever for 4 day and fatigue and achy/joint pain lasted for at least a couple weeks. On February 11/12, 2021 started with double vision, progressively getting worse and constant starting on 2/17. Sought medical treatment on 2/18 with emergent MRI ordered and completed on 2/18. MRI results showed swelling/inflammation in the brain, specifically on the left side. Treatment thus far has been antiviral medication, seeing specialists - Ophthalmologist and Neurologist on 2/24 and 2/25 respectively. Further treatment is ongoing but will include ongoing lab work, IVIG infusions starting 3/1 for 3 consecutive days, repeat MRI, potential LP and Quarantine for a minimum of 30 days following the first IVIG treatment. Neurologist diagnosis is ADEM at this time.

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.

After receiving the vaccine on Thursday I had a very metallic taste. Shortly after breakfast on the morning of the 25 I had a lump in my throat as though my food didn't go all the way down. Then, as the day wore on I got more & more fatigued; later in the day my lips were mildly numb. I had no appetite at supper time and started getting a headache along with chills. All day Saturday I had flu-like symptoms, chills (no fever) extreme tiredness and a dull headache and laid under a blanket all day, no energy. Saturday evening around dinner time I started feeling better and Sunday woke up feeling as though nothing had happened other than a dull headache and soreness at the injection site.

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.

Pt reported feeling dizziness and vision problems shortly after receiving COVID-19 vaccine. VSS throughout incident. Pt reported that symptoms resolved after 15-20 minutes. Pt coherent and talking throughout incident. No s/s of allergic reaction observed or reported during or after incident. Pt denied any SOB and in was in no apparent distress once symptoms resolved. Pt left clinic after 30 minutes.

She received Moderna COVID-19 vaccine 2/17/21 and developed symptoms of left ear discomfort followed by left sided facial and eye droop on 2/27/21. She was seen by MD on 2/27/21 and was confirmed to have Bell's Palsy. She was given prednisone with taper and valacyclovir for 7 days. Also advised to wear an eye patch.

Left side of head/face numbness with continued left ear pain/discomfort. No current treatment. PCP following.

2 days after the second dose of the moderna vaccine I suddenly started seeing blurry out of my right eye I let it go for about 4 days thinking it was something just in my eyes I sent after that went to an urgent care at my doctor's office where they sent me to the ER I had an MRI done nothing was found was then sent to opthamologist specialist who at first diagnosed me as a torn retina second day I went to a retina specialist who confirmed it was not a torn right now but swollen behind my eyes I wasn't to be seen until another week later and hopes the swelling would go down and February 25th I return back to dr. When the retina specialist who indicated that it was still swollen and it's a possibility I will not see clearly out of that high again still waiting for various specialties

Started feeling face tightness and numbness around lips and lower portion of face while driving home after getting the vaccine. Still feeling a lesser feeling of these symptoms, Thursday, 4 March 2021.

Patient complained of the back of her tongue felt swollen and that it felt like "there is a cherry pit stuck in my throat". Patients BP was elevated. No excessive saliva, No issues with breathing.

Patient stated the night after receiving vaccine, she had a sore arm which was also red and warm. She slept that night and woke up to a swollen face and tongue. She stated it was hard to speak and swallow. Patient stated they took Benadryl for her reaction. Patient reported her reaction had settled by 3/6/21

That night my arm (at the site and the entire muscle) was very sore and felt heavy; this pain continued throughout the following day. At about 8:00 AM on the morning following the injection, I had chills with intense muscle spasms. At about 9:00 AM, I developed a headache (and I am not at all prone to headaches). I was also extremely thirsty. By 9:30 I developed a fever which lasted all day. I was teaching and had no access to Tylenol, so I taught through it. My temp ranged from 99.8 to 103.8. I also felt weak and woozy. When I got home, took two extra strength Tylenol and rested. I had a few bouts of chills and loose stools. I went to bed at 10:00 PM, slept well, and woke with no adverse symptoms at all, other than a sore arm. I was very surprised by these physical side effects as this was the first time I have had adverse effects from any medication.

She had not eaten but 15 minutes after injection, she felt as if her blood sugar dropping. She purchased a candy bar and ate it on the way. Her husband was driving. She does not remember trip. She was still feeling bad and they got a shake, she was not able to chew. They went straight home and checked blood sugar which was 62. This was approximately 1 hour after she ate candy bar. She started to feel better after another hour and ate a hamburger. She proceeded to sleep a lot the rest of the day. She stated she has never had a low blood sugar episode that severe before.

The very next day I woke up with itchy eyes, as if something was inside, but then progressed during the day to both eyes very red and itchy. I woke up better the next day. (today) A swollen spot about 2.5" x 3' on top of my feet. Skin was darker and hurt. Next day (today) a bit better but still there. I did not had any injury. Sore where the shot was given.

NUMBNESS/TINGLING LIPS. PT HAD SAME RXN WITH 1ST COVID SHOT, BUT WAS CLEARED BY ALLERGIST TO RECEIVE 2ND WITH PT TAKING 25MG BENADRYL PO BEFORE VACCINE AND 25MG PO AFTER. PT WAS GIVEN 25MG BENADRYL IM AFTER VACCINE INSTEAD. PT HELD FOR 45 MINUTES POST VACCINE UNTIL NUMBNESS TO LIPS SUBSIDED. PT INSTRUCTED TO GO TO ED OR CALL 911 IF S/S REOCCURED. PT STATES UNDERSTANDING.

Tingling back of head. Numbness cheeks, upper lip, gums, nose. Loss of peripheral vision right eye. Taste like lidocaine in saliva. Fluid retention. Extreme thirst and lack of urine. Brown urine. Swelling tongue. Lacy red rash on abdomen and legs. Headache. Dry skin with itching forehead.

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.

Had normal reaction to covid shot,fever,body aches and fatigue. Jan 29 dizzy and unable to focus, no appointments available with pcp, went to urgent care and sent to er for possible stroke, stroke ruled out and sent to physical therapy for vertigo then not spinning and regaining balance. Feb 17 vertigo returned on right and left sides, treated. Feb 19 left sided vertigo treated,Feb 22 left sided vertigo treated, March 1 right sided vertigo treated, March 5 negative for vertigo but still dizzy and off balance, vestibular exercises required to regain balance.. Positive for covid in July.

25 minutes after receiving shot while driving home left side of head hairline felt like electrical line, left eye began twitching, hard to drive, head did not feel normal-felt like heavy, heavy brain fog. 40 minutes after shot, trouble walking, had to use cane and hang onto wall/furniture, very painful walking. Brain fog lasted 24 hours. Trouble walking for 3 days. Nose bleed on 1st night after getting shot while sleeping. For first 2 nights after getting shot had tingly, like many fine needles from knees up to waist. First 2 days had hot/cold feeling, nausea...all in all incredibly unpleasant.

At 2:50 patient reported feeling dizzy and felt like she was going to "pass out" BP taken- 111/75, HR- 107, POX 98%. Patient was asked by RN to remove sweater and mask. Patient reported feeling better, however feeling a little dizzy and nauseated. Patient denied swellings of tongue, chest tightness. Patient asked for water and was given water. Patient sat in the chair for a few minutes and refused to lay down, patient reported feeling better after having water and reported feeling this before. Patient reported feeling better , vitals retaken BP-114/75, HR-77, PT reported feeling much better and wanted to go home to eat as she did not eat lunch. Patient refused to stay longer and reported "I just want to go home to eat". Patient was called at home at 03:47 and asked how she was feeling. Patient reported feeling much better and was now home and about to have something to eat. Patient was advised to

Woke 8 hours after the vaccine to excruciating right ear pain, nausea, aches. Weakness, aches, general flu like symptoms for all of the next day (Sunday). Woke up Monday feeling much better but not 100%. Felt worse Tuesday with muscle weakness. Tuesday night lymph nodes in neck were very enlarged. Approximately baseball size. Weakness, fever, malaise all day Wednesday.

I started feeling sick on February 19, developed ear pain behind my ear on February 19 and experienced Bells Palsy starting February 22. Slight droop of face beginning at 10 am, by noon 1/2 my face was completely paralyzed, with my left eye is frozen open.

1/8/2021 vaccination 1/12/2021 Woke up with intense back and neck pain. A really swollen face, nose, swollen 'everywhere'. I couldn't stand because of so much pain. Fever 101 which is very high for me, swollen eyes; went on for 4 days. The swelling went down after 3 days. The joint pain didn't resolve for 7 days. I had a teleconference with my Dr. He said if things get worse, call me or go to nearest ER. I took Tylenol, Advil. My doctor recommended that I only have the 1 vaccine. *I had very bad case of COVID in 03/2020. I didn't go to the hospital but I should have. My husband and I both were COVID + and bad cases. My O2 got down to 82. We had traveled a wedding. We didn't want to infect anyone.

FIrst week: Left arm where dosage was given: hard like a ball, tender, sore. Body Achy, extreme fatigue. At wake up eyes dry Second week: Left arm still hard like a knot, feverish, skin area red. Facial cheeks red daily, Body aching, fatigued, Headache and in a daze - unclear foggy thinking. Third week: Left arm itchy, knot gone, redness gone. Body aches less minimal, less sleepy. Headaches are stronger and I drink about 1/2 gallon of water per day. Facial cheeks red on and off. Fogginess and dizziness still present. Next injection 03/19/2021 - same location and time

2 days later, what felt like white canker sores began to develop in my mouth. It continues to get worse, painful, spreading in my mouth and I felt it in my throat. Around day 4 of symptoms, it felt painful in my gums as if they were a little swollen or had sores in them. Mostly on the right side on my tongue and right side of my mouth, with my tongue the worst. But it is all over my mouth and hurts swallowing. On day 5, I woke up with swollen lips and in so much pain (kept increasing every day) and I went to the immediate care. Doctor said mouth is all red with the white mouth sores that are painful. Diagnosis was ?mucositis? mouth sores and I got prescribed prednisone, lidocaine hydrochloride solution to rinse, and another medicine by mouth. Concurrently from that Monday (2 days after shot): onset of flu-like symptoms: feverish for a day, extreme fatigue, headaches, body aches and pains.

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.

patient had tingly lips and mouth after 8 minutes, monitored for 30 minutes with no worsening of symptoms. BP 140/95 when first had symptoms with pulse of 88. at end BP was 140/98 with pulse of 80. patient had no other symptoms of allergy. recommended to follow up with urgent care and had husband drive her home

A single blister (less than 1cm in diameter) appeared at back of roof of mouth near rear-most molar on left side. Gums inflamed and bleeding around tooth number 12 when brushing teeth in the morning. Blister broke within 3 hours of being noticed, leaving a slightly tender spot on roof of mouth. Around 11pm on 13 March, right outer ear felt warm, tender to the touch, and inflamed. (For decades, I have been regularly experiencing headaches once or twice a month and this ear often becomes tender at the same time of the headaches. I did not have a headache during this occurrence of outer ear pain.)

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.

Within 15 min of receiving vaccine patient felt she had severe dryness in her mouth and throat. she felt a lump in her throat and tingling of her tongue. For the next one hour she was monitored. Her BP was in the 150/85 range, P from 94-84 bpm range and pO2 was between 94 - 96%. she was given 25 mg Diphenhydramine PO and was sent home independently. since her symptoms had improved. She was referred to the clinic's allergist and encouraged to contact her primary care provider.

Patient is a 60 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 044A21A on 3/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:38am patient c/o numbness/tingling to mouth; lips and tongue. No swelling noted to face or mouth. Patient denies shortness of breath or difficulty breathing Patient was treated/managed as follows: 11:40am VS BP 118/82, HR 65, RR 18, O2 sat 98% on room air. Patient reports numbness and tingling feeling resolving. 11:50am VS BP 116/86, HR 62, RR 18, O2 sat 98% on room air. Reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 11:52am Escorted to car by RN.

I was waiting as required and I started feeling itchy. Then it started in my legs and knees, and ended up staying in there an extra 20 min. I left and got halfway over the bridge and had to go back. My lips got numb and the tip of my tongue. I kept having to clear my throat. I went to the ER and my heart felt like it was pounding out of my chest. Once they gave me the Benadryl, Pepcid and steroids via IV, it got better but didn't go away. They also gave me oral steroids to take at home. The symptoms remained for 3 days or more. I also had a metallic taste in my mouth. I was awakened during the night multiple times. After about 3 days the itchiness and blotchiness went away, but the taste remained for like a week. After a full week, I was back to 100%.

Tinnitis in both ears that comes and goes in volume accompanied by minor earache and headache. The tinnitis can get quite loud at times Fatigue which gets overwhelming at times Skin rash on fingers similar to my reactions to food allergies, but I've had no exposure to any known allergens, All symptoms started 2 days after receiving the first dose of Moderna and are continuing at this time.

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 .

pt was walking out of the building after getting the vax she had a headache right away along with ringing in both ears. The vax administrator told her to try the medicine Similasan for the ringing in her ears. She says it only helps temporally. She had these same symptoms after taking the 1st covid vax and they went away after 27 days. She will contact her PCP and get a referral an ENT if these symptoms to do go away after a this time frame.

COVID 19 Moderna vaccine second shot: Stomach ache/burning/metallic taste in mouth is the prevalent complain. . 12 hours after the shot I had fever 100.4 F aches all over, headache, tiredness, some stomach discomfort. All these lasted 24 hours. Stomach problems still continues, almost 3 weeks. First stomach pain(upper part of stomach), and burning, than pain, couple days pain in the stomach and metallic taste in the moth.. pain still continues but a bit more under control with medication. It feels like there is something on the top part of my stomach.. Tried several medications, not all taken on same days but switched to some different one when the one I am using was not working well. Tums, milk of magnesia, pepto-bismal stopped all but now using Prilosec.

Numbness in mouth, lips teeth, Redness in face, itching on face and head, rash across arms and chest. Joint pain, fatigue. Took Benadryl went to bed.

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.

Moderna Covid-19 Vaccine EUA. Little problems until early this morning, no major soreness,etc. until I leaned against the wall on that arm, and suddenly lots of pain in that shoulder. About 5 minutes later, ringing in the ears, hot flashes, and dizziness. I sat down on the couch and felt better in between 5 & 10 minutes later.

I started feeling really thirsty and was drinking tons of water, and soon came to realize that water didn't make a difference and that I dry mouth. I've never had this in my life. I don't have diabetes or anything I can find online that would cause it. I'm very concerned that this isn't going to go away, because I'm at 9 days, and it's still a big problem.

3/3 - very sore arm & achyness, 3/4 - sore arm continued, 3/5 - woke up with vertigo that subsided quickly, but dizziness, and headache on right side with brain fog continued, 3/7 - lymph node under right arm swollen and very sore and lasted about 1 week. vertigo in the morning stopped, but dizziness and headache continued, 3/9 - soreness in the arm is back with swelling, redness and itchy. this only lasted a couple of days 3/17 - dizziness and headache continued. dizziness is worse in the morning. developed a back spasm probably unrelated to the vaccine, but started taking meloxican for inflamation of the back. Coincidentally, it seemed to help with headache and dizziness. Still taking meloxican and headache and dizziness are minimal, but still present. Will be getting off the meloxican on Friday, 3/26, and we'll see??? 3/ 20 - started with fever blisters and mouth ulcers(probably from shot or stress all this has brought on my body)

Vaccine 1 - all arm pain for 6 days Vaccine 2 - severe all body pain for 20 hours, fever, headache caused blindness in one eye, dizzy, weak, ringing in ears. 48 hours after vaccine - pain and fever gone but dizziness and ear ringing still ongoing.

Received the 1st dose of Moderna. Within a few hours began suffering from tinnitus. Has persisted off and on since.

Strange taste in mouth..maybe metallic. Lasted an hour or so. Flushing of face. Day 2 ..after shot feel very tired.

On day 3 post vaccine I started with Vertigo so bad I couldn't get out of bed. I also ended up with pretty bad headaches, feeling like someone was squeezing my head, ear fullness and pain, brain fog, and the inability to walk straight without falling or bumping into the walls. Occasional Nausea. At almost week 3 I've tried Motrin, 1,000 mg a day, Psuedofed, as needed, Miclazine, and Vitamine C

Returned 35 min post injection c/o feeling light headed, tingling in face, and neck. observed patent to have generalized redness of face and neck area. within 3 min small red blotches inner forearms, itching in scalp and neck. Pt c/o swelling in upper lip which was present. 911 was called & at 4:33 pm Epinephrine 0.3ml 1:1000 given left lateral thigh area . 120/76 P- 110, R-20 Pulse oxy 96 %. 4:37 EMS arrived and transported patient to Er.

Itchy mouth/neck. No hives. "Chest feel tight" Benedryl 25 mg given. itching decreased 11:14 B/P160/92, Pulse Ox 97%, RR14 and Pulse 71 11:24 140/82, Pulse Ox 98%, RR 12 Pulse 78 11:40 B/P 130/78 , Pulse OX 99%, RR 12 Pulse 77 Per RN observer patient felt fine when she left. No symptoms.

(* Temp listed with Tylenol on board) The first night after my vaccine my Fitbit registered my breath rate decreasing to 10 which has never happened in the four years I?ve been wearing a Fitbit. Last night, night three after the vaccine I set a record in the other direction? My breath rate increased to 23 which is also outside of my normal range. I am curious if this has been found with other people received Moderna Vaccine Vaccine and I?m concerned because I live alone and have heart disease and COPD. The bodyaches and all of the common side effects have resolved. Today I have a sore throat and an ear ache. Is any of this normal?

My gums started bleeding and I don't normally have bleeding gums. It continued on for about two weeks - about 10 days into it, I called the dentist. And he took a look and it didn't look like anything was infected. And it did just go away after about two weeks or so. Subjuctoval hematomas - looks like my eye is bleeding - it was my left eye - that symptom started about a week or two weeks ago. That lasted a few days and I haven't gotten anything else since then with my eyes.

Strong headache, nausea, muscle pain, joints pain, dizziness, chest pain, feel very thirsty, chills, fever,sore throat , fatigue, itching all over my body . The headache was very strong to me , Iam afraid to have the second dose next month

I expected a sore arm, but it hurt so much I could barely move it, and when I did, I winced in pain. As the night went on, my neck and shoulders became very stiff. Was unable to sleep due to the discomfort and pain, even after taking Advil. The following morning my lower back was aching so much I had to lay down. I was cold, but my hands and feet were super cold. I could barely eat and had bad heartburn when I did. The second night my teeth hurt. However, when I had the virus in December (recently tested positive for the antibodies), I had none of those symptons and did not feel as bad as I did from the vaccine.

3.19.21:Dry mouth started 30 minutes after receiving vaccine. Felt sick/drugged and dry mouth for 6 hours. Sensation lessened in next 3 hours. Slept and no symptoms 3.20.21 3.26.21: Soreness in muscle area, about 2 x 1 inch square patch about an inch below injection site on left arm. Soreness continued 3.26.21 to 3.28.21 evening when sore area became a red blotch that itched. 3.29.21: Applied over the counter steroid cream over area in morning and site no longer itched. 3.30.21: Red blotch area no longer red nor itchy.

extreme pain 1-10 = 15, hours of tears. Entire body experienced shaking, felt like my body was injected with poison. I was nauseous for over 36 hours, along with above pain and shaking. Headache, blurring vision also present. HOME TREATMENT: Alka Seltzer PM at 2 am calmed me until 5 am. At 8 am another Alka Seltzer pm - this only help with the need to vomit and I could nap for 15 mins or so before the pain just became too much. 2 pm 2 Bayer Asprin...I could only sip water, tea and 4 teaspoons of soup. 8 pm 2 more Bayer Asprin and 2 more at 2 am. Around 6 am the feeling of being full of posion, aches and headache subsided and I was able to sleep. I slept until 5:30 pm that night solid. Today is Monday and I'm a bit tired but feel much better. The churning in my stomach still comes but not often - only once today. Eating normal, just small amount once a day no appetite. I live 45 minutes out of town with 3 feet of snow...had the weather and my location not been an issue I would have gone to the ER...had I received no relief from the OTC I would have gone to hospital.

Patient was 10 minutes post vaccine sitting in observation area. She was talking to her friend and suddenly asked to be taken to her office. She said that she was seeing 3 of him. The friend went to the EMS personel who were staffing the event for assistance. 10:15-BP was 176/112 R arm, 10:20-167/114. Double and triple vision continued. She was put on a stretcher by EMTs. Head was elevated 45 degrees. 10:25-153/101, HR 88, still seeing "double". Began to chill and entire body was shaking profusely. Blankets were give. 10:30 AM-154/81, SaO2-99%, P-87. Husband, a retired paramedic, who had been notified, arrived. 10:35 AM-154/95, P-91 10:40 AM-156/94, 10:45 AM-158. Paremedics and nursing staff advised for patient to go to the ER or Urgent Care but she refused. 10:50-BP was 166/138, P-91. Husband insisted that he would monitor her at home. Taken to car by stretcher to go home. 9 PM, I called patient to follow up. She said that her double vision lasted for hours but finally subsided and that she had a "wicked headache". She said she did not feel like herself.

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.

First noticed a sore back of the mouth, my throat itself did not hurt when swallowing, just the way back of mouth. Then I noticed a rash on the trunk of my body. Below shoulder blades, above panty line. Most red spots on front of body, sporadically spaced. Not itchy. Some spots on back side. Two areas where the spots were more grouped like half inch by 1.5 inch both on left side of body under armpit and top of breast. Otherwise spaced all over like on belly area. Day of shot I was anxious and was a very little dizzy with chest flipping after shot, but could breath fine. I think I noticed the sore throat next the next evening. And maybe the rash the next day after that - not really sure of the timeline. Today is 1 week and 3 days after shot. I still have the rash. The sore throat is much better. Chest still flip flops but not very often - still could be anxiousness.

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.

Concern - left side facial paralysis Onset: 3/26/21 - pt received first COVID vaccine (moderna) into the left arm; pt is concerned about bell's palsy Description: left side facial paralysis/pain, left ear pain - pt says things sound different/louder Intensity: mild Progression of Symptoms: worsening Accompanying Signs & Symptoms: trouble talking, minor trouble swallowing/eating Previous history of similar problem: none Precipitating factors: Worsened by: lying down on left side Alleviating factors: Improved by: none Therapies tried and outcome: aspirin, heat packs - not helpful This previously healthy 60-year-old female presents to the clinic to be evaluated for left facial drooping and numbness sensation that started after she received her first Covid vaccine on 3/26/2021. She denies any weakness in her upper or lower extremities. She is not feeling ill or having fevers. She is unable to blink the left eye and the left side of her mouth droops downward. Symptoms are consistent with left sided Bell's palsy. There are some reports of this occurring after the Moderna Covid vaccine, but not clear causal evidence at this time. She was given a prescription for prednisone and I am contacting MDH to file a report. I recommended against starting an antiviral

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.

Splitting headache, swollen eyes and lymph nodes in neck, felt beat with a bat (hurt to be touched), injection site 3" in diameter and swollen and red, brain fog, could not lift head or arms for 24 hours, high temperature 102, extreme joint pain.

Patient reports blisters on the back of her tongue. She doesn't know when they appeared. They are not painful.

She got the vaccine and she immediately felt a warm flush in her left arm. She was ok, and waited for a few minutes after. An hour later she felt that her tongue was very heady and the inner sides of her cheeks in her mouth were numb. She did not have problems with her throat, but the tongue was heavy. She was extreme tired, very, very fatigued. About 12 hours later her head started feeling dizzy like she was in a boat. Yesterday morning, 3/31/21 her whole body was aching and in pain, and she took one regular Tylenol that helped her through the day and by the end of the day she was so tired and out of it, and had chills from about noon, so cold that she was trembling. She also had warm feelings in her hand as well. She went to bed early and slept for about 9 hours as she was extremely tired. She feels a little better today, but not back to feeling completely well.

A spontaneous report was received from a consumer [United States] concerning 60 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced worsening of meniere's disease symptoms/meniere's disease, scratchy throat/oropharyngeal discomfort, sinus pressure/paranasal sinus discomfort, dry cough/cough, phlegm/productive cough, vomiting. The patient's medical history was not reported. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 046A21A) on 18 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection. On 18 Mar 2021 the patient developed a dry cough, scratchy throat, sinus pressure, phlegm, vomiting x1, and worsening of her Meniere's disease symptoms. The medically significant event is meniere's disease. Treatment of the event was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events worsening of meniere's disease symptoms, scratchy throat, sinus pressure, dry cough, phlegm, and vomiting was not reported.; Reporter'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, a causal relationship cannot be excluded. Vomiting is consistent with the product known safety profile.

About 5 minutes after vaccine, I had onset to headache starting in the back of my head and over my top and it very quickly escalated - to felt like someone hit me in the back of my head. I hunched over; I was shaky and light- headed and needed help standing up and they put me in a wheelchair. I was feeling very confused and they caused me an Emergency response team at the Hospital. They did vitals and I don't remember what they were. My BP may have been a little elevated. I was nauseous; I had light sensitivity. They checked my blood sugar which was fine. They had me lay there and rest for an hour. The light headedness went away and the nausea went away and I had the headaches for the next two solid days. No treatment. I did have fevers as high as 102 almost - 101 something. Typical flu like symptoms with severe migraines. I was having all the curtains closed, couldn't look at a screen for two days - I was down with the migraine. The third day, I was better which was my day off. They kept me out of work until the 26th, I think I was back to work by the 27th.

Fever 100 Elevated heart rate 93 bpm (normal 60 bpm) Headache Buzzing in the head Body aches and chills No treatment. Symptoms subsided at 48 hours

24 hours after the vaccine (Wed around 1), I was feeling weak and could barely keep my eyes open. I ran a fever as high as 102 and stayed around 100 for at least the next 18 few hours. All I wanted to do was sleep and my head hurt . It felt like I had COVID all over again. (I was tested for COVID 1/16/21 and confirmed on 1/19/21). By Friday morning, I was feeling much better. I know have a strange metallic taste in my mouth.)

Fever up to 102.4. Took Tylenol and it would usually come down to the high 99?s. If it didn?t come down took Ibuprofen also. Started Tuesday 10pm. Called pc Friday am and spoke to nurse. Told to alternate Tylenol and Ibuprofen for 24 hours then hold to Check for fever. Did that over the weekend and still had fever. Monday am still had fever without Tylenol/Ibuprofen. Hoping Tuesday, tomorrow, will be better. Loss of taste started Wednesday evening and continues.

Redness, heat, swelling, itching rash down length of vaccine arm, hand and same side leg. Numbness in shin and ankle same side leg. Redness and itching around same side eye. Heart pain 5 times in succession. Pain and stiffness in same side neck and shoulder. Facial and head itching. Temperature dropped to 95. Severe chills.

Partial numbness on left side of face....heavy feeling and partial ear loss confirmed with hearing test on left side ( same side as injection ). Initially partial ringing with certain sounds like running the vacuum cleaner or hair dryer. Started developing constant heavy ringing in left ear on 4/5/21.

Vaccine #1: Only the sore arm as described on the Fact Sheet. Vaccine #2: Stabbing anterior, posterior, and lateral left thorax chest pain at approx. 3 hours post injection lasting 2-5 seconds. Cardiac arrhythmias at 10 hours post injection: I could feel the arrhythmias as they were about to start with fullness in my throat. Unable to detect radial pulse during episodes and no cardiac beats heard on auscultation. Complete compensatory pause noted per palpation and auscultation. Frequency of about two (2) episodes every 30-45 minutes for approximately three (3) hours, with gradual decrease in frequency over 24 hours. By 24 hours post to present none noted. During all of these episodes I was supine. At 72 hours post the axillary swelling and chest pain (not the same size as the stabbing pain) noted at 36 hours post had decreased from a full football in size to approx 1/2 a football. Captured a picture of that (the half-size football), but not the full-size event. Considerable abdominal pain to LLQ at approx 90-100 hours post vaccine #2 that persisted for 24+ hours.

My left arm puffed up on Saturday, late afternoon, evening. It was painful to touch around the vaccination spot and hurt to put pressure on. Sunday I ran a low fever; it reached 99.1 near the end of the Ibuprofen time limit (~ every 4 hours). I stayed wet with sweat and my back itched throughout the day. Food tasted bad--my stomach was sour. I was lethargic and slept most of Sunday and straight through Sunday night/Monday morning. My nose and cheeks pealed this (Monday) morning and I look as if I have a mild suntan. I haven't been in the sun or wind for more than a few minutes, for over a week and I haven't been outside at all since I received my vaccine. The soreness in my arm is now only at the vaccination spot and it is tender only if I press it; touching it no longer causes wincing. I feel flushed but no llonger have a fever. I'm no longer taking Ibuprofen. Food is tasting better today but it's not back to normal--my stomach is still a little sour.

Tinnitus began immediately following vaccine. At nighttime when the surrounding noise is reduced and the quiet occurs, I now find it difficult to fall asleep because there is a continual loud buzzing/ringing noise running throughout my brain and extending through my ear canals. I have never had Tinnitus and always pitied people that had the condition and never understood the issue, until now. There should be a warning on these vaccines that they may cause Tinnitus. In this instance, ignorance is not bliss because blissful sleep is no longer going to be allowed in a certain percentage of the population that receives these vaccines? I intend to contact my doctor for testing. I am disappointed that no one in charge has brought this to the attention of the public. We have the right to make factual decisions. There are numerous people suffering from Tinnitus currently being ignored. Given this condition, how can I take another vaccine knowing it could further exacerbate this problem.

Pt stated her "tongue felt thick" and felt her "heart racing" immediately after injection. Pt moved to observation area and offered oral diphenhydramine, pt declined. Pt BP and HR were initially elevated at 168//80 and 129. BP decreased to 140/80 and HR to 100 after five minutes of observation. Pt reported gradual improvement with symptoms for 30 minutes, until reporting a sudden worsening of angioedema, "tingling all over", tachycardia, and syncope. RN administered 0.5 mg of epinephrine IM to L upper thigh and called 911 for ambulance transport. Pt reported some improvement in symptoms after administration of epi, but symptoms not resolved. RN considered administering second epi dose, but deferred when ambulance and EMTs arrived five minutes after first dose of epi. Pt transported to local hospital for further follow up.

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.

Client received 1st dose of Moderna vaccine at 1305. At 1320 client reported it "feels hard to swallow." Client was also experiencing dizziness, and tongue numbness. Client VS at 1320 were O2 93% on room air, P 90, BP 190/102, and R 16. Client did not experience any SOB or difficulty breathing. Client had no visible swelling or hives. Client reports "being worked up about this all day" in regards to getting her vaccine. Client has HTN and is on medication, but reports drinking "12 cups of extra strong coffee and 1 Mtn. Dew" before getting her vaccination. Client BP at 1330 was 170/90 and at 1335 168/90. At 1330 client reports difficulty swallowing and tongue numbness had resolved. Client was kept on continuous pulse oximetry until symptoms resolved. Client advised to follow up with her PCP in regards to elevated BP. Client saw Dr. on 4/1/21 in regards to her BP and symptoms following vaccination. Per client her BP was 122/70 at her office visit. Client states that Dr. said it was okay to get her 2nd dose in 4 weeks, but that client "should lay off of the caffeine."

Pts throat felt itchy, she felt like her tongue was tingling. Normal Vital signs, O2 sat 98%, no hives, no difficulty sipping water, speaks without difficulty. Pt was transferred to medical center for evaluation

Loss of balance, severe muscle pain all over my body, sever nausea, massive headaches, exhaustion, trouble staying awake, nightmares, sweats, chills, abdominal pain, excessive thirst. As of this writing going on for more than 24 hours.

First a headache within 6-7 hours, and tired. Within the 8th hour after vaccine a fever came on and headache worsened, arm became sore. Within 2 hours after that (10 hours after vaccine) I was shaking uncontrollably, shivering, and had a fever of 105. I literally could barely hold thermometer or my cell phone. My arm was too sore to lay on our use to really lift myself to turn in bed. The fever was down to about 103 in morning but stayed over 102 the entire day following vaccine. The following day, massive diarrhea and fever staying at 100 or so. Today, 3 days after vaccine, I still have a headache, mild, earache, mildly swollen glands, diarrhea. And no appetite. I have eaten very little since the shot

Tinnitus. I did not notice immediately, but believe it started shortly after the first shot. it has gotten progressively worse.

Flu like symptoms the following day, chills, fever, sore bones, severe headache 2 days after 2nd dose my nose and lips started burning & tingling like I was getting cold sores or fever blisters. Lips swelled up with cold sores and canker sores inside mouth

Sat up in bed at 3:30 am with sound of jets roaring in both ears, then went to loud noise in head, still ringing loud in left ear, right ear is better but louder than normal, so hot from chest up felt like I could combust from inside out

On April 8, I began to feel extremely tired and unwell. During that night, I woke up dizzy and feeling sick to my stomach. I experienced extreme dizziness, jaw pain, headache, light sensitivity, vomiting (once), pain in my lower abdomen, several bowel movements, loss of appetite, and I slept during the day and night. It was very difficult to stand upright or walk. I began to feel better April 11 and was able to eat and walk. I still have a bit of dizziness and nauseousness, but I am able to eat, walk, and do daily activities.

Patient received Covid vaccine (Moderna Lot number 028A21A - short dated expiration) on 4/7/2021. Patient came down with an earache on Saturday 4/17/2021. On Sunday 4/18/2021 patient had mouth droopiness and went to the ER. She was then diagnosed with Bells Palsy at that time

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.

Urticaria generalized, thorax, abdominal wall, arms, legs, hands and genitalia and tongue swelling 4/2/201. Rash persistent to date but has diminished with Allegra 180mg once a day and Prednisone 20mg once a day for 7 days then 10mg once a day for 7 days which started just yesterday (had no ride to get meds up until yesterday)

Muscle pain in the left arm for 3 days, fever for 24 hours, headache on and off for a few days, fever blisters and mouth soreness developed after the fever, queasy stomach until Monday the 12th, overall fatigue for a few days as well

PATIENT RECEIVED SECOND DOSE OF MODERNA COVID-19 VACCINE, AND 2 DAYS LATER HAD ADVERSE EFFECTS: FEVER OF 101.4, FACIAL PAIN, MUSCLE ACHES, AND TINNITIS. ALL SYMPTOMS RESOLVED EXCEPT FOR THE TINNITIS. PT TX SELF WITH OTC MEDS.

Insomnia, joint and muscle aches and pain, earache, exhaustion, swollen glands. Desperately tired and could not sleep all night. Aches, pain and fatigue continue the day after shot.

Within 5 mins after, momentary hearing lose in both ears X 2 Day 2, began experiencing, extreme lethergy Day 2 began experiencing stumbling gate Day 2 symptoms lasted approx 3 weeks.

Pt had the vaccine, went through observation period of 15 minutes and had been discharged. Left the building and was in car driving away when numbness began in her face. She describes feeling like she had been to the dentist and had a novacaine injection, her right ear felt as if it were plugged with cotton. Her left arm and tongue felt a little numb as well. Vital signs were BP 140/96, AP-96, Respirations 20 unlabored. Color pink. Alert and oriented x3. Signs and symptoms did not increase, but did persist and so local EMS notified. No medications given at this time. Care resumed by EMS/transported to hospital. Patient had no history of this type of reaction.

High fever, 104,F, chills, headache, nausea, left neck jawache, ocular headache, lethargy all extending over 8 days

Lips swelled so badly, they cracked and scabbed and took about 2-1/2 weeks for the new skin to grow. Taste was affected for the same time period, everything tasted awful, if I could taste it at all. Inside of mouth felt "astringent" for several weeks, as if had been drinking cranberry juice.

Extreme full body weakness- Full body soreness Sore throat Headache Blurry vision Fever- lasted for 4 days- treated with lots of fluids Advil Tylenol. Slept as much as possible. 5th and 6th day sore throat bad headache. Missed 4 days of work

Patient called Pharmacy to report pain behind eyes, cold symptoms (cough and runny nose), pain in neck and back, chills, gas and burping

Buzzing in left ear started a few hours after receiving the vaccine in March 24th and the buzzing has been on going since. All day every day.

A few hours post vaccination I had a metallic taste in my mouth. Approx. 12 hours post vaccination I awoke with chills and muscle ache and headache. The headache lasted the entire day along with moderate fatigue. (took two naps during the workday totaling 2 1/2 hours and went to bed a 9pm). When I awoke the following day all signs were gone (except for mild arm soreness that lasted another 24 hours but not an impairment)

I woke up on March 9th, 2021, and my left eye was swollen shut and my right eye was partially swollen. I am not an alarmist and I thought I was having an allergy reaction to food or the enviroment. It occurred to me that this may be a response to the Moderna vaccination. I did some research and discovered an adverse response is facial swelling and there was a photo of my exact adverse response. It has not gone away is today it has gotten worse. I went to the Clinic this morning. I did call Moderna and report this the last week in March. My second shot was scheduled for Monday, April 5th and I was hesitant to take the shot when I was still exhibiting an adverse response. I am starting to really be concerned as this has now started to go down into my entire face. It is extremely uncomfortable and very itchy. Never mind it is very unattractive -my swollen, red, and itchy eyes and now entire face. At this time it is impossible to know if this is a permanent condition. It has been 6 weeks and starting the 7th week with worsening coniditon.

Within 5 minutes, it appeared tongue was swelling a bit. A metallic taste was also present. Next 3 days, mild fatigue, low grade fever, headache and sore arm were experience. Day 4 light headedness and fatigue increased and grew progressively worse each day. Heartbeat & blood pressure elevated over normal, but not in dangerous zone. It felt like when I had anemia years earlier. Day 8 I went to urgent care, suspecting anemia. Blood test was normal, except for slightly lower sodium. Day 9 I followed up with regular doctor, and Thyroid test was ordered. It was normal. Day 10 tongue swelling and metallic taste improved, and other symptoms started to subside. As of day 18, all symptoms gone, I felt "normal" again and was able to resume regular activity and exercise routine.

Headache, chills, body aches, nausea, vomiting, diarrhea, fatigue, worsening of tinnitus. Symptoms stated on evening of injection (4/13/21) and lasted through 4/18/21.

Lymph-node pain under arm (same as injected arm), radiated from underarm to under left breast; duration from 04-03-2021 through 04-07-2021 Metallic taste in mouth. Intermittent from day of injection to current date of this report (04-20-2021).

Second day second shot, chills, headache, nausea, 4 day after second shot, bleeding gums (never had problems with my gums) nose bleed and bruising

Patient reports persistent but less obvious cognitive change described as being in a cloud x 2 weeks. Reports received second moderna covid vaccine 4/6 at which time she experience right facial swelling around eye, tongue numbness, difficulty swallowing and confusion that began 20 min after injection. Reports she drove around for 2 hours trying to remember/find her way home and couldn't/didn't think to call husband. Did not take benadryl or attempt to trt sx with any other medication. Reports similar but more mild rx to initial dose 3/9

Severe chills, extreme fatigue, severe pain in joints, muscle pain, nausea, loud ringing in ears. Sill have pain in both hips 6 days later but it is FINALLY beginning to subside.

A few hours after the shot I began experiencing vision problems in my left eye and flashing lights that were diagnosed later in the week as a torn retina.

Tinnitus is MUCH worse, starting Sunday April 4th, in the evening. Much worse the following morning, all day, subsided a small amount on Tuesday, then came back next day. Tinnitus has continued to be very much worse since that day

Lymph nodes swollen over collarbone and stiff neck on left side, after two weeks left eye is blurry and may have a swollen nerve . MRI done to be sure nothing else is causing the nerve swelling.

patient started to feel itching and swelling of tongue. 25mg Benedryl give and monitored for additional 30 min

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.

DAY AFTER WAS TIRED, ON DAY 4 WOKE UP WITH RED BLOODSHOT EYES, EYELIDS AND PRESSURE IN EYES. 2PM WENT TO DRS OFFICE BECAUSE IT GOT RELLY BAD EXTREMELY RED, SOME PRESSURE, TIRED.

Severe chills, tremors for 8 hrs.. TX. Advil, mild relief Severe frontal lobe headache with light sensitivity for 24 hrs. TX. ALEVE, no relief

They thought they were having a stroke; Facial paresthesia; The right side of their face felt numb, like with paralysis; Their face was swollen; Right upper extremity paresthesia; Blurry vision; Dizzy; Nervous as hell; Felt like someone hit them with a gun in the right temple with Novocain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain). On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (They thought they were having a stroke) (seriousness criterion hospitalization), PARAESTHESIA (Facial paresthesia) (seriousness criterion hospitalization), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis) (seriousness criterion hospitalization), SWELLING FACE (Their face was swollen) (seriousness criterion hospitalization) and PARAESTHESIA (Right upper extremity paresthesia) (seriousness criterion hospitalization). The patient was hospitalized from 14-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, PARAESTHESIA, PARAESTHESIA and SWELLING FACE. On 11-Apr-2021, VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: normal (normal) Normal. In April 2021, Blood test: normal (normal) Normal. In April 2021, Echocardiogram: normal (normal) Normal. In April 2021, Lumbar puncture: negative (Negative) Negative for Lyme disease. In April 2021, Magnetic resonance imaging brain: normal (normal) Normal (2x). In April 2021, Ultrasound Doppler: normal (normal) Normal. In April 2021, X-ray: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was unknown. Treatment information was not provided.; 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 is requested.

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

Extreme dizziness, nausea, headache, vomiting left ear pain. Went to 2 different urgent cares in 2 different towns. 1st one couldn't find anything just gave me a prescription for Meclizine for dizziness. Urgent care said small left ear irritation that was it. Gave me a steroid shot another prescription of Meclizine and sent me on my way. Nothing has changed and I can't get rid of the severe dizziness and ear ache. I have not been sick at all with Covid-19 or anything else since Covid-19 started in March 2020. And this has all started since I received the vaccine

After the first dose I had arm pain only and left after 40 minutes. The next day around noon I started feeling my mouth, lips and tongue hurting. It was hard to eat except yogurt but I was able to breathe fine. I also had hives on my hands and left toes. . The next day it was worse so I went to an urgent care. They prescribed methylprednisone and follow up with a doctor and allergist. Both thought it was a delayed reaction to the vaccine. After 3 days I was able to eat more solid food. After discussions with both the doctor and allergist, since I really wanted to get the second dose, I received a prednisone prescription, epi prescription, and benadryl. I took 1 benadryl before the second shot (no zyrtec that day). I am taking benadryl every 6 hours round the clock. So far, I have the feelings of beginning of swelling when I don't take the benadryl promplty. I have not taken the prednisone (but will check with doctor to see if it is better to knock out the swell reaction with benadryl longer or start prednisone). I'm not sure if it is bad swelling as with the first vaccine, or minor.

The day after the injection, I had headache, chills, sweats, bad taste, fatigue, lethergy. One week after I developed stabbing head pain, that continued off and on for several hours and several days. 18 days after I developed migraine that caused me to take time off work and go to bed.

2 days after shot, 2 days of extreme diarrhea, awoke with all hands and feet in extreme pain . Left arm felt like a log then the trigger finger returned on left hand. All arthritis swelled with pain. Right ear started popping as if traveling but still home. Ringing in ear got louder.

PATIENT INDICATES THAT SHE HAS TINNITUS BUT THE NEXT DAY AFTER GIVING HER THE VACCINE, THE NOISE INCREASED AND TO DATE IT HAS NOT IMPROVED

Patient felt that her muscles in her shoulders seized up, started getting chills, and that her face was starting to swell in her lips, eyes, and cheeks 20 minutes after receiving her second dose. She was treated with 25 mg diphenhydramine and remained seated for 20 minutes further. She went home after that and was going to take a second dose of diphenhydramine after eating dinner.

Swollen red rash upper left arm, itchy lasted 5 days . Also experienced numb tingly feelings in both hands, arms & lips - still experiencing these symptoms to a lesser degree. Felt flush - like blood pressure was up ( FYI I have low blood pressure) and lite headed at times - a feeling of being a little off On the 3rd day had some sharp pains in my left are

besides a sore arm , back muscle soreness and canker soar in my mouth and cold sore on my lower right lip

8 day's after shot developed swelling/ heat/ and redness at site of shot. Now after every time i eat I taste metal

Bell's Palsy; Right Eye does not close; Sometimes she can not talk; Red Left Arm (from injection site all the way to elbow); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant), EYE DISORDER (Right Eye does not close), SPEECH DISORDER (Sometimes she can not talk) and VACCINATION SITE ERYTHEMA (Red Left Arm (from injection site all the way to elbow)). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), EYE DISORDER (Right Eye does not close), SPEECH DISORDER (Sometimes she can not talk) and VACCINATION SITE ERYTHEMA (Red Left Arm (from injection site all the way to elbow)) outcome was unknown. Not Provided On 21 Apr 2021, the patient was diagnosed with Bell's Palsy. Treatment information included unspecified oral antibiotics and steroids. This case concerns a 60-year-old female with a serious unexpected event of facial paralysis, and nonserious unexpected eye disorder and speech disorder and expected vaccination site erythema. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of facial paralysis, and nonserious unexpected eye disorder and speech disorder and expected vaccination site erythema. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Bell's Palsy, face twisted; Burning in the mouth; Lips swelling; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy, face twisted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy, face twisted) (seriousness criterion medically significant), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling). At the time of the report, FACIAL PARALYSIS (Bell's Palsy, face twisted), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; 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.

101 fever for 6 hours, 99 fever for 15 hours, severe fatigue, body aches with muscle spasms, no appetite, no taste, frequent urination, headache. Self care at home. Most improvement within 24 hours but appetite has not fully returned not taste.

LOW GRADE FEVER SCRATCHING COUGH SLEPT 34 HOURS AFTER SHOT TASTE AND SMELL AFFECTED STUFFY NOSE HEADACHE

Swollen/red/painful arm, headache, rapid heart rate, chills, metallic taste in mouth, hives on arms & legs, restless sleep.

Thick, scaly, itchy rash appeared 2 wks after 1st dose from base of spine upward to just below bra area , also exyending outward from spine about 6" each side of waist& also along shin of left leg. Appears to be fading away presently after more than 3 mon. Also experienced a fine, prickly type rash across buttocks that lasted abt 3 wks as well as brief intervals of intense itching in nostrils & ear canals that subside then recur.

Very dizzy with loud ringing in both ears. Fever, body aches, headache. I expected the fever/body aches but the extreme dizziness makes driving/working not possible.

After my first shot, I was very tired and did not feel very good for about 10 days. My arm was also very, very sore. In addition, I had GI issues (lots of loose stools and some cramping) within the first six hours of taking the first dose. Those symptoms went away fairly soon, but when I ate dried cranberries again the same thing occurred so I think that might have been the issue. Around April 11th, I almost passed out twice in the night when I got up to go to the bathroom and I did not feel very good. I was in an office two days before where the staff had been fully vaccinated, but two of the staff were not wearing masks and I overheard one of them saying they had not been feeling good. I felt fine on the date of my second vaccine on April 20th so I went in for my shot. Right after my first shot I felt fine. However, about eight to 10 hours later, I started running a temperature, had chills, terrible muscle aches, felt terrible generally, and started having ringing in my ears. All of my symptoms got much worse and I am sure my fever was at least 102 , but I never took it until my chills were better and at that point it was 101. I then took 500 mg of Tylenol and within about three hours my fever was reduced to 99. In about 30 hours, my fever was gone and I felt better, but was still very tired and had ringing in my ears. It has been almost two weeks since my second shot and I still have ringing in my ears and it is worse when I am lying down or am quite. I am also a little more tired than usual and my insomnia is worse than usual. My main concern is the ringing in my ears.

Loss of Taste for a couple of weeks. Now everything I eat tastes bitter. I cant taste salt, sweet, or sour food.

8 hours after receiving: fever 101.2, metallic taste in mouth, scratchy throat, dizzy, drippy nose, severe chills with shaking, mild headache and exhaustion to the point that after waking the next morning I could only remain awake for 2-3 hours before needing a 2-hour nap. I took Tylenol and snuggled in blankets even though that day it was 80 degrees. The next day my fever was 99.6 degrees. I was chilled but not shaking. I had enough energy to do computer work for 4 hours before needing a nap. Little muscle strength, metallic taste in mouth, drippy nose and scratchy throat with no appetite.

Hives, swelling, pain at injection site eight days after injection; started taking Benadryl; went on to get hives on body 24 hours later then started with severe migraines; was sick for five days. Six days later I noticed a blind spot in my left eye field of vision which was diagnosed to be Optic Neuritis for which I have been hospitalized and treated for and have been very ill since.

Numb, tingling hand on left arm, numb throat, roof of mouth and top lip. Administered liquid Benadryl. Stayed at site for observation. Symptoms subsided within 45 minutes.

Swollen neck, Achy neck, stiff neck and Left arm. Headache, teeth hurting. Swelling started in my lymph glands esp. left arm, Lower calves hurting and bottom of my feet. Second day left lymph glands swelling more, I didn't do anything. Body hurting like the flu. Third day, headache continues, swollen neck,, glands, calves & feet.

Patient had felt something in her eye and was not sure what it was. She tried cleaning it with Visine, but she complains that there is a black line in her vision from one eye. She is concerned that it might be due the Moderna Covid 19 vaccine that she received on 04/30/21, as she did not have this issue prior to vaccination.

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)

Patient called on 5/5/21 and stated she had an adverse reaction to the covid vaccine. She said she got the shot on Tuesday and on Wednesday she started feeling bad. Thursday, she had no voice which has lasted for one month. Friday her bones began hurting and between Friday and Sunday she started having head congestion, chest heaviness, and on Sunday she started running a fever at nighttime only that lasted for 3 nights. She said all symptoms have resolved with the exception of a clear voice.

Fatigue with whole body muscle spasms (legs, arms...). I have previous gotten muscle spasms like this when I had reactions to Remicade (used to treat neurosarcoidosis). Ever since I got this shot (2nd covid-19 moderna vaccine), my spasticity from my neurosarcoidosis has gotten worse. I am having chronic tightness and pain. The increase in pain initially lasted for 10 days. However, since then, the pain from spasticity in my muscles has resumed. And in April, I started seeing spots in my vision from the left side of my left eye. I don't know if it is related. I saw a neuro-ophthalmologist and he could not find a cause. He has been considering an MRI.

Headache started 12 hours after the 10 AM injection. Over the next 10 hours muscle aches and joint aches set in with severe chills and fatigue. Felt nauseated/ did not vomit. My eyes ached. I stayed in bed for 24 hours. Two days after the injection most of the symptoms had subsided but my vision was very blurry. I have experienced the same type of blurry vision after taking Nyquil, so I don't take it anymore. Now 3 days after the second Covid shot, my vision is clearing. I am developing a cold sore which I feel may be another reaction to the vaccine. I did not take any medication for the symptoms and did not report it to my doctor. I just wanted the fact of the symptoms to be included with the CDC data.

60 y/o Hispanic female c/o dull left temporal area headache 7/10, sour taste in mouth and tingling in bilateral legs 15 mins after receiving 2nd dose of the vaccine. She reported that she had similar symptom with first dose of the vaccine, has Hx of migraine, takes no meds and she last ate at 9am (6 hrs ago). She was assessed and monitored by NP, EMT, and paramedic. BP - 129/86, HR - 65, resp - 14, O2 sat 98% on RA. Pupils size 4, PERRL, MAE. She was given snacks and H2O and kept at site until she reported that she felt better and had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911and go to the ED, see her PCP, register with V-safe. She verbalized understanding and willingness to comply. Also instructed to take Tylenol 650mg Q6h PRN headache. She left site in no acute distress, awake, alert, oriented to person, place, time and situation.

Upon review for patient's second dose of Moderna, she explained that for her first dose she experienced a tingling sensation on her throat area as similar as when she experienced anaphylactic reactions due to Aspirin an Penicillin allergies. This happened during the 30 mins observation period and she did not report it. She says that the tingling sensation subsided while she was at the store and then went home and took a dose of Benadryl. I proceeded to contact her PCP for consultation since the patient did not report the incident to her doctor. The doctor could not be reached and the patient was instructed to discuss the risk vs benefit of receiving a second dose. Patient went to her doctor's office and he approved the second dose with a previous 24hr period of pre-medication with Benadryl 25mg every 6 hrs as indicated in a letter provided by the doctor. Patient was then re-scheduled for Health Clinic on 05/12/21.

Started with extreme fatigue first day of shot. The next day left arm was very hot and swollen. That night a red spot developed down farther on upper left arm than the injection site. Monday morning many more spots appears at middle of upper arm that were raised and very hot to the touch and eyes and face felt as if it was swollen. Put cold wet wash rag on face and left arm where the spots developed. Call Dr and got in that day at 1:15. He said that it was the lymphatic system that it could have leaked into or got into. He said if it got worse or if I have chest pain to call immediately, and he would get me in that day. My BP was 141/92 which is higher than normal.

She got her vaccine, she had no reactions at all. On the 4th day 3/13/21, had a blister on the inside of her right nose that had clear fluid for it. She went to the doctor for this and he popped the blister to get it to drain. It drained on the outside of her nose and down to the back of her throat which caused a burning sensation in the back of her throat and a nasty metal taste in her mouth. it also caused her voice to change. This has been going on ever since this occurred. She has been to a couple of ENT providers for this, the first one put her on steroids which didn't change anything. After that her regular physician ordered a CAT scan and sent to a Dr. who is now treating her. he has her doing a sinus flush with salt water right now, and he is having a special medication made. He feels that there is a problem and that there is a possibility that her brain fluid is leaking out. A couple of days after that she got a cyst under the right breast and she thought it was a pimple and it continued to grow and she went to the ER as it was very painful. She was put in Clindamycin and told to put warm compresses on it, and to watch it. It did pop open and it oozed, and they sent her to see a surgeon for the breast lesion as it is very large now. He went in a made a small incision and opened the wound up for drainage and put packing in it, which is still ongoing and still undergoing treatment for that. He put her on more Clindamycin and pain medications, Hydrocodone. All of her doctors have told her not to take the 2nd vaccine.

sudden on-set of the worst rheumatoid arthritis flare-up of my entire life. (With the exception of a few minor flare-ups, before April 25 I was about 20 years in remission, after having JRA during my childhood and having my left knee replaced.) I have never in my life experienced an arthritis flare-up like this one. I have extreme pain and stiffness in my wrists, both hands, all knuckles of every finger, right shoulder, jaw, and left ankle. Before this recent flare-up, I never had problems with my hands or wrists, and I never experienced this type of extremely sudden on-set, extreme pain, stiffness and many joints affected at one time.

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

She got her vaccine, she was fine the first day, walking around, going to the mall, driving and no issues. She went to bed and about 8:55 she woke up and was freezing. She threw on an extra blanket on the bed and immediately she felt as if somebody had kicked her in the back with a boot all night long, and laid in bed and moan and drank water as she was thirsty. She laid in bed the rest of the day. She had pain in the injection site and swelling, and then she had joint pains. It felt like all of her joints had pain, slight headache. She took some Ibuprofen for her symptoms. Her husband came home and was able to assist her in eating and taking care of her. The following day she was still tired and fatigued for about a week, but she was able to function and do her normal routine of things.

She got her vaccine, she was fine the first day, walking around, going to the mall, driving and no issues. She went to bed and about 8:55 she woke up and was freezing. She threw on an extra blanket on the bed and immediately she felt as if somebody had kicked her in the back with a boot all night long, and laid in bed and moan and drank water as she was thirsty. She laid in bed the rest of the day. She had pain in the injection site and swelling, and then she had joint pains. It felt like all of her joints had pain, slight headache. She took some Ibuprofen for her symptoms. Her husband came home and was able to assist her in eating and taking care of her. The following day she was still tired and fatigued for about a week, but she was able to function and do her normal routine of things.

Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; Pain; couldn't eat anything down; eye was so swollen; Passed out right after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out right after the injection) 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. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out right after the injection) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out right after the injection), VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant list is provided. Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days

She got her vaccine, had no reactions. She woke up on 5/12/21 and had extreme headache, blood pressure was high, nausea and vomiting, extreme pain behind her eyes, blurry vision. Later in the afternoon she had diarrhea. She called her PCP that evening and he prescribed Ondansetron (Zofran). On Thursday she continued to have the blurred and double vision with some nausea and dizziness and headaches which have been on-going, especially on the left side of her head. She went to the ER on Friday evening 5/14/21 where her BP at it's highest point was 195/126 and a pulse of 99. They started doing some actions to determine if she was having a stroke. They did a CT scan and gave her medications to get her BP down, started an IV. She was then admitted to HCF that evening. They kept her overnight and did an MRI on 5/15/21, had to start wearing an eye patch on her left eye due to dizziness and was not able to walk without covering the one eye and needed assistance to walk across the room. Everything was clear on the MRI and CAT scan. She saw two resident internist and then she saw a neurologist while being in the hospital. The neurologist diagnosed her with left third nerve palsy as a result from the vaccine and the high BP. They released her that evening with instructions to see an Ophthalmologist the following week, which she did on 5/17/21 and saw Dr. He concurred with the neurologist diagnosis and felt that there was really nothing that they needed to do and for it to run it's course and let it heal which will take anywhere from 2 weeks to 4 months. She was informed to continue to wear the eye patch until the dizziness and double vision improve. There is pain still behind the left eye, and still has high BP and have prescribed medications for that. Her PCP started her on Amlodipine/HCTZ 10/12.5 mg. She then ended up in the ER again last night on 5/19/21. They put her on fluids as she started vomiting again and could not keep any of the medications down that she was prescribed. So they gave her fluids and started a steroid in the IV fluids to help with the pain and inflammation behind her eye, as well as headache medications as well. She was then sent home last night and now the pain in her eye is about a 5 since receiving the steroids. She was also started on Prednisone 20 mg to start today as when she was in the ER they told her to start that. She has not had any nausea or vomiting today, and seems to be OK, but is still taking the Zofran for this. She was able to eat a little bit today and hold it down, but has not had much in the way of an appetite since receiving the vaccine.

05/14/2021 Sudden hearing loss in left ear. Pressure in ear. Sound amplified in right ear. In evening schirping starts in left ear. Progresses to constant static and sound of trickling water by next morning. As of 05/20/2021 conditions have remained stable: hearing loss and tinnitus the same. No history of hearing related issues.

Bad headache, 103° fever, dry eyes, eye pain, both ears hurt, unable to do any activity. Chills,Severe bone, muscle pain, no appetite. Fever rose from 99.2° to 103° during day. Evening sweating, weakness, dizziness

Patient received second dose of Moderna Covid 19 vaccine and experienced light headed-ness and vision disturbances upon standing approximately 2 minutes after the injection the patient than proceeded to complain about dry mouth, dizziness, itchiness. Patient was observed for approx. 20 minutes by pharmacist, she never last consciousness during that initial period. BP measured after injection was 149/101 pulse 91bpm. Patient rose after 20 minutes and proceeded to go shopping in the store and returned to the pharmacy approximately 25 minutes later. The patient ate a banana and candy bar and stated she did not feel capable of pushing her cart to her car or driving home. She then stated she had a systemic tingling/itching feeling, was feeling drowsy, tongue felt fuzzy/possibly swollen and decided to lay down on the floor on her own accord due to feeling faint. Patient stated these symptoms were worsening as she was laying down and had a supine BP measurement of 175/103 104 pulse. Patient at one point closed her eyes and did not respond for several seconds and when she came too she consented to Epinephrine injection, which was administered intramuscularly into the right outer thigh. Paramedics arrived and transported patient to hospital. Patient called pharmacy about 2 hours later and was very appreciative of the efforts made by the pharmacist and stated she was being discharged on corticosteroids and all symptoms had resolved after steroids were given at ER.

Patient bent down to pick something up and lost vision in her left eye, described it as a field of black with shooting colors like fireworks in her eye. She presented to her optometrist Dr. She also presented to the ER for further evaluation. She underwent lab work and a CT of the head without contrast. She was diagnosed with a retinal occlusion of the left eye.

05/19/21 Rash, 05/20/21 Earache (resolved 05/22/21), 05/21/21 Diarrhea (resolved 05/21/21),05/23/21 dizziness,nausea,ringing in the ear ,room spinning,not able to balance and walk(still not resolved as of 05/24/21) Arm warm to touch still not resolved as of 05/24/21.Advised to see MD if condition does not resolve.

05/15/2021 1300: Received first dose of Moderna COVID vaccine. No issues. 05/16/2021: No issues. 05/17/2021: No issues. 05/18/2021 0800: Some occasional vision blurriness as if my reading/computer glasses were smudged. I kept wiping my glasses all day. That evening, I was anxious and unable to settle down. I did not go to bed until 1:00 AM. 05/19/2021 0500: Brief strange chest sensation (not pain; not pressure; just a strange sensation). 05/19/2021 0800: Dizziness and more noticeable blurred vision which continued throughout the day. 1st BP at home 122/81 2nd BP at home 117/77 05/19/2021 0940: Brief strange chest sensation (not pain; not pressure; just a strange sensation) while driving to doctor's office. 05/19/2021 1015: I happened to have scheduled an annual wellness visit for May 19 at 10:15 AM with a new primary care physician because my previous PCP (in the same practice) has been on a very long medical leave of absence. I was dizzy and having some balance problems walking from the parking lot to the office. 1st BP 143/88 Temperature 97.2 Weight 222.1 EKG good 2nd BP 130/76 Heart: soft murmur Thyroid: symmetrical The blurred vision and dizziness were getting much worse during my appointment. Dr. said he thought the symptoms were likely a side effect of the vaccine but wanted to order an MRI to make sure my brain was OK. Dr. arranged a same day appointment at a Clinic for 3:00 PM. Dr. advised me to rest, stay well hydrated, and not skip meals. My balance was very bad leaving the office and remained bad for about 6 hours. Dr. called me with the results of the MRI and said there was no stroke or clot, and that he thought the symptoms would slowly dissipate. 05/20/2021 0800: I woke up with ringing in my left ear that sounded like a combination of soft static coupled with soft sounds at a higher pitch. The ringing lasted about 1 hour. I had dizziness and blurred vision throughout the day, but it was less severe than the previous day. 05/21/2021 through 05/25/2021: I have had much less dizziness and it usually occurs only in the morning. I still have occasional vision blurriness throughout the day. It is most noticeable when I am working at the computer. I feel as if I have a little brain fog because it takes me longer to figure out how to type some things such as my email address, passwords, etc.

Within a couple hours of the second dose my tinnitus exploded and got extremely loud. It has continued to be very loud. Also Followed by a continued fogginess and occasional dull headache.

Got metallic taste in the mouth following shot approximately one minute after and last 30 minutes. Also when walking out having a hard time swallowing, stopped on top of the stairs and swallowed but went to car and waiting x20 minutes before leaving/ after feeling better.

Itching in mouth, back of throat, head, face, neck arms, shoulders approx 30 mins to 1 hour after Light headedness shortly after shot Body ache, joint pain started few hours after shot Terrible headache on 2nd day Intense joint pain especially knees 3rd day after Nothing other than the light headedness has stopped.

patient reports that after getting the first vaccine she had tinnitus in both ears, constant buzzing that has lasted through the second vaccine as well

Start date on 5/5/2021 Left arm and hand pain, Off balance. Left foot drags.Then Left leg,foot pain,numbness, pins and needles, aches, 4th week moved to torso, aches and pain. Alway daily Headaches on right side of head, extreme tireness, hard to walk with out using my cane. 3rd week moved to right leg and foot.Always Brain fog, since the beginingg. Hard to remember things off and on. I need to rest and nap daily. Blurr vision 2nd week at home noticed. Wearing my eye glasses more. Ear pain and Dizziness/Vertigo on 5/16/2021 Doctor Prescribes Prednesone for 2 weeks. Helped somewhat. Taking Ibuprohen, CBD oil for pain, Doing stretches, yoga, PT exercises to strenght muschles, Chiropractic adjustments weekly and massage helps too. Going to try accupuncture next week. I think I have Gullian Barre Syndrom. I have all the symptoms due to the 2nd Moderma Vaccine on 5/5/2021. Cannot work. Missed a month of work now. May have to go on disability.

Patient reported losing complete hearing in her right ear on 5/14/2021. She went to the Dr who prescribed amoxicillin and said it looked ok but was giving amoxicillin just in case. Patients hearing did not return and is currently 100% deaf in her right ear since 2 days after her first dose of Moderna COVID vaccine.

SEVERE PERSISTENT HEADACHE, FEVER, INANITION,NUMBNESS, TINGLING , FATIGUE, EFFORT INTOLERANCE, VISUAL CHANGES, AND GENERALLY UNWELL

Pt called call center on 5/10/21. Complained of sxs starting 4/30/21 headache,blurred vision felling tired,slight occasional dizziness,right eyelid twitching on/off,diarrhea and feeling anxious. Pt was advised to go to ED for evaluation

24 hours later patient had her tongue and face start swelling. increased pressure in her sinuses. lasted 6-8 hours and went away

i had severe lymph nodes swelling pain under my eye. I went to the doctor to get an ultrasound because i had pain but they didn't find anything. I had flare up because i have thyroid disease my eye swelled up and had a significant dryness. i went to the eye doctor and he ordered blood test

had 2nd shot at 9 am woke up 2 am throwing up with chills and fever and stomach discomfort. took advil; when i woke back up at 6 am underneath my tongue was so swollen I could not talk and difficultly in swallowing. Took an allegra and swelling went down about 2 hours. Now I have ulcers/sores under my tongue, slight sore throat and ears. As of today, June 16th, condition still persists.

About 10 hours after the second vaccine injection, there was a high pitched sound in my head/ears. It has been consistent since that time with no relief. I have not received any treatment for the condition.

Have ringing in my left ear started either before or after 2nd covid vax. And have dry red eyes right worse than left. Also have fatigue. Still have all three symptoms

Pt was given her 2nd dose of COVID vaccine at 9:48 am. At 9:54 am pt was asked if she was feeling okay and pt reported that she had "tingling in her throat". Assistance called for and vitals obtained(157/74) pulse rate 83, sat o2 100%. Pt reported chest pain to RN. RN reported clear breath sounds and no labored breathing. Dr. arrived besdie patient and pt was evaluated. At 10:02 am pts vital was (144/76) HR 76 and sat o2 on room air 100%. Dr. provided samples of Xyzal to patient. Patient was clear of hives and at 10:05 am pt was reporting that she was feeling better and had no chest pain. At that time pts vitals was (142/76) HR 74 with sats 99% on room air, respirations 18. 1017- BP-143/76, HR-73, Res-18, sats- 100% Patient alert and oriented at this time. No resp distress noted. Patient reports she is feeling better and denies any chest pain at this time. Will continue monitoring. 1029- BP-136/70, HR-68, Res-18, sats- 99% Patient continues to converse in casual conversation. No distress noted. Instructions provided for patient to call 911 if displays signs and symptoms of anaphylaxis reaction. Patient waiting for transportation (son). 1055- BP-156/73, HR-72, Res-18, sats- 100% Patient walked out of room to check out. No distress noted.

Headache, fatigue, nausea, heavy legs, whooshing in the head, temperature, exhaustion, joint pain, knee pain, sore leg muscles , sore arm joints, sore lower back

on 6-28 woke up with a swollen bottom lip. could not have been from something I ate as day before not feeling well and slept all day.

Lost vision in one eye; Shngles; Right arm hurt after 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS UNILATERAL (Lost vision in one eye) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A0 and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunocompromised and Autoimmune disorder. Previously administered products included for an unreported indication: Shingrix. Concurrent medical conditions included Breast cancer, Heart failure, Lupus syndrome (Lupus) and Shingles. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (Right arm hurt after 2nd dose). In June 2021, the patient experienced HERPES ZOSTER (Shngles). On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost vision in one eye) (seriousness criterion medically significant). On 07-Feb-2021, MYALGIA (Right arm hurt after 2nd dose) had resolved. At the time of the report, BLINDNESS UNILATERAL (Lost vision in one eye) and HERPES ZOSTER (Shngles) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient took medications for autoimmune conditions and mild pain medication. Consumer got her 1st dose on 05Feb2021 (Lot # 010M20A) and 2nd dose on 05Mar2021 (Lot # 025A21A0. Both doses were administered at her workplace. Consumer states that after receiving both doses, her right arm hurt. The onset was the following day (06Feb2021 and 06Mar2021) and duration was about 24 hours. Consumer states that 1st dose hurt more than 2nd dose. The intensity consumer described was 1st dose hurt 2 times more than tetanus shot. Consumer states she is immunocompromised. She has past medical history of lupus, breast cancer, heart failure, and shingles. Consumer states that she completed the vaccination series for shingles about 3 years ago. Consumer came down with shingles in first part of June (exact dates unknown). She did not know she had shingles until she went for an eye examination. During examination consumer was diagnosed with shingles. Consumer is still recovering from shingles and has lost vision in one eye. Consumer does not blame shingles on the covid-19 vaccine. Consumer did not take any medications to alleviate any possible adverse events, but she did state she take medications for autoimmune conditions and mild pain medication. 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. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. . This case was linked to MOD-2021-228299 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding however by prior history of lupus, breast cancer and patient use of "autoimmune medications" not specified and self-reported history of autoimmune disorders and immunodeficiency. .

The day after receiving the Covid 19 injection, I had an headache, chilling, and my eyes were swollen. After a couple of days, I had a stye under my right eye. It was very sore.

The day after my 1st dose I had a change in vision in my right eye. I went to a retina specialist who diagnosed cotton wool spot. The evening after my 2nd dose I ran a low fever, was nauseas, sore all over (especially in my arm, back, neck & head),lost sense of taste & smell and was exhausted.

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.

After approximately 5 minutes after receiving her second Moderna, Covid-19 vaccine, the patient reported have a dry mouth/throat and was coughing. We gave her a bottle of water and continued to check on her. About 5 minutes later she said her throat was "itching and was scratchy." I gave her 50mg of oral liquid diphenhydramine. After about 5 more minutes she said her throat was feeling some better. About 10 minutes later, she said her throat felt much better. She stayed an additional 15 to 20 minutes and when she left she said she felt fine. I called her about 3 hours later at her home and she said she was okay and felt tine.

Prediabetic; Blackout; Foamy urine; Pain in feet; Lost Quality of sight; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Prediabetic) and LOSS OF CONSCIOUSNESS (Blackout) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, ALBUTEROL [SALBUTAMOL] for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2020, the patient experienced URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight). On an unknown date, the patient experienced DIABETES MELLITUS (Prediabetic) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Prediabetic), LOSS OF CONSCIOUSNESS (Blackout), URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were reported were aolrapadine Allergy and Cpap Machine for apnea. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested This case was linked to MOD-2021-237497 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

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.

Felt like Heroin withdrawal, fatigue, and irritated. Later rash and blisters near the joints, joint pain, worst of it on pelvis and hip. So far, only seen doctor for pain and was given the anti-shingles vax. Was recommended to take anti-histamine. Still waiting to see if it will clear up.

Loss of taste. It started with my coffee tasting like water and currently I can only taste the heat affect of spices while eating. No treatment. Not getting better.

main adverse reaction is tinnitis with no relief to date; will consider this permanent damage. Temporary reactions were 5-7 days intermittent fever, fatigue, headache, muscle aches.

Covid Postive; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid Postive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced COVID-19 (Covid Postive) (seriousness criterion medically significant), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, COVID-19 (Covid Postive), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 97.9 (Inconclusive) 97.9°F. On 24-Jun-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included a thyroid medication (not further specified). Treatment information was not reported. Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.

sensation as injection was moving thru body-down left arm and across shoulder blade- till in evening -up neck, flushing of face-left side of tongue tingling, general heat from body, alternate with chills, lymph node behind left ear very sensitive, 2nd day sore developed in front of left ear and on top of left side of tongue and under tongue, still first day symptoms, 3rd day sores continue half way to lip in a line, still all other symptoms- 4th day- line of sores is to mouth and on chin of only left side mouth has numerous small blisters- gums, cheek, still other symptoms. 5th day worse on sores - diagnosed with Shingles

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.

Sore arm, very high fever (103), chills, aches tired. Symptoms subsided after 36 hours. Tinnitus noticeable and worsened within a month. Tinnitus continues.

sudden extreme exhaustion, chills high fever, spasmodic vomiting. could not move out of bed, My temperature went quickly up to 103.7 and I was delirious not making sense when I spoke. I called the doctor and they prescribed an anti vomiting which helped and made me be able to drink fluids but I became very dehydrated and severely constipated for days after this event. It took my 6 weeks with strange ailments a long the way to feel better. On April 21st I could not see out of my right eye . I went to the walk in clinic who then sent me to the Hospital for a cat scan. They called it a visual aura which I never had in my life.

Six Days after the first vaccine I woke up smelling everything as very gamey deer meat, or a extremely strong vitamin smell. This has continued, going on 2 months now.

Day 1- Fatigue, bad headache, body aches, hot flashes, sweats, arm soreness, fatigue Day 2- Severe flu symptoms included nausea, diarrhea, headache, body aches, restlessness, insomnia, fever, severe arm, neck and shoulder pain, sweats, fatigue Day 3- Nausea, loose stools, bloating, gas, headache, body aches, burning eyes, vertigo, fatigue, insomnia, anxiousness

onset of Tinnitus, temporary loss of hearing in right ear. within 2 hours after vaccine. regained hearing within an hour. on July 26, 2021 at 800 pm sudden hear loss in left ear. gained hearing back. tinnitus continues with no relief.

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.

Swelling of R jaw, unable to open mouth completely, difficulty eating, some discomfort. I took Motrin for pain.

6-8 minutes after the shot felt a sensation from left shoulder slowly sweeping across body, going into face and neck to the inside of left eye. Face had a weird feeling also. Headache, tonged tingling. Left and went to the car. Face was red and swollen all over. Skin looked like she was skiing in the middle of winter. She went back inside the hospital to her department on the 5th floor and stayed about 30 minutes. Then she went home. Half bottom lip was swollen, Both eyes got itchy, glassy, watery. Behind sinuses hurt really bad. Next day pain in hips both knees. Took 2 full days for the redness to go away from face. Had dark circles under eyes. Took Claritin. Hair has been shedding, sever brain fog at work. Her employer told her to take some time off from work . Upper teeth hurt.

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)

After patient observed for 45 min. and left the site, driving away felt she could not swallow. This lasted about a minute. Also, felt as if left side of face was going to become numb and felt pain in back of left knee. Left eye felt dry. These symptoms lasted about a minute. She put eye drops in eye when she got home and ate with no difficulty. She spoke with her doctor today.

Patient received her 1st dose of the COVID-19 Moderna vaccine at her employer's on-site vaccination clinic today, 1/8/21. Patient was observed for 30 minutes following vaccine administration per recommendations, and did not report feeling any reaction. Patient has a known bee sting allergy. Approximately 1 hour following administration, patient began to experience "numbness and tingling in the tongue, and difficulty swallowing" but did not experience tongue swelling. She contacted school nurse who immediately recommended patient go to the emergency department at Hospital for evaluation. Hospital evaluated patient, and prescribed Benadryl 50 mg every 6 hours for the reaction. The emergency department at Hospital may be reached for additional information as needed.

At approximately 3:30 pm the next day (27 hours later), I noticed significant tearing from both eyes, while outside walking. When I returned home, and checked in the mirror, I noticed significant puffiness around the eyes (though not to the point of closure or impaired vision), especially in the inner corners (L>R). I contacted my PCP at 4:45 pm and was instructed to go to the Urgent Care. I was seen there and evaluated, then was discharged without any treatment plan. I had no other symptoms and felt great, and even felt the puffiness had subsided a little bit by the time I left the clinic. Today, 1/8/2021, at 7:30 am awakening, the eyes are quite puffy again, and my nose actually appears a bit swollen on the sides near the eyes. I hear clicking sounds in my sinuses and have a small amount of sinus pressure. I applied ice packs to the eye lids in an effort to reduce swelling, which seems to help a little. Please note that I had botox in my forehead and around the outside corners of the eyes, and dermal filler under the eyes (12/7/2021), this being the first time for the filler.

Moderna COVID-19 Vaccine EUA Began with headache, flushed face then sore arm about 6 hours after injection. Within 2 hours after I had severe chills, worsening headache with severe light sensitivity and nausea, severe heartburn, severe muscle aches, fever of 102.8, fatigue.

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, UrticariaPruritus, facial tingling and allodynia, shooting pain into right eye and teeth Narrative: self treated with rx gabapentin 200mg once then 100mg qhs for 4 nights

Upper and lower lip and inside of lower lip broke out in blisters - treated with acyclovir, viscous lidocaine and Maalox

Waited at the vaccine location 30 minutes and felt fine, driving home started to feel tingling and numbness on lips, face, face was puffy, mouth was dry, hard to swallow. Went to Medical Center as it was closest to home. This was about 1 hour after the shot was received. My chest was feeling tight when I arrived at the hospital and started with a slight headache.They checked my vitals BP was 146/91, pulse was 107, SPO2 was 98, temperature was 97.9. They gave me 2 Benadryl pills and had me stay in a room. After a few hours my vitals returned to normal and I was feeling better. They kept me a few more hours to make sure the symptoms did not return. I was discharged with a prescription for benadryl and zyrtec to take as needed. Only took the Benadryl that evening and the next morning with Tylenol. My arm was sore the next day but felt fine.

Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she could stand up. Walked in the bathroom had pain in stomach, was very hot and freezing at the same time, was shaking. Head hurt was hurting so bad. Tried standing up from toilet, was passed out. Eye, half of face is bruised and swollen , eye shut for two days. More than forty minutes passed before she could call her husband. Does not remember anything because she was passed out. Husband came in and grabbed her, to get her back into bed. she could not stand. Went to ER at Hospital. Had CT scan, blood work , EKG, chest xray. Was still kind of out of it but was able to communicate with nurses. Face is still black and blue. Last night got up at 4:00 a.m. something was wrong with her throat. Felt like a walnut was in her throat. Went to doctor this morning. They said it was a reaction from the shot. Got an EpiPen, prednisone. Call them in 2 days to let them know how she's doing and also wear a heart monitor because they do not know how to take care of her, Has had vision blurriness in both eyes. Has not felt well at all.

Floaters and flashes - right eye - did not have them before the injection - and I have reported - I have not had any treatment - unknown if I need to get treatment and unknown if I should get the next dose

1)strong metallic taste/taste disturbance 3-4 days 2)moderate frontal headache 3 days 3)moderate fatigue 3 days 4)deltoid, triceps and biceps myalgia left arm --2 days

that evening experienced on her face especially her ears the next day the itching increased but facial edema started appearing along with drainage from her ears on Saturday Jan 9th, eyelids edematous plus increased facial edema and increased ear drainage seen in the clinic on Saturday Jan 9th and was prescribed medications

Felt as if head was underwater (ear pressure), and headache on top of head, felt puny from time of administration, gradually lessening throughout the evening.

Patient received her first dose of Moderna vaccine on 1.8.2021. Patient called infection control nurse on 1.15.21 and reported her tongue turned black yesterday (1/14). Patient denies use of Pepto or any new medication that she doesn?t routinely take. Patient states she did brush her tongue but it continues to be discolored. Patient denies dry mouth, pain, swelling, or ShOB with it. Patient DOES report macroglossia. Patient denies any other symptoms or recent exposures. Patient instructed to follow up with her PCP.

Pt c/o (BUE) Both upper extremities tingling started @ 12:56PM Pt also c/o facial tingling in her face and her mouth. Pt. denies SOB, chest pain, SOs 97%, HR 98% 1:21PM c/o feeling light headed

61 y.o. female who arrived by Home presented to the emergency department for Evaluation of syncopal episode. Patient reports earlier this morning at 330 she awoke to go get a glass of water, states that she felt significantly weak and felt that she would drop the glass of water she was going to get it. She describes mild associated lightheadedness but denies vertigo, visual disturbance, chest pain, dyspnea. She that went to ambulate to the living room so she lied on the couch, but does not exactly remember what happened after this. She remembers that there is a chair and she thinks she may have fallen forward and hit her head against a chair and fell down to the ground. She notes that she had currently has a fat lip and feels slight abrasions on her knees bilaterally. History is notable for hypertension, dyslipidemia, states has been compliant with her medications. No recent illnesses, cough, colds. She underwent vaccination 3 days ago for COVID with the majority of vaccine and reported 2 days ago she had mild body aches and myalgias, however at present states she feels largely asymptomatic. She was encouraged to present to the emergency department at the request of her coworkers Laboratory work-up largely unremarkable. CT head no acute process. EKG my read sinus rhythm, normal PR, QRS, QTc, no ST segment changes or T wave inversions concerning for ischemia. Discussed the work with the patient recommended that she follow-up as an outpatient with her primary care provider, also provided with a Zio patch and recommend to follow-up with cardiology. Patient extravascular fat study with plan felt comfortable for discharge home. Discharged in stable condition

Vaccine at 0900; itchy eyes by 0950; lips swelling than face. Got hives on face and rest of body itchy. Took 25 mg Benadryl at 1015. By 1130 hives were gone but itching continued. Used eye allergy relief. Lips swollen for 24 hours. No shortness of breath. At 2100 got rapid heart rate till about 2130. Resolved. Continued having itchy skin and eyes for 4 days. On 01/14/2021 started fexofenadine 180 mg one per day and used eye drops as needed for itchy eyes

pt stated she woke up 3 days after taking vaccination w/ swollen lips, red ring around lips and raw feeling. Swelling has since deceased but still has red ring and lips feel irritated.

Tooth sensitivity Mouth sores - gums, palate, lips, tongue swollen with sores. On and off since vaccination. Lasts several days then dissipates. 3 episodes so far - lasting 2 days. Dental sensitivity has been constant. I have been treating with mouthwashes with some relief.

After 24 hours after injection woke with a severe ear ache, swollen glands and sore throat on the Right side only. Took ibuprofen for pain/inflammation for two days, called Primary care for appt. to see if I had an ear infection or red throat. Was seen by Dr. four days after vaccine, was told that ears were clear and throat looked good. Lymph nodes in neck seemed swollen.

Patient reports she received Moderna Covid 19 vaccine lot #039K20A on 12/31/2021. Patient reports she developed fatigue, T 100.8, swelling and hardness at injection site 24-48 hrs after receiving vaccine. Patient self managed with Tylenol and rest. The following week, patient reports she had intermittent odd heart sensation. On 1/12/21 patient noticed a 5-6 inch red itchy mark at injection site. That night, patient developed tinnitus in the right ear. On 1/13/21 patient went to Urgent Care, then saw her otolaryngologist. Patient reports she had an ECG and labs. These tests were normal. On 1/15/21, patient went to PCP. Patient had halter monitor and is awaiting results. PCP submitted referral. Patient is awaiting appointment with allergist and employee health provider. Patient missed 3 days of work. Patient states "redness at injection site is fading and tinnitus is better."

After I received my shot I was waiting the required 15 minutes when my throat became scratchy, thinking nothing about I left and while driving I notice I was having trouble swallowing and my mouth was dry. However, I could breathe easily so I just remained to relax and slowly swallowing my salia over and over again. Once home took a benedryl and was able to drink water without any problems. My throat is still somewhat scratchy after 2 hours.

Extreme arm pain--feels like arm is broken. Also feels like an air pocket in ear on the side of the vaccine.

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.

Hives and rash on injection site which spread to entire body. Lips and tongue swelling. Seen at urgent care and received injection of prednisone and follow up prescription

Migraine with extremely bright and larger than usual scintillating photoscotoma visual Aura. Headache, stuffy nose, light sensitivity, sound sensitivity, duration approx 3 hours, treated with ibuprofen. Had chills 2 times each day for 2 days following.

1/14/21 8 AM patient noticed BILATERAL TEMPORAL RASH WITH PURITIS progressively getting worse spreading down and getting worse on both side meeting at nose. Pt. states that it is gradually getting worse. Pt. states that she has been taking zyrtec twice daily for one week. pt. states that rash developed on bilateral wrists. Pt. states that she started using hydrocortisone cream to face and wrists. Pt. states that this looked like plaque psoriasis. Pt. states that her rash is red and streaky and right side worse than left. No swelling, no throat closing. Puffy eyes as well.

Neck on left side became extremely painful and sore and could turn my head didnt sleep the first night and had a slight headache. Everything was fine within 2 days. Like nothing happened. On Day 9 experianced a flash of light out of left eye and a floating blob that came and went throughout the day. Saw Dr and he said this is typical of the aging process. Dont know if it was related just weird it happened now. Arm was sore for 2 Days but nothing major. Other than that i felt fine.

Pt received second dose of vaccine and went to the observation area. She was risk stratified into the high risk (30 minute obsevation) category based on a previous anaphylactic response to shelffish requiring epinhephrine. She reported only a minor pruritis after the first dose of the vaccine. While in the observation area she reported auditory exclusion to her male partner, then reportedly went unconcsious immediately. Employees working in the observation area were notified and summoned medical assistance. A medical provider (PA) arrived and found the pt supine in the passenger seat and unresponsive. Her pulse was weak and thready. One dose of 0.3mg epi autoinjector was administered to her R lateral thigh at 12:03p

I received the first dose on the 16th that night I had soreness to the arm and didn't feel good just general body mild aches. Next day I felt better the following night I felt like I had some mild flu again next day I was better and then I seem to return to normal on the evening of the 23rd I started to feel like I have a little bit of a fever or headache but I didn't register a fever on the 24th I felt like I had a mild cold that evening it got worse my headache was getting much worse my head hurt a lot but there was no temperature the 25th I didn't feel good so I went ahead and went down and took a code test then the 26 I was feeling a lot worse I had had been in the bathroom all day no diarrhea just constantly having to clear my bowels I had a bad headache sore throat dry mouth just felt bad so I went and got a wrap it cuz it test it came back negative on the 27th which is today I got the results from the regular test I took on the 25th and it was negative I still don't feel good I'm very fatigued my head hurts I overall just don't feel good my throat hurts so I'm not sure if I just caught a regular flu or what's going on I pretty much self isolate I've been to the hospital to get my shot on the 16th I went to the doctor's office for a routine Pap test on the 19th and I went to grocery store one time. I did go into a fishing store on 23rd to get a net I was only in the store for 5 minutes and I double mask. Today once again I have no energy my head hurts it's not the headache isn't is bad I just feel like there's something wrong with my head my throat still hurts my mouth is still a little dry so I'm not sure if this is just a flu but I wanted to report the symptoms just in case

After receiving covid vaccine(moderna second dose), began to feel thickening of tongue, raspy voice and hard to swallow, numbness of face, very hot, racing heart rate and shakiness. All this happened about 10-12 minutes after injection. taken to ER via cart for evaluation. Pt evaluated in the ED at 1048, given Benadryl and prednisone PO, and discharged at 1213

At injection site: Swelling Redness Hard Very hot Tender to touch Started as triangular spot1/25 Doubled in size 1/26 Dispersing 1/4 larder at bottom 1/27 *coincidentally or not I got an irritation under my upper right lip 1/25 To present. Painful somewhere between a canker and a cold sore (no tingling).

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.

I had rush in my chest and a taste in my mouth when it was administered then couldnt swallow food 2 hours later could swallow liquid I took benedryl 3 different times throughout the night, next day could swallow food.

Strong chills, shivering and excruciating body aches from morning and through the night without improvement from Jan 21 till present Jan 29. On Jan 28 started feeling tingling in the right side of my mouth: lower lip, toung ON Jan 29the tigling and numbness increased and spread wider, not to right cheek, right ear, entire lower lip and tounge

Mouth tingling and tongue "heaviness", itchy lips. We have seen this reaction before, treated with 25mg benedryl. Symptoms improved after about 20 minutes.

Complained of a "thick tongue" and tingling around the mouth. Treated with 25mg of benedryl. Symptoms resolved in approx. 20 minutes after receiving the benedryl.

10 minutes after receiving the intramuscular Covid-19 Moderna vaccination patient started to feel tingling sensation on the right side of her face, arm and leg and a dizzy. She also had a metallic type taste in her mouth. When called to the area client was talking and had no signs or symptoms of distress. Was speaking without difficulty and ambulating without difficulty. She reported that she had not taken her blood pressure (hypotensive) medication today nor had she eaten anything. The issue was resolving quickly while speaking with her. Lung sounds clear, heart rate normal. 124/72 84 20 (TPR). Denied headache, weakness or numbness. Client improved while speaking with her and was released to home with her daughter who was directed to stay with her the rest of the day and call 911 for any medical emergency.

16 hours after my second dose of the Moderna vaccination, I started having intermittent sense of smell episodes. The smell is very strong and very unpleasant, almost revolting. They are combination smells that I can't readily describe. I have been inside my home while this is happening and not cooking or being exposed to anything new or different. I have not ever in my life had this experience and believe that somehow it is related to the vaccination I just received yesterday. My first does was fine with no side effects other than a sore arm. Again, my arm is sore and a little swollen at injection site but that is fine and expected! The smell thing is extremely strange. I'm just going to wait it out but I thought for research sake, Moderna would want to know about this side effect.

Headache the next morning; Headache the day after that, as well (Jan 1). January 2 - developed a little bit of a cough. Got a PCR COVID test and that was on the Jan. 2; on January 3 - achy; tired and that night - low grade fever - (took ibuprofen); January 4 - negative test came back for COVID; Got a different test on the 4th - Posterior -Positive; my symptoms continued (but no fever) - and very tired and really achy. Tuesday - still coughing (5th); on 8th - lost sense of smell for 24 hours and it came back. Continued coughing for a month. Just stopped having cough and chest tightness at end of January. Got second dose on 27th - symptoms repeated except no cough yet.

Within 10 minutes of shot: slight nauseousness then throat instantly went completely dry. Kept clearing throat. Drank 5 glasses of water. Took Benadryl that night to sleep. Next day slept only 41 minutes in 36 hour period. Followed that with a nap, woke up with migraine and vomited. I haven't vomited in over 25 years. Next two days had a slight headache. Then back to normal.

For about 5 days it really hurt to brush my teeth - they were very sensitive to brushing. No other pain during the day - just when brushing morning and night. Reporting because I saw that some people have lost a tooth to long Covid and I wondered if there was any relation. It resolved on its own.

Pt reported chest pain as well as headache, blurry vision and dizziness. BP was found to be 208/110. EMS was called and pt was transported to ED via private car due to pt not wanting to go by ambulance. Per chart notes, pt presented to ED and also reported hives however she left the ED without being seen.

Pt states swelling and pain to left side of face, eye and ear started on 1/26/21 later in the evening then became itchy. No prior history of reaction to vaccines. Patient saw her PCP and gave her Bactrim . NKDA and no history of cosmetic procedures.

Patient was waiting in the lobby for observation for any adverse reactions. Patient walked up to the front office receptionist and disclosed that her upper was swelling for approximately 10 minutes. Patient was brought back into a room at 12:14 pm and was given Benadryl at 12:18pm. We assured she had a driver to take her home. Patient tolerated Benadryl well after 15 minutes of observation patients upper lip swelling has gone down.

Extremely sore left arm for days 1-3, On third day awoke with debilitating dizziness, nausea and headache. Dizziness was so extreme any movement sent my head spinning and I began sweating and experienced nausea. Had to go to the hospital for treatment. Dizziness continued on the fourth morning but subsides after taking 25mg of Meclizine HCL. headache continues as well. Other side effects: Complete loss of appetite Blurred vision in right eye

Six hours post vaccination- chills, fever, headache. Twelve hours post vaccination- chills, fever, headache, nausea. Feb 4, 2021 - Swollen lymph node at right clavicle; Swollen right eye; swollen, warm, hard knot in right arm below injection site; headache.

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"

Patient stated that 45 min. after receiving her first Maderna COVID-19 vaccination she experienced some drainage in the back of her throat and was unable to speak for an unspecified amount of time.

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.

2-4-21: 1 hour after injection my legs were weak and I had balance issues. 2 hours later 99.1 temperature. Extremely sore right arm. 2-5-21: Next day felt weak and had diarrhea. 2-6-21: Diarrhea and hives on stomach and upper thighs. Swollen eyes. Sore right arm.

Pt reports many allergies. Was advised not to get the shot unless done in the ED. Pt spoke to another Nurse with out my knowledge and got the shot.After ten minutes pt began itching all over, Red raised rash began appearing over her body, lips felt tingly. Given Benadryl 50 mgs chewable tabs at approx 10:20am. Emergency services Called and pt went to the ER and was advised that she cannot get a 2nd dose of COVID because it's contraindicated due to severe allergic reaction. Pt went to ED but was not admitted. States Received IV fluids and some medicine that made her sleepy of unknown name. Was sleepy for 3 days after that and all signs and symptoms resolved. Wants to get 2nd dose even though we said not to. Will get in ED.

Second day started feeling very tired arm swollen painful chills lips tingled and dizzy. Very lethargic went to be about 9 that night and woke up Sunday feeling fine.

One week after receiving the vaccine, I started having a chemical smell 24/7 that no one else can smell. It?s been over a week now and the smell continues to be a problem 24/7 for me. It started in the middle of the night while I was getting ready for bed.

Chills Muscle aches Joint pain, specifically lower back and right hand long finger headache photophobia redness at injection site itching at injection site hard lump at injection site slight nausea fatigue

Around 11:00 P.M. the (evening of the day I received the 2nd dose) I started experiencing symptoms: I experienced Fever,, body aches, jaw pain (my teeth hurt), injection site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, weakness, and a fast heartbeat Of course, I did not sleep well. . At around 11:00 the next morning all symptoms had subsided with the exception of feeling exhausted. I was using v-safe to report my symptoms but never received any reminders about the second shot, and did not get a reminder until Sunday, which of course by then, all symptoms were gone and answered how I felt that day which was fine. I just felt it was important to report the symptoms accurately.

10 minutes after receiving vaccine I had sudden sharp pains in my right ear. I have had extensive surgery in and around that ear due to cholesteatoma and perilymph fistula, and I have had some nerve damage to the balance nerve. The bones of hearing have been removed and replaced with titanium artificial bones that do not work, so I am deaf in that ear. These pains were severe, as if a number of steak knives were stabbing me at once, but the pain only lasted about a minute and subsided. 3 or 4 minutes later the pain recurred exactly as before but lasted a shorter duration and at a lower level of pain. The ear felt congested the rest of the day and I avoided driving after getting home. I have had no further problems, except that I went for more dental work on 2/8, and had a dizzy spell after getting anesthetic, maybe a little heart racing for just 5 minutes or so.

Temperature of 102.2 (afternoon of 2/6/2021) Headache (11:30 am 2/6/2021 - am of 2/7/2021) Ear ache (11:30 am 2/6/2021 - am of 2/7/2021) Fatigue (11:30 am 2/6/2021 - pm of 2/7/2021) Body aches (11:30 am 2/6/2021 - pm of 2/7/2021) Felt like my body temperature had trouble regulating (pm of 2/7/2021 until am of 2/9/2021)

Chills, Headache, Lethargy, Nausea, Lip Swelling progressing from bottom left lip ... all of these symptoms 15 hours after vaccine. Then right bottom lip 34 hours after , top lip fully swollen by 40 hours after injection. All symptoms subsided at 48hours EXCEPT top and lower lips still very swollen despite Zyrtec daily and Benedry one dose before bed on 2/9. Past history of this injections. Aug 4, 2020 I had Juvaderm Volbella injections around my lips. I called my Dr Office and got a Medrol Dose pak

Reports intermittent fluttering sensation in right ear and constant ringing in left ear that started 2 days after receiving second dose of vaccine. Referred to PCP for further evaluation.

Pt reports two days after vaccination eyes became "itchy, irritated, and glazed" and at times "painful". Symptoms would "come and go". Received second dose of Moderna COVID-19 vaccine on 1/21/21 with same symptoms 2-3 days after that dose that have continued off and on since then.

Pt reports had "glazed, irritated, and itchy" eyes about two days after first dose of Moderna COVID-19 vaccine and that happened off and on between her first dose and second dose of the vaccine. 2-3 days after the second dose experienced the same symptoms listed above as she did after receiving the first dose. Symptoms have continued off and on since receiving second dose of Moderna COVID-19 vaccine. Reports symptoms resolve with Benadryl.

Migraine shortly after vaccine, Next day starting when I woke up: fever 102 which lasted 2 hours; sore and very swollen arm lasted 48+ hours; back pain lasted 48 hours; skin pain lasted 24 hours; swollen feet with bruising lasted 48 hours, bruising and pain for a week plus (still happening); numbing and tingling in jaw lasted 1 hours; upset stomach with diarrhea lasted 48 hours;

Approximately 40 minute after receiving the Moderna COVID-19 Vaccine EAU in my left upper arm , I experienced a thickening of my tongue and a tingling feeling It felt as though it was in the forward part of my tongue. It felt very odd and was very scary. I had no tingling in my lips or in my throat. I could speak, drink water and eat. The sensation lasted approximately 5 hours until it felt somewhat back to normal. I have my second doze of the Moderna vaccine scheduled for March 5. I am worried about getting it after having this reaction. Please advise me.

Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.

patient developed hives and swollen lips after her vaccine. we administered 50 mg liquid benadryl and monitored, her symptoms resolved.

Developed lightheadedness, dizziness, progressively worsening headache, dense ringing in ears, extreme fatigue and sleepiness (sleeping 14 hours first night, 12 hours second night), unable to stay upright for more than 30 min, nausea, body aches, fever, chills, sweats, muscle weakness, totally unfunctional, Call out sick to work for 2 days; Tx'd w/ advil, ubrelvy rescue med for fever, headache w/ some relief

Patient woke on Saturday morning at 1am after receiving Moderna coronavirus vaccine on Friday afternoon with the sensation that her tongue was swollen. She saw that it looked swollen and took Benadryl. She has continued to need Benadryl for the past 2 days because as the dose wears out of her system, the swelling reoccurs. She denies SOB, lips/facial swelling, or dysphagia. Course is stable.

Two nights after had extreme vision change like blacking out (lasted 30 seconds). Did not black out but have been lightheaded (slightly dizzy) since then. It comes in waves. I feel like it could be caused by inner ear and not sure the vaccine has anything to do with it. Visited my doctor on 2/11/21 and she assessed dizziness. Put me on steroid inhaler, nasal washes, antihistamine.

About 8 days after the vaccine, I had sinus and headache. Aches in the back of my eyes. I felt sinus congestion.

Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , whole body chills that lasted 2-3 hours (until 1/25 and now on occasion) , night sweats ( 1/12-1/25) , diarrhea (1/23 - 1/25), headache (1/25 to current date), dizziness (1/25). On Jan. 25: Went to bathroom around 3:15 p.m. with diarrhea and became woozy so decided to get off of the toilet and sit down on the floor. Husband found me semi conscious on the floor with drool at about 4:10 p.m. He tried to awaken me and found me not lucid, speech was garbled, fragmented responsiveness and could not keep upright position, could not give details to the situation. Husband called 911. Ambulance transported to hospital ER during hospital exams and tests patient was not lucid and this continued for the next 32 hours. EKG, EEG, CT scan, MRI, Blood/Lab work; all tests were negative indicating no seizure , healthy heart, clear brain scan, no stroke, white blood count normal, dehydrated. All tests negative with all doctors unable to find a reason for this situation other than the Moderna vaccine considered highly for the situation. Advised patient not to take the second dose of Moderna.

The night after receiving the vaccine the patient states her tongue and inside of lips were swollen and painful. She was even unable to remove her dentures due to the tightness. This continued into the next day. No shortness of breath reported. She took some Benadryl which she reports helped however it has been 5 days now and she continues to have poor taste and tongue is still feeling strange. She also states today she is developing the tongue and lip swelling again, she denies trouble breathing and is aware if at any time this begins or there is any concern this may start to call 911 for emergency care. She is taking Benadryl again now which has helped with this since the immunization and has left a message with her PCP. I am currently calling her PCP to report this also.

Initial reaction was a tickle in the back of throat. I tested positive on the 10th and had multiple issues including bilateral pneumonia. From the second vaccine, I had chills, severe headache, diarrhea, fatigue, swollen face.

Patient presented with tongue swelling and facial swelling, it was barely perceptive to medical personnel but patient has subjective symptoms. Symptoms started 30 minutes after her injection and worsened over the course of 30 minutes. Symptoms then stabilized and she was seen in the ER 2-1/2 hours after symptom onset. She was treated with epinephrine 0.3 mg IM with improvement. She was observed in the ER for 2 hours. She had subjective return of sensation of tongue swelling though no objective findings. She was observed for another hour with no change in status. No further intervention initiated.

Awakened by very painful left arm (7 on 1-10 scale), headache (3-4), general discomfort and restlessness. Within one hour, progressed to bone-rattling, teeth-chattering chills and inability to get warm for several hours, neck and low back pain (7-8), general intense fatigue but inability to sleep because of other discomforts. Over-the-counter Tylenol and a warm magnesium bath temporarily diminished symptoms, but relief was short-lived. Symptoms progressed in early afternoon to diarrhea for about 2 hours and increased fatigue, temperature up to 100.2 (my normal 97.6), headache pain progressed to 4-5, neck and low back remained 7-8. Tylenol seemed to have no effect. Evening (5pm) brought nausea and increased overall discomfort, fatigue, and pain. Aspirin - no effect. At 11:30 p.m. I took Motrin 600 mg and was then able to doze off and on. Throughout I remained very thirsty and consumed many glasses of water and herbal tea. Awoke at 3:45 a.m. 2/22 with only very slight headache, no nausea. Slept soundly until 6:30 a.m. Some fatigue persists, with left-sided pain (5-6) in neck and low back. Left arm remains sore (3-4). No great appetite, but no nausea

Temporary inflammation of lips. Had filler (Juvaderm) 12 months prior to vaccine. Symptoms lasted only 3 or 4 days.

Large itchy sore welt appeared on day 8 after first vaccine below the injection site. Looked like a hive at first. Applied hydrocortisone cream with relief. This rash is,still present 12 hours later. In morning had some fleeting jaw,pain too. Arm was,sore few days then no symptoms until today. Read about this on Google, seems to fit COVID arm.

02/25/2021 - 02/26/2021 Fever lasting approximately 18 hours 102* at peak. 2/272021 - approximately 6:00 pm getting progressively worse eyes were burning. Continue through night, I did not associate this with vaccine and did not report. 02/28/2021 - continued burning sensation , blurred vision, unable to read print ( I do not need or use readers). Sensitive to light. Continuing to complete daily activities without problems.

my tongue got very swollen, my throat burned and my ears hurt. Took benedryl and it cleared up my tongue issue in 15 minutes. My throat and ears felt better when I woke up on the 2/28/2021

Unable to focus eyes, dizzy, faint, falling over started 2 hrs after injection. Extreme tiredness 3 hrs after injection so bad couldn?t get up. Symptoms lasted 24 hrs. Soreness in arm, shoulder then neck of left side injection prohibiting sleep 48 hrs after injection.

102 fever, aching in neck and shoulders area, lymph nodes under left arm pain and swelling, arm soreness and warm to touch, chills, headache, mild tightness in middle of chest, teeth hurthing.

COVID19 (moderna) Shot was taken at 11:00 in the left arm on Saturday Feb 27 At 5:00 PM On Feb 27 my left eye began having black swirlies. They were like black strings. I have NEVER had swirlies in my life. At 8:00 PM Feb 27 on top of the swirlies that had moved to my peripheral vision left side of the left eye, I began having bright flashes like lightening. On Sunday Feb 28 the swirlies stayed just as peripheral vision and the bright flashes were noticed more in the late evening. Today March 1 they are still there and were more noticeable as I was driving to work. As I am typing this the swirlie moves from the center to the left side of the eye.

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.

about 20 minutes after the injection my cheeks got red and warm, 5 minutes later my chin turned red. after about 30 minutes or so my chin and lower lip felt numb. this feeling was irritating but did not get worse, just very noticeable for about 5 hours. The next day my chin was a little tingly but was gone by the afternoon. My arm was very sore for 3 days.

I had the vaccine on 2/16. On 2/22 at 5:30 pm I suddenly started having double vision. I saw an eye doctor that evening. I had no face drooping. I had not headache or muscle weakness and my pupils were the same size. If I covered one eye (did not matter which one) the double vision was not present. The next morning 2/23 I woke up with no double vision but throughout the day it came back a few times but resolved each time. I went to Medical Center on 2/2 and had a complete exam. So far all labs have come back in normal range. I have tracked my blood pressure twice a day since this happened. BP is great I am a very healthy person. Exercise daily. The only thing different in my life is having the vaccine dose. It was my first dose. The double vision seems to be resolving more and more each day. Happening less and shorter episodes. My eyes have been check by medical extensively on 2/2. They cannot find a reason for the double vision. I would like to know if this has been reported by anyone else and if so did it resolve. Also if the person took the second dose and did they have problems. I am supposed to have my second dose on 2/16. I am not sure what I should do. I still have symptoms although they are much milder and seem to be resolving. I have never felt bad at all during any of it and have continued to exercise.

Patient stated that she immediately felt a "fluid like" presence in both ears after getting injection. After waiting 15 minutes, she returned home (approximately one hour after) and started feeling "hot like". She looked in the mirror and her face and upper extremities appeared "sunburned" and she had hives on upper torso and neck. She then presented to ER and was treated with Bendaryl 50mg, Solu-Medrol 40mg and Pepcid 20mg IV. She was released after being monitored.

I ran a fever of 103+ for 24 hours followed by EXTREME mouth pain and NUMEROUS oral lesions lasting for 7 days. The pain was so severe I was unable to eat without using the numbing medication prescribed by my health care provider. My health care provider instructed me to report my symptoms.

Developed a raised, red, itchy reaction one week after injection; had a similar reaction the day of and following the injection, but it had gone away after 3 days

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.

About 15 minutes after vaccine, I felt a fever blister pop up on my bottom lip. Within 5 minutes of that, my mouth filled with a 'metalic' taste( not exactly, but as close as I can get) then the roof of my mouth at the gum line began to 'blister' or become sensitive. This morning, after taking my synthroid, the entire roof of my mouth is now affected. My morning coffee seemed to improve it for a bit. It's not a severe reaction, but one worth reporting. My injection site is tender, but that's not unusual.

Had double vision for about two hours. Took my blood pressure and it was normal. Did not call my doctor. Rested for 2 hours and it went away

Within an hour lost all taste. Within 3 hours fever and chills. By next day muscle aches and lethargy. As of today's date still have no taste. The fever, chills, muscle aches lasted until March 3rd. Since the 3rd I have had random fevers that are gone within a few hours. I'm still exhausted all the time.

By early the next morning, my mouth started developing sores & my tongue became increasingly swollen. I had a sore throat for about 15 days; at about one week past this dose, my right shoulder froze & the rotator joint was swollen & incredibly painful to the touch. I lost the use of my right arm entirely for about five days, then the swelling & pain slowly subsided. My eyes were burning & my arm was weak but I made a full recovery about 18 days after this dose. The last symptoms were severe headaches, accompanied by an inability to remain asleep. I took Tylenol & Tylenol PM to alleviate pain & regain some sleep & did report these symptoms to my doctor.

tingling sensation left arm, light headed, body extremely weak-could not get up, almost passed out, could barely speak, stomach nausea. EMT arrived checked blood pressure with finger (she did not tell us first result when I was extremely weak and felt like was about to pass out and had blurred vision-husband said I was barely responsive and couldn't move to get up), EMT then said would take BP again and while putting on arm cuff I vomited 2 times. After vomiting I felt immediately somewhat better, EMT took blood pressure and she said it was normal. EMT took blood sugar and she said it was normal All less than 15 minutes after shot. We then waited at EMT direction for another 15 minutes. We left the clinic and parked just outside till 10:30. I am now feeling better, just tired.

Sore dark red patch will pealing dry skin on top. About the size of a quarter. Red sore patch on the roof of my mouth, also the size of quarter.

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.

Vaccine administered, patient complaint of tingling hands, feet, mouth. complained of feeling warm and itchy. Benadryl 50 mg given orally. Vital signs stable. Patient stated she felt better at 3:10 pm. discharged to home accompanied by companion.

Called to observation area due to patient concern about metallic taste in mouth starting about 15 minutes after injection. Heart RRR no murmur not tachycardic, lungs CTAB. No ShOB, chest pain, tightness, N/V or other symptoms. She is taking azithromycin and prednisone currently. Has been taking the prednisone in AM, took dose today and has two left. Instructed her to take next prednisone this evening and last one tomorrow PM. Instructed to call the clinic or present to ER if any new issues.

Within 5 minutes I felt post-nasal drip, then my inner left ear started feeling swollen and clogged. Then the area from my left ear to my cheek and left side of nose felt numb. Almost like novocaine had been injected. After 10 minutes my chest started feeling a little tight. After 15 minutes I left the facility and used my inhaler (I have occasional asthma) and my chest opened right up. The numb feeling on left side of my face & ear persisted and I developed a headache around my left eye. I was very tired that afternoon, took tyelenol and went to bed early. Woke up and the numbness was mostly gone.

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.

Three days after receiving the shot I woke up with fever sores all over my bottom and top lips. I put Abreva on it. The next day, I woke up and both lips were swollen, the left side of my face was swollen and the left side of my lip was twisted to the left. I contacted my allergist and spoke to him online and sent pictures. He advised me to take Benedryl every 4 hours or Zyrtec twice a day. If it got worse call back. That evening some of the swollen ness went down. Little by little each day the swollen went down but the cold sores remained. By Saturday which is today the swollen ness is all gone but all the cold sores are remaining and are painful. I am continuing to take Zyrtec and treat the cold sores with cream.

Immediately following the shot I became lightheaded and stayed longer than the mandatory 15 minutes. Later that evening My are was sore and I continued to be dizzy. By nighttime I felt achy and tired. About 6 hours after the shot a fever started and I took Tylenol. By 1am I had 101.3, the rigors and a headache and dizziness which I still have 4 days later. My fever ran for over 48 hours and would not respond to any ibuprofen or Tylenol. My joint and muscle pain was severe, my balance was off. I could barely move my arm. Today I am now nauseous. I was not this sick when I had Covid. My fever would at least relent. I?ve lost time from work and my life. I have heart palpitations and my resting heart rate has gone up. Pressure feels strange behind my eyes. My legs are sore. I called my doctor two days after my vaccine and she minimized my symptoms.

About 6 hours after receiving vaccine, the usual arm soreness became more prominent then chills, headache and nausea. Also, a terrible metallic taste in my mouth started making me produce increase saliva. My tongue felt numb and have become swollen. (This took 5-6 hours to subside, the tongue swelling was about 2x size but never increased beyond that size.) Also, during the time the systems started, I had waves of prickly or fizzy feelings that were different from the chills. These lasted at least 24 hours.

starting about 24 hours after vaccine I began having a sever headache. I went to bed very early (8 pm) and work multiple times throughout the night. I had a fever that peaked at 101.2 (SEVERE BODY SHAKING) could not drink enough to quench my thirst. I also had severe body and joint aches. I finally fell asleep again about 4 am, woke at 6 am and felt better. Fever was gone but body aches have continued as has the headache. It is now Monday 1:50 pm (about 48 hours after the 2nd COVID vaccine)

5 minutes post vaccination patient patient informed pharmacist on staff she had blurred vision. Pharmacist had her sit and took her blood pressure (143/95). She reported nausea and heart palpitations shortly following, upon which a manager (Trish) accompanied her to the bathroom. Patient denies vomiting. At 4:50pm patient Blood Pressure was 147/98. Patient reported resolution of nausea, blurred vision, and heart palpitations. Patient states she took her medication as prescribed today. denies taking meclizine today. Patient released to friend who drove her home.

10 days later have a swollen arm, severe headaches for 2 days and started having intense ringing in my ears (which I have never had before)

My eyes Swelled within two hours. Headache within 24 hours. Benadryl helped with the swelling. Still swollen after 48 hours

Within 4 hours I had pain radiating up my arm to my neck and in my lower jaw. The next day 3/4/2021 I had a migraine, nausea, weak, off balance, diaphoretic, chills, dizzy, my neck was sore and I could barely move it and my lower jaw hurt. Medicine did not alleviate my symptoms. 3/5/2021 I had a bad headache, nausea, weak, dizzy, off balance and a slight sore neck. 3/6/2021 I had a headache, weak slight nausea. 3/7/2021 I had a headache and was tired.

5-10 minutes after administration, patient experienced the following adverse reactions to her first dose COVID Vaccine: On-site Lead medical physician, MD, was notified and patient was moved from observation open area to sectioned area for patient care. Nausea/vomiting, sweating, shaking, decreased blood pressure (90/40), tingling tongue. Patient was given 25 mg Benadryl per oral. 911 was called . Patient's blood pressure increased to 100/60 within 5 minutes. Patient's condition improved prior to EMT transport.

after 30 minutes approximately of receiving the shot Covid Madura vaccination I began having a loud humming in both ears and this has continued and has not stop and I just received my second shot of the Madera vaccination and ringing still continues never stops.I have never had this condition before whatsoever, and I?m very concerned.

The patient described red, chapped lips, with a small amount of swelling, that started the day after receiving the Covid vaccine. She states that her lips remain very dry and there appears to be a red outline around the edges of her lips. Stated she will be calling her doctor on Monday.

symptoms started to develop a day after the shot i had swelling on hands after a week after the covid 19 vaccination.. lips swollen, puffy on left side face, i have been taking aspirin, and some prednisone 10 mg and benedryl . i thought its was allergies then i realize my left side face still swollen

Nine days after receiving the vaccine, my vaccine site on my arm started itching really bad, and when I went to scratch it, I felt a very large (~size of a tennis ball) bump on my arm that was also very hard and very red. Initially, I thought it must be a spider bite, though I haven?t noticed any spiders in my home, and I simply watched it for any sign of infection (which never happened). The next day I also noticed an unusually high degree of fatigue which limited my ability to do much of anything for three days, thus far! Throughout the day and night, without warning, my eyes become really heavy, and I feel like I?m going to immediately drop off to sleep. My eyes also begin to burn, and when I close them I simply fall asleep for about a half hour. This has been happening off and on all day for three days, so far. I have no idea if there?s any connection to the vaccine or to the sudden appearance of a hard, big, red, itchy bump at the vaccination site on my left arm.

Woke up with a sore throat and flu like symptoms. Arm was red, hot, and extremely sore. Had severe chills, but no fever. As the day went on, the flu like pain increased by 100%. Dizziness ensued, and I could not move my head without nausea and an intense knife-like pain on the right side of my neck. All previous mildly sore areas were now on fire. Then the sirens happened. I have mild ringing in my ears due to chemotherapy, but this was just like I was standing next to an ambulance, for 8 hours. It has been over a week, and I am still fatigued with body pain.

March 19, 2021, I receive the vaccine at 3:00 pm , Friday afternoon. At 9:00 pm my arm started to get very sore at the injection site. I had a low grade fever. At 10:30 the pain went up my neck and down my back. I took ibuprofen and went to bed. I woke up 4 hours later, had a low grade and took Tylenol. Saturday am, I woke up and every inch of my body ached. I had a low grade fever, this went on all day. Sunday I woke up with no fever. My arm, neck and shoulders still ached, I took ibuprofen. Monday morning was the same as Sunday morning. Tuesday morning the glands in my neck on the left side are swollen and there is a lump, my arm is still sore and the pain is also in my left shoulder. I took ibuprofen in the morning before I went to work and more ibuprofen on my lunch hour and before I went to bed. No fever, sore arm and very sore glands in my neck on the left side, there is also a lump on my neck. The pain goes up in my left ear. I am writing this Tuesday, March 23rd right before I go to bed.

1st MODERNA shot Feb3 at 8:45 am; At 5 pm noticed TASTE DISTURBANCE (dirty, dry, metallic taste). Much worse after vaccine dose #2 (March 3 at 10:45 am), and has in recent days become constant rather than intermittent. Is a chef, and describes this change as a taste "note" added to but not replacing other flavors. Does NOT perceive this as change or diminishment of smell. HOT FLASHES AND CHILLS, starting roughly Feb 17, lasting about 1 wk. Now generally feeling chilly (change). FATIGUE, MUSCLE ACHES, JOINT PAINS: In the morning feels about 2/3 of normal energy, after noon energy decreases much more. Continuous since first vaccine administration to present. Background: Describes self as "fastidious." Not aware of any exposures in recent months. Patient tested about 6 times in last year for COVID19, most recently in January, always negative. Has been checking temperature twice daily through pandemic, always normal. 12-years post-menopausal. Has pituitary microadenoma, thought 5 yrs ago to be stable, not checked since.

One week ago starting 3/17/2021, pt. developed severe left ear pain which progressed to left facial pain. I evaluated her yesterday in clinic. Over course of afternoon 3/23/2021, she developed left facial paralysis consistent with Bells Palsy. I sent her for MRI which confirmed diagnosis.

Developed Bell?s Palsy to left side of face. Unable to blink left eye, numbness to left side lips/ mouth Being treated with Prednisone and Valacyclovir

March 20: Onset of SEVERE facial pain, left side. Cheek, ear, jaw area to occiput. March 22: Pain lessening, taking Gabapentin. March 23: Sudden onset of L facial paralysis, drooping, tearing, lips and tongue numb, trouble drinking and swallowing, difficulty speaking. Saw PCP, sent for stat MRI ER. Result show inflammation and compression of several cranial nerves. Put on high dose prednisone, antiviral, and upped Gabapentin dosage. March 24: Today RIGHT side of face, numb lips, unable to smile, drooling and difficulty drinking and speaking. L side of face the sam, no improvement. NOTE: Had 2nd Shingles vaccine dose on February 16th, 2021, 16 days after 2nd Moderna.

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.

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.

Numbness around mouth (whole mouth including upper and lower lips) as she had received lidocaine, started 15 min after the vaccine and lasted 4 hours. There no other symptoms

no symptoms after waiting 30 minutes, then mild fatigue 3 hours later then woke from sleep at 11pm with a rapid heart rate about 100/minute, widespread numbness and tingling around mouth, chin, arms and calves. called 911 BP was 135/77 98 pulox 68 pulse. Numerous episodes similar happened since usually at night. PCP advised allergist related to COVID reaction. ECHO,EKG were ok. adjusted meds to see if related and no change. also had very bloodshot eyes ,rash on legs and more need for Xopenex inhaler. Addressed with pulmonologist as well.

14 hours after receiving vaccine chills for 24 hours, fever low grade 12 hours, eyes burning, horrible headache that just doesn't want to go away not even tylenol helped, nausea, fatigue, arm pain , arm pits swollen and hurt, heart rate elevated for 48 hours. The first shot I had all of this but didn't have headache. This second shot was much worse.

About 24 hours after vaccine , an itching /burning rash started on the side of my face. it spread from chin area up to high cheekbone area. It was red but not bumpy, hardly visible. The Itching continued and has not subsided since it started. That side of my face appeared swollen. My lips were also itching.My throat on the same side as rash feels itchy as well. I began taking Benadryl every 6 hours with only slight improvement. I still have a rash after four days. The rash has not spread and remains in the same area. 4 days.

3/26 - left arm at injection site became swollen, itchy, red and warm to the touch, right side of face in the upper lip and gum area experiencing numbness affect .

Lips began itching/swelling after 2 hours. Itching stopped after 24 hours, swelling in upper lip still evident after 4 days. No trouble breathing. Continuing to monitor.

Saturday afternoon start to feel fatigue 8:00 pm 102.7 degrees (2 Tylenols) 9:00 pm 103.2 10:00 pm 103.7 11:00pm 2 Tylenols 11:00 102. degrees Frim 8:00 - Monday 7:00 am; pain was immense; legs, arms, abdomen, jaw, neck and a headache to the moon and back. offset every 4 hrs Tylenols' Monday; continue pain on right side, left chest and headache; continue to us Tylenols' every 4 hrs.

Injection was given in left arm and within seconds after the injection the patient began complaining of a strange salty chemical taste in her mouth followed by tingling on the roof of her mouth and a intense hot feeling, described as if like scolding the roof of her mouth with hot liquids. The same feeling then began to ravel to the back of her neck.

Minor -pain at injection site, pain in right wrist and vision change which started about 3 hours after injection on Friday. Later in day I noticed a new dark circular floater. Saw retinologist on Monday and learned I had a posterior vitreous detachment and Weiss ring. Seems like more than a coincidence as I had no prior injury, my blood sugar is fairly well controlled, and I was well hydrated.

Day 1 sore arm shoulder to fingers also teeth, arm warm to touch. Day 2 red blotchy spots like hives on arm also on chest and stomach area just below breast and under breast. Day 3 red blotchy spots turned into red like pimple looking that itched, day 4 upset stomach with diarrhea all day, day 5 red blotchy spots on chest area have now turned into red spots like a pimple looking rash that itch. Day 6 red spots that itch on my legs behind my knees. Day 7 most all of the above is gone but still have the red pimple looking rash on my chest area and behind the knee area they have now developed scabs and do not itch as bad. My doctor recommended I report these affects with you.

Felt nauseous then saw stars within 15 minutes. Went home and ran fever 101.3 for 2 days. Couldn?t move from couch. Very tired times one week. Then profuse sweating two nights. And now having blood sugar issues where I crash and need to be careful to eat carefully and sleep extra. With caution I don?t see stars but still not sleeping well. Mood. Concentration. Sight. All affected during episodes.

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.

Broken blood vessel in her right eye; A spontaneous report was received from a consumer concerning a 61-year-old, adult female patient who received Moderna's COVID-19 vaccine and experienced broken blood vessel in her right eye/eye haemorrhage. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number 014M20A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection. On 06 Mar 2021, after receiving the first dose, the patient observed broken blood vessel in her right eye. She had no pain and no vision impairment. The event broken blood vessel in her right eye was considered as medically significant. No treatment information was provided for the event. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event broken blood vessel in her right eye was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

On Wednesday, March 24th my husband and I got our 1st Moderna vaccine at 8:30 am. Felt good the rest of the day. On Thursday, March 25th I woke up and the bag under my right eye was really swollen and I felt like I had a big cold sore coming out on the top right side of my lip. My arm was swollen like a 2x2 area and tender but other than that I felt good. At 9:30 am that same day I started getting a headache and my stomach felt really upset. I didn't throw up but felt like I was going to. About 10:00 am I really felt sick to my stomach and extremely tired. My headache was more intense and mostly on my right side (same side as my eye and cold sore). By noon I had the chills and was running a temperature over 100. At 3:00 when I got done with work I slept. I was only awake for a total of 1 hour and went to bed for the night at 8:15 pm. I still had a bad headache, upset stomach and chills and my arm was swelling bigger but I slept all night. On Friday, March 26th I woke up and my face looked worse. The cold sore was getting bigger and the bag under my eye was huge making my eye almost shut. I still had a bad headache and the injection site was getting bigger and stuck out far. It was hot to the touch. It was bright red and bumpy and hurt to touch it. I no longer was sick to my stomach and I had no fever. My face was still looking awful and about 2:00 pm I started running a fever again. I still had a headache. I still felt tired. On Saturday March 27th, my bag under my eye looked a little better but the cold sore was getting worse. I had a slight headache, no fever and not sick to my stomach. However, the lump at the injection site got huge. It was the size of the palm of my hand and stuck up about an inch. It was hot to the touch and red. By 9:00 pm my eye and face were worse and the right side of my face was drooping. On Sunday March 28th 8:00 am my face was worse and itchy. The cold sore was spreading up the right side of my drooping face and my eye was almost shut. I called the Teledoc and had a video call. She said that the vaccine triggered a virus in my system. She called in a prescription for Valacyclovier 1GM 4 pills. Took 2 pills at noon and then the last 2 that night before bed. She said to give it 2-3 days and it should clear up. On Monday, March 29th 6:30 am the lump in my arm is a little smaller but my eye is worse. I looked horrible. On Tuesday, March 30th I still had a low grade headache and my lip and right side of my face is kinda numb. I called my doctor and made an appointment for Wednesday, March 31st. On Wednesday, March 31, 2021, I woke up and now had a canker sore inside my top lip on the right side of my face in addition to looking like a monster. I went to the doctor?s office at 7:30 am and she said that I definitely have a virus going on and now I have Bell?s Palsy as a result. The doctor gave me a prescription for Valacyclovier 1GM tablets to take 3 times a day for 7 days. She also prescribed Prednisone 20 MG to take 3 tablets for 7 days to relief the itching and irritability of my face.

03/23/2021 - large red patch at injection site;; 03/27/2021 - extreme under eye inflammation (have photos)

dizziness, blurred vision, ear ringing, ear pressure, fatigue/malaise, mild headache, sluggishness, brain fog, difficulty speaking, joint pain, symptoms from 8 hours after vaccination until 48 hours after vaccination

Severe body aches, chills, low grade fever of 100.6, pain in left arm. Periodic pain in ears, head and neck. Lethargy. Symptoms continued for 24 hours and resolved themselves without use of any otc pain meds.

Patient complained of blurry vision, left felt heavy, right eye was throbbing , numbness in the mouth, face felt swollen. Even though NP checked and face was not swollen.

Patient reports feeling warm and coughing (coughing spell) she reports feeling lips a little numb. Pt reports she had covid-19 in Nov. 2020. Patient reports symptoms improved, cleared by EMS. BP171/93, 170/90, pulse 91, Spo2 99-100%

Patient alerted pharmacy that she had experienced swelling and itching from influenza shots in the past, and has asthma and allergies, however has never had to use an Epi-pen in the past. Patient seemed very nervous, but insisted she was OK to receive the shot. Pharmacist on duty administered Moderna to patient, and waited next to her for several minutes to observe for possible reaction. Patient felt fine after several minutes of talking, so pharmacist advised patient and her husband to let her know if patient started feeling SOB, or itchy, or swelling of face, and went back to pharmacy to complete rxs in que. At that time a different patient who had just received the Moderna vaccine passed out, and pt witnessed this, further increasing her anxiety. 911 was called for the patient who passed out. During the next half hour, pharmacist kept checking on pt. She indicated her tongue seemed to be swelling. So pharmacist on duty asked EMT to check out pt after they had finished taking care of patient who had passed out. EMT checked pt throat, and assured her there was no swelling, however suggested diphenhydramine 25-50mg to be proactive. Pharmacist on duty asked pt if she would like diphenhydramine, and she said, "Yes, Please." So pharmacist provided the diphenhydramine to pt, and she took 50mg. After that she seemed to be fine, and her husband took her home.

Moderate to severe allergic reaction - puffy face and lips; itching, skin burning all over; fever and chills

2-6-2021 Woke up with muscle aches, headache and low grade fever (100.5), sore arm. 2-7-2021 Fever resolved. Fatigued. Sore arm. 2-8-2021 Able to go to work. 3-6-2021 Woke up with intense headache, muscle aches, fever over 101.0, shaking chills and 7 mouth ulcers. This lasted until 3-16-2021. Fever resolved 3-17-2021. Mouth ulcers resolved over time. 3-7-2021 Went to healthcare facility - viral illness 3-8-2021 Went to healthcare facility for fluids due to dehydration. Dx Viral illness 3-13-2021 Went to HCGH for fluids. Dx Viral illness. 3-15-2021 Healthcare facility Follow up and Blood work.

Starting 3/25 evening I experienced severe fatigue, then next day severe body aches, fever 101,, headache. All stated as known side effects. Then on Sunday 3/28 I woke to find my mouth felt like I had burned the roof of my mouth starting behind my front teeth all the way up the roof. As I continued to improve with the body aches, I was left with the mouth issue and a fever blister on my lip. The burning mouth continued and did not start improving until Friday 4/2. It made it very difficult to eat anything other than soft foods. It is about 90 percent cleared up as of today 4/3. I had tried to find if anyone else had reported this mouth issue online but only found swollen lips, so wanted to report my experience.

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.

Became ill: weakness, uncontrollable shakes, fever 100.9, very cold/chilled, thirst, body aches, injection sight ache. The discomfort in arm is slowly getting better....but it's 2.5 days later and not gone. Furthermore, my arm injection sight is red and warm to the touch.

Tinnitus of the right ear. Occurs continuously. I started taking Zinc once daily on 4/3/21 with no effect yet.

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

First vaccine given on 03/05/21 were listed side effects , achy joints and fatigue and very very sore arm lasting over 1 week. The sore joints and fatigue only lasted 48 hrs. The second vaccine as listed in this report, given on 4/2/21 cause fever up to 102, achy joints, nausea and extreme fatigue. I also had swollen lymph nodes under arm injected and swollen glads under my chin on side of injection and the unexpected side effect of extreme tooth pain on upper and lower teeth only on side of injection. (Left). The tooth pain was almost all teeth on the left upper and lower mouth . Nerve like pain. I thought maybe it was a coincidence, but it started resolving at same time and rate as other symptoms and now my teeth seem fine. It was probably the worst of the side affects cause I could not eat or drink anything hot or cold without pain. It took 3.5 days for all symptoms to subside but they all went away including the tooth pain.

After 48 hours, mouth irritation on palate and lip corners, after 72 hours fever blisters, 2 on lips and 1 on hard palate. I get them with sunburn, stress, etc. ( I had had the typical arm pain, headache, fatigue, muscle and joint pain and fever on day two).

Patient presenting with complaint of roof of mouth and tongue tingling. Provider assessed patient Ordered Benadryl 25mg PO at 10:23 Vital Signs at 10:22 BP: 136/80 HR:78 RR:18 02:98% Provider notes state anxiety related, no cranial nerve, sensory motor deficit. Patient monitored for 30 min. Symptoms improved advised to go to ER if symptoms worsen.

Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Tingling to tongue, phlegm to back of throat, tingling inside of mouth. Assessment : Time of assessment 1205 Alert and oriented. Patient reported after 25 minutes of a 30 minute observation feeling tingling to the inside of her mouth, the tip of her tongue tingling and phlegm to the back of the throat. She denies difficulty swallowing (drinking water), no rashes, no swelling of tongue noted. Actions taken: Vaers form completed, medications given, observed additional 30 minutes. There were no vitals filed for this visit. Medications administered: 1212-Benadryl 12.5 mg elixir by RN; 1215- Pepcid 20 mg po by RN as approved by RN (medication available not scored, so the whole 20 mg tablet given). After 5 minutes per protocol to give additional 12.5 mg Benadryl, patient refused 2nd dose and says she's starting to feel better. Disposition: After additional 30 minutes observation, patient reports no tingling to tip of tongue and inside of mouth has no tingling. She says the phlegm is still there, but not as much. She is discharged to go home and advised to follow up with her PCP about the symptoms due to she reported after 1st dose when she was going home, she had the same sensation of tingling to the mouth/tongue. I advised to call 911 if symptoms return, she verbalized understanding. Advised to buy some Benadryl liquid to take if needed as instructed by PCP.

AWARE OF A LOUD CONTINUOS RINGING (TINITIS) IN BOTH EARS 7-8 HRS (9PM) AFTER INJECTION. I HAVE HAD TINITIS FOR A COUPLE YEARS BUT HAS DRAMATICALLY DECREASED SINCE LEAVING WORKSITE 12/4/20. IT CONTINUES AS OF NOW (4/6/21 9:30 AM). I HAVE A THERMOMETER THAT GOES IN MY EAR FOR A DIGITAL READING. CURRENT LOW GRADE FEVER BUT I COULDN'T USE IT IN MY LEFT EAR THIS MORNING (8:45AM) DUE TO PAINFUL BUMPS AROUND MY EAR CANAL ENTRY AREA. I HAD TO USE OTHER EAR (NON VACINATED SIDE).

She got the vaccine, and then had headache, fever and slight fatigue. No she has welts all over her body, very itchy, they get warm to the touch and it started in a couple of spots and now are everywhere. When she wakes up she gets more, and feels like she's in a horror movie. Notified her doctor and he wants her to take Benadryl at night and using Benadryl cream, but it's not completely alleviating the symptoms. The patient states that she is miserable.

Eyes swollen and red since vaccine. Swollen on second day after vaccine and went to DR thought it was pink eye. They did Covid test and I was negative but been putting drops in eyes and still red. One week after that I started having ringing in the ears. Went to my primary health care provider but never thought about it being because of the vaccine. Said that if it continued would need to see ENT. Constant ringing and am seeing ENT today.

severe arm pain 3 days, dizziness, nausea, irritated urination, severe stomach pain, pinching in bladder, double vision, chills

Flu like sysmptom including ringing in ears, headache, fatigue and fever. Covid arm with lesion approximately 4" in diameter with fever and itching.

first dose-stabbing pains in joints, fever, tired=4 days second dose=42 hours later-throwing up, diarrhea, aches, sore throat, congestion, lost sense of smell & taste, tiredness, weight loss. effects have laster 8. days so far.

I have hx of episodes of sudden elevation of BP and pulse with accompanying other symptoms from possible adrenaline surges. When I sat down for my observation period, it felt like the start of one of those episodes except I had tingling in my hands which was different and a metallic taste in my mouth. Pulse and respirations were normal. Took many slow deep breaths to help calm the possible adrenaline surge I thought I was starting to experience. Felt ok by the time I was released from the 15 minute observation area. After driving about 5 minutes towards home, I started to get chest tightness and my throat felt strange and swallowing was not normal. I didn't feel well in general. No rash or hives. Breathing was ok. When I got home, I took 2 Benadryl. After two hours I felt much better except for the chest pain which felt like my "normal" atypical chest pain and lasted a little while longer. The chest tightness was gone though and the throat and swallowing had improved also.

4/6/21 @ 09:10a - Received Moderna #1 / Just felt "tired" 4/7/21 @10:00p - After a shower, noticed some generalized scalp and skin itchiness, thought it was from the hot water. Had felt tired all day, but this was the first time I felt the itchiness, It was very "light", but was all over my body, moving from arms to legs, face, etc. No rash noted, no cutaneous reaction at injection site. 4/8/21 all day - Very light itchiness persisted, got worse after going outside (Phoenix temp in 90's). At times, my face and mouth felt scratchy. Still no raised rash or cutaneous reaction at injection site, but my skin looked a bit "irritated" in patches that resolved. Treatments: 4/8/21 @8:00p - Benadryl 50mg / Famotidine 20mg / Felt better, itchiness subsided, was able to relax 4/9/21 @00:12a - Benadryl 25mg 04/9/21@ 01:30a - Benadriy 25mg - fell asleep 4/9/21 @ 09:00a - Zyrtec - Felt OK 4/9/21 @ 10:00a - Famotidine - Felt OK, but later got itchy again 4/9/21 @ 1:10p - Benadryl 25 mg / will repeat in 4 hrs or increase to 50mg per medical advice

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.

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.

Dizziness and blurred vision occurred about 5 minutes after administration. Blurred vision subsided 7-10 min later. Dizziness subsided about 20 minutes later.

Full-blown flu-like symptoms: fever, muscle pain, swollen lymph nodes, chills, tiredness, fatigue, sensitive skin, sensitive eyes, headache started in the evening of the vaccination date; acetaminophen caplets and liquid NyQuill were taken, to alleviate the symptoms; the symptoms took three days to subside On the third-fourth day ?Moderna Arm? appeared: red hot fist-size area on the shoulder of injection; resolved itself in two days On the fifth day severe skin itch all over body (back, legs, arms, scalp); and severe itch in both eyes appeared; Benadryl and cortisone cream were used on skin, which helped slightly;Visine was used in eyes, with no positive effect; The itch on skin and in eyes is still present at the time of filling this form

Pt. called 4/12/2021 to report that the night of her 2nd Moderna vaccine 4/9/2021 she started experiencing H/A, fever, chills, sweating, fatigue, loss of smell, sore throat with occasional cough, and occasional shooting nerve pain to the front of her body. All of this lasted through Saturday and subsided except the H/A has lasted through today 4/12/2021.

swollen tongue, loss of speech, drooping eye & right side of mouth, drooling, can't swallow good for eating or drinking, basically developed Bell's Palsy consistent burping (air burping)

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

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

Metallic taste in mouth for last 2+ weeks. Also been experiencing a tingling sensation in both legs for last 2+ weeks, some also in arms, but mostly in legs.

Received first does on 3-14-21 at 4:00 p.m. No adverse effects. Received second dose on 4-11-21 at 3:00 p.m. Well hydrated the day before. Woke about 2:00 a.m. due to pain in injection site. Took one Tylenol tab. Restless light sleep for about 4 hours. Some chills. Woke about 5:00 a.m. Ate light breakfast. Developed low grade fever (99) for several hours. Took second Tylenol tab. Fatigue, Lack of appetite. Sore injection site. Slept 2.5 hours. Lethargic rest of the day. Didn't eat much. To bed early. 4-12-21 Considerably better. Although developed metal taste in mouth all day. 4-13-21 Feel normal and metallic taste gone.

PATIENT STATES SHE WAS VERY HOT LAST NIGHT, AND WOKE UP TO A KNOT THE SIZE OF A PEA ABOUT 2-3 INCHES FROM THE SITE OF ADMINISTRATION. SHE RUBBED THE SITE, AND THEN THE KNOT BEGAN TO GET BIGGER. PATIENT ALSO NOTICED A LINE OF KNOTS DOWN HER ARM, AND THAT AREA IS RED. PATIENT STATED HER EYES ARE RED, SHE IS FEELING VERY RUN DOWN AS WELL.

Patient reported tongue swelling and nausea/dizziness about 15 minutes following vaccine. An epinephrine pen (0.3 mg) was administered to right outer thigh, patient immediately saw reduction of symptoms. Patient was monitored for additional 15 minutes and advised to follow up with an urgent care or emergency room.

On April 10, 2021, patient reported losing vision in right eye. Saw primary physician on 4/14/2021 and had ultrasound of the neck done on 4/14/2021. Patient reported per phone on 4/15/2021 that she was told that she had a stroke in her right eye. Was placed on ASA 325mg and Clotidogrel 75mg.

Felt like I had Covid19 all over again. 30 hours of misery! Bad body aches, chills all night, lining of skull and back of neck going into the head felt warm, feverish. Inner ear ached, back of eyeballs ached, joints ached badly. Tylenol lessened the pain somewhat, but didn't get rid of it. Had sharp pain in heart during the night. No position in bed helped, neither did walking around until I went back to bed and laid down on my stomach. Pain then subsided and didn't come back. Was headachy for 3 days after the injection.

Nose sores and raw tongue. Fever 101.6 Chills, Swelling, High Blood Sugar 442 constipation, blurred vision, very weak. My husband had to guide me to restroom and back to bed. These were the only times I was up and mobile. Muscle and joint pain

Pt with severe headaches for 2 days after vaccination. Also vision changes, bilateral temple pain/tenderness. Improved after from 10/10 to 3/10, but headache continues through today 4/15/21. Workup is ongoing.

About 9 hours after receiving 2nd dose of vaccine, patient awoke with quite significant itching (vaccine site as well head, neck, scalp, ears, trunk, arms, palms, and legs) , swelling around eyes (almost swollen shut), and tightness in chest. After 1st dose of vaccine, she had mild swelling around eyes and a little tightness in chest that she thought was related to pollen.

paresthesias left face, left arm, tongue. Reoccurred with second vaccine on 01/30/2021 and has not resolved.

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.

I was sick the whole next day... upset stomach...no energy- slept most of the day,,,headache, even teeth hurt

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

Aprox 8 minuted after receiving the vaccine, I noticed prickling (pins and needles) starting to occur on my forehead, then including the nose as well. I felt numbness at the tip of my nose. I took my glasses off and my vision was blurry. I felt weak (almost faint), I felt a chill running through my arms and lightheaded. I was able to get the attention of the person monitoring us in the 15 minute wait area and she took me to the side to a nurse and EMS person was stated. I felt almost that feeling when they start an IV up (that weakness). My blood pressure remained relatively constant the times they checked it though I did feel a racing heart at moments. In about 30 minutes the obvious pins and needles was starting

3 days after 2nd vaccine I had a large red itchy patch around the vaccination site. 8 days after the 2nd vaccine I had intense swelling under my eyes (about the size of a golf ball) Photos available by request.

I have received both Moderna vaccines. After the first shot the tinnitus began and only got worse after the second shot.

tinnitus started 2 wks after first moderna vaccine. Got second dose and symptoms dramatically worsened. She reached out to me today. I referred her to ENT.

Headache behind the eyes started at 11:01 am, nausea started at 11:10am. Fever 101.8 degrees F started after 12:00pm. Following day 04/18/2021 fever reached 200.1 degrees F. Fever broke early morning Monday 04/19/2021 Nausea and headache stopped. Diminished sense of smell and taste and lack of appetite persist.

Within minutes of vaccine, slight taste in mouth, otherwise only a slightly sore arm and no appetite. Within 12 hours, sharp pain in both knees, right ankle, right wrist; throbbing right arm, dizzy/vertigo, very rapid heartbeat. Within 24 hours, bedridden with low grade fever, continued dizziness, very rapid heartbeat, headache, but no joint pain. Within 36 hours, still rapid heartbeat with erratic pulse at times, and no appetite. Within 48 hours, heart rate beginning to slow somewhat, increasing with exertion. By 72 hours, heart rate finally back to pre-vaccine rate. Six days after injection, dizziness returns. On seventh day, dizziness is gone but still no appetite. Funny taste persists. Anticipate post-vaccine issues to continue until day 10, same as first dose.

61y F hx HLD presenting with concern for allergic reaction after Moderna covid-19 vaccine - received 1st dose Moderna vaccine on 4/17 at Pharmacy at around 12:40pm states that within 10-12 minutes developed a headache that resolved spontaneously - Then she felt like her throat was sore and tongue was swelling. Difficult to tell if it was hard to breathe because she says she was panicking. When she drank liquid, it made her throat feel better - states her b/l hands swelled and turned purple - went to ED shortly after, received IV benadryl, and all symptoms improved. ED records reviewed- normal examination, including oropharygeal and lung exam. D/c on benadryl only, no epi-pen or steroids - since d/c from ED she has been taking Benadryl 50mg about 3 times day. Last dose this morning - last episode of tongue swelling was yesterday morning. No swelling today but took benadryl as prophylactic

Within minutes, flush down the body. Then a very funny taste in my mouth (lasting several days). Within a few more minutes, rapid heartbeat with some intermittent skipping (lasted for 4 hours). Complete loss of appetite (lasted for several days). Couldn't lift left for two days. During the week from time of injection, one day of fatigue.

Patient had fever, chills, body aches and fatigue the next day. Sunday she felt better. Monday she had fever, chills, congestion, dry cough. Tuesday she also had diarrhea, decreased appetite, loss of smell and taste and headache. She is having pressure in her chest with taking deep breaths.

Woke up with body aches and sweating. Stomach and lower back was hurting extremely where I couldn?t stand, Could not get out of bed till after noon. Went to sit for lunch and got faint. Passed out but was slurring, drooling and couldn?t even open my eyes for over 10 minutes. My daughter called 911. I was still unconscious when EMT got there. They checked vitals and I slowly stabilized. Still have a lot of weakness and stomach ache

I have had raging in both ears since the second dose of the Moderna vaccine. I have not seen a doctor yet. I thought it would be temporary but it's continuing and it's extremely distracting and makes listening very difficult.

Patient stated that about an hour after she received the vaccine she started to break out in a rash on her trunk and arms. She stated that it started to get better later that night but kept reappearing throughout the week. She said that she woke up on 4/4/21 with common symptoms of Bell's palsy. She has facial muscle weakness, pain in her jaw and pain that radiates to the back of her head, and she states that her tongue is numb. She stated that she can still taste and smell like normal. The rash is no longer there but she is still showing signs of Bell's palsy.

lightheadedness on the 5th day after 2nd shot. Feels like the top of head is missing and pressure around and behind eyes.

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.

In addition to common headache, tiredness, lightheadedness and nausea, am having vision problems in right eye. Vision is blurry or even blank.

Patient received 2nd Covid Vaccine Lot #021B21A, in L deltoid on 4-2-21. She stated she went to bed late on Saturday 4-3-21, noticed scratchy throat, woke up Sunday 4-4-21 with rash, welts, itching, tingling around the mouth, denied SOB. She stated she just thought she "had gotten into something" and started taking Benadryl as needed. Symptoms not resolved, she was seen at Outpatient Care on Tuesday 4-13-21. Now being managed by PCP. Patient taking Hydroxyzine and triamcinolone cream.

Tinnitus. Mild tinnitus started after first vaccine. Much worse after second vaccine. Has not stopped after 10 days. Physician said to use nasal steroid which made it even worse after 2 days so i discontinued. Now just taking Claritin D and waiting to see if it goes away on it's own.. Physician also mentioned oral steroids but am I afraid those will make it worse like the nasal steroid did.

Migraine headache started at 8PM on 04/22/2021. Intensity increased over next 26 hours. Took 2 Tylenol at 10PM on 04/23/2021. Headache resolved by 6AM on 4/24/2021. Body aches started at 10PM on 4/22/2021 and continued through 6 AM on 04/24/2021. Blurred vision started at 1PM on 4/23/2021 and resolved by 6AM on 04/24/2021. Mild nausea started at 8PM on 4/22/2021 and resolved by 6AM on 4/24/2021.

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.

Covid19 vaccine: vaccination today, pt was getting second dose of moderna when 10 minutes later she started experiencing palpitations, flushed face, lip swelling, lightheadedness. No respiratory distress. Pt given benadryl by medics. Pt had history of anaphylaxis to cat dander. Given epi in ED. Stable after 3h ED obs. Rpt VS without tachycardia/hypertension despite epi. DC with return precautions.

WITHIN ONE MINUTE, PT EXPERIENCED NAUSEA, BURNING IN THE CHEST AND THROAT AND A BAD TASTE IN HER MOUTH. THE PHARMACIST ON DUTY TEST HER BLOOD PRESSURE AND IT WAS 198-90. HER SON CAME TO PICK HER UP AND HE CALLED AN AMBULANCE. THE EMT TOLD HER TAKE IT EASY BUT DID NOT ADVISE GOING TO THE HOSPITAL. HER BP CONTINUED TO BE HIGH AND HER DOCTOR HAS HER SCHEDULED FOR APPOINTMENTS EVERY 3 DAYS TO KEEP AN EYE ON HER. SHE IS WAITING FOR EKG RESULTS AND HER BP HAS COME DOWN BUT IS NOT BACK TO NORMAL AS OF 4-21-21.

About 3 minutes after leaving the drive-through vaccine center (following the 15 minute wait period during which I felt fine), while driving home, I felt dizzy, ears ringing, and light-headed and it kept increasing. Luckily, I pulled into a parking lot, called 911, and fainted. I regained awareness after a couple of minutes with a fire truck arriving, but was foggy and sweating. I recovered after several minutes and did not get transported anywhere. Firemen advised me to drink lots of water. I felt very tired but otherwise OK by about 35 minutes after the shot.

Woke up in the middle of the night to use the bathroom the day after receiving 2nd vaccine. I needed to turn left to get to the bathroom but turned right instead. Same morning woke up and felt really bad. I could not see right. I could not read my phone. Went back to bed and slept 8+ hours. Was sick feeling on Friday, Saturday and Sunday. Slept a lot!! Had chills. Took my temperature and it was 93 degrees. Could not see correctly for about one week. I usually wear reading glasses but could not as glasses made me really dizzy. I could smell really really well (smelled sour milk about 2 feet away). It was like the vaccine made my senses better. Took about a week before my vision seemed to return back to normal.

"Moderna COVID-19 Vaccine EUA" -- received 1st dose 3/27/2021 Received 1st Moderna vaccine in R arm on 3/27/21. Within first hour, she had a headache, R eye pain, and felt tired; symptoms subsided after she laid down. On 3/31 in early AM, felt sudden and more severe headache and same eye pain, and "electrical contractions down neck, back, and spine." Went to medical facility, then transferred to hospital, and transferred to another hospital via helicopter. 61-year-old female, generally very healthy, on no medications, here complaining of sudden onset right sided stabbing/electrical headache which began 30 minutes prior to arrival. She states she was standing at work when had sudden onset severe headache radiating into her right eye. Stating that it feels like my right eyeball is going to explode. She ranks the pain a 9 out of 10. She does have a history of migraine headaches which have never been evaluated with imaging or by neurology. They were normally frontal, and she has not had one in more than 2 years. She states that this headache is dramatically different than her prior migraines. Patient states associated with this sudden onset headache, she had bilateral neck pain, and substernal chest pain. Upon arrival to clinic, she points to her substernal region as the site of her chest pain. She denies associated shortness of breath, irregular heart rate/rhythm, presyncope. She does feel slightly weak. Of note, patient states she had a MODERNA COVID-19 vaccine on Saturday and subsequently had some right-sided shoulder pain. Her symptoms are on the same side. - 7:50 AM: BP 165/109 (R arm); pulse 86; no antihypertensives given, given a total of 100 mcg fentanyl over 1 hr - 9:04 AM: BP 150/92 (R arm); pulse 60; transferred to hospital and then to transfered to another hospital via helicopter for SAH 3/31/2021 ED - given nicardipine IV, dexamethasone IV, levetiracetam, and antiemetics. Nero noted that no associated trauma, LOC, or seizure with the HA, Neuro assessment - day 4 (plus possible re-rupture within last 24 hours) of good clinical grade HH2 low volume aSAH due to ruptured R ICA ANR 4/1/2021 - completed successful and uncomplicated RICA oblong aneurysm coiling (successful coil elimination & preservation adjacent PcommA infundibulum). Patient was admitted to critical care for post procedure care, monitoring, and management of sodium, blood pressure, and headache. Levetiracetam discontinued since patient did not have any seizures. 4/7/2021 - discharged

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

patient experienced left side facial swelling the morning after she received her first dose and she could not open her left eye.

day 29 mid afternoon, I felt an explosion in the right ear. This caused a destabilization of the sound in that ear, which was heard louder on the right than on the left. On the 30th, around 9am, I began to feel that I couldn't close my right eye well, and around 11am, the right side of my mouth became paralyzed. it was like a paralysis on the right side of the face. I have no strength on the right side to blow my nose, the right eye does not close properly, and the mouth on the right side does not move the same as the left.

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.

2 days of flu-like sx. She then developed sudden onset of bleeding of gums bruising and vaginal bleeding. High concern for thrombocytopenia. her Sx resolved at day 5 post-vaccine. Her platelets were slightly low 7 days post-vaccine. High clinical suspicion for low platelets

2nd dose - mild joint pain, body aches, fever and sore arm for a few days (arm better this time as I kept it moving right after shot). Headache, fatigue, lethargy and general malaise lasted for a week. Headache was different than my "normal" ones and didn't respond to just acetaminophen, and barely to the aspirin/caffeine/acetaminophen combo of excedrin. Appetite was good for the day of and day after the shot but then I had constant nausea and loss of appetite from Monday until Friday afternoon - no vomiting, thanks goodness, but I couldn't read, look at screens or function for 4+ days. The headache and nausea combo were awful - makes me sick thinking of it. 1st dose resulted in headache, mild joint pain, body aches, fever and very sore arm for a few days.

The first shot I was dizzy, ran a fever, nausea and chills for 36 hours- moderate to sick. But the second shot I was violently sick with fever, migraine, nausea, chills and extreme dizziness. I am still very dizzy and have an issue with my left ear blocking. I feel as if I have permanent sea sickness.

ringing in ears, migraines, pain in ears-worse after second vaccine. continuing, nauseous loud noises, sounds bad hurt. sleep horrible. lifechanging worse after 2nd vaccine. and continuing worse on left side that shot was given on. First time right arm

The odd thing was red patchy swellings on my left calf, where I have varicose veins already. It didn't hurt and I didn't notice it til after I showered that evening. The other symptoms were expected: an overall body flush without a true fever, achiness, eye and headaches, fatigue, geneally dragged out. Like a mini version of COVID, really. It took several days to resolve completely. The bruising on my calf segued to more of a hives, then a dark bruising as if it had been bumped.

I had the second Moderna shot that afternoon, scheduled for 4:15pm but it was about 4:30pm when I got it. I moved around as instructed by my doc, and after 15 minutes went back to my car. I noticed after another several minutes that my pulse was still elevated so opted to go back in and talk to a health care professional. Pulse was 120. Paramedic wanted me to lie down in waiting area but I didn't want to be in such a potentially germy environment, and the guy next to me who had fainted earlier was just getting up himself. She walked me back to my car, where I agreed to wait, listen to a stress relief hypnosis audio and see if my pulse rate would calm down. She came back out w/ a BP cuff and said my blood pressure was 210 over 130 (or some number over 100; I don't recall which) and she said I needed to get in an ambulance right away and go to the hospital. I said I would make my own decisions about my body and I wanted to try a couple of other things first, promised not to leave, contacted my doctor, naturopath. (Note: I did not have any other worrisome symptoms -- blurred vision, dizziness, etc. My head was a little buzzy, but whether out of fear or in reaction to the shot I didn't know. I was a little flushed). He asked me a bunch of questions, said my body hadn't had time to mount an immune response to the vaccine and that I had likely had a histamine reaction to a preservative in the vaccine (or similar), which a couple of his other patients had experienced. He asked if I'd been drinking fluids (yes, plenty), had eaten recently (no, so he suggested I have some food; I had some nuts, a little cheese and some Cheez-Its so had that), asked if I had an antihistamine around -- I did, but I don't do well with Benadryl and didn't have Claritin, but after looking through my bag found some Allervive, an herbal product he compounds. He said, "That's perfect." I took two of the three capsules and hung up. Staff were checking up on me in my car every ten minutes or so, by the way, very kind and professional as I had been quite upset at the whole "get in an ambulance" scenario. He thought some of my reaction was probably also stress-related, and I noticed before the shot that I was teary, not from anxiety but the kind you get when you feel relief after a long ordeal. I didn't feel anxiety, really, until the first blood pressure measurement. He also let me know that if the bottom number didn't drop below 100 they couldn't let me go. After eating, drinking some more water and taking the Allervive my BP was down to 138 over 75 in just a few minutes. I agreed to stick around and make sure it stuck. We re-tested again about 15 minutes later, perhaps longer, and it was the same. I had been a little flushed but that had gone away too. I left and went for a light walk and eventually drove home without incident. I had symptoms after the shot that could have been related to my body fighting off the allergic reaction or to the vaccine itself, but they were pretty mild (fatigue later that night; occasional heart rate elevation sometimes after eating or with very mild exertion -- not unusual for me if I'm "fighting off" something; sore, itchy, red blotch sized between a quarter and a half dollar at vaccination site -- it is still a little tender today and appears a bit bruised; a bit sinus headache-y for three days, especially when I bent down to tie my shoes or something like that - also not that unusual as I often seem to "cleanse" through my sinuses when I have a bug or am fighting something off). In hindsight, I think the symptoms I had after the first shot, which lasted about 9 hours, may have been fighting off the allergic reaction and not a reaction to the virus vaccine itself.

Ringing in my ears (which I have had for many years at a LOW and TOLERABLE level - I would only occasionally notice it, maybe once or twice a month) became louder and impossible to tune out. I have had constant LOUD high pitched ringing in my ears DAILY for almost four weeks now, and it has not decreased in volume. I also have brain fog and am very forgetful (not a normal characteristic of me).

Dizziness & ringing in right ear. Ringing in ear has been non-stop since April 7th. Flonase prescribed to clear fluid. ENT says nothing else to prescribe or do.

Mild headache, started the same evening and lasting the next day. Stomach pain, sharp pain starting 1 week after vaccination lasting one day. *Ringing in both ears, starting 2 days after vaccination and still continuing. Worse at night. Bruise and pain at injection site, starting the same evening and continuing for about 1 week.

one week after second vaccine develop swelling of lips . treatment with benadrly and ice pack today 05/8/2021 came into clinic and recieved medrol dose pack and instructed to f/u with pcp or if worsening to go toer

Severe Tinnitus started 24 to 48 hours after 2nd Moderna shot on 4/15/21 to covid-19 vaccine. Testing & Treatment scheduled. It continues/is unresolved, i.e., it appears to be permanent.

Chills, fever, body aches, fatigue, nausea, horrible taste that continues, body odor change, urine and feces have peculiar odor, that also continues.

Day 1 dizziness, mild headache, could not get warm, no fever, diarrhea, extreme nausea, severely increased ringing of left ear. Day 2 same as day 1, day 3 - day 8 dehydration and sever ringing of ears. Day 9 sudden diminished hearing in the left ear. Ringing and hearing loss remain today 5/12/21. I saw my regular physician, an ENT PA, and Audiologist. Took hearing test which confirmed loss of hearing in left ear (compared to previous test; right ear was the same). Took 10 mg of Prednisone for 10 days to regain hearing, did not improve (2nd hearing test), had an MRI, no significant finding. I am now taking sleeping aids.

Although I have tinnitus, it is now very high pitched constant squealing which has increased drastically after my 2nd injection

AFTERNOON AFTER INJECTION SEVERE HEADACHE .. DAY 2 EVENING LOSS OF SMELL AND TASTE ALONG WITH UPPER LIP TIGHT AND TONGUE SWELLING AND JUST FEELS ODD.

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.

Louder Tinnitus, brain fog. Started the next morning. Itchy rash at injection site one week later. Gone by time to see Dr.. Called to ask about appointment, it was agreed, no more need to go at that time. Tinnitus settled down a little before second dose. After second dose tinnitus has become much worse. It goes from loud to louder. I do know how to live with my tinnitus. This is Much worse than when I first started to have it. Brain fog comes and goes. Has not improved. Dizziness (vertigo?) has to be added now too. Have needed to sit down several times now, this is not normal for me. Feet and hands will feel as if I wearing thick gloves. Comes and goes.

Within the first week after the vaccine, I began to get zapping electrical-like pains in the nerves in my fingertips and heels of my feet. I developed sharp twitching of my limbs, fingers, and one night, even my tongue. A mild tremor that I had been feeling since a prior medication reaction (Tamoxifen) suddenly escalated. Over the next week, the tremor began to have the same electrical quality in my upper arms and legs. It reminds me at times of that feeling when you chew on tinfoil. The shaking (whole body) wakes me at night and at times makes it impossible to drive, write, weave, or play my musical instrument. This week, I've had moments where my head literally wags like a dog's tail. My feet Charlie horse painfully. My upper arms and legs are developing a pervasive weakness, and I'm now unsteady on my feet. I'm sleeping more, napping many times in a day, and my usually boundless physical stamina is gone. Today I've had times of breathlessness. I can no longer function normally. If this continues, I will end up "disabled".

Ringing in the ear started 10 days after my 2nd dose of Moderna. I went to my general physician and he sent me to an Ear Nose and Throat Specialist. From there, I started doing research and saw other posting online regarding these effects from the vaccine.

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.

Loss of vision in left eye. 3/22/2021 Optimal Sight 3/22/2021 Retinal Surgeons 3/30/2021 Direct Imaging MRI 4/19/2021 Eye Institute

She got her vaccine, walked away after 15 minutes and had no reactions. The following week at 5:00 on 4/29/21 was watching TV and started having double vision that would come and go. Then she got in the car thinking it would go away, got 2 blocks up the road and the lines on the road were crazy. She closed one eye and drove back home. She called her eye doctor and got in the same day, and they told her she had cranial nerve 6th palsy. He told her to wear an eye patch. She can do anything now for a longer amount of time (15 minutes) before she has double vision, but cannot drive without having her one eye patched (right eye). She has had no other reactions to the vaccine. She has not been diagnosed with this in the past, and was fine up until the vaccine. She went to her PCP this past week and they did blood work and tested her for Lyme and did a sedimentation and C-reactive protein, and those were all negative. She had blood work the week before her A1C which is 6.8, and her regular 3 month diabetes work up. She is scheduled to have an MRI of her brain to confirm that she did not have a stroke, which she has no history of.

Waited 30 minutes after injection, was fine. Almost immediately after I left I started feeling numbness around my lips. Within minutes my gums started feeling numb. Then my whole face felt numb. Not extreme - Not like Novocain at the dentist, but definitely strong enough to cause concern. I was on the fence about calling a doctor, but it seemed to level off. My face and lips remained numb for a couple of hours. Gums were not too bad. It didn?t completely go away until well into the evening.

Day after shot: achy, tired, fever 100.1, ringing in ears, and localized reaction at injection site. After 48 hours, feeling better, except localized reaction at injection site (lasted about a week) and ringing in ears (still occurring). Saw healthcare provider on April 22 for ringing in ears.

Immediately had blurry vision, neck stiffness, systolic blood pressure up to 150s. Patient reports that she has been unwell since her second vaccine. Having myalgias and fevers up to 102. She was diagnosed with lingular pneumonia at urgent care on 5/10/2021. She believes that this is related to the vaccine. After treatment with doxycycline, she is starting to improve.

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.

Severe ringing/buzzing in my ears within two hours of the vaccine. I contacted my ENT on April 9th, April 15th and May 5th. I was scheduled for testing with an audiologist.

After the first dose there was minimal side affects with some fatigue and joint pain. The second dose side affects started 2 days after the injection. There was a fever, abdominal rash and joint pain. The fatigue lasted 2 weeks. The tinnitus started about 2 days after the second injection and still persist with no improvement.

I got the vaccine at 2:30 and that night I went to bed and had chills, headache, fatigue and ear ringing. Everything lasted about 16 hours except the ear ringing. The ringing in one ear is so constant and sound like a pulsating fan while the other ear sounds like constant humming.

Loss my voice, had laryngitis. Cough quite a bit. Had green mucus. I went to see the doctor. They gave me z pack and steroid. They also did Covid-19 test, which came back negative.

Her lips starting not working right as of Saturday following the vaccine. The facial pain present starting Tuesday before the vaccine was gone. Symptoms progress and by Monday eye was not shutting and she was experiencing facial droopping. Patient went to ER. Patient also experiencing left arm tingling from shoulder blade to middle of her hand.

Please note: 1st dose on RIGHT Arm, 2nd dose on LEFT Arm. First Dose, Moderna, Lot Number: 044A21A on 3/10/2021 1st day, 3/10/2021 only slight pain LEFT arm (vaccination arm) that evening. 3/11/2021 more pain in arm and just tired. 3/12/2021 body (achy) all over and dizzy all day. 3/13/2021 dizziness continued and tiredness set in (forced myself to get up and go!). 3/14/2021 extreme fatigue now in full force, no appetite and a slight metal fog. 3/15/2021 fatigue continued, dismissed appetite (forcing myself to eat) and still having body aches. 3/16/2021 still feeling run down, however dizziness dismissed. 3/17/2021 started to feel better but body ache continued. 3/18/2021 some symptoms started to improve but fatigue and lack of concentration continued. 2nd Dose, Moderna, Lot Number: 036B21A on 4/07/2021 on 4/07/2021 only slight pain RIGHT arm (vaccination arm) that evening, staying hydrated as suggested by the nurse 4/08/2021 no bad symptoms but injection site was bruised and raised, not sure why. 4/09/2021 started to feel tired and my right shoulder was hurting a bit. 4/10/2021 extreme pain under arm pit of right arm, achy all over and tired. 4/11/2021 swelling of lymph nodes under my arm and neck. Felt really sick and achy all over. Diminished energy and no taste. Forced myself to eat. I continued to stay well hydrated. From 4/11/2021 through 5/01/2021: The swelling under the right armpit continued to increase in size and the pain continued to increase. At one point I could hardly touch the area and I was having problems sleeping. My Right armpit and arm and my neck continue to bother me to no end. I could not sleep well and my Metal fog increased. Short Memory loss: I could not remember things that I did just a few seconds before. Since I had started a log to record my progress with my vaccinations, I kept writing all symptoms and problems down. I developed COVID Arm. My appetite has decreased, and I was very, very tired all of the time during this period. 5/02/2021 I started to feel better but unknown to me, my natural body defenses were down. Any little cut or scratch was not healing. And I was still having short memory lapses and occasional fatigue spells. I was relatively healthy before!! 5/04/2021 I had a run in with a wasp and I scratched my Left eye while trying to defend my eye from this insect. 5/07/2021 I had developed eye problems on my left eye and an infection on my face, left eye lid and ocular ulcers inside my left eye. I also had macular abrasions. I went to my Primary Care Provide and she prescribed oral antibiotics Doxycycline HYC 100MG, 1 daily for 30 days and an antibiotic ointment Erythromycin OPHTH Oin.t 3.5MG, 4 times per day for 5 days. 5/10/2021 My eye problem and infection got worse so I was referred to my Ophthalmologist. She confirmed that my Left eye and eyelid and cheek were infected and she added an antibiotic eye drop to the list of medications. 5/12/2021 My left eye hurts a lot and the left side of my face hurt a lot, so I was directed to proceed to the nearest Emergency Room. The ER Doctor changed my antibiotic to Clindamycin 300 MG, every 6 hours for 10 days. 5/26/2021 after finishing the Clindamycin antibiotics I had developed Thrush of the Mouth and I went to an Urgent Care facility, while there they checked my problems and drew a culture and prescribed Nystatin Oral Suspension, 1000MG, at 6 ML, every 6 hours for 7 days or until the Thrush causing Yeast Fungi is eliminated. I'm still suffering from a compromised immune system directly related to the COVID 19 Moderna Vaccinations. I'm still trying to put my life back together and I'm still dealing with the dangers of infections taking over my body from this fragile state. The Moderna Covid Vaccine has brought havoc into my life. Please use this information to warn others of side effects. Please provide additional information to the general public on steps that can be taken by the Covid vaccination recipients to make our immune system strong again. How do we now deal with metal fog? How can we deal with short memory lapses? How can we fend off infections? Please Help! 5/30/2021 In conclusion, the Moderna COVID vaccines have changed my life and I'm still living a nightmare filled with problems and infections from a greatly diminished and compromised immune system. I do not know how long will my body and health will continue to be compromised, all I know that I'm not the same. I still have to be careful with any little scratches and even paper cuts do not heal! I'm still taking antibiotics today and dealing with health problems that were not present before my COVID Moderna vaccinations.

5am 5/01 - severe dizziness, loss of vision, shakiness heart palpitations 5am 5/02 - severe dizziness 7:30 05/02 - Post coffee, severe heart palpitations vertigo

Patient received her first moderna vaccine on 6/3/21, pharmacist advised patient to wait in the waiting area for 15 minutes. The patient was waiting near the pharmacy, she went to the restroom and approach one of our associates saying she felt tired. The pharmacist went to check on the patient to see how she was feeling, the patient wanted to leave the store but the pharmacist advised against and had the patient return to chair. Patient informed the pharmacist that her legs and arms were weak. The pharmacist ensured patient knew who she was, where she was, the date and year. Patient then stated that her vision was blurry. The patient was able to answer all of these questions with no problems. Pharmacist asked the patient if she was comfortable with her calling an ambulance to check patient, the patient was resistant to calling an ambulance, the pharmacist did call the patient's son so he could come to the store to assist his mother. We decided it was best to call an ambulance after multiple minutes of the symptoms continuing. Pharmacist inquired about health condition, patient is diabetic so we attempted to get the patient's blood sugar and got the patient a soda to help with low blood sugar. Patient stated she felt slightly better after the soda but she was still very weak when ambulance arrived, the EMT advised the patient it was best to go to the ER to be examined. Son of the patient stated that she has episodes before where patient will be overstimulated and gets quite fatigued.

About 8 hours following injection, ears started ringing on both sides. I went to the ENT and neurologist, awaiting MRI. Over the counter remedies (Ring Stop) have not been helpful. As a result of the vaccine, I have constant ringing in both ears all day long, cannot sleep, and need to use a sound machine to block out some of the sounds from the tinnitus.

Sore tongue; Loss of teeth; Drug interaction; Feeling hot; Discopathy; Feeling bad; Yeast infection of the skin; Extremties itchy sensation; Eye swelling; cold; Diarrhea; Cramps of extremities; Back discomfort; Neck pain; red rash; Back arthritis; injection site pruritus; Nauseous; Itchy eyes; Eyes red; Watering eyes; allergy; Swelling of legs; Rheumatoid arthiritis aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) 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 products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Rheumatoid arthritis, PROMETHAZINE for an unknown indication, OXYBUTYNIN for an unknown indication and AZITHROMYCIN (Z-PAK) for an unknown indication. The patient's past medical history included Rheumatoid arthritis, Low back pain in 2018 and Hernia repair (and mesh) in 2018. In 2013, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose., PROMETHAZINE (Subcutaneous) at an unspecified dose, OXYBUTYNIN (unknown route) at an unspecified dose and AZITHROMYCIN (Z-PAK) (unknown route) at an unspecified dose. In December 2020, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergy). In March 2021, the patient experienced PERIPHERAL SWELLING (Swelling of legs). On 19-May-2021, the patient experienced EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes). On an unknown date, the patient experienced GLOSSODYNIA (Sore tongue), TOOTH LOSS (Loss of teeth), DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot), INTERVERTEBRAL DISC DISORDER (Discopathy), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps of extremities), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain), RASH ERYTHEMATOUS (red rash), SPONDYLITIS (Back arthritis), VACCINATION SITE PRURITUS (injection site pruritus) and NAUSEA (Nauseous). The patient was treated with HYDROCODONE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated), GLOSSODYNIA (Sore tongue), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), MUSCLE SPASMS (Cramps of extremities), HYPERSENSITIVITY (allergy), PERIPHERAL SWELLING (Swelling of legs), SPONDYLITIS (Back arthritis), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes) had not resolved, TOOTH LOSS (Loss of teeth), INTERVERTEBRAL DISC DISORDER (Discopathy), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain) and NAUSEA (Nauseous) outcome was unknown, DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot) and DIARRHOEA (Diarrhea) was resolving and RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PRURITUS (injection site pruritus) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Lab Result: Pain scale: Unknown test date - no results reported Uric acid test: Unknown test date - no results reported Urine test: 27-Apr-2021 - no results reported Vitamin D test: Unknown test date - no results reported X-Ray: ??-Mar-2021 - no results reported 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. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up 2 information included additional events eye pruritus, ocular hyperaemia, lacrimation increased, and spondylitis. Outcome of events nausea and diarrhea updated to recovering. Outcome of events muscle spasms and fungal skin infection updated to not recovered.; 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.

Patient reports swelling of the tongue and lips more than 30 minutes after first dose of Moderna Covid vaccine on 5/13/21. She dis not seek medical care at the time. Patient insists on getting second dose which she received 6/10/21 with no observed adverse events.

Immediately after I got the vaccine, I tested sugar, in the back of my throat, like fake sugar. After 12 hrs. I got headache and fever (104.6) ( could have be higher) I took a cold shower, to get temperature down. I cracked my teeth guard from my jaw, and I have brain fogs and hard time finding words. I have a PHD and now I can?t think. Affected my memory and speech, I have joint pain. I called and they told me to go to ER if fever reaches 105 but I managed to have the temperature down, so I did not have to go back.

Macular Hole; Optical visual changes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MACULAR HOLE (Macular Hole) 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. No medical history information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D [VITAMIN D NOS], ZINC, FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MACULAR HOLE (Macular Hole) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Optical visual changes). The patient was treated with Surgery for Macular hole. At the time of the report, MACULAR HOLE (Macular Hole) and VISUAL IMPAIRMENT (Optical visual changes) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that Macular Hole required a surgery 7 weeks after (17 May 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. 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.

Ongoing intermittent facial swelling of both eyes, lips, and hives and associated itching of forehead, chin and neck. Each episode lasts 4-6 days at intervals of every 15-20 days. Initial symptoms began January 5, 2021 (one week after having reviewed the initial vaccine dose). Current medications: Allegra D 360mg BID Pepcid 20mg BID Plaquenil 200mg BID Singular 10mg QD Recently added for breakthrough hives: Prednisone 40mg QD x 2 days then 20mg QD x 2 days

Several hours after receiving this vaccine (first dose), my right ear began to hurt. The pain intensified as the evening wore on. The next morning the pain was gone, but I had ringing in my ear. In the past I have had some very mild, short-lived bouts of tinnitus before, but this was more intense than I'd ever experienced before. The ringing was loud enough that it broke through daily noise. It was loud enough to break through even during boisterous conversations in a room in which the television set also turned on. It was also so loud that it interfered with my sleep. Over the course of the past several months the ringing in my ears has become softer, but it is still there and still occassionally breaks through the ambient noises of daily life.

Tinnitus started 15 minutes after the second shot and I have had it non-stop since then. Today will be almost six-weeks since the second shot and Tinnitus is not letting up/not stopping.

LOST HEARING IN LEFT EAR. HAD FIRST STEROID SHOT THROUGH EARDRUM APRIL 15 SECOND STEROID SHOT APRIL 22 HEARING HAS BEEN RESTORED

dizziness, severe fatigue, severe joint pain, muscle pain, headaches, diarrhea. loss of taste lasting more than 2 months now. still ongoing as of 6/30/21.

I had a very dry mouth with a chalky feeling to it. My taste was altered, but not gone. It started out as a metallic taste but now nothing taste good. I get a dry cough at times. My sinus's feel really dry too. I have difficulty swallowing foods like bread and crackers. i had a upper GI test did that showed a schatzki ring in my esophagus. I had a CAT scan of my neck and throat area, but I haven't gotten results to that yet. My doctor feels as though my symptoms could be related to rheumatoid arthritis.

Day 1: Fever, chills, sweating, incontinence, diarrhea, vomiting, extremely cold hands and feet, swollen left arm with large red raised area 6" x 8". Continued through day 3. Day 3: cold sores, bleeding gums and mouth sores,. Week 2: itchy rash on lower left arm,

Initially on evening of receiving the 2nd vaccine, I had extreme chills, fatigue, muscle aches, joint pain, pain at vaccine site on left arm, head ache and sensitivity to light. These symptoms lasted for several days. However the fatigue has continued ever since. I only have energy for a couple of hours in the morning, then I am ready for a nap or only a low key day. After two weeks I felt heart palpitations and went to the emergency room to be check out. Since then I followed up with a doctor who referred me to a cardiologist. I will be having a stress test on future date. On 6/26/2021 I woke up feeling all the same symptoms as the day of the shot. I was so tired I could barely keep my eyes open and slept most of the day. I was better the next day, but continue to feel fatigued. I had to quit my full time job due to the lack of stamina. two weeks after the 2nd vaccine.

Early morning, an excessive burning sensation appeared on my nose and on the left side of my face. Additionally an unknown toothache/ nerve pain on the upper/maxillary. After 5 days lesions looking like blisters appeared on the left side of my face. A pain that can be described as someone pouring hot oil on my left side of the face became permanent and my face and eyes were swollen as if someone beat me up. As soon as the visible signs were progressing I went to my primary care doctor and she diagnosed me with shingles / Herpes Zoster. I struggled with this horrible disease for a month and the most difficult part of the recuperation process was to put the swelling of my eyes and face under control. I could not open my left eye because of the excessive swelling and the pain which was uncontrollable. My primary care doctor advised me to be extremely careful with my eyes because I could lose my sight due to the shingles. Additionally, I was seen at the dr because of the excessive swelling in my eye, and the pain that accompanied it and would not go away.

Patient received first dose moderna vaccine on 7/12/21 at approximately 1235. Patient requested assistance due to "having an allergic reaction" at 1250. Patient reports, feeling "a little dizzy", lips tingling, and "it feels like when I go into a-fib." Initial vital signs: 140/70, 80 HR, 95% on RA, 17 RR. Patient stated during initial vital signs that her symptoms were resolving. Patient denied any shortness of breath, throat swelling or chest pain. Requested patient remain for 10-15 additional minutes of monitoring. At 1305 patient stated symptoms were resolved. Vital signs as follows: 130/72, 83 HR, 16 RR, 93% on RA.

Right after the vaccine, I felt bad for the day and the next day, I woke up and felt tired but nothing that kept me from doing anything And the next day after that everything was fine. On June 26, No fever or anything. I just had an earache and I gave it a couple of days to see if it would go away on its own. By Tuesday, I called the doctor and they got me in Thursday. It looked like my left ear was a little red - and right ear looked fine. Prescribed antibiotics for two weeks and I took those and I went back last Thursday and it looked better. She's my ear doctor and she knows me as she has done surgery on my ears. I have had a lot of ear issues before but this was the first time I have ever had an earache.

My lips were numb 45 minutes after my vaccine and 7 or 8 days later I had a mini stroke but unsure if related to the vaccine.

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.

Has been vaccinated in the past with Moderna. Developed sore throat, loss of taste and loss of smell.

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.

Headache weakness, lost of taste Narrative: Informed employee to go get COVID tested since employee reported loss of taste, headache, muscle aches, and weakness. Employee understood and stated that she would.

about an hour after injection, i noticed a bitter taste in the back of my throat and upper back toward tonsils and is still there for now. i am fine.. i just wanted you to. know it has that side effect. i plan to get the second part of the vaccine.

within 20 minutes: metallic taste in mouth, tingling and numb lips/tongue - resolved with OTC antihistamine use

patient has a hx of anaphylaxis to pears. Within 5 minutes of vaccine developed tingling and numbness to lips and tongue. patient escorted to the emergency department for further evaluation and treatment.

Confusion, Fever, SkinRash, Rash, Diarrhea, NauseaVomiting, HYPERtension, SWOLLEN TONGUE W/RASH; HIGH SED RATE

Patient reported feeling flushed and shaky after injection. Episode was short lived. After second episode it was decided to transport patient to ED for evaluation via wheelchair. ED notes: patients states she felt very flushed, cheeks were flushed, very slight itchiness in her mouth and tongue and very slight nausea and very shaky. Denied shortness of breath or chest pain. Medications given: 1815 diphenhydramine 50mg IV 1820 methylprednisolone 125mg IV Normal saline bolus 1840 famotidine 20mg IV 1817 hydroxyzine hydrochloride 50mg IM 1841 epinephrine 0.3mg IM 1823

Blurred vision, numbness in the mouth and high blood pressure. Benadryl 25 mg PO was administered approximately 1 hour post vaccination. Employee was instructed to see primary attending physician.

tongue and central facial numbness resolved within 3 hrs Narrative: reports 3hrs of numbness but no medical f/u at time

nausea, chills ,temp of 101.3, exhaustion, upper breast lymph nodes painful , loss of taste & smell - occurred over 1 week time frame

very sore left arm with in hrs . Went on to devlop 7/10 neck left shoulder joint and lower back pain with in hrs . Extreme exhustion and nausea, headache -couldnt eat dinner on thursday night had a brief left ear ache through the night and periods of extreme chills /shaking , no food friday , called out sickNow RIGHT arm hurting ! -symptoms continued went to bed at 1800 hrs and woke up at midnight with soaking wet bedlinens and pjs . Family helped me change linen . Took M otrin 800mgs po and slept throguh the rest of the night woke up sat AM and was perfectly fine , hungry and back to usual self ( Of interest : was hospitalized with COVID 19 pneumonia march 2020 for one week ,received the anti malaria drug ( at that time was the recommended tx .) Still tested positive 4 months out in July 2020 at location(that sample is frozen at facility - and have not rested ( maybe had an acute response to the vaccine due to antibodies from primary infection ???

ACCORDING TO PATIENT STARTED WITH FEVER AFTER VACCINE THAT EVENING . THEN THE NEXT DAY SHE STARTED WITH SWELLING OF THE LIPS, TONGUE AND GUMS SO WENT TO ER WHERE SHE WAS GIVEN BENADRYL, TYLENOL AND STEROIDS

WITHIN 18 HRS FROM INJECTION / SYMPTOMS STARTED SATURDAY 01/09/2021 @ ~ 1400HRS DIARRHEA CHILLS LOW GRADE FEVER 99.8 JOINT PAIN JAW PAIN BODY ACHES HEADACHE NEAUSEAUS LIGHT HEADED FATIGUE HYPOXIC ON EXERTION SYPMPTOM SUBSIDED ON SUNDAY 01/10/2021 @ ~ 1500HRS

I stayed my 30 minutes as directed in a room since I have needed IV Benedryl in past with blood transfusions. Toward the end of my 30-minute wait, I noticed my lips tingling/swelling. I ALWAYS carry an antihistamine with me, so I walked out to my car and noticed that my lips felt full. I needed to run my tongue around them and I immediately took a Zyrtec. I never did feel short of breath, but with many times in my life getting giant hives due to allergies/ blood transfusion ( secondary to my hemophilia), I feel this was a type of allergic reaction. I've never had the lip-tingling thing before with any other vaccine. I've had both pneumonia and both Shingrix vaccines and always get my influenza vaccine since I'm immunosuppressed and work in a Doctors office daily.

Started getting the chills, a severe headache and fever of 101.3. Nausea the next day was unable to eat, chilling all day with a fever, extreme tiredness, back pain, diarrrhea and eyes hurting, fever rising to 101.5. Fever on Monday dropping to 99.9 and chilling with no energy. Tuesday back still hurts, no energy, had dark urine in the am. diarrhea in the afternoon. Lost 7 lbs.

Had headache, fatigue , muscle aches arm and body. muscle aches upper chest and legs, chills, nausea,dry mouth,loss of appetite. I was tested on 1/6/21 result positive for covid. was prescribed azithtromycin 500mg , 1 tablet per day for 7 days. I took tylenol for pain and quarantined since then.

Pt developed facial itching 15 minutes after Moderna Covid vaccine injection.. Benadryl 25 mg capsule given po per order Dr. Will be observed x 30 more minutes. 9am C/O oral itching, examined again by Dr. No SOB or difficulty breathing, 9:15am Tx to AUC per DR. Was given Benadryl, Solumedrol and Pepcid. To be discharged home with EpiPen

Upon awakening the morning after the vaccination, I experienced swelling in my ankles, feet and fingers I also experienced swelling in my face where I had received filler injections six months ago. I also experienced feeling very spacey and foggy in addition to ringing in my ears, pins and needles all over my skin as well as a burning sensation on my upper back, buttocks and thighs. Finally, I felt extremely fatigued and lethargic. I had no fever or headache but had soreness at the injection site. I dosed with 600 mg of ibuprofen b.i.d. the first day as well as 50 mg of Benadryl at bedtime. While I got some relief from these medications, I still remain symptomatic on day two after receiving the vaccination.

Moderna COVID-19 Vaccine: Metallic taste in mouth after 15 minute wait time. Taste diminished after 30 minutes

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.

Lost sense of taste approximately 1 week after receiving vaccine. Have had no treatment because I don't know what to do.

hi, I had tingling a few hours after receiving the first does of the modern vaccine, mostly in my chin, tongue and lips. I have since then had on and off nueropothy, from severe numbness and tingling throughout my entire body and head, to mild tingling, some of it being so severe, that I could not sleep. My general practioner has advised that I do not get the booster.

Had vaccine at 3:21 pm Started itching at 4:05 pm- eye lids, scalp, bottom of foot, face felt tight- no respiratory issues. Took Benadryl with moderate relief. Area was red and sore about the size of a ping pong ball area. Area cleared on 121/2021. On 1/22/2021 area of vaccine became red, hard and itching. I took Benadryl with no change. Called provider on 1/23/2021 and was seen virtually. Area is now between 6-7 cm . Advised to apply ice, topical steroid cream and marked the area,. Prescription for Bactrim was given incase symptoms increased. This helped some on 1/24/2021 in PM area increased , I had general malaise and a stiff neck with joint pain. I started the prescribed Bactrim-for questionable cellulitis. provider recommended I not receive the second dose

1/13/2021-9am pt. received the moderna vaccine to left arm. Around 3-4 pm patient developed headache, nausea, and could not lift her left arm, muscle aches, and swelling to right eye, Pt. states that she took Arnica on day number two. Pt. states that she cannot say if arnica helped with symptoms or she naturally became better. Pt. states symptoms resolved on 1/16/21.

Morning of 1/24/21 (Sunday), patient saw that the right side of her face was drooping, her right eye was swollen and excessively tearing. Patient noted drooling out of the right side of mouth when drinking fluids or eating food. Patient was unable to chew on the right side, had difficulty speaking due to the drooping of the right side of her mouth. Symptoms persisted into the next day. Patient was seen by her PCP and was diagnosed with Facial Palsy (Bell's Palsy). Patient's neurological assessment was negative for stroke symptoms.

Limb heaviness within 5 minutes of second vaccination. Subsided in approximately 25 minutes. Patient also reported that she experienced a similar reaction immediately after first vaccination plus the inability to visualize words (i.e. she couldn't read what was on the paper she was holding).

Jan. 16 10pm: achey neck, limbs,head ache,, Jan 17, 9am.. -19th. Pain became extremely achy in entire body, stomach, ribcage, arms, thighs , and neck.Weakness in stamina. Freezing unmanageable chills,itchy watery eyes, extreme arm pain. Severe lethargy, sleepiness.Unable to walk out of the house for 3 days.These symptoms be came less intense beginning Jan. 19 about 12PM. I am still incredibly tired and now my ulcerative colitis has flared up and I'm losing blood through stool.

RECEIVED CALL FROM PT. SHE HAD HER 2ND MODERNA VACCINE 1/25 IN THE OFFICE. STATES WOKE UP AROUND 2AM WITH TERRIBLE HEADACHE, AND THEN AS MORNING PROGRESSED, SHE NOTICED SWELLING OF THE RIGHT SIDE OF HER FACE. EXTENDS FROM JAW UP ALONG NOSE AND BACK TO MID CHEEK. STATE SHE FEELS FINE OTHERWISE. STATES SHE WHEN SHE SMILES BOTH SIDE OF MOUTH TURN UP, NO LOSS OF SENSATION. PT STATES SHE DOES NOT HAVE SMART PHONE AND CANNOT FILL OUT VSAFE INFO, NO COMPUTER AT HOME EITHER. ASKED PT IF THIS RN CAN FILL OUT VAERS ON HER BEHALF. PT AGREEABLE.

Metallic taste post injection Fever 102 degrees (by 8pm eve of shot) Tylenol only reducing fever to 101 Severe chills/shakes Insomnia Confusion Dizziness Tachycardia (125 bpm) persistent the first night) Loose stools Incontinence

Documents reviewed. Vaccine administered, patient tolerated well. Patient reported sensation of tongue numbness 20 minutes after administration. Numbness resolved after ~5 minutes, patient did not develop any new or worsening symptoms after resolution of numbness. Vitals - BP 171/73, then 153/96 HR 51, then 95 O2 sat 100% then 99% Patient was advised to call 911 if she develops any tongue swelling, throat tightness/itching or shortness of breath today.

Started 1/11/21 at work. I am a medical professional. Left arm tingling and numbness. Floaters and flashers mostly in left eye. Scattered ones in right eye. Elevated blood pressure 147/79 (normal for me near 120/70) Pulse 106. My normal is in 60's. R:20 POX: 95% RA. Worked full shift 2P-10:30PM. Got good night sleep. Still had symptoms on 1/12/21 so went to urgent care. I still have these symptoms.

headache, pain under left cheek bone, slight earache in left ear, body aches and pains in lower extremities - thighs, behind knee caps, calves and ankles.

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

within about 5 min after getting shot my mouth , lips and tongue began to feel weird, Tongue swelled

Allergic reaction occuring 4 hours after #2 dose of Moderna: symptoms were sudden onset of flushing, tachycardia, swelling of lower lip and feeling of need to clear throat due to sensation in throat. Took Benadryl at home due to edema of lip and feeling the need to clear throat.

Moderna COVID-19 Vaccine EUA Sunday, Jan 24 2021 Afternoon - Chills, Achiness Dinnertime - Addition of Nausea Evening - Addition of Joint Pain, Muscle Pain and Fatigue Monday, Jan 25 2021 Basically out of it all day with extreme fatigue, headache similar to a migraine where it hurt to even move my head, stiff neck, chills, nausea, muscle and joint pain. Did not take temperature as I was sleeping most of the day, made it to the bathroom but that was it. Tuesday, Jan 26, 2021 Less fatigued, headache and stiff neck was there but not nearly as bad. Still had the chills, nausea, muscle and joint pain. Temp was 99.4 when taken Wednesday & Thursday (Jan 27 & 28, 2021) - Each day felt a bit better but still seemed to tire easily and gradually got back to feeling like eating something. Friday, Jan 29, 2021 - Felt pretty much back to normal but tire easily. Sat Jan 30 - Monday Feb 1, 2021 - Still feel I am tiring easy but each day gets better. Monday Feb 1, 2021 - Afternoon - Have tingling in throat and right ear. Typical of reaction to IGG Infusion. Have taken Benadryl 25. If continues will call PCP.

3 hours after shot severe pain around the injection shot Difficult to use the arm for the next 48 hours very sore around injection sight About 8 hours after developed chills and tiredness and just was not feeling well 2nd day right arm still very sore and very tired general feeling of being unwell maliles by the 3rd day only felt more normal right arm only sore if you touched it or laid on it felt a little more energized. Then 02/01/21 exactly one week later had a strange feeling in my head not a headache not dizzy just felt an unusual feeling in my head of not feeling quite right especially with movement then 2 hours later had a ringing in my ears have no ear infection noting unusual im an RN and would report any other conditions. then that evening i began feeling itchy at my injection sight but i was just iching it though my clothes and wondered why i'm so itchy on my shoulder I really didn't think about the shot as it was 7 days later. The itchy feeling continued so I went to the bathroom took my shirt off and saw a rash which i will include pictures of the rash if I could. i was alarmed and concerned about the big rash and the papules sticking up. It's now the next day 02/02/21 I still have a big rash on my arm it's about 6 inches long 3 inches wide red elevated. I googled it and it said it was the covid arm or something. I am willing to provide pictures

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) .

20 min after shot, arm tingled, then lower lip went numb, then tongue swole up. Fire dept personnel had me take 2 of my own 12.5 chewable benedryl that were dated 2018. Then i left approx 20 min later with tongue almost at normal size, on the way home it started to swell again so i went to the emergency rm at hosp. They gave me iv benedryl, iv steroids, 1 hrs later i started coughing and lungs nurning, they gave me a chest xray and more iv benedryl. In about another hour or 2 they. Decided i had stabilized and sent me home with a prescription of prednisone 40mg for 2 days and then 20 mg for 2 days.

Patient described flushing, lips tingling. No itching, hives or shortness of breath reported. No facial/lip swelling reported. Patient took Benadryl that she brought with her. Event improved within minutes. No other intervention.

10 minutes after shot I felt, chest congestion and a strange taste in my mouth. I stayed at injection facility for over an hour to make sure I would feel better. Later that evening, I was fine without any marks on injection site. Nine days later I got an itchy, sore arm with a bulls eye, raised red rash larger than a quarter, about 1.75" and a bit warmer than other areas of the arm.

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.

Day after vaccine I had sore arm, swollen at the injection site, swollen ear lobes (lasted 24 hours), itching both arms, itching jaws, itching scalp, 2 days later still itching

Chills, fever101 for greater than 36 hours, then low grade for 24. Eyes burned, unable to have open, headache for 36-48 hours. Localized reaction. Arm with hard knot at site, baseball size, diffuse redness from upper arm to elbow and around to underarm and axilla area. Started on oral antibiotics on day 7 for cellulitis to arm

Very swollen arm that began within 6 hours and pain and still swollen after 48 hours. Fits of sneezing and roof of my mouth began to itch after 8 hours from vaccine and continue after 48 hours of vaccine. Headache began within 8 hours of vaccine and still after 48 hours. Fever of 102 degrees began 8 hours hours after vaccine and fever still continues after 48 hours . Chills 8 hours after vaccine and finally stopped after 40 hours. Dizziness began 14 hours after after vaccine and still continue after 48 hours. Fatigue began 18 hours after vaccine and still continuing after 48 hours from vaccine.

Immediately after I received the shot, I felt my whole left arm get very warm. Before going to bed Wednesday evening, my arm began to hurt. Beginning at approx. 1:00 am after receiving shot, I got a headache which kept me up most of the night. The headache continued until Friday morning with taking Tylenol every 4 hours. Thursday other than my head hurting, my body hurt and I had a loss of appetite. Thursday evening I got chills, and ran a temperature. I was still taking Tylenol. I was able to keep my temp at bay only getting to 100.5 at the highest. Thursday night with all my pain, I did not sleep well again. My left arm hurt so bad and I was having a hard time letting it rest at my side. I realized my left armpit was swollen and down my left side to my breast I was very sore and tender. I woke Friday morning without a headache. I worked out at a gym on Friday but was not able to keep up with my usual routine. I still did not have an appetite but ate just for the energy. Food did not taste good. I had Covid in early November and lost my taste and smell. It returned so I'm not sure why food is not tasting good. It almost has a bland, metal taste if that makes sense. I felt like I was on the road to recovery only to run a temp again Friday evening. I got chills and knew what what was coming. No temp on Saturday as of yet. I do not have a headache which I am glad. My left arm still hurts but I am getting better range of motion. It is still very tender under the armpit area.

1/30/21 at 1pm developed lower lip swelling, progressed down chin to L cheek, no shortness of breath or chest pain Following day extremely tired Started on prednisone x 5 days with Pepcid. Symptoms totally resolved after 2 days

I ALREADY FILLED OUT ONE PRIOR FORM CONCERNING MY REACTION REGARDING THIS INJECTION. MY NECK AND NECK NODES ARE STILL ENLARGED AND TENDER,IT IS MY SCAPULAR REGION AND POSTERIOR NECK REGION. THIS IS NOT NORMAL . I'M NOT SURE I REPORTED RIGHT ARM TENDERNESS AND ERYTHEMA. IK HAVE A PHOTO. I ALSO EXPERIENCED TINGLING AROUND LIPS BUT THOUGHT I WAS GOING TO GET A COLD SORE, BUT TALKING TO PEOPLE SAID I SHOULD REPORT THIS AS WEL SINCE I DIDN'T GET A COLD SORE. I HAVE INCREASED FATIGUE SINCE INJECTION.

Getting up 2 days after the shot I began experiencing facial and hand tremors, As the day progressed, they became more frequent and overt. This continued for several days, eventually reducing severity after 5-6 days. I was winking with both eyes involuntary, face twitching, hand and fingers twitching and jerking

Within 1 hour of receiving 2nd vaccine, I started to get pain behind my right eye. That night, the pain turned into shooting pains on right side of head, every 3 to 45 seconds at worse. Head pain continued to Daturday, the 13th, when it stared migrating to right ear (same stabbing-type pain). By Tuesday the 16th, if further migrated to glands below my right jaw line ( same stabbing-type pain). Over last 48 hrs I have also developed scaly patches on right half of scalp. Tonight I started developing scaly rash on top of right side of face. As of now, stabbing pains continue in right side of head, right ear, and right side of throat. On Friday the 12th I also had swelling and tenderness under left arm. This has dissipated.

covid vaccination on 2/8/21. 2/9/21 arm with welt a little sore, was exhausted by end of day. On 2/10/21, felt intense fatigue. Took temp and was 102 temp. On 2/11/21 had sores in mouth--now gone. Welt on arm is now gone. Has been fine ever since. Never had cold sores in past.

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.

Symptom first started with soreness in the left tonsil, then swelling and now the pain has moved to my ear canal. This has been going on for 3 days and I have to take Tylenol and provide relief so I can sleep.

Within 1-2 minutes, felt like an infusion or flush with a chemical/metallic smell, taste. Extreme weakness, dizziness. Had to sit down for a long time, couldn't really open my eyes. Bad head feeling. Eyes hurt, but were not swollen. No swelling, just that constant metallic overwhelming. Dizzy. Stayed at pharmacy for about 40 minutes. On drive home, hot face, metallic infusion, very warm. Fever at home, achy all over, 99.8, very dizzy, brain fog, very weak, arm sore. Next morning, no better. Took a Nexium and immediately big hive popped up on my chest. Disappeared about an hour later. Took 3 days to feel like myself. Still concerned about allergic reaction. I'm a little itchy, tingly. I'm now terrified of getting that second shot.

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.

Tinnitus: persistent high pitch ringing (more prominent in the right ear). No prior history of Tinnitus. No prior issues with hearing acuity or medical complications related to my ears

lost hearing in right ear; ringing in the ear; A spontaneous report was received from a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ringing in the ear and loss of hearing in the right. The patient's medical history was not provided. Products known to have been used by the patient were not included. On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced ringing in the ear and lost hearing in the right ear. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, ringing in the ear and lost hearing in the right ear was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Waited 15 minutes in clinic after vaccine. On the way home, notice slight numbness in left face and left side of neck. It never got worse and went away after approximately 2 hours. Woke up in the middle of the night with a metallic smell. Noticed metallic smell on hands, washed hands and this kept up the following day. Had a metallic taste in mouth that lasted all the following day.

Patient face became flushed, lips got tingly and numb, then tongue felt tingly and numb. Patient has been able to eat drink and swallow. She also reports feeling nauseous

Red Rash on her Chest. Patient felt a tickle feeling in her throat. She was alone and did not feel comfortable driving home. Pateitn requested transport to Hospital ER for further evaluation.

1. About 4-5 minutes after getting vaccinated my left eye had new floaters and what looked like strands of hair. They cleared after 35 minutes except for a few floaters. 2. About 1.5 days later for 24 hours I had a headache and took advil. Injection site was tender 24 hours after injection for a couple of days.

Mouth blisters, dizziness, chills, fever, fever blisters, cough, rash, and arm pain about 2 hours after injection of vaccine.

Dull headache and tired immediately following injection on 2/27 and throughout the day. Then at 1am that night(2/28), started having sharp stabbing pains in left arm, back, neck and left side of jaw. Very weak and chilled. No fever. Symptoms lasted until about 4pm on 2/28 then started to subside and mostly gone by 2/29 A.M. Continue to have sore arm at the injection spot.

at 1000 BP 125/87, P=92, R=16. Reports burning of her entire tongue and scratchiness at the back of her trhoat. Denies SOB or selling of tongue or throat. At 1010 denies that her S and S are worse. Instructed patient on the need to F/U with her PCP as needed.

Ocular migraine. Onset 3/2/2021 around 4 pm EST. Started with kaleidoscopic peripheral vision, then blurry and blocked vision. Also included headache behind left eye. Vision problems lasted around 30 minutes. Headache for several hours. I took migraine OTC meds, plus Tylenol.

Within 6 hours I was fatigued and went to bed early at 8:30. Extremely thirsty in the night and developed a Post nasal drip. Woke later than usual at 9:00 feeling very feeble- nauseated, tired, muscle twitching. Sat for two hours. No appetite. Headache developed and fever of 100.8 F at 11:00 AM. Call my doctor. Spoke to Advice nurse who said to relax if still with symptoms in 48-72 hours call back for a telehealth appointment. Took acetaminophen. Head still hurt . Went back to bed.Fever down at noon to 99.5F. Ate a popsicle at 1:00 PM and vomited it up at 1:45. Have been resting since it?s almost 5:00 PM.

C/O numbness around lips, able to stick tongue out and move, no discoloration around lips, able to talk without difficulty, pt states at 13:15BP 150/90 Hr 71 Spo2 100, 13:30 BP 154/105, HR 74 Spo2 100 13:35 that she feels anxious and will take her anti anxiety meds at home. instructed to F/U with PCP.

Moderna COVID 19 Vaccine EUA facial numbness, quick onset, 20 minutes post injection. began at nose, and spread quickly across cheeks, to chin. very slight tingling at tip of tongue. No swelling, No difficulty swallowing or breathing. Resolved without intervention beginning after about 1 hour and totally resolved 1 1/2 hours after onset. Over next 4 days periodic recurrence of facial numbness less pronounced, with rapid resolution within minutes (total 3-4 episodes). Always beginning at nose and spreading across cheeks and chin.

SWOLLEN TONGUE, WHEN TO EMERGENCY ROOM GIVEN MEDICATION DISCHARGE AFTER 3 HRS, SEND HOME WITH MEDICATION.

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.

Slightly fatigued, bad taste/tingling in mouth and throat. No sign or symptom of distress, respirations even and unlabored. skin pink warm and dry. Monitored for further problems then released.

No symptoms other than sore arm and tiredness with 1st shot With, the second shot I developed a cold sore and multiple mouth canker sores.

101.3 fever, nausea, debilitating headache day following vaccine. Cold sores erupted in nose & on lip 2nd day after vaccine. On 3rd day after vaccine visited dentist & they noticed unusual gum irritation, swelling. Cleaning was very painful & this is unusual for me.

2/25/2021 OS became swollen to the point where she could not open her eye. It was swollen for two days. On 3/3/2021 OD became swollen. Pt seen at eye doctor 3/5/2021 who diagnosed eyelid edema of unknown cause and reccomended hot compresses bid. Full resolution today 3/8/2021.

I experienced mild tingling and numbness in my lips, which lasted for several hours. I had taken an Allegra 24 the evening of 3/8/2021, no treatment was necessary.

Client states "feeling warm, shaky, tongue tingling and dry", observed face flushed. O2 Saturation = 98%

Pt received her first dose of the Moderna COVID19 vaccine. When pt sat down in observation she reported feeling a strange sensation in the back of her throat and a funny taste in her mouth. BP 169/85, HR 77 O2Sat WNL. Pt was evaluated by EMS. Pt signed refusal for transport to the ED.

A 63-year-old female with a medical history of Hashimoto?s Disease, on Levothyroxine 88 micrograms (4 days per week) and 100 micrograms (3 days per week), presented to the emergency department with a 7-day history of acute onset of severe, debilitating, fatigue, weakness, anorexia and malaise. She had no clear precipitating events, stated that she was in her usual states of health, active, working as an optometrist at a University hospital. Stated that 1 week before symptom oncer she had her first dose of Moderna COVID-19 Vaccine EUA. Stated that 24hrs later her symptoms started associated with low grade subjective fever, however her fever disappeared, and she persisted with severe fatigue. She was unable to do her regular activities of daily living and was hoping her symptoms would resolve but upon persistence and given the severity of her complains she presented to evaluation. She denied recently starting any new medications/supplements, or recent change in her levothyroxine dose. There were no headaches, cough, diarrhea, sore throat, rhinorrhea, myalgia, arthralgia, weakness, recent infectious illness or sick contacts. She was diagnosed with Hashimoto?s Disease over 10 years prior and had been on the same dose for more than 2 years. VS were stable and within normal limits, physical exam was only remarkable for weakness on 4 extremities 4/5, lethargy, bradylalia, bilateral ptosis, no focal neurologic deficits, sensation intact. Laboratory workup revealed normal Hb 14.8, normal renal and kidney function, normal cortisol level, TSH normal 3.7, normal FT4: 1.2, normal CPK, negative tox screen. ESR and CRP were performed, and both were found to be elevated ESR 74, CRP 28, at that moment we decided to do immunologic workup showing high titers of ANA >1:320 with a nuclear speckled pattern, and a positive rheumatoid factor 60. At this point a full rheumatologic panel was performed which was negative for anti-Ach receptor Abs, negative anti-CCP, anti- dsDNA, anti-smith, negative anti-Jo1, anti-RNP, negative anti-TPO, negative anti-SCL70, normal C4 and C3 however elevated total CH50 > 60, positive anti-SSA and anti-SSB. Her symptoms of severe fatigue persisted throughout her admission and it was decided to give her a course of prednisone 40mg for 5 days and follow up as outpatient with a Rheumatologist. Repeat workup 2 weeks after discharge showed still elevated ESR at 72, high CRP 17, rheum factor elevated again at 67. At this point no clear cause was identified as she did not have any symptoms of Sjogren or anything else other than severe persisting fatigue. Another course of steroids was given and 1 month later she stated that she was much improved and was able to go back to work. Stated that she would not take her second covid MODERNA vaccine dose due to fear of recurrence of symptoms. It appeared that this vaccine triggered a severe inflammatory and autoimmune reaction in this patient with history of Hashimoto?s disease. The association between MODERNA vaccine and development of autoimmunity and inflammatory reaction needs to be assessed.

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.

I had the Moderna vaccination on Feb 25 and on March 4 (day 10) my eyes and cheeks were swollen like a chipmunk. I?ve had no dermal fillers. My eyes and face are still swollen so I went to my Dr today. He has me on Benedryl and Prednisone.

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.

Moderate nausea for 7 days post vaccine. However, 7 days post vaccination, red, bumpy rash appeared just inferior to injection site; RT deltoid. Warm and firm to the touch. Measures 2.25" S/I and 1.5" A/P. It appears to be getting larger as of this evening. No longer individual bumps , more like wheals. I have used a pen to draw around the perimeter to monitor progress. Also, 3/10/21, experienced left sided jaw pain. No hx of TMJ disorder, ever! Unable to open mouth fully and become concerning. Fortunately, it resolved in less than 24 hrs.

Swollen tongue, red,splotchy puffy cheeks, giggly lips , mild nausea Sought medical attention- given epinephrine and prednisone and Benadryl

Approx. 20 hours after 2nd dose: Woke up feeling nausea, fatigued, fever, chills. After 1 episode of nausea, I started experiencing more than mild muscle cramps. Could not lay on either side. Darkened room because light/ sound was adding to already severe headache. Used cold washcloths on forehead. Was having trouble trying to walk, use restroom, frequent urination but could only sip water. Over the next 24 hours...just slept and used bathroom. Severe muscle cramps, chills, fever, headaches. Called my Dr.'s nurse-she advised to hydrate and to go to ER if needed. 24 hours later, I realized I would be okay...but took me another 24-36 hours to feel 80% normal. Lost 8LBs. during 48 hours. Experienced extreme dreams/delusions.

After the second vaccine on Feb 17, 2021, she was febrile for four days. However since then, she is experiencing headaches, nausea, and taste and smell disorders. Have you seen other cases of this over three weeks post second vaccine?

12 minutes after shot, lip starting to go a little numb cheek bone area starting to go a little numb left eye getting droopy. Face is flushed. Half hour after shot started getting a little nauseated.

Patient developed lip swelling post vaccination. Benadryl given on scene. Symptoms rapidly resolved. Did not go to hospital at the time. Next day called a telemedicine service for recurrence of symptoms, called and urgent care too. Advised to go to ER. Went to ER and received IV bendaryl. Discharged to home.

my lips felt dry and my throat was scratchy. The throat resolved within 24H, but my lips swelled. (Not huge, not like angioedema). But, it's been a month and they are still large and puffy. The skin above and below my lips is numb. Symptoms are worse in the cold (I have trouble speaking or drinking through a straw).

Patient awoke the day after the vaccine and noticed her left ear swollen and trouble moving parts of her face, the symptoms progressed over the course of the next few days until she was unable to move the entirety of the left side of her face and head. At this moment in the fear of a stroke she went to a local Emergency Department where she was given the diagnosis of Bell's Palsy secondary to the vaccine

Quite suddenly, rash, large hard area around injection site, itch. No pain. Not excited over it. Just waiting to see what happens next.

tongue swelling; fingers cramping up; flu like symptoms; white dot big as dime solid white; swelling in her arm; arm red; pain all the way down to arm; A spontaneous report was received from a consumer concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling, white dot big as dime solid white (papule), fingers cramping up (muscle spasms), flu like symptoms, vaccination site swelling, vaccination site erythema and vaccination site pain. The patient's medical history was not provided. Concomitant medications reported were levothyroxine, lisinopril , premarin 0.625, omeprazole, valacyclovir, d-amphetamine salt. On 05-Mar-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced swelling in her arm, . arm red, white dot big as dime solid white, tongue swelling, pain all the way down to arm , fingers cramping up, flu like symptoms. On 07-Mar-2021 the patient reported to the hospital, was evaluated by a physician who took blood and advised her to go home and take diphenhydramine. Treatment details included tylenol and benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, tongue swelling,white dot big as dime solid white,fingers cramping up, flu like symptoms, vaccination site swelling, vaccination site erythema and vaccination site pain, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Shortly after vaccination, patient developed hives and tongue swelling. EMS at the site treated with 50mg benadryl, 125mg solu-medrol, and patient was transported to ER.

Right ear ache, outside back ear sore to touch, ache went down neck and slightly swollen. began at 11:30 a.m Got home from work at 4:00 took 2 Tylenol and slept for an hour and a half and pain was starting to ease. Pain gone 8:00 p.m

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

102 Fever, Hives, muscle aches, joint pain, dizziness, lethargy, nausea, chills, diarrhea, eye pain, headache, neck/back pain, swollen at injection site and armpit, loss of bladder control 1st night, excessive urination.

Moderna COVID-19 Vaccine EUA ---3/16/21 and 3/17/21 just felt fatigue. On the morning of 3/18/21, my mouth, felt like cotton mouth. My teeth felt tender and sore. My lips and tongue felt really strange. It felt like I had dental work done and the numbing was starting to wear off. Tingling, and very sensitive to food texture (never lost sense of taste). When I ate, the food texture all tasted like mush. This went on for several days, and just today (3/21/21), I am beginning to feel more normal (just slight symptoms).

Woke up in the morning and my tinnitus was a lot louder than usual. (I also had that symptom when I had Covid in late October.) I felt really tired even though I just woke up. Also tired throughout the day. I was cold all day. Had a fever. I was sore/achy on sides of my body from under my arms to my waist. Sore arm at injection site. I took Tylenol in the early evening and that made me start feeling better.

Dose 1 - Loss of smell by that evening. Rash about the size of a tennis ball where injection was given. Regained smell the evening of 2-21-2021. Went to Dr. 2-22-2021. Tested positive for COVID19. Was given a Z pack and Ivermectin. Also put on Vitamin D, C, Multi-Vitamin, Quercertin and Green Tea. Dose 2 - 03-19-2021 Rash about the size of a tennis ball w/ hard lump and fever and still that way today. Was told to apply ice pack, hydrocortizone cream, and take Tylenol and Benedryl. Was in bed for 2 days (03-20-21 & 03-21-21) with fatigue, aches, chills, fever, headache, dizziness, nausea

I woke up twice during the night of March 20/21 and experienced severe vertigo/dizziness. I could not walk without holding onto something. The vertigo has persisted but has lessened since Saturday night/Sunday morning. My right ear also seems plugged and there is ringing in my left ear. I started feeling slightly nauseous on March 22.

The day after injection started to have right eye pain, similar to being bumped in the eye. One week later the eye has a stye. It is red with a bump under the lid. Confirmed diagnosis on 3/22/21 with health care professional: Hordeolum externum of right upper eyelid.

Within 20 min of receiving the injection, my upper lip was tingling and swelling slightly. Within an hour, the left side of my face was numb back to behind my left ear. My eardrum was tingling also. I had slight swelling on my face and tightness of my cheek muscle. I never felt any tingling or numbness in my throat or tongue. It took about 36 hours for it to completely go away.

My mouth felt like it was tingling and my upper lip swelled a bit. I did not seek treatment anywhere. Observed for any changes and would have sought treatment if it had advanced. Lasted approx. 2 hours. Lip returned to normal size. Would not have submitted this report if I I was not due for second shot on April 16th. Concerned because have had allergic reactions to several medication in past NSAID very serious reaction and Lisinopril severe rash. Question - should I pre-medicate with benadryl prior to second injection?

Fever 101, body aches, chills, headache, red swollen eyes, arm at site began to swell, turn hot and itch. Rash traveled down and around my arm for abut 8 inches. The rash started on 3/21.

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

headache, fatigue, day one and to present body aches bad taste in mouth day 2 to present arm pain day one to day 3

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

Severe muscle weakness, chills, burning eyes, dark orange urine, kidney pain, migraine headache, nausea, chest heaviness but not short of breathe. 27 hours in bed except to go to the bathroom, weakness so severe it hurt my whole body to turn on my side.

I got the chills, layed down and tried to warm up. My left arm is in pain. fell asleep briefly, woke up to extreme stabbing pains in the right temple of my head. I barely could walk to the bathroom and I layed on the floor because of the pain in my head. I can feel the pulse of my heartbeat in my head. I had intense nausea. I managed to get to bed. I drove to work the next day but my boss sent me home because I was the same. My eyes feel like they are flickering and are in pain. I feel like its a nerve in my eyes that are messing with me and are very painful. I am afraid to take the second shot.

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

First dose of Moderna Vaccine was received at approximately 11:30 a.m. on 3/18/2021. When I woke up on 3/19/2021 about 5 a.m., my lips were swollen and I had blisters inside my mouth. I took Benadryl. As of 3/24/2021, I still have blisters, but they are better. Lips are not swollen as bad. I have never had cold sores or fever blisters.

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.

Upon waking on 3/17/21 at 6:00 a.m. (the day after my second dose of the Moderna Covid-19 vaccine). I experienced floaters and blurred vision in my left eye. There was one larger black spot in my field of vision larger than the floaters. The large black spot has gone away in my left eye on the same day it occurred. The blurred vision and floaters continue (over a week later) in my left eye.

BP fell with severe vomiting Fatigue, and inability to see because of spots in my eyes. Had to crawl to bathroom unable to walk

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.

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.

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.

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,

Shot @ 250pm; couldn't even Tell she'd poked me! Mentioned Dr reiterating advice re tylenol and ibuprofen; that I take Both, ibuprofen due @ 3pm. 2 nurses said should be okay since I'm used to it. Advice is re profilactic use against side effects. ~ Left @ 305p (15min watch for allergic reaction) Left grocery @ 345pm, headed north to pick up dinner Almost immediately, it felt like I'd been hit in the left eye with a baseball bat (cheekbone & eye socket); REALLY Intense 'migraine', left side only. Took back road to dinner, finally subsided to an odd ache. Called clinic as soon as I parked. Checked w nurse - it IS a side effect. "Don't take any ibuprofen." I'd taken mine @ 305pm with my Gaba. Don't take any more. Tylenol is okay. Recording this, it is now 5:55pm, and ache has migrated to center forehead; also experiencing facial numbness, left side & lips. ARGH! 607pm, now into the right side of forehead, somewhat into the temple. Oh! At the left lower back of the skull, near lymph node. Man! This thing just keeps bouncing around! 620pm back at the left cheekbone & eye socket Oh! I Did take my temp shortly after getting home, 97.6° - my norm ?~? Slept well, thru the night. Left arm pain when I rolled, so Nope. Called clinic to ask about advil, Can resume taking as usual. Per nurse. Fri evening, sat w chin in hand; pain in left jawbone along the bottom. That passed/eased at least. Then, have 'pain to touch' at base of skull. (Was rubbing neck) ~ as of Wed 3.31, haven't experienced any more 'vac migraines' for a while. Did have some (approx 5) intermittently for abt two weeks after. ~ also experienced extreme fatigue/exhaustion 1st 60 - 72 hours before back to my norm.

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?

DAY2: POST SHOT PATIENT DEVELOPED 104 FEVER AND HAD SYNCOPAL EPISODE, DAY3: DEVELOPED VESICULAR SORES IN NOSE DAY4: EXTREME ARM PAIN AND PAIN TO RIGHT SIDE OF CHEST WITH DEEP INSPIRATION AND COUGH DAY5: RIGHT SHARP EAR PAIN ALL DAYS EXTREME NAUSA AND GENERALIZED WEAKNESS, SEEN IN CLINIC ON DAY 7 POST SHOT

About the 18th of March (one week after vaccination) sore gums and sores inside my mouth began to appear. They gradually became worse until my whole mouth was sore (difficult to eat and swallow). I rinsed often with mouthwash and by Tuesday the 21st it was improving and better by Wednesday the 22nd.

About an hour after vaccine, began to notice some swelling in my face and lips. It was unpleasant, but never felt threatening. Finally subsided about 5 hours after vaccine. I was also had some soreness at the injection site, was extremely fatigued and began running fever (highest was 99.7--my normal temperature runs around 97.8) around 4 hours after vaccine. I drank a lot of Gatorade Zero with electrolytes and then went to bed. By the next morning, I felt fine.

Following 2nd Moderna vaccine on 3/30/2021, she developed swelling of her gum and tissue under her tongue within an hour of her injection. Her tongue did not swell. She and a family member looked in her mouth. The gums were inflamed, swollen, and painful. Under her tongue she had raised bumps, some with fluid (blisters) and 2 grey patches. On 3/31/2021 mouth remained swollen and painful, she was fatigued, and dev fever, chills, headache and muscle aches. She had a knee that felt inflamed and painful. She took Tylenol twice. At the time of this report her gums are somewhat better in some areas, but not in other areas. She reports difficulty eating due to the discomfort. Under her tongue remains unchanged.

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.

Patient said symptoms started about 10 pm the night of the first dose, and she "felt fine" around noon the next day. In addition to fever, HA, aches, and chills, she also experienced a dry mouth.

within 30 minutes of shot: dizziness, fast heart beat, hand shaking lasted 30-45 minutes, chills, lasted 30 hours. in 24 hours: headache, congestion, left side of face--gums/teeth starting hurting, teeth got very sensitive. sore left arm. on going side effects as of March 28. Have lessened a little bit. as of March 30. side effects except teeth sensitivity has subsided.

Started to feel itchy next day followed by swollen around eyes/ cheeks and upper face. History of dermal fillers in the face. Inflammatory response limited to face.

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.

30 mins after getting shot in my left arm, my left side of my tongue went numb and I tasted a bitter flavor in the back of my mouth also left hand tingled and the left side of my face felt flushed, it lasted for a hour I did take some cold and flu over the counter med and felt better with in 20 mins. but scarey

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.

Constant tinnitus which started March 24 and has not gone away. At times it is extremely loud and hard to focus on other things other times low buzz/hissing lie noise. Attempting to get appt with ENT but currently have appt next week with primary care Dr.

Stroke symptoms, double vision, numbness of lips, tongue , mouth and gums. General weekness, shaking and confusion. Symptoms began receding after 20 minutes. As EMS arived

Patient states she was hospitalized the next day due to her tongue swelling, trouble swallowing, edema (swelling in ankles and legs)

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 bad headache and eye socket pain 1 hour after 2nd moderna -- a few hours later felt weak and diff walking / slower walking - woke next AM and could not stand or walk without assistance

Had vaccine at noon on 4/5. Worst headache I have ever had in my life except for once when I had the flu with a fever 21 years ago- headache began in middle of night on 4/6. I had sensitivity to light ( never had that before) slept intermittently for about 36 hours, took no pain meds because pharmacist said to try not to, if I had a reaction. I did not take zolpidem tartrate second night ( I took 1/2 a pill the first night before I really knew I was having a reaction) Drank lots of water as supposed to keep hydrated. Had significant chills, but no fever, for first 24 hours after symptoms began. Was confined to bed for a day and a half. Headache had improved by morning of 4/7, and resolved by evening of 4/7/21.

The day after my second dose of Moderna COVID-19 vaccine, I had sudden onset tinnitus in both ears. It persists one week later. Never louder, never softer. Always there. No OTC medicine helps. The noise level is moderate (6 out of 10). I also have stuffy sinuses since the vaccination, but relieving sinus pressure using cold medicine does not stop the tinnitus. My blood pressure is now measuring "low hypertension," whereas before it was reliably normal. The soonest an ENT doctor can see me is in 3 weeks. I'm very concerned about possible hearing loss, but at this time, I would guess any hearing loss is mild.

Ringing in ears off and on for several days since the vaccine. Began the afternoon after receiving vaccine. It becomes worse in the evenings.

Within five minutes, the muscle spasms began in my neck and left upper trap. It spread over the day to both sides of my neck, arms, upper and lower traps, thighs. I have had continuous fatigue. The swelling of arms, hands, legs, abdominal cramps, nausea, diarrhea, bone on bone joint tightness and clicking in my fingers, was all worst the first 4-5 days. In the second 4-5 days, my face and tongue started swelling more. The swelling had gone down in my legs and arms, but it seems to be coming back. The elevated temperature (over 99 daily since April 3rd), blurry vision, and migraines kicked in. The fatigue is persistent. A mild headache is persistent, if I don't have a migraine. I am still sick.

On the 7th day after receiving the vaccination I experienced a sudden onset of severe Vertigo. I could not walk or open my eyes due to the sensation of the room tilting and moving which resulted in severe uncontrollable vomiting. The severe vertigo lasted 24 hours. However, I continue to have intermittent bouts of dizzyness, nausea and loss of hearing that occurs 10-15 times a day lasting 5-10 minutes. Allthogh I am able to walk about now, I still can not drive due to safety concerns. My biggest fear, of course being if this is going to be permenant or if it will resolve. Item 21 can not be addressed at this time as it is still unresolved.

Day 1 - energy drain tired 4 hours post injection Day 2 - Swollen and tender Axillary Lymph Nodes both arms, tired Day 3 and 4 and 5- Tired, nausea, chills and sweats, body aches, deep bone pain and stiffness, excessive thirst Day 5 - increasing neck and shoulder pain, heat in shoulders, inflammatory response in old injury sites Day 6 - deep bone pain, soaking sweats, exhaustion, sharp and tightening neck pain and headache Day 7 - so far so good

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

Audio disturbance: rushing sound in ears. Later, audio hallucination (banging in left ear). Both incidents lasted only a few seconds

Tinnitus- loud ringing in ears, especially left ear. Began within 24 hours of 2nd Moderna vaccine and has increased in noise level. Sounds like cicadas. Immediately after vaccine I had pressure/pain in both jaws, and my ears felt clogged. The jaw pain was replaced by the ears ringing.

After 20 minutes patient felt blurriness and could not move her body for a few seconds , after sitting and drinking some water, patient felt much better and was able to walk

As I was driving away from vac site, I became increasingly disoriented and could not navigate a very easy route home which should take about 40minutes. Suddenly unable to read freeway signs or judge distances, or speed on the freeway. Light began to hurt my eyes, headache pounded & became extremely nauseous and tired. Got off fwy, because I didn't feel safe, planned to take surface streets, but became so disoriented (on a route I know well) it took about 1 1/2 hours to get to a familiar location that should have taken 20 mins. K ept making wrong turns even when using maps. Finally, had to call my husband to pick me up. Couldn't make it home & I use this route often and have been for over 20 years. Once home, extremely tired for about 3 days. As the weeks went by my disorientation did not completely go back to normal. I still am impaired (compared to my normal functioning). Unable to juggle a few items in my head as I normally do. My brain feels foggy & I am having memory issues with things that are routine. When I went to have my hair colored on 2/26/21 my hair looked the same as always afterward, but when I returned 4/1/21, I had lost about 1/3 of my hair -- it began falling out each time I brushed it or washed. It seems to have stopped falling out for now.

My body just felt bad and did not feel well for 10 days, and anxiety was incipient , with the second shot four days later it felt like an anxiety attack on steroids, and left me with annoying tinnitus in left ear. Tinnitus and anxiety continues , and not feeling well, painful rash on arm that received the shot on second dose, which cleared up, and painful headache for 24 hrs, various aches and pains

Right sided tingling, right sided weakness, flashes of light of the left eye, interrupted sleep, right pinky turned purple.

Woke up on April 7th with a mild headache. As the day progressed it got worse. Friday April 9th, went to Health Care Provider, treated me for a sinus infection. April 15th, went back & she ordered a cat scan on my brain & everything was good. Today still have headache, it?s not subsiding at all. I was even given medicine for migraines. Not helping at all. Health Care Provider suggested I file a report.

Patient was given COVID-19 vaccine and was in 15 mins observation period. Patient complaint of throat numbing, tongue was swelling and left eye was twitching. We called the rapid respond team of our clinic and Dr and his team did assessment. Patient was observed for 30 more minutes. Patient was authorized to go home. It turned out that it was a minor allergic reaction and patient is to report to emergency room if she doesn't get better when she gets home.

FRIDAY: Unusual tiredness began approximately 10 hours after injection (at bedtime). Woke up in middle of night with mild headache, feeling of dehydration and having chills. SATURDAY: Throughout the following day, mild headache off and on, fever of up to 102* and extreme sleepiness continued. I could stay awake no more than an hour without an overwhelming need to sleep. Virtually no appetite but I was thirsty. I took Tylenol a couple of times but otherwise let things run their course. By the end of the day, a small appetite returned. Chills during the 2nd night were there, but lessened. SUNDAY: The following morning (approx 44 hours after injection), I felt better, less exhausted but continued to have a low grade fever (100*) for a few more hours. I did not nap the entire day but was extremely low on energy and had to rest several times. Splotchy rash developed on upper arm of the injected arm (right). MONDAY: Tiredness continued into the next day but no longer had a fever. Rash worsened but not to the degree of the rash that developed on the left arm (1st injection). Rash resolved after a couple of days. Somewhat itchy.

Shortly after my first dose of Moderna on 3/13, I experienced a constant ringing in both ears, very noticeable during the daytime and when trying to sleep. I also experienced some dizziness / mild vertigo that still comes and goes. After my second dose on 4/13, the ringing has become much louder, so I did research and learned this is a common side effect. I also have pulsating / throbbing in both ears. I had no other side effects with dose #1, but experienced extreme chills, aches and fever (101.3) for two days following dose #2. Both my husband and son had two doses of the Pfizer vaccine and had none of these side effects (good for them, unlucky for me!).

Severe headache and tinnitus, very cold/couldn't get warm, nausea/diarrhea, felt as though I could not move, extremely swollen and sore armpit glands on same side as injection

I have developed tinnitus that was never present before second vaccine. I have had a hearing test, medication change and have now been scheduled for a test to determine no blockage in my neck on 4/23/2021. My blood pressure is continued to be normal with today?s reading 122/70.

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

Immediately following administration (approx 3:15pm) patient mentioned having a "funny taste in her mouth". She described it as a metallic taste. This persisted for about 7 or 8 minutes. At that time, she stated that the taste went away and she had a headache just over her left eye. At about 15 minutes post-vaccination, the patient said the headache was "mostly better" and that she was ready to leave. I did advise her to take Tylenol to treat the headache if needed.

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

Got the vaccine had shooting pain down the arm, about 10 days after she got ringing in her ears, which started pretty loud. Then she got ear stuffiness, which comes and goes and comes when she's laying down at night and eases up during the day somewhat. She then had pulsating tinnitus, both at the same time. It's very scary, did it do permanent damage and doesn't allow her to sleep. She went to an ENT last week on 4/15/21 and was informed that a few people had come in with the same. He looked in her ears and had no wax in it. Her hearing was impeccable for her age, and did not see anything abnormal. Is going to send her for a carotid artery test in the middle of May. There was not much that he could do for it. She has an audiologist who is a friend and told her that it might subside over time if it was viral tinnitus. The ringing is going down but the stuffiness feeling is still there. She is going to get the 2nd vaccine, but scared that this is going to flare up again.

Left eye infection on 3/19/21,3 internal styes (lower lid); swelling, infection, pain, itching. 3/22/21 trip to urgent care-prescribed Ofloxacin sterile eye drops, both eyes 3x day.3/26/21-2 additional styes developed internal upper lid left eye. 3/27/21 trip to urgent care-prescribed 300 mg Clindamycin 3 x day for 10 days. 3/29/21 follow up with Optometrist. No further prescriptions. Infections mostly clear 4/2/21. 4/15/21-6th stye developed inside lower lid a week after 2nd dose. Treating at home with warm compresses and eye drops.

Since the day after receiving the 2nd dose of Moderna, I have had buzzing in my ears, particularly on the Left side (same side as vaccination).

delerious; Fever; Rash; horrible body aches; Skin on fire; severe headache; pounding a rod into brain; dizzy; lack of concentration; eyes not dilating; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delerious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DELIRIUM (delerious) (seriousness criterion medically significant), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration), MIOSIS (eyes not dilating) and TINNITUS (ringing in ears). At the time of the report, DELIRIUM (delerious), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration) and MIOSIS (eyes not dilating) outcome was unknown and TINNITUS (ringing in ears) had not resolved. This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Right corner of eye appears to have a burst blood vessel causing the inner area of right sclera to be bloodshot.

Lost taste in mouth (3 days) Fever (1 day) Chills (1 day) Severe Fatigue (3 days) body aches and muscle pain (1 day) Pain in arm where injection happened (3 days) Nausea could not eat for (2 days)

My lips became numb, then my tongue and the tip of my nose began to tingle. I took Benadryl about 20 minutes after onset (when I got home), and the tingling stopped within 30 minutes. The numbness wore off after an hour or so. I felt normal by evening. No recurrence. Headaches that night and over the next day.

Patient returned to pharmacy on 04/21/21 to tell us she had a very high fever of 104 after the vaccine, but is better now. She states she has blisters inside her mouth, nose and on her lips that hurt. I advised her to see her doctor and to try and take benadryl but watch for sedation

Fever 101.2, fatigue, general body aches, headache, no appetite and sensitivity to light Remained in bed 4/9/2021, 4/10/2021 and 4/11/2021. I was able to get out of bed on Monday 4/12/2021 and Tuesday 4/13/2021, no longer had a fever but still experienced fatigue and general aches. I was able to resume normal activities Wednesday 4/14/2021.

right eye started burning on 03/20/2021, a few hours later I noticed my mouth was affected and couldnt spit toothpaste, within 48 hours everything on the right side of my face was paralyzed; blurred vision, couldnt smile, chew or blind, no sensation

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.

Excessive thirst with both courses for four days, and no, I am not a diabetic, and no, I was not dehydrated prior. 2nd course, 2nd day, chills to the bone, slept EIGHTEEN HOURS.

Ringing in the ears - lasted approximately 24 hours (I sometimes have tinnitus); briefly lightheadeda couple of times the day of the vaccine

After receiving Moderna dose 2, pt initially with progressive swelling and erythema of the left lateral upper arm overlying the site of injection. On 1/30/21, appox 3 days later, presents to ED with progressive swelling of her left lower lip. No tongue swelling. Denies difficulty breathing/swallowing. No other rashes. VS T 98.4F, P 52, RR 19, BP 109/81, SpO2 97% RA, Weight 176 lb 5.9 oz; CBC & CMP WNL. Administered in ED: Benadryl 50mg IVP, Solu-MEDROL 125mg IVP D/C with new Rx for: Benadryl 25mg - take 1 capsule PO every 6 hours PRN for itching for up to 7 days; Pepcid 20mg - take 1 tablet PO BID x4 days; prednisone 20mg - take 2 tablets PO daily x4 days.

The day after my first vaccine, early morning, I started feeling headachy, fatigued, slight fever. Since then I have felt like I have a low grade flu. It has been 10 weeks now since my first vaccine and I still have headaches, sinus pressure, jaw pain, neck pain, fatigue, general malaise.

Within 5 minutes, I started to feel tingly all over my body, weak then shakey, light headed then anxiety started to appear, couldn't take a deep breath, little dizzy. I was able to walk, so I asked to see a Nurse. I was taken to an area where I was given oxygen and rest. My blood sugar was taken, per my request, it was (BG 160) I had eaten breakfast that morning. I rested with oxygen for about 30 minutes, I felt an improvement, so Nurse asked to stand/walk slow...I did and got just a little dizzy, so I sat with oxygen for about another 20-25 minutes and decided to go home. Nurse checked my oxygen level, she said it was 100% and my heart rate/pulse was 78. I decided with the agreement of the Nurse, that I was was okay to go home and rest. Upon arriving at home, I drank some water and rested. My arm didn't hurt at all, until a few hours later and then for 1 day. I took a nap, when I awoke a had a slight headache, but was feeling much better, not dizzy, light headed and weakness was minimal, as well as shakiness was minimal. Also, a little taste at back of throat/sinus area, like a post nasal drip, kind of like when I go to the dentist. I never did take Benadryl. That strange sensation went away within the day.

A subnormal temperature as low as 96.2 but around 97.4 for the past 10 days, with an occassional temp above 98. I am normally 98.6. A sensation of very sharp prickles ( very fine like stinging nettles) followed by itching. The sensation would last for approximately 15 minutes and then stop. This happened all over my body, not just in the same place all the time. Occasionally there were tiny raised bumps, but they disappeared after a short while. Little tiny bumps in my mouth on the inside of my lips, that look like blisters or tiny pinpricks. I also have had some on my gums. They have remained in some areas but gone away in others. I gone to urgent care to be examined and they cannot tell me what they are.

Covid arm rash appeared suddenly on both elbows and also across face in mask pattern. Also noted the day before that my left eye turned red and then cleared out too....not broken blood vessel. After rash became itchy in various spots and also developed brain fog and mild headache and exaustion, but was fine and active during the day prior to this, also yawning a lot.

First reaction was Moderna Arm ... & then Tinnitis (constant ringing in left ear). Difficulty sleeping w/ ringing 24/7. Ringing is worse when laying down. Continuous ringing in both ears after the 2nd dose.

Fever 101.4 x6 hours Headache Light headed and unsteady Fatigue All over muscle soreness and fatigue Bone pain at elbows Achy eyes Brain fog

Patient received the COVID-19 Vaccine. She reports symptoms of sudden onset headache and dizziness upon walking. Patient stated she has a history of multiple allergies in the past. She also endorsed a "funny taste in my mouth." Patient taken to observation triage area for further assessment. Patient did not appear pale or diaphoretic, breathing with no difficulty, no swelling noted, no rash or itching, no nausea or vomiting. Vitals a follows: 10:40 B/P 131/84 HR 74 O2 98 10:45 B/P 127/77 HR 70 O2 99 10:50 B/P 127/67 HR 72 O2 99 10:55 B/P 126/65 HR 67 O2 99 11:00 B/P 125/75 HR 71 O2 99. Patient also stated that she did not eat. Patient received the COVID-19 Vaccine. She reports symptoms of sudden onset headache and dizziness upon walking. Patient stated she has a history of multiple allergies in the past. She also endorsed a "funny taste in my mouth." Patient taken to observation triage area for further assessment. Patient did not appear pale or diaphoretic, breathing with no difficulty, no swelling noted, no rash or itching, no nausea or vomiting. Vitals a follows: 10:40 B/P 131/84 HR 74 O2 98 10:45 B/P 127/77 HR 70 O2 99 10:50 B/P 127/67 HR 72 O2 99 10:55 B/P 126/65 HR 67 O2 99 11:00 B/P 125/75 HR 71 O2 99. Patient also stated that she did not eat or drink anything prior to coming into clinic for her vaccine. Given a bottle of water and 2 crackers and felt better. Patient ambulated with steady gait in no apparent distress and went home safely.t or drink anything prior to coming into clinic for her vaccine. Given a bottle of water and 2 crackers and felt better. Patient ambulated with steady gait in no apparent distress and went home safely.

My hearing sounded like I was under water and then I started hearing?static? in both ears which has become progressively worse with no relief.

Immediate elevated heart rate 155 resting for 4 hours. Dizziness onset 72 hours later with ear ringing. Now 7 weeks later and vertigo and tinnitus continued. ENT visit and tests show no known cause.

Pt reports feeling a "little shakey" with itching to face/top of head/back of neck and dry mouth. Self administered chlortrimeton, an allergy medication that she usually takes Qday for cat allergies. Within 15 minutes she reported itchy feeling had resolved.

Pt states 1.5 hours after 1st dose of moderna vaccine her ears started to feel muffled and could not hear as well

Notes per administering nurse 4:40 pm Vaccine given in Left arm (deltoid) 4:50 pm Pt says it tastes metallic in mouth 4:55pm States lips "feel numb" 5:00pm Diphenhydramine 50 mg/ml (1 ml) given IM in Right deltoid muscle, BP 141/94, HR 84, no visible signs of respiratory distress, no dizziness (denies), denies having any other symptoms 5:10 pm Says her lips feel less numb now, sitting on chair, talking husband here after she called him via cellphone 5:15 pm BP 138/108, HR 74, still talking, sitting in chair. Husband got her warm tea, drinking. Denies any new issues. Lips still slightly numb, no respiratory distress visible. Denise any respiratory or throat issues. 5:25 BP 164/94, HR 84 5:35 BP 153/80. Calm, talking joking, husband at her side. Husband went to bring car to Vons front door. 5:45 Walked with her and assisted her to her husbands car. Other symptoms subsided. No new symptoms, no respiratory distress .Able to walk to car without difficulty. Encouraged to call 911 if allergy symptoms incrase or reappear again.

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 getting my 2nd dose of Moderna vaccine, I started experiencing ringing in my ears and it's getting louder. I went to see an ENT and he said it's tinnitus.

Client received the 2nd dose of Moderna COVID vaccine lot # 016C21A and expiration date 5/22/21 at 9:27am. Client reports to EMT blurred vision and dizziness. Nurse provided client with a water bottle and took vitals. At 9:36am vitals: blood pressure:167/95 , pulse:80 , and oxygen:97%. Client is sitting up in chair alert and oriented x 4. Client reports her medical history includes diabetes. Client cannot recall oral medication taken for diabetes. Client reports skipping meal this morning. Client denies having any chest pain or headache. At 9:41am vitals: blood pressure:152/82, pulse:75 , and oxygen:97%. Client reports blurriness and dizziness are slightly improved and no other symptoms. Nurse has client place feet up on another chair. At 9:46 am vitals: blood pressure:151/91 , pulse:83, and oxygen: 97%. Client reports dizziness and blurred vision are improving. At 9:51am vitals: blood pressure: 151/85, pulse:78, and oxygen:98%. Client reports feeling 70% better. Provide client with ER precautions and to follow up with her provider in TJ. At 9:56am vitals: blood pressure:157/80, pulse:74, and oxygen:97%. Client reports slight blurriness and dizziness improved. At 10:01am vitals: blood pressure:150/90, pulse:79 , and oxygen:97%. Client alert and oriented and reports symptoms are improving. At 10:06am vitals: blood pressure:160/96 remove chair from feet and retake blood pressure: 150/96, pulse:76, and oxygen:99%. Client reports all symptoms have resolved. Call Supervisor to case consult. Supervisor told Nurse to remind client about ER precautions and to review symptoms of concern such as chest pain, shortness of breath, etc. Nurse review ER precautions again. At 10:13am client went to restroom with EMT. Client walked out with a steady gait at 10:17AM.

Fever, chills, ache, loss of taste for 24 hours. Then a large swollen red rash appeared on 4/27 and has continued to spread from injection site down to elbow. The area is tender to touch and itches, feels like fiberglass is stabbing the affected area.

I am experiencing a metallic taste in my mouth, I am having trouble tasting my food and cannot taste some foods at all.

Swelling of arm from elbow to should, all redness and itchy too, started the next day. Itchy eyes and redness on face 4 hours after vaccine. Next day - Fatigue, severe chills, headache, nausea