Moderna

Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment.

Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.

After 15 minutes discomfort in Chest raising blood pressure also Numbness in lips after 6 hours and after 24 hours. Is it due to vaccine reactions

Caller had vaccine at 2:30 pm today. Vaccine given in left arm. Now states he has quarter size swelling on his left side of his face starting from his left eye to his mouth with redness and itching. Advised to call his PCP. 24 follow up will be done.

PATIENT WOKE UP WITH RIGHT EYE REALLY RED SWOLLEN. ALSO FACE WAS SWOLLEN. TOOK BENADRYL WHICH HELPED TO ALLEVIATE AND BRING DOWN SWOLLEN FACE.

Bleeding gums , painless bruises of back, Started about 10 days after vaccine, has now 02/16/21 stopped

mouth seems to have swollen up, my lips, my tongue feels like sand paper. My mouth feels like I've been gurgling with gasoline. and it is painful to brush teeth. Still have rash from the 1st shot on my shoulder. My lips are chapped.

Flu like without fever. Extreme ache overall; Extreme muscle weakness, joint ache/pain, headache, labored breathing, eyesight slightly blurred, arthritis pain increased.

1st shot flu symptoms exactly 12 hours was feeling better 12 hrs later,,,,,, 2nd shot flu like symptoms 16 hours after shot , day 2 had weird headaches for 5days,had covid in october ,still no taste or smell

New onset Myasthenia gravis. Patient initially presented in the ED on 2/23/2021 with complaint of left facial droop, slurred speech and double vision. His stroke score was 2, for left facial droop. nAChR antibody test this test has come back positive, making it likely that this patients symptoms are due to acute myasthenia gravis. The patient continued to experience double vision and eye weakness associated with trouble swallowing that has continued to worsen and was brought the hospital for re-assessment at the request of his wife.

Moderate pain in joints over 3 week period. Pain in fingers, shoulders, elbows, wrists, Jaws, .... 2nd Moderna shot, one week of joint pain

Modern COVID-19 vaccine Patient collapsed on bathroom floor 20 hours post injection. Could not get up 911 summoned and taken to ER. Given fluids and Tylenol for excess immunologic response. Loss of fluids excessive about 12 hours post injection. Loss of taste 24 hours after injection. Dry cough 48 hours after injection. Long dormant herpes simplex eruption 72 hours injection. Fever continued for 48 hours after injection but controlled with tylenol.

Approximately 8 hrs after the second Moderna vaccination I starting having chills. These continued and increased in intensity along with the onset of fever. I did not have an accurate means of taking my temperature at the time. Over the course of the night on the 17th/18th of February the chills and fever never subsided, even with two doses of Tylenol. The day of the 18th, fever and chills continued along with a feeling of intense malaise. My sternum was very sore and it hurt to breathe as a result of the prolonged shivering. I had no appetite and ate absolutely nothing the day of the 18th. In the early morning hours of the 19th my fever broke as did the chills. However, later in the day, a thermometer was obtained and my fever was 101.4 degrees. When taken at bedtime, it was down the 99 degrees and returned to normal later with no future spikes. On the morning of the 20th when I awoke, I noticed a stinging soreness in my mouth and lip area, followed later in the day with my nostrils and inner nose. This turned out to be an intense outbreak of Herpes. The roof of my mouth, gums, upper surface of my tongue, lips, nostrils, and inner nose ultimately became covered and extremely painful. These lesions were not typical blebs, but were tiny, albeit most painful. After five days they resolved and I have had no further issues. As a possible area to investigate - I had had the second Shingles booster 14 days prior to my first Moderna COVID vaccination. I understand Shingles is also a Herpes family virus.

Patient without prior otologic diagnosis. Presented to clinic with left sudden hearing loss. He received second dose of Moderna vaccine and noted hearing loss 7-10 days after. Currently completed oral steroids and receiving intratympanic steroid injections.

About a week after receiving the second COVID-19 vaccination I noticed that my sense of taste was significantly degraded and I have a slightly metallic taste in my mouth. The condition has continued without any resolution or improvement since its onset

Itching after 30 minutes. Full body hives after 45 minutes. Facial swelling and itching. Racing heartbeat. Took Tylenol at the one hour mark. The hives itching lessened after three hours. The facial swelling and under skin full body itching, extreme tinnitus and racing heart lasted at least 10 days. Two blood pressure readings during the first week confirmed higher blood pressure. Everything was normal after 14 days. My allergist recommended not taking the 2nd Moderna shot. I am now seeking his guidance on getting the J&J shot - hopefully a test on whether I can tolerate its polysorbate.

Severe tinnitus in both ears beginning shortly after first dose and continuing to this date. difficulty sleeping and concentrating with this condition. Prednisone burst has not affected the severity. Able to sleep somewhat with 2 Gabapentin capsules. Blood pressure under control with Ramipril. Tried acupuncture with negative results. I have seen many other reports of this side effect.

1/13 vaccination 1/15 My head, both ears were plugged up like on an airplane. For about a day, they were both clogged; the R ear cleared up .The L ear went down 70% in hearing, tinnitus went up and lasted for several weeks. I talked to the CDC and nurse who sent to minute clinic and prescribed flonase. I started using the flonase; my hearing started to clear up. Hearing test at the clinic and it was back to normal. I did have a HA for 6 weeks after vaccination. After 2nd vaccination, it started to get better 2 weeks after.

Felt a little off the day after I received the first shot. Lost my hearing in my right ear only on March 22, 2021.

on feb 21, 4 days after second dose, developed a chronic persistent headache in setting of no prior history of significant headaches. --headache: no change in vision or blindspots; blurry vision noted (just had an eye exam in early February - slight change in prescription), location frontal top of hairline, continuous - every waking minute since Feb 21, has surges of intensity (never crippling, but always there), seems to be worse in evening, able sleep, appetite has been down -- nothing improves the headache (meds have no effect), no photophobia, no phonophobia, temperature does not impact it

Woke up at approximately 4:00 am with headache and severe dizziness. It was so bad it forced me to go to Emergency Room at the Medical Center 3/7/21. They checked my eyes that were bouncing back and forth, gave me IV, did an EKG. Prescribed Meclizine 25 mg for the dizziness, three times a day. Absolutely no help. Went to Primary Care Physician, and he thought it might be an inner ear infection and gave me a prescription for progressive Steroid Treatment. No help. Got appointment for 4/9/21 with Ear, Nose and Throat specialist. At the same appointment was sent to see, an Audiologist in the same building. The two doctors determined it was not an inner ear problem. I was then advised to get a Cat Scan of my Brain and see my cardiologist. I am now in my 6th week of major dizziness which has affected all aspects of my life.

Very painful arm.........Very weak whole body next day......had to urinate 4 times at night. (usually I only go once) vision weakened for 24 hours

Beginning of a blood clot in the middle of the left calf muscle; Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) in a 76-year-old male 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 COPD and Asthma. Concomitant products included FEXOFENADINE for Allergy, ALBUTEROL SULFATE for Asthma, PARACETAMOL (TYLENOL) for Migraine, TIZANIDINE, ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM CHLORIDE, VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], MINERALS NOS, COLECALCIFEROL (VITAMIN D3), GABAPENTIN, PRIMIDONE, RANITIDINE, CLOPIDOGREL, BUTALBITAL, CAFFEINE, MELATONIN, TERAZOSIN, ZINC, FINASTERIDE, MONTELUKAST, LUBIPROSTONE (AMITIZA), TAMSULOSIN, SIMVASTATIN, ATENOLOL, CHLORTALIDONE, PANTOPRAZOLE, MIRABEGRON (MYRBETRIQ), POLYETHYLENE GLYCOL [MACROGOL], FENOFIBRATE, SODIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MILK OF MAGNESIA), SULFADIAZINE SILVER (SILVER SULFADIAZINE) and FLUTICASONE for an unknown indication. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) (seriousness criterion medically significant), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea). At the time of the report, THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient normally stays with diarrhea because takes double of the normal amount of the polyethylene glycol daily, takes 17 grams twice a day. And there is the beginning of a blood clot in the middle of the left calf muscle which may be related to his COPD, but he had to see a doctor about it. 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. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-163528 (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. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

about 3 weeks ago, the patient experienced a swollen optic nerve that continues as off 7-10-21. loss of vision. Also 3 days ago, he developed a whole body rash

Upper lip, left cheek, part of right cheek swelled up. We have pictures with times pictures were taken from different angles. Ice was applied and generic Benadryl was given, 2 tables. Swelling started at 5 pm, continued to increase until approx 8:30 pm. Upon waking face was still swollen the next day. Swelling started to decrease noticeably approximately noon on the 9th. By 7pm on the 9th most swelling had decreased, except for left lower cheek and upper lip still had noticeable swelling. This report is being filled out at 7:10pmon January 9, 2021.

Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.

loss of vision in Rt eye for 15 minutes Narrative: When pt presented to COVID VACCINE CLINIC for 2nd dose he reported that a few days after his 1st dose (2 or 3 days later- he was not sure), he experienced loss of vision in his right eye lasting 15 minutes which returned to normal ever since then so he attributed it to the vaccine. Information was forwarded to pt's Primary Care Provider to determine if further medical evaluation recommended.

Hearing loss in left ear; A spontaneous report was received from a 77-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing loss in the left ear. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient started to experience hearing loss in the left ear. Tinny sound in left ear. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, hearing loss in the left ear, was unknown.; Reporter's Comments: This case concerns a 77 year-old, male patient, who experienced event of hearing loss in the left ear . The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

TODAY (7/10/2021 - VERY DIZZY FOR ALL DAYS AFTER SHOT, URINE BLOCKAGE, BEING SEEN ALSO BY DR , C FOR BLADDER CANCER, TREATMENT, CYTOLOGY, NURSE WEEKLY, CATHETER TREATMENT 9 WEEKS. TODAY 7/10/2021 AFTERNOON BECAME VERY DEPRESSED, SCARY, DRY MOUTH, SOME KIND OF 'HIGH SPEED HUMMING IN MY HEAD AFTER VACC, BALANCE PROBLEMS BUT A LITTLE UPLIFTED AFTER 2ND VACC, INSOMNIA, EVEN WITH OTC SLEEP AIDS, SUDDENLY, AROUND 7:00 PM PACIFIC, DEPRESSION 'FELL OFF' THANK GOD. VERY SELF-RELIANT, STRONG INDIVIDUA, NON-RELIGIOUS, EDUCATED, BA LITURATURE, AA COMPUTERS - PROFESSION NOW RETIRED

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

I had the shot late afternoon on Saturday and woke up Sunday morning with a major ringing and I would guess 90% loss of hearing in my left ear, to day is Friday and I still am unable to hear anything in my left ear I saw my Docter on Monday and she indicated my ear was a little swollen and gave me a prescription for Methylprednisolone 4 MG and after two days on it I still am unable to hear anything in the left ear

Reported via Nurse Triage / PCP: Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting. States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night. Symptoms worsened today and patient became weak and fainted. Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head. Is awake and alert now, but still weak and only able to take 1 or 2 steps. No chest pain or breathing difficulty and no fever. Feeling very nauseous. Caller requesting prescription for zofran. Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER. From Emergency Department: Patient presenting with chief complaint of syncopal episode which was witnessed by his wife. He reported the got dizzy and lightheaded and then passed out while seated. The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state. He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence. He has not been feeling well ever since receiving his 2nd COVID-19 vaccine. By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids. His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago. Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated. I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient. With negative testing and resolution of his symptoms he is stable for discharge home. Close return precautions were given.

Patient states that a day after having the vaccine, he developed severe stiffness in his hips and shoulders, muscle aches, had a headache on and off, chills, felt tired, had night sweats, lost his appetite, and taste was off. There symptoms lasted 10-12 days. He was tested for Covid 19 on 2/28 with an antigen test and was negative and tested again on 3/2 with a PCR and was negative . He is starting to feel better now. Called his physician who felt that these symptoms were due to the vaccine, encouraged him to go ahead and get second dose.

I developed serious hives all over my body, my throat closed up and my tongue swelled up. We called in 911 and the paramedics gave me benadryl and prednisone.

He received the vaccine and after 2 hours he went home and was paralyzed from the waist down. He tried to stand up and then he passed out on the floor for about 10-15 minutes. He went to sleep and woke up around 5 hours later. He then tried it again and urinated on himself and he fell down on the floor, passed out without getting up until the morning. He did call his doctor who was not available, spoke to the nurse and advised to go to the hospital. He is weak and cannot drive so he did not go to the hospital. He slept the rest of that day and the following day. Then when he saw his doctor about 2 days ago, he described his reaction and told to report the reaction and that he would report it himself. He was advised not to take the 2nd vaccination. He is no longer having the heavy reaction, his muscles are aching and his vision is blurred, especially on his back and the shoulder. His doctor did do blood work at the office visit.

Moderna COVID-19 Vaccine Around 8 hours after the shot, my left shoulder started to hur, when I raised my arm. Over the next few hours I grew more tired than usual with a very low-level, generalized ache. I went to sleep at 11. I woke up at 2 in quite a bit of generalized pain, left shoulder so painful I could not lie on my left side, unable to get comfortable in any position, feeling worse and worse. At 2:30 I got up, which immediately made me feel a bit better. I took an acetominophen, a half codeine acetominophen #3, and around 5 ml promethazine/codeine syrup. At around 4:00 I had some cheese and bread. At around 4:30 I was able to go back to sleep. I got up at 8:30, still achy/hurting, but distinctly better. I am writing this at 11 a.m. One other thing to note: after the shot I seemed to be having a very odd, mild allergic reaction intermittently, when I ate some foods that I eat every day. Mostly it was a case of my hard palate itching.

Severe Chills Fever Full body ache - joints/muscles Lost Balance - fell twice Incoherent Confusion ulcers in mouth and on tongue Swollen lips no strength - could not stand up on my own dehydration

On or about 06 March I began to experience slight dizziness, and noticed that SOME things I was seeing were apparently moving. A neighbor is experiencing very SIMILAR symptoms. He is also 77 years old, and had his MODERNA booster shot about a week or so before I had mine, and we chatted this morning, so I concluded that our symptoms APPEAR to be related to the MODERNA booster.

He had the injection, had the sore arm and approximately 3 hours after the vaccination he began to experience severe chest pain across his entire chest and into his jaw, which was exacerbated upon taking a deep breath. He called his cardiologist who advised him to go to the ER. He was worked up, subsequently admitted from 2/8/21 to 2/11/21, a lot was ruled out but no specific diagnosis made at that time. They did note some pleural effusion and pericardial effusion at that time. Upon discharge on 2/11/21, starting Thursday evening he continued to have pain in the chest, but not as severe as when he entered into the hospital. Every evening including last night has began with severe night sweats, low grade fever and the chest pains have continued. Went to see his PCP, Cardiologist and his Electrophysiologist several days later the following after discharge, he does have a pacemaker, and was told by all three of them that he has pericarditis and that the reaction could have been related to the vaccination. It seemed more than coincidental that the symptoms did not appear until 3 hours after the vaccine. Was put on Colchicine to treat the pericarditis and then received a 2nd opinion and has reinstituted the colchicine. His low grade fever has finally dissipated. During the day he feels okay, but still continues with the chest pains and the night sweats. His hemoglobin dropped in the hospital possibly related to the heparin and then put on Eliquis postop, and now discontinued, and received an iron infusion to boost his hemoglobin. He is scheduled for another iron infusion this Wednesday. He went to see GI physician and feels that he may have a bleed due to the infusion. He has had an anastomosis due to Crohn's disease and feels that's where the bleed may have been coming from as he did have an ulceration at last colonoscopy. He did have atrial flutter due this and was advised to have an ablation, and trying to reduce the pericarditis and FU later with other heart related problems.

blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased). The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride. On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient felt kind of sleepy. On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site. On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90. He said his normal blood pressure was 20/70. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event of blood pressure was high at 160/90 was not resolved at the time of this report. The outcome of left eye blood covered inside, kind of sleepy, itching around injection site, and injection site reddish and oval shaped was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

At this point I am going to give you an account of my past 14 months health and how I know it is related to the covid virus. i am sure i have had long covid from december 2019 or january 2020 to the present based on symptoms i incurred on these dates. On my first night I ended up vomiting my guts out at 2:00 in the am. The following 2 weeks I had constant diarrhea. At the end of those 2 weeks, i ended up in emergency room. And this all happening when i haven't' vomited in over 30 years. vital signs and blood work were good at the hospital and the drs were confused as to why i felt so bad. i returned home the next day where our permanent home is, and 3 months later the covid thing surfaced. at first being thought of as a respiratory disease. then in the past months it is surfacing that it may now be considered a gastrointestinal disease that progresses to a respiratory disease. after checking the five main symptoms of long covid i discovered that i have at least 3 of the 5 common symptoms for this. Those being extreme fatigue, joint pain, and cough. In addition to the long covid symptoms, I have encountered tasting issues on and off again. I have had many discussions with my primary care doctor, and no results or conclusive information came from my inquiries. Then on feb 12, 2021 I got my first moderna shot. About 2-3 weeks later I encountered a sharp pain in a muscle in my neck left side. Shortly thereafter I got very light headed. Then another week later while driving a motor home, I encountered a frightening experience with my eyes, and the neck pain and soreness was still there. My vision was very blurred and I was seeing double vision at different angles. I ended up at the medical center and was admitted for 4 days. Before I was admitted, I saw a local ophthalmologist here and he diagnosed me with a condition known as ?edema in optic nerve, inferior, consistent with optic nephropathy?. The symptom I had to get me to the doctor was I was losing eyesight in my left eye. After hd steroid treatment for 4 days, and a plethora of tests, including spinal tap, multiple mri?s, and probably over 20 blood tests (11 at one draw), I was released 3-18-2021 and still can?t see above the equator line of my left eye. And I also am extremely sensitive to light. I also have sensitivity inside my eye as best described as a soreness, especially when I try to look upwards. I have a follow up appt with the ophthalmologists that I first saw that advised me to get to the hospital. And that is on mar 26th 2021. to mention another point of interest, my granddaughters boyfriends mother is a charge nurse at the emergency ward at the hospital, and she has said that they also have recently encountered emergency patients, who have recently received moderna, and are also having issues with eye problems. What problems in particular, I haven?t a clue at this time. This is at the very least, extremely alarming to me, and I have no idea whether I may completely lose all function of my left eye., or not. But I adamantly feel this should be investigated by the cdc and any and all other agencies that should be involved. I would be willing to have further discussions via phone or whatever to help you out with an investigation.

I lost vision in my right eye. The Doctor tested my eye and told me I had a eye stroke. He said he did not think it was related to the vaccine.

Tinnitus in both ears 5 minutes after administration of 2nd Moderna injection. Lasted from 1:50 pm 'tll bed time. Woke up with no tinnitus.

On the evening after the vaccine was given, the patient stated that his right leg started to itch excessively, this was alleviated with cortisone cream. On Wednesday morning, both of his hands began to itch and that's when he called his doctor to report the issue. On Tuesday, March 30, the patient reported swelling on his lower right lip.

Infarct; Double vision; Dizziness; A spontaneous report (United States) was received from a consumer concerning a 77-years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an infarct that effected the left thalamus of his brain (Thalamic infarction), double vision (Diplopia) and dizzinesss (Dizziness). The patient's medical history was not provided. Concomitant medication included amlodipine for unknown indication. On 02 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number004M20A) intramuscularly in the left ( non-dominant) arm and on 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number- 001A21A) intramuscularly on the left (non-dominant) arm for prophylaxis of COVID-19 infection. On 17Feb2021, patient states that he had an infarct that effected the left thalamus of his brain. On the same day around 8pm he was driving not far from his house and developed double vision and dizziness. Once reached home he went to bed, upon waking up in the morning symptoms were still present, at this time he went to the emergency room. Patient was hospitalized for 2 nights and 2 days. While hospitalized he had several blood test done and a CAT scan done and also had an MRI on 24Feb2021, report details were not reported. Treatment for the event included are plavix, Catapres, rosuvastatin and doxazosin. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable The events double vision and dizziness were as recovered on 19-feb-2021. The outcome of the event, Infarct was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Loss of hearing; Tinnitus; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced deafness/hearing loss and tinnitus. The patient's medical history, was not provided. Concomitant medications reported included prednisone. On 21 Jan 2021, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in an unknown location for prophylaxis of COVID-19 infection. Approximately two days after vaccination the patient developed hearing loss in his left ear. He consulted doctor but was unable to find the medical reason for his loss of hearing. Also, the patient reported tinnitus. The patient has another appointment with ENT on 06 Apr 2021. The patient is going for a blood work for to confirm for the antibodies after the vaccination. The event deafness was considered as serious and medically significant. The treatment information was not reported. Action taken with mRNA-1273 in response to the events was not reported. The events, loss of hearing and tinnitus was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

30 hours after receiving second dose, experienced high pitched sound in ears. Erroneously thought it was an amber alert on my smart phone. Soon became a constant swooshing sound. Hearing was then impaired so that I could not make out what my wife was saying to me standing right in front of her without hearing aids in my ears. With my hearing aids inserted, I can hear her speaking now but hearing ability has clearly been diminished.

He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb. He called his doctor and she told him to go to the ER, which he did at Hospital. They did a CAT scan of his brain. They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing. They had given him 2 narcotics for anxiety before the scan. He was then transferred to Hospital in . He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM. He was hospitalized for 7 days, and discharged him with instructions on what he is able to do. They started him on new blood pressure medicines for his kidney's. On 3/26/21, lot# 028A21A. He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.

On Tuesday, February 16, I received my 1st Moderna Covid vaccine. On Tuesday, March 16, I received my 2nd Moderna Covid vaccine at 11AM and Eylea shots (one in each eye) at 2PM. I have been receiving Eylea every 3 months for about 3 years in one or both eyes. On Saturday, March 20 at about 11:30AM, while sitting at traffic light, I saw what appeared to be a translucent sheet of plastic cover the left driver's window and the left half of the windshield. This was only visible in the left eye. Twenty seconds later, a yellow opaqueness developed in the left eye, which eventually cleared, but vision was still blurry. When I got home, I called my retinologist. He recommended I go into a dark room and close my eyes. At this time, I had white translucent vision in the lower left quadrant of vision in both eyes. My retinologist sent me to Eye Hospital Emergency Department, which is part of Hospital. After being assess at Eye Emergency Room, I was admitted to Hospital for a right occipital lobe stroke that was confirmed by multiple MRIs of the head. I was told that I was experiencing an ocular migraine (although I had no pain.) I was discharged on Monday, March 22, on Eliquis. As of April 15, all of the yellow opaque and white translucent visions are gone. However my left eye vision remains blurred and hazy. I have since been diagnosed with age-related cataracts in both eyes and a fast-moving cataract in top portion of left lens. I will also report this occurrence to the reporting system.

Patient became light headed and blacked out, did not know where he was. Indicated his right eye was red and swollen.

Patient had COVID infection in 12/2020. Had 1st moderna vaccine 1/31/21. developed new headaches 2/12/21. 2nd dose of moderna COVID vaccine on 2/25/21. on 3/18/21 admitted to the hospital with right sided weakness, expressive aphasia, left gaze preference and right hemineglect found to have a left posterior parietal intracranial hemorrhage with vasogenic edema and extensive venous sinus clot involving the superior sagittal sinus, bilateral transvere sinsu and sigmoid sinus to the level of the jugular veins. He stabilized and was airlifted from one place to another to have hospice care.

Started experiencing a bad headache behind the right eye on Wed 1/27 at night, and on Feb. 7th could not get out of bed, his left shoulder blade became so painful went to the ED Feb. 8. Sent home the next day. The pain was so bad he thought he was having a heart attack. Took NTG did not help. Returned to ED on the 10th - stayed in in hospital for 8 days. Specialists were seen and nothing could help with the pain. Consulted with cancer doctors, and neurologists, doing tests to diagnosis. Dr. gave a nerve block and a week later the pain started to get better a week later on a holiday. Pain still comes and goes. Pain Started getting worse today 4/23/21. Must lie down on right side to get any relief. Has lost 50 pounds is very weak and getting weaker every day. and it is very painful to walk 40 steps to the garage. The TENS unit is not helping with the pain. Getting a spinal test.

77 y.o., male come to ED on 12/24/20, with complaint of SOB and neck swelling. Per ED notes, PE: Large left side neck mass (Erythematous, warm and tender). Possible abscess vs gland infx vs lymphadenitis , which started 4 hours PTA. Pt stated he woke up with the symptoms after having his COVID vaccination yesterday (12/23/20). Patient was given clindamycin in ED, had an anaphylactic reaction (neck, tongue and epiglottis swelling), developed progressive respiratory distress requiring intubation. Noted to develop complete heart block, had 2 cardiac arrests with preceding bradycardia, had transvenous pacer and and tolerated procedure well. He was discharged back to SNF on 1/02/21. Patient noted to have a subclavian DVT on DC, and will start Eliquis.

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

05/14/21 0800---Woke up and right eye vision went from 20/20 to 20/200. Also, near vision was restored to normal from having to wear reading glasses. Couldn't focus well enough to read normal street signs while driving. Monitored over weekend. 05/17/21 1000--Examined by ophthalmologist, suspected retina damage, referred to Retina Specialist STAT. 05/17/21 1300- Examined by Retina specialist-- no damage noted.

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

Pt woke up the following morning blind in right eye. Seen by Opthamologist and is being followed by PCP.

Two weeks after shot, patient reported severe head and neck pain resulting in ER visit. He underwent CAT scan , received pain meds for one week. Patient followed up with primary 5/3-recieved nasal spray. On 5/7, ER visit -head/neck pain-CT scan, xray, medication given-nothing found on tests. On 5/17, ER visit due to left eye lid unable to close and lip twitching-Xray and CAT scan diagnosed with Belle's Palsy, which has since resolved but patient continues to be in pain. Following up with neurologist in future

After 2+ days of pain, soreness, swelling at injection site this abated. Today, 4 days after dose I have cold-like symptoms ... runny nose, watery eyes and slight sore throat. Been outside twice and maintain social distancing, wear mask.

Patient had tingling in lips and fingers. Benadryl 25 mg po given at 1021. 1021: BP 144/74 HR 58 RR 12 O2 sat 100% 1038: BP 144/68 HR 58 RR 15 O2 sat 99% Pt released home.

Intermittent sharp pain in top of skull began yesterday and has moved to intermittent sharp pain in right ear. No treatment. Just waiting to see if it subsides

Late Friday evening, my upper front gums became extremely sensitive, to the point I could not brush my teeth that night. Saturday morning, the sensitivity spread to the back side of my upper teeth and it felt like I had small blisters on the roof of my mouth from drinking too hot a beverage. That evening I developed a deep cough, and I started taking Halls cough drops. Sunday I started taking a cough syrup and chest expecturant. Monday I call my dentist but his office was closed. My temperature was in 100.1 range. On Tuesday I saw my dentist and he was somewhat taken back. My temperature was in the 99.5 range. He mentioned COVID Tongue issues but had no data, and he put me on a fungal mouthwash.

Within one minute of my injection l felt numbness surround my mouth. Three minutes later I felt flushed. I asked my wife if my face was red and she said, ?yes?. I felt somewhat weak and paramedic called the Dr over. We talked and he determined that I had not eaten. Walked me around car, put me in the passenger seat. My wife then drove. I was a little disoriented late but didn?t complain. Since then I have felt like I did in July 2019 when I had coronial virus. Felt bad, 93oxygen, 77 heart beat which is high for me. Friday I did not get out of bed nor went outside. Sat more of the SamE. Woke up at midnight sat and felt better. I?m better but weak.

Patient had a sore arm on the evening of vaccination. The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb. He was transported by ambulance to the ER and admitted. He received IV therapy and acetaminophen. He states he vomited February 4th. An X-ray was performed on his abdomen and he was given a diagnosis of Ileus. The next day, February 5th, he was able to have a BM and eat. After he was able to eat, he was released from the hospital. Shortly after being released from the hospital his lips started breaking out in fever blisters. He estimates he had 50 or so cold sores and his lips were extremely swollen and red. After seeing his regular health care provider, he started a round of Valcyclovir. On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.

1011: After receiving Covid vaccine, pt c/o lips tingling 1013: Benadryl 12.5 mg po given 1021: Benadryl 25 mg po given 1031: Feeling much improved

Moderna Covid-19 Vaccine EUA given February 16, 2021 followed two days later with left eye irritation that has persisted until now (February 21, 2021

The patient received his first dose of the Moderna vaccine. He reports that approximately 2 hours after the injection he began to have right sided tongue swelling. He was assessed in the ED. He had no facial swelling but there was right sided tongue swelling present. Oral airway was patent. Tachycardia was present (HR 116) and BP 197/96. He was given Benadryl, Solu-Medrol, and IV fluids. He was later considered stable and was dicharged 3 hours later.

An in-home fall, dizziness, slurred speech, blurry vision, felt very ill. Did not lose consciousness. Was able to sleep. Day after event was okay. Two days after event, dizziness and loss of balance re-occurred twice during the day -- but did not precipitate a fall.

1/8 vaccination *1-8-1/11 I felt fine 1/12 7am, when i woke up my eye was goopy, sticky, L eye. I could not blink. I noticed more problems later in the day; my mouth wasn't working properly (couldn't eat properly). I tried to call and make appt with PCP. Informed to go smile in front of mirror, my smile was sagging on L side. Informed to call 911. TX to hospital, for possible stroke. Dr. ran tests Dr. audio / visual consult *diagnosed with Bells Palsy 1/21 started to feel better **2/5/2021 2nd vaccination

Saturday 02/27 thru this morning: Low pains in upper left chest / Low pains in middle of left side of back Tuesday 03/02/2021: Headache and pain in left eye / Sitting watching tv on Tuesday 3/2/2021 and almost passed out Have never experienced anything like this before so think it may be vaccine related. Then saw the news report about women getting false positive mammogram results only on the same side they had their vaccine in and that seems to be the case with my events - all on left side.

He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk. On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine. Next day, he started having jaw stiffness and had difficulty in brushing his teeth. He was complaining of blurry vision in both eyes. He denied any double vision. He stated he could not read things which he was able to read 2 days ago. A day before he presented to Hospital, he was not able to walk at all and he required walker. According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center. Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis. pt underwent imaging of CNS, LP and extensive laboratory testing.

3/17/21 ER Triage note: "Pt c/o lips and and facial swelling. No sob, no problems swallowing. Onset this am. Denies pain."

8 days after the Covid 19 Moderna Vaccine #1 was received, I started having adverse symptoms: left side of mouth was numb, face got numb and then left eye would not close completely. After Emergency Room visit, I was given a Cat Scan and MRI and the neurologist diagnosed my condition as Bells Palsy.

First injection resulted in Nose Blead overnight and significant bleeding of the gums the second day resolved by the third day without treatment Second injection likely caused delayed reaction 17 days later, Significant swollen upper lip . Will seek medical attention when EMO opens

Patient went to ER on 3/19/21 for sudden idiopathic hearing loss, right ear. was given prednisone and meclizine and followed up with Dr. on 4/6/21. pt is now receiving ongoing treatment from ENT specialist for steroid injections in ear to try and regain hearing.

Sudden, unilateral sensorineural hearing loss developed 02/28/2021 0630.. Oral prednisone taper, trans-tympanic steroid injection. No improvement in hearing to date.

Patient on 4/18/21 experienced "chicken wire" vision (never before an issue), after vision issues patient said he lost vision on and off for the next 24 hours, accompanied with mental confusion, and was unable to get out of bed on the morning of 4/19/21. Next two days a continued decline in in ability to ambulate and demonstrated neurological deficits on 4/20/21 of impaired vision, cognition and experienced difficulty in moving limbs. Patient was in a car accident on 4/21/21, is now hospitalized, unable to ambulate, and has further neurological deficits with impaired speech, cognition, and movement as well as pneumonia.

Patient stated had some fever and other expected side effects after second shot. 3 days after shot started to have some eye itching and irritation. Was seen 5 days after the eye symptoms started and noted to have corneal dendrites right eye, herpes keratitis. No known previous episodes. Started treatment and will follow up.

Sensorineural hearing loss (sudden hearing loss in right ear) concurrent with labyrinthitis. Late evening preparing for bed on March 3, 2021 experienced a ringing in right ear. Awoke at 3:30 am on March 4 with severe vertigo, no hearing in right ear. Required ED visit to stabilize, MRI and scans ruled out stroke or other brain issues, thus dx as labyrinthitis. Sent home with Meclizine and instruction to visit with primary care as soon as possible. Started 10 trial of oral Prednisone at 60 mg daily on March 12. Signs of vertigo, mostly unsteadiness and having to walk with cane, and some vision impairment and inability to focus continued at least seven weeks, just recently having finally cleared. However, following three intratympanic injections of Prednisone, I still have total hearing loss in the right ear.

Procedures - documented in this encounter Procedure Name Priority Date/Time Associated Diagnosis Comments SARS COV-2 RNA ROUTINE 04/23/2021 9:14 AM EDT Sick 4/26/2021COVID-19 virus infection +1 more Dx Progress Notes Encounter Date: 4/26/2021 ? ? Signed Expand AllCollapse All History of Present Illness: Patient ID: Patient is a 78 y.o. male who presents today, via phone, with the following complaints: Tested April 24 positive Covid 19. He got the first vaccine 3 weeks ago and was supposed to get the second one tomorrow. o When did symptoms start? 4/20/2021 o Fever: ?Yes ?No o Cough: ?Yes ?No "terrible" Productive--phlegm o Shortness of Breath: ?Yes ?No o Chest Tightness:?Yes ?No o Body Aches: ?Yes ?No o Headaches: ?Yes ?No o Sore Throat: ?Yes ?No o Nasal Drainage: ?Yes ?No A lot: Thin and wet o Sinus Pressure: ?Yes ?No o GI Symptoms: ?Yes ?No o Ear Pain/Fullness: ?Yes ?No o Loss of Taste or Smell: ?Yes ?No Both o Medications Taken: Mucinex, Tylenol, Zyrtec o Sick contacts:?Yes ?No Cough is the most bothersome symptom.

Sudden hearing loss; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), MULTIVITAMIN & MINERAL and ANTIOXIDANTS NOS for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported the hearing loss happen on left ear. No treatment information for the event was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

HPI/Subjective: 78 yo with above PMH who presents for new patient evaluation. He was admitted to hospital on 4/3-4/5 for acute episode of dizzines jaw pain found to be hypertensive with elevated troponin. Troponin peaked at 10K. Echo showed no WMAs. Angiogram showed mild distal PLA disease but no other obstructive disease. Cardiac MRI showed a focal area of mid wall LGE consistent with myocarditis. Supportive treatment. Additionally during this admission was found to have small acute L occipital infarcts and tiny infarcts vs artifact in the left thalamus and medulla. Lipid panel and HbA1c unrevealing. ECHO unrevealing. CTA was unrevealing. Patient will D/C with zio patch. Long term blood pressure goal is <130/80. Today, reports feeling OK. No recurrence of the dizziness or jaw pain that brought him into the hospital. No chest pain or pressure or syncope or dyspnea on exertion. No orthopnea, PND or LE edema. Walking 2 miles fast pace without any symptoms. Blood pressures are 130-200s (pre increase in Lisinopril) lower in the morning and worse in the afternoon/evening. Former smoker (quit in '85). Family history - Mom had a AVR in 70s

Sudden inability to move and delirious and hallucinating. Hospital ran numerous tests to find problem without being able to determine.

Tinnitus - increasing in intensity - continuous - moderate to severe. Finished a medal pack 2 days ago - no relief (?worsening). Can't get in to see an ENT specialist for another month. We are snow birds - so I saw another MD (actually his PA) who checked my ears with an otoscope, removed some ear wax. No change in symptoms

Jab 5pm; 11pm brief dizziness, slight headache (rare for me); 5am diarrhea for 3 hours; very tired for two days, on/off headache; next four days woke before dawn to very strong heart palpitations... jumping heart... each time soon following with strong headache; I could at strongest beats see the beats through 'flashes' in my eyes; standing or walking to bathroom felt faint, sometimes wondering if will pass out; always begins while lying down; sleeping on both sides, on back the same; sitting in chair seemed to eventually help; once up and eventually more active palpitations have settled down to a few 'reminders' during the day and evening. Fear going to bed now., eleven days after 2nd Moderna.

I have had crippling tinnitus in both ears 24/7 since the covid shots. Sometimes so loud I cannot hear anything or anyone else.

Pt had vaccination at city site. Waitied 15 min after shot and was cleared to go. Reported to wife that he was very thristy, so they stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and defib, he had ROSC. Was taken to cath lab for intervention (stents) and is now in ICU.

48 hours after vaccination, patient developed right sided facial droop, excessive tearing in right eye, inability to close right eye fully, inability to raise right eyebrow. Patient advised to not take 2nd vaccine dose. He was given oral corticosteroid prescription and advised to use eye lubrication ointment frequently and wear eye patch at night. He was advised to see Ophthalmologist to make sure no injury to cornea since he is unable to fully close eye and potential for eye drying at night when sleeping.

The day after the second Moderna shot I had a fever of 100.8, aching bones throughout my body. Arms ,neck back, legs and feet. Headache and burning and stinging eyes. I called the hospital and they advised that I follow up if there was no improvement. I have very little energy and am resting.

Pt called RN to car. He states he is feeling his eyes swell and some tightness in his chest. SpO2=95%, no wheeze on auscultation. Pt reports history of asthma and allergies. 25mg Benadryl PO given. Symptoms resolved. Pt observed 30 minutes by RN and MD and sent home with emergency precautions. Pt and wife state understanding.

pt states after getting vax on 2/6/2021 he got and itchy feeling around injection site. On 2/7/2021 the pt noticed a 3x3 red, swollen area around injection site and hot to the touch. Pt also had a tender spot under his right eye. Pt states he does not have a temp. Pt has not contacted his PCP yet but will if his symptoms do not subside.

Currently waiting for dental work (crown removal and replacement to treat cavity). 2/18/21 Started to experience toothache (R) which got worse as the day progressed. Tylenol didn't help. Took one tab of Percocet (5-325) to allow me to sleep. 2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm. 2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness, difficulty in standing. Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18: 2/20/21 Felt better when I woke up. Temp normal. Ate breakfast. Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100) 2/22/21 Fully recovered. No lingering issues. Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.

PT PRESENTED TO EMERGENCY ROOM WITH NOTED RASH THAT CAN BE DESCRIBED AS MACULAR, PAPULAR, URTICCARIAL LOCATED ON THE BODY DIFFUSELY. THERE IS ALSO SWELLING, THAT IS MILD, OF THE RIGHT EYE AND LEFT EYE, MINIMAL SWELLING TO BOTH LIPS. PT STATES THE SYMPTOMS BEGAN 2 DAYS AGO AND HE RECENTLY RECEIVED HIS FIRST COVID-19 VACCINE 6 DAYS AGO. PATIENT DISCHARGED WITH THE FOLLOWING PRESCRIPTIONS: PEPCID 20 MG, 1 TABLET ORAL EVERY 12 HOURS FOR 5 DAYS. PREDNISONE 20 MG ORAL TABLET, 2 TABLETS ONCE DAILY FOR 5 DAYS. VISTARIL 50 MG ORAL CAPSULE, TAKE 2 CAPSULES 4 TIMES PER DAY AS NEEDED FOR ITCHING. PT ADVISED TO FOLLOW-UP WITH HIS PCP IN 3-4 DAYS FOR RECHECK OF TODAY'S COMPLAINTS, DO NOT DRIVE WHILE TAKING MEDICATIONS THAT MAY IMPAIR HIM, AND TO RETURN TO THE EMERGENCY ROOM IF SYMPTOMS WORSEN OR PERSIST OR IF THERE ARE ANY QUESTIONS OR CONCERNS THAT ARISE AT HOME.

The next morning, I looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right. called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.

Fever ( temp 100.5 ), chills and body shaking Legs very week, barely walk and legs collapsed twice so went to bed for most on day. Slight metal taste in mouth. Didn't want to eat. Shot on Sun., down for count on Mon.,felt better on Tues and Ok by Wed.

Left eye blurred vision - persistent, worse at the end of the day. Difficulty focusing. Also general overall fatigue.

blurred vision: unable to focus dizziness: blood pressure spike: gradually rising. 185/110 after 90 minues

Five to six hours after the shot, tinnitus began in my right ear. Two days after the shot, I experienced complete hearing loss in my right ear. To date (five days after the shot), I still have complete hearing loss in my right ear.

Got my 2nd Moderna shot on 2/12/21 at 3:00. At about 7:00 pm I developed incredible pain in my right side of my jaw. I could not bite down on not bite down with my teeth and could barely eat (on the left side of my mouth). With some Advil, I was able to sleep (poorly). This lasted for two more days then went away. On 3/14/21 it began to recur but very mildly. This also lasted 2 more days then went away On 3/18/21 I had a dental appointment (not because of this - just routine). The dentist felt my reaction was totally related to the shot and not my teeth (which are in bad shape).

I received the first dose Moderna, and it started off with left ear being plugged up and it wouldn?t clear subsequently I get a strong solid tone, I?ve gotten amplified sounds out of the left ear, If I?m watching tv the voice comes through in a burbling way and at times I?m watching tv straight ahead and the left ear hears the sound from the side and the right ear hears the tv. I have no other known reasons to suspect anything else to have caused the problems, the only thing I can relate the change to is having the two vaccinations. I saw ENT an did a hearing test with significant loss of hearing in left ear and that was followed up with a basil endoscopy and no determination could be made from that. I?m scheduled for a brain scan on March 30th.

3 weeks after his 2nd shot, he was seen in the ER due to drooling, facial spasms, and facial paralysis. After many tests and MRI, they found a mass tumor on his brain, They transferred him to Med Center and they did more testing. On March 13th they preformed surgery to remove the mass tumor. After pathology reports were ran, it came back as a cancerous tumor know as a Glioblastoma or GBM. They were able to remove 80%. The remainder of the tumor was in a part of the brain that they would run the risk of permanent damage or paralysis. He will undergo Chemo and Radiation to treat the 20% left.

Significant hearing problem in left ear / loss of hearing in left ear; Gets loud ringing in the ear; Amplified sounds after taking first dose; A spontaneous report was received from a consumer concerning himself, 79-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced significant hearing problem in left ear, loss of hearing in left ear/deafness unilateral, gets loud ringing in the ear/tinnitus, amplified sounds after taking the first dose of the moderna vaccine/ ear disorder. The patient's medical history was not provided. Concomitant medications reported included acetylsalicylic acid, simvastatin, vitamin D, multivitamin and levothyroxine for product use for unknown indication. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route for prophylaxis of COVID-19 infection. Patient reports that he was scheduled for a brain scan. On 28 Jan 2021, the patient experienced significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable. The outcome of the event(s), significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine was unknown.; 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.

When I woke up on March 31, I discovered I had lost total hearing in my right ear. I went immediately to see my doctor. There was no wax buildup, and the outer ear was clear. I went the same day to see my Audiologist (since I wear hearing aids), and upon testing discovered there was a total loss of hearing in the right ear. The left ear was the same as test results in October, 2020. On April 2 I went to see dr. He determined that I had suffered SSNHL, Sudden Sensory Neural Hearing Loss. Dr. prescribed Prednisone, 10 mg tablets: 6 at one time for 4 days, then 4 at one time for 4 days, then 2 tablets for 4 days, then 1, then 1/2. As of this date, April 6 there is yet no improvement

Spots in left eye Feb 23, normal headache cleared Feb 25. March 2 bad headache returned, March 3 about noon I notice tightness in lower throat. Progressed into lung area around 2:00. It became difficult to breathe. I went to the emergency clinic about 5:00. They did an EKG found no serious problems and suggested I head to the hospital. I arrived there about 6:15 the breathing was exceeding difficult. I could not lay on my back. My lungs on both sides felt like they were on fire when I tried to inhale

Tinnitus in both ears became severe after vaccination and after taking seven doses of Azelastine HCL and Fluticasone; also headaches around sinuses

Modern a COVID-19 Vacine EUA was received. Within 2 days my eyes began itching, then sores developed in both upper and lower eyelids. An antibiotic and then an ointment was prescribed. Conditions still persist nearly 2 months after vaccination.

started with chills and slight fever. Went to bed; however, wears a CPAP. At around 2am spouse awoke and heard strange gurgling sounds. Husband sleeps on back due to CPAP. Upon turning on light discovered he had thrown up and had regurgitated the vomit into his mask and back down throat. Very high fever, body hot all over, in state of confusion and slid off bed; tongue swollen and hard to understand him. Called paramedics and they took him to hospital immediately saying "he was in bad shape". Admitted to Hospital at around 6am after being in emergency room and treated with antibiotics and steroid. Stayed in hospital 4 days. Diagnosis: aspirated pneumonia. Home but with health care.

lost most the hearing in the left ear; had a bad day generally; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (lost most the hearing in the left ear) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DEAFNESS UNILATERAL (lost most the hearing in the left ear) (seriousness criterion medically significant) and FEELING ABNORMAL (had a bad day generally). In April 2021, DEAFNESS UNILATERAL (lost most the hearing in the left ear) was resolving. At the time of the report, FEELING ABNORMAL (had a bad day generally) outcome was unknown. No relevant concomitant medications were reported. The patient confirmed lost most of the hearing in the left ear by a visit to the clinic after a hearing exam was done. The patient stated that he can hear better now but the left ear was not usable and could not use a telephone. It was better now but still not ok and was still "metallic." The patient does not know if 2nd dose had influenced the hearing and stated that he did not have prior history of hearing issues. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Lost the function in right side/ could not write; Tremor; Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid; Hematoma on the left side of the brain/ slight hematoma on the right side of his brain; Could not hold anything at all in right hand even a spoon, almost like he had a stroke; Dragging right foot; Headache; Total fatigue; Totally wiped out, took everything out of him to go to the bathroom; Could hardly get up and had no control in his fett; He was not acting right; Something going on with his eye, movement to the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain), MOBILITY DECREASED (Lost the function in right side/ could not write), TREMOR (Tremor), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) and LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) (seriousness criteria hospitalization prolonged and medically significant), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) (seriousness criterion hospitalization prolonged) and EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (He was not acting right). On 22-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) (seriousness criterion medically significant) and ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom). On an unknown date, the patient experienced MOBILITY DECREASED (Lost the function in right side/ could not write) (seriousness criterion hospitalization prolonged), TREMOR (Tremor) (seriousness criterion hospitalization prolonged), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), GAIT DISTURBANCE (Dragging right foot), HEADACHE (Headache) and FATIGUE (Total fatigue). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy for Mobility decreased. At the time of the report, CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) and MOBILITY DECREASED (Lost the function in right side/ could not write) was resolving, TREMOR (Tremor) had resolved, CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid), LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes), FEELING ABNORMAL (He was not acting right), GAIT DISTURBANCE (Dragging right foot), ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom) and HEADACHE (Headache) outcome was unknown and FATIGUE (Total fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) Hematoma on the left side of the brain. On 20-Apr-2021, Scan: hematoma reduced in size No hematoma was present on the base of the spine. On 22-Apr-2021, Scan: improved Scan showed improvement. Patient stayed in the intensive care unit for 5 days then in critical care unit for 1 day and then sent home. On 20 Apr 2021 patient was again taken to Emergency Room. They gave him pain medicine which helped with the headache and send him home. On 22 Apr 2021 patient was again taken to hospital due to some conditions along with fatigue. and given medication for sleep. On 18 May 2021 the patient was seen by the neurosurgeon. Hematoma did not go away by now. Patient is in physical therapy to regain the use of his hand, can write now, sensory issues have cleared up. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient states onset of tinnitus and loss of hearing approx 6-7 days after receipt of Moderna dose 1 on 5/12/2021.

I became aware of a deterioration in my hearing probably iin April. My hearing has been somewhat impaired for several years but not to the level that I wanted to use hearing aids. I responded to a commercial offer of a free hearing test. I visited the clinic but had to delay the testing for another week. When I did get the test, the hearing in my left ear was makedly inferior to that in my right ear. The audiologist was concerned they may be some blockage. I made an appointment to be seen. The hearing test confirmed the far greater hearing impairment in the left ear. There was no blockage of the canal.

TIA; Lost vision on the left side; lump in left leg; vasculitis in the varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient required on full anticoagulation due to events experienced. Lab details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient complained of severe left eye itching. He self treated with OTC Benadryl and said it subsided. Saw patient today and the itch has resolved.

Pt. received Moderna vaccine at 10:45a.m. ten minutes later pt. started complaining of pain behind both ears. Pt. denied chest pain, SOB at the time. Pt. remained in the office. Approximately thirty minutes later, pt. developed chest pain on the left side. EKG was attempted but could not be performed due to pt. stated it was his chest was hurting when he laid back. Pt. was given 2 liters of Depo Medrol IM and placed call to 911. EMS arrived within fifteen minutes. Pt. was transported to ED.

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

NURSE WAS CALLED TO FACILITY. PT WAS NOTED TO BE MORE CONFUSED THAN USUAL. HE TOLD NURSE THAT THINGS WERE "FLYING THROUGH THE AIR". HE DID HAVE 2+ PITTING EDEMA TO BLE(NEW TO HIM). HE DID THINK THE DATE WAS MARCH 4, 2091. LEFT EYE ALSO SLIGHTLY RED/SWOLLEN. VSS AT THIS TIME. MD NOTIFIED. CG INSTRUCTED TO MONITOR FOR WORSENING EDEMA, INCREASED SOB, INCREASED CONFUSION/HALLUCINATIONS.

Bleeding into the retina of his left eye, obscuring vision Received injection of Avastin into left eye the next day No improvement yet We understand this could easily have been the natural course of his previously diagnosed macular degeneration, it?s just that he hadn?t bled in many years, and never in that eye, and after recently getting covid injection and it being experimental we thought we should report it in case

Nausia, chills, fever, and taste modification. Modification in tongue sinsitivity. Soreness in arm of injection Taste and toungue sensitivity lingers. Fever and chills lasted one day .

Pt reports Aura in Left eye without Migraine pain daily since vaccine. States the aura started peripherally and then moved medial

Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506

Tongue swelling, Benadryl was given and symptoms resolved. was observed for 3 hours with no further swelling.

Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21.

Loss of taste, smell, brain fog. Am not currently being treated. Side effects began the next day after my 2nd dose on March 1st.

one episode of heavy sweating...followed by 5 days of not being able to walk in my home more than 10 feet without having to sit due to severe pain and cramping in upper part of both les. Also unable to lift either or both arms above my waist without sever pain or cramping. this lasted for 5 days before subsiding. three days later both ankles and my lower left leg became swollen. this has presisted for 10 days.

Day 1 following shot - slept all day Day 2 headache, chills, low grade fever 99.7, sharp pain on side of head every 20 seconds Day 3 headache, chills, sharp pain on side of head every 20 seconds; Significant upper lip swelling started at noon. Still swollen at same level at 7pm. No additional swelling .

Adverse event occurred after 2nd dose. Rash developed under lower lip across middle of the face and a lump developed inside the left nostril. 5 days later, rash and lump in nose still present, mild pain in back right side of the head (behind the ear) developed. Pain behind the right ear grew more intense each day and on Thursday, March 11 was seen at Urgent Care with intense pain. Was diagnosed with Shingles and prescribed Valacyclovir and Prednisone, Acetaminophen-Codeine for pain. Saw Dr. on Monday, March 15. Pain is gradually reducing, but still present today, March 22, 2021.

Sudden vision loss Saw retinologist, not an eye problem Saw PC doctor who ordered mri (scheduled) Have appt scheduled with cardiologist

Have had mild tinnitus for many years. Within two weeks of my first injection I noticed a major increase in the hissing condition. Generally daytime noise and background noise would mask the earlier condition. With the worsened condition background noise will no longer mask the noise. It's constant.

Total loss of hearing in left ear. Steroids by mouth-13 days Steroids injections in ear -once a week for 3 weeks

i got the shot on Friday,03/26/ at 01:30 in the afternoon. i felt ok and went to bed about 11: that night. when i woke up the next morning i saw black dots and then black zigzag lines floating around. then black webs and specks about the size of a large ant moving around. i took Tylenol and it helped for a while. the same thing happened the next day and went a way that night.i Kept taking Tylenol every six or eight hours and it seems to help a little..

This is an 81-year-old male with a history of dementia also a history non traumatic SAH over the right cerebral convexity in 7/17 thought due to amyloid angiopathy , stroke and TIA who is brought by his wife for evaluation of changes that she noted last night around 9:00. She stated around 9 when she was getting ready for bed she thought his speech was a little bit thick but thought she had worn about since they were outside doing a lot of walking and had been to a picnic. The morning of the admission he has been more tired his tongue has been thick his speech is been a little bit slurred and his gait was slow with a shuffling gait. In the afternoon when visiting her son he recommended she bring him in immediately for evaluation.head CT showed small amount of bilateral subarachnoid hemorrhage Neurosurgery at Medical Center was consulted and no surgical intervention was recommended. He was transferred to Hospital for further evaluation treatment . repeat ct head was stable. He was discharged on 5/20/2021 and his aspirin was stopped. He also tested positive for covid 19 despite being fully vaccinated. ddimer was 1787- venous doppler was not done. he did not require oxygen. He was placed on quarantine on dc. Called wife on 5/22 and she reports he is complaining of fatigue but no cough or sob. He also has a history of covid 19 on 12/20 and was hospitalized and discharged on 1/6/21 and tested negative on 1/7/21. during that admission he was treated with remdesivir and decadron. He did not require oxygen. His hospital stay was protracted due to deconditioning and confusion but he was ultimately discharged home . the baby aspirin was added on dc. mri during that admission was normal with no acute abnl seen.

Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.). On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

The clinic gave me the shots --But the doctor at Medical Center checked by hearing losss. Shoulders hurt very bad and could not sleep on side. Still hurt now. My hearing went bad between my two shots. I did have hearing add's but after shots it really got bad and Doctor says I am a candidate for hearing implants now.

Muscle twitching, lost balance and fell in the bathroom and couldn't get up for 15 minutes, extremely dry mouth, stated he kept feeling like his body was "pulling to the right".

Client called to report that the night that he received the vaccine he noticed a small red rash around mouth and nose. Reported that he took Benadryl at that time. On 2/21/2021 he reported elevated B/P and rash has continued but now the redness is on face and jaw line.

pt states after taking the vax he woke up with headache and sinus congestion. After getting up next morning he noticed a numbness on the left side of his face, mouth and teeth. He got a tingling sensation that moved from his arm down into his thumb and then spread into his other fingers. He shook his hand and it seemed to disappeared. Pt has not contacted his PCP with symptoms.

Patient received vaccine on 2/8 at 2:50pm. On 2/9 at 10am, patient was found unresponsive. EMS noted R gaze preference and L sided contracture. Patient was intubated and symptoms resolved when given Versed. Concern for seizure activity.

Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air." On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.

3/6/2021 9:30 AM: Client experienced dizziness, lightheadedness, all over body weakness, light sensitivity, nausea, and vomiting. Episode lasted for about 30 minutes, client was in a parked car at time of incident. Once client returned home he slept for 4-5 hours and woke up feeling "100% better."

At 9:30 am Saturday morning client got light headed, dizziness, bright lights became bothersome, and experienced weakness all over body which lasted approximately 30 minutes. Client then became nauseous and threw up within 30 minutes of other symptoms. Once client got home he slept for approximatley 4-5 hours, woke up feeling 100 % better.

My ears felt "slightly stuffed" similar to the change in elevation after my first shot. First the left side then the right side but it cleared up in about three hours. This was no big deal but a friend of mine that is retired from the CDC said I should report it. I get my second shot on March 15th,

diplopia, lacunar stroke, 4th cranial nerve palsy Narrative: 1st COVID vaccine dose 2/8/21. To ED for evaluation of diplopia 2/19/21. Vertical diplopia in right eye x 3 days. No pan in eye, fever, chills, N/V, chest pain, abdominal pain, SOB, swelling, numbness or weakness. Neuro exams without focal findings. Discharged from ED to follow up with neuro on 2/22. Neuro impression 81 year old male with history of cerebral microvascular disease, appear to be some cognitive decline with recent onset binocular diplopia. Most likely secondary to diabetes, doubtful myasthenia, brainstem stroke. 4th cranial nerve palsy. MRI ordered and found (2/26) to have lacunar infarcts.

I?m 81 years old and had my first Moderna Covid-19 vaccination on March 4th. Within a few days I developed a continuous very high pitch ring in both ears. I had never experienced this before, and thought it would go away. Then I asked my wife why she thought I would all of a sudden have ringing in my ears, and she said it?s tinnitus. I had never heard of tinnitus before, so I looked it up. None of the causes listed in the article from the clinic seemed to match my situation. I thought maybe it would go away, but it?s been 10 days and no change. It doesn?t seem to have affected my hearing that I can tell. Also I?m not a stressful person. I don?t know if it will go away, or there?s anything that can be done, or if I should see a doctor. I suppose I can live with it, but it is annoying. The most important question is whether or not I should get the second vaccination scheduled for April 1, 2021 as that might even make it worse.

stomach and colon pain, headache, weakness, a-fib, short of breath, loss of taste. All symptoms occurred subsequent to suspected COVID 2/15/2020 (was not tested at the time because there wasn't much COVID in Utah where I lived at that early date). Symptoms continued for a year, was getting better the last couple of weeks before the 2nd COVID shot and then relapsed (including had regained sense of taste for 2 weeks. then lost it again after the shot).

About one week after first vaccine shot, blood test showed very high level of inflammation (Crp) that led to Double Vision. I was put on Prednisone (60 mg/day) . In the past few weeks, I've had several more blood tests, a brain MRI, surgery to perform biopsies on both eyes (biopsies tested positive for both eyes), and a current plan to involve a Rheumatologist.

pt discovered blurry vision/vision loss 1 hour after getting the immunization. Has not resolved as of 04-9-21

Diagnosis - Left forehead shingles with left eye involvement Allodynia of left face and left front scalp about 4/7/21 Left eye soreness and slight redness 4/8/21 Raised red blemishes on left forehead 4/9/21

Received the second dose on 2/11/21 and on 2/13/21 I started to experience severe headaches. This is highly unusual since I haven't had a headache in 30 years. I waited a few days to see if they would dissipate in a few days. It is now April 21, 2021 and I get headaches every day some more sever in the afternoon. If I sneeze or bend down it feels like my head is coming apart. Even at the time during the day when the headache subsides the pressure behind my eyes remain till the next flare up. The only time I get relief is when I lay down for bed. I sleep through the entire night. This is not fun. I need some help. I have MRIs, specialist prescribing pills

A few weeks after vaccination , blurry vision, , not feeling well,increased shortness of breath, ringing in ears, dizziness

12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.

The injection site began to hurt the evening of the day of the injection. I did not sleep well that night and was generally achy and fatigued the next day. Additionally I had a very dry mouth . By that evening I began to feel better although I was still a little tired but by the next day began to feel normal. The injection site is still tender (day 3) but getting better.

The day following vaccination, 12/31/2020 at 1230, the patient had an acute onset of shortness of breath, tachypnea (rate 34)wheezing, tachycardia (rate 130s and irregular), oxygen desaturation (89 to 91% on room air), and clear rhinorrhea, non-productive cough. Earlier in the day he complained of not feeling well, but non-specific. He was assessed and given an albuterol nebulizer treatment. In the coming hour, his wheezing resolved, work of breathing improved, heart rate and respirations decreased. He was ambulating around without signs of activity intolerance. It was felt that he was stable and back to baseline, so he was monitored by the nursing staff. A chest x-ray was ordered but not completed. On 1/1/2021 at approximately 0925, a nursing assistant described loss of consciousness for 20-25 seconds. It appeared that he was not breathing, slumped over in the chair at the breakfast table eating cream of wheat, eyes rolled back in his head. He regained consciousness, breathing normally after coughing. He did not appear to be choking. His heart rate was recorded as irregular, rate 32 by the nursing staff. He was transported to the Emergency Department at Hospital for evaluation. No concerning findings.

Ten hours after I had a Severe allergic reaction. My eyes were itching and watering. I was incredibly nervous and anxious. I couldn't relax or sleep. NO SHOULDER OR ARM PAIN. Swelling and puffiness in my face ( eyes, nose, and sides of my head). I was fine the next day.

Patient received first dose of Moderna vaccine 1/27/21 and presented to urgent care 2/8/21 with complaint of sores on inside of lower lip. Patient reported that sores started on 2/5/21 and seem to be growing in size. Patient did not recall any injury and sees dentist regularly for annual cleaning. Patient also does not smoke or chew tobacco. Patient was referred to his dentist who was able to get patient in and felt that lesions and ulcerations were not infectious or cancerous. The NP ordered lab work and recommend patient follow up with PCP. Labs came back two hours later and showed patient had a platelet count of 1 (THOUS/uL). Patient was sent to ER at Hospital 1 and was transferred to Hospital 2 for a hematology work-up. Patient is currently admitted and receiving IVIG and steroids

Pt co lightheadedness after covid vaccine. Has waited over 15 minutes. Reports "floaters". Declines water. States" I just don't feel right". BP 120/62, Pulse 67. Denies difficulty breathing or diziness. Pt taken to ER via wheelchair with wife.

The night of the vaccine at 9:00 PM his right arm was totally numb. He got up and took magnesium maleate, and it started clearing up the numbness, and took a baby aspirin. His right eye went blurry as if he had a cataract in that eye. Part of the eye was different, crescent vision. He then took some vitamins for eye, and took an Astroxanthem and started to have some benefit. He then took Epicor and it cleared up. A couple of days later he then had some blurry vision again and took some more vitamins, and it cleared up. He did get some dry eye drops and is using them. All the symptoms have resolved now. He does have an appointment with his eye doctor next month. Has not seen a regular MD or PCP in over 10 years.

Day 5: upset stomach and blurry vision Day 6: Brian fog Day 7: flu like symptoms and slept or 12 hours

On February 26 I got my second Moderna booster shot. On March 2 I got a blood test for my routine medical annual checkup. It showed my RBC and my WBC were below the minimum normal levels and my platelet count was 100, well below the 140 lower normal limit. Also, my lower lip was swollen and chapped. On March 8 I went in for a second blood hematology panel. My WBC was normal, my RBC was 4.31 where 4.5 is normal, and my platelet count was 123. My lower lip was still swollen and chapped. Today on March 13, my lower lip is still swollen and chapped.

Approximately four hours after administration of Moderna vaccine the patient had a sudden syncopal event without warning. He suffered a scalp contusion. His equilibrium, hearing and vision were diminished for 7-10 days thereafter, gradually returning to normal.

very confused and didn't remember the first day, diarrhea, and nausea, couldn't move or walk; this was similar to when he had covid, chills, nausea and fever also. I was so weak I couldn't get into bed. I still have foggy thinking and blurry vision.

11 days of extreme flu like symptoms. High fever, chills, nausea, severe body aches, loss of appetite and thirst. Turned into a lung infection. Took antibiotics and steroids

Per letter received from patient and phone interview, patient has long history of severe Glaucoma. Patient reports being blind in right eye for many years. Doctors have treated the left eye successfully with medications since the age of 35 to prevent blindness of the left eye. Patient reports pressure in left eye has been well controlled with 4 different Glaucoma eye drops daily. Pressure in the left eye has been maintained at 10 and 12. Patient states his vision was stable until second Moderna vaccination on 02/05/2021. Within a few days, the patient noticed change in his vision. After 1.5 weeks, patient reached out to doctor. Patient was seem by Dr. on 2/24/21 and found left eye pressure had increased to 30. Patient was immediately referred to a Glaucoma Specialist. That same day, about 4-5 hours later, he noted the pressure had increased to 40. Dr. agreed to perform shunt surgery, and did so on 3/10/21. Initially this reduced the pressure to 8. During the next week or 2, it increased to 11. During the patient's most recent follow up visit, the pressure was at 15. At that point, Dr. decided to remove a suture to reduce the pressure more. Patient reports vision has only slightly improved since this all began. Next follow up appt is on 4/28/21. Patient states in his opinion, he has sustained significant vision impairment as a result of the second Moderna vaccine.

Developing flushing of face within 15 minutes of vaccination, upon getting home, noted full body rash - itchy bumps. Headache and lightheaded with a slight little cough and able to taste something in mouth immediate. then one week later, 1/18/21 developed stabbing chest pain, medivac'ed 1/19/ 21 to tertiary facility hospital. had 2 stents placed on 1/20/21. Received second dose of Moderna on 2/09/21, again having flushing, headache, taste, smell of medicine, rash, less severe than first dose. Took a nap following. Hurt all over all night 2/10/21. 2/11/21 felt somewhat better. one week later, again experienced shooting chest pain on 2/16/21 (pain 'down my breast bone'). Has not followed up with medical care. Has been 'living with it' due to expense of Medivac. Finally does have a follow up appointment with Dr. on June 7th.

Swelling on left and right side of temporal areas of the face; High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition; Diagnosed him with temporal arthritis; Double vision in both eyes; Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face) and DIPLOPIA (Double vision in both eyes) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol total abnormal NOS (Patient takes Lipitor for cholesterol). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (Swelling on left and right side of temporal areas of the face) (seriousness criterion hospitalization) and DIPLOPIA (Double vision in both eyes) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition) (seriousness criterion hospitalization), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis) (seriousness criterion hospitalization) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to DIPLOPIA, GIANT CELL ARTERITIS and INFLAMMATION. The patient was treated with PREDNISONE at a dose of 60 mg and PREDNISONE on 25-May-2021 at a dose of 40 milligram. At the time of the report, INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face), DIPLOPIA (Double vision in both eyes) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. On 17Mar2021, the patient began to experience double vision in both eyes as well as swelling on the left and right side of the temporal areas of the face. The patient underwent a biopsy of both sides of the face, results were not provided. Ultimately, the patient was diagnosed with "temporal arthritis" along with "having high levels of inflammation in his body" by his rheumatologist. On 16Apr2021, the patient was admitted in the hospital for four days until 19Apr2021 for observation. The patient received high doses of steroids/prednisone for treatment including 60 milligrams for one month and then 40 milligrams starting 25May2021. It was recommended by the patient's physician that he not receive his second Moderna COVID-19 vaccination which was originally scheduled for 07Apr2021. Further clinical course is unknown/not reported at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up received. Follow-up contained no new information.; 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.

rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel

Patient experienced normal immune related response after dose two (Friday afternoon)- chills beginning about 12 hours after vaccination (Saturday morning) and ending by Saturday at 4 pm. On Sunday morning, patient reported feeling as though something was in his eye. He went to the mirror and saw that his eyelid and mouth were drooping on one side of his face. He lives in an assisted living facility and immediately sought medical attention by the staff and was taken to the nearest emergency department to verify that this reaction was not a stroke. Emergency room physician determined that it was not a stroke and the patient was diagnosed with Bell's Palsy, potentially related to his recent vaccination. Patient was prescribed steroids and an eye lubricant drop. On Monday, the patient is still experiencing the facial drooping.

Sore arm, 2nd day tongue swelled huge went to ER got shot of Benadryl and steroid tired and some dizzy

1406: After receiving COVID vaccine, pt c/o sudden lightheadedness, LE weakness, bilat ear pressure, tingling sensation to nose, HA pressure 1410: BP 118/78 HR 52 RR 16 SpO2 99% Add. RN called; head of car seat lowered; pt denied CP or SOB. 1417: HR 60 SpO2 98% Missed heart beats noted on auscultation by NP; pt denies cardiac hx; dizziness persisting 1430: HR 62 SpO2 97% Pt requested to stand; 3 RNs on standby to assist 1432: BP 117/70 HR 58 RR 16 SpO2 97% Pt states, "I feel totally normal." O2 1 L N/C 1450: O2 weaned; no missed beats noted; sxs resolved 1455: Emergency precautions given; pt verbalized understanding; released home

On 11/25/20 had a physical and they took him off of Atenolol, and put him on Metoprolol, one a day at bedtime. He took those for almost 2 months without any problem until he got his shot. He took his pill at 10:00 when he went to bed, woke him up around 12:30 AM and had severe itching all over his back, and his mouth, tooth area felt like they fell asleep. Got some water and rinsed his mouth and felt that it was something he ate. Again for the next 2 nights after taking his blood pressure medicine he was woken up with the same feeling (like it was asleep). It did not affect his swallowing. He then called his doctor and he put him back on his other medicine, and not having any trouble since switching back to Atenolol. He is scheduled for the 2nd vaccine on 2/25/21. Has an APT with his PCP 2/16/21.

1437: Pt arrived to observation area pale, diaphoretic and drooling. Pt disoriented for 4-5 minutes. Per daugher, pt not at baseline. Bp 84/52, 89, o2 sat 98% room air. 1443: Vital signs improved 142/74, 98%sat room air, no longer pail. Daughter request 911 and transfer to ER. Daughter stated pt had previously had a similar episode. 1452: pt care transferred to 911 and pt transferred to ER.

VAMS ID 100781798. On the day following vaccine administration, the wife of named individual called to report non-allergic symptoms that occurred approximately 7 hours after vaccine administration. Wife reports that after husband awoke from a nap that lasted about 2 hours she observed him to have bilateral "whole body" muscle stiffness including "legs crossed and could not uncross them" and stiff jaw like a "lock jaw". Lasted 20 minutes and then he was well the following day and beyond. He has a known but unspecified, well controlled seizure disorder but symptoms did not resemble usual seizure activity. Reporter notified usual health care office, and patient was seen by Dr. on 2/8/21. I spoke with his wife who reported symptoms to our office. Wife advised that per Dr. he classified it as a post-vaccination "adverse neurological event". Wife further advised that per Dr., patient can proceed with getting his second dose of Moderna COVID-19 vaccine.

Both pt and his wife were sitting in observation after receiving their COVID19 vaccination. They both reported feeling tingling in their throats and a strange taste in their mouths. Trinity EMS was already available in clinic. They evaluated both recipients who then reported feeling better. Both recipients signed refusal for transport to the hospital.

On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it. He got up and got dressed, went about his day. Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind. At that time, his speech became slurred. They got a neighbor, who is a nurse, to come over. She recommended medical attention. They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred. There were no cognitive issues. Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke. Bell's Palsy was diagnosed. He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home. As of today, Monday, February 22, his symptoms are improving.

Approx 10 hrs after shot began to see black circle with football shape inside of circle. Entire thing kept moving away and then coming closer. Could not see during this event. Tried closing eyes but was still there when I opened them. Fell asleep approximately 20 minutes later and eyes were fine in morning. Note that I did have eye surgery about 6 years ago and had surgical lens implants.

I am reporting on an odd syndrome that could be related to COVID-19 and the vaccination: a most acrid smell that I had never encountered before, and only once since then, 11 days after the second COVID shot. I was woken up by the smell and went around the house trying to find the source. The smell was strongest in the bedroom, and so I had to be the source, either a heightened and distorted sense of smell or passing gas while asleep. Possibly my gut is reacting to something COVID. I wanted you to have this information in case you collect statistics on such.

I have experienced continuous but tolerable ringing in my left ear for more than 35 years. There has been no ringing in my right ear. Following my 2nd Moderna vaccination, I experienced increased ringing volume in my left ear and onset of temporary low level ringing in my right ear. The right ear has cleared but the left ear ringing has not.

Lost all my vision; A spontaneous report was received from a consumer who was an 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost all my vision (blindness). The patient's medical history, as provided by the reporter, included an eye transplant 9 or 10 years ago. Concomitant medication included acetylsalicylic acid, metformin, tamsulosin, ropinirole, Ramipril, and gabapentin. On 09 Feb 2021 at 10:00 AM, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 09 FEB 2021, at exactly 10:00 PM, the patient "lost all my vision." He stated he had an adverse reaction to his first injection and said "my first shot messed up my vision." By 5 am, his vision was perfect. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The event of lost all my vision was considered resolved on 10 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient felt very tired on the day following administration of the vaccine, with subsequent rapid total loss of hearing in the L ear and partial loss of hearing in the R ear. Hearing loss was preceded by intense tinnitus. Subsequently patient was seen by physician and audiologist on March 9th, hearing loss was confirmed. Patient was started on prednisone by physician.

I lost the hearing in my left earon March 4 three days after receiving the 2nd shot of Moderna vaccine, See details below: Report of adverse reaction (hearing loss) following second injection of COVID-19 vaccine on March 1, 2021. I believe I have had a bad reaction from the second COVID-19 vaccination, which occurred on March 1 at Three days after the injection I could not hear through my left ear. The vaccine identification is: Moderna vaccine, 2nd dose, 3/01/21, Lot#: 006M20A The sequence of events to date (3/14/21) is as follows: Mar 1, Mon: I received the second Moderna vaccination at Retirement Community. No reaction. Ran 2 miles in the afternoon. Mar 2, Tues: Felt slightly ill. Headache. No energy. Vaccination arm very sore. Did not feel well enough to work at my desk or to run. Mar 3, Wed: Felt better. Worked as volunteer at vaccination clinic, but tired easily. Did not run afterwards. In the evening, noticed some hearing difficulties in left ear, including greatly increased tinnitus. Mar 4, Thur: Awakened in morning with no hearing in left ear, and growing diminishment of hearing in right ear. No running. Mar 5, Fri: No hearing in left ear and diminished hearing in right ear. Tinnitus level high. Called my otolaryngologist; doctor not available; scheduled appointment for March 16. Visited Urgent Care; physician assistant found no obvious problem. Visited Clinic; (my primary care physician) not available; nurse practitioner advised me to wait to see Dr. on Mar 8 at my scheduled annual wellness checkup. Ran 2 miles. Mar 6, Sat: No hearing in left ear. Right ear continues to lose hearing. Ran 2 miles. Mar 7, Sun: Left ear deaf. Right ear hearing is poor and distorted. No running Mar 8, Mon: Left ear deaf. Right ear hearing is deteriorating. Had difficulties understanding speech. Reported hearing problem to Dr. at my annual wellness exam. She said I should report it to FDA. I requested that she do so because I had some difficulty in trying to make the report. She prescribed Mirtazapine for several concurrent health issues. Ran 2 miles. Mar 9, Tue: Met with Dr. (otolaryngology) and Dr. (audiologist). A hearing test showed left ear functionally deaf and right ear poor as before. Given order for a head MRI and prescription for prednisone and instructed to return in two weeks. Dr. urged me to report problem to the CDC. Ran 2 miles. Mar 10, Wed: Hearing problems as before. Deaf in left ear and hear with difficulty in right ear. Tinnitus very loud. No running. Tried to send report to CDC/VAERS (email not successful). Mar 11, Thur: Started 20 mg of prednisone; within 6 hours hearing began to slowly return in left ear. Ran 2 miles. Mar 12, Fri: Hearing in left ear returned to 70-80% of normal and right ear improved also. Had head MRI in evening. No running. Mar 13, Sat: Hearing continued to improve in both ears. Tinnitus remained loud. Ran 3 miles. Mar 14, Sun: Hearing has plateaued in both ears, although TV audio seemed a bit muffled. No running. Mar 15 onwards: Awaiting lab results of head MRI. Next appointment with Dr. is March 23. (End of report)

COVID 19 GOT POSITIVE RESULT ON 02/13/2021 FOR TEST COLLECTED 2 DAYS EARLIER AT PHARMACY. COUGH HEAD COLD SORE THROAT LASTED 10 DAYS ... TOOK MOTRIN AND TtYNELOL i MADE A SEPARATE REPORT ABOUT THE FIZZING IN MY HEAD 24/7 CONTINUSLY SINCE fEB 10/21 I showed up for scheduled 2nd Shot on 3/6 BUT HEAD NURSE FROM hEALTH dEPT strongly RECOMMENDED not TO TAKE IT BEFORE MAY 15 2021 TO AVOID A SEVERE REACTION

Vertigo ,severe dizziness, Can not walk straight, fell 4 times . Had MRI MRA. visited ENT <Neualogist They found nothing to cause dizziness . Also blurred vision , headache. At witts end. Citizens should know of this adverse reaction

My uncle, died on February 17, 2021. He was admitted on February 2, 2021 6 days after taking the COVID-19 Moderna vaccine (1/28/2021). After the shot was administered, he developed all the COVID-19 symptoms (loss of taste, smell, high temperature, and had trouble breathing). He was deprived of oxygen and had labored breathing and was acting confused. The home health nurse contacted his primary care physician and was instructed to bring him into the ER.

Within three days of shot started with blurred vision, swerving while driving, progressing rapidly to unable to hold fork, falling down. Hospitalized since. Lost all motor skills, unable to walk, stand, feed self, control urine, slurring speech. No stroke. MRI found "lesions" in brain, spine/neck area, lung and stomach. Four Neurologists examined. They still are perplexed. One said she has not seen anything like this in her 20 years. Spent week in hospital, now in rehab center Minor improvement in ability to feed self (still can not hold fork), Receiving physical therapy.

I took the First dose of the vaccine on 01/28/2021 and the lot number is 007M20A. And I took the second dose of the vaccine on 02/25/2021 and the lot number is 002A21A. on 02/02/2021 i started to get very dizzy and I was hospitalized for 4 days. The hospital referred me to a physical therapist, the physical therapist referred me to a eye doctor that stated the prism in my eyes keeps changing. I can no longer drive because I am too dizzy. How am I supposed to go to the doctors office or take care of myself or my wife.

temperarily lost sight in left eye; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS TRANSIENT (temperarily lost sight in left eye) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee replacement (Right knee replacement surgery) in 2017. Concurrent medical conditions included Blood pressure high since 2014 and Benign prostatic hypertrophy since 2000. Concomitant products included TAMSULOSIN, LOSARTAN and NIFEDIPINE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021 at 2:30 AM, the patient experienced BLINDNESS TRANSIENT (temperarily lost sight in left eye) (seriousness criterion medically significant). On 12-Jun-2021, BLINDNESS TRANSIENT (temperarily lost sight in left eye) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Computerised tomogram: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLINDNESS TRANSIENT (temperarily lost sight in left eye) to be possibly related. Patient's treatment product details not provided. It was ambiguously reported that outcome of the event was resolved on 12-Jun-2021 and unknown. The first event occurred the day after the first vaccine shot the left toe swelled and the swelling and pain worked its way into the lower leg. Required a doctor visit, ultra sound and xray did not show any damage to the toe, foot or leg. Blood tests showed uric acid levels in the high end of the normal range. After treatment in office with an injection the pain and swelling subsided. No long term effects from this event. The second event occurred after the second vaccine shot. Two weeks after the second shot was administered (Saturday 6/12/21), temporarily lost sight in my left eye while driving. Went to the ER for treatment. Assement showed no retinal detachment. On Monday visited family doctor and she recommended that patient see by an eye doctor and ordered some additional blood tests blood tests. Family doctor appointment for follow up visit scheduled for 7/28/21. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. This case was linked to MOD-2021-040178, MOD-2021-245133 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear

Blurred vision, off balance, low blood pressure. Sent to ER and was admitted to hospital. Tested negative for Covid19 on 1/25/2021 at hospital. Returned to community 1/26/2021 and was sent to the ER within hours of being back from hospital. He remains at the hospital and will be returning on hospice.

Saturday 01/30/2021 lost peripheral vision. Went to hospital Was given Mri and ultra sound of head and neck stayed until sunday afternoon. Slept Sunday night Now have not been able to sleep at night at all since

patient came into the office for swelling under left eye he noted 2 hours after 2nd injection of covid vaccine. Denied blurred vision or pain in eyes. Denied shortness of breath, chest pain at assessment. Patient was monitored in office. Patient was advised of ER precautions and discharged to home with no signs or symptoms of acute distress.

loss of hearing/hearing completely gone in right ear; Ringing in left ear; probably vertigo; Extreme dizziness; blood pressure was 214/113; vomitng; Weakness; nasal drip; dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee; diminished hearing in left ear/sounds like listening through a drum; pressure in temples like a hammer on each side of head; headache in back of head; A spontaneous report was received from a consumer who was also an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme dizziness, nausea ,vomiting, nasal drip, weakness, loss of hearing/hearing completely gone in right ear (deafness unilateral), diminished hearing in left ear/sounds like listening through a drum (hypoacusis), blood pressure was 214/113 (blood pressure increased), pressure in temples like a hammer on each side of head (head pressure), headache in back of head, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 020L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported he felt fine for about one week after the vaccination. Then, in the early morning of 05 Feb 2021, right after midnight, he experienced extreme dizziness, vomiting, weakness, nasal drip, and loss of hearing including ringing in his left ear and no sound in his right ear. He also started to notice a dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient was taken by ambulance to the hospital. In the ambulance, he vomited and his blood pressure was 214/113. He was placed the COVID-19 wing of the emergency room (ER) and given tests including a COVID-19 test, sonogram, "echogram", MRI, and EKG (results not provided). The patient reported he was admitted to the hospital. He was told he probably had vertigo. After his ER visit, the patient had appointments with his general practitioner, an ear nose and throat specialist, and a hearing specialist. He was told his hearing was completely gone in his right ear and diminished in his left ear. The patient could still somewhat hear out of his left ear but it sounds like listening through a drum. He states he has to have his television up very loud to be able to hear it. At the time of this report, the patient continued to feel extremely weak, dizzy, and he had pressure in temples like a hammer on each side of his head, a headache in back of his head, and the hearing changes. Treatment for the events included unspecified medications in the ER. Action taken with mRNA-1273 in response to the events was not reported. The events of dizziness, weakness, loss of hearing/hearing completely gone in right ear, vertigo, weakness, diminished hearing in left ear/sounds like listening through a drum, pressure in temples like a hammer on each side of head, and headache in back of head were not resolved at the time of this report. The outcome of the events of blood pressure was 214/113, nausea, nasal drip, vomiting, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee was unknown.; Reporter's Comments: This case concerns an 84 year old, male patient, who experienced a serious unexpected event of Deafness (unilateral) among others, 9 days after receiving 1st dose of mRNA- 1273 (Lot# 020L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

Patient apparently was in the bathroom, shaving. Patient's wife was in the kitchen. He does not recall exactly what happened other than he fell backwards. His wife heard a "thud." She went into the bathroom and the patient was not responding. Eyes were open but he was not focusing. He did have generalized shaking of his extremities. Nine-one-one was called at this time. Patient does complain of some mild back pain. He denies any significant headache. There has been no nausea or vomiting. He was diagnosed with syncope event and new onset bells palsy.

2/22/21 - achy/weak, nausea/vomiting with clear vomit taste like blood, no fever 2/23/21 to 2/25/21 - continues with weakness and developed joint pain and red rash on arm that had injection - rash lasted 4 days 3/12/21 - developed pain behind left knee and down to left foot 3/15/21 - knee/leg pain contiues and goes to urgent care - diagnosed with DVT 3/22/21 - developed chest pain, goes to ER, diagnosed with kidney stones

3 days post vaccination patient experienced diarrhea, 10 days post vaccination patient experience fatigue, loss of taste and smell and was "bedridden"

Blurred Vision; Falling down; Speech; Motor skills/dropping fork; Lesions on spine; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VISION BLURRED (Blurred Vision) (seriousness criterion hospitalization), FALL (Falling down) (seriousness criterion hospitalization), SPEECH DISORDER (Speech) (seriousness criterion hospitalization), MOTOR DYSFUNCTION (Motor skills/dropping fork) (seriousness criterion hospitalization) and SPINAL DISORDER (Lesions on spine) (seriousness criterion hospitalization). At the time of the report, VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) had not resolved. Concomitant product use was not provided by the reporter. No treatment information was provided. On 28-Apr-2021 patient received his second dose of vaccine and after 13 days he started to felt the symptoms. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atrophy and some small vessel occlusive changes. He tested positive for Covid by PCR in the emergency department on 1/22. His oxygen saturation was stable. He did have a fever and describes falling off the toilet because of some generalized leg weakness and uncoordination. He has had some chronic left greater than right upper extremity sensory loss following prior cervical spine stenosis requiring urgent surgery in 3/2019. He has had some chronic left foot drop as well. He reports being somewhat deconditioned having spent some time in bed to the above episode but is now ambulating with a cane at home and has occupational and physical therapy in place. He has been mildly dyspneic on exertion above baseline but attributes this to some deconditioning. He did have an episode of lower dental pain with ambulation in the office that was more than usual though denies associated chest pain or pressure and has had no jaw or shoulder pain with exertion. Review of systems is negative for headache.

One week after I received the second MODERNA dose, I experienced swelling of my upper lip and tenderness of facial muscles left side of my face. The symptoms are similar to the sensation I feel after a dental procedure when I have an injection. I have experienced side effects for one week. ( , ,

Temporary blindness for 10 minutes in only one eye; A spontaneous report was received from a nurse concerning a 85-year-old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temporary blindness for 10 minutes in only one eye/blindness transient . The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 01 Mar 2021, approximately 2 days prior to the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in left non dominant arm for prophylaxis of COVID-19 infection prophylaxis. On 03 Mar 2021, after first dose of vaccine, the patient experienced temporary blindness for 10 minutes in only one eye. The event temporary blindness for 10 minutes in only one eye was considered as medically significant. He visited doctor and after the investigation, it was confirmed that patient was fine. Treatment medication for the event included Clopidogrel bisulfate. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, temporary blindness for 10 minutes in only one eye was resolved on 03 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

developed stomach pain beginning minuets after the shot administered. Left site 15 minuets after the shot and returned home. Stomach pain increased and in a sitting position vision started to become blurred and I passed out for a very short period of time. After that proceeded to have uncontrolled diaherrea and developed blood in the stool and on the toilet paper. Mild spotting continues the day after the shot. No other adverse symptoms.

4/7/2021: Red arm started at site with ecchymosis, redness extended down the arm. 4/9/2021: Rash with pustules, leak clear fluid, pruritis 4/12/2021: Eye swelling, red arm and rash subsided.

Lost hearing in his right ear; Partial hearing in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in his right ear) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in his right ear) (seriousness criterion medically significant) and HYPOACUSIS (Partial hearing in his left ear). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in his right ear) and HYPOACUSIS (Partial hearing in his left ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications and treatment details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Pt received Moderna covid vaccine on 1/11/21. Began experiencing "violent shaking" and decreased appetite yesterday morning, throughout the day yesterday became delirious and unable to recognize people, understand speech, control his bladder or walk without falling.

55 minutes (12:00pm) after receiving 1st dose of Moderna COVID-19 vaccine resident was shaky all over. States he's had panic attacks but it "doesn't feel like that". Denies chest pain. Denies shortness of breath. Visibly shaking. Facial Hx of diabetes and had just finished lunch. Blood sugar 189. 02= 98% on room air, BP 140/70 Pulse 106. At 12:07 complains that tongue feels numb and throat feels tight. 12:08 pm, Epi-pen administered to left outer thigh. 12:16pm states he's feeling better. Shaking has subsided. Tongue numbness almost gone. 12:31pm T= 98.3 02 = 98% P=80 BP= 114/72

Resident received 1st dose Moderna Covid-19 vaccine at 11:06am. At 12:00pm, resident complained of feeling shaky "all over" and was visibly jittery. Denied shortness of breath, chest pain or throat tightness. Face had a pallor appearance. States he's had panic attacks in the past but this "doesn't feel like that". Blood sugar 189 (had just finished lunch). BP = 140/70, P = 106, 02 = 98%. At 12:07 resident states that tongue and lips feel numb and throat feels tight. 12:08pm Epi-pen administered into left outer thigh. 12:16pm resident states he's feeling better. Shakiness resolving. Numbness letting up. At 12:30pm resident reports feeling back to normal. T = 98.3, P = 80, BP = 114/72, 02 = 98% on room air. Event reported to the resident's medical provider.

ethmoid sinus congestion/headache; onset at approx 10 mins of dose 1 administration; resolving in 15 mins

Teeth and Jaw ache, upper and lower left side, also tenderness and ache left temporal mandible joint, slight tingling and numbness left lips. Suficiently severe that saw regular dentist on emergency basis 1 week after injection—X-rays taken, but no obvious infections or absesses. Dentist suggested was result of grinding of teeth and would eventually subside. No previous episodes of teeth grinding however. Now 5 weeks later, still continuous moderate jaw ache—occasionally quite painful, slight end-molar tenderness, slight tenderness in left mandible joint. Numbness in left lips gone. Only treatment has been Tylenol, 500 mg, 1 to 3 times/day.

Several hours after receiving the vaccine, patient developed a swollen tongue and was admitted over night to the hospital for observation.

The patient's caregiver reported via phone that a few hours after vaccination, the patients left eye became swollen and blue/purple. No other symptoms were noted.

He was brought into the ER via EMS for altered mental status. He does have an underlying dementia but is normally able to hold a conversation and take care of himself. He was standing at kitchen sink staring off and drooling from his mouth. He was not able to answer questions, unable to find the words, and was weak. Admitted to hospital.

S/S began Saturday, 3/6/21. Patient was unable to walk or stand. He had to crawl. He also lost his vision, and was only able to see frame of television. He couldn't see anything else in the room. Approximately, 2200 or 2300, his vision returned. He also was able to get up out of chair. He did not seek medical care or report to a health professional until the following Monday, 3/8/21. He saw a urologist (didn't remember name) who instructed him not to get the second dose. He is now reporting the episode to the Pharmacy today.

Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17. He started c/o discomfort and appetite decreased. 2/18/21 had low grade fever. 2/22 fever and generalized weakness and abnormal labs (elevated potassium). 2/22 hydration was started. 2/25 antibiotic started for UTI for 7 days. Patient seem to improve except appetite. Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March. On 3/2/21, patient received 2nd dose of Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite. By 3/4/21, patient was noticed to have trouble chewing and swallowing. Speech was ordered. On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility. On 3/8/21, it was noted patient had intermittent confusion. By 3/10/21, patient was more alert. Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management. Then on 3/27/21 he became disoriented, wheezing, labored breathing, Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94. Oxygen started and sent to ER. Family reported patient is admitted to hospital with mild stroke and UTI. The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae. This seems similar to timing of actual COVID infection pattern when it is the actual virus.

Woke up March 12th at about 8 am with severe welling in left hand and arm - ballooned up - and right eye. Started to subside after a few hours. Did telehealth visit, who recommended urgent care. No medication was given; advised to wait and watch. By afternoon, swelling had eased considerably; completely disappeared after 48 hours.

received the first dose of the vaccine on April 8. He presented to the emergency room on April 27 with generalized weakness and inability to ambulate. He had an episode of blurred vision, pain and weakness in his left leg. A stroke was ruled out. His family refused the second dose of the Covid vaccine.

ventral tongue and lip tingling, beginning 20 min after vaccination, improving over hours beginning prior to and continuing after Diphenhydramine, 50-75% resolved after 2 hrs and fully resolved on awakening this am, no SOB, no lip swelling, no rash, no nausea, no throat fullness, no fever

During the observation period, client started to complain of "feeling goofy," blurry vision after 24 minutes of receiving the 1st dose of the Moderna vaccine at 2:48pm. Client stated she was very anxious regarding vaccine and missed her meds. At 3:22pm, juice, water, meds (Xanax 1mg, lisinopril 5mg, eye med po) was given with improvement. She denied shortness of breath, oral/airway symptoms, rash, pruritic, faintness, weakness or nausea.

pt had no problems the day of the vax but next day he started having itching on his back, arm, and leg. Later that day his gums hurt like he had a toothache for 3 days. (pt has dentures) On 3/7/2021 pt becomes lightheaded. On 3/8/2021 pt started having pains in both fingers moving up to the arms and to the chest. On 3/10/2021 early am he woke up with severe pain from his fingertips to his shoulders and then across his chest and he thought he was going to die. He took Tylenol. The meds helped but pain came back about 2 hours later (around 8 AM) so took more Tylenol. Fever of 99.7. BP 145/80. pulse 65. Pt states that the pain he has had is not all at one time but happens like one thing at a time. Pt called medical office and was instructed to continue taking Tylenol and if he had anymore episodes where he felt he was dying to go to the ER. Pt is feeling some better now with just some pain in the shoulders and will contact his

Nine days after receiving the shot, patient broke out in hives on his abdomen. The hospital told him to take Benadryl which did not reduce the hives. The hives continued to spread over his abdomen and become itchier. On day 11 after the shot, his lips began to swell. On day 12, January 26, he went to the emergency room due to the lip swelling and hives. They prescribed 10mg Cetirizine HCL twice per day. He took it for three days. The lip swelling went down and the hives started to subside the day he started to take the Cetirizine. Note: He had two hives appear on his chest within 24 hours of the second dose. That was COVID-19 (Moderna) 013M20A on February 11, 2021. He immediately took the Citirizine for three days and they did not get any worse and cleared up.

total scalp area, ear to ear became sore to touch. Minor headache was infrequent. Several days later the tender scalp receded to the right side only. Unable to sleep but in one position. The soreness has now traveled to include my right eye socket. Dr unable to determine a fix.

Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home. Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%. He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI. Comfort care measures were implemented and he died 4/15.

2 days after the vaccine pt developed a stomach ache radiating to the back ,after several tests and seven weeks later pt. was diagnosis with multiple myeloma went blind and passed away,

The day following the second injection the patient noticed loss of smell and taste. No other symptoms of COVID. No fevers, chills, cough or dyspnea

Bells' Palsy, started on March 4th, right sided facial droop, and visual changes. Admitted to Hospital, worked up for CVA, and started on steroids and valacyclovir

Severe headaches, loss of appetite, jaw claudication, tongue discomfort, difficulty swallowing, elevated CRP. Treated with prednisone 20mg, 1 tablet by mouth three times daily. Continued headaches and jaw discomfort. Still treating with steroid.

About 15 min after the pt received the 2nd Moderna covid vacdine, he started complaining of dizziness. BP 118/66, HR 64, SpO2 98% RA. About 15 min later he is dizzy, eyes watering, with blurry vision. Pt waited about 30 min more BP 138/82, HR 58, SpO2 99% RA. Pt said vision still blurry but getting better. Dizziness resolved.

My dad had his first Moderna shot on 3/2/21; second shot was on 3/30/21. On 3/3/21, he woke up and got Bell's Palsy. After doing some serious research, I discovered that Bell's Palsy is a side affect and per VAERS,, there's over 400 cases. My dad's right side of his face was getting worse to wear he couldn't close his right eye and as of today, 4/23/21, he still can't close it and my mom has to continue to put eye drops in his eye so his eye doesn't dry and damage his cornea. My dad goes see's his eye dr every two (2) weeks. One time the eye dr told my mom that my dad's face was getting better when it was obvious that it was getting worse. My dad has Dimentia and from this reaction to his first shot, the dimentia has gotten worse; going downhill really fast and this is coming from my mom who is with him 24/7. Prior to getting the second shot on 3/30/21, all the doctors were telling my mom that it's fine for my dad to get the second shot. I told my mom that I didn't have a good feeling about my dad getting the second shot since most of the common side effects come with the second and if my dad is like this from the first shot, I can't imagine what would happen from getting the second shot. My dad said that he didn't want the second shot and all that he wants is eye to get better and to this day, that's all he wants and we keep on telling my dad that it'll eventually go away but we don't know when. Studies need to be done on who the vaccine reacts to those with dimentia. Not enough studies on why people get Bell's Palsy and other major side effects from the vaccine.

On 0126/2021-After 4 hours, left arm, became stiff in muscle down to wrist plus pain and ache upon movement plus itching from left armpit to stomach; subsided by 4pm; then next 4 days, patient awakened about 1:30 am to 2:30 am with constant pain in arm; took 2 Tylenol, lessened by 6 am. Then at 1:30 am 01/31/2021, flat in bed, awakened by a severe pain in both shoulders, arms, sides with movement of crushing sensation and weird feeling going down left side to belt line, crossing over and meeting at right side belt line; with crushing, paralyzed effect for about 30 minutes. i felt like about ready to die. Tried arms and legs to work with some exercise, helped little. Got up,for toilet to urinate, took 2 tylenol,

I did have and still have soreness of shoulder where I got the injection. That I can expect to stay. When I woke up at 1:00 am my lips and my tongue were in lots of trouble. Its hard to describe, somewhere between numbness and whatever. They sent an ambulance, they looked at it and had me move my tongue and said the area wasn't swollen so they said it would be ok sooner or later. The second day that was a little bit improved but even until now my lips are not normal. By the second day i was having a swallowing problem, the back of my throat feels like the top of my throat. Even when I swallow saliva its not good. But i am still able to eat. So lips and throat are still a problem. When I went to get the shot I was quite able to walk but not long distance. By the second day i began to have a problem in my back, I assume just muscular unless something is wrong in the vertebrate. I can barely walk now, I just shuffle one foot ahead of the other. At any moment if I move I just collapse. I'm always using a cane and always have something to hold on to because I don't know the next minute I'm going to go down, it is very bad.

Per granddaughter's report, pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance, reported difficulty seeing, and did not recognize some family members. By Sunday, 1/31, pt was unable to be awakened, would not eat, and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed. Granddaughter reported he died 2/1 around 10am in the morning.

per Wife; Patient was driven home, felt lethargic, went to bed early, around 6. in the Morning, Patient was having facial pain. Was seen by dentist on Saturday, returned a few days later, both Dr.'s evaluated patient. Was seen by a third Dentist. Since then, pain has been in face and jaw. Slightly sore and swollen at injection site. Pain caused patients blood pressure to rise. Per Dr. after visit: Left facial painonset morning after vaccine. Dental etiology excluded. Clinical features consistent with trigeminal neuralgia

Hospitalized w/Covid symptoms 5 days. Shortness of breath, fatigue , bad taste in back of throat still exist today 02/23/2021

Dose #2 The patient received Moderna COVID-19 Vaccine 0.5 ml IM. MVX (Manuf); Lot#; Exp Date: MOD; 006M20A; 07/12/2021 Date/Time:Feb 18,2021@16:37 Administration Anatomic site: Left Deltoid Vaccine administered by protocol without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. Vet developed an itchy red-purple rash all over his body and pains lasting seconds from rough of mouth and radiating to temple that happens every 10 min to every few hours.

May 24, 2021 at bedtime I noticed I could not swallow my evening meds correctly, my wife noticed my left eye and mouth were drooping May 25, 2021 admitted to Hospital, underwent many tests and it was determined that I had suffered a minor ischemic stroke May 26, 2021 discharged from hospital