Moderna

This is a 40 y.o. female who presents with abrupt onset of nausea vomiting, diarrhea, myalgias, headache about 2 hours after receiving her 1st Moderna COVID-19 vaccine at 1300 hrs.. She describes myalgias extending from the area of her left deltoid injection site over her shoulders and over her entire upper body. No neck or back pain. She describes diffuse throbbing headache with no positional component. She has had relentless nausea vomiting and retching. She has been up vomiting stomach contents to bile multiple times. She has had loose watery brown diarrhea multiple times. She describes diffuse abdominal crampy pain with increased tearing retching and vomiting. She denies any shortness of breath cough or wheezing. Voice is normal. No swallowing dysfunction or pain. No intraoral or facial swelling. She denies rash or pruritus. No arthralgias. Patient reports prior anaphylaxis with shortness of breath and tight airways, difficulty speaking and swallowing, and relationship to coconut ingestion few years prior. No other known food/nut reactions. Patient is a CNA for care at home. Last Covid test was 2 weeks ago which was negative. She reports she has been tested every 2 weeks routinely. Review of Systems Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain, diarrhea and nausea. Negative for vomiting. Musculoskeletal: Positive for myalgias. Negative for arthralgias, back pain and neck pain. Neurological: Positive for headaches. Negative for dizziness, weakness and numbness. Physical Exam BP 126/73 | Pulse 120 | Temp 37.1 °C (98.8 °F) | Resp 18 | Ht 1.575 m (5' 2") | Wt 68 kg (150 lb) | SpO2 100% | BMI 27.44 kg/m² ED Course as of Dec 30 2340 Wed Dec 30, 2020 2128 Reevaluation: Nausea improved. Abdominal cramping resolved. No further diarrhea or vomiting. Still complains of headache and muscle cramping through her upper shoulders and arm. Will remedicate with steroid and acetaminophen 2258 Reevaluation: Patient improved. Pain/myalgias improved. Headache now mild and dull. Continues with no further.nausea vomiting or diarrhea. She would like to try fluids at this time. Assuming toleration we will plan on discharge home. 2326 Reevaluation: Patient feels improved. Headache essentially gone. Taking p.o. fluids well. Discharge instructions discussed. She is very familiar with an EpiPen because of her daughter's prior use. Discharge instructions discussed. ASSESSMENT and PLAN This is a 40 y.o. female who presents with nausea vomiting diarrhea, myalgias, diffuse abdominal cramping, severe global headache, onset about 2 hours after first dose Moderna COVID-19 vaccine. Exam with intact mental status, neurologic system. Abdomen with some diffuse tenderness but no evidence of peritoneal sign. She had diffuse palpable soft tissue muscular type tenderness through her upper extremity shoulder and bilateral paraspinal back. She had no meningeal signs. She had no cardiorespiratory signs or symptoms. Her chest was clear. Voice normal. Swallowing normal. Oropharyngeal region normal. Initial ED ED management focused on rehydration, antiemetics and subsequent treatment for presumptive anaphylaxis with likely system involvement gastrointestinal and neurologic. She was treated with Solu-Medrol, famotidine and acetaminophen. She improved during ED course and did not require epinephrine. Symptoms at ED reevaluation/discharge were resolved. Clinical impression favors anaphylaxis over medication side effect given time course and abrupt onset of symptomatology and signs. She has a distant history of anaphylaxis to coconut-based product in her past. She has no history of ongoing allergic chronic history otherwise. Other organ systems appeared stable at onset and through ED course including cardiovascular and pulmonary. Plan is for discharge home with rest fluids. She will have a course of steroids/prednisone and famotidine. She was sent home with an EpiPen and understands use and precautions. Discussed ED "return immediately if" parameters with patient. Ongoing FOLLOW UP evaluation/care coordination via PCP recommended. Patient voices good understanding of current evaluation, follow-up & return recommendations and discharge instructions. Encounter Diagnosis Anaphylaxis due to vaccination, initial encounter Plan: -d/c home. No work next 2 days. Off work note provided -COVID-19 testing pending -rest with activity as tolerated -diet as tolerated & increased fluids as discussed -acetaminophen PRN -Prednisone 40 mg daily to finish 4 more days -Famotidine 40 mg daily to finish 4 more days -Zofran as needed (patient has at home) -Loratadine 10 mg OTC as needed -PCP f/u -ED return for interval worsening -instructions discussed & as documented

At about 1330 on 30DEC, the patient received the 1st dose of the Moderna COVID-19 vaccine. Less than five minutes after the vaccine was administered, the patient noticed a metallic taste. About two to three minutes afterwards, the patient noticed a ?tingling? sensation mostly on the left side of the face and minimally on the right side. Almost immediately after the ?tingling? sensation, the patient felt the sensation of an increased heart rate and checked his pulse with his watch that had a pulse sensor. The watch indicated that he had a heart rate of 115 bpm. This sensation of an increased heart rate subsided after for one or two minutes and repeat pulse measurement was in the low 90s. Towards the end of the 15 minute post-vaccination observation period, the medical technician did the final check on the patient. The patient admitted to experiencing a metallic taste and a mild tingling sensation on the neck and face area. The service member was immediately brought back to the treatment room were a faint red rash and was noticed on the left side of the neck by the medical providers present. Two doses of Benadryl 25mg were given and the patient was told to continue to be observed in the observation area. After about 20 minutes, the tingling sensation resolved. The patient checked his pulse again and it was in the low 70s. The metallic taste resolved after about one and a half hours after the start of the symptom.

Pins & needles/tingling sensation and numbness located throughout the body including the throat, mouth and tongue. Gradually diminished over 24 hours and has now resolved.

Arm soreness for 3 days following injection Fatigue day after injection Sore throat, feels like swollen tonsils began 2 days after injection and continues today Visible sore under tongue began 2 days after injection and continues today

Initially patient felt warmth on top of head and around eyes and ears 20 minutes later experienced fuzzy vision, pain in back of right eye Warmth on top of head and around ears has gone away as well as fuzziness but patient is still feeling consistent pain behind right eye

Patient received the Maderna Covid-19 vaccine. Was sitting in observation for 10 minutes post vaccine and got up to "make a call." I was called to the conference room at 0815. Caregivers heard a loud noise and found patient on the ground in the hallway right outside the observation room. Patient states "I got dizzy and started getting tunnel vision" also states that this happens at times with needles/ blood draws since he was a kid. Patient set up on his own, denies head/neck pain. Denies any injury. Stood on his own and guided into observation for more time- set in chair. 0832 checked with patient , still denies injury, denies anymore dizziness. Encouraged him to go to the ED to get checked out. Patient denies head/neck pain or any S/S at this time. Declines ED. 0847- Patient denies dizziness, s/s and declines going to ED. Walked out, gait steady.

Starting this morning, the left side of my face has gone numb. There is a charlie horse like feeling in my left cheek, which is now also present in my left jaw. The left side of my tongue is numb with slight pain, and my bottom lip is numb on the left side, and the feeling stops at the middle like there were a line drawn down my face. My upper left cheek and the side of my left eye have a constant, moderate burning feeling. The shot was in my left arm. The Dr. at urgent care said it was not a stroke, so that's good. I have never experienced anything like this before. It has now been over 13 hours.

The shot was administered in my left arm. I experienced localized swelling and axillary lymph node tenderness immediately after injection under my left armpit. The right side of my face also became numb for about 5 minutes. The next morning the areas around my eyes were swollen and I had two styes in my right eye. I do not know if these were related. These symptoms lasted approximately 3 days. Some minimal swelling and tenderness seemed to remain, and approximately a week later I experienced a painful resurgence of the swelling at the injection site that was far larger, harder and more painful. I took Benadryl and Ibuprofen. These relieved the symptoms within 48 hours.

Ear ache started on 1-19-21 and started antibiotics. Rash on ear started 1-22-21 Facial paralysis on right side of face on 1-25-21 Went to ER on 1-25-21. Diagnosed with herpes zoster oticus. Started treatment of Valacyclovir and Prednisone. Treated by ENT on 1-29-21. Had hearing test and no hearing loss was detected. Prescribed stronger dose of prednisone because there was not any improvement in facial paralysis. Still experiencing facial paralysis on the right side. It?s unknown if it will be permanent.

I was given the Moderna covid vaccine on January 21. I only had swelling and redness to the injection site. But today my back is covered in swollen red spots that are itchy and my lips are extremely swollen. I have not used anything different on my body nor have I consume anything different.

Moderna Covid Vaccine second dose Fever and chills Muscle aches Redness around injection site Sore eyes

Bilateral neck stiffness with limited mobility, nausea and vomiting. Started next day and persisted. ER visit on 1/12 migraine cocktail and bilateral nerve blockers no assistance. Used anti-inflammatory meds, acetaminophen and Zofran for daily treatment. Progression of symptoms got worse occurring with double vision. Had ER visit after several test listed below diagnosed with aseptic meningitis. Placed on pain killer and steroids treatment to subside symptoms.

Shortly after receiving shot (within the 20 minute observation period) patient began to feel very dizzy to the point of not feeling steady enough to stand. He said he felt like his head was being compressed. His lower lip began to feel numb and tingly, eventually this feeling spread into his mouth and throat. He was coherent the entire time. He received oral Benadryl while waiting for his wife to arrive to drive him to the emergency room.

Acute left sensorineural hearing loss with tinnitus. Significant hearing impairment noted on audiometric evaluation. Symptoms began a day after receiving the second dose of the moderna vacccine.

Elevated heart rate (130 at rest for 10+ hours, my normal is 70-80) Elevated blood pressure (150/89 at rest for 10 + hours, my normal is 110/70) Extreme headache, light sensitive Nausea Mild anaphylaxis itching/burning/tingling in lips, tongue and throat Feeling of intoxication, disoriented, slurred speech, dizziness Rash/redness that spread beyond injection site on to back of shoulder Agitation Itchiness Peeling of skin in mouth/cheeks Blisters on roof of mouth Chest tightness with normal breathing Jaw pain Treatment as listed below; continue with Benadryl every 6 hours and ibuprofen; return if symptoms continue or worsen

Patient reported tingeling sensation in his throat and "a lump in his throat" about thirty minutes after receiving the vaccination. 100mg of Benadryl was given per standing order protocol. Recommended patient contact PCP or immunologist for guidance on 2nd dose.

10:05 AFTER RECEIVING INJECTION TO L DELTIOD CLIENT C/O MOUTH AND BACK OF TONGUE SWELLING. B/P 150/112, R-18 EVEN AND UNLABORED, P-86 AND REGULAR. CLIENT ALERT AND ORIENTED. FACE AND TONGUE ASSESSED; NO SIGNS OF SWELLING NOTED. FACIAL SKIN TONE APPEAR PALE AND ASHEN. NO SWEATING OBSERVED. CLIENT REFUSED EPI INJECTION. 911 CALLED. 10:15- B/P 162/128 R- 18 EVEN AND UNLABORED, P-68 AND REGULAR. CLIENT IS SPEAKING WITHOUT DIFFICULTY. ALERT AND ORIENTED. CLIENT CONTINUES TO APPEAR PALE WITH NO SWEATING. CLIENT CONTINUES TO REPORT TONGUE FEELING "NUMB". ADVISED CLIENT TO DISCUSS 2 ND WITH PCP. 10:18-B/P 165/122 BY EMS. CLIENT ALERT AND ORIENTED. SPEAKING. RESPIRATION UNLABORED. 10:25- CLIENT LEFT FACILITY VIA EMS ALERT AND ORIENTED TIMES 5.

Within minutes of receiving my Moderna Covid-19 vaccine around 5pm, my left eye felt irritated. I didn't think much of it but it stayed slightly irritated. About 1am, as I prepared for bed, it had become red and was quite irritated. I went to sleep and woke up in the middle of the night and my eye was quite irritated and it was filled with tears. The next two days it remained irritated in this way, red and painful. As of now (over 48 hours later), it is still red and irritated.

Received first dose of Moderna vaccine on Tuesday 2/23/2021 and began to feel tingling on the right side of my head and an ear ache the next day (Wednesday 2/24/2021). The symptoms got progressively worse over the next few days and on Sunday 2/28/2021 the right side of my face was completely paralyzed. I sought emergency care at Hospital Emergency Room where I was diagnosed with Bells Palsy. The doctor who treated me strongly believes that the Bells Palsy was due to the Moderna vaccine. Today (9 days post vaccine) the entire right side of my face continues to be completely paralyzed with no signs of improvement.

All symptoms started 6 hours after second moderna vaccine - CC - Fatigue ++, swollen glands, body aches - back pain, fever. Fever for 5 days. Bad headache. + bleeding gums 3/4/21 with rash to hands, arms today.

On 28-FEB-2021, at approximately 2000, I developed left facial numbness felt on top of the left forehead, left eyebrow, left nasal bridge, inside of left nose (nares), top and bottom of left lip, left side of the cheek, and left side of the tongue. Left eye blin is weak and unable to fully close left eye. Left ear was aggravated and irritated when scratched. Hearing is distorted, felt as if I had been submerged in water for a prolonged amount of time. There is ringing at times on left ear as well. Symptoms were progressive. Today (05-MAR-2021), also developed vertiginous sensation and light-headedness.

Dry mouth, dizziness and throat tightness. Benadryl 25 mg oral administered by . Pt was observed for an additional 30 min, symptoms improved. Pt discharged home.

04:01: pt received Moderna vaccine injection. 04:21 pm left eye slightly swollen. Pt did not report until 04:31pm. pt was told to wait so we can treat it but he refused. Pt states that he will take Benadryl at home. pt states that he gets this kind of allergic reaction constantly and he takes Benadryl. pt states that this allergy is mild. he has experienced worse swollen eye than this. pt advised to go to E.R if symptoms continues or worse. he was also told to follow up with pcp asap. pt signed a waiver and left. pt left at about 04:45 pm. no change in eye condition.

Fever, chills, extreme muscle pain beginning 12 hours after second dose and lasting 24 hours. Extreme nerve pain in face and head and metallic taste beginning on 3/6 overnight and continuing to worsen over the next 72 hours. Within 48 hours of onset of symptoms, facial paralysis and loss of taste (suspected Bell?s palsy, awaiting confirmation) began in addition to worsening pain and extreme discomfort. Still ongoing.

Acute hearing loss in right ear. Muffled, ringing sound one day after vaccine administered. Was sleeping and heard a high pitched sound from right ear. Waited several weeks for it to clear up. Finally went to my PCP and was started on steroids. That did not help. Saw an ENT specialist and restarted on another round of steroids.

Patient states that approximately 2-3 days post-injection he began to have swelling in throat, neck, jaw, and ear on the left side of body. He states that it was severe swelling and that he had difficulty swallowing. States that he took OTC antihistamine in large doses. Rates the severity of his condition on a scale as 10/10. Approximately three days post onset, he states his condition is now 6-7/10.

Patient received vaccine on 3/6/21 in the afternoon and his symptom started in the early morning of 3/7/21 continuing today with subjective fever, chills, facial pain, and mouth blisters. Has used APAP for fever control, last dosage yesterday night. Patient complains of difficulty eating due to lip swelling and blisters. On physical examination, patient is afebrile, has lip angioedema and multiple blisters on perioral region. Patient has difficulty opening his mouth due to lip swelling and pain. Patient was prescribed prednisone 40mg po qd for 5 days, acyclovir-hydrocortisone 5-1% topical, Lidocaine oral viscous solution for oral pain control as needed, OTC ibuprofen recommended as needed

Patient received vaccine at 3:15 pm on 3/12/21 and stayed in pharmacy area for 15 min (he left feeling fine). After about an hour 4:15 he showed back up at the pharmacy telling our pharmacy technician that he lost his voice and his throat was closing. She rushed him to the waiting room where I, pharmacist, came out and asked him what was going on. He stated he was with a client and suddenly lost his voice, and felt his throat starting to close. I asked if he was having trouble breathing and he said yes because his throat was closing and his whole arm was tingling. I had him take his mask down and try to take a few deep breaths first. I asked for permission to administer an Epi-pen which he gave verbal consent. 911 was called. Patient stated he did not want 911 called because he was going to refuse service. After a min or so patient stated his throat was back open and he was feeling good. I informed him paramedics are on their way and he needed to stay in the waiting room because effects of the EpiPen can wear off in 15 min. I stayed with him and watched until paramedics arrived. Paramedics sat with him and he did refuse service (they did take his blood pressure). When paramedics asked the patient about when he came in they asked if he was having trouble breathing and he responded "no I could breathe, my voice was just hoarse" (which is the opposite of what he told the technician and myself). He also sounded like it was very hard to breathe. I did information to the paramedics after saying that he told us his throat was closing of which they stated that they figured that was the case and they knew the patient and assumed he would refuse service. Patient was in contact with his primary care doctor who told him he could go home if his BP was ok but to make sure he had someone to drive him home. Patient had his wife come to get him and they left.

Until 1 week after Moderna 1st dose (030M20A) on Sat. 2.13.2021. Within few hours, developed dry cough and later slight fever, runny nose, and pimple like on the back of the tongue. Bleed start when scraping the tongue after brushing teeth. One week later on Sunday 2.21 the coughing started and stay consistent (over the counter cough and flu med did not do anything) until the week of 2nd dose...Called doctor on March 9, 2021 with chronic dry coughing. I had concerns abt 2nd dose due date but he approved and told me to take allergy med and prescribed benzonatate. The benzonatate was useless against the cough and only the allergy helped stopped the coughing!

Patient felt to be in distress at the close of his observation time. He was complaining of trouble with focusing his eyes, left sided chest pain, and was diaphoretic. Pt appeared to be in moderate distress and very anxious. I examined the pt through the car window and listened to his heart and lungs. Pt was not in respiratory distress and heart rate and rhythm were regular. Reassurance was provided to the pt, but he was also told that to be safe I recommended that he be evaluated in the emergency department and that he be transported via ambulance. Pt expressed understanding and agreed to going to the ED but was refusing transport via EMS. Pt was the passenger in the vehicle and he said that the driver could just take him. I expressed that transport via EMS would be the safest but we could not make him go via EMS and that if they wanted to leave via private vehicle then they could but i still recommended that he be evaluated in the ED. He expressed understanding and that he would go directly to the ED via personal car.

1 hour after shot, felt: Chest tightness Increased heart beat Felt warm in face Difficulty breathing Loss of taste Lasted about 1 hour. Chest tightness and difficulty breathing were mild and intermittent. Occasional chest pain. Nothing severe just felt uncomfortable. After symptoms subsided, contacted doctor who recommended I go to urgent care to be checked out.

Approx1255: Patient stated he was not feeling well, light-headed. Patient pale, sweating. He asked to lie down. Encouraged to take deep breaths. Patient asked to step outside of room, assisted to hallway chair for air. Wife at side, encouraging to take deep breaths. Patient stated he could not see us and slumped in chair with eyes open and glazed. Shallow breathing, unresponsive to sternal rub. Lips noted to turn purple-blue and then gray. Called for assistance and LVN at patient side obtaining VS, patient took deep breath and started to become responsive. VS at approx. 1303: BP104/47, HR 57, 02 Sat 95%. Patient talking, continued pale and diaphoretic. 911 called and EMS arrived at approx. 1305 Transferred to hospital.

A little less than 3 hours after getting the shot, I noticed the injection site was getting very sore. Within about a half hour of first noticing it, that entire muscle was aching a lot. It?s now 4:50pm and it hurts to lift my arm, reach for anything, I can even feel it just by typing this out. I?ve also noticed I?m pretty tired, my joints feel very achey like when I have a cold, and I?m incredibly thirsty. The pain in the muscle at injection site is by far the worst symptom though. It?s extremely painful. I did not expect that since it didn?t hurt when getting the actual shot. Took my temp and it?s normal. The aching joints are far less painful than my arm, but are an issue nonetheless. Had I known this would happen beforehand, I would still get the shot, so as long as it doesn?t get a lot worse or something else haplens, all in all I?d have to say it was worth it.

Patient had facial twitch and his tongue felt like it had a film on it around 3/17/2021. Patient had right sided facial paralysis starting 3/21/2021. Patient went to the ER that day and was diagnosed with Bells Palsy. Was Given IV steroids that day in the ER and was put on oral Valtrex and Prednisone. Patient was told that symptoms were caught early. 3/24/2021 patient reports that symptoms are starting to resolve and he is starting to get more feeling around his mouth.

Began to have tinnitus after ~5 hours, fullness of ears and pain in face/right ear. Have no history of tinnitus. Approximately 5 days later, began to experience vertigo. It is now 8 days and there has been no reduction in either symptom after being subscribed prednisone.

Second dose received on March 17, 2021 (same clinic). Starting on Wednesday, March 24 my tongue felt numb (dime size, center of tongue) - could not taste in that spot but rest of tongue was ok. It progressively got worse - Saturday, March 27 and Sunday, March 28 felt foggy, more numbness on left side of face, specifically lip area. On Monday, March 29 speech was slurred, numbness was worse. Sent photos to neurologist due to concern for stroke and he said call my PCP and my PCP said to go to the ER. Diagnosed with Bells Palsy.

c/o weird tingling in throat and dry mouth, BP111/78 P81, water given and observed, s/s went away, staff walked pt to car, driver present

10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID-19 vaccine with associated hypotension, bradycardia, diaphoresis, and visual disturbance (spots in his vision) that self-resolved after being shaken.

PATIENT PASSED OUT AND APPEARED TO BE HAVING A SIEZURE WITH EYES ROLLING BACK IN HEAD. HE WAS SLUMPED IN CHAIR. NON- RESPONSIVE. wAS ABOUT TO ADMINISTER EPINEPHRINE , WHEN HE CAME TO. HIS VOICE WAS WEAK AND SAID NO TO EPI. HE WAS DIAPHORETIC AND VERY PALE. EMS CAME ONTO SCENE AND TOOK OVER. BLOOD PRESSURE WAS 80/53 PER EMS. HE REFUSED FOR THEM TO TAKE HIM. WIFE WAS CALLED AND CAME TO GET HIM BUT HE HAD TROUBLE STANDING AND HAD TO SIT AWAHILE. IT WAS ABOUT 45MINUTES BEFORE HE EXITED WITH ASSISTANCE. ATTEMPTED TO CONTACT HIM LATER AND HAD TO LEAVE MESSAGE

4/1/2021 1:15 PM T 98F P 72 B/P 180/130, 1:30 PM T 99F P 77 B/P 160/110, 1:45 PM T 97F P 77 B/P 170/110, c/o metallic taste, felt very anxious, lay in supine position on First Aid cot, ice packs to patient's head and neck at request of patient, requested and tolerated water, became dizzy when lifted head, lay back down for 15 minutes, taken via w/c to van for girl friend to drive home, advised to go home and rest, ambulatory without symptoms at time of discharge to home.

Right eye pain within 30 minutes leading to blood in scalers. Sclera appears to have broken blood vessels throughout bottom half of eyeball. Woke up following morning with crust similar to conjunctivitis.

I have been experiencing Tinnitus in my left ear (vaccination side) since the 9th day after vaccination. The mild ear pulsing feeling comes frequently in a day, and it may last a few seconds every time.

Headache, dry throat, dry eyes, fever, chills, achy joints, upset stomach, dizziness, tired, nauseous.

vision right eye/left eye became little blurry; pain behind the right eye/left eye; losing vision in right eye; hurt behind the eyes; seeing double at a distance; excruciating headache; puking/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (losing vision in right eye) and SCLERITIS (hurt behind the eyes) in a 40-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 No adverse event. Concomitant products included IBUPROFEN for Back pain, ACICLOVIR SODIUM (ACYCLOVIR) for Cold. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced HEADACHE (excruciating headache) and VOMITING (puking/vomiting). On 06-Apr-2021, the patient experienced SCLERITIS (hurt behind the eyes) (seriousness criterion medically significant) and DIPLOPIA (seeing double at a distance). On an unknown date, the patient experienced BLINDNESS (losing vision in right eye) (seriousness criterion medically significant), VISION BLURRED (vision right eye/left eye became little blurry) and EYE PAIN (pain behind the right eye/left eye). At the time of the report, BLINDNESS (losing vision in right eye), SCLERITIS (hurt behind the eyes), EYE PAIN (pain behind the right eye/left eye), DIPLOPIA (seeing double at a distance), HEADACHE (excruciating headache) and VOMITING (puking/vomiting) outcome was unknown and VISION BLURRED (vision right eye/left eye became little blurry) had not resolved. Treatment medication was not reported. Very limited information regarding these events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Diarrhea from the second day after the vaccine until today. Blurred vision. Numbness of the face and arms. Pain in legs and feet. Headache.

Patient reports facial drooping with onset approximately 36 hours after vaccination with the first dosage of the Moderna COVID-19 vaccine. Reports difficulty closing the left eye and drooping of the left corner of the mouth. Denies left eye pain and dryness. Denies hyperacusis. Denies fever. Physical examination shows left-sided flattening of the nasolabial fold and forehead. Bell's sign positive in the left eye. Reduced facial movements on the left side. Provisional diagnosis is Bell Palsy. Patient was prescribed prednisone taper and referred to neurology and PCP.

What a nightmare. Moderna shot #1 caused rapid hair loss and arm soreness for a week and low grade nausea. But shot #2, holy moly... 12 hours post shot, I developed a fever, chills, violent shaking much of the night, weight loss, nausea, kept throwing up, massive migraine, heart rate racing, every cell in my body throbbing in pain, difficulty urinating, simply staying alive was exhausting. It faded a couple days after the shot, and in its place, fatigue, difficulty getting a full breath in. And now I have tinnitus--constant ear ringing. Absolute torture. And of course significantly more hair loss. So let's add anxiety and depression to the list because of this hell. What a regret it was to get injected with this poison. Rather just keep masking and avoiding people than be stuck with these permanent, life debilitating problems. I know it wont change anything, but I figure I'd report it anyway. What a nightmare. This crap should not be given to anyone with an autoimmune disorder.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/21. Lot#026L20A; 2nd dose: 01/27/21, Lot# 029L20A; Diagnosed covid positive: 03/31/21; Exposure: Unknown; Symptoms: Nasal Congestion, loss of smell.

Visual defitict: floaters and blurry vision, headaches, swollen lymph nodes, involuntary tremors, numbness and tingling, progressively worse since his 2nd Moderna vaccine on March 29, 2021 Unable to see neurologist, earliest appointment 30 days out.

Severe drop in blood pressure, dizziness nausea.. 48 hours after tingling in tongue, roof of mouth,gums..itching on back and legs..

Left face swelling along jaw line, exacerbated by chewing, painful when eating, but otherwise just sore. No issues with breathing

Two days after receiving my 2nd dose, I began experiencing tinnitus in my right ear. It sounds like a low, rumbling, "whooshing" sound that intensifies when hearing sounds with low/bass frequencies. So far, I've tried treating it by flushing out my ear and applying ear drops, but it has not been effective.

Roughly 45 hrs after receiving the second shot on 3/26/21, I woken up to very noticeable / semi loud constant ringing in both ears. The volume of the ringing had reduced during the day, but it was constant until the evening when it went away. On 4/12/21, I had woken up to the ringing again and has been constant in both ears ever since and still continues to this day, 4/26/21. It is very noticeable and a loud high pitch ringing that occasionally seems to vary in volume, but still very unnerving as it has been almost 2 weeks of constant tinnitus.

He got the vaccine, and when he woke up the 2nd day his throat felt dry and felt like it was sore. His arm felt sore as if somebody hit him several times, very sore. I felt sick, felt queasy, nauseous wanting to vomit but did not. He felt really tired, fatigued because he didn't get any sleep that night. He went all day feeling terrible, nauseous, felt like being through the ringer an flushed, which went on for 2-3 days. He now feels a lot better, but felt like he was getting the flu. He did not take anything for it and did take some medicine to help him sleep and did get a lot of rest and sleep. He did drink a lot of liquids to keep his throat lubricated. He also did have a throbbing headache, which he normally does not get headaches and felt terrible. He did take some aspirin for that. The symptoms have all resolved and feels perfectly fine now. Stated that he has never felt so bad in his life.

Pt called at 1502 4/21/2021 regarding of left eye got red after covid vaccination. Pt denies emergency s/sx. Noted no health issue currently. Pt describes his left sclera part of eye got red this morning after covid vaccine without swelling.

I developed pulsatile tinnitus in my right ear about 24 hours after the shot. Didn't think it was a big deal at first but it came back every evening and even now my ear still feels weird all the time even when the whooshing goes away. For about three weeks it came back nearly every night now it just happens on random nights. I didn't get my second shot because I didn't want to risk making it worse. I am very-much a vaccine advocate but I think it's strange that I never hear anything about tinnitus as a common symptom. When I went looking I immediately found a TON of anecdotal evidence of the Moderna vaccine causing tinnitus from people stories almost exactly like mine. More should be done to understand this.

Tinnitus, muffled hearing/ loss of hearing, pressure in both ears. Seen by NP at Couldn?t find cause. Wanted to refer to ENT Dr.

Patient with known shellfish allergy and mention of being a hypochondriac. NP advised patient to wait 30 minutes in pharmacy area after receiving vaccine and longer if needed. Patient stated that he experienced a dry/ itchy throat after receiving his first dose of the Moderna vaccine which self resolved within 2 hours and did not require Benadryl. Patient here for his second dose of the Moderna vaccine at 16:13 on 5/3/21. At 16:28 patient stated that he was experiencing a dry/ itchy throat, swelling of his uvula, and difficulty swallowing. Benadryl was given to the patient at that time. After taking, patient stated dry throat improved and symptoms did not worsen. Patient purchased Benadryl for home and left the pharmacy area with his wife at 16:50.

Patient became weak . diaphoretic and was observed to have full dilation of pupils. Patient became unresponsive, un able to obtain a pulse. Patient lowered to the floor. Patient became responsive but remained disoriented. Paramedics were called. Patient had orthostatic hypotension and became bradycardic.(NR 30 BPM) He was transported to ED of Hospital. Patient indicates that he has a fear of needles and got "woozy" after immunization. Patient had two syncopal episodes. Patient reports having similar episodes in the past with blood draws. BP in ED was 113/61 and 111/60, EKG normal

pt reports ringing in his ears that has been occurring intermittently. This started two days after his vaccination (1st dose Moderna). He says that at times it goes away and then comes back. He said that last night the ringing was so bad he was not able to sleep.

Sudden onset of muscle spasms approximately 16 hours after 2nd Moderna Vaccine for COVID-19 followed by: ?Low-Midgrade fever,Dizziness, Dry Mouth, Muscle Pain, Injection Site Pain, Difficulty Swallowing, Chills, Skin Sensitivity, Teeth Grinding, Loss of Appetite, Loss of Sense of Time, Feral Hallucinations, Feelings of Regret.

Seizure; Spike Body temperature; Swollen Lip; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), BODY TEMPERATURE INCREASED (Spike Body temperature), LIP SWELLING (Swollen Lip) and HEADACHE (Headache). At the time of the report, SEIZURE (Seizure), BODY TEMPERATURE INCREASED (Spike Body temperature), LIP SWELLING (Swollen Lip) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: inconclusive (Inconclusive) temperature is not coming down, it is not going up, but it is also not coming down. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included paracetamol. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I have developed bilateral Tinnitus accompanied by occasional headaches. The ringing has not stopped since it began approx 10 days after the first doese.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Vomiting-Medium, Additional Details: Five minutes after administering the vaccine, the patient was dizzy with blurred vision. Soon thereafter, he vomited. Once he completed vomiting, patient stated that he "felt a lot better". Blood pressure was normal at 115/85. He contacted his wife to pick him up. Follow-up call: Patient stated that he had no reaction after.

PT BEGAN TO C/O TONGUE NUMBNESS, TOP OF MOUTH SWELLING AND TONGUE GETTING "THICK", PT GIVEN 50MG OF BENADRYL IM MONITORED FOR 40 MINS, RIDE CAME AND GOT PT, PT EDUCATED ON S/S OF ANAPYHYLACTICS AND WHEN TO CALL 911 SUCH AS INCREASE TONGUE SWELLING, SHORTNESS OF BREATH, HIVES. PT VERBALIZED UNDERSTANDING.

Patient received COVID-19 vaccine at 10:00am. Developed facial swelling (lips, eyes, face) 2-3 hrs later. Went to ER on 5/19/21 @ 06:00. Was given "2 shots" and observed x 3 hrs, then sent home with Benadryl.

missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown. No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

pt had redness in left eye. He had a small bump in his eyebrow and more redness around his nose. The redness was spreading on his face. On 6/1/21 he went to PCP. He was diagnosed with Herpes Zoster. He was prescribed Valtrex. He says the headaches are getting worse and has deep internal face pain so he called doctor and will have a FU phone appt on 6/2/21.

I have developed tinnitus in both ears which is massively effecting my quality of life. Fatigue Headaches all of the time Periods of confusion/brain fog Dizziness

My gums turned purple for 3 days starting on February 25th. I also developed canker sores. It ended up going away

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient had some dizziness, pale color, fell out of chair and on to floor after receiving shot. patient was alert and responsive, sat down again and held on to counter for about 30 minutes. patient stated he no longer felt dizzy or strange. I took patient's BP and it was 99/58 with HR of 55 bpm, patient stated he is very fit and this was normal for him. I allowed patient to leave at that point, contacted him on 6/22, he said he was well and had experienced no additional issues after leaving.

After 12 hours, I threw-up & felt very weak. Also, sensitive to motion. I felt normal after a nights rest, but my sense of smell & taste were gone. Plus, increased congestion. After a month, the senses are only slight. I had visited my PCP & received a negative Covid test. I can't understand why my senses have not returned.

Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Has loss of vision in right eye) (seriousness criteria hospitalization and medically significant) and HEADACHE (Has headaches) (seriousness criterion hospitalization). The patient was hospitalized on 21-Jun-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEADACHE. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) outcome was unknown. No concomitant medication information was provided by the reporter. Treatment information was unknown. It was reported that the patient experienced stroke 3 days after receiving the 2nd dose of the vaccine. He was hospitalized on 21Jun2021. Patient also had headaches and loss of vision in right eye, and both started the day of stroke. 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.

Woke up with light sensitivity and head pressure. Have had continued difficulty with foggy feeling, light sensitivity, and tingling in hands and face. Not been able to think clearly for 3 weeks.

Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers. Suffer from migraines, sensitivity to light. nerve pain. Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.

48 hrs after the vaccination, both ears started ringing intensely. The initial level was a 5 and it went up to like a level 10 at night. It stayed persistent for almost 6 weeks. The intensity decreased over time. It averaged out to a level of 4-7, it had gone from a level 10 down to a maximum of a range to 4 to 7 on May 8, 2021. It eventually stayed within that range and it would go down to level 2. After 06/21/2021 it got to a point were it was unnoticeable. It still randomly comes back to a level 5. But now it's at level 1. I had the Dose 2, on 07/12/2021, and I don't notice the ringing but sometimes it randomly comes back at a level 1.

FLUSHING, STIFFNESS IN LEFT ARM MOVING UPWARDS TOWARD NECK. NUMBNESS IN THROAT/MOUTH/FACE. ADMINISTERED ORAL DIPHENHYDRAMINE 25MG AND CALLED PT'S PCP. PCP WAS ABLE TO SEE PATIENT IMMEDIATELY AND PATIENT TRANSPORTED TO THE OFFICE (ON-SITE).

Developed minor stabbing pain in L temporal/occipital region. Intermittent within first ten minutes. Also felt slight sharp pain in meatus of L hand within first 30 minutes. Also intermittent and resolved within a few hours. Slight headache the following day that would come and go. Developed L side abdominal sharp pain (4/10) within one hour. Pain persisted for more than 24 hours, is tender to palpation. Developed stuffiness and slighlty itchy eyes in first 30 minutes. Had some minor skin itching in various places with no discernible hives. I develped a brief hive 12 hours later on my leg but it is not uncommon for me to get an occasional hive on my skin as I have sensitivites to various fabrics, etc.

Reported numbness in lips and L Malar area; no angioedema Narrative: Employee was taken to facility in wheelchair, evaluated and stable. Diagnosis vasovagal due to needle anxiety vs mild allergic reaction to MODERNA vaccine. Given 50mg Benadryl and Solumedrol 125mg IM. Monitored for 30 minutes, completely asymptomatic. Release home in care of wife.

Bell Palsy Type Symptoms on the right side of my face. Sun the 17th I began to feel my tongue tingle. Thought I had burn my tongue on hot food. Didn't think anything of it, Monday my right eye began to water like crazy. Didn't think anything of it. Tuesday morning I had a hard time eating breakfast because I couldn't open my mouth wide enough and was hitting my bottom lip with my teeth. i thought it was strange but didn't think anything of it. Took a shower about 11;30 and when I looked in the mirror I notice the ride side of my face was not responding like the left side, I called my doctors office and they got me right in. After a brief consultation they called ER and told me I would be on my way. I checked into ER at about 1;30pm.

Pt was driving down the road 18-24 hours after receiving vaccine when all of a sudden he experienced dizziness, rapid heartrate, headache, blurred vision, hives to chest and arms, edema and redness at injection site. Pt went to Hospital via EMS on 1-21-20 and was given 50mg Benadryl on ambulance. Pt states that he was diagnosed with a "reaction to the vaccine and I was given prednisone, pepcid and Tylenol in ED." Pt was called on 1-22-21 by Public Health nurse and states that he was feeling much better today but still had the redness and swelling at injection site.

Assessed onsite by EMT for an allergic reaction. Presented with a left swollen lower left eye, vitals sign normal, no rash or hives, no trouble breathing. Patient provided by EMT with benadryl 25 mg, self administered by mouth at 12:08 pm. Patient was reassessed by EMT at 12:15 pm with notable improvement. Released by EMT to caregiver.

Cold sore inside part of lip, single angiodema type rash/hive on outside part of lip directly opposite cold sore, elevated resting heart rate at 95-105 (normal 71-80

The following day I was tired and my head felt like it was in a fog and I couldn?t focus my eyes. The top of my head was sensitive and I started running a low grade fever (99.1) at about the 26 hour mark from receiving the 2nd shot. Symptoms persisted until about hour 36 when the fever broke. By hour 48 I felt much better but had low stamina. At hour 60, I feel completely normal.

Had a very slight ache in back of neck about 30 min after shot. About 4-5 hours later my glands leading from the neck to my ears on both sides felt slightly swollen. It was not painful, but noticeable - sort of how you feel when you can tell a cold is coming on. My tongue also felt slightly swollen and a little bit of dry mouth. symptoms disappeared By the next day.

Symptoms began just after midnight the following day of shot. Between midnight and 2 am Isuffered from severe chills and sweating. When I woke up at 5 Am I suffered from severe headache. Remainder of the day I had extreme digestive issues that continued over the next several days. At the conclusion of the second day I developed a fever of 101. Pinpointed severe pain developed at the base of my neck between my shoulder blades. That pain remained for approximately 24 to 48 hours that lead to extreme pain and stiff neck on my right side. Chills and periodic fever developed for two days past shot. By day three I had extreme right side neck pain that continued down into my right shoulder blade. By day four and five I suffered from extreme neck pain and severe headache that was focused from my right eye through my head down the right side of my neck to my right shoulder blade. By day 4 this continued with dizziness and blurred vision. I had inability to eat and strong feelings to vomit but only didn't because I hadn't consumed any food that day. I continued to suffer from extreme headaches and complete physical exhaustion with inability to stay away. In addition, I continued to have periodic chills but with no fever. As I submit this in day 5 I still suffer from lack of energy and the stiff neck remains down through my right shoulder blade.

1/29/21 0700 received vaccine 2100 started not feeling well fever of 99 1/30/21 0300 fever was between 102 and 103.5 1000 fever stayed around 101 to 102 1/31/21 1000 fever was down to 99 and disappeared around 1500 2/4/21 I started having a sore throat and some mild ear pain. 2/5/21 ear pain was getting worse. 2/6/21 ear pain was very bad 2/7/21 went to the clinic they gave me amoxicillin for and ear infection 2/10/21 ear pain was still the same and things were not getting any better. I called my doctor and he switched me to amoxicillin-clav. I was not able to pick it up until 1/11/21. 1/11/21 my left eye started bothering me and if felt like pink eye. 2/12/21 I started getting a metal taste in my mouth and it started feeling numb. I called my doctor back around 1300 and he told me to switch back to the regular amoxicillin. By 1640 my vision in my left eye started to get blurry and my entire left side of my face was numb and paralyzed =. My doctor told me to go to the ER. Being the stubborn person I am I didn?t go right away. 2/13/21 I went to the hospital. I was diagnosed with Bell?s Paulsy. The doctor did not seem to think I had an ear infection. My entire left side of my face is paralyzed. I still have pain behind my right ear and around the ear canal. My vision in my left eye is terrible. My speech is getting slurry. 2/16/21 I followed up with my primary doctor. He is hoping with the treatment I'm on this will go away in 1 to 2 weeks. He encouraged me to fill this adverse reaction form out. I have a follow on 2/17/21 with and ophthalmologist for my blurred vision.

Pt reported throat feeling tingly and tighter ~20 minutes after vaccine, thought it was normal. Later that day, pt experienced tongue swelling and trouble breathing. Went to urgent care, got steroid treatment. Still lasted after several days. Went to the hospital, got more steroid treatment. Pt reports it is "on and off" now, 4 weeks after first dose. No history of allergic reactions to other meds/vaccines.

Patient stated that the day after receiving the Moderna vaccine he started having issues with his vision and issues seeing color. Patient also states he felt like his body was locking up and aching all over. Pt started having rash on his arm today (4 days post injection).

Patient received first dose of Moderna covid-19 vaccine and went to the 15 minute monitoring area. Per the ED notes patient felt dizzy and developed tunnel vision prior to the patient passing out 15 minutes after getting the vaccine. Similar episodes in the past due to fear of needles. Patient was on floor and rapid response called, patient taken to the ED for evaluation and was discharged in stable condition with vasovagal syncope.

Headache, Metalic taste, Monitored for 30mins. 17:32 Headache better, instructed to F/U with PCP if symptom returns or worsen, state understanding left for home.

After first shot of Moderna, I had light headaches during the first 5 days. Then I start hearing noise in the right hear... when walking every steps is resonating in my ear. I can clearly hear a degradation of my hearing. Driving a car makes some noise in the hear.

4:30pm- vaccine given. 4:40pm- client reported having a 'weird sensation' in the back of his throat to EMT. 4:45pm- 25mg PO benadryl given. In stable condition. Declined SOB, itching, hives. No angioedema noted. 5:00pm- client states no worsening or improvement of 'weird sensation' to the back of his throat. Another 25 PO benadryl given. 5:15pm- client reports all symptoms resolved. Monitored and left at 5:25pm. Declined any further medical care during time in public health vaccine clinic.

Moderna COVID-19 Vaccine Allergic reaction happened about 2:30 min after the injection, with eyes swelling, right eye more than half covered. Congestion, runny nose, itchy back of tongue and palate. I consulted with my healthcare provider (Dr, not the pharmacy that administered the shot) to know what to do and since I didn't have any noticeable breathing problem, she advised to take some Benadryl and monitor. Lot number was handwritten so 1st, 2nd, fifth and sixth characters have been interpreted as above. first character could be a O, 0 or D. Second and sixth character could be a I or 1. Fifth character could be a 2 or Z.

Left sided Bell's Palsy starting 12 March with numbness and change in the taste in his mouth. By Sunday, March 14 she started to develop left sided facial weakness, particularly his mouth. He denied any drooping on his mouth and noted some drooping near his nostril. He was also unable to move his eyebrows on that side. Starting on Monday, March 15 he began to have difficulties closing his left eyelid.

Dizzy; short term memory sucks and it's frustrating; Can't see well; Fibromyalgia; bone pain; Neuropathy; Feeling aches in the body; Bells palsy-paralysis on the left side of the face/ pressure on the left side of the face and neck; headache; Ringing in the ears; Pressure in the ears; A spontaneous report was received from consumer concerning a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pressure in ears/ear discomfort, ringing in ears/tinnitus, pressure on the left side of the face and neck which was found to be Bell's Palsy/facial paralysis, Headache, neuropathy peripheral, fibromyalgia, memory impairment, couldn't see well/visual decrease, feeling aches in the body/myalgia, and dizziness. The patient's medical history included neuropathy and fibromyalgia and past cancer. No relevant concomitant medications were reported. On 03 Feb 2021, the patient received the first of two doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 24FEB2021 the patient began experiencing pressure and a ringing in the ears and then started like a pressure on the left side of the face and neck. On 25FEB2021, the patient started having a headache and on 26FEB2021 the paralysis on the left side of the face began. The patient said that it worsened, couldn't eat, couldn't speak, and went to the hospital. The patient said that they had a CT Scan, and the result was that it wasn't a stroke. Vitals were taken and blood work came back normal. The conclusion was Bell's Palsy. The patient stated that they couldn't see well and were dizzy. The patient said that they were experiencing fibromyalgia and neuropathy that they had when they had cancer. The patient also mentioned that they were experiencing some bone pain and that their short term memory was not good and was frustrating. Treatment of these events were not reported. The outcome of the events, ear discomfort, tinnitus, facial paralysis, headache, neuropathy peripheral, fibromyalgia, memory impairment, visual decrease, myalgia and dizziness were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of neuropathy, fibromyalgia and past history of cancer remains the contributing factors. Further information has been requested.

Diarrhea; Injection site is sore; Felt hot; Pain from my arm radiated into my armpit; The most intense, crazy, scary nightmare that I've had in my entire life; Iodine flavor in his mouth; A spontaneous report was received from a consumer concerning for himself a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most intense, crazy, scary nightmare that i've had in my entire life/nightmare, iodine flavor in his mouth/dysgeusia, diarrhea, pain from my arm radiated into my armpit/pain in extremities, felt hot, Injection site is sore/ Vaccination site pain. The patient's Current Condition included TMJ. Concomitant medications reported were hydrocodone, Carisoprodol both used for TMJ. On 13Mar2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 13Mar2021, the patient experienced the event iodine flavor in his mouth. On 15Mar2021, the patient experienced the event most intense, crazy, scary nightmare that he had in his entire life and the same day he visited Emergency room. On an unknown date, the patient experienced the events diarrhea, pain from my arm radiated into my armpit, felt hot and injection site was sore. The event pain from his arm radiated to armpit was reported medically significant. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of events, most intense, crazy, scary nightmare that he had in his entire life, iodine flavor in his mouth, diarrhea, pain from arm radiated into his armpit, felt hot, injection site was sore was unknown, at the time of this report.; Reporter's Comments: This case concerns a 41 Y/O M with a serious unexpected event of pain in extremity and nonserious unexpected diarrhea, dysgeusia, feeling hot, nightmare, and expected vaccination site pain. Event onset the same day as first dose mRNA-1273. Treated with hydrocodone and Soma. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

3 days post vaccine awoke with severe tinnitus. Tinnitus has persisted ever since. Sleep now requires interventions such as melatonin and sound masking to overcome sounds of tinnitus.

About 2 weeks after recieving my first dose I developed rashes all of my body. The second day in addition to the rash, my lips were very swollen.

Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A spontaneous report was received from a consumer who was a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete loss of vision (blindness), fatigue, blurred vision, spike in blood sugar (blood sugar increased), and hearing impairment "whoosh" (hearing impaired). The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications were insulin glargine and insulin lispro. The patient said he was compliant with his insulin injections. On 29 Dec 2020 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient experienced a spike in blood sugar. He tested his blood sugar immediately following the vaccination and it was in the 280-380 range. Prior to the vaccine, it was 100 to 150. On an unspecified date, his hemoglobin A1C was below 7. On 05 Jan 2021, he experienced hearing impairment "whoosh". On 09 Jan 2021, the patient experienced complete vision loss. On 11 Jan 2021, he experienced blurred vision. Action taken with mRNA-1273 in response to the events was not reported. The event of complete vision loss resolved on 11 Jan 2021. The outcomes of the events of fatigue, blurred vision, hearing impairment "whoosh", and blood sugar spike were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of diabetes remains a confounding factor. Further information has been requested.

About 1 hour after injection I started feeling mild tingling in my face and throat. I then lost my voice for approximately 5 minutes. As the next few days started to progress I started noticing mild muscle spasms all over my body, mostly in my legs; waking up in the middle of the night, dry mouth, night sweat (1 occurrence), sudden onset of rapid and irregular heart beat (1 occurrence); kidney pain (right and left), upper abdominal pain (right and left). Prior to vaccine I did not experience any of these events.

Pateint returned 30 mimnutes after vaccine c/o itchy and dry throat, patient was administered EPI-Pen

From the evening of the day I received the vaccine I had migraine, muscle pain, joint pain, hot flashes, insomnia, dehydration, fatigue, and my eye sight was getting bad. All resolved by 4pm Wednesday March 31st but my eyesight is getting progressively worse. I cant read anything on the TV. Normally with my contacts I have 20/10 vision but now with my contacts in I still cannot see anything clearly.

I received the shot at about 3 pm on April 2nd. That night my arm was very sore. Took a couple ibuprofen. On Saturday my arm was still sore so took some more Ibuprofen. Sunday I was feeling fine until about 8 pm when I started to get a little dizzy. On Monday when I woke up I could barely raise my head. Everything was spinning. I was very dizzy and my mouth was dry. I had no concept of time. 2 mins would feel like 2 hours and 2 hour could feel like 2 mins. I started to feel a little better around 4 pm. Today I still feel a little hazy in the head.

Moderna COVID-19 Vaccine EUA All of the reactions occurred roughly 20-30 minutes after receiving vaccine Both arms numb from shoulder down. Lasted for about 6 hrs Neck muscle sore/strained feeling. Lasted for most of the day Slight loss of smell. This lasted about 36 hrs Nose became numb. This lasted about 36 hrs as well Vertigo/dizziness. Lasted about 20 minutes Tiredness. I took a 2 hr nap and was not tired afterwards. FYI its not normal for me to take naps at all. Arm at injection site very sore and weak for about 3 days after

Muscle twitching in calf muscles begain immediately after injection. Muscle twitching in right calf muscle continued for 11 hours before subsiding. Increase in tinnitus level 7 hours later; tinnitus likely at higher baseline level weeks later. Two small spots of petechiae developed on left arm five days later: one spot on shoulder, other spot underneath bicep.

i started to toss and turn , i couldn't sleep all night, my reaches are non stop. i could not move up from my bed today. im able to walk around little better because the Tylenol. ive had fever too the whole day and night. i couldn't see well , my coordination was off.

Approximately 54 hours after receiving shot I noticed a couple hives on the lower portion of my body. I didn't think much of it and went to bed around 10pm. I woke up around 1am on 3/20 and noticed that my lips were very swollen and I had several hives on the lower half of my body. Additionally my scrotum was enlarged. Other than the physical symptoms I felt fine - no fever, body aches, pain, or respiratory issues. I decided to go back to bed after taking 2 Advil. I woke up at 7am and was still having a reaction so I decided to go to the ER. While at the ER the gave me steroid and Benadryl which immediately started working to reduce the reaction. They took blood work which came back "essentially perfect" according to the Dr. I was discharged and prescribed an epipen, and a steroid which i took for two days. I was instructed to follow up with my primary care physician which I did on 3/26. The ER Dr believed that my reaction was caused by something that i had ate; however, to the best of my knowledge, I am NOT allergic to any foods. Shortly before the reaction I had eaten a can of ravioli and some bread. The can from a 12 pack that we bought at the grocery store approximately 6 months ago. It as the last can in the pack and I did not have a reaction to any of the previous cans. I met with my family Dr's PA the following week and she indicated that while there is no way to know with 100% confidence that the reaction was from the shot, she noted that it was highly unlikely that my reaction was from the ravioli can. The PA informed me that I needed to use extra caution should I decide to get the second shot. I am scheduled to receive the second shot on 4/14.

I've lived with low level tinnitus for many years. My tinnitus worsened about four days after the vaccination and has remained elevated since the vaccination.

2nd shot Petechiae sever around both eyes within a few hours of injection, no trauma, coughing, vomiting, vision became slightly cloudy after 48 hours. Vomiting after 24hours briefly. Body aches, dizzy, time perception off, 102 fever 2 days. Weakness and stomach discomfort bloating pain. Severe testicular pain. 1st injection lot 026A21A 106 fever for 3 days, fever 4 days, symtoms 1 week, weakness, cold flashes, hot flashes, tingling, testicular pain, sleep issues, severe time skips and slow downs. Chest ache. Muscle aches. Had covid-19 in July 2020 contracted via facility

new food allergies emerged within a couple of days. (banana, strawberry, honey). Now experiencing dysgeusia since the vaccine. Many foods taste rotten. It has slightly improved but still very strong alteration in food tastes.

I suffered a stroke on March 19, 2021 that effected my Occipital and Temporal Lobes on the right side of my brain. The primary symptom was almost total and complete blindness. Taken to emergency room, made a stroke alert, tPA cleared clot, spent 5 days at the hospital.

I?ve been vaccinated for 2 months now. My new symptoms just started to really ramp up 3 weeks ago. Of course I had the initial symptoms of being sick for 2 and 1/2 days after my second shot?.but recently it started with leg aches and then it matriculated up into my upper body. My legs have since become less achy per say. Now it?s my upper body and mostly in my shoulders (more in the one I received the shots in), back pain, and general fatigue. Currently still dealing with the upper body ache discomfort, cold hands and feet but I noticed that I have a slight headache always and my vision has became a little blurry in one eye. The headache severity is day to day but what?s interesting now is I?m having ear ringing and sensitivity to sound. Headache seems to emulate from the back of my skull and the crown of my head. The other lingering piece is the fatigue after doing activities. I?m an active guy and recently my body gets really achy after I do anything super strenuous and I get tired. Also feeling a little shaky, some rapid heart rate, and some circulation issues in my legs and arms. Note; never experienced these issues before the Vaccine aside from the normal wear and tear of an active lifestyle.

CHILLS, FEVER,SHARP/PIERCING CHEST PAIN, ENTIRE BODY WEAKNESS, ENTIRE BODY ACHES, HEADACHE, DRY THROAT.

Pt stated that he woke up the next morning with ringing in his R ear the day after the 2d vaccine. He stated that he is still having ringing in his ear today.

Black Tongue. Tongue looked black and had to brush off black with tooth brush. I have never had black tongue before. I have excellent oral hygrine. I do not smoke or use tobacco products. When I looked it up it said it could be caused by medication side effects, and the only thing that has changed with medication recently is having my 1st shot 10 days prior. I did not see it listed as a side effect of the vaccine, so I figured I should report it.

Patient developed itching 10 mins post-vaccination. Itching moved from upper body to head and inside mouth. Felt slight soreness in throat 45 mins in. Took diphenhydramine 25mg. Symptoms slowly dissipated. Stayed under observation a total of 1.5 hours. No feeling of obstruction in throat, no shortness of breath or wheezing, no rash or swelling. VS normal, physical exam normal. Slight increase in heart rtate which may have been due to Adderall.

Moderna Vaccine - 2nd dose 4/14: ~3PM administered vaccine 4/15: Headache and Joint Pain 4/16: Ear started popping. Loss of hearing -- > Ringing in Ear -- > Vertigo

On 4/24/2021, noticed the tingling and itching sensation on my top lip that happens whenever a cold sore is about to present. Took my prescribed Valtrex and it resolved in about 48 hours.

Sudden onset of tinnitus in right ear noticed several days after 1st covid vaccine. Ringing is constant and have not had this issue before.

I started noticing mild tinnitus shortly after my first shot of the COVID vaccine. It became much more severe after the second shot.

Discomfort/pain in left shoulder at site of injection beginning approximately 10 hours after receiving shot; Muscle and joint discomfort/pain throughout back, shoulders, and legs; Abnormal smell/taste in back of nose/mouth; These effects continue through the day following the injection.

Shingles attack of the face. Eye swollen shut. Forehead and scalp rash. Tingling of head. Eye pain and blurriness.

Within about twelve hours, I started noticing hyper sensitivity to my nerves. Later that evening when I went to sleep and set my AC as normal, I woke up shivering incredibly hard, and had to turn up the temperature three degrees before I was not shaking HARD. I see a chiropractor every other day. I could feel my joint dislocations MUCH more intensely. My teeth were incredibly sensitive. My muscles that were recovering from working out were in much more recovery pain than they have ever been. The first two days were pretty intense. I used tylenol to calm them down, but still noticed my nerves felt not sensitive, but the feeling I was getting was much more intense. I wasn't feeling things I shouldn't, I was feeling what I expected at what seemed like a multiple of about three. It reduced slowly over the course of a week. After a week, I still feel like it is slightly heightened. My first shot had similar affect, but not as bad. I want to say it lasted 3-4 days the first time.

Pt fainted after telling wife he feels unwell, then passed out in wheelchair & didn't recall event. BP 99/60. Pt reported feeling nauseous & eye twitching. Given 8oz apple juice & graham crackers & 8oz water. After 25 min pt reported feeling better but tired. 1.5hrs after vaccine given pt was escorted to car with family and informed to follow up with PCP. Per pt's wife, pt had flushing with first dose

Migraine, sensitivity to light, fever, chills, body aches a lot of pain at shoulder . Brutal experience , felt so bad considered hospital

I tested positive for COVID19 in December and had developed a slight ringing in my left ear (tinnitus) due to the virus. After I took my first dose of the vaccine the tinnitus became much louder and noticeable and is still very loud. I did not have a noticeable increase after my second dose of the vaccine. It stayed consistent throughout.

patient had experienced blurry vision starting 1 hour after receiving the vaccine.the vision had gotten worse since then and today he came to pharmacy to report the issue. the eyes looked little red as well. we recommended that patient go see an ophthomalogist

The same evening of when I received the shot, approximately 6 hrs after, I started to hear ringing in my left ear. It is now 17 days after my symptoms first appeared, and it has not gone away or gotten any better.

Some blurred vision with objects far away about 15-30 minutes after the shit. Then I felt fine for about 12 hours after the shot (1st moderna shot on 1/21/21, 2nd moderna shot on 06/02/21). About 9:00 pm I had soreness in my arm and body aches. By 2 am on 6/3, the body aches were extreme, along with chills, and a low fever 99-100. The headache that followed lasted hours and was terrible. I had not been sick, or felt sick, in more than a year, and experienced only a sore arm with the first shot. The after affects from the second shot were terrible and I am afraid and anxious. I hope I don't die.

Tinnitus in right ear since getting vaccine. I got the shot in the right arm as well (may be unrelated). Unable to sleep with tinnitus. Nausea and little appetite, losing weight. All started the day I received the vaccine. There are days when tinnitus is lower level and no nausea, but it returns. Still like this almost 2 months later.

First dose of Moderna given 03/12/2021. Second dose of Moderna given 04/09/2021. Patient experienced redness, pain, light sensitivity, and decreased vision in the left eye on 04/23/2021. Seen in ER. Did not require an over night stay at this facility. Diagnosis of severe uveitis/ glaucoma. Followed by visit with Eye Specialist. Treatment included steroid eye drops, atropine eye drops, and timolol eye drops.

Moderna COVID-10 Vaccine EUA. Patient developed congestion, slight tightness in throat and a funny taste in mouth. Vital signs stable. Feeling continued, administered famotidine and cetirizine HCl, monitored until symptoms resolved.

Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-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. No medical history was reported by the reporter. No treatment information was provided. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-229259 (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

I smell smoke. Anywhere, anytime. if I hold something close to my nose I can smell what it actually is but when I am just smelling ambient air, it smells as though there is cigarette smoke going right in my nose. sometimes to the point where it may cause me to tear up.

2 weeks after the second shot my hearing got super sensitive and that became headaches that persist. I have also have a hard time keeping an erection that is completely new to me.

3 weeks after the second dose of Moderna vaccine I started developing Meniere's type of symptoms. Loss of hearing bilateral not vertigo. I visited an ENT, was prescribed steroids. Since then attacks have becoming more frequent and now on weekly basis. Did MRI, ruled out possible other pathologies. Noticed exacerbation of tinnitus on the traumatized ear. I just want to report what has been happening to me since February not sure if related to the vaccine, just reporting what has been happening since vaccination. Also, no other illnesses since February.

Full Hearing loss in left ear the next day after receiving the 1st shot. Also light headed as if my head was full of helium.

Sudden fast heart/pounding rate about 30 min after vaccination. Followed by immediate warm feeling, light headedness (similar to feeling of passing out). Every 10-15 min after that for the next 90 minutes a similar but less intense increase in heart rate would occur. During this next 90 minutes my hands were very tingly and clammy, my adrenaline seemed high, and my throat was suddenly very dry requiring several cups of water. Overall intensity of the heart pounding sensation decreased with each episode and overall my heart felt normal about 2 hrs past vaccination. A headache then developed along with fogginess and persisted the rest of the day.

Two hours after vaccine, I had pain in the neck at my thyroid gland and what seems to be the lymph glands behind it on the right hand side. It was tender. I took tylenol to deal with it. That pain persisted all the next day on Friday and again took tylenol and ibuprofen to deal with it. Then Saturday AM I was awaked early with severe throbbing pain in same thyroid/lymph area, it hurt to swallow, turn my head, and the pain was radiating up to my right ear. I was also having cold sweats. I managed to get the pain down again with tylenol and ibuprofen. On Sunday I spiked a temp of 100.8 and was having flu like symptoms, like body aches and more chills. I got the temp down but my heart rate remained elevated and I found it difficult to catch my breath. This went on for hours. I eventually had to go to the ER, where my pulse eventually came down. Nothing like this has ever happened before. The ER staff could not explain what had happened to me. At the time of writing this on Tuesday, 5 days after vaccine, I again had a lot of cold sweats this morning and there is still some tenderness in the lymph gland area near above the right side of my thyroid gland, but I am feeling better overall.

Woke up at 2 am the morning after the injection with my arm extremely sore, swollen, red, and feverish to the touch that has continued for 4 days now. I also experienced a fever for 2 days after the injection along with dizziness, weakness, fatigue, headache, body aches, vision changes, and ringing in both ears. As of today 1/12/21 I am still experiencing symptoms even while using Benadryl allergy tablets by mouth and anti-itch cream applied to the injection site.

fever developed and increased to 101.5 within an hour, the next 36 hours I experience continued fever over 101 that was reduced by 1000 mg of Tylenol, severe muscular body aches, general weakness, and persistent headache localized behind the eyes. The symptoms sided over the last 12 hours of the 36 hours mentioned. A very light state of feeling tired persisted another 24 hrs as well as a slightly elevated temperature (1-1.5 degrees). I was positive for Covid in March of 2019 for a total of 6 weeks. The first two weeks were the most intense. This felt like a scaled down version of those two weeks. I never required hospitalization or supplemental oxygen in March.

Approximately 45 minutes after vaccination felt sensation of mouth becoming completely dry, felt as though regular swallowing process interrupted. Had a glass of water and resolved. Evaluated by doctor and had pulse of 92 (high for patient) and elevated blood pressure 148/92. Rest of vitals normal. Felt anxious. Ate lunch, had about 6 more episodes of mouth drying out, last one about 10 hours after vaccine. Resolved with water. Took benedryl 50mg. Next felt fatigue and right arm soreness. Felt normal within 48 hours.

Approximately 15" after receiving vaccine, patient stated his 'throat started to feel tight, tongue felt swollen and face and head itchy". Medical staff administered Benadryl, took VS and stayed with patient. Voice is very hoarse. Medical provider in with patient and did a physical assessment. At 30" patient stated his tongue remained swollen, more Benadryl given. Medical staff remains with patient. After about 60 minutes from time of administration of vaccine he drove himself home. Rested all afternoon, did take Tylenol. Stated he had a restless night, not much sleep, very achy, tongue and throat better.

3 minutes after vaccination the patient began to feel a tingling and pain in his arm where the vaccine was placed. Within minutes the patient began to feel faint and proceeded to faint as he was gently laid to the ground by the healthcare provider to initiate an emergency response. The patient was alert and oriented at 5:30 but felt nausea and a tingling sensation in the tongue. The patient stated that he had been fasting for 2 days and we determined low blood sugar likely played into his response to the vaccine. Glucose gel was placed in mouth and patient felt better within 15 minutes.

Initial onset at time listed- fever, severe myalgias, rigors, sweating, headache, anorexia, thirst, lethargy. Felt like severe flu. No pulmonary symptoms or GI symptoms. Symptoms improved with first ibuprofen dosing on 6Feb2021. Fever and myalgias recurred after Ibuprofen dosing subsided evening of 6 Feb2021. Full resolutions of symptoms on 8Feb2021

~ 1 -2 second patient stated that he was feeling heat in his arm; face noted to flushed ~30 seconds continue to have burning ~ 1 min moved to Isolation; c/o metallic taste in mouth and feels nausea ~ patient appears the same - allergic symptoms reviewed multiple times 1514 162/102 112; c/o tongue thickness ~1516 stated he felt mild tightness to in throat ~ 1518 136/96 100; states he is feeling worse; EPI pen suggested patient declined ~1520 paten states his allergist had told him that he is not a candidate for the Moderna Vaccine ~ 1524 EMT was called given patients condition and the allergist suggested no vaccinations ~1524 patient continues to refuse EPI administration despite c/o throat tightness and enlarged tongue; able swallow and tongue visually appears normal 1528 131/81 100 99%; stated tightness is improving 1530 158/106 104 flushed able to swallow; lung sound are clear; no increased WOB 1533 EMT at bedside - care endorsed to EMT after rport given As he was leaving with EMT patient stated he may have had COVID 19 ~ December 12 to 20 2019

Lip numbness more on left, but bilateral. Onset 3 hr after injection, worsen over 6 hours. Improved after 12 hours but did not resolve after 1 month.

Severe chills starting at bedtime; no amount of layers could fix. Felt like I was in the arctic without any protection. Shivering was like I was having a seizure for about 3 hours. Severe nausea to the point where I can hardly eat. I'm down almost 5 pounds since Wed morning. Severe headache since Wed night that feels like I have an ice pick in my forehead. Excessive fatigue, sleeping about 16 hours Thur and today (Friday). Severe dizziness when standing from a chair or bed; need to brace on wall for about five minutes before episode passes. Loss of taste and smell. Severe neck pain. Photo sensitivity. Runny nose and sever sinus pressure. Maintaining a temperature of about 100 and 101. Had to take off work Thur and half day off today, teleworking the other half.

I suffer from mild tinnitus and high frequency hearing loss. Approximately 45 hours after receiving injection, my tinnitus and hearing loss in my left ear became significantly worse. I would say 20-40% worse.

4 hours after administration of noticed his face had become numb and his lip was not "moving as it should." Rt side of face was affected, His blood pressure was elevated at 160/110 at noon. Only other symptom was his arm hurt "alittle." States symptoms are improving and minimal over the weekend. He has noticed them getting worse when he needs to talk alot or with his mask rubbing on his face. Does report his BP has remained elevated and he continues to check each day. Today was 120/95. Does report drinking alot of coffee.

On the first day I had a huge lump underneath my armpit I did not become too concerned with that I read it was something that could happen regarding the lymph node. 10 days later I woke up at 3:30 in the morning and had to dial 911 my throat felt like it was closing and my lips were both swollen. I went in the ambulance they brought me to the emergency room where they gave me Benadryl a steroid and some IV fluids. as soon as I receive the Benadryl my throat started to open up and my lips both started to go down . My lip continue to swell for the next three days on and off often on. Every time it swelled up I took Benadryl and every time sure enough it went away . The day I came home from the hospital I thought I was doing much better until that following night I became severely nauseous. I don?t know if it was something that they had given me in the hospital or still a reaction that was going on in my body, but I had some sort of stomach bug I threw up that whole day, had chills sweats and a pounding headache that would not go away for over 48 hours .I was unable to eat or drink for 24 hours and had to go to an urgent care where they provided me with some medication for nausea. My concern right now is I am hearing that the second shot hits a lot harder than the first one and if this was a reaction to the shot I am very afraid of what will go on if I get the second one. I cannot take a chance with my life. I really want to shot I work in an environment where I am working with the department which is why I was able to get the vaccine so early I feel safe being vaccinated I am very disappointed that this happened I just cannot take a chance having a family etc. Also I have very bad medical in Sherance so I am dealing with all of the bills from this hospital stay I have a deductible which I can?t afford and then only 50% is covered afterwards. That is the reason I do not go to the hospital under no circumstance unless I am dying which that night I was that scared I felt the need I had to go.

He had the vaccine and 3/1/21 he had numbness on the right side of his mouth. His eye started watering as well . Mother took him to the doctor who diagnosed him with Bell's Palsy. Dr. prescribed Prednisone and Valacyclovir for these symptoms. He still has some drooping of his eye and mouth, but doctor said it may take a couple of weeks. He does have blurry vision due to this as well. The injection site itself has no problems. He has a FU next week with his doctor.

Unilateral sudden hearing loss, left ear. Normal tympanogram, normal temporal CT. No headache, visual change, dizziness, otalgia, tinnitus. Symmetrical facial movements. Exam was consistent with conductive hearing loss. Was referred to ENT, started on corticosteroids. Outcome undetermined.

Headache, Fever 101.3, Left arm Temp 103.3, Nausea, Chills, Body Aches, Very sore arm, metallic taste in the mouth, tired and sleepy,

Patient recieved first dose of the Moderna vaccination and about five minutes after recieving the vaccine, started to feel lightheaded, dizzy, and tingling of the tounge. Patient was assesed by onsite medical staff and ALS resources were called. The patient was transported by local EMS to Hospital.

I was driving on the highway and experienced numbness starting in my lips. This numbness then moved throughout my body into my limbs. I had some mobility and was able to pull off of the highway down an exit but at one point, I could not lift my legs or control my hands. I called 911 but it was very difficult to do so with the numbness. I then started to regain my mobility but had some continued numbness around the left side of my mouth. The paramedics tested my vitals and everything came back as normal. They recommended that I have someone come pick me up. So I had a neighbor come pick me up and someone drive my car home. I did not lose any vision or mental capacity throughout this. It was just a wave of numbness throughout my entire body. It lasted 5-10 minutes but felt like an eternity. I am lucky to be alive and to not have crashed my vehicle into someone or something.

Arm hurt after shot, I waited the 15 minutes and nothing else happened so I went home. On way home my lips started to tingle a bit and I felt warmer over my body. I got home and felt exhausted for multiple days but on the first day I could not sleep. By the weekend I was just worn out and slept all day the following Sat and Sunday. My arm hurt so bad I couldn?t lay on it and I even today either have phantom arm pain or real arm pain. But I know where the shot was because I feel it. It still feels like a deep tissue bruise.

Slight swelling of area around right eye, vision is not affected. Left eye not affected. Slight headache.

Moderna COVID?19 Vaccine EUA Apart from the fatigue, sore arm and feverishness I had on the day of the vaccination, I woke the next day with what looked like Subconjunctival hemorrhage in my right eye. It was a bright red spot in my cornea and both my eyes were sore. Since then, the hemorrhage has spread within my right eye. My eyes are still sore and I get a sharp/shooting pain in my right eye intermittently. I also feel some soreness in my right temple and under the ear.

On March 30th I lost taste on half of my mouth. When I woke up March 31 my entire right side of my face was dropping and was not responsive to facial motion. Went to the ER to get checked out. They did testing to make sure to rule out a stroke. And found it to be Bell?s Palsy. I was given a prescription of steroids , antibiotic, and eye ointment. I was told to go for a follow up with my Family doctor. I have that scheduled for April 5th at 3:15pm with Dr.. I have had to miss two days of work so far due to this adverse side effect.

A few days after receiving my second dose of Moderna, I began having very loud tinnitus in both ears that has not subsided.

Facial droop, ear pain, headache on left side. Vertigo and confusion. Diagnosed as Bell's Palsy after CT scan and MRI showed no sign of stroke.

About 18 hours after my second covid vaccination I became quite ill. I requested from my boss that I be allowed to leave as I was not feeling well. I was ache all over, skin sensitivity, light sensitivity, feeling feverish and suddenly exhausted. Very tired. Just wanted to close my eyes. I went home and went to bed where for the next 5 hours I was in and out of poor dream disturbed sleep. Waking up moaning and very uncomfortable. Constant headache. Mild blurry vision. Very sore arm at injection site.

Patient had a vasovagal response after the COVID vaccine. He was seated, saw his own blood and warned me. He began to start blacking out. He had full conciousness, only loss of sight and difficulty hearing for about 5 minutes. I took his BP while he was seated, 104/54 (he reports a normal BP around ~110/60). He sat until he regained sight and drank a full bottle of water. I continued to watch him for an additional 15 minutes and retook his BP= 116/58. Patient informed to call the pharmacy at any time for questions, follow up, etc. Full recovery, patient reports being fine and went about his day.

ear fullness-went to ent was given antibiotics but ear fullness remains now tinnitus is starting to happen. Went to an acupuncturist a few times but issue remains at the same time the ear fullness started, my right hip was sore (previous orthoscopic hip surgery june 2020) made an appointment for the orthopedic and received my second shot while waiting for the appointment. Woke up after second shot with throbbing pain the the hip. The intensity has declined but the constant pain persists. Orthopedic prescribed Meloxicam which has dulled the pain but again it remains

Moderately severe tinnitus developed a few weeks after the shot. No prior bouts with tinnitus before shot. Tinnitus has not gone away after about a month.

Tinnitus in left ear for two days, followed by severe Vertigo and headache after over-exercise. Steadily waning over following three days.

Minor headache day after vaccine. pain in left upper teeth 2 days later, subsided after 1 week. 2 weeks after the vaccine, on April 4th, patient had severe thunderclap coital headache, and has had mild headaches (possibliy stress induced) since. MRI/MRA showed only empty sella, which is likely incidental.

Inflammation under my tongue and on my tongue. Swelling under my tongue swelling on my lips (upper and below)

One week after 1st shot experienced blurred vision then in subsequent days had head pressure and slight headaches. Headaches were behind the eyes mainly with pressure on the sides of the head. Developed Tinnitus with ringing in both ears constantly. Headaches have gotten less but Tinnitus is constant. Still today, 26 days after the vaccine my Tinnitus is there. No prior history of Tinnitus or any other medical condition.

Tinnitus. It's been a week now. Starting the day after receiving vaccine, the ringing in ears has not gone away.

Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's wife called into the pharmacy about 3 hours after the patient recieved their vaccine. Patient's wife reported that the patient was experiencing blurred vision. No other symptoms were reported and patient's wife answered no when asked if the patient was experiencing trouble breathing, rash/hives, dizziness, nausea/vomiting etc.

I developed a decent case of tinnitus in my left ear today. I?ve had it before?likely due to my TMJ but this is pretty annoying. It?s been nonstop for about 7 hours. Could be a coincidence but thought I should report.

42 year old male who was complaining of itchy throat, feels like - his throat is closing. Able to speak in full sentences. Spo2 on RA 98%. Felt the same way on his first dose of moderna vaccine.

These symptoms happened during the time of the injection on 4/24/2021 and lasted from Saturday 4/24/2021 until Tuesday 4/27/2021: intermittent slight tongue spasms, slight tightness in the back of the throat, dry mouth - since 4/27/2021 these symptoms have stopped but now there is less sensation than normal in the tongue and the back of the throat which is still ongoing as of 5/1/2021. // These symptoms happened during the injection on 4/24/2021 and only lasted until the observation time at the vaccination location was over : lips felt very lightly swollen, very slight tinge in eye sockets.

hearing loss; Ears popping; tinnitus/wavy sounds; headache; joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of DEAFNESS (hearing loss) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (joint pain). On 18-Apr-2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), EAR DISCOMFORT (Ears popping) and TINNITUS (tinnitus/wavy sounds). At the time of the report, DEAFNESS (hearing loss), EAR DISCOMFORT (Ears popping), TINNITUS (tinnitus/wavy sounds), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.

Fevers and chills overnight afterwards (this was the second shot). Also experienced intermittent severe tinnitus and moderate hearing loss that is slowly getting better but continues 3 weeks after the injection.

The customer just got his first Moderna covid 19 doe #1 around 2:30 pm. About 5 minutes later called me to inform me that he felt dizzy. When I came out he looked at me with his lazy eye and sweat. He did not say anything then his eyes rolled back then fainted. He did not remember the event . I pat him on his shoulder and he was awake right a way. I called 911 but he felt better before the emergency people arrived and they checked him out. He refused to go to the hospital.

At around 12:00 AM the morning after the vaccination, I woke up with a mild fever. I had extreme thirst that could not be quenched and was unable to go back to sleep. The entire day after the vaccination my stomach was slightly upset, but mostly I felt bad the rest of the day due to the lack of sleep. After work that day, I came home and went to bed around 6 PM. The symptoms went away after getting some sleep and were overall minor, but the extreme thirst was something I had never experienced before.

After the first shot, I developed tinnitus in my right ear a few days later. At first, it was intermittent but became permanent as time went on. It was permanent by the time I received the second shot. After the second shot, it remained and the tinnitus that was in my left ear is also now much louder.

Tinnitus starting on the left side after the second Moderna shot and continuing still. The ringing in my ear is distracting and quite loud at times. In addition to the persistent tinnitis, I experienced intense headaches to the point where I was seeing flashes of light as well as cold sweats, body chills.

After about 10 minutes he returned to the pharmacy stating his throat felt dry and scratchy and he felt a little dizzy. He was advised to sit down. He was given a bottle of water. The patient then purchased Benadryl and took 50mg. He continued to sit in the pharmacy and his symptoms were monitored. The patient stated that his symptoms were not worsening, but they were not residing either. The patient remained in the pharmacy for approximately 1 hour with no worsening of symptoms. He was advised not to drive after taking the Benadryl. He contacted a friend to meet him at the pharmacy. He then stated he was going to go home and continue to monitor his symptoms. He stated he will seek medical attention if his symptoms worsened. He was advised to contact his physician and inform him of the incident. The patient was advised not to get the second unless his doctor still recommended it, and if so, to receive the dose in a facility. The patient listed no allergies. The patient was asked if he had ever had a severe allergic reaction to anything in the past, and the patient responded he had not.

Day 3 - severe dizziness. Day 4 - vomiting, vertigo, fever, muscle aches, chills, nausea, headache. Day 5-8 dizziness, blurred vision, headache. Dizziness is severe and persistent, making it difficult to see straight or walk. Missed one week of work so far. Have tried tylenol, dramamine, and sudafed with no lasting change.

Mild fever Extreme weakness and body ache Pounding head ache Mouth ulcer Breathlessness Increased heart rate (85bpm instead of normal 65bpm resting) Symptoms started about 12 hours after vaccination (this was the second dose) an persisted till 48 hours after vaccination gradually getting better Taking crocin alleviated symptoms

Severe illness, weakness, extreme fatigue, muscle spasms, pain in muscles, pain in joints, complete insomnia, tinnitus, head ache

Patient received his first dose of COVID vaccine on 4/24/21. Around 4/30/21 (~ 1 week prior to admission), pt developed cough, runny nose, lack of appetite, loss of smell, and shortness of breath. Pt's symptoms became progressively worse, and he presented to the ED on 5/7/21, where he tested positive for COVID. Pt was found to be hypoxic (89% SpO2) and was started on supplemental O2. He was also admitted to the hospital for COVID treatment .

Tinnitus - significant worsening of steady whine in both ears (right somewhat louder) began approximately 2 weeks after second Moderna dose. No treatment, no improvement.

Nine days after 2nd shot, sudden, nearly complete hearing loss occurred in right ear, which previously was within normal hearing ranges.

Patient presenting to clinic after receiving second dose of his Moderna CoVID-19 shot. Patient with previous history of angioedema with various other vaccinations including the first dose of Moderna. Patient has been previously worked up by allergy/immunology for his recent reactions, has been placed on Zyrtec 10 mg daily along with other antihistamine for the last 24 hours as premedication for this second shot. Patient states that previously he has had to go to the ED for angioedema, has pictures with him. He usually receives IV prednisone and observation. Patient states that the prednisone resolves his symptoms almost immediately. Today he is only complaining of some perioral tingling. With the first dose of the vaccination patient states that he had perioral tingling, some lip swelling, and abdominal discomfort. Patient denies any trouble with swallowing, swelling, tongue swelling, speaking, shortness of breath, or chest pain.

I have never had a migraine before the Vaccine. First migraine was the day after the first shot. Second migraine was approximately 2 weeks later and had visual disturbances. Third migraine was the day after the second shot. Fourth migraine (worst of all of them) occurred approximately two weeks after the second shot and had significant visual disturbances that occurred while driving.

The night I got the vaccine, I had severe heart palpitations that continued for a couple of weeks but very severe the first night. Since the second night I have had severe insomnia. Tried trazodone, ambien then clonazepam in that order. Clonazepam helped but I weaned myself off after 3 weeks, did not want to get addicted to them and I also started having tinnitus in right year. Not sure if it is from vaccine, lack of sleep or clonazpeam. 9 weeks out since 1st dose and I continue to suffer from severe insomnia. Only get about 4-5 hours of sleep that is fractured. Takes hours to fall asleep. Skipped 2nd dose due to side effect after 1st dose. Never had sleep issues ever.

I am a pharmacist with 17 years of clinical experience and so medically literate. The night of the vaccine I had severe heart palpitations that woke me every 2 hours, but I managed to get some sleep. The 2nd night I could not fall asleep at all. I stayed up all night. 2nd night tried melatonin and benadryl, and only manged to sleep 2 hours very late in the night. This went on for a week. I saw a doctor and was given trazodone. It helped fall asleep but kept waking up every hour or 2 and then trouble falling asleep afterwards. So only managed 3-4 hours of sleep each night. I had side effects from Trazodone with mood changes so had to stop taking it. I saw another doctor based on a friend's recommendation who was going through the same issue. I was prescribed clonazepam 1mg. I was finally able to sleep a full night. I took it for 7-10 days and tried to taper back since I did not want to be dependent on it and wanted to go back to sleeping without any sleeping aids. Klonopin 0.5mg seemed to be helping so on a follow-up appointment, I was given a months supply of clonazepam 0.5mg. I took that for a week and tried to taper that further and that did not help with sleep. Amidst of this I started having tinnitus in the right ear and I never had tinnitus before. I don' t know if it was triggered by sleep deprivation, the vaccine or the clonazepam. But I stopped taking clonazepam altogether after 3 weeks. 9 weeks out since the 1st dose and I can sleep a little on alternate nights only. And that sleep is fractured. So one night of almost no sleep and one night of 3-4 of hours of sleep if lucky. I tried benadryl and it helps a little but the trouble falling asleep is just as severe and continue to wake up every 2-3 hours. 8 hours in bed and only manage 3-4 hours of sleep. I skipped the 2nd dose due to continued issues with sleep. Looking for answers and guidance on how best to treat this and if/when this will be over for me.

Pt stood up with the help of his cane after receiving his 2nd dose of moderna covid19. He started walking towards me as i held the door. He went stiff and started tipping over. I ran in and tried to keep him from falling. I guided him to the wall and down to the floor. His friend who also received the shot, came in to assist me since pt. is pretty big and was dead weight. His friend said this happens several times a day. We sat him up and waited. He then started having a seizure that lasted 3-5 seconds. Then he stated he was seeing black spots and felt weird. I called EMS and the police and EMT's took him out on a stretcher.

Severe Tinnitus in both ears; I never had tinnitus one day in my life until taking the vaccine. Since taking the vaccine, I have near constant tinnitus. It is very severe and often does not go away for several days. When it does seem to go away, it will typically return in about 24 hours. Rarely has a full day passed since it started where it was not present. I went to see a doctor. I told him I had never had tinnitus before taking the vaccine and he said there was absolutely no possibility of it being the cause. I told him I did not believe that and was certain it was an adverse reaction from the Covid vaccine. Since then, I have been researching and it appears I'm not the only person to have the adverse reaction. I have recently called his office and told them that I wanted it reported as an adverse reaction on my behalf. All they said was he made a note in my file about it but acted like it wouldn't be reported.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave

Started with loud ringing in my left ear at 2pm, followed 2 hours later with complete hearing loss in left ear and then woke up the next morning at 6:30am with severe vertigo (nausea and inability to walk). Vertigo got better after lights turned on to the point that I had no nausea anymore, but needed to hold onto things while walking. Ringing Went to urgent care at 10am to get assessed and after speaking with an ENT they prescribed Prednisone and Meclizine. Meclizine didn't help so only took for 2 days, was on Prednisone for 3 weeks .

Ringing in ears. Extreme fatigue. Tingling sensation (like hitting funny bone) started in fingers and toes until entire body tingled. Disoriented, feeling spaced out, unable to focus. Symptoms lasted all day. Went 1 week without any symptoms then all of them came back in spells that last 10 minutes to 1 hour or more. Symptoms still continue.

Patient got bruising and red spots on over his body about 7 days after receiving first dose of Moderna Covid vaccine. He also had bleeding gum and bloody nose. His platelet count dropped significantly to 5000. Patient was diagnosed with immune thrombocytopenia and was admitted to hospital for treatment over 2 days. He got 2 bags of IVIG over 2 days and given Dexamethasone daily for 4 days.

No immediate symptoms were noticed on the first vaccine, just a sore arm. On the second those I was in bed for almost 3 days with severe migraines, multiple joint pain, sensitivity to light, and severe body aches.

On 06/11/2021 I had the second dose and on 06/12/2021 I started to have flu like symptoms and then on 6/13/2021 the tinnitus started. I felt pressure in the back of my head as well as like feeling weakness and fatigue and some anxiety. I decided to call my doctor and they got me in like 5 days after that. They checked my ears and my throat, and they had a specialist looked at my symptoms and suggested steroids, but they decided not to do steroids because it would affect the efficacy of the vaccine. They suggested to do mediation, yoga, or acupuncture. I still have the tinnitus.

I was diagnosed with Bells Palsey. Droopy face (right side) Slurred speech Crooked lips Watering eye Was put on steroids and eye drops for 7 days.

member was vaccinated on 12/29 - 1-2 hours later developed injection site soreness/swelling/chills/fatigue/intermittent headaches/"head cold like symptoms" - yesterday evening developed R facial swelling including to upper lip and numbness in face - is able to smile and use muscles normally no facial dropping but face is still puffy today after 50 mg Benadryl. Member has R inner ear itching but denies throat tightness/difficulty breathing

Dizziness on the day of injection. Followed by extreme fatigue, fever (101.4), headaches starting 24 hours after injection and lasting 48 hours. Sense of smell began to return after 36hrs after injection (lost smell and taste in August 2020 due to COVID-19 and it has not returned).

about 10-15 minutes after injection, felt tightness in throat and sore throat with a little difficulty breathing. Notified onsite RN who immediately gave him 50mg oral Benadryl. Vitals done by EMT onsite, BP `164/108, P=110, slightly swollen tongue. Did not have Pulse Oximeter until 30m after reaction. At that time, O2=94%. 15m after Benadryl patient stated he felt 80% better. 45m after Benadryl patient felt 95% better, BP = 134/96, P= 64, O2=98% and no tongue swelling. Patient wife will pick him up and drive him home. Instructed to take 50mg in 4 hours and call 911 if any symptoms return.

Member received vaccine at clinic around 1002. He then returned to work at clinic. He reports he started feeling dizzy and nauseated around 1200. A medical emergency was called around 1215. Symptoms progressed to flushing, red raised rash and seeing spots. Member was given epi 0.3 mg IM and Benadryl 50mg IM with resolution of symptoms. Member was observed for 1 hour then discharged to home with a follow up phone visit 1/8/21 PM. He was advised to continue taking Benadryl 50 mg PO every 6 hours x 24 hours and was given an epi pen to use in case emergent symptoms returned.

Approximately 30 minutes after the vaccination, I felt a sensation (pressure in my ears and tingling throughout my body), then I could feel my heart start to race. My best estimate as the fast heartbeat last for between 60-120 seconds. I experienced the tingling feeling one more time, about 15 minutes later.

Extreme thirst despite high water intake. My mouth felt like a desert and I could not drink enough water to satiate my thirst. Duration approximately 27 hours.

Patient reported tongue pain located on the edges of the tongue, dizziness, shortness of breath. Initial vital signs 108- HR 99% Pulse OX room air- 220/100

Within 4 hours of receiving second dose of MOderna Covid 19 vaccine, patient began experiencing tinnitus b/l. Since then , now 6 days later, symptoms have not changed, slightly worse in right ear. On exam, some long-standing sclerosis b/l, otherwise PE was neg.

Ever since the 3rd day after taking the 2nd shot. I have had about a degree of fever during the day and night. Every night since last Tuesday January 27th I have woken up drenched in sweat multiple times a night. Assuming this is a fever breaking. I reported this to my doctor today and he advised me to go to this site. If it continues I will see him next week. I have also had chills and eyes burning during the day ever since the 2nd shot. The day after the 2nd shot my fever went to 101.5. But I did not think that irregular since I heard that was a possibility. The days after though I dont think are a regular vaccine event.

Patient stated he could feel his lip was swollen. The RN was unable to see swelling. He was observed eating and drinking after his vaccine. She asked him to stay past is 15 minutes and he chose not to. Back in his unit he stated his tongue was swelling. His co-workers gave him Benadryl and Claritin. He saw the physician who was unable to determine any issues. Patient was very sleepy due to the Benadryl and Claritin.

Patient 43 YO Asian male reported adverse reaction with the first dose of COVID Vaccine. He stated that he had heart palpitation for days, then specified x 2 days after the first COVID vaccine. He reported that, he was seen by his provider for the palpitation incident. Denied palpitation at this time at time for presenting for 2nd dose. He also was subsequently Dx with new onset hypertension as well.

Slightly Flushed Skin; Numb tip of tongue; 30 minutes after leaving; Slight fever and arm pain; 10 hours after leaving

Baseball sized diameter swelling around injection site, red (like a rash) in color, itchy, painful to touch and warm to touch. Rash looked yellow to black and blue around the edges as it progressed down the arm. Over the course of 5 days spread from injection site, around the elbow and into the forearm. Hip, knee, foot, shoulder and elbow pain on left side only, Body aches, nausea, visual impairment and loss of balance. Difficulty concentrating and relative "brain fog". Severe drowsiness in the sense of falling asleep while talking to someone and then no memory of it. Chest pressure and constant feeling of being out of breath. Cannot catch breath walking across the house from one room to the next. Severity of symptoms subsided within 24 hours, but some linger up to the time of this report. They are shortness of breath, rash with warmth and pain, lack of concentration and brain fog. Elbow still tender to touch.

Began to have pain around ear and behind right eye. Headaches moved to upper back of head. Felt weird on right eye. headache got worse, took ibuprofen. Next morning right side of face couldn't move or blink, then entire right side of face unable to move. Diagnosed at Urgent Care with Bell's Palsy. Started on prednisone and gabapentin. Following day, seen in the ER, had normal MRI. Started on antiviral acyclovir. Pain was still intense, given Norco. 12 days since vaccine.

Woke up on 2/13/2020 and upon standing had severe vertigo that lasted 10-15 seconds accompanied by nausea and vomiting. He then would then have on and off again vertigo for 6 days through 2/19/2020 accompanied by nausea (no vomiting). Vertigo was mostly positional, worse when going from recumbent position to sitting or standing. Would occur throughout the day. Experienced extreme fatigue from 2/13/2021 through the 2/19, that was progressively better as time went on. , Experienced general weakness, mental fogginess, and "heaviness" behind eyes and in the occipital muscles. Muscle aches in legs and torso were worse in the AM and present from 2/13/21 to 2/19/21 that got progressively better further out from vaccination.

A few days after COVID19 vaccine administration on the patient's L arm he developed a L eye stye and a new L upper lip herpes labias outbreak, patient has a history of cold sores in the past. Patient applied topical abreva to the cold sore which he has used in the past resulting in upper lip swelling. Unclear if the upper lip swelling is a result of the abreava or delayed from the vaccine.

Woke up and noticed he had no feeling to one side of his face, swelling to his top lip and a weird feeling in his mouth like he had just been to the dentist.

Tingling and swelling to lips with progressive tingling and swelling to chin area and neck about 5-10 mins post injection. Given Benadryl 50mg PO and Epinepherine 0.3mg/0.3mL. EMS called. Pt declined transport to hopital, opted to have wife drive him.

Pt received first dose of COVID-19 vaccine Moderna today at approximately 8:17am. Pt was observed for 15 minutes post-vaccine administration with no complaints. Pt reports an hour later developed a change of sensation to bilateral cheeks and around the mouth. Described it as a "tingling like coming off novovaine." Denes redness, swelling, weakness in the face or slurring of words. Reports lasting for about an hour or so and resolved completely without intervention. Pt returned to clinic for evaluation by physician without any current symptoms. BP 121/81 HR 73 RR 16 SPo2 98% on RA. CN 2-12 intact/symmetric. No increased work of breathing, speaks in full sentences.

Within 48 hours of receiving the COVID vaccine, I began having extreme pressure and discomfort in my right ear. Symptoms included dizziness, fullness in the ear and hearing loss. This persisted for several days. As a first course of action, I took Tylenol and antihistamines. I saw my PCP a few days later and he misdiagnosed my condition and suggested that I continue with antihistamines and Flonase. Two weeks later my condition had improved only slightly and I became more concerned. I asked my PCP whether a short course of steroids was warranted (at the suggestion of my mom and wife, who are both health care professionals). He prescribed a "dose pack," which I started on or about Monday, Feb. 22. Later that week, I connected with an ENT who is a friend of a friend . When I told him my story and symptoms he was extremely concerned and got me an immediate appointment on Friday, Feb. 26. At that visit I was diagnosed with acute and severe Sensorineural hearing loss (SNHL) that had resulted in 92% hearing loss in my right ear. Additional symptoms continue to include fullness, tinnitus and other discomfort. None of these issues existed prior to my COVID vaccine shot. I am currently undergoing a treatment of high dose prednisone and steroid injections in my ear. I am scheduled for another visit with doctor on Friday, March 12.

For both shots received, 4-5 days later developed sores on inside top of mouth , around 3-4 small chunks of skin inside of mouth missing

Seven hours after receiving the second dose of the vaccine I experienced two hours of mild nausea, mild dizziness, and mild jaw soreness.

Slurred and slow speech, blurry vision in left eye. Symptoms appeared about 24 hours after vaccine and remain as of 96 hours.

Went to clinic on 3/14/2021 due to feeling like his vision is off and he feels like it is difficult to find words since getting his first Covid vaccine on Friday 3/12/2014. Followed up in MD office 3/16/2021 with patient stating he is still having issues with slurred speech and difficulty finding words. PMD recommended going straight to ER. Stroke was ruled out, patient following up with Neurologist as outpatient.

1) Started severe palpitation within minutes 2) It followed by severe dizziness and visual haziness 3) After doctors made me lying down on the bed, started feeling better

After 24 hours, I started having body aches, that night couldn't sleep I took Ibuprofen it helped, over the weekend I kept taking Ibuprofen. Monday my tongue and half of head was sensitive and weird, it kind of hurt to rub through my hair and tongue felt like pins and needles this lasted through Thursday, and that morning woke up wit a lump behind my ear, I went to clinic, the doctor or PA diagnosed me with shingles, but I don't have any sores, he gave me a prescription but the next morning I woke up and notice i lost facial control on left side, could blink or close mouth on left side. I went to clinic and they diagnosed me with Bells Palsy and gave me a prescription for steroids and that was last Friday and its been a week that I've been on these meds. The main problem is the Bells Palsy has made my left side not work, dizziness, pain down my neck, the lump behind my ear finally went away after a week but the paralysis on the left side of my face is still there and the dizziness. I was having headaches but stayed on top of it with Advil and today I go back to clinic for a follow up appointment.

Sore and practically immobile arm starting 4 hours after injection. Treated with Advil. I could lift my arm the next day and recovered the third day. Inside of mouth felt sore and inflamed starting approximately 8 hours after injection. Lower face and lips swollen at approximately 10 hours after injection. Treated with Benadryl for 2 days. My breathing and swallowing was not effected so I did not seek medical treatment. Swelling disappeared 2 days after injection. Indigestion started 1 week after injection. Treating with occasional otc antacid. I have never had indigestion before.

Mild ear pain/discomfort in left ear and slight ringing in ear. Chewing exasperates the pain/discomfort.

extreme fatigue that went away after 48 hours I now have a hearing problem that I did not have prior to the vacceine , I am not sure if it is a eustacean tube disorder but everything sounds muffled and it is like when you need to get your ear to pop but it wont. This has been going on for 5 days now and I plan to see a doctor to see if anything can be done, I am hoping that this is not a permanant issue. I have read of other people having hearing loss from the vacceines from all 3 manufacturers

Tinnitus in Left ear after first dose. Constant. Ringing in right ear started after second dose. Both are constant yet slightly different pitch.

Approximately 14 minutes post-vaccination patient stood up from chair in waiting area complaining of nausea and GI complaints. Patient was instructed by pharmacist on duty giving vaccinations to immediately sit down. Patient described nausea and feeling a little cold. Patient's smart watch reported a heart rate of 56 bpm at around 1:18pm. Pharmacist assessment showed that patient was cold to the touch, not dizzy, slightly uncomfortable, and after a few minutes was visibly perspiring. Patient took 1/3 of a bottle of water provided to him while waiting for Emergency Responders were contacted. Patient then noted that they had some tongue swelling and upon observation by Pharmacist on duty patient's tongue was inflammed and lightly swollen. Emergency Responders advised against further fluids or food intake so patient was denied further fluids until Emergency Responders arrived. Patient was layed flat on the floor as a precaution until Emergency Responders arrived. Patient was assessed at around 1:20pm by Firefighters who arrived on the scene first and vitals were taken. Upon instruction by Firefighters patient stood up straight and noted no signs of dizziness. Firefighters did note some swelling of the tongue and patient insisted on being evaluated at the Hospital.

Client received the COVID vaccine (Moderna, 1st dose, lot #041AB21A, exp. 5/6/2021) at 1527. EMT observed the client to be pale and diaphoretic; he and RN responded at 1532. The client complained of dizziness, feeling clammy, and ringing in his ears, as well as spotty vision. His vital signs were as follows: blood pressure 96/78, heart rate 50, respiratory rate 20, and O2 99%. The client stated that he has hypertension and he takes losartan. He takes no other medications, has no other medical conditions, and has no allergies that he is aware of. The client was alert and oriented, and his pupils were equal and reactive to light. He stated that he ate breakfast and a snack at 11 am, but nothing for lunch. The client was offered water. At 1536, the client complained of tingling in his arms and numbness in his tongue. His color had returned to normal. No difficulty breathing, no swelling observed around his mouth or tongue, no complaint of metallic taste. Repeat vital signs were as follows: blood pressure 110/80, heart rate 87, O2 99%. He refused benadryl. At 1541, the client stated that his tongue was no longer numb but his arms were still tingling. He was less diaphoretic. His vital signs were as follows: blood pressure of 116/82, heart rate of 92, respiratory rate 14, and O2 97%. At 1545, the client stated he was no longer dizzy and his symptoms had resolved. Education provided regarding, emergency response and AMR activation, and primary care follow up. At 1550, the client was able to stand up and walk without any dizziness or feeling lightheaded. At 1558, the client's repeat vital signs were as follows: blood pressure 140/99, heart rate 99, respiratory rate 16, and O2 97%. The client was escorted outside by the EMT, and stated he was walking across the parking lot to get some food to eat before returning home. The client left the facility ambulating with a steady gate.

Swelling on lower lip right side 14 hours after injection. Subsided at 20 hours after injection and then lower lip left side swelling occured. Both subsided between 26-30 hours post vaccine but 36 hours after vaccine, full upper lip swelling occurred. Subsided 48-52 hours after vaccine.

SORE THROAT RININGING IN EARS HEADACHE HYPERTENSION PATIENT SELF TRANSPORTED TO EMERGENCY ROOM REFUSED EMS TRANSPORT

Moderna COVID-19 Vaccine EUA Tinnitus, left ear, moderate, still occurring 10 days later, following up with ENT

48 hrs after vaccine administration he experienced headache (Entire head), generalized body aches, upper & lower lip numbness, altered taste, fatigue and generalized muscle weakness.

Light and intermittent tinnitus after the first shot. Loud and persistent tinnitus heard 24/7 after the second shot. Severely impacted sleep. Only able to sleep 2 hours a night even with white noise.

Sore gums, just a few days after 2 dose, most recent within a few weeks excessive gum bleeding to the point of seeing my doctor who encouraged me to report this.

Patient came into the store today to let me know of the side effects he experienced. Patient chose not to wait the recommended 15 min following his vaccine and instead went into his parked vehicle. He immediately experienced visual disturbances, extreme sweating, light headedness. Symptoms continued even with his A/C on high. He did not fill he could return into our store and waited @ 20minutes till he felt better. The remainder of the day he did not feel right and may have had issues concentrating at a schedule trust fund appt who he had with his wife. Symptoms eventually subsided.

Vital signs 108/61 pulse 71 pulse ox 100%,; ED Note: 43 y.o. male otherwise healthy presents to the ED with syncope s/p second Moderna Vaccine, onset 1530 this afternoon. Patient reports after receiving the shot, he felt a burning sensation to the injection site on his left arm. He then explains that he began losing his peripheral and ended up losing his vision. Patient then initially felt better but notes he got bad real fast. He mentions he ended up losing consciousness but is unsure for how long. He reports a history of syncope following blood draws but never before with vaccinations. Patient states when he woke up, he felt sweaty, clammy, and nauseous. He notes he currently feels fine otherwise and denies any chest pain, shortness of breath, or palpitations. He denies having any symptoms following administration of the first dose of the Moderna Vaccine. evaluated the patient at bedside and the patient has verbalized agreement and understanding to the plan at this time of discharge without further questions. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.

hearing loss and tinnitus in left ear. Currently being treated with steroids: I got an injection of steroid in the left ear and I'm taking 60 mg/day of prednisone for 1 week.

30 minutes after the shot I started to feel numbnes and hot on left of my face and ear. It didn't really worried me at that time because I thought it is normal and it will go away. It didn't go away and I felt hotness around my face ear, and my hearing in my right ear was slighly worse, including some pain in the ear. First time I contacted my family doctor 4 days later when the symptoms got worse. My dr told me to use Ibuprofen 600 3 times a day for 3 days. After I didn't see any improvement I scheduled the appointment and saw my doctor 8 days after the vaccination. My doctor said my ear is clear and there was no infection and she gave me different antinflamatory medicine to take it for a week tis time. She didn't think that was from the vaccine though. After a week It seems that I felt better but still not completely recovered. I stopped taking this medication after a week as descibed. the sympthomcame back and now I'm 16 days after the shot and 6 day before the second dose and I'm scared what to do.

Moderna Covid-19 Vaccine EUA. Patient reported ear pain / sensitivity, which radiated from ear to shoulder, beginning approximately one hour after vaccination, and lasting approximately three hours. The event then recurred ten days later, and, again, lasted approximately three hours. Patient also reported lymph node swelling in the arm pit of the left arm, where the injection was given.

I received my second dose at 9:00 AM this morning, and by noon I had lost all taste and smell. I was fine this morning before I got the shot.

I started experiencing ear pressure in both ears and tinnitus. My hearing acuity is also now suffering a bit. I have no history of hearing conditions/ailments.

Pt. came in for his 2nd Moderna dose and reported to the pharmacist that he has been experiencing a metallic taste in his mouth ever since getting his 1st Moderna dose in May. Pt. stated he is still experiencing this side effect today.

Patient received Moderna dose #1 on 3-28-2021 and Moderna dose #2 on 429-2021. I do not have the immunization location or injection site information. He developed right side facial numbness, right side tinnitus and hearing loss on 5-19-2021. He was evaluated at Hospital ER where a CT of Head was apparently normal; I do not have access to this report. No medication was given and he was discharged from the ER. He present to our (ENT) office on 5-6-2021. At this time he reports right side tinnitus and right side subjective hearing loss. He no longer had facial paresthesia. His ENT/Neuro exam was normal. An audiogram was performed and right sensorineural hearing loss was noted, the acoustic reflexes were consistent with the SNHL. He was administered high dose Prednisone

Patient presented after recently receiving the first dose of Moderna vaccine with dizziness, blurred vision, and hearing disturbances with associated nausea and vomiting. Patient's labs in the ER revealed significantly elevated free T4 and was started on hydrocortisone and methimazole therapy.

Swelling of the left eye, with rash/skin eruption on face. Received IV of Solumedrol 125mg and Pepcid 20 mg at a facility. Was prescribed Prednisone for 5 days.

On 6/4/21 at 11:30 am, I went deaf in my right ear suddenly. It started with tinnitus and I went deaf over the course of a few minutes. 6/4/21 Urgent care visit: no sound detected in right ear 6/4/21 Emergency room visit: Oral steroid prescribed. 6/7/21 ENT specialist visit: Hearing test for baseline, diagnosed sudden onset hearing loss and additional oral Steroids prescribed. 6/14/21 ENT specialist visit: Hearing test shows no significant improvement: Steroid injections into ear prescribed and done in office 6/21/21 ENT specialist visit: 2nd steroid injection into ear done. 6/22/21 MRI of head done: (results not in yet) Future 6/25/21: ENT specialist visit: 3rd steroid injection into ear scheduled.

Metallic taste in mouth for about 4 hrs after vaccine. Ringing in left ear overlayed when any sound was heard above background noise for about 1 hr. Light-Headedness for 1 hr after vaccine.

Day after pain in the area of my lung scar and under arm , skin rashes as well in chest, they come back and then it was fine for a while but recently in June with Heatwave 1 and currently heatwave2- I felt horrible pressure and pain in my chest and could not breath and the nebulizer wasnt helping. I got an xray and the doctor at the City Md refused to believe me that this was related to vaccine and my lung wound from a previous surgery that increases inflammation as I am now experiencing. I am asking to please help me get a cooling airc conditioner in my kitchen/ bathroom area as it is also where I will be teaching virtually hybrid schedule and only feel relieved in cool air. My school that I teach at is in some rooms adding daily heat exhaustion and I would greatly like if possible any help or treatment and or rehabiliation phyical therapy and also reexamining the area where my origial surgery was and how this can be dangerous for people taking the vaccine.

Rapid Heart Beat Blurry Vision High Fever - Approaching 2 weeks Strong Dizziness/Vertigo Rashes Week long Headaches Hard to breath Ringing in ears Deep ache/pain in leg & arm with leg swelling

4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after vaccine before subsiding

33 hours post vaccination: experienced heartburn, discomfort followed by urticaria on my neck, trunk, armpit, and back. Took diphenhydramine. Woke up with no itching by some swelling of left eyelid. At 1500 1/7/21, some outbreak of urticaria on my back, underarm, neck, trunk area, and groin area. Took lower dose of diphenhydramine.

Patient reported stroke-like symptoms as he was driving to work: started "feeling funny" with dizziness; progressed to feeling weakness in left side of face with facial drooping; tingling in left hand progressed to numbness and weakness in left arm and leg; difficultly coordinating motor movement in right arm; difficulty/ diminished speech "tongue felt fat." Symptoms resolved within appx 1+ hour from onset. Per patient, he was given an injection at the hospital (unsure for what?) and was discharged with a prescription for chlorthalidone 25mg daily, blood pressure was elevated.

Since Wednesday 01/06/21, have had on and off unusual taste, almost metallic taste in the mouth intermittently. Today, 01/22/21, lost my sense of taste. Went to take the Rapid Covid test and was negative,

~ 2 HRS AFTER RECEIVING THE SHOT ON 01/05/2021 I EXPERIENCE HEADACHE AND SORENESS AND NUMBNESS ON THE INJECTED SIDE. WHEN I GOT HOME I WASNT FEELING WELL AND STARTED TO EXPERIENCE CHILLS, WEAKNESS AND MY HEADACHE WORSEN. TO THIS DATE IM EXPERIENCING THE FOLLOWING SYMPTOMS: HEADACHE, BODY PAIN, LOST OF TASTE AND SMELL, LOW GRADE FEVER AND SHOOTING PAIN ON MY R LOWER RIB CAGE.

At 2 am on 1/1/21, sudden onset severe left calf muscular cramping which resolved in about a minute. Soreness persisted for 4 days. No preceding activity peformed to have caused this. Same evening, insomnia, uncomfortable abdominal bloating, vivid dreams, and ?light? night sweats primarily affecting lower extremities. This also lasted for about 4-5 days. On 1/6/21, 7 days post injection, woke up in morning completely drenched from a night sweat. Things improved in days to come although a certain subtle feeling of hyperalertness has persisted. On Tuesday 1/12, began with a mild to moderate bifrontal headache. Fortunately, I do not typically get headaches. Tylenol and sleep relieved but headache returned on Wednesday evening and persisted through late afternoon Friday 1/15 possibly lateralizing slightly to the right. Saturday morning 1/16, no headache, but sudden onset of focal right lower neck tenderness situated around the thyroid/sternocleidomastoid region. No throat pain, sneezing, coughing. This progressively got worse throughout the day and particularly at night(8-9/10 pain scale) with discomfort on swallowing and with radiation to right subdmandibular region and right ear. Some temperature imbalance overnight and last few nights with slight night sweats. Not feeling feverish. Neck pain has persisted since then to today 1/20/21 and steadily improved. 2 separate Ibuprofen doses have appeared to help. ENT to be seen today.

Shortly after receiving vaccination Patient experienced ringing in ears, sweating and felt light headed. Patient received Epi in left thigh. EMT arrived and took over care. Patient declined transport to ER.

Checked sugar when I got home at 5:30pm, sugar was 570. More insulin was used as my sugar is never that high. Experienced blurry vision, and not completely oriented

Patient reported right sided facial drooping on 2/1/2021 stating that it began three days prior to him reporting it. MD documentation: Pt unable to blink right eye, lift right brow and right side of mouth is drooping. PERLA. Pt denied right sided weakness/headache. Pt has demonstrated elevated blood pressures since receiving Covid 19 Vaccine not previously demonstrated.

High fever 104F with chills and sweating- has been on going since symptom on set with periods of some relief (Tylenol will bring fever down to 101 F). Nerve pain, "my nerves are on fire." It seems to be rotating through various nerve clusters. At first it was through his arms, then shifted to the back of his left leg, then the right, then down to his toes, then fingers. Joint pain, this was bad enough he buckled a couple times and fell the night of 02/05/2021 twice. Facial swelling, most pronounced on nose, lips, and chin. This started 02/05/2021 at around 10:00 AM. It has been variable in degree since it has started. Vomiting, started 02/05/2021 at around 09:30 PM. This was after a period of nausea. The vomitting has since slowed down, but not stopped.

Near vasovagal syncope 5 days after 2nd dose. 5 days after my second COVID vaccine, I was outside in snowy, cold weather about a mile from my car. I had stopped moving to rearrange some items. While stopped, I started to feel lightheaded, develop tunnel vision, and feel faint, almost to the point of blacking out. I put my head down and legs up and felt somewhat better. I then attempted to return to my car. I could go 100-200 yards at a stretch, before having to purposefully fall down and elevate my legs. I traveled the mile back to my car like this (slowly). I could not check my pulse because my hands were too cold; my respiration rate was elevated. At the car, I drank fluids and warmed up and began to recover enough to get home.

Jaw pain, tingling sensation of lips, back muscle tightening. BP 133/91 (pulse 102)' repeat BP 115/76. O2 sat 99%.

Tongue itching (given 25 mg benadryl) in 1 hr 45 min progressed to throat swelling (patient self admin epi pen while in car) drove to ER and given IV steroids. At time of report still mild tongue itching + headaches Some dizziness, MD followup 2-12-21.

12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.

Accepted vaccine in the left arm at 2:30 PM on 03/12/2021. At approximately 10 PM same date begin feeling headache along with body aches. At 2 AM on 03/13/2021 awaken by flu-like symptoms - body aches, headaches, night sweats, weak muscles Same flu-like symptoms continued until the next day 03/14/2021 until 6 PM, some relief but a headache and weak muscles continued. At approximately 10 PM on 3/14/2021 symptoms continued as headache, right ear began to have pain associated like an ear infection and upper jaw/teeth were throbbing until approximately 6 AM on 3/15/2021. Waking on 3/15/2021 around 7:30 AM only a headache persists and slight muscle weakness.

3/12/2021: Fever 100.1F; lasting from 2:30pm through 3:30pm; elevated temp of 99.2-99.6 until 3/15/2021 3/12/2021: Chills ~8pm until ~2am on 3/13/2021 nasal congestion 3/13/2021 7:30am-11:00am elevated pulse ~115bpm sporadically from 3/13/2021-3/15/2021 swollen neck glands/throat tightness 3/14/2021 8pm-11pm numb lips & tongue 3/15/2021 2pm-3pm

Moderna vaccine dose 1 was administered at around 1:40 PM. Pt reports itchiness, N/V,and dizziness about 10 minutes after injection. Epinephrine 0.3 mg administered IM LVG 15 minutes post vaccine. S/S resolved for about 5-10 minutes. S/S returned including SOB, with throat/tongue/lip swelling and tingling. Started PT on 2 L O2 via NC. Administered another 0.3 mg of epinephrine IM LVG. S/S did not resolve so another 0.3 mg of epinephrine was administered IM LVG. Patient still reported SOB, generalized itchiness, and throat swelling. 125 mg of Solumedrol was then administered IM RVG. 50 mg of diphenhydramine was administered IVP in the left forearm. EMS was called and patient refused transport to hospital. S/S resolved.

No reaction for first 4 or 5 hours, increasing in pain until left arm and shoulder became immobilized. Severe pain when touched, and slowly backing off after full 48 hours. It?s been 10 days and Left arm shoulder has about 85% mobility. Swelling in armpit also still present but almost gone. I have a lock jaw kind of sensation still lingering as well. No infection detected at injection point. Worried for dose two.

36 hours after last dose of maderna vaccine he has the usual aches but swollen puffy eyes which he took benedryll and ibuprofin . that subsided but then until now on and off stomach pains. he is also feeling weak. No fever

That night, about 5 hours later, my lower eyelids swelled up, starting with the left side. It was controlled with 10 mg Claritin, BID. The symptoms lasted for about 1 week. I saw my physician about day 3. He recommended not getting the 2nd dose of the vaccine. He recommended either the Claritin (that I ended up taking) or prednisone.

3/25 7PM started to feel chills and body aches and woke up in the middle of the night with a fever. 3/26 Continued fever (103.1), body ache, foggy head, head ache, slight loss of taste 3/27 Fever broke, still body ached, foggy head, head ache, slight loss of taste 3/28 foggy head, slight loss of taste 3/29 foggy head, slight loss of taste

Patient with no prior otologic history presented to clinic 2-3 days after first dose of vaccine with bilateral tinnitus and aural fullness. No associated hearing loss or vertigo.

Following administration of vaccine patient started to have difficulty swallowing and tingling in mouth and tongue. Patient was given liquid diphenhydramine and water and stated the difficulty swallowing improved but his mouth still had the tingling sensation. Patient never reported facial swelling or difficulty breathing and declined an EpiPen. After 30 minutes or so patient reported improvement and left our facility. We reached out to the patient later that day and they had continual improvement, but felt they had experienced a possible allergic reaction.

Recurrence of tinnitus after 8 years of not experiencing with loud noises or just around me. Subjectively, background tinnitus is about 2X what it was before and tinnitus with loud noises is 10X-20X more intense to the point of making me try to avoid the noise triggering it.

Non stop ringing in ears (sometimes seems to be in head rather than ears). The ringing sounds like a solid high pitch sound which varies in intensity. Slight intermittent nausea. Brain fog. Currently trying OTC antioxidants, vitamins and antihistamines. Vitamin c, vitamin e, magnesium, r-Ala, nac, coq10, astaxanthin, zyrtec and Tylenol or advil. No improvement currently. Have ENT appt scheduled for Monday. 4/5.

Blurred vision, "heavy" feeling in the throat, nose became mostly numb, lips had some numbness, extreme paleness. No issues with breathing (even while wearing a mask). Reaction started with blurred vision while reading (during the waiting period at the vaccination clinic). Started within 10 minutes of receiving vaccine. Then the throat heaviness started, nose became numb, and lips were somewhat numb. It occurred in waves, with a few minutes of symptoms, then a mild relief of symptoms (but not total relief), then symptoms returned. This continued for 30-45 minutes. Received water and 2 Benadryl at the vaccination clinic from RN. Benadryl didn't seem to have any impact on symptoms.

Received first Moderna shot on 3/20. Experienced severe vertigo episodes on 3/23, 3/24, and then again on 4/8 (all with spinning, dizziness, vomiting, sweating, chills). Visited an ENT doctor. Did an ENG showing weakness in the right ear. Have had ringing in the right ear for several weeks. Have a hearing test scheduled for 4/20 and am currently on dizziness medication. Also have an MRI scheduled. Have the 2nd shot scheduled for 4/17 and need guidance on whether to take it.

Patient in observation. Patient complaining of cottonmouth, tongue numbness, difficulty swallowing, numb lips, and throat swelling. Vital signs BP-153/97, HR-88, RR-18. Benadryl 50mg give orally by EMT. Patient AOx4, lung sounds clear bilaterally, no hives notes, no injuries noted. Patient monitored. Patient reports feeling better after receiving Benadryl. Vital signs BP-164/45, HR-82, RR-16. Patient reports no more symptoms. Patient educated about adverse reactions and when to seek medical attention. Patient verbalizes understanding.

PATIENT RECEIVED VACCINE FRIDAY 4/9/21 AROUND 4 PM. PATIENT STATES WHEN HE WOKE UP SATURDAY 4/10/21 HIS RIGHT EYE WAS RED AND HURT. PATIENT STATED PAIN WAS RESOLVED BUT THE REDNESS REMAINED. PATIENT DID NOT SEEK MEDICAL TREATMENT.

Approx 15mins after having the shot administered I sat in my car and felt the medication coming on by it clouding my vision then causing me to faint (and by description from my fiancé) I had what appeared to be a mild seizure. I was out for a minute or two and when I was conscious again my vision was blurry and I felt very drunk for the next 45mins - hour. I also felt like I could taste the chemicals from the vaccine when I became conscious again. The drunk/vertigo feeling subsided slowly over time but I was given a Benadryl from the pharmacist so I?m not sure when the dizziness stopped but I definitely could not drive home. My fainting was not due to any anxiety due to having a shot or anything, I was perfectly fine for approx 10-15 mins after the vaccine then I felt a cold feeling coming on from my right shoulder then up my neck then I got foggy and dizzy and passed out

Patient received his second dose of Moderna. The patient did mention that he had a reaction of his tongue swelling on his first dose, but took Claritin per his PCP. Staff instructed him that he would have a 30 minute observation time due to his history of immunization reactions and sulfa and various food allergies. During observation, the patient got the attention to let him know that he felt his tongue swelling. EMS was activated along with the first set of vitals being taken. The vital signs are as follows: 1645 - 150/100 HR 87 RR 18 O2 97 1655 - 140/95 HR 89 RR 16 O2 93 1705 - 138/83 HR 88 RR 16 02 93 1715 - 135/80 HR 83 RR 14 02 97 As EMS was arriving he stated that he still felt his tongue was swollen, but denied difficulty breathing or worsening symptoms. In the EMS assessment, patient was monitored via a 12 lead which yielded sinus rhythm. Patient declined transport to the hospital via EMS as he was alert and oriented x 3. Patient was advised to contact his PCP about the reaction to his second dose. RN instructed the patient to contact 911 if there is shortness of breath, difficulty breathing, and any other sign of distress

Patient is a 45 year old male A & O x4 complaining of anxiety approximately 5 minutes after receiving the injection. Patient stated that he became very anxious with slight blurred vision. Patient stated that he has had similar events in the past when he is in a medical environment. Patient was placed in a sitting position in the medical evaluation area with vital signs obtained. Initial blood pressure was low but improved to normal limits quickly once in the sitting position and patient stated that his symptoms completely resolved. Patient has a history of anxiety, and allergy to an unknown antibiotic and takes no medications. Negative chest pain, shortness of breath, weakness, dizziness, blurred vision, anxiety and there were no signs of allergic reaction or stroke. Patient was able to stand with no symptoms and continued to deny any complaint. Patient denied any further care and stated that his wife would drive him home. Patient was advised of risks, consequences and when to seek medical care. Patient was accompanied to his vehicle by (EMT) and left with his wife via private vehicle.

In early AM hours of Apr 23 I began to feel very weak. At around 3:15am when I got up to use the bathroom, my eyes clouded over and I passed out on the bat Herron floor. I regained consciousness after almost 10 minutes. Luckily I was not injured. But I was practically bedridden all day Apr 23.

Rash on face, in ear ,arms,,soreness on left shoulder ,headache,,itch in eyes,,pain on left hand ,,fatigue,,

Significant loss of hearing in left ear. Tinnitus and pressure in left ear causing equilibrium issues and nausea.

Tinnitus in right ear. Some loss of hearing in right ear. Tight upper back and neck muscles. Sharp headache pain.

Ears started ringing same evening as shot received. Ears have been ringing constantly ever since. (3 weeks so far).

Patient reported a slight itch on the top of his pallet in his mouth. It went away after a while. After a 12 hour follow up the patient is fine and the itch has gone away.

Pressure behind left ear causing dizziness/lightheadedness. The pressure is accompanied with occasional ringing in the left ear, sometimes very loud ringing.

6 days after shot got cloudy head and ringing in persistent ringing in ears, particularly my right ear. Now been 15 days since shot and still have steady ringing. Went to emt last week, my hearing is ok but they can't do anything directly about my ear ringing. Head has mostly cleared at this point but ear still ringing. Can't sleep at night.

Burning sensation and swollen red raised skin at eyelids, and under eyes. Grey half moon circles under eyes. Sore to touch

1 or 2 minutes after shot started feeling dizzy. Heart rate felt like it dropped and blood pressure felt very low. Vision was dark and I spent most of the time concentrating on breathing. I did not lose consciousness or pass out at any time. I was with my wife and children so they were able to give me the timeline. My wife noted I started sweating after about 5 minutes. The symptoms peaked at about 10 minutes and faded slowly after that. Because I felt like the worst of the event had passed we did not report the event at the time. When we got home I laid down for about an hour. My shoulder started hurting about this time as well. I feel I was recovered from the initial symptoms within 2 days. My shoulder was in pain for about 3 days, with the first two days being much worse than the third.

Patient presented to clinic today for 2nd dose of Moderna, reported to nurse that 3 weeks after vaccination, woke up that morning with tongue tingling, right side of mouth numb and drawing, unable to shut right eye. Reports he saw his provider and was diagnosed with Bell's Palsy. Was given Prednisone 50mg PO QD, an anti-viral (patient did not know the name), and eye drops. Nurse contacted our medical director who recommended we hold on giving 2nd dose and have patient first discuss with primary MD.

tongue swelled up and nothing would help the swelling at the same facility i was vaccinated at. i could not drink water or eveneat applesauce. the swelling did not go down for at 2 weeks until i demanded a referral to a better facility. i ended up being admitted to the hospital 3 times in 2 weeks. my tongue is still swollen as of today

Two days after getting his first Moderna Covid vaccine shot my father suddenly lost his ability to hear from his left ear.

Within 8 1/2 hrs. after vaccination (2nd COVID-19 Moderna vaccination): moderate to severe headache, fever 100.3 , body aches and chills, cough, sinus drainage, slight tightness in chest, eyes watering, and sore at injection site (left arm).

Beginning on May 13, I?ve experienced heavy headedness, dizziness, and some nausea on 5/13, 5/14, and 5/15

Extreme increase in tinnitus in left ear and also new tinnitus in right ear. Uncertain if additional hearing loss has occurred.

Initially, the patient had dizziness, lightheadedness and a syncopal episode within 5 minutes of the vaccine. He returned to normal fairly quickly and went home by report. He presented to the ER shortly after with palpitations and shortness of breath and required a dose of IM epinephrine. Patient since had intermittent fatigue, dizziness, blurred and vision changes as well as tinnitus. On May 31, 2021, patient presented to the ER with headache, lethargy, weakness, diaphoresis and dizziness. Additionally, noted to have slurred speech by his wife. MRI of the brain done at 4 am on 5/31/21 showed the following "1. Acute bilateral cerebellar infarcts are seen with a right posterior 4.3 mm focus a left middle cerebellar peduncle 3.2 mm focus and a left superior cerebellar 7.9 mm linear focus. 2. Occlusion of the left vertebral artery extending into the basilar artery with reconstitution of the basilar artery via bilateral posterior communicating arteries. Findings are concerning for acute dissection occlusion. Consider further evaluation with MRA head and neck. 3. Question subtle area of restricted diffusion seen within the left dorsal medulla better appreciated on the maps measuring approximately 4.9 mm. Left lateral pontine 7.3 mm focus of restricted diffusion versus artifact. These infarcts are not definite and could be artifactual asymmetry.'. He required admission, heparin drip and neurology consult at that time, as well as permissive hypertension. shortly after 1 pm on May 31, he developed chest pain with ischemic changes on EKG requiring cardiology consult with possible intervention, though this was being coordinated with interventional neurology, as he also required basilar angiogram for his MRI findings. as cardiology and interventional neurology were coordinating taking patient for intervention, he became further unresponsive, though maintained his pulse, and required intubation and transfer to ICU, as well as repeat CT of the head to evaluate for continued thrombosis of his basilar system. Work up is still on going

Initial headache, body aches, chills, vertigo, nausea, vomiting. Subsided 36 hours after injection. Returned two weeks later with headaches, vertigo, malaise, tinnitus and diplopia. Symptoms gradually lessened over time but still remain four months later.

Adverse event #1: Numbness of the fingertips on both hands. Ingested one tablet of Tylenol. Fingertips return to normal about 60 minutes thereafter. Adverse event #2: Prickly sensation on the left side of the tongue only. No treatment. Prickly sensation on the left side of the tongue subsided after 75 minutes.

high-frequency hearing loss; ringing in left ear; congestion in left ear; on and off pain in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (high-frequency hearing loss) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (ringing in left ear), EAR CONGESTION (congestion in left ear) and EAR PAIN (on and off pain in left ear). On an unknown date, the patient experienced DEAFNESS (high-frequency hearing loss) (seriousness criterion medically significant). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency; CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) ongoing since an unknown date at an unspecified dose and frequency; ALPHA LIPOIC ACID ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; AZELASTINE ongoing since an unknown date at an unspecified dose and frequency; FLUTICASONE ongoing since an unknown date at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. On 04-May-2021, EAR CONGESTION (congestion in left ear) had resolved. At the time of the report, DEAFNESS (high-frequency hearing loss) and TINNITUS (ringing in left ear) had not resolved and EAR PAIN (on and off pain in left ear) outcome was unknown. The patient was taking no concomitant medications. Treatment included a two week trial for hearing aid that provided notch therapy for tinnitus but patient had not noticed any improvement in hearing or ringing. Completed the course of prednisone and antibiotic with no improvement. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Events added, case upgraded to serious and event details updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded

Developed Tinnitus some time after the second. I cannot recall the exact date but it was within a month of receiving the second dose.

Besides being very tired, I woke up to severe tinnitus ringing in my ears. I thought that it would eventually go away but it hasn't and I wake up to it each morning and it's with me throughout the day.

I have ringing in my ears that comes and goes. Sometimes it is very loud. It can be in both my ears and other times only in my left ear. This started days after receiving the second shot. I still have this condition two months later. Unknown if this is going to be permanent.

Pain at injection site for 3 days, nausea and diarrhea for 7 days after shot?and still experiencing, itchy swollen eyes for 7 days after shot and still experiencing, fatigue for 7days still experiencing

40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent; numbness on toes of his right foot; difficulty moving his right leg to use break pedal while driving his car; right foot was not going on the ground during his walk; left ear started buzzing with hollow sound which gradually increased every week; feeling tickling; Pain in hand; Numbness on fingers; started feeling that skin bellow his eye and right side of his face was falling; fever; pain in his right arm; shivering; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent), HYPOAESTHESIA (numbness on toes of his right foot), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car) and GAIT DISTURBANCE (right foot was not going on the ground during his walk) in a 44-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. No medical history was provided by the reporter. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), SEMAGLUTIDE (RYBELSUS) and ATORVASTATIN for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSAESTHESIA (started feeling that skin bellow his eye and right side of his face was falling). On an unknown date, the patient experienced DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent) (seriousness criterion medically significant), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car) (seriousness criterion medically significant), PARAESTHESIA (feeling tickling), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness on fingers). an unknown date, the patient experienced HYPOAESTHESIA (numbness on toes of his right foot) (seriousness criterion medically significant) and GAIT DISTURBANCE (right foot was not going on the ground during his walk) (seriousness criterion medically significant). an unknown date, the patient experienced TINNITUS (left ear started buzzing with hollow sound which gradually increased every week). an unknown date, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain in his right arm) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DEAFNESS (40 to 50 % of hearing loss on left side/his right ear is also affected as well but not to the great extent), HYPOAESTHESIA (numbness on toes of his right foot), MUSCULAR WEAKNESS (difficulty moving his right leg to use break pedal while driving his car), GAIT DISTURBANCE (right foot was not going on the ground during his walk), DYSAESTHESIA (started feeling that skin bellow his eye and right side of his face was falling), TINNITUS (left ear started buzzing with hollow sound which gradually increased every week), PARAESTHESIA (feeling tickling), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness on fingers) outcome was unknown and PYREXIA (fever), VACCINATION SITE PAIN (pain in his right arm) and CHILLS (shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Acoustic stimulation tests: abnormal (abnormal) 40 to 50 % of hearing loss on left side and mentioned that his right ear is also affected as well but not to the great extent.. After 24 hours of the second dose patient developed shivering, fever and pain in his right arm which lasted for 2 to 3 days. Patient could not get out of bed and had to take Tylenol to treat the symptoms. After 5 days, patient started feeling normal. Patient stated that 1 week after the second dose, his left ear started buzzing with hollow sound which gradually increased every week. Patient was referred to ENT specialist by his primary care doctor. ENT doctor performed hearing test and diagnosed the patient with 40 to 50 % of hearing loss on left side and mentioned that his right ear is also affected as well but not to the great extent. Patient stated that After 10 days (on 26/27May2021), his right foot was not going on the ground during his walk and started feeling tickling, numbness on toes of his right foot. Patient mentioned that the numbness kept going upwards and towards under his knee. One or two weeks ago, patient was having difficulty moving his right leg to use break pedal while driving his car. Patient stated that he is walking, running on treadmill and doing yoga daily. Patient's walking got a little better but he still has numbness in his toes. Patient was told to get ABR test done and might need MRI test. Two weeks back from today (16Jul2021), Patient started feeling that skin bellow his eye and right side of his face was falling. Patient confirmed that he is still feeling the same. Patient informed his doctor about the symptoms and he was referred to a neurologist. Patient has an appointment with neurologist on 04AUG2021. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

40 to 50 % of hearing loss on left side; his right ear is also affected as well but not to the great extent.; Pain in his right arm; Could not get out of bed; Left ear started buzzing with hollow sound which gradually increased every week; Tickling; Numbness on toes of his right foot; Started feeling that skin bellow his eye and right side of his face was falling; Difficulty moving his right leg to use break pedal while driving his car; Mild Fever; Pain in his hand; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (40 to 50 % of hearing loss on left side) and DEAFNESS (his right ear is also affected as well but not to the great extent.) in a 44-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. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (RYVEL PLUS) and ATORVASTATIN for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEAFNESS (40 to 50 % of hearing loss on left side) (seriousness criterion medically significant), DEAFNESS (his right ear is also affected as well but not to the great extent.) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in his right arm), MALAISE (Could not get out of bed), TINNITUS (Left ear started buzzing with hollow sound which gradually increased every week), FEELING ABNORMAL (Tickling), HYPOAESTHESIA (Numbness on toes of his right foot), SKIN EXFOLIATION (Started feeling that skin bellow his eye and right side of his face was falling), MOBILITY DECREASED (Difficulty moving his right leg to use break pedal while driving his car), PYREXIA (Mild Fever), MYALGIA (Pain in his hand) and CHILLS (Shivering). The patient was treated with PARACETAMOL (TYLENOL) for Malaise, at an unspecified dose and frequency. At the time of the report, DEAFNESS (40 to 50 % of hearing loss on left side), DEAFNESS (his right ear is also affected as well but not to the great extent.), PAIN IN EXTREMITY (Pain in his right arm), MALAISE (Could not get out of bed), TINNITUS (Left ear started buzzing with hollow sound which gradually increased every week), FEELING ABNORMAL (Tickling), HYPOAESTHESIA (Numbness on toes of his right foot), SKIN EXFOLIATION (Started feeling that skin bellow his eye and right side of his face was falling), MOBILITY DECREASED (Difficulty moving his right leg to use break pedal while driving his car), PYREXIA (Mild Fever), MYALGIA (Pain in his hand) and CHILLS (Shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) 40 to 50 % of hearing loss on left side and mentioned that his right ear is also affected as well but not to the great extent.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-259292 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Tinnitus in bilateral ears, not improved. Have had prednisone Corse without improvement. Have followed with PCP.

Significant Tinnitus like I've never experienced. Extremely loud and very concerning. Sounds like a deafening number of cicadas. The sound can be masked by external sounds at times but when it would otherwise be quiet the ringing becomes overwhelming.

Patient reported throat feeling dry 5 minutes after vaccine administration. He drank some apple juice. He reported that his throat felt tight, and that he was becoming hoarse about 25 minutes after vaccine administration. He was able to walk to a treatment area, where he was assessed and 0.3 ml Epinephrine by Epi Pen was administered into antero lateral thigh, and EMS was called. Patient reported symptom improvement after 3-5 minutes. EMS transported patient to the Emergency Department for evaluation.

Mild nausea at about 20 minutes post injection. Not unusual for me. Was on a 30 minute hold. Felt good. Left the station. Started to feel a little difficult to swallow. Tongue obviously swollen. No difficulty breathing. No hives. Called PCP. Notified Deputy Chief. Drove to clinic as precaution. Dr. advised of reaction. Dr. advised me to take Benadryl, 50mg, Every 6 hours for that day and the folllowing. Swelling improved within 1-2 hours of first Benadryl dose.

Patient presenting approx 45 minutes after injection with facial swelling to eyelids and upper face. Also had an associated pruritic rash on right upper back region. No swelling to mouth, lips or tongue. No SOB or wheezing. Symptoms improved (decreased swelling) with 50mg PO benadryl. Was discharged after monitoring for 2 hours. Provided rx for epi pen upon discharge.

Pt received Covid-19 vaccine at 1300. After no reportable symptoms for approximately 2 hours, reported back to immunizations for additional vaccine. After administration of last vaccine, pt leaned head back (pt was seated), eyes rolled in back of head, and appeared pale and diaphoretic. After a few seconds, pt regained consciousness. Pt continued to rest with legs propped up and cold compress on neck. VS were taken following event: BP 115/80. SPO2 93%, T 96.8, R 16. Pt reports hx of "passing out" with blood draws and previous vaccinations. Provider visited with pt and was okay to leave facility.

Confusion, Headache, Myalgia, Arthralgia, Swelling and pain at the injection site, fatigue, tingling, feeling of heat in feet, chest tightness, eye pain Narrative:

Confusion, Headache, Myalgia, Arthralgia, Swelling and pain at the injection site, fatigue, tingling, feeling of heat in feet, chest tightness, eye pain. Narrative:

8JAN21- 1630 - 1730 - light headed, sporadically saw stars every 2 seconds, in wave pattern. 2000-2400- Did not sleep well. Felt dizzy, light headed. Loud ringing in ears. Buzzing of head. 9JAN2021 -Cold sweat, nauseous, prickly pin and needles come and go in hands, arms, legs, and feet. Sharp 2 second knife pains in chest and sides come and go. Strong metallic taste in mouth, even water taste metallic. slight numbness feeling in arms and legs. Very fast heart beat when standing up (120). Immediately drops (to 80) when I lay down. Very loud ringing in ears and buzzing in head. Extreme weakness in muscles. Very fatigued. 10JAN2021 Feeling a little better. Still light headed and slight ringing in ears and buzzing in head. 11JAN2021 Even better but still slight buzzing in head. Very tired and fatigued. Injection site on arm was normally sore (like flu shots). NO headache. NO fever.

All symptoms occurred at the 12-24hr mark: metallic taste, chest tightness, limb (needle like) itching, cold sweats, body ache/pain, chills, nausea. All symptoms resided except for malaise after the 24hr mark. Malaise current through today(11JAN21)

Morning following vaccine had sour stomach and did not take medications. Did not prevent me from having normal day. 2200 began to have chills, checked temperature it was 100.4 and took 2 ibuprofen and went to bed. Woke up at 00:30 with fever of 102.7 and took 1000 mg acetaminophen. Restless night of sleep, waking up very thirsty, felt terrible. Alarm at 06:45 with no fever and felt tired but not bad. Went to work and felt fatigued but able to perform job. No further adverse events.

Within 1 minute of receiving vaccination, heart rate increase to over 145 bpm. Blood pressure increased significantly. Began sweating profusely. Developed a very dry mouth and high rate of breathing. Lasted for about 20-30 minutes and then returned to normal.

Vaccine was administered to patient in his room at 12:50pm. After the patient finished his lunch in his room he was wheeled out to the nursing station for observation. at 1:30pm the nurse wheeled patient into our working/set up area and stated that patient is having a vaccine reaction. I observed that his lips were noticeably swollen. I asked patient to stick out his tongue, it also was noticeably swollen. Only the tip of his tongue extended about 1/2 inch past his lips. I administered 0.3mg of Epinephrine via and epi-pen into his right thigh and instructed the nursing staff to call 911. Patient improved markedly over the next 10 minutes when Fire Department EMT's arrived. Nursing staff monitored his blood pressure, heart rate and pulse and oxygen sat. heart rate was elevated somewhat likely due to epi , BP was 121/73, pulse steady and ox sat good. Fire Department transported patient to a nearby ER for further evaluation and treatment if necessary.

20 minutes after vaccination, complained of tingling of the side of the tongue and mild throat swelling Pt was seen in ED, given pepcid and loratadine, and discharged home

pt stated that he had bells palsy symptoms the day after he received the vaccine. Unable to smile with left side of face, slight eye droop. Symptoms resolved in 24 hours. He received 2nd dose 1/27/21 as he did not state he had a reaction when asked prior to receiving the dose.

was seen by provider 03/11/2021 with swollen eyes, rash all over with some blisters. prednisone was given. eyes remain swollen somewhat and some rash, but better.

Following day experienced flu-like symptoms until 5 pm, then was fine. 3 days after the shot, started experiencing tinnitus and still have it 10 days after shot.

After about 30 minutes he said his throat felt weird. That night. Later he said he didn?t feel good and he said these are just normal reactions. I with pneumonia, or he thought he was catching pneumonia from me. Not possible he had the vaccine. Then the next morning he was still having difficulty breathing. Then Saturday 03/20/2021. afternoon he couldn?t catch his breath. I ran to get my phone and came back and he was dead. Called 911 and did CPR. They arrived and got a heart beat and put him on a breathing machine. He is in a medical induced coma. With a 50/50. Chance of survival.

I've experienced most of the symptoms described in the fact sheet. Additionally, I have been experiencing tremendous, piercing pain in both ears. It comes and goes. I have been experiencing it 3-5 times a day. The pain comes into both ears at the same time. It is unlike any other discomfort and pain I've ever experienced.

Patient stated he experienced lost of taste on the same day that vaccine was administered. The next day, patient was fatigue. Stated speech was sluggish and was not able to consume food due to drooping of the left side of mouth. Also stated that he was not able to close the left eye. Patient was seen at emergency clinic on 3/27/2021. Stated that he was diagnosed with Bell's Palsy. Patient was prescribed steroids and was advised to follow up with primary care physician.

I started to hear noise in my right ear. noise is not loud but continues. the noise is like something in ear moving around. shaking and changing head positions do not change the pattern of such noise . my left ear behaves normal.

Severe tinnitus. Ringing in left ear, pressure in left ear, loss of high frequency hearing in left ear

The patient is a 45 y/o male prisoner who presented 4/3/2021 with 3 days of headache, neck pain and stiffness, sensitivity to light, and nausea. He was found to have extensive dural venous sinus thrombosis causing the symptoms. He has hypothyroidism was taking levothyroxine 150 mcg daily at time of vaccination. On admission on 4/3/2021 his TSH was found to be 12 and levothyroxine dose was increased to 175 mcg on 4/4/2021. He has no prior history of thrombosis and the only family member with thrombosis is his mother who had DVTs associated with lung cancer. He has a history of prior COVID-19 infection in April of 2020 and at that time reported 3-4 days of mild symptoms and was not hospitalized or given anticoagulation. He has not had fevers, chills, or other symptoms of infection. He received his first dose of the Moderna COVID-19 vaccine at the prison on 3/23/2021 which was 9 days prior to symptom on set 12 days prior to presentation at the hospital. He reports 2-3 days of arm soreness at the injection site in his right arm, mild neck soreness, and fatigue after the injection which had resolved prior to his current symptoms starting. He currently remains hospitalized and is being treated with anticoagulation.

Moderna COVID-19 Vaccine EUA first dose given at 6pm. Mild pain at injection site within a few hours. 3am (9 hours after injection) I went to the bathroom, and while standing got dizzy and lightheaded tried to sit down. Collapsed while trying to sit down and hit head on bathroom floor. Cut right eyebrow on floor. Tried to get back to bed and was in and out of consciousness for 30-60 seconds per spouse. Vasovagal response symptoms. Cold sweats. I was very thirsty and drank a tall glass of water. 5 minutes later I stood up and went back to bed feeling fine. I slept the rest of the night and felt fine the next day, and for the rest of the weekend with no other symptoms.

Swelling in body. Particular face and eye. One one is completely shut. Lots of discomfort and inability to work. Can send a picture. It has not started healing yet. Swelling is still very high.

Extreme chills/shaking Extreme sweating: Facial sweating had a weird consistency that was more viscus than normal sweat. Extreme back pain Skin felt like it was boiling, like needles were pushing out of my skin Extreme arm pain at injection point that ran down the arm Pressure in eyes, and increased redness in one eye, almost like vessels had broken Muscle pain and cramps Runny nose Sore throat/massive increase in acid reflux Diarrhea

I woke up the day after my 2nd Moderna vaccine shot with loud ringing in both ears and it has continued for 4 straight days. Sudden onset that morning - had never experienced this ringing sensation before. Possible tinnitus.

Began experiencing dizziness 2 days after shot. Dizziness is more severe when laying down. Also feels like inner ears are sore. Experiencing ringing in ears as well. This has lasted for almost 4 weeks. Dizziness is a bit better, but still experiencing pressure and ringing in ears. Tried using nasal sprays and allergy medicine to help alleviate symptoms. Doesn?t help.

Incessant tinnitus in both ears which is more prevalent in a quiet room and when trying to sleep; occasional, intermittent ear ringing separately in each ear (for 5 to 10 seconds) but has been more infrequent than the incessant tinnitus; feel slightly off balance / unsteady; sensation of wanting to "open" Eustachian tubes by yawning; ear fullness / clogged, as if there is liquid in them blocking sound; occasional popping/cracking in ears; occasional itch of inside the ear; slight pressure in the head; a feeling of being mentally "slower" or "brain fog"; an occasional pulse in ear (not with my heart's pulse) which is akin to hearing a drum beat a few times inside your head; incessant tinnitus sounds is like you've left a TV on but it is on no channel or has no cable input; symptoms have created much anxiety.

Severe tinnitus began about 0100 on 02/11/2021, waking me out of a sound sleep, and keeping me awake for the rest of the night. Symptoms persist, and seem to be worse at night, while at home and not at work. PCP has me taking Lipo-Flavonoid Plus, to help with the symptoms, which help eliminate some of the loud buzzing, but not all of it.

After first vaccine on March 15, I only had arm pain at injection site, but I started having pretty regular ringing in my ears, mainly in my left ear and for a very shorty duration each time it occurred. After second injection, I had pain at injection site shortly after injection that became much more intense and moved to my bicep the next morning. On the first day, I also felt tired and unable to concentrate, which became more severe on the second day before subsiding on the third. On the morning of the second day, I began having random, brief pinching pains in different parts of my body. These have occurred randomly since that day, at most 10 times a day or so, primarily in neck, arms and legs. I had a fever of 100.2 on the evening of the second day. The ringing in my ears is now very quiet and high pitched, but more or less constant and in both ears. Whenever it is quiet, I hear it or if I pay attention when it is not quiet, it is still there. I noticed the constant ringing yesterday morning (April 17) and it has persisted.

Pt received his first Moderna vaccine on 2/25/2021. 3 days later he developed significant oral pain located on the roof of his mouth, back of mouth and throat. He presented to clinic about 1 week later for evaluation. There were no obvious signs of trauma or infection at the time. He followed up with this Dentist and it was suggested he likely had a chemical burn secondary to citrus foods. He followed up with another provider and was treated with a 3 day course of an antiviral medication for herpes without any change in symptoms. He hasn't had oral herpes before, but has had shingles. He received his second Moderna vaccine on 3/25/2021 and 3 days later developed significant throat pain and swelling in his neck glands that was visible to him. His symptoms improved slightly, but have never completely resolved. He has had what feels like a dry sore throat for 7-8 weeks and intermittent white patches in the back of his mouth. He has no history of or active allergy symptoms. Was treated for oral candidiasis on 4/19/2021, but it's unclear if his vaccine triggered these symptoms.

Previously healthy 46 yoM received moderna dose 1 on 4/9. On 4/13 starts noticing a petechial rash on bilateral feet. This spreads up the legs with some involvement in the torso. On 4/15 notices mucosal bleeding with gums while brushing teeth, increasing spontaneous nose bleeds overnight. On 4/21 has a telehealth PCP visit, sent for lab work which shows thrombocytopenia with a platelet count of 2k as well as a hemoglobin of 12.9. Is sent to the ED with repeat platelet count of 1k. Previously platelets were 143k in 2019. Pt admitted for further work-up

Day 1 - exhaustion, joint pain; Day 2, 3 - chills, aches; Day 5 - stuffiness in ears (feeling of fluid) then ringing in both ears started in afternoon.

I haven?t had a headache for years until this weekend. Sore and achey around and behind left eye and left forehead.

Patient arrived for second dose and stated that ever since they got their first shot, they have experienced tinnitus. Stated they had never had tinnitus before and it's been severe enough to keep them awake at night.

Eye began twitching on left side several days after vaccine and continues to twitch. No preexisting instances of eye twitching.

severe pain at injection site, horrible headache, dizzy, blurry vision, sensitivity to light, congestion, difficulty breathing, cough, heavy chest, abdomen swollen and tender to touch, nausea, bloating, loose stool, moaning, fever, sweats, chills, severe joint pain full body, restless, unable to sleep, unable to eat or get out of bed or work

I had kaleidoscope vision for about 20 minutes that afternoon. That evening my facial paralysis went away. I suffered from partial facial paralysis for two years from a sever episode of Bell?s palsy. The paralysis complete went away two days after got the vaccine.

Patient stated tongue and arm were tingly about 10 minutes after vaccine administration. He was feeling like he was having an allergic reaction to vaccination. Patient said allergic reactions to foods normally clear up with Benadryl. Patient carried Benadryl in car with him, took 50 mg. We waited to EMS to arrive to further evaluate. Patient went to the hospital for further evaluation.

Moderna COVID-19 Vaccine EUA: 2nd dose Please see continuation page ... Inside arm and armpit itching after 5 minutes Diarrhea after 3 hrs which stopped in an hr Transient Shortness of breath after 15 hrs ( last about half an hr): oxygen level 95-100 Chills starting after 15 hr Slight fever ~99f Hearth beat: 95 (normal rate ~60) Extreme Nausea w/o vomiting for 3 to 4 hrs Extremely sensitive to smells (pleasant or unpleasant) triggering nausea Stomach and esophagus intense cramps for 4 hrs so intense that I had to call 911 (they didn't prescribe anything other than Tylenol or NyQuil which I couldn't take due to nausea) Passed out multiple times Hallucinations and talking gibberish Lack of concentration

Suddent onset of tinnitus in the left ear. Has not abated. Only reporting because my biological brother (1 1/2 years younger) also had the onset of tinnitus after receiving the vaccine (Pfiser).

Pt reports on April 15th he began feeling fatigue, fever, aches, lip swelling, and soft palate swelling that lasted two days. Pt said he could not sleep laying down because his soft palate blocked his breathing. Pt reports taking an antihistamine and feeling better after 4 days. Pt showed photos of lip swelling, and he reported it to his health care provider. His health care provider sent an email that recommended not receiving the second dose of Moderna. However, pt was automatically scheduled from his first visit to get second dose, and pt showed up to site to discuss it and showed this vaccinator the email and photos and described this course. This vaccinator did not administer second dose of vaccine and recommended discussing alternatives with MD.

Moderate ringing in left ear. Ive had a mild ringing since my time in the military, but the ringing is much more noticeable and as of right now, only in left ear. At times it seems mild, other times it seems very intense and very annoying.

Fever, Chills, Nausea, Photosensitivity, Headache and Tinnitus within first day. After second day all returned to normal, except the Tinnitus. It is persistent, severe and worse on one side.

Dizziness, loss of hearing and heavy fatigue two weeks after first dose. Hearing recovered three days after loss. The resting issues lasting for almost three weeks so far. I'm currently on medical leave of absence. Doctor diagnosed me with dizziness and vertigo. Looking at computer screens and walking trigger this the most. Driving is fine.

Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side; Tongue was also swollen; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) in a 45-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. No Medical History information was reported. On 30-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue was also swollen). At the time of the report, DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) and SWOLLEN TONGUE (Tongue was also swollen) outcome was unknown. Concomitant medications and treatment details were not provided. The action taken with mRNA-1273 in response to the event was not applicable. The patient reported that he had gone deaf in his right ear after getting the 2nd dose and could not hear anything on right side. His tongue was also swollen after getting the 2nd dose. Company comment:Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Profound hearing loss in right ear; Tinnitus in left ear. These symptoms began the evening after the dose was administered and were intermittent throughout each day, eventually resolving entirely about a week later.

Pt reported lips tingling, tight throat, Benadryl 25mg tab administered, no difficulty swallowing, VS stable. No symptom improvement at 20 minutes and expressed a feeling of having a golf ball stuck in his throat, denied SOB, itchiness, no noted hives, denied chest pain/tightness, dizziness, vision changes or anxiety. Benadryl 25 mg tab administered, no noted or voiced difficulty with swallowing. VS stable. Pt observed another 30 minutes and symptoms began to resolve. Full resolutions of symptoms at 3 hours, pt discharged home @ 13:20. Emergency situations reviewed with instructions to call 911 if reoccurrence of symptoms.

I have tinnitus and mild ear pain in my right ear. My doctor examined my ears and did not see any ear wax or inflammation. I got very sick in late February 2020 with COVID-like symptoms (severe headache, fever of 104, fatigue, loss of taste, and a dry cough). Approximately 3 days into being sick I developed a significant pain in my right ear. It took me approximately 6 to 7 days to recover and the ear pain subsided. The dry cough lasted another two weeks or so. I went to the ER because my headache was so intense and my fever was so high. They gave me a flu test but that came back negative. They were not able to diagnose what I had. The tinnitus and ear pain started approximately 1 week after my first Moderna dose and has lasted now for about 6 weeks. My doctor prescribed prednisone but that is not working.

The patient reported on 06/12/21 to the pharmacy he started having tinnitis in his right ear 1 week following vaccination. He went to the doctor and was diagnosed with post viral neuralgia of the right ear. The patient stated his doctor believed it was vaccine related. The patient also reported having thought he had been ill with Covid-19 in February 2020 before testing was readily available and at that time he had ear pain in is right ear (same ear) with the illness.

Experienced severe pain in both eyes hours after the second dose. This continued for about 12 hours along with other symptoms, including fever. Foe weeks following, the eye pain continued to come and go. On May 26, I was diagnosed with inflamed Iris and a degradation of my eye fluid in both eyes. I am still being treated with steroid drops.

Increased SOB." feels like I am breathing through a straw". Itchy rash chest, neck and eyes. " feels like I got hit by a truck".

I developed Tinnitus in both ears. The noise was so loud I could sleep, concentrate or go about daily life. Two weeks after the first vaccine shot it started. It wasn?t terrible at that time. Then, one week after the second shot it became terrible. I went to the urgent care. They sent me to the ER and they did a CAT Scan to rule out tumors. I then found out other people have gotten the same thing from the vaccine and was directed to a doctor who put my on a prednisone antibiotic. With no relief I went to an ENT who tested my hearing. I had moderate hearing loss from the Tinnitus. I started sound therapy and had to get hearing aids a few weeks ago on June 25, 2021. The hearing aids are helping to mask the noise of the tinnitus.

Jan 15 – Moderna Shot #1 – no side effects. Feb 12 –Moderna Shot #2 – Side effects: fever, malaise, fatigue, site injection pain. Feb 13 - Side effects: fevers 99.2-100.4, body aches, lethargy Feb 14 – Side Effects: morning fevers, midday and afternoon felt like all nerves were on fire specifically the sciatic. Pain radiating down arms and it hurt to type email to (professors at ) Feb 14-17 – Side effects: nausea, mental fog, headache, fatigue Feb 18 – Side effects: (added to already listed above) lymphedema and swelling in ankles and feet. Feb 28 – side effects were still persistent, and breathing had worsened, so I sought out medical help.

patient face got swollen around 6 pm on 07/19/2021. He feels numb on left side of face and this morning on 07/20/2021 around 5 am his eye almost was shut closed due to swelling. Now swelling got better. Still he feels numb on his face.

- pt came into the clinic after being vaccinated 24 hours ago at another facility with fever, body aches and lost of tase

Dizziness flushing on L side, numbness through teeth and lips, swelling under L eye, L arm swelling, Narrative:

2 hours post injection patient vocalized lower abdominal discomfort accompanied by multiple episodes of diarrhea following day diarrhea subsides but patient notes lethargy, blurred vision, chills/fever (max 102) and itchy, tender, red induration to left deltoid at injection site. Induration has enlarged to current 11cmx9cm in size. Area marked for monitoring

Loss of vision; Possible lowgrade central retinal occlusion; retinal venous dilation; Decreased vision; Unexplained Retinal Hemorrhages; A spontaneous report was received from an ophthalmologist retinal specialist concerning a 46-year-old, male patient who received Moderna's COVID-19 Vaccine and developed loss of vision, decreased vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Dec 2020, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 27 Dec 2020, the patient experienced decreased vision. On 29 Dec 2020, the physician examined the patient. There was some retinal hemorrhage, venous dilation, and possible low grade central retinal occlusion. Lab work was requested by the physician and results were pending. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, loss of vision, decreased vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion were unknown.; Reporter's Comments: This case concerns a 46 year old male patient. The patient's medical history is not provided. The patient experienced a serious, unexpected event of loss of vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion. The event occurred 4 days after first dose of the mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information are required for further assessment.

pt after injection had pain in injection site with tingling down to the fingertips. Pt stated next day he felt nauseas w/ swelling of the right lymph nodes and hot/cold flashes with vomiting. pt also experienced body aches and fatigue w/ rapid heart beat and sore throat, cough and lost his voice.

headaches , sometime so severe that wake me up from sleep. happening every night for last three nights, it started after 30 hours of getting the vaccine. Headache is so severe that I feel like i will collapse. during the day feels like weight on head and eyes feel heavy.

I developed tinnitus in my ears about 3 to 4 hours after vaccine. I normally don't get this. Rarely after a concert or game but short lived. This has stuck around and I kept waiting for it to disappear. Unfortunately it has not. My right ear is worse than my left but the tinnitus remains so I thought I should report it. I have been looking on-line for any other reports and see none. This may be coincidence but due to lack of resolution of tinnitus, I thought I should report it. My flu-like symptoms (headache, shaking chills, sore arm) disappeared within 36 hours.

Itchy mouth, difficulty swallowing, sweating, feeling that tongue was swelling, light chest tightness. Given 50mg Benadryl. Symptoms subsided. Was required to wait additional 30minutes for observation.

I began to have a fever 18 hours after receiving the vaccine. Then when I woke up approximately 24 hours after receiving the vaccine, I felt severe sinus pressure, headache, light sensitivity, body aches, slight nausea, continued fever cycling, and lethargy. These symptoms began to resolve 24 hours after they started. These were the exact same symptoms that I experienced when I had Covid-19.

Fever, hot and cold flashes, extreme body aches all over, headache, ringing in both ears, cramps in both legs, shooting nerve pain up and down both legs, nausea, loss of apatite, agitation, sleepiness.

8 days after my first dose, 01/20/2021, around 9am, my eyes started to turn red, and teary and difficulty to look on computer screens and TV. Thinking it might be a Conjunctivitis, assuming it was a windy week in my area, I did do some yard work. That night it started to build pressure, pain and headache. I asked my spouse to buy me eyedrops., did used with no relief. I've putting cold packs at the beginning, but it gives me more headache, I changed to warm compress, and had some relief. For 4 days I suffered the same symptoms and discomfort, not until the 4th day (Friday) I can't take it anymore, I went to an urgent care, they check my V/S, BP is elevated, ranging from 140's/92's. They check my eye pressure, it was elevated. The PA prescribed Tobramycin eyedrop(Tobrex) and recommend me to see an Ophthalmologist to do further evaluation. The next day 5th day (Saturday) went to Dr., get evaluated both of my eyes had high pressure,

Per patient, woke up on the morning after the day following his vaccination (2/9/21) with chest pain, shortness of breath, and feeling light-headed. He tried to sit up, saw red dots, and "passed out" momentarily. He had severe headache upon awakening, ringing in ears, and blurry vision. Went back to bed and slept all day. Symptoms worsened every time he tried to get up. Woke up this AM, with symptoms persisting. Came in for OV, BP noted to be elevated at 150/106. Patient was sent to hospital via ambulance for further work-up and management.

itching of throat and tongue and feeling hot. pt removed some of his clothes and was given water to drink and ice packs to cool him. Also felt some numbness of his tongue. no respiratory distress noted and no coughing noted. signs were normal. pt continued to be able to talk and was alert at all times.

Within a few minutes while sitting on the chair after injection, felt my heart suddenly race, a flushing sensation occurred, and I tasted something in my mouth (chemical or metallic taste). I started to get dizzy and was sweating. Called over the Fire Dept personnel who were administering the injections and they helped me (fluids, ECG, etc.). During this time they stated that my blood pressure dropped to the low 40's (not sure the exact number) and my heart rate as well. My complexion was pale to them and sweating a lot. After administering IV fluids a few minutes later my BP and HR started to rise. My SpO2 was good. Transported to ER for evaluation and labwork.

Within 5 minutes I had blurred vision, foggy brain and dizziness. This lasted about an hour, and after that I was fine. It seemed to come on fast, and then leave just as fast.

Patient was reporting numbness of arm , neck and head on left side and ear pain 15 minutes after receiving the vaccine. Patient was observed for another 15 minutes and he reported no numbness but tingling in shoulder and arm on the left side. He still had pain wear his ear was described as a tightness he felt on his head and neck as well. A blood pressure was taken and patient's blood pressure was 178/124. 911 was called and EMTs arrived to assess the patient.

itchy face started about 3-4 days after vaccine. Did not think anything of it. Got significantly worse within 2 days of the second vaccine

within 5 minutes of receiving the vaccine patient became light headed, cold clammy skin with cold sweats, blurry vision, dizzy, pale/gray skin, and short of breath. Pulse was 60 and BP 90/60- epinephrine 0.5 mg given, pt BP 80/60 returned to 129/88. EMS evaluated patient- patient declined to go with EMS to ER or to go to the ER- pt stated 1 hour after onset that he felt fine and declined to go to ER eventhough he was advised to but states that he will go if he feels he needs to but that he feels normal now.

body aches, chills, and stomach ache, fatigue, headache, nausea, mild voice loss, mouth sweats, ear-ache, red eyes, swollen lymph

1. I was completely normal the day of the second dose. 2. The next day, I had quite significant chills, body aches, fatigue, and some nausea. I also had a metallic taste. 3. Fortunately, the chills, body aches, and fatigue went away the second day. However, I continued to have the metallic taste for days. 4. Also, starting the third day and I still have a cough and tightness in my lungs. I went into a doctor at urgent care four days after the second dose (due to a concern about the cough and tightness in my lungs). All of my vitals were normal and they attributed to side effects from the vaccine. Also, they gave me an inhaler. 5. The inhaler has been somewhat helpful, but I had a consistent cough as well as some tightness in my lungs for two weeks after the second dose. On unusually stressful days, it was even worse. 6. The cough has improved, but I still have it occasionally throughout the day as well as the tightness in my lungs. 7. Finally, I continue to have the metallic taste.

Forty-five following vaccination reported that he was driving home and started feeling "flushed". He reported that he looked in his rear view mirror and stated that his face was "very red". He also reports that he had a foul taste in his mouth "like he was chewing on an onion. He denied seeing any rash, shortness of breath, sweating, palpitations or racing heart. He stated that symptoms lasted for a half hour. He denied taking anything to alleviate the symptoms. Afterwards he reports that he felt good.

Since the first does, I have been experiencing intermittent tinnitus. The increase in occurrence seems related to being vaccinated.

Two or three days after receiving my first shot of the Moderna vaccine, I began having severe tinnitus (ringing in ears). I have had minor tinnitus for the past five years as a result of attending a very loud concert, however, that normally didn't disrupt me. The tinnitus since my vaccine has been so severe that it sometimes keeps me from falling asleep or wakens me. After a few weeks, the tinnitus was less severe, but it has not returned to its normal levels. I've read of many other people who have the same symptom, so I'm hesitant about getting another vaccine dose. I'll get guidance from my ENT.

Inflammed, tender, painful lymph nodes on right side of body, facial drooping, constant eye watering, difficult to close mouth and to speak clearly, challenging to shut eye.

Extremely swollen, hard and painful lymph nodes in left arm, left pectoral, under left clavicle/first rib; extremely swollen tongue and gums; hives across left shoulder, neck, chest and abdomen - all persisted for 5 days

2 days after this vaccine, Pt had paralysis of left cheek and lower part of right cheek (closer to jawline), and paralysis and drooping of left eye, unable to fully close Left eye. Patient came to see me 4 days after the vaccination about this condition, and i suggested that he sees his medical provider.

I got my 1st Moderna Covid Vaccine shot on 3/6/21. I started to notice my tinnitus more than usual. I got my 2nd Moderna Vaccine shot on 4/5/21. Then on April 9th around 4AM it's like someone turned my tinnitus up. It got significantly louder out of the blue. Was harder to sleep. I still hear it now while I am awake which I usually don't notice it. I also feel slightly dizzy as I walk around the house.

28 hrs post vaccine: Headache begins. About 10 sharp pains in left brain over next 4 hours. Tinnitus starts, stops, starts a few times. Sharp headache pains stop. Normal headache + Tinnitus continues Now 9 days after vaccine: Headache continues and Tinnitus has never stopped. Headache is gradually decreasing, Tinnitus is not.

Rcvd Moderna 1st does. Began feeling sharp almost scratchy pain to left of left nipple. Followed by numb/flush feeling running from left ear down the side of face and neck. Numbness to the left side of tongue. Continues as of 12:10pm

Client reported itching beginning around the mouth then going to face and extremities. Client was given Benadryl with symptom resolve.

Pt reports onset on metallic taste in mouth after first vaccination, pt also reports urine and stool both have stool. Pt reports smell is most noticeable after eating any protein (eggs, meat, fish). Pt described immediately after first vaccine was strong enough to make him avoid eating; pt reported to primary care provider 5 wks later reporting symptoms are less severe now. Pt still notices smell with eating proteins, but now is less noticeable. Pt received second Moderna vaccine 4/27/21 regardless of smell he has been experiencing since first vaccine dose.

Pt developed Bell's Palsey(left facial droop, unable to close left eye. He stated symptoms developed on 4/21/2021 when he noticed he was drooling and liquid was coming back out of mouth while trying to drink fluids. Stroke was ruled out by MRI. He is currently recieving these medications for treatment: Prednisone 60mg daily for 7 days, Acyclovir 400mg TID for 7 days and eye drops and lubricant

Pain in Shoulder blade area-day 2 , Headaches & ear aches-7 days, chills-2 days, eye pain-7 days and then onset of Bell's Palsy which started on day (Monday,4/25). Treatments: steroids, antibiotics, ear and eye drops Seen at Urgent care-day 2 and ER-day 3 and primary care physician-day 7

On 04/14/21 I laid down to bed and noticed my tinitus went from moderate to servere. Usually I can notice it if I tried but now could not sleep, can hear it over tv and music. Two weeks later still bad and seems to be increasing. Also noticed little blood spots showing up on skin on chest, legs, arms. very small, raised, and probably around 20-30 on whole body.

Tinnitus spike in both ears. I have very mild tinnitus (1 out of 10 in left ear, 2/10 in right ear). About April 13, 2021, my tinnitus began to significantly increase, especially in my right ear (3/10 left ear, 5/10 right ear). It was annoying, but I was able to sleep. Though I did get a little anxious about whether it was permanent or would get worse. It peaked on May 1, 2021 (4/10 left ear, 6/10 right ear), and has been slowly getting better since then. I'd now characterize the left ear varying between 2-3/10, and right ear varying between 3-4/10.

On May 8th, around 2:15 pm, I started getting severe double vision in my left eye. I could barely see out of my left eye because of this. I thought this could be a sign of a blood clot, so I drank a few glasses of wine and the symptoms went away after about 15 minutes. It has not reoccurred.

Ringing in ears started about 1 week after 1st shot. Has not gone away...fairly consistent on a daily basis...really no better/worse times...just constant and consistent

Estimated 90% hearing loss and severe tinnitus of right ear 14 days after 1st injection of moderna covid19 vaccine.

Ear pain, pressure and fullness in both ears, but left side worse. Constant ringing in both ears. Dizziness and nausea. 10 days of antibiotics and Sudafed, 5 days of prednisone, and multiple days of allergy medications have not worked or helped alleviate symptoms.

Moderna COVID-19 Vaccine EUA: immediately upon receiving injection, heart began racing, and what had been a relatively quite ringing in my ears for the past year or two, also immediately became 2-3x louder (maybe even more?), where it has remained ever since (nearly 2 months). The heart rate settled down within a few second, but the ringing persisted, and has continued. Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone I used to hear on an airplane sometimes, but it was so quiet that I only noticed when I would wake up in the morning or at other random times when everything around me was very quiet. Since the vaccine, however, it has become loud enough that it's impossible not to notice it constantly; not so loud that I can't hear other things around me or people talking, but definitely loud enough that it's unmistakably there and can at times be a real distraction to focus and even conversation.

After 8 days I started feeling a headache I took ibuprofen then I felt numbness of my mouth and my right eye would not fully close only half way, my mouth started drooping sideways when I ate and swallowed food, my throat felt strange the liquid like water would come out a little. My eyes burned, predominately my right eye.

Moderna COVID-19 Vaccine EUA Per first aid provider at vaccine POD: Chief Complaint: lips tingling, no swelling or rash noted, patient monitored for 30 minutes, medical options of Benadryl discussed, patient refused, symptoms resolved, patient instructed if symptoms reoccur to take Benadryl per package directions, seek medical help if symptoms persist or other symptoms develop.

Began 30 minutes after shot and has continued to various degrees since then: Head pressure, headache, ear pressure and pain, jaw pain, knee joint pain, tingling and numbness in arms and legs, nausea.

1-2 hours after receiving second vaccine injection, noted severe weakness and heavy feeling in legs. Had to leave work to go home. 2 days later noted onset of tongue numbness and unable to sip coffee. Noted progressive drooping left side of face, difficulty speaking clearly, and tearing of left eye; also numbness and burning of tops of feet. Evaluated in the ED on 4/27/2021. Noted to have dysarthria and left facial nerve palsy. CT head and MRI head demonstrated no hemorrhage, mass effect. On CT scan, intracranial vessel calcification noted c/w cranial atherosclerosis. On MRI few nonspecific high T2-weighted foci within the subcortical white matter of the frontal lobes of uncertain clinical significance. Pt given scripts for Valtrex and 7 day course of steroids.

Telephone consult performed on 05/27/2021 @ 1530 by APRN. Pt assessed by Nurse at vaccination site. Pt received Moderna COVID-19 vaccine dose #1 on 05/27/2021 at 1415. Pt was observed for 15 minutes at vaccination site, left at 1430 without reactions. Nurse documented on vaccine consent form: 1530- Pt returned to vaccination location complaining of sudden onset of blurred vision and ocular pressure to right eye. Denies H/A, N/V, dizziness. Bilateral equal hand grasp. Denies history of migraines. BP 160/80; P 84; R 18; O2 sat 98% on room air. 1539: APRN called for consult and spoke to the patient. Pt reports a partial loss of vision to right eye which has subsided, but persistent bilateral blurred vision remains. Pt sts visual changes began ~ 1515. Pt reports he has a childhood stutter. Pt denies H/A, changes in speech, hearing, memory. Denies LOC/falls or dysequilibrium. Denies any medical history, including HTN. Pt is alert, oriented x 4. Discussed possibility of CVA with the patient and the need for emergent care via EMS, and explained rationale. Pt understood and agrees. notified 911. 1607: EMS arrival. Medics verbally report BP 158/100 on first set of VS to Nurse. Pt left vaccination site via EMS to be transported to Hospital.

Overwhelming exhaustion, indigestion and bowel irritation, lethargic and prolong feelings of vertigo during focus.

Broke out in hive and a rash, throat swelled, eyes swelled, problems with heart and lungs and sinus issues really bad... lasted over 3 months and still having some effects.

Condition aggravated; Palpitations; Tinnitus; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Asthma and Allergy NOS. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and LOSARTAN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion disability), PALPITATIONS (Palpitations) (seriousness criterion disability) and TINNITUS (Tinnitus) (seriousness criterion disability). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) 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. Immediately upon receiving injection, the patient's heart began racing, and what had been a relatively quite ringing in his ears for the past year or two, also immediately became 2-3x louder (maybe even more), where it had remained ever since (nearly 2 months). The heart rate settled down within a few second, but the ringing persisted, and continued. Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone he used to hear on an airplane sometimes, but it was so quiet that he only noticed when he would wake up in the morning or at other random times when everything around him was very quiet. Since the vaccine, however, it became loud enough that it was impossible not to notice it constantly; not so loud that he could not hear other things around him or people talking, but definitely loud enough that it was unmistakably there and could at times be a real distraction to focus and even conversation. Treatment medications were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

For 5 to 6 days after shot all muscles tightened, shaking alot, hot but cold. Jaw hurts from shivering. Etc. For a whole month, Right arm still hurts when moved in curtain directions. Lack of sleep because waking up in pain. after up awhile if I move in certain ways hurts with sharp pain, sometimes spasms. Occasionally tightens up. Seems to be getting worse.

105.2 degree fever the next day - took 3 rounds of Tylenol and fever finally broke on Saturday April 24th. Since Friday April 23rd, I have had ringing in my left ear (tinnitus) and now have minor hearing loss in the left ear.

About two weeks after getting my first shot, besides the typical pain at the injection site ( felt like a decent punch to the arm for about 1 week), I had the sensation of having an abscessed tooth. I?ve had an abscessed tooth before and the sensation was the same. Both sides of my jaw were very sore, hard to open my mouth, pain radiating up my jaw and into my ears on both sides of my face. The next day my face muscles ?dropped? like they became too relaxed and it seemed to me exactly like my abscessed tooth from the past. I had started to take some antibiotics that I have on hand in preparation for a visit to the oral surgeon. Three days of this and the pain and my muscle issue disappeared. I should note that I lost my taste throughout the three days that this happened. Everything is normal since, just wanted to bring this up and report this strange reaction.

observed the patient sitting down head lowred looking uncomfortable, called a translater, patient felt dizzy nausiated and had blurry vision. I had him lay down with feet up bp 89/41/54 at 1:25pm , a few minutes later he said his visiion had improved and took some water. at 1:30 bp was 97/61 60 some improvement but felt worse a few min later 1:34 bp 94/59 60 and at 1:44 bp 97/69 57 he felt well enough to stand, walk around at 1:49 he left with his freinds but confided to the translater that he was still nausated. (he had not eaten lunch yet) I avdvised that if he still felt bad that he should consider seeing a doctor. He and his friends then purchased some crackers and tylenol before leaving the store.

Minor hearing loss; Ringing in his left ear (tinnitus); Fever ranging from 104.2 to 105.2 degrees F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Minor hearing loss) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DEAFNESS (Minor hearing loss) (seriousness criterion medically significant), TINNITUS (Ringing in his left ear (tinnitus)) and PYREXIA (Fever ranging from 104.2 to 105.2 degrees F). The patient was treated with PARACETAMOL (TYLENOL) on 23-Apr-2021 for Fever, at a dose of 1 dosage form and PREDNISONE for Tinnitus and Hearing loss, at a dose of UNK dosage form. At the time of the report, DEAFNESS (Minor hearing loss) had not resolved, TINNITUS (Ringing in his left ear (tinnitus)) outcome was unknown and PYREXIA (Fever ranging from 104.2 to 105.2 degrees F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 104.7 (High) 104.7 degree Fahrenheit at 06:00 AM and 105.2 (High) 105.2 degree Fahrenheit at 2-3 PM. On 24-Apr-2021, Body temperature: 104.2 (High) 104.2 degree Fahrenheit at 03:00 AM. Concomitant product use was not provided. Patient saw ear, nose and throat (ENT) specialist who advised him prednisone for four weeks and steroid drops for 2 weeks but the hearing did not come back, so patient stopped using medications. Patient had 3 different hearing test over few weeks. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-220405 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

I went to bed on the night I received my second does of the Moderna vaccine. I woke up at 2 am with a riningin noise in my head that wouldn't go away. I went to the doctor and they said it was Tinnitus.

Fever of 102-103 for three days. Chills, fatigue, headache, blurred vision, dizziness, body aches, congestion, and small productive cough for five days. Fatigue, headache, slight dizziness and improving cough on days six and seven (today).

Dizziness, HYPERtension & Tachycardia Narrative: within 5 minutes after vaccine experienced chest tightness, lightheadedness. On examination BP 190/110, pulse 112. Ear flushing. A&O x 3. No cardiac or respiratory distress. 25mg of Benadryl orally was given. Escorted to the ER in wheelchair. Discharged from the ER diagnosed as HTN and Anxiety. Discharged home in stable condition.

Recieved first Vaccine on Wednesday 1/13/2021 and tested Positive for COVID 19 on Saturday 1/16/2021. Only Symptoms are loss of taste and smell.

Day 1: first hour slight euphoria -- hours 2-8 felt like a surge of epinephrine, speedy when speaking, stammering occasionally Day 2 - 4: felt like final day of having flu, achy, weak, overall off Day 5-8: extreme fatigue Day 10-11: slight fatigue, brain slow Day 12-14: strange subtle brain sensations, flow of blood to the head shifting, occasional lightheadedness, vision worse, nervous system a bit jerky

S/p vaccination reports burning and tingling feeling in throat w/noted redness to forehead, bilateral cheeks, and hands; IM Benadryl 0.25mg x 1 administered by MD denies any respiratory distress/ throat swelling/ none noted. O2 Sat 98% RA Medical monitoring x 30 min w/ minimal improvement Recommendation for patient to be further evaluated. Released from site facility for further f/up

Patient c/o Numbness of the peri-oral numbness within 5 minutes of getting the vaccaine, strange taste in the mouth soon after the vaccine. Patient had taken Benadryl , pressure in the eyes and tightness in the chest. Patient continues to have mild episodic vertigo since then.

Temperature 106, Malaise, Nausea, Vomiting, Joint redness, swelling and pain (hands), back pain, headache, visual disturbance (photosensitivity), Vertigo, Muscle Weakness, Shortness of breath all occuring over four day period. Continue to run a low grade temperature (99) intermittently.

Patient stated that he had some lip tingling after first time dose after leaving from observation. That did diminish on its own. 3:00pm Tongue tingling. 25mg of Benadryl given. BP, P, 02 through out observation. VS WNL normal and all symptoms resolved prior to leaving at 3:35pm. Patient verbalized feeling comfortable to leave. Director of Nursing and PCP will be notified.

Just over 24 hours after receiving shot, I had a pressure located at the top of my right eye. Not the lid, not the sinus area above, the actual eyeball. I'm an optometrist, so the following day, one of my partners examined me and found no cause. It was uncomfortable for the remainder of the day as well as the next. Saturday, 3 days after getting shot, I felt extreme pressure within the right eye. No vision problems, no pain with eye movements, no peripheral vision loss; just a lot of pressure/soreness. I spoke with a colleague in a specialty eye care practice. Since symptoms continued, though milder the following day, he ordered a CT scan. I had the scan Jan 21 (8 days after receiving first vaccine dose). I took Aleve and a sinus decongestant (though pain did not feel like sinus pain and was not located within sinus area) No other symptoms occurred and it reduced in severity and now asymptomatic since Jan 24.

My mouth is mildly numb. No paralysis, just a somewhat numb tongue, chin, cheek (jawline). It is not completely numb.

Since receiving Moderna shot #1 vaccine I have experienced three gout attacks. It is unusual for me to have this many gout attacks in such a short time period. Additionally, physical activity has been very challenging since receiving the shot. I fatigue and become short of breath very quickly. During the first workout that I did, on 02/01/2021, after receiving the shot I became extremely dizzy, my eyes became light sensitive and my hands trembled; symptoms lasted for approximately 45 minutes.

Experienced lightheadedness and ringing in ears. Payed down and drank liquids. The symptoms have slowly subsided. I currently have some ringing in my ears but at a background level/volume.

Shortly after the shot I began to feel itchiness in my right eye through out the day. The next day 2/13/21 I woke up with blood in my right eye. I did not have any itchiness, pain, or teary eye. On 2/14/21 the blood now was in 75% of my right eye. Today on 2/15/21 I went to urgent care to have it checked out and they told me I had a ruptured blood vessel. My entire eye is now covered in blood. I had not experienced any vomiting or had any cough of any type, or hit my eye anywhere for this to happen.

Approximately 45 minutes after injection mild onset of anaphylaxis response. Numb tongue, tingly lips, mild throat constriction but no issues swallowing or breathing. About 60 minutes post-injection, the patient self-administered two 25 mg tablets of Benadryl. Symptoms subsided 120 minutes later.

Initial soreness in shoulder starting one hour after injection and continued for two days. Right eye pain started about 18 hours after injection. Chills and low grade fever (99.1) recorded 26.5 hours after injection. Body Aches, primarily back, and general weakness occurred 28 hours after injection 400mg of Advil taken 32 hours after injection and prior to bed time. No symptoms following morning/day.

Around 2:30-3:00 am on March 6, 2021, I woke up to my lips being Swollen and a headache, and High Blood Pressure. I have been keeping my lips moist and applying a hot towel to my lips

Right sided mild facial swelling, left side facial droop-eye, corner of mouth, decreased forehead creases, loss of nasolabial fold and impaired speech.Treatment includes Acyclovir 400mg orally five times a day, Prednisone 10mg orally daily, Lacri-lube S.O.P. ophthalmic ointment to left eye at bedtime. Patient was to follow-up in 1 week. At follow-up patient continued to have left sided facial droop, feels like his left nostril is "closed", left ear feels full, swelling to left neck and shoulder. Provider plan to continue current medications and continue facial exercises. Follow-up set for 1 month.

Pt reports decrease hearing to bilateral ears after vaccine administration Observed for 45 mins reported slight improvement in difficulty hearing Pt was educated to follow up PCP or visit ER if symptom doesnt improve or gets worse Pt verbalized understanding

3/18 - received Moderna #1 (not sure where this was done) 3/19 - developed raised itchy rash, mostly on trunk; went to hospital, got prednisone 60, Benadryl, Pepcid, sent home 3/20 - took prednisone 60 and Benadryl at home 3/21 - hives worsened, now involving buttocks, thighs, face, with mild periorbital swelling; went to emergency department, got Benadryl, Pepcid, sent home 3/22 - developed mild lip swelling, admitted to hospital for observation. Got epi 0.3 mg IM, Decadron 10 mg IV, Zyrtec 10 mg, Pepcid 40 mg po, Benadryl 25 mg po, with improvement. Allergy consulted, felt this was likely delayed hypersensitivity reaction to Moderna, but couldn't exclude lisinopril side effect. They recommended Zyrtec 10 mg bid for 1 wk, and stay off lisinopril. Will follow up in Clinic to determine how to approach 2nd shot.

Patient has canker sores on tongue, cheeks, gums. Lesions are very inflamed and painful. Has not seen a doctor yet.

Three days after receiving my second dose of the Moderna COVID vaccine, I had a sudden onset of tinnitus. I've never had tinnitus symptoms before with any other vaccine or in general (aside from acute tinnitus after rock concerts), much less sudden onset tinnitus. Once the normal, published side effects (aching, sore arm, fatigue) subsided, I immediately began noticing a constant ringing/buzzing in my ears. The left ear is more prominent, but I have it in both ears. I also experience a higher sensitivity to loud sounds. As of 4/2/2021, I still have mild-moderate ringing in my ears, especially in quiet situations.

Approx 5-10 minutes after receiving vaccine, Medical Member was called over to patient in chair who was found to be verbally unresponsive with eyes closed. Noxious stimuli applied without response. Eyes closed, when manually opened, noted to have dysconjugate gaze with 5mm sluggish pupils. Patient then exhibited upper/lower extremity tonic/clonic movements <10 seconds. After, patient spontaneously opened eyes, became verbal and answered all questions appropriately with clear speech. Moved all extremities spontaneously without focal deficit. BP: 98/61 HR 41 RR 16 EMS call to evaluate patient. Patient left building with EMS.

Approx 10 minutes after patient received vaccine, he began to complain of chest pains, dizziness, and blurry vision. His vitals were stable at BP 133/95, HR 90, Pulse ox 97% on room air. His symptoms persisted so 911 was promptly called. Dr. came and assessed patient and he was found to have clear lungs with no abnormal heart sounds. When EMS arrived, his vitals were very similar and still stable. Patient was taken to Hospital. I spoke with him the following day, 4/7/21, and he reported that his labs were all unremarkable and they treated him for a panic attack and he was feeling well by the time he got home.

Received my first shot on the 6th of April at or about 1600 (4pm). No side effects other than general soreness in upper arm/shoulder area. First major side effect started to kick in around 1700 (5pm) on Thursday April 8 2021. At that time my voice started cracking, fading in and out with a sore/scratchy throat. When I woke up on Friday April 9 2021 at 0700 my voice was gone and my throat has a numb feeling to it.

About 30 min after leaving the vaccination site I was driving home and felt face getting flush and tingly, on one side of my face. Felt slight swelling of my mouth and tongue. Those lasted about 45 min to an hour and they dissipated and then about a week later I started having a full body sensation, I started feeling like a burning sensation all through my body, like an internal sunburn all through my body and I have been feeling like that ever since. It also started oscillating between the burning sensation and a cold sensation. I also feel like pins and needles and most recently numbing of my hands and arms. It has been chronic since then. My PCP told me to take Zyrtec 30mg a day OTC and it did not help. I then met with a neurologist and allergist. Allergist did not believe it was an allergic reaction. The neurologist prescribed prednisone and it did not help. She also prescribed B12 (I have a history of B12 deficiency) and she initially diagnosed me with sensory malfiber polyneuropathy. She has been running some auto immune tests and some have come back normal and she is trying to figure it out the next plan of care. It is not just a sensation, part of it is physiological because my ears for example sometimes get very red and hot to the touch and my hands get very cold.

3 days of significant shoulder soreness, even worse than I normally get after flu vaccinations. More significantly, on Saturday April 17th I began to experience "popping" sounds in my right ear. Overnight my ear began to ache a fair amount. It has subsided some since. This is my first ear ache since I was in elementary school in the 1980s and is not common to allergies. It seems clearly related to the vaccine, This was my first shot with Moderna.

Moderna COVID-19 Vaccine EUA Pt. presented with dizziness, weakness, double vision, slurred speech, nausea, vomiting, diarrhea, and unable to stand/walk. Vaccine given at 1030, patient first c/o symptoms at 1135. Symptoms progressively became worse and was sent to ER at 1650.

Difficulty in breathing; Swelling of face; Swelling of face and tongue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (Not sure about the allergy). On 15-Apr-2021 at 1:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021 at 2:22 PM, the patient experienced DYSPNOEA (Difficulty in breathing) (seriousness criteria medically significant and intervention required), SWELLING FACE (Swelling of face) (seriousness criteria medically significant and intervention required) and SWOLLEN TONGUE (Swelling of face and tongue) (seriousness criteria medically significant and intervention required). At the time of the report, DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. EpiPen and 50 mg of Benadryl were given intramuscularly as a treatment for the events. 9-1-1 was called for further evaluation. No information on concomitant medications. 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.

I felt fine the day of and in the evening. woke to ringing in my left ear the next morning. very slight nausea. By the evening ringing has become very loud and almost have lost the hearing in the left ear. noises in the right ear sound unusual. The ringing has stayed the same on day 2. very loud. Those are the only two side effects so far.

patient presented to emergency room with severe headache and blurry vision. diagnosed with cavernous sinus thrombosis

First injection, no issues. Second injection led to blood glucose of 368 about an hour post injection. Beginning the morning of Sunday, 04/18/21, I had a low blood glucose episode early in the morning (meaning blood glucose 30 mg/dL or below). Typical to these I react by sweating profusely, trembling, visual anomalies, anxiety. Never in my life have I experienced what I did on 04/18/21 concurrent with low blood glucose out of dozens and dozens of such episodes in my lifetime since being diagnosed with type 1 diabetes at age 3. I suffered right side weakness (hand, arm, leg, trouble focusing right eye). My blood glucose at that time was low and I immediately drank some juice and ate something, but even an hour into the episode I was experiencing right side weakness and difficulty keeping my footing and hand action.

Severe ear ringing, headache, gross mouth, raw throat, diarrhea, nausea, exhaustion, blurred vision, dry skin/chapped lips, cold sore

Bilateral new onset tinnitus started about 1 week following dose 1. It has continued, with slight improvement after 4 weeks. No treatment has been attempted.

Extreme fatigue, confusion/"brain fog," and chest tightness which have mostly subsided. Tinnitus: Loud ringing in ears has not stopped.

Moderna COVID-19 Vaccine EUA Since receiving my second shot of the Moderna vaccine, my tinnitus has been louder and more intense.

S: At 3:40pm, 47yo Male presented for worsening dizziness and vomitting x1 since first dose Moderna COVID vaccine this AM at 10:54am. Patient deteriorating and c/o additional chest pain during intake. Patient getting paler and significantly more dizzy. Per MD, 911 called for patient as he was developing visual disturbances. B: Patient has severe anaphylaxis allergic reaction to penicillin and stated he took 3x Norco this Am. Prior to COVID vaccination, Advised patient that it is safer to consult with his PCP or our doctor here and then receive the COVID vaccine. Patient stated he would rather get the vaccine now and assume all responsibility. Patient observed for 30 mins post-vaccination. At approx. 1110, patient felt dizzy. After crackers and Apple juice, patient stated he felt better. Prior to discharge at 1125, verified with patient that he no longer feels any symptoms. A: At 3:40p, Vitals taken, WNL. Patient immediately assessed by urgent care MD, hemoglobin & Blood glucose WNL. EKG performed per MD. Ambulance called per MD at 3:53pm. 4:00pm EMS arrived. 4:09pm Patient left for Hospital.

Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue) swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).

Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Tingling in hands which went away after a while. Called EMS per patients request, vitals were fine, symptoms improved after about forty minutes

Extreme pain left shoulder, burning and radiant feeling. It lasted for 2 days. I went to urgent care facility, got X-rays and ekg, results were normal. Pain was onset by a common cold, sore throat and aphonia.

Second dose number from the record card 019B21A Later in the day after the first dose (3/20/21) I had ringing in my ear. This was a constant sound in both ears that was present at all times. Over the next 3 weeks the noise level of the ringing fluctuated while moving downward in noise level. By 3 weeks after the first dose the ringing was almost gone. I received the second dose 4/17/21 and later in the day the noise level was higher than it ever was after the first dose. As I type this 3+ weeks later the noise level has not gone down at all. It is with me at all times. It makes it hard to fall asleep at times and is there the instant I wake. In the last 1+ week I have noticed a pressure in my ears.

" I received the dose in my left arm and immediately after I was escorted from the treatment room to the waiting area I noticed a metallic taste in my mouth. I sat down to wait for my 15 minutes to be up as requested by the pharmacist. Within a minute of waiting my tongue started feeling numb on my left side and the left side of my face started tingling (cheek and region just below my eye). I also felt like my throat was tight and felt like I needed to clear my throat. I started researching "face tingling moderna" as I was getting concerned. I waited in the chairs for 20 minutes or so and no one came out of the pharmacy. My symptoms had not worsened but were not all the way gone with the face tingling remaining the longest. I decided to do some shopping as planned and would report my symptoms to the pharmacy if they didn't go away. All in all my symptoms lasted 25-30 minutes with the most intensity in the first 15 minutes."

Woke up April 30th and was unable to blink/close my right eye and right side of mouth. Went to the emergency room. they gave me a CT scan to rule out stroke and determined it was Bell's Palsy.

Sudden HEARING LOSS in upper frequency range in left ear and accompanying TINNITUS starting on 5/2/21 at 7 PM. Primary physician visit on 05/10/21. Technician confirmed hearing loss. Referral to ENT. ENT visit on 05/11/21 reconfirmed hearing loss. Doctor said it was most likely the vaccine - he was the 2nd or 3rd person in a week he had seen with the same symptoms. Prescribed Prednisone 20 MG tab starting at 60 mg per day for a week, tapering to 40 the next week, 20 the next week, and 10 the final week. On day 4 right now. The evening of the shot for 24 hours had flu-like symptoms, aching joints, headache, general lethargy. No appetite for 48 hours.

He got his vaccine, he just had a little arm pain and some stomach problems, but nothing much. Then he noticed partial loss of taste and then Friday he was not able to close his eye and then went to the ER on Saturday has partial left sided facial paralysis, pain in his eye, drooling on the left side, and difficulty speaking. He was diagnosed with Bell's palsy. They gave him some steroid of Prednisone for 6 days and Valacyclovir for 7 days as well for treatment of this. He has had no improvement in his symptoms yet. Was told that it takes a minimum of at least 3 weeks.

I received my second dose last month. I didn?t notice this symptom until maybe a week or two ago. But it seem to be more constant and it?s gotten to the point that for the last few days I am walking around thinking a tv, or light or fan or something electrical is on. The reason being, I?m getting a constant high pitched tone in my right ear. It sounds almost like a high pitched dog whistle. If Will it ever go away. Thanks in advance.

Pt began to get tunnel vision, dizziness, migraine, upper back pain, and extreme fatigue approximately 6 hours after the dose was injected. He denied treatment and decided to rest instead - which helped. He drank about 5 bottles of water, but his urine remained dark. The tunnel vision lasted for about an half-hour. The rest of the symptoms remain, and he now has a fever as well.

Itching around face, lips and tongue. Lost hair in patches on my face and along my hairline. Itching around mouth lasted on and off for a couple of days. Second dose received at 11:30 am on 4/29. Same itchiness + additional patchy hair loss started two weeks later. Occasional itchiness of lips and face continue through 5/24.

Numbness on top of young and my lips. I had confusion, anxiety headache, lungs were feeling extremely hot, nauseous, increase heart rate and elevate blood pressure extreme confusion . I was rushed inside the Er. I received a Ct scan, ,lab work, and a EKG I received IV ,fluids,Ativan,, Diphenhydramine, famotidine and Prednisone.

I received my first Moderna shot on March 22 and my second on April 19. I had very bad side effects both times, though the second was worse with chills, dizziness, some light fever, body aches, sweating. This lasted up to two weeks after my second dose. I hardly ever take sick time off, but I had to leave work several times due to vaccine symptoms showing up. A month later, around May 15th, I started to feel a waxy feeling on the roof of my mouth and I had noticed even before this that I couldn't whistle like I normally can. By May 23, I went to the ER for facial paralysis on my right side. I was diagnosed with Bell's palsy. At this moment it's just my face, no other body parts.

I experienced an increase in volume of my tinnitus perception in my left ear. My head feels stuffy and I am slightly dizzy. These symptoms have caused insomnia, nausea, rapid weight-loss, and panic attacks. Treatment has been Flonase daily, anti-inflammatory diet, no caffeine, drinking lots of water, and resting.

my eyes were swollen then following day after my second shot. my right eye was nearly swollen shut. It took 2 full days for the swelling to get close to normal. I took benadryl during that time. On my first shot I did have a red, itchy, hot spot at the site of injection but no other symptoms.

Vaccine information (brand name, dosage, lot number) Date, time, and location administered: Date: 4/27/2021; Time: ? m; Location: Pharmacy Date and time when adverse event(s) started: Date: 4/28/2021; Time: afternoon Description of the adverse event, including medical treatment and diagnosis: Description: Symptoms include: Worst headache of life Exam Findings include: No focal neurologic findings but given history, CT head ordered.

None immediately after the shot. But I noticed the ringing on my left ear started gradually and it's been several weeks and even with steroids it won't go away.

Patient left work early due to heart fluttering and pain behind eyes. He went home and tried to rest, but ended up feeling worse and went to Emergency Room.

He reports on the morning of 9 May he awakened with swelling of his lips and around his eyes and a generalized rash (described as non-pruritic, red, coin-shaped/sized ?patches? sparing palms and soles). He took a dose of oral Benadryl with some improvement and then presented to the ER where he received an oral corticosteroid. Total serum tryptase level draw in the ER normal. His rash resolved over the next 24 hours. Lesions not pruritic or painful; resolved without post-inflammatory changes. No laryngeal, rhinoconjunctival, pulmonary, GI, neurologic, or cardiovascular symptoms. No blistering lesions, mucosal ulcers, fever/chills, or painful/swollen joints. Episode not associated with cold, food, heat/sweating, exercise, medications, NSAID use, latex exposure, alcohol, or insect bites/stings. While he had ingested beef the night before he reports he has since ingested and tolerated beef without adverse reaction. He received his second dose of the Moderna mRNA vaccine three days prior.

began having dizziness and mild swelling in skin about both eyes, mild headache, still present, but somewhat less

Mild tinnitus has become much more severe with occasional earaches. Still ongoing 2 months after first vaccine.

First vaccination 5-7-2021 resulted in approximately 5 days of flu-like symptoms. Fatigue, constant fever (100), chills and achy joints. Second vaccination 6-4-2021 resulted in approximately 2 days of flu like symptoms. Similar to first vaccination. Additional effect included alteration of smell and taste. Many things such as meat (chicken, beef, pork), garlic, ginger, coffee has a similar foul odor and taste. Even gasoline fumes at the gas station have the same foul odor as coffee brewing in my kitchen. This secondary effect has remained since the second vaccination and shows no sign of stopping. Some food that is edible includes pasta, rice, bread. Limited seasoning such as salt, pepper, butter and red pepper flake. As a whole the dairy family seems to be ok. Milk, butter, ice cream, cheese, etc. It seems the most prolific or prominent smelling and tasting things have the same foul pungent odor and taste. One common bad taste. Not different bad tastes for different foods.

Started having these symptoms which the doctor treated it as gout flareups and kidney failure. How ever it has been going for 4 months now that I know this is an adverse symptoms from the vaccine. After the first dose: inflammation of both feet, knee, elbow. hands and fingers. Fever, chills comes and goes After the 2nd dose: continued inflammation of both feet, knee, elbow comes and goes and fingers. Hives all over body Headache Feeling extra tired Feeling of body filled with fluid Blood shot eyes - fluid draining from both eyes Neck Pain Shoulder pain Pain all over body from head to toe (joints & muscle) Unable to stand at times

After 2nd COVID VACCINE on 6/15/2021, 6/28 Notices Lump on my neck and went to Doctor Dr sent me for X-RAY After 6/28, i had feeling tires/fatigued and notices the lump on neck started smelling and pain. 7/6 I went to see a Dr and she was referred me to 1) take blood draw 2) ultrasound on my neck. After both results were completed, she was referred me to ENT doctor. 7/15 I went to see (ENT doctor) and I was referred to do biopsy my thyroid nodule. 7/23 i had biopsy my thyroid nodule.

HEAD AND CHEST CONGESTION, HOARSE VOICE, PHLEGM, BODY ACHES, CHILLS, SWEATS DIFFUSE, LOSS OF TASTE AND SMELL, RUNNY NOSE

Incident occurred at a COVID19 mass vaccination clinic. Within 5-10 minutes after vaccination, client complaint of dizziness, nausea, and right eye was twitching and drooping. Client stated that they had a history of penicillin allergy with a hives/rash reaction. Client checked his sugar and it was at 138. EMS that was on-site checked vitals @11:22 BP 160/100 pulse 72 resp 16 pupils NTL , alert and verbal, skin normal, respirations normal; @11:33 BP 160/105. Client initially refusing transport by EMS. After 45 minutes of blood pressure not dropping, client agreed. @11:50 EMS transport by EMS. Hospital has attempted to reach client for follow up of outcome but has not received return call.

10 minutes after injection started having metallic taste, pressure to the left back tongue, left arm heaviness and fatigue Narrative:

I became fatigued and weak January 9, beginning to resolve Jan 11, when I lost my sense of smell and tested positive for Covid-19.

About 10 min after the vax I started feeling tingling in my mouth and my tongue felt swollen, out of place. They sent me to the ER for observation and after receiving the Epinephrine, I felt much better after about 2 hours or so. They kept me for observation until 7PM.

3 days following injection, pt developed severe vertigo, headache, bilateral eye pain, weakness. Pt advised to rest, hydrate and use APAP and/or ibuprofen for headache. Pt declined in-person evaluation. Symptoms improved within 24 hours.

I had my second injection on Sunday morning 1/24/21 at 9:00 AM. I was fine through the day. The previous dose (dose #1) was on 12/29/20 and I became symptomatic the following day. I had aches, malaise and fevers of 102.7 on 12/30/20. The fevers lasted approximately 12 hours and resolved with Tylenol. My left deltoid was very swollen and quite painful. The swelling and pain resolved within 24 hours after the first injection. Prior to dose #2 and through the day on 1/24, I used Tylenol and Celebrex, both medications were ingested at 8:45 and the tylenol wa again ingested at 11pm prior to going yo bed. By 12:15, I had severe bilateral calf pain. Fever started shortly after that. Severe Headaches and Photophobia began at around 1 am. I had a vey difficult time walking and was quite dizzy through the night. Unable to sleep more than a couple of minutes at a time. By 6:45 am, my fever was around 103.5. I have used Tylenol and Ibuprofen since 1/25/21, 6:45 am. both medications have been utilized around the clock on TID basis. Fever dissipated by 1/25/21 evening. Only a mild headache is present. The injection site was swollen, indurated and painful to touch similar to cellulitis. I have not used antibiotics, drew a line and have monitored the redness, it is slowly resolving. By 17:30 on 1/26/21, I have a mild headache, mild malaise and chills. No fever. Arm is still swollen red and hot. I have not had respiratory or GI symptoms and have no history f Covid Exposure and have tested negative on multiple occasions.

Nausea, Chills, Headache, Fever, Tired/Sore muscles & joints, irritation to eyes and throat, and cough.

Within 6-8 h after receiving the vaccine, I noticed progressive pain on my left shoulder and upper arm. I could not sleep on my left side. At 22 h after the vaccine I could not abduct my arm due to the local pain, became prostrated (had to lay down all day), lost appetite (only ate 2 cookies all day) and became very fatigued (went to sleep at night at 7 pm instead of my 10 pm regular sleeping time). I measured my temperature twice and it was 37.5 C. I didn't take antiinflammatory nor analgesic medicine. At 48 h after the vaccine, I was already 80% better, and at 72 h has back to normal. I had short-lived (2-3 days) COVID-19 symptoms in March 2020 (anosmia, diarrhea, anorexia) and high titers of anti-SARS-CoV-2 serum IgG in May and October (I did the latter was part of an experiment to evaluate the duration of antibody persistence. I am fully vaccinated and this was by far my most severe vaccinal reaction.

About 5 minutes after receiving vaccination case client reported he was having numbness and tingling sensation on tongue. No shortness of breath. BP 150/80 Pulse 88 continued to observe case, tingling sensation and numbness sensation was not resolving. Reported was just not "feeling right" Benadryl 50mg po given about approx 12:10 Case was instructed to call for transportation home from clinic and to be observed at home to continue monitoring. Case stayed at clinic til approx 12:40 and departed with brother He reported he the numbness and tingling had subsided. Case was also instructed to notify his Dr which he did while at clinic to notify of the reaction. The office reported he would receive a call back yesterday. Case was instructed by this nurse to call 911 if symptoms worsened. Case had reported he also had bendaryl at home and for mild symptoms he could take again after 6:00 pm. Spoke with case today. He reported he had an appt yesterday at Drs office for 4:30, however he developed severe headache and nausea. He was seen in ER. reported his BP was WNL and he was instructed to take tylenol for headache. Symptoms resolved when he left hospital and he denied any headache, nausea, tingling or numbness today. He was provided a note to return to work for today

On approximately the evening o 01/21/21 the patient began to experience headaches. The headaches have been intermittent continuing on till the date of this report (02/04/21). The patient has been taking acetaminophen with relieve. On approximately 02/01, it was noted by coworkers that the patient's right side of the face would not move when he would talk. Around the same time, the patients right eye became watery and the patient's wife stated she noted some gurgling. Due to the onset of these new symptoms, the patient went to see the doctor on 02/04/21. Per the patient's wife, the doctor diagnosed the patient with a very mild form of Bell's Palsy and prescribed steroids to the patient. The name of the steroid was not disclosed.

After initial vaccination patient reported experiencing metallic taste in tongue and tingling. the tingling sensation persisted several weeks and the patient visited an allergist for further assessment. upon evaluation allergist noted sloughing on the tongue 4 weeks after the initial vaccination. patient was deemed ineligible for 2nd vaccination per recommendation from allergist.

After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital 1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain, loss sensation right side and double vision. I'm scheduled for Cerebral Angiogram in Feb.

Fever, Chills, Lymph Node swelling, Body ache, Joint Pain, Loss of Smell / Taste, Extreme Headache, Fatigue, Nausea. Pretty much felt like I was hit by a bus for 24+ hours. Pain at injection site for 48+ hours.

6 days of severe headaches, body aches, cold sweats, swollen lymph nodes; 2 days of on and off fevers (started on 3rd day), over 100 Fahrenheit; 2 days of ears swollen up, red, ringing, and pain.

I had all listed most-common side effects (fever, body aches, chills, fever, fatigue). The main, additional side effect I want to report is lymph-node shooting pains under my right armpit and throughout my right arm and forearm that occurred on 2/11 and 2/12 (one and two days after). Three days after the shot, I noticed slight lymph node shooting pain on my right jaw, under ear. I?ll be getting the second shot...it beats COVID-19 by at least a mile!

Two days after the injection on Wednesday, red spots began to appear on the neck from Friday. From the evening it began to spread to the chest and legs. Saturday got worse, so itching in my neck and chest. The eyes were swollen and the double eyelid disappeared. On Sunday, my eyes were swollen and pus started to form from the red spots. On Monday, I couldn't go to work because my eyes were so swollen, and my skin became dry and itchy.

developed slight eye tearing and left ear pressure within 24 hours of vaccination. followed by left facial drooped. was seen in ER on day 3 after vaccination, diagnosed with Bells Palsy. treated with eye care and oral prednisone.

PT reports vaccine on a Tuesday morning at 930, at 6PM> 9 hours after injection L ear fullness/pain/pressure. Wednesday, L eye watery and pain behind L ear. Thursday dribbled when drinking water when working overnight shift. upon awakening Friday afternoon, speech was "off" noted L side of face drooped and unable to close L eye. went to Urgent care and referred to ED for suspected stroke due to High BP> member stopped HTN meds 8/2020. Seen at Holy Redeemer Hospital ED and dx Bell's palsy. now on steroids, eye ointment and metoprolol.

Primary Adverse Event: Tinnitus in right ear, slight loss of hearing in right ear. First noticed 3/14 at approximately 3:00pm (28 hours after vaccination) and has continued through time of this report. Additional side effects: Fever and chills started approximately 10 hours after vaccination and persisted for approximately 7 hours. Fatigue began approximately 4 hours after vaccination and has gradually become less as of the timing of this report.

Both eyes very swollen, watery and itching on evening of 3/16. Appeared pretty quickly. Could be 'normal' allergies, but was quite a bit more of a reaction than I would normally get. I don't believe I've had my eyes swell this much before that I can remember. During day of 3/16 did not do anything outside in or around normal triggers when doing something like yard work. Took Kroger brand max strength sinus relief pills and went to bed. Morning of 3/17 eyes still swollen but not as much...much less watering and itching. Still swollen some at the time of this submission.

Once, for a short time while performing a mild workout in the gym, and again a couple hours later, and for an extended duration (approximately 40 minutes), while checking out at Costco I experienced what I believe to have been aura migraines without headache (or ocular migraines) in my right eye. What initially appeared to be a slight glare, I later determined was an obscuration of the lower half of my vision in that eye which could be described as a clouding effect. While disorienting and concerning, with closing/covering that eye, the problem slowly resolved itself. Within about 20 minutes, I had enough vision to comfortably and safely drive home. Another 20 minutes after that and the event had ended as far as I could tell. I have never experienced anything like this in the past. Doing some (dangerous, I know) searching online, I discovered what it might be called and learned that there were some reports of similar events occurring with other vaccine recipients. Since I don't have a primary care physician, I'm hoping it is directly related to the vaccine and I hope it doesn't happen again with the second dose since my eyes are a critical part of my job.

Vision problems primarily in the right eye. Still on going. Was hospitalized. Diagnosed with Optic Neuritis

I Started having a rigning on my right ear and lost my hearing for a few days, went to a ear specialist which prescribed steroids for 14 days, my hearing come back but the ringning is not gone yet and it is very noticeable

Metallic nickel or penny flavor in my mouth. Reminds me of when I went through my cancer treatment after receiving chemotherapy treatments.

Low grade ringing in my ears (tinnitus). It is not too loud but is somewhat persistent. I have not sought any treatment for it.

Increase in intensity of my tinnitus of my left ear noticed after receiving the injection. First noticed it the next morning, but did not think too much of it, but it has been consistently of greater intensity that before the injection.

I had a 9:15 am appointment, received the shot about 9:30 am. Shopped in store for 10-min and drove to run more errands. About 9:45 am driving, I noticed my face starting to numb on my right hand side beginning with my upper lip, around my nostril, cheek and jaw line. After an hour of numbness, I called my doctors office and spoke with a nurse. The nurse had not heard of these symptoms before and sent me to the local ER at the hospital. As we drove to the ER, I noticed my jaw muscles getting tighter, but not so over powering that it felt like it would lock up. While under observation for an an hour or so, a Physician?s Assistant did neurological exams as my symptoms looked like a potential mild stroke. I passed the exams and sent home to observe any changes. The morning of day two (today), I have strong flu like symptoms with chills, shivering, aching muscles and the skin on my back and neck have a pins and needles feeling. What?s more, I have a present ringing in my ears today.

Within 2 minutes of patient receiving shot his eyes started to cross and his hands formed a fist and he tensed up and brought them towards his chest. His head rolled back and his eyes started to rolled back. His wife was next to him and held his neck. the pharmacist administered an Epi-pen into his left thigh and 911 was called. He became conscious within seconds of receiving the Epi-pen. He was able to verbally communicate and was able to tell us his age. He was very thirsty & became very sweaty in the minutes after he came to. He said he's never had a severe reaction after vaccines, never gets the flu shot and doesn't have history of seizures. Paramedics came immediately and took him to the Hospital.

night after vaccine i awoke with ringing in my left ear. it has been constant since then.. going on day 3

patient self reported tetracycline allergy that resulted in difficulty breathing and hives. Reaction happened many years ago. I asked patient to wait an additional 10 minutes for a total of 25 minutes so we could keep him under observation. After his 25 minutes patient reported that his fingers felt swollen and he had taken his wedding ring off to show me. Patient also reported that his lips felt "tingly". I observed the patient and noted no flushing, no sweating, no rapid pulse. I took the patients blood pressure and it was 121/80. I gave the patient Benadryl and asked him to wait for another 15 minutes so I could observe him. After the 15 minutes I observed the patient again and he still had no flushing or swelling and he reported that he no longer felt "tingly" and felt fine.

After two days I experienced a loud ringing noise in both of my ears. It's been over two weeks and the noise has not subsided. I have a Son that suffers from tinnitus - I would compare the symptoms to those of my son's tinnitus. I have had to purchase a white noise machine to assist with sleeping. This is very alarming - had I known of the outcome I would not have taken the vaccine. I hope this noise reduces over time. I would be happy to discuss more if requested.

1 day after (3/12) - general body ache until 10am. 2 day after (3/13) - same as my Covid experience - bad sinus pressure behind eyes/pain behind eyes/eyes burned/fatigue. 3 day after (3/14) - same as 3/13, but slightly less/fatigue. 3/15 thru 3/29 - slight pressure behind eyes and went away on 3/29.

Noticed periodic tinnitus a few days after receiving the 2nd shot, has not gone away and has intensified over the last 4 days

Ice pick headache behind eye on same side as shot (left) - persistent for 3 days Chills / sweats - persistent for 2 days Slight fever - persistent for 2 days teeth ache on left side (same side as shot) - persistent for 2 days

FEVER, UNCONTROLLABLE SHAKING, MUSCLE ACHES, JOINT PAIN, HEAD ACHE, ECCESSIVE SWEATING, LETHARGIC, SORE THROAT, RASH, BURNING SENSATION ON SKIN, TOOTH ACHE, SLIGHT NAUSSEA, MIND FOG,

Within two minutes of being injected, I had a flush sensation throughout my body and became very nauseous, faint and got a headache. The symptoms persisted for 30 minutes so the pharmacist called an ambulance to the store. The paramedics checked my vital signs which were stable but recommended that I go to the nearest hospital for further examination and treatment.

Headaches, nausea, vomiting, diarrhea, cold sweats, tinnitus, nasal pressure, congested ear, fatigue, short of breath

48 y/o retired male comes to clinic with complaint of rash that has been present since 02APR2021. States he suspects this may be the effect of second COVID vaccination which was on 31MAR2021, confirms using hydrocortisone cream for symptoms. Denies any SOB, difficulty breathing, swelling of throat, vision changes, abdominal pain, diarrhea, but confirms itching. Confirms hx of similar rash after getting flu shot. PE show erythematous maculopapular rash over bilateral hand/arms/legs, neck and posterior trunk that is itchy.

SUBJECT: second dose of COVID-19 was administered on 10 April 2021, using the manufacturer Moderna with lot number 031A21A. Injection site was upper left arm, intramuscular. The developed unusual reactions: persistent headaches with photophobia that started on Sunday Night, that had worsen today with anorexia, fatigue and joints pains. He was evaluate by medical provider who recommended a Treatment and recommended to go home rest, takes plenty of fluids and VAERS report. He will return to work when he becomes asymptomatic (7-10 days). This note documenst this unusual reaction to COVID-19 vaccine on the medical records and follow any procedures set forth to follow-up on this case and to report it to the VAERS program. This is to document the injury in case he requires medical treatment.

Day after had severe gum bleeding at dentist cleaning, on February 24th had a blood nose hemmorage, needed to go to emergency department. They had to insert a nasal balloon because I wouldn't clot for about 4 hrs.

patient fainted about 7 minutes after his shot at the clinic. he was sitting and fainted in his seat. The nurse and pharmacists rushed over right away and he was barely responding. his tongue and lips were seen to be swelling. The nurse administered the auvi-q right away and less than a minute, the patient came back and was confused about what happened. he started sweating and his tongue and lips came back to normal. he was monitored for about an hour - he called his doctor because he refused to go to the hospital. his doctor assured he would be okay after being monitored an hour, said to take benadryl around the clock and call 911 if anything happens. patient agreed

Horrible tinnitus and vertigo day 2 after 2nd shot. Almost 3 weeks later the crippling tinnitus and vertigo are unchanged. I am very scared and frustrated at this point.

Pt received second dose moderna vaccine. Did not bring first dose vaccine card, unable to obtain first dose lot number and date of vaccination from patient. Pt left facility and upon approaching stop light in front of building, pt began to experience SOB with fast heart rate and mouth dryness. Pt returned to facility to seek medical attention. Brought to med obs #1 via wheelchair by staff for evaluation. Reports mild improvement of symptoms upon arrival to med obs. No s/s of distress noted upon pt arrival. Pt reports taking prescribed lisinopril PTA this AM. Upon assessment of VS, BP elevated. Pt states he occasionally has SBP 200+/DBP 100+. Denies s/s of anxiety at present and denies headache/vision changes. VS are as follows: 1314: BP 187/107 (RUE), rechecked on LUE 233/134, HR 75, RR 17, O2 sat 98% on RA. 1319: BP 233/118 (LUE), rechecked on RUE 242/122, HR 104, RR 16, O2 sat 99% on RA. Per VS parameters, pt qualifies for EMS transport for ER evaluation of elevated BP. Notified in-house PA of need for assessment and confirmation of EMS need for transport as well as notification to lead supervisor. Constable at employee entrance notified to assist in arriving EMS. Upon assessment of pt by PA, pt disclosed he is non-compliant with prescribed lisinopril at home and will occasionally use medication PRN or double/triple his dosage based on symptoms. PA provided education on proper use of lisinopril and confirmed need for higher level of care. Pt agreeable to EMS transport for further evaluation. 9-1-1 called. While awaiting EMS arrival, pt reported sweating of hands and shallow breathing, stating, "I feel like I have to concentrate on my breathing now." Pt not in distress. EMS arrived to transport pt to Hospital. Pt alert and oriented x4 and ambulatory from stretcher to EMS gurney upon transfer. VS while awaiting EMS arrival are as follows: 1324: BP 249/126, HR 83, RR 17, O2 sat 100% on RA 1329: BP 247/109, HR 85, RR 18, O2 sat 100% on RA 1336: BP 243/112, HR 84, RR 20, O2 sat 100% on RA 1347: BP 245/144, HR 87, RR 18, O2 sat 100% on RA

I got 2nd shot on 10 am 04/13/2021 I feel o.k during date time. I am getting tire a little around 6pm. I cam back take later dinner around 9 pm. I feel like have a cold after 10:30pm I drink a lot and went to bed almost midnight. While I was sleeping, my body aches and hurts. I almost wake up 9:30 am. then I felt some strange I can not hear well from my left ear. Even I could not take phone using my left ear because I can not hear well what they said. I thought it will be better because it might by vaccine and i am tire However, this Symptom did not got away. I heard some noise from my ear and I can only heard sound around 10% comparing with normal hearing I reported my medical doctor on Wed night and I communicate with him by phone 2:30 pm 04/14/2021. He recorded my symptom. and I have schedule to check my hearing test on 2;20pm 04/22/2021

Fever, chills, achy bones on first day. Side of face where shot was administered sensitive to touch and sensation of needles. Gums on side of shot inflamed and sensitive to the touch

Tonight started getting really bad tinnitus in my right ear only, and pulsing. Never had that like this before so loud and pulsing, Checked online and a lot of people are reporting that as a side effect. it only started an hour ago so nothing else to report yet, i'm assuming it's temporary.

Patient received the 2nd Moderna vaccine on 4/19/2021. On 4/20/21, patient had typical side effects such as fever, fatigue, headache, and arm soreness. Patient took Tylenol to treat symptoms. On 4/21/21, patient said he started to develop swelling around base of neck on both sides and had difficulty breathing. He stated that he also had right arm numbness where the injection was given as well as blurry vision. According to patient, his blood pressure was 220/145 and his blood glucose was over 300. Patient went to primary care physician on 4/26/21 about his neck still being swollen after his vaccination. He said his physician gave him diphenhydramine and a steroid shot for the reaction. Patient came to the pharmacy to report his side effects on 4/26/2021.

Ability to speak started changing immediately after vaccine, Pt did not notice it but assessment showed his tongue was swelling. He also reported having an itchy throat. He went to the ER via ambulance and was given IV Benadryl, symptoms resolved quickly but reports his throat remained 'scratchy' until following day.

Patient reports, on the afternoon after the vaccine, he started to feel weak, and had some discomfort with blurry vision in both eyes with pain and discomfort in his right eye. He continued to work. On 4-11-21, he went to work feeling weak with pain/discomfort in his right eye with blurry vision in both eyes. The pain was so much with blurry vision that he had asked someone else to take him to the airport to travel back home. He traveled back home via airplane. On 4-12-21, his condition did not change. He consulted with his Commander and unit staff, and would go see an eye doctor. He was seen by a civilian eye doctor on 4-15-21, 4-16-21, 4-27-21, and military doctor on 5-1-21. He was diagnosed with Anterior Uveitis, pupils unequal, pupil bound.

Blurred vision. Unable to focus both eyes together, with or without prescription eyeglasses and/or contact lenses. Able to focus, see clearer with one eye closed at a time from both eyes.

Pt reported at ~2000 hours on 4/27/2021, he experienced chills, body pain, and a lot of pain in his left arm. And late into the night his body pain worsen and had the shivers. On 4/28/2021, pt reported the pain in his left arm radiates up into the left side of his jaw area and there is a ball size lump underneath his left ear area with pain when he turn his head. Pt reported he took Tylenol on 4/27/2021 at 2300 hours up until 4/28/2021 1400 hours, helped with the chills and body pain. Advised pt that ADEs usually occur within first 3 days post-vaccination and resolve within 1-2 days of onset. Lymphadenopathy is not as common and usually resolves within 10 days. Advised pt can take either Iburprofen or Aleve with food to help with the pain. Recommend pt to contact MD if pain worsen or swelling has not gone down by next week. PharmD

2nd and 3rd week had off and on mild headaches (but never have headaches otherwise) felt pressure in my head when bending over. 4th week developed ringing in the ears (tinnitus)...tinnitus has not resolved as of this submission

Patient waited the required 15 minutes after I administered his second dose of the Moderna vaccine. When he handed the timer back to me, he said he was starting to feel a strange pain on the right side his jaw, ear and throat suddenly. I told him to have a seat so that I can monitor him further. A few minutes later he said his vision started to become blurry and his mouth became very dry. We brought him a bottle of water. He said he didn't feel any better and was feeling worse. I suggested to the caregiver that was with him to take him to the emergency room since he was able to talk, walk and breath on his own still. I told his caregiver to call me back at the pharmacy to update me on his status. The caregiver did call me back and it was confirmed that he was having an allergic reaction and he had to be given high dose Benadryl.

Fever (as high as 103.5) for 48 hours, severe leg pain in both legs (especially in both knees) , chills, swollen and dry eyes, restless legs, arm pain (same arm as shot), big red rash on same arm as shot (still there 4 days later) , mouth blisters, fever blisters on lips, fatigue, lethargic (still occurring), day dreaming (still occurring), severe headaches, blurry vision, change in taste (still occurring)

I am having a tinnitus on my left ear after my first covid 19 vaccine shot and seems to get worse after a second shot.

Second Moderna COVID-19 vaccine created adverse reaction. Similar to flu symptoms,; however, I began hearing a constant, high-frequency static sound in my head. It has been continuous all day, all night, for 5 weeks now. It never goes away! It seems like tinnitus. I am concerned because it hasn?t gone away and is always present (for 5 weeks now!)

Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) 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.). Concomitant products included MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. US-MODERNATX, INC.-MOD-2021-101752:

5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage.

Fever and chills with sensation of skin being hot began 15 hours post injection. Took 400mg ibuprofen every 4-6 hours. Exceeded six hours without ibuprofen and fever returned 27 hours post injection. Took 400 mg ibuprofen and immediately became nauseous. Began walking up stairs and lost consciousness and seized/convulsed briefly (witnessed by my wife). Upon regaining consciousness, I was immediately aware of what happened, date, time, etc., so we did not seek medical attention. Continued ibuprofen every 4-6 hours. On two occasions post loss of consciousness, the first within an hour and the second four hours later, I felt tingly and smelled a strong scent of acetone or ammonia. Both passed quickly. Fever broke soon after second incidence. All symptoms were gone within 48 hours of injection.

PATIENT WAS NOT NERVOUS ABOUT RECEIVING HIS FIRST DOSE. OUR IMMUNIZATION CERTIFIED PHARMACY TECH ADMINISTERED THE DOSE. ABOUT 2 MINUTES LATER HE STATED HE WAS FEELING TINGLY AND HIS EAR TURNED A WHITE COLOR. THE TECHNICIAN CALLED ME INTO THE ROOM WHERE I EXAMINED THE PATIENT. HE WAS NOT RESPONDING AND HIS EYES WERE DILATED. HE WAS TRYING TO BREATH BUT HE WAS HAVING DIFFICULTY. WE MOVED HIM TO THE GROUND AND PLACED HIM ON HIS SIDE TO MAKE SURE HE DID NOT ASPERATE. AFTER ABOUT 20 SECONDS OF BEING ON THE GROUD HE STARTED BREATHING NORMALLY AND WAS CONSCIOUS. THE ENTIRE EPISODE LASTED ABOUT 1 MINUTE (MAYBE SLIGHLY LONGER). EMS ARRIVED A FEW MINUTES LATER. HIS PULSE WAS LOW (ABOUT 50 BPM PER EMS) BUT HIS BLOOD PRESSURE WAS NORMAL (UNSURE OF THE VALUE). HE SAID HE REMEMBERED TALKING TO US AND THE NEXT THING HE KNEW HE WAS LAYING ON THE GROUND. HE WAS VERY NAUSEOUS AFTERWARDS FOR ABOUT 45 MINUTES (HE THREW UP TWICE). WE CONTACTED THE PATIENT THE DAY AFTER AND HE SAID HE WAS FINE AND THAT HE ONLY HAD A SORE ARM. WE BELIEVE THAT HIS BLOOD PRESSURE DROPPED TOO LOW AND CAUSED A VASOVAGAL TYPE RESPONSE.

loud ear ringing began about 10 hours after the vaccine, both after the first and second dose of Moderna. After first dose, ringing lasted about 24 hours. It just began again after the 2nd dose. No actions being taken at this time, waiting to see if it goes away after 24 hours again.

Patient felt faint within 2 minutes of vaccination. His vision went dark. When I walked back into the room he was pale and sweating, but responding to questions from the person he arrived with. His arm twitched a few times and his head rolled to the side for a few seconds. Then he regained consciousness, but momentarily looked confused. The patient has a history of seizures, but has not suffered from one in 10 years. After that, the patient remained alert, but continued to sweat and felt light headed for most of standard wait time post vaccination. After the 15 minute wait period the patient felt more normal and left.

2-3 weeks post injection developed headaches, ear pressure, head pressure, bleeding gums. 4 weeks post injection developed ringing, hissing, and crackling in ears

pt states experienced ringing in the ears approx 3 hours after vaccination and has continued to experience ever since

The day of the first dose of the COVID 19 Moderna vaccine I experienced tinnitus in my right ear for about 2 hours. Thereafter, I started feeling my heartbeat in my ear every time I laid down and intermittent tinnitus . In early June, I started feeling pain in the same affected ear. At that time I went to my primary care physician who prescribed me antibiotics(Amoxilin) infection. After completing the five day treatment of antibiotics symptoms did not improve so I made an appointment with an ENT and went to an urgent care clinic where they prescribed me an antibiotic and steroid drop but that medication did not improve my symptoms. At the appointment with the ENT on June 9th I was diagnosed with a bulging ear drum and ear infection. More oral antibiotics were prescribed with a steroid to reduce swelling. Pain in the ear seemed to subside but I still had ear fullness and redness. At the follow up appointment on 6/30 a hearing test was done where it was discovered that I lost about 50 percent of my hearing on right ear. I still have tinnitus and hearing loss today.

Raised his sugar and dropped quickly, made his blood pressure spike A week after first vax smell and taste has become a problem and after 2nd vax it became more pronounce. Pt is becoming very down and despondent and is in need of help with problems.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient experienced flushing then was in and out of consciousness for a few minutes. BP was normal when checked 20 min after experience.

Pt. symptoms included: swelling in the eyes, chest tightness, lump in throat, tachycardia, hypertension, and wheezes. Pt. was treated on scene with .5mg of epinephrine (IM) and albuterol inhaler in route to hospital.

Headache, arthralgia, metallic taste Narrative: Patient previous covid dx: 3/19/2020; antibodies at least as of 10/22/2020 vaccine: 12/31/2020, the next day awaoke with sore arm and mild headache sx progressed over next 4 hours to severe headache and neck/bilat shoulder pain and profound malaise. Some migratory arthralgias, transient lower extremity pains, and a metallic taste. Reminiscent of covid for about 6 hours. Some relief with nsaids and apap. By 30 hours later, just tired and soreness at injection site

Headache, Myalgia, Photophobia, fatigue Narrative: Onset about 8 hours after receiveing vaccine. 24 after vaccine, H/A is much improved.

Dizziness, Headache, Myalgia, NauseaVomiting, Fatigue, chills, Right ear pain, dizziness, fuzzy vision, Right sided numbness Narrative: Employee reported fatigue, chills, myalgia, severe right ear pain (drilling like sensation), dizzines, nausea, vomiting and right sided numbness / tingling. CT completed - suspected intracranial bleeding. Transferred to local ED for care and management.

About 1 hour after vaccination the individuals left side of face went numb and left tongue became numb. He also felt very flushed. About two hours after vaccination the symptoms slowly resolved and the next day symptoms were 90% resolved. Numbness involved only the left scalp and face and left side of tongue.

severe tinnitus and loss of hearing as some tones. persistent since day after vaccination and continuing through time of reporting to VAERS.

DEVELOPED COUGH, SORE THROAT, HEAD CONGESTION, AND EYES BURNING 1/5/21 (DAY 7 AFTER VACCINATION), ALSO HAD +ANTIGEN TEST 1/5/21, +PCR 1/7/21.

Rash on Back and on sides wrapping around to the front of chest, primarily on the back. Associated with urticaria. The patient developed headache, lack of taste, fatigue as well as the aforementioned rash on 1/14/2021(6 days after receiving first dose of covid vaccine. A rapid covid test was positive on 1/14/2021 also. The patient was prescribed claritin, methylprednisolone for the rash after seeing his family physician virtually and the family physician recommended he contact where he was vaccinated to report these symptoms. I have reached out to the patient for additional information and he has declined, so I do not have any access to details on his positive covid test or records from that virtual encounter.

~1730 on 1/26/21, Pt reports they developed left hand pruritus which then progressed into urticaria on both arms- at this time taking Diphenhydramine 50mg po. Within 10min, urticaria throughout the entire body. During trip to ED, tongue developed itch and lips became swollen but denies any respiratory symptom involvement. ED course= IM Epi, IV Methylprednisolone, and famotidine. Next morning, Pt currently has slight pruritus but nothing further.

Four days after my first dose, I developed a weird odor that smelled like fabric softener (olfactory missensation) which lasted about two weeks. Then it happened again, four days after my second dose, but only lasted two days.

Day of vaccination (Day 1): Feeling of coldness on left side of chest, like there's ice in my chest; brought to ED for observation. EKG done, WNL. Given tylenol then sent home with benadryl. Once home, felt very, very cold, had to wear long sleeve shirt and fleece pants; persisted up to the present. Day 2: additional symptoms: dizziness, slight SOB, headache, head felt heavy, slight cough; SOB resolved by day 3. Other symptoms still present. Day 3: additional symptoms- salty taste in mouth & numbness of cheeks. Day 4: Dizziness, headache, salty taste, numbness of cheeks worsened. Went to ED, given IV fluids, sent home. Day 5 - diarrhea; Day 6 - diarrhea resolved; headache, dizziness/lightheadedness persisted. + nausea/retching but no vomiting v

About 1 hour after the injection, he noted tingling in his tongue bilaterally. A few hours later, tongue felt numb (both sides) and noted drooling out of his mouth. Drooling is has lessened over the day but still has tongue feeling numb. Per report, RNs checked him at work and had symmetric face and reports no visual changes to his face. No other facial symptoms. Has soreness/aches and fatigue this evening and arm is sore at the injection site but that started later.

One hour after second dose of vaccine developed oral tingling. Developed tongue numbness and drooling. Treated with Benadryl

2/6/2021 The day after my second Moderna vaccine shot. Woke up at 0300 feeling like I got hit by a Mack truck. Total body aches, especially the injection site on the right shoulder, the left shoulder at the old injection site (mirror pain?, Psychosomatic?, Real?), headache, jaw ache, sensitivity to light, stiffness and soreness in all muscles and joints, lethargy, no stuffy nose or congestion, but surprisingly no nausea/vomiting, instead I was super hungry. All day this persisted. I was hungry but could only eat half portions at most. Finally, after dinner, the body aches and headache had subsided. Still super tired, still painful at the injection site. I spent most of the day wearing sweatpants and sweatshirt with the hood up either on the couch or in bed with the covers up, and no sweating. Had some chills and a mild fever that came and went. At night, while wearing only my underwear, after being asleep for only an hour or two, I woke up to extreme sweating. The sheets were soaked and we had to change them. My wife said I was dripping sweat like I had just finished running for an hour. Took a shower and went back to bed in just my underwear. Had a couple more episodes when I thought I might start the extreme sweating so I flipped the covers off for a few minutes each time so I wouldn?t overheat. It did not feel like I was overheating under the covers ? just felt like I was about to start sweating again. Weird. 2/7/2021 The second day after the vaccine shot. Feeling much better, but still lethargic. Woke up late around 1030. Had brunch. Took a shower, got dressed and had to go back to bed because of the tiredness. No more chills or fever. By the late afternoon and evening I was feeling mostly back to normal. Had a full sized, normal dinner. Slept well, in my underwear, no sweating, and no chills. 2/8/2021 The third day after the vaccine shot. Woke up feeling totally normal. Got in a good 18 mile bike ride and felt fine.

02/03-02/04/2021 TEMPERATURE 100.5 *F, TREATMENT WITH TYLENOL. 02/05/2021 FELT WORSE IN THE MORNING, TREATMENT WITH ALEVE, FELT BETTER. EVENING BEGAN TO HAVE CHEST PAIN, BODYACHE, NECK/JAW PAIN - WENT TO EMERGENCY ROOM. CARDIAC LABS ELEVATED ADMITTED TO HOSPITAL. ALL OTHER TESTS CAME BACK WITHIN LIMITS BUT CATH NOT AVAILABLE ON THE SEEKENDS SO HELD. PATIENT CATH WAS CLEAR, RELEASED APPROX 1600 02/08/2021 WITH INSTRUCTIONS TO FOLLOW-UP WITH PCM. PCM APPOINTMENT SCHEDULED FOR 02/12/2021.

Fatigue, tingling in lips and face Narrative: Employee reported localized swelling, chills with diaphoresis, extreme fatigue & tingling in lips face lasting several hours. Pt recovered spontaneously without further intervention.

2-16-21; headache, eyes sensitive sunlight, sore left shoulder. 2-17-21; sore left shoulder, eyes sensitive to sunlight, headache, triceps on left arm sensitive to the touch with some swelling. 2-18-21: armpit swollen with a huge round circle underneath armpit area. no rash, no redness, no fluid leakage. Called and spoke with on-call nurse, who told me to use cold packs. Made an appointment with my doctor over the telephone. administered probiotics/antibiotics for 7 days. NOTE: Shot was given in my left shoulder, all problems are on the left side. I also had corvid in September 2020 and it took me at least 3 months to recover or feel normal again.

For about 24 hours after getting shot I felt like I was having an ongoing egg allergy - even though I know there are no eggs - I would call it minor but noticeable - my neuropathy also flared up immediately so badly that my arch on my felt foot was causing so much pain I thought I must have torn something - however after about 36 hours it disappeared - my sense of taste has also suddenly changed - after about 24 hours so that when I drink something it tastes like it has turned sour or metallic

Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past. Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. Patient's breathing pattern became shallow & snoring sounds noted. Patient did not respond when spoken to nor did he respond to soft shaking of shoulders. Patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. BP 120/72, HR 64, O2 sats 99%, RR 20. Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS arrived to find the patient regaining stability. Patient reported to EMS that his is familiar with this type of response and declined to be taken to

Given second shot on Wed 2/24 at 12pm -- Had flu like symptoms for one day. Woke up on Sat 2/27 with sudden hearing loss in left ear. Hearing loss was accompanied by a loud static sound and pressure. Saw ENT specialist on Tue 3/2 -- no evidence of any wax buildup. She immediately sent me for hearing test; showed 70% loss. Both doctors feel this is a Viral infection and that it may have occurred due to my strong immune response I had to the COVID vaccine. Was prescribed 60mg of Prednisone for two weeks; am on day 3 as of writing this. Am going to see another specialist tomorrow, 3/5/21. I am a healthy 50yr old male with no previous hearing problems. The only change in my life was getting the vaccine. I think this important to report, although I have yet to find any link between vaccine and SSHL. I have been tested over the last year a few times (mouth swab) and all test were negative. I have not been tested since my hearing loss, though I don't feel sick at all. I have read that some people who actually had COVID experienced new or increased tinnitus but did not find anyone who had actual hearing loss -- this was just doing some online reading; not actual study reports.

At about 4:00 or 4:30, I broke out in hives on my arms, inner thighs - legs, back, stomach - I called my health care provider and she had me take a Benadryl, on Sunday these were going away. At 5:00 pm, I got out of work, I went straight home because I felt so weak and my eyes got watery (didn't go to work out afterward) and I got the chills and my bones started to hurt, I went to bed and slept all - my bones were in horrific pain - especially in my back. Saturday morning, I felt the same -I took OTC med for the pain - no fever; body aches, watery eyes and I was very weak. I drank orange juice and I took some Zinc; vitamin C - and I hurt all that day - bones still achy but not quite as much. Sunday morning, I wasn't normal but better and by Sunday noon I was better; not weak anymore. On a scale from one to 10, I felt like a ten when it was bad. My injection site was sore for a good four days. I took it on a Friday but Tuesday the arm was good to go.

Pt onset with c/o numbness and tingling to lips. Denied SOB, tongue swelling, difficulty swallowing, itching, or rash. Denied any other symptoms. He received Benadryl 50 mg PO at 0922 AM. Vital Signs: 80-20 137/86 SPO2 96% on room air. At 0935 the patient reports he is feeling better and stated to RN "that Benadryl works fast". VS HR 87 BP 131/80 SPO2 96% on RA. He left vaccination site ambulatory with two peers in no distress.

4pm. Headaches, chills, low fever, joint pains, muscle pains, weakness, dizziness, diarrhea, swollen glands, thirst

Tinnitus in left ear (high pitched frequency), dizziness, loss of concentration, anxiety and trouble sleeping.

Chills, body aches, joint pain, loss of energy, head aches, Kidney pain, shortness of breath and coughing. Teeth hurt, Point of injection sore ness

Pain on the left arm and then I started having chills. Around 9:30PM I started having fever of 103 and my whole body was trembling. I took ibuprofen and went to sleep, I woke up several times during my sleep. When I woke up at 10AM my fever was 104, I tried eating but I did not have any taste. Today, I took 2 pills of acetaminophen and I am waiting for the reaction, I feel dizzy.

Moderna COVID-19 Vaccine EUA. Starting the next morning, Fever, body ache, headache, back/joint pain, something in my left armpit swole up between a golf ball to tennis ball size, throat sore, swelling in tongue and gums (kind of blistery like I burnt it on hot pizza is the best way I can describe it). most of the symptoms lasted for a day and a half or so. Four days later, still feverish at times, mouth is still tender (most of the swelling went down but not all) swelling in armpit has went down but not gone.

Shortness of breath, lips numb/tingling/swollen, redness around injection site spreading to right side of neck and across face with onset approximately 20-30 minutes after injection. Treatment: patient was taken to ED, given clonidine 0.1mg PO, Epi-pen 0.3mg, and solu-medrol 125mg IVP. Patient recovered and was discharged to home with Medrol dose pack and po Benadryl. Treating physician advised patient not to take second dose in series.

I have experienced on-and-off Pulsatile Tinnitus in right ear since the evening of 3/17/24. I haven't seen my doctor yet about it... It's just been annoying.

Unexpected Dizzyness Unexpected Tinitus (regular/expected muscle/joint aches) (regular/expected tiredness/exhaustion)

I have tinnitus and a clogged whooshing sound in my left ear; my hearing is gone. It's been almost2 weeks.

Mild Headache lasting 4 days. Increase in perceived volume of previously existing tinnitus (doubling of volume, has not changed since shortly after the 2nd shot)

42 hours after started notice noise is heard in the left ear. Not sure about right ear. Still the ringing noise on the left ear after 23 days. Checked with in ENT specialist and reported hear loss in the high frequency sound. It is TENNITUS. 22nd day I had a dizziness.

Tinnitus became very apparent about a week after my second dose. Had second dose on 02/19/21, that lot # is 004M20A. It is not affecting my ability to hear yet, but it is still extremely annoying. Previous to these vaccines, I did have very mild tinnitus, I would only hear the whine in a very quiet room. Now I hear it all the time and it does not go away when there are normal sounds in the household or even outside.

THE DAY AFTER HE RECEIVED THE VACCINE HE SAID HIS HEARING FELT LIKE HE WAS IN A WIND TUNNEL, AND THE VERTIGO STARTED. WITHIN 3 DAYS OF THAT HE LOST ALL HEARING IN HIS LEFT EAR. HE SAW HIS PRIMARY DOCTOR WHO TRIED SOME STEROIDS AND ALLERGY MEDICATIONS. HE WAS REFERRED TO EAR INSTITUTE. The Institute HAS INJECTED STEROIDS INTO HIS LET EAR SEVERAL TIMES, BUT STILL NO HEARING IN HIS LEFT HEAR, AND HE STILL HAS VERTIGO. SINCE THIS HIS BLOOD PRESSURE HAS BEEN INCREASING FROM NORMAL TO THE POINT HIS PROVIDER DID AN EKG ON HIM, WHICH WAS NORMAL SINUS RYTHM. HE KNOW THAT THIS IS GETTING REPORTED, IF YOU HAVE ANY QUESTIONS FOR HIM, HE WOULD BE HAPPY TO ANSWER THEM. NOTE: WHEN HIS PRIMARY REVIEW HIS CHART, HE TOLD patient THAT

Petechiae to arms, chest, abdomen, and back. Fever of 104 on 1/11/21. Elevated creatnine. Admitted to Emergency room for dehydration and diagnosed with covid 19. On 3/20/21 lost vision to left eye. Saw the doctor and diagnosed with optic neuritis. On 4/11/21 lost vision to right eye. Went to emergency room, at the local medical center emergency room and the doctor also diagnosed with optic neuritis.

Cold and shivering Persisting High fever , over 18 hours Headache and facial/jaw ache Hyper tiredness

Dizziness, blurred vision, fatigue, headaches, chills, low grade fever, muscle pain, joint pain, high blood pressure, and swelling of the throat.

confusion/was not coherent; blurry vision; vomited; cardiac outcomes went up, from the lab results they were elevated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion/was not coherent) (seriousness criterion hospitalization), VISION BLURRED (blurry vision) (seriousness criterion hospitalization), VOMITING (vomited) (seriousness criterion hospitalization) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had his first dose of the Moderna COVID-19 vaccine yesterday and immediately felt the vaccine go to his chest and down to the toes; 30-40 minutes after had confusion, blurry vision; he made it to a hospital in Dallas where he vomited, he could not read at the moment, could not call 911, did not know how to send his location, how to call or text, he was not coherent. Was admitted in the ER with altered mental state, he was not responsive when she went to see him. He stayed overnight, his cardiac outcomes went up, from the lab results they were elevated. They performed CT scans, neurological checks, a holter monitor, MRI, multiple blood works and everything was clear.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Per the member: I received shot number 1 Moderna COIVD-19 vaccine on 27FEB21 at approximately 09:47 that morning. Had minor soreness on the injection site on my left arm. Rest of the day did not observe any adverse action. On 28FEB21 at around 12:15, I felt warm and flush. I assessed that my body was reacting to the the vaccine and that afternoon went to the unit aid station at the military compound I was located at and had a slight fever with a temperature of 99.1. I continued to hydrate, eat regular meals, work, and noticed now irregularities in body functions. Continued on page 2...

Patient is a personal acquaintance of reporter. Patient contacted reporter on 4/15/21 at 10:18 pm complaining of onset of extreme dizziness, vomiting, "eyes not catching up with my head", extreme fatigue, and feeling like they are "about to pass out". Patient also noted onset of SOB and lower chest pain accompanied by "weird taste" but not metallic taste. Patient was unable to describe the unusual taste. Patient was encouraged to use OTC medications to treat headache and fever, encouraged to use OTC Benadryl/Dramamine. Monitor for worsening and report to ER if symptoms worsened, changed, or failed to improve. Per patient, symptoms lasted through the night and until approximately 3:00 AM on 4/16/21. Patient's wife reported blood sugar of 154 mg/dl, B/P 164/88, and Pulse 70 bpm using home monitors. On 4/16/21, the patient reported onset of fever greater than 101 at approximately 2:00-3:00 AM which lasted approximately 18 hours. Fever onset was accompanied by headache which has persisted from 4/16/21 through 4/22/21. Patient contacted writer on 4/21/21 to state that he still does not feel well, headaches continue and fatigue is persistent. Generally states that he does not feel well.

APPROXIMATELY 10 MINUTES AFTER INJECTION, PATIENT BEGAN FEELING DIZZY, SWEATING AND FELL IN THE BACK OF THE AISLE WHILE GRABBING HIS MOTHER TO SIT WITH HIM. I SAT PATIENT DOWN AND ASKED WHAT SYMPTOMS HE WAS EXPERIENCING. HE SAID HE HAD ABSOLUTELY NO TROUBLE BREATHING AND JUST FELT LIGHT HEADED, SOME FLOATERS IN HIS EYES AND SWEATY. I IMMEDIATELY TOOK HIS BLOOD PRESSURE WHICH WAS LOW AND OFFERED HIM WATER, AND GATORADE. PATIENT DID NOT WANT US TO CALL EMS BUT DUE TO LOW BLOOD PRESSURE, EMS WAS CALLED. ALL VITALS WERE CHECKED ABOUT 10-15 MIN LATER BY EMS AND EVERYTHING CHECKED OUT OK. PATIENT DECLINED SERVICES AND TRANSPORATION TO HOSPITAL AND STATED THAT HE FELT MUCH BETTER. FOLLOWED UP WITH PATIENT AN HOUR LATER VIA PHONE AND PATIENT WAS FEELING MUCH BETTER AND WAS JUST RESTING; CALLED AGAIN AT 6:30PM AND PATIENT SAID HE FELT 100% AND I COUNSELED HIM ON VISITING THE ER ASAP IF ANY SYMPTOMS, OR FEELING ILL RETURNED.

Ears ringing. It happened about 2-5 times for a short while over about 2 days either early this week or late last week. I did not associate it with the vaccine until reading an article about it today, so I just assumed it was the latest surprise from it aging body and didn't think to much of it. Also it head felt "hazy" at least once, but that has been happening literally my entire life.

Very strong Ear ringing (Tinnitus) in left ear that has been 100% constant since April 16th 2021. Headaches have been intermittent also. Pre April 16th 2021 i was not experiencing any issues of tinnitus nor regular headaches.

Client received 2nd dose of COVID-19 vaccine at 3:26pm. At 3:32pm RN was notified that client was not feeling well and had requested water. Check in with client who reported he was feeling dizzy and nauseous. Took client to cot by wheel chair. Check pulse (92bpm) and pulse ox (95 SpO2). Gave cold compress for neck and forehead. Client vomited small amount of yellow vomitous. Client grey/ashen in color when mask removed. LPN assesed for neck/back, jaw, and shoulder pain. Client became diaphoretic and he removed his vest. Client stated he had jaw pain and pain in back. Also reported arm pain and felling tired a few days before. EMS called. Interpreter used for interaction at cot.

Sudden sensorineural hearing loss 3 days after 1st injection and then Bell's Palsy about 10 days later.

Patient experience mild allergy reactions to the Moderna Vaccine. Patient has swollen eyes that cause blurry vision. Patient consulted with a physician to start treatment for his symptoms.

After second shot I developed severe TINNITUS on my right rear. Its a constant non stop ringing that initiates anxiety and panic and unable to sleep. its been over a month and it has not gone away.

constant ear ringing (buzz), headache for about 4 days after injection, light nausea for about 3 days

Chief Complaint...Tingling of back and sides of tongue which began at 5:08. 5:10: REPORTS STARTING TO DISSIPATE 5:17 MOSTLY RESOLVED (TINGLINING). LEFT CLINIC. WAS EDUCATED ON CALLING 911 IF SYMPTOMS WORSEN OR ADDITIONAL SYMPTOMS APPEAR. ENCOURAGED TO REPORT THROUGH V-SAFE 5/3/2021...Follow up call placed with no return call or text/message .

body and joint aches all over body. pain/swelling/hardness in left shoulder (continues into next day--injection site). cold hands and feet, chills, low-grade fever of 100.4., headache, sinus pressure, diarrhea. thirsty.

Seasonal allergies and dust allergies were severely aggravated to the point of significantly increased inflammation of eye lids, itchy eyes, face, neck, and rash on hands that have persisted for two weeks on a far more severe level of inflammation than ever experienced before. Prescription for Prednisone 10mg (38 tablets) and over-the counter Cortisone 10 with aloe vera. Also, washing affected area with Alkaline88 pH-balanced purified water has provided instant relief to itchiness and irritation.

Loss of hearing the next day. Always had excellent hearing till second shot. It?s now 30 days after second shot with sufficient loss of hearing. Both ears now ringing. Can?t get into doctor appointment right away. Loss over 30 percent of hearing.

Approx. 4.5 mm Red Spot on right eye, below pupil. No pain, no irritation... just the Red Spot on the eye.

Two days after dose-2 of Moderna COVID-19 vaccine I developed tinnitus in my right ear. This was nearly 3 weeks ago. It's a constant, persistent humming like a fan or refrigerator sound. It's quieter in the morning and gets louder throughout the day. It can make me dizzy and queasy while driving a car. Sometimes this sensation occurs even while walking around my house.

bad taste in mouth (sweet things do not taste sweet) Started Saturday, 5/22/21 still reporting same adverse event on Sunday. Bad headache, nausea and vomiting also started Sunday 5/23

Suffered the following side effects starting at 2am on Sunday and ending around midnight on Sunday. Fever Sweating Tingling tongue Sore body to the touch - Almost like the nerve ending in my skin were hypersensitive Headache Swollen shoulder Diarrhea

Seizure like phenomena; Breath sounds abnormal; Dizziness; Dyskinesia; Eyelid function disorder; Fall; Hyperhidrosis; Hypopnoea; Hypotonia; Muscle twitching; Pallor; Presyncope; Restless legs syndrome; Tremor; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like phenomena) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vagal reaction (patient stated he has experienced vagal responses to injections in the past). On 02-Mar-2021 at 5:46 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like phenomena) (seriousness criterion medically significant). 02-Mar-2021, the patient experienced BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like phenomena), BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: 120/72 (normal) 120/72 mmHg. On 02-Mar-2021, Heart rate: 64 (normal) 64 beats per minute. On 02-Mar-2021, Oxygen saturation: 99 (normal) 99%. On 02-Mar-2021, Respiratory rate: 20 (normal) 20 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. The patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being in the observation chair the patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp and slumped to the right side, his eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. The patient's breathing pattern became shallow and snoring sounds were noted. The patient did not respond when spoken to nor did he respond to soft shaking of the shoulders. The patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. The patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS (emergency medical services) arrived to find the patient regaining stability. The patient reported to EMS that he is familiar with this type of response and declined to be taken anywhere. Treatment medications were not reported. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.

Had 2-3 days of tinnitus in the right ear. The tinnitus presented as a low-pitched hum, that was most prevalent in the morning upon waking. After the 2nd dose of the Moderna vaccine on May 3rd, 2021, the tinnitus returned within two days. This tinnitus continues to the time of this submission. The symptom presents the same (low hum, right ear), and varies in severity from day to day. It is still most noticeable in the morning, and some days is severe enough to wake me from sleep. I have planned visit to ENT specialist June 1st for this condition.

Feel Suicidal; Brain fog; severe tinnitus; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Feel Suicidal) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 02UMZUD) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concurrent medical conditions included Drug allergy (Fluroquinoline antibiotics). Concomitant products included ALPRAZOLAM from 02-Feb-2012 to an unknown date for Sleep disorder NOS, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (severe tinnitus) and VERTIGO (vertigo). On an unknown date, the patient experienced SUICIDAL IDEATION (Feel Suicidal) (seriousness criterion medically significant) and FEELING ABNORMAL (Brain fog). At the time of the report, SUICIDAL IDEATION (Feel Suicidal) outcome was unknown and FEELING ABNORMAL (Brain fog), TINNITUS (severe tinnitus) and VERTIGO (vertigo) had not resolved. It was still debilitating an had remained the same for the last 3 weeks. Doctor cleaned patient's ears and told him it was an inflammation from the vaccine, that it would go away. No treatment information 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. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new events suicidal ideation and feeling abnormal; 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.

Tinnitus symptoms have been amplified, louder and all the time now. I did have it ever so often before, but now I always have the ringing in my ears and it's louder. I've seen an ENT for it and there is nothing they can do about it.

The morning after I received the vaccine, I woke up and I had flu like symptoms. I had a low grade fever, some nausea, ringing in my ears and fatigue. By bedtime that night, I felt normal except for the tinnitus that stayed. I went to the doctor on 03/26, an audiologist, and she told me that it is tinnitus and she had another patient that got tinnitus after the vaccine also. I am having a lot of trouble hearing now. The doctor told me that the ringing that I hear is a short circuit in my brain. It's not so much in my ear, but from the processing of the brain. This is a habituation, which means I am listening to sounds through an app or web link to teach my brain how to ignore that sound. There is not any treatment for this condition. I will follow up with the doctor in a year.

For the following month till now my eyes have been very dry and red. Focus changes were dramatically slower than normal up to 30 seconds. While being treated for a retina issue they noted that my eye pressure was was higher that when it was tested a few months previously with measures of 23 and 25 for the eyes. There was no history of this in previous measures and the previous values were 13 and 15 . On their recommendation I have been using lubricating eye drops several times a day. This has helped but stopping brings the irritation back. I have lived in the same house, alone, for several years and have not experienced this before. It could be allergies but it seemed worth noting.

Pt reported experiencing blurred vision and some lightheadedness. However symptoms resolved with time. Vitals signs stable. Pt AAOx4 with no other complaints. Sent home in stable condition. Advised to have eat upon departure. Accompanied by family.

104° fever, 2nd day following shot. Managed with OTC medication. Developed severe jaw and tooth pain approximately 4-5 days following dose 2 on right lower jaw. I had recently had a tooth that fractured in that area and was crowned as repair. Pain was so intense I could not sleep and radiated along the entire jaw. Ibuprofen treatment, but marginally helped pain. During dental appointment on 6/1, X-rays were taken, and it was confirmed no defects or other issues with tooth. Pain continued for approximately 1 week longer before disappearing. Pain was so intense at times that I could barely function. No other vaccinated persons I know had similar symptoms, but none had recently had dental work. Total duration of the issue was approximately 2-3 weeks from appearance to relief of symptoms.

3 weeks after second shot, I felt Dizziness and head confusion, that lasted about 1 week. The next week, my primary symptom was headache (left side) and eye pain (left side) The following week Tinnitus started and has been pretty constant ever since. It's been about two weeks straight of Tinnitus. Some eye twitching on right as is starting the last week. Headaches are still present but comes and goes and not as bad as originally, but still present. I'm on week 6 since symptoms started (Tinnitus is primary symptom, headaches, eye pain, eye twitching are secondary)

Patient also reporting cough, body aches, malaise, and diarrhea for ~4-5 days; unable to pin down date of onset. He reports loss of smell that he endorses as 2/2 congestion. Patient vaccinated for COVID with 2nd dose in March, but brother and father were not and are currently treated for it with his father still in the hospital. At OSH, COVID + flu PCR combination swab + for COVID. No oxygen requirement.

I came home and exercised and I was a little tired for 2-3 hours after shot and I had some general sight soreness but it wasn't terrible. I got a good night sleep that night. I got up next day and it was tender but I wasn't groggy. The next afternoon I started noticing some increased ringing in left ear. I've had tinnitus before but it seemed like it was getting worse. I noticed it more after vaccine. I also noticed new ringing in right ear where I've never had tinnitus before. That got louder probably within 24-48 hour period because I remember Holiday Sunday at church it was noticeable at breakfast than it had been over the past 48 hours. That's when I started getting concerned. I went to PCP (Dr.) on 04/14/2021 and everything looked fine apart from wax built up in right ear. I made appt with ENT 05/12/2021 and they said everything looked OK in ears and they seen me 10 years prior and did see normal ear loss because of aging. They put me on a regimen of steroids for loss of hearing and ringing in ears and I took the steroid for 20 days. For my f/u appt I noticed more of a decline in hearing and ordered a hearing aid. I did talk to ENT again and they said they see 2-3 patients a week with amplifications of ringing in ear after receiving the vaccine.

Pt. states 04/28/2021 horrible headache, vision problems, muscle/joint pain, pain induced vomiting, rash throughout body. Still currently has signs of rash. Brain swelling, 05/02/2021 ER visit. 05/04/2021 Primary visit Ct scans, MRI, blood-work ran. Elevated white-blood count, nuero symptoms similar to ALS. Swelling around abdominal mid-section/ribs area, neuropathy in the legs and feet. Prescribed steroids for swelling 3x. Tramadol prescribed.

hearing loss at high frequencies; developed ringing sensation in both ears/Tinnitus symptom is still persisting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss at high frequencies) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included ALLOPURINOL from 01-Jan-2015 to an unknown date for Gout. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting). On an unknown date, the patient experienced DEAFNESS (hearing loss at high frequencies) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss at high frequencies) and TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received contains information about developed ringing sensation in both ears/Tinnitus symptom is still persisting, sore arm injection site :Case upgraded to Serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Severe swollwn face and lips, slurred speech and red hives all across the body. Mild breathing difficulty. Had to call 911 and was taken to the hospital

On May 17th 2021, I woke up with numbness on the left side of my face. The symptoms were all sensory and not motor, there was no drooping or muscle weakness. I felt pain and tingling and electric shock type of symptoms along with numbness involving the three branches of the Trigeminal nerve. Initially I felt numbness mostly in the V3 branch involving my lower jaw and it gradually moved up to involve my teeth and gums and under my eye. Pain in my gums caused me not to be able to eat and the headaches that this was causing were getting worse. I went in to urgent care on May 26th to have diagnostic tests done including a CT scan with and without contrast which ruled out stroke and aneurysm. I then had an MRI without contrast to rule out multiple sclerosis which came back unremarkable. Which then led to the diagnosis of trigeminal neuralgia. Initially I was prescribed nortriptyline for my symptoms. I tried taking this and I didn?t notice any improvement in my symptoms and the side effects made it difficult for me to complete my daily work tasks. I was then prescribed carbamazepine and again, I experienced negative side effects with no reduction in my symptoms. I have no other risk factors for developing trigeminal neuralgia, I am otherwise healthy with mild hypertension that is well controlled on medication and I have not had any injury or surgery near this nerve that would put me as risk. At this point I have been asking my neurologist if I could have an MRI with contrast to see if there are vessels compressing the nerve. I feel that I need to get to the bottom of this and keep trying to find the root cause of this because the medication does not improve my symptoms. I am trying to figure out it this is an immune triggered attack on the nerve or if there is something compressing the nerve. I have never had any nerve palsies before, and I don?t have any chronic illness such as diabetes that would increase my risk of developing nerve palsy.

On 4/25/2021 I experienced a sever case of Vertigo. In trying to fix a loose tank on a toilet I proceeded to lay flat on the gound to tighten some bolts on the underside of the take. As soon as I rolled from my back to my left side I felt as though the entire room was spinning and I was unable to move or control myself. A friend witnessed it. For the next several days I was unable to walk straight and felt as though I was always drunk. I had to call into work for several days and once I felt a little better I had my wife drive me to my office. I still have minor events of dizzyness from time to time. Also to add to the issues my ears (yes both) have not stopped ringing since.

Cold sores on nose and mouth Tingling nerve sensation on face, scalp, and neck Minor first outbreak of shingles (painful bumps under right armpit) Tinnitus (from a 1 out of 10, to a 2 out of 10)

i was driving and my left eye stopped tracking with my right eye. I had to pull over and let my daughter drive this lasted maybe 3 minutes . I have never had this happen before. I don't get sick or have issues I have never taken a sick day in 20 plus years and I am fairly healthy

12/30/2020, onset s/s runny nose, dry cough, itchy, watery eyes. Inner elbow flushing similar to taking niacin, Most notably headache and low back pain. Both knees hurt, tight stomach and malaise.

During the 15 minute wait after receiving vaccine, pt stated his lips and tongue felt tingly. Pt was attended to by EMS. Pt stayed an additional 15 minutes for a total of 30 minutes. Pt stated he felt fine. EMS said pt could leave. pt left in stable condition.

Injection was painless. Within 5 minutes of vaccine felt dizzy and had heart rate into the 120's. Duration approximately 5 minutes then tachycardia and dizziness resolved. Also had a tremor. No angioedema, urticaria or other skin/mucosal findings. Was not anxious. Arrived home and wife and children told me I looked flushed and noticed my pupils were significantly dilated. The flushing and dilated pupils resolved over the next hour. No shortness of breath or hoarse voice of any kind however my mouth felt extremely dry. I did not do anything for treatment. Spontaneous resolution.

Dizziness, increased blood pressure, dry mouth Narrative: Within 10 minutes of receiving vaccine patient complaining of dizziness, increased blood pressure and dry mouth. Sent to urgent care within the building for evaluation. EKG performed. No meds given

1. Woke up the day after receiving the first dose without the ability to taste anything. I could smell soaps/mint/fragrant lotions etc, if I sniffed it up close, but I could not taste anything. I tested this with several different types of food. This lasted until about 12:30 pm that day. When I ate lunch I could taste my food again. This was a strange event for me. I have never lost my sense of taste before. 2. The evening of the third day after receiving the first dose of the moderna COVID-19 vaccine I experienced an approximate 4 inch diameter redness and itching around the injection site on my left shoulder. There was also an itchy rash that extended across my chest and back to my right shoulder. I took an antihistamine and went to bed. When I awoke the next day the rash extending across my chest, back, and right shoulder was gone. However, my left shoulder still itched for the rest of that day. The itchiness was gone when I awoke the next day.

Bodyaches, fatigue, chills, tenderness over site of injection, thirsty, shiver, sweats. ( hot and cold)

Employee seen in clinic on 1/21/21 for severe headache (9 on 0-10 scale), severe neck pain (9 on 0-10 scale), lymph node involvement on left arm and left side of neck, bilateral leg cramps, nausea, vomiting, sensitivity to light, low grade fever (99.5), chills, upper and lower back pain (7 on 0-10 scale). Injection site; rash covering 3 x 4.5 inches on upper left arm above deltoid and below acromium process with 1/2 x 1/2 inch bulla. Gave ice pack for left arm, gauze for Bulla. Sent employee home with instructions to take NSAIDS after arriving home and before sleep. BP 143/96, Pulse 96, temp 99.5

Felt his throat tingling, then noted (and confirmed by his wife) that his nose was swelling. Never had tongue, pharynx or lip swelling, only the nose.

101+F Fever, severe chills, severe body aches, moderate headache, moderate lethargy, inability to think clearly. Onset 10 hr after injection and persisted 2 days.

Bell's Palsy/ Facial paralysis/ Dropiness on the rightside; Light sensitivity; Tearing; Felt like flu; Sore; A spontaneous report was received from a 50 year-old, male patient who received Moderna's COVID-19 vaccine and experienced sore, felt like had the flu, light sensitivity, tearing of his right eye, Bell's palsy (right eye won't blink on its own, lip and speech issues). The patient's medical history was not provided. Concomitant medications were not reported. On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A), intramuscularly in left arm, for prophylaxis of COVID-19 infection. On 10 Jan 2021, he was sore, felt like had the flu. On 13 Jan 2021, he experienced light sensitivity, and tearing of his right eye. On 19 Jan 2021, he went to the emergency room and found with facial paralysis, droopiness on the right side. He was diagnosed with Bell's palsy (right eye won't blink on its own, lip and speech issues). Treatment included Valtrex. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, sore, felt like had the flu was considered resolved on 11 Jan 2021. The outcome of the event, Bell's palsy (right eye won't blink on its own, lip and speech issues) was not recovered. The outcome of the events, light sensitivity, and tearing of right eye was unknown.; Reporter's Comments: This case concerns a 50-year-old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis and unexpected non-serious events of Influenza, Pain, Photophobia and Lacrimation increased. The events of Influenza and Pain occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 025J20A). Photophobia and Lacrimation increased occurred approximately four days after the first dose of mRNA-1273 (Lot number: 025J20A). Event of Facial Paralysis was diagnosed approximately ten days after the first dose of mRNA-1273 (Lot number: 025J20A). Treatment included Valtrex. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Swelling of face/mouth. Rash and itchy all over body. lips are not as swollen as they were this am at 6:00am and Rash is still visible but not itchy, time I'm writing this is 12:33pm

Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizziness; pulse going up to 95,( when normal is in the 60's). Then sat down an hour later and almost immediately a deep tiredness. got off work early, went home and had no other problems until I attempted to go to sleep. Somewhere around nine o'clock, I started getting muscle cramps so I went to the couch. Shortly after, my right arm, (vaccinated arm) became extremely sore; shortly after, my total body ached; no relief from lying on my left, right, stomach or back; hurt to even sit upright. Then, I started getting cold chills; which alternated with hot flashes and periods of nausea. My mouth went extremely dry, so when I struggled to go use the bathroom, I would wobble my way to the kitchen and want to take a big drink of water, attempted to swallow two tylenol, gagged and started throwing up. Went back to bed and started getting continuous headaches that would move to different places. This happened the rest of the night and most of Thursday when most of the worst symptoms happened. Was able to sleep Thursday night and thought I was feeling better, until I stood up. Today, I was not able to stand longer than one half an hour at any one point; had to lie down and rest while doing any kind of activity. I haven't been able to keep anything down; either vomiting or diarrhea. Have been slowly feeling better with occasional headache.

Per Observer RN; Caregiver reported feeling "flushed." Observer noted facial flushing. Caregiver reported "blurred vision, itchiness all over body as well as dizziness." Approx. 10 minutes later also reported "chills."

Tongue and gland swelling, fatigue, joint pain, chills, nausea, redness, soreness at injection site. Symptoms started approximately an hour and a half to two hours after injection. Symptoms lasted approximately three days then tapered off.

tinny, metallic taste and feeling in mouth, consistent for entire week following vaccine and fatigue in evening.

12 hours after vaccine developed altered taste, altered smell, significant fatigue, poor concentration, headache with pressure in frontal area of head

Dysgeusia - Faint metallic taste experienced within 30 minutes post injection. I am continuing to experience this (transient) 24 hours later. Injection site reaction - soreness, bruising 24 hours post injection (pain is 4 out of 10) Diarrhea - have experienced 3 bouts of diarrhea with onset around 12 hours post injection and continuing to 24 hours post injection.

After I got the shot, on the way home, I started feeling tingling on tongue and lips; had a metallic taste. I felt like I had allergies - I was a little congested - but the next morning, 04:00 am - I was still congested - and was still breathing short and shallow. I get to work and I'm open mouth breathing - not breathing correctly. It felt like my lungs were swollen on the inside and throat was swollen on inside. Couldn't palpate and feel it but just couldn't access the lower lungs breathing-wise. Started getting dizzy and couldn't think - from 05:00 am to 09:00 am - and I decided I couldn't work anymore. I went to headquarters and I couldn't talk from lack of breathing - would have to stop just to think or just to breathe. I drove by the clinic where I was got my vaccine and decided to go in - I was so dizzy and I realized I shouldn't be driving. They told me to get up and move and I told them I couldn't breathe and I'm not one to say that but they called an ambulance that took me ER. (I was a LPN at one time so I wasn't anxious.) And they told me it was anxiety - and they kept telling me to breathe. But it wasn't an anxiety attack at all. My heartrate was normal. I was shallow breathing. They gave me a paper bag to breathe into. That's it .I was there for a couple of hours. They had told me to rest. I shouldn't have gotten out of bed that morning - my body just didn't want to move. I felt a little better after a couple of hours and people helped me from there to get home. After that, I felt better - about 4 pm or 5 pm. Second vaccine - felt flu like symptoms for three days after. I still feel a little weird - my bones hurt and I'm achy. Just not feeling right. Note: When I was in the emergency room - my hands were purple. Circulation was weird.They told me my oxygen levels were fine and that I just needed to breathe. It caused carpal tunnel in my wrist - I had nerve damage on that about three weeks - I have about 80 percent nerve damage from previous and so when something irritates it - it takes a while to recover from it but I have. I consulted with a doctor about the reaction to first vaccine before getting the second vaccine.

Skin below eye (near sinuses) was swollen, red, and tender to the touch Tuesday morning. On Wednesday morning it had spread down to his upper lip and across his nose to the right of his face.

Hives at neck and right side of back accompanied by extreme itching/burning-36 hours after, increased zyrtec dosage; swollen face-16 hours after; metallic taste-onset was 4 hours from inject and persisted for 7 days; pimples/white heads on left arm-16 hours after injection and persisted through day 12; intermittent tremors/shaking hands-6 hours after injection and persisted through 48 hours; mental confusion/fog-4 hours after injection and persisted through 48 hours; left arm numbness from injection site to wrist-4 hours after injection, episodic persistence through day 4.

Extreme dizziness and numbness in mouth and teeth within 1 hour of shot. These symptoms went away for a day but have since returned.

Auditory issues: ringing in both ears. Sometimes louder in one or the other. Ringing is day and night.

-Sore arm: started about 2 hours after injection. By 18 hours after, it felt like I had a really bad bruise there. It was throbbing always, more painful to stretch the deltoid where the shot was given, and sharply painful if I used that muscle to lift my arm. This continued until about 30 hours when it started to reduce in intensity until being gone about 60 hours (2.5 days) after the shot. -General lethargy: started about 6-7 hours after shot. Peaked about 24 hours. Still able to get up and move around but very tired. Gone at about 43 hour mark. -Body aches: timeframes the same as lethargy. Felt at worst like a bad flu. - Headache and lightheadedness: Started about 2 hours after injection. Never got really bad, but was fairly consistently there until about 36 hour mark. - Burning eyes: started about 7 hours after shot, was annoying and lasted until about 33 hour mark. - Coughing: mild but distinct dry cough started about 18 hours after shot and lasted to about 30 hour mark.

April 1, same day as shot, around 10pm my nose experienced intense pain to the point of drawing tears along with blurry vision. Pain would be rated a 9 on a 10 scale. This was not caused by any impact to my nose. I was sitting in my chair and watching TV. This lasted 5 minutes and then "went away". April 3, two days after shot, left index finger and left middle finger are shaking (still shaking and has been for last 6 hours). This was noticed upon waking up and is still occurring. I am fatigued.

Bell?s palsy indicators: tingling and pain in left forehead lobe, left jaw, left cheek, and especially within left ear. Events have been on and off since a few hours after the first injection.

Moderate to severe burning affect on left side on tongue. started almost day after or so still having it as of now 4/9 but little better than before.

Metal taste in mouth. Toung swollen and discolored with red and white patches. Keeped clean and rinsed with salt water. I still have the symptoms, but it does seem to be getting slightly better. It did not seem to change when I received my second shot. Second shot made me tired and I felt like I was coming down with the flu. I slept for 10.5 hours and woke up feeling much better. All the flu symptoms where gone by the following day.

Patient received the COVID-19 vaccine at approximately 1300 on 3/18/21 without incident. Patient woke from sleep at 0100 on 3/19/21 to find his top lip significantly swollen. He was able to breath and talk. He took Benadryl 50mg at home before coming to the ED. He maintained his airway the entire encounter and the swelling was contained in his lips. He received Depo-Medrol 80 mg IM x 1 and Zyrtec 20mg PO x 1 and was observed. His swelling resolved and he was discharged with a prescription for Prednisone 10mg with a tapering dose over 4 days. He was advised not receive the second dose of COVID vaccine at this time.

I felt one small tingle in my left hand (I am right-handed) and I had a funny taste in my mouth. Later that night, after eating, I started feeling a tingling sensation in my arms and back. It seemed to get worse after I ate some oatmeal cookies cooked with flour shortly before bed. Early the next morning, the tingling developed into itchy skin on my back, shoulders, and arms. I am not really breaking out and I am making sure to stay hydrated. I am hypothesizing that the side effects I am experiencing may be due to consuming refined flour and refined sugars that my body cannot metabolize. At least for now, I plan to stay away from refined sugars and flours until my 2nd dose of the Moderna shot. Day 2: I woke up on my left side and the pinky and ring fingers on my left hand were asleep. I went back to sleep on my back and woke up with fingers on my left and right side asleep. As I got ready for work, I experienced trapezius muscle soreness.

Fever, chills, aches, difficulty breathing, confusion, shaking, Swollen joints hands, neck, throat, and tongue lasting from 4/15-4/18. Convulsions began 4/16-4/17. Treated with benadryl and ibuprofen and Tylenol and albuteral inhaler.

Nasal/sinus congestion appeared Mon 4/5 (17-days after injection) Congestion resolved on Wed 4/7, but right ear had very high pitched humming (tinnitus). On Sat 4/10 both ears began humming (tinnitus). Mild fullness sensation in both ears, slight drainage from Eustachian tubes (back of throat), no active infection. Hearing test results showed loss of 10-40 decibel range in right ear at all frequencies: left ear mostly normal Prescribed prednisone, 40 mg/day for 3 days (symtoms remained) Prescribed methypredisone 6-day tapering dose pack (symptoms remained) Delayed second dose of Moderna vaccine until Mon 4/26 (5.5 weeks after first dose)

Within 24 hours of 2nd dose I experienced tongue swelling and sores on my tongue. Out of concern, I went for a covid test on 4/16. Results came back negative on sunday AM on 4/18. My tongue had gotten worse, and I was also now experiencing sinus pressure and ear pain. I went to the pharmacy minit clinic. They diagnosed the tongue pain and sores as thrush, and saw ear fluid. They felt there could be an infection going on. Nystatin oral suspension and Amoxicillin-Clav 875-125 were prescribed. About an hour after coming home, I started experiencing symptom of Bells Palsy which progressed to fully affecting my right side of my face. I saw my PCP on 4/19 and he confirmed Bells Palsy. Added Prednison 20MG and a Famciclovir 500MG, and order a blood test

After both the first and second vaccine shots, I had the same reaction. 15 to 20 minutes after the shot, I felt a numbness in my mouth. I also had a slight throat constriction sensation that I know well given my history with severe allergic reactions to tree nuts. However, to be clear, the reaction to the vaccine shots was far more mild than my reaction to tree nuts. If I eat any tree nuts, I have a severe reaction that involves throat closure, hives, vomiting and related symptoms for 6-8 hours. While the Epipen shot helps with keeping my throat open, it does not reduce all of the other symptoms. Here, the throat constriction was only approx. 1/100th of the reaction I have when I eat tree nuts. Further, the slight throat constriction and mouth numbness only lasted 10-15 minutes, as compared to 6-8 hours if I eat tree nuts. I did not need to use an Epipen.

Lips began to tingle and felt full but no swelling. Bottom inside lip turned bright red. some bright red spots upper on upper lips/gum. Began about 5 min after first dose. Redness began to go away after 45 min. Felt normal in about an hour.

Experienced Sudden Sensorineural Hearing Loss (SSNHL) in the left ear beginning in early morning on March 24, 2021. Hearing loss occurred over the course of approximately 1 hour. Initial care sought through an urgent care on March 24, followed by my primary care physician on March 26, and then emergency room on March 27. Emergency room consulted with Dr and began treatment with oral course of prednisone, 50mg tablet once per day for a total of 6 days. Referred to Dr, ENT, on an emergent basis. Full audiological testing performed on March 29 at Dr office showed profound hearing loss (80-110 db) across all frequencies in left ear, with a speech recognition of 0%. Also experienced aural fullness and tinnitus in left ear. Received intratympanic injections of dexamethasone at Dr office on March 29, April 6 and April 15. I began to notice extremely gradual improvement of ability to hear starting on March 30, with slow incremental improvement continuing to date, but so far only partial recovery has occurred. A second full audiological assessment was performed on April 15 at Dr office, and results showed left ear hearing had improved to "asymmetric mild sloping to profound" hearing loss (25 -95 db from low to high frequencies), speech recognition improved to 48%. Complete recovery has been described as unlikely, but final recovery level is unknown and will be assessed in the coming months - most recovery from SSNHL occurs in the initial month following onset. Next appointment will be in 6 months to assess final hearing level in left ear and discuss amplification (hearing aid) if necessary.