Moderna

I woke up at approximately 4:00 am with an extremely dry mouth. I went into the bathroom and took a drink of water. I returned to bed. I noticed that my breathing was becoming more rapid. I had trouble catching my breath. I sat up on the side of the bed. My heart was pounding and quick. My breathing was difficult. I woke up my wife. After about 5 minutes my symptoms improved. She took my pulse which was now at 62ppm. I laid back down in a reclined position. My symptoms of difficulty breathing and elevated heart rate quickly returned. My pulse was now up to 98 ppm. I sat up again. My symptoms gradually improved. Being unsure of what was going on my wife called 911. The ambulance arrived in about 8 minutes. I was about 60% better. Vitals were improving other than my blood pressure which was 180/100 Being unsure of what was happening, I was transported to Hospital. I had a chest x-ray, a chest CT scan with contrast to rule out a blood clot, blood work including tests to rule out MI x2. All test were negative. By about 6:30 am I was feeling at least 80% better. My breathing I felt had returned to normal. My pulse was down into the 50"s which is my normal range.

1305: vaccine administered 1312: Client reports facial numbness, feeling faint, short episode of shortness of breath x 1 min that resolved already, O2: 97%, P: 74 1315: Given life savers candy, BP 142/82 LA, Temp 98.1, Lungs CTAB 1317: States that he is no longer feeling faint but still has lip numbness, capri sun given 1325: Client states he is feeling better 1335: Client feels ok to drive. Released from clinic

On 01/05/21: Numbness, pins and needles, tingling to the right side of body: arm, legs, torso, hands, feet, face, tongue, lips. Arms felt like it was going to explode. If standing on two feet, cannot feel right foot on ground. On 01/13/21: - Cannot feel texture or sense of touch from elbow to fingers and from knee down to toes.

Back and neck stiffness, trouble swallowing, tongue thickness, facial twitch, and shortness of breathe.

20 MINUTES AFTER INJECTION CLIENT COMPLAINED OF VISUAL DISTURBANCES. HE STATES THE WHITE TRUCK PARKED NEXT TO HIM APPEARED PINK FOR A SPLIT SECOND THEN RETURNED BACK TO LOOKING WHITE. CALLED EMS PER PROTOCOL MANUAL B/P 220/90, PATIENT THEN ALSO COMPLAINED OF CHEST PAIN/TIGHTNESS. ASA 325MG WAS GIVEN TO PATIENT PER PROTOCOL AND 4 L OXYGEN VIA NC. PATIENT WAS TRANSPORTED VIA EMS TO HOSPITAL.

sx: felt hot, tingling at corners of mouth, dry mouth s: lungs cta b/l, upper airway cta b/l, no uvular swelling, no rash tx: benadryl 50 mg PO x 1, monitoring outcome: 911 called, pt monitored, ambulance cancelled, monitored in clinic, condition improved/resolved, discharged home with epi pen and instructions to call 911 if airway irritation develops.

Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.

60 yo with pruritic rash and mild lip and facial swelling the day after getting first dose of Moderna vaccine and lasting for 7 days, no throat pain, difficult swallowing or breathing; similar rash after either flu or shingles vaccine; pt nad Throat clear, no stridor, trismus, swelling or drooling, lungs clear, cvrrr, abd sof,t nt both arms with diffuse macular paular , blanching areas; Imp probable allergic reaction

Patient has experienced ringing in ears since getting the vaccine; not a huge deal, just annoying. Message left on 12/30/20.

Extreme untreatable Headaches, burning sensation left side of body, backache left side, Eye Pain and sudden onset of shingles.

Rash on inner wrists, upper thighs and scrotum along with 100 degree fever awoke me around 3:00am Feb 6. At 7:06 am I noticed left side facial swelling and slightly obstructed throat. Swelling worsened only slightly from 7am to 9am. At 9am I took 100mg Benadryl and withing 45 minutes swelling was subsiding and breathing was normal. Arrived at ER at around 11:am. Was treated with EPINEPHrine, methylPREDNISolone and saline IV. Released after a few hours

Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.

Fever (102.7), headache, soreness of arm, lymphnode swelling (axilary), tea colored urine (prior to rehydration), cotton mouth. Tx: ACTM PRN over 3 days for fever, Increased fluids

On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7, CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.

Mile to moderate tinnitus predominately in the right ear, but sometimes also sensed in the left. The sensation began within 5-10 minutes of the injection and continues to date. The intensity of the ringing varies, and seems a bit less pronounced as time goes by.

About 15-20 minutes after receiving the vaccine, patient experienced burning and tingling on his tongue and hands. Patient took 2 Benadryl 25mg capsules and was monitored for 15 minutes. Stated he was feeling much better and it was going home. I followed up with him this evening at 8pm and he was stating he felt fine now and just drowsy from Benadryl.

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

Pt stated experienced paralysis on left side. Stated his left eye was numb and vision blurry. Lasted about 8-12 hours starting about 3 hours after receiving covid vaccine.

THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE. THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK. HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE. PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021. HE WAS DISCHARGED HOME IN STABLE CONDITION .

Patient experienced severe migraine headache with visual changes within 15 minutes of receiving vaccine.

Vaccination on Wednesday. Felt normal fatigue and pain Wed/Thu/Fri. Felt completely fine Fri evening and Saturday. Woke up Sunday with severe dizziness and slight ringing in ears. Rest didnt help. Took Benedryl and seemed to get better in the night. Woke up Monday again with dizziness. Slightly better but still not able to work or do activities. Pharmacy referred to Physician - waiting for that appointment.

Patient received their vaccine and sat in a chair, within approx. two minutes the patient told another patient they felt hot, I was already walking to the patient to check on them,. The patient's eyes were glazed, Almost immediately the patients eyes rolled back in his head. I shook his arm and shouted to him , he was unresponsive with agonal breaths.. I shouted for help from the other nurses. RNs came immediately. We moved him to the floor, called for an epinephrine injection to be prepared, I began to prepare the site for epinephrine injection to his thigh, nurse checked for pulse... at this time the patient was still unresponsive with agonal breaths... no pulse was felt so compressions were commenced by RN. Nurse gave approx. 15 compressions to the patients chest , the patient spontaneously began to recover. Carotid and radial pulses were felt at this time. Breathing returned to normal. While this was occurring, we called a code blue and 911 was activated. By the time 911 responded the patient was fully conscious , alert and responsive. He could tell us his name and how he felt prior to this incident. The patient was transferred via a stretcher by EMS 911 and RN accompanied him to the ER to give a report. The timeframe for being pulseless and having agonal breaths lasted no more than 30-40 seconds. Patient denied any history of a seizure disorder. No epinephrine or IM Benadryl were administered at the incident site by the responding staff due to the spontaneous recovery.

Hazy/foggy vision, temporary. For about 7 days after both doses, my eyesight got very foggy, severely limiting my ability to get anything done. It took about 2 days to get to its worst, was bad for about three days, then about 2 days to clear up. Vision basically returned to "normal" after each event.

was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: Tired feeling, eyes burning, flushed feeling. Assessment : Time of assessment 0912. Actions taken: BP 162/79, P 82, 97% O2 saturation. He was placed in a wheelchair and taken out to the triage area by RC-EMS. Blood sugar 122. 12 Lead EKG done, patient monitored additional 15 minutes and reported feeling better. Last BP 165/82, P 83. He was able to get off the stretcher and ambulate to the door to go home with his wife. Instructed to call 911 if symptoms reappear, she verbalized understanding.

08:20 am Received 2nd dose of Moderna. Hx of facial swelling to sulfa, so pt was to remain for observation for 30 minutes. At 08:45 am complained of feeling like her eyes were swelling. Pt's daughter was in the car with her and did not notice patient looking any different. No distress noted nor obvious swelling of face, eyes, lips, etc. O2 sat 98% pulse 72. Administered 25 mg benadryl chewable tablet and observed pt for another 30 minutes. At 9:30 am pt reported feeling better, no other problems noted. Pt was discharged to home and told to take benadryl q 6 hrs for the next day and seek emergency care if condition worsened. Call to pt on 03/26/21 revealed that pt had no further problems.

Received the first COVID vaccine on March 18 and two days later I suddenly lost hearing in my left ear. This was near total hearing loss. I could only hear a slight buzz when putting a phone to my ear and listening for the dial tone. Went to my health care provider a couple of days later. They cleaned both ears and examined for any obvious problems. This seemed to improve the hearing in the ear slightly. Physician's Assistant said the hearing loss was most likely a reaction to the vaccine and advised giving it two weeks to see if it improves. Hearing didn't improve much (if at all) throughout the remainder of the week. Over the weekend of March 27-28 hearing seemed to be improving. This morning, March 29, hearing has noticeably improved and I can carry on a phone conversation using my left ear. Hearing is not back to normal yet but it is much better than a few days ago.

Nurse was notified by Staff that patient stated he was jittery. Checked on patient and he stated that he just felt jittery. Denied any problems breathing or SOB. Eyes were red and appeared irritated. Stated that he had had angiogram before and had reaction to dye. Waited additional 15 minutes. Dismissed at 0943 since s/s resolved, but referred to ER if he had return of s/s.

severe tinnitus, hearing loss along with body aches the day following 2nd dose of Moderna. The body aches cleared after one day, the tinnitus and hearing loss has not. The symptoms are more pronounced and severe in the morning and clears to more manageable levels by mid-day

fever of 101.8, aches from tips of right fingers to tips of left fingers and down my back to my buttocks, headache, blurry vision,extreme fatigue. all lasted about 28hours. now just pain at the injection site.

Severe body, neck and joint pain. Stomach cramps, headache, fever reach 101.8, vertigo, face and lips felt numb, absolute exhaustion. These symptoms lasted for 48 hours although the worst of it was the first 24. Many of the same symptoms we the same I had with Covid in November -December 2020. I did not, however experience sore throat or congestion.

Severe bloodshot left eye -- I do have a picture if helpful to you Minor nasal congestion Slight headache 1 day prior to the bloodshot eye - relieved by Tylenol

Vaccine administered at 11:00 am at 11:10 client reported throat and tongue tingling, dizziness and difficulty breathing. Administered 1 mg epinephrine. EMS was called and transported client to the hospital where he was admitted under observation.

loss of sight in his eyes; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (loss of sight in his eyes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 31-Mar-2021, the patient experienced BLINDNESS (loss of sight in his eyes) (seriousness criterion medically significant). At the time of the report, BLINDNESS (loss of sight in his eyes) and VACCINATION SITE PAIN (Soreness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact; 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 of vaccination site pain, a causal relationship cannot be excluded. However,very limited information regarding the event of Blindness has been provided at this time. Further information has been requested.

Overview of symptoms in order of occurrence: Pain in the arm; Dry eyes; Fatigue; Nausea; Headache; Chills; Joint pain; Muscle aches; Dizziness; Measured Fever; and Arm rash. Symptoms of greatest concern: Nausea, Headache, Chills for 1-2 days; and the ongoing Fatigue is now in its 4th day. Details of symptoms with time of onset, duration and severity are provided below (Note: Injection with 2nd dose of Moderna vaccine took place at 9:24AM on 07APR21): 07APR21, 10:30AM ? Arm Pain: Onset of mild pain in arm that was noticed when not touching the arm; Level of pain was a ?1? out of 10). An annoying level of pain where the pain ramped up to 3 or 4 on a scale of 10 when the arm was moved about began at 7:00PM on 07APR21 and lasted 12 hours until 7:00AM on 08APR21. The pain diminished to a mild ache for another 33 hours until it became insignificant by 4:00PM on 09APR21. 07APR21, 1:00PM ? Dry Eyes: Onset of an intermittent feeling of very dry eyes that lasted approximately 1-2 hours at a time and continued over a period of 9 hours until 10PM on 07APR21. 07APR21, 3:30PM - Fatigue: Onset of mild fatigue that steadily increased until bedtime at 10:00PM on 07APR21; and was significantly more pronounced at 1:00AM on 08APR21 (was difficult to stand and walk 20? to closet to obtain a thermometer; could not walk straight and bumped into hallway on left 4-5 times). Fatigue was rather frightening and severe from 3:00AM to 3:30AM on 08APR21 when I crawled to the bathroom, but could not get off my knees and collapsed on the floor until I could return to bed by crawling on the floor. Was able to stand again at 7:00AM on 08APR21 and walked (slowly) 30? to a sofa. Slept from 10PM on 07APR21 to 1:00AM on 08APR21; 4:00-7:30AM on 08APR21; 8:30-10:30AM on 08APR21; 11:00AM to 3:00PM on 08APR21; 7:00PM on 08APR21 to 3:00AM on 09APR21; 3:30AM to 7:30AM on 09APR21; 9:30PM on 09APR21 to 9:15AM on 10APR21; 6:40PM on 10APR21 to 7:00AM on 11APR21. Ongoing weariness continues as I write this at 11:00AM on 11APR21. 07APR21, 7:10PM - Nausea: Onset of continuous nausea that lasted 13 hours and 20 minutes until 08APR21, 8:30AM. Nausea was particularly bad with intermittent dry heaves for the 7.5 hours lasting from 1:00AM to 8:30AM on 08APR21; Nausea then came in waves for 23 more hours until 09Apr21, 7:30AM when it was finally gone. 07APR21, 7:10PM - Headache: Onset of headache that has lasted 4 days (as of 11APR21, 10:30AM). Finally gave in and took one extended release tablet of 650mg Acetaminophen tablet about 25 hours after the vaccination (i.e., took painkiller at 10:30AM on 08APR21). Took two Ibuprofen at 9:00AM on 11APR21. 07APR21, 7:15PM ? Chills: Onset of chills that increased to intermittent shivering by bedtime at 10PM on 07APR21. Awoke at 1:00AM on 08APR21 and could not get warm. Two hours later, at 3:00AM, I felt completely opposite and could not feel cool. These symptoms gradually subsided and were gone by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Joint Pain and Muscle Aches: Onset of joint pain and muscle aches that occasionally became annoying with twinges of pain. These symptoms subsided by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Dizziness: Onset of mild dizziness that lasted 12 hours until 7:15AM on 08APR21. 08APR21, 1:00AM ? Measured Fever: Decided to measure temperature due to significant chills and shivering and found temperature was 101.0 at 1:00AM on 08APR21. At 3:00PM on 08APR21, my temperature was 100.2 (this was 4.5 hours after taking one extended release tablet of 650mg acetaminophen). At 3:00AM on 09APR21, my temperature measured 98.6 degrees and has remained near there ever since. 09APR21, 4:00PM ? Arm Rash: First noticed presence of a rash measuring about 2? x 3? on upper arm near the area that received the injection. Mild itchiness was present about an hour later and a topical 2% diphenhydramine gel was applied. The rash had dissipated by 5PM on 10APR21.

I was extremely tired on Saturday. My shoulder hurt. About 3 pm, while urinating, I felt very light-headed as if I was about to faint. I stopped urinating and went back to bed. That evening, about 8:30, I tried to eat dinner, but after three bites, I felt extremely tired. I leaned back in my chair, and I passed out. My wife woke me, but it took several minutes. She said my eyes rolled back in my head. She splashed water on my face. She said that I stopped breathing. I woke up, then pushed my plate away and put my head on the table. I could not hold it up. I was sweating profusely. After several minutes, I felt that I was about to have diarrhea. My daughter and wife tried to walk me to the bathroom, but I did not have the energy to get there. I collapsed in the hall and hit my head on the door jamb. After several minute of trying , they pulled me up, and I then got the strength to walk the rest of the way. I had diarrhea, not suddenly, but it was as if my GI system emptied. It was soft, not loose, and there was a lot. I went back to bed, and eventually slept. I felt queasy the next day (Sunday), and I felt lightheaded at times, so I just sat or laid down. But I was feeling better. Today (Monday) I feel much better. A little tired, but much better. I went to the Pharmacy this morning, and they referred me to this website. I did not see the doctor.

severe debilitating tinnitus in my right ear started approximately 2 weeks after the 2nd moderna shot on March 17. 2021. Intermittent mild to severe headaches. Unable to sleep as the pitch in ear is constant.

Ringing in head, primarily in morning when waking or after nap, may lessen within an hour or so, but has been consistent throughout the day at times. Has been ongoing following dose 1 of moderna 3/10/2021, dose 2 of moderna administered 4/7/2021.

The patient reported severe pain in the arm of injection that started between 1-2 hours post vaccination. The following day he noticed floaters in his vision. He made an appointment with a regular eye dr (4/4/21) who referred him to a Retina specialist At the appointment with the retina specialist they noticed holes in the patients retina. They dr had to preform freezing and gas treatment to prevent the retina from detaching. The doctor wants the patient to recheck in 3 months.

Patient says tat ringing started in both ears three to four days after the vaccination. He says the ringing started very loud and has decreased over time but is still ringing.

Five minutes after second dose of moderna, patient complaints of scratchy throat and numbness to the left side of his tongue. Benadryl 50 mg given IM and monitored additional 30 minutes and patient called X 2 in the next two hours with resolution of symptoms. Follow up with PCP, UC or ER if any worsening of symptoms. CNP

4 days after injection the roof of my mouth became blistered and sore, I thought that I had possibly burned it with hot water, this lasted about 4-5 days and then cleared up. I then received my second dose of the vaccine on 03/05/2021and again 4 days after the injection the same thing happened, it lasted about 5-4 days and then cleared up. There have been no issues since

stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMLODIPINE for an unknown indication. The patient's past medical history included No adverse event (No medical history reported. ). On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

Because pt was uncomfortable he did not use his CPAP machine. 45 hours after second dose was administered my husband was sitting up in bed eating breakfast, He tilted his head back to swallow his his escitalopram and baby aspirin, sipped his coffee chewed and swallowed. He then went speechless and began staring off to his left. He lost consciousness. His chin stretched out to the left and his head rolled back as did his eyes. Eyelids remained open. His head and upper body began to tremble and seemed stiff though his hands remained down by his side. Time slows when in such an emotional situation but I think the complete event lasted about 35 real seconds. I wonder if his temperature being elevated a couple of degrees and with his absolute lymphocytes on the rise if his strong immune response revealed a family predisposition to dystonia?

Since Mar 29-Vertigo(Dizziness) fluctuating, more severe in AM-every day since. Tinnitus-pre-existing, now worse. Lethargy. 2 visits to Primary care doc.

Throat tightness, metal taste in mouth. Patients blood pressure and pulse ox remained normal throughout and there were no signs of oral or facial edema and no signs of accesory breathing. Given epinephrine and benadryl on site

moderate, related, bilateral tinnitis, still ongoing with no diminishment in intensity, now 60 days post-vaccination

18-days after the shot I felt off - Started with taste, was not right. I was tried - ran down. 3-days later I had to go to the emergency. I was thinking a mild stoke but it was Bell's palsy. (So now I have Bell's Palsy) Was this from the Covid - 19 Shot? I don't know - Thats why I am filling out this paperwork - to get some answers and to let you know

After receiving the immunization patient became unconscious, unresponsive, diaphoretic, incontinent and was drooling from the mouth. The patient did not respond to verbal or physical stimuli and his pulse was weak. Due to the patients position it is unknown if the patient was breathing or not. At this point epinephrine was administered into the patients left thigh. Within a 2-5 minutes the patient regained consciousness. He was alert and oriented at this time. His blood sugar was testing using his continuous glucose monitoring system and was 191. 911 was called and the paramedics took the patient to the hospital.

Patient woke up on Friday April 30 at 4:00 am and noticed upper lip swelling. He is unsure if this is vaccine related or work related (landscaper works outside). He did not take any allergy medicine for the lip swelling, but according to patient it went away by 6:00 pm the same day.

Tinnitus in both ears. A very loud, high-pitched "ringing" noise, like an "angry" violin, in both ears

AFTER THE 2ND SHOT ON 4/30/21 AFTERNOON, PT HAD SORE ARM AT AROUND 7 PM AND WENT TO BED AT 8PM. HE SLEPT THROUGH SATURDAY AND WOKE UP ON SUNDAY 5AM . HE NOTICED THAT CAN'T FOCUS HIS EYES TO READ OR SEE HIS COMPUTER SCREEN. BUT HE CAN SEE FROM BIG ITEMS FROM AFAR. HE TOOK THE DAY OFF FROM WORK ON MONDAY, AND SAID THAT HE HAS STILL HAS A HARD TIME READING OR SEEING COMPUTER SCREEN. HE HAS TO CLOSE HIS EYES FOR SEVERAL SECONDS AND FOCUS AGAIN BEFORE HE CAN READ ANYTHING. THIS CONDITION IS STILL ONGOING AS OF TODAY (5/4/21). HE SAID HE NEVER NEEDED READING GLASSES BEFORE. WE ADVISED HIM TO SEE EITHER TRY READING GLASSES IF THAT WILL HELP HIM OR IF NOT, HE CAN CONSULT WITH AN EYE DOCTOR FOR THIS REASON

After the initial dose, I noticed my tinnitus worsened -- higher pitch and louder. It improved before the second dose. After the second dose, it again immediately worsened and I have noticeably worse tinnitus still. I now have severe tinnitus. The effects came on quickly.

BLURRED VISION - I've perfect mid-range and long-distance vision and everything is now blurry. All the other side effects have subsided except the blurred vision. Other Symptoms that have since subsided: headache, chills, upset stomach, muscle aches

The same night as my second injection I woke up drenched in sweat. The following day (Sunday)I felt very rough but by Monday was feeling well apart from having very sore gums that hurt when I brushed my teeth. By the following day (Tuesday) my lips, and tip of the tongue had become numb and tingly as if I had returned from the dentist and had novocaine administered the effects of which had not fully worn off. The front of my mouth has stopped producing saliva so I get cotton mouth a lot and my teeth stick to the inside of my gums at the front if I do not constantly move my tongue around.

Patient received his first dose of COVID-19 Moderna vaccine from a LPH clinic. This was a County Public Health event. Tim's administration was unremarkable and RN was the vaccinator. Patient went home to develop a sever headache and lost of peripheral vision. The loss of vision lasted two weeks and was so significant that he thought he had developed the COVID-19 illness and sought evaluation from Dr. He tested negative for COVID-19 and Dr. felt it was his immune system's response to the vaccine, given his history of migraines. He reported this to LPH today, 5/14/21 when he arrived for his 2nd dose. He has discussed dose #2 with his MD. He was counseled and feels the risk of COVID and neurological effects is too great and wants to proceed with dose #2. He is aware this VAERS was submitted and open to any contact. RN PHN

05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT FELT FINE AFTER THE CLINIC BUT LATER AT HOME STARTED FEELING SICK. PATIENT WAITED UNTIL SUNDAY 5/9/21 TO SEEK MEDICAL ATTENTION AT THE HOSPITAL AND WAS ADMITTED FOR STROKE. PATIENT REPORTED LOSS OF VISION IN ONE EYE. THE HOSPITAL NEUROLOGIST TOLD PATIENT THAT IT WAS DUE TO CLOTS IN HIS EYE. PATIENT IS WATING TO SEE AN OPTHALMALOGIST ABOUT THE EYE CLOTS. PATIENT HAS NOT BEEN BACK TO WORK SINCE FEELING SICK. EMPLOYER STATES HAS NOT RECEIVED ANY NOTICE FROM DOCTOR STATING ANY CAUSE OR RELATION TO VACCINE

Tinnitus that started the same day or next day after the vaccine was given and continued for two weeks.

(Moderna COVID?19 Vaccine EUA) Chills, sweats, nausea, and migraine headaches. Also, respiratory congestion and cough. Symptoms started 24 hours after vaccination (not all at once) and persisted for 9 days total. Loss of appetite and loss of taste for certain foods. I lost 8 lbs. during this period.

Tinnitus and loss of hearing in my left ear. After the first shot I lost partial hearing in my left ear: thought it was wax The second shot caused the tinnitus and loss of hearing in the left ear.

Severe dental pain (9/10) beginning several days after vaccination, affecting upper left and lower right molars. Molar on lower right turned out to have an abcess, and required a root canal and crown. Mild tooth ache on upper left continues at low level. Immediate post vaccine course after 1st injection complicated by swollen and painful (injection) arm; after second vaccination - course complicated by pain in injection arm, fever to 104, myalgia and fatigue.

Two weeks after the shot, light dry cough. cough turned into shortness of breath. Left foot started to burn. Ringing in both ears. Breathing is better now, but not normal. Left foot still burns and ringing in both ears. Sparkles in eyes/may not be related. Hospital said could not say if symptoms were vaccine related. I have a kidney problem, the Doctor at hosptial said to follow up with primary care physician

Approximately 20 hours after the injection I was sick with much fatigue and body aches. At about 30 hours had fever, 102 temp with face and injection sites hot to touch. Fatigue and aches lasted the next 24 hours. I also developed about 4 cankers sores in my mouth within about 30 to 48 hours and they continue today 6/27 at 1400 hours. Also have fatigue and aches but less severe than the 24-48 hours following the vaccine.

Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient experienced blurred vision for 6-7 hours after vaccine administration.

Approximately 04/27/21, I started getting a sharp pain above my right ear, eye, forehead and right temple. I went to Urgent Care and was diagnosed with Shingles. The sores began to irritate my right eye, so I saw my Eye Dr who also diagnosed me with Shingles. ( My R eye and vision all checked out ok ). Except for Shingles. I then saw my Primary Care Dr. who also diagnosed me with shingles. All three doctors diagnosed Shingles due to the possibility of a low immune system caused by the vaccine. To this date, I am still suffering from the nerve pain above my right eye and forehead area. I broke out twice within this period which is unusual.

So, that was a Monday that I got the shot and come Saturday, when I was trying to drive, I was getting double vision. SO that is four days later, I was just seeing double so that day I just did not know what was going on so I just waited. So On Sunday I went to the ER and the DR there did a CAT scan on me and did some bloodwork and did not find anything abnormal. The DR there told me to see an Optometrist and that DR diagnosed my doubled vision as abducens nerve palsy. It did not improve, so he had me go to my PCD and he sent me to a ENT specialist and prescribed me antibiotics. I do not have the date but I saw the ENT Dr and he looked me over, no blood or anything. He also did a scope inside my nose and did not find anything of significance to report. He prescribed me to see another Optician. I saw her and they did an MRI and a lot more blood work there and I got the results from there. So those results showed there was no tumor or anything like that. The optician at UW had me go back to see someone else, who looked me over again recently and said that the best course to take at this time would to wait about 3 months and see if it improves more. It has been about a month right now and it has only approved a little.

tinnitus - wasn't aware of it initially after shot - became more pronounced after a week - hasn't dissipated over time

headache ringing in ears and light sensitivity and one week later redness swelling and itching at injection site.

Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open. Also some nasal drainage and feeling of unwell. Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out. Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here.

Freezing to death, chills, sweating. hurting everywhere so bad, and really bad headache, nausea, chest pain, lowered his blood pressure, sore muscles, extreme tiredness, ambulance picked him up and was in the ER all day giving him fluids, took about 2-3 days before he started feeling better. The whites of his eyes are still red.

Dizzy, lightheaded, severe headache, shaking, freezing cold, profuse sweating, muscle aches, joint pain, tachycardia, minor chest pain, nausea, dehydration with constant thirst, metallic taste in mouth. Took 2 tylenol pm pills, drank water and 7-up. Symptoms were gone 20 hours later except for very sore right arm, neck and back muscles which were completely gone and normal by day 3.

NIGHT AFTER VACCINATION : WOKE UP WITH CHILLS AND HOT SWEATS DAY AFTER: SEVERE FATGIUE , EYES WERE RED

headache radiating to teeth with eyes bulging and blurred vision. muscle aches radiating from shoulder down to the back. Aferbile with chills

Tender two nights after vaccine admin that self resolved. 21 days after, the arm started throbbing and having deltoid spasms. Pain radiated from elbow to skull up To ears. Spasm would come and go. Tingling in forearm also reported. Lasted three or four days and then went away the day before the second shot.

* Lightheaded, achy joints and heavyness night of day two *lightheaded (unstable), tingling (electrodes in my brain day three * lightheaded unstable dizzy with head motions - now to present time * motion of head throws off balance, I have to rest to regain lightheadness (never hand this feeling before * on today 2/17/2021 I went to urgent care , EKG, CAT scan, blood work. it's said that all test are normal large amount of fuild was discovered between ear, never had this before, will seek a specialist opinion

Received at approximately 2:30pm. At just after midnight following vaccine, woke up and had what appeared to be Vertigo/dizziness. This has not completely gone away since onset on 1/21/2021. I began having "floaters" in my vision beginning about 8am following vaccine. This has not gone away. I did have a bout of vertigo in January 2020, that had not reoccurred since that time. I have not had "floaters" prior to the 2nd dose of the vaccine.

approx 5 days after vaccination, pt states he developed itching and swelling around left ear, that then spread left side of arm over the last few days. Lesions were without vesicles or drainage, primarily raised red lesions related to hives. He visited dermatologist who rx'ed antihistamines, benadryl and OTC hydrocortisone. Denies anaphylactic reaction with no SOB, respiratory distress, swelling of tongue, mouth, eyes or lips. As of now, he is no longer itchy but with rash still present. He will have f/u on 3/8 with dermatologist for final opinion about whether he can receive his next vaccine as scheduled on 3/11/21.

Right side face swelling, right eye sore to the touch, dizziness on the first two days. Next day, sharp cramping in different parts of the body at different times lasted about a day and half and a little dizziness. Today, he's doing ok.

Had COVID vaccine on 02.11.21. States the next morning his anxiety was very high. States he did not know who he was. Still experiencing a lot of anxiety at night. Admits to heart palpitations and hard time breathing. Can't sit still. Reports manic episodes and cycles of depression over the course of hours. Patient states it has gotten a tiny bit better. Tried trazodone which helps temporarily. Denies chest pain. Patient states he has no appetite. Palpitations resolved pretty quickly. Shortness of breath is described as tightness that comes with anxiety feeling. Resolves with shoulder massage. Occurring three times per day. Also admits to dry mouth. Patient admits to needing to sleep with multiple pillows or feeling like he had to sit up and couldn't lay down as shortness of breath would get worse. EKG in office on 2/24/21 showed ST-T changes and given symptoms patient was transferred to emergency room via ambulance. Work up in hospital was unremarkable and patient was diagnosed with pericarditis (unknown etiology) and prescribed NSAIDS from ER and discharged. Admission not required. Patient followed up to us as outpatient on 03.02.21. Patient felt much better and had not take motrin for 1 day. COVID testing obtained at this point (unclear why ER did not send it). Patient referred to outpatient cardiology given risk of cardiovascular disease, stress echo, and event monitor.

Client reported being bothered by 'blurry vision' about 25 minutes after receiving the Moderna vaccine, accompanied by feeling dizzy and lightheaded. Speech was normal, grip strength equal and strong. Blood pressure was low (85/58), HR 94. Client drank 12 oz water over 5 minutes, BP improved to 95/60 w/ HR 86 (11:48). Client still c/o blurry vision and light headedness, but was talkative and making jokes. He started to stand (to test his balance) but was still unsteady. Gave him another bottle of water, explaining re: low BP and hydration. Reassessed after an additional 5 minutes (11:53) with BP further improved to 100/62. Denied improvement in vision or lightheadedness. Client sat for 30 more minutes. I attended to another client at 12:00, with another RN monitoring him. When I returned to check on him, she said he did not exhibit any signs of being in distress and got up to leave voluntarily.

Patient complained of tightening of throat and tingling of the lips, stated it feels "similar to a reaction to a bee sting". A doctor was notified, and ordered sublingual Zyrtec be given, 10mg of Zyrtec given sublingually. Symptoms resolved and patient was discharged from clinic.

I had Covid in December, 2020. Test result positive on 12/16, tested 12/15. Symptom's then were- chills, complete body sweats (soaking), fever (spiked to 102F, but would subside quickly), intense body aches and pain, lost taste and smell. All symptom's lasted for apprx 3 weeks, except sense and smell, that took 3 + additional weeks to return to almost pre-covid. I drank pedialyte and cranberry juice, took EmergenC, a daily Multi as well as extra vitamins C and D everyday. For pain a took 6-800 mg of Ibuprofen as needed. Did not lose my appetite.

23 HOURS AFTER VACCINE DEVELOPED LIP SWELLING , BODY PRURITIS, AND BILATERAL BLOTCHY HANDS. ABDOMINAL PERIUMBILICAL PAIN. SYMPTOMS LASTED 12 HOURS. STARTED ON OZEMPIC 7 WEEKS AGO AND HAD SAME ABDOMINAL PAIN 3 WEEKS AGO BUT NONE OF THE OTHER SYMPTOMS. THIS ABDOMINAL PAIN MAY NOT BE RELATED. IMPRESSION: PROBABLE ALLERGY TO MODERNA. PCP WAS NOTIFIED BY VACCINE CLINC. PATIENT ADVISED TO SEE ALLERGIST IF HE CHOOSES TO PROCEED WITH SECOND DOSE OF MODERNA.

fainting, sweating, eyes rolled back, slouched over in chair then perked back up. still complained of dizziness and sweating. called 911 within 1 min of episode and paramedics came to take over. Patient was talking and coherent but sweaty.

Received vaccine, and no reactions. Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye. General soreness around his mouth when he tries to eat or talk a lot. Limited movement of his face do to swelling, difficulty closing his eye, and headache. Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21. Was given corticosteroids for 9 days Prednisone 60 mg. The symptoms are slowly improving but still has the Bell's palsy.

Facial swelling and slight lip swelling and redness to skin which began about 90 minutes after the vaccination. He was seen in an emergency room and treated with diphenhydramine, famotidine and prednisone and discharged on the same. He improved in the ER but reports that he had recurrent facial swelling over the next few days when antihistamine wore off. Resolved after a few days. Seen in the office on 3/18/21 and doing fine off medication.

started having intermittent headache on 03/08/2021 which he describes as dull pressure starting in his frontal sinuses and working the way posteriorly on both sides. They are intermittently present and range from 2?5/10 in severity. No associated photophobia. He has been taking Tylenol at home which provides moderate amount of relief. He saw a provider on 3/15 and was prescribed high-dose Augmentin at that time which he has been taking without improvement. He endorses subjective fevers and chills but his body temperature was 99 F. Mouth ulcers started a few days ago. With that, it became very difficult for him to eat or drink due to excessive pain. He became concerned because he was also on immunosuppression for transplant and ended up coming to the ER for further evaluation where he was admitted. Of note, he was switched from Tacrolimus to Sirolimus 3 days prior to his vaccine 3/20 while inpatient, developed fever of 101. Blood cultures negative. Around time of drug changes and vaccine, patient also had a tooth repair.

I had Covid in November and was told that there was a high probability that I would get sick but was not prepared for this. It is like I am sick all over. Fever, no taste (It all reminds me of cardboard), exhausted, sleeping, no appetite, mild nausea, headache, winded easily

pt states that he developed a headache, sore arm, had fatigue along with body aches and pains. He was dizzy and eyes were very droopy. He woke up next day and his arm is very sore, he is very tired and has a flushed face. Pt feels like his symptoms are improving now.

Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted at least 1 hour). Eventually went away. Then two days later, Tinitus and lethargy similar to past MS symptoms, felt "off".

At midnight on03/27/2021 a ringing started in my right ear. I was unable to sleep the whole night so I can recall the ringing (sounded like someone was ringing a small Christmas bell in my ear) it was intermittent, starting and stopping the whole night. The next day 03/27/2021 it became more and more constant. Today is 03/28/2021 and it?s constant now and in both ears

Memory problems, some increase in headaches. Also issues with balance and bumping into walls. Still to not have smell or taste. These symptoms have continued for 3 months after vaccine. Initially after vaccine became acutely ill with high fevers 102-104 f. Also became severely weak with severe muscle aches and severe headaches. This lasted for 7 days with worst at the beginning. Then I have had the memory loss and equilibrium and loss of ability to spell simples words that I had no issues with before. I have had these symptoms for 3 months. I thought it would all get better but it has not. I thought I better let you know these problems. I did not want to but because they have continued I thought I better tell you.

Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.

I have a prior history of occasional minor tinnitus. A few weeks after the 2nd Moderna vaccine, the tinnitus has become louder and now it is constant. I don't know if it's related to the vaccine, but it's gotten much worse over the past two weeks.

Pt complaint of cough, Loss of smell taste and bilateral ankle swelling. Pt was advised to isolate, get tested and seek medical care for swollen ankle

Ringing in one ear a few minutes after injection. Fatigue and slight nausea first night and next day but is now gone. Tinnitus continued and is now a bit worse today.

When called to follow up regarding missed second dose appointment, patient stated he saw he physician "a couple of weeks ago" regarding tinnitis following his first dose and decided not to get the second dose.

100 degree temperature, sore throat, chills, body ache, head ache, ring in ears, and extreme fatigue.

Development of bilateral Tinnitus and decreased hearing. (Ears feel and act as if they have water in them), Hearing decreased approx 50% bilaterally.

Received second Moderna vaccine on 3/12/21, and on 4/1 awoken with intense pressure in ears. Contacted physician who prescribed antibiotics, and hydrocortisone ear drops on 4/2.. The pain intensified along with constant loud ringing in the ears. Unable to sleep and with pain in both ears along with sensitivity to sounds increased. Finally went to ER on 4/5. Was diagnosed with Tinnitus. This problem with the intense and constant ringing in both ears has occurred after the second dose of the Modera vaccine.

PATIENT COMPLAINED OF DOUBLE VISION FOR 1 HOUR ON MONDAY. EPISODE RESOLVED AND NO FURTHER ISSUES REPORTED

61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became. He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight". He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities. He had no trouble with his vision or cognition. He had no trouble with the previous vaccine. Presently the symptoms are resolving. Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23

Patient came in for first dose of Moderna vaccine. He reported no previous allergic reactions in the past. Once the patient received a vaccine, he was instructed to wait for 15 minutes. Close to the 15 minute mark, patient described his arm and face feeling "hot and a bit heavy" on the side he received the vaccine. Patient reported no swelling of the throat or face area. He had no trouble breathing. Patient did report he was experiencing some dry mouth. I assessed the patient for any rash, redness or hives around his face, arm and chest area. Patient was told to lie down on the floor and we elevated his legs. At this point, pt was still reporting no trouble breathing, but still felt hot around his arm, face, and chest area. An ice pack was placed around his face and neck which helped a bit. Patient kept describing a sensation of tightness and heaviness around his left arm and fingers . We continued to observe the patient for another 30 minutes till paramedics arrived to take the patient to a nearby hospital.

Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, injection site considerably more painful/tender than with first dose, inability to sleep all night, a bit light headed, weak and balance problems while walking, dry mouth After roughly 6 hours, most symptoms gone or greatly improved. Still had some headache and body aches, felt mildly feverish, injection site still painful, fatigue due to lack of sleept

Experienced Tinnitus in both ears. First noticed on Tuesday, February 23rd. By a week later the Tinnitus was only in my left ear. Consulted with my General Practitioner prior to second vaccine dose. The doctor on Tuesday, A that I receive the second dose. Received the second vaccine dose on March 20th, one month after the first. The Tinnitus persisted after the second dose. Referred me to an ENT Specialist. There has still been no improvement in the Tinnitus!

Patient developed vision changes, dizziness, and right sided weakness after receiving 1st dose of vaccine. Patients BP was measured at 230/118, HR: 58, pOx: 99% on RA. Patient determined to be experiencing hypertensive emergency and emergency services were called in order to r/o possible stroke.

patient c/o mouth dryness, slight headache, and slight upset stomach. Provided water to patient. patient seen by Dr. Monitored patient for additional 30 minutes. After 30 minute observation patient felt better and no longer had symptoms. Patient was sent home and was advised to eat breakfast. patient verbalized understood and agreed.

During 15 wait, after inoculation, I noticed some muffled hearing in my left ear, that I wrote off to head congestion. Later that evening, I noticed the effect was sustained. Woke up the next morning, 4/27, with some ringing in my left ear, and muffled hearing. Worked on computer all day with no improvement, and no noticeable change. Decided to report what may be a side effect. About 5 years ago, I had Ramsay Hunt Syndrome, with left side of face paralyzed, and very painful aural nerve attack in left ear, and loss of sense of sweet taste. After about 8 weeks I had recovered 90%, or more. No problems since then, as my sweet taste slowly returned.

Patient presented to the Emergency department on 4/25/21 with complaints about a rash on the forehead which started out as small blisters and is now become open blisters and some scabbing. Started on 4/23/21 per patient report to the ED provider. On 4/25/21 he is having swelling of his left eye and was concerned about ophthalmologic involvement, denies any foreign body sensation or pain, just can't keep his eyelids open. Patient stated had received the Covid vaccine several days before this started (second shot on 4/21/21)

Tinnitus (ringing in the ears), not sure if it comes and goes or just when occupied I do not hear it. Only other symptom was sore arm after each injection. Was only tired after the second shot.

Tinnitus. I did not have tinnitus prior to the vaccine. Two days later it started and it has been more than six weeks - it's still going and not showing any signs of improvement.

extreme fatigue leading to frequent sleep day and night for 2 full days, lethargic, joint pains, chills, metallic taste, mild cough, no fever - some improvement with paracetamol 500mg QID. Metallic taste remains to date (5/4/21), though improved. I am a physician, if not i would have panicked and gone to the ER.

Patient developed a loss of taste about 5 days after vaccine as well as headache and cough. He was tested for covid-19 and was negative. We prescribed a short course of steroids. All symptoms cleared up besides loss of taste which patient states has only returned to about 50%.

Additional History:. 61 yo M with a PMH HTN and HLD presents to the office with a mod-severe red itchy bumpy blistering rash that has persisted x 1 wk. Pt states he first noticed the rash on his right insole of his foot on 3/17 and over the course of the next few days the rash spread to both feet and got more red with large blisters forming and opening up. He went to the ER 3/20 where he was diagnosed with folliculitis and cellulitis and placed on PO doxycycline and topical Mupirocin. He has been using the meds as prescribed since 3/20. Pt presents to the clinic because the rash has persisted and the medications prescribed have not helped. Pt reports the blisters are now opening up and he's worried about them becoming infected. His feet are also swelling. Pt states that there are no relieving factors identified yet, but notes that water/sweating seems to make the rash worse.He does have a PCP but has not been seen anywhere other that the ER over the weekend. Of note, Pt states that he received his last Moderna vaccination 1/28/21 and had some rashes and swelling of his eyelid, then received his shingles vaccine "a few weeks later" and then the rash on his feet started about a month after receiving the shingles vaccine.1 . Toe rash location details: (all toes involved anterior/posteriorly B feet) Patient presents with rash, described as red, pale, tender, bumpy, itchy and weeping. The rash is located in skin folds, on the dorsum of both feet, on the soles, on the sun-exposed areas, on the extensor surfaces, on the flexural surfaces and in an asymmetric distribution on the toe(s). Associated symptoms include no abdominal pain, no arthralgias, no cough, no diarrhea, no fatigue, no fever, no headache, no lightheadedness, no malaise, no myalgias, no nail changes, no nausea, no neck stiffness, no shortness of breath, no sore throat, no swollen glands, no urethral discharge and no vaginal discharge. Onset was sudden 1 week(s) ago. The rash is spreading, becoming more red and becoming more pruritic. Changes have occurred over the last 7 day(s). Symptoms are moderate in severity. Precipitating and/or exacerbating factors include 2nd COVID 19 vaccine end of January, Shingles vaccine mid-February, but not carpeting, not exacerbated by chemical exposure, not exacerbated by cold exposure, not exacerbated by food triggers, not exacerbated by heat exposure, not exacerbated by humidity, not exacerbated by exposure to illness, not exacerbated by insect bite, not exacerbated by medication, not exacerbated by personal care products, no contact with pets, not soaps/detergents, not exacerbated by stress, not exacerbated by sun exposure and not exacerbated by tick bite. no recent contact with poison plants No relieving factors are noted. PE normal except for: Skin: (diffuse vesicular rash in various stages of eruption on B feet, not following dermatomal distribution. Rash is fluid filled vesicles with scattered bullae on bilateral anterior/posterior foot, extending onto soles, covering all parts of B toes, and spreading onto L calf area. There are several open bullae to R sole without evidence of active infection present. Sensation is intact to bilateral feet without current hypersensitivity or tenderness. Diffuse excoriation present without evidence of infection. NV intact) On exam, the skin was warm, has rash and was not diaphoresis. has drainage Rash(s): vesicular rash that was erythematous, that was becoming confluent, that blanched with pressure, that was excoriated, that did not have fine scales, that did not have thick scales, that had sharply demarcated borders and that was weeping on the lower extremities. Assessment 1. Dyshidrotic eczema (L30.1) Plan Calamine lotion may be used for itching.; Dermatology Referral Physician Referral See Referral Comment! Done: 24Mar2021 Ordered; For: Dyshidrotic eczema; Ordered By: Dr. Performed: Due: 07Apr2021 Laterality 1 : Bilateral Body Part 1 : Foot Reason for referral : Evaluate and Treat Plan: take otc antihistamine during the day, may start otc benadryl at night as needed. 4 packets Loratadine provided in office. Start otc barrier cream such as aquapor or eucerin cream. May use otc calamine lotion for itching as needed. 6 packets Calagel (topical diphenhydramine) provided to patient and applied in office. Ed on emergent s/s, pt verbalized understanding. If you experience and difficulty breathing or swelling of the face/lips please go to te ER. Please follow up with PCP for further eval/management of potential post-vaccine immune mediated reaction. Pt educated on reporting reaction to VAERS.hhs.gov website in order to help identify potential side effects with current COVID 19 vaccines. Referred to dermatology for new onset eczema to rule out alternate diagnoses and determine potential contributing factors.

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Rash on forearms started 05/06/2021, lasted 3 days, then went away, R eye got red & sore x3 days, then resolved; L eye, neck & face are now affected, pt attributes sx to 2nd COVID vaccine, has been using Sarna topical & oral Benadryl with good results

The first Moderna shot on 4/6/2021 was fine with no reaction. The second Moderna shot on 5/5/2021...the arm one week later was red/sore... By the 11th of May, I had chills, joints were sore, slight fever, fatique....then within days... a head ache from my forehead that wrapped around down my left side of face (which was quite swollen under my eye (red) as well as cheek and painful to my left ear and back of head. This has lasted since the llth of May.. Went to doctor (primary) on the 18th of May and he took notes and gave me the antibiotic Azithromycin 250 mg. Today, the 20th, when I woke up my eye was still looking like it was pushed back. When I look in the m;irror, one eye looks bigger than the other and one looks like is has receded in my face..

Loss my hearing in left ear; Light ringing/buzzing in right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss my hearing in left ear) in a 61-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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS UNILATERAL (Loss my hearing in left ear) (seriousness criterion medically significant) and TINNITUS (Light ringing/buzzing in right ear). At the time of the report, DEAFNESS UNILATERAL (Loss my hearing in left ear) and TINNITUS (Light ringing/buzzing in right ear) 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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-118211 (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.

About 1month afterward starting having facial swelling and tingling from jaw/lips to eyeball on the right side, with eyeball pressue. I also have tingling, numbness, burning to both lower legs from the knee down to the feet. I can have burning and sometimes my feet are freezing at the same time. Lower back pain also. The burning and sensations have gone on for awhile now. Also tinnittis which is currently off the charts with pain, lost 30 lbs as I get so ill from the noise I cannot eat---have nausea when the symptoms are to bad.

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-141559 (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.

Patient presented to emergency department around 7:00pm with signs and symptoms consistent with stoke. In the drive to the hospital, patient could not speak, move the right side of his body, and was drooling. Patient was immediately taken for a head CT and was diagnosed with a massive hemorrhagic stroke. The on call neurosurgeon wall called in the perform and emergency craniotomy. Patient underwent craniotomy and neurosurgeon was unable to find source or cause of bleed. Patient was sent to ICU for recovery. Patient was on a ventilator and receiving hypertonic saline for brain swelling. Patient never regained mobility in right side of body or speech. Patient tried rehabilitation, but patient's brain continued to swell with increase neuro-cognitive decline. Neurosurgeon was unable to determine cause of recurring edema and patient was not a candidate for repeat surgery. Patient failed rehab qualifications due to repeat brain swelling and was eventually placed in hospice care to pass.

Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.

Day 1 through 12-None. Day 12 fatigue and developed skin pain on left side of face and ear. Pain progressed to scalp and left side of face. Day 14 went to urgent care and Dx shingles. Doctors notes-"Shingles v trigeminal neuralgia?" . Rx VALTREX. No relief and moderate to severe pain extended to other side of face and scalp. Day 16 went back to urgent care. Rash on forehead and no blisters. Rash is maculopapular. Not shingles and discontinue VALTREX. Rx Prednisone and Cetirizine (oral). Resolved after 5 days. Following up with allergist on 6/7/21 for advice on second dose.

Timeline was exactly the same as that of the first dose. Day one, nothing, day 2 very sore arm, days 3,4,5 nothing. Day 6 reaction. After the first dose I developed high fever, body aches and lethargy on the sixth day and it lasted several days. On the second dose, it followed the same timeline, but on day 6 my lips and cheeks swelled and kept swelling for 7 hours even though I was admitted to the hospital emergency room within the first hour and they gave me 4 drugs by IV to counteract the swelling. The doctors told me I was having an allergic reaction, but I had not eaten anything out of the ordinary and I've never had an allergic reaction of any kind. They were reluctant to admit that it was a Covid vaccine reaction, but they couldn't find any other answer and I knew it was... the timing was too coincidental. Also, the drugs they gave did nothing and it took several days for my facial swelling to diminish.

Immediately after the vaccination nothing, but 2 hours later I became aware of a ringing sensation in both of my ears. This is still ongoing to this day. I let a week go by and it was still there, I reported it to my doctor through a video chat. My doctor suggested to let it go and see what happens and contact him after I had my second vaccine and 2 weeks after that. I got back in touch with him and told him it hadn't gone away. He examined me and referred me to an audiologist. Audiologist had seen similar symptoms in other patients. It wasn't affecting the way I hold my conversations, I can watch TV, it does not get in the way. The audiologist stated there was a possibility it could disappear or never go away.

Sudden significant blurring of right eye. Loss of depth perception and daily headaches. Condition has not resolved itself.

I have developed loud, high pitched ringing in both of my ears which is continuous (tinnitus). At first I did not connect it with the vaccine but I?ve since been told by the health professional at hospital that seem tinnitus patients for their network, that he has seen around 15 people who recently took the Moderna or Phizer Covid vaccines that have reported the same thing

2 hours after second vaccine developed headache. 4 hours after vaccination developed double vision. Was seen in Emergency Department. No other symptoms such as nausea, vomiting, fatigue, fever, focal weakness, or confusion. Headaches intermittent on left side near orbit. Resolved about 6/7/2021. Evaluated by ophthalmologist, neuro-ophthalmologist and neurologist. Thought to be peripheral nerve inflammation C-8 Still double vision 6/21/2021, mostly affects near vision which is difficult for his work and leisure.

Twenty fours after the shot I had flu-like symptoms which lasted for twelve hours. Three weeks after the vaccine I started to have extreme symptoms of Tinnitus which is constant. It is much worse than what I have experienced before. My hearing is also affected in my left year. The hearing loss started before the Tinnitus. The Tinnitus has woken me up at night and it comes in waves in both ears. It has been four weeks and it has not improved. I have had Tinnitus in the past since a car accident and is is usually manageable. It happens more often and is more severe. I plan to see an ENT to consult on the issue.

The day after the vaccine he started to get an headache, brain fog, and dizziness. He also lost his sense of smell and taste. Went to see his doctor stated they increased his Effexor. They tried giving him Atarax but it didn't work also gave him supplements L-theanine 200 ml, Ashwagandha 200ml and Magnesium Glycinate 300ml said it helped a little.

Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few days of ok and then walking up my 3 stairs to my house, i got dizzy, my eyes went black and white abd squiggly, instantly massive headache, and stomach aches, my bones hurt thruout my torso... ongoing headaches, Tired all the time, my eyes are blurry alot, Very shaky all the time, loss of appitite, brain fog, back aches

Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bipolar disorder. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient reported that the adverse events started immediately after the first shot. Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered. This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.

severe ringing in both ears. started 45 mins after injection. also, cold sweat for approx 5 mins after injection. to date ringing still there and very severe.

1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness 4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches 7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus Note, items 2, 8 and 9 remain

around 15 mins. post injection c/o "tongue felt numb". Was medicated immediately with 50mg of Benadryl and within 5 minutes client reported that his tongue sensation was normal again. Was observed for an additional 30 minutes-vital signs stable and released to f/u with PCP. Called client later in the day and reported he felt "fine".

At work 24 hours after vaccine administration - Lip swelling, jaw swelling increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.

Starts with blurred vision, followed by headaches. Treatment; 600mg Advil Headaches last for about 24hrs

About eight hours after the injection, I noticed some hearing impairment in my left ear. Sounds are muffled, almost as if I have water trapped in the ear canal. I noticed this right before I went to bed, and the hearing loss is still present and similar in magnitude this morning. There is no pain, and the hearing in my right ear seems to be normal, although I can't rule out some slight loss on that side. Aside from a slightly sore arm at the injection site, I've had no other side effects (e.g., no fever) from the vaccination.

Fatigued. Retired to sleep at 2/2/2021 @ 1800 hrs. Woke at 2330 hours experiencing pain in right arm, chills and RINGING IN EARS. The ringing in ears lasted 2 days. Bilateral ear ringing. Increased dramatically. Note: In 12/2017 he experienced ringing of ears. 2020 decreased substantially to mild level.

He received the vaccine on Thursday. The left nostril started running, then his eye started getting vision issues on Saturday. He went to sleep and thought it would be better. On Sunday morning he could not stand the sunlight at all, and pain on top of the eye. He went to the ER and they called the eye doctor in. He didn't know what was going on, had blood work done. He told him to FU with his doctor. Gave him eye drops, Ibuprofen and eye cream to go into the eye. He is feeling better today, but when the light hits it a certain way the pain is bad, but it clears. In the morning he has to get used to the sunlight. His eye is red. He is to FU with his PCP.

Weakness after exercising 5 hours after vaccination. Chills while sleeping Saturday evening. Sore arm, head ache in early hour of Sunday. Lost sense of smell and taste while eating breakfast on Sunday morning ( 8:00 AM) Mild headache for the remaining of the day, no taste or smell during lunch (2:00 PM). Before going to bed (10:00PM) regain faint sense of smell, took 2 Tylenol. Woke up fine on Monday morning, smell and taste is back to normal.

Patient received Moderna Vaccine yesterday 03/03/2021 and woke this morning 03/04/2021 with swollen eye. Patient called the hospital and was advised to go to ER. Patient took Benadryl and called the health department to notify us of reaction Patient was advised to follow up with ER if swelling continues and if difficult breathing or tongue swelling occurs.

Swollen lips, slight rash on my face 50 mg Benadryl upon noticing the swelling around 8:30 pm 50 mg Benadryl at 4:30 M the next morning 9:45 am lips are still swollen

Extreme fatigue, swollen lymph node on left side of neck, sore jaw, sore nasal cavity, headache. No treatment and still recovering. Feeling a little better each day.

Delayed (8 day delay) allergic reaction. Swollen, inflamed ears -- both upper portions of external ear (helix, anti-helix, triangular fossa). Isolated clustering of small bumps and blistering on hands and feet and systemic bumps and blisters on torso, arms, and legs. Receiving hydroxyzine HCL, topical cream for itching. Day 8 after vaccine itching at vaccine site, hands and feet and inflamed ears. Each day after the itching symptoms are easing, although the blistering began day 10 after vaccine.

Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue

The patient reported feeling a rush of blood to his head and then head pain localized in his forehead about 10-15 minutes after receiving the vaccine which lasted for about 5 minutes. He then reported having a strange taste in his mouth about 15-20 minutes after receiving the vaccine which lasted for 10-15 minutes. All of these reactions resolved on their own by about 30 minutes after the vaccine before he left the facility.

i have a constant "Fuzzy Buzzing " in my ears that i have never had before. i have not seen a doctor yet.

Patient reports feeling a little dizzy, pressure on his head, ringing in his right ear. Felt better after a few minutes. Cleared by EMS

Itching in 10 minutes followed by reddening of skin and red splotches, extreme headaches, body aches, fever, sweats, chills, cough, nausau, swelling of lymphs nodes in chest and groin, shortness of breath, and light sensitivity.

Loss of hearing in L ear, tinnitus in L ear, Fullness in L ear, Episode of Vertigo resulting in an emergency Room visit.

Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,

Starting on 03/23/2021 I started experiencing ringing and some pressure in both ears. The ringing is constant and a 6 on a scale of 1-10. I have never experienced constant ringing (Tinnitus) before. I am very healthy with no medical conditions.

9-10 minutes after the injection the mucous membraines in my mouth (including tongue and lips) went totally dry and tonue and lips started tingling/buzzing and went numb. No productin of saliva was happening making swallowing difficult. Additionally eyes felt dry/itchy. Tongue and lips also felt swollen but didn't appear swollen. I was able to work up a slight amount of saliva after few minutes and swallow with moderate difficulty. Purchased a bottle of water and had no difficulty swallowing that. Did not seek assistance as my heart rate was normal, no difficulty breathing, no outbreak of hives or swolllen face/extremeities. Departed store at 25 min. as symptoms get worse. Symptoms gradually abated by 12 hour mark.

Fever 102.3, muscle pains, and blurred vision for 3 days, which has not been reported among side effects of this vaccine by CDC

Had the Moderna vaccine 4-7 days later experienced Tinnitus. Feels a little pressure and occasionally when popped ears felt like had temporary relief of the pressure and tinnitus. Warm compress and pressure with fingers massaging at base of skull and gave relief until fall asleep. Both the tinnitus and the pressure seemed to improve with the heat and pressure, It is constant and does not seem to be drowned out by other sounds. Hearing is good. Tried IBU for a week and did not help much. Was taking 4 doses/day and no improvement, one incidence of standing at the counter and seemed like floor moved. It passed quickly. Other than this no other vertigo or lightheadenes.

Developed Tinnitus 1 day after Moderna vaccine shot. Ringing in Left Ear began March 17, vaccinated on 16th.

About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up. Started seeing stars, vision narrowing. I laid down on the floor, and it seemed like I was having a hard time breathing. The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down. I felt like I was passing out. The pharmacist checked my BP and it was like 80 something. He felt I was having an allergic reaction so gave me a show with an Eppy pen. They called paramedics. I started feeling better but paramedics said I should still go to ER so ambulance took me to ER. They ran blood tests, EKG, and chest Xray. After a few hours they released me. They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it

I was experiencing mild tinnitus off and on prior to getting my first shot. Like three or four times a week in the afternoons and evenings. The day after I got my first shot (Moderna), the tinnitus was immediately noticeable while waking up that day and has been constant ever since. It is currently barely tolerable but I'm having second thoughts about getting the second dose. As best I can tell, there is no treatment available for tinnitus.

He has had tinnitus for years, had the second dose of vaccine and 10 days later has the worst tinnitus in his right ear. The tinnitus in his left ear is normal.(for him). He says there's lots of pressure. He spent the day outside doing yard work and has hay fever symptoms (runny nose, sinus pressure. He says he feels pressure in the right ear as well as ramped up tinnitus.

Sore arm, occasional burning sensation in arm, fever (102.5 °F), stiff joints, teeth sensitivity - 9th and 10th April

pt says he felt a warming sensation in his shoulder and his head after taking the vax. He woke up next day he had some dizziness, fatigue, headache, and had intensified the ringing in his ears. He wears a hearing aid to help mask the Tinnitus noise in his right ear. He says the noise has increased since having this 2nd dose. Pt says his Tinnitus normally ranges about a 4 but now it is about a 7 out of 10.

Approximately 36 hours after shot experienced dizziness and nauseousness. After throwing up, experienced tinnitus which has not subsided.

Lost hearing in the left ear; Tinnitus (ringing in the left ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing in the left ear) in a 62-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 (No reported medical history). Concomitant products included LOSARTAN, AMOXICILLIN and PREDNISONE for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Tinnitus (ringing in the left ear)). On an unknown date, the patient experienced DEAFNESS (Lost hearing in the left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Lost hearing in the left ear) and TINNITUS (Tinnitus (ringing in the left ear)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) Hearing loss. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was taking other unspecified concomitant medications. On an unknown date, the patient went to an urgent care ear throat specialist with a chief complaint of tinnitus and had a hearing test. The patient was diagnosed with hearing loss in the left ear and was given a steroid prescription. Based on the current available information and the 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 the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Patient received his second dose of the moderna vaccine 3/30, and then at 5:30 pm the same day suffered vision loss in left eye. 62YM with history of carotid art stenosis who reports he was at a bar drinking beer with some friends, when he noted decreased vision in his left eye, like a graying out of his vision. It was painless. Went home and it did not improve so he came to the ER. Loss of vision occurred around 5:30 PM 3/30. He was evaluated in the ER by ophthalmology, who performed a dilated eye exam and diagnosed the patient with an acute central retinal artery occlusion, and performed an anterior chamber paracentesis to relieve pressure. Patient had improvement in his vision over the next 24-48 hours, but has remaining deficits.

Patient woke up the morning of 04/13/21 and explained to his wife that he felt "foggy" mentally. He went about his morning chores on the farm. He came inside to sit in his recliner with his feet elevated for almost an hour. At approximately 9:40 am, his wife observed that patient suddenly stiffened without warning and cried out. His arms stretched over his head in the chair and his legs stiffened like a board. His body was visibly contracted. He continued to cry out. His eyes were closed, he was salivating, and his forehead was sweating. His wife watched him move his arms suddenly to his lap, however, his fists were clenched tight. She tried to get his attention by calling to him. She noticed his lips were turning blue. She continued shaking him, shouting and then slapped him. Patient did not respond. She called 911. After 7 minutes, he finally relaxed some and started snoring loudly in the chair. He continued sleeping soundly for about 10 minutes while she waited for EMS to arrive. The wife did elevate his head , as she was told by 911 to do so. She was not able to wake him up during this time period. When the EMS arrived, he was just starting to move. They got him up to stand and he was able to verbalize his need to go to the restroom. They arrived at the hospital at approximately 10:25 am and was released after testing at approximately 2:30 pm.

I personally began developing left eye symptoms (eye pain, redness, decreased vision and seeing halos around lights in my left eye only) on February 21 and was subsequently diagnosed with pretty severe, acute left eye anterior uveitis on February 23. (Thankfully, it appears to have fully resolved with a course of ocular steroid eyedrops.) I received my initial Moderna vaccine on January 4, with my second dose on January 27. I have never had anterior uveitis before, and of course I have no idea if it is related to my vaccination. I am at increased risk for anterior uveitis as I have psoriasis and I am HLA B27 positive.

he received Moderna vaccine on 03/15/2021 and on 04/13/2021. On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911. Per neurology consult 4/15 - "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something. He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words." Tm 103.4. On exam 4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements. + headache. Keppra and / or mirapex, then ativan later, seemed to help. Symptoms had completely resolved by 4/16/21.

Headache Joint pain Back pain Eye pain Fever shaking chills Fatigue Tiredness After a week tiredness still present and moderate fatigue

Patient reports he started experiencing ringing in his ears within 4-5 hours after his first dose of the Moderna COVID19 vaccine. He was seen by Medical Center for evaluation but no significant findings were reported. Patient did experience mild tinnitus prior to receiving his first dose of the COVID19 vaccine.

After chewing a few minutes, the back right lower side of my tongue has an almost fatigue feeling of muscle pain and I'm too tired to keep chewing.

PT EXPERIENCE DIZZINESS AND BLURRED VISIONAPPROXIMATELY 20 MINUTES POST IMMUNIZATION, TOOK PT BLOOD PRESSURE AND GLUCOSE READING. PT REMAINED AT PHARMACY FOR ABOUT 45 MINUTES UNDER OBSERVATION. HE FELT BETTER AND LEFT PHARMACY

Patient complained of dizziness and ringing in his ears 30 minutes after 2nd dose of Moderna. A doctor on site evaluated the patient and he was observed for 30 minutes and discharged when symptoms resolved. Vital signs stable.

Received the second Moderna shot on 4-22-21 at 5:00pm. Noticed the next day around noon that my sense of taste and smell were greatly diminished. Food that had a strong taste and smell came across as weak or had no taste. I could not smell strong scents around the house ( hand soaps ) unless I held it up to my noise.

Severe stabbing pain in the head ,jaws,teeth, dizziness, profuse sweating, feeling like your burning up,pain in the joints, toes,fingers,still having stabbing pain through the temples 10 days after the last vaccination, nausea,severe constipation,never before,pain in the spine, feel fine for 5 minutes then suddenly feel like you've been hit by a truck!feels like you can't think clearly!

Bleeding Gums, Rash, fatigued, shortness of breath, random joint pain, fever, chills, brain fog, electric shock in arms, left arm weakness. 2 emergency rooms, 1 walk in medical center, 1 doctor visit, cardiologist, rheumatologist. Extensive blood work at both ER's and Doctors, x-rays, EXG, cat scan. Yesterday received cortisone shot left arm. Presently on prednisone 2o mg 2x, hydroxyzine 25mg 2x bed, gabapentin 100 mgg 3x.

By 14:00 on 4/30/2021 my body started aching all over. by 20:00 the pain was severe, even the arches of my feet hurt. I had taken acetaminophen by 18:00 and again at 24:00. Much to no avail. At 06:00 the pain was pretty severe yet and acetaminophen was not cutting it. I had some hydrocodone from a previous injury still in my medicine cabinet, so I took one of them. It made a big difference. By 08:00 most of the symptoms had diminished. I didn't take anything else until 17:00. By then my left arm was really hurting. By 21:00 the pain was all the way down my arm and up into my neck and jaw. I took another hydrocodone. The pain was still pretty severe at 22:30 so I took 2 Ibuprofen. my pain had diminished enough to get to sleep by 23:30. When I work up this morning my pain was localized to just around the injection site .

Possible breakthrough COVID infection. The patient tested positive, asymptomatically, on 5/3/2021. He received two doses of the COVID vaccine on 3/11/21 and 4/8/21. He states that members of his household tested positive for COVID 6 weeks prior to 5/3/21 and he experienced anosmia and sore throat at that time but never got tested to confirm if he had COVID.

Symptoms started on day 7 After first vaccination. Symptoms included: headache which continued for 21 days, dizziness, blurred vision, light sensory issues, imbalance, night sweats, and tinnitus. Symptoms mostly resolve themselves In 21 days with the exception of tinnitus

Patient previously suffered from Tinnitus. Within 24 hours after receiving Moderna shot, Tinnitus grew markedly worse and has not subsided or returned to the pre-vaccine level. This side effect was NEVER disclosed to the patient. Had patient known this, he would NEVER have gotten the Covid-19 vaccine because living with heightened Tinnitus is unbearable.

some 11 weeks from 2nd injection, painful, half dozen canker sores broke out inside lips, lips purple and swollen, sensitive tongue. swished with warm salt water, took4K mg Lysine for four days to

After receiving the maderna vaccine two weeks ago , I have notice that I now experience outdoor allergies that I never had before. I have itchy eyes and running noses when outside, when inside I seem to have no side effects.

Woke up with head-spinning dizziness the first night the symptoms started. Since then I've had regular headaches and an ongoing sense of subtle lightheadedness. The dizziness returns if I move my head too drastically, particularly if I lie down quickly in certain directions. If I am careful through the day I am not dizzy but there's the lightheadedness. Existing tinnitus also seems aggravated.

RN administered Moderna 0.5ml vaccine IM into patient left deltoid at 8:00am. At 8:20am, patient reported he had a 'sharp pain going down the left side of his neck into his left pain.' At 08:30am, pt stated that the root of his mouth was tingling and this tongue. Patient was able to speak full sentences and denied any shortness of breath. Provider evaluated patient, due to tingling in root of mouth and tongue, provider verbalized to administered an EPI pen. EPI pen was administered at 08:43am and EMS was called due to office policy. Patient was transported via EMS to hospital.

After my first shot on March 10, I had minor soreness around the injection site and fatigue the day following the injection. After my second shot on April 6, I had minor soreness around the injection site, fatigue which lasted two days and low grade fever which I treated with one 400mg dose of ibuprofen. I also developed a persistent high pitch "ringing" in my head/ears. I believe it's what is know as tinnitus. The volume on a range of 1(low) to 10(high) is 2/3 to 5/6. For the first four weeks after my second shot, the ringing was constant and daily. I noticed beginning week 5 that there would be days where it would completely stop or be barely noticeable. The quiet periods ranged from a couple of hours to almost an entire day. The quiet periods are generally begin in the mornings when I first get up. Otherwise they don't appear to follow a pattern. I also noticed, if I consume alcohol it lessens or eliminates the ringing.

Five days after receiving my first dose of the Moderna vaccine, I experience some numbness in the 4th and 5th fingers of my left arm, which was the arm of injection. I also experience the beginnings of a strange metallic taste in my mouth. Sort of an iron/zinc/copper taste in my mouth that tainted the flavor of the morning cup of coffee and the other things I ate. I thought it might be something wrong with me -- like some sort of cancer or something, but saw that others had experience the same symptom. The taste sensation disappeared on 5/10/2021, a month after my second dose of my COVID-19. I am still am experiencing episodic numbness in the 4th and 5th fingers on my left hand.

1) Soreness in injection site and arm where the shot was administered 2) Tiredeness and very light fever 3) Teeth sensitivity to cold

Constant ringing in both ears, tinnitus. Onset two days after second dose. Ringing remains constant, not getting worse or better.

reports that the patient called her over and informed her that he was experiencing left head pain and the he had a bump there that was not there before and he just felt after he had received his vaccine (5/19/21 at 1102am)." escorted pt to triage area and stayed with pt until ARNP was able to assist him 3-5 minutes later.reports that pt was unable to concentrate or answer questions appropriately when she spoke with him. pt sitting upright with both arms on knees, appears to be in pain. pt reports the same situation to ARNP as what was reported to. Vitals obtained 1110: 119/76 BP, 75HR, 98%. pt A&OX3, Pt denies a hx of DM2, HTN, and anxiety. Lesion on L forehead was appreciated and was erythematic along with his L cheek. pt denies any previous trauma or bug bites this AM states " I came home, took a shower and then came to get my shot." visual acuity test performed and PERRLA present and pt able to follow without issue. B.F.A.S.T. completed to r/o stroke symptoms and it was negative. Lesion on L side of head continued to grow and pt's L eye visually was closing (or getting smaller). pt then reports that L side of face began to be numb and L arm with pain. he then agreed to be seen at ED; EMS called at 1115. Second set of vitals obtained 121/86 BP, 75 HR, 95%. pt given 2 tabs of benadryl at 1122. EMS arrived at 1130 and pt left with them.

Patient stated that had earache Monday - Thursday after vaccine on Saturday. On Friday, woke up and right side of face frozen. Patient diagnosed it as Bells Palsy.

@1/31/2021 Pain started in left ankle Lasted @10 Days. Swollen joints and pain. Swollen joints continued and pain moved throughout different parts of the body. (Right knee, right ankle, etc..) Pain increased every day until he couldn't stand it anymore so on 2/23/2021 went to emergency room for the first time in his life as the patient. Doctor gave him predniSONE 10 mg Discharge Diagnosis: Inflammatory arthropathy; Left arm pain; Tendinitis. 2/26/21 went to PC doctor Diagnosis New onset Polyarthropathy Prescribed PredniSONE 10 mg for 5 days. 3/2/21 Received 2nd Covid Vaccine shot. 3/8/21 called PC doctor still in extreme pain. Doctor prescribed Diclofenac Sodium 50 mg. 1 tablet every 8 hours. 3/9-3/10 started slurred speech. 3/10/21 Emergency room. Discharged Diagnosis Polyarthralgia (Joint pain) Prescribed methLPREDNIsolone 10 mg for 5 days. 3/11/21 Dr. called telling him to stop taking the Diclofenac Sodium immediately. Continued taking PredniSONE until 3/18/21. 3/22/21 sent to Gastrologist noted to have progressive microcytic anemia without GI bleeding, B12, folate, iron panel, EGD and Colonoscopy ASAP, Joint Swelling, Rheumatology evaluation pending, slurred speech, consider neurology evaluation. 3/31/21 Colonoscopy and Endoscopy performed. 4/1/21 Rheumatologist Appointment - First Appointment with this doctor. 4/5/21 Gasterology doctor diagnosed him having H-Pylori infection. All of his biopsies came back negative."H-Pylori Diagnosis - Amoxicillin 500 MG 2 Capsules twice daily for 14 Days /Omeprazole 20 MG 1 capsule twice daily for 14 days/Clarithromycin 500 MG 1 tablet twice daily for 14 Days. 4/8/21-4/10/21 Hands started shaking. 4/29/21 PC doctor appointment. Still experiencing fatigue and very pale. Can't catch his breath and gets tired very easily. Doctor took him off of his blood pressure medicine. 4/30/2021-5/2/2021 Had a horrible weekend. Pain/Fatigue/Absolutely No Energy 5/3/2021 stopped at PC office to see doctor. Took blood for more tests. Still experiencing pain in his body and swollen joints. "Prescription for Iron Tablets Take 1 pill in the am and 1 pill in the pm for 1 month Ferrous Sulfate 325mg (5gr) 5/7/2021 patient looks horrible today. He looks almost yellow to me and 1 of his eyes is bloodshot He has no energy (ZERO) and is very tired. He has lost over 15 pounds. 5/7/2021 patient called PC Doctor and asked him to look at his lab work. Dr. called and told him he made arrangements for him to go and see Neuropathist ASAP. Patient met Dr that same day. Dr. sent patient over to Hospital. In the ER they took blood, EKG test, CT scan of his lower abdomen and pelvis. They took a Chest X-Ray. He was given 60 mg of Steriods and started on IV fluid. They also scanned his head. Acute renal failure. Transabdominal ultrasound of the kidneys obtained. Ultrasound retroperitoneal kidneys. Findings: The right kidney measures 10.8 x 6.8 X 7.1 cm The left kidney measures 11.8 X 7.3 x 6.2 cm. There is mild bilateral renal cortical atrophy. There is increased renal cortical echogenicity of both kidneys. There is no hydronephrosis or shadowing renal calcui. The bladder is partically distended and unremarkable. Medical renal disease. No hydronophrosis or shadowing renal calculi. Clincial Indication: ARF-Other Acute renal failure. 5/10/21 Kidney Biopsy. Prednisone 20 MG Tablets Take 3 Tablets by Mouth Daily for 10 Days. 5/13/2021 Dr. visit diagnosis Focal Necrotizing and Crescentic Glomerulonephritis, Pauci-Immune Nine 0f 25 (36%) nonglobally sclerotic glomeruli show necrosis and/or cellular/fibrocellular crescent formation. Correlation with ANCA serologies is recommended. 05/17/2021 Prednisone 20mg. Next doctor appointment scheduled Monday, May 24, 2021. I also have 9 different Blood Lab Test Reports if you need to see them. My husband went from running 3 miles a day with nothing wrong with him except reflex condition to not being able to move at all. I'm not sure if it is related to the vaccine or not but I wanted to submit this report just in case. Please let us know if you have any further questions or need any additional information. Thank you.

Started with ear ache. Headache in back of head. Then got bells palsy. When to ER on 5/22/21. Got medications.

Blood clot in urine (black in color) (described it as mucous like and black in color).; Blood in urine (Red in color)(described it as mucous like and black in color).; Aways thirsty; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) in a 62-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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) (seriousness criterion medically significant), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty). At the time of the report, HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty) 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. No concomitant medications was reported.. No allergy reported. No treatment done. Patient did not inform health care provider yet. 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.

Tinnitus - high pitch in B ears, worse on L. Does not affect overall hearing however, more obvious in evening when there's less background noise.

Excessive swelling of face and eye lids;tingling sensation on face-immediatly the morning aftervacination Discoloration of cheek and texture change to skin at cheek-continuous through next three (3) weeks

Ringing in ear (mostly left ear) since (more or less) receiving the second dose of the Moderna Covid19 vaccine.

Pt initially contacted clinic describing shortness of breath present the night before, and no other symptoms. Pt advised to go to ED or call 911. Pt contacted today and he described his symptoms differently, specifically as: aprox 5 hours after COVID immunization, developed fever 102, sweating, loss of small and taste, diarrhea, fatigue beginning noc of immunization and gradually fading over ~3.5 days. Only residual Sx pt endorses at this time are diarrhea and fatigue. Pt given advice directly from Provider to go to emergency dept/call 911. Pt cont. to decline to attend emergency dept /urgent care of get COVID test, saying "I'll ride it out."

Sudden Hearing Loss in Left Ear & Tinnitus- On April 26, 2021, 12 days after my second Moderna vaccine. I woke up with no hearing in my left ear. I had my ear checked and there it was not infected, my primary care physician suspected it could be Allergies to pollen and said to take Fluticoasoe Propionate Nasal spray twice a day and one tab 24 Hr. Claritin D one time a day. After 4 days with no improvement to the hearing in my left ear, I decided to see an ENT. My first appointment was Friday, April 30, 2021, my Audiological Evaluation was 30 (mild) range in right ear and below 96 (profound) in my ear. The doctor prescribed an MRI (which came out normal), and put me on Prednisone 10mg for 12 days. I completed my oral Prednisone 20 mg 12 Day pack as prescribed, on my third visit (05/14/21) to ENT (slight improvement to hearing) he began Steroid injections into my left ear. Thus far I have had four steroid shots 05-18-21, 05-21-21, 05-25-21, each Audiological Evaluation since receiving the steroid injections show steady improvement and my hearing range is mild to moderate to severe. I am scheduled for another steroid injection and hearing test on 06-01-21. ENT also started me on Lipo Flavonoid for Tinnitus 6 pills a day (which has not improved). Last appointment on June 8/2021.

Fatigue, 102 temp, headache, swelling at the injection site, pain behind my eyes, skin painful to the touch. sore body aches, cold and hot chills, appetite suppressed, lower abdominal pain and cramps, diarrhea, All events lasted 24 hours except: Headaches, skin pain, and body aches, and appetite suppression, which lasted another 24 hours. After 48 hours just appetite suppression.

Episodes of flashing lights at left eye to episodes of partial loss of vision for 48 hours ( by March 1,2 2021) . Ischemic left optic neuropathy as per retina specialist. Problem appears resolved to this date.

Ongoing pain in teeth, ear, head, neck, shoulders, mostly centered on left side of body. First shot was in left arm. Second shot in right arm. Previously, I have never had TMJ or bruxism issues, both of which have been diagnosed in the past two months and seem to have resulted from the post-vaccine pain. My GP prescribed anti-inflammatory pills that have helped to some extent with the neck pain and helped diminish the clenching. The original post-vax pain continues unabated, now three months later.

On the 9th day after receiving Dose 1 of the Moderna mRNA vaccine shot, I had a ring in my left ear followed by a sting much like a bee sting. The ring was like a phone ring.

62-year-old male with history of hypertension presented to the hospital with chest pain. Chest pain centrally located, pressure-like sensation radiating to the left upper extremity and left side of the jaw. Associated with sweating. He had difficulty breathing when he had the chest pain. Patient was nauseous. NSTEMI. Cardiac Catheterization performed.

First shot: Mild sharp headaches of short duration. Difficulty breathing. Severe Tinnitus. Second shot: Severe Tinnitus.

Tinnitus is both ears. Feeling of blocked ears and pressure in ears, and loss of balance. Left ear worse than right ear. Hearing loss.

Had a really swollen, sore arm - and under arm pits it was really swollen too. I toughed it out for a couple of weeks. I called the clinic when it was still sore. I was not able to lift weights when I exercise - I was dropping them. I called the clinic and talked to a nurse. On June 22nd, around 1:00 or 2:00 - my whole left side went numb. I couldn't speak. Left side of face was drooping. I had blurred vision. But then it got a little better within an hour or two ( I could communicate) and I called the clinic said to come in on 23rd - doctor thought I was still having a stroke due to symptoms observed. I have an optometrist is going to check my eyes. I am going to get a physical done next month (August 9th) at the clinic. I work out and tried to do some neck exercises - and dr noticed a past injury of left side of face -that happened 45 years ago - on the CT. Dr wonders if it's related to that . I decided to do some neck exercises on Monday and yesterday I was bedridden after doing those exercises - lymph nodes swelled up. I still have some blurry vision; my face is still drooping but just a little bit. I do jumble my words.

Within 2 weeks of my first injection I became experiencing diffuse muscle and joint pain through my shoulders, back, and leg. The pain during the first several weeks was so extreme that I was unable to sleep. I then began experiencing tinnitus. Since that time the tinnitus has persisted and I have severe low back and hip pain. All X-rays from an orthopedic consult have shown mild arthritic changes. I had MRI?s of the hip and lumbar spine 3 days ago and am awaiting the results. My activities have been significantly limited due to pain any the tinnitus has gotten worse. A week of prednisone therapy provided temporary relief of the tinnitus and some relief of hip pain. Both symptoms quickly returned within a day of prednisone being discontinued. Although I have a history of mild hearing loss, I have never had tinnitus before and the low back pain, sciatica, and hip pain were non existent prior to the first dose of the Moderna vaccine. I did have the second dose on April 6, but noticed no changes after that dose.

On June 19, 2021 I woke up with a sudden Single Sided Hearing Loss (SSHL) in my left hear. I awoke to a loud tone in the left ear for approximately 5 minutes followed by profound deafness. I was treated in the Hospital Urgent Care that day. I did not have any ear infections, water in the ear, eardrum damage, earwax, or other identifiable cause for my hearing loss. I was prescribed prednisone orally for 15 days. On June 21, 2021 I was examined by an Audiologist at the ENT Clinic. They confirmed the profound hearing loss in the left ear with a greater than 100 db hearing loss in all frequencies in that ear. On June 25, 2021 I was examined by my regular Audiologist at the Medical Center. She again confirmed a profound hearing loss with more than 90 db loss in all frequencies in the left ear. She has ordered a hearing aid. I was referred to the Ear Clinic. I was examined there by a Nurse Practitioner who found no visible reason for my hearing loss. I have received three corticosteroid shots in my ear. I have been referred to be evaluated for Minier's disease.

Head ache, Chill, Fever (100.4 to 100.80), Body ache, Light burning eyes, loss test for 2 days. Took Tylenol x2 (500mg) for 2 days.

My oxygen levels dropped below what they had been previously as I am recovering from Covid infection tested positive 20 October 2020. If I do anything at all other then set my oxygen levels would drop into the low 80's. I have also been monitoring my sugar levels. I am not diabetic but did so because in ICU was using steroids which elevated sugar levels. I continued to monitor it at home because I had to do injections for several weeks after leaving the hospital. Have not had to use insulin til the other day. Vision is very blurry. Had that problem in the hospital but it has gone away but since I had the first vaccine everything is now blurry. Left leg hurts to put weight on the heel. I have nerve damage to the left leg but this is a unique issue. I'm running a low grade fever 100.2 - in the morning it is normally 96.5-97.6 and this temperature was in the morning the day after the shot. Neck is very sore. I have rods from C3-C6 and the pain is in the muscle glands closer to the surface. It is almost like it is attacking all areas of the body I previously had issues. I spent October 25 - November 13 in Hospital, majority of time in ICU.

Approximately 18 hours after receiving the vaccine, I developed a fever ranging from 101-102.4. I had muscle aches and for a short time, blurred vision. After resting for approximately 12 hours, taking Tylenol and drinking water, my symptoms subsided.

Have had off and on swelling of my lips and face for the past seven days. First time was full face swelling about 51 hours after vaccine and and 20 hours after eating lobster and other shellfish pasts dinner. (63 and never been allergic to shellfish before) on Saturday. First swelling went down slowly and gone within 24 hours. Following Tuesday, woke to swelling/numbness of lower right mouth & lip. Lessened throughout day. Thursday, woke to upper left and upper right lips numb and swollen. Lessened throughout day. Today, woke to lower left lip numb and swollen like I?d been punched in mouth. Wife insisted I go see doctor immediately.

Mild headache and nausea about 30 minutes after injection. In middle of night had pain and swelling in left eye (same side of body as injection), left arm pain the next day.

- extreme neck pain,. Comparable to pinched nerve type of pain in neck. Originated on the left side but now primarily on the right side - blurred vision in right eye.

My noises of tinnitus is a high squeal, louder in my right ear and yet pretty loud in my left ear. I was hoping it was going to fade but I am now 21 days later without reduction of the issue.

Approximately three days of my first Moderna dose, I began to have difficulty rinsing and spitting from my mouth after brushing my teeth. There is a some what dull pain above the left side of my top lip. I do not get full pressure when spitting and the left side of my mouth does not seem to move when I spit. It almost feels like it was shot up with Novacaine. I went swimming on March 14 and when I blew air out of my mouth none came out of the left side.

intermittent headache and blood pressure is erratic sometimes going as high as 170/130. Eye floaters and eye flashes and high BP caused ER visit on Sunday 3/14/2021.

Approximately 10 days after first dose, swelling or inflammation under the tongue . Appears to be inflammation of papillae of Wharton's duct based upon images observed on-line. Whether this is related to the vaccine or not, I'm not sure. I have never had this inflammation before.

Tinnitus followed by acute hearing loss left side approximately 4 weeks after second COVID 19 dose. Currently treated with Prednisone with little improvement. Scheduled for MRI 3/25

Moderate Tinnitus 2 days after injection. Migraine 6 days after. Tinnitus is continuing and has not stopped after 12 days. Tinnitus is high pitched and constant Also had sore arm around injection site for 3 days

rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering. The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam. On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection. On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

DEVELOPED TRANSIENT EAR/JAW (THROAT?) PAIN APPROX 7 DAYS POST VACCINE. DEVELOPED RIGHT SIDE FACIAL WEAKNESS/PARALYSIS ON 1/29/21. SYMPTOMS INCLUDED DIFFICULTY CHEWING FOOD, ASSYMETRIC SMILE (NO MOEVEMENT OF RIGHT SIDE OF MOUTH), SPILLING OF LIQUID FROM RIGHT SIDE OF MOUTH WHEN DRINKING AND ALSO TEARING, WEAKNESSOF RIGHT EYE. SAW MY DOCTOR ON 2/7/21 HIS IMPRESSION WAS OF POSSIBLE BELL'S PALSY (FACIAL PARALYSIS) . STARTED ME ON VALACYCLOVIR 1 GR TID ON 2/8/21 . REFERRED TO NEUROLOGIST WHO I SAW ON 2/9/21 PERFORMED NEURO EXAM AND REFFERED ME FOR MRI OF HEAD TO RULE OUT STROKE, mY SYMPTOMS IMPROVED SOMEWHAT ON 2/10/21 AND CONTINUED TO GET BETTER COMPLETELY BY 2/14/21. MRI DONE ON 2/12/21 INDICATED NO SIGN OF STROKE.

Pt received first Moderna COVID-19 vaccine on 3/15/21. Starting 3/27, patient began to have acute onset dizziness, muffled hearing, loss of consciousness and sinus congestion. On 3/28, this dizziness lead to a fall in which he hit his head and was sent to the ED. Pt tested positive for COVID 19 while in the ED, and was admitted.

Patient reported pain in center of black and vision blurry approximately 10 -15 min. Patient with poor color and sweaty. Patient Pulse OX 77% , HR 50. 1555 - Epinephrine 0.3mg administered IM left thigh. Oxygen (full face mask) applied at 15L. Patient pulse ox 98%. Patient report still feeling poorly. 1402 - Benadryl 100 mg IM Right Deltoid administered. 1406 - B/P - 125/82 Pulse Ox 98% HR - 56 Oxygen slowly decreased to 5 L. EMS transported to ER

Received the Moderna COVID-19 vaccine. Ten days after vaccination constant ringing in the ears primarily on right side. Experienced low level tinnitus in the past which was tolerable. The ringing in the years is significant after the vaccine. It is now at a moderate level. Sleeping is difficult without using ambien. The ringing is constant through the day.

Some ringing in both ears. Not all the time. I haven?t yet seen a doctor or done anything to treat it. Seems louder today (3 days after vaccination)

"cold sores"/HSV-1 on lower lip encompassing left two-thirds associated with significant swelling and development of single multiple vesicles to larger more coalescent ones. Also swelling and sensitivities to left upper and lower gum line and palate with minimal focal nodular mass effects.

After 15 min receiving 2nd dose Moderna vaccine (Covid) left hand, lips, face and chin numbness and tingling. Light headed.

Approximately 2 weeks ago, I started having a constant ringing/noise in my ears. It has become very annoying!! It's constant.

about 14 minutes into 15 minute post vaccination wait time, pt stated he was feeling dizzy and having blurred vision. Gave pt water to drink and observed pt for another 15 mins; he said the dizziness got better but still slightly blurry vision. Suggested he follow up with primary MD if that did not resolve.

Nasal congestion, sneezing, Itchy/red eyes, progressed into bronchitis which included significant unproductive cough. Used generic "Claratin" at first. 6 days after injection, began prescribed NEO-POLY-DEX eye drops, Fluticasone Prop 50 mcg nose spray, Albuterol inhalations. 8 days after injection got an Albuterol breathing treatment and began prescribed 5-day Prednisone 20 mg treatment. Using over the counter DM cough suppresant since 6 days after injection. As of 10 days after injection, expect to start prescribed antibiotic (type yet unknown) and Tessalon Perles for cough. Note that I have "Hay Fever", but this event was notably more severe than have experienced in years. Also tend toward bronchitis annually.

I have developed tinnitus in both of my ears. I have never experienced this before. I have received second dose and the tinnitus has continued.

Woke up on 4/15/21 w/ "stinging to lips", generalized facial swelling present. No rash, SOB, or hives present.

In the weeks following, I have had occasional unexplained tiredness, blocked ears and tinnitus. The blocked ear last 2 days and the tinnitus seems to have gotten worse. I have no idea if these symptoms are related to the the vaccine but thought I should let you know.

Unusual (reason for submission): Blood 02 dropped to 94-96 the day after 2nd COVID vaccination. I take O2 reading daily (generally). Always been rock solid at 98 with maybe a 97 every two months. This is really an outlier event. Reading taken on six different fingers with one monitor reset. Returned to 98 following day. Other expected symptoms: Temp 99.8 (generally 97.6 - 98.0). Injection shoulder sore, felt puffy (but no visual difference). Medium "Brain Fog" (senses seemed disconnected, lack of concentration). Lethargic legs (not sore or weak, just slow to respond). Left neck and ear aches. Slept about 14 hours day after shot. No symptoms other than sore arm the day of shot. BP and blood sugars up, but at higher end of my normal ranges. BP 175/93 (16th). (at 149/93 on 17th). Blood stick reading 198 (16th). (at 158 on 17th)

Headache, fever, nausea, chills, body aches, dizziness, tiredness, and ear ringing. All symptoms subsided accept for dizziness and ear ringing as of 4/18 6pm.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: PATIENT DEVELOPED BLISTERS AND SORES IN MOUTH APPROXIMATELY 1 WEEK AFTER RECEIVING VACCINATION. WENT TO PRIMARY CARE DOCTOR WHO DID BLOOD WORK WHICH SHOWED A PLATELET LEVEL UNDER 2000. PATIENT WAS HOSPITALIZED AND GIVEN STEROIDS BUT HAS SINCE RECOVERED.

Decrease in vision of both eyes on the fourth day following vaccination. No improvement yet. Has not experienced anything similar in the past.

Within 3 hours experienced significant ear noise and pressure, similar to clogged ears when sick. Within 2 more hours (5 from vaccine time), symptoms reduced to only low-level hissing equal across ears, i.e. tinnitus. During the 2 weeks since vaccine, hissing has remained exactly the same 24 hrs per day. Occasional much louder, higher frequency ringing has occured at least twice but only for short durations of 30 seconds.

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

I am experiencing severe tinnitus. I suffer from tinnitus anyway, but it became much worse after the first shot and has not subsided. I received the second shot 04/24/2021 at 1:00 p.m. and it seems to have gotten worse still. I have not sought treatment. Maybe the tinnitus is not related to the vaccine, or this is inconsequential, but I feel I have a responsibility to report it.

Tinnitus became noticeable one week after receiving the first dose. Pursued recommended treatments, reducing NSAIDS and ear wax removal. No improvement since symptoms began.

Developed right-sided headache with facial weakness and numbness on April 19. Blurred vision and ptosis, inability to hold liquids in right side of mouth, irregular smile, and nose bleeds. CT of head same day was negative for any acute findings. Evaluated by optometrist on April 22 and referred to other eye specialist. Evaluated on April 27 by specialist and diagnosed with Bell's palsy. Prescribed steroids and acyclovir. Family reports patient's facial weakness has improved significantly, smile is equalizing and patient is able to blink and move muscles in forehead. Still has some residual symptoms at this time.

A few minutes after the shot, I started to see "Floaters" in the field of vision of my sight. The amount /density of floaters is analogous to medium rain fall. After about an hour, kit kind of went away except for my left eye. I see a couple good size black "Floaters", and has stay that way since.

Patient described a cold sweat and chills, then he lost consciousness and his neighbors called EMS. He was seen at Hospital. In the aftermath, the patient complains of hearing loss.

A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast

4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole body rash with severe itching, swelling in mouth and throat, extreme weakness, close to fainting within minutes. Emergency room visit, EPI pen injection, steroid injection, EKG, chest x-ray, blood work. 4 hours of observation in hospital. Still weak today, voice weak, and can't seem to take in enough oxygen to go on a walk or do simple yoga stretches.

Ringing Ears all day long (Tinnitus?) Occurred after 3 days to a week. Affecting quality of sleep. Worse at around Bed time. Also noticeable fatigue. Running at about 80-90% of my previous normal.

A few weeks after my vaccination I began hearing ringing or background noise in my ears, never had it before.

Acute Sialoadenitis Inflammation of salivary glands Swollen under jaw and tongue painful Increase pain with each day Pain move up to parotida and ear

Feb 28, Sunday: went sleep around 12:45am, woke up 7:15 am, fever 100.6 F, dizziness, complete hearing loss in right ear, fatigue, stayed in bed for a few hours, fever continued through the day, 100.2 to 102.1 F Mar 1, Monday: went sleep 12:00 am, fever 100.4F. Woke up 8am, sudden hearing loss (SHL) in right ear continued, no change, and 99.6F in morning, dizziness, fever was gone by afternoon. SHL continued. Mar 2, Tuesday: SHL continued, dizziness, temperature 96.7F, body ache and soreness were less. Went to Otolaryngology for checkup and treatment at 11:40 am. Diagnose results: complete hearing loss in right ear. Received treatment: injection into right ear and prescription of Prednisone 10mg, injectio

Nerve palsy in right eye causing double vision. Cat scan no results yet. Prism on glasses to correct vision.

About a week after the second dose: Increased volume of Tinnitus in both left and right ears. Sometimes twice the volume and unbearably distracting and exhausting

Within 2-3 hours of vaccine developed swelling of tongue and throat with difficulty breathing. Patient applied ice and took Aspirin. Episode lasted 6 hours. Patient did not seek medical attention. This was revealed at the time of the second dose assessment.

Patient thinks that the vaccine exacerbate symptoms of his autoimmune desease, his right knee was swollen and he experienced pink eye.

per patient: "On 5/26/21 received the 2nd dose of Moderna Vaccine. Around noon experienced headache, left earche and tingling to left foot. Around 1pm started having trouble breathing and later that evening felt like someone was standing on my chest. Took Excedrin EC for headaches. Headache lasted for a day or two. Felt like i was forcing myself to breathe instead of coming naturally".

Loss of hearing in right ear. Hear nothing but white sound, and a sound like a metal cable clanging. Primary care physician thought maybe it was a sinus infection, since it just happened. Put on first round of antibiotics on 5/11, and still no better, was put on 2nd round of antibiotics on 5/25. Still no improvement on 6/9. Ear canal is clean, and clear.

5 DAYS AFTER SHOT 1 BECAME FEVERISH (102.4), EVERYTHING TASTED SALTY, TIED, DIFFICULTY BREATHING, PHYSICALLY WEAK

Mouth went numb and throat tightened up within 5 min of injection. Was administered epipedrine and Benadryl and taken to emergency room by ambulance and observed until noon and released.

Skin rednesses/inflamation/flushing that started in hands and since initial and second covid vaccination has spread to arms, legs, torso and face resulting in FATIGUE and MUSCLE WEAKNESS. Eye and nasal irritation along with rash arounf lips. Tingling and numbess in feet and ankles. Weight loss

Hives/rash first appeared near injection sight on 6/1/2021, becoming more severe through 6/9/2021. Medical intervention was sought from primary healthcare provider on 6/9/2021, whereas the hives became severe and facial swelling on the right side of the face appeared and lasted from 6/10/2021 through 6/14/2021. It was during this time that eye irritation appeared. As of this reporting the hives are still persisting, coming in 'waves' of almost unbearable itchiness, varying between a few minutes to 3 hours, with the duration varying between a few minutes to 3 hours as well. Disrupted sleep cycles have been a peripheral side affect, caused by the hives

Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.

18 hours after vaccine experienced chills, joint pain, fatigue followed by sweats and low grade fever . Flu like symptoms subsided 36 hours later. Next about 3 days later FLASHING LIGHTS IN LEFT EYE WHICH SUBSIDED AFTER THREE OR 4 DAYS AND ,PERSISTENT DAILY CHRONIC HEADACHE AND INTRACRANIALPRESSURE WHICH HAS NOT SUBSIDED AT TIME OF THIS REPORT 26 DAYS IN DURATION AND STILL PRESENT.NO PREVIOUS HX OF HEADACHES.

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

Patient's wife called to inquire if lip swelling was side effected of covid vaccine. Information obtained from conversation with wife: had 2nd dose of Moderna COVID-19 on Friday 7/2/2021 * 7/3/2021 notice lower lip swollen throughout the day. * 7/4/2021- lower lip resolved. Then upper lip began to swell. Still swollen as of approx 4:15 pm 7/4/2021. Also noticed small white bumps on lower arm. * Swelling localized to lip, no report of systemic reactions, did not report any symptoms except normal expected side effects ie tired * Stated has never received any dermal fillers * Had surgery on 6/30/2021, IV antibiotics administered, stated did not receive any steroids during surgery

Started developing canker sores and raw spots on oral mucosa, tongue and gums approximately three days after injection, peaking in severity 7/3/2021. Started improving yesterday and nearly cleared up by today. **In retrospect, patient recalls having a sore mouth with no visual lesions after first dose for a few days**

Patient states noticed tonsil swelling on July 9, 5 days after receiving first dose of Moderna vaccine. Swelling and inflammation present, patient states still persists but does not report any breathing or swallowing difficulty. Pt also reports using OTC tylenol for mild fever after vaccination. Patient states he is seeking tonsil examination as soon as available but does not report any additional side effects.

about 4 days after vaccine administration patient developed rash behind right ear and periauricular area, persistent headache, scalp tender to the touch as if he had sunburn, seen 3/21/21 diagnosed with shingles prescribed valtrex rash resolved in about 3 days. 4/1/21 patient seen again continued headache, diminished hearing on right side, rash resolved. Audiologist referral placed meclizine prescription given. 4/12 seen again, dizziness, ringing in right ear, hearing loss, dizziness is not positional but emanating from the right side. Lightheaded, woozy feeling, numbness/tingling, and sunburn-like feeling around right ear down neck. Chiropractor performed epley maneuver no improvement, meclizine ineffective. Now also describing "feels like water in ear". 4/15/21 Audiogram demonstrated sloping sensorineural hearing loss right ear with STS score of 76% and type A tympanogram, symptoms persisting urgent ENT referral sent. 4/28/21 seen by ENT Right ear with hearing loss and disequilibrium prednisone 60mg once daily in the morning prescribed, repeat audiogram 1 week, MRI with contrast ordered. 5/7/21 ENT completed course of prednisone hearing has significantly improved on right side still describing equilibrium, NOT acute episodic vertigo. Audiogram SDS improved from 76% to 92% and SRT improved 30-10DB. Physical therapy offered. 5/18//21 MRI performed impression: 1-no acute findings, no acute neuroma, no abnormal enhancement temporal bones eitherside. 2-several nonenhancing white matter T2 Flair hyprintensisties bilaterally 3-giant cisterna magna 4- generalized cortical atrophy 6/7/21 follow up with ENT still experiencing disequilibrium MRI does not show any significant pathology to account for hearing loss or disequilibrium. 7/7/21 follow up with PCP patient reports he is not feeling any better, symptoms of loss of balance and tinnitus continue although hearing in right ear largely improved.

Pt and other foster home residents and CGs received COVID shot #1 at 11:30 am within the foster home after POA consented to pt's vax. At ~9p, CG heard pt vocalize a loud sound, CG checked on him and entire body and stomach so rigid, lips were pressed together/pale and pale throughout. Stopped breathing for a few seconds. CG couldn't get BP or pulse initially. Say tears rolling down face. 87/45, 56, 97.2F, 91% on RA. After 10 mins was 129/53, 48, 91%. Called 911, 79/47, couldn't get pulse. Due to POLST comfort measures, EMS did not transfer pt to ER. After EMS left, pt "came to" again, pt signed EMS consent NOT to be transferred to ER. Pt's POA didn't pick up the phone. Current VS: 111/64, 69, afebrile. POA does not want pt to receive the second COVID shot.

Left side of face paralysis, primarily noted in mouth and left eye. Can not blink left eye, continues to tear up. Left side of mouth does not move while trying to smile/eat/talk. Emergency Room visited 1/24/20. MRI, CT Scans run to determine if stroke occurred. Diagnosis is Bells Palsy with seven days of steroids prescribed (Prednisone 20mg - two tabs once per day).

Not sure if this was related to vaccine. 2 days after getting 2nd dose I developed eye pain and irritation. I was seen and diagnosed with ocular shingles. Currently being treated with Valacyclovir.

Patient went to his primary care md because he was having an ocular disturbance. The md described it as a ocular migraine but voiced his concern that it could be a TIA. The patient experienced this 3 days after receiving shot. The patient did follow up with an eye doctor where they were told everything looked normal. patient concerned this was unnecessary and then question consequence of receiving second dose.

Right side Lips, face became numb. Right eye drooped, along with corner of mouth right side Right side of tongue became numb, swelling of right jaw lymph node, ear ache, dry mouth.

Severe flu like symptoms, weakness, nausea, vomiting, muscle aches, dry throat, difficulty swallowing, 102 temperature

States took the CoVid vaccine a week ago in his rt arm (Not currently in LINKS). Began with facial droop and numbness - did have a hx of Bells palsy 12 years ago. Obvious facial asymmetry noted with nerve paralysis on the right and is unable to fully close eyelid and the side of his moth is drooping and unable to close completely.

The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing.

I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

Painful injection site, sick stomach, fever, earache, headache, After 24 hours from injection I developed a bloody taste in mouth, severe bloody nose.

Pain in right ear. Piercing nerve pain ear canal infection, numerous antibiotics anti fungal, CT scan symptoms a little better but no resolution.

MILD ITCHING: OVERALL BODY ITCHING MANIFESTED APPRX. 4 HOURS AFTER INJECTION ESPECIALLY AT FEET, EYES, HANDS AND ARMS. NO RASH. PATIENT TOOK DIPHENHYDRAMINE FOR ITCHING. ITCHING LASTED APPRX. 24 HOURS. AUDITORY SENSITIVITY: MINOR SOUNDS SEEMED AMPLIFIED. TO THE POINT OF IRRITATION TINNITUS: SEVERE TINNITUS 4 TO 10 HOURS AFTER VACCINATION. HAD SOMEWHAT DISAPPEARED BY 8 AM FOLLOWING DAY. PATIENT STILL HAS MINOR TINNITUS. MUSCLE AND JOINT STIFFNESS: MUSCLE AND JOINT STIFFNESS MANIFESTED APPRX. 2 DAYS AFTER INJECTION AND LASTED FOR APPRX. 5 DAYS TOTAL. PATIENT HAD NO INJECTION SITE REDNESS OR SWELLING. PATIENT DID NOT SEEK MEDICAL TREATMENT FOR SYMPTOMS.

Before the COVID vaccine, I had a very mild case of tinnitus in the left ear. There was no discernible ringing, except occasionally at night in bed when it was quiet. One hour after the 1st COVID vaccine shot on March 2nd, there was extremely loud ringing in the left ear, which scared me terribly. It lasted about a minute. Whille the ringing is not as loud, there is constant ringing which overcomes everyday sound. For instance, when talking to people or watching television, the ringing is still heard. In addition, the ringing is often pulsating, which is a new experience for me. Clearly, my tinnitus has gotten much worse as a result of the event. I AM CONCERNED THE 2ND DOSE WILL MAKE THE RINGING WORSE.

Officer reported feeling dizzy, blurred vision, lips were numb and tingling to the left side of his face. Vitals signs were taken and his condition and complaints were reported to NP. An evaluation was done and a granola bar was given since the officer reported he did not eat this morning. Another set of vital signs were taken and then NP consulted with Dr. who recommended that the officer be seen in the ER for further evaluation. Officer was then transported to local ER by wife.

Patient expericed slight tightening of throat/tingling. But was able to swallow. He was asked to take Benadryl but he refused and was given loratadine 10mg tab (1) by mouth. He was observed for 30 minutes and a was driven home. A follow up was conducted 4 hours later he was fine.

19 hours: left eye went dark, left leg muscle contraction, 21 hrs: major muscles seized for 15 minutes(felt like they were tearing from bone), Fever for next 12 hours

Patient without prior otologic history noticed left sided hearing loss and tinnitus 1-2 weeks after second dose of Moderna vaccine. No vertigo.

Dose 1 on 2/5/2021 Dose 2 on 3/5/2021 Symptom of loss of hearing in my right ear resulting in tinnitus in the right ear (ringing)

Patient described yellowing of skin and eyes. This was not observed by provider. Lab work including bilirubin and LFTs were all normal. Patient then reported on 3-25-21 that since the day after 2nd vaccine, he has had intermittent paresthesia's in left cheek, left arm and left leg. No weakness.

Lips and cheeks were numb and I had a headache and fever with body aches. It lasted two and one half days

Right ear feeling like there is a pressure in my ear like it is plugged and there's some hearing loss. These symptoms are continuous.

Vaccine side effects included fever, headache, cough, dry throat, muscle pain, joint pain, gastrointestinal distress, abdominal pain, insomnia, arm pain, sweating, chills.

On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot. The site were I had to shot was burning like it had been branded. I had brain fog couldn't remember what i was doing up. Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area. the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch. Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.

Moderna Covid-19 Vaccine EUA Was vaccinated Thursday morning 9am or so and awoke Friday morning with muscle ache, joint pain, cramping muscles, chill, sweats etc, These lasted 24 - 36 hours and then I had a severe allergic reaction on my tongue which swelled up worryingly, this was about 5pm on Saturday. I took 4 Benadryl over 3 hours and slept until Sunday morning. I awoke Sunday morning with quite a lot of muscle pain, like after a workout. I took 2 Motrin and felt fine after about 30 minutes. I do have pictures of how swollen my tongue got on the Saturday evening

Went to. the urgent care on 3/20 after waking up two days after getting first COVID-19 Moderna vaccine Had sever ear pain and sore throat. Dr. looked at it and thought it was ear infection snd prescO

dry cough, chills, and at that time he tested positive to COVID-19. symptoms have progressively worsened with diarrhea, fever with T-max of 101°, loss of taste and smell sensations

Moderna COVID-19 Vaccine EUA Mild headache/eye aches, vertigo, no elevated body temp. Eight days after injection got a large, splotchy rash around injection site. At nine days the rash turned into a 2"x4" hive with various hive around it on my shoulder and neck.

Rash, Mild Lip swelling Patient called Allergist she told him to take Benadryl and predasone also NOT to get the second dose in 4 weeks. she did tell him to get J and J vaccine in 4 weeks

Tinnitus medium to high pitch buzzing in both ears. Started approximately 10 days after first shot. Still present.

diagnosed with Bell's palsy; severe watering of left eye; tingling around mouth area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bell's palsy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 362A1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent insertion NOS in 2008. Concurrent medical conditions included Lyme disease since 09-Mar-2021 and Bell's palsy since 09-Mar-2021. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bell's palsy) (seriousness criterion medically significant), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area). At the time of the report, FACIAL PARALYSIS (diagnosed with Bell's palsy), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Of note, patient has a history of Lyme disease, Bell's palsy.

1.) Strong soreness in lower back and gut area. Hard to bend over. I don't typically suffer from back pain and didn't exert or do anything that might have strained muscles. Pain seems muscular in back and deep in lower gut/groin area in front. 2.) More concerning is the tinnitus or ear ringing I am experiencing. Very loud and unrelenting. Feels like ears need to be popped such as when air pressure changes. However, can't swallow hard or chew hard enough to clear ears. It's a bit flummoxing as it is unrelenting. Sounds like cicadas in my head.

Xerostomia dry mouth noticed two days after first shot and has continued until present. On recommendation of tele doctor I went to the urgent care and they drew blood for testing and the results were negative for any systemic cause

Shingles; Sore throat; Swelling of the left side of his face; Ear infection; Rash on the side of his face, inside his ear, and on his scalp; Loss of hearing; Drooping of his left lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Loss of hearing) and FACIAL PARALYSIS (Drooping of his left lip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 recorded medical history). Concomitant products included AMOXICILLIN SODIUM (AMOXYCILLIN [AMOXICILLIN SODIUM]) for Laceration. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), FACIAL PARALYSIS (Drooping of his left lip) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp). On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, DEAFNESS (Loss of hearing), FACIAL PARALYSIS (Drooping of his left lip), HERPES ZOSTER (Shingles), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient went to urgent care center for the events experienced. Treatment for the events included ciprofloxacin 0.3%, dexamethasone 0.1% suspension and cefdinir. Treatment for shingles included valacyclovir 1mg, gabapentin 300mg, and prednisolone 4mg. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant follow up appended.; 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.

Allergic reaction (mouth and lip swelling) after eating almonds and pecans. I have eaten almonds and pecans my entire life and this is the first allergic reaction ever. I took fexofenadine and the swelling abated after several hours. I have not eaten nuts since, and there has been no recurrence.

About 2 days after administration of moderna covid vaccine, patient stated he started noticing a plugged ear with pressure in the ear. patient seen an Ears, nose and throat (E. N. T.) physician for issue. Hearing test conducted showed some hearing impairment as compared to patient's baseline hearing. E.N.T exam showed no fluid in ear. Patient was treated with both oral and otic steroids and symptoms resolved with treatment.

Vacinated on March 8th. Sent home from wsork next day at noon with feaver and fatigue. Next 4 days with fever, fatigue, headache, and muscle pain. Fever broke Friday night. Saturday noticed vision loss. Macula neuroretinopathy worsens each day. Disabled. Treating with 60 mg/day prednisone starting 4-13-2021.

Tinnitus increased dramatically and has continued for 28 days. No changes since initial flare up. It continues to be very loud.

2:15 pm. Complained of dizziness, blurred vision and diaphoresis. Stated he has prior fear of needles. 2:20 VS 95/65; p79; Sat 97. R. 14. Offered water, cereal bar. Stated he felt better. Assessed by NP and onsite EMS. Remained in Observation for 30 minutes. Discharged home 2:50 pm. All symptoms resolved.

Medical Summary - Friday, April 9, 2021 Patient received 2nd Moderna vaccination at Care Center. (1st Vaccination at Care Center unremarkable.) Approximately five minutes after vaccination, seated in Observation area patient leaned forward with elbows on knees, when asked stated he felt light-headed, put his head between his knees, wanted to lie down. He lowered himself to floor, with help transferred to different chair, sipped water, given lollipop, suddenly unresponsive, eyes glazed and rolled back, teeth clenched on lollipop stick, leaning to left side, incontinent of urine, no abnormal arm or leg movements, duration ~ or under 1 minute. Lollipop removed by staff, vitals: BP 1 Additional information for Item 18: Lollipop removed by staff, vitals: BP 117/72, P68, SpO2 Room Air 96%: now alert and oriented x4, no shortness of breath, no chest discomfort, able to sit in chair without support, was surprised by incontinence. Stated he felt sleepy, tired, and with staff assistance walked to next room for observation where he laid down on carpeted floor. He had no further episode of LOC, remained alert and oriented but continued to feel "tired". No complaints of chest discomfort or shortness of breath. ~ One hour post-incident BP 94/58 with repeat BP 120/82. ~ Two hours post-incident BP 118/80 (his usual he said) sipped water and electrolytes solution. Patient verbalized several times this event much different from previous events associated with blood draws which he described like typical vasovagal reactions with recovery within ~ 15 minutes. Drs. spoke with patient via telephone: PLAN o Can go home today o Do not drive today o Son will pick him up and stay with him for about 24 hours until wife returns from out of town o Appointment scheduled with PA at PMD office for Monday April 12 @ 8:00am – Patient called the office and I listened via speaker, his PMD is out-of-office till later in month, this is first available at the practice o Dr. recommend PMD work-up to also include EEG and CT Scan o R/O vasovagal event v. seizure v. other etiology o Dr. will contact him by phone later today PA-C MD

Patient reported headache and swelling and itching of his face. He declined treatment (diphenhydramine) or staying longer to be monitored. Noted itching was decreasing before leaving at end of 30min monitoring - left clinic alert and otherwise well enough to contact someone familiar to him should symptoms become worse per clinic nurse.

MODERATE ITCHING FOLLOWING FIRST AND SECOND VACCINATIONS. ITCHING LASTED 24 HOURS AFTER FIRST SHOT. TREATED WITH BENADRYL. ITCHING LASTED ABOUT 4 HOURS FOLLOWING SECOND SHOT. TREATED WITH BENADRYL. TINNITUS AND AUDITORY SENSITIVITY BEGAN WITHIN 6 HOURS OF THE FIRST INJECTION. SUBSIDED BUT STILL PERSISTENT UP TO AND AFTER THE SECOND INJECTION. TINNITUS HAS BECOME WORSE 10 DAYS AFTER SECOND INJECTION. IT IS LOUDER AND MOSTLY IN LEFT EAR. AUDITORY SENSITIVITY HAS BECOME WORSE ALSO.

Noticeable increase in volume of existing tinnitus. I used to only be able to hear the ringing if the room was quiet and I actually listened for the tinnitus. Now I hear it all the time. Even so, it is not debilitating and can be ignored if there is extraneous noise and I am busy doing something that distracts me from it. So far it has not affected my sleep.

3/13/2021 Lt shoulder rash and lt eye swollen; 4/14/21 had acupuncture for neck pain; 4/15/21 herpes rash started LUE advanced to both UE, neck, lt ear, and lt hip; lt eye swollen Increased Valtrex from 500 mg daily to 1 gm three times daily. Advil for pain. Benadryl for itching. Initial rash abating; new rash developing; eye swelling diminishing.

Randomly approx 4-5 times over the next 3 weeks, first my left eye, and then my left eye would go black from the outside in, as though I was going to pass out. I would remain still and my vision would come back, first in the right eye and then the left eye. It always happened the same way. My left eye would begin to go black from the outside circumference to the middle, losing site, and then the right eye would start to do the same thing. It hasnt happened again after that first month of reoccurrences, and it never happened before the shots.

PATIENT STATES: WITHIN FIVE MINUTES OF INJECTION MY FACE BEGAN TINGLING ON THE LEFT SIDE STARTING IN MY CHIN AND MOVING UPT O INCLUDE MY ENTIRE MOUTH, LIPS, UNDER MY LEFT EYE AND THE ENTIRE LEFT SIDE OF MY FACE AND HEAD. THE TINGLING BECAME NUMBNESS AND VISION ISSUES IN MY LEFT EYE. I STARTED EXPERIENCING HEART ARRHYTHMIAS DIZZINESS AND VERTIGO. I THINK IT WAS CAUSING ME SOME STRESS, WHICH CAUSED ME TO BE HYPERSENSITIVE TO EVERTHING. I WAS SITTING IN MY CAR FOR THEREQUIRED 15 MINUTES AND AT THAT TIME I WENT INTO THE PHARMACY TO REPORT IT BUT THERE WERE SO BUSY THAT I COULD NOT GET ANYONE'S ATTENTION TO ALERT THEM SO MY WIFE AND I LEFT. WE WENT TO A COFFEE SHOP, I HAD SOME CAFFEINE AND I FELT OK TO DRIVE BACK HOME TO REST.

Approximately one month after first shot experienced itchy hands and feet in the morning. Also at times hands would go red and itch - no blisters or other artifacts. Eating cold foods make mouth swell and itch. Other parts of body itch with no outward appearance of redness etc. Issue happens at random times no know other cause. No other health conditions. Obtained second dose 4/20/21 Lot Number 039B21A. Itching redness issue no change to date after second dose. Unknown if issue related to vaccine. Only significant event was the vaccine shot. Have not seeked medical treatment. If issue persists or gets worse will seek medical advise.

I left feverish within two hours after recieving Dose 1 of the Moderna vaccine. I also experienced at the same time the odd sensation of smelling dog feces throughout my house's second floor, but no dog has ever been on this floor. Windows were also closed. Both events lasts only between 2-3 hours.

About a week after 1st injection an intensely loud ringing in my ears commenced. The ringing has continued - non-stop - since its onset. My hearing was considered excellent before the ringing started, as I was a professionally-trained ornithologist who could identify bird species by their vocalization - even very faint or distant calling. Now, I have to concentrate to discern the identify of singing birds due to confounding din from the tinnitus. Unfortunately, I did not realize that my recent onset of tinnitus could be related to the covid-19 vaccine I had a week earlier, and I got my 2nd vaccination shot last Wednesday (4/21). The ringing has continued unabated, and I am aware of it every waking moment.

Please note the patient did not receive the vaccine at this hospital so lot # is not available. Submitting to VAERS since patient had an anaphylactic reaction and unsure if vaccination site submitted. 64 y.o. male who arrived to the emergency department for Allergic reaction. Patient developed airway, tongue, lip swelling 5-10 minutes after receiving his second Moderna COVID vaccination today. He was given 2 IM Epipens at site where the vaccine was administered then transferred to ED by EMS. EMS gave him Benadryl and a DuoNeb treatment. Patient reported mild relief. He still reported tongue, oral floor, and throat swelling. Discharged from ED in stable condition after 4 hours of observation

Tinnitus, hissing and ringing for 3.5 weeks at this point. Started suddenly approximately 3.5 weeks following my first vaccine shot and a couple for days prior to my second vaccine.

loss of hearing on the right ear; ear ache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (loss of hearing on the right ear) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ear infection (had a major ear infection back in 2003) in 2003. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DEAFNESS UNILATERAL (loss of hearing on the right ear) (seriousness criterion medically significant) and EAR PAIN (ear ache). At the time of the report, DEAFNESS UNILATERAL (loss of hearing on the right ear) and EAR PAIN (ear ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information included Ear washing. 1 percent Neomycin and 3.5 mg Polymyxin Suspension , 3 drops 4 times a day. Action taken with response to the events are 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.

It has been one week since the injection. I continue to have moderate/hi tinnitus. I continue to have memory problems, thinking challenges, edgy, low grade headache, 'numbiness' of the brain, 'hollowness' of the brain. I feel like the chemicals of my brain have been significantly impacted. The severity of the symptoms are 99% leaning me not to have the second vaccine injection.

20% overall energy reduction, abnormal sweating while walking in 60 degree weather, Abnormal Shortness of breath upon exertion , Tinnitus tone change, Intermittent occasional chest wall cramping that goes away

Two days after receiving second Moderna vaccine, recipient experienced Bell's Palsy effecting right side of his face, right eye dry and unable to blink, droop and drooling right side of mouth. patient was evaluated by his primary physician and no other cause of for the palsy was determined.

Left eye began seeing flashes, almost like sparks, in peripheral vision (outer-side of vision). Occurs in both low and bright lighting conditions. Occurs periodically, once every few hours. Have never experienced this before. Is still occurring as of 5/7/21. Incidentally, day after 2nd dose, I was very tired with flu-like symptoms. I slept almost all day.

CN#3 palsy; left eye ptosis; double vision; This spontaneous case was reported by a physician and describes the occurrence of IIIRD NERVE PARALYSIS (CN#3 palsy) in a 64-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 19-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 21-Apr-2021, the patient experienced IIIRD NERVE PARALYSIS (CN#3 palsy) (seriousness criteria disability and medically significant), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision). At the time of the report, IIIRD NERVE PARALYSIS (CN#3 palsy), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The reporter is the brother of the patient and reported that there were no adverse events after the first dose of the vaccine. On an unspecified date, an ophthalmologist was consulted who confirmed the diagnosis of cranial nerve 3 palsy. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

-Tinnitus occurred within 24 hours of receiving second Moderna Dosage. - Still occurring after 6 days, with no relief. Actual increasing after the 4th day.

I'm experiencing ptosis (droopy left eye) and double vision. The Ophthalmologist diagnosed my condition as "Third Cranial Nerve Palsy" and that it would take 3 to 6 months to cure itself and that sometimes this condition may take as long as a year. If it doesn't cure itself surgery will be required and special glasses to wear.

pt states the next morning when he woke up his left arm was sore and he had fatigue. He started having a humming noise like a ringing in both ears. He had his 2nd dose on 4/12/21 where he had the common symptoms but continued to have the ringing in the ears. Today on 5/10/21 a month later he is still having trouble with his left ear. He says it is completely plugged and feels like there is water in it. He will contact his PCP for medical advice.

Headache, Nausea, Hot Temperature (sweating profusely), coughing (damage to chest), body aches, lethargic, sleeping 16 hours, blurriness, large amount of mucus. Tired, results similar to pnumonia.

3 weeks after injection: Sudden onset of hearing loss in one ear, feeling of fullness/congestion in ear. Absolutely not a bacterial ear infection - no soreness/pain, redness, or discharge. Visited an ENT Dr. and inner ear issue confirmed. Hearing test showed significant loss or hearing (loudness) and loss of word discrimination. Fri, 2-Apr: 1st COVID shot (Moderna). Slightly sore arm, no other symptoms/side-effects, all clear in 24 hrs. Fri, 23-Apr: Relatively rapid (over an hour or so) onset of hearing loss in left ear. Feeling of fullness in left ear, thought it might be congestion. Sat, 24-Apr: No change/improvement in hearing of feeling of fullness in left ear. Sun, 25-Apr: I started to feel dizzy. I developed vertigo, though I did not get nauseous. Slept it off. Mon, 26-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing or feeling of fullness in left ear. Dizziness returned after dinner. Vertigo followed, more severe than the previous night. Unable to walk without help. Vomited and the nausea passed. Vertigo abated a bit, though still present. Slept it off. Tue, 27-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing of feeling of fullness in left ear Wed, 28-Apr: Saw ENT. First hearing test. Test confirmed quite a bit of hearing loss in left ear and some in the right ear. Thu, 29-Apr: 2nd COVID shot (Moderna). No side-effects until evening. Slight body ache, mild headache, maybe a mild fever. Some dizziness after eating. Fri, 30-Apr: Continued mild side-effects from COVID shot. Some dizziness after eating Sat, 1-May: Side-effects from COVID shot completely gone. Left ear noticeably worse. Sounds more attenuated, speech sounded more distorted. Sun, 2-May: No improvement in hearing Mon, 3-May: 2nd hearing test. Test confirmed significantly reduced hearing (volume) and speech recognition in left ear. Agreed to steroid injections to try to clear the suspected fluid retention/swelling. Tue: 4-May: 1st eardrum injection (10 mg dexamethasone) at 11:00 AM. No noticeable effect through bedtime. Wed, 5-May: Woke up with notably improved hearing in left ear (now only 10 or 20% attenuated). However, felt dizzy as soon as I woke up. Dizziness persisted until late afternoon. Thu, 6-May: No dizziness Fri, 7-May: 2nd eardrum injection (10 mg dexamethasone) at 11:30 AM. No noticeable effect through bedtime. Sat, 8-May: No improvement in left ear hearing, mildly dizzy when I woke up, dizziness persisted until late afternoon. Hearing not great in right ear over the course of the day (maybe 20% attenuated) Sun, 9-May: Minimal improvement in left ear hearing, if any. Right ear still partially impaired. A little light headed at times, no real dizziness. Mon, 10-May: Not dizzy when I woke up at 5:30 AM. Made a cup of coffee and ate an oat bran muffin at 6:15. Felt mildly dizzy by 6:30, persisted through the day and started to abate by evening. Tue, 11-May: No dizziness when I woke up. Hearing in left ear marginally improved. 3rd eardrum injection at 4:30 PM. Wed, 12-May: Woke up with improved hearing in left ear, still some attenuation, almost no distortion, still some feeling of fullness in the ear. No dizziness. Thu, 13-May: Woke up with hearing unchanged from Wed (i.e. no back-sliding). No dizziness in AM, though slightly lightheaded. Hearing degraded as the day progressed. Fri: 14-May: Woke up with hearing worse as compared to Thursday. Feeling of congestion/fullness in ears (more on the left than the right). Slightly lightheaded, no dizziness.

17 days post vaccination as the first step in prep for a colonoscopy I experienced a reaction to the laxative Miralax, a 17 gram dose. First sneezing, the a flushed feeling accompanied by tingling and itching in hands and feet, the swelling of the lips, nose and tongue. The flushed feeling turned into a cold sweat and shaking. These symptoms started within 20-25 minutes from ingesting the Miralax and lasted for about an hour and 30 minutes before they began to subside. The puffiness and some pain continued in my face until after midnight, the Miralax was taken approximately 5:45pm I cannot say for certain whether I have ever taken Miralax before, I think so as prep for another colonoscopy over 10 years ago but not certain on that. I am reporting this per my doctor's request.

Reports experiencing complete hearing loss in his right ear 2-3 weeks after his first COVID vaccine. It has not resolved.

Symptoms are variable but some combination troubles me every day since March 6, excepting the twelve days I was on the Prednisone prescription. In general, pain increases during sleeping hours, when I grow stiff and less flexible. I wake several times during the night (almost hourly) dry-mouthed. I don't know if pain wakes me or not. I rise with great difficulty and hobble to the bathroom. Mornings are the worst part of the day, but I find if I keep moving, I loosen up and the general inflexibility goes away, and to some degree, so does the pain. It is never entirely gone. I also find that the pain seems to generally occur during movement and not at rest, although the pelvic pain and upper leg pain has and does occur while at rest. The most regularly-occuring pain is hamstring and shoulder (shot locations). Rising from a laying or seated position has always been the most difficult. Lately, pelvic pain has been rare, and knee pain intermittent.

Initially developed earache, fever sore throat so went to Urgicenter on 3/19. Diagnosed with ear infection and given prescriptions for Cefdinir and Dexmethasone. On 3/27 had not improved & had a rash on left side of face, in/out ear and scalp. Earache had intensified to a stabbing pain. Returned to same Urgent care and was diagnosed with shingles in my left ear. Left side of face had started to droop, particularly left side of mouth and jaw was sagging and swelling. Had lost hearing in left ear. This was if most concern since I already have hearing loss and wear hearing aids. Follow up visit with Audiologist revealed no additional hearing loss from previous tests. After changing medications

confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb brain fog memory issues. very very tired super weak ... second shot, same but with added lower back pain and leg cramps. massive headache, went to the doc, he told me that first event was a stroke. now i have a blockage carotid left side in my neck. sent me for ultra sound them ct scan. waiting to see vascular doc after discovery 80% blockage. sill very tired very weak. brain fog, hands going numb eye sight weaker. bad smell in my nose sometimes., not sleeping well. short of breathe.

Upon arrival for second dose, pt stated that he's noticed some changes in his ears and hearing. He stated that a "high pitched hissing sound" comes and goes. It is predominately in his left ear, his first injection was given in his left arm, but occasionally will get the sensation in his right ear too. The frequency that he experiences it hasn't changed in the 4 weeks since the first dose. He's concerned that the second will make it worse.

The symptoms started 3 hours after the 2nd dose of COVID. I felt pain in my left arm ( the same arm where I was injected ), chills and fever across my body, sweating, numbness and electric tingling in head, dizziness and vertigo with sensation of wanting to vomit, a lot of pain in my joints, watery eyes and pain in my eyeballs, lack of equilibrium and orientation, and other symptoms.

Dizzy spells. There have usually been other factors involved (extreme heat, exhaustion, alcohol) so I've not worried about it. However, in the same time frame I have begun to have a constant ringing in the ears. The dizzy spells are getting worse and today lost me a job. I mentioned it to one of the doctors when he was treating me for a sprained wrist that I got when a dizzy spell caused me to fall down. He blamed the ringing on me being exposed to loud noises. He said the dizzy spells were from drinking and smoking. This was the first time I'd ever seen this doctor and he gave me those diagnoses without any examination.

Person experienced vertigo, vomiting, double vision, low body temp of 95*. Took him to the ED Hospital. It was determined that he had suffered a small Ischemic Stroke. He was given Asprin and Lipitor (Atorvastatin) and an anti nausea medication. Several tests were done as outlined in Item 19 below.

red,hard knot on it; Rashes and hives all over the body; Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow; He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles; Patient was wondering who he should to go to, so someone can can write "Do not give the second dose; Upper lip was really swollen; Upper lip was really swollen; Puffiness around the eyes; burning sensation on his upper lip on the inside; Felt pressure on his face; Swollen eyes; Feeling exhausted; Swollen face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the second episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), FATIGUE (Feeling exhausted), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The patient's past medical history included Stroke (he had a mild stroke 2 years ago on August 27th and his right arm, right leg, and right foot were paralyzed.). Previously administered products included for No adverse event: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EYE SWELLING (Swollen eyes), SWELLING FACE (Swollen face) and FATIGUE (Feeling exhausted). On 15-Apr-2021, the patient experienced the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face) and the second episode of LIP SWELLING (Upper lip was really swollen). On an unknown date, the patient experienced MASS (red,hard knot on it), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDINE ACID REDUCER) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 15-Apr-2021, PERIORBITAL SWELLING (Puffiness around the eyes) had resolved. At the time of the report, BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the last episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow) and FATIGUE (Feeling exhausted) was resolving and GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) outcome was unknown. Not Provided 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. Other non drug treatment include Ice pack to alleviate the Rash. The patient experienced just felt different. The patient rang his HCP who advised him to go to emergency room. The patient was discharged a few hours later.Patient mentioned that he is not allergic to anything and found it strange that he would have severe allergic reactions from the vaccine.During the month of May, there were a couple of times where his face was swollen, upper lip was swollen, rashes and hives on the upper arms and upper thighs. On 07 Jun 2021, his face was swollen again. Patient noticed there were rashes under his arms about two inches long and on the left arm inside of the elbow, there was a very red, hard knot on it. Patient put a cold compression to alleviate the rash. Patient is concerned because he had never been allergic to anything in his life until this incident happened. He received other vaccines like the flu vaccine and he did not experience any side effects from the vaccine. Patient also reported that he has been feeling exhausted everyday.He has not taken any allergy medications since his last allergic reactions. He was currently not experiencing any symptoms.Patient is concerned about exhaustion and the swollen face that he had woken up to three times from 14 Apr 2021- 07 Jun 2021. Healthcare professional advised patient not to take the Second dose. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, Updated events outcome to recovering and Seriousness criteria in events tab,reporter information updated, Historical vaccine in other relevant history updated,Vaccine route of administration updated in events tab and added event (Gait inability) and reporter information.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded

Patient reported that he had the vaccine about two weeks ago and three days after the vaccine he started experiencing a very dry mouth, burning and discomfort. Pt also reported sores in the corners of his mouth that won't heal. Pt said that is has not gotten any better since the symptoms first appeared. He said that this has never happened before and nothing changed in his medical history except receiving the vaccine.

I have developed persistent tinnitus, of a frequency over 8000Hz, and it is 24/7. I visited my doctor today to ask for a hearing test and I've been referred to Head and Neck Dept. I find myself having to use earbuds to listen to white noise during the day to try to drown out the ringing. I have no medication changes, no head injury, no loud noises. I am retired.

Tinnitus (ringing in both ears), treatment: none, This started 45 minutes after of receiving my second Moderna shot. As of today I still have Tinnitus.

Patient presented with angioedema. He stated the day after his second shot, he had what appeared to be 2 cold sores, one on each corner of his mouth. He says each day the swelling has gotten worse. (Presenting from vaccine almost 6 weeks ago) He was advised to seek medical advice, to which he declined. He was then advised that if he would not do that, he should take benadryl and ibuprofen.

passed away; short of breath; unwell & very unwell; extremely thirsty; dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) in a 64-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 Oxygen therapy (Required Oxygen Assistance in the office). Concurrent medical conditions included Diabetes and Brain tumor. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth). The patient died on 16-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information is not provided. Concomitant medication is not provided. Reporter states that the friend stated that the patient had other underlining conditions, patient needed oxygen assistance in the office,friend advised patient to go to the ER and Patient refused Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Ringing in the ears within two days of receiving the second dose. It is constant and most distracting at night time, when watching TV or reading. It has not lessened in any way since it has started. My primary care physician says there is nothing he can do. I noticed other on-line feedback about this side effect after the 2nd dose of the covid vaccine so I wish to report it.

Beginning 1.5 hours after the 2nd Moderna dose, my hands began shaking, and my arm was sore. These symptoms continue today and have not gotten better. Beginning 2 days after the shot, my left foot from my toes to my ankle turned black and green. Beginning 1 week after the shot, my toes turned purple; this has continued on and off since May 5, 2021. Beginning 2 weeks after the shot, the lymph nodes in my neck, roof of my mouth, nose, and ears were swollen and tender. At random times, I would get hot and begin to sweat profusely 2-3 times per day, and my ears would get extremely red. At this time, my temperature would be between 100F and 101F, and my blood pressure was elevated. These symptoms lasted about 4 weeks. Beginning 3 weeks after the shot, I developed a walnut-sized, squishy knot on the inside of the joint of my left elbow. I also began losing the hair in my armpits and have since completely lost all the hair in my armpits and on my legs. Beginning 4 weeks after the shot, I developed a golf-ball-sized, squishy knot on the inside of my right knee, similar to the one that appeared on my elbow. I also developed a walnut-sized, squishy knot on my left knee just below the kneecap. Beginning 5 weeks after the shot, I developed shin splints but had not completed any running or other activities that could explain the tenderness in my shins. Beginning 6 weeks after the shot, I noticed a loss of muscle mass in my arms and legs. Beginning 7 weeks after the shot, I have had severe chest pain three times. Each felt like I was having a heart attack; 2 times were in the middle of the night and 1 time was early in the morning. Beginning 8 weeks after the shot, I began getting lightheaded at random which has caused me to fall multiple times. In addition, I have begun bruising very easily; the bruises take weeks to heal. My left eye is also extremely tender and waters more than normal. Beginning 9 weeks after the shot, I notice that I have begun drooling even though I have never drooled in the past. My gums occasionally feel tender when I brush my teeth.

01/16 Pt was called for status of vaccination. He reported fever, chills, body aches, nausea, diarrhea, temporary loss of taste and soreness at injection site. Pt did not call nor report to ER as advised when sx first occurred. He reported to RN during this call that symptoms resolved on 01/16.

Ringing of ears (tinnitus) starting hours after vaccination and continuing into day 3 after vaccination

STARTED 1.5 HOURS AFTER VACCINATION. BURNING AT SITE. TRAVELED UP SHOULDER, NECK, CHECK, AROUND EAR, SIDE OF HEAD, AND EYE. AREA BURNING THEN WENT NUMB AND LOST SENSE OF HEARING IN THAT EAR. HEARING RETURNED WITHIN 24 HOURS. AREA STILL NUMB. NEVER HAD FEVER OR OTHER SYMPTOMS. OTHERWISE FEELS FINE. PT STATES SYSTEMS IMPROVED EXCEPT SKIN IS STILL NUMB TO THE TOUCH. REACTION REPORTED BY PATIENT'S SPOUSE TODAY 1/20/21 AT 11:58 AM IN PERSON AT THE CCHD.

1.5 HOURS AFTER VACCINATION BURNING BEGAN AT SITE AND TRAVELS UP SHOULDER, NECK CHEEK, EAR, SIDE OF HEAD AND AROUND EYE. WENT NUMB. LOST HEARING FOR ABOUT 10 HOURS. AREA IS STILL NUMB TO THE TOUCH BUT HEARING IT FULLY RETURNED. NEVER RAN FEVER. NO OTHER SYMPTOMS. STATES FEELS FINE OTHERWISE.

Small scotoma inferior vision of left eye very slight/subtle. Retinal examination by Dr in the morning of 1/12/21 showed a left eye cottonwool spot, which corresponded the location of the scotoma. No other retinal infarcts or hemorrhages were present. I have no known risk factors for a retinal vaso occlusive event.

On Friday 1/22/21 9:30 pm patient reports sudden onset of visual changes such as double vision with vertigo. He presented to Hospital to the emergency room. Treatment CT (negative) -blood work then transferred to healthcare facility via ambulance where he had an MRI (negative) and a CTA (negative). He was diagnosed with Lateral Sixth Nerve Palsy. He was intructed to follow with ophthamalogy and neurology and priamry care providers.

Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear . Diagnosed by family practitioner as Bells Palsy

Patient reports feeling "like a cold is coming on, a little odd in my throat, a little odd in my head"

Flushing and pressure feeling in my head/face and ringing in my ears increased immediately after injection. Then proceeded to get a slight noticeable increase in heart rate. After setting for approximately 15 minutes I was released to leave. I mentioned to them that I just lived down the street and told them if I had any further issues or symptoms I would call them. Approximately 30 minutes later I was having a slight lightning of the throat or airway and some slight tightness in breathing. This tightness continued for approximately 2 hrs. I called the clinic and was attempting to get there recommendations but the nurse had left. I was told to get the ambulance personnel. As a prior EMT I felt that an ambulance was not needed at this time. I took 2 ea Benadryl tablets and those symptoms lessened. Some numbness in lips and face, and felt heart beating in lips. That all subsided as well after taking Benadryl. Still trying to get with a provider that could give me advise moving forward. The doctor was busy with an Emergency.

Vaccine taken on 1/20. 1/24 began symptoms of exhaustion, fatigue, headache and brain fog. 1/24 began additional symptoms of decrease /altered taste in mouth. symptoms last 3-4 days.

After about 3 days I developed a very dry mouth. It is like my salavery glands have stopped working. Very bad cotton mouth. Can not eat most foods, only those with high moister content. ****I AM NOT SURE THIS IS A VACCINE REACTION***** I am reporting it just in case others report similar symptoms.

Two days after getting shot started getting ringing in both ears. Has gotten louder high pitched buzzing sound in both ears and still have it

1. One hour after injection severe tinnitus (bilateral) which has persisted 2. FIve hours after injection arm swelling and mod-severe pain at injection site - resolving after 3 days but left with low grade pain 3. Seven hours after injection developed moderate headache, fever to 101 F, and shaking chills that lasted about 4-5 hours, generalized achiness, mod-severe fatigue 4. #1 has persisted, with varying intensity 5. #3 chills stopped after 4-5 hours, took tylenol twice to relieve fever Have persistent low-grade headache 6. I have a photo, injection has given very medially near tendon, remains tender with decreased ROM

2021 ICD-10-CM Diagnosis Code H90.41 Sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side. Onset of right side diminshed hearing the morning of Sunday Jan. 31st, 2021. More pronounced by Wednesday am Feb. 3rd, 2021. Seen at the University for Medical Sciences in the outpatient clinic. No significant wax in either canal. Bilateral type A tympanograms. Markedly abnormal audiogram compared to base line obtained by same facility approx. 8 months earlier. 60 DB loss across all hearing ranges right ear only. Left unchanged.

caller states the pt lost hearing in his right ear. pt went to his audiologist and his test shows his hearing is 0-5 percent hearing loss. He was referred to Doctor and his appt is in 2 weeks. He is on high dose of prednisone taper meds.

History Chief Complaint Patient presents with ? Elevated Blood Pressure ? Dizziness multiple times a day Patient who presents to the emergency department today for evaluation of hypertension, head pain, blurry vision, and neck pain. He states about 6 months ago he had open heart surgery. Since that time he states that he has been having intermittent episodes of blurry vision usually lasts a few minutes and resolve on their own. Today however, he notes that the blurry vision lasted for greater than 5 minutes and he started to become concerned. During that time he also began to experience some pain in his neck and a headache in the back of his head. He took his blood pressure at that time and noted that his systolic blood pressure was in the 190s. This alarmed him and so they called EMS. When EMS arrived they rechecked his blood pressure again and his systolic blood pressure was over 200. Upon arrival here to the ER he states that he is feeling much better and his blood pressure appears to be better as well. At this time he states he still having some right shoulder pain and a little bit of right-sided neck pain but he does state that he had his Covid vaccine yesterday in his right arm. Currently patient states he still has a little bit of a posterior headache but it is much improved. He denies any fevers, body aches, chills, cough, chest pain, shortness of breath, palpitations, lightheadedness, nausea, vomiting, abdominal pain, diarrhea, constipation, dysuria, hematuria, or swelling of the lower extremities. He has no known drug allergies. ? ED Course: I discussed physical exam finding with patient. Apparently most of his symptoms have already resolved at this time. His blood pressure is back down to 142/98. I still advise since he was having some weird blurry vision I would like to get a CBC, CMP, troponin, EKG, and a chest x-ray. Patient agreeable to this plan of care. We will also continue to monitor his blood pressure to ensure that it does not spike back up. Patient's work-up was unremarkable. His blood pressures down to 123/60 and states he is feeling much better. This point time it sounds like what happened was a hypertensive urgency. I advised him he needs to contact his PCP and schedule close follow-up discuss if anything further needs to be done. At this time though he is safe to be discharged home with strict return precautions. ED Course Procedures Clinical Impressions as of Jan 20 2235 Hypertensive urgency Plan: New Prescriptions No Prescriptions at Discharge. Disposition: Discharge

Minutes after shot felt woozy and light headed. As my fifteens was up , I started getting severe heightened sense of smell and could smell body odors from people all around me. Threw up before exiting building in rest room.Needed to get out of building ASAP fast for fresh air . Breathing-20 degree fresh air maskless helped but still felt weak so wife and medical aids brought me inside to isolated area on a cot to rest and take vitals . When I was sick with COVID-19 in September 2020 I had same issues with heightened smell and taste before I lost them for three months.

JAN 21 received moderna vaccine and he stated his ear was hurting - went to ENT, was later dx with shingles by dermatalogist. Was prescribed anitvirals - completed within 7 days , Feb 5th.

I awoke at 3:00 a.m. this morning (Feb 16) with itching in my skin beginning to be felt. By 3:30 am it was widespread and developing a rash over much of my torso and arms. This appears now to have run its course. My nose and lips swelled. My nose became hard and numb. Both now less swollen than early on. My body temperature was 95.4 degrees. I felt dizzy when standing, and there were waves of mild nausea. I had major nasal congestion and could breathe only through my mouth. My CPAP machine (which I use all night every night) was on before the 3 am wakeup, and I donned it again when I returned to bed at around 4 am. Nasal congestion now has improved a lot. On two occasions (maybe around 4 am) I noticed a minor wheeze. On a couple of occasions I coughed lightly, and it was a sore one from the chest. I still have some dizziness, and now an intermittent headache. Before going to bed last night I took two Naproxen Sodium PM tablets for some neck pain.

1) Tinnitus - The principal adverse event was a significant increase in my tinnitus, to levels I hadn't experienced since I originally developed the condition following a viral infection in May 2006. I first noticed mild tinnitus the day after the injection and it gradually became worse over two weeks. [not recovered] 2) Sore arm - I had a hard time lifting my arm the evening of the injection. I recovered in a day. [recovered] 3) "COVID arm" - My right arm became red swollen and itchy for about three days, starting a week after the injection. [recovered]

Anaphylaxis, hives, whips around waist and butt, itching ,swollen lips . Was given epic Pen and Benadryl , Pepsi?s and steroids 24 hours and it returned when to doctors office and received another steroid shot

miembro viril esta muerto-virile member is dead; bad taste in mouth; loss of taste; legs are very weak especially in the knees, sometimes not able to stand in his feet; pain in the arm; A spontaneous report was received from a consumer who was also a 65-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and "miembro viril esta muerto" meaning "his virile member is dead" or having erectile dysfunction. The patient's medical history included a hernia intervention on 20 Jan 2021, HIV positive, and has headaches. Products known to have been used by the patient included a multivitamin and HIV medicines. Patient states that he received "injections for headaches in his brain, " however no medications are specified. Patient has no known allergies. On 25 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, one day after the mRNA-1273 vaccine was given, the patient noted that he had a little pain in the arm but nothing to worry. On 28 Jan 2021, the patient stated that he started to have a bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and erectile dysfunction. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and having erectile dysfunction is unknown.; Reporter's Comments: Based on the current available information, the absence of an other etiologies and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine

Vaccine - Moderna COVID-19 EUA, dose 1. Patient received the first dose on 2/1 around 6PM PST in his left arm. By 2/2, the patient experienced arm soreness, and by 9PM, he felt pain in his right ear. On the morning of 2/3, the patient woke up with hearing loss in his right ear, slight dizziness and nausea, but was able to work and eat with normal appetite. On 2/4, the patient woke up with general malaise, dizziness, lightheaded feeling, GI discomfort (minor diarrhea and vomiting), sweating, and chills. The patient still experienced hearing loss. The patient was fatigued, and had no appetite; stayed hydrated and slept most of the day. The patient gradually became less fatigued and gained appetite from 2/5-2/8. On 2/8, the patient visited urgent care for his ear. The NP on site observed yellow fluid in the patient's right ear and prescribed amoxicillin and flonase generic. The patient took the amoxicillin for 10 days and flonase generic for 14 days. On 2/22 (D21 post vaccine), the patient saw his PCP, still reported hearing loss, but the doctor did not report any findings. The patient received a referral for the ear specialist. To date, 2/23, the patient has hearing loss in his right ear.

First reported rash around site of injection that developed about 8-9 days post vaccination. I have now developed a large canker sore on the inside lower lip.

Rash above right eye the day after the injection. Numbness on the right side around ear and my ear feels stopped up. I am putting an antibiotic cream on the rash and taking ibuprofen for discomfort.

Chills, Sweats, Low Grade Fever, Dizziness, Shakes, very bad injection site pain. Blurry vision, trouble sleeping.

I developed a swollen lymph node in my right side neck just under lower jaw at rear. This presented itself as strong jaw pain like a bad cavity and soreness at the lymph node. I have a sore throat and have not been able to hardly chew or swallow without pain. This is still going on as of 3/3/21 but seems to be easing up a bit. I have a Dr. appointment on 2/9/21 to check it out.

Woke up and the room was spinning, carefully walked to the bathroom for drink of water, had to sit and wait for the room to stop spinning. When I tried to lay down it started spinning again and I found I could not focus on single spot. At 9am The spinning stopped but I feel very weak.

Patient started experiencing dizziness, blurred vision, a "rush", increased blood pressure, feeling hot, tingling in arms, and appeared flushed. Occurred approx. 15 minutes after vaccination. Patient was given water and a snack and was told to take deep breaths. Blood pressure was monitored and returned to normal before patient exit. Patient was assisted by wife. No medications were given.

Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021. On the morning of March 4, 2021, I was still experiencing a right sided headache as well as double vision. I was no longer able to drive at that point. I took my blood pressure digitally at the local pharmacy twice where it was 200/104. I went home to call my physician and also have my wife take my blood pressure manually. My blood pressure at that time was 214/106. I went to the hospital where they examined me and then discharged me with a General Headache without a know cause. I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning. My visit the next day showed an elevated blood pressure, double vision, and a continuing headache. My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd. Later that day my blood pressure was down, but still not in the normal range. The following day, March 6, 2021, I was still having the same issues despite the changes in medication. I took my blood pressure at 6 pm and it was 199/104. I immediately went to another hospital where I was admitted as a "stroke alert" patient in hypertensive emergency. I am presently being followed as an inpatient in order to get these issues under control.

Myasthenia Gravis, treatment and outcome pending. Ptosis, vertical diplopia, jaw fatigue Positive acetylcholine receptor binding, receptor modulating and receptor blocking antibodies

Symptoms began 3/5/21 and resolved by 3/8/21, included headache, fever, sore throat, fatigue, turning pale, feeling 'woozy', body aches, sweating, nightmares, ear ache and nerve "jumping" bottom lip. Self treated OTC tylenol, ibuprofen, oral fluids.

Really bad ringing in both ears started a couple weeks after vaccination, have never had ringing in my ears before and it seems to be getting worse.

3 days after second injection of Moderna COVID vaccine my tinnitus increased in volume to a level I could barely hear and never experienced before. It was difficult to sleep. By morning the ringing had decreased in volume, more like I normally have. I thought it might have been a coincidence, however my wife has now had a similar reaction to J&J vaccine and I have seen others reporting the same issue. My prior reaction to the first and second shots were soreness at the injection site which resolved after 4-5 days.

Patient waited at the pharmacy for 15 minutes with no problems at all. Patient's wife called back 2 hours later around 12:43pm and said the patient noticed a metallic taste in his mouth about 15 minutes after his vaccination. No other adverse issues. I called patient back around 2:15pm and he was resting with no other issues per consult with wife. Advised patient's wife to seek immediate medical attention if any other adverse events developed (rash, swelling, itching, tickle in throat any difficulty breathing, facial drooping or anything out of the ordinary). Also advised patients wife to contact us if there were any changes or if the patient had to seek medical treatment.

Body aches, fatigue, chills, fever began approximately 18 hours after second dose; these symptoms (except for fatigue) eventually resolved. Have had a high pitched ringing or hissing in ears since receiving the vaccine; did not make the connection to the vaccine because tinnitus was not disclosed as a side effect, and no questions about this side effect were raised in follow up surveys. Yesterday, while reading an article about someone, committing suicide, I saw a reference to tinnitus. Only now do I see many reports online of this side effect.

Began about 21 hours after injection with weakness and mild muscle aches all over. Over next 2-4 hours weakness and aches worsened and also felt scratchy throat and sometimes mild chills. Slept about 3 hours, woke still feeling sick, took 2 Tylenol and had light supper, then slept all night. Better but still weak next morning (3/24), rested in day, nearly normal by evening 3/24.

12 hrs after shot around midnight, Dizzy when eyes open, Body ache , Joint pain , Fatigue, Chills, Sinus pressure , Slight Headache and Thirsty, 5 glasses of water in 5 hours, lasted 24 hours. Off work on Thursday 3-25-21. Friday 3-26-21 at 1am symtoms gone except for back pain. Saturday 3-27-21 1am Night sweats x 3 till 5am. Went to work Saturday

Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29

Vaccine reaction and Uvular swelling. Shot site remained sore, swelling on left side of throat and tongue. Treated with Diphenhydramine and Methylpredisolone sodium succinate injections at 5:27 p.m., March 26th. Prescribed famotidine, 20 mg and methylpredisolone, 4 mg. Recommended benedryl, 25 mg, every 6 hrs. Recommended follow up with primary doctor. Doctor did not want second covid shot administered. Relief immediate from treatment.

6 hours after shot my throat closed a bit and had trouble swallowing. . . I took 2 benedryl and drove to ER at Hosp. . . They said it wasn't too bad. Observed me for 2 hours . . I went home . . I asked for Epipen script.

Left eye was not closing; Left face drooping; Extreme pain behind his left ear; Can't blink; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left side of his face was drooping/facial paralysis, extreme pain behind his left ear/ear pain, can't blink/corneal reflex decreased, and his left eye was not closing/eye movement disorder. The patient's medical history included COPD, congestive heart disease and chronic problems with his back. No relevant concomitant medications were reported. On 4 Jan 2021, 17 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021 the patient had an unexpected reaction. He got up that morning and felt fine, but as the day went on, he noticed that when he spoke, the left side of his mouth was not moving, then he noticed his left eye was not closing and that side of his face was drooping. He was not in any pain at that point. He made an appointment to see his general doctor the next day, 22 Jan 2021, after the exam he was diagnosed him with Bell's Palsy (BP) and referred him to a neurologist and ophthalmologist. The earliest he could see the ophthalmologist back was next week and he could not get the neuro to call him back. His doctor prescribed him prednisone which he completed after 7 days but said the BP symptoms have not improved. Then on Saturday, 30 Jan 2021, he started feeling extreme pain behind his left ear. Everyday the pain got worse. His pain medications were not helping the pain behind his left ear. He could not see out of his left eye and he could not blink. The event left side of his face was drooping was considered as medically significant. Action taken with mRNA-1273 in response to the events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not provided. The events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Sore injection site, 102° fever, eyes hurting, sensitive to light, elbow, knee & ankle joint pain. Lasted about 10 hrs, 10 AM to 8 PM. Took 2 tylenol at 730 PM.

Patient had covid vaccine and then 1 day later, developed worsening PVCs. Patient has a history of PVCs and Vtach for which he has a pacemaker. Patient is historically very symptomatic with his PVCs. These worsened over the course of a week which lead to worsening substernal chest pain and he presented to the ER on 3/15/2021 and due to his history of CAD, was hospitalized for observation, discharged on 3/16/2021. He had labs, echocardiogram while in the hospital. His metoprolol was increased to help decrease symptomatic PVCs. On 3/9/2021, patient developed chills, difficulty swallowing and the sensation of his throat and tongue being swollen, along with some generalized itching. He presented to the ER 3/9/2021 due to these symptoms and these symptoms resolved without interventions and he was discharged home. He then developed lower lip swelling on 3/15/2021.

Approximately 12 hrs after the vaccine injection I experiences mild flu like symptoms. The flu like symptoms went away around 24 hrs after the injection. The following morning around 3:00 AM I woke up with severe lateral movement. I was not able to walk, experienced severe vertigo and nausea. These symptoms began to reduce 24 hrs later. At this point double vertical vision began and lasted for approximately one week. Currently I have mild vertigo 18 days after the injection. I am able to drive safely and the vertigo symptoms are reducing day by day.

Have had increase in Tinnitus. Have had partial loss of hearing in left ear, across all frequencies, and particularly at low frequencies. I test my hearing at home. Have had hearing loss in both ears from 2013 thru 2017 but that resolved in 2018 and 2018 thru now hearing has been excellent.

Vaccine administered on 3/26/21. First symptom of fatigue noticed on 3/28. Late evening 3/29/21 had early indication of sore throat on left side. Awoke 3/30/21 with continued fatigue and sore throat that only indicated when swallowing with pain extending to behind left ear. Started and continued salt water gargle to date. Visited Primary Care Provider on 4/1/21 for evaluation. PCP evaluated and said to continue gargle and Ibuprofin as needed for discomfort. Fatigue and sore throat while swallowing has continued with some periods of lesser indications. Contacted PCP office on 4/7/21 to report continued conditions and asked if there was a possibility of a recurrence of Mononucleosis (diagnosed in 1986) PCP ordered Mono Test which came back positive today 4/8/21

On day 4 after the first dose, I woke up with a whistling noise in my ears. I never had this condition before. After some research, I learned that Tinnitus is a rare but known side effect primarily for Moderna but also for Pfizer Covid vaccine. The whistling sound is not extremely loud but it's definitely there and has made sleeping at night difficult. Twelve days later, it still there and it's quite bothersome. It gives me pause to take the second dose scheduled for April 29.

blurred vision and sweats within 5 minutes of injection. +throat tightness. stomach cramping started several hours later.

Tinnitus- Current and continuous during all day beginning 2 days following 2nd injection. Causes sleep disruption. Experienced almost daily, but not all day tinnitus beginning a few days after 1st injection.

Approx 10 minutes after receiving vaccine, pt called out for help from his car in the waiting area. Was monitoring the area and went to assess patient. He stated he felt faint. O2 sat 94%, pt diaphoretic, pale, drooling, tongue protruding from mouth, eyes open, but difficult to arouse, unable to respond. Epi administered and EMS contacted. Pt then lost consciousness. Grossly diaphoretic, clammy to touch, in and out of consciousness, pupils small but reactive, BP 84/48, R16, pulse 68. Unable to obtain O2 sat as monitor wouldn't register values. Lost consciousness again. Not responding to sternal rub. Gave 2nd dose of epi and maintained airway with jaw thrust. Pt regained consciousness

Sharp pain in left ear; on a off for a couple of minutes Pulsating pain in left ear and left should, three seconds apart for about two minutes Pulsating pain in left thigh Mucus in throat

week after second dose patient skin became pink, eyes swelled almost shut, feeling of picky feeling inside Patient currently taking Xyzal

I received the Moderna Vaccine on March 11, 2021. Ten days later, on March 21, i noticed the first hives on my legs. By March 23, the hives had spread across my body and the injection site on my left arm was inflamed. I went to the doctor's office and the prescribed Benadryl and Hydrocortosone cream. Five days later, the hives were still active and my upper lip swelled up. I contacted my doctor's office via a tele-medical call and they prescribed Allegra and Zyrtec also. By April 5, the swelling of my upper lip had gone down and my injection site was better, but the hives were still all over my body. I went back to the doctor's office and they precscribed Prednizone as well. After taking prednizone for 5 days and other medication for seven days I was able to stop all medications without the return of the hives.

Two days after my first Moderna Covid-19 vaccination, on 03/05/2021 8am when I woke up my vision was slightly bleary as the day progressed it got worse at 4pm I had double vision. This lasted 24 hours until the next day.

Developed Tinnitus or ringing in ears. 24/7. Hard to determine if ringing is in both ears or predominately in right ear.

given Moderna Covid vaccine and begin feeling the need to swallow more, clear throat, 50 mg of Benadryl taken by mouth with no relief sent to the ER

stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-076248 (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 these events, a causal relationship cannot be excluded. .

Ten days after first dose patient developed NAION and edema of superior optic nerve left eye, had inferior visual field defect. Ten days after second dose of vaccine developed NAION to left eye a second time, with vision loss of superior visual field. This resulted in count fingers vision in the left eye. Treated with inpatient hospital stay, IV steroid infusions. Pt is now on steroid taper and has 20/200 vision in left eye. Patient is still legally blind in that eye. Work up including MRO of brain and orbits, CT angiogram were normal. Labs, ESR, CRP and platelets were also normal.

Headache & significant increase in Tinnitus both ears started 3 - 4 days after second Moderna vaccine shot.

General ache, tiredness. Injection site sensitivity. Tinnitus in both ears started a couple of days after the first injection. Continues to date.

Tinnitus was at a manageable level, like crickits in background, After the shot, a high pitch ringing started and it has not stopped. I will not take the 2nd shot due to not knowing how worse the tinnitus might elevate. I have had tinnitus for approx 2.5 years ( with some hearing loss ), but I have been able to train my brain to handle this. The tinnitus is 24x7, non stop, only relief is when you actually get to sleep. It's been a bigger issue to deal with since I took the Moderna shot. Had I known it would have affected tinnitus, I would not have taken the 1st shot. My daughter advised me to google moderna/tinnitus. I did and read all the reports on that. I wish I had read that first. I looked at the list of side effects, tinnitus was not on the list, so it never occurred to me it would be an issue. It is a big issue when you deal with it everyday of your life.

I want to be really clear. Within 6 hours after the 2nd shot, I developed extreme fatigue. By about 9 pm, I experienced chills, moderate muscle cramps and headache. I expected this might happen based on news reports and articles of same. By about 6 pm the next day, these symptoms completely resolved and I felt perfectly fine. Sometime within the next week (I estimated date/time), I developed a high-pitched ringing in my left ear. On May 30th, I saw my primary care doctor who prescribed Montelukast; and told me to continue my OTC Zyrtec and Flonase Sensimist. In addition, he suggested OTC Sudafed, which I have not started as it makes me anxious and disturbs my sleep. I have never before had tinnitus and the onset was sudden.

Tinnitus - a noticeable, constant ringing in my left ear. Noticed in mid-April, following second dose. No treatment at this time but will inform my PCP.

Had tinnitus prior to first moderna vaccine, aprroximately 7 days after vaccine noticed tinnitus has worsened.

SIGNIFICANT WORSENING OF PRE-EXISTING MILD TINNITUS. ONGOING AS OF TODAY'S DATE. TEMPORARY L HIP PAIN WITH INFLAMMATION UNTIL 4/3/21

Site of injection (left shoulder) was slightly sore after about 4 or 5 hours. Shot was administered at 8:05AM. Felt fine until about 6:45PM. Noticed aches and painst beginning in neck, shoulders, and a slight headache which came and went. at 8PM, was very tired and began to feel somewhat lightheaded. Went to bed and felt chills. Awakened six or seven times during the night to urinate. Was a little dizzy each time I rose from the bed. Also felt feverish and took my temperature. It was elevated to 99.3F, which for me is definitely elevated, since it is usually no higher than 98.6 and is often around 97.9F. Felt very tired the next morning and had continued mild aches and pains and occaisional shingles-like stabbing pains in rotator cuff of left arm , mastoid bone behind right and left ears, and occaisional random stabbing pains in earl lobes. The pains were mild to moderate on occaision. Left arm was a little sore during movement, especially near the shoulder. Felt very tired throughout the day and went to bed at 8PM the day after the shot. That evening in to nightime when I would get up to go to the bathroom, I began to feel better and after midnight of the second day, I felt pretty much back to normal. The lightheadedness, aches and pains, and tiredness all went away by the morning . I would also report that I ate normally during these effects and did not suffer any nausea or feel like vomiting at any time.

Left mild to profound sudden sensorineural hearing loss 3 weeks after COVID vaccine. Associated tinnitus.

A few hours after my second shot I got a mild headache, tired, and a bit blurry vision. The next day things got worse with high fever, bad headache, and very tired. The bad side effects went away after 4 days but since then I often feel tired with a mild headache and a little chest pain now and then. Before my vaccination, I played tennis 3 times a week, each time I played about 2 to 3 hours continuously without feeling tired. But after the vaccination, it takes only 15 to 30 minutes for me to run out of breath so I have to slow down to catch my breaths. My stamina is adversely effected after my vaccination . I'm afraid that I have a case of Myocarditis, a condition similar to Pericarditis, which is an inflammation of tissue surrounding the heart, that caused by the vaccine.

With in 10 min. after receiving the vaccination I started to wheeze, cough and itch my eyes. I immediately had trouble breathing with the feeling that my throat was closing. That's when the EMT's took me to the ambulance and gave me an injection and other treatment that I can not remember and then I was transferred to the hospital. At the hospital I received more meds and within a short time other then being tired I felt better. I went home and went to bed a slept to the next morning.

I received the COVID Vaccine on March 11, 2021. Ten days later, on March 21, i noticed the first hives on my legs. By March 23, the hives had spread across my body and the injection site on my left arm was inflamed. I went to the doctor's office and he prescribed Benadryl and Hydrocortosone cream. Five days later, the hives were still active and my upper lip swelled up. I contacted my doctor's office via a tele-medical call and they prescribed Allegra and Zyrtec also. By April 5, the swelling of my upper lip had gone down and my injection site was better, but the hives were still all over my body. I went back to the doctor's office and they precscribed Prednizone as well. After taking prednizone for 5 days and

metallic taste almost immediately after the second dose, also explained that it happened with the first dose too but a little later (30 minutes) and lasted for 3 days

2-3 days of swelling of throat/neck with a sensation of a foreign body in throat then lost voice or raspy voice for weeks.

Sudden Sensorineural hearing loss Woke up one morning and no hearing in the right ear. Family physician treated for possible sinus infection. No results from treatment. Then referred to ENT and verified Sudden Sensorineural hearing loss. Prednisone increased after hearing in the left ear also became diminished. After weeks of prednisone, left ear stabilized. No recovery of hearing in right ear,

Pt presented to pharmacy about 7:00pm on 6/22/21 stating he had gotten a rash on both arms and a place around his left eye about 3 days after his second Moderna Covid shot that he received on 6/17/2021. Both arms had sparse, red spots on them. On the side of his left eye he had it was a little red and looked a little swollen. He stated they itched some and his "itch" pills at home did not help (he could not tell me the name of them). He did state that about 3 weeks ago he had taken some steroid pills for poison ivy. He did not fill them at this pharmacy and could not tell me the name of them. He said the spots and the swelling on his eye were worse in the mornings. Told pt I would contact his primary care doctor tomorrow and he said he would as well.

headaches, chills and fever. I had really achy joint and couldn't even pick a glass. I had a taste of metal. It lasted about 24 hours.

passed out due to pain from the shingles; went blind for two weeks; neuropathy in left eye; Shingles progressive around his eyes/ shingles on his face and on his eye; tooth fracture; haemorrhoids; pain in right arm; calcium deposit build up; injuring neck; injuring back; still has pain above left eye; bad tooth ache; toothache and cavity on left side; teeth have become more brittle; fungal rash; low back pain on the right side; teeth have been a real problem; sleep all day; loosing teeth; constipation; gaining weight; muscle spasm; allergies; big knot over his eye; nerve damage above left eye; someimes breaks out in a rash with red spots; fell; rash on outer right leg that was painful; pain in my hips; tired, worn out , exhausted; fever for at least 2 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), NEUROPATHY PERIPHERAL (neuropathy in left eye) and OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) in a 65-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. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera. Concurrent medical conditions included Kidney stones (Kidney stones), Blood uric acid increased, Myeloproliferative disorder, Postherpetic polyneuropathy, CML, Itching, Haemochromatosis and Polycythemia vera. Concomitant products included MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]), ATORVASTATIN CALCIUM (LIPITOR), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]), AMOXICILLIN, LORATADINE (CLARITIN [LORATADINE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ALLOPURINOL, OXYCODONE, PREGABALIN (LYRICA), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS, UBIDECARENONE and DOCUSATE SODIUM for an unknown indication. On 27-Mar-2017, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 15 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles) (seriousness criterion medically significant), BLINDNESS TRANSIENT (went blind for two weeks) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy in left eye) (seriousness criterion medically significant), OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) (seriousness criterion medically significant), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), PAIN IN EXTREMITY (pain in right arm), CALCINOSIS (calcium deposit build up), NECK INJURY (injuring neck), BACK INJURY (injuring back), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), TEETH BRITTLE (teeth have become more brittle), FUNGAL SKIN INFECTION (fungal rash), BACK PAIN (low back pain on the right side), TOOTH INFECTION (teeth have been a real problem), SOMNOLENCE (sleep all day), TOOTH LOSS (loosing teeth), CONSTIPATION (constipation), WEIGHT INCREASED (gaining weight), MUSCLE SPASMS (muscle spasm), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), NERVE INJURY (nerve damage above left eye), RASH MACULAR (someimes breaks out in a rash with red spots), FALL (fell), RASH (rash on outer right leg that was painful), ARTHRALGIA (pain in my hips), FATIGUE (tired, worn out , exhausted) and PYREXIA (fever for at least 2 hours). The patient was treated with TERBINAFINE HYDROCHLORIDE (TERFINABINE) for Fungal infection, at a dose of 250 mg. At the time of the report, LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), BACK PAIN (low back pain on the right side) and PYREXIA (fever for at least 2 hours) had resolved, NEUROPATHY PERIPHERAL (neuropathy in left eye), PAIN IN EXTREMITY (pain in right arm), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), FUNGAL SKIN INFECTION (fungal rash), SOMNOLENCE (sleep all day), MUSCLE SPASMS (muscle spasm), RASH MACULAR (someimes breaks out in a rash with red spots), RASH (rash on outer right leg that was painful) and ARTHRALGIA (pain in my hips) had not resolved, OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), CALCINOSIS (calcium deposit build up), BACK INJURY (injuring back), TEETH BRITTLE (teeth have become more brittle), TOOTH INFECTION (teeth have been a real problem), TOOTH LOSS (loosing teeth), WEIGHT INCREASED (gaining weight), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), FALL (fell) and FATIGUE (tired, worn out , exhausted) outcome was unknown and NECK INJURY (injuring neck), CONSTIPATION (constipation) and NERVE INJURY (nerve damage above left eye) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.

Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Trouble moving or getting out of position; Pain in his arm; Feeling some symptoms including some chill; A little bit of blood after the injection; Pain during injection; When he has the headaches, he cannot even be driving; Headaches and has bad vision during his migraines; Bad vision during his migraines; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) in a 65-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. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. Concurrent medical conditions included Sleep disorder and Eczema. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once a day. On 12-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection). On 18-Mar-2021, the patient experienced MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill). In 2021, the patient experienced IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) (seriousness criterion disability), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines). On 21-Mar-2021, MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines) had not resolved and INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter causality was updated from not reported to unassessable. 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 events, a causal relationship cannot be excluded. however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied follow-up.

separation of the vitreous detachment in my right eye with a little bleading; Eye bleeding; MIgraine arc aura in the left eye; Aura in left eye duration 5 min periodically; Color blotches in left eye duration 5 min periodically; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITREOUS DETACHMENT (separation of the vitreous detachment in my right eye with a little bleading) and EYE HAEMORRHAGE (Eye bleeding) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (allergic to Seldane.), Drug allergy (strong reactions to opiates), Kidney function abnormal, Enlarged prostate since 2019 and Calcium pyrophosphate dihydrate deposition disease. Concomitant products included LORATADINE (CLARITINE) for Allergy, COLCHICINE from 2019 to an unknown date for Calcium pyrophosphate dihydrate deposition disease, TAMSULOSIN HYDROCHLORIDE (MAXFLO) from 2020 to an unknown date for Enlarged prostate, CALCIUM CITRATE from 2010 to an unknown date for Osteopenia, COLECALCIFEROL (D3) for an unknown indication. On 25-Feb-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced AURA (Aura in left eye duration 5 min periodically) and CHROMATOPSIA (Color blotches in left eye duration 5 min periodically). On 16-Apr-2021, the patient experienced MIGRAINE WITH AURA (MIgraine arc aura in the left eye). On an unknown date, the patient experienced VITREOUS DETACHMENT (separation of the vitreous detachment in my right eye with a little bleading) (seriousness criterion medically significant) and EYE HAEMORRHAGE (Eye bleeding) (seriousness criterion medically significant). The patient was treated with AZELASTINE for Nasal congestion, at an unspecified dose and frequency. On 20-Apr-2021, AURA (Aura in left eye duration 5 min periodically) and CHROMATOPSIA (Color blotches in left eye duration 5 min periodically) had resolved. At the time of the report, VITREOUS DETACHMENT (separation of the vitreous detachment in my right eye with a little bleading), EYE HAEMORRHAGE (Eye bleeding) and MIGRAINE WITH AURA (MIgraine arc aura in the left eye) outcome was unknown. Treatment information was not reported. Ophthalmologist advised the patient that no procedures were required for the event, separation of the vitreous detachment in my right eye with a little bleeding. 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-Jun-2021: A follow up was received on 10-MAY-2021 Which had patient's demographics, medical history, concomitant medications and event (Migraine Aura). On 04-Jul-2021: No new information was provided. On 05-Jul-2021: Additional event, separation of the vitreous detachment in my right eye with a little bleading, was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENHYDRAMINE 25MG IM INJECTION AND MONITORED FOR SIGNS OF ADDITIONAL ALLERGIC RXN/ANAPHYLAXIS. S/S RESOLVED S/ DIPHENHYDRAMINE AND TIME. PT WAS ALSO MILDLY HYPOCAPNIC ON ETCO2 MONITORING AND STATED THAT S/S COULD BE DUE TO MILD ANXIETY.

Both eyes became very itchy on Saturday January 2. Sunday morning January 3, my left eye was very red. Both eyes very dry and itchy. By noon Sunday, left eye redness gone. Both eyes itchy. Monday the 4th, ithcy gone but both eyes very dry. By Wednesday the 6th all back to normal. No other symptoms related to vaccination during this period.

On Jan 11, 21 immediately after the vaccine I felt my heart wad high. Then after an hour I felt dizzy for couple hours. At night on the same day, I had chills, temperature 101 F. Had Tylenol. Next day on January 12, 21 felt feverish, body pain, tired and lost some food taste. So slept all day. Same later in the evening started coughing. January 13 and 14, 21 felt tired and dizzy when I stand up. Had cough syrup and today it has improved. However, still feel dizzy but hope to recover gradually. Daughter is listed as my doctor. She is my daughter. She watches me but she is not my official physician.

Sore arm 5 hours after shot, low grade fatigue and fever and blood shot eyes 10 hours after shot, at 12 hours ever to 100.1, body aches, chills, joint pains, sore swollen neck glands, heart rate increased to 98 from 64 and O2 saturation dropped to 93% from 98 %. After 24 hours, aches and pains were 80% better, heart rate and O2 saturation the same and fever 99.3 orally.

5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9:00 am. - progression of previous symptoms with addition of discomfort on chest area, severe acid reflux. 1:00 pm. - further progression of previous symptoms with addition of pain in neck and jaw area and headache, occasional feeling of shortness of breath. 7:00 pm - all symptoms began to progressively decrease in mostly the same order of onset. 11:00 pm - Continued decrease in symptom severity. 1/24 @ 8:00 am - Symptoms subsided with exception of minor degree of swallowing difficulty and reflux.

About one hour after the shot I experienced a very mild, but noticeable, tingling sensation on my lips/mouth. I did not notice any tingling on my tongue or throat, or anywhere else on my body. The tingling sensation last about three hours and never recurred.

Severe chills the night of the shot, teeth chattering, couldn't get warm; next afternoon, chills resumed mid afternoon. Decided to get into bed to warm up. Walking up the stairs and holding both rails - left and right - I blacked out, fell forward and hit my mouth on the edge of one stair, and my ribs on the edge of another stair. Lots of blood,, chipped a tooth, lots of swelling in my mouth, deep laceration on my face and very sore ribs. Saw doctor the next day. No stitches required and ribs are bruised only. I will need dental work done to repair my teeth.

8 hours after injection started with extreme fatigue, chills , sore arm. Over next 7 days experienced severe symptoms : fatigue, myalgias, chills, arm pain, nausea, vomiting , abdominal pain, mental fog, insomnia, anorexia, change smell.

Myalgias, arthralgias, headache, photophobia, sweats, chills lethargy all lasting twelve hours improved with ibuprofen

Tinnitis since vaccination, moderately severe and not a sufferer of Tinnitis in this long of term period before.

Body aches, fatigue, swollen face/eyes, rash all over body, with welts, cough, itchy . Headache. I still have swollen bilateral eyes!

About 2 hours after receiving the COVID shot, while seated in my recliner, watching TV, I began to feel a sickened feeling with tightness in my chest and heart area. The sensation lasted for about 15 minutes then completely subsided. About 4 hours later upon retiring to bed before falling asleep, I began to experience a abnormal sound in both my ears. I covered my ears and the sound remained unchanged. I do suffer tinnitus and am used to ringing in my ears. This was more of a rushing metallic sound similar to the rushing water but high pitched and metallic. This anomaly lasted for around 30 minutes.

-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank. With change of position was able to get comfortable after which pain resolved. This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation. Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present

Bell's Palsy, drooping and extreme pain started behind ear on February 22. Getting worse each day. Extreme headache immediately after injection and continues to this day.

Fatigue and smell and taste were off. Everything tastes and smells like its stale or old or almost no smell. Because the symptoms were similar to covid I had a rapid test and a pcr test done. BOTH came back negative

I had very severe cf starting in 1996. It remained severe for approximately 5 years after which it was semi acute for another 5 years. After that i would have periodic relapses several times a year for varying lengths of time. For the last 10 years irt has been much better with occasional symptoms. However i received my second dose of the Moderna vaccine on february 23, 2021 and had a strong flu like response. I am now experiencing a mild to moderate relapse of my cf. brain fog, difficulty tracking with my vision, chills, etc. when i had severe cf i had this symptom where my scalp would feellike it was in a spasm. That has returned. I have dealt with tcf long enough to know when it occurs and this is definitely a response to the covid vaccine.

Seizure around 4:40 am on 2/27/2021. Shaking, eyes drawn in, fists clenched, some foaming at mouth, unresponsive. Ambulance called to the home. Transported to hospital.

He complained of dizziness the evening of the shot. He went to bed and when he woke up the next morning he was having double vision. Is eye drifted off to the side and he was too dizzy to get up. He was taken to the hospital. They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason, so they could not determine for sure if he had a stroke. They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side. The nurse practitioner saw him today and she reports he is doing very well now. He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow.

Customer had a vasovagal rx nearly immediately after receiving vaccine at approximately 1210. pulse of 50 when taken. Drooling, diaphoretic. unable to arouse when calling his name. did sternal rub, moved patient head to upright position and customer started to waken. asked for cold water and drank readily. started to ask coherent questions. sat with patient approximately 20-30 min before allowing him to leave.. He told us after the fact that he has passed out before when giving blood. Must lie down when giving blood or shots. He was not concerned because he has experience this same reaction . Pt left on his on accord at 1300. Did not tell staff of this problem before he got the vaccine.

Patient was given Moderna vaccination and was waiting in the post-vaccine area. Patient reported to the associate that he was feeling funny. The pharmacist was called and the patient reported feeling light headed and dizzy. While talking the pharmacist the patients eyes rolled back in his head. The pharmacist held his shoulders and his hand and continued to speak to the patient. He regained consciousness. The patient was able to move to his knees and then to lie on his back on the floor with his feet elevated. The injection site was clear and smooth. He had no fever. After resting 15 minutes his color improved and was conversing well. He was able to sit up and his blood pressure was taken. His blood pressure was within normal range. He sat for another 15 min and drank some juice. He was feeling well enough to go home in the care of his wife.

Approximately 5 hours after receiving my first Moderna vaccine I developed a cough, fever, chills, runny nose. I assumed these were some of the symptoms as a result of the vaccine. I monitored my fever for several hours. The cough persisted for the next 9 plus days and I didn't have any desire to eat or drink liquids. I lost my taste and smell during this 9 day period. On February 25 my wife and I took a Covid-19 self test at pharmacy. Also on this same date I went to urgent care My wife was concerned about my labored breathing. My vitals were checked and I requested a chest xray. I was given 2 prescriptions. 1 for Prednisone 20mg and Ventolin.

My right ear has been fluttering . About 10 hours last night, and continuing now. I had a concussion around 1990 from a bike accident with no helmet. I hit the ground on the right side of my head which effected my left ear and a lot of hearing loss. I?m theorizing that the moderna vaccine has triggered something and now my inner or middle right ear is pulsating. I?m thinking it?s blood flow I?m hearing. But whatever it is, it?s annoying

Sore arm, entire back pain and stiffness, Neck muscles sore and stiff, Fever, Chills, pain in shoulder joint, eyes pounding and extreme light sensitivity, Most of the adverse reactions gone, except sore shoulder joints and stiff neck muscles

Beginning approx 36 hours post inoculation, had glandular swelling in neck under jaw, arm pits, (both sides), the concerning thing was the rear of my tough swelled and felt like it had canker sores on it, both sides back my my molars, both sides, down into my throat. Benadryl relieves some of the swelling which would be quite bad without.

Moderna Covid-19 Vaccine EUA Persistent rash on both arms, hands, fingers, and face Swelling behind left ear, swelling around left eye on face, severe swelling on both hands, and fingers. Severe itching on arms. Treatment used cortizone cream, and Tylenol. Allergic symptoms persisted for 8 days, gradually improving after day 6.

fatigue, body aches, chills, poor appetite Narrative: Patient is a 65 year-old-male who received the Moderna COVID-19 vaccine on 2/12/21. On 2/23/21, patient contacted his primary care nurse to inform he was having side effects from the vaccine, including headache, fever, chills, fatigue, body aches, rash on top of his feet that extends to his knees, bumps on his chest, bleeding from nose, mouth, and gums, and hyperglycemia. Patient reported took aspirin and Airborne for the symptoms. His primary care provider ordered bloodwork to be done the next day. On 2/24/21, patient had the following labs done: BMP (WNL except for glucose which was 363 mg/dL), CBC with diff (notable for very low platelets of 1 K/mm3), and PT/INR/PTT (all WNL). PCP examined patient and noted no obvious rash on chest, skin fair but not pale, no significant bruising or acute bleeding but petechial rash from the knees down. Patient had been sent home to rest while awaiting lab results. Once lab results returned, patient was contacted and instructed to go to the local ED due to his critically low platelets. Patient went to the local ED, bloodwork showed platelets of 4000 at that time. He was tested for COVID-19 on presentation and was found to be COVID-positive. Patient was diagnosed with idiopathic thrombocytopenia purpura. He was given a total of 4 platelet transfusions as well as IVIG for 2 days and prednisone for 4 days. Platelets reached 78,000 before patient was discharged on 2/26/21. At the time of this reaction, patient's active medications included: metformin, testosterone cypionate inj, allopurinol, atorvastatin, carvedilol, dulaglutide, empagliflozin, lisinopril, aspirin, calcium/vitamin D, multivitamin. He also received the TDaP vaccine 1/21/21 (22 days prior to the COVID-19 vaccine). Post-discharge follow up with primary care provider on 3/5/21 revealed patient feeling better, no bruising, bleeding, fever, or chills since discharge. Patient finished the course of oral prednisone started in the hospital. Glucose remains elevated. PMD to recheck CBC for platelets once patient is done with his mandatory quarantine for positive COVID-19 test results.

Developed sore throat on March 3, then had negative strep test. Sore throat persisted and saw ENT with normal exam. Lost sense of smell and taste on March 7th. Negative Covid test on March 10. Developed swelling in left leg on March 9, and had ultrasound on March 10 that showed DVT. Was hospitalized on March 10 and had second negative Covid test by PCR.

At 7pm, on 3/16, the patient sat down to watch tv and was having difficulty seeing the tv. He then went to his computer and could not see the type on the screen. The loss of sight seemed to be in both eyes. The center of his eyes were blurry. His blood pressure was 190/110. This was the highest it had ever been. He went to urgent care and on his way, his sight returned. Sight had been altered for about 1/2 hour. An EKG revealed PVC. Urgent care sent him to the hospital, where his BP was 163/110 (higher than normal). ER doctor thought pt had a TIA. REturned home at 3:30am, slept most of 3/17. On 3/18 he felt better, but BP was higher than normal at 163/95

After experiencing chills, fever, hot flashes and stomach aching, extreme swelling around the left eye occurred to the point that there was no vision possible. This swelling lasted for more than 2 full days. Began to subside several hours after taking prednisone to reduce swelling.

Tinniitus - Ringing in ears: Annoyance level varies daily and hourly. Maximum level in left ear 5 out of 10. Maximum level in right ear 3 out of 10.

joint pain, swelling arm/feet/legs/neck, headache, lower back pain, blurry eye, insomnia, neuropathy in arms and legs, itchy

Sensorineural hearing loss (SNHL) of left ear. Started on morning of 3/4/2021. On-going - Sudden idiopathic hearing loss, left ear On-going - Tinnitus of left ear Dr. Notes - 3/26/2021 No subjective improvement in hearing loss and nonpulsatile noise since completing oral steroids and having undergone 3 intratympanic injections Is interested in completing the fourth injection as discussed before reassessing, this was done today without any issues Independently reviewed MRI IAC results. Shows inflammation of the left cochlear nerve without mass lesion. Radiology also felt that there was inflammation of the 7th cranial nerve as comparison with the right. Discussed these findings with patient and provided copy of report.

At 15 minutes post administration he started to feel his lips tingle. Patient was observed for an additional 5 minutes and at 20 minutes did feel like his tongue was swelling. Initial dose of Epi was given immediately. Patient was then transported to the hospital ER. While in transit he did require an additional dose of Epi. Once in the ER he was treated with steroids and Benadryl and was discharged later that same day.

I developed severe tinnitus after receiving the second Moderna vaccine and it has not subsided. It's interfering with my daily life and has adversely affected the quality of my life. Today I'm going to see an ENT doctor for evaluation. Now I see and hear that many people are experiencing the same loud ringing tinnitus after receiving the Moderna vaccine. I can only make the correlation that the loud ringing that goes on 24/7 began after getting the vaccinations.

Monday 2/29 in the morning felt a little dizzy Tuesday 2/30 in the morning felt something was not right. Felt a little more dizzy Wednesday morning had full blown vertigo. So bad I could hardly stand up. Never in my like had I ever had vertigo. At 3:00 pm Two Doctors adjusted the left ear twice to get the crystals right. No issues with the right ear. The left ear is the one I have ringing in. Had to use a neck brace for 2 days and slept in a chair for two night. No more dizziness. But for 4 weeks was not myself

Very sore arm (1 hour after injection. Lasted for more than 24 hours) Fever/chills (overnight following injection) Severe headache (24 hours) Tinnitus (started several hours after injection and still continues more than 24 hours later) Dizziness when standing up (24 hours) Dry mouth

Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up. The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded

Swelling of throat and tongue. Chewed some Benadryl Tablets, about 20 minutes after taking Benadryl issue went away

TIRED CHILLS THIRSTY SLIGHT FEVER ACHES PAINS VERY SLEEPY (2 HR NAP IN AFTERNOON) (1 HOUR NAP AFTER DINNER) 9 HOURS OVERNIGHT SLEEP

fever for 2 days, treated with Tylonol; headache for 4 days treated with Aleve or Tylonol; severe malaise for 3 days treated with bed rest; moderate to severe toothaches treated with Tylonol and Aleve; severe fatigue for 7 days treated with rest at first and then mild exercise; fatigue continues

After first dose I experienced light headed ness After second dose I experienced muffled hearing in both ears five days later

3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. felt he was getting very hot. itching down back of his head into his arms. reported pain in his throat, dificulty swallowing, felt like something was stuck in his throat. felt he had an upset stomach but did not think he was going to vomit. denied trouble breathing in his chest. no lip swelling, no eyelid swelling, no hives. pulse regular. 74. BP 150/70. O2 sat 98%. 0.3mg Epi given to right thigh at 1432. pt complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. BP 180/90 at 1435. reported "hammer to his head" headache at 1437. cotninued blurry vision and globus. BP 172/94 at 1438. 0.3mg Epi given to left thigh at 1438. 1440 pt getting very shaky, handoff given to ambulance.

weakness; inability to rise; frequent urination; lack of taste for food/loss of sense of taste; inability to produce a bowel movement; inability to walk/inability to reach bathroom; blood sugar higher than normal; blood pressure higher than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (inability to walk/inability to reach bathroom), ASTHENIA (weakness), DYSSTASIA (inability to rise), POLLAKIURIA (frequent urination), AGEUSIA (lack of taste for food/loss of sense of taste) and CONSTIPATION (inability to produce a bowel movement) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (10 day hospitalization and administration of oxygen therapy) on 01-Nov-2020. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (inability to walk/inability to reach bathroom) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSSTASIA (inability to rise) (seriousness criterion hospitalization), POLLAKIURIA (frequent urination) (seriousness criterion hospitalization), AGEUSIA (lack of taste for food/loss of sense of taste) (seriousness criterion hospitalization) and CONSTIPATION (inability to produce a bowel movement) (seriousness criterion hospitalization). In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to AGEUSIA, CONSTIPATION, DYSSTASIA, GAIT DISTURBANCE and POLLAKIURIA, and then from 03-Mar-2021 to 06-Mar-2021 due to ASTHENIA. On 06-Mar-2021, GAIT DISTURBANCE (inability to walk/inability to reach bathroom) and CONSTIPATION (inability to produce a bowel movement) had resolved. On 24-Mar-2021, ASTHENIA (weakness), DYSSTASIA (inability to rise) and AGEUSIA (lack of taste for food/loss of sense of taste) had resolved. At the time of the report, POLLAKIURIA (frequent urination), BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment History includes ER visit, hospitalization, IV fluids, IV medications, "injections for blood sugar", EKG, scope to check for blood clots, physical therapy. Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus; Sender's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus

Moderna COVID-19 Vaccine EUA. Chills, Fever, Aching Joints, Aching Muscles, Runny Nose & Eyes, Shortness of Breath

Ringing in both ears after first dose. This subsided just before the second dose. After the second dose ringing came back in both ears. As of now ringing is mostly in my left ear and occasionally both ears. After either dose, I experienced headache for a couple of days.

Suffered stroke like symtems on April 12. Severe headache ,right arm tingly and numb, sissy when I got from chair, vision seem blurry. Took 800mg of ibproferin and things improved. Right hand Remains slightly numb

received 2nd dose today and approximately 2 minutes after receiving vaccine, became unresponsive. I was present and carried behind the curtain and placed the on the floor. began to posture and have tonic clonic movement. Pupils were fixed and dilated. This lasted nearly 3 minutes during which time his airway and C spine was protected and an ambulance was called. regained consciousness and stated that he has passed out from vaccines several years ago. does not have a history of seizure. A complete neuro exam was performed: intact as tested, cerebellar exam is intact, speech is of a regular and steady cadence, transported to ED

I've had Tinnitus for several years, but only a mild case. Since receiving the 1st vaccine it has gotten increasingly worse

Pain on gums; Body aches; High temperature (102F); Blistering on lips ("like a giant cold sore, but not a cold sore"); Brown coloration on mouth; Woke up in a puddle of sweat; Dryness on mouth; Soreness on mouth; Bad respiratory infection ("worse than before"); This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPRIN), METOPROLOL, TRIMEBUTINE MALEATE (BUMETIN [TRIMEBUTINE MALEATE]), EZETIMIBE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST SODIUM (MONTELUCAST), ALBUTEROL [SALBUTAMOL], AZELASTIN [AZELASTINE] and GLYCERYL TRINITRATE (NITROLINGUAL) for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) (seriousness criterion medically significant). On 24-Mar-2021, the patient experienced PIGMENTATION DISORDER (Brown coloration on mouth), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth) and ORAL PAIN (Soreness on mouth). On 27-Mar-2021, the patient experienced LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")). On an unknown date, the patient experienced GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)). At the time of the report, RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth), ORAL PAIN (Soreness on mouth), LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")), GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)) had resolved and PIGMENTATION DISORDER (Brown coloration on mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) 102 F. Patient reported that patient did not seek medical attention for any of the reported symptoms. Patient reported that "patient received some Tylenol, at the beginning after symptoms following second dose". No additional information reported. Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.

approx 30 mins after dose given patient started to feel tingling and burning in his tongue. He had a similar reaction after his first dose of Moderna on 3/12/21. vital signs taken and 50 mg of Benadryl given PO. Patient monitored in clinic.30 mins after administration patient said he felt like the tingling and burning was less and improving. Patient to return to clinic if symptoms worsen.

At the time and date stated, My whole body turned bright red in color, skin swelled and got hives all over, except for my face did not well or get hives, but my lips did start to swell some. I did NOT have trouble breathing. I went to the Emergency room. The medications prescribed: Benedryl, Famotidine (pepcid) . I did take the medication for five days as prescribed, symptoms did subside. The ER doctor did recommend Not to receive the second dose of the Covid-19 vaccine due to possible more adverse affects or problems.

Six days following his Moderna vaccination he began to notice some pain in his neck. On the seventh day post vaccination, he noticed he was unable to drink well from a straw because his mouth would not close normally. His symptoms did not improve, and on the ninth day, he noticed drooping of his face and went to the ER, where he was diagnosed with Bell's Palsy. He has improved some now and states, "I'm getting better every day." He continues to receive physical therapy and reports his speech is improving, and he is now able to close his eye on the affected side.

Almost immediately got 'woozy' and fell off the chair onto the floor. His eyes were glassy and his hands and arms were jerking. He was able to get back up on the chair and said that he was ok, but he looked pale and felt a little clammy. He sat on the chair and drank some water while we were waiting for the EMS. He said that he had breakfast but no lunch. While he was sitting on the chair his eyes glassed over again and he made some grunting sounds. EMS came checked him out and said that his vitals where okay, and he wanted to drive home which was 15 miles away. The EMS gave him a report as to what happened and his vitals incase he needed to seek further medical attention.

Increased ringing of the ears (tinnitus) and flare up of fibromyalgia. Approximately 2 ½ hours after vaccine dose was administered. For the next couple of days, I am monitoring to see if the flare up will subside. This was my first dose of the vaccine.

PATIENT CALLED TODAY 4/26/21 CONCERNED ABOUT THE SECOND SHOT IN THE MODERNA VACCINE SERIES. HE STATED THAT AFTER THE FIRST DOSE ON 4/20/21 HE EXPERIENCED A FEELING OF BEING OVERWHELMED THAT LASTED ABOUT 3 HOURS. HE FELT A SENSATION OF THROAT AND LIP SWELLING, TINGLING OF THE TONGUE AND FEELING OF DISCOMFORT. PATIENT STATED THAT HE HAS HAD REACTIONS TO POLYETHYLENE GLYCOL IN THE PAST.

Within 3 minutes of getting COVID-19 moderna first shot, he started getting warm and then hot, tingling, knot in the throat, dizziness, and called a safety medic over, they took vitals, then doctors showed up , and a medic gave him 2 Epi?s on the thighs left and right leg, low blood pressure and high pressure, then they transported him in ambulance and he has severe neck pain. They wanted to give a third epi shot in the ambulance but they didn?t do it. They monitored him at the hospital and received an ekg no fluids.

Watery eyes rentlsly coughing fatigue vomiting diarrhea dizzy shortness of breath weakness in muscles in arms wheezing head ache. Chils fever it was just like I had covid-19 again

He got his vaccine, within 24 hours later he had hives, his lips and face swelled up, he had a low grade temp of 99.8 having chills and wanting to stay warm and lay in bed with multiple blankets. After his daughter noticed it about 2 hours later they went to the ER, and they gave him a steroid, Benadryl and a steroid and gave him IV Pepcid until the swelling went down and he felt better. They gave him 6 days worth of Benadryl, and steroids which he did take for that. After 6 days and after 24 hours he broke again in the same manner and they told him that it was okay as long as he was breathing well. He then went to the UC and he bought OTC Benadryl which he continued. Then exactly 30 days after he went to the ER on 4/24/21 he broke again with the lips swelling, hives, temperature was normal but feeling achy and the same symptoms he had from the beginning. He went to his PCP and he has him now on steroids, Benadryl and the Pepcid when needed as well. He takes the Benadryl as needed and then the symptoms subside and the reaction comes back. If he does not do the Benadryl until later this evening then his lips will start tightening and then swell.

numbness in right side of face after shot next morning same side of face drooping and trouble opening right eye

Next day mouth and lips swollen, eyes puffy, top of tongue swollen up. Ate breakfast, cheeks swelled up again, today 5/6/2021 still cheeks a bit swollen. Has not had this reaction with moderna shot only second.

Non-Arteritic Anterior Ischemic Optic Neuropathy event, unspecified laterality, no treatment available, partial loss of sight in left eye.

Patient sitting in observation room, received first Moderna vaccine at 1010 am. Stated to observation staff that he is feeling dizzy and trouble reading.. Patient stated that he did not eat and that he did not take any medication. VS at 1105am BP 124/66, HR 100 and O2sat 96%. 1108 BP 123/67, HR 98, O2sat 98. VS@ 1111am BP 100/79, HR 94, O2sat 97% encouraged to drink and eat some crackers..VS @1114 BP 109/68,HR 104,O2sat 99%. VS @ 1117 BP 124/62, HR 105, O2sat 99%.Patient continued sitting and stated some head pressure on the top , not sure if HA, but no dizziness. 1125 Patient went to restroom and stated improprovement ,decrease in HA/pressure. VSS BP 124/64, HR 96 and O2sat 97% Patient felt 1145 am.comfortable going home at 1145.

Left neck gland connecting to left ear is swollen and earache. Has lessened everyday. Almost gone at this submittal. Self care, 325 mg aspirin first day. Nothing taken since.

A few weeks after receiving the second dose of the vaccine my ears started to ring. Went to my PCP who referred me to an ENT . However, I don't have an appointment till June 21.n/n

Approximately 30 minutes after vaccine resident c/o dizziness, right sided headache, blurry vision, weakness. Resident also talking but making no sense.

intermittent right throbbing headache, lasting one hour associated with nausea no vomiting. Headache recurs every 2 hours. He has a headache 5-6 days. During the headache he is warm, However, on 5-26-2021 when he woke up, he had same headache but at this time he also had pain in the right lower jaw on the right side of his neck. This is nondescript and persisted at this time

MY tinnitus had been an afterthought after a few years when it first occurred in 2004. Soon after the 2nd moderna vaccine, it has gotten progressively worse. Met with my ENT a few days ago and he informed me he has had numerous patients complain about tinnitus after receiving a COVID vaccine. Some of my friends and relatives have also mentioned the same thing. The ringing in left ear is constant and is getting worse. Since a hearing test on 5/26 showed I have "Asymmetrical sensorineural hearing loss, unilateraL, with restricted hearing on contralateral side", he has ordered a "MRI BRAIN+INTERNAL AUDITORY CANAL, W/WO CONTRAST. My MRI appt is 6/3.

symptoms start 5/31/21. R facial droop, R blurred vision, inability to close R eye. Presented with irretractable n/v, dyspagia, and obstipation on 5/27/21.

Acute brain stem stroke; Lost vision in both eyes; Lumps on biceps of both arms; Couldn't swallow; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM STROKE (Acute brain stem stroke) and BLINDNESS (Lost vision in both eyes) in a 66-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 AMLODIPINE and LOSARTAN for Blood pressure management, ATORVASTATIN for Cholesterol, POTASSIUM for Hypokalemia. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BRAIN STEM STROKE (Acute brain stem stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Lost vision in both eyes) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Couldn't swallow) and COVID-19 (Covid-19). In February 2021, the patient experienced NODULE (Lumps on biceps of both arms). The patient was hospitalized on 22-Jan-2021 due to BLINDNESS and BRAIN STEM STROKE. On 01-Mar-2021, BLINDNESS (Lost vision in both eyes) had resolved. At the time of the report, BRAIN STEM STROKE (Acute brain stem stroke), COVID-19 (Covid-19) and NODULE (Lumps on biceps of both arms) outcome was unknown and DYSPHAGIA (Couldn't swallow) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Covid-19 positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

He had numbness in face and lips that started 15-20 minutes after the vaccine. The altered facial sensation lasted for the remainder of the same day. Altered sensation was bilateral and described as his tongue and lips felt heavy and swollen. Did not see any swelling, however. Had difficulty talking, eating and drinking and compared it to having the face numb after having dental work done. This altered sensation resolved by the next day and pt. reports back to 100% of normal. He has always had tinnitus but states his ears have been ringing a lot more since his first Covid vaccine.

36 hours of fever, chills, rigors, sweats. Generalized pain and malaise. But this is not the adverse event I wish to report. There was hyperacusis with tinnitus. The tinnitus has continued for 3 months. Also the vaccine has caused my wife to mumble. I can hear her speaking, but have to ask her to repeat herself - this is a daily occurrence. Previously I had mild tinnitus that was only audible in quiet situations when I was inactive (laying in bed before falling asleep. It is now constant.

3/26 temp started of over 100F x3 days, severe ache in every joint, hard to concentrate or remember; on 3/28, started rash all over body so called MD, they did COVID-19 test which was negative; that afternoon, rash went up neck and side of face -went to Urgent Care, had elevated pulse (120 bpm) so did EKG and other tests, got IVs hooked up and provider thought he was having a heart attack so transferred from clinic to ER -received steroids and rash went away almost immediately, determined was not a heart attack, believed instead a side effect from COVID-19 vaccination. lingering effects of fatigue, shortness of breath, ears ringing. now has new diagnosis of asthma and on inhaler.

March 1 to March 11, 2021: Light-headedness, presyncope events progressively worsen for 10 days. Continuous symptoms of Myocarditis such as heart palpitations, arrhythmias, and irregular pulse. Tachycardia and Bradycardia. Some chest discomfort. Occasional blood pressure spikes and drops. Sudden onset Glaucoma in left eye over two months following vaccine. March 11 Admitted to Emergency room, High blood pressure peaks at systolic 205 mm Hg. Pulse irregular and drops to 30 beats per minute in Emergency ward. Cardiac arrhythmias evident. Several episodes of presyncope over few hours.

Ringing in ears noticed approximately 6-7 hours after injection, intensity increased for approximately 18 hours then plateaued, and has remained at this plateaued level to the present with minor changes above and below this level. I had not been exposed to any loud, sudden, or unusual noises at any time for many days prior to injection.

Dehydrated; Collapsed; Cardiac death/the patient woke up and then grab it's chest and collapsed; Started having heart issues; Chest pain; Lose it's appetite; Thirsty; Short of breath/got very winded; Fatigue/ very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DEATH (Cardiac death/the patient woke up and then grab it's chest and collapsed), DEHYDRATION (Dehydrated) and CIRCULATORY COLLAPSE (Collapsed) in a 66-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 CHLORTHALIDONE, LOSARTAN POTASSIUM, MELOXICAM, METOPROLOL SUCCINATE, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE SODIUM), TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HCL), RIVAROXABAN (XARELTO), AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and TADALAFIL for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEHYDRATION (Dehydrated) (seriousness criterion hospitalization), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired). On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Collapsed) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The reported cause of death was Cardiac death. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydrated), CIRCULATORY COLLAPSE (Collapsed), CARDIAC DISORDER (Started having heart issues), CHEST PAIN (Chest pain), DECREASED APPETITE (Lose it's appetite), THIRST (Thirsty), DYSPNOEA (Short of breath/got very winded) and FATIGUE (Fatigue/ very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive and inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 vaccine due to the events was not applicable. The reporter informed that the patient had received both doses of mRNA-1273 vaccine. He first lost his appetite and started feeling thirsty on the following day after vaccination, which worsened progressively for the next five days. The patient then started having chest pain, was short of breath and experienced fatigue. He got very winded when he went to the bathroom and felt very tired for the next two days, When he went to the hospital, the doctor said that he would need to be admitted if he doesn't feel well. On a Wednesday, the patient went to the hospital and an ECG was done. The reporter informed that when the doctor compared it with an ECG from few days before, he could not believe it was of the same patient's. The patient was taken to the ER (emergency room) and was them transferred to ICU (intensive care unit) as he was dehydrated. Dehydration was treated and at the time the patient started having heart issues. By Friday, the patient started doing better and the doctor discussed discharging him. On Saturday, when the patient woke up he grabbed his chest and collapsed. The reporter informed that they were not able to get an autopsy but the death was assumed to be cardiac death. It was reported that the patient passed away approximately nine days after receiving the second dose of the vaccine. The reporter further informed that the patient was in good health and had a full 'cardiac work' prior to his vaccination. Company comment: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding medical history and course in the hospital is required for further evaluation.; Reported Cause(s) of Death: Cardiac death

My left ear started popping up. Went to my primary doctor and prescribed ear droops. This problem continue after treatment. My hearing abilities decreased due a this adverse effect.

Anaphylactic reaction, Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of, eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP, STEROIDS, MULTIPLE MEDS

Patient was in waiting area after vaccination and after a few minutes it was noted that his head had hyperextended and his eyes rolled. Laid on floor as he was unresponsive. Mask removed and gurgling noise and saliva noticed in his airway. Vitals assessed and it was detected in both his carotid and radial arteries that there was not pulse. CPR initiated. After only two compressions patient opened his eyes and started breathing on his own. He was awake, not oriented with a weak pulse. Patient provided juice sitting up in case this was diabetic reaction. EMS arrived. They did an EKG. Patient denied being transported to ER. Patient was released to care of wife at 12:30 who was instructed to bring him to ER if any symptoms reappeared.

PATIENT EXPERIENCED ISSUES WITH SOME LIP SWELLING AND PRESENTED TO THE PHARMACY ON FRIDAY JANUARY 19TH IN THE MORNING. HE HAD VISIBLE SWELLING ON ONE SIDE OF BOTH LIPS . HE PURCHASED SOME DIPHENYDRAMING 25MG OTC AND LEFT. ACCORDING TO HIS WIFE VIA PHONE TO US (ON JAN 26 6PM) HE HAD BEEN ADMITTED TO THE ER AND WAS ON A VENTILATOR DUE TO SEVERE SWELLING OF HIS LIPS, NECK AND TONGUE. HIS AIRWAY HAD BECOME COMPROMISED AND HE WAS STARTING TO EXPERIENCE NAUSEA AND VOMITING. HE WAS IMMEDIATELY INTUBATED AND PLACED ON A VENTILATOR EVEN THOUGH HE WAS STILL CAPABLE OF BREATHING ON HIS OWN. DRS WERE FEARFUL OF MORE SWELLING AND WANTED TO SEDATE HIM AND BEGIN TREATMENTS.

About six minutes after the vaccination, while sitting in the clinic, I experienced a feeling like I was about to lose consciousness, together with salivary gland activation and heavier breathing. This lasted about one minute and I did not pass out. But about 25 minutes later, while driving home (alone), I experienced the same thing but for about 5 or 6 minutes. Fortunately I didn't pass out. About an hour after the shot I felt sort of back to normal.

Chills, nausea, headache, fatigue. Side effects started approximately 24 hours after first injection. Chills lasted approximately 8 hours. Side effects resolved within 24 hours. I had been diagnosed with Covid prior. Tested positive on 1/6/21. Symptom started 1/2/21. Mild Case. Fatigue, headache, nausea, dry cough, Acted like a real bad Sinus Infection. Post Nasal Drip. Loss of taste and smell. No Fever at any time. Blood Oxygen levels fine (96% - 99%). Vitals fine and stable. Doctor prescribed double dose (11 days) of azythromiacin.

Swollen lips and a extreme soreness of the skin on the inner lips. Areas of the inner lip skin seemed to blister as if burned and sloughed off. No, I have never had lip fillers, botox or other lip injections. My care provider prescribed a 6 day steroid pack. The swelling stopped and reversed shortly after the first dose was taken. My inner lip skin healed and was normal after 5 days. I would like to know if your recommendation as to whether I should get the second shot or not? I'm sure I could get the steroid pack in advance in case I have a similar reaction to the second shot.

Waking up at 3:30am Friday the 5th it was difficult to open my eyes, like my eyes were glued shut. When I finally opened them everything looked crystallized, I couldn?t see the tv which was on but it was brighter in that area, I couldn?t make out anything. I closed my eyes for a few minutes and opened them with the same results. I closed my eyes about 4 times and then finally I could make out everything . The only thing different that I took was the vaccine and a packet of Thera Flu. Nothing else has happened since except a sore arm which lasted 4 days

Approximately 15 hours after the injection I experienced very sore arm, fever, chills, muscle aches, headache, sinus congestion, and loss of taste. All symptoms began to subside within 24 hours of occurrence except for sense of taste.

I experienced dry mouth really bad. My breath has been really rough on me, very dry. I called my PCP to follow up with him on my situation. I used Biotine mouth wash since the vaccine. I will see my PCP on 02-11-2021 for follow up status. I will be going to see my dentist Monday 02-15-2021.

Client anxious about receiving first dose. Said he checked with his doctor as he has multiple antibiotic allergies. His doctor told him to get a COVID vaccine. He received the vaccine and was asked to wait 30 minutes. After a 15 minute wait, he stated he felt chest tightness, swelling in his eyes, face and neck. His blood pressure was elevated at 180/100 and his heart rate was 150. He felt hot/cold and felt he was going to pass out. Cool cloth to forehead and comfort position. after 5 minutes his blood pressure back to 140/80 and pulse down to 100. He continued to state his face/neck and chest were swelling and felt tight. He continued to talk without lack of oxygen. He asked an ambulance be called. He was taken to a local hospital for evaluation and was released home. No medications were given and no face/neck swelling were noted by healthcare workers. Family states he is home and doing well.

These reactions started 15 days AFTER the 1st Moderna vaccination: Feb 1, 2021 Left eye swollen shut; within hours - right eye & face swell, hives form on neck, arms, trunk. By noon, jaw was tight. Went to ER, prescribed diphenhydramine 25 mg, famotidine 20 mg & prednisone 20 mg for 3 days. Feb 2, 2021, large welt like (some bigger than dollar-size coin) swelling on head & right arm. Ears swell Feb 3, return to ER, given liquid corticosteroid in higher dose said to last 52 hours. Feb 4 hands swell, heartburn feeling in chest, light headed, overall body weakness. Begin running temp (under-arm) (between 100.5-100.8) which lasts until afternoon the following day (Feb 5) Feb 6, feet swell, Feb 7, upper lip swells; visi

wife reports - chills, increased thirst, headache, achy, tachycardia - heart rate up to 180 - states had to use "emergency medication"

Tue - normal arm pain from shot, chills, in the evening and following day, extreme fatigue and chills the following day (wed), first night (tue) - salivary glands reduced or stopped saliva - extreme dry mouth, following day (wed)okay. Thu morning, woke up fine.

Beginning five days after vaccine administered: Extreme swelling on lower eyelids and on foreskin of penis. Penile symptom resolved within a week; eyelid swelling persists. Concurrently, widespread dermatitis (hives?) over most of body: most severe on both sides of abdomen and under both arms and legs. Extreme itchiness, especially at night. Was prescribed 5-day run of Prednizone at hospital Emergency Room on 1/31 , with minimal relief. Dermatological symptoms persisting as of today 2/13.

Metallic taste in mouth. Tastes similar to aspirin. Tingling feeling on lips that has a numbing slight burning effect. Total body itches. Pain in entire left arm like it has been punched at about a level 4/10 ain.

Temperature spiked from 97.2 to 102. Fever broke 45 hours after shot, but left with bad headache and cough. Took another 24 hours for headache to go away. Cough still exists. Still little appetite. Things that I normally would like, I don't want or don't taste just right. Having to force myself to eat. It was worse than when I actually had Covid-19 in March 2020.

Significant increase in tinnitus starting about 10 days after the injection. First observed in right ear and then in the left ear. This is a long time 20 year sufferer of tinnitus. The observation is a very significant change in the level experienced. Concerned about having the second injection and impact it would have on quality of life if this does not subside.

pt stated that later the day after receiving the vax that he started having pain on the left side of his head. The pain went from jaw to temple. He wasn't able to speak for 3 days. On 2/17/2021 he went to the hospital. They thought he may have Bell's Palsy so the they did a XRAY and CT. They were not able to find anything other than facial swelling so he was discharged and told to come back if he did not get better and they would make him an appt w/ an ENT. He started taking Aleve. He no longer has constant pain but his mouth still hurts when he opens it. He will contact his PCP to let her know what happened and to let her know that he will not be taking his 2nd covid vax dose.

Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was sitting in observation and his head and eyes rolled back. He was observed to go into a shock state, possibly seizure for a few minutes. After a few minutes, patient regain orientation and was alert and was able to answer questions before the ambulance arrived. Patient left with the ambulance to the emergency room.

Systemic: Fainting / Unresponsive-Severe, Systemic: shortness of breath-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was sitting in observation when he suddenly had his head and eyes rolled back. Patient's daughter alerted the pharmacist on duty that he felt like he couldn't breathe. Patient went into a possible seizure. His eyes rolled back and his body went stiff. After a few minutes, patient was alert and oriented enough to answer questions coherently before the ambulance arrived. Patient went on the ambulance.

Patient presents to the clinic for evaluation of itchy eyes and bilateral eyes swelling that started on saturday after getting the vaccine. Also, states that his left arm was very painful over the weekend. He did not take any medications for it. Pt does not report any other s/s like fever, headaches, fatigue, no chest pain, no SOB, no rash. Denies any other systemic s/s of allergic reaction. No blurry vision or eye pain. Pt is a very poor historian and forgetful. Pt states that he forgot to let providers and medical staff that he had had a Pfizer vaccine at clinic on feb 15th, states that "he did not remember" and forgot to write it on the fomulary or communicate w/ provider. Pt did not bring vaccination record at the day of vaccine until today. Patient thought he could get second vaccine any time. Patient reports feeling well. No side effects. Tx given: loratadine 10 mg daily x 30 days, zaditor eye drops, short term prednisone 10 mg daily x 5 days.

Pt received first COVID vaccine on 1/23 and on 2/12 developed persistent periorbital headache and on 2/14 developed OS ptosis and diagnosed w/CN3 palsy

Felt SOB, little headache. After getting home, felt more fatigued, tiredness, tingling in throat, eyelids appear darker. Biggest complaint is being tired and fatigued.

He had blurred vision for a period of time. Extremely high aggression, a little delusional and confused.

Narrative: 67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm.

Ringing in left ear and brain area (tinnitus) Received hearing test, MRI and sinus exams Nothing found other than age related normal hearing loss

12 days after his second Moderna COVID vaccine, my father developed Shingles. His left eyelid is incredibly swollen and his right eyelid began to swell today. That is his only symptom. He?s on an antiviral and gabapentin. He had received both doses of his shingles vaccines about 3 years prior. We have no idea if related to COVID vaccine but wanted to make you all aware.

started with minor swelling in glands, then tightness of chest, breathing difficulty, then eyes began to swell,

?I recd the first moderna vaccine 2-13-2021 at 11 AM. Headache, right side only, started same day at 7:30 PM, sore shoulder at vaccine site about 10:30 PM same day. Both were gone the next morning. I recd the second dose of the moderna vaccine 3-13-2021 at 11 AM. By 2 PM I had a ranging head ache, again right side only. I drove four hours to the vaccination site, hospital. I was driving home when this started. I stopped to purchase Tylenol about 3 pm which it turns out had no effect. I was driving west into a setting sun, as the headache got worse, my eyes became more and more sensitive to the sun, I stopped a second time to purchase a second pair of sunglasses that I could wear over the first pair, that didn?t help, I ended up stopping at a rest area until the sun set. I got to my house at about 6 PM, by then I could no longer wear my prescription glasses, besides the headache I was now very dizzy. At about 9 PM the pain started, between my shoulder blades first, never at the injection site. From that time on, including today, the pain has constantly moved around my body, the worst pain is associated with areas that arthritis affects me, hips, knees, hands, ankles. I have had a mild fever, ranging from 100.9 Saturday night to 100.3 now at11 AM 3-15-2021. Yesterday, 3-14, my head was swearing, my feet were ice cold. I had an electric blanket from my waist down and an ice pack on head. If I have ever felt worse in my life I don?t remember when that would have been. The pain has moderated today, I expect the worst is now over. If as the health specialists are suggesting a booster will be required this fall I will undoubtedly have incredibly significant reservations with this vaccine.

Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty. Patient got vaccine at end of usual Friday am dialysis treatment. He was observed for about 30" and no untoward event noted, vitals usual. At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information. He gets up late as hemodialysis starts at 515 am. No reported problems on Friday. On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am. On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up. 911 called and he was given resuscitation efforts of unknown duration which were unsuccessful. He was pronounced dead at 11 am and the mortuary was called. No premortem labs, et al.

15 minutes after the shot i started seeing flashes of lightning type things in my right eye it kept it up for about a hour,, now i have blurring in that eye in the lower portion of it like there my glasses are dirty and eye seem to water more than normal..

Severe shaking chills, low grade fever, mild headache, night sweats, dry mouth, weakness and low energy, slight dizziness,

Systemic: HOT IN THROAT AND NOSE -Medium, Additional Details: COMPLAINED OF THROAT BEING WARM AND NOSE BEING WARM. VITALS WERE STABLE AND EXAMINED BY CLINIC NP. DAUGHTER SAID AFTER LEAVING HE WAS COUGHING AND HAVING TROUBLE SPEAKING SO SHE TOOK TO THE ER AND THEY GAVE BENADRYL, STEROID(UNKNOWN) AND PRESCRIBED EPIPEN DOCTOR SAID REACTION WAS MODERATE. DOCTOR ADVISED NOT RECEIVING THE SECOND DOSE.

Given shot in hospita, then within 15 minutes brought to Emergency Room, after I Became non-responsive, While in Emergency Room had following issues: large rash and itching on upper body, Bruise down arm from injection site, extreme Headache, High Blood Pressure, Loud Ringing in ears, shaking and body tremors. Benadryl given for rash and itching.

Site: Itching at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Received dose #1 on 2/11/21 and dose #2 on 3/11/21. I have had mild tinnitus for about 14 years, about a 2 on a scale of one to ten. About one week after the second dose I noticed that the ringing in my ears is much louder, probably a four or five. I can think of no other reason other than the vaccine for this to occur. The increased volume has not subsided over the past four days. I have not required medical attention for this event.

Moderna COVID-19 Vaccine EUA That evening started with headache, muscle aches, nausea. About 4:30 am next morning I got up to use bathroom and passed out for unknown length of time. I tried to go back to bed and passed out two more times. The 3rd time my wife says my eyes rolled back in my head and she could not arouse me for 3 to 5 minutes. I went back to bed to sleep. Several hours later I was still to dizzy to stand and had a knot on the back of my head from the falls. We called 911 and I went to ER at Hospital for further evaluation.

No immediate adverse reaction. No fever. Day 2 post vaccination fatigue, blurred vision, confusion, weakness, lethargy, inability to concentrate, loss of balance, anxiety feeling weird. Symptoms would come- had to lay down-last ~2 hours-feel okay. Again, same symptoms would start; 4-5 times a day every day. By day 7 post vaccination symptoms were severe; activities of daily living severely compromised. Blood pressure elevated 180's/100's (no history of hypertension). Emergency room visit was unremarkable. Next morning, 03/15/2021, EMS called to home. Blood pressure 217/112 finger stick 178 (no history diabetes). Transported to ER. B/P remained elevated. Cardiac negative. Head CT negative. Medications given in ER: Labatelol 10mg IV. Monitored and released to home. Diagnosis: Hypertensive Encephalapathy with TIA's. New onset hypertension. Meds: Lisinopril 10 mg daily. Seen by primary care on 03/17/2021. Elevated blood pressure continued 150/100's.

Second dose of Moderna COVID vaccine 3/17/21, onset of swelling of conjunctiva and blurry vision in both eyes on 3/18 with progression of vision loss to no light perception in left eye by 3/19 AM. Sent to ED and admitted to hospital after outpatient ophthalmology exam and started treatment with 1g methylprednisolone IV daily x5 days on 3/20. As of 3/22 eye pain had subsided but no improvement in vision. Has been in hospital 4 days at this point with uncertain discharge date.

redness 4-1/2 inches in diameter surrounding the injection site. Puffiness of the eyes. Both lasting three days.

Started getting ringing in my ears about 5 or 6 days after getting my second injection of the Moderna vaccine on March 7th. I received the first injection on February 7th. I didn't notice any side effects from the first shot other than minor soreness in the injection site of my left arm. I had minor soreness with the second shot as well but it was less than the first. I did take two 400 mg Anacin plus caffeine (32mg) 3 days before my second shot for a sinus headache I had at the time. I am going to see my ear, nose and throat doctor this Friday 3/26 to have him check me out and maybe get a hearing test if he thinks it's necessary.

Fever , Headache , Joint pain , Body aches , Chills , Fatigue , thirst. Took 4 low dose aspirin. Symptoms were gone in a little less than 48 hours.

1815 parasthesias L tongue/ palate. No other neuro or other symptoms 1900 gradually resolved. Now no symptoms PS retired ED physician

Headache, eyes hurt, ears ringing, body aches, cold shivering and night sweats and night. Couldn?t sleep at all first night. Symptoms lasted four days.

My first Covid-19 vaccination was on February 2, 2021. I had little or no side effects with pain at the exception of pain at the injection site, and minor body aches for two days. My second Covid-19 vaccination was on March 5, 2021. I experienced a terrible headache, nausea, bodyaches, slight fever, and chills. These symptoms lasted for 3-4 days. A couple days later I began to hear a hissing sound in my right ear. There is nothing I can do to eliminate it, and it continues today. Sometimes it?s soft, and sometimes it?s very loud, but always constant. I reported it to my family doctor on March 23, 2021.

After second shot I have developed severe Tinnitas. Have just seen/confirm Tinnitas with ENT SPECIALIST.

I noticed the tinnitus in my right ear has elevated. I've had tinnitus for a long time and have managed it. Now all of a sudden it has gotten worse and I have no explanation for it. I have read many website posts of people claiming the same thing. This could all be my imagination. I don't know and I don't have anyone to discuss it with. Pleas help.

SEVERE TINNITUS 24 to 36 hours after the injection I suffered tinnitus in both ears, the same sound both times. The reaction lasted for 2-3 days after the first injection. After the second shot the tinnitus started about the same time after the shot but was louder, pulsating, and has not let up at all. I am still suffering from this now. The current outcome is that I will be seaking additional medical care if this does not improve.

Physical weakness for 10 hours Chills for 10 minutes Sweats for 10 minutes 2 or 3 times Body Aches in small of the back Ache at injection site Slight nausea for 10 minutes, 2 or 3 times Dry Mouth - feeling of dehydration (solved by drinking water) Drowsiness - required a 3 hour day-time nap.

Onset variety of symptoms approximately 3/29, 10 days after 2nd covid vaccine: fever, chills swelling in his axilla, ear pain and discharge, headache, body/joint aches. Seen in clinic 3/31 and treated with augmentin for otitis, which he took with some improvement but return of drainage 3 days later. Intermittent urinary discomfort, which improved briefly then returned and culminated in passage of a small amount of blood. Was seen in ED for that, and confirmed to have RBC in urine, but CT abd/pelvis negative, CBC normal. Was told evaluation normal but may need to see urology. He thinks may have passed small kidney stone. Ten days later, continues with fevers (subjective - has no thermometer), chills, body aches, joint pain, headaches. Axillary swelling has decreased in size but he feels a pain deeper inside at that area. Pain & fever improve with tylenol but both return when it wears off. No further urinary symptoms. No rashes No recent travel Feels a little pressure in his chest to breathe, but no difficulty breathing. Never had cough No contact with COVID positive (or suspected positive) person - has only been at home. Was offered COVID test in ED but declined due to did not feel he was at risk of having come in contact with it.

04/01/2021 (Same day as vaccination): fatigue 04/02/2021: fatigue, insomnia, muscle aches, joint aches, headache, fever, congestion, shortness of breath, gastrointestinal pain/aches, vertigo, blurry vision, chills, overheating, excessive sweating, slowed thinking, lack of appetite 04/03/2021: same as previous day, but a little less severe 04/04/2021 ~ 04/08/2021 (less severe than previous days): fatigue, muscle aches, headache, congestion, shortness of breath, vertigo, blurry vision, slowed thinking I believe that either the vaccination exacerbated the symptoms of my Lyme disease, or the Lyme disease exacerbated the side effects of the vaccination.

Patient started to get a twitching of the eye and some mouth tightening and loosening two days after vaccine. He went in and was seen by the physician twice. The first time was for a CT and other blood tests to ensure he didn't have a stroke. The second appointment was to tell him that it wasn't a stroke and nothing else was wrong, so they assumed it was the vaccine. He also went to the eye doctor during this time to ensure that it wasn't going to affect his stigmatism due to the fact that he couldn't wear his contacts only his glasses and his stigmatism is so bad he has to wear hard contacts. Due to the twitching he couldn't wear the contacts. It was reported to us on 04/08/2021 and he was still have some eye twitching, but not bad and his mouth symptoms had pretty much resolved. The physician said that it should go away in 1-2 weeks and if not he was suppose to see her one more time.

Started having tinnitus and ears are plugging up and having some balance problems. Earlier in the week have had real sore arm, sore muscles all over and body and head aches. Have had more than usual fatigue and felt super weak. Blood sugar also seems higher than normal for extended periods

1 week after receiving 2nd dose of Moderna Covid 19 vaccine started having increase blood pressures and then pain left temporal head. Reports history of temporal arteritis in past and this was flared due to injection, Mild blurred vision left eye when pain flared. improving after 2-3 weeks.

Chills, nausea, headache, fatigue, fever 101.2F, body aches, muscle cramps, joint pain, severe tinnitus.

He got the vaccine, when she gave him the shot if felt like liquid fire going in, it was then fine. Two hours later the arm started swelling up and got so swollen he could hardly move the shoulder. Then it started moving into the shoulder quadrant, as far as your fingers can spread, all the way back onto the back itself. It then traveled up to the neck, to the spine to the ear in that quadrant and stops at the knot behind the ear. The pain is so bad that you press on the knot behind the ear the headache will go away. The headache is so intense it feels like it's going to blow off and takes migraine headache medicine which does not help it. It now has caused vision issues, he cannot read/blurry vision with large print things close up. He can see fine 5' or further with no problems, but nothing up close and he can't drive due to this or use the computer as he can't see the keyboard to type. The pain has continued even up until today, 4/14/21. The shot area is fine now. Originally when the symptoms started he could not turn his head as it hurt so bad, and has taken all this amount of time to actually turn his head some, but cannot turn it to the left much. He can gently and slowly turn his head but it is painful. He has gone to his doctor and went to the COVID clinic with the first vaccine who want to see him to a neurologist.

PATIENT REPORT THE SYMPTOMS STAR 3 DAYS AFTHER THE SECOND DOSE OF MODERNA VACCINE. THIS SYMPTOMS WAS RASH IN THE THIGS AND THE BACK, CHANGE IN THE VOICE AND INFLAMATION IN THE LIPS AREA.

severe tinnitus, happened a few days after the second shot. had mild tinnitus previous to shots. Much worse than ever before. No other factors I know of. My stress level overall is low.

Minor pain at site of shot on arm right after shot. Minor tongue swelling following night. 5 days following first shot, experienced sudden flash and onset of severe imbalance. Went to bed 3/3/21 and experienced profuse sweating, dizziness, imbalance and nausea. Slept for 30 hours, Upon waking, symptoms continued, along with fatigue and loss of appetite for additional 2 days. About 10 days after first shot, nausea disappeared and appetite returned, with gradual improvement in other symptoms. Continued experiencing mild fatigue, mental fogginess, dizziness and imbalance 6 weeks after first shot and 2 weeks after second shot, with these symptoms gradually improving and mostly gone as of date of this form.

Maderno shot 2 Day 1-shot site sore Day 2-4-left entire arm sore, numb , head aches, off balance, tired- stayed at home rested drank fluids, Tylenol Ongoing- since shot 2- been to Dr, have ongoing balance issues, sounds seem over sensitive, head fog, weird feeling in head, mri scheduled on head , 5/6/2021,

Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to Hospital (cardiac). I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above).

Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to the Hospital (cardiac) area. I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above). Health Department administers vaccinations at a local convention center but has no permanent offices/staff there.

Pt reports PMH of tinnitus since 20 YO. He states about a year ago, he had a sore throat and saw Dr. His Dr. checked for strep, which was negative, but he didn't check for COVID. However, since that illness, his tinnitus has worsened. Then, since his first dose of COVID-19 vaccine, pt said his tinnitus has worsened/changed. He is now "hearing additional tones" and "it's more sensitive now". Patient will continue to monitor and follow up with Dr. if necessary.

Severe headache, chills (temporary), watery eyes, swollen tongue, great difficulty swallowing and difficult to eat due to inability to swallow (long-lasting). I have to mash my food to be able to get it down.

PT SAID HE HAS SEVERE MUSCLE ACHES, JOINT PAIN, COUGHING, HAD TROUBLE BREATHING AND WENT BLIND FOR A PERIOD OF TIME. ALSO NOTED HE HAS COUGHED UP STUFF SINCE THEN. DID NOT SEEK MEDICAL ATTENTION .

Received Moderna vaccines on 2/5/21, 3/2/21 Tested positive for COVID 19 by PCR on 5/25/21 onset of symptoms 5/23/21 with diarrhea, congestion/rhinorrhea;anosmia/dysgeusia;cough;nausea/vomiting/abdominal pain

Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.

Occurrence of tinnitus which Had long been in remission in one ear, and sudden unexplained hearing loss in same ear

On Saturday, May 15, while sitting with his wife, "froze" for a short period of time, approximately 1-2 minutes. His wife did not know what was wrong and urged him to go to the hospital. His son brought him to the hospital, he presented with elevated blood pressure, a slightly asymmetric smile, and black tongue. He was admitted to the hospital and multiple tests (brain scans, electrocardiogram, etc.) were run to try to diagnose what had occurred. On the afternoon of Sunday, May 16, in the midst of being discharged from the hospital, pt had another "episode" which was later categorized by physicians as being a partial complex seizure, where he "froze" and became unresponsive for approximately 1 minute. During the event, he was wearing a heart monitor, which showed no unusual heart activity, but his blood oxygen level dropped during the event. On Sunday, May 16, pt had a second partial complex seizure (third seizure over the 2-day period). This seizure was timed at being approximately one minute in duration. Following the seizures on 5/16, patient was given Ativan and also a 1500mg loading dose of Keppra. On Monday, May 17, patient had a EEG administered, which indicated that there was no unusual activity occurring in the brain during the test. He was advised to continuing taking Keppra at 750mg/day. Pt does not have a family history of epilepsy, never played contact sports, and has not suffered brain injuries such as a concussion.

AFIB; chest pain; he couldn't see the road; He's sluggish; chest discomfort; fogginess in head; he sleeps a lot; fogginess in head; Headache; chest discomfort; high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and ATRIAL FIBRILLATION (AFIB) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (high blood pressure), the first episode of CHEST DISCOMFORT (chest discomfort), the first episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache). On 14-May-2021, the patient experienced ATRIAL FIBRILLATION (AFIB) (seriousness criteria hospitalization and medically significant) and SOMNOLENCE (he sleeps a lot). On 24-May-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest discomfort) and the second episode of FEELING ABNORMAL (fogginess in head). On 25-May-2021, the patient experienced VISUAL IMPAIRMENT (he couldn't see the road) and SLUGGISHNESS (He's sluggish). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to ATRIAL FIBRILLATION and CHEST PAIN. At the time of the report, CHEST PAIN (chest pain), ATRIAL FIBRILLATION (AFIB), BLOOD PRESSURE INCREASED (high blood pressure), VISUAL IMPAIRMENT (he couldn't see the road), SLUGGISHNESS (He's sluggish), SOMNOLENCE (he sleeps a lot), the last episode of CHEST DISCOMFORT (chest discomfort), the last episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache) outcome was unknown. Unknown On 03-Mar-2021, Blood pressure measurement result was unknown. On 09-Mar-2021, patient had head scan and coronary test and results were unknown. On 05-Apr-2021, patient had Electrocardiogram and X-ray tests and results were unknown. On 19-Apr-2021, lab work result was unknown. On 27-apr-2021 patient wore heart monitor for two days. On 28-Apr-2021, Angiogram result was unknown .On 25-May-2021, Electrocardiogram result was unknown. No concomitant medications were reported. No treatment information was provided. Patient was in the emeragncy two times and hospitalized one time. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-may-2021 contains new laboratory data and new event.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Palsy. Drooping of lift side of face and twitching of eye and left eye doesn?t close. About a week and a half

Ringing in ears, tinnitus. Went to get ears tested and tech performing test stated I was the 3rd person she had tested that day with Tinnitus starting after receiving the vaccine

It started with a pain in my wrist. Then it started to move up my arm, into my shoulder. It felt like a tingling, burning sensation. This is my right arm, not the left arm where I received the second dose. I was having trouble sleeping at night and I was having a stabbing sensation in my ear. I had a toothache in my mouth on the right side. They gave me amoxicillin. The tooth pain went away, and my ear did to a few days later. The pain in my arm did not go away. I went to the ER and they told me I might have carpal tunnel syndrome. They gave me steroids. I also have a tingling sensation in my fingers. My normal doctor told me I had the symptoms of a pinched nerve, but they didn't think it was a pinched nerve, but nerve damage. I went to a neurologist. I was having so much pain in my arm that I was having trouble sleeping. The neurologist said they would have to run tests.

On 3/31/2021 went blind in left eye. Diagnosed with major blood clot in left eye. Has had injections into eye on 3/31, 5/12, 6/23. Scheduled for another 8/4/21.

Significant muscle/body ache and soreness, headache, ear ache, fever, lethargic. Two days after vaccine and symptoms are lessening but have not entirely gone away.

Patient was experiencing blurry vision approximately 15 minutes after receiving the 2nd dose of the moderna COVID-19 vaccine

LETHARGY DECREASED MOBILITY DECREASE IN APPETITE CONFUSION DAYTIME LETHARGY INSOMNIA VERTIGO NAUSEA VOMITING VISION DISTURBANCE

Tinnitus. A white noise and slightly muffled effect. Hearing acuity doesn?t seem affected. (No hearing test administered)

5/15- evening of and day after 2nd shot complained of severe headache 6/1- Suffered clot and hemorrhagic stroke/burst aneurysm. Husband was Airlifted to Hospital where he was rated a level 4, catastrophic event. He spent over 32 days in the ICU ON LIFE SUPPORT and as of day 52, remains in the hospital. His brain injury from the burst clot is life-changing. He is incapacitated and has lost 80% of his vision. He cognitively is significantly compromised and needs full assist and will likely never be Independant again- if he survives.

5 minutes after the vaccination was given, patient developed soft swelling periorbital area, mostly under the eye. No other symptoms. Swelling decreased after 1/2 hour. No other adverse effects.

Chief Complaint Patient presents with ? Vomiting     pt reports dry heaving and nausea that started an hour ago   Patient is an 68 y.o. year old male with PMHx significant for HTN, BPH, who presents to the ED today with nausea and dry heaving for one hour PTA. States that he was at work as a courier when he had onset of sensation of room spinning, nausea, and dry heaving. Also having tinnitus which he thinks is b/l. This happened once about two weeks ago and resolved spontaneously overnight when he was asleep. No preceding illnesses, medication changes, or other associated symptoms. Vertigo has no clear exacerbating or relieving factors. Has not yet taken anything for symptoms.   The patient denies fevers, chills, headaches, syncope, chest pain, shortness of breath, rhinorrhea, sore throat, cough, abdominal pain, changes in usual bowel movements, changes with urination, back pain, pain anywhere else in body. The patient has no sick contacts, recent travel history.

Started to feel tightness in my throat, dryness in my mouth, numbing lips and warmth throughout my body. Stopped at Hospital and was treated intravenously with Steroids and Pepcid. After 2 hours left hospital feeling much better with slight numbness in lips

Felt fine after injection, walked 5 miles home & assured loved ones before going to bed that vaccination went fine with no side effects. After midnight I woke in the dark with many of the same symptoms as when I had COVID in March/April 2020: extreme allover body aches, terrible thirst, extreme weakness. Next day (Wednesday) symptoms continued; too weak & achy to watch all but the core parts of the inauguration; too uncomfortable to read or to concentrate on music or anything else. Absolutely no appetite so I didn't eat. Wednesday night I tossed & turned all night with a chill that I couldn't lose even with the heaviest down comforter & supplementary blankets. That night & the following day I also noticed a distorted sense of time, where hours seem to pass v-e-r-y s-l-o-w-l-y. On Thursday night two more symptoms appeared: a tremendous cough that I couldn't stop or assuage with the normal remedies (e.g., lozenges, tea with honey), and that kept me from falling asleep till dawn; and diarrhea (which was limited because I hadn't eaten since Monday dinner so I didn't have much food in my system). The cough felt like it might develop into a sore throat (which had been my first symptom when I had COVID) but it never did. Yesterday (Friday) I felt as if my symptoms (other than residual weakness) were abating, and Friday night I got a full night of unbroken sleep. I awoke on Saturday morning with no symptoms, and felt well enough to challenge myself by attempting my usual 90-minute yoga/stretch workout, which proved to be no problem. Now, at 4 pm on Saturday--about 100 hours after my shot--I feel fairly normal & seem to have no further symptoms. I do plan to lie low & take things easy, and to have as little outside contact as possible between now and my second shot (scheduled for 2/16) in order to minimize the possibility of re-infection.

After shot dizzy and light headed; Had shot Tuesday Friday night left side jaw pain and teeth misaligned due to jaw not closing due to pain and swelling.

angina attack, difficulty breathing and uncontrolled muscle spasms treated and controlled with nitroclycerin, left side of body went numb, difficulty walking, disorientation/dizziness, blurred vision, severe headache, severe muscle and joint pain, weakness.

seem to have lost some sense of smell and getting light headed or dizzy foggy feelings and a little ache in back

HCP was called to a patient with "tongue swelling". HCP asked MD for an Epi Pen and the paramedics are O2. O2 was applied at 2L per NC. . HCP approached vehicle where a 68yo white male was sitting in his vehicle on the driver side. Quick assessment revealed erythema of the face and angioedema. Pt was able to speak clearly, was CTA and had RRR. 911 was called. BP 160/90. EpiPen dose 1 was injected into right vastus lateralis and pt reported improvement at 1057. HCP asked for injectable diphenhydramine. HCP continued to monitor pt with RRR and CTA but erythema and angioedema began again along with swollen tongue so EpiPen dose 2 was injected into right vastus lateralis. 50mg IM diphenhydramine was injected into the right deltoid while fire rescue began to arrive on scene. Pt did not report difficulty breathing. Pt did report previous anaphylaxis to fire ant bites/stings and did report being allergic to bee stings. Fire rescue transported patient without difficulty. HCP called pt later that night at 2030 who reported doing better but still having tongue swelling.

About one hour after the vaccine, developed tingling around my lips and mouth similar to my previous experience with ideopathic angiodema. Ended up going to the ER but received no treatment. Just letting you know of my experience for individuals in a similar position.

Beginning about 12 hours after receiving the vaccine I started having really bad headaches, behind my eyes radiating to the back of the head. At about 15 hours post vaccine I had chills, fever. The chills and fever were bad enough that in addition to sleeping under two blankets I had to put on a thick fleece ?hoodie? and pulled the hoodie over my head. I developed about 48 hrs of nasal congestion, and some retrosternal chest pain. I had one episode of nausea with vomiting about 8:00 am the next morning. I had to take two 325 mg Tylenol every 4-6 hrs to deal with the headache and fever. The most severe symptoms of headache and fever subsided in about 24 to 36 hrs after the vaccine was administered. I had a lot of fatigue for several days, along with aches and pains. It took me about 5 days to really start feeling normal again, but the fatigue lingered for a few more days.

Neck pain near the top of the neck at the base of the skull slightly to the right of the center began around Feb 1. Began taking Ibuprofin, but it did not go away. Thought I had muscle strain, but surprisingly there was no stiffness or loss of motion. Tried massage, heat, and cold packs with limited relief. Began interfering with sleep over the next few days. On the evening of Feb 4, I noticed a strange sensation on the right side of my tongue as if I was losing taste or feeling there. At 3 AM got out o bed due to neck pain and noticed right eye felt strange and was drooping. When I got up at 8 AM I saw eye droop and smile was only on one side of mouth. Called my doctor and was directed to an advice nurse who told me to go to the ER right away, since this could be a stroke or Bell's Palsy. Went to ER and was diagnosed as Bell's Palsy after blood tests, EKG, CT scan, and tests of limbs. Given medications and and released with prescriptions sent to CVS for prednisone and valacyclovir.

White part of right eye has broken blood vessels. 1/2 of eye is bright red. Eye is scratchy but no other problems. Has never happened before. Noticed about three hours after injection

~ 7 minutes post injection, patient reports ?warmness in throat?. ~10 minutes post injection patient reports to being asymptomatic, V/S BP-130/75, HR-78, O2-98%, Resp. 20. ~30 minutes post complaint patient continues reporting asymptomatic. Education provided to seek medical attention if symptoms worsen. Patient expresses understanding.

Vaccine given ~2:05 PM. Patient reported no problems 15 minutes post vaccine. Patient called around 3:30 PM to state he may be experiencing "itchy tongue" and "scratchy throat", which started about 15 minutes after he left the store (~30 min post vaccine). He reported no other signs/sx at the time. He was advised to seek immediate medical attention since wife was with him, he's ~5 min from local hospital, and no other severe sx were currently present. However, he was advised to contact 911 if any severe reaction (e.g., difficulty breathing, passing out, etc.) appears. Pt said he would discuss this with his wife, and we discussed that an allergic reaction can progress quickly. He said he has benadryl on hand, but we discussed that benadryl will not be enough if patient does develop a severe allergic reaction/anaphylaxis. Patient was advised to contact his on-call Dr. for a second opinion at the very least if he does not go to the ED and to continue monitoring for additional signs/sx of allergic reaction. Patient was advised to follow up with us in a few days for update.

Hx of vertigo, migraine associated, 5 days after 1 vaccine 1/4/2021 had an episode of vertigo 1/18, later in January had another episode of vertigo. Last night was the 3rd episode. #1 Moderna 12/30/20. Reports acute episode of vertigo 1/4 (5 days post vaccine). A second episode 1/18 (19 days post vaccine). Decided to delay getting #2 Moderna by one week. Received #2 Moderna on 2/3. c/o mild fatigue 24-48 hrs post vaccine. Reports a 3rd episode of acute vertigo 6 days post #2 Moderna on 2/9. Each episode of vertigo lasted 2-5 hrs associated with n/v/diarrhea. No meds taken to treat sx. vertigo following a URI 11/2017. Complete w/u by physician 3/2018 with audiology testing and brain imaging. Found to have some sensorineural hearing loss in left ear. Poss vestibular migraines vs Meniere's Disease. Remote hx headaches and ocular migraines with aura. No episodes of vertigo since 2018 until these recently described episodes in the 1-2 week period following vaccine administration.

Observed patient getting fanning patient as he became light-headed and explained blurry vision. Patient became increasingly unresponsive and pale. Immediately obtained an Epinephrine 0.3mg pen and injected into thigh, patient immediately vomited and 911 was called.

2/12/21 - Recieved the Covid 19 vaccine 2/13/21 - 5 pm. Fever, chills, no appetite, no taste, no smell, fatigue - was gone by 8 am the next day. Took Tyenol and rest. Taste and smell returned. 2/14/21 - 5 pm. Was eating and had a sip of wine. Felt like I was choking and had a strange sensation in the head. Felt like I blacked out for 2 seconds and was drolling. This is the only time that I have experienced this.

Headache, body (muscle) aches, stuffy head, runny nose, itchy/burning eyes, low grade fever, fatigue/lethargy, mild nausea, colon cramps. Symptoms were not severe. I just wanted to make you aware of them, since I understand that it is rare to have symptoms after the first dose (which this was). I was not in any place or around any people to be exposed to a oold or flu virus.

Ocular Issue--had vision change at 9:30am on 2 /10/21, could not focus on his computer screne, esp right eye, central focus and had a right eye stabbing pain, patient has had 3 day migraines years ago with vomiting etc. On the day of hospital admission, 2-11-21 after a walk in the bright snow, then sex and a nap, patient was disoriented for 15 minutes, then it mostly resolved. But his memory was a bit off for the next 6 hours. It took him 3 tries to get his wife's name correct. Briefly he didn't know where he was and did not recognize his cat. So he went to the ER.

Pain at injection site, upper left arm Fever, chills, slight headache, and loss of taste and appetite Joint pain throughout body, exhaustion.

Fatigue, stiff & sore muscles, mental cloudiness Extreme opthalmic Photosensitivity causing White Light Blindness after looking at cell phone (iPhone 12 Pro) and TV. outside naturalight and Indoor lights particularly BLINDING! Began to subside 24 hours after 2nd dose lasting about 4 days. I am medical professional, Clinical Speciality Pharmacist.

Felt dizzy, blurry vision, passed out, pale. Short of breath and vomited. RPh gave epinephrine which worked right away. Squad came and took to ED where he was observed for 4 hours. They did a chest xray, troponin, EKG, Lab work. Everything normal. Name of physician or treating hospital: ED- MD. Pharmacist advised not to get the 2nd dose. ED MD advised to get a 2nd dose. His MD told him to get the 2nd dose in a medical setting where he can be monitored.

Much like my experience of COVID in 3/2020 and after my first shot of vaccine in 1/2021: extreme chills, extreme achiness, extreme weakness & fatigue, extreme dry mouth, extreme chapped lips. Duration of side effects after first shot was 4 days; duration after second shot was 48 hours, with lingering fatigue & dry mouth until at least a week after the shot. Symptoms, though severe, resolved themselves in the time frames described above.

The day of my second Vaccine 02/11/2021 at around 5:00 PM I was feeling fine and was sitting in the toilet and pulled my pants down and was horrified to see my whole sexual organ inflated. I quickly took Benadryl and a few hours later it started to get back to normal. It did not hurt or anything but slowly got back to normal. The next day 02/112/2021 I was itching on the right side of my stomach and had a big red bump. I kept taking Benadryl 50mg every 6 hours for the next 7 days because otherwise as soon as i stopped taking the medicine I would have itching and bumps in my arms and side of my stomach. I had my lips swollen, my right eye lid droop. I still have episodes of itching and bumps 16 days after vaccine

Insomnia followed by fever ,chills, muscle pains, extreme pain at injection site, vomitting, skin hurt all over, dizziness, and I had a headache. Everytime I moved my eyes, I could hear a whooshing sound in my ears. I had to wear sunglasses and stay in the dark, as the light hurt my eyes. It lasted for 24 hours, and another 12 hours of and extreme stomach ache.

The roof of his mouth became sore and raw and his tongue swelled. He had to resort to a liquid diet for a few days, and today he states that he still has some minor mouth soreness

Approximately 11 hours post-injection, general tiredness crept over me. Decided to call it a night early and before I could get in bed, the chills and shaking began. This continued for approximately 4 hours. I was thirsty and struggled to get up and get water, as I was getting weak and unsure of my stance. No fever, but headache and general joint aching began around midnight. Sleep was practically nonexistent. Got out of bed around 7 a.m. to eat and take acetaminophen for headache. Also prepared and started pushing electrolyte sports fluids (drink tabs). Ate a piece of toast with jelly and could not taste it. Had lost my sense of taste. Went back to bed for my first of 2 morning naps. After my second nap, approximately 11:00 a.m., most of the symptoms had abated although I was still weak. Had oatmeal with protein powder (standard breakfast for me) and more electrolytes. Recovery was rapid and by 3:00 p.m., all symptoms except loss of taste had resolved. Taste finally return the next day.

Pt received the 1st dose of the Moderna Vaccine and the next day developed a rash on his abdomen and back as well as slight tongue swelling. Denies difficulty swallowing, nausea, vomiting, diarrhea, constipation or shortness of breath. No tongue swelling since then. Did not seek further evaluation at the time, symptoms of tongue swelling resolved on their own. Rash has improved slightly but is still somewhat persistent.

Effects which happened 14 hours after shot: Extreme Lower abdominal pain which made me hump over to walk. Had, bright light flashes with my eyes closed and pain around my eye socket. Rippling tingles across my chest, arms, and legs. Had minor head ache which went on and off. Also had minor flu like general muscle pain. Above pains disappeared about 7 hours after start. There was NO arm swelling or major arm pain, slight arm soreness the next day when arm is elevated.

Patients states he woke up the day after vaccination at 3am with aches all over his body. His muscles, bones, feet and hands ached. He states he also feels like he has a fever but did not check with a thermometer. His eyes also felt like they were burning and has slight labored breathing. He took 25mg of Benadryl prior to the vaccine and at 3am the next morning. He will continue with scheduled Benadryl and APAP until symptoms improve.

Approximately 7 hours after vaccination, suffered an almost immediate nausea, weakness and dizziness which lead me to pass out for several minutes; these symptoms passed within 24 hours. Had pain in the right lower jaw below a dental implant and pain below the hip in the right ischium (in the hip with an artificial hip replacement). The jaw pain disappeared in 2 weeks, and the hip pain still evident after 3 weeks. X-ray of right hip revealed no abnormalities.

severe fever after 7 hours-103-104 lasted 11 hours-reduced fever 15 more hours, chills, accelerated pulse, rapid breathing, nausea-no food or water 15 hours, enlarged lymph gland under right jaw (did notice an enhanced sense of smell during both 1st and 2nd shot reaction period)

left Facial paralysis, left eye tearing - dispatch to ED to R/O stroke. Pt was diagnosed with Bells Palsy and discharged home with prednisone and valacyclovir.

Patient reported ringing in ears and nausea less than 30 minutes after receiving vaccination. VS 108/64 HR 68 at that time. He was given 35 mg liquid Benadryl orally by mouth at time of event and reported that he was starting to feel better by 1035. follow up BP was 110/62. He had reported having the same issue with the first dose that resided on it's own. Followed up later in the afternoon and he stated the ringing was still present, but had diminished greatly and he was feeling a bit tired and nauseous.

PT STATED THAT BEGINNING THE AFTERNOON/EVENING FOLLOWING THE VACCINE HE HAD A SPELL OF VERTIGO. HE HAS NEVER HAD VERTIGO PREVIOUSLY. HE CONTINUED TO HAVE INTERMITTENT SPELLS OF VERTIGO THAT CONTINUED AND WORSENED OVER THE NEXT 48 HOURS. HE STATED THAT HIS EYES DIDNT FOCUS WELL AND HE SAW EXAGGERATED LIGHT IMAGES. HE GOT A WALKER OUT THAT HAD BEEN USED FOR A PREVIOUS HIP REPLACEMENT SURGERY DUE TO HIS UNSTEADY GAIT. HE HAD A SEVERE HEADACHE AND FELT GENERALLY UNWELL. HE STATED THAT IT WAS "THE WORST THING HE HAS EVER BEEN THROUGH AND HE IS 68 YEARS OLD. HE WOULDNT TAKE ANOTHER DOSE IF I PAID HIM AND HE FELT LIKE HE WAS ON SOME KIND OF TRIP."

3 1/2 weeks after getting the vaccine my side effects returned when I started taking an antibiotics for a skin infection (minocycline). The first time the side effects lasted 36 hours, the second time 24 hours. Side effects included fever, dizziness, nausea, skin hurt, eye hurt (I had to wear sunglasses inside), and I heard swishing sounds everytime I moved my eyes.

The patient reported that he had a burning sensation on the front part of his tongue, a chemical taste in his mouth, feeling achy, and he lost his taste the same day he received the first dose of his vaccine. He said that most of the side effects resolved by the next day. The burning sensation on his tongue has persisted during the month.

PATIENT CALLED TO INFORM US THAT HIS VISION IS BLURRY AND DOUBLED AS OF 03/21/21. HE IS NOT SURE IF IT HAS ANYTHING TO DO WITH THE VACCINE, AND IS GOING TO FOLLOW UP WITH A DOCTOR, BUT THINKS HIS DOCTOR HAS MOVED AND UNSURE OF WHERE SHE IS BUT WAS INTRUCTED TO MAKE SURE HE GETS INTO A DOCTOR AS SOON AS POSSIBLE.

Bells Palsy as per ER in Facial numbness and weakness, unable to move eyelid on left side change in food taste per pt

Client reported first COVID vaccine on 02/19/21 and second vaccine on 03/22/21, adverse reaction may have slightly started after first vaccine but noticeable on 03/23/21. Client having an unstable equilibrium, dizziness more with standing up, blurred vision with glasses on, and spots in eyes (more in left than right). Client has called PCP, awaiting response. Client has been treating adverse reaction wth taking his prescribed medications and eating meals.

Diarhhea,bleeding gums-one day, sore throat, some loss of energy. USED gargling and lozengers for sore throat and more rest for the loss of energy.Drank plenty of fluids and let the diarrhea run its coarse.

3 minute span, 7 minutes into 15 minute post vaccine wait... BP dropped to 68/57.. pale, dry, blue lips... visual disturbance... nausea, dry heaves, dizzy, close to fainting... left side of body has more color than right side.... BP returned to 100/71 within 2 minutes... coherent throughout

A lot of difficulty breathing, catching breath and getting oxygen; stabbing burning pain all over and joints ache; dizziness with eyes wanting to always close and seeing black spots; severe facial pain around bridge of nose and eyebrows; tremendous fatigue and weakness.

Within 48 hours of second Moderna vaccine but after 24 hours from time of shot, while casually sitting and noticing that my body was uniformly extremely cold to the touch, I experienced flashing colored dots in my right eye and for several days after a "floater" in my right eye.

received call from patient's wife. reports received 2nd COVID 10 vaccine on 3/25/21 and 2 days later husband went deaf at 5pm on 3/27/21. Went to the ER, then regular physician. Was referred to audiology. Wife states all physicians informed that cause of deafness was caused by the vaccine. Patient may or may not get full hearing back. Reports left hearing has partially returned and right hearing has not.

Developed an absolutely maddening case of tinnitus, not normal ringing but excruciatingly loud clicking recurring usually every 2 minutes. (quite unbearable) (on same side as vaccination) 2 days later my same side eye became quite bloodshot. later the other eye also became bloodshot.

Diagnosed with Bell's Palsy on 03/14/2021 left side of face, could not close left eye, left side mouth would not move, could not wrinkle left forehead..

Parotitis - Primary Very swollen face on my right side (apposite side from injection site) On Thursday 3/11/21 (after injection Tuesday morning 3/9/21) woke with swollen right side of face. Eating painful. Friday extreme swelling, externally visible and very painful. Saw Dr. who started course of rimethoprim-sulfamethoxazole (Bactrim DS) 160-800 mg TABS. Over weekend swelling and pain went down, but it was a full 2 weeks before I felt almost all of the symptoms were gone. This is not a condition I have ever had before.

I'm an FP physician - reporting on behalf of my father - although my father is taking immune therapy - within approximately 36 hours after receiving the second dose of Moderna he developed the anticipated side effects of body aches, fatigue, fever, joint pain however he also developed a sand paper like rash on his tongue and erythema and pain in his mouth these symptoms were fairly severe for 3-4 days and lasted a total of 10 days. He chose not to take medication to treat. He did lose approximately 4 lbs which he has regained. I didn't connect the two immediately but a close friend of mine who is a nurse - her sister had also had a similar event in close relation to having received the moderna vaccine - I've encouraged her to report as well. I hope this information is helpful.

muscle pain,cognitive impairment,severe headache, fever, joint pain,chills, shaking,drenching sweat,fatigue,chest pain,eye pain,nausea

Pt has a history of CVA and aspiration pneumonia in Feb 2021. Pt had been on olanzapine since 2/24 at Institute. He was given his second Moderna Covid-19 vaccine on 03/10/21. Per note on 3/12, pt had seizure like symptoms at 0545 for approx. 45 seconds (eye rolling, lack of response, increased confusion) Per staff, there was no flexing of limbs or loss of bowel or bladder control. No noted stroke like symptoms but he appeared more confused at neuro check. Pt was back to baseline at 15 min neuro check. Pt reported to have had additional seizure, of approx. 4 minutes duration, during morning report that day-but when MD got to his room, he appeared ?post ictal with a mildly agitated restless delirium? rolling back and forth on the floor, moaning, and not making eye contact. Pt did lose control of his bladder. Olanzapine was discontinued on 3/12, due to potential to lower the seizure threshold. Divalproex was initiated for seizures. Per note 3/22-no additional seizure type symptoms have occurred.

Arm pain with redness and swelling at injection site, headache, severe shaking/chills, fever of 102.7 for 2 days, numbness on left side of face including tongue and gums with a slight facial droop lasting for 3 days, night time hallucinations lasting 6 days.

A couple of weeks after getting the 2nd Moderna vaccine I started noticing a strange uncommon smell. it did not smell like anything I had smelled before. For a while I thought it was something in the house like a pest that died in the wall, or liquid spill that i wasn't aware of. Eventually I realized that certain things around the house would intensify the smell such as coffee or liquid hand soap. The smell of these items was being altered to smell like something else. As of this date I still have this symptom, although it varies from day to day. My taste seems ok.

Tinnitus both ears ongoing since the morning after the second shot. No adverse effects from the first shot.

sudden right sensorineural hearing loss--pt has complete hearing loss in right ear and did not respond to treatment.

pt states that tinnitus volume has increased by 4 levels, states previously having mild tinnitus but it has worsened.

I had double vision. Ejection fraction was at 40-40% at the doctor in August of 2020. Mid February I went into the hospital with the double vision. No treatment was given, just a change in medication for the ejection fraction. I was told to go home and it should clear up on it's own.

Approximately two weeks after receiving my second COVID vaccination on March 15, I developed tinnitus in both ears. I experience a constant, high-pitched ringing in both ears. Now, two months later, the condition has not changed.

imbalance & unsteadiness - at various times during the day light headiness, feeling of head congestion, head pressure, ear ringing, & ?full? ears ? constant

I received my second dose of Moderna vaccine on 3/24/2021 and approximately one week later I experienced sudden loss of hearing in my right ear. A diagnosis of sudden severe sensorineural hearing loss was confirmed by both audiologist and MD ENT specialist. Hearing aid is no longer of benefit and treatment plan includes a future unilateral cochlear implant for my right ear.

severe Running nose, severe watery eyes, running eyes, red eyes, inflamed eyes, itchy eyes, sandpaper effect on touching eyes, pain on both eyes. blurry eye sight from 5am Thursday morning 5/3 Treated with Muro 128, Tobramycin and Dexamethasone Ophthalmic Suspension

Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS 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 CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-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 High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided by the reporter Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.

Within hours : visual obscura - and increased bilateral tinnitus that is rampant and still is with me as of this writing, now some 18 post 2nd injection days latter!! Then some 4 hours latter, dramatically reduced stamina, with onset of fatigue which lead to sleeping the next 72 to 84 hours and only being able to get up out of bed to urinate. Body aches and sore injection arm during this time about 2 days total. Used a Far Infrared heating pad to help mitigate the symptoms; unsure if it helped. In the first 5 days, very weak and feeble feeling, physically and mentally (cognitively speaking). Saw my doctor after that.

Woke up the morning after the first shot with a sagging face on the left, watery eyes, runny nose. Was taken to the hospital May 30 to get checked and was diagnosed with Bell's Palsy, given antibiotics, steroids, and and eye ointment. As of June 16th he still has not recovered.

That night my shoulder hurt and i had a little fever. The next day i was bedridden with a fever, body aches, and my shoulder hurt. Better the next day and went back to work. In the last 2 months i have had a slight headache daily, still some soreness in my arm where the shot was give, swollen joints in my hands, and a significant loss of smell and taste. I also have less energy and my breathing is a little labored.

Patient called on 6/18/2021 to report a case of Bell's palsy after receiving Moderna vaccine shot on 4/24/2021.He said he has numbness, pain and weakness in the left side of his face, lips, upper teeth and eye pain. He started documenting symptoms on 5/10/2021 and his provider knows about that .He does not remember when he started experiencing side effects. He had appointment with his eye care professional who sent him to PCP to evaluate signs similar to stroke. After visiting his doctor ,he was diagnosed with Bell's palsy.