Moderna

Tingling of tongue, lips, nose and cheeks lasted 5 hours . No swelling Unusual taste in mouth lasted only 5 hours

Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00. Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.

Pt c/o having 'weird feeling/not feeling good' and increase heart rate about 7-8 minutes after receiving vaccine. Pt denied any shortness of breath at the time, no swelling of face, BBS clear and equal with equal rise and fall of the chest wall, alert and oriented X 4, able to speak in complete sentences. Progressed to report 'lips feeling like they are swelling approximately 18 minutes after the vaccine was administered. 911 was activated. Epinephrine 0.3 mg IM via epi autoinjector was administered to left thigh. Pt still c/o feeling that her lips were swelling 8 minutes after first dose of Epinephrine; therefore, another dose of 0.3 mg Epinephrine IM via epi autoinjector was administered to left thigh. Diphenhydramine 25 mg IV was administered 2 minutes after second dose of Epinephrine. IV fluids administered as well, while awaiting arrive of EMS. EMS arrived on scene approximately 30 minutes after called. Blood glucose was 120 mg/dl approximately 25 minutes after vaccine administration. Pt report feeling better after the 2nd dose of Epinephrine and Diphendydramine and 500 ml of Normal saline IV. Pt was transported via EMS to the ER for further evaluation and treatment.

severe pain in neck and shoulder area, slight fever, swollen glands, affected vision for over five days

Extreme pain in arm (not just sore) and body aches, as if run over by a truck, chills (could not get warm), worst headache I can ever remember having, felt like ice picks thru my head, sensitive to light and noise, lasted from 2:00am until approx. 9:00pm on 1/19.

Five minutes after the vaccine was injected, I became dizzy, my eyes teared and face swelled up and throat tightened. The EMT's came, checked my lungs, etc. and talked me through the episode which lasted about 15 minutes. Then the swelling subsided. I suspect it had, because I had dermal fillers approximately a year ago. I had no other adverse affects, except for tiredness that evening. People should be warned about this because it is a frightening event. I have never had an adverse reaction to a vaccine before.

Stabbing top back, right side, head pain ( Sat), redness and blisters on right side of face (Wed), right eye pain and blisters (Fri).

Patient was complaining of eye issue on Thursday 01/21 and new medication was ordered. Received vaccine Friday 01/22 and had no other complaints other than facial twitching. Primary MD was contacted and patient was transferred to hospital for evaluation due to facial dropping.

Approximately 20 minutes after vaccine injection, patient complained of tingling in tongue. Patient then noticed a strange taste in her mouth and tongue began feeling "thick" at that time. Approximately 10 minutes later, patient noticed that lips and mouth began feeling numb and tingly. Our regional MD was called and advised nurses to have epinephrine on standby and to notify EMS. Ambulance arrived approximately 15 minutes after patient alerted staff of reaction. No medications were administered by Health Department staff, however patient did take one Benadryl that she had in her pocket. Upon arrival, EMS advised patient to take second Benadryl pill that she had in her pocket. EMS transported patient to local hospital. Called to check on patient 4 hours later, patient has made a full recovery and is resting at home. Patient states that she was given a steroid at the hospital and monitored for several hours before being sent home.

Patient c/o tingling in mouth/tongue approximately 15 mins after receiving vaccination. No difficulty breathing/SOB/difficulty swallowing. B/P 132/70 HR 80 Resp 16 Medicated with 25mg PO Benadryl

Patient came out of a sleep feeling numb all over and head felt empty. Thrashed about on floor with muscle spasms in both legs. Kept trying to hold onto head and not swallow the tongue. The attempt to swallow the tongue went on for one hour, if the patient was reclining on a bed. If standing, the tongue felt sore. The patient was still shaken, the next morning.

Pt got drowsy and her eyes were droopy. Family members stated her blood sugar gets low sometimes and we gave her a glucose tablet and water. Pt was feeling much better and talking within ten minutes. We stayed with the patient and monitored her continuously until her observation time was complete and when she left with family she was alert, oriented, and said she felt much better. Instructed patient and her family to give us a call if they had any further questions or concerns and to go to the ER if any serious reaction symptoms occurred.

Patient started to experience increased heart rate, tingling of the tongue (possibly swelling) patient just said it felt weird, feeling flushed or feeling hot, back of neck seemed warm. Shot was given 12pm (noon) 15 minutes later patient started to experience these symptoms. Blood pressure was checked initially (147/78).

9 DAYS AFTER VACCINATION ITCHING, HIVES ON BACK AND ARMS; ARM HEAVY; TONGUE HEAVY; DIZZY, HEART POUNDING; CHEST TIGHTNESS ED visit 01/21 --given Decadron and Benadryl IV for allergic reaction Urgent Care visit 01/25 for chest tightness

Immediate swelling of tongue. Within 4 minutes of receiving shot. Slight nauseaness. Tongue returned to normal approx three hours later.

RIGHT ARM SWOLLEN ABOUT 5 INCHES IN DIAMETER. HUTS AND ITCHES. ASL EYES WERE VERY DRY AND LEFT EAR LOB HURTS

developed "funny" feeling in the tongue at about 12:15. by 7pm had itching as well. started Benadry that evening (Friday) & through weekend. resolved by Monday 2/1/21 Had this tongue reaction to allergy shots in the past.

About 10 days after receiving the vaccine, pt started to hear rings in left ear. Then she started to noticing hearing loss. As of today she has lost almost all hearing in her left ear. She has no other symptoms after receiving the vaccine.

Patient reported being flushed, dizzy, and having blurred vision. We gave her water and kept monitoring her to evaluate for 30 minutes to see if she needed to get checked out in the adjacent urgent care. She felt better after waiting for 30 minutes and did not need to seek treatment.

At 10:58 am patient stated "I feel like I'm going to pass out". EMS called. At 11:02 am patient stated "I feel faint" & c/o nausea and a "humming sensation" at bilateral ears. Applied cool compresses and monitored until EMS arrived at 11:14 am. Patient transported to local ER by EMS. Vital signs stable.

Itchiness on both arms, tongue strange feeling , pain on site of vaccine 30 minutes after vaccination. 7 days after vaccination, hardness on site of vaccine, redness, very itchy.

At beginning of second week, white pustules appeared on right upper eyelid, across my lower lip, and a few on both lower arms. By the third week, all but my eyelid have healed up. Eyelid was the largest and is still large and white, however is not red and inflamed as in the beginning.

Immediately once the vaccine was injected, patient felt a tingling sensation rush through her body. She also experienced a taste in her mouth within 5 minutes of the vaccine and lasted for about 30-60 minutes after the vaccine.

Hemorrhage on right eye; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine and experienced hemorrhage on the right eye. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the day following her injection, the patient experienced a right eye hemorrhage. The patient also informed that she had a substance of unknown origin injected into her eye, when she visited the eye doctor. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The second dose is scheduled for 24 Feb 2021. The outcome for the event hemorrhage on the right eye was not reported.; Reporter's Comments: This case concerns a 76-year-old, female, who experienced serious events of Eye haemorrhage after receiving first dose of mRNA-1273. Noting her recent visit (unknown date) to an eye doctor involved an injection into her eye may remain as confounder. 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. Follow-up information is expected.

NO fever at all during this time or shortness of breath. Pain in the arm at injection site up into neck and top of head. (48 hours) Tylenol for pain. About 3pm Saturday 2/6: Concerning spike of blood pressure 154/92-resulted in urgent care visit. Covid test taken as precaution by MD. Mom not "feeling well" 0630 Sunday 2/7: BP spike to 166/109, Blurry vision, dizziness. EMS called to assess at home. followed up by ER visit. all tests resulted negative. BP dropped to 120/72. On discharge BP up to 162/92. Lisinopril prescribed for HBP. 1 dose given. Monday 2/8: Vomiting and diarrhea, lightheaded. EMS called for assessment, BP drop 100/70. Hydration, rest. Moderate/Severe fatigue and aches (6-7 days) Mild lethargy. (24-36 hrs)

Developed fever up to 99, severe aching in all joints, headache, chills, loss of taste, injection site in arm sore. Felt fine evening of 2/2/21 (date of injection) and awoke 0500 2/03/21 with symptoms listed here. Fever broke about midnight of 2/3/21 and only mild headache and feeling of fatigue next 2 days and then all symptoms completely disappeared.

The area around my eyes turned red and puffed up for at least 48 hours. I have never had Botox or any other injections around my eyes. This happened after the first dose, also.

Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's Palsey right side of face, along with headache, herpes on left corner of mouth, fatigue and ?Epstein-Barr. I was exposed to the virus by my hairdresser on 2-11-21 and she developed symptoms and tested positive 4 days later

Patient developed right facial zoster following her first dose of the Moderna Covid-19 vaccine. She was placed on valacyclovir and gabapentin. She was seen by Ophthalmology due to eyelid involvement and double vision. She was immunized 20 JAN and developed zoster 06FEB.

Pt reported feeling an "awareness" of a tongue & tingling of tongue. No other symptoms Tingling decreased after Benadryl 12.5 mg

2/23/2021, 6:30 PM facial flushing, 10:30 PM diminished. 2/24/2021, 3 am awakened from restful sleep, sinus congestion progressed to bronchial congestion to chest tightness to difficulty breathing, throat tightening sensation, tongue tingling progressed to thickened sensation, slight difficulty swallowing water. Symptoms occurred over the course of 1.5 hrs. 4:45 am symptoms spontaneously ended. 5:00 am symptoms no longer present, body fatigue, restful sleep.

headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat, 02/22 thru 02/25/2021 Doctor prescribed PredniSONE 20 MG TAB CADI beginning 02/25/2021 for 5 days, on going, no outcome

Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard. Hairstylist removed her mask and she then passed out. Called 911. They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy. After several minutes she came out of it. Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am. Her color was still pale and she was still incoherent. While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled. I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75. She stayed with me for the rest of Saturday. Her sugar was still high Saturday evening and Sunday morning. Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.

Tinnitus - started ~4 days post vaccine administration. Still occurring 8 days later but lessening in severity of symptom

18 hours after Moderna shot 2 my eyes swelled up and became itchy and red. My eyes are sill inflamed as of now 3/06/2021. Also I have been running a low grade fever, and have headaches. These symptoms are managed with Tylenol.

Dizziness for month following Burning eyes for month following Skin rash below injection site - 7 days later; lasted week

Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes. Next day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.

Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.

Patient was given immunization at 7:30am, at 7:50am she reported her hands were a little tingly. The patients blood pressure was taken 203/125. She then reported a dry mouth, feeling flush, and a little difficulty swallowing. 911 was called and her blood pressure was monitored. 7:56am 181/108 HR65, 7:59am 184/98 HR 57 8:03am 189/110 HR 62. EMS arrived and took over. EMS transported patient to the hospital to be monitored due to blood pressure.

72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part. 3/16 woke up feeling much better and able to eat, smell and taste about 75%. Spoke via text with doctors office personnel for advice 3/14 and 3/15...very supportive!

Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed assistance. chills shortness of breath excessive thirst

Fatigue, lost appetite, congestion, bronchial congestion, chest tightness, throat tightness, difficulty breathing, tingling/thickness of tongue

soreness of arm, fatigue, loss of taste, loss of appetite, chills, pain in the back of head and neck, nausea and vomiting, right arm numb and tingling

Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vaccine; extreme chills for hours so hard to sleep, because whole body shaking; arm sore to raise and lower, all joints ache, especially knees and neck; fatigue and little energy; runny nose. Feeling better next day, but tinnitus noise still strong, left arm and joints hurt, and low energy.

Migraine type headache, dry mouth, achy arms (both arms not just at injection site), heaviness in lower extremities (inability to get out of bed for several hours).

Woke up on 03/16/2021 and noticed left eye ,the white area was blood shot. No drainage, no itching, no visual changes from baseline. No swelling noted. She has been using a cold washcloth on eye without any relief. Patient was instructed to contact her eye Dr. that she is going to for treatment of her macular degeneration and discuss this. PHN also noted that if her eye specialist was not in or clinic not open to contact her local primary eye doctor. PHN instructed patient to monitor for drainage, swelling, itching, eye pressure, headache,temperature, vomiting or any changes in vision, to be seen by MD. 03/22/2021 TC to patient who notes that when she woke up on 03/21/21 her symptoms have resolved. She was to eye Dr. locally today 03/22/21 but was told she could cancel if s/s resolved.

Patient was in the office on 3/19/21 for her first dose of Moderna COVID vaccine. 15 minutes after administration of vaccine, patient expressed she was feeling hypertensive and her hands were feeling cold. Patient was taken to an exam room for evaluation with assistance of language interpreter and RN. BP of 220/120 with symptoms of headache and blurry vision. No chest pain. No signs of anaphylaxis. Patient stated she was feeling slightly better after 3 minutes. Repeat vitals of BP 180/94, pulse 80, RR 32, O2 sat 98%. Patient did take BP meds as prescribed. Plan to go to the ED was communicated to patient and her brother in law to which they agreed. Patient requested that her brother-in-law drive her to the ED instead of activated EMS. Report was called to the hospital ED recieving provider by myself with diagnosis of hypertensive emergency.

The day following the 2nd injection I experienced visual disturbance (similar to prior to a Migraine headache) followed by a moderate headache and generally not feeling well, This has occurred once daily now for 11 days. Two Tylenol and resting alleviates the issue. I have also noted many episodes of the atrial tachycardia through out each day. No treatment other than rest/relaxation.

The evening of the first shot on February 5, I had a strong headache, muscle aches and was extremely tired for the next two days. I had brain fog for the next 2 weeks. Tylenol and Advil mostly relieved physical discomfort. I had the second shot March 16. The next day I had a severe headache, no energy, achy body, chills and fever and on the second day after the shot my temperature was 101.4 - 101.8. Tylenol and Advil relieved the symptoms. Today, one week after the second shot I developed a pungent chemical taste in my mouth and a similar sense of smell. The tip of my tongue is tingling, and while I can breathe in deeply, my chest feels heavy, like I'm not getting enough oxygen.

Pt states that she developed a dozen lumps underneath her right arm the day after her second shot of vaccine. She also developed an eye infection and a sore on her lip the day after as well.

I had a severe migraine - and I don't have headaches. My whole face hurt. (I have two optic aneurisms and I was afraid they were starting to bleed out.) My eye was running water even more at that point and I also had some mucus in my eye. I went to ER. January 8 and they did a CT scan - and they gave me something IV for pain. They told me to take extra strength Tylenol every four hours and that didn't help. After one hour, I was in severe pain again. At that point, both eyes were tearing. I went to the dentist (Monday) -and they did x-rays - ( to see if I had a tooth issue and I went to my ENT doctor (Tuesday)- and he said it didn't appear that I had a major infection. still in severe pain - she gave me a prescription to get rid of infection in my eyes. She gave me a steroid shot - which stopped the pain. The following week, I had an appt with an ophthalmologist- I was not in pain any more and my eyes had pretty much cleared up. He said I probably had a viral or bacterial infection prior and when I got the vaccine then that was why I got a migraine. 2nd vaccine - 30th of January (8:30) - I slept all that day - I was sleepy the whole day and the Sunday, I had flu like symptoms and after that I was fine. This week, I have the infection in my eyes again. I went back to the Dr yesterday to get an antibiotic because I was having the same kind of infections. This time - infection in my left eye, with tearing and mucus. They had me do the eye drops again and nasal spray I've been using.

On approx. March 6th I noticed I was having a ringing in my ears. It has persisted since then, no better no worse. It does not keep me up at night but it is annoying. I don't know if it is related to the vaccine shot but I kept thinking that it could be a delayed reaction. Maybe it started before but at a lower level and took until the 6th for me to notice. This week (week of March 22) I read a news article about someone who committed suicide because he was having severe bouts of tinitis since having had a case of covid. That made me think that my tinitis could be related to the vaccine. I tried to red up on tinitis and it seems that there is no treatment for this. Am I correct in that information?

On 2-28, I started having tinnitus after never having it before the shot. It was extra loud suddenly on 3-1-21 about 1:00 PM. On 3-26-21, 7:00 PM, it was extra loud in right ear and has been louder (in both ears) ever since. It is louder sometimes than others.

2/1 midnight woke up with fever, chills 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. Husband could hear better than me without his hearing aids.) 3/18 went to doctor. He thought I had fluid in my ears. Put me on fluticasonne Propionate Nasal spray, stopped meloxicam Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. on 3/1 at 11:45 am had 2nd moderna vaccine shot. By midnight I had fever, chills 3/2 fever, chills am, very tired.

2/1 midnight woke up with fever, chills. 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam. Began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. (Husband could hear better than me without his hearing aids.) (3/18 went to doctor ). He thought I had fluid in my ears. Put me on fluticasone Propionate Nasal spray, stopped meloxicam. Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. On 3/1 at 11:45 am had 2nd Moderna vaccine shot. By midnight I had fever, chills. 3/2 fever, chills am, very tired. 3/2 in the evening I thought I would watch tv. I turned it on and the mouths were moving but I couldn't understand anything they were saying. 3/8 Went to ENT and had a hearing test. I still had tinnitus. Test results showed that I have a moderate to severe hearing loss in conversation area in both ears. 3/9 Went to ENT who prescribed prednisone beginning with 60 mg. 3/30 Had another hearing test at ENT. Test results showed no improvement, hearing still as on 3/8. So end results I have tinnitus all the time and a hearing loss that I did not have before taking the vaccine.

Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness). The consumer's medical history was not provided. No relevant concomitant medications were reported. On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.

brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog. The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported. On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired. On an unknown date patient experienced brain fog. On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The headache, tired and brain fog was ongoing and for other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Acute-onset vertical binocular diplopia found on 2/19/21 exam by me to be a left fourth nerve palsy. By follow up on 3/19/21 the diplopia has essentially resolved and the left fourth nerve palsy was measured to be nearly resolved as well.

Giant cell arteritis. Symptoms started 2 days after COVID with upper back and neck pain, lymph node enlargement and tenderness, TMJ pain/trimus. After second dose of Moderna vaccine, worsening sympotms with intermittent sharp lancing pain behind right ear, right >left frontal headache, lancing pain on forehead that radiated to back of head, scalp tenderness, no vision changes or temporal artery tenderness. Labs, exams, CT head and MRI/MRA head done. Video, telephone, office visit, ER visits. Prednisone started. Temporal artery ultrasound negative. Temporal artery biopsy consistent with temporal arteritis. Symptoms improved with prednisone.

It is what I would call severe tinnitus. Like billions of crickets and also an additional "zoom" sound whenever I move, or particularly move my head. I have had tinnitus before this, but never this bad. Some days are worse than others. It has lessened somewhat since the injection. I am afraid to get the second shot.

DIARRHEA 3 TIMES IN 5 HOURS AND NAUSEA, EYES BURNING, HEADACHE, TIREDNESS, VACCINATION SITE VERY SORE WHICH LASTED 2-3 DAYS. THE TIREDNESS AND GENERAL NOT FEELING WELL RETURNED SEVERAL TIMES DURING THE NEXT 3 WEEKS. AFTER THE SECOND SHOT ON 3/31/21 AT A VACCINATION SITE. THE SIDE EFFECTS STARTED AFTER 20 HOURS AS FOLLOWS: ACHY ALL OVER, HEADACHE, CHILLS, BURNING EYES, HOT FLASHES, TIREDNESS WHICH HAS BEEN HAPPENING OFF AND ON SINCE 3/31/21. FEEL I MAY NEED BLOOD WORK TO SEE WHAT IS GOING ON. I HAVE HAD EPSTEIN BARR VIRUS AND WONDER IF THIS HAS BEEN REACTIVATED.

shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side extreme squeezing & twisting sensation of heart; intense bone pain in areas that were injured 15 years prior- neck, posterior thorax, sacral area- all on right side only- day 2; awoke day 3 drenched, extreme diaphoreses- loss of 4 lbs; others less intense- loss appetite & thirst, Rt side only parietal and also occipital headache; tired & weak. Ended in 7 days.

She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a bit nauseous today), face red and swollen, jaw hurt, stomach pains-she couldn't eat.

On 03/20/21 a day after receiving 1st dose of Moderna, I woke up at around 8am with a dark bruise on the right outside corner of my bottom lip. I checked it in the mirror and noticed a dark bruise inside the same area. I also noticed some small boil like bumps on the same corner of my right bottom lip. Also some sort of lesions inside of my mouth on the right cheek and inside the right side of the bottom lip and inside the bottom of the skin between my gums and bottom of bottom lip. The next day 03/21/21 the bruises were gone, but the small bumps and lesions were still there and have been until the present. I did not call my doctor or go to urgent care, because I got very sick to my stomach like stomach flu, and it takes forever to get through to make an appointment with the clinic and urgent care. I was going to call for an appointment today, but have had diahrrea for the last week. I also don't know what type of doctor to call for oral type problems. I was going to call my insurance company to ask them. I have a great doctor, but I don't feel like waiting on the phone to get through to my doctor or urgent care. So haven't been seen by a doctor.

After first Moderna vaccine had several migraines with the Z's but they were unusual. Usually I have a path of Z's going left to right and then at my age I had a very slight headache. These looked different with broken up lights. and I woke up with them.Then on Feb 24 :1t 1:15 I had my second. The next morning I woke up with a hazy eyesight but I thought it might be a migraine. I somehow knew it wasn't but didn't go to a doctor. The next morning definitely knew. Saw 2 doctors one in emergency situation he placed me on steroids but I had lost part of my eye sight.

Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tonsils starting around March 21. Had to go to urgent care on March 28. Strange headache on left side. Finger tips and toes went numb. Covid vaccine related illness(chills, body aches, shallow breathing) started 1 week after 2nd vaccine. Ongoing shortness of breathe.

Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking cough, rapid heartbeat, miscellaneous pangs around body, earaches, edginess, swollen feet and face. Started about 4/06/21 and beginning to subside around 04/11/21

complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,

Face / tongue / throat swelling sensation without problems breathing or swallowing or speaking Prescription medication needed

3/19/21 2:30 am Fever lasting aprox 3 days 3/30/21 8:00 pm 100.5 Fever & aches lasting 4 hours 3/31/21 7:30 pm 101.1 Fever & aches lasting 4 hours 4/1/21 2:00 am Fever & Aches with EXTREME chills lasting 1 hr. 4/1/21 Cold sores and cankars lasting 1 week 4/10/21 very mild cold

after 3 minutes of getting shot, patient developed headache, labored breathing, tongue swelling, burning sensation in the chest, and was flushed. she was at a drive through administration facility run by Hospital Systems. she was given benadryl and epinephrine and then was driven to the ED, where she was given IV steroids. she also developed flu like symptoms which she is still having now.

patient had covid shot given to her at drive up. she states immediately she started having a headache, labored breathing, tongue swelling and burning in her chest along with being flushed. the physician on site gave her benadryl and epinephrine, and she was then driven to another ED where she was given IV steroids. she states the vaccine adverse event was not reported by any of the facilities that took care of her that day. she also has had flu like symptoms since she got her shot and she is still recovering.

Traverse myelitis. Extremely painful neck and back in joints which moved outwards to arms and legs. Started on about day 4. Could no walk to toilet. Pain moved out from joints to muscles in arms and legs. It is improving but after 30 days! Also my tinnitis got worse. I have never had a vaccine or a flu shot in my 76 yr life.

Within approximately 30 minutes post vaccination, the patient returned to the pharmacy stating her tongue was tingling and her chest felt very tight. She did not appear to be in any distress. Despite this we had epinephrine at the ready. At this time she offered that her last flu vaccine caused this kind of response but this time it was worse. When asked why she did not share this initially, she said, " i didnt see a place on the sheet for it". Over the next 30 minutes her tongue tingling resolved, however her chest remained tight. Her tongue tingling then recurred, at this time I suggested she needed a more appropriate setting to be monitored. The patient agreed, we called 911 and EMTS transferred her to the local hospital. At the time of transfer, the patient appeared stable without visible symptoms.

I received second shot of Moderna at the same location on 02/14/2021. Approximately April 14, I experienced tinnitus and it has continued until this date. I also had a hearing test and was told by the audiologist that I had a profound hearing loss. Up to this point, I have never had an ear infection and had no problem with hearing. I am reporting this event in case there are others and you may find the vaccine causes sudden hearing loss and/or tinnitus.

By 11:30 AM headache starting, eyes burning By 12:30 could not get warm even with thermostat at 80°. Very bad gas. By 7PM temperature 101°. By 2:30 pm severe nausea. Began vomiting and then retching by 9:30 PM which was on and off for 5 hours. From about 11 PM through the night and into the next morning so hot could not use covers even as the temperature went down to 79°. Headache was extreme. Gradually began to subside throughout the afternoon. Days 3-4-5-6 after the vaccination bright pink full body rash. bright pink covered all the skin. Itching days 5-6.

shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment include Benadryl and Tylenol.. Event Start date and stop date updated. 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 28-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: Significant 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.

I have Tinnitus. All tests have been performed and I have been "living with it" for almost 20 years. After my secon shot it's been getting increasingly louder. I have been waking up in the night due to the intensity. I did not consult my doctor because I thought it was part of my usual Tinnitus which they always say cannot be cured.

Unstable dizziness; Constant swishing noise in left ear; Wite blood cell at 10.8 and should be 10.2.; head aches.

Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history

I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.

the first event was a few days after the shot when my cheeks turned bright red. This lasted about 2 and a half to three weeks. My cheeks are still a redder color than usual (my skin is light olive-toned( the second event(s) occurred April 23rd and again May 21st. My peripheral vision was obstructed by shivering white rings with black lines. One of my eye doctors told me that they were ocular migraines. The first event lasted about one half to three quarters of an hour. The second event was 15 to 20 minutes.

Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel flu-like though. and within the first few hours I had "Moderna arm" - right near the injection site - big red splotch and the arm was sore. The redness in the arm lasted a good week. It was a red blotch but not itchy or swollen. I didn't feel well for a few days after the vaccine. The symptoms came and went as far as how I felt - chills, weak, not feeling terrific for those first few days or so. A month after the second shot, I had a rash on my neck. It came and went - a little itchy and then not itchy. (This happened for a month.) And then at the same time, I felt the same original symptoms - chills and not feeling good. It lasted about three days - the chills and weakness. And then it went away. Even since, April, I get this periodically - I feel weak in the knees, I get the chills and I have to take a Tylenol or something. The middle of May, I was taking off my makeup and I felt a burning on my face (same stuff I've been using for 20 years on my face) red splotch from top of nose and all around and on cheekbones and down the face - it was puffy, swollen, red and caused bags under my eyes and redness under my eyes- and it still is. He gave me a cortisone lotion (my dermatologist) - It's not as red as it was but if I press on it the redness comes back. I have not changed anything with make-up; lotion or food. I have photos of it that I can send of my face. It's still here - maybe not as bright - and I'm not sure that I notice difference using the cortisone cream. It's been a good six weeks since it started on the face.

Systemic: Allergic: Rash Generalized-Medium, Additional Details: metallic taste in mouth, hives/rash on chest, legs, and arms. red and a little itchy

My right eye became very painful, hurt and felt scratchy until 12/31/2020. My arm still aches and it is 1/2/2021. I also ache everywhere and still do. I am extrememy tired all the time and at times have to lie down. On going.

Patient woke up 1/3/21 with a sore mouth that burns and has skin peeling inside. Patient tried to do a hydrogen peroxide oral rinse that worsened the pain. Patient woke up at 2:00 am 1/4/21 with worsening pain and bigger rash inside of mouth.

About 4 hours after vaccination, I started with itchy eyes, then mild swelling of upper and lower eyelids, which lasted about 2 hours. I also experienced itching of head, face, neck, upper trunk and arms from about 1:30 pm, for 4 or 5 hours, without any visible rash.

Tingling began at 11:12am, one hour after injection. Tingling in both lips. Tingling continued on right side from bottom lip to chin. Tingling not severe, but quite noticeable. Initial sensation lasted ten minutes, then continued for 4 hours slowly dissipating and ending about 3pm.

pts daughter states she has severe confusion with slow speech with difficulty speaking and slow movement Also has extreme muscle pain and double vision. Pt had urge to urinate but could not. Pts daughter states she is still having some symptoms but is improving and will see her doctor next week for a regular scheduled appt. Pt started the medicine Cymbalta in November 2020 for her Fibromyalgia but had developed confusion from it so the doctor took her off of it on January 11th 2021 and was doing well until the day of the vaccination.

Within 3-4 minutes of receiving I felt as though my eyes "popped" . I mentioned to my husband with me something happened to my eyes. Vision was clear but eyes felt strange. I looked at eyes when I got home but did not see anything other redness. Next morning my eyes were very red and had seepage as if conjunctivitis. I have had allergic conjunctivitis for years in spring or fall. Two days later I could see my eyelids were swollen, inside eyes very red, scratchy feeling. Today the sixth day and eyes no longer feel swollen but very irritated. I am using refresh tears and Claritin 10mg.

On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my chest. The next day (1/27) I woke with chills and fever ranging from 99 to 102.4 degrees. And a severe headache., also very tired....Stayed in bed most of the day. On 1/28 I broke out in hives on my chest and stomach. Also have very sore muscles, especially in my legs, and shortness of breath.

My vision in both eyes went blurry. I could not read even with my usual reading glasses and a magnifying glass. I could not see anything more than 5 feet away clearly even though my right eye is 20/20 vision. My eyes ached. By the next evening all blurriness had cleared up. No repeat problem.

My arm was a little sore and a little achy first day. Next morning, Body aches and chills all day long, had a funny taste in my mouth, no apatite as afternoon progressed developed diarrhea, nausea, was sitting on the toilet and fainted. Woke up and got up and went straight to bed and slept the entire night and got up the next morning, I was just tired and weak feeling, kind of dozing on and off. the next day Saturday i was feeling much better, and then Sunday i was perfectly fine.

I awoke on 1/23/2021 (Saturday) morning to find my face and especially my lips swollen. Contacted doctor's office for the on-call; he strongly suggested I visit the ER. Was kept there for 2-3 hours for observation. Was considered "hypertensive," routine blood work done (CBC, metabolic panel) all of which were normal. Was given Prednisone and ZyrTec. After no change in my condition, was discharged with instruction to contact primary physician and continue to take Prednisone and ZyrTec for the next four more days. The reason for the facial and lip swelling could not be determined......It was indicated that the swelling could be one of several things including an allergic reaction to something topical like a lip balm (I used a Blistix application before bed), a reaction to one of my medication (BP med-Olmesartan, which they told me to discontinue) or less likely a reaction to the COVID vaccine.

Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster outbreak on lips, low grade fever.

Resident came by my office to report an adverse reaction to the first COVID vaccine given around 11 am on 01/30/2021. She describes her tongue feeling slightly swollen while eating her dinner around 6pm 1/30/21. The next morning around 5 am she woke with tongue very swollen. She took Benadryl 25 mg at 5 am, 10 am and 8 pm. Today the tongue no longer appears swollen but is reddened the distal third. She reports unable to drink anything hot.Adverse reaction report filed with VAERS.

Pt. rptd. on 02/01/2021 having severe body aches, fatigue, inability to taste, (R) arm achy swollen & red "looked like bite mark", & itchy rash allover body Pt. declined injection of solumedrol benadryl or treatment. Wrote script for hydroxyzine 10mg tab, po, 1tab TID, prn. Tylenol (acetaminophen) 500mg 2tab po q8hrs prn. for body aches. Called 02/02/2021 to check on pt and no answer. Left vm.

Sudden onset in the evening of Feb 1 (17 days after initial dose)--chills, fever, headache, muscle ache, discomfort in upper chest and jaw. Temperature 100.1 which is about three degrees above my normal temp. Night sweats. Following day, malaise, headache, and discomfort when inhaling a full breath. Night sweats again. Today, much better. Able to breath fully without discomfort, not muscle aches or headache, but tired feeling.

Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pressure spike, dizziness, heart palpations, ear ringing, dry mouth, weakness and trembly, visual aura with eyes closed of red ball in field of vision, some pain at temple as if migraine tho I only have had migraines in first trimesters of pregnancy, adolescence and at time of diagnosis of hyperthyroidism. Have had blood pressure brief spikes in past (possible tyramine sensitivity) but this persisted rather than momentary. Live alone and was at home so called Ambulance. Took over 12 minutes for ER to come after called when symptoms did not quickly resolve. Was still having symptoms though blood pressure had dropped to

On 2/3 upon rising my vision was blurry for awhile. At 8PM I had Kaleidoscope Auras in both eyes. I have never experienced either of these events.

Pt received 1st dose of moderna covid vaccine at 0942. At 0953, pt reported feeling hot and eyes feeling funny. Moved to exam room. BP185/82, pulse 70, o2 94% on 4l/nc (pt on home o2 at same flowrate). Reported "spots" in eyes. Spots and hot feeling resolved by 1008. Pt reported jaw stiffness at 1008, states feels similar to when she sits for a long time. Dr notified and benadryl given per order. Continued to monitor patient. At 1047, pt reported that jaw felt "tired", no other c/o. 1101-Dr updated on pt condition, Dr stated that patient may be discharged to home with husband and may receive 2nd dose of vaccine, but should take benadryl prior to appointment. Vital signs remained stable, bp 173/73, pulse 71, SpO2 91% on 4l/nc at discharge.

Client reports having a headache over left eye about 1 1/2 hours after injection. Client woke up on 2/9/2021 to a swollen face. Swelling to both eyes and "bruising" under both eyes. Client is experiencing light sensitivity. Continues to have a headache and discomfort over left eye. Denies respiratory distress and reports no rash. Recommended follow up with PCP.

Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and soreness of whole left side of body. Body aches and tiredness

Large area of swelling, hot to the touch, redness in a patch about 6 inches long and two inches wide on the arm below the vaccination site. Numbness in the right side of the lips three days after the vaccination. The numbness frightened me as I feared a TIA or return of Bell's palsy. Went to ER on Feb .7 when the numbness happened. Was examined by ER physicians, Blood work was completed, CAT scan done, cursory stroke exam completed by a PA and resident. No diagnosis was made except for adverse reaction to the Moderna vaccine. I had had COVID symptoms beginning on or about November 30, 2020. Was not treated by a doctor at that time. Just seemed like having a common cold. Have never before had any adverse reaction to any vaccination.

Burning lips, throat tickle, 4 inch red patch raised snd located approximately 2 inches below injection site, itchiness all over body. 12 hours after injection

Tingling in the tip of my tongue as well as in all fingertips. Took two Benadryl within a half-hour of the injection. The tingling disappeared in the fingertips, but my tongue, although no longer tingling, still feels sore and irritated almost two weeks after the injection. As far as I can tell, no swelling involved. Also still experiencing tiredness.

weak arm/pain/couldn't move, chills, fever, headache, lips swollen, face pain when touching, huge pouch under eyes/cheeks sore, hoarse

I developed all the symptoms of Covid, except fever. The cough was the worst. Had taste, but it is still off; nothing tastes right. I had a Covid test on 01/24/2021 that came back negative. I had two more tests in the hospital on 2/9/2021 that also came back negative. I went to hospital on doctor's orders due to some blurry vision and concern about blood clots, which I did not have. Symptoms persisted until 2/12/2021.

"Moderna COVID-19 Vaccine EUA; second dose caused all COVID-19 symptoms (or so it seemed) within 12 hours of shot. Great discomfort for two days...and now diahrrea on the third day. Not able to eat but bits at a time. Coffee taste terrible. Fever is back to normal now.

I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back of the head. My head and neck and mouth and face were in excruciating pain.

At aproximately 15 minutes after patient had the 1st Vaccine she complained of upper and lower lips feeling tingly. A couple of minutes later she said she had some difficulty swallowing saliva and the sensation of her throat feeling tight. She then reported resolve of her lips tingling but reoccurrence of same. She was given water and juice to drink w/o difficulty. She continued complaining of throat swelling sensation becoming worse and denied SOB. Patient stated she does smoke tobacco. VS 142/88 P 90 P/Ox 86% on RA Appears anxious w/o distress Heart RRR Lungs Some very mild diffuse wheezing A/P At approximately 45-55 minutes patient monitored with improvement in P/Ox to 91% on RA but continued complaining of sensation of throat closing. 911 called, IV started, paramedics administered Benadryl and patient was transported to ED without need of O2.

Patient describes "dry throat" and "metallic taste in mouth" starting immediately after vaccination. Patient was observed to repeatedly clear her throat. Denies shortness of breath, denies difficulty swallowing, denies cough, denies chest pain. After 30 minutes, she's no longer clearing her throat. She continued to deny shortness of breath, difficulty swallowing, cough, chest pain. She was advised to follow up with her primary care provider. Discharged with her son. Son states understanding of all. Patient was afebrile, pulse 72, BP 140/85, RR 16. Patients states that she took her hypertensive medications today and that her blood pressure is normally in this range.

Headaches, shortness of breath, left droopy eye.....achy and tired....lasted 5 days.... droopy eye lasted a week

2 days after vaccination I noticed that I had a blood red bruise just under my left eye, close to nostril; I noticed blood in left nostril on 3rd day, and that evening noticed that I had redness in corner of my left eye with a red spot in very corner, which led me to reporting it here. I have not yet had contact with my doctor, but plan to call him and/or ophthalmologist tomorrow, Monday.

Client reported "weird" taste in mouth, Tingling lips & Rt. hand tingling @ 1215 pm. BP 162/78 @ 1225 pm. BP @ 1235 pm 168/78 @ 1245 pm 166/78, @ 1255 pm 158/70, @ 105 pm 155/70. Monitored client for worsening symptoms. Symptoms remain unchanged. Team lead called FNP. Verbal order for Benadryl 50mg IM. Benadryl 50mg given in Lt. thigh. Symptoms subsided. Continued

Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swelling starting soon after vaccination. Patient did not take diphenhydramine. During clinic visit seven days after vaccination patient reported chest burning, alternating hot/cold sensation, fever, facial erythema, and sensitivity to smell. No swelling or erythema noted on physical exam: findings include malaise/fatigue, tinnitus, constipation, back pain, nervousness, and insomnia. Vital signs all within normal ranges. Patient discharged home from clinic stable with prescription for hydroxyzine.

Vaccine was administered at 2:05pm on 02/02/2021. At 6:00pm EST my mouth felt odd as if I burned my palate. After 48 hours the feeling did not subside so I made an appointment to visit my oral surgeon. On 02/04/2021 I visited my oral surgeon who took multiple pictutes of my mouth/palate and felt it was a reaction to the vaccine. She prescribed a mouthwash as treatment and a follow up in 2 weeks.

2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of face; 2-21 - tired, tingling along jaw line; 2-24-21 - sniffles,intense tingliness on and under tongue, feeling of numb lips; 2-25-21 numb lips - called Facility, talked with advise nurse: 2-26-21 swollen gland, slight headache. Video visit with Dr,; She said if symptoms continued for another week to call back and that an MRI might be considered. . Symptoms of tingling, sense of numb lips primarily on left side have continued daily through today 3-5-21. Called advise nurse today and am waiting for a call back from Facility.

After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd dose on 2/25/21, pain at shot site, redness & swelling. On 2/26/21, heavy chills, short of breath, face flushed, temp 98. Pain in low back & right upper arm (torn ligaments). Pain more severe than previously. 2/27/21 Shot site sore, itchy, red, swollen, short of breath, headache. Heavy chills towards evening. 2/28/21, Light pain at shot site, site swollen, warm to touch, labored breathing. Shakey, anxious, doom & gloom, food seems tasteless. Evening feeling better, swelling down, flashes if left eye. 3/1/21 arm itchy, no swelling, arm aches slightly. Pain in low back severe, right arm pain. There was only 26 days between the two doses. The pain in back may be from scoliosis. Pain in right arm, torn ligaments. But after receiving vaccine, these pains increased tremendously, as well as the shortness of breath and extreme groin pain (maybe from fibroids?).

scratchy feeling on the outside of her throat, dizzy and light headed. She carries an EPI pen for allergic reactions.

High fever of 102, dizziness, headache, pain in left side of jaw, neck , chest. Nausea, weakness, seizure.,( Never seized before) left eye burning high blood pressure. Symptoms started in bed while asleep 12 hrs after 2 nd vacccine

Patient received Moderna Vaccine 1/21/2021. 2 days prior to vaccine administration patient had vertigo and sinus allergies that resolved. Patient canceled her 2nd dose appointment on 2/18/2021 reporting she had been sick. She rescheduled 2 times on 3/4/2021 and 3/11/2021 but canceled those appts as well reporting still not feeling well. She called 3/10/2021 and informed nurse of persistent symptoms that started 2 weeks after receiving her 1st dose of Moderna Vaccine. The symptoms reported throat burning, metallic taste in mouth, metallic smell in urine, body weakness, warm sensation over body, ear pressure and nausea. She reports she has been to an ENT doctor 2 times, her PCP 1 time and the ER 1 time. She and her doctor's are unsure if her symptoms are related to her first injection.

Immediately, sharp shooting pain from injection site ( the back of my arm, not the middle) when all the way down my arm and was severe in my pulse side of my wrist. I reported it. The pain resolve mostly after 30 minutes. Either Feb. 28 or March 1 woke up with my left eye being red from broken blood vessel. March 3, slight burning with urination. 1X March 4 no burning until about 4:30 pm, and then also much blood. 15 minutes later, the same.

Sudden dizziness with some nausea and cold drenching sweat - no fever - extremely weak and fatigued and could barely stand and then severe headache came on about 10 minutes into episode. Dizziness lasted approximately 2 hours until I could safely move and then began to subside. I noticed my eyes did not want to focus well and was seeing spots when I tried writing down what happened. Chills began and I felt extremely cold, my head felt "foggy" and tight, ringing in ears started and headache moved to migraine level. Slight fever 99.8. Main dizziness did pass after about 2 hours but other things continue to linger on an off. I just feel "off". I have actually heard other seniors mention some of these very symptoms so am not super alarmed, however, I did not have any of these side effects before the vaccine for Covid-19. I did experience extreme fatigue and bad headaches since I received the first dose on January 27, 2021. I have not called my doctor regarding these side effects since I have heard many seniors complain of very similar reactions. I have rested as much as possible, tried to stay hydrated, and taken Tylenol when needed. For the dizziness I tried to stay as still as possible and put my head between my knees until it finally passed.

received shot at ll:45 am was fine went home. about 4:00 started to get cold. developed flu like symptoms, headache, fatigue little bit of fever, pain up back of neck and to my ears. was in bed all night on 3/12/21, stayed in bed all day 3/13/21. Had some oatmeal, gatorade, juice. Could not taste anything back to bed. Sunday got up thought I was good. But dizzy and lightheaded, little itching on my legs and a little nausea. Had tuna sandwich could not taste it, thought it was awful. Back to bed all day. Monday I am up but still dizzy when standing trying to stay up but just sitting. Taste has come back.

Patient came and said that she felt a slight tingling in her tongue and that it had slight swelling but otherwise was fine and wanted to go home. I offered to give her benadryl but she refused. No other symptoms noted or complained about. Told her to also fill out this form online via her phone and she said that she was willing. She looked alert and I noticed no other issues except what she told me.

Allergic reaction with bright redness and swelling of face, tingling, itching and swelling of tongue, mouth, gums, tingling, heat and itching in hands and fingers, feet,insoles, between toes, in crook of arms, behind knees, itchy eyes, ears, scalp, increased itching throughout body

The Sat or Sun after I got the vaccine, a quick pain shot around my eyeball in my right eye. It kind of radiated around my eyeball. Then, about a minute later, I experienced a second episode that was less intense. About a week later, I had another quick pain behind my left eye. I had no vision changes or any other symptoms afterwards.

After DOSE 2 had swelling of several body parts, lip, ear lobe, arm and ring finger( had to have rings cut off), lasted close to a month

I had a slight fever, body aches and headache for 2 days, after each dose. Tinnitus, which I've had a few times over the years, started about 10 days after my first dose (01/18/21). I received my 2nd dose on 02/15/21. The tinnitus has continued, about 4-5 days per week. I have seen my ENT twice. He suggested I try melatonin.

Started with headache and mental confusion within a hour of first injection. Right eye was becoming blurry by day 3 and loss of vision apx 6 days after first injection.

Caller stated she got Moderna vaccine on Saturday and was fine. She stated yesterday she had a few side effects, ie fever, headache, fatigue, which she stated are gone. She stated when she woke up today she was fine but then noticed her eyes were a little bit swollen. She stated she has history of eyes swelling when she eats alot of salt. No Lot number available at the time of this notification.

Respiratory. Labored breathing, felt strange, little tingling in hands, tongue felt thick a little layet

Patient complained of lips and tongue tingling; denied any shortness of breath; Benadryl (5cc) administered. Advised to go home and go to bed. After reaction started, she admitted that she has this happen after any type of vaccine received. Did not advise of this when completing questionnaire - only acknowledged allergy to statin.

Loss of voice! No ability to make a resonant voice. Just breathiness. This was preceded by fever and chills which lasted one night, the following day, and was better after the second night of sleep. Fever was gone in the morning but SO WAS MY VOICE!

Mom became agitated. Would not sleep. Stayed continuously awake for approximately 40 hours. Could not be redirected. So tired she was swaying on her feet, but could not be convinced to lay down. After 2 days we were able to get 50 mg Trazadone from our doctor. After sleeping for 6-8 hours she then did another 24 hours awake. We upped the dose to 100 mg. By this point the event had started to pass. During this time we also noticed mom was running a low fever in the morning. 99.5 - 100.5. It would go away in the afternoon. During this time mom was hallucinating - having conversations with people who were not there. Mom's hearing declined during the event as well. As of 2 days ago mom's temperature seems to be back to normal in the morning. This "event" has impacted mom's mental and physical decline. She seemingly overnight now needs help showering and toileting, and sometimes dressing. (This kind of decline is common for dementia. Each time over the past 5 years that mom has had some physically stressful even such as hurting her foot or getting a bad stomach virus, she has come out the other side degraded) The reason I'm reporting this is that the behavior changes were sudden, seemed to peak, and then subside. There is a correlation with the second moderna shot, and so I though it was important to report.

She got moderna vaccine at 9:30 AM. She started to get itchy lips and fuzzy tongue shortly after immunization given. This is a similar reaction as when she has had carbocaine and novacaine. She is having no breathing issues. No facial swelling. She got benadryll at 10:04 AM. She notes that has helped - the burning in her throat is better now after the benadryl. She is currently feeling like she still something in her throat, wants to clear it. Were better then throat scratchiness occurred and same throat burning and foreign body feeling returned. Epi pen given in office and patient was sent to the ER. Her vitals were stable and she had her son here who felt comfortable transporting her to the ER.

High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth 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.

30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT LIKE THERE WERE LITTLE SWORDS, MY BREATHNG BECAME A LITTLED LABORED. WHEN I GOT OUR OF MY CAR AND WAS ALKING INTO Y HOME I FELT VERY WEAK. I WAS VERY AFRAID! I CALLED 911, EMT'S DID MY VITALS, BLOOD PRESSURE HIGH, OXYGEN 95 WHICH IS NOT Y NORM(99). AFTER MUCH DISCUSSION THEY WERE WORRIED I WAS HAVING A STROKE, THE AMBULANCE TOOK ME TO THE HOSPITAL. DID CAT SCAN. BLOOD TESTS. WATCHED ME. I WAS THERE ALL DAY. SENT HOME AT ABOUT 5:30PM HOSPITAL.

As I was driving at 70 mph along the highway 4 days after I had my second dose of the COVID-19 vaccine, suddenly I went blind in my right eye. I was blind in that eye for about 10 minutes. We drove right away to my eye doctor, who sent me to the ER. The hospital is Stroke Certified. They admitted me and did a stroke workup. I was in the hospital for 1 day (24 hours) which included overnight. The treating HCP concluded that I had experienced an ocular stroke. Since it was exactly 4 days after my second dose of the Moderna COVID-19 vaccine, it most likely was caused by that vaccine.

I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination. No medical advice was sought and acetaminophen was taken on an as-needed basis. What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first

first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - sore arm, sore back of neck from headache (muscles seemed frozen for days), really cold from 8pm to 4am with debilitating headache. left side of body was without coordination, hip, knee, ankle didn't work. Went sideways with all joints when walking. 03/18/2021 - passed out in bathroom due to pain. Hit door frame and had large lump on forehead. Bowel mess to clean up. 03/21/2021 - didn't dress, still wobbly stomache upset, neck sore, dizzyness, ate squash and beans. 04/01/2021 - still have stomache upset and though day temperature is over 70 degrees, am very cold, tired as soon as do just one thing. continues

Patient with underlying bilateral SNHL, patient noted that ~ 3 weeks after second dose she noticed drop in hearing on the left. Audio from 3/31 with decreased hearing on the left compared to prior audios. Currently on oral steroids, antivirals and underwent first intertympanic injection.

Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated that she was not feeling well and sat back down. Stated that she was feeling short of breath and was not seeing clearling. Writer instructed Office support to call 911. Client continued to have heavy breating and pulse was weak at about 30 beats per minute. Gave epinephrine injection in Right thigh and EMS arrived. Client increased respirations and heart rate increased.

Blood clot that caused total vision loss in right eye. It occurred on 04/03/2021. Was treated by ophthalmologist at eye Center, and at Hospital,

Per individual, she stated she woke up a last week and her eye was swollen "almost shut", red, itchy and had "a scaly crust" She stated she went to the local ER and was prescribed an antibiotic, steroid and antihistamine. She stated she is not sure why it would do this, but wanted to report it.

Approx 2 weeks after 2nd shot, I developed severe body aches and felt like I had the flu and a week or so after that I had vertigo, tinnitus and extreme exhaustion. That lasted for 2-3 days and then dizziness to present, but lessening

small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) in a 77-year-old female 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 Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Eliquis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) 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 06-Mar-2021, the patient experienced ATRIAL FIBRILLATION (heart went to into a-fib) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (hurting badly at injection site). On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (light and dark spots). The patient was hospitalized for 4 days due to ATRIAL FIBRILLATION and CEREBROVASCULAR ACCIDENT. At the time of the report, ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) outcome was unknown, VISUAL IMPAIRMENT (light and dark spots) had resolved and VACCINATION SITE PAIN (hurting badly at injection site) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. This case was linked to US-MODERNATX, INC.-MOD-2021-060976 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-060976:MOD-2021-060528 (Wife case)

Morning after injection, I sat down at the breakfast table and said to my husband" I can see you, but everything else out the windows (there is a bank of windows surrounding table) is completely grey....I can't see trees or house next door." The next I knew he was peeling me off the floor after I completely fainted and fell off my chair. No injury other than small bruises and head bump. He got me back to bed and doctor was not needed.

Patient states that she started having trouble feeling tired, having difficulty concentrating/making decisions, vision problems, and dizziness/lightheadedness after the first vaccine dose on 1/26/21. She was not very clear on timeframe of onset of individual symptoms. She received her second dose on 2/26/21. She was diagnosed with A-fib during the time between her 2 doses. She did not notify pharmacy where vaccine was administered of her suspected side effects until 4/20/21. Patient states she has seen several of her healthcare providers to see if they could find any reason for her to be experiencing these things other than the vaccine but she says they haven't found anything.

Client started to c/o symptoms approximately 10 minutes after vaccination. She c/o numbness in her fingers, feet, and lips. Stated that she had heaviness in her chest and a pain that shot from her chest to her back lasting only a few seconds. She c/o dizziness. Client reported her BS was 140 this AM, B/P was 136/82, pulse regular and steady. EMS called to evaluate the client at 0930. EMS checked her BS which was 324, and her B/P was increasing. Client was transported to the hospital for further evaluation.

I had my first Moderna vaccine on February 13, and about 20 minutes later my tongue began to feel like novocaine wearing off. This lasted about two hours, and then I had no further reactions . My second shot was on March 13, and the same thing happened., tongue tingling, lasting 2 hours, then no further problems. On March 29 I woke up with lesions under my tongue, and a brief time of having difficulty moving my tongue. During the day my tongue felt strange and the lesions hurt. Since the 29th the lesions have disappeared, and each day my tongue improved. Today, April 23, I would describe my tongue as feeling like I have burned it on something hot, uncomfortable but not painful.

Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; 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 patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.

"Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21. She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.

Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injection site; Itchy at the injection site; Extreme fatigue / Could not get up for 2 days / Lay down for 2 days; Headache with flashing light; Broke her L2 vertebra; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis, Blood pressure high and Migraine. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light). At the time of the report, LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra), PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light) outcome was unknown. Not Provided No concomitant medications were reported. No treatment information was 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 for all events except Lumbar vertebral fracture which is unlikely. This case was linked to MOD-2021-092132 (Patient Link).; 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 for all events except Lumbar vertebral fracture which is unlikely.

Extreme chapped lips. Started out very dry, tight, red, and sore. Then they were very dry around the outside of the lips and the center of the lips that touch was sticky. When you smile, you feel as if your lips are going to split. This has lasted for two months and is still continuing. I am using a steroid cream twice a day on my lips. Using a combination of coconut oil and lavender essential oil in between to keep my lips soft. This has helped but it seems as if it gets worse if I stop treatment.

started with a red blotchy rash and urticara, she went to ER and he tongue was swelling on Sunday 4/23/21. Patient ended up in ICU intubated.

While driving home today, 5/7, one day after 2nd dose administered pt began to have blurry vision. Husband was driving. All of a sudden pt was looking out the window and things were very blurry. No other symptoms noted at the time. No Tx. at 12pm pt states vision is a little blurry but not as bad.

Only a sore arm, but about a week after the first dose I had sensitivity in my front teeth that progressively got more sensitive. I took some Aleve to help with the sensitivity.

Pt called about a month after her second dose. She had been to the dentist and was asked why her tongue was white, splotchy, and had blisters. She also had a bitter taste in her mouth. Pt noticed some soreness while brushing her teeth before going to the dentist that day, but nothing previously. Pt was not sure if it was from the vaccination.

Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mild Brain pause) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical report provided by the reporter. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Mild Brain pause) (seriousness criterion medically significant), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head). At the time of the report, MENTAL IMPAIRMENT (Mild Brain pause), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The rechallenge was positive. This case was linked to MOD-2021-114463 (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.

She got her vaccine, about a day and a half her arm was sore and itchy. Then later on it was red, splotchy kind of redness, but not at the point of the injection, just a couple of inches below towards the elbow. This lasted for about a week. The soreness went away but could see redness in the area, which took about 4 weeks for this to disappear completely. She had a headache which lasted for a short period of time, and disappeared. She also had a swollen lymph node along her waste that were sore about 2 days after the vaccine, which also disappeared and had it only for a day or two. She started noticing a sound, thinking it was in her old house the 2nd week of April, but moved to a quieter neighborhood and still noticed it. She was reading an article this morning in the paper and realized the sound that she was hearing was tinnitus. She was only born with one ear and it sounds more like a beeping sound than a ringing, but it continues to bother her. She does not notice it when she's out driving around from the other noises in the environment but when it's quiet due to the one ear she can hear it. With only one ear she cannot determine the direction of where the sound is coming from, but does notice it during quietness. She puts her ear up to the wall to determine where the sound is coming from and plugged her ear, and determine it was from the ear itself. She is worried about it getting worse or not getting any better with only having the one ear.

Patient reports 3 weeks prior to presentation to our hospital bruising and petechial rash as well as gum bleeding. At time of presentation she was found to have platelets <5K, normal hemoglobin and WBC . Diagnosed with ITP and started on treatment

As soon as I arrived home I noticed the sound was louder. I was very distressed already having experience with Tinnitus. The next night on the news i heard that an increase of cases of Tinnitus after the shot and also as I had and increase in loudness.

On March 6, 2021, three days after second Moderna vaccine, I had sudden onset deafness in my right ear and progressing dis equilibrium. Within a couple of hours I could barely walk. Extreme dizziness/vertigo, nausea. Went to ER next day, 3/7 and was transferred after about 5 hours to Medical Center. Was eventually diagnosed with Idiopathic Labyrinthitis. ER wanted to admit me at 11:30pm but I hadn't eaten or had any fluids and they don't feed people in the ER so I went home. Conditions worsened with walking like a very drunk person and brain fog, dizziness, vertigo. Went back to ER where they completed all kinds of tests and scans.

Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and knife-like sharp pains in legs 5- 7 days heavy nasal mucus discharge painful muscles and joints; fatigue, unstable balance, sensitivity to light lasted 3-4 days 3rd day sore upper left arm with rash from injection site to elbow lasted 3-4 days Symptoms generally cleared up by June 16. Treatment: bed rest, fluids and 1000 mg Tylenol every 6 hrs over 4 days

I was having shooting pains through my head which were severe and in my right ear was soar as well (tender to touch with shooting pain). I did not have any energy and couldn't concentrate since the pains were happening all the time. My doctor treated me with Valtrex and a topical pain killer (Lidocaine). I was diagnosed with Shingles but did not break out. It took about a month to recover from the Shingles and then my ear continued to hurt for another two to three weeks. Now, everything seems to be fine.

can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot. 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.

I never considered it as an adverse effect. I did wonder if by stimulating my immune system if it stimulated the shingles. I had pain in my shoulder and going up the side of my bed. It wrapped around my head and behind my eye. I had had shingles before and it felt like shingles pain. I noticed I was breaking out on my shoulder and starting up the side of my neck. I went to the urgent care and they diagnosed me with shingles. They gave me some medicine and it went away 2 weeks later. It didn't affect my eye itself, but it did affect my eyelid and around my eye. I saw my regular doctor later on. I just had a prescheduled appointment with her. I did tell her about it. She looked at the area and said I was healing up nicely. She suggested I get the shingles vaccine.

weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chills, was losing her balance, headaches, temporal artery on right side of her head is bothering her, diagnosed with gastroparesis, right arm/near breast is sore, developed tremors

didn't get the second dose; Blood pressure High; Heart beat raised up to 110 bpm; Throat raspy; Throat dry; Knees swollen,knuckles swollen; Knees red, knuckles red, face red; Knees hot, knuckles hot; A little bit of fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure High) (seriousness criterion medically significant), TACHYCARDIA (Heart beat raised up to 110 bpm) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat raspy) (seriousness criterion medically significant), DRY THROAT (Throat dry) (seriousness criterion medically significant), JOINT SWELLING (Knees swollen,knuckles swollen) (seriousness criterion medically significant), ERYTHEMA (Knees red, knuckles red, face red) (seriousness criterion medically significant), FEELING HOT (Knees hot, knuckles hot) (seriousness criterion medically significant), PYREXIA (A little bit of fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't get the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form; ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form and AMLODIPINE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 210/110 mmhg (High) Blood pressure went up very high. On 04-Feb-2021, Heart rate: 110 bpm (High) Heart beat was raised all day. 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 relevant concomitant medications were reported. Patient went to the Emergency Room and diagnosed for allergic reaction. 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

Woke up 0n 4/22 /2021 with eyes blood red, headaches, chills . Called eye doctor and was given different medication for glocoma. It made eyes swell and itch . Patient was taken off that med. and pit back on the original. Patient is still having chills and cough and headaches

Patient reported blurry vision shortly after vaccination while being monitored. No other side effects reported. Patient was monitored until symptoms eventually resolved.

15 minutes after Moderna COVID vaccine patient experienced dizziness, slight chest tightness, and numbness to her lower lip. She was given benadryl 25 mg. Her dizziness, chest tightness, and lip numbness resolved. She did have elevated blood pressure reading at 1200 was 130/90 1230 was 180/82 it took 2 hours of resting to get her blood pressure down to 152/82

Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Saturday after her vaccine 1-16-21 she had chest pain, chills, fever, her blood pressure went up, jaw pain, and grinding of her teeth that lasted for one day.

Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Saturday following her vaccine she had chest pain, pain in her jaw, chills, fever, her BP went up, and grinding of her teeth for just that one day and then it went away.

Moderna COVID-19 Vaccine EUA chills, shortness of breath, fatigue, body and muscles sore to the touch headache with funny feeling, sluggish, flushed, no taste. sore throat, nausea (not vomiting), severe leg cramps, droopy, eyes won't focus and want to close, lumpy throat that is sore to the touch

Pt received her first dose of COVID19 vaccine on 1/13/2021 at the health department clinic. Pt then called the health department on 1/19/2021 stating once she got home her bottom lip swelled up and so did her eye lids. On 1/19/2021 the pt reported she could not speak with me (RN) further as she was about to go on a zoom meeting with her allergist to discuss the event. RN asked pt to call the LHD back. 1/20/2021 RN called pt to discuss further, pt stated she is in the grocery store and cannot speak. RN asked pt what the allergist recommended. Pt stated the allergist recommended getting the 2nd dose of the vaccine however with additional pre-medications. Pt stated she could not speak with RN further and would call me back. 1/25/2021 - pt did not call clinic back. RN called pt to get more details on the event. Pt reported her allergist would like her to get the 2nd injection in the hospital, while taking Singulair the night before and Zyrtec and Benadryl the day of. RN advised the pt her allergic reaction is a contraindication to receiving the 2nd dose per CDC guidelines. Pt verbalized understanding and will discuss with her allergist further. Pt also mentioned possible allergy to Polysorbate during call on 1/25/2021 however she reports because she tolerates Miralax on a regular basis her allergist does not believe it to be a true allergy. Pt did not mention this in VAMS. I was not the vaccinator.

BOTH HANDS GOT BEET RED AND SKIN AROUND MOUTH ITCHES STARTING AT 9PM. TOOK 1 BENADRYL AT 9PM AND HANDS WENT BACK TO NORMAL AND MOUTH SKIN NO LONGER ITCHES. WARNED TO CALL EMS IF ANY MORE ISSUES.

My forehead felt like it was swelling. Lips were tingling. Took 2 Tylenol. Stayed home and rested. Disappeared in a couple of hours, around 1:30PM. Felt fine thereafter.

patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a severe headache and fever, unknown exact temp, nausea and vomiting. Fever stopped on 1/20/21 per patient. She reports her eyes seemed blurry for several days, like haziness. States she felt like her heart was racing for a few days beginning on 1/18/21. She did have a routine doctors apt on 1/22/21 and her physician completed bloodwork, unsure of labs or results. Her physician said that she should report her symptoms after the vaccine. She also had swelling and redness to her left upper arm all the way down to her elbow area after the vaccine.

Flushing 2-5 minutes after the injection; numbness in tongue and difficulty swallowing 20 - 25 minutes after infection

1102: After receiving COVID vaccine, pt reported feeling a strange sensation on throat area; no sense of edema; no tingling or thickness to tongue. Juice provided and tolerated 1105: HR 75 RR 16 SpO2 98% 1111: Benadryl 12.5 mg suspension given. 1130: HR 82 SpO2 100%. Pt reports "feeling fine" so released home, driven by spouse.

Sore throat - 1/28/21 woke up Arm pain - 1/28/21 woke up Itchy eyes - 1/28/21 evening and currently Itchy ears - 1/28/21 evening and currently Itchy in the arm of vaccine - 1/28/21 evening and currently

0920: 10 mins after receiving COVID vaccine, pt began experiencing a tingling tongue; has had a previous reaction to the pneumo-vax. Benadryl po given. Pt released home once stable.

Extreme pain in jaw. Lump tmj and in throat. Swollen glands on left side. Sharp pain when swallowing and ear ache.

head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breath 2-3 hours (2 different times) next day after vaccination, increased vertigo symptoms since vaccination & still remains, but other symptoms are improved. Note: just wondering if interaction of the steroid injections every two weeks with the covid vaccination???? (in answer to be if recovered...all except the increase of vertigo)

Red circle, appx. 1 1/2 inch diameter on upper left shoulder in area of Vaccine administered. Tingling and pain in mouth and gums

12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID test; Positive Bamlanivimab; treatment/infusion; 3 hours 15 days isolation 1/18/2021

per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff neck for a couple of hours that evening, unable to eat Tuesday, Wednesday, feverish, and shaking. Slowly recovering through week. As of today per pt. "feels perfectly line"

Day #1 Intense itching, swelling and redness within 3 hours after injection Day #4 Swollen tongue, itching, difficulty swallowing, coughing, wheezing. Called 911 and transported to Hospital. Received Prednisone 20mg for 5 days, Famotidine 20mg Day #9 Tele-visit with Dr. Received Azithromycin 250mg for coughing. continued Azithromycin Day #10 Symptoms returned. Swollen tongue, difficulty swallowing, breathing difficulty, left arm is swollen, red and itching at injection site. continued Azithromycin Day #11 Woke up with same symptoms in addition to nausea. continued Azithromycin

25 minutes after receiving her 1st dose of Moderna, the patient complained of having a sensation of swollen lips and tasting the vaccine. Her lips did not appear swollen, she had no shortness of breath, no rash or hives. The patient has a prior history of allergic reactions to shrimp and other injectables (not specified). Per the patient, by the time I spoke with her, her symptoms were already resolving. Her vital signs were recorded and reported to Doctor on duty. Instructions were received to continue monitoring the patient and she could be discharged when her symptoms were completely resolved. After an additional 20 minutes, per the patient, her symptoms were all gone and "felt fine". The patient was discharged to home. Patient left the clinic by wheelchair accompanied by her family member. She was instructed to call 911 if her symptoms worsened and/or contact her primary physician. The patient was asymptomatic upon discharge.

Late Saturday I noticed my lip dropping to the right and by morning my right eye was dropping. On the way to theER my eye felt like it had sand in it and I had to hold my hand over it and my mouth and lips felt like I had a shot of novicane and it was hard to pronounce certain words. I have to eat small things because it is difficult puttinng food in my mouth and I can not feel the food in my mouth on the right side and if food gets over there it gets between my gums and my cheek, to drink I have to position a straw in my mouth on a certain point and some goes back down in the straw.

Patient had reaction to COVID vaccine. Caused swelling lips, hives around the around the mouth and mild numbness. Was given benadryl 25mg, PO and was advised son to take patient to urgent care for further evaluation. Patient denied SOB and closing throat at the time of visited. Patient was in stable health condition before leaving.

about 3:30 the next morning i woke up with dry mouth and went to the bath room and tried to drink water and my throat had closed up and i couldn't breathe I was not able to drink water and and kept gasping for air. finally after a few minutes i was able to catch my breath and i started to wheeze and then my chest hurt when i would breath. And then i woke up today and i was fine.

I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100. took a tylenol. I woke up at 5am the 10th and I was shaking and having chills and I was hot and cold... I was dizzy and my eyes hurt. My arm was hurting. I took another tylenol. at 6am I called my NP daughter for advice and she told her it was a reaction of the vaccine. my fever was 102.5. I was advised to take more tylenol and to rest. the fever broke later that morning but I was still experiencing those side effects. 3 days later I'm still not 100%.

TINGLING IN TONGUE & GUMS ADVANCED TO BURNING & NUMBNESS- TONGUE FEELING OF THICKNESS WITH RAPID HEART RATE. TREATED WITH BENADRYL & PREDNISONE 20MG 1 DAILY FOR 5 DAYS STILL FEEL AFFECTS 02/05/2021

Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheeks. . Took Benadryl and 16 ounces of water around 1hour 15 minutes after shot Two hours after shot experience slight sore throat lightheadedness head cold symptoms Symptoms lasted another six hours took a second then a drill. Rank another three bottles of water Symptoms became lighter with a little bit of a headache After 20 hours everything went away except tiredness and light headaches

extreme temperature drop; extreme fatigue; headache; joint pain; right side of face and ear painful; Next day - drenched, trouble controlling temperature, headache & joint pain and nausea

I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscle and body aches, bone and jaw pain, no appetite, nausea and diarrhea?all starting on the same day and rather severe by the next day.

Eleven days after vaccine, full body internal itching and redness of hands and arms, also swelling of lips and tongue

Pt began to complain of feeling dizzy. Initial BP was 130/80. Pt then began to complain of double vision and her head feeling "tight". BP at that time was 160/77. EMS called due to increasing BP, double vision and headache. BP when EMS arrived was systolic BP of 180. Pt also complained of nausea. EMS did not transport patient to ED per daughters request to wait at clinic under observation for 30 min in the quiet and then will go home. Pt observed for 30 min and all symptoms resolved within 30 min. Pt taken home by private care.

2/9/12-1st lightheaded, metallic taste in mouth, dizzyness, high systolic BP x3, q5 min: 186/80, 180/80, 153/83, normal systolic 120, HR WNL. Ct feels reaction r/t anxiousness prior to vaccination, 'I don't like shots' , Ref to PCP, appt w/ ENT on 03/02/21.

Experienced severe acid reflux with white, coated tongue for 3 days 4th and 5th days nausea, headache, chills aching joints from neck to feet on 2/19 left arm sore (it was not sore except for day after injection) and itchy

My tongue has turned dark gray/black... Not sure of the exact day it turned gray, but it has been this way for 2 plus weeks...

Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post injection for observation. Patient reported that she felt her tongue swelling and had difficulty swallowing. Patient anxious, but in no respiratory distress. BP 130/72. Patient was instructed to take some slow deep breaths. Patient continued to c/o tongue feeling thick and she had hacking cough and c/o difficulty swallowing. Patient was given Epinephrine 0.3 auto injector to right thigh at 1:32 pm by RN. BP 150/92, P 90 R 20, Patient also given Diphenhydramine 50mg IM to left deltoid by RN, Supervisor. Patient remained alert and oriented. BP 176/92 at 1:37 pm. EMS arrived on site and monitored patient with EKG, Pulse oximeter, BP and pulse. Patient had some shaking. She remained alert and oriented. Patient refused transport by ambulance to ER. She did agree to go to ER by private car. Patient's husband resent and to transport patient by car to Medical Center. EMS followed patient to hospital. Confirmed that patient was taken to Medical Center ER, by RN.

Patient complained of tingling and numbness of lips after receiving vaccine. Patient stated this occurred with dose #1 and was instructed to take 12.5 mg of Benadryl 30 minutes prior to arrival for this dose, which she did. She was given 25 mg liquid Benadryl now and had swelling of bottom lip. She was monitored for an additional 30 minutes and had no further complaints of numbness/tingling and states that her symptoms had disappeared. She left with her family at that point.

Patient reported that her lips tingled and that she was having difficulty breathing at 11:00 am. An EMT onsite made contact with the patient and there were no signs of anaphylactic shock. EMS was contacted and responded. EMS evaluated the patient. Patient was not transported.

My antidepressant, Sertraline has stopped working. After the shot, my eyes got blurry. About 5 days later I thought I had a headache from sinus. After medication and doctor visits, it is not sinus. No appetite. shaky, insomnia, no interest in ordinary activities. Constant headache. Feel very sick.

Client reports that at 1500 on 2/24/21 (same day as vaccination) she noted her lips were swelling and "tingly feeling." Client denies rash, difficulty breathing, dizziness, or other symptoms. Client advised to try Benadryl and check in with physician if needed. Client reports she has not had anything new to eat, but did have a yogurt with fruit from the local senior center and she does have a soy allergy. Follow up on 2/26/21 client explains that she took benedryl at 1600 on 2/24/21, again at 2000, went to bed, and woke on 2/25/21 and took a 3rd dose. Client reports that at that time the swelling was improved and she has not had any symptoms since.

My lips started to swell and got very red on Day #5. I started applying vaseline. By day #7, I called my dr who wasn't in and spoke to his associate. She said if it got worse to follow up with my dr. They continued to get worse and by Day #9, I called my doctor and sent him a photo. He told me to take benedryl and an antihistamine (zyrtec). By the next day, the lips were worse, sent another photo and he prescribed Prednisone 20 mg for 5 days. I had a lot of trouble eating and drinking. My lips also felt like pins were constantly being stuck in them. The prednisone helped but it took at least another week before my lips returned to normal. On the advice of my doctor, I did not get the second Moderna dose.

10 minutes after injection sudden increase in bp to 17 8/90, swelling of tongue and nasal passages, fever 3 degrees higher.

2/23/21:Headache, sore arm 2/24/21: High Fever 100 degrees: 8:00 p.m. Blurry eyes, Stuffy, runny nose. Sore arm. Sneezing. Felt ill. 2/25/21: Fever slowly came down during the day. Arm itchy and sore. Hot arm. 2/26/21: Hot, itchy, sore arm. Red area near injection site. 2/27/27: Arm still red, sore itchy. nausea.

0854: Rec'd Covid vaccine 0859: About 5 min after rec'ing vaccine, pt c/o itchy throat; had previous reaction to Moderna vaccine & PNA vaccine 0903: BP 120/70 HR 62 RR 20 SpO2 98% 0904: Benadryl 25 mg po given 0908: Pt c/o sl more itchy throat & tongue swelling 0914: Itching resolved 0916: BP 122/72 HR 62 RR 20 SpO2 99% 0926: BP 121/74 HR 56 RR 18 Sp)2 100% Right arm tingling/itchy, tongue tingling/itchy again; breathing feels "ok" 0927: Benadryl 25 mg po repeated 0929: Feeling "a little bit more labored breathing"; clear lungs 0934: Feeling better 0939: Itchy throat resolving; breathing better

12 hours after 1st covid vaccine she began having swelling of the left side of her face, cheek, eyelid. She also noticed tender lymph notes in her neck on the left side. Denied any recent illness, no rash/hives. Denies problems breathing, no swelling of tongue. Seen on 2/25/21 at PCP office. Assessment by Dr. on 2/25: "mild residual soft tissue swelling noted in the cheek laterally and into the chin and skin above the left eye. There is tenderness to palpation along the left side of her neck with mild fullness of the lymph nodes.

The first night she had the chills real bad. She got up to go to the bathroom and was so could she didn't think she was going to get back to bed. She took 2 Tylenol, and went back and laid down. She then awoke the next day starting to have some chills but not as bad as the night before. She covered up with an electric blanket in a chair and finally passed over. She noticed Saturday that she had nausea and dizziness. She then had tenderness in her mouth, used warm salty water which seems to be helping. She cannot eat any hard food on it due to the discomfort. She has continued nausea in the evenings. No problems with the arm where she got the vaccine. She feels it it getting some better, but the dizziness and nausea is the worst issue. She did call her doctor and they told her that they could not give her anything for the rash in her mouth, and the chills. They told her that it had to run it's course.

With the first shot, I experienced chills for a day and a half. Absolutely could not get warm. With the second shot, I experienced chills; was clammy at the same time as the chills; very fatigued and could not stay awake; my muscles, joints and my whole body ached; headache; sinus infection (for which I am currently on an antibiotic); nausea; loss of appetite (lost 5 pounds); loss of taste and smell for 2-3 days. Too weak to make it to the bathroom by myself. I felt like I was in a delirium but my husband said that I was not incoherent. Appetite is still not normal. Mouth was so dry that I was not able to feel any moisture at all which I feel led to my sinus infection.

Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Severe headache; A spontaneous report was received from a reporter like consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like retinal haemorrhage, eye inflammation, headache, visual impairment, retinal migraine. The patient's medication history was not provided. Concomitant medications were not provided. On 17 Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 030M20A) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. On 18 Feb 2021, 28 hours following the vaccine administration, the patient experienced events like very small hemorrhage inside left eye, swelling inside the left eye, headache, impaired vision, ocular migraine with swelling inside the eye being medically significant. Laboratory details were not provided. No treatment information was provided. The outcome of the event was unknown. Action taken with mRNA-1273 in response to the events were not reported.; Reporter'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. Headache is consistent with the known safety profile of the vaccine.

Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation). The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, 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.

Pt. came for her second Moderna COVID vaccine shot. After 15 minutes, noted flushing and tongue swollen and shortness of breathe. Tingling in her hands and lower legs. Shaking. Pt. was transported to our ED department.

Per patient's son, the patient developed a rash at the site of vaccination 4 days after the vaccine. She also began developing swollen, cracked lips and swollen hands and feet with a blistering rash. The symptoms were reported to our pharmacy by the patients son 28 days after her vaccine, on 3/15/21. The patient was due for her second dose on that day, and he wondered if she should still get it. We instructed him to call her Dr. After seeing her Dr for an appointment today, the patient was told not to get the second dose of the Moderna vaccine.

3 days after vaccine experienced fever, extreme muscle pain, extreme bone pain, head ache, chills. 13 days after vaccine experienced extreme swelling in glad under left ear and down the neck under chin. Ear ache in both ears but worse in the left ear. Visited physician next day and was prescribed an antibiotic. Was better in 14 days.

joint ache, nausea, fatigue, no appetite, no taste, very weak, difficult swallowing, memory problems,. Start evening of 2/25 to present - 3/22/21 Emergency room treatment: blood profile, X-rays, Cat Scan, urine analysis, etc. All OK.

3ays after shot massive depressive episode, suicidal. 4 days after, exhaustion, muscle weakness (I normally walk 2 - 4 miles daily)- this continued for almost two weeks. Along with weakness, extraordinary "brain fog", vertigo, loud tinnitus (buzzing). 2 1/2 weeks in I found an elliptical itching rash at the vaccine site. almost a month later I'm still suffering from dizziness, brain fog, and exhaustion. 2nd dose due 26th March and I'm scared to proceed.

Headache and loss of balance within 1 .5 hrs. after vaccine, recurring, at 8:30 pm. Recurring next day at noon and then at 12:00 am. My lips became numb( like I had a nova cane shot) upon standing I had difficulty with balance and walking and my head felt foggy until 3 A.M. I almost called 911. I took Tylenol, Claritin and Pepsid and finally felt better. On Sunday my head felt foggy and my balance was not good. Then again on Tuesday, I had intermitent episodes.

Additional side affect on Saturday night episode where my lips became numb, my balance was unsteady, and I had difficulty walking, my head was foggy-- and additionally I felt shaky inside. Just as if you have the shivers. This is in addition to my events with the headaches. I am very worried about the second shot in the vaccine.

Patient has a history of anaphylaxsis. Vaccine was administered at 9:46am to right deltoid. At 10:15, patient described feeling a little bit funny. The patient complained of tongue swelling at 10:20am. Vitals signs Heart Rate 61 BP 152/62 spo2 was 97%. At 10:25, the patient was assessed by an on site APN and was administered Benedryl 50mg IM. She was placed in a supine position. At 10;52am, the patient reported feeling better and was discharge to home setting.

25 minutes after administrating the 2nd moderna vaccine. , patient started complain of tongue swelling . BP 183/101 , Pulse 81. symptom wasn't getting worse . Called 911. they evaluate patient. Bp was still high, There are no signs of anaphylaxis. Recommend to go to hospital for follow up . Patient stayed in the pharmacy for 20 minutes after 911 left and felt good and left home.

Low grade fever (100), chills, slight sore throat, mild headache, eyes burning, lassitude, lack of appetite

The patient received the second dose of the COVID19 vaccine. There were rather normal symptoms the week after receiving it. However, a few weeks later the patient acutely developed shingles (as determined by her primary care provider). Symptoms experienced: numbness in the mouth and tongue, red, enlarged bumps at the tip of the tongue, itchy skin and bumps in the skin surrounding the mouth, pain in and behind the left ear, tiredness, drowsiness. The symptoms developed all within the same day and still persist at the writing of this report. The doctor does not know if this was a result of the vaccine, but says we should not discard the possibility. The patient did have varicella in her youth

fever for 55 hours. 101.1 to 103.4,last temp 4pm Sunday 99.8. vomiting , severe body pain, chills, shaking, no taste, weak, sweating . took tylenol and advil. called my pcp she said it should last about 24 hours. As of tuesday 4/6/21 still very tired.

Chills started at 4:00 PM on 3/26/2021, I woke up at 1:30 AM, chills were gone but had a headache which lasted 2 days. Nausea started that morning and increased in intensity associated with dry mouth. The nausea was constant. I couldn't stand the smell of food. I drank lots of water, forced myself to eat some crackers, lay on the sofa all day for several days. On 3/29 I started taking Omeprazole. On 4/3 my nausea started improving and by 4/5 was gone.

She got her vaccine, and within a couple of hours had fever, cold chills, achy body, fatigue. The following week she lost her taste, and ever since she has cold chills constantly, is weak, cannot do anything. She is light headed, her vision is sometimes blurred and will not go away. She has been taking Tylenol for fever. She went to the ER because it was so bad, and they did a CT scan, EKG, chest x-ray for pneumonia, and did blood work. They could not find anything wrong with her. She has also been to her doctor who checked her over and could not find anything wrong either.

vomiting, diarrhea, n/v, metallic taste in mouth, syncope, weakness, anorexia, abdominal cramping Drinking warm ginger-ale, dried cheerios, sips of water with some relief. Recommended Mylanta to help soothe stomach. 4/23-symptoms lasted 1 week; feels improved. Still fatigues easily.

Within about 45 mins . after I received the shot (and had left the facility), I was driving home and began to feel the left side of my mouth (my lips) swell up (as if I had been give novacane at the dentist), then the area under my left cheek bone began to swell up as well; nothing hurt, I had no chest/back pains (had a double by-pass 16 yrs. ago, no further heart problems), no pain, tingling, in arms, legs; my doctor's office is closed Friday afternoons, so went to Emergency Medical office where was diagnosed with Bell's Palsy; went to my own doctor following Tuesday; swelling had decreased, on and off; by Saturday (i.e. one week after the shot) I also had a red very itchy rash on my left arm at the vaccination site; swelling still not gone by third week after shot, so went to my ENT (allergist) who said it was not Bell's P., recommended not getting 2nd shot; then (4th week after the shot and still some swelling around the cheek) went to my Cardiologist, did EKG, all OK, but he said both the rash and swelling were allergic reactions and I should not get the second shot - so I will not get the second shot. Now (7 weeks from shot, am still "aware" of lips and cheeks - not exactly swollen, but like an injury that is not completely healed - this occurs when I am "tensed up" about something (l trying to get to an appointment on time :)

COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID Diagnoses After Vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID Diagnoses After Vaccination) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID Diagnoses After Vaccination), NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Source of sample- Nasopharyngeal. 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. Relevant concomitant medications were not reported. Treatment information included Monoclonal antibody therapy as bamlanivimab infusion for the virus start on 19 Jan 2021. Company Comment: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information included adverse events (chills, cough, nausea, diarrhea, nasal congestion and loss of taste), hospitalization confirmation, laboratory exam performed date and treatment information as bamlanivimab infusion.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Hearing loss; Vertigo; Tinnitus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was provided by the reporter. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS (Hearing loss), VERTIGO (Vertigo) and TINNITUS (Tinnitus) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient went to audiologist and was given a hearing aide. 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.; 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.

Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot; Woke up shaking; Eyesight effected; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure. 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot) (seriousness criteria hospitalization prolonged, disability and life threatening), TREMOR (Woke up shaking) (seriousness criterion hospitalization prolonged) and VISUAL IMPAIRMENT (Eyesight effected) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in March 2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by the patient, within two weeks prior to the event, included seizure medication. Treatment for the event included intensive care and stroke unit. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time. Further information has been requested.

Five minutes after vaccine was given the patient experienced a tightness in her jaw. Her mouth was very dry and also she experienced an unpleasant taste. This was immediately reported to the head nurse. She was given 25 mg of Benadryl po which she swallowed without difficulty. Her VS were monitored. her BP was 154/48 , P was 86 and O2 sat 95%. She was monitored for 20 minutes and she her symptoms resolved 10 min after taking the Benadryl. Her Bp was 154/74, P was 86 and O2 Sat 94%. Patient was also on her own oxygen via nasal cannula at 3 liters. She did not feel sleepy and stated she felt comfortable to drive home. Her symptoms were resolved and she was in no distress. she was discharged after 20 min.

1) Most significant reaction began 10 days after receiving vaccination. Itchiness primarily on back & buttocks w/a little on arms, legs, and abdomen. Red raised bumps appeared w/increased itchiness each day & continues to present (Day 4). Took one Benadryl on Day 4 w/slight but temporary relief. 2) Additional reactions prior to outbreak of rash include: a) swollen lymph glands on right side of neck two days post vaccine lasting for two days. and b) Left ear ache/pain on 4/28/21 lasting one day.

Woke up day after shot with uncontrollable full body itching which last for two weeks & scratched so hard all the time that I broke a blood vessel in my eye. Nothing helped (Benadryl, etc.) The next day I started to have constant ringing & humming in both ears. It has not subsided at all & I am struggling to hear people talk to me now, at least 15-20% hearing loss. One of the worst experiences of my life & am so sorry I got the shot. I have NEVER gotten a flu shot that is recommended every year, & I NEVER GET THE FLU. MY DOCTOR TOLD ME I HAVE A HIGH TOLERANCE FOR WHATEVER STRAIN IS GOING AROUND. I wish I could turn back time - I would never agreed to get the Moderna - now I am doomed for life with a hearing disability & Tinnituus. I now read all the reports & learn that Moderna vaccine was not tested (even it had been - it wouldn't have passed.) For sure I will not get 2nd Booster shot - or any other vaccine that comes along. Someone told me that they had such sever itching that they had to go to Urgent Care for medical treatment on legs because they stratched so much they could stop the bleeding! NEVER AGAIN!

2 weeks after 2nd moderna vaccine forehead became numb, then within 2 weeks from that the numbness moved down through left eye,cheek and mouth area - the numbness comes and goes - no changes in cognitive function - still has been occurring occasionally

Patient presented to the ED on 5/5/2021 for dizziness and double vision. Patient was subsequently hospitalized with vertebrobasilar insufficiency. These visits are within 6 weeks of receiving COVID vaccination.

Did not receive the 2nd dose of vaccine; Bell's palsy got worse; Bell's palsy got worse; Mouth got numb, and has to use straw at the corner of the mouth for drinking; Difficulty to speak/problem to forming words/problem while eating; Mouth gets dry soon; Have eye problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy got worse) and CONDITION AGGRAVATED (Bell's palsy got worse) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bell's palsy since December 2020. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy got worse) (seriousness criterion medically significant), CONDITION AGGRAVATED (Bell's palsy got worse) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (Mouth got numb, and has to use straw at the corner of the mouth for drinking), ORAL DISCOMFORT (Difficulty to speak/problem to forming words/problem while eating), DRY MOUTH (Mouth gets dry soon) and OCULAR DISCOMFORT (Have eye problem). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Did not receive the 2nd dose of vaccine). The patient was treated with DOXYCYCLINE for Bell's palsy, at a dose of UNK dosage form; Physical therapy (Acupuncture and facial physiotherapy) for Bell's palsy; Physical therapy (Acupuncture and facial physiotherapy) for Condition aggravated; Physical therapy (Acupuncture and facial physiotherapy) for Hypoaesthesia oral; Physical therapy (Acupuncture and facial physiotherapy) for Oral discomfort; Physical therapy (Acupuncture and facial physiotherapy) for Dry mouth and Physical therapy (Acupuncture and facial physiotherapy) for Ocular discomfort. At the time of the report, BELL'S PALSY (Bell's palsy got worse), CONDITION AGGRAVATED (Bell's palsy got worse), HYPOAESTHESIA ORAL (Mouth got numb, and has to use straw at the corner of the mouth for drinking), ORAL DISCOMFORT (Difficulty to speak/problem to forming words/problem while eating), DRY MOUTH (Mouth gets dry soon) and OCULAR DISCOMFORT (Have eye problem) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Did not receive the 2nd dose of vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Patient visited the Neurologist, and the Infectious Disease Physician. Concomitant product use was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for the event of Bell's palsy got worse. Company causality for Incomplete course of vaccination was assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for the event of Bell's palsy got worse. Company causality for Incomplete course of vaccination was assessed as not applicable.

24 hours after vaccination, my entire body head to toes became violently itchy - with bright red welts wherever I scratched. On the 2nd day after I noticed a loud hissing sound in both ears. It has now been 60 days with NO RELIEF! I have undergone comprehensive hearing exam which shows hearing loss & Tinnitus. Both are now permanent. There is no treatment and the outcome is bleak: Loss of hearing, constant hissing in ears and extreme sensitivity to touch - skin turns to bright red welts if scratched at all & welts last about 20 minutes. All body parts head to toe.

very sore left arm for 4 days. No energy, shivers, muscle aches, mild ear ache with ringing in ears, light headed for 13 days

I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.

I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.

sleep for 36 hours, then nauseas, headache, After that four 4 months no taste or smell Terrible taste in mouth

Severe heart issues resulting in fall, loss of consciousness and a laceration to head. Brain hematoma which is effecting eye function. HIGH blood pressure, pulmonary concerns, thyroid module. Tests and treatment plans still in development. Patient did have a pacemaker inserted. Multiple CAT scans, blood draws, x-rays have been preformed and 1 biopsy on the calendar.

Tested POSITIVE for COVID-19 on Friday, July 2, 2021. Was held a tele-med appointment over the phone. Referred me as a candidate to receive a monoclonal antibody infusion which I had on July 5, 2021. My symptoms are deep cough, tightness in my chest, sore throat, slight headache, tiredness and loss of taste.

Terrible itch and whelps on palm of hand and bottom of foot, then lip , tongue and throat , used epi pen to control. this is on going and keeps happening

5/28/2021 Patient started experiencing sharp pain in her left ear. In May patient had stroke symptoms for about 15 mins. Speech was slurred and she could not remember people. In June stabbing pain and left feverish and had a episode of loose stool.

Two days following Covid vaccine2,I woke up with severly painful red left eye. I went to opthamologist on emergency. Treated for split/cornea above above the pupil, then covered with contact patch & given antibiotic & drops for redness; returned for several follow up visits w/associate, Dr. who continued treating me even with oral antibiotics to try to treat the severe redness now in both eyes. He also prescribed Rx for dry eyes. I was referred to eye specialist. Dr. diagnosed as immune reaction to Covid vaccine. I saw all Drs. still visual impairment persists!

Two weeks after 2nd dose of Moderna developed upper lip swelling and all over red, blotchy, itchy rash. This continued after decreasing dose of Prednisone and prescription antihistamine. Second dosing (increased time) of Presdnisone taken with no relief. Continued with increased itch, Started Allegra 180 mg daily and prescription cream to be applied twice a day. Also prescribed Hydroxyzine to be taken at night to control itch and help me sleep. Now 3 months later, starting to see rash greatly decrease. Stopped "green" pill, changed laundry products to all -clear and changed shampoo and conditioner, All had no effect on decrease in problem.

Sore throat, pain across shoulders and down arms and earaches , all of which came on suddenly while walking outside some 7 hrs after vaccination

Patient reports that she had facial swelling and some tongue swelling. She took Benadryl and it was helpful.

After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.

Day 8 after vaccination, left arm in area of injection developed a rash with swelling, warmth, and soreness that had previously disappeared several days after injection. Coincidentally my left eyelid was also swollen and itchy .

Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across chest, deep inside, very uncomfortable and scary, and couldn't get a deep breath. Visual problem lasted about 1 hr.; chest/lung feeling lasted about 5-8 mins., tightness in chest lasted about 10-15 mins. Later in afternoon had pain/edema at injection site, left shoulder joint pain. As of today, 2/3, it's minimal.

Patient called on 2/5/21 complaining of redness and itching in the arm around site of injection. Patient states it just came up. Patient then went to urgent care on Sunday, 2/7/2021, and was given steroids and antibiotics, but states she did also have complaints of earache.

Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The following morning she reported to her husband inability to taste food or drink. She developed nausea and vomiting which persisted from 1/30/21 through her death. She was found deceased in bed by her husband this morning.

Face became very hot, vision blurred momentarily; I continued to feel very hot although the car window was down and it was a cool day; then I realized that my nasal passages were swelling. First symptoms subsided after 10 min, nasal passages were returning to normal after 15 min. No treatment given. I didn't even report it as I didn't see anyone to report it to until I was pulling out of the Fairgrounds.

AFTER RECEIVING THE VACCINE, SHE STATED THAT HER TONGUE ON NUMB OR TINGLING. ON SITE EMS RESPONDED. SHE RECIEVED 1 DIPHENHYDRAME 25MG WHEN SHE INITALLY TOLD THE NURSE. EMS EVALUATED HER AND GAVE HER A 2ND DIPHENHYDRAMINE 25MG CAPSULE. VITAL ARE BELOW. SHE FELT BETTER AND EMS RELASED HER TO HOME

Day 1: Some blurred vision and labored breathing immediately after injection*, numbness and tingling of the tongue, body aches and pains all day. Day 2: Vision and breathing now normal. Numbness and tingling of tongue has lessened. Body aches and pain more prominent. * Please note that this mobile clinic that came to my mom's home was not set up for a serious reaction, nor did they stay and wait at least 15 minutes. My mom was told that she would have flu like symptoms and then they left.

very bad pain from head to toe in every muscle, bone and joint, nausea, weakness, freezing cold and the worst was from about 10 pm feb 18 to about 11 am feb 19 but the weakness went on through feb 20. Felt pretty much over it by Feb 21 but still some weakness and fatigue. Also a very sore arm that turned pink and feb 22 is still sore and pink and itchy but not as bad as the previous days. I have always gotten a sore arm with flu shots but not as bad as this time so I didn't consider that a bad reaction.

She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth. Her cheeks were swollen, she felt that maybe her tongue was as well. She got the liquid Benadryl and let it stay there and it helps that feeling. She had taken the Zyrtec and Singulair the night before. She did the inhaler puff in the morning, the feeling did not go away. She then took the Ventolin and it seemed to calm down. The symptoms then went away and didn't come back, and thought that she was ok. She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do. She is fine now.

REPORTED SLIGHT LIP SWELLING AND SOME DIFFICULTY SWALLOWING, PATIENT TOOK BENADRYL 25 MG ORAL DR OFFICE NOTIFIED, SPOKE TO EMPLOYEE

ON FEBRUARY 11, I AWOKE WITH A RUNNY NOSE WITH HEADACHE, EYE ACHE, TEOOTHACHE ON RIGHT SIDE OF MOUTH--UPPER AND LOWER. I ALSO FELT A COLD SORE COMING ON. I TOOK SUDAFED PE AND VALCYCLOVIR, WHICH USUALLY SOLVES THE ISSUE. THESE SYSMPTOMS CONTINUED AND I CONTINUED WITH SUDAFED AND VALCYCLOVIR. I SAW MY DENTIST ON FEBRUARY 11 AND WAS TOLD THERE THERE WERE NO ISSUES AND PERHAPS THE PAIN WAS CAUSED BY SINUS ISSUES. I INCREASED THE VALCYCLOVIR TO THREE TABS A DAY RATHER THAN ONE. THE TEETH ISSUE SPREAD TO THE LEFT SIDE OF MY MOUTH AND TWO MORE COLD SORES APPEARED, ANOTHER ON MY UPPER LIP AND ONE AT THE EDGE OF MY LEFT NOSTRIL. I HAD A ZOOM MEETING WITH MY DOCTOR ON MARCH 1. SHE INCREASED THE VALCYCLOVIR TO 1000M. THREE TIMES A DAY. THE COLD SORES HAVE DISAPPEARED, BUT THE OTHER SYMPTOMS CONTINUE, BUT THE PAIN HAS LESSENED SOMEWHAT. I TAKE TYLENOL WHEN THE DISCOMFORT BEGINS TO INTERFERE WITH MY DAILY LIFE.

Extraordinary fatigue & sleepiness. As of today, back to normal for 2 days. Right eye bloodshot & painful with feeling of something big in the eye. Left eye not affected. Vision not lost. Examined by two of the ophthalmologists. Could not find anything in the eye or any sign of disease, i.e. glaucoma. Prescribed steroidal eye drops. As of today, condition worse in the morning, but bloodshot fading and pain subsiding. May be going back to see them March 11, 2021.

Patient developed redness and discomfort in her right eye a few days after the vaccine and within a week had lost all vision in the eye from an aggressive infectious versus inflammatory response. She was cultured for infection and everything came back negative. She was treated initially with antibiotics and anti-viral medication and did not start to improve until was started on frequent topical and oral steroids. She has still lost most of her vision but the inflammation is improving within the anterior chamber but her cornea is still opacified. She has a history of shingles that affected this eye but it had been quiet and she does not seem to be responding to anti viral medication.

Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection. 15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue. The events occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient receive first dose of Moderna vaccine on March 1st. On March 8th she woke with itchy eyes and a few welts dispersed throughout her body. March 9th she visited her primary care physician with full body welts and was prescribed prednisone. March 10 she called the pharmacy to inform of the situation

on 2.15.2021 Pt stated c itching + Rash and she took benadryl and on 2/16/2021 she notice the rash worsening + lip swelling, she went to ER and was given epinephrine

Received the vaccine, came home and both of her cheeks were bright well, as well as her forehead. Her tongue is real sore and feels as if she burnt her tongue. The top of her gums in her mouth were all red and hurting as well. She got real nervous and antsy. She had this for a few days, then about 4 days later called the doctor and went to the clinic and she has canker sores in her mouth. They told her they would probably go away in a week or two, and it was 2 weeks yesterday from her vaccine. They have gotten better but they are not totally gone, and her mouth still does not feel right, but does not feel as bad as it did, does not feel normal. The tip still feels like she burnt it. He wants to check her again around the 17th, did not give her any treatment for it. The pharmacy wants her to recheck with her doctor in regard to getting the 2nd vaccine or not, or to get it at a doctors office to watch her more closely.

5. Brief History and Hospital Course: Patient is a/an 79 y.o. female with a past history significant for HTN, HLD, and DM who presented to facility on 3/9/2021 with complaints of severe 8/10 right jaw pain lasting 3 minutes. EKG with new left BBB and troponin mildly elevated 8-17-35-26. She was seen by Cardiology and determined to have NSTEMI and taken for cardiac cath with drug eluting stent placed to LAD. Echo was also ordered with evidence of murmur. Cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55%. Dyssynchronous interventricular septal motion, likely related to conduction abnormality/bundle branch block. Grade I diastolic dysfunction. Annulus is severely calcified. Severely calcified and restricted opening of posterior mitral leaflet. Mild mitral valve stenosis at the max. She remained stable post stent placement. She remained on dual antiplatelet therapy

At 1415, patient reported tingling and numbness to her lips. No c/o shortness of breath, tongue swelling or itching. At 1416- assessed by Dr., lungs clear, no stridor, slight rash to bridge of nose. At 1421- 0.3mg epinephrine IM administered. BP 130/84, HR 84, and O2 at 97% on room air. At 1431- 25mg IM of Benadryl given and at 1432, 124 mg of Solu-Medrol administered IM. Patient's vital signs continued to be monitored and remained stable over the next hour. At 1525, patient was reassessed by Dr. and was able to be discharged from clinic. 1540 - Patient's son picked her up and took her home with instructions for a competent adult to remain with her for the rest of the evening. Patient had an Epi-pen at home already and was instructed to use and call 911 if additional symptoms. The following day, patient was contacted by clinic Provider .and reported feeling fine and no new symptoms. On the morning of 3/11/21, patient called clinic with onset of facial swelling and shortness of breath. She was advised to go to the ER.

Per Pt report, "while driving home experience facial numbess, tingling in tongue, tingling in RUE. Pt went to the ER.

We are using the Drive thru method at Airport. Client received COVID-19 vaccine and afterwards drove to Recovery Room. Client states she had a metallic taste in her mouth. 76-20. Respirations Good. She says this happens to her when she has a CAT Scan with IVP dye. Put her in the 30 min line. She drank some water and felt better. When 30 min was done, she went home. Daughter was with her. Told client if any other problems, to call her Dr.

The patient stated that she gets paralyzed after getting vaccines. I asked her if she had someone in the pharmacy to help her. She said she came alone. I told her I would have her wait 30mins after dose to make sure there were no issues. After I gave her the shot, she looked at me and said that didn't hurt at all. Then she looked and said my neck hurts. So I had her take deep breaths with me to get her to calm down as she appeared anxious. She was doing great then she went limp. I held her head up and asked her is she was ok. She said she was, but then her breathing become shallow. She was un responsive at this time with her tongue pushing her mask off her mouth. So I lowered her mask and her tongue appeared to be enlarged. I had my technician call 911 and I gave her a dose of epinephrine 0.3 mg. She was unresponsive, but breathing on her own. The paramedics came and got her vitals, placed her on stretcher, and put in a medicine line to give her medications if need be. She left somewhat unresponsive. They said she should be fine and took her to ER.

I immediately could 'taste' the shot in my mouth. Then, tongue began to feel prickly, and then lips felt the same way. Slight dizziness. After 15 minutes, I left the pharmacy, could drive my car and felt only slight dizziness. However, the tongue and lips continued to feel burning/prickly for the rest of the day. I did not report this to the pharmacy. If the 2nd shot does this again, I will report it to them.

Patient states she has had blurry vision and pain in her eyes when she moves her head for approximately a week after receiving the vaccine.

transient pain behind L eye followed by slurred speech x 15-20 minutes about 2 hours after administration of vaccine

Arm pain started the next evening after the shot; but pain went away after 3 days; but the pain returned more severely 7 days later. The pain both times was so severe that the arm was immobilized. And the second bout of pain involved the hand, arm, neck, and ear ache. The pain slightly subsided yesterday, but came back more intense today. raises concern about incorrect injection technique causing severe shoulder pain (SIRVA)

79 year old Female received the 1st dose of the Moderna COVID-19 Vaccine Lot# 030A21A on 03/12/2021 @ 09:40. Pt was placed in observation for 30 minutes and then released. On the drive home pt felt tightness in the chest, chest pain, roof of mouth was swelling and burning, severe itching on the arm, (shortness of breath was experienced while walking to the car), and immediately drove to ED. Pt was admitted to the ED 03/12/2021 @ 11:00 and was discharged 03/12/2021 @ 12:30. Pt was given Prednisone, Benedryl, Pepcid, Potassium, and Clonidine in the ED. Upon discharge, pt was advised by the ED to come back if symptoms come back/worsen, make an appointment with primary doctor, and was given a prescription for Prednisone and Atarax (hydroxyzine) 25mg. Morning of 03/13/2021 pt reported throat was narrowing, dificulty swallowing, lips feeling tingly, and shortness of breath when normally walking down the hall. Pt went to ED , was admitted 03/13/2021 @ 12:00 and discharged same day 03/13/2021 @ 17:00. Pt takes Amlodipine 5mg qd, Levothyroxine 25mcg qd, Losartan 50mg bid, Furosemide 40mg qd, Diltiazem 120 mg qd, Tizanidine 2mg qhs, Anatrozole 1mg qd, Venlofaxine ER 37.5mg qd, Clonidine 0.1mg (PRN when SBP > 170), K 20 mEq, Folic Acid, B12, Homocysteine Factor, IBU (PRN for discomfort), and Cetirizine. Pt is diagnosed with osteoarthritis, obstructive sleep apnea, degenerative joint disease, degenerative dsic disease, scoliosis, hypertension, cardiac arrhythmia, hypothyroidism, breast cancer remission (5 years of remission on the left breast and 4 years of remission on the right breast). Pt is allergic to Sulfa drugs, Nitrofurantoin (Macrobid), and Prempro. Pt made an appointment with the primary doctor for 04/01/2021 and the cardiologist appointment is scheduled for 04/22/2021. Pt was advised to call cardiologist and move the appointment to the next availability, consult primary doctor and cardiologist to see if it is advised to received the second dose and abide by their recommendation, and immediately go to the ED for for any symptoms/side-effects. SPI was consulted and Dr was notified.

the evening of the vaccine started having tongue swelling, difficulty breathing, itching, and tachycardia. lasted 3 days

Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers, lost speech, lost eyesight. The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided. On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak. Patient went to hospital and treatment activities for events was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine. Critical details such as the onset date of the event is lacking. Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.

After going to bed I woke up around 12:30 pm with itchy sensations on my hands, underarms and torso; also my tongue became swollen. I Felt weak and nauseous but did not vomit. After drinking a glass of water I went back to sleep. I awoke in the morning 3/28/21 @ 8am My itchy areas were gone. I did not feel weak, just tired. The swelling of my tongue gradually reduced during the day and now it is normal (7:30pm). There was no treatment.

Difficulty swallowing, swollen lips - benadryl Subsequently - Diarrhea, migraines and chest discomfort.

Received vaccine on 01/26/2021 and unknowingly experienced event. Early morning of 01/28/2021 had fainting spell and thought it was caused by low blood pressure. Felt fine for remainder of day. On evening of 01/29/2021 I started having strange symptoms. Could not concentrate, vision impaired and couldn?t figure out what evening meds I needed to take. Decided to go? to hospital on 01/30/2021. Getting ready, I passed out and husband called emergency services. Husband learned later in the day that I had a stroke. Doctors i;nfo?rmed that had blood clots in heart and lungs. Doctors advi;se not to get second vaccine shot.

Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days of intense headaches, followed by two days of flu-like symptoms and 99.0 fever and heart palpitations, and for the next two weeks intense frequent diarrhea and continuing heart palpitations, which continue to current date.

feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergic reaction; mucus in her nose,terrible back drip; Tickle in her chest,tickle in her throat; heaviness in her chest; hoarseness; cough; lost her voice; described her symptoms as bronchitis like; described her symptoms as laryngitis; felt like she had an entire respiratory infection; A spontaneous report was received from a consumer concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 7 minutes after first dose immediate allergic reaction(hypersensitivity), mucus in her nose and terrible back drip(secretion discharge), tickle in her chest and tickle in her throat(general discomfort), heaviness in her chest(chest discomfort) choking on the mucus(choking), hoarseness(Dysphonia), cough, lost her voice(aphonia), described her symptoms as bronchitis like(bronchitis), described her symptoms as laryngitis(laryngitis), felt like she had an entire respiratory infection,(respiratory infection) feels like she is still not okay(feeling abnormal). The patient's medical history was not provided. Concomitant medications reported were Claritin, Vit D, Calcium Pills, Mirtazapine, antidepressants, multivitamins for drug use for unknown indication. On 16 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004MZ0A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event(s) 7 minutes after first dose immediate allergic reaction , mucus in her nose , terrible back drip , tickle in her chest, tickle in her throat , heaviness in her chest ,choking on the mucus, hoarseness, cough , lost her voice ,described her symptoms as bronchitis like, described her symptoms as laryngitis, felt like she had an entire respiratory infection . Event choking on the mucus was considered medically significant. On 24 Feb 2021, the patient experienced the event(s) feels like she is still not okay. Treatment details included Robitussin and Honey, she has taken Tylenol for symptoms with only 20% relief. Her doctor states that if she does not, improve he will give her prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), 7 minutes after first dose immediate allergic reaction, mucus in her nose,terrible back drip, tickle in her chest, tickle in her throat, heaviness in her chest, choking on the mucus, hoarseness, cough, lost her voice, described her symptoms as bronchitis like, described her symptoms a laryngitis, felt like she had an entire respiratory infection, feels like she is still not okay was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected choking and NS unexpected hypersensitivity, rhinorrhea, discomfort, chest discomfort, dysphonia, cough, aphonia, bronchitis, laryngitis, respiratory tract infection, feeling abnormal. Event onset 7 minutes after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration about 8 hours

The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went downstairs on my seat (bottom) so I could go down. I then stayed on the couch and called for help. My tongue swelled up and filled my mouth. My neck glands were swelling and my hands itched and they were red (no welts) like crazy. I took Benadryl and it eased up and I went back to bed. The next morning that was gone. I have had another allergic reaction since then and this time I thought I was getting shingles - my throat got very very red, ears itched and my hands itched and I had ropey welts where my bra sat. My whole stomach area was very itchy. I called the doctor (after hours phone call - on the 31st) - and she assured me that I wasn't getting shingles as I already have had them twice. I took Benadryl and then the doctor prescribed a non-drowsy antihistamine - Claritin - and I am taking that every day. I am not someone that has allergic stuff occur. These took it down and I haven't had it again.

Out-of-sorts feeling, lethargic, achy, tired, sore arm, itchy eyes This continued for 4-5 days but the out-of-sorts, zoomed out feeling returned yesterday. The itchy, runny eyes has been constant

Tiredness, extreme emotion - tears out of proportion to stimulus, inability to focus following one of sleeplessness

Date and time adverse event started: 3/18/21 - 1PM Adverse events experienced and are they still occurring now: 3 HOURS POST MODERNA VACCINE ON 3/18/21 PATIENT BEGIN FEELING TINGLING/NUMB IN HER LIPS AND A HOT "WEIRD SENSATION THROUGH THE BODY" THAT RESOLVED WITHIN 3 MINUTES. What happened as a result of the adverse event? RESOLVED SPONTANEOUSLY

Patient states she started having a headache, sore arm, and feeling generally unwell the day after the vaccine. She stated she had "little red dots" in her mouth that were fluid filled which appeared the day after her second dose. No adverse events reported after the first vaccine dose.

Was given first dose of Moderna Covid vaccine and within 10 minutes started c/o tingling lips, numbness in tongue and back of throat and tingling in cheeks. Refused to take benadryl and watched for 30 minutes. O2 sat 96%.

Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.

POST VACCIANTION, PT. REPORTS RINING IN BIALTERAL EARS, TRANSFERRED TO MED OBS VIA WHEELCHAIR ACCOMPANIED, UPON ASSESSMENT IN MED OBS, PT. REPORTS RINGING IN EARS SUBSIDED, CONTINUES TOREPORT MILD HEADACHE, VS OBTAINED. OFFERED LITE SNACK AND WATER. REPORTS SYMPTOMS SUBSIDED. PT. ESCORTED TO EXIT WITH STAFF AND FAMILY MEMEBR VIA WC AT 1429. VS AS FOLLOWS 1412 BP SITTING 144/61 HR 68 RESP 17, O2 SATS 94% 1417 BP SITTING 134/62 HR 68 RESP 17 O2 SATS 98% 1421 BP STANDING 135/72, HR 69, RESP 17, O2 SATS 98%

Starting early February about 2 weeks after vaccine administration pt began having intermittent headaches and jaw pain, which progressed to rapid and complete painless vision loss 4/20/21 to right eye. Seen same day in ophthalmology clinic, diagnosed with optic nerve ischemia, likely GCA, Rx'd 80mg PO prednisone, lab evaluation started which revealed elevated CRP. This, in combination new new grey 'veil' over vision of L eye the next day 4/21/21, led to admission and initiation of 1,000mg daily IV methylprednisolone. Unfortunately pt then progressed to complete painless loss of vision of left eye as well on 4/23/21 while inpatient on high dose steroids. Patient is now completely blind in both eyes.

Stuffed nose, scratchy throat, pressure in head and sinus area. Burning swollen mouth and nose. Teeth feel gritty.

Second dose not given; it was like if periaureal area felt some numbness; there was no visual swelling just the feeling of swelling and numbness; Flushed; Sweaty; possible allergic reaction; Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine; the top of her lip was numb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to vaccine (Allergy to Hepatitis B vaccine.), Psoriasis, Chest pain and Sinus disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (the top of her lip was numb). On 04-Feb-2021, the patient experienced ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness), VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty) and HYPERSENSITIVITY (possible allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given). On 04-Feb-2021, HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness) and VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness) had resolved. At the time of the report, ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Second dose not given) outcome was unknown and FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), HYPERSENSITIVITY (possible allergic reaction) and HYPOAESTHESIA ORAL (the top of her lip was numb) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 198/80 193/80 at 14:38 144/66 at 15:58. On 04-Feb-2021, Body temperature: 97.4 97.4 at 14:48 97.6 at 15:58. On 04-Feb-2021, Heart rate: 77 77 at 14:38 71 at 15:58. On 04-Feb-2021, Mean arterial pressure: 117 117 at 14:38 92 at 15:58. On 04-Feb-2021, Oxygen saturation: 98 percent 98 percent at 14:38 99 percent at 15:58. On 04-Feb-2021, Pain assessment: 4 pain level 4/10. On 04-Feb-2021, Respiratory rate: 18 18 at 14:38 20 at 15:58. 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. Follow up received on 13-May-2021 was significant and included the completed VAERS form. The new events of missed second dose of covid-19 vaccine, angioedema, allergic reaction, flushing, sweaty, numbness top lip were added and medical history was updated. On 04-Feb-2021, it was reported that the patient developed perioral swelling and numbness that came on approximately fifteen minutes after receiving her first covid-19 vaccine. The patient was taken to the emergency department, and was kept under observation for two hours with no worsening of her condition. Treatment medication included 50 milligram of Benadryl (diphenhydramine). The patient was given a prescription for diphenhydramine and asked to follow-up with her primary care physician/ emergency department if symptoms worsened. Company comment This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received included the completed VAER form and medical records from the emergency department. Additional information included medical history, patient demographics, age of patient, patient contact details, concomitant medication, new events with outcome of events, missed second dose.; Sender's Comments: This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Left side of her face seemed frozen; Gland and cheeks were swollen; Super tired; Carotid artery was hurting; Sinus was hurting; Could taste the medicine; Little lump on her neck by her ear; Bacterial infection at the injection site; Black scab and a lot of pus at the injection site; Black scab and a lot of pus at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of her face seemed frozen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left shoulder). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, LORATADINE (CLARITIN [LORATADINE]) and COLLAGEN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear) and FATIGUE (Super tired). On 06-Apr-2021, the patient experienced FACIAL PARALYSIS (Left side of her face seemed frozen) (seriousness criterion medically significant) and LYMPHADENOPATHY (Gland and cheeks were swollen). In April 2021, the patient experienced INJECTION SITE INFECTION (Bacterial infection at the injection site), INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site). On 29-Apr-2021, INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site) had resolved. At the time of the report, FACIAL PARALYSIS (Left side of her face seemed frozen), NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear), INJECTION SITE INFECTION (Bacterial infection at the injection site) and FATIGUE (Super tired) outcome was unknown and LYMPHADENOPATHY (Gland and cheeks were swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant medication included: high blood pressure medicine (unspecified), "calfix 10 mg, and "a whole lot of holistic medicine for arthritis." The patient's 2nd dose of the Moderna COVID--19 vaccine was supposed to be on 07-May-2021 but the pharmacy denied her the second dose due to their reaction she had to the first dose given in her left non-dominant arm. The doctor advised that the patient had a bacterial infection at the injection site. The patient was still swollen as of 07-May-2021 and was unsure when all the symptoms began and resolved. The vaccine provider advised the patient that she would be unable to get the second dose unless she went to the hospital. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD21-091284, US-MODERNATX, INC.-MOD-2021-138847 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD21-091284:crosslinked US-MODERNATX, INC.-MOD-2021-138847:Daughter's case

Inflammation of mouth and gums started on 2nd day after 1st vaccination. Mouth inflammation cleared in about 8 days. Inflammation returned in May and has worsened. Gums and front teeth are very sensitive. Some days are worse than others. Front center right tooth feels loose off and on during the day.

Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for more than 2 hours and resistent to regular strength acetimeniphan. Over the same two months, continuous low level headaches, chills, disrupted sleep.

Patient had loss of Vision. Patient stated seeing round black spots immediately and could not see. Patient started experiencing loss of hearing around may 30th. Patient only had simple side effects from the first shot. The patient had chills, shakes and headaches.

Hearing loss; Vestibulocochlear-neuritis; Tinnitus; Traumatic situation; Vertigo; Dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form; LORAZEPAM (ATIVAN) at a dose of 1 dosage form; PREDNISONE at a dose of 40 mg once a day; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at a dose of 1 dosage form and METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) at a dose of 1 dosage form. At the time of the report, DEAFNESS (Hearing loss), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Patient has through three emergency room visits and two hospitalizations because of her symptoms Patient has been going to balance therapy once a week. Lab details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-219233 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

prednisone worsened her symptoms; Hearing loss; manstasis; Tinnitus; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of METASTASIS (Metastasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Co-suspect product included non-company product PREDNISONE for an unknown indication. No medical history reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PREDNISONE (unknown route) 40 mg once a day. On 25JAN2021 and she was experiencing hearing loss, tinnitus, menstasis, and vomiting. During the time when her symptoms started happening, she had no idea what was going on. Patient has through three emergency room visits and two hospitalizations because of her symptoms. Her doctor prescribed her medications to treat her vomiting. She reported that prednisone worsened her symptoms.On 26-Jan-2021, the patient experienced ILL-DEFINED DISORDER (Manstasis) (seriousness criteria hospitalization and medically significant), DEAFNESS (Hearing loss) (seriousness criteria hospitalization and medically significant), TINNITUS (Tinnitus) (seriousness criterion hospitalization), and VOMITING (Vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (prednisone worsened her symptoms) (seriousness criterion hospitalization). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Adverse event, at a dose of 1 dosage form; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Adverse event, at a dose of 1 dosage form; LORAZEPAM (ATIVAN) for Adverse event, at a dose of 1 dosage form; Physical therapy for Metastasis; Physical therapy for Deafness; Physical therapy for Tinnitus and Physical therapy (Therapy helping her with her balance) for Vestibular neuronitis. At the time of the report, ILL-DEFINED DISORDER (Manstasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had through three emergency room visits and two hospitalizations because of her symptoms. The patient stopped taking Ativan because she heard the medication can worsen her symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Patient medical history may provide alterative justification for the vents occurrence.

autoimmune hepatitis; Pain in various parts of the body; Slept for 15 hrs a day; Constant ring in the ears; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE HEPATITIS (autoimmune hepatitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CICLOSPORIN (RESTASIS), QUETIAPINE FUMARATE (SEROQUEL) and AZATHIOPRINE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (autoimmune hepatitis) (seriousness criterion medically significant). On 15-Mar-2021, PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, AUTOIMMUNE HEPATITIS (autoimmune hepatitis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient 's Concomitant medications reported were PII(36):AaS6l0Skg/HfTSAD212iZdgVLaJ0VFhupdqo 10mg daily No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-jun-2021; 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 has serpiginous choroiditis of unclear etiology, diagnosed 2017 with about 6 total lifetime flares with unclear triggers. She had COVID-19 infection 12/2020, with no significant symptoms. She was treated with monoclonal Ab infusion (bamlanivinab) which she received 12/24/20. After the infusion she developed fatigue, headache, nausea lasting for 1 day that were self limited. Subsequently, her arthritis has significantly worsened since 1/2021 and continues to be very poorly controlled with significant arthralgia. She received her first dose of Moderna COVID-19 vaccine on 3/26/21, ~90 days after her infection. On 3/28/21, she developed blurred vision in left eye, no other symptoms. Specifically no rashes, no respiratory symptoms, no GI symptoms. She went to her Ophthalmologist on 3/30/21 who noted she has a flare of Serpiginous choroiditis in left eye. She had prior Utiq infusion 1/12/21 still active in left eye. Given flare, her methotrexate dose was increased from 4 tabs to 6 tabs and she was given 4mg intravitreal dexamethasone in left eye on 3/30/21. She was seen by Rheumatology on 4/5/21 who noted her arthralgia could be from viral infection, but did note the source of her current choroiditis flare is unclear and could not advise on whether or not she should receive the second COVID-19 vaccine. She returned to ophthalmology on 4/7/21 when she received a second dose of intravitreal dexamethasone 4mg in left eye. She again returned to Ophthalmology on 4/21/21 where she received a 3rd dose of intravitreal dexamethasone 4mg given persistent inflammation. Her vision has continued to be slightly blurred in left eye, but no worsening since receiving dexamethasone. She was due to receive the second dose of the COVID-19 vaccine on 4/27/21, and she was referred by her ophthalmologist to allergy/immunology clinic 5/3/21 to determine the safety of receiving her second dose of moderna vaccine. Our team performed a literature review that revealed that vaccines (though not specifically the COVID-19 vaccine) can be associated with serpiginous choroiditis flares, therefore we recommended she not receive her second dose of the Moderna vaccine series given risk of recurrent flare. Based on chart review completed today, she continues to struggle with this flare and continues to require intravitreal steroid injections.

I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the night three days after the vaccine. My lips were swelling up and I had a tickling feeling at the back of my throat. My lips were getting bigger and bigger. I went to the ER and I was given prednisone and Benadryl. My symptoms subsided a little but when the prednisone wore off, I started to have lingering symptoms. The symptoms returned and I had another course of prednisone. I still have permanent swelling in my hands five months later which started about two weeks after the vaccine. My fingers are puffy and swollen in both hands. My index fingers are the worst. I have white knuckles.

12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt "wired and worked up". Noises made her anxious. Patient states "everything smelled bad". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped 12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.

Patient states she had complete loss of hearing for 2-3 hours the evening after receiving the vaccination. She states that she took a Tylenol dose, and her hearing came back to normal a few hours later.

1st day (10:30 am):- left arm sore/painful, overnight : freezing, burning sensation and extreme fatigue. 2nd day(01/15/21):- left arm still sore not painful but fatigue continued 3rd day(1/16/21):- 10:30 am, Temple left vein burst at the fore head from middle to left eye, covered with red dots bleeding from left temple eye until 6:00 pm throbbing pain all day and night. 4th day (01/17/21):- Swollen left side of face, internal bleeding around the left eye, slight throbbing pain, extreme fatigue. 5th day (01/08/21):- Swelling/bruises and internal bleeding visible. Less fatigue, able to go to pharmacy to report. *Report as presented by the Patient.

Swelling of lips and face; and rawness inside of mouth after approximately 3 days. lasted approx 3 days with swelling gone completely after 7 days. Rawness and blisters in mouth are still active.

late Saturday, headache, buzzing in head, doctor Monday steroid shot, Thursday night buzzing in head again soreness of shoulder

Sudden short episodes (less than 5 minutes) of excessive salivation followed by nausea. Hours later it morphed into continual nausea and vomiting not related to food intake or any illness - continued for 36 hours.

On the car ride home within a 1/2 hour left side of face started numbing and it comes and goes ever since the date of vaccine. It goes down to the lips. There is pain associated with the numbness and it's concerning it hasn't gone away. Went to internist today who said he wasn't comfortable with this outcome and suggested calling Neurologist. Waiting on appointment.

After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like electrical discharges between ears and sharp pain in joints.. In morning chills, sharp pain in joints that made walking difficult, fever of 100.1. Felt miserable all day. Second night: slept well and felt much better in morning and almost myself again. Still some muscle pain in injection arm. No adverse effect after first dose on January 10.

Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognition, unsteady gate, loss of appetite. Weird feeling in head to the point of losing focus and almost passing out. Severe symptoms lasted for five days until 2/6/21. Currently limited fatigue, slight cough.

Patient received vaccine on 2/13/21 at 2:30pm. went home called after 2 hours around 4:30pm stating that her face turned red& puffy, lips swollen & throat feel funny. Instructed patient to go ER right away. Doctor at the ER diagnosed the patient & mentioned that she had an allergic reaction to the vaccine & put her on prednisone Taper dose. Patient mentioned that she is home & doing fine now, on prednisone taper schedule.

Reddening and burning of top of ears. Blood pressure became erratic. Going from dangerously low to dangerously high. lowest reading 80/50 highest reading 200/100. Still erratic

about 40 minutes after shot: taste in mouth then swollen tingly warm lips, sinuses swollen, tingly and warm in nose and forehead, "shadowy" vision I took 2 zyrtec a few minutes after symptoms started, lasted for 8 - 10 hours Then I was fine

the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell, 2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today

Heavy legs, numbness in arms, reported swelling of face, tingling of tongue. Hypertensive. Hx of anxiety, HTN on Zanax. Only took 1/2 dose this morning. Patient taken to emergency room.

Stabbing abdominal pain for a week that was diagnosed as shingles 3/15/21. Recurrence of trigeminal ear pain 2 days after shot. 102 fever the whole day after the shot

Client states her eyes swelled shut, her hands became swollen and she had noisy breathing(maybe wheezing) all started 2 days after vaccine and the symptoms didn't resolve until 8 days after they started. She did not obtain medical care. She doesn't speak English and didn't know she should've gone to the ER. Plans to now schedule to see her doctor to find out if she should get a different covid vaccine as she had a reaction to Moderna.

Swelling of lips and face. Started where I had rubbed Aquaphor Healing Ointment on the nose the night of the Vaccine shot. Some of the ointment got on the right lip and face during the night. Next morning swelling of right upper lip and right ride of face. During the day left side of face swelled up. Trip to ER for IV of Benadryl, Pepcid, and Steroid.

pt states about a week after she took her 2nd covid vax the skin above her eyes turned red and itchy. Her eyelids and ears are itchy, red, skin is very dry and scaly. Pt is taking Benadryl and also using Vaseline and zinc oxide. She is still having these symptoms and will contact her PCP if they do not subside.

A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm. On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon. On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date. The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I developed bleeding of the left eye in front of the retina. Broken blood vessels. Had my second vaccine and it happened again 3 days later Call me for more information

After 2nd shot, sore arm and achy joints for about 2-3 days. Then, about 5 weeks, developed headaches, ear aches and achiness in neck and lower skull. Then about 6 weeks later (3/29/21) got dizzy and felt no energy, still had headaches, slight ear aches and achiness in neck and lower skull. Lasted about 3 days but seems to be better (took Meclazine starting on 3/30. This all concerned me until I saw my chiropractor today (3/31) and he told me 2 of his patients had dizziness too. They took Benedryl and that helped immensely. They told him that they looked it up and dizziness can be a an adverse reaction to the Covid vaccs. I looked it up on FB and saw that dizziness can be a reaction although the timeline for it to happen varied greatly - from immediately after to 3 weeks after. In my case it's about 6 weeks after. Felt ok in between the vacc #2 and first reaction of sore arm. 5 weeks after til next reaction of achy neck, skull and earaches. 6 weeks after Vacc # 2 til dizziness.

patient received first dose on 02-02-21, had some signs like described, but didn't correlate till the second dose. Symptoms include; dry mouth, chapped lips, no taste, cannot tolerate spicy food. She is still experiencing symptoms

Vertigo, nausea, dizzyness, vomitting, hearing loss. All symptoms lasted 48 hours. Went to Urgent care and was givenMeclizine 12.5mg and Ondansetron 4mg. Dizziness and nausea lessened over the next 3 days. Went to ENT doctor - Hearing test on 3/29/21 revealed total loss of hearing in right ear. Hearing in left ear was diminished before vaccination and that was about the same after the vaccination. ENT injected steriod into right ear on 3/31/21. Second steriod injection on 4/2/21. No improvement in hearing so far. Dizziness continues off and on. Still unstable and needs to use a walker.

patient called stating her mouth was dry and tongue was dry and she felt dizzy upon walking--after further talking with patient, she had only eaten a banana all day. I told patient she probably not eaten enough today nor drank enough liquids.

Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 AM had severe pain in left arm, could not move it. Experienced light-headedness, all over body ache. Arm pain was so bad i didn't want to move. couldn't sleep all night. tried to eat breakfast but got dizzy, cold and clammy, couldnt eat. Stayed in bed until around 5 PM because of arm pain and general malaise Was finally able to eat and took a tylenol and fell asleep as light-headedness abated and arm pain was better. Next day was better but couldn't lift arm well until 15th still some pain to this day

Tightness in neck muscles. Then lips swelled. Then inside of nostrils swelled. All fairly slightly. Was all over by 3:15pm same day

March 15, 2021 admitted Hoppital - lost vision in right eye due to blood clot retinal artery oclusion March 15 & 16 CT scan, Blood work, chest X-ray, mri March 16 discharged from Hospital March 17 Retina Center March 22 Clinic March 29 Neuroscience Clinic - ecocardiogram and ACT monitor for 30 days April 19 Retina Center

Severe eye pain requiring prednisolone eye drops, per patient could have resulted in vision loss. One eye only.

Patient presented 4/28/2021 for second Moderna Covid 19 vaccine. Patient stated that since her first dose of Moderna Covid 19 vaccine on 3/30/2021 she "could not taste anything".

Three days after injection 1 I developed a server tooth ache that lasted three days. two weeks after second shot I developed a severe toothache that has lasted five days and still persists will be seeing a dentists on 5/02.2021. ( hopefully) Is this a known symptom of the covid vacination.

Received second dose of Covid-19 Moderna vaccine on 2/8/21. On 3/10/2021 she went to ophthalmologist for normal checkup. Did have her eyes dilated (Tropi-Phen). 3/14/21 started having what she thought was floaters in her left eye, has a history of floaters. Then 3/16/21 got worse with blurred vision in both eyes. 3/22/21 Retinal specialist diagnosis of panuveitis with significant vitritis and retinal vasculitis on angiogram. On 3/24/2021 she was started on 60 mg of prednisone daily along with Prednisolone acetate eye drops. Vision beginning to improve. Due to ADRs from steroids (SOB, insomnia, hyperglycemia, myopathy) , started on Humira 4/27/21 with goal to taper steroids. Patient has been unable to work due to vision issues.

Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant) and PHOTOPSIA (Flickering lights). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and PHOTOPSIA (Flickering lights) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment medications are not provided. The patient was taken to the emergency room, where the patient was evaluated and released without an overnight stay. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the patient was lethargic and had no energy to perform normal household duties. On the 3rd day after the shot, patient developed tachycardia for several minutes, became feverish with a clammy sweat and had vertigo saying the room was spinning and said she felt like fainting. She could not recognize her son, asking him, "Who are you?" Patient lost site in her eyes which was recovered several minutes later. Patient felt better starting the 4th day.

A few hours after vaccine, right arm started to get red and swell. Patient had chills, fever, headache. Feeling unwell. Two to three days later she felt like she had Covid-19 again. Right Arm continued to swell from shoulder to elbow for 3 weeks. The arm was hot to the touch. Fever, headache, chills, diarrhea for 3 days. Had Covid-19 feeling all over again. Poor taste and sense of dread. Did not seek medical treatment for swelling in arm or symptoms.

The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing in my ear. I went to the doctor and my BP was high, but the ringing persisted even when it was regulated. I was sent to an ENT and was told that tinnitus is usually a nerve issue. Initially, I didn't think it had anything to do with the vaccine until my neighbor told me about her experience. She said that there isn't any treatment for it, so I'm still dealing with the ringing.

She got her 2nd vaccine, they kept her 30 minutes as she had problems with the 1st one, her BP was okay and that she could drive home and was told to drink a lot of water. She went home and after every bottle of water she had 3-4 episodes of diarrhea and kept drinking water all day and after 3-4 she did not have any more diarrhea. She had some pain in her arm. She started having visions of chicken scratches/white lines across her eyebrows from the left to the right across her whole forehead. She always has this vision discrepancy all day long inside the house and outside when she goes and gets the mail. She first went to the eye doctor as she was having floaters, white lines visually appearing but have not had them for a long time, and these did not go away and they were not the usual floaters like she had before. They got her in the office immediately and that doctor said that he did not have an answer for her and he didn't find anything wrong with her eyes. She told him that she was worried about what happened after the vaccine. She went to her PCP and she ended up in the hospital as she has a problem with her left rotator cuff and needs surgery on that but is waiting for her leg to heal from total knee surgery. When she lays down at night she has chest pains, and didn't know what it was and was told that there is a nerve that runs down from the shoulder and crosses over to the heart and gives the feeling of chest pains. She had tests done and they did not give her any answers to what the pains were. She then went to her PCP again and told her about the vision issues and she didn't have an answer to her issues either. Her daughter suggested that perhaps her BP was an issue and she brought that to her attention and she told her to document it and to FU this week with her nurse to see that everything was working okay. She states that her BP has never been the same, she has never had a BP problem before. She takes it every morning between 9-10 AM. 131/86, 139/80, at 5:00 132/74, 148/88, 133/84, 139/92, yesterday was 137/83, today 132/84. She has been placed on BP medicine, Cardizem 30 mg.

As far as I know, I was sitting after dinner reading and I was aware that I could not see well out of my right out, it was very blurry and at the very same time though I had a very sharp pain in the left occipital region. So I was most worried about my eye because I know something was wrong. First thing in the morning I called my eye DR and she told me that I had a right side occlusion in my right eye. So then what she had me do was wait a couple weeks to see if it would go away spontaneously and it didn't. So I went to a retinal specialist and they gave me shots in that eye because I could still not see out of my eye. It has not completely cleared but it is much better. I also had a severe pain in my neck and brain. I went to the ER and the DR that evaluated me there didn't know what my diagnosis was at the time but he put me on some medications that he thought would help with the inflammation. So he put me on cortisone and gave me a prescription for valacyclovir, because I have a history of herpes infections all over my body. SO that was on the Sunday that I went to the ER. Then by Wednesday the pain was so severe that I went to the ER at the hospital because I was so uncomfortable and worried. At the end of five weeks it just went away. I did see a neurologist but it was over by then, he said the diagnosis was occipital issues.

Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (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. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.

On Jan 7, 2021 I developed a low fever (100.1), chills, scratchy throat, stuffy nose, and headache. On Jan 8, I was tested positive for Covid with the quick result test. Fever and headache are now gone, but I continue to have scratchy throat and nasal congestion. No medical treatment sought but I am now quarantined for 2 weeks.

SWEELING OF LIPS AND FACE. She started Benadryl 2 days after but after 2 doses the swelling increased. Saw the doctor who gaver her an injection (forget the name) and the predsolone med pack. The swelling started to go down 2 days after taking this medication. A week after taking the Moderna vaccine and taking this medication her swelling was gone. Medication was started on Wed Jan 21,2012 and completed on Tue Jan 26, 2021. The swelling didn't get life threatening but when we noticed that inflamation was worsening and Benadryl didnt work we worried and she went to see the doctor for the treatment described above.

Patient's tongue and lips started swelling and she was having problems swallowing and talking. These were primary symptoms she experienced while at the site. Emergency services were called and she was taken to the hospital.

11:30 Reports throat dryness s/p vaccination, during 15 minute monitoring; "throat feels restricted" w/no additional complaints Po hydration/ water given, 02 via NRM applied, continued monitoring; NAD, respirations unlabored; BP 140/90 P 65 RR 14 O2SAT 99%RA 11:45 "feels better"; BP 140/89 P 63 RR 14 O2 SAT 98% RA; released from facility w/ daughter

TRANSIENT ISCHEMIC ATTACK= AFFECTED FACE, WITH PARESTHESIAS, BLURRY VISION, GENERAL WEAKNESS, WHICH RESOLVED IN A FEW MINUTES.

Twice the first night I lost bladder control. Today I have sores inside my lower lip. Not serious but not a mention of the possibilities

Jaw bone popping and sometimes out of place, lower back pain . Reporting for your side effect information only. No need for medical attention ar this time

1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DEVIATING TO RIGHT SIDE, BLURRED VISION, DIZZINESS, FEELING OF MAJOR DISTRESS 2-, MUSCLE SORENESS STARTED TO INCREASE AFTER ONE WEEK AND HAS CONTINUED TO INCREASE OVER TIME, BECOMING WORSE AT 4 WEEKS, AND LIMITING EXERCISE: CANNOT RAISE ARM, OR DO ANY MOVEMENT THAT REQUIRES MUSCLE FLEXION OR EXTENSION.

Started at 5 am throwing up, sore, weak, headache, freezing On Sunday 2 days after shot felt better, still weak and started canker sores in mouth and swelling. Still have symptoms as of today 2/18/21. Doctor calling in steroid.

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

fever, chills body aches, shortness of breath, urinary frequency, factigue, headache, body aches, water does not taste good.

pt stated after she received the vax she got a strange taste in her mouth. At 1 AM pt woke up with a heavy feeling in her left arm. Her left arm, hand and fingers started to swell. At 3 AM her head felt warm and the entire left side of her face was swollen, including lips, gums, nose and eyelids. Her teeth felt strange. At 5AM she could feel a sensation going down the left inside of her body moving from her neck to her toe. Then the right side of her face started to swell from the neck to the top of her head. Pt woke up at 7 AM next day and the swelling was starting to go down on the right side. On 2/26/2021 she is noticing the swelling is going down out of her left side. She never really had any pain or discomfort just swelling. Pt. has not contacted her PCP at this time.

Woke up in the middle of the night with a hugely swollen tongue. Also had sensitivity to light and discomfort on cheeks of face. Was given epinephrin and demerol. Was observed for 4 hours and released to come home. Tongue swelling completely gone by 3 pm and other symptoms by next morning.

Temperature of 101 degrees Fahrenheit lasting 3 days Severe chills Nausea and vomiting Headache with sensitivity to light, continuing to today's date. Rash on back developed on day 5, treated with diphenhydramine cream

Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swelling, hard lump, redness near injection site - began on day February 15. Hardness lasted five days, redness lasted 13 days Sleep disturbances - difficulty getting to sleep, waking in middle of night with feeling of disorientation - began on February 15 and lasted for four nights. Eye pain with feeling of object in eye and red, itchy eyelids. Began February 17 and recurred intermittently for six days.

slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain in center of chest, neck, head no trouble breathing, greast weakness, difficulty rising and standing -- best lying in bed under warm covers- Like the worst cases of flu or virus I've ever had.. Very thirsty

Symptoms: ulcers inside lower lip, mild swelling inside mouth, roof of mouth, tongue, throat, nasal swelling. Same reaction I've had to penicillin, etc. No rash. Same symptoms occur with ACE inhibitor reaction. 60 mg Allegra taken every 12 hours made symptoms milder, but didn't go away. Did not feel well in general, no appetite. Today, March 6, almost no symptoms, it has been more than 12 hours since the last Allegra.

During post vaccination observation period reported feeling hot and nauseous. Was hypertensive 214/102 and couldn't recall if she took her antihypertension medicine that day. BP decreased to 187/86, pt anxious and felt tingling sensation and tightness in face and gums. Transported to ED, no difficulty breathing, no facial swelling and no hives. Given diphenhydramine and d/c to home.

Patient reports experiencing change in taste starting approximate 1 week after her second Covid19 vaccination.

She had no issues with the 1st dose in the series. She did not have any symptoms but acknowledged feeling anxious about the side effects prior to arrival for vaccine. After the 2nd dose, she experienced chest pain, jaw pain, body numbness and tingling, and nausea. She did not have vomiting, shortness of breath, syncope, or headache. She was hypertensive on the cardiac monitor and EKG with T wave inversion in lead III, otherwise unremarkable. Heart rate stable, alert and oriented, cardiopulmonary exam benign. She was sent to the ER for further workup, but did not seem to have any allergic reaction to the vaccine. It is unknown what occurred at ER, as she either went to a separate health system or did not go at all.

9:45am pt c/o a "little tingling on upper and lowers lips". Pt speech and mental status at baseline. Pt able to swallow water and mental status at baseline. No noted redness or hives on patient body. Pt refusing Benadryl x 2. Pt reports at 10AM " I am feeling better or less tingling only a "tiny bit". Pt at 10:10am "I am better now". Pt able to ambulate safely to checkout area.

Immediately started seeing blurry and then eyes burned for 24 hours to the point that you couldn?t see. had to go to the optometrist for eyedrops

Patient reported tongue tingling. Then advised that she was feeling light headed. Patient then began slurring words and stuttering. Patient was given 25 mg of Benadryl IM. Then transported via ambulance to the local ER.

I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was very quiet. When we were going home they told me I was swerving, all over the road and they told me to stop, they would drive, I said no, i don't trust anyone with my car. We got home, I remember changing into my nightgown and was texting someone and I suddenly I stopped. After that I was unresponsive. I would not answer anyone, they said I looked pale and stared into the air. They called my children and they came and emergency personnel was called. I was taken to a hospital and they transferred me to another hospital. I stayed there for 3-4 days. After going home it took me some days to be able to walk without assistance. I wanted to say I had covid in May (1st time) and September (2nd time) . I still do not have taste or smell back from the covid. I can only eat 3 or 4 bites and then I am done.

A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.

Got the vaccine and about an hour later started losing vision in the left eye. Everything appeared blurry and had to stop wearing contacts and switch to glasses.

Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) 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 concomitant medications provided. No treatment was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Increase ringing in right ear. Ringing started in left ear. Headaches & Dizziness. Cold like symptoms--some coughing, sneezing, runny nose. Shortness of breath.

chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.

I have horrible ringing buzzingin my ears. Started first with buzzing in ears just at night for about two weeks. After two weeks it is all the time buzzing. Seems to be louder in the evening and night. It is causing anxiety.

Rash on arms, legs and feet. Red Blisters and Water Blisters (both large and small), very itchy and hot. Has gone to the Dermatologist and have had biopsies extracted from both arms . The allergy specialist has given me Steroids. I have also had an allergy attack where my Tongue swelled up and I went to the ER.

She got her vaccine, the arm was a little sore. Then about 30 minutes had sinus problems, but then for 2 days she had fever and chills. Then the ringing in her ears started within a week after that. She does have tinnitus but it intensified since the vaccine. She had a teleconference call with her doctor who told her that it was not one of the symptoms of the vaccine and told her to have her hearing checked.

4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN

Onset began the evening of the vaccination severe chills and did not feel well. On the first week had extreme fatigue. The second week I lost my sense of smell and taste. The fatigue and lost of smell and taste lasted up to five weeks. I gradually felt better, but it took about 8 weeks before I felt better.

The patient recieved the second dose of Moderna vaccine on 5/10/2021, she called us today 6/3/2021, and reported that on third day after the shot , she had slight fever then she felt severe side effects: she lost smell and taste, headache, pain and swelling in joints and dizziness. The symtoms still last till now and we advised her to see her doctor right away.

I began feeling dizzy, nauseous, weak in legs, blurred vision in early May which continued throughout the month. On June 3 I experienced an event like no other. My legs felt like rubber and tried but could not speak. My husband carried me to the sofa, when I sat down I felt disoriented, and saw a circle in front of my eyes. I felt as if I was about to pass out. I saw my cardiologist a week later. He is concerned that the neurological symptoms are new. He suspects I had a mini stroke despite being on blood thinner for my CHF and referred me to a neurologist. He suggested I report this sudden change to VAERS.

The following day I felt a little sluggish the next day. 4-5 days later my throat began bothering. It was extremely red and constantly painful. I also had a few blister looking spots on the sides of my tongue.

Severe headaches, eye pain, ear pain, jaw pain on the left side, extreme stiffness in neck. Sent to hospital. Outpatient surgery on both temples. Biopsy. Diagnosed with Greater Cell Arteritis. Inflamation of the temporal arteries. On medication- pregnezone 50 mg daily, fosamax 70 mg weekly. Also dealing with a side effect of the prenezone- elevated blood pressure and on medication 5ml amlodipine daily.

Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management

Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.

Called at 8 am this morning to inform me of a reaction to her COVID vaccine. She received the vaccine on Tuesday, 1/19/21. The next day she noted the back of her tongue on the R side was swollen. On Thurs, 1/21/21, she reports she woke up with the back of her tongue swollen on both sides such that she had some trouble speaking and needed to be very careful with chewing so she would not bite her tongue. She stated she also had drippy sinuses and an earache which then woke her up several times during the night last night. Today she reports the tongue swelling is only to the back R side of her tongue. She continues to have ear pain. She states she had not reported the symptoms to anyone before her call because she had not felt the symptoms were life-threatening. I asked her if she had taken any benedryl, and she stated the only medication she had taken was her analgesic herbal supplement. She states she has never had a vaccination reaction in the past. I advised her to call her PCP and be seen, which she was able to do. After she was seen, she called and stated while the clinician was looking at her tongue, it started to have shooting pains when she moved it to the right. The clinician stated her tongue and throat were not visibly swollen, noted no swollen lymph nodes, and noted no ear abnormalities.

Pt received her vaccine and about 10 minutes later she began c/o of a tickle in her throat and then her throat felt like it was getting tighter and she had mild SOB. Treatment--- she was taken to ER for evaluation where she was given IV solumedrol and IV Benadryl and IV fluids. After being in ER for approximately 2 hours she was discharged to home.

About 10 minutes after receiving the vaccine, pt began complaining of a tickle in her throat and mild SOB. After 13 minutes she began complaining of her throat feeling tight.

Patient developed acute-onset vertical diplopia several hours after receiving the Moderna vaccine (first dose). When seen by me on 1/19/21 there was evidence of ongoing left fourth nerve palsy causing the new double vision

The following symptoms began the day after the shot: headache, dizziness, tiredness, fever, complete loss of hearing in right ear, partial loss of hearing in left ear, Hearing loss lasted 6 hours before beginning to improve. Most symptoms were gone by end of 4th day. Tiredness remains along with occasional dizziness.

Sharp shooting pain in right ear, sharp pain in forehead. Red, hard blotch on left upper arm measuring 3" x 6". Decreasing redness each day since Feb 4th.

I took a tylenol when I got home. I fell asleep and when I woke up that afternoon I had a large fever blister on my upper lip that is very swollen. I applied Embersole

SHE COMPLAINED OF UPPER LIP NUMBNESS. ON SITE EMS/PHYSCIAN RESPONDED. VITALS WERE WITHIN NORMAL LIMITS. EMS RELEASED TO TO HOME

On, February 3, the 7th day after vaccine, patient began itching all over her body (torso, arms, and hands). there was no rash visible. On February 7, Sunday, at 7:00 pm, her lower lip started burning. At 9:00 pm, her tongue began feeling unusual - slightly swollen. the itching had continued all this time since February 3. At 11:15 pm on February 7, she took 50 mg of benadryl and no zolpidem that night. the next morning, the itching had stopped and burning of lips stopped. Tongue did not feel normal until 3:30 pm that day, February 8.

Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.

Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him. Adverse reaction was TIA. TIA symptoms lasted 5-10 minutes max per patient.

On Sunday the 2/21/2021, about 3PM I noticed that the area where I received the vaccination was red, swollen, itching, and sore. I googled search and found it was a rare but real reaction vaccine, called COVID ARM. According to the information I read it occurs between 7-9 days after vaccination. Mine occurred exactly 7 days later. I have been putting Hydrocortisone cream with Aloe in it and on it. Today it is more sore then itching and still red. The Hydrocortisone with Aloe seemed to help. I have also noticed my eyes have been watering a lot more since receiving the vaccine.

About 4 hours after receiving the first dose of the Moderna COVID-19 Vaccine, patient felt headache, itchy face/neck, right side ear ache. Headache persisted into the next day. Took Tylenol which mildly relieved symptoms of headache and ear ache.

On 2nd day following vaccine I woke with a really hard jaw pain Its hard to eat, chew or even open mouth. Now on 2/26/21 it still hurts however it is better, there is a slight swelling at the bottom of my right ear. The bone.( It seems) Question is: is this a known reaction? About 10 minutes following the vaccine my upper left lip became numb ,but only a few seconds then disappeared.

Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in fainting and falling, proceeded to faint multiple times - lost all bodily functions, eyes rolled in back of head multiple times and 911. Did get back to ability to get home but now repeats herself more than before and seemed to have lost some mental capacity till Wednesday March 10 / she now is better but scared to do anything on her own as fearing issues again

I had no effect until after i went to sleep.. After midnight i awoke to itching all over. By morning my eyes were closed to slits and beneath my eyes were bags as large as teabags, i also had a low grade fever, aches and pains and extreme fatigue. This lasted for a while so ,on Feb 2.. I went to the doctor who gave me a steroid shot. On the 4th i was not as achy though still tired and the bags under my eyes persisted ...My eyes were still itchy and almost closed... She gave me another steroid shot.. i was also advised not to get second steroid shot by several doctors, a doctor and a Immunologist.. also advised against getting second dose. The fatigue remains and the swelling under eyes remains though not as pronounced as it was at first. I would like to be safe. Is the johnson and johnson an option for me? I would not like after effects Please get back to me with some suggestions and advice as to my being fully safe. thank you.

Loss of vision L eye with pain. Was able to see DO next AM. Dx secondary noninfectious iridocyclitis left eye. Thought to be secondary to autoimmune disease.

Began approx 36 hours after injection. Extreme chills, threw up > 5 X, Lip Swelled, eyes (1 more than the other). Did not take a hydrocodone this day.

Site: Pain at Injection Site-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 6 hour after vaccine, patient was awoken from sleep with tingling sensation in tongue. Patient felt tachycardic and felt like body was going to break out into hives. Patient did not have rashes or itching but took benadryl anyway. All her symptoms went away roughly 30 minutes later.

Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that "this ain't good" or "this ain't right". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral

Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue. The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19. Treatment details included the use of some nebulizers and quarantine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was 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 except for the events of COVID-19 and Pneumonia. The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.

Broken of the right eye vein that led to bleeding; excruciating pain (like a labor pain; Diarrhea; vaginal bleeding; Dizziness; Stomach Cramping; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: excruciating pain - like a labor pain (pain), stomach cramping (abdominal pain upper), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included: methotrexate. On 22Jan2021, the patient received their first of two planned doses of Moderna's COVD-19 Vaccine (mRNA-1273, lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. Later on 22Jan2021, the patient began to develop: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). She reports these events lasted for 1 day and then stopped. The patient states she still experiences stomach cramping (abdominal pain upper), The patient confirmed she consulted with her physician and blood work was done. The results of the blood work were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. Patient is wondering if these events are normal and if she should receive her second dose. The outcome of the events: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorthage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage) is considered to be resolved based on patient reported duration of 1 day. The outcome of event: stomaching cramping (abdominal pain upper) is considered not recovered/not resolved per patient report.; Reporter's Comments: This case concerns a 82-years-old, female patient who experienced: excruciating pain- like a labor pain, abdominal pain upper, diarrhea, vaginal bleeding, dizziness and eye haemorrhage. Very limited information regarding this events has been provided at this time. Further information has been requested.

tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneumonia; A Spontaneous was received from a Consumer concerning a 82-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right lower lobe pneumonia (Pneumonia), loss of taste (Ageusia), loss of smell (Anosmia), tested positive for Covid infection (COVID-19) and BP: 130/68 (Blood pressure abnormal). The patient's medical history was included Chronic Obstructive Pulmonary Disease(COPD), blood pressure and Obstructive sleep Apnoea. Concomitant medications was included ATORVASTATIN CALCIUM for cholesterol, ACETYLSALICYLIC ACID for unknown indication, Advair for COPD, SALBUTAMOL for COPD, TIOTROPIUM BROMIDE for COPD and CPAP for Obstructive Sleep Apnoea. On 22-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no: 013L20) via unknown route in the Left arm for prophylaxis of COVID-19 infection. On 03-MAR-2021, It was reported that the patient experienced loss of taste, loss of smell and BP: 130/68. On 04 Mar 2021, the patient was tested positive for Covid infection . On 09 Mar 2021, the patient was experienced right lower lobe pneumonia. The pneumonia was medically significant. Treatment information was Nebulizer treatment, Antibiotics for 5 days for Pneumonia and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 19 Mar 2021, the outcome of the event, tested positive for Covid Infection was resolved. On an unknown date, the outcome of the events right lower lobe pneumonia, loss of taste, loss of smell, and BP: 130/68 was unknown.; Reporter's Comments: This case concerns an 82 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected COVID-19, anosmia, ageusia, and blood pressure abnormal. Event onset 19 days after first dose mRNA-1273. Treated with antibiotics and Tylenol. COVID-19 resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

A spontaneous report was received from a consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass. The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported. On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl. Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

The patient received her FIRST dose of Moderna COVID vaccine on 1/26/21 and SECOND dose on 2/23/21. On 3/8, she first started to experience shortness of breath, which was attributable to cardiac etiology and diastolic heart failure at the time, but which in retrospect may have been her earliest symptom of new onset myasthenia gravis, which is the AE I am wanting to report. She was hospitalized from 3/8-3/13, and underwent extensive cardiac workup that was negative. She again developed shortness of breath on 3/17/21 and was re-admitted to the hospital on 3/18/21 for diuresis for presumed diastolic heart failure exacerbation, received diuresis from 3/18-3/22/21 but then developed new onset diplopia, at which pint I evaluated her in neurological consultation on 3/22. Her brain MRI disclosed an UNrelated incidental small left cerebellar infract, but her neurological exam showed a new R lateral rectus palsy and new moderate to severe left eyelid ptosis, suspicious for myasthenia gravis. Anti-acetylcholineseterase antibodies--- binding, blocking, and modulating, were all sent off and came back all strongly positive on 3/26-27/21. The patient then called stating she had developed recurrent shortness of breath, new onset dysphagia, and worsening double vision. I urgently re-evaluated her in outpatient follow-up in my office on 4/2/21 and sent her immediately to the hospital to be readmitted, where she remains as of this reporting date and she has been receiving IVIG with improvement in her symptoms. She did NOT have any previous known history of eyelid ptosis, dysphagia, diplopia, or muscle weakness. In retrospect, the patient states that her current symptomatology began around 3/7/21 with the benefit of hindsight. I am reporting this event because it is very unusual for an 82 year old WOMAN to develop new onset of myasthenia gravis, and it is a known autoimmune disease, and a vaccine would be a plausible trigger for its development, or trigger for its first symptomatic manifestation. I was also especially concerned because my fellow neurologist, ALSO had a patient develop myasthenia gravis about 2 weeks or so following their second dose of the Pfizer COVID vaccine. It would be an EXTRAORDINARY coincidence for two instances of new onset myasthenia gravis to occur 2 weeks post- vaccination at essentially the same time in an institution of our size, so we both felt obliged to report both cases ASAP to the VAERS. I was not able to reach the patient in her hospital room today to get additional specifics about where she got the vaccine, its lot number etc., however she is a retired and has indicated her willingness to provide you with any and all additional information you need, and I am also personally very willing to provide any additional information about her eventual outcome.

hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.

Sight has gotten worse; Hearing is worse; Taste is weird; Normal cough; Tested positive for COVID a few days after vaccination; Felt so sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID a few days after vaccination) (seriousness criterion hospitalization). On 18-Jan-2021, the patient experienced MALAISE (Felt so sick) (seriousness criterion hospitalization) and COUGH (Normal cough) (seriousness criterion hospitalization). In February 2021, the patient experienced VISUAL IMPAIRMENT (Sight has gotten worse) (seriousness criterion hospitalization), HYPOACUSIS (Hearing is worse) (seriousness criterion hospitalization) and TASTE DISORDER (Taste is weird) (seriousness criterion hospitalization). The patient was hospitalized from 18-Jan-2021 to 01-Feb-2021 due to MALAISE. At the time of the report, COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-064065 (Linked Report).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-064065:serious_case

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

First Moderna vaccine given on 03/18/21. On 4/13/21 her left eye was red and she had a headache, but 4/14/21 she was unable to see clearly out of the left eye. She saw an ophthalmologist on 4/15/21 and the eye started improving on 04/16/21. On 04/16/21 she received her second moderna vaccine and the next day she had another headache and was unable to see out of her right eye. She had an emergency appointment with the ophthalmologist on 04/19/21 and a recheck on 04/19/21. By 04/20/21 the right eye started improving.

Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome - Memory loss

Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory loss.

lyme disease type symptoms; blood sugar decreased; right arm pain at injection site; fatigue; generalized body ache; chills; runny nose; cough; left arm pain-no injection; left eye twitch; This spontaneous case was reported by a nurse and describes the occurrence of LYME DISEASE (lyme disease type symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014MZ01) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Arm injury (left arm cannot raise arm) in 2012, Dislocation of vertebra (3 vertebrae out of place), Radiofrequency ablation (ablation in neck), Low back pain (bilateral), HLA-B*27 positive, Kidney stones, Reiter's syndrome, Salmonella infection, unspecified (dating back to 1981) and Knee replacement (two knee replacements). Concurrent medical conditions included Diabetes, Asthma, Lyme disease and Fibromyalgia (fibromyalgia with neck and shoulder pain). Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, INSULIN GLARGINE (LANTUS) for Diabetes, MINOCYCLINE, DAPSONE, ATOVAQUONE, PROGUANIL HYDROCHLORIDE (MALARONE) and LEUCOVORIN [FOLINIC ACID] for Lyme disease, CODEINE PHOSPHATE (CODINE), PARACETAMOL (TYLENOL) and DIAZEPAM (VALIUM) for Pain. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced BLEPHAROSPASM (left eye twitch). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose), COUGH (cough) and PAIN IN EXTREMITY (left arm pain-no injection). On 12-Apr-2021, the patient experienced LYME DISEASE (lyme disease type symptoms) (seriousness criterion medically significant), BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills). On 20-Mar-2021, BLEPHAROSPASM (left eye twitch), RHINORRHOEA (runny nose) and COUGH (cough) had resolved. At the time of the report, LYME DISEASE (lyme disease type symptoms), PAIN IN EXTREMITY (left arm pain-no injection), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills) outcome was unknown and BLOOD GLUCOSE DECREASED (blood sugar decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood glucose: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient's extremities are red and splotchy. Patient has swelling under right eye that is sore to touch. Patient reported no issues with vision but has slight blur of vision at times that goes away when blinking. She is taking Benadryl to help with swelling and will follow up with physician if symptoms do not improve.

started running temp and had pain in the left side of her neck and head. Next day left jaw and lips were numb so could barely talk. Pt saw her PCP Dr. and was told it was a side effect from the vax. Left eye started swelling so went to eye Dr. on 4/14/21. She was prescribed eye drops but continued to use her regular eye drops. At times her eye continues to feel hard and that the vision has been impaired and jaws feels funny.

Client stated that night after receiving the vaccine she became dizzy, had chills, had vision issues where her eyes could not focus, and her vision was blurry. Client stated that she felt like she was doomed, and maybe having a stroke. Said her symptoms lasted about 2-3 days.

developed tear on retina; " trouble in eyes"; annoyance in her right ear; noise in her ear, going away and she does have Tinnitus; severe fatigue and vaccine made her tired; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (developed tear on retina) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired). On an unknown date, the patient experienced RETINAL TEAR (developed tear on retina) (seriousness criterion medically significant) and OCULAR DISCOMFORT (" trouble in eyes"). The patient was treated with Laser therapy for Retinal tear and Laser therapy for Ocular discomfort. At the time of the report, RETINAL TEAR (developed tear on retina), OCULAR DISCOMFORT (" trouble in eyes"), EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. The patient started having trouble in eyes and developed tear on retina(retinal tear) two weeks ago. She went to her doctor and received laser treatment. Very limited information regarding the events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-Jul-2021 added new events.; Sender's Comments: Very limited information regarding the events has been provided at this time. No further information is expected.

Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent

patient reached out to pharmacy on 1-19-21 to report that her arm was sore and red all the way down to her elbow and "itchy". she also stated that above her upper lip, was blisters and red, itchy, tender and swollen. she report this started on the day after her vaccination. i asked her if she had run any fever to which she wasn't aware that she had. i suggested the blisters on her lip could possibly be fever blisters but she reports to have never had them before. she reports no other rash- just the arm of her injection and her lip. i instructed her to take a benadryl and some tylenol and i will follow up with her tomorrow - she did report that it does appear to be getting better as of today (tuesday)

Blooded stools; Eyes are a little bit itchy; Right eye swollen; A spontaneous report was received from a consumer who was an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient's medical history was not provided. Concomitant medications reported included magnesium. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J00/NA) intramuscularly for prophylaxis of COVID-19 infection. On the evening of 04 Jan 2021, the patient experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient reported having blooded stools that were not diarrhea, but had occurred three or four times. Treatment for the events included non specified allergy medicine for the eyes. On 06 Jan 2021, the patient reported feeling better in regard to the blooded stools and was unsure if it was actually blood or not in her stools and she had ate spicy and red food. Action taken with mRNA-1273 in response to the events was not provided. The event, blooded stools, was considered resolved. The outcome for the events, eyes are a little bit itchy and right eye swollen was unknown.; Reporter's Comments: This case concerns an 83-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 025J00/NA), and who experienced the unlisted serious event of Haematochezia and the unlisted non-serious events of Eye pruritus and Eye swelling. Based on the current available information and temporal association between the use of the product and the start date of the event on the day of vaccination, a causal relationship cannot be excluded making the events possibly related to the vaccine.

fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day), but very tired and sleepy.

2:30pm Received 1st dose of Moderna. Hx of SOB/swelling with allergy shots. 2:45pm c/o itching around lips. VS BP 166/19 P 90 o2 sat 97% RA, alert, ambulatory. 2:50pm Benadryl 50 mg IM stat LGM. 2:55pm BP 171/71 P 90 O2 sat 98% RA, reports itching resolved. 3:00pm BP 147/88 P 87 O2 sat 97% RA. 3:15pm ambulatory, but became unsteady, sat in chair. 3:19pm BP 153/75 P 77 3:24pm BP 148/78 P 80 3:25pm ambulatory to truck. 3:28pm husband returned to clinic to report wife's rash. Instructed to go to ER. Report called to ER. 01/21/21. F/U call. Pt reports observed in ER, no treatment. Instructed to take Benadryl 50 mg po bid x 2 days. No further problems.

didn't sleep well the night of injection, about an hr ago my stomach started cramping and it went to my throat like i was gaging and it went through your arms and into your head.

pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.

Patient received vaccine and was in the monitoring center when she made staff aware of tingle in lips. Patient vitals were taken and stable with elevated blood pressure due to not taking morning medication. While documenting and staying with the patient stated that the tingle was moving into cheeks and throat. Per 25mg IM once given. Patient symptoms resolved within 15 mins. Vitals stables and discharged home.

Bad headache, very stuffy nose, I couldn't breathe and almost went to the hospital. Ears were ringing, my eyes were ready to pop out of my head. Temples hurt, lymph glands were swollen, sore throat. Mostly in upper part of anatomy above collar bone. It made me very weak, I had trouble getting out of rocking chair to answer phone. So I took another Tylenol. I usually only take 1-2 Tylenol a day and that was my second one by the middle of the day. I had to lay down and I live alone so I was nervous and had phone beside me and debated calling 911 which I have never done. I dozed and when I woke up about a couple of hours later it was much better. Still had headache and a little stuffiness but anybody can handle that. Also, I was very nauseated and couldn't eat but I did drink water.

woke up in the night with a "thick tongue" on 2/10/21. this resolved by morning, patient has body aches now but will take tylenol. advised to take benadryl and call 911 if tongue swelling returns or any other signs/symptoms of allergic reaction

-Pt had her 2nd COVID vaccine on 2/5/21, and during the night at 2 am on Saturday, 2/6/21, she woke up to go to the bathroom; she noticed numbness around the left side of her mouth affecting her lips; she also noted drooping of the left side of her mouth at this time -She did not have a headache -She did not think she was having a stroke as she had no numbness or tingling or weakness in her extremities, so she didn't go to the ER -She is having trouble closing her left eyelids -She feels like she had novocaine injected into the left upper/lower lip -When she tries to drink, liquid dribbles out of the side of her mouth -She can still taste, but her mouth tastes like salt -On Saturday, she had a fever of 100.6 -No trouble walking-No confusion -No h/o stroke or TIA -No weakness, numbness or tingling in extremities -No vision changes -No slurring of speech -No recent infections -No ear pain or tinnitus -She is allergic to iodinated contrast, but has never had gadolinium

Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number 023M20A. Exp. 8-10-2021. Patient had no pain with injection. Tolerated well. Approximately 30 seconds to one minute after injection patient reported to nurse that her mouth and throat felt dry. This nurse asked the patient if she was feeling anything else different and if her throat felt itchy. Patient reported that her throat did feel a little itchy. This nurse called for assistance. RN obtained Dynamap to take patient vital signs. This nurse stayed by patient's side at all times. NP responded and was by patient's side throughout event. Patient now reporting feeling very hot. Ice pack applied to back of her neck. Initial vital signs 184/87, Map 123, HR 119. Patient tachypnic and tachycardic. Pulse ox WNL at 99%. Lung sounds clear. Radial pulse obtained, rapid. First responder called for with overhead page. Next vital signs 189/79.map of 113. HR 116. Patient still tachypnic and tachycardic with a pulse ox of 99%. Patient reports she is feeling dizzy and hot still. Able to answer questions and was oriented at all times. Dr and first responder team arrived at scene. Patient able to answer questions. Is still dizzy and not feeling well. Patient transferred safely to cart and strapped in with safety straps. All patient belongings placed on cart with her. Patient taken to ED for evaluation.

Patient stated tingling of lips and tongue. I asked her to take an antihistamine if she had one. She stated she had claritin and would send her husband to the store to get benadryl. By the time he got back she was feeling better.

Five days ago, patient received her 2nd COVID vaccination. Following that she had myalgias and some sedation/confusion. She apparently stumbled and struck her head. She did not lose consciousness. She did recover from her symptoms by the next day. She has some soreness on her scalp in the scratch but no significant hematoma. However, she then developed some swelling and redness beneath her eyes. She is here to evaluate that. She she is back to her normal self. Comments: Patient has ecchymosis in swelling beneath both eyes and the bridge of her nose. It is nontender. Scalp-minor area of tenderness in the right vertex. There is a slight abrasion on the skin. No signs of hematoma. Assessment / Plan: 1. Contusion of scalp, initial encounter Contusion right scalp-I suspect patient's lungs are delicate skin informed a small hematoma. The swelling and bruising and 5th settle down into her eye sockets. I reassured patient that this will resolve the next 1-2 weeks. I believe patient had some severe myalgias and fatigue after a COVID shot. I do not think this is a longstanding problem. Expect her to get back to her normal self. Patient did have COVID-19 approximately 3 and half months ago. I told her that people have more significant reaction to the COVID vaccine after having had the illness. At this point, I do not agree need further workup.

Patient in the 30 minute wait time had an allergic reaction to the vaccine. She had an reaction that caused her tongue to swell and produced slight itching. Patient presented for Second dose with Epi-Pen and Benadryl. Doctor determined that based on first dose reaction it was not safe for her to attempt the second dose. Second dose of vaccine was not administered.

arm got red from elbow to shoulder. Hands, Feet and Mouth develop blisters and peel. hands are raw and red

Woke up with severe dizziness,ringing in the ears, vomiting. Unable to get out of bed until 3 pm. Lasting into 2nd day, but less severe today.

mild swelling of tongue & lips lasted till around 2pm but came back off and on till that evening lie a wave passing thru my mouth. Only other effect was around 5pm got the chills & didn't get warm till went to bed at 10pm. End of tongue has not been same since like constantly irritated

Immediately following the second vaccination, the individual's arm felt heavy and she had pain at the injection site. Around 10-11 hours later that evening, the individual started feeling dizzy, experienced fever and chills, had shooting pain in her arm at the injection site, severe fatigue, appetite loss, headache and experienced diplopia. These symptoms lasted about a day and a half. The first 24 hours were the worst.

She got the vaccine, she had no problems, felt rather fatigued for a day or so. Then on 3/18/21 she had a bright rash on her thighs, it didn't itch, just ridges and red marks. Then her lips were swelling, used what she uses on fever blisters. She has used what she has used before which has not helped her. She has not called her doctor. She still does have the rash, it has faded some but it did come back.

Moderna vaccine #1 administered on 1/18/21 Adverse event observed 1/24/21 @ 1am: soft tissue swelling eyelids, cheeks, lips. No swelling of gums, tongue or throat. Severity: Moderate. No airway obstruction. Severe itching of eyelids, face. Interference with speech due to swelling. treated with OTC diphenhydramine 25 mg oral every 6 hours. Adverse event lasted 72 hours. Moderna vaccine #2 administered 2/22/21 Adverse event observed 3/2/21 @ 1am: severe edema peri-orbital tissue, intense redness peri-orbital tissue; intense itching of eyelids. Skin changes over few days to "lizard skin". Chronic redness, itching, swelling, texture changes; Scheduled for dermatologist tomorrow, 4/7/21. Approximate length of time adverse reaction has existed > 30 days.

second shot, 3/17, next day muscle aches and sleeping 3/18. on 3/19 sinus flared up with headaches, sore throat, swollen glands, ear aches and yellow discharge from sinus

partial loss of vision , starting 7 p.m. vaccine admin 10:45 am , 2 hours loss on vision and ongoing distorted vision ,blurriness, heart palpitations

4-19-21 afternoon hearing was failing in left ear. Loss of hearing has only gotten worse over the last 5 days. Sounds like a tunnel and echoing - can not hear conversations. 4-7-21 Muscle and joint pain/soreness, extreme tiredness symptoms lasted for 3 days

Herpes breakout on gums and lips with swelling and swelling of joints with severe pain (left ankle and right wrist)

nausea, VERY SEVERE Muscle -nerve pain in feet, legs, hips, hands along with numbness, and severe weakness and balance problems--pain unbearable. Am now getting Oxygam infusions. Also have had continual sores in mouth and on lips. I am not over this yet, but pain has gotten some better.

On January 26th said she was seeing double images one and above the other. The next day she seen her doctor for this matter.

sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. 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 29-Jun-2021: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; 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.

At 4:27 pm client stated she was developing a rash on face. BP 220/110, P 80, R16. Epinephrine .5ml given IM at 4:31pm. Reported tongue felt thick and difficulty breathing, BP 210/100, P 64, R 18. Benadryl 50mg given at 4:34pm, rash on face less, BP 178/88, P 60, R 18. Transferred by private vehicle to Hospital at 4:45pm.

Initially, the first night, my feet felt extreme cold. All over soreness the night of the shot and all the next day and evening. Headache the night of the shot and all the next day and evening. Aspirin does not touch it. Ear ringing, still. Left calf pain and shooting pain into my left foot. Needless to say, all the above seemingly getting worse into evening of the 2nd day.

Given shot on Monday, January 11, 2021 at 10:15 am . Was fine until 7:30 pm that night. Felt like I was drugged and couldn't keep my eyes open. Slept (except for bathroom stops) until 7:30 pm on Tuesday night. Very red and large knot on shot arm. Lasted many days. Very sleepy for days, Dull headaches. Stomach upset. Very foggy thought processes for more than a week. Blurry vision for a few days. Joint pain. Spoke with Moderna and they suggested I talk to my doctor. Doctor told me the side effects would go away within ten days. Most of they did.

Moderna COVID-19 Vaccine EUA Inability to eat (nausea), unpleasant taste, extreme weakness, inability to think appropriately (unable to recall words, slow thought process), diarrhea -- all occurred for two days and have resolved themselves without treatment; still weak but am increasing liquids, salts, immodium (not today), frequent rests, cancelling Physical Therapy and private clarinet instruction

pt stated that she woke up with left arm throbbing, has chills, was extremely thirsty, very fatigued, has cough and nausea with no appetite. Pt states she is not sure if she has a temp but took 500 mg Tylenol at 3:00AM. Pt will contact PCP for medical advice.

At 11 pm she threw up. Then she got achey and incredibly dry mouth. Her arm was really sore and she was cold.

The next day: aches, fatigue, low grade fever. The following day: awoke with red, puffy, itchy eyes, extreme itching on both arms.

The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending.

1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was 4 inches across and swollen and warm. Pt also having difficulty breathing, Went to Doctor and ER due to breathing distress. Was monitored but not admitted. Still continues to experience headaches, chills, and an increase in salivary secretions.

Patient reported that she felt like her throat was closing few hours after receiving her vaccine. She reported that she took Benadryl and she felt better. She reported that the next day the roof of her mouth and her lips started swelling and again took Benadryl and the swelling did not go away then she started taking prednisone 20mg along with Benadryl and she felt better.

84 yo woman here to follow up from recent episode of vasculitis. She started getting a rash - started 7 days after 2nd dose of vaccine At last visit, we did testing for vasculitis after the rash looked more vasculitic to me; ANCA testing was positive, as was ANA. - 17 days after 2nd vaccine She was given prednisone 20 mg taper over the last 8 days. She is feeling much better in terms of her rash and swelling. She is having surgery on the 29th for her BCC on the left eyelid. She is noticing blurred vision in both eyes since this all started and she is mentioning this to the eye doctor when she sees them. She says her head was fuzzy when this started and this is better but is still "fuzzy sometimes" Her renal function was normal. Her CBC was mildly elevated WBC but otherwise normal. She denies any breathing problems, blood in stools or blood in urine, or neurologic symptoms other than the fuzzy head.

Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms were sore; The back of her head ached; upper back hurt; Felt wiped out; A Spontaneous report, was received from a consumer concerning a 84-year- old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced fell like autoimmune flared up (autoimmune disorder), back of her head ached (headache), both arms were sore (limb discomfort), her upper back hurt (back pain), wiped out (fatigue) and extreme dry mouth. Patient's medical history included Sjogren's syndrome, Autoimmune thyroiditis. On 04 Feb 2021, the patient got the first dose of mRNA-1273 (Lot number: 016M20A) intramuscular upper arm location injection prophylaxis for COVID-19 infection. After 8 hours of receiving the first dose she felt like her autoimmune disease flared up, both of her arm were sored, the back of her head ached, her upper back hurt. She felt wiped out and went to bed much earlier than she normally does. The next day, her mouth was extremely dry, her lips and tongue was stuck together (due to the dry mouth). She did not take anything to alleviate the symptoms. She has not called her healthcare provider. Consent was given for safety to follow up. The action taken for fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown. The outcome for the events fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (pain in extremity, headache, back pain, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event-Autoimmune disorder has been provided. The subject's history of Sjogren's syndrome may remain a risk factor for dry mouth. Further information has been requested.

Morning after 2nd shot felt great deal of fatigue, to the point of returning to bed. Spent rest of day on couch with no strength. Beginning of front of head headache. This headache has continued to this day, also some visual blurring. Fuzzy head thinking feeling. These conditions are on going as of today 03/25/2021.

Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen levels went down, she sweated profusely, her eyes were rolling out, she was also congested and had gurgling sounds and started foaming at the mouth. Hospice care and Medical workers came through to help. X-rays were performed along CT scans of the brain and lungs at Hospital. X-rays of the chest showed ammonia and with lab work performed showed she also had an UTI infection. A Covid test was done which was negative. She was given Tylenol at Hospice Care. After her second dose she also went through the same symptoms but overall is doing well now and is stabilized.

stomach cramps, vomitting, lower abd pain, extreme body temp changes, vision changes, was "seeing things, squirrels and mice to be specific", INR was "out of whack", blood was too thin, numerous bruising. Was seeing and hearing things no one else was

arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt, tightmess in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,

Sinus infection got worse; Headache; Lost hearing; Had bothering tinnitus; All her body feels sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing) in an 84-year-old female 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. The patient's past medical history included Allergy (Allergy to Vaccine NOS). Concurrent medical conditions included Diabetes. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick) and HEADACHE (Headache). On an unknown date, the patient experienced SINUSITIS (Sinus infection got worse). At the time of the report, DEAFNESS (Lost hearing), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick), SINUSITIS (Sinus infection got worse) and HEADACHE (Headache) outcome was unknown. No concomitant medicines reported. Treatment information included unspecified antibiotic, diphenhydramine and prednisone. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. Action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

sudden complete loss of hearing in left ear received 2 shots in ear and was put on antibiotics and antibacterial pills for 10 days No return of hearing at all

allergic reaction. mouth lips tongue and throat swelling. was still able to breathe and speak freely but lasted the entire day. gums tingling all day. (swelling was enough to smooth out upper lip wrinkles)

My mother had her first Moderna COVID-19 vaccination on March 1st. On March 10th, she suffered a blood clot in her eye that caused the eye to lose vision. Her eye doctor said she is now permanently legally blind in that eye.... I do not know if the blood clot was caused by the vaccine, but I am reporting it in case there is a correlation.

Patient describes having pain behind her right eye and blindness. She says she had a stroke behind her eye and that it took a long time to get anyone to see her. She is receiving shots in her eye. She thinks it is related to the vaccine. Her doctor whom she sees for the shots says it was a coincidence.

She awakened in the middle of the night feeling much pain in arm where injection was. Felt like she would throw up but couldn't move from the bed. Felt like her face was drawn and tight. This morning, she has been very shaky, sounds like some congestion in her chest (cough), very tired, very dry mouth. She is never sick, so this is alarming to her and to me.

Patient had an immediate reaction following the 1st Moderna COVID-19 Vaccine administration on 01/18/2021. S/S began immediately following the injection, and were scratchy, dry throat, dry cough, slight wheezing in upper bilateral lobes. Treated with 50 mg Benadryl, monitored for 30 minutes which included vital signs. Patient recovered- home with husband. Advised patient to follow up immediately with urgent care or primary care physician.

LADY SAYS WITHIN A HOUR OF VACCINATION SHE EXPERIENCED NUMBNESS IN THE EAR AND PAIN IN HER JAW (TOOTHACHE TYPE PAIN). SHE ALSO HAD THE SORENESS IN THE ARM FOR 3 DAYS. ALL SYMPTOMS HAPPENED ON HER LEFT SIDE (INJECTION SIDE).

Within 5 mins of vaccination the patient reported tingling tongue and mouth. Headache beginning about 11:16 am

Evening of injection, tongue started bothering her with little bumps. Lower inside lower lip had bumps on it. Took Benadryl. During the week Wednesday, left eyelid was swollen, and then before going to bed both were swollen. Seem to have gotten better. Went to the doctor and advised to not take the 2nd vaccine. Has had light headedness and dizziness since the day after the vaccine, still having some symptoms.

Thursday morning at 5:00 started having chills, started running a fever 101 to 102 all day, arm was swollen and real red, shoulder and neck pain, started sneezing, and eyes were watering, had weakness in legs, Friday the fever remained in the 90s. As of today, 01/25/2021 no fever, just arm pain and swelling and red. have taken some Ibuprofen every four hours

The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.

01/21/2021 @ 14:45 staff notified of client in parking lot, waiting her 15 min waiting period, stating her tongue was numb, O2 at 8Lpm/NC started. At 14:57 numbness sensation had resolved. PCP notified, ct referred to ER. Spouse drove ct to ER, assessed by Doctor, only BP monitored, tongue sensation gone, MD told ct he was unsure if reaction was from the vaccine or not, in the ER for 1.5hrs then d/c home. Ct agreed to f/u with PCP to be evaluated to determine if ct should receive dose #2. If t second dose recommended ct will be scheduled to receive at the hospital.

Right side of head..mouth pain with guns, tongue, roof of mouth..eye and ear pain.....following morning with cold sweats and weakness

Patient experienced pain in her mouth that traveled to her head. Onsite EMS was called vitals were taken BP 162/73 98% O2 room air HR 86. Throat Clear, patient did not describs an headache, experienced chills with first Moderna shot.

next day after shot, I experienced blurred vision for most of morning, saw double eyes...the eyes were one over the other and was hard to focus, i used clear eyes to see if it would help, it did somewhat, still at this time, afternoon, it is still hard to focus, but not as bad.

Sore arm and tired after injection. Woke up Feb. 20th at 3:00am with severe headache, face ache, pain in eye socket and teeth, neck ache, left shoulder ache, left arm ache

pt stated that the next day after getting the vax she started feeling foggy so went back to bed. Pt had to take Aleve because she was feeling cruddy and couldn't see straight. Had headache, low fever and body aches. Pt drank some water but it came back up as soon as she drank it. Pt states she feels some better today.

#1 the lot # is very hard to read due to handwriting on card I was given so I hope it is correct. It could also be 012620A Received the vaccine and that night around 10 PM I started having chills and my body started shaking for about 1 1/2 hours. The next morning, I had a dry mouth and vomiting with mucous going down the back of my throat, low grade fever of 99.6F loss of appetite and diarrhea which lasted about 17 hours. My arm hurt and later it started itching. A rash formed around the injection site. I went to Urgent Care. They said I got an infection from the needle and gave me an antibiotic and told me to use a heating pad to stop the itch. i got a blister on my arm which my son used a needle to puncture it and water came out. Nothing helped so I went to my primary doctor, Dr. He said I was highly allergic to the vaccine and gave me a script for Prednisone which I took for 7 days (start high with pills and then reduce amount I think 3 of 10 mg ) he advised me not to take the second shot for the vaccine so I cancelled the appointment as the doctor said it would make me sicker.

received her 1st Moderna vaccine today at the clinic at 1015. She was observed for 15 minutes post injection for any signs of reaction. She left clinic with no signs of symptoms or concerns. She states about half way home on her drive she started to have facial numbness around her mouth, so she decided to come back to the vaccine clinic for evaluation. She did not have any concerns with swallowing, SOB, swelling, itching, or rash. Vitals signs were BP 179/77, pulse 69 and 99% on room air. We discussed her allergies at length, none of concern to vaccinator. Monitored for another 20 minutes with no concerns, stated "it may be a little better." Numbness was still just around her mouth and no where else. Advised her to continue to monitor her symptoms at home and if they got worse she should be seen in the ER. Patient did state she has Benadryl at home and was considering taking one as a precautionary. Writer advised her to contact her PCP regarding her symptoms and to inquire about her 2nd dose. Patient verbalized understanding and agreement with plan, no further questions or concerns. VAERS report completed online.

Sore throat, right ear pain and most severe: shooting pains on right rear portion of head that lasted 20 hours and then all symptoms disappeared.

headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around that time. was found 4 days afterwards by home health aid in bed, with bowel incontinence, disoriented, weak and unable to speak. Pt states also had diminished sight and hearing. pt is diabetic and had elevated blood glucose readings that have persisted almost a month following the vaccine, per pt report

On the 2nd dose, the next day I experienced redness in my left eye. I tried a dry eye lubricant that didn't work. I wen to my optometrist who advised that I had pink eye and gave me an antibiotic

Patient developed stroke-like symptoms (right flashing light/temporary vision loss, word-finding difficulty) 24 hours after completion of Moderna COVID vaccination requiring hospitalization for stroke workup.

After patient received vaccine, ~20 minutes later patient became difficult to arouse. Patient was diaphoretic and drooling, caregiver suspected glucose levels were out of range. Clinic manager called 911, EMS arrived on scene. Blood glucose was checked reading 302. Caregiver noted patient did not eat this morning. After EMS arrived on the scene patient became responsive to everyone. EMS determined no acute concerns.

Had a sore throat & chills second night after receiving vaccine. Today Sunday 1-24-20 woke up with "head cold" like symptoms runny nose, constant sneezing, itchy eyes & sore throat

Received report of resident under 30 minute observation complaining that tongue is swelling, EMS called by long term care facility, this nurse discussed client with caregiver monitoring client who reported client had tongue swelling, face flushed, and that client seemed "affected" client verified it felt like her tongue was swellling, like happened when she had previous allergic reaction to PCN in pas Epinephrine given at 1520 IM right vastus lateralis; EMS arrived and took over care and trasported to ED per hospital records client given diphenhydramine 25 mg capsue and dexamethasone 10 mg tablet, observed three hours after given epi and released back to long term care facility

Day 3 -experienced depth perception issues Day 4- double vision Day 4 - possible stroke, double vision, admitted into hospital and treated stroke protocol Day 6 - released from hospital w double vision and depth perception issues added blood thinners and 3 meds to help prevent future strokes. Met w optimalmologist starting vision therapy. Still waiting to meet w neutrogist

I was talking on the phone and all of the the sudden I couldn't feel my cheekbone and all the way up to the eye socket and my tongue felt like a sponge, and I couldn't breathe very good. So I got my friend to take to me to the ER and they gave me oxygen, and the next my tongue was still swollen and had blisters on it. They recommended scheduling a follow appointment with PCP. They gave me a shot and three prednisone pills to take on a taper.

Vaccine was given on 01-29-2021 at 3 pm.On 02-05-21 patient stated she noticed her vision was blurry at night when she was reading in bed--this happened 3 nights in a row and on 02-08-2021 she said her vision was blurry driving home during daylight. Had Heart palpitations on 02-08-2021 and again on 02-09-2021. On 02-08-2021 she was in shower and noticed her left arm was itching where it had been sore from getting injection and when she looked in the mirror she noticed how swollen and red it was. Stated it was very warm to touch, red and very itchy. PC today on 02-09-2021 to Health Dept requesting advice on what she could do to help it.Had taken some Benadryl the night before.Had attempted ER visit on 02-08-2021 but was there x 3- 4 hrs and was never seen so she left.

Lips felt puffy; Patient was observed and given 50 mg Benadryl; Patient left with husband after observation for another 50 minutes, saying she felt fine

my mother developed a rash on chest, back, face with facial swelling, lip swelling and tongue swelling 10 days after second vaccination. Placed on steroids and prescription antihistamines. not sure if related to vaccine but no other change or administration of anything else.

Back and head arched back. eyes Rolled back arms flexed and extended lasting 1minute. Pt recovered on her own walked her own into building. Family reported episode occurred 45 min to 1 hr after receiving . vaccine

day after vaccine, pt woke w/ a swollen upper lip that lasted a couple of days after that had swelling and redness at the injection site.

overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg weakness, nausea, dizziness, mouth ulcers outbreak, face flushing , this happened during the week following the Monday vaccination...?.still have some mouth sores and face flushing

Reports to PCP on 2/12/21 that she has been having fatigue and "ringing in ears" (tinnitus) which started 1 day after her vaccination on 2/4/21. Pt was seen in-clinic at urgent care on 2/13/21. Ear exam was normal. Pt was referred for audiology exam and then follow-up with ENT for referral.

Pt received Moderna vaccine and had a severe allerigic reaction and swelling of the lips. had to give epi pen

Patient waited in parking lot 15-20 minutes . She noted a headache when she got home. About 3 pm she developed tingling in her face and lips (lasted 3-4 hours), increased heartrate (lasted about 3 hours), increased blood pressure (for about 2 hours), The next day she noted dizziness and weakness, lower extremity redness (redness lasted about 3 days).

Received vaccine on Feb 25. One Feb 28 started feeling like coming down with cold with runny nose and by evening mouth was beginning to feel strange. Monday through Wed with sores on lips, gums, tongue. roof of mouth. Sores were red inside and not raised on lips sores were blister like, raised and sore. Sore on tongue also blister like. All sores were painful. Had difficulty eating especially sour things. Gums were very sore. Today, is feeling a little better. Issue not yet resolved. Tried salt water mouth rinse with fair results to decrease pain. Used OTC meds for pain relief.

Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg. The patient's medical history included cellulitis in left leg. No concomitant medications were reported. On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not. Patient did not take anything to treat symptoms but contacted her doctor and pharmacist. The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine. Seriousness criteria for the event of swelling and edema was medically important. Action taken with mRNA-1273 was unknown. The outcome for all the events was considered as recovered/resolved. No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.

Hearing loss in left ear (complete loss). Right ear hearing is diminished. This was confirmed by two hearing tests. Not gradual but sudden onset. Was told it is permanent.

I had no adverse effects. I did notice in the months after the shots that my tinnitus had increased ten-fold. I didn't associate this with the shot until I heard it mentioned on TV show.

An avid crossword puzzle worker for 50 yrs, suddenly doesn't work them anymore. Short-term memory is worse than before. Left side of the mouth droops. Weight loss. Confused. Complained about leg weakness, legs and knees hurt, hard to walk, being tired, drooling, dry mouth, mind not right.

The following morning patient awoke and said she felt very tired and was complaining of severe stomach gas and bloating. She did not have an appetite and just wanted to sleep and or lay down. The following day she complained that she had a canker sore in her mouth and a headache, still extremely fatigued. The stomach discomfort stayed with her for about a week and seems to have subsided.

Several days following 2nd Covid vaccine, patient began experiencing visual changes including seeing "sparkles", black spots, loss of color and blurriness. 8 days following the vaccine, patient lost vision in left eye and was taken to the ER and diagnosed with vasculitis. Large doses of Prednisone were administered as a means of protecting the other eye from loss of vision. A biopsy determined that the diagnosis was small cell vasculitis. Patient was in hospital for one week and returned home. Patient was under the care of specialists but becoming weaker. Approximately 6 weeks later, patient could no longer bear her own weight and was re-admitted to the hospital where additional tests were run. Medical staff were unclear what was causing the decline and patient passed away while still under their care.

Patient reports tingling in the tip of her tongue since getting the vaccine (for the past 3 days). She also reported extreme fatigue once she got home (felt fine at the pharmacy during the observation period). She also states she was so fatigued she didn't remember driving home and had to crawl from her front door to her bed and that she was in bed fatigued for 2 days. She has recovered from the fatigue but is still experiencing tingling in the tip of her tongue, which she hasn't experienced before receiving the vaccine.

VACCINE GIVEN AT APPROXIMATELY 12:40. AFTER 15 MINUTE MONITORING PERIOD, PATIENT WAS ASKED BY MONITOR IF SHE WAS FEELING OKAY. PATIENT REPORTS SHE DOES NOT FEEL THE SAME AS BEFORE THE VACCINE. MONITOR STATES PATIENT WAS SHAKING AND HAD NOT PLACED ARM BACK IN SLEEVE FROM INJECTION 15 MINUTES PRIOR. MONITOR IMMEDIATELY GETS NURSE TO ASSESS PATIENT. AT 1257 BLOOD PRESSURE IS 122/62 AND HEART RATE IS 62. PATIENT REPORTS TO NURSE THAT HER HEAD FEELS FULL AND HER EYES ARE HEAVY. DENIES ANY OTHER SIGNS OR SYMPTOMS. PATIENT STATES SHE IS READY TO LEAVE. NURSES ADVISE PATIENT RECOMMENDATIONS TO BE EVALUATED BY EMS. PATIENT REFUSES STATING SHE WILL NOT WAIT. SHE STATES SHE IS READY TO GO HOME AND IF SHE FEELS BAD WHILE DRIVING SHE WILL PULL OVER. RISKS OF LEAVING AGAIN DISCUSSED WITH PATIENT. SHE ONCE AGAIN REFUSES TO WAIT ANY LONGER AND LEAVES.

Had the vaccine, and was fine and had problems after the first vaccine as well, which he prescribed benadryl and a Benadryl cream. He then called her back in a couple of days and she told him that she was fine. She saw the nurse at the facility who told her to call the eye doctor after the first vaccine, and this is exactly the same as the first vaccine. Her eye doctor had started her on a 2nd glaucoma drop Ropressor, and then with the reaction told her to stop taking it. Her eye is worse today than it was yesterday, and has been using cold packs which feel good to her eye. Was also running a fever of 99.9 and felt achy.

Lips tingling and swelling - same day as vaccine. Also developed a sore underneath the lip Also, slight swelling om side of head (above ear - along hairline) and a small bump, and cheeks slightly swollen. No pain, no nausea. Felt fine otherwise On Monday, red blotch under 1 eye. Lip swelling is reduced. On Tuesday. Redness under 2nd eye slight rash Feeling fine otherwise.

10-15 minutes after vaccination patient complained of dizziness, blurred vision, and shortness of breath. Patient states she felt slightly short of breath walking into the clinic prior to vaccination but did not mention symptoms to staff. Patient was evaluated by clinic medical director and EMS staff. No objective signs of local or systemic reaction, only patient's subjective statements. Patient was transported to Hospital for further evaluation.

At 30 minutes post vaccination, patient felt dizzy; tingling of tongue and lips. Doctor observing patient, assessed VS. 12:10pm - BP 145/74, HR 75, O2 sat 98%. 12:27pm - BP 120/68, HR 67, O2 sat 99%. Patient discharged. Home at 12:29.

pt stated that about 2 days after getting the covid vax her upper left arm was sore and she developed a dry cough. She lost her voice since her throat was hoarse. She had alot of mucus and nasal congestion. On 1/29/2021 pt stated she was very very weak and could hardly function. On 2/1/2021 she was worse and started running 101 temperature. She contacted her PCP where he recommended for her not to take her 2nd covid vax dose but did not give her any medical advice. She is still having periods of weakness at this time.

Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.

1323 Pt c/o tingling of lips. No SOB. HR-60. Pt given benadryl 50mg PO. Pt reported feeling better and left at 1338

30 hours later , profound sensorineural hearing loss in right ear. Treated by steroid, hearing returned in one week . Black tarry stools INR increased from 2 to 12 ER visit , admitted to hospital on March 23. TIAs

After 1st dose Moderna developed sores in her mouth - blisters that formed and broke. She took the 2nd dose Moderna 3/19/2021. The blisters continued to form and break. One lesion was large, approx the size of a dime, and filled with blood. She saw her physician 4/6/2021 and received a prescription for Prednisone.

Temporary loss of vision in left eye for about 1 min (called Amaurosis Fugax) . Afterwards enhanced dryness of both eyes with feeling of solids at both ends of eye but is getting better with 5 min heat pad over eyes and using eye wetting solutions about 4 times a day. Dryness getting better each day. These effects 4 days after Moderna Vaccine first dose.

Right side hearing loss; Dizziness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Right side hearing loss) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DEAFNESS (Right side hearing loss) (seriousness criterion medically significant), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DEAFNESS (Right side hearing loss), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Magnetic resonance imaging: normal (normal) normal. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information 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.

Became very dizzy with loss of balance. Sight in left eye became very blurry. Significant difficulty walking. Significant cognitive impairment including loss of memory and not understanding what was being said to her. Fell over and broke her left arm that required surgery.

blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) 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 previous medical history was provided). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Optic neRve Swelling in Right eye causing Loss of sight, 20-30 minutes after 2nd CoviD Vaccine . Damage is PeRmanont due to Lack of Blood Flow

Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Ringing in ear, dizzy, loud ringing. Have gotten MRI, saw specialist ear nose and throat, cardiologist

Hemmoragic Stroke. Began with vision difficulty in the morning. Then I noticed she had left sided neglect. Went to ER. Treated with Andresxa (to counteract Elaquis). In SICU for 2 nights then telemetry unit for 3 nights. CUrrently in Rehab.

Resident undergoing wound care. Vaccine given and approximately 5 minutes after administration, this resident noted to have rapid jerking eye movement determined to be seizure activity. After the seizure, resident stabilized. Resident was asked if she was feeling ok and she nodded her head yes in agreement. Resident has a history of seizures and is being treated with Dilantin and Keppra.

localized cheek and tongue swelling, with some itching at same location, which began approx 10-12 after IM injectgion

after 15 minute observation, pt complained of dizziness upon standing, shorty after c/o of shortness of breath, chest tightness, heavinees to tongue.

All symptom occurred on the right side. Same side where the vaccine was given. Mouth drooping, eye tearing and won't close, paralyses of the right side of the face in general

Patient called and stated day after receiving her second dose of Moderna she began to have generalized edema BLE, BUE, and swelling around joints, she states her vision doesn't seem the same, slightly blurry, but she can see, states hard to describe. States she had a fever 101. on day after and took Tylenol - fever resolved. Other symptoms continue.

PATIENT REPORTED TO PHARMACY WITH DROOPINESS OF RIGHT EYE ON 3-12-21 AND WAS TOLD TO PURCHASE OTC EYE DROPS FOR IT. THE NEXT DAY (3-13-21) SHE CAME TO PHARMACY WEARING EYE PATCH ON RIGHT EYE. SHE SAID SHE WENT TO HOSPITAL ON 3-12-21 AND WAS TOLD DIAGNOSED WITH BELLS PALSY, NO PREVIOUS HISTORY.

She got the vaccine, everything was fine, they warned her about being sick. She did not have any reaction at all until she woke up 13 days later on 3/5/2021 and her left eye was blind. She had some sort of blob that changes colors and moves around. It sometimes is orange. She knew she did not have macular degeneration as it centers it. Sometimes it sparkles and has grain to it. He said that she had an arterial blood, and that leaked from the carotid artery into the eye has not completely sealed off. She can see out of the right eye perfectly, but she cannot see a little out of the left eye. If she's watching the TV she can see the top of the newscasters hair, but she cannot see anything below that. Her vision is upward either, can see out of either side, but cannot below horizontal down. He told her that it was basically a stroke that didn't reach her brain and went to her eye. He told her to return to see him (ophthalmologist) on 5/18/21 at 10:00 AM. She also is to see her PCP on 5/20/21.

My lips became chapped and I had a sore on my upper lip almost on its center and a sore just below my lower lip, again almost in its center. Both sores are healed now. But I have cracked lips like a drool at both edges of my lips and down my face. And my lips continue to be mildly chapped at their edges. I keep them covered with a lip repair salve.

Pain in eyes; Lips was swollen; Itchy; Burning; all around her cheeks and near the nose was in pain; Like a rash; Mouth went to one side of her face; Left side of her face get swollen; 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful; Big and red spot in the upper part of her face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL ASYMMETRY (Mouth went to one side of her face) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high (Takes medications for high blood pressure.). Concomitant products included INSULIN for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FACIAL ASYMMETRY (Mouth went to one side of her face) (seriousness criterion medically significant), SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash). 02-Apr-2021, the patient experienced ERYTHEMA (Big and red spot in the upper part of her face). On 06-Apr-2021, the patient experienced EYE PAIN (Pain in eyes). At the time of the report, FACIAL ASYMMETRY (Mouth went to one side of her face) and ERYTHEMA (Big and red spot in the upper part of her face) was resolving and SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), EYE PAIN (Pain in eyes), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash) outcome was unknown. Treatment: Hydrocortisone and Antihistamine Concomitant: A couple of High blood pressure medication Additional information:Immediately after receiving the vaccine (she thinks) the L side of her face get swollen. Her lips was swollen, all around her cheeks and near the nose was in pain. And developed 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful. She also developed a big and red spot in the upper part of her face. Still there but is getting better (seem is going away). Her mouth went to one side of her face, to the R side. It still there but is getting better (tomorrow is going to be a week). Also, 4 days after the 2nd dose her eyes started to hurting and couldn't put drops. She never had fever, cough, chills or nausea. 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.

Loss of hearing four hours after receiving the vaccine (second dose). Developed ringing in the ears. Left ear hearing loss. April 21 hearing evaluation showed approximately 30 dB hearing loss at 2,000 and 3,000 in the left ear only. Right ear hearing is similar to prior to the vaccination.

VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after receiving COVID-19 vaccine. Seen resident immediately in apartment around 1310 accompanied by CM sitting in chair. Alert and oriented to person, place, time, and situation. Verbal and able to make needs known. Speech clear and coherent. No slurred speech or facial drooping noted. Resident received the 1st dose of Moderna COVID-19 vaccine around 1200. She was observed for 30 min by ARR staff immediately after vaccine was administered. She then went to grab coffee and went to her apartment. She did not yet eat lunch. Resident c/o feeling "woozy" and eyes feeling heavy/"uncomfortable". Continued from above: Resident has a history of anaphylaxis and several allergies. Called EMS around 1320. While waiting for EMS rechecked BP several times with SBP between 200-215. She denies any SOB, numbness, tingling, or indigestion. SpO2: 97-98%RA. Resident then stated she has slight tightness/discomfort to her left chest. EMS arrived and left ARR at 1414 and sent to Medical Center.

At 9am on 1/14/21, Patient was unable to speak and unable to move her arms. After an undetermined period of time (likely less than 5 minutes), she was able to call me (her daughter). She could hardly move her mouth but she was able to tell me that she needed help. I arrived about 20 minutes later. She had full movement at that time and was able to speak. Her BP was 140/73, HR 60. She was tired but scared to go to sleep around 5pm so we went to the local ER. Her labs, EKG, and MRI were all normal for her age. Today (1/15/21) at 10:30am, she experience the same thing but only in her face. She was able to move her arms but not able to talk. I was with her and could tell that she was fully conscious and aware, just couldn't move. It happened again but not as severely after she ate lunch around 12pm.

called the clinic the day after the vaccine to report her lips and tongue had felt tingly and that she is OK now. She declined to come in to be seen. Her daughter, also called, later, to report that lip and tongue swelling. denies ever having any trouble breathing or any other reaction. This was added to her Electronic medical record and documented .

Patient complained of a tingling in her tongue. Has a history of allergic reactions to other medications and foods. Vital signs taken and remained stable throughout time. Patient was given Benadryl 25 mg po at 12:45 and states relief. Stated that symptoms were lessening/improving. Patient was discharged with daughter to be driven home in personal vehicle.

Paralysis swelling. Seizure, lost eye sight, partial speech ! And is bed riding and loss of balance

Stroke in left occipital lobe Feb 1 & Feb 2 Right peripheral vision effected in both eyes 2 heart stops on Feb 10, 2021 Pacemaker implanted after heart stops

Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel like I could pass out? and then passing out. Slight movement of mouth for air, some drooling.

Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm to elbow, severe word finding deficit. Word finding problems subsided in 90 minutes. Arm swollen for 2 weeks. Headache lasted one day. Fever blisters lasted 2 weeks.

Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, and blurred vision. She was taken to the ER, but refused a CT scan. She was given a saline bolus. As of 03/19/21 her vision is still blurred and she is more disoriented than her baseline.

Patient had a COVID vaccine on 3/12/21, this was her Second dose of Mederna vaccine. She states she had a scrap on her right elbow 4 hours after she states it turned red and swelled up. She then scrapped her left pointer finger and that swelled and turned red and going up just past her wrist. She states these are really improving but the swelling and itching around her left eye is getting worse. She feels her nose feels swollen. She states her eye is matted shut in the AM. She feels fatigued.

lip swelling, denies any SOB or difficulty swallowing. Adverse reaction treated with Benadryl 25mg IM with improvement within 30 minutes . Disposition Home with VS stable.

This was the 2nd Moderna Shot on 2-18-2021. She received the first shot on 1-22-2021. Patient verbally reported to me that about 4 hours after the shot, she began experiencing severe shocks all over her face and into her left neck and chest area. This quickly worsened to include her left arm. That all resolved after a nap. But when she woke up, and went to the mirror, she noted that her left face was slow and drooping. She went to the ER. It was noted that she was having a severe problem with swallowing. She also was noting severe pain in left external ear canal. She had obvious severe breakout in the left ear canal - and the immediate area. She was sent home - and came to my office the next day. By that time, the symptoms had become much much worse. She was unable to swallow. The outbreak in the left ear was much more pronounced. And her entire left face and left tongue were paralyzed. She was diagnosed with the Ramsay-Hunt Syndrome - she was unable to talk or swallow. She was readmitted back into the hospital.

While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck, down back, around to chest. Became very SOB. Called 911. Ambulance took me to hospital ER then ICU. Developed exquisite headache. Given pain meds and slept. Dr saw me the next morning. I had not had a heart attack. They had no DX. I think I had a 23 day delayed reaction to shot #2.