Moderna

Awoke with nausea and myalgias. Nausea and myalgias progressed. Fever and chills within a few hours. Very weak and fatigued. Myalgias became severe. Severe rigors and fever >102 about 26 hours post vaccine. Fever, myalgias, anorexia, nausea lasted approximately 30 hours. I felt like I had COVID all over again (I had it in July).

Sore arm, fatigue,chills ,nauseousness ,vomiting on 12/292020 . Chills ,nausea, vomiting started around 6 pm

Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm

Headache, Myalgia, Arthralgia, Fever, injection site pain/redness/swelling, chills, fatigue, night sweats Narrative: Employee reports experiencing fever, chills, night sweats, headaches, joint and muscle aches, fatigue, and injection site pain/swelling/redness. Reports all symptoms have resolved.

Sore arm for 36 hours. Onset within an hour after recieving the vaccination, Slight malaze for 24 hours. Onset the next morning post vaccination.

Vagal response--lightheaded, nausea, queasy, cold sweats, felt like I might pass out--lasted about 10-15 minutes and then

Approximately 5 minutes after recieving the Moderna COVID vaccine #1 at 7:55am, he said he felt "clammy, warm inside". He was placed on VS monitor, BP 157/110, HR 72, O2sat 100%. He sts. hx of Hypertension and took his medication about 2 hours ago. He was monitored for 40 minutes. He stated he was feeling better. BP 144/96, HR 68, O2sat 97%. He remained awake and alert throughout. He left vaccine clinic ambulatory with steady gait.

After monitoring patient for 15 mins he then returned to his office. Called around 30 mins or so later and stated he was experiencing itching all over body and extreme nausea. Employee health went to office to check on patient. Face did appear flushed, but no rash seen. Stayed with patient until he stated he felt better and no further issues.

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

Began to feel ill ( stomach pain / Headache ) .. my skin became flushed ( face was very red ) blood pressure was elevated ( 180/90) I normally have low BP.

1. Incontrollable Shaking of body and limbs-- for 2 days, 2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days

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

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

Covid Moderna administered 12/23/20, 2 PM 15 min later, tingling lower left face. Numbness inc 1-2 hrs, tingling down to left arm (IM site). Resolved in 2 days

DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for 2/5/2021 at 7:15am

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

Felt like a wasp sting at injection, very euphoric 8 minutes later and began the sweats, face is flushed and full feeling and medium headache

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

Chills, muscle ache, nausea, headache 1/21/21 took tylenol at 3:30am and again at noon. Most symptoms went away by morning. General muscle ache continued through out the day. Morning of 1/22/20, all symptoms gone except for a little ache in right arm.

Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise. Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained. Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours. Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms. I often work through illnesses like the flu. Couldn?t work through this.

Moderna COVID-19 Vaccine EUA Had chills during night. Took Naproxen with some relief. 12N had uncontrolted shaking and chills and malaise, unable to handle mouse to do work. No redness, swelling or irritation of injection site. Extremely tired.

C/0 feeling "hot flashes" an hour after vaccination given. As the evening progressed C/O joint aches, HA, low grade temp (99.8 F at 6 p.m., muscle cramps and restlessness during the night (2 a.m.) and feeling of "electrical shocks" in his muscles. 1/27/21- C/O joint pain HA and muscle cramps-took gabapentin and Tylenol and feeling better. 1/28/21 Able to work, feeling better, but not 100% yet.

After second Moderna shot, Pt developed nausea, headache, extreme fatique, and bad back and leg cramps/spasms to the point where he couldn't walk. These symptoms lasted for 48 hours and gradually subsided. His wife (me) was so frightened that I will not be getting the Moderna series since it's so dangerous and will caution friends and family as well.

The following day 1/29/2021, I started with chills and then later night sweats. I also had headaches. Saturday1/30/2021, I had muscle pain and joint pain throughout my body most notably in my right knee and right hip. Today, Monday 2/1/2021, my rib cage is sore with muscle pain.

body flushing, fatigue, and itchiness of his right arm accompanied by intense over his entire left arm. Patient felt his body getting overheated

I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 hours afterwards) with severe chills, shoulder, knees & most joints aching badly, bones in both feet aching with any movements, both arms sore along with severe stomach cramps & nausea, these all lasted through the night and day with a fever of 101 at 7am but by 4pm all but the stomach cramps were replaced by just nausea but severe headache and weakness all over were felt. I remained in bed until about 4pm 2/5/21 & soaked in a hot bath which relieved the joint pains. Headache, nausea & weakness continued 2/6/2021 & 2/7/2021 with the headaches coming if any sudden movements such as coughing or standing up too fast & nausea irritated by eating anything but saltine crackers. Today is 2/7/2021, took sick days from work 2/5, 2/6 & 2/7.

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

Aches, chills, typical flu type symptoms, Fever to 102 F. Lasted till about midnight. Fever broke and felt fine afterwards. Also had pain in arm on both shots. Worse the first night then less each day for about 3 days.

Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint pain, fatigue, mild cough, temperature elevated but not high, about 99 degrees. Symptoms varied over about 24 hours then subsided. Injection was Friday morning, Friday night not much sleep due to symptoms, all day Saturday in bed, slept well Saturday night, and Sunday fatigue and achiness only.

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

Temperature of 100.6 with chills, fatigue and sore arm; Adverse reactions have gone away by 9:00 am Friday, Feb 12, 2021

Since 12 Feb to present I have had aching bones and joints alone constant fatigue and general weakness in my left arm.

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

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

Patient had a Seizures Without Status Epilepticus after the vaccine. Onsite EMS was called vitals were taken BP 164/100 BG 154 HR 93. Patient Treated and Transported by the EMS to the hospital.

On 2/6/21, I noticed that my right arm had a large patch of erythema 10cm by 8cm that was hot to touch and tender. The patch was slow to resolve but is mostly resolved today 2/18/2021.

Right after the injection, I felt an electric shock feeling in my hand. This was followed by right hand numbness and tingling in the entire hand. This symptoms of numbness and tingling decreased in severity, but now has been stable: every day, I am experiencing numbness of the right hand, extending from my wrist and involving my palm and my pinky and ring finger. The feeling is not decreased by Tylenol.

The patient was given his vaccine at 11:40am and a few minutes later 11:43am he said he was feeling very flushed and off. He said this extremities (hands and feet) felt hot and blotchy which is not normal for him (he does have neuropathy). He was sitting down for a couple minutes and I gave him water to drink just to calm down if it had been anxiety, but it did not seem to help. He started to complain of his heart pounding and beating rapidly. He said he was sweating and just felt very strange. I asked if he was short of breath at all which he denied. I immediately called 911 to have him be checked out and make sure he was ok since his symptoms had been going on for a few minutes, he was still complaining, and was not resolved with sitting or drinking a cold water. The patient did state that he had not eaten yet today (he does intermittent fasting and normally does not eat until 2pm), he did not take his blood pressure medication atenolol, and had driven about an hour here with his mother as she also got the vaccine today. While waiting for the ambulance I took his blood pressure which was very high 187/95mmHg which the patient confirmed is high for him. The ambulance arrived within 10 minutes and they checked him out. He did decline to go to the hospital after a thorough evaluation. The patient left once the paramedics cleared him at about 12:35pm so he was sitting and being monitored for a good 45 minutes before he left the store. The patient was never given any meds during this process and was cleared to go home by paramedics.

At 0600 on 23 Feb I woke up with a temp of 101.9 (normally, I am at 97.4) headache, stuffy head, body ache and a sore arm at the injection site. I had elevated temperatures for the next 24 hours. Headaches also lasted 24 hours. Also, this was accompanied by fatigue. Even the slightest exertion winded me.

Patient began feeling tingling sensation and tightness in chest. Denies difficulty swallowing, swollen tongue, or shortness of breath. States he feels like heart is racing. Lungs auscultated and BBS clear. EMT in attendance. Patient declines w/c to private observation area. Patient called wife to come into vaccine building (she is outside in car). 1630: HR 113; O2 sat 99% 1632: Patient having vigorous tremors. Fingers cold to touch. Gave Benadryl liquid 20 mL/50 mg PO. Patient declines ambulance transport. Patient wants to go home with wife. BP 158/98. 1635 wife in attendance. Wife states he will not want to go via ambulance. Strongly recommended that patient transports via ambulance. Recommended that patient go to urgent care clinic or ED for further evaluation. Wife went to bring car to exit area. 1640: O2 99%, HR: 105; no shortness of breath noted. Patient remains alert and oriented, still having tremors. 1645: convinced patient to go outside in w/c for fresh air. Patient agreed and taken to private observation area out back door. Patient removed mask and patient encouraged to deep breath. Upper body shaking continues. Hands remain very cold. 1650: patient's wife returned. Wife states she will take him to an urgent care area. She states she also has an epi pen if he worsens. She states if he improves she will take him home and monitor him. Patient declined w/c transport to private vehicle. 1655: patient left ambulatory with wife, no shortness of breath. Continues to shake.

102.4 fever, body aches from the back of my neck to the back of my ankles, fatigue, throbbing migraine, no appetite

after vaccination, patient felt dizzy. seated patient who stated "im dizzy" patient stated he only had milk in am which is his usual routine. patient also stated he felt weak. patient given cup of water to drink. patient observed for 30 minutes and patient felt better. was observed while standing with no dizziness ad weakness verbalized by patient. instructed to return to his home and rest, eat, drink liquids; also if any further reactions patient to call 911. patient verbalized understanding and left clinic ambulatory with no complaints

Pt received his 2nd Covid vaccine. After waiting for 15 mins pt stated that he felt very weak. Pt was seen by FNP. She listened to the pt's heart. She asked for his blood pressure and blood sugar to be checked. She also asked for him to wait an additional 15 mins. After wait time was over pt stated that he felt well enough to leave. He still had weakness but stated it wasn't worse.

less than 12 hours my whole right side went limp, i woke up to get ready for work the day after the shot and my whole right side was limp and numb, as i was trying to get dressed the use of my arm and leg came back around slowly, the whole right side was tingley all day. and it made me sick

Day after getting injection, my right side (leg, foot, hand, arm) went numb (feeling asleep). After a week, the symptoms are still the same. My feet were already numb from type 2 diabetes and MS, now the right side is numb.

Right elbow redness soreness burning , right kneecap burning Pimples on left shoulder and neck area very itchy right and left wrist area pimples and itchy FYI Elbow and wrist pimples had 2 small holes on each sore that almost looked like I was bitten by something but I wasnt. Dermatologist stated to apply Mometasone Furoate Ointment USP,0.1% which helped with the burning and itching.

Heart palpitations; shortness of breath; dizziness; hands shaken. Events lasted about 3 minutes. Then disappeared. They checked my blood pressure and it was elevated 155/110. High blood pressure remained for 2 days.

Patient had generalized weakness event, similar to MS exacerbation. It lasted approximately 24 hours, rapid recovery after overnight admission to the hospital.

Patient had vaccine and waited the 15 minute waiting period. He felt well after 15 minutes and left the observation waiting area. He went up front to purchase something 5 minutes later and collapsed face first on the floor as observed by a nearby customer. The customer said he started having convulsing seizures and the customer went to aid in keeping the patient safe. the pharmacy manager (myself) was alerted and I immediately ran upfront to the patient with the emergency bag. 911 was already on the cashiers phone. They dispatched an ambulance. The only treatment was keeping the patient on his side and safe. He was having some labored breathing initially which quickly calmed down. The EMT arrived and they called his Dr office off the VAR. They said he had some hx of seizure. He had selected no to question #6 on VAR (Have you had History of seizure for which you are on medication for). He became conscious before transport to the hospital. The EMT stated that he seemed to be covering as expected from seizure. He was then transported to Hospital Center.

Sore arm. Headache. Dizzy 7pm same night. Didn't sleep well. Achy especially in knees and back. 3/7 am slight fever 100. Headache all day. Still sore arm. Body ache, no appetite.

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

Uncontrollable shaking as from chills, fever up to 101.6 (possibly was higher before checking), fatigue, no interest in food or drink. Symptoms came on quickly, and subsided in 8-9 hours. (Almost exactly 24 hours after the shot.)

Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the area of the heart. Went to ER and was given EKG, Chest X-Ray, and blood tests to check for heart attack. Symptoms subsided after a bit. Labs were inconclusive. Sent home. Continued to have lingering aching in the heart region the next day. Throughout the weekend, continued to experience alternating sweats and chills, nausea and increased pain in hip joints causing difficulty to walk. Stayed home from work on Monday, March 8, 2021 with the same symptoms continuing. Tuesday, March 9, 2021 began experiencing excruciating thigh and knee pain to the point of barely being able to stand or walk. Returned to the ER where they administered Torodol and pain subsided. Will be seeing primary care physician Tuesday afternoon.

Vomiting, diarrhea, shaking, difficulty breathing, OSat down to 90, whole body sensitive to touch, pain in left arm

pt states that his arm was sore that day of the vax but when he woke up he had body aches and pain, fever and massive headache. Pt is taking Advil. Pt has contacted his PCP regarding his symptoms and is waiting for a CB.

I read today of "covid arm," as described in an article about a symptom that may arise for those who got the Moderna vaccine. I simply wish to share my reaction for the sake of the statistics. The evening after I took the first shot of the vaccine I had a hard red bump on my arm near the injection site. My arm ached that night, and was notably better already in the morning, without aches the following day. The blister was gone the next day. I'm relatively healthy, trail run and get strenuous exercise usually twice a week.

3/2 early afternoon after vaccine #2 experienced weakness, chills, and body temperature fluctuations for about 1 1/2 hours . Resolved af 1 1/2 hours.

Moderna COVID-19 Vaccine EUA About 5 or 6 hours after the vaccine was given I developed inflamed toes on both feet. Puffy and red. itchy and slight burning. Three days later still have the symptoms.

Patient reports feeling lightheaded, dizzy. Passed out a couple times. Presents sweating, flushing, and clammy skin. Patient reports having veso vagal previously. EMs preformed EKG and results were normal. Refused EMS transport

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

Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats

Body Aches and Neck Tenderness starting 2/18/21 and currently continuing through today (3/12/21). Diagnosed with thyroiditis on 3/9/2021

At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.

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

Extreme fatigue followed by muscle aches, mostly in upper thighs and knees, headache and fever reaching 102 Began at approximately 15:00 on 3/9/21 lasting approximately 12 hours. No adverse effects since

Starting the morning after shot when I got up at 4.00am I was having reactions to the shot. Hot, Cold, Headache , muscle pain, tired, nausea, loss of appetite like a bad case of flu. also which has been the biggest most unexpected side effect is that my left testicle was swollen and painful. All my flu like systems continued as well thru Wednesday 03/10/2021. started feeling some better except for being tired and the swelling and pain in testicle. Thursday morning went to Urgent Care, did examination with urinalysis and thought possible infection. Recommended ultrasound and prescribed Doxycycline HYC 100MG, also Ibuprofen 800mg.

I received my 1st COVID vaccination at about 10:30am on Monday, March 8th, 2021. I engage in rigorous aerobic exercise regularly, including swimming. On the day of my 1st vaccination I did not exercise that day. About 24 hours later, late morning March 9th, I was at the pool for a workout that lasted about 90 minutes. Usually in the pool I may experience a bit of lower leg cramping, if any. But during this swim I experienced a considerable amount of lower leg cramping. After my March 9th swim I was not in the pool again until three days later on March 12th. During that swim I experienced absolutely NO leg cramps. I can?t say if the cramping 24 hours after my 1st vaccination was caused by it, or if it was simply coincidental.

In right arm (injection arm) slight neuropathy extending to by fingers. Side effect started day of injection. Side effect still evident as of time date of this report (March 15, 2021).

Approximately after 45 mins of giving the vaccine, he started to feel numbness on the right side of the face. Including the temple, part of the eye and right cheek. 4 days have passed and at the moment he still has that same symptoms. The Clinic cannot treat him, they told him to go to the Emergency Room.

3/4/21 out of breath , peaked 3/08/21. 3/09 pain in right lower leg Hospitalized 4 days - 5 hour procedure for Acute DVT and Acute Saddle pulmonary Embolus

Fever/ Chills/ Pain in my whole body/ Sicker than I was ever before in my life. Lose of Memory. Head Aches/ Leg pain that wasn't there before vaccination.

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

pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection

Before administration patient was given handout regarding Moderna information and read through handout patient denied any previous adverse reactions to vaccines and consent was signed. Patient received vaccine at 1407. Around 5 minutes after administration the nurse was notified that patient was "not ok". RN quickly assessed patient and called for help. At first assessment, patient was having involuntary movements and delayed verbal response to questions. Shortly after he began labored breathing and became unresponsive. He continued having involuntary movements in bilateral upper extremities. He did not respond to sternal rub. At that time EMS was called. BP was 50/32 in right arm with HR of 52 and O2 saturation of 93% on room air. EMS arrived to the clinic approximately 5-6 min after patient began having adverse reaction. EMS took over care at that time. He was then transferred to ED by ambulance for further evaluation.

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

On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine. Afterward, the patient experienced no adverse side effects. About 48 hours later, however, at 2pm on March 18th, the patient's spouse attempted to wake him from a nap. The patient seemed much groggier than normal and his expression appeared vacant. When pressed by his spouse, the patient could not say who he was, or who his wife was. He agreed to travel with his wife to the hospital. At the hospital, a healthcare professional asked the patient who he was. He answered with his correct name. He also correctly identified his spouse by name. But when asked where he was, the patient gave a long and incoherent response. After this initial screening, doctors at the hospital evaluated the patient for a stroke. They ruled this out as a possibility. Next, they suspected the patient's MS lesions may have contributed to his "cognitive event." However, after comparing his 2018 scan to a current scan, they determined this was unlikely the cause. After about 24 hours at the hospital, a neurologist hypothesized that the patient had experienced a seizure. Another doctor at the facility concurred with this assessment. By late Friday (more than 24 hours after the episode), the patient had regained most of their cognitive functioning, though he still experienced mild confusion around the week's events (even preceding the "cognitive event"). Prior to now, the patient has never had a seizure before.

Patient complains of left neck muscular soreness minutes after vaccination. Denies chest pain/pressure, shortness of breath, lip/tongue swelling, dizziness. On physical exam, has mild muscle spasm at left sternocleidomastoid muscle, normal neck ROM, normal cardiac & pulmonay exam, vitals stable. ECG earlier this AM w/o ischemic changed. Advised rehydration & topical/OTC treatments of muscle soreness. Labs ordered to eval for cramping. Symptoms improved by 30 min.

This may be purely coincidence, but the reaction was so severe, I thought you should have the puzzle piece. On March 23 I donated blood. Within 30 minutes I had a fever of 100.9, was extremely weak and sleepy, had the worst sore throat and radiating down in my memory. It was difficult to even speak. I have donated blood in decades and never had an adverse event.

Arm sore for a week Hurt into chest Felt extremely fatigued for about 5 days. Ran fever over 100 for 2 days. Felt fine after 5 days.

Patient woke up in middle of night the following day after the vaccination with shaking, muscle weakness, dizziness, severe muscle soreness, and inability to walk. Patient went to emergency room to rule out more serious complications. All tests came out normal and was told the symptoms were a reaction to the vaccine. The symptoms continued for 2 days, but eased up with time. Patient was feeling normal 5 to 6 days after administration.

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

Bad chills and started shaking for 10 minutes along with a fever 101 and very tired with headache. I'm still tired on day 2.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: IRREGULAR HEART BEATS. PATIENT REFUSED TO HAVE US CALL PARAMEDICS. WIFE IS TAKING HIM HOME. WE DID SUGGEST FOR HIM TO GO TO THE HOSPITAL AND PROVIDED THE ADDRESS OF THE CLOSEST HOSPITAL BUT PATIENT REFUSED.

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

1. Fever ~101 for 48 hours, dropping to 99.5 next 24 hours 2. Very achy muscles for ~48 hours, slight to moderate achy next 24 hours. 3. Very fatigued 36 hours, gradual improvement for next 32 hours. 4. Painful skin on both arms and hands for ~36 hours. 5. Swollen lower right leg and ankle for 24 hours. 6. Water retention for 12 hours. Treated self with Tylenol initial 12 hours then Advil afterwards.

Patient is complaining of profound fatigue for the past five (5) days since his vaccination, He states that he has been unable to leave his bed since he got is shot. Also reports , left arm pain (vaccination site). stiffness. Today he is ambulating with a walker (typically uses a cane).

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

3/30/21 - Vaccination administered 0645, minor soreness at injection site. 3/31/21 - Upon awakening at 0600, minor soreness at injection site with additional minor pain in right trapezius muscle. Later, 400 p.m. feeling of minor weakness, 900 p.m. more noticeable pain (muscle soreness) in right trapezius. 4/1//2 - Awaken at 3:00 a.m. by more severe pain in right trapezius. Upon getting out of bed at 6:00 a.m. found pain expanded to full right trapezius, partial extension to middle of right pectoral, fully up right side of neck, and partially in right armpit. Right side of face experiencing numbness along right cheek bone and right side of right eye. Experiencing increased pain when raise right arm elbow above shoulder. Typing this is difficult.

1st vaccination on March, 4, 2021 - Right arm, soreness at injection site for 2-3 days. No swelling. After that I was fine. 2nd vaccination on April 1, 2021 - Right arm, Slight bodily flushing within 15 minutes of injection. About 4:00 PM started to develop mild aches and chills.. As the day progressed, aches and chills became substantial with a 2:00 AM temperature of around 102 degrees F headache and mild nausea. now 5:00 PM the following day ,i.e., now, with a temperature of 100.5. F. Injection site slightly diminished in pain. No swelling. Monitoring my condition.

The evening of the shot, around 10pm, I noticed that I was getting chills. A hour or two later the fever started. Sleep was difficult in bed because of pain in right arm. Fever and chills continued Saturday, with a high temperature of 101.5F, along with body aches and pain. Symptoms started to lessen on Sunday, chills first then fever, and finally disappeared on Sunday night. Pain at injection site lasted for a few more days.

Opposite arm pain. Then chills and pain in all joints and muscles. It lasted all night following injection. The next few days I felt tired and easily out of breath.

Received 1st covid 19 vaccine Friday the 2nd, Saturday 4/3 he experienced dizziness, weakness, loss of balance, numbness, slurred speech, went to ED Sunday morning, admitted to Med Surg floor 4/4/2021

Elbow area started hurting then Shoulder and triceps area. Then it spread to lower arm. March 31 a rash started on lower arm and noticed swelling of arm and wrist. Rash continued until drying and started going away April 3. Arm is still sore, painful and swollen. Have taken Aleve for pain.

9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was wheeled to the stretcher were he was advised to lay down. BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57 Client still complaining of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild reactions and to call 911 if he began experiencing chest pains ,difficulty breathing or any other severe reactions. Client released with his wife and 2 other family members.

The day after vaccination, the patient started having numbness in the opposite arm as the shot. He did not report anything at that time because he didn't think it was a result of the vaccination since it was not in the arm that he got the vaccine. He just had a nerve conduction study done and there is nerve damage in that opposite arm where he once had a rotator cuff injury. The doctor told him that he thinks the vaccine aggravated his old injury somehow even though it was in the other arm. The doctor told the patient he has seen the vaccine even aggravate old leg injuries. The doctor said it will heal with time.

On 2/25/21, two days after receiving this 2nd COVID injection, he developed right leg pain/discomfort (medial thigh and medial posterior calf), which lasted for 10 days, then developed a right foot drop that worsened for one week (worse at about 19 days after the vaccine where he had trouble walking because he could not keep his foot dorsiflexed due to weakness - not pain), then gradually improved. By the time I saw him on 3/23/21 the leg discomfort and foot drop had mostly resolved but was still present. Denies trauma or any other sxs. [ Of note, he had is first COVID vaccine on 1/14/21 and 10 days later was admitted to medical center with hypoxia and DOE, dx with acute hypoxic respiratory failure due to COVID pneumonia and requiring HFNC, discharged after one week.]

My feet felt like there was lint between my toes, As the days when by this became tingling and has worked it's way up my legs.

At 10:40pm, i was awakened by a high heart beat, approx 86 while sleeping, then had very short breath which i had to deep breath for about 2.5 hours , plus shakes, headache , and body aches, after about 3-4 hours i fell back to sleep and the next day at 12 noon, Everything was back to normal and totally fine.

Chills and fever started within 4 hours of the shot, followed by a severe migraine headache lasting two days along with soreness and weakness in the arm that was vaccinated. Day 2 had a fever of 102.5 on and off throughout the entire day and night, along with nausea, vomiting, and some diarrhea. Dizzyness and fatigue lasted into the 3rd day.

The night after my first vaccine, I awoke at about 3:45AM with extreme aches and pains all over my body for about 4 hours, then I was okay. Twelve days later, I tried to go for a short walk with my wife and the pain in my left leg was horrible at times. The calf muscle was swollen and pink and very warm to the touch. Also my toes were kind of purple and my ankles were badly swollen. I thought the toes and ankles might be related to my Bradycardia, but the calf muscle sent us to the ER to be checked for a blood clot. They did check the major arteries, as those are the dangerous ones, but did not check the calf as they said if one was there it wouldn't throw to the lungs or heart. I was discharged. The swelling went down in the calf. Still some aches in the back of both legs now when I walk very far - but really not bad. Having the purple toes and a possible blood clot... my daughter who is a nurse encouraged me to submit this information. Thank you.

I recieved the first Moderna Covid 19 Vaccine 1/08/2021 and there were no problems. The second Covid 19 Vaccine on 2/05/2021 went the same but after approximately two weeks I noticed soreness between my miidle and ring finger on my left hand along with soreness but thought nothing of it. the Pain eventually got worse. I went to my doctor on 3/25/2021 and was prescribed Naproxin and Voltaren Gel. The discomfort in my left had continues continues. There is selling above this area and the inside of my hand below those fingers hurts and my hand when I close it feels tight and this I atribute to the swelling. My doctor ran labs and all were negative even for Gout. There is a dense feeling in my left upper arm that comes and goes and some tingling. My left hand will have a burning feeling on the ring finger knuckle and experience pain when I fully open my hand. I have not injured my left hand in any way. I find it very unusual because I am right handed. I would appreciate any assistant if possible. I can send photographs if needed of my hand. Blood Work: URIC ACID 4.5 mg/dL 3.4 - 7.2 mg/dL General information Collected: 03/25/2021 11:39 AM from BLOOD Resulted: 03/25/2021 9:16 PM Result status: Final result

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

3 hours of uncontrollable shaking starting at 2 am Friday. 3 hours Extreme painful urination. Total body aches, joint pain, 3 days insomnia. 1 1/2 days Fever, headaches, Neck/shoulder pain. 3 days intermittent shooting pain left side of head. Still feeling somewhat tired and not 100% as of this report but getting better each day. Took Tylenol and let it ride its course.

Beginning in upper thighs around 4 days post vaccine - both legs. Becoming severe by 10 days post vaccine - moving to back of thighs and finally calf muscles over the next 6 weeks post vaccination. Self treated with Advil up to 1800 mg per day and using ice on legs before bed. Fever spike each night with night sweats sometimes up to 3x a night during this 6 week period. About 2 weeks post vaccine afternoon temperature spike - went on for another 2 weeks. Dry, unproductive couch began about 3 weeks post vaccine. Tested negative for Covid-19 4x during this period. Tested negative for influenza and other known infectious diseases. By week 6 post vaccine, leg muscle pain subsided, night sweats continued for 1 more week, cough persisted but dissipated around week 7 post vaccine.

mild fever cold sweats severe headaches nausea bad shaking dizziness severe fatigue achy joints severe pain at injection site loss of energy loss of appetite diarrheafelt just like covid 19 symptons lasted approx. 2.5 days

pt had flu like symptoms, fever chills etc right off. Today he started with a rash over his face and neck and hot also. pt is calling dr just to make sure rash doesn't need any medication besides benadryl. Pt also was taking bactrim and stopped 4/12/21

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

High fever reaching at least 103.8 overnight following receiving the vaccine that morning. Fever accompanied by chills,, shaking, headache, rapid heart rate, and sweats continuing until approximately 8:00 am the following morning. Fatigue lingering after fever broke for 2-3 more days.

Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy. On 06-Apr-2021, the patient received first dose (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown. Treatment was not reported/ unknown. 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 with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

Within 24 hours of injection, fever of 101.0 for over 24 hours, headache, inability to keep awake or keep eyes open, worsened my IBS and my neuropathy to the point of screaming, my body couldn't detect temperature changes even when inside room temp went from 70 to 86 degrees. Three times I fell into semi-conscious state and awoke within minutes not knowing where I was at or what was happening to me. Symptoms went away around 60 hours after injection.

Clinic visit 4/7/21: "60 y.o. year-old male who presents for left calf pain, swelling, and bruising that began on 03/27/2021. Patient states that 2 days prior to symptom onset he received the Moderna COVID-19 vaccine. He did have symptoms of fever 102 F for approximately 24 hours. After the resolution of his fever he notice swelling of the leg with tenderness any line of bruising going down the medial aspect of his leg. He noticed more prominence of varicose veins of the left leg and began using a compression stocking. His varicose veins seem to worsen with sitting as well as tenderness, and improves with walking. He notes a tenderness over the upper calf. He denies any history of DVT/PE. He notes that two brothers sustained blood clots, one he believes was in varicose veins which were ultimately stripped and the other he is not sure of the exact nature of the clots. He is unaware of any hereditary clotting disorder in his family. He denies any shortness of breath, difficulties breathing, or chest pains." He was sent home with aspirin 325mg daily. Hospital admission 4/11/21 " 60 year old male with no PMH comes in c/o LLE pain that originally started 2 weeks ago and intermittently getting worse. The pain started around the left calf and has moved its way up to his thigh/groin area. The pain is sharp, 7/10, worse when standing, slight improvement with aspirin. Pt denies tingling, numbness, CP, shob, N/V/D, blurry vision or weakness. Associated symptoms include erythematic rash around left inner thigh, tender to touch, and swelling of calf/thigh. He works with heavy machinery but is always sitting down 1-2 hours at a time. He does have family history of DVT/PE. He is not on any daily NSAIDs or other anticoagulation and denies smoking." he was started on a heparin drip then transitioned to Eliquis and discharged the next day.

Patient had the vaccine in the arm for approximately 1 minute before becoming pale and beginning to shake. The patient had a representative that stated he was a diabetic and did not eat before the vaccine, believing that his glucose was dropping. He was given a shot of glucose before having an episode similar to a seizure. Diphenhydramine and an Epipen were obtained but were not needed to be administered as the side effects subsided. The patient wanted EMS to be called. EMS arrived at the facility and the patient was assessed. Patient left on his on will.

Approximately 1 hour after the vaccination, Patient reported feeling a sudden "pop" in his head. That was followed by loss of balance, weakness, and inability to walk. He collapsed and either passed out or slept for 2-3 hours. Upon awakening he still felt weak and unbalanced. He also had bitten his tongue and lip while unconscious. He slowly recovered over a period of 3-4 days after the vaccination. He has never before had a stroke or a seizure. No one was with him to observe any of his symptoms.

Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.

Within an hour or two of the vaccine second dose every area where I have ever had joint problems gave me problems. The worst was the arthritis in my left thumb, which also suffers from Carpal tunnel. My thumb where I do have arthritis became so painful and sensitive to any movement that I could not use it. At one point the pain took me to my knees. I now think that the far above average pain in that joint that I have been having for several weeks may have been from the first dose but the extreme increase in pain right after the vaccine seems very likely to be the vaccine. I also had painful electric like jolts in my back and ankle and have been experiencing higher than normal chest, center of rib cage pain. All these areas are problem spots for me but for all of them to flare up at once right after the vaccine is unprecedented as was the pain in my left wrist/thumb.

Weakness pain in all muscles and joints fever 100.4f dizziness inability to regulate temp (I'm freezing.). If this gets much worse I will go to the hospital. This set of symptoms mirrors exactly what happened when I got Covid last December, but worse and progressing faster.

Developed vomiting 04/20/21 in the evening. This a.m. 04/21/21 he was experiencing weakness and vomiting. He fell while in the bathroom, and states it was because he wad so weak. He seems to be doing better now, but due to the weakness writer opted to report to VAERS. He refused medical treatment.

On 4/3/21 about 2 weeks after my 1st dose of Moderna I noticed a raised rash/hives on my left middle back consistent with shingles I?ve had before. Very itchy but painful to the touch. While rash stayed localized the itchy sensation grew larger and wrapped around my left side to my left lower stomach. Itchy, painful to touch and actually also numb. Situation persists now almost 3 weeks later. Situation is livable but uncomfortable. Virtual doctor consultation to monitor situation.

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

Got the shot Thursday. On Friday I had no energy, and was finding it hard to breath. My upper chest became very congested Saturday night I was very crackly in my chest and could not take a deep breath. On Saturday it was so bad, I thought I had Pneumonia bad. I called my doctor and they require a Covid test before I could get an X-ray. Of course I live in Oregon where there are plenty of providers near by giving FREE RAPID COVID TESTS, Every single damn one required a Doctor's consultation and APPROVAL before I could get the free test. So I waited until Monday to take the test, I got the results on Thursday. By Monday all symptoms including my chest congestion.

I got my first moderna shot on 4/6, numbness on left side of my body include left face and whole head start 4 days later, also strong headache; then dizziness and vertigo start on day 11. Have not gone away yet. I went to see my doctor and waiting for the CT scan and vascular result.

Patient was here to receive his 2nd Covid-19 vaccine. He did not have his card. The person at the check in table looked him up in database to verify date of first shot He wrote on sticky note and gave to patient. Patient proceeded to nurse to get vaccine. He told her he was there for 2nd Moderna Vaccine. Vaccine was given and after that it was noticed that the name on the paper was not the same. The person who was scribing brought it to my attention that the date was too early for patient. When verifying the date I noticed that it was documented that he had received a Pfizer Vaccine on 03/29/2021. I instructed hi that our records show that he received the Pfizer Vaccine on 03/29/2021. He still states he received the Moderna Vaccine. I instructed him to send me a picture of his card he states was at home. He sent a picture on 03/18/2021 which showed he did receive the Pfizer vaccine on 03/29/2021 . He states his arm was sore. I followed up with him on 03/19/2021 and his arm was better. I instructed him that he did not have to repeat either one of the vaccines at this time.

Passed Out; Suspecting Seizures pending EEG Results; Sore Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (medication history was not reported) and Pacemaker insertion (cardiac) since an unknown date. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed Out) (seriousness criteria hospitalization and medically significant) and SEIZURE (Suspecting Seizures pending EEG Results) (seriousness criterion hospitalization). On 10-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported. diagnosis yet to be determent Suspecting Seizures pending EEG results 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 is available at this time. Further information is 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 is available at this time. Further information is requested.

Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.

loss of appetite, diarrhea, fatigue, chills and fever and sore arm. All but chills, fever, sore arm have lasted 5 days so far

Afib and now an irregular heart rhythm, a never before heart arrhythmia.. Also newly diagnosed PVC.. And constantly breaking out in cool clammy sweats and shortness of breath. Never had this issue until 2 weeks after my first moderna vaccination

Sudden onset, fell once, no LOC, right arm felt like "spaghetti" then feeling came back Refused ED, lasted about 2 days. At f/u office visit on 4/20/21 - patient reported residual numbness right arm with difficulty grasping items, new numbness left leg

TREMORS IN HANDS THAT STARTED THE DAY AFTER VACCINE AND HAVE CONTINUED TO GET WORSE. THE PATIENT'S ONCOLOGIST TOLD HIM THAT THIS IS NOT A COMMON SIDE EFFECT FROM TREATMENT OR RADIATION. HIS PCP HAS REFERRED HIM TO A NEUROLOGIST FOR FURTHER EVALUATION.

Patient is a 60 y.o male with a history of arthritis who presents to the ED with numbness for the last two months. He was seen at the neurology clinic earlier today from where he was referred to the ED because of concern myelitis. He states that the numbness started in her toes and has been gradually radiating upward into his upper thoracic area. He denies cough, fever, chills, CP, or SOB. Patient states his sx started after receiving an injection in his neck for arthritis by orthopedics on 2/16/21. Additionally, he states that he received his first covid-19 vaccine (Moderna) on 2/17/21. He was evaluated in the ED for paresthesias on 4/11/21, where he was worked up with an MRI of the Lumbar spine that showed no acute processes, so he discharged with return precautions and instructions to follow-up with spine outpatient. Patient is currently admitted to the hospital and latest Assessment and plan are below: Possible Vaccination induced Transverse myelitis versus cord neoplasm Multifocal CNS white matter inflammatory process -possibility of post vaccine autoimmune myelitis. Received Moderna vaccine 2/17, 3/20 -Repeat MRI of C and T-spine with and without contrast post plasma exchange (per neurology 2 to 3 months after completion of treatment) and if no improvement in the lesion, would need spinal cord biopsy

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

On 4/9/20 patient developed bilateral numbness and tingling to arms, hands, feet and legs. Went to ED on 4/16/20 Labs and CT head were normal. Had decreased strength and sensitivity in extremities and Babinski's were upward going. Discharged to home without medication and to F/U with PCP in 4-6 days. Saw PCP on 4/20/21. He had S&G hyeresthesia, + Rhomberg, failed tandem walk, and dysdiadochokinesia. Neuropatic pain in shoulders, arms, legs, hands, and feet with weakness in hands and arms and sensory loss in left leg. Was unable to get immediate MRI so patient was admitted directly to hospital. MRI showed concern for transverse myelitis felt to be secondary to Covid 19 vaccine. He will not get second dose. Improved to near baseline with treatment of high dose steroids. He also had an STEMI and was taken to the Cath lab where they found 50% blockage in a coronary artery. They felt STEMI was caused by spasm. Pt was discharged home on 4/26/21 and is having physical therapy to help regain his mobility.

Couple days after 1st shot I started to feel tightness in upper back and then it started to bother my right hand. The pain would wake me up at night a couple of times- I would take extra strength tylenol and use a vibrator on it. Just before the 2nd shot I started to feel a little better. After the 2nd shot it made both my arms hurt but mostly my hands. I also had pain and difficulty raising and lowering my arms. Went to see my doctor; P.A. on 4/29/21 because my right hand was swollen. A blood panel was taken and results were good. Was prescribed Cadista-MethylPrednisolone 4mg.

bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (bell's palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. The patient was treated with prednisone. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

1st day: Soreness in right arm. 28 hours later: all Joints very achy. Fever of 100.3 degrees. Chills Intestinal distress. diarrhea. gas. overall exhaustion.

Started with hard to get up off of low seating area. weakness in chest muscles. legs,arms. severe pain in chest muscles,shoulders biceps, then radiating down in arms and hands.. trouble walking up stairs, raising arms above my head. getting dressed, washing my hair and general hygine issues. My hands started swelling very bad and continue. The amount of muscle weekness and pain i have i have never experienced in my lifetime. I have been to multiple doctors and have had many tests done. Prior to the Covid 19 vaccine i was a 60 yr old and now feel like a 90 yr old with many health problems.

"Moderna COVID-19 Vaccine Was relaxing and getting ready to read my book on phone. A few minutes after taking the vaccine, blood pressure fell, dizzy with risk of passing out, weak, very rapid heart beat, nausea. Jumped up and starting moving to create energy to avoid passing out. The dizziness reduced somewhat and did not get worse, but was still present. Heart rate slowed after a significant period of time. Then symptoms resolved. No emotional triggers and no history of any such events at any time in 60 years.

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

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

I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.

About 35 minutes after the shot, I started having numbness on the right side of my face. The shot was in my left arm. The numbness could best be described as similar to when I would get novacaine or a similar anesthetic at a dentist before drilling cavities. My face does not feel puffy, but when I touch the skin on my right side from my right eye socket down my cheek to my jaw line, I feel numbness compared to my left side. I did not have this side effect after my first dose of the Moderna shot.

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

Debilitating pain in left arm, exceeding that of a broken limb. 101*F fever, chills, sweat spells, body ache, headache, mental fog, upset stomach. I've never felt more sick in my life. Would have gone to ER however my wife suffered the same vaccination reaction (was vaccinated at the same time/location) and was unable to drive.

It started with a strong headache the day after the second dose which went to the back of the neck and later I started feeling tingling on the left side of my face, I went to the clinic and the doctor told me it was facial paralysis.

1. Sore upper left arm for a few days 2. Mild numbness in left arm from elbow down to fingers similar to tendonitis (experienced from day 1 to current day 10) 3. Significant upper body itchy rash on abdomen, back, arms, hands, chest, neck and face starting 8 days after injection and continuing.

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

On or around April 15th I developed a pain in my left calf. As a senior citizen and avid golfer I chalked this up to age and activity. But the problem didn't go away and on some days would be more painful than others. Additionally, the point where my calf hurt seem to move around and sometimes be higher on my calf behind my knee. Some days the pain was gone altogether only to return the later that same day or the next. At the beginning of May I started to develop a cough. I had no fever or other symptoms so I thought it might be seasonal allergies. The cough continued to get worse so I made an appointment with my doctor on 5/26/21 and was seen that day. I was given a COVID test even though I had taken the vaccine and scheduled for an ultrasound on Friday 5/28/21. During the ultrasound they discovered a DVT in my left calf that extended from my ankle to behind my knee. Since I was also coughing they scheduled me for a CT scan that same day. The CT scan showed multiple PE's in both lungs. They sent me to the hospital.

I received the Moderna Shot in My R arm on Wednesday 4/28/21. My R arm stayed sore ( not at the injection site ) but up in the shoulder joint. It was stiff and sore with abduction or any rotational movements. On may 10th I noticed that the injection sit was showing signs of irritation. Ove the next 2-3 day lesions formed at the posterior aspect of the shoulder joint and in the crook of the R elbow. By the end of the week lesions began to form on the anterior forearm 2 inches below the elbow joint and 1/2 way down the anterior forearm. A small Lesion also formed 3 inches above the wrist on radial aspect of the forearm and another small lesion on the bas of the R hand just below the wrist. I started on proteolytic enzymes, L lysine and an anti viral 3x a day and acupuncture. Now on 5/27 the lesions are mostly gone and the pain in the shoulder is almost gone also

Initially sore arm and sore left breast. Then over next 2 hours tingling and numbness on left arm and left side of head and then left leg. So my Doctor ordered to go to to ER for fear of stroke. Spent 4 hours in ER and tingling and numbness dissipated and all tests negative.

Approximately 15 minutes after the Moderna covid vaccination, patient reported tingling in the left hand. The vaccine was administered in the left deltoid. Patient denied other symptoms. BP left arm was 132/80, pulse 68. No respiratory problems. Monitored patient again for approx 10 more minutes, no further reactions noted. Patient was permitted to leave. Advised to call the office or report to the ER with any further concerns.

Extreme swelling and pain in left hand, saw doctor 4/26/21. Was thought to be gout and was given Prednisone for 10 days. Swelling/ pain minimized. Had scheduled chemotherapy on 5/6 and 5/7. Swelling/pain returned. Saw doctor on 5/13 and both primary and oncologist via video conference determined it could be cellulitis. Was given Doxycycline and was to follow up with doctor on 5/17 but I had an emergency visit with nurse practitioner on 5/15 with swelling from fingers to middle of my left arm. Was sent to hospital, then transferred to secondary hospital to see hand specialist, in case surgery was needed. It was not. Until my release on 5/19, I was on round-the-clock antibiotics and given pain meds as needed. Currently still do not have full use of my left hand. Chemo scheduled for 6/3 and 6/4. Oncologist will make determination whether to move forward or postpone.

Patient received 1st vaccine on 4/29/2021 (no side effects), 2nd vaccine on 5/27/2021 (patient states he had sore joints). On 6/5 He awoke at 3:00 a.m. in the setting of leg cramps. He got out of bed to walk off the cramps, but then developed substernal chest pain. He describes the pain as ?squeezing? and cramping with radiation towards the left shoulder. He began to feel lightheaded and diaphoretic, and thus began driving himself to the ED. On the way, he felt his symptoms were worsening so he called dispatch he recommended he pull over at a nearby gas station. EMS met him there and transported him the rest of the way to the ED. In the outside ED, he was initially hypertensive to 175/99.

He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.

The main symptom I had a head to toe rash. The rash was profusely on my stomach, I though I was going to have scars from the rash. It was extremely itchy. I also got tingly fingers, which I still have as of today. I made 3 trips to the walk-in clinic and got cortisone shots and cortisone pills 3 different times. I also gained 15 pounds over that time period. I also went to a allergist and he advised I was probably allergic to something in the shot. He advised not to take the second shot. All the other healthcare providers advised me not to take the second shot as well. I have not had the second shot due to the symptoms I had. With the "tingly" fingers there was also joint pain in the wrist and hands.

L deltoid pain and intermittent tingling for 1.25 months after vaccination - which keeps him up at night.

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

Severe fatigue and weakness, headache, general muscle ache, fever, lack of appetite Unable to function - 5 days in duration

pain left upper arm since injection, can't sleep on that side because of pain. Throbbing. No position helps. Tingles in fingers if picks things up. Can't put hand in hip pocket because it hurts to move arm back that far. Patient states he feels like there's a knot under left shoulder blade. Felt dehydrated when had lab draw 2 weeks ago (1 week after shot). Grip strength right 94.6lb, left 24.6lb, "makes it throb" when grasping.

Extreme pain in right arm and shoulder; unable to move right arm or shoulder. ER 2/22/2021 - Las Vegas two days later -(First, I did Teladoc first and they had me put a cold compress on it for a day or two (I tried cold and eat). ) Time kept going on and I kept not getting better. I waited two weeks to see my regular doctor and then I ended up in ER again because of pain. They gave me a shot of morphine. Sent me for an MRI and told me to see my doctor. My doctor sent me to another surgeon who had worked on my arm on my left shoulder . Months went by before I found out there was not anything physically wrong with the arm/shoulder. Trying to do Physical therapy twice a week - I'm unable to fully work - I'm a licensed aircraft technician. I'm doing a desk job and type with one hand.

Approximately 2 to 3 weeks after my second Moderna shot, I began experiencing pain radiating from my shoulders to my hands. Within days after that, I started to feel my entire body becoming inflamed. I am experiencing excessive inflammation throughout my body. Lab tests conducted two days ago found my sedimentary rate at thirty-four. As a result of the inflammation, I have become unable to use my hands to perform menial functions as dressing myself, where my hands are unable to pull socks over my feet. The inflammation continues today. The pain level experienced as a result of the increased inflammation as resulted in significant diminished capacity for performing my daily routine.

Like he was going to pass out; Weakness; Cold sweat; The vaccinator pulled out the needle, blood came out and ran down his arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Like he was going to pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Passed out (Patient has history of passing out when blood drawn from right arm as it usually hits a nerve). On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Like he was going to pass out) (seriousness criterion medically significant), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm). At the time of the report, LOSS OF CONSCIOUSNESS (Like he was going to pass out), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm) outcome was unknown. Patient has drank water & ate M&M to relieve the symptoms. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was 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. Further information has been requested. Of note, the patient's history of 'passing out when he gets blood drawn on his right arm because they usually hit a nerve' is a confounding factor that may play a possible contributory role.

Muscle aches, arm soreness, shoulder tightness, lightheadedness (better), decreased appetite. patient taking tylenol and aleve to help alleviate symptoms. Symptoms began 6/23/2021 at 6PM. lightheadedness recovered.

My right arm still hurts and it is hard for me to move it. My range of motion has diminished some. It has been 3 months and the pain still persists. I had the second dose on 4/28/2021 my arm was still sore from the first shot. Seemed like the second shot did not hurt at all compared to the first shot. How long will the the pain continue? Who do I see for this? My pcp said to just keep an eye on the situation.

On the evening after receiving the COVID19 vaccination (May 7), I experienced severe flu-like symptoms. On May 8 these symptoms gradually disappeared, but during the night I woke and was drenched in sweat. The night sweats continued for the next four nights and then disappeared. On May 13 my wife heard a strange noise in my chest which I later identified as a heart murmur. I did not have any pain or other obvious symptoms, but I felt a slight tingling in my toes and fingers. I went to urgent care, where I was referred for an echocardiogram. The echocardiogram was performed on the morning of May 21, and endocarditis with highly mobile vegetation on the right coronary cusp leaflet of the aortic valve was identified.

Patient passed out, fell to floor, got up in sweats, shaking. Patient was given water, orange juice, BP taken, BP rose with second reading, called paramedics, patient was checked out by EMS and was ok after 30 or so minutes. patient was able to go home by himself.

Pain at the BL axilla and numbness and tinging at hands. Began immediately following the injection and worsened in subsequent weeks.

In February patient had the explosive onset of severe paresthesias and subsequently was diagnosed with demyelinating peripheral polyneuropathy in all 4 extremities confirmed by EMG /nerve conduction study. Work-up was completely negative for all other etiologies and felt to be related to the vaccine. Things have slowly improved with medication treatment

Significant neuropathy in toes, feet and up through ankles as well as a numb patch just below knees. Along with the numbness is tingling, pins and needles, and muscle twitching, Also experiencing intermittent burning feelings in finger and decrease in overall sensation in arms, hands and fingers. A similar loss of sensation is occurring around my collar bone and along my neck. These symptom were first noticed on April 23rd (I checked my web searches to see when I first looked up neuropathy in the feet) and have only been getting progressively worse. My PCP is unsure about what is happening and is currently and it is placing it under the familiar diagnosis of idiopathic. I am currently pursuing acupuncture. Both my PCP and acupuncture provider have stated that they are seeing an uptick in this sort of symptom profile!

Stiffness in both hands and sharp Pain in the right hand !!! Index & middle finger swollen !!! Pain is still going on for 3 months till today so far continues !!!

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

I have been experiencing a tingling and numbness in my right arm. It starts in the front part (anterior) of my right shoulder and continues down through my elbow and forearm into my right hand. The worst numbness and tingling in my right hand is in my right thumb. I couldn't understand what is causing this tingling and numbness until I read news reports about a rare connection between the Covid-19 vaccine and these types of symptoms. I wanted to report this right away.

Had a seizure, 2 other reactions like seizures; Could not breathe, has breathing problems; Was really sick; could not get out of bed for 4 days; shoulder pain; muscle pain; Felt a little nauseated; Is really fatigued, tired; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure, 2 other reactions like seizures) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Diverticulitis, Narcolepsy and Vertigo. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (Had a seizure, 2 other reactions like seizures) (seriousness criterion medically significant), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired). At the time of the report, SEIZURE (Had a seizure, 2 other reactions like seizures), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired) outcome was unknown. The patient's medical history also included an unknown syndrome (could not understand the name). Concomitant product was not reported. The patient had experienced shoulder pain, muscle pain, fannnnd had elt a little nauseated. Three and a half weeks after having the second shot , he had a seizure, was really sick, could not breathe (started after he got the seizure), and it was horrible. At the time of the report, the patient continued to have muscle pain and everything, predominantly in his upper chest, and has breathing problems; he had never smoked or anything. He also had 2 other seizures like reactions. He was really fatigued and tired. He could not get out of bed for 4 days. He went to doctor but was given no aditional treatment. At some point after he had the seizure, the patient saw his doctor. Treatment was not reported. Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.

60 yo M who developed delirium and was in ER 5/7/21 for this. Described by son/boss as difficulty focusing x 2-3 weeks, diffuse body weakness, paranoia, anxiety. CT head was neg, pt was discharged home. outpatient MRI brain suggested Creutzfeldt Jakob disease CJD. He was seen by neurology, who confirmed CJD by LP, he is now nonverbal and dependent on all ADL's, going into hospice

I woke up with a sore throat on 06/11/2021 at 6:00AM. I woke up coughing and it felt like a burning sensation in bronchial tubes and a tightness and I thought I had Covid. and I thought I was getting sick and it went into my sinuses. I had a really bad pressure in sinuses and mucous. I waited 20 days bc I thought I had a cold. I felt tired. I went to urgent care and they did rapid Covid test that was negative and they put me on Dicloxacillin and I was feeling better within 3 days.

"swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown. the swelling and hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.

Swelling in cheek. Patient states swelling was at the site of nerve in cheek. Nerve felt hard. Was not painful, just slightly tender if touched. Patient read online to take Benadryl. Swelling subsided in a couple of days.

within 24 hours, the patient developed diarrhea, fever, chills, dizziness, headaches, fatigue, muscle cramps, vomiting, aches, and pains throughout the entire body. Symptoms subsided after 48 hours after the shot was administered. Symptoms were most prevalent from 14-30 hours after initial vaccine. Hot showers alleviated pain, and aided vomiting Bed rest when possible. Oral medication to relieve fevers/chills were ineffective due to vomiting.

High Fever, Chills, Weakness, Pains (joint & Muscle), Cough, Note; this was worse then when I originally had COVID in April 2020.

Patient reports low back pain fever and anxiety began 2300 on the day of vaccination. He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain. The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021. Patient was treated to diphenhydramine and symptoms resolved

Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour

Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101

Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Tylenol, sleep till 3:30 PM, went back to sleep at 6Pm and woke up 6am.

Headache, Diarrhea, chills Narrative: headache, tenderness on the left side of neck, mild chills, diarrhea

Pt has nonresponsive episode on 12/30/20 30 minutes after receiving his 1st injection of moderna covid vaccine. Became responsive 3 minutes later. Pt current patient at LTC facility hx of CVA and pseudobuldar palsy

Myalgia night sweats, chills, fatigue Narrative: Employee received vaccine on 12/30/2020 and began experiencing symptoms (chills, fatigue, night sweats, body aches) on 12/31/2020. Reports took "pain pills" however no information to dose/frequency or name of medication provided. Employee reports has not fully recovered as of 01/06/2021.

I was fine the day of the vaccine. When I woke up the next day I felt like I had a severe case of the Flu. I had severe body aches, headache, muscle weakness, worse cough, injection site pain and swelling, chills, weakness/tiredness, I felt like I had been hit by a car. I just tried to sleep and drink Gator Aid. The second day out from vaccination I felt much better. Just slight headache, body aches, weakness. My injection site started to hurt later in the second day. It still hurts today-seven days out from administration.

No problems on vaccination day. I woke up the next day with severe flu-like symptoms. I had a severe headache, severe body aches, cough, injection site pain, weakness, extreme tiredness, The flu like symptoms lasted one day and were gone by the evening of the second day out from vaccination. One week later I still have muscle pain at the injection site.

Reports feeling of chills, debilitating headache, muscle aches. No fever. Tylenol does not help. Unable to get out of bed.

patch on your arm shaped like a square of 2x2x2x2 that red in the middle and the outside edge is yellow and blue like a tattoo, it was hard the first then, a little tender but mostly reddish, square and yellowish blue brushing.

about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )

feverish, chills, shaking, 99.9 fever, extremely nauseous, Zofran did not work, nausea went away that night, fatigue, red square size of a stamp at injection site, size has increased in size, Dr rx Bactrim antibiotic

Patient received the vaccine, and waited 30 minutes, due to history of allergies. After the vaccine, he walked to his car, and he felt flushed and facial tightness. He was driven home, took Benadryl, and then a 1.5 hour nap. When he woke up all symptoms had resolved and he has not had any symptoms since.

Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. Fever 102.9. Severe headache. Vomiting next morning. Bedridden 36 hours total.

Bad Charlie horses in both legs from the thighs to the hamstrings to the calf muscles to the tops of both feet . Started about 9:15 pm and lasted 35 minutes to get them walked out . Came on without any warning. I do get muscle cramps in my calf muscles but never from my thighs to my feet and the pain was a good 0 no pain and 10 the worst pain mine was a 15 I had all I could do to stay standing up and walking them off. Called a friend and she gave me some muscle relaxing pills. Not looking for 2nd dose in Feb 12th 2021

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

Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F

About 12 hours after receiving the vaccine I experienced severe stomach cramps, followed by diarrhea, and vomiting. The episode lasted for about 4 hours. After it was over I felt very weak and stayed home but no further symptoms arose.

I started feeling flush and got a pain in the center of my chest. At first it felt like congestion, but then started radiating into my shoulders, then into my arms and up into my neck. They called an ambulance. They gave me Benadryl and aspirin, which made me feel better. They missed twice trying to blood, but said I refused, so they couldn't get blood results. I don't know if it was an allergic reaction.

patient sent home from work on the morning of 1/21/2021 due to muscle pain, weakness, nausea. Symptoms worsened including decrease in o2 sats 72% (compared to normal mid-90%), patient was unable to ambulate due to muscle weakness/pain, pulse elevated to greater than 100 bpm. Ambulance was called and arrived to the home where patient resides at 8:55 am on 1/22/2021. Home director emailed symptoms to the pharmacy after the patient left for the ER. Pharmacist called home director to get additional info. As of 1:03 pm on 1/22/2021 patient has returned home after ER staff determined his symptoms were an adverse reaction to Moderna. He was advised by the ER staff to rest and drink plenty of liquids. Pharmacy advised home director to contact patient primary provider to report ADR and determine if the 2nd dose of Moderna is advised by the primary provider. The pharmacist will follow-up with the house director status on 1/23/2020 before 3 pm and will have any additional ADR's reported to the pharmacy and the patients primary provider

approximately 24 hours after the injection, I had no fever, but chills, sweats and overall since of fatigue. My resting heart rate was at 100 for a few hours. Normally, it's around 76. I noticed on deep breaths, I felt the need to cough (no phlegm, just a dry cough. One or two coughs per attempt). No medical care sought. Those symptoms dissipated and I felt good. Then on January 20 and 21, the chills returned. They lasted about 8-10 hours, then they were gone. I also developed a headache during the 20 and 21 episodes. I checked yes in the below adverse recovery box, but I am uncertain as to what tonight and the rest of the days have in store.

Bilateral swollen forearms, numbness on left fingers, chest tightness; seen & cleared by EMS. Due to past medical history of asbestos lungs, client instructed to go to emergency room

lightheadedness, headache, aches in the legs post-vaccination which improved with rest food and hydration

Swelling of lymph nodes under left arm pit. Started sometime during Wednesday night. Didn't know about it until Thursday morning when I felt slight pain and tenderness in my arm pit. Checked with my doctor and she confirmed it.

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

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

At first I was fine, later that night my arm was hurting, then the next thing I know everything was hurting in my body. I had to take off work Tuesday and Wednesday. I think I also had a little fever. Today I am feeling better, the arm is just a little sore.

2nd shot stung a bit unlike 1st one. around 10:30am head felt woozy/slightly dizzy, left work at 1:30pm dizzyness getting a little worst body started aching. fell asleep for about 30 minutes once home, bed at 9:30pm and started to shake violently like I was freezing but not cold, didn't feel like I had a fever, put on sweatpants and tshirt, turned on elec. blanket, I stopped shaking after about 45 minutes, took acetaminophen and 1 dose of zquil and fell asleep. up at 3:30am in pain, especially my left arm I couldn't lift with pain. called out of work all muscles and joints hurt, less pain with no movement, more acetaminphen every 6 hrs, started feeling better around 4Am Saturday

Patient reports known onset of right foot drop the following day of vaccination (time unknown, reported "Evening time"). Currently being worked up in the clinic, but now patient is day 12 of foot drop without any significant improvement. Unsure if vaccine reaction, reporting out of caution. Patient has no recent trauma or injury to spine. Signs/Symptoms: Weakness in Dorsiflexion/Eversion of right foot, Mild weakness of right hip extension, Decreased sensation to right lateral lower leg, steppage gait

PATIENT WOKE UP WITH PAIN IN HIS ARM FROM HIS SHOULDER SOCKET TO THE MID BICEP ON THE INJECTED ARM (LEFT). THERE WAS NO DISCOLORATION ANYWHERE OR BRUSING. THERE WAS NO HEAT. IT WAS DEFINATELY MUSCULAR PAIN. THE PAIN PERSISTED FOR 3 WEEKS TREATING WITH IBUPROFEN OVER THE COUNTER. THE ARM HURT SO MUCH HE COULD BARELY LIFT IT TO EVEN SHOWER OR WASH HIS HAIR.

Pain right arm- site of injection- not able to move for almost 3 days, followed by chills, body ache, and headache. Symptoms lasted for 3 days.

Moderna COVID-19 Vaccine EUA - 2nd shot - Pain in L Arm at injection siterna COVID-19 Vaccine EUA - General weakness, flu-like symptoms

Occurring in late evening of 2/8/21 and all day 2/9/21: Muscular aches/soreness/stiffness (no intense pain)...primarily lower back, lower sides (kidney area), upper back, neck. Left upper arm "pain" at injection site. Slight fatigue. Very slight headache (not serious). Fingers of both hands ache (not sure if arthritis flareup). NO fever.

starting 18 hours after shot, chills, fever, muscular shaking, weakness in legs and jpoint pain specifically in the hips. Lasted 12 hours and then went away

Pt started to have restless leg symptoms (which he only feels at night) 15 minutes after vaccination. He also started to have muscle twitching and a visible tremor. He developed some subjective SOB, RR30. Lung sounds clear. His BP was 179/80. He was given water and monitored for 45 minutes, at which point his RR was 16 and BP dropped to 160 systolic. Tremor cleared up. RLS symptoms resolved. He was sent home with education to go to ED with worsening symptoms.

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

After Covid vaccination #1, patient was instructed to be monitored for 30 minutes due to history of sulfa allergy. After about 5 minutes of observation, she approached me (pharmacist) saying she had tingling and a little numbness in right side of lower face. She reported no difficulty breathing and no other symptoms. I consulted the two other pharmacists I was with and we decided to not take any immediate action but continue monitoring. I checked in with patient every few minutes to ask if symptoms were getting better/worse. For first 30 minutes, pt said symptoms were the same. After about 30 minutes, she said she had a little itching down her throat, but still no difficulty breathing. We gave her 50 mg diphenhydramine and monitored for 30 more minutes. After 1 full hour of observation, she never reported difficulty breathing. She did get tired from the Benadryl and was up on moving around and said feeling slightly better. After 1 hour, she went back to her room.

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

Starting around 5 pm on day of vaccine I started getting a low grade fever and it continued through the next 24 hours. I took 2 500 mg Acetaminophen around 10 pm and went to bed. During the night I had some cold sweats and did not sleep well. The next day, I had chills and some body aches. I too 2 500 mg acetaminophen two more times during the day. I was fatigued with some body aches throughout the day. The next day was very similar to the 2nd day after the shot but no fever. It is now the 4th day after the shot and I feel back to normal.

2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.

Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.

after first injection I began having the worst G.I symptoms. Cramping/diarrhea abodemin pain . Symptoms like diverticulitis. Seconds injection same symptoms. 8 wks later still having symptoms.

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

Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to lay down, stay home from work. Rested. Took Tylenol and slept throughout the day. Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature up. Jogged for 60 minutes, returned, ate and rested again. 4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level. 5th day back to normal.

Patient was unable to get out of bed the whole day and missed all three meals. Patient had a fever of 100.6 and had generalized weakness and malaise. Patient was also confused. Patient was experiencing tachypnea and shallow breathing.

Gave moderna vaccine at 3:23pm in right deltoid. During observation period, patient was experiencing tingling in both of his hands. Due to past history of allergic reactions, gave him diphenhydramine at 3:42pm. He felt okay for a short period of time and then started to have tightness in his chest. He could still breathe fine, but called 911 due to past anaphylactic reactions. While on the phone with 911 he stated feeling more tightness in his and then decided to give epi-pen shot in left upper left thigh at 4:02pm. The EMT showed up immediately after and took patients vitals. EMT advised if wanted follow up monitoring could take him to ER. Patient wanted to go to ER for further monitoring. We followed up with patient's wife and she said he was still not feeling very good and had follow up appointments with his cardiologist. He also came in the store on 2-26-21 and all his test were normal, but still was not feeling like himself.

About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But about Friday, my right hand began to ache a bit. It became excruciating by Sunday. My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints. The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.

Ok I got my 2nd shot on Tuesday (03/02/2021) about 2:30 p.m. and was feeling great all evening. I woke up at 2:30 a.m. and thought I'd been hit by a truck, my whole body was aching like nothing I've ever experienced. I also got chills and was shaking I thought I was on one of those machines that shake paint cans. I also had (and still do) a headache. The body aches subsided about 10:00 p.m. (03/03/2021). It is now about 5:00 p.m. on Thursday 03/04/2021 and I still have a slight headache and I am fatigued but starting to get some energy. On my left arm where I got my shot it is very warm, red, and about the size of a goose egg in the area I got the shot.

Headache, grogginess, jittery, shivering, soreness at point of shot, tiredness, feel like a truck ran over me, extremely lethargic. now it's the second day. Feeling cold stopped, a little better.

3:45 pm moderna vaccine given via IM 4:00 pm pt reports both hands tingling sensation. 4:04: V/s Bp=120/70, P67, o2 sat=96% , R18. 4:15pm both hands tingling sensation almost resolved. pt was discharge. Advised pt to go to E.R if symptoms continues. And follow up with pcp asap.

Next day developed right leg pain. Following day diagnosed with a new deep venous thrombosis of the popliteal vein, right leg

Client phoned; C/o face swelling; trouble breathing; dizziness and weakness. 911 phoned for client home address; client refused medical care/ambulance service.

Pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection; Sugar was very high; Blood pressure was very high; Face look flushed; A spontaneous report was received from a consumer concerning a 61-years-old male patient who experienced pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection (cellulitis), sugar was very high (blood glucose increased), blood pressure was very high (blood pressure increased), and face looked flushed (flushing). The patient's medical history included diabetes mellitus, heart disease (unspecified), kidney failure, and chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the event, included insulin and oral medications for diabetes (unspecified), rosuvastatin calcium, acetylsalicylic acid, umeclidinium bromide and vilanterol trifenatate, diuretics unspecified (water pills), omeprazole magnesium, and cortisone. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient got cortisone injection. On 18 Feb 2021, the patient experienced high sugar level, high blood pressure and face looked flushed. On 20 Feb 2021, the patient started having pain in the ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection. Treatment for the events included Keflex. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events of pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection, sugar was very high, blood pressure was very high, and face looked flushed, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

1. Shaking chills, fever and flu symptoms for one day followed by a day with malaise. 2. Daily diarrhea, watery stool, cramping and bleeding lasting one month. Currently slowly resolving. Treated with a variety of remedies over the month, individually and in combination. ( Pepto bismol, charcoal capsules, imodium, rice, tumeric, and Xifaxin) Imodium would stop the cramping but not the wateriness of the stool. Unlike any diarrhea over the course of my life. I will not be taking any booster shots.

Extreme chills and fever. Cold sweats. Shaking. I took 1 Aleve and went to bed at 8pm. Had chills throughout the night. Woke up the next morning feeling much better.

After first shot in series, I developed slight headache, minor weakness, minor shoulder pain. After second shot in series, 8 hours post-injection, I developed headache, moderate to severe joint pain throughout, fever around 100, extreme fatigue and weakness, slight difficulty breathing. Went to bed for 19 hours and began to feel better with recovery in two days. 14 days post-injection, I developed a systemic rash throughout my body. Consulted with my PC physician. Was prescribed Medrol Dose Pack. This had very minor effect on rash. Returned to physician for consult upon completion of steroid series. I then received a steroid shot intramuscular in right hip and one week oral steroid protocol. This achieved a more positive result, almost clearing up the rash. I had a consult with a dermatologist on 03/02/2021 who confirmed the opinion that the rash was probably a side effect of the Moderna vaccine. The rash has returned fully as of 3/14/2021.

received vaccine friday afternoon saturday started feeling extremely dizzy and weak, difficulty walking sunday unable to walk, blood pressure high, tremors called 911

Patient reported having trouble closing left eye, left facial weakness, and left facial drooping Patient was treated in ED and given prednisone and acyclovir

March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch. March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.

Patient had 2 waves of cold sweats during his 15 minutes waiting period. Patient also felt palpitation or racing heartbeat. Throat became scratchy. Globus sensation. Denied swelling of the throat.

Maderna Covid Vaccine 2nd dose Extreme chills that night, got up to go the bathroom,, had sweats and suddenly felt very dizzy and fainted on the bathroom floor. Felt very weak and couldn't get off the floor. Had a fever of 101.6, Wife had to help me get up after some time on the floor.

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

Patient taken to the Emergency Department following first dose. He felt like his heart was racing and his hands and feet tingling. Was given benadryl in the ED and advised to discuss second dose with his primary care provider. He has a history of allergies to shellfish and possibly other allergens.

flu like symptoms body ache fatigue mild fever felt like my nerve endings on my arm were sensitive ,,chills.....its been 48 hours seems to have gotten better just a little worn out

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Started to have chills around 7:00pm Friday night, then around 4:00am Saturday morning, I got up to use the bathroom and pasted out in the bathroom. My wife sad she heard a loud noise and came into the bathroom to see what had happened. She called my daughter and son-in law to come over and get me up I couldn't move at the time, I must have hit my back and neck because they are sore. Then Saturday night I had sweats all night, today I fell a little better except for my back and neck, I have a doctor's app. Friday. I am concerned about the 2nd shot if the 1st shot did this to me.

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

Severely sore should/arm. Extreme fatigue and hot sweats at second day. No side effects at day two of vaccination.

Fatigue several hours after shot with soreness in arm. From 3/19 - 3/23 I experienced chills and significant body aches and feelings of sudden fatigue that required me to lay down and nap. I felt I had a fever and had a low fever of 99 on and off while taking Tylenol. I only took my temperature a couple of times. The last three days I?ve felt better and really only feel more fatigued usually and have been going to bed earlier.

On the evening of February 24th after the I received the vaccine, I had severe pain on my left lower back radiating all the way to my left foot with tingling. I didn't sleep for 4 nights and I had difficulty walking. On February 28th I went to Emergency Room and I was given a Toradol shot. On Monday, March 1st I went to my primary doctor and gave Prednisone, Gabapentin and Meloxicam tablets then I was given 9 days off from work. Up to the present, I'm under physical therapy and I still have on and off pain on my left leg.

Patient received first dose of Moderna vaccination and soon after felt tingling in left upper arm. Patient received medical attention and refused to go to hospital. Patient advised he felt better at the time of this report.

Please note: The vaccination record I received with lot number is very difficult to read!!! My first vaccination was 12/31/20 and lot number written down but hard to read is (U37K2OA but could be V37K20A) The second shot was 1/27/21 and lot number written down could be (0412OA, or could read O912OA!) I had symptoms of a Pulmonary embolism while cross country skiing March 18 and officially diagnosed with PE on March 22, 2021. I was tested for Covid 19 on March 23, 2021 with negative results. I had been reporting my side effects (which were none) for the previous 6 weeks following the second vaccination. I did have cramping like feeling in my right calf following a x-country ski weekend about 4 weeks prior to the actual PE (2/22/21) but it appeared to resolve after about 7-10 days

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

Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination

Got the vaccine, no reaction to the site. He was able to sleep okay, but then he starting on 3/20/21 his lower back and legs were very painful, really aching for the entire week. The lower back and thighs were sore for the entire week, and didn't know if it was from the vaccine, but talked to some coworkers and they too had the same reaction and missed work. These symptoms lasted until about 3/29/21, and had a miserable week all week lying on a heating pad/ice. He could not sit for very long, couldn't be in the car for longer than 20 minutes. He took Tylenol and Diclofenac for these symptoms.

Severe pain in left arm - elbow, wrist and forearm. Had same reaction to flu shot in December but didn't correlate it to the shot until this second event

Extreme pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my shoulder. I did not have the rash or redness at the injection site. I could not move my arm without felling pain and could not sleep well because of it.

Patient was in observation area after vaccine administration. Twelve minutes after vaccination, he fell to the floor and appeared to be having a seizure. Staff protected him from injury, and administered oxygen, and called EMS. He stopped seizing, then had another seizure before EMS came to transport him to the ER.

Severe vertigo, with cold sweat, extreme nausea-went to ER-given cardiac, blood and CT tests. Symptoms going away. Will follow up with ENT

Monday 3/29/2021 at 9:00 am received the second Moderna vaccine. After 5:00pm, pain started at the injection location followed by body chills. Tuesday & Wednesday 3/30-31/2021: Arm pain, body chills, and joint pains. Thursday 4/1/2021: light arm pain, on and off body chills, joint pains, and fatigue. The second shot?s symptoms were less severe than the first shot.

Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough. The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue. On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious. On 25 Mar 2021, he coughed up some yellow mucus. Treatment for the events reported included pacemaker and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

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

Chills, shaking, cold, sleeplessness - 12hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination. Experienced a continuous and higher than normal rest heart rate, up to 120 ppm, for two days straight after vaccination - this is 30 to 40 bpm above my normal rest heart rate - on day three my rest heart rate returned to normal (80-90bpm) Blood glucose levels were unexplainably higher than expected on the morning reading after the vaccination - 176 mg/dl. Normal expected result range 90 to 135 mg/dl.

Three days after second vaccine, the skin on my back and under my left arm is sore. Shot was on left side. Soreness is now on upper left back and under left arm. Has lasted now for 8 days.

I was very sore in the back and shoulders the following day. Also, my blood sugar dropped severely into the low 60's and I was shivering cold. Two days later I started to develop a rash that worsened over the next several days. I tried treating it with Benadryl spray and tablets but there was no relief. A doctor prescribed Prednisone which also provided little to no relief.

On April 1, 2 weeks after Dose 1, began experiencing upper R arm aching radiating from shoulder to elbow, similar to strain. However, no injury or muscle strain occurred. In addition, began feeling tired in the afternoons, yawning continuously for a few hours. Pain relieved with Aleve. Reoccurs daily. Symptoms have continued. Knowing my daily activity, these are not usual symptoms for me. Of course there is nothing to link this to the vaccine, however, I feel it prudent to report. When I initially received the shot, I had some aching at the shot site, but that went away after a few days.

Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male 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 No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Intermittent Arm and Hand Tingling, Numbness, Occasional shocking and minor loss of grip. Right hand more severe than left. Increasing frequency as time passes. Duration 10 minutes to several hours. I have not seeked medical help yet. Hoping this is a temporary issue.

Got his vaccine, and he was told to sit in a chair for about 15 minutes to see if he would have a reaction. At first he did not have any reaction. As time went on he developed a slight headache, then his body felt warm. When he went to bed he tried to sleep and he could not and turned from side to side, and still could not rest, very restless, insomnia. Then he noticed a pain in his right leg at the bottom by his ankle. He then noticed that his right side was sort of numb and tingling, which went on for about 15 minutes and then it stopped. The headache has subsided. He has the soreness in the arm, but not like it was before. All of his symptoms are subsiding. He did not take anything for these symptoms.

Fever, body aches, fatigue, arm soreness-Onset 16 hours after vaccine, symptoms resolved within 24 hours of onset. Tylenol

the patient stated that he noticed that the left side of his face and his left arm up to the point of injection became numb at about 8:00 pm the evening that he received his second dose of the moderna covid vaccine. He stated that the condition has been improving some as he moves his arm around. I urged the patient to call their primary care doctor to rule out any other possible causes of this issue.

Significant fatigue - 36+ hours Deep muscular contraction, soreness at injection site Slightly elevated body temperature (97.5F to 99.0F)

Sore arm, prolonged fever lasting 32 hours so far, the fever has not subsided yet. Extreme tiredness, I have slept for almost 30 hours. Aches and a side ribs are sore. I also fainted and fell several times during the night.

Moderna COVID-19 Vaccine EUA. Approx 10 hrs post-vacc, sore arm & feeling that my body was "fighting something" (much as after other vaccs/inf post-BMT (shingrix, reclast). At 12 hrs post-vacc, feeling feverish, chills, body aches, trouble sleeping, temp=98.6, pulse=72 (unusual for me. Normal vitals: temp=97.2 to 97.5, pulse=55-62). Trouble sleeping throughout the first night, only 5 hrs sleep maximum. Next morning, at 23 hrs post-vacc, continued trouble sleeping, body aches, chills, sore arm, temp=99.7, pulse=90 (at complete rest, very unusual for me). FYI, i was well hydrated. At 27 hrs post-vacc all same symptoms plus headache, significant malaise, brain fog, remained in bed all day, temp=99.5, pulse=75. Fever.....Fever broke at aprox 35 hrs post-vacc, began to feel a bit better, temp=98.7, pulse=78. At 38 hrs post-vacc (4/10 at 2:00am), i got up from bed to pee, feeling alot better & vitals approaching normal, temp=97.8, pulse=58. At 43 hrs post-vacc (4/10 @ 9am), feeling tired but otherwise recovered, vitals back to my normal ranges: temp=97.2, pulse=56. FYI, after dose #1 of Moderna covid-19 vacc, i had sore arm, mild feeling that my body was "fighting something," and trouble sleeping the first night, but NO fever and no other adverse symptoms.

Ever since first shot my fibromyalgia has been going through the worst inflammatory flare ever. Arms hurt. Biceps hurt. Forearms hurt. Thighs hurt. Calves hurt. Everything hurts. My fibromyalgia was under control until I had the Moderna vaccine. Over five weeks now and am in constant pain.

Lethargic, disoriented, fever 103.7, muscle weakness, joint pain- needed help to walk, weakness, joint pain and fever lasted 2days. Still feeling a little disoriented, balance off a little after 6 days and sore arm,

DEVELOPED HIVE LIKE APPEARANCE ON 04/05-SAW THE DR ON 04/07, RECEIVED STEROID, BY 04/10 IT WAS MUCH WORSE WITH PIERCING PAIN AND BURNING ALONG WITH HEADACHES, AND ON 04/12 SAW THE DR AGAIN, DIAGNOSED WITH SHINGLES

Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040. Pt reported no allergies to medications, no severe allergic reaction in the past. Pt states doing fine with the 1st dose of the Moderna vaccine. Pt was waiting his observation time of 15 min and began itching face, arms, and legs. Nurse questioned pt if he was feeling ok? If he is itching? Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water. Pt declined. Pt started clearing throat and coughing. Nurse questioned pt if he was still feeling ok and again offered pt some water. Pt declined. Pt reports that he is feeling ok. Pt's timer alarmed and pt got up ready to leave. When asked if he is doing ok, pt reports that he is. Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out. Pt was escorted by nurse. Nurse questioned pt again if he is feeling ok. Pt states that he is. Nurse notifies pt that if he not feeling ok then he should come back. Pt states understanding and exits building. Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building. Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified. Pt grabs the wall while ambulating. Nurse provided stand by assist. Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately. Crash cart arrives. Epi 0.3mg autoinjector administered IM to LT at approx 1100. IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered. Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered. Pt O2 sat 97% on RA, HR 102. Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called. Approx 1113 pt O2 sat 90% on RA. Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider. Pt's wife contacted via pt's cell phone. Approx 1116 Epi 0.3mg administered IM to LT as ordered. Pt O2 sat 97% on 2L O2, HR 87. Pt reports itching getting worse. Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119. Approx 1125 EMS arrived. Approx 1127 BP 183/75. Pt taken by ambulance with EMS to ER at approx 1135. Report called to ER by provider. ER transfer form faxed to ER.

4/1/2021 Shivers/Shakes at about 10pm, Fever was high 102+, after midnight began vomiting for along period and until empty. Chills continued with fever thru the night. 04/02/2021: The next day had severe headache and fever all day. Went to bed at 10pm and woke the next day feeling much better. 04/03/2021 Weak all day but headach was gone. Had some shortness of breath for almost a week.

After patient got vaccinated. He was in observation area and complaint of lightheaded, tingling right arm and finger. History of myocardial infarction and stage 4 neck cancer. Patient speech became delayed and did not responded to questions being asked. Paramedics responded. Patient vitals stable. Blood sugar normal. Patient felt better and less dizzy. No shortness of breath. Alert and oriented. No transportation needed.

Pt found unresponsive in hospital room with large amount of vomit. Patient pronounced dead shortly after with cause of death noted to be aspiration pneumonia with hypoxemia leading to cardiac arrest. Pt received vaccine 1 month prior so I wanted to report this.

Narrative: Patient called PCP to report he experienced a hypoglycemic episode after receiving the first of two injections of the Moderna COVID vaccine at public vaccination site (church). The episode was level 3 episode hypoglycemia (Standards of Medical Care in Diabetes 2021). His travelling companion thought he fell asleep on the ride to his home but had difficulty arousing him and called 911. The paramedics advised his blood glucose was 29 mg/dl and that they and other emergency personnel have responded to similar calls for patients experiencing severe hypoglycemia after receiving the vaccine. Patient reports receiving assistance from first responders/paramedics and not recurrence. Specific treatment not documented. Of note, patient with T2DM and CKD on HD, on insulin glargine and insulin aspart. At 2/23/21 pharmacotherapy appointment, reported eating healthier and eating less. Blood glucose of 29 confirmed by patient's continuous blood glucose monitoring device. No other significant lows (AM readings in 70s) noted on log.

The individual felt faint / light headed as he walked towards his vehicle following 15 min observation period . He Did not feel that he would be able to safely operate his vehicle . Returned to the observation area Glucose levels were within normal range reading was normal. Blood Pressure reading and pulse were within normal limits. No abnormal respirations. Appeared flushed and slightly diaphoretic after additional 10 min of observation at vaccine site . Decision made at 3:30 PM to transport to the ER. Patient agreed

Mild headache, muscle stiffness, lack of energy, Uncontrollable shaking chills overnight followed by low grade fever.

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

Very sore arm for 1st week. Arm still sore after 2nd week. Flu like symptoms for 3 days. Observed "gray" stools (affecting my liver) after 3 days; diarrhea; Low grade flu continued for 4 weeks. Fatigue, mild body aches

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

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

Left hand (same arm as vaccine administered) completely numb. Can move fingers, but no feeling except constant tingling. Has persisted about a day now.

After my second shot after approximately 8 hours I got a severe headache perfuse sweating and vomiting, this went on continuously until Monday when I went to a family practitioner, she blew off my symptoms and sent me home where I continued to have these symptoms on and off. When on I was completely disabled. I filed a complaint they called on 4/15/2021, and told me I should go to ER, I told them I was flying the next day to see my mother who is passing away. I promised if my symptoms were still there in morning I would go to ER. I woke up feeling great and then I had a bowel movement my headache was so bad I thought I was having a stroke, I started sweating bullets and vomiting. it was so bad the only thing I can compare it to was when I had Tick fever in the early 90's. I called 911 at hospital I was in a dangerous arrhythmia throwing PAC's and going in and out of 2nd third degree heart blocks. They can not figure out why, the neurologist I saw theory is the same I had, a severe inflammatory reaction to the 2nd moderna shot. He put me on a 3 day course of prednisone which helped a lot in my recovery. I am currently on a heart monitor to see if the heart block was just temporary. I see the neurologist again in 3 weeks.

High fever started few hours after vaccination and continued for 2 days. Chills, shivers, very uncomfortable. I felt the same way when I had Covid 2 months ago.

5 days went by, no reaction, thought I was home clear. I woke up on the 6th day ON FIRE. Not one part of my body that wasn't screaming. I popped Acetaminophen like Tic Tacs for 2 days. Initially, I thought I was going to die, then I was afraid I wouldn't. Never been through anything like that. I don't think I'll get the second dose. I've heard the second is far worse than the first.

Injection site redness...more than 5 days. Arm soreness has decreased daily. Initial noticed effect besides slight soreness in arm... Chills 10 to 11 hours after injection. These increased for next 12 hours. Weakness, moderate to severe nausea( vomiting).. lasted 2 days. Not able to keep food down. Headaches...slight to moderate migraine headache..3 days..in duration...decreasing in severity daily. On second night and third night.....profuse sweating on Second night....restless and little sleep. Third night slight sweats in early morning. After 4 days....eating and getting energy back from a really bad experience.

Veteran contacted call center, Reporting LT Arm swelling from hand to above elbow, No redness reported around injection site. Veteran reports swelling has incresed over last 24 hours, painful to rest arm on object. No other symptoms reported, including No elevation in body temperature. Directed veteran to mission act urgent care for evaluation.

In the past I had a bicep injury. They gave me stem cell treatment. Beyond the normal shoulder pain, I had pain in the specific area of the original injury much more than anywhere else

Patient had 2nd dose today. While the patient was here he indicated that he wanted the vaccine in his right arm this time because approx. 1 week after getting his vaccine in his left arm he started having intermittent pain in his upper left arm where he had received his first dose. He did not seek any medical treatment for this condition. When asked for further details he stated that he would have a sensation of being stung by a bee or feeling a needle going into his muscle whenever he thought about having gotten his shot. However he also said that when he exercises that area of his arm is more sore than his right arm and occasionally when he would lay down after he felt a "little tingling" in his left deltoid region for a while.

Headache, fatigue, chills with some shaking, slight nausea, soreness at injection site. Started in the afternoon and increased until about midnight. Took a normal ibuprofen dose. Slept and mostly resolved by morning. Mild symptoms today (May 4). Note: I had minimal symptoms with the first dose; less soreness at the injection site, which came on more gradually. Reporting this more for data purposes, not as a health problem.

He is newly hypertensive with blood pressure 160/72 with continued cold sweats/"blah" feelings for the month since his second covid vaccine. Suspect he's having symptomatic hypertension. BP has never been uncontrolled recently and he was last seen 3/21

had sided weakness - face - arm - leg. Patient went to ER was given tenecteplase 50mg IV. Patient's symptoms clinically resolved

3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down /or take any meds/had to miss work/ disoreinted/ just kept sleeping all day and night felt better the next morning... went to work on Thursday 05/ 06/ 2021 felt about 95 % better in about 24 hours......no food and no meds and very week....feeling better now, besides tender stomach from dry heeving

Morning after vaccination, around 7am awoke feeling slightly unwell, worsened through the morning to slight fever, headache, nausea, chills, genera debilitating discomfort; began abating 8-10pm and returned to comfortable condition around midnight

4/30: "pain radiates down the right arm and shoulder blade x 5 days Pain underneath right shoulder blade Radiates down right arm Numbness or tingling Of right arm and fingers Patient with decreased strength" 5/2: neck pain x 7 days. Status post fusion surgery in 89 then had right arm and hand issues Last Sunday 5/2 night pain from verterba arm hand pain with tingle Similar to prior pain Was seen in Urgent care , referral sent to phys med from Urgent care md" "have been experiencing crippling pain at the c4-c5-c6 range in my neck, the same region that I had a fusion surgery in 1989. The pain is severe, between 9-10 nonstop. This began a few days after receiving my first shot on April 20th.

Nerve pain across front and back of torso, blisters along nerve trunks. Diagnosed as shingles. Toradol injection, oral prednisone, and Franchville prescribed.

Still feeling weak and tired even upon waking from sleep. I only have a few hours of work time at the most before exhaustion happens.

vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown. No concomitant medications were reported. No corrective treatment was provided. 28-Feb-2021, he was hospitalized for vertigo for 3 days. 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. Very limited information regarding these events have 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. Very limited information regarding these events have been provided at this time. Further information has been requested.

Approximately 2 1/2 weeks after receiving my first dose of the Moderna vaccine, I woke up on January 16 in severe pain in my right shoulder and arm. Approximately two hours later I developed paralysis in my right fourth and fifth finger. I eventually saw a neurologist who diagnosed me as having Turner parsonage syndrome. The pain has resolved but I continued to have paralysis in my right fourth and fifth finger and the lateral portion of my right hand.

Uncontrollable violent shaking that lasted for more than 24 hours that almost sent me to the emergency room at our local hospital

I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.

Pt felt flushed and light-headed after receiving vaccine. Received Benadryl and Zantac form pharmacist. Remained in vaccination booth with wife for monitoring. After 30 minutes pt felt fine and went home. Instructed to seek medical attention if needed. This PharmD called pt at home 1 hr later to check on him. Pt stated he felt fine and did not need immediate medical attention.

A few hours after receiving the shot, my left arm got a little sore. The next day, and for about 2 weeks after getting the shot, my arm remained sore at and around the injection site. Then 3 days later my arms and legs and around my waistline broke out in small, hard bumps and rashes. The rashes worsened to the point of oozing a clear liquid and became very painful. It felt like I had broken glass circulating in my bloodstream. It got so bad I drove myself down to the Montage Health urgent care facility.

Started with slurred speech, difficulty with balance, weakness on 5-1-21. Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness. Admitted to hospital and was diagnosed with stroke.

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

observed slurred speech, drooping side of face, says he was diagnosed by hospital on 5/18/21 with bells palsy

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

Presents to emergency department with complaints of intermittent chest pain for 4 days. Denies any radiation of his chest pain. He also complains of having leg weakness with trying to stand or ambulate x4 days. States that his legs feel like "gummy". Wife notes that the patient has to hold onto objects to aid in ambulation which is not normal for him. The patient denies any headache or dizziness. He denies any acute vision changes. He denies any numbness or tingling to his lower extremities. Denies any history of stroke.

kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass; very tired/very fatigue; urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body; sore arm; slept a lot after the shot; did not have any antibodies after the first vaccine of Moderna; very bad lower back pain both sides within a few hours of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) in a 61-year-old male 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 Herpes virus infection (Improved after Shingles Vaccine.) on 24-Jun-2008. Previously administered products included for an unreported indication: SHINGRIX (First dose- Oct-2019 and Second dose-Feb-2020) from October 2019 to February 2021. Concurrent medical conditions included HIV infection since 18-Feb-1998, Renal agenesis (born without left kidney), Drug allergy (Fluroquine allergy), Contrast media allergy, Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhea (Improved with daily Morphine ER) since 10-Jan-1996. Concomitant products included AMLODIPINE for Blood pressure management, RITONAVIR, ABACAVIR, DOLUTEGRAVIR SODIUM (TIVICAY), DARUNAVIR ETHANOLATE (PREZISTA) and ABACAVIR SULFATE (ZIAGEN) for HIV infection, ACYCLOVIR [ACICLOVIR], MORPHINE, PRAVASTATIN and FINASTERIDE for an unknown indication. On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (very bad lower back pain both sides within a few hours of the injection). On 12-Mar-2021 at 1:30 PM, the patient experienced URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna). On an unknown date, the patient experienced DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue). The patient was hospitalized on 15-Mar-2021 due to URINARY RETENTION. On 13-Mar-2021, URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) had resolved with sequelae. On 22-Mar-2021, DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna) outcome was unknown. At the time of the report, DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue) outcome was unknown and BACK PAIN (very bad lower back pain both sides within a few hours of the injection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine: (High) Elevated creatine numbers.. On 22-Mar-2021, Antibody test: (Inconclusive) No antibodies were developed 10 days after 1st dose of vaccination.. On 22-Mar-2021, Blood creatine:. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported that he was born with only one kidney(Right). The patient was enrolled in a COVID-19 study for the last several months. Sequelae for the event of urinary retention included elevated creatine. No treatment was reported for the events. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event urinary retention was upgraded to serious. Seriousness criteria hospitalization was included for urinary retention. Lab data for antibody test and creatine test were added. Allergy (Fluroquine,contrast dye), historical vaccine(Shingles Vaccine), historical condition(Herpes Virus Infection) were updated in other relevant history. Current condition asthma, mitral valve disease and diarrhea were also added. On 12-May-2021: Additional information provided on 12-May-2021 included an additional 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 event, a causal relationship cannot be excluded.

passed away suddenly a day after getting his first Moderna covid vaccine. He got the vaccine said he felt fine other that having a sore arm he has in good spirits and joking around according to his coworkers. He died suddenly a day later circumstances are unknown ,He had passed before he was discovered. No autopsy was done. Aneurysm is suspected.

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

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

Patient presented 5/22 with acute onset right sided weakness and aphasia, found to have left MCA stroke. He was last normal at 0200 and was found at 0600 when he was found by hi wife. He was not a candidate for tPA as he was outside of the time window once he arrived to ER. He underwent IR thrombectomy with TICI 2B, residual clot in the left A1 and left M3 vessels. He suffered a large territory stroke with malignant cerebral edema requiring emergent decompressive hemicraniectomy. He has been unable to be extubated thus far, as he is unable to protect his airway. He has severe aphasia and right hemiplegia.

Dizziness, lightheadedness, imbalance, ataxia Nausea, vomiting Hospitalized for extensive work-up, Possible diagnoses Guillain-Barre variant (Miller Fisher)

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

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

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

1) within 1 week of having received 2nd dose of Moderna vaccine I developed a low grade fever and was quite lethargic soon after awakening; (May/15 - May/21); 2) I started feeling less lethargic but something was not right; 3) on Sunday 5/23 - I awoke to a fever and night sweats; this would continue every night I tried to sleep from Sunday 5/23 - Friday June/04. 4) I reported this to my primary care physician and a blood draw appt was made for May/27 and face-face annual check-up on June/1st. 5) Several of my blood marker results were concerning and I was asked to repeat blood test and include Urine test. I am being told that I have markers for potential Multiple Myeloma.

DVT- developed leg pain and swelling for several days. Presented to ED for evaluation. Found to have RLE DVT

Patient, received his first dose of moderna covid vaccine 5/8/21 administered by myself staff. Today 6/5/21 he came in for his second dose. He said he still feels discomfort in his arm but not enough to not want to receive the second dose. He said its not painful, he just feels a little discomfort sometimes when he touches the area or lays on it. I told him that if he still feels like this in a week after the second dose he should make an appointment with is doctor.

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

Shortness of breath, injection site soreness, fever, weakness, night sweats first night following injection and progressively worsened.

Racing heart, blood pressure drops feel clammy. 2 severe events many smaller events. Heart rate gets to near 100. My idle heart rate is in the mid 50's.

From the evening on 2021-06-11(Fri), of the 2nd shot of Moderna CoVid-19 vaccine, the whole body was knocked out until the late morning of 2021-06-13(Sun), with pain all over the body, headache, sore throat. Had to be in bed. The reason for this report is that the symptom is contrary to the listed side effects. The 1st shot of Moderna Covid-19 vaccine was taken on 2021-05-12(Wed). After the 1st shot, the side effect symptoms are within the listed. Injected arm was swollen and pain there lasted several days. Except the side effect on arm, other side effects were not noticed. === continued It is understood that the side effect is less after the 2nd shot. However, in my case, after the 2nd shot, the side effect symptoms are far beyond the listed, as described earlier. FYI, the 2nd shot was given a different healthcare worker(LVN?), who was a receptionist for the 1st shot. She used unprotected(disposable dry cotton piece) to clean injection spot and the disposable bandage after shot. Subject suspicion goes for overdose. Please advise.

Patient states that he is paralyzed on whole left side of body. Was told he has slurred speech as well. Patient could not move.

Fall due to weakness, severe myalgias, abdominal pain, elevated troponin, burning and pain in the lower legs and feet.

started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination; slept a lot after the shot; covid like flu symptoms; very weak/very weak feeling; terrible diarrhea; Zero appetite now for 3 days although eating once a day; no longer able to sleep at night; pain in my heart/pain moved from left side heart area and slid toward my left side; neck glands swelled last week/2swollen neck glands; very tired/very fatigue; Bad headache; chills (no fever); heart attack-like pain; lost 20 pounds of his body in the next 24 hours,weight was 184/185; sweat really bad/terrible night sweats; I had pain which I felt like was in the right kidney and lower right abdominal area; I had pain which I felt like was in the right kidney and lower right abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart attack-like pain) and POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after shingles vaccine. February 2020 second dose. October 2019 first dose.) on 24-Jun-2008. Previously administered products included for Shingles: Shingles vaccine in February 2020. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included HIV disease since 18-Feb-1988, Renal agenesis, Drug allergy (Allergy to Floriquins), Allergy to chemicals (Contrast dye allergy), Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhoea (Improved with daily morphine ER.) since 01-Oct-1996. Concomitant products included RITONAVIR, DOLUTEGRAVIR SODIUM (TIVICAY) and DARUNAVIR ETHANOLATE (PREZISTA) for HIV disease, AMLODIPINE BESYLATE, ACYCLOVIR [ACICLOVIR], PRAVASTATIN, FINASTERIDE, ABACAVIR SULFATE (ZIAGEN) and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185) and NIGHT SWEATS (sweat really bad/terrible night sweats). On 17-May-2021, the patient experienced ANGINA PECTORIS (heart attack-like pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area), ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)). The patient was hospitalized from 09-Apr-2021 to 14-Apr-2021 due to POLYURIA. On 10-Apr-2021, POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) had resolved. At the time of the report, ANGINA PECTORIS (heart attack-like pain) had not resolved, WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185), NIGHT SWEATS (sweat really bad/terrible night sweats), SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)) outcome was unknown and RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area) and ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. On an unknown date, Blood creatine: high (High) high. On an unknown date, Electrocardiogram: unknown (Inconclusive) unknown. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications included blood pressure medication. Follow-up received on 11-May-2021 included the completed ADR form with significant information about the patient's medical history and new events. Follow-up received on 12-May-2021 included additional details of lower abdominal pain experienced by the patient. The patient reported that he sought medical care from a doctor's office from 09-Apr-2021 to 15-Apr-2021. significant follow-up received on 03-june-2021 This is a report of a 61-years polymorbid male under multiple chronic therapies; who presented various adverse events after receiving the second dose of the product. For the event heart pain/angina pectoris, the patient was not hospitalized. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-073550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up included additional details about the adverse event reported in the initial SD of pain right side abdomen. On 03-Jun-2021: Significant follow-up added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.

Pain in left elbow and loss of strength in left arm. Got worse after the second dose of Moderna on April 18th. Learning to live with it, like an old sports injury. Hoping the pain subsides, if not I will go to the doctor.

Chest pain down right arm into right hand, radiating down into abdomen. Symptoms started 0800 hours 06/17/2021. Symptoms returned 06/18/2021 at 0600 hours. Emergency Department visit Dx: STEMI Treated with IV heparin and metoprolol

About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by severe sinus congestion which lasted for about 10 days. This has been followed by ongoing severe fatigue, inflammation of my joins, painful movement and walking, brain fog and inability to concentrate. i am still dealing with the debilitating effects 7 weeks out.

Patient came to the Pharmacy yesterday morning (June 20, 2021) around 10:00 AM. He said he received his first dose of Moderna at our pharmacy on May 25, 2021 and complains of shooting pain in his left arm where he received the vaccine, however he does not recall the exact spot where the vaccine was given. He reports not having a shoulder injury or pain prior to receiving the vaccine. Pharmacist and Pharmacy Technician were on duty that day and the patient said that the "female technician" was the one who gave him the shot. The patient reported feeling no pain when he received the vaccine, but days after receiving the vaccine he reported 10 out of 10 pain. This lasted a few days, then the pain subsided to a 5 out of 10. A few days after that, the patient reported the pain going back to a 10 out of 10 and it has been this way ever since. The patient came to the pharmacy with his left arm in a bent position and said he has been unable to extend it fully without causing a lot of pain. He said that even performing small tasks such as reaching over to his right shoulder causes him a lot of pain.

EXTREME shakes, scary I was shaking so much. Weak, couldnt sleep, Extreme sweating. Very fatigued, arm very sore.

Moderna Covid-19 Vaccine EUA fatigue,head ache,night sweats, unintentional loss of weight blood work abnormality pcp referred to hematologist

Patient states that he had "EXTREME whole body shakes( not chills), Nausea and vomited 1 small amount

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

Day after vaccine, pt had fatigue and ?brain fog? which he attributed to normal vaccine side effect. Over the next several days, he did not improve. Reports that people kept asking what was wrong with him as he was having memory issues and word finding difficulty. His symptoms persisted through 6/9, when first eval for sympotms in my office

My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila

rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication 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. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; 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 is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

No reaction to first vaccine. Night after second vaccine, woke up with hands locked together, fatigue, headache and body aches. Patient states he had to have his fingers pulled apart. Each day since, he has continued with hands "locking". Patient states he has been using a stress ball to help relax the muscles in both hands. Patient is concerned since the problem is not only happening at night, but also during the times he is walking, "my hands clinch up."

Pain in arm spread to shoulder neck and back. Over a period of several month traveled down my back into my left hip and travels down by thigh into my left knee

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

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

Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site) and my wife had to call 9-1-1 and EMT's took me to hospital and I was hospitalized for four days. Hospital. I am recovering from the medications still but I have recovered from the health event from the vaccine.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: muscle cramps in leg-Mild

Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021. On 14-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High. Concomitant medication and Treatment medication use was not provided by reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21. He is now a hemi-plegic with severe apraxia and aphasia, unable to work, communicate or care for himself. He had no health issues prior to the vaccination. He was in ICU, Intensive care and hospital for 2 months and rehab continues.

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

Discomfort and soreness at the injection point and left elbow joint about 2 hours after vaccinated. Similar to my 1st vaccine 4 weeks earlier, except this time my elbow joint had some soreness. The soreness and swelling continued to get worse throughout the day and could not sleep well that night. The following day I woke up with a painful and swollen elbow joint, and still had soreness around the injection point. By the afternoon I could not move or extend my left arm with severe pain. The swelling and pain increased and Advil or ice was not effective in reducing these symptoms. The pain and swelling got so severe and I could no longer tolerate the pain and went to Urgent Care. I continue to experience left elbow joint pain, and now experience similar joint swelling and pain in my ankle and knee. It's not as severe and painful as my left elbow joint. I am making this report now because 2 days ago I started to develop the same symptoms in my right elbow joint and leg/hip joint, and now I can barely walk. The joint pain is severe so I will seek medical treatment today.

Uncontrolled muscle spasms radiating up left arm and in hand. Spasms lasted 10 days. Followed by hand shacking and weakness in left arm. Currently left hand is not as steady as it was before vaccine and left arm feels weak.

Congestion like a head cold, raspy throat, nausea, headache, low grade fever 100. -Tylenol taken for fever

Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.

Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:

Moderna COVID-19 Vaccine EUA - I have experienced the following : The injection site is very tender to the touch. The soles of my feet have become numb. Slight exhaustion through the first 24 hours after the vaccine.

4 days after injection, redness and severe itching at site. Treating with warm compress and Benadryl cream.

On January 11th, 2021 patient called to report that he will probably not get the second dose of Moderna due to side effects he had after he received the first dose of Moderna. He reports that for a week after he had brain fog, ie. couldnt remember common things, he reported that he got a 1/2 dollar size black and blue mark to skin where the injection was given, and reports it is still there two weeks after receiving the injection. He also stated that his arm was very painful after the injection.

Significant pain at injection site, worsening overnight. 24+ hours later I am still having difficulty raising my L arm to shoulder level. Significant point tenderness as well. Pain about a 6/10.

Headache for 48 hours from injection, Fever 100.4 approximately 24-36 hours from injection, weakness and fatigue fir approximately 72 hours

severe chills and shaking- bundled up, no other treatment, symptoms abated after a few hours, muscle aches and malaise next day treated with naproxen

COVID-19 Vaccine EUA. Severe pain at injection site approx 6 hours after injection. Weakness, joint pain, slight headache started around 7:00pm 1/23/21 and continue at the time of this reporting 8:00am 1/24/21 If symptoms persist beyond today I will schedule a visit with my primary care physician.

On 1/16/21 stiffness in the hips. Sharp pains in the lower extremities. Prolonged standing and lying down pain. Joint stiffness, and muscle tenderness. All these pains were on the same side of the injection on left arm.

Dec. 29, 2020 - first Moderna Vaccine dose. On same day I had mild localized injection site soreness/pain & felt minimally tired. The next day the injection site was a little more sore/panful & I had moderate headache the whole day. The next day I was fine, Jan. 26, 2021- second Moderna Vaccine dose. Six hrs. later the injection site was mildly sore/painful. 12 hrs. after receiving the dose I began to feel body aches, some chills, decreased energy level & did not fall asleep the whole night. The next day I had moderate headache, continued to have some infrequent chills, body aches, decreased energy level & injection site soreness/pain was still mild but had increased from day before.

Moderna COVID-19 Vaccine EUA. Received 2nd dose on 1/28/21 approx. 10:30 a.m. Approx. 13:30 p.m. ears began feeling warm, left shoulder more painful to touch than first injection, and body slightly sluggish. Left work approx. 17:00, upon arrival home wife noticed my ears were red and I felt very warm. Digital temperature of forehead was 102.7, and ears were 106.4. Took digital B/P and it was 185 / 85. Took two Aleve tabs and sat down to rest. One hour later took temps again and forehead was 100.4 and ears were 102.4. Still felt drained. Removed some clothing, took shower and to sleep. 02:00 a.m. awoke, temps within normal range. Next morning B/P normal as well 135 / 56.

High temperature, difficulty breathing pain in abdomen and ribs. Shallow breathing to try and avoid cough as it hurts so much. Temp in the middle of the night reached 102.4F Chills and uncontrollable shaking.

Narrative: Respiratory failure / respiratory depression went to ED / ICU 2/1/2021. Frail patient. 1st vaccine 12/23/2020 Moderna Lot 039K20A exp 6/20/2021, 2nd vaccine 1/20/2020 Moderna Lot 013L20A exp 7/8/2021

nausea - 30-45 minutes shortly after injection 1/29/21 fatigue body aches - began shortly after injection, continuing but lessened muscle spasms - from 2/2/21 to 2/3/21

Moderna COVID vaccine Lot#004M20A-2nd dose administered. At 9 hours I developed moderate chills and shaking with teeth chattering lasting 1.5 hours with full recovery. Myalgias persist into second day.

Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.

1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger. 1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; senstaion of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity. Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal." Released from post vaccination area.

Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24 hours after vaccine was administered and still continues. Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue SOB started 24 hours after and continues slightly

severe weakness, nausea, extreme diarrhea, fever, muscle aches all over, headache, shakes, Chronic cough much worse than ever and still is.

Fever of 100.0 lasting approximately 12 hours. Slight body aches, lack of energy lasting through 2/13/2021. Largely resolved, by 2/14/2021 a.m.. Pain at the left arm injection site continuing through 2/14/2021. Treated with acetaminophen, 200mg three times daily. Discontinued 2/14/2021 a.m.

a 62 y/o M who presents with concerns for an allergic reaction to the second dose of the Covid vaccine. According to him he got the vaccine around 8:45 AM. He has a history of anaphylactic type reactions with a swelling and urticaria in the past but has not had any symptoms in the last 5 years. He felt sudden onset pit in his stomach, tingling and warm sensations over his face and some chest tightness. He denies all the symptoms currently. He did get medications prior to arrival but states his symptoms were already getting better before he been given anything. He was given epinephrine as well as Benadryl beforehand. He denies any symptoms currently. Denies headache, change in vision, difficulty swallowing, lightheadedness or vertigo, chest pain, sore throat, wheezing, cough, nausea or vomiting, rash, falls or injuries. Denies any recent foreign travel or sick contacts. He did work a full shift yesterday and was coming off a 24-hour shift prior to getting his vaccination. He denies any significant reactions to the first vaccine. Medical Decision Making On initial presentation is an overall well-appearing 62-year-old male who has normal vital signs without fever or tachycardia. He is presenting with concern for allergic reaction of the field to a recent vaccination. The vaccine was given roughly 1 hour prior to arrival. He was given epinephrine intramuscularly as well as IV Benadryl. He states he is currently feeling mildly tired from the Benadryl. He denies any other recurrent symptomatology and feels better. Examination is not concerning for anaphylaxis at this time, no evidence of airway involvement or multisystem involvement. No evidence of local allergic reaction. Low clinical concern for occult infection, metabolic abnormality, ACS or arrhythmia for a cause of his symptoms. He is overall very well-appearing. Labs have been obtained as part of screening for reactions to the vaccination per CDC recommendations including a tryptase and C4 complement. They were drawn over an hour after the vaccine was administered. ECG was within normal limits. After observation patient remained asymptomatic. Did offer steroids, however he wanted to hold off on them as he just got his vaccination which seems appropriate at this time. He was sent home with a new EpiPen. We also gave him follow-up in the allergy clinic. He has any worsening symptoms we do recommend he use the EpiPen as well as call 911. He is understanding. At this point he stable for outpatient management. I did tell him he should expect to feel aches and potentially have inflammatory response to the vaccine, he is understanding of this. Pt was discharged home/self-care. Pt provided strict return precautions, including but not limited to, any worsening symptoms or any new concerning symptoms. Otherwise, Pt instructed to see PCP on an as needed basis.

Intense Injection site pain. Much worse than first does (in left arm). Fever and feelings of overheating. Chills to the point of not being able to get warm. Sleeplessness and fatigue. Headache and fogginess. All symptoms occurred overnight while in bed. Arm pain remains as well as headache and fogginess after attempting to sleep for 7 hours.

Good night of the injection about 11 hours after I got the injection I started to feel very achy and very sore and then led to shiver passing and turning headache and all of the above the next morning I woke up feeling okay I ate a very small portion of yogurts and oatmeal took two sips of coffee and had to go to the bathroom it was very intense I would stuck in the bathroom for an hour intermittently going number 2 and vomiting very sick and scary the rest of the day I was weak and miserable with a temperature and the temperature lasted all the way until last night it range from one hundred and one point eight two last night at a hundred and 128 I had severe muscle aches after I tip my prod element injection yesterday it which is a Statin anyway that today I feel much better but it was very intense I also developed a swollen lymph node under my left armpit the same arm where they did the injection and it was hot and painful I'm afraid to take the second injection but I want to complete the process if possible

Right arm pain with movement starting next day after injection 12/24/2020 and then about one week later the injection site is painful to touch, redness present, swelling, and itching.

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

Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable. CPR initiated, Ambulance summoned. Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired.

Moderna COVID-19 Vaccine EUA: I received my second dose of this vaccine about 9:45am on 2/24/2021. About 7:00pm that same day I began to feel achy. A few hours later I began running a low-grade fever. The worst period of side effects was about 11:30pm - 1:30pm during which I had a fever of over 100,, with aches and frequent chills (pretty much every minute during those 2 hours I would shake with chills even though I felt extremely hot). I was taking ibuprofen at the time (at 7pm and 11pm) yet did not experience any significant relief from the chills & fever until about 1:30am. I continued to feel achy the rest of the night with an off-and on low-grade fever (99-100), despite regular appropriate use of OTC NSAIDS (ibuprofen & tylenol). The fever went away by about 8:00am, and the overall achiness largely went away by 10:30am. At no time did I require any other medical attention.

Extreme Sore Deltoid (1st sign progressed over day). The following symptoms started around 9 pm and increased through the night: severe headache, nausea, malaise, other joint pain - especially joints of previous injuries (lifetime), chills, hot flashes, tiredness - though inability to sleep. I needed to take Tylenol through the night which did help with headache. The symptoms were significantly decreased by 6 pm that day (Feb 24th).

Patient has had numbness and tingling both arms, weakness of legs and fatigue since 2 days after his Covid Vaccine Jan 6th. Has had 2 syncopal episodes since then. Had a syncopal episode Feb 15 and again 2/26/21

Intense chills and muscle cramps. I put on insulated underwear and got some control over shaking. Took 5 ibuprofen and was able to get a few hours sleep.

Dizziness started approximately 30 minutes after injection, weakness approximately within two hours along with extremely tiredness. Muscle pain in left leg started approximately 24 hours after injection.

Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.

3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen every 4 hours. Around 2:00pm, uncontrolled shivering due to chills started. By 3:30, had muscle\joint pain in back and began feeling lightheaded. At 5:30, was unsteady on feet, pounding headache, fever of 101.8F and no appetite for dinner. Fell asleep on couch, woke at 7:30 pm, discontinued ibuprofen and acetaminophen, took 500mg Excedrin, fever of 102.8F and went to bed. Uncontrolled shivering resumed around 8:30pm, woke up several times during the night drenched in sweat and took ibuprofen at 4:30 am. Awoke at 8:30 am on 3/4 drenched in sweat again, took hot shower, had light breakfast and took 500mg Excedrin. Temperature is currently 99.3F

left side of face drooping, given prednisone 10mg take 6 tabs qd for 5 days, then 5 tabs,x's 2 days, 4 tabs qd x's 2 days,3 tabs qd x's 2 days,2 tabs qd x's 2 days then 1 tab qd x's 2 days

After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.

Initially severe chills, joint aches all over, dry cough after 1 day. That went away after 24 hours. Then a severe pain only at the Left Iliac Crest and surrounding muscles. At times very difficult to bear weight or ambulate up steps. Continues tenderness in muscle area just above Iliac Crest. Pain and weakness varies with no particular rhythm. Pain varies from 2-3/10 to 9-10/10 that takes breath away. Pain and tenderness continue to this day.

Woke up at 2:00 am extreme headache I took ibuprofen 200 ml. 7:00 am very weak headache not as bad. Day 2: dull headache, very fatigued, muscle ache between shoulders into upper neck. Day 3: same as Day 2. Day 4 same as Day 2 but now small rash on hip. Day 5 dull headache and rash, not fatigued and no muscle aches. I hope this info is helpful.

Tingly sensation at tips of fingers later became numb, next weaker than day before. But arm was getting worse .

I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to ask if I should get the second one? I was able to get an appointment for a Covid vaccination thru store/pharmacy. I had the shot about 4:00 on Friday. On Saturday about noon I started not to feel right; head ache and stomach. About 4:00 I started to get an increase in my temperature. At 5:30 I started getting uncontrollable shaking. Over a span of about 30 minutes I had 4 or 5 episodes that lasted 30 - 45 seconds. I had a temperature at one point that reached 102.3 I took 200 mg of Ibuprofen every three hours before falling asleep for the night. On Sunday morning I still had a slight temperature (99.9), but it seemed like all my body joints ached. I ended up feeling better about 4:00 on Sunday. Reply

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

I don't have the lot number for the second dose so i listed the lot number from my first dose. Second dose left arm Feb 4th 930am. A few days later i noticed an itchy spot left temple slightly red. Persisted and slowly spread. Left side face, scalp neck shoulders chest, back and eventually entire body. Very itchy, red rash. Went to ER FEB 27TH. treatment with 7 day prednisone. Sx improved but did not resolve. Went back to ER March 13 due to increasing sx swelling and numbness in face. Back on prednisone follow ups scheduled

The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The stiff neck and headaches and general malaise has persisted throughout even until now. As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.

sudden death, while sleeping 2 days after injection Vaccine 3/12/21 last seen conversant and comfortable at 3a 3/14/21 Found nonresponsive and not breathing at 8:30a 3/14/21

3/16/2021 - 6 PM lower left arm lite tingling, at 8 PM blood pressure dropped from 80 to 61 bpm (111/64), at 9 PM now left arm and left side of face lite tingling. 3/17/2021 - Still lower left arm and face has light tingling. 3/18/2021 - 3:40 AM felt nauseated. Took a Tum. Now at 1:40PM the tingle is stronger on lower left arm and left side of face is slightly numb.

tingling in lower left arm; tingling in face; mild nausea -- tingling started in left arm about 8pm night of shot and has maintained since then. experienced tingling in face starting next day

On Friday (05.19.2021), fourteen days after receiving the first dose of the Moderna COVID-19 vaccine (on 03.05.2021) at pharmacy, I began experiencing body aches (mostly leg cramps) followed by nausea, headache, and fatigue. They continued through the next 36 hours. Today (Sunday, 03.21.2021) the headache subsided, but the nausea and fatigue remain, albeit less so than yesterday. I had similar symptoms in the first 24 hours of receiving the first dose but understand that to be a very common experience.

Moderna COVID-19 Vaccine EUA - suspected stroke symptoms was in the ER 3/22/21 released determined likely not a stroke per CT Scan. Returned to ER 3/23/21 as symptoms became more severe overnight - was diagnosed with Bells Palsy via MRI. Prescribed steroid. Treatment was at hospital emergency room.

drive through setup, within minutes after injection, began to feel tingling in forehead which moved down my body. Between 5-10 minutes after injection, I just passed out (don't recall that happening). Woke to 2 EMT's by my side asking to check my blood pressure.. I don't recall the numbers however they stated I 'bottomed out'. shortly after gaining consciousness, I became nausea loosing contents of stomach twice. Remained under observation for 30+ minutes, then wife drove me home. Slept until 5:00 when I was steady enough to walk unaided, and finally eat some dinner.

His neuropathy is off the hook, really bad; Condition aggravated; Severe pain in his arm; A spontaneous report was received from a consumer concerning a 62-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced symptoms of neuropathy gone through the roof and really bad and pain in arm. The patient's medical history states he has an autonomic nervous system problem. Concomitant medications were not reported. On 26 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 number: 022M20A) for prophylaxis of COVID-19 infection. Patient received the vaccine on 26 Feb 2021 and reports that day he had severe pain in arm for around a week. His neuropathy is off the hook and really bad. Treatment for the events were not provided. Lab tests mention 2 negative COVID tests in Mar 2020, but he was not tested for antibodies he says. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, neuropathy gone through roof and really bad, was considered unknown. The outcome of the event pain in arm was considered recovered on 05 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient received the first vaccine 03/04/2021. Patient was contacted to return to the clinic for his second injection and patient received the second injection 03/16/2021. Scheduling staff contacted the patient to schedule the second dose and the patient stated he had already been to the clinic and had received the second dose. Scheduling staff notified the clinical supervisors of the event. Patient was contacted by telephone 3/25/2021. Patient stated his arm was sore after each vaccine and he had a headache the day after the second vaccine, but no other adverse reactions were reported. Patient was instructed that he should not get the series repeated and patient was instructed to notify the clinic with any questions or concerns. The patient was receptive with conversation.

Pt went unresponsive at home per wife, was transported to hospital by EMS and died after getting to the hospital. This is not a suspected allergic reaction to the COVID Moderna vaccine at this time.

Chills, extreme body/joint aches, very sore arm, fatigue starting the evening of the vaccine , lasting yet today 3-26

Woke up with chills, headache, and sore muscles. Did not take my temperature, but felt flushed. Felt lethargic the whole day after the shot (2nd dose of Moderna COVID-19 vaccine).

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

Arm was a bit achy later in day I received the shot but nothing bad. Started feeling chilled about 11:30 pm the day of my shot (Saturday). Woke up about 2:30 am Sunday with chills and sweating. Woke up several times during the night with chills and sweats. Started having slight headache during the night. Took a couple of Tylenol. Woke up about 9 am day after shot (Sunday). Was very tired but chills and sweating were gone still had slight headache. Was exhausted remainder of day. Just stayed in bed and rested entire day. Started to feel better later in the evening about 8:30 pm. Went to bed about 10:30 pm and slept until 9 am Monday morning. All adverse effects were gone.

Patient received 1st dose of Moderna Covid-19 and patient had a seizure while waiting in the waiting area.

Starting approximately 18 hours after first dose on 3.01.21: Severe migraine-like headache for 24 hours (I have experienced severe chronic migraines for the past 35 years, so I know what I'm talking about) Flu-like body aches for 48 hours Vomiting and nausea for 48 hours Sweats and chills for 36 hours, but no fever All I wanted to do for two/three days was sleep After second dose on 3.29.21: Some body aches and general malaise, but nothing dramatic like after the first dose

I had the usual symptoms, but one symptom I don't see anywhere. Usual: Sore vaccine site, body aches and pains, headache, tiredness. I was unable to sleep due to the symptoms the first night. I convalesced the entire next day and tired easily for the next two days after that. Here's the unusual side affect: I had uncontrollable and very painful leg cramps, that I could not relax. I had to take a muscle relaxer. That was the night of the second vaccine. The cramps were abated thereafter. I am reporting them because I saw them as a side effect no where online.

Bell's Palsy; A spontaneous report was received from a consumer, concerning herself, a 62-years-old, male patient, who received Moderna's COVID-19 vaccine and experienced event Bell's palsy. The patient's medical history included Hypertension. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Valsartan 5mg /320mg indicated for Blood Pressure, megarad to lower cholesterol. On 2 Mar 2021, approximately 2-3 weeks prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) via unknown route in left arm for COVID-19 infection prophylaxis. On 17 Mar 2021, The patient experienced Bell's Palsy. The patient felt sore in mouth. on 18 Mar 2021, it was full paralysis of mouth and the drooping face. Eventual diagnosis made was Bell's Palsy. Treatment information included 80 mg of prednisone once a day for about 7 days and valacyclovir hcl 1gm tablet - TID for 7 days Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event Bell's palsy 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, a causal relationship cannot be excluded.

bell's palsy; A spontaneous report from was received from a Consumer concerning a 62-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bells palsy. The patient had a history of Bells palsy in the last five years. No relevant concomitant medications were reported. On 07 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 25 Mar 2021, the patient experienced the event Bells palsy. Laboratory details was not provided. Treatment medication included prednisone and valacyclovir. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded. Patient's prior history of Bell's palsy is considered a risk factor.

Sudden onset of chest pressure with weakness and numbness in hands and legs. Systolic blood pressure on presentation to the ED was 235, indicating hypertensive emergency.

Got the vaccine on 3/26/21 had no problems, and then Saturday morning at around 3:00-4:00 he had a sore arm, nauseous feeling and threw up water a couple of times, and did not eat. He finally ate something that evening, and started having left arm pain, aches and pains. He was having chills, and then fell asleep again and woke up in sweats. He also developed some diarrhea going into Sunday, and Sunday morning his temp went down, his blood oxygen went up and started feeling better. He also still had some chills, and very little sweats than before. On Monday he felt better, his blood oxygen was back to 100, temperature was better. On Tuesday he felt much better and by yesterday 3/31/21 he felt back to normal again. He did take some Tylenol and Ibuprofen for his symptoms during the course of the event.

Pain in L hand and fingers woke me up from sleep at about 430am on 3/26. When making a fist, felt clicking on pinky. Felt and LOOKED like TENDON GLIDE ISSUE (based on my occupational therapy knowledge-base). Believe I did a ice message (I usually don't initiate warmth till after 1st 24 hours.) Did tendon glide exercises and later did a functional activity (washing dishes -squeezing the sponge). Resolved post about 1 hour without need for medications. Need to maximally avoid taking NSAIDs due to my chronic mild platelet issue. Do NOT recall any musculoskeletal issues on the L upper extremity. 3/26 not recall onset of symptoms - believe near noon - Significant Headache & Fatigue x several hours. Slept several hours. May be related to being awake in the middle of the night & PMH of mTBI w/residual symptoms - .

patient had a fever for 24 hours, increased heartrate for 24 hours and a tingling that started around the injection site and traveled to his elbow and down to his fingers. He also had a tingling on his left leg. This tingling started about 24 hours after the shot and is still continuing to occur. The tingling is only on his left side which is the side of his body that received the shot.

106°F fever; severe shakes; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106°F fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERPYREXIA (106°F fever) (seriousness criterion medically significant), TREMOR (severe shakes) and FATIGUE (very fatigued). At the time of the report, HYPERPYREXIA (106°F fever), TREMOR (severe shakes) and FATIGUE (very fatigued) outcome was unknown. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

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

*Vaccination administered on March 11, 2021. (Moderna) *Donated blood platelets on March 21, 2021. (This process was exhausting for patient.) *Numbness and tingling in the left foot begins on March 30, 2021. ** Patient had Guillain-Barre Syndrome back in the fall of 1996, so the numbness and tingling were a red flag. By the time patient was admitted into the hospital on April 6, 2021, he was experiencing numbness and tingling in both feet and tingling on the finger tips of both hands.

After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination . I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand. At that point, 7:00am 03/23/21, my wife drove me to the ER. I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.

High fever (104) Severe body aches, dizziness, Severe twitching in hands and legs. After 24 hours, symptoms are beginning to subside

Dose was injected into left arm approx 1:30 on 4-8. Resumed normal daily activity including rigorous 1.5 hrs of tennis from 18:00-19:30. Left arm was a little sore, but no other adverse effects of vaccination. At approx. 01:00 on 4-9 I was awoken by what felt like severe chills with elevated heart rate. I tried to walk around my house to see if that would ease the symptoms, it did not. About 01:45 I started drinking a Brisk ice tea. That helped & allowed me to fall back asleep. Felt sluggish all day 4-9 with flu-like body aches & pains, so stayed in bed most of day. On 4-10 I resumed my normal activity level.

Unable to sleep due to pain in right arm, chills, adjusted heat to try to sleep but that didn't work. Decided to take hot shower but that caused me to vomit several times. Once I stopped vomiting I started to feel better.

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

Shortly after receiving vaccination patient's wife began honking her car horn. This nurse went to vehicle, patient was clammy, cool to touch, diaphoretic. He was not verbal and had vomit coming out of his mouth. EMS contacted. Vital signs were within normal limits. EMS cleared patient. Wife attributes reaction to severe anxiety related to anything medical.

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

NUMBNESS AND TINGLING IN BOTH ARMS, BOTH LEGS, BOTH HANDS, AND BOTH FEET. PERIPHERAL NEUROPATHY THAT I NEVER HAD BEFORE THE VACCINE. BULGING VEINS ON ARMS AND LEGS, HANDS AND FEET. STILL CONTINUING.

The day after my first shot I seemed to develop nerve damage in right foot. I went 11 days in severe pain and half my foot was numb. Doctor said nerve damage but no idea of cause. It?s been over 3 weeks now and pain is minimal but 1/4 of foot is still numb. Was going to get 2nd shot today and realized the pain started the day after I got my first shot.

I received the shot around 9:15 AM. Early afternoon started feeling tired and a general feeling of unwell. Went to bed around 9:00 PM. Woke up at 10:00 PM with real bad chills and headache. Got up at 1:00 AM 4/12/21 very hot and chills. Took my temp and it was 103 degrees. Felt dizzy and weak. Took two Acetaminophen and went back to bed. Got up around 4:00 AM still hot. Took temp and it was 101.6. Took two more Acetaminophen and went back to bed. Continued this type of treatment all day. Drank water and rested. All day had temp, headache, fatigue, and nausea. Went to bed at 7:00 PM after taking 2 Tylenol PM's. Upon getting up (4/14/21), took my temp 99.5 degrees. Still have slight headache and fatigue, but feeling better.

On 01/20/2021 I got the vaccine. About 36 hrs later, I developed hives from left shoulder down to hand left. I had to remove my wedding ring. I also developed hives on my shin from knee to down to my ankle. I still have numbness in both thumbs and forefingers like they are asleep.

Received the vaccine Saturday am 3/20/2021. Saturday pm had numbness in right foot that lasted a few minutes. Headache off and on started Sunday 3/21/2021. No medication taken for headache. On Tuesday evening 3/23/2021, driving home from work had a sensation of something being wrong. After arriving home at 7 pm had a short term memory loss. Could not remember details of the day, for instance, or that he'd already had the Moderna shot three days prior. Was driven to the emergency room at about 9:30 pm. Memory gradually improved over the hours following the spell. They kept him in hospital until 3/25/2021, doing tests to rule out stroke, seizure, brain tumor etc. All tests came back negative. Was diagnosed with Transient Global Amnesia.

Slight Nausea 20 mins about 10:15 - 10:20 AM after injection vomiting about 5:00pm Nausea for about 2 hrs after vomiting. sore arm for a day after injection Small itchy Bumps/Rash, over entire back for two or three days after inection

I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce palpitations, the week prior and during the day of the stroke. I tried to take Flecainide twice before in the past few months, but I was unable to tolerate it. When I had the stroke, I didn't realize I was having one since I'm in very good health. I emailed my electro-cardiologist about my symptoms that day and found it difficult to use the appropriate words and reading the email later, I could see a number of mistakes. My ability to comprehend spoken language that day was impaired. I could only keep a few sentences in my head at a time and my attention span was poor as well, like having significant ADHD, which I don't have. I was unable to retain simple amounts of information the day of the stroke. I didn't seek treatment on the day of the stroke since I felt it was more of the side effects I had been experiencing from Flecainide. After going to the hospital I felt good and much improved, cognitively. An ER neurologist said that my stroke was a 2 on a scale of 1 to 42. Over the remainder of March and until this day (April 16, 2021), I have made steady and rapid improvement. I attribute my recovery to the lower level of stroke damage and the fact that I worked out every day with physical exercise and I worked out cognitively by doing a series of activities that I chose myself: reading out loud, reciting poetry and tongue twisters, playing logic and puzzle games on the PC, returning to my writing tasks for work, practicing grammar, and speaking at length with family and friends as a way to practice speaking. I had one appointment with an occupational therapist and two appointments with a speech therapist and have completed assessment. I now feel I am nearly completely recovered with an odd sense of some improvement in certain areas such as heightened mood and quicker connections for noticing practical matters.

Shot given at 9 am. Chills, body aches, headache, and 100.6 fever started at 9 pm. Temp went up to 101.6 at 10 pm. Chills stopped about midnight, headache persisted, temp dropped to 100.6. Did not sleep well. The next morning about 6 am, temp dropped to 99.9, headache persisted. Temp normal 24 hours after shot, headache went away, body aches subsided. Never took any pain medication, though I knew I could. I do take excedrin migraine about 5x per week normally. Was happy about side effects as it confirmed my immune system strong. Symptoms tolerable and subsided after about 24 hours. Spent most of day after shot in bed. Arm did not get that sore (Shingles shot 2 much worse). All side effects gone after 48 hours. Glad I resisted temptation to take pain meds though I know it would have been ok to take after shot. No side effects after Moderna shot 1, except for a sore arm.

Patient described lightheadedness and left arm tingling approximately 15min after receiving vaccine. Vitals WNL, patient elected to stay additional 15min for monitoring. Patient discharged from clinic at 9:40am.

major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse effect. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported. The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.

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

Within 5 to 10 minutes felt flushed, then a head rush. Got worse to the point where I was blacking out. Slumped in my chair grasping the sides holding on. Informed the person that gave injection that I might pass out, she said that I could sit there until I felt ready to go. Took deep yoga breaths while grasping on the chair hoping I would not pass out fall and crack my head. It slowly subsided. She kept saying I could go when I felt better. Really! I finally left after 30 minutes. Sat in my car with windows open for another half hour. Felt better as the day went on, slept well and felt better the next day.

On 4/6/2021 woke up with severe left muscle cramp in left leg. Next 3 to 5 days tried massage, ice, compression and Motrin - no relief. Did no treatment for the next couple of days. Went to primary care doctor and then got an ultra-sound on 4/14/2021 at clinic - by Doctor. Results showed had three blood clots in left leg. Started on Eliquis that day.

Right hip pain lead to sciatica like nerve pain. Using ice and lidocaine to reduce pain. Severe, recurring nasal discharge and minor amount of sneezing first night after shot. After the discharge ended after a few hours I felt that my (prevaccine) sinus infection congestion in upper sinuses actually got better. I have taken a lot of prednisone for chronic sinusitis and asthma and after the vaccine (espec first night and second day) I felt similar (unable to sleep--jittery--flushed). Slight fever that never exceeded 100 degrees first night and second day. Normal temperature 48 hours later.

Aching neck and upper back shoulders, lack of energy (~6PM). Chills and low grade fever sore injection site (~1AM). Sore injection site and lack of energy (following morning).

Extensive DVT requiring surgery. Received second Moderna vaccine approximately one week prior to admission, presented with acute onset of left leg swelling and pain. Left lower extremity ultrasound demonstrated an extensive deep venous thrombosis extending from the common femoral vein into the peritoneal and posterior tibial vein with a patent IVC. He was given a treatment dose of enoxaparin and admitted to the hospitalist service. Overnight he developed diminished sensation in his toes and vascular surgery was consulted. On 3/31/2021 he underwent mechanical thrombectomy of the left superficial femoral and common femoral veins as well as stenting of the left common iliac vein stent. Of note he was noted to have May Thurner physiology with compression of the left common iliac vein by the external iliac artery on the right. Post procedurally the patient's swelling and edema was significantly improved. He did not have any significant pain or difficulty ambulating. On postoperative day #1 he was evaluated and found to be hemodynamically stable with improvement of his symptoms and stable for discharge home. Prior to discharge it was discussed with the patient that he will need to be on a loading dose of Eliquis for 7 days, followed by a maintenance dose of 5 mg twice daily. No h/o COVID.

Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to confusion, fever and loss of cognitive impairment. (unable to walk and speak) speech was out of context) and loss of muscle use and fever.

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

Severe case of shingles (Herpes Zoster) started 3/26/2021 just cleared up but severe pain from neuropathy. (I know of another case where I work of someone in their 20's).

Fever, chills, headache, body aches, lack of energy. From 4/7/21 6 am until 4/8 4 pm. Headache did not subside until 4/9 10 pm

Second Dose Side Effects A fast heartbeat Dizziness and weakness Fatigue/tiredness Headache Muscle & Joint pain Chills Fever Nausea Vomitting Diarrhea Abdominal pain Lost OVER 20 lbs from starvation, inability to eat for 5 weeks, this skyrocketed ALT and AST.

Right leg behind knee is feeling pain and numb. While sleep my wife noted that left leg and both arms are trembling like convulsion. when I wake up I feel a cold spine pain coming from neck down to right leg. Also, at night my wife mentioned that many times I grabbed her right hand or arm very tight and she wakes me ups.

Initial presenting symptoms upon awakening four days after his shot were muscle spasms, "felt things in his chest," and dark urine. Within 48 he was confused and was unable to state his last name, which progressed to unresponsiveness by ~7 days after the vaccine. He has since become comatose and his brain MRI is notable for hyperintensity involving the deep gray nuclei as well as the periventricular and subcortical white matter diffusely, bilaterally. The etiology of his comatose state is still under investigation, but a detailed infectious, autoimmune, and malignancy work up at 2 different medical centers and have since been unrevealing as to alternate causes.

My arm was very sore to the touch and hurt to move. I developed symtoms like a bad flu withou chest and nasal symptoms. I had a bad headache. Severe fatigue and body aches. Ran a temp of 99.1 for about 12 hours. Took no reducers. From the night of the shot to mid-day (48 hours later) I slept 30 hours. I woke up to use the restroom. I drank a lot of water. After 48 hours and all that sleep and water, I felt better. A little fatigue for a couple of days more.

I woke up at 3:10 am feeling cold and chilling. I took by temperature and it was 98.4. I normally have a temperature of 97.1 - 97.7. I take it daily multiple times. My hands were cold. When I got up and started moving around I didn't have any more chills. When I got up at 6:30 am. I just didn't feel well in general. Slight feeling of sniffles, congestion. I would get some aches that went away in a few seconds. They were at various points in my body, knee joints, muscles, and my head. They were simply a nuisance. I felt tired all day. My blood pressure was up 15-20 points on both numbers during the day. I've told my doctor when my blood pressure is higher, I'm having more aches and pains as though I'm fighting a virus. I tolerated the symptoms most of the day, letting my immune system try to work it out. My symptoms seemed worse at 5:45 pm, so I took two ibuprofen. My temperature was 98.9 at that point. The highest it's been. All my symptoms got better until 1:15 am. I woke up feeling like I was chilling, but not as bad as yesterday, so I took two more ibuprofen. I feel 50% better today and haven't taken any ibuprofen. Here is the really strange part. I had these exact symptoms and similar temperature ranges twic last year. In July and October I think. I didn't get tested last year because they were minor symptoms. They were just nuisance symptoms. I took ibuprofen right away last year. I followed the masking guidelines, social distancing, etc. So, is it just coincidence I had similar symptoms last year two times, that I had when I getting the inactive Moderna vaccine? I had no reaction to the first shot. I just wanted to provide the information in case it is helpful. Very strange. I expect no other symptoms in a couple of days.

Client complaints of feeling hot. Client was brought to observation area via wheelchair. Vital signs stable. Client was offered, water icepack and mint. Client reported feeling better. Encouraged client to report at the next vaccine appointment.

Client has had a very achy arm since his second injection on April 8th. It was bruised but is healing. Client had a flare up yesterday 04/22/21 of not being able to move left arm well. Client states the injection site is 3 to 3.5 inches below shoulder. Client advised to place heat on arm for 20 mins and complete range of motion exercises.

The vaccine was given outside of the system (? county program). Patient's daughter thinks diffuse or migrating arthralgias started about 4 days after the vaccine was given. He visited ED on 3/09 complaining of pain in multiple joints for 3 weeks. No labs were done then. He returned 3/19 with difficulty walking and talking, was sent to SNF after MRI with diagnosis (probably incorrect) of acute cerebral infarct. He returned to the ED on 3/29 less alert, and no longer able to speak. LP showed 10 WBC (mostly lymphs) and protein 70. MRI was repeated, looked similar to previous scan , but reinterpreted as diffuse cerebritis, worst in basal ganglia. By 4/02 he was deeply obtunded ... (cont. on next page)

1) After midnight, I began to get what felt like the shivers, but they were unlike anything I had ever seen or experienced, as I could not stop shaking, feeling like I had to try to get warm. I had a heat pack under my back, and no temperature, but for 25 minutes, kept shaking. 2) At 10am in the morning, I began hallucinating, which has never happened to me before, and I only recognize because when my Dad was dying of prostate cancer, they had him on morphine and he began to see things. It was a very specific hallucination, of being in a specific from in front of a specific computer talking to a person. I feel quite reluctant to share this. This lasted for somewhere between 30 and 45 minutes. 3) I've vomited once, and had diarrhea, drinking lots of water, and only using Tylenol. I did not take the Tylenol until after I stopped shivering.

I was typing in this section when I was timed out due to "inactivity". Pls change your definition of "inactivity". I do not believe that I will be able to duplicate what I previously wrote before being timed out. I will do the best I can. To the best of my recollection and ability. NOTE: Automatic Wrist BP readings (also takes pulse) closely follows manually-taken Stethoscope Sphygmomanometer readings. 4/22/21 Doing active range of motion pre and post injection. 7:45pm Signs & Symptoms (S/S) Mild - arm discomfort w/swelling, fatigue, lightheadedness, and body ache. Ice- alternating periods of 15 minutes on, then off - done several times. Lessen arm discomfort, no redness noted. Slow increase S/S through night. 4/23/21 mid afternoon- marked increase S/S plus start sporadic flush feeling, noted 1 x 1 inch oval red area over site. 8pm- Increased & more constant flushed. Temp 98.9 F. Noted marked increase body ache, first moving across chest, then descending to both toes/feet. 9pm- Temp 100.4 F. Monitoring temp, hoping peaked. 9:30pm 99.9 F- 9:50pm Felt very dizzy, self-palpated pulse- felt weaker than my normal, noted more distended veins on arms. Asked wife to get pulse oximeter- sat/pulse ranging 93-97, depending on finger, hand, how long on each; noted amplitude lower than my normal; 82-86 range pulse. 9:53pm Obtained BP R wrist supine 105/61 Pulse 82. Felt too dizzy for BP to be done in sitting. BP confirmed by second reading. BP wrist supine sys about 30 -35 & diastolic about 10-20 below baseline. 9:56pm Took 1000mg Acetaminophen. 11pm Temp less than 99, marked decrease head to toe pain, more towards my mild lightheadedness at times due to my mild TB baseline. Able to ambulate. 4/23/21 4-5 am Temp low 98 range (more my normal). 7am BP L wrist supine 135/70 Pulse 69. Sat 98 reading obtained very quickly, pulse amplitude more my normal. Feeling better but not to Pre-vax. Repeated BP & Sat readings twice during the rest of date. Don?t recall time of 1st BP 135/70 Pulse 70 & Sat 96/Pulse 69, noted injection site redness. 9:30pm- started having headaches, pain on L side head (near site of my head wound/mild TBI site), slight increase lightheadedness, injection site red area increased in pain & size to covering almost full deltoid area. BP 125/73 Pulse 65 Sat 97/ Pulse 65. Both Sat numbers obtained very quickly, as per my normal. Ice used. Alleviated pain to tolerable. Monitoring size of red area & intensity/duration of lightheadedness. Recall a strong tingling sensation going down my left arm once. Noted change in sensation afterwards. Slight increase lightheadedness felt due to what usually happens in change in weather, like rain coming. Rain occurred. 4/25/21- Basically the peripheral of deltoid showing redness with some scattered redness centrally. At 8pm redness fully covering deltoid area. Will continue to monitor ("Covid arm"). Other than fatigue thought due to vax, NO S/S of markedly reduce platelets. If need be, will contact Teledoc. Have prior training as a respiratory therapist & occupational therapist.

I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood pressure, a little dizziness and weakness.

Arm Pain - Lasted 2 days, No treatment Headache - Mild to Medium Headache lasted 36 hours. No treatment, no medications taken Fever - Slowly rose to a high of 101.2. Fever last 36 hours. No treatment, No medications taken

Polymyalgia rheumatica; Pain became more consistent; Arm pain/pain is in his arm; Could not lift arm; Inflammatory reaction; Shaking; he could not get out of bed, was shaking, and used a cane to walk; Pain in legs got worse; Bedridden; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pain, Rash, Panic attack (2 episodes) and Anxiety. Previously administered products included for an unreported indication: PREDNISONE (for 6 days). Concomitant products included PREDNISONE for Pain and Rash, METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), PAIN (Pain became more consistent), PAIN IN EXTREMITY (Arm pain/pain is in his arm), ARTHRALGIA (Pain in shoulders), HYPOKINESIA (Could not lift arm), ARTHRALGIA (Left hip hurt), INFLAMMATION (Inflammatory reaction), TREMOR (Shaking), GAIT DISTURBANCE (he could not get out of bed, was shaking, and used a cane to walk), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in legs got worse). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN (Pain became more consistent), PAIN IN EXTREMITY (Arm pain/pain is in his arm), ARTHRALGIA (Pain in shoulders), ARTHRALGIA (Left hip hurt), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in legs got worse) had not resolved and HYPOKINESIA (Could not lift arm), INFLAMMATION (Inflammatory reaction), TREMOR (Shaking) and GAIT DISTURBANCE (he could not get out of bed, was shaking, and used a cane to walk) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Since the patient's first dose of the Moderna vaccine, he had not been on prednisone the whole time but was recently put on a Medrol pack. He was diagnosed with polymyalgia rheumatica as his pain became more consistent after the first dose of the vaccine. His pain is in his arm and shoulders, his left hip hurt and he was not able to lift his arm all the way up. The patient believed that the vaccine may had caused an inflammatory reaction that aggravated his pain that was present before the vaccine. The patient also stated there was a time that he was not able to get out of bed, he was shaking, and had to use a cane to walk. He says he never had joint pain, only stiffness when waking up and soreness in his hip and leg that was painful. After the vaccine, his arm hurt to the extent he could not sleep on it and the pain in his legs had worsened. He makes it very clear he had a lot of pain prior to the vaccine, but the pain he was experiencing now is more consistent. This case was linked to MOD-2021-081568 (E2B Linked Report).; Sender's Comments: MOD-2021-081568:crosslink

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

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

Severe headache for 20 hrs. starting at 2am. Very weak and no apatite. Severe lower back pain for 30+ hrs. Slight fever for short period of time. (100.1) Sore arm at shot location.

Patient admitted with left sided weakness on 4/21/21. First covid-19 vaccine (Moderna) received on 3/23/21. MRI/MRA shows acute infarcts of the right caudate body and striatum. H/o HTN, hep C with cirrhosis, COPD, tobacco abuse, alcohol use disorder, GTC seizure disorder. ECHO on 4/21/21 which was normal. Patient thought to be actively overusing alcohol at home. Patient was treated for stroke and discharged on medications to help with alcohol withdrawal symptoms (clonidine, gabapentin) as well as aspirin, plavix, and atorvastatin for new stroke. Thrombocytopenia noted (platelets 50K), however patient?s platelets have historically been low likely related to alcohol use. Per hospitalist discharge summary, low suspicion for vaccine induced thrombocytopenia. HIT Ab test ordered on 4/21/21, resulted negative. It seems to be coincidental that stroke occurred about a month after patient?s first covid-19 vaccine but reported to VAERS for completeness. Did not add covid-19 vaccine to patient?s allergy list. Patient received second covid-19 vaccine (Moderna) on 4/28/21.

On Friday, April 9, 2021 PT received the second Covid shot. The shot was administered in the right arm. About 6:00 pm on that same day significant pain started, affecting his right arm, elbow, shoulder , and chest. By Monday 4/12/2021 the pain was so severe he went to a local clinic to get checked. He was prescribed Naproxen for pain. He was still in so much pain on Tuesday 4/13 /2021 he went to the ER . They took him immediately back to check for possible heart attack and blood clot. After a stay of 6 hours the tests came back that there was no heart attack or a blood clot. He was prescribed more pain medication. Still not getting any relief from pain and now PT's fingers are going numb, PT went to See Dr. on 4/15/2021. Dr. determined that the shot had somehow effected the nerve endings. He gave him a dose pack of steroids by pill. He told him to check back if not better in a while. The week of April 19 the pain eased up through the day to around a level 3, to only return at night to a level 10, resulting in more loss of sleep. PT went back to Dr. on Friday, 4/23/2021 and received a steroid shot in the hip and a prescription of Gabapentin. The Dr's opinion was that it could take weeks to get better, and discussed getting a referral to a neurologist. Today is Thursday, April 29 and PT's pain is still constant through the day at about a level 3-4 , but at night the pain level is severe.

pt says he woke up next day and he had a sore arm and other common flu like symptoms that subsided the same day. On 4/25/2021 he woke up w/ Bells Palsy on the left side of his face. He called his PCP . He had a tele-visit and was prescribed Valacyclovir 1gm every 8 hrs and prednisone 3 20mg tabs once daily. On 4/29/21 he had a tele-health visit w/ NP . He was prescribed some sleep meds. Today 4/30/20 he has a headache behind his left ear. He will FU w/ his PCP Magen Mallet on 5/3/21.

Patient developed left leg swelling and pain. Ultrasound performed showing superficial thrombophlebitis of L posterior tibial vein.

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

Pt reported that he was vaccinated around 2:45 pm and at 6:45 pm the same day began to feel nauseous and light headed. He states he was so weak he had trouble getting into bed. He also experienced feeling cold and sweaty. He states he took his temperature and did not have a fever. He states he felt a little better around 8:30 pm and ate crackers and soup. He states he didn't sleep well and was still nauseous and felt like he had heartburn around 5 am. He states he was able to eat at 7 am the next morning (3/13) and took a shower around noon. Pt states he took his blood pressure on the morning of 3/13 and that it was low. He says he took his blood pressure daily until the 22nd, and it took about a week for it to return to normal for him. Pt reports that he saw his primary care provider on 3/18/21 and his EKG was normal but his BMP was elevated. PCP referred him to cardiologist.

Patient developed severe bruising on left inner side of the arm. This developed around one week after the second dose of the Moderna vaccine. He also informed us that the night before he had wrapped a CPAP cord around the arm. The arm had a ball that was painful at touch. Patient came in today (05/04/21). The bruise was still there but formed a yellow color indicating the bruise is dissolving. There was no heat or nodule in the middle. Informed patient to call his PCP as soon as he can. He is due to have surgery next week for his DVT issue on the left leg.

6 days later pain in chest, next day went to lung, called the Ambulance. Admitted to the hospital, on 2nd day transferred to another hospital 4th day, went to arm. Released from the hospital after 7 days in the hospital. Still have numbness tingling and pain in the right arm. Going to have EMG today.

Bells Palsy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 25-Apr-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown. Action taken with the mRNA-1273 in response to the events was not applicable. Treatment medication are Valacyclovir, Prednisone and Gabapentin. 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.

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

fatigue, slight shortness of breathe for couple hours, especially if i went for a walk, sore arm that got worse a day after shot then started to subside 36 hours after shot.

Began as low grade fever and night sweats on 4/5/21. After two weeks began having difficulty breathing, and fever reached 102°F and was more constant. Pulse rate increased by almost 50% over 2-1/2 weeks. On 4/23/21, after 2-1/2 weeks of increasing fever, pulse rate, and breathing difficulty, pulse rate shot up past 200 so I went to the ER. Kept in ER for 4 days, was on oxygen for first 3 days. Diagnosed with Pericardial Effusion caused by Viral Pericarditis. Treated with anti-inflammatory medications. Have had two more SVT (SupraVentricular Tachycardia) episodes since; had to go back to ER for one of them Slowly recovering over several weeks.

Developed signs and symptoms of left posterior thalamic stroke with sensory loss and pain. Began approximately 10 hours post injection and has persisted since that time.

Patient states his arm is still extremely sore 4 days after he received the shot; patient thought shot was given higher than previous dose; has not seen a healthcare provider

Bell's palsy (a neurological condition where drooping of the eye lid and the face happens); This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LISINOPRIL, LOVASTATIN, QUETIAPINE FUMARATE (SEROQUEL) and TRAZODONE for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No adverse event as Medical History was reported. Patient did not receive the second dose of the vaccine due to this condition. Treatment information 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.; 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.

Body & joint pain, shivering chills, some numbness on right arm and slight discomfort urinating. This progressed gradually from approximately 18 hrs. after I received the 2nd dose.At about 22hrs.-26hrs. I experienced the most severe of the aforementioned symptoms.After I awoke the next at morning at 5:00am I still was feeling a little achy. By 10:00am I wasn't experiencing any symptoms.

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

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

10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy.

10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy. ADDENDUM: TEMP WAS 97.1 THIS MORNING (MY NORMAL TEMP) 97.1 WHICH IS MY NORMAL TEMP AND JUST NOW WENT UP TO 100.2 AT 6PM ET

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

Patient reported fatigue and progressive weakness since given vaccination. Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.

Patient developed sore arm and leg cramps that went away the next day but starting on 1900-2000 the same day as the 1st vaccine, patient became very nauseous and vomited. As of 3/12 patient can not eat properly. He is taking Zofran but symptoms are still persisiting. Patients stool is really runny and he can not get his blood sugar below 200.

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

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

Moderna COVID-19 Vaccine EUA 1st Dose: On April 24, 2021....No adverse side-effects. 2nd Dose: On May 22, 2021 (4PM)....No initial side-effects. However, I woke up at 4AM on Sunday May 23, 2021.....experiencing severe non-stop "body shaking/chills"....This lasted for approx. 1 hour. Sunday May 23, 2021 - 9AM ----Presently my only complaints are a "flu-like" weakness and tiredness. No chills since 5AM.

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

No initial reactions or side effects from the first dose on April 12, 2021. Three weeks later on May 3, 2021 if felt fatigued by evening time and had chills and sweats all night. No energy on May 4, 2021 and slept all day with bouts of chills and sweats but never had a temperature over 98F. Woke up the morning of May 5, 2021 and discovered a large red patch centered over my left hip THR incision scar. The incision scar was very sore and a dark purple. I had a dull dehydration type of headache and had to urinate about every 20 minutes on May 4th. Went to the emergency room and was diagnosed to have cellulitis and given a 7 day dose of antibiotics and 10 day dose of antiviral medication. The rash never was very itch and started to subside immediately after taking the first dosage of these two medications. Went to see my primary physician on May 10, 2021 and he believes I had vasculitis and not cellulitis. No signs of any insect bites or cuts to have started the infection/inflammation. He noticed that blood vessels in and around the red patch which was about the size of a dinner plate were elevated to the surface. Followed up with Dr on May 25th via telemedicine visit and he ordered another series of blood lab and urine tests on June 10, 2021, to make sure my ESR, CRP, and urinalysis results were continuing to decline.

Patient's wife reports a diabetic episode the morning after receiving the vaccine. The patient was fine going to bed the night before, but in the morning about 20 hours after receiving the shot the patient was unresponsive to wake up in the morning. He struggled to open his eyes, but was able to awake with some coaxing. His blood sugar was 175, but came down after taking measures to lower his sugar. He was able to get up and walk around, drive like normal within 2-3 hours after waking up. The patient's wife states the reaction was abnormal, nothing different occurred the night before, the only change was the vaccine administration.

6/3 @ about 10:00Am felt warm sensation in my head then 3 bouts of disinyness in succession. I had to sit on the ground for a couple minutes because I felt I was at risk of passing out

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

05/07/2021 1000 - Headache, slight numbness of left side of face, body aches continuous. 05/08/2021 0800 - Lower extremity aches 48 hours duration. 05/09/2021 0600 - Red non itching red rash noted on chest, 6 hours duration. 05/25/2021 1500 - Elevated blood pressure. Diagnosed with mild hypertension with no previous history of mild hypertension.

HE DEVELOPED A SEIZURE DISORDER 2 WEEKS AFTER HIS FIRST MODERNA VACCINATION AND WAS HOSPITALIZED FOR 3 DAYS AT HOSPITAL.

I do not know if this is related to my vaccine but I thought you should know this information. I was diagnosed with Bell's Palsy, on 5/18/21 treatment valacyclovir

Chills, fever, body aches, muscle aches, flu like symptoms, loss of apatite, extreme discomfort lasting ~ 2 days

I had pain in my arm and it was swollen up. I was really tired. I had a headache (low grade), dizziness, and an hour or 2 later I started getting chills really bad. The next day I felt dizzy and kind of foggy. I did not take my temperature.

Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the vaccine was not the cause, he had other medical issues too. This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

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

1st vaccination had little after effects. 2nd vaccination: terrible leg pain...within 2 hrs. of the 2nd shot left knee swelling and one week later right knee swelling to where I can't hardly walk or bend either. Knee pain persists to today (06/16/2021).

I experienced immediate chest pain, chills, difficulty sleeping, numbness, dizziness when standing. Vomiting. Occasional elbow pain on left arm.

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

Had sweats within a few hours but seemed ok. Around 3AM had a seizure but just like a eyes open no one home which passed within 15 minutes. Got up and around 9 AM had a full blown seizure kicking, moaning, unconscious Fire dept responded to home we were staying at and so did fire truck. Patient was transported to the ER where he stayed a few hours . Given chest x ray, blood draw, and an IV bag . We went to his seizure Dr once back to report incident

Initially started with the common known left underarm lymph node pain and mild swelling. After a couple of weeks the lymph node pain continued and intensified with additional pain radiating up and around the entire left shoulder for about two more weeks. Then at about 4 weeks later, the ongoing pain continued, with an additional burning nerve pain and numbness radiating down the upper arm, across the elbow and down the lower arm into the wrist. No relief of pain, now at 11 weeks post second vaccination.

Patient became disoriented incontinent extremely high blood pressure lethargic exhausted confused jumbled speech

I had the injection on 03/04/2021 I had the first dose on the vaccine on 03/06/2021 four days after that I had lower pain in my back, right glute and right leg. Three more days after that on 03/13/2021 I could not get up from the couch and my right food could not raise up. I was hospitalized at the emergency department. I got there at 8 or 9 o clock at night and was hospitalized until the next day. I was there for around 5 days. It ended up being diagnosed as a infectious disease. I was on Vancomycin IV. I was then put on vancomycin home infusion for six more weeks that along with opiates for the pain.

Starting about 3 minutes after receiving the vaccine patient began to have shaking in right hand and arm. Patient reported that he felt like he was going to have a seizure. After about 15 minutes patients shaking in arm got worse and then patient had a seizure. Following patients seizure he continued to have shakiness in hand and arm for approximately another 20 minutes. After this patients arm and hand returned to normal and patient was fine.

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

a couple days after the second shot his arm swelled up; After his whole upper torso swelled up; has no strength in his arm; pain in his muscl; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) in a 62-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) , while the parent received the product for COVID-19 vaccination. No Medical History information was reported. In 2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the adult was diagnosed with PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up) (seriousness criterion hospitalization), SWELLING (After his whole upper torso swelled up) (seriousness criterion hospitalization), ASTHENIA (has no strength in his arm) (seriousness criterion hospitalization) and MYALGIA (pain in his muscl) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to ASTHENIA, MYALGIA, PERIPHERAL SWELLING and SWELLING. At the time of the report, PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) outcome was unknown. The action taken with mRNA-1273 in response to the event was not applicable. The patient had been in the hospital for a week due to symptoms. couple days after the second shot his arm swelled up and then after his whole upper torso swelled up. The patient had no strength in his arm and pain in his muscle. No concomitant medication information was provided by the reporter. No treatment information was 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.; 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.

APPROXIMATELY ONE MINUTE AFTER RECEIVING MODERNA, PT REPORTED FEELING DIZZY AND HOT. I APPLIED ICE PACK TO WRISTS AND A COOL CLOTH TO BACK OF PTS NECK. PT SAID HE COULD HEAR HIS HEART BEAT LOUDLY IN HIS EARS SO I THEN CHECKED PTS BLOOD PRESSURE , PULSE OX, AND PULSE RATE. PTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED BUT PULSE OX AND PULSE RATE WERE NORMAL. APPROXIMATELY 5-10 MINUTES LATER, I RECHECKED PTS BLOOD PRESSURE AND IT NORMAL. PT ASKED FOR AND DRANK A BOTTLE OF COLD WATER. AFTER 35 MINUTES PT SAID HE WAS FEELING BACK TO NORMAL.

1st shot 3/13/2021 my left arm still hurts 4 months later. Not a constant pain but for example if i stretch or try to sleep on my left side or if i flex my muscle. Even though it hurt i did have my seconfd shot on 4/15/2021 Please advise am getting very concerened

Extreme muscle pain in right arm, upper & lower arm, pain is in the muscle not the joint(s). I have had this pain for several months. I have pain while driving, using the mouse & keyboard at the pc.

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

Suffered an unwitnessed fall this evening ~ 0130. Prior to this he had been ambulating in the dayroom around midnight without difficulty at his baseline and interacting with staff. He then went to his room. During rounds ~0130, the staff found him in the bathroom face down. He stated he lost his balance but was not able to provide more information. He was assisted up and he had difficulty walking . RN noted three abrasions on his forehead and one on his chin. His vitals were 146/86, 20, 74, 97.2. He had a change in his baseline mentation and ambulatory status at that time. Patient transferred to local ED, where he was seen by two providers. At that time, patient was noted to be using his right arm and left.

Transverse myelitis, with symptom onset around 6/22. Symptoms began with bilateral lower extremity weakness and pain, and then progressed to constipation and concomitant bandlike abdominal pain.

On March 31st, 2021 I received my first shot of the Moderna Vaccine, after testing negative following a 5 week session with Covid-19. The results of the first shot was a violent reaction within 10 minutes of the vaccination. Symptomes included; tingling in my face, followed by the 2 extreme symptomes (numbing left ear and left neck spasming) that I experienced during my spell with the Covid-19 on January 5th 2021, I was diagnosed with Viral Pneumonia. After vaccination, I was sent to the emergency room for treatment. While waiting for the ER personnel to address my symptomes, I went numb from top of my head to my toes. I told the nurse what happened and the medical staff came in and started treatment of (Benytrel, steroids by I.V. delivery. I broke into a red rash from head-to-stomach. The doctor administered Adrenaline to speed the medication effect. I left the hospital 2.5 hours later, pink skin color instead of red. The rash would come and go for 30 days. Because of the reaction I experienced. I did not move forward with the 2nd shot in fear of another violent reaction. So, I had a strong case of the Covid-19 without any breathing problems and had my first shot of Moderna vaccine. What are my options to be fully protected against the New Delta variant? My current age is 62. Please advise! Thanks

Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188. We had him lay down and about 10 minutes later his blood pressure was 140/70. After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.

Person had a fever of 102.4, pulse rate of 118, he was non-responsive with edema of the right calf & ankle this morning when he was assessed.

Symptoms were first noticed the following day of the vaccination at at 6 AM. They were chills, hands and feet being extremely and unusually cold, fatigue, body aches and soreness at point of vaccination. Body temperature increased but not to above 98.6.

On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.

3 days after receiving vaccine am experiencing extreme pain inmy lower back and knee, weakness all over

Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia.

Patient sat down and alerted observation that he was experiencing feeling flushed and felt his pulse was faster than usual. He took off his jacket to cool down. As time progressed, he said he did not feel as dizzy. Patient was in observation for over thirty minutes. EMS arrived at scene to evaluated patient. Patient signed a refusal form to go to the hospital and to receive treatment. Pulse 76, pressure 121/83, oxygen was 96. Patient was instructed to download the app .

Event: Horrific night sweats Time: Each of 5 nights after first vaccination, each event was less severe than prior event Description: Awoke at night after injection (12-14 hours after injection) totally drenched in sweat and needed to towel off to get rid of sweat. No other symptoms except for mildly sore arm. Had only one episode. During the next 5 nights had similar events, but each was less severe than the previous event. I have had occasional mild night sweats associated with Zoloft in the past, but these in association with the vaccine were orders of magnitude more severe

Thursday Nite starting at 11 PM: A warm feeling at the top of my head like a heat lamp. Lasted 15 Minutes. Then Left Leg, Two Toes start pulsating/shaking uncontrollably. I rubbed with the right foot...it would stop...then start back up. Lasted 30 Minutes. Then my chest started feeling like I had a bad sunburn on my skin. Lasted 30 Minutes...all the while these strange things were going on, I noticed I had asthma. I ONLY get asthma if I have a cold or flu. I thought to get up and take an inhaler but decided against it worried about an adverse reaction to the vaccination. I fell back to sleep and awoke with no asthma and all strange symptoms gone. Then Friday afternoon I developed chills and a queasy stomach (belching and gas and loose stools.) I checked my temperature (on multiple occasions) and it was normal. These two conditions lasted until Saturday. Also on Saturday, I developed aches in my neck. Then very late Saturday Night, I awoke to a sweat drenched tee shirt but chills were gone. Sunday...today....I feel perfect.

8/10 arm pain, chills , fever, malaise a few hours after 2nd dose. Sx slightly improved today. First dose with minimal SE's.

Was fine after receiving shot. Woke up at 4: 00 a.m. next morning with 101.5 fever. Took Tylenol but would not go down. Called primary doctor. Told me to take ADVIL. Still would not go down. After hours and very weak, called 911 and ambulance too me to the hospital. Arrived and they too vitals. Still high fever. Blood work showed high white blond count. stayed at hospital until late at night. Fever went down. Told me some people have thee type of issues with Moderna. Checked brochure Moderna provided says fever but not High fever. Doctor dismissed me from ER and told me to rest the next two days. I had Covid in October 2020. They wnet ahead and did another test. Waiting on results

Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Soreness in left arm, tiredness approximately 12 hours after receiving vaccine; symptoms were gone the next day.

Arrived to the hospital with questionable stroke, 2 seizures in route to hospital (witnessed by EMS personnel) approximately 8 hours after injection.

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

Muscle pain and cramp like symptoms mostly in legs over night for 6 days, fatigue, loss of weight and appetite

2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on the signs of Stroke "FAST" Patient Issues: Physical shaking like Parkinsons , Heart Palpitations and rapid BPM, Chest Pressure, shallow breathing, stuttered speech, Slurred Speech, Headaches, Confusion and lack of short term recall, red flush face, difficulty in comprehending conversations, reading

Patient experienced a grand mal seizure approximately 4 hours after receiving his first dose of the Moderna vaccine.

Day 1: sore arm, fatigue, headache Day 2: headache, fatigue, chills, mild nausea, body aches, joint stiffness Day 3: sore arm, fatigue, lower back pain, chills at night Day 4: sore arm, a period of body aches, a phase of fatigue, sudden lower back, neck, and knee pain Day 5: sore arm, fever, chills, lower back pain, stiff joints, neck pain, headache

Received 2nd vaccine in morning at 10am, that night at Midnight started a fever. Fever of 102.2. Fever lasted for 24 hours. Muscle aches and pains, joint pain, lower back pain right side, headache. Fever broke after 24 hours. Some continued weakness for a couple days. Then back to mostly normal. 10 days later, mild fever returned in the evening of 2/9, and 2/10, temp of 101. These second rounds of fever went away during the day. And temp was between 99.8 and 101.2. My question is: Is it normal to get a mild fever 10 days after 2nd vaccine shot?

high fever unresponsive to tylenol, muscle pain and weakness, sore arm, joint pain, mild shortness of breath, headache

2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence 2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise, cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement

The second day after I got the vaccine shot, I started to have pain on my left shoulder. I thought it was the normal adverse reaction and I kept watching it until the pain continues with tingly sensation on my left middle finger. I called my family doctor and schedule an appointment to see him. My doctor advised me to take Aleve or Ibuprofen for one week and also go to Community hospital employment office which I did and they noticed I have swelling on my left neck ( lymph nodes ) I have pain on my left shoulder and Tingly on my left middle finger hence am submitting this report.

Developed Bell's Palsy left side of face 96 hours after vaccination, after having neck stiffness and headache that started 48 hours after the vacc. Condition diagnosed by family physician.

Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Second and now third day have speech trouble, articulating is difficult, stumbling somewhat, typing is very difficult. No fever, cough, or flu-like symptoms.

Severe muscle spasms in both shoulders extending down the arm where the vaccine was injected. Nausea, fever and servers soreness at site of injection

Got the 2nd dose of Corona Vaccine Moderna at 12:45pm yesterday - at 6p, started to feel weak/dizzy - then this am on 2/22/21 at approx 6:30, pt had a syncopal episode with preceding dizziness, denies cp/fever.

I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs. I then tried to drink cranberry juice and eat 3 bites of a banana which I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days

Morning after shot was at church and all of a sudden got nauseous and very hot for a number of minutes, then passed out before leaving church. Had a cut lip, nose and have a stiff(sore) neck last day or so.

Severe chills, shaking and fever lasting 6 hours. Fatigue lightheaded dizziness vomiting next 2 days +

I have been having muscle spasms, uncontrollable jerking and shaking, mostly when I'm at rest. I'm also getting a little tingling in fingertips and toes. I have had muscle tension in upper back and shoulders, generalized irritability. It is affecting my sleep. I went to the emergency room today, and I have a doctor's appointment scheduled and neurology on Wednesday. ER gave me some fluids.

Vitals Stable. BP 150/89 / BP 150/89 / BP147/88 HR 70 / HR 64 / HR 64 RR 16 / RR 16 / RR 16.

Pain in left arm radiating down to left hand, muscle cramps and soreness. Loss of strength. All problems is to this date.

About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to the top of my head. It almost like little shocks going thru my body. I had a video appointment with my Dr. and he prescribes doxycycline and prednisone. The next day the fever went away and started to feel better (48 hours later). I also tested positive for Covid on 12/24/20, I didn't wait 90 days before I got my vaccine. I felt awful with the second dose, almost worse than being in the midst of Covid. I'm currently on Workman's Comp. I'm constantly out of breathe and have no energy, I use to have tons of energy. From my atoms apple to my sternum I have tons of pain. My lungs feel like I'm smoking and have tons of pressure. My Dr. ran test because I have the worst head aches. I'm like slow motion.

Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134. MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93% and 97%. Client continued to be diaphoretic, pale, also shaky

I felt fine the day of the shot. During the early AM of the next day, I felt significant body aches. As the next day unfolded the other major symptoms included Fatigue, chills, fever of 101, headache and body aches. I got into bed at 3PM Wednesday afternoon, continued to have some combination of the symptoms adding night sweats. The next morning, all symptoms cleared. Body temperature was back to normal. March of 2020, I had severe Covid illness. I was in bed from March 18 to April 1, then Hospitalized April 1 to April 6. It took me until about the first of June 2020 to recover and rebuild stamina. I had brain frog until Nov 2020 neck and headaches until the present time (March 5, 2021)

PER PT DAUGHTER. RECEIVED VACCINE AND HAD NORMAL SORENESS OF SITE. AFTER 5 DAYS, HAD SEVERE PAIN IN LOWER EXTREMITIES AND HAD TO GO TO HOSPITAL ER 3/5/21. WAS GIVEN STEROIDS AND NSAID AS WELL AS PAIN SHOT DURING VISIT BUT DIDN'T HELP PAIN MUCH. FELT A LITTLE BETTER NEXT DAY BUT WENT TO PRIMARY CARE AND WAS TOLD TO STOP MEDICATIONS FROM HOSPITAL. NOW WAITING FOR ULTRASOUND. DURING THE COURSE HAS EXPERIENCED SEVERE PAIN, SWELLING, HOT FLASHES, NAUSEA, AND LOSS OF APPETITE.

3hrs following injection severe headache 12 hours following injection 102- 105 fever lasting 24 hours. Tylenol dropped the fever from 105 to 102. Accompanying fatigue, weakness. Unable to get out of bed for 24 hours. Fatigue continued for additional 24-48 hours. No lasting fever past 24 hours of onset.

Evening of was sore shoulder muscle, lasting for 3 days. Starting on 2nd day, soreness down into upper arm, almost to elbow. 3rd day sore and itching. Upper arm, just below shoulder muscle appears red like sunburn. Area about 3 inches, shaped like upside down heart. This area still sore and very itchy. No blisters or noticeable bumps, but slightly raised and harder than surrounding areas. Still prominent on March 9th.

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

About 15 minutes after the injection approx 10:55am I started felling light headed and slight dizziness, Its now 3:00 pm still a little light headed, flushed and feeling tired. I've not done any treatment for the symptoms

Several hours after the vaccination, my back started itching. The itching lasted that evening and into the next morning and then subsided - no treatment done. No rash. Also had fatigue the entire day after the vaccination. My right arm was sore.

Moderna COVID-19 Vaccine EUA. Approximately one week after receiving the first vaccine, I began experiencing pain in my left elbow and now it has also moved down to my knuckles on my left hand. It continues to this day and is sometimes severe.

Patient wife called clinic at 1156 am. Patient lethargic, too weak to stand or walk, dry heaves. Advised to call 911 and take to ER. Called patient 3/17 for details. States on 3/4/21 in the evening, he developed HA, chills, and body aches. 3/5/21 took a shower and became light-headed, near-syncope or syncopal episode reported by patient. Wife gave him a Zofran ODT, which relieved the dry heaves. He rested remainder of day. Felt mostly better by 3/7/21, with remaining fatigue until 3/9/21.

Wife reported symptoms of all-over tingling, increased heart rate , and increased BP. Patient took over-the-counter Benadryl and symptoms subsided.

Exstreme chills and body shaking for over 1 hour at 2 am next morning. Complete body ache all over. Headache and sick to stomach with no vomiting. Cold chills off and on for 2 days and very fatigue.

Day 1 Arm soreness; Day 2 - alternating times of trembling/chill with fever conditions throughout the day. After 5PM mainly 101 fever, tired, muscle aches, headcahes, chills, hair follicles hurting ( had this when I had COVID-19 mid-March 2020); My symptoms from the 1st shot brought back memories of how the COVID-19 virus felt, except I did not have the congestion and sinus issues. Fever broke at 3AM morning of March 13, woke up soaking wet, entire body and hair drenched as if I stepped out of the shower, did not dry off and got into bed. Felt fatigued Day 3 but feeling a lot better, able to be more active. Today is March 19, 8 days since shot #1 and my arm at the Vaccine site is still a bit sore, redness has subsided however. Worried post shot 2 may be worse.

Moderna COVID?19 Vaccine: I was recovering from a mild sprained ankle/foot for about a week. At the time of vaccination I had very little pain and could easily put full weight on the foot. About 13 hours after the injection, I awoke to a throbbing foot and severe pain in that foot. I could no longer apply any weight to it and it exhibited considerable swelling. I visited the doctor and am now resting, icing, compressing, and elevating the foot. Diclofenac Sodium was prescribed for pain. Vaccine induced stimulation of an inflammation response is a possible explanation.

illness onset 1 day post vaccine (headache, fever, chills, aches) Severe body rash and Prurtus appearing over multiply locations on the torso, back, head, legs and arms approximately 2 weeks after second (2nd) Moderna vaccination shot. Other symptoms include headache, fatigue, dizziness, asthenia, Current course of treatment prescribed for rash is Prednisone 20mg. Symptoms as yet NOT resolved.

In November of 2020 I was diagnosed with COVID 19 and subsequently recovered. This was my first Moderna shot. I took the shot in the right arm and completed my work day with no side effects. I went to the gym that night - as usual - and wanted to "work that arm" a little. I had a good workout, no issues. Went home, ate and went to bed. About 1 or 2 am I woke up with the hottest raging inferno flu-like fever I can recall having as an adult. I did not want to alert my wife, so I simply stayed in bed and did not measure my fever level. My guess is it was >102. Fever continued until a.m. and deep body pain hit me. At dawn my fever measured 101. I took acetaminophen and took a cold shower. Fever subsided for a short while. Then it came back. I felt weak and flu-pain so I stayed home from work and simply slept it off. Symptoms slowly subsided by 7pm day 2. Day 3 I was not 100% but I went to work and was fine. No other symptoms since.

Patient reported "covid" rash that he had from previous infection last year that got worse after vaccine, patient reported chest tightness feeling like his sore arm made his chest hurt.

On 2-24-21 I received my first dose lot #030M20A and had flu like illness the following day that lasted all day. The 2nd dose I started to feel bad that afternoon , I didn't sleep at all that night running a fever, cold chills, my body was sore and ached,restless, headache , and very weak. If I knew this is how I would had felt I would have never got the shot! And I will never again it was that bad.

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

Severe pain right foot at base of big toe - same as possible gout attack for past two years. Could not walk on foot and very sensitive to touch. Took Mitigare and was nauseous all day. Next morning pain subsided but nausea stayed with me by Saturday morning everything was back to normal

After the first day I developed soreness at the injection site. After about 2 days, the soreness moved to my left shoulder joint. Currently, 8 days after the injection, my left shoulder joint remains sore and any motion to left my left arm laterally from my side is painful; like my joint is inflamed. There is no redness or other visible external signs or discoloration. I can not say for certain it is linked to the Modern vaccine as I've had left shoulder issues infrequently in the past. But timing wise, my current discomfort started shortly after receiving the vaccine.

Fever, chills, headache, fatigue and soreness in the arm where I got the shot; started feeling worse about 8 hours after getting the vaccine. Lasted about 36 hours.

Migraine, shoulder/back pain and states went to ER and treated for bell's palsy. Went to ER 3/19/21 per patient

Body aches, strong head aches, heartburn, bloating, nausea, calmly, feel hot but no fever---for 3 days and counting

Had first COVID vaccine dose in right deltoid 3/30/21. On 4/2/21 started having soreness in his back and right breast. Was seen in urgent care 4/3/21 after noticing some bumps, and was diagnosed with shingles (noted to be located in right shoulderblade area).

Patient developed right facial drooping 20 minutes post vaccination. He went to ER and was diagnosed with right Bell's palsy.

Per administering nurse: "Gave benardryl 25mg PO x 1 dose. Feeling flushed, light headed, O2% 97%, HR 88, stayed for 1 hr felt back to baseline after 1 hr, left to go home safely"

Grand mal seizure at 11:30 a.m. Continued having seizures until 2:00 a.m. 3/29/21 He had not had a seizure for 3 weeks. He had not had seizures for this long a period of time for as long as we have on record. His neurologist stated to give him Ativan each time they were becoming constant,

Arm sore 48 hours. Day 4 post shot lymph nodes became very painful. Saw Primary Care Doctor at 7 days after shot - Dr. ran blood tests, did not indicate vaccine could be the cause. Bloodwork normal. Day 11 (Sat Apr 3) and 12 (Sun Apr 4) experienced cold chills and shaking about midnight. Day 13 (Apr 5) at about 5:30 p.m. experienced cold chills and shaking and 101.5 fever - controlled by Tylenol. Followed by sweats when Tylenol wore off over night. Shaking lasts about 5-10 minutes, cold until heating pad applied - about 30 minutes. Day 14 (Tue Apr 6), 15 (Wed Apr 7), early evening chill and shakes - Tylenol stops it. Pt. feels FINE during the day - with just sore lymph glands and some fatigue. There has been only one episode of chills/shaking per day, always in the evening. Experienced sweats overnight only on Day 13 and 15, so far. Symptoms are alarming, and uncomfortable at night. Daytime symptoms of fatigue and sore lymph nodes do not impair daily activities. He continues to take Tylenol as needed.

rash, bumps and itching on neck and chest on right side of body. muscle sore in area of administration. warm to touch. Advised patient representative to inform PCP of reaction prior to receiving 2nd dose. Tried to contact patient, left voice messages, no response to obtain further information for reporting and to check on current condition.

Patient got 1st Moderna Covid vaccine on 3/24/21. On 3/29 patient started getting a runny nose. By 4/2 patient started getting fatigue with loss of appetite and on 4/3 started getting right sided abdominal pain with movement. Seen in the clinic on 4/5 with tachycardia 112 apical and temp 99.1, abdominal pain was feeling a little better and only reproducible with use of abdominal muscles. No resp symptoms except intermittent runny nose. Patient appeared very dehydrated on exam, IVF were offered but patient declined. Labs were done and patient was encouraged to aggressively hydrate at home. US abdomen was ordered STAT. Patient declined US on 4/6 because he was busy so it was scheduled 4/7. Covid test scheduled for next available apt. On 4/6: Labs showed mild increase in WBCs and dehydration but otherwise no major abnormalities. Patient reported new onset swelling, redness, and pain in his R leg and concern for DVT. He reports family history of DVT in his mother. US of the leg was added to his testing on 4/7. He also reported on and off chills. 4/7: Report called for US Abdomen was negative but patient did have extensive DVT in the right leg. Eliquis was called in and patient instructed to pick up and begin immediately. He denies any respiratory symptoms today but still intermittent chills. He reports that abdominal pain has resolved.

Patient stated he experienced bilateral involuntary hand movement, bilateral hand weakness, bilateral leg weakness "shaking" that started around 9 pm, and lasted until mid morning of 3/6/2021. Patient states, " I was unable to get out of bed for almost 2 days, due to shaking/muscle weakness." Patient states he experienced a fever at the same time. Patient called the nurse number to report a reaction/ seek care, but the patient states. "The person said there was nothing they could do to help him." Patient had person stay with him to assist him with daily cares.

Patient came the the pharmacy for the Covid vaccination (Moderna). After Intra-muscular injection, Patient was asked to stay for 15 minutes in order to observe the side effects/Allergic reactions if any. After 5 minutes-Patient reported that he is feeling anxiety or numbness on his left hand and arm. Patient states his left hand grip was not as strong as before.-We checked blood pressure, Blood pressure came out to be 212/116. We called the management Pharmacy protocol-Code White- for injury), Management asked the patient if we need to 911?. He said yes and we called 911. Paramedics took him to the hospital.

Injection site red and hot, hard oblong swollen place; also, tingling in thumb; weakness & trembling in that arm.

Next day fever mild headache severe redness and aching left arm/during the week left arm itching under armpits and wrist, went to physician on Friday 4/9/2021

Two days later and continues today patient does not feel well, having body aches, feeling sluggish, low energy and tired quickly. MD does not want them to have the 2nd dose of vaccine per wife.

Arm became red, hot, swollen and itchy down to elbow. Experienced worst fibromyalgia flare I have ever had for approximately 24 hours.

Started on 4/9/21 (1 day post vaccination) with lower back pain and impaired ability to walk. Progressed to numbness and pain in the lower extremities. Unable to walk. Presented to the Emergency Room on 4/10/21 and was admitted. MRI showed inflammation in spinal cord. Treated with IVIG and IV steroids. Diagnosed as myelitis. Remains hospitalized and scheduled for spinal tap 4/12/21

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

The patient came in this evening and wanted to report his adverse reaction to me. He stated that the day after he received his second dose of the Moderna COVID-19 vaccine on 3/26/21 he had several severe side effects start that are ongoing. He had a large red lump appear on his arm that was swollen, sore, and red. His arm is still sore. He also began to have severe body aches and weakness. He stated that the weakness has not gone away and he is still having difficulty performing daily tasks. He stated that he reported the reaction to his physician.

I have red sore spots on my toes on both legs. They are red and tender and painful to touch and walk. They seem to vary a bit from day to day. I did not visit a doctor. I never had something like this before and nothing changed in my behavior or shoes. Just concerned about what they are and how to treat them.

My left hand was in severe pain for maybe two hours. I took three Aleve to try and stop the pain. I could not close my hand into a fist, nor could I hold anything in my hand. No grip at all. My hand remained like this for most of her night. Today it is a little better, I can close my hand and make a fist, but I am unable to close tightly and grip anything. I feel as though the strength in my left hand is gone for now. No pain today but the muscles in my wrist and in my left hand are still somewhat tight and present what feels like muscle tightness parallel to a pulling of the muscle. I rode my motorcycle to work yesterday, the morning ride was good, on the way home, my hand started with the pain thing. It was severe enough to prevent me from using the clutch lever properly. Presenting a lot of pain squeezing the lever to engage the clutch.

Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.

Patient's wife called PCP's office to report possible vaccine reaction. Approximately 4 days after vaccine, patient had significantly worse neuropathy in bilateral extremities as well as sleeplessness. These are chronic conditions for the patient but per wife they were notably worse following vaccination.

Pain in bones and joints (one day) Migraine headaches (for four days straight) Had to go to emergency room. No real relief from side effects. Just had to suffer until it was over which would 4/15/21

Pt. reports immediately feeling tingling in both hands and some dizziness with mild nausea. Pt. denies ever having similar reaction to vaccines or blood draws. He reported he does have an allergy to "streptomycin mixed with penicillin". Pt's BP initially elevated in treatment room. EKG ordered and reviewed by physician. As time passed pt. reports symptoms "dissipating". Pt. evaluated for 30 minutes and sent home with ER precautions given.

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021. On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

later that night patient began to have extreme back pain, legs hurt even to touch (lasted for days), knees rubbery ...patient had pain for 11 days...patient had dizziness and his balance was off...patient had difficulty breathing ...patient stayed in the er all day underwent a battery of tests "all day" ...in the end didnt have answers ....still having problems breathing and coughing ...patient was zapped of all energy and had difficulty even dressing self

very sore arm, nausea, headaches, high temperature (99.4), felt like a zombie, felt sick, stayed in bed, unable to concentrate

received the vaccine on Monday 4/19/21 into his left arm Tuesday 4/20/21 he went to work but after lunch became extremely fatigued and achy, went home to sleep it off Wednesday 4/21/21 he woke up with right UE/LE numbness and weakness which persisted until Thursday 4/22/21 so sought medical attention

Constant "tingling" from below elbow down to thumb and hand. I have not reported this to my doctor. Planning to "wait and see" if it clears soon.

I received my second dose of Modena vaccine last Thursday (4/15) morning at 9am. No initial reaction occurred. Later that Thursday my arm got the expected tenderness, muscle ache. Towards evening, I got pretty tired and was starting to get some body aches, took 2 tylenol and went to bed at 9pm. Slept in late and was tired. Started to feel like mild flu which is what I expected. Friday took some naps and continued mild flu symptoms. Went to bed about 8pm and got up at 5:00, feeling a bit better. Saturday I continued to improve, arm was much better, less flu symptoms, didn't need tylenol, had turned the corner. Cont'd... Saturday evening was going to go to bed at 10pm and noticed my left cheek was kind of pressing against my gums - it was swollen. It continued to swell some but was not hindering my throat or breathing. I decided to stay awake, keep an eye on it and if necessary would go to an emergency room. The swelling increased only slightly more over the next couple of hours to the size of maybe a golf ball (a bit less) on the left side and a much smaller amount on the right side. No airway effects. I did apply some ice but not sure if that had an effect. I slept for a few hours. Sunday morning I did not take my medications as a precaution. Sunday the swelling was slightly less and seemed to be going down a bit. I took 2 Benedryl at 11:00 am which really knocked me out, slept. Sunday evening the swelling was noticeably improved but not gone. Took 1 Benedryl at 10:00pm bedtime. Monday still had a bit of swelling on left and right swelling is nearly gone. No other symptoms.

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

Began feeling warm within a few hours after vaccine. Was clammy at first, with slightly elevated temperature. By nighttime, had severe shaking, chills, profuse sweating & unable to sleep. We didn?t take temperature, but he finally stopped shaking mid-morning the following day. Was weak and very fatigued two full days. It was like an instant flu, but it was only the first jab and most reports of reaction seem to follow the 2nd. Think it may be due to presence of antibodies post-COVID.

Sore arm (early symptom); slight chills (12 hours later); mild fever (100F-12+ hours later); headache (12+ hours later). Rest; Advil.

patient developed pain and muscle spasm on the left anteriolateral aspect of the thigh, symptoms improving, occurrence after injection. he was being treated for a few week prior for acute back pain with imaging showing degenerative disk disease

Left side of head fells like needles; Arm pain; Sleepiness and fatigue; Splitting headache on the left side of head/throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left side of head fells like needles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tuberculosis. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (Left side of head fells like needles) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing). At the time of the report, PARAESTHESIA (Left side of head fells like needles), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing) had not resolved. Concomitant medication was not reported. Treatment medication included paracetamol and oxycodone 5 mg. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company comment:This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and non serious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and nonserious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. 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.

Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing

1st, after about 2 hours: sore shoulder 2nd, after about 5 hours: whole arm, chest, back and side pain. 3rd, next morning: all of the above, plus dizziness and nauseated, but no vomiting. Fever peaked at 101.4. This lasted all day. 4th, next morning: Fever, dizziness and nausea gone. Pain reduced. Sore arm remains.

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

Approximately 12 hours after injection - head ache, body ache, fever (highest was 102.8) body shakes, night sweats. Continuing as I write this.

Sudden, sever vomiting, chest & heart pain, mild fever, pain/discomfort in both shoulders, increased shakiness.

Extreme pain in arm at injection site beginning 6 hours after injection and lasting 4 days. Fever, chills, shaking, body aches beginning 6 hours after injection and lasting 2 days.

First day after the shot the arm was extremely sore; could not lift. Now, 5+ weeks later the arm is burning and the fingers are extremely burning and tingling. Pain is a 9 and 10.

12 hours after Moderna vaccine # 2 developed high temp of 103 degree's, body aches, head ache and a moderate to severe cough. The cough makes it difficult for me to speak. I saw a doctor at Urgent care who said all symptoms are 'normal'.

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

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

Occasional tingling and temporary numbness starting from the thumb and indicator finger up to the upper, front part of the left arm. When it happens rubbing or massaging relieves it. However it is getting worse as time goes on.

A few days after the second vaccine began to experience malaise symptoms in the early evening hours continuing throughout the night with low grade fever, headache. ~ 3 weeks later continues to experience the same with night sweats.

I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir

Intestinal gurgling, heavy sweating, palor, general malaise occurred within 10 minutes of receiving vaccine. Symptoms persisted for 5 hours until bedtime. Next morning had fatigue, headache and feeling of scalp tingling but other symptoms had lessened or subsided.

Hello, Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM. The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home. Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects. Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days. Then I also started with a slight fever, which of the times checked, reached about 101. Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch. I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again. That went on all day. When laying down that night the cramping would subside enough to sleep a little on and off during the night. The calf muscle cramping started to gradually subside, but took about 17 days to go completely away. The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended. Best regards,

Patient reported 5/10/21 that one week after vaccine, around May 1st, he developed a pain in his left shoulder. He reported no pain immediately after vaccine given. The pain starts at his shoulder to his elbow, and to his fingers. He states it feels like nerve pain. He says the pain does not go away. I referred him to follow-up with his doctor. He understood.

it was convulsive shaking; I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes; chill bumps; I could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (it was convulsive shaking) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SEIZURE (it was convulsive shaking) (seriousness criterion medically significant), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up). On 20-Apr-2021, SEIZURE (it was convulsive shaking), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, patient was scared to take the 2nd vaccine. Patient almost fell back. 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 received injection in left arm 3/18/21. When expected soreness in arm resolved several days later patient still experienced mild to moderate joint and muscle pain in left shoulder. Patient has no preexisting condition and engaged in no activity that would explain symptoms. Patient canceled second dose of vaccine because of symptoms, which continue to date. Patient is managing symptoms with OTC medication and has received no medical treatment at this time

Approx 12 hours after second dose experienced chills, sore joints and fatigue, as well as a sore arm. That condition lasted 24 hours.

DAY AFTER IMMUNIZATION PATIENT'S INJECTION SITE SWELLED UP MORE THAN AN INCH HIGH AROUND ENTIRE DELTOID AND THE ENTIRE DELTOID AREA TURNED BRIGHT RED ACCOMPANIED BY SEVERE PAIN AT INJECTION SITE, REDIATING DOWN THE ARM AND AROUND THE BACK UP THROUGH THE NECK. HE SUFFERED A HEADACHE. AT 6 DAYS POST VACCINE HIS ARM STILL ACHES AT NIGHT AND HAS BRUISE ACROSS ENTIRE DELTOID.

1.) 5/13 Sore Arm....no concerns 2.) 5/14 Minor enlargement of glands in neck 3.) 5/15 Increased enlargement of glands in neck....felt minor constriction of throat by 11:00 PM 4.) 5/16 Glands in neck swollen....breathing constriction is increasing. Will take Benadryl and monitor .....if no better by afternoon then I will head to emergency room

Patient did not have any reaction to first dose of Moderna vaccine. After second dose he started to feel dizzy and had tingling effect on eyes, facial area , right arm . Also he lost his balance and fell from chair while waiting in post vaccination area after vaccination. Patient was given Benadryl and monitored for while . He felt better after 30 minutes but not completely. Patient refused to call 911. I also called him in the afternoon and he stated he still has tingling effect but he is getting better. I called doctor's office and spoke with nurse and informed her about adverse reaction.

Pt states that he woke up the next morning and his entire left arm was swollen and numb. The following day, two days after the vaccination, the entire left side of his body was swollen and numb. The patient went to the hospital on April 6, 2021, and was hospitalized for ten days. Upon admission, he had bloody urine, swelling and numbness on the left side of his body, and was short of breath and coughing up blood. Pt was diagnosed with pneumonia while admitted to hospital.

feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE. On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient did not receive any treatment medication. No concomitant medication was reported. The patient spoke to his doctor about not getting the 2nd shot. 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.

SEVERE ARM PAIN IN RIGHT ARM IMMIETELY AFTER RECEIVING VACCICE, NOW GETTING WORSE, WEAKNESS, LOSS OF FEELING, SHOULDER PAIN, ELBOW PAIN HAND PAIN-CANNOT MOVE ALL MY FINGERS, SORENESS, SLEEPLESSNES DUE TO PAIN ,NUMNESS, CANNOT LIFT,CANNOT SWIM , CANNOT USE THAT ARM AT ALL

He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was that was for 2 days. Then his breathing starting getting worse. He started coughing, couldn't lay down, could not sleep due to that. He went to the ER and they told him that there was nothing wrong and that it was just allergies. They told him to go home and take some OTC cold medicine and that everything would be okay. A week later he went to another ER for the same thing as he continued not to be able to breath, they did a bunch of tests and said that nothing was wrong and that it was just a call. He then went to Hospital ER and they released him stating it had just a cold. He then called his cardiologist and they told him to go back to Hospital, was admitted on 5/11/21 and they did more tests and said that he had a blood clot in his left lung and said that it had nothing to do with the vaccine. He was discharged on 5/13/21. They put him on Heparin while in the hospital and sent him home as a disgruntled patient. They also told him that he had fluid around his heart and gave him medicine to get that taken away. They sent him home on Lasix and Eliquis. He then went to another hospital on Friday 5/14/21 as he was going crazy about the blood clot and went there and was kept there for 3 days and discharged on 5/16/21 with the same medications, Lasix and Eliquis. He was also told that he had fluid around his heart again. Before the vaccine he was very healthy, and was able to jog around his neighborhood and now he's not able to do so, and they told him that he was now having heart failure and is having trouble breathing because his heart is swelling up. He went to see his cardiologist last Friday and that's when she told him about his heart failure. ADMISSIONS: ADMITTED 5/11/21 TO 5/13/21; 5/14/21 to 5/16/21.

Started with swelling hands during moderate exercise (3 mile walk). Tingling started in hands shortly thereafter and continues. Secondarily, muscle tightness especially in legs (quads very tight). Coincidentally perhaps is development strained calf muscle during a run. Finally, and related to tingling. I experience my arms "going to sleep" at night depending on which side I'm sleeping on. Summary: Tingling in fingers persists. Arms "going to sleep" at night. Tight muscles (seems to be subsiding)

I recently had blood work done for an annual physical. The blood was drawn the same day I received the @nd dose of the vaccine.. I met with the Dr, 4 days later for my physical. He indicated my white blood cells were low and platelets were low. I did not have any adverse side effects other than a slightly sore arm. That particular blood test was accomplished, and the white cell count went back to normal and the platelets are improving, and I still feel no side effects. My primary care provider just wanted me to keep your company informed of the situation.

Fever went up to 37 degrees celsius at 10.30 am, about 18 hours after vaccination. Shortly after a strong headache arose. I became very weak and felt bad for the whole day 27th may. I woke up this morning with all the above symptoms disappeared.

This report concerns the aftermath of the second of the two Moderna vaccinations that I received: Mild point of injection pain. Fever after 48 hours 100.4 F, lasted one day. Heavy night sweat on third night after shot. After about 10 days, a light but persistent rash developed on my upper right shoulder. Approximately a week later, I experienced :"tingling" through out my right shoulder. This right shoulder has had prior rotator cuff damage (in the early 1990s). The sensations of tingling in the shoulder are identical to those from the past,. There is also an itching sensation that is best described as "inside the skin", not on the surface. In the last two weeks, the rash has expanded to my right chest. There is little to no surface lesions or irritation, just itching and tingling as mentioned, with very slight raised bumps. None of these symptoms were present before the vaccination. The tingling is heightened depending on arm position and when I am prone. There is no associated pain. The itching, tingling, and rash have not gone away. Today is May 27th. I went to my family doctor today for other reasons, and mentioned the rash and post-vaccine reraction to him.

Patient lost consciousness and was in and out for roughly 5 minutes. Clammy, sweaty, confused. EMS was called. vitals checked. patient cleared. pt went home from pharmacy with wife.

After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

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

Dizziness Weakness Face dropped. Right side Breathing labored 30 mins. Benadryl given Happened again that night. Right side face droop and right side motor function affected. Still can't lift right leg correctly

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

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

Nerve damage Pain at time of injection by nurse. Currently experiencing pain and phantom shot replication.

Serious lower left back which I believe was my left kidney. The serious pain problems started the day after receiving the shot and lasted for at least two weeks. As the kidney pain started, my fingers started to feel numb and they have felt numb ever since. Left hand is a little worse then my right hand. Want to get second shot but?? I have walking pneumonia since 1973, since I was 15 years old, and will die if I get Covid 19. I need help to know what happened to me, and maybe monitor me during second shot. I am open research person. I am a 64 year old man that has had walking pneumonia since I was 15 years old in 1973. I know that if I do get Covid-19 I will quickly die. I need vaccination from Covid-19. I received my first Moderna Covid 19 vaccine on Thursday March 18th, 2021 after 3 PM and immediately had problems. I had problems in my left lower back which I believe was my left kidney. The serious pain problems started the day after receiving my first Covid 19 Moderna shot and the pain lasted for at least two weeks. Immediately as the kidney pain started, my fingers started to feel numb and they have felt this way ever since. This lead me to the situation of "I am damned if I do and damned if I do not". I want to get the second Covid-19 vaccine shot because I am truly scared to die if I do get Covid 19. But if I do get the second shot, what will happen to me? I am scared that it may have the kidney pain again, may worsen my numb fingers problem, and/or do other damage to my body. It may already have caused other problems? In summation, whether I get the second Covid-19 vaccination shot or not: Get the second shot: 1. Everything could be OK? 2. I could have Kidney pain again, possibly doing damage or more damage to my body, even my numb fingers could get worse! Not get the second shot: 1. Be lucky and not get Covid-19. 2. Get Covid-19 and die. I want very much to get the second Covid-19 shot, but I am scared and I find nobody cares about what had and has happened to me regarding my kidney pain and my fingers becoming numb, and any future consequences to me if I get the second shot. I do not know what to do. My current and main concern to me, for now, that if I do get the second Covid-19 shot I will get that kidney pain and may do worse damage to my fingers feeling numb or possibly other damage to my body. I am not sure what happened, as a non medical person I can only guess things like maybe I have blood clots that reduce the circulation in my hands. I just recently got on government assistance only because of this Covid-19 problem and I had a very hard time trying to find a job, I had no choice. I have not been on government assistance long enough to get financially stable to afford medical insurance, but I plan to do so as soon as I can. I tried to tell my doctor, but she kept telling me to go to the emergency room. So, I finally went to the Hospital on Friday April 16th. They checked my bloodwork and told me I was OK and OK to get the second shot, but I had really no explanation as to what had happened to me, my kidney, or my still numb fingers, or most of all, what might happen if I get my second shot. I am hoping to get help, for someone to care about me, my health, and my future health. The numbness in my left hand has been a little stronger than my right hand. I had the shot in the left arm and my left kidney had the pain, if any of these matter. The left kidney problem was very painful within 2 days. I could not do anything due to the pain. I could forget about dealing with my feet in any way, such as to tie or untie shoes, put on or remove socks, getting out of bed, and just about anything I did, any movement at all was very painful. What has me very worried is the continuous numbness of my fingers. I want to get back to work and my profession involves computers and keyboards, and my numbness in my fingers bothers me, even having problem feeling the raised bump on the ‘f' and ‘j' keys. The most immediate problem is trying to untie shoestrings, which I cannot feel to do due to my fingers feeling numb. This problem with my fingers affect my life in many ways continuously everyday. I cannot feel zip lock bag openings. I have had a left kidney problem once before over 2 years ago, which I believe was a result of doing Benicar for my blood pressure. I have only had that problem that once and I got off Benicar and have never had the problem since, not until a day after I had my first Moderna Covid 19 vaccine shot March 18th. For both of these times, the left kidney pain I immediately stopped all of my medicines and after a few weeks the pain went away. This time was muc worse than the first time. I have high blood pressure, diabetes, and high cholesterol and take medicines for these. I resumed these medicines after the pains went away. As to the fingers feeling numb, I have never had this problem in my life. My left hand fingers are a little worse than my right hand fingers. They feel as if they are very cold for frozen, or I have burnt my fingers. I have never felt this feeling ever in my life. At the beginning of, January 1st to be exact, when I was 15 years old and in the 10th grade, I came down with pneumonia and was very sick. It was not until the middle of March when my mother took me to the emergency late at night when she got a doctor to see me on the side. The doctor gave me prescriptions of antibiotics, cough syrup, and Guaifenesin (which was a prescription in 1973 and is the main ingredient in Mucinex). For the next 2 weeks I came home from school and laid down on the sofa and filled up about a third to a quarter of a medium size mixing bowl with phlegm from my lungs. After that doctors have told me I ruined my lungs and I will have walking pneumonia for the rest of my life. I have lived with this problem and have had to pay special attention to my lungs my whole life. When I saw on TV a report on the second e-cigarette and what if did to the lungs, I said that looks like what happened to my lungs when I was 15 years old. I recently saw news that someone had a similar problem. However, because of my walking pneumonia I need to get the second shot or vaccinated in whatever way, I want to live. Please help!

Shoulder, arm, elbow, back leg, foot pain. Arm, hand weakness, numbness. Prednisone drug alleviated pain for 5 days, but pain returned after prescription expired.

left leg pain and swelling developed on 5/26/2021, did not seek treatment until 6/9/2021 as not resolving. Evaluated in ER 6/9/21, identified on ultrasound left popliteal and calf deep vein thrombosis. Started on anticoagulation therapy, Eliquis 10mg BID, ongoing treatment, reduced to 5mg BID after 7 days and will continue to monitor renal function.

Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea and teeth chattering, cold and could not move my left arm . Same arm as shot. I had a temperature of 101.2 Took tylenol, still sore and chills. Had to call in to work to say I was sick. Took naps mostly throughout the day, fever still persisting around 101. Took Tylenol, 2 hours later fever down to 99.1. Could not stay awake for long. Slept most of the day.

Client received 2nd dose Moderna vaccine 4-19-21. States he felt tired, weak, and noticed drooping of mouth and face 4-21-21. States was seen per MD, 4-23-21 and diagnosed with Bell's Palsy and was treated. States symptoms persisted for approximately 3 weeks. Client's reporting date 4-23-21, and states all symptoms have resolved at this time.

I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.

Pt stated that he has had swelling, tingling, and pain up and down his arm. He is also reporting mild pain down one side of his chest which is not going away. The second shot of Moderna was give 05-03-2021.

Inflamed nerves beginning in upper legs, then going to lower extremities, severe nerve pain, followed by body weKNESS,

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

Systemic: Chest Tightness/ Heaviness/ Pain-Severe, Systemic: Flushed/ Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

Migraine headache hit and was excruciating pain that wasn't lessened by any over-the-counter pain reliever. The migraine continued on a constant basis that had my husband in bed in the dark for 8 days straight. I contacted his Physician numerous times and also the Nurses line. After numerous contacts he was finally prescribed Imitrex pills. He took 2 separate doses that finally had the migraine lift in intensity. His Physician was reluctant to prescribe a second prescription to have on hand if this reoccurred. The migraine headaches have continued. My husband saw his Physician June 28th but we haven't received it. In addition to the migraine his ulcer flared up due to the over-the-counter medication. Another development in my husband is his cognitive decline and his short-term memory is really bad. My husband retired at age 62 years after running a bank with numerous staff for 43 years. There is no way that he could be running the bank if he was still working. I strongly believe that these health issues are because of the vaccine!

Within hours of vaccine became somnolent. Trouble staying awake for first 3 days, then somnolence slowly faded over 2-3 weeks. 4 weeks out fatigue a miner issue but not resolved. By mid June began having exacerbation of reactive airway disease (irritable larynx/cough variant asthma) marked by increase in cough with bouts of shortness of breath. Usual triggers for such exacerbation not present. Bouts of hot flashes/sweats but no fever. By late June high barometric pressure weather system (a known trigger) settled in for 5 days causing increased symptoms. Saw Primary Dr. 6/29, prescribed Doxycycline. Today is day 7 of antibiotic, exacerbation is milder, but it remains.

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

Pt. states after receiving 2nd Moderna 05/07/2021 experiencing pain both shoulder blades, weakness and pain in the calves (trouble standing). Pain subsided in calves, weakness in legs. Physician stating Neuropathy diagnosed in arms and legs. Full blood tests done (Possible Lupus) 06/11/2021. Still experiencing symptoms.

Admitted to the ER complaining of 103-104 fever, extreme fatigue, headache, weakness, and nausea. Initial diagnosis was inflammation and sepsis from unknown origin. Patient was slightly anemic and had borderline enlargement of the heart on Xray. Pulse Ox levels were 91-93 prior to giving 02. Patient had traces of blood and protein in urine. WBC levels were normal. Blood cultures failed to reveal a bacterial, viral, or fungal infection. IV Antibiotics were administered and patient was discharged with no fever after 5 days. However, patient began experiencing mild afib onn the 5th day. Metoprolol was prescribed and patient scheduled a follow up echocardiogram. No infection ever located.

He develops symptoms of Gamper a syndrome with tingling paresthesias in the lower extremities and weakness involving the lower extremities more so than the upper extremities, reduced hand dexterity, and some tingling and numbness in the fingers as well.

It took until probably the following afternoon on the 10th that I started getting migraines. The next 30 days I had migraines for the next 28 of them. It turns out I was seeing my Oncologist and they found that I had a lesion on my skull and I thought the pain was due to that and come to find out the lesion had nothing to do with oncology and the lesion was triggered by the vaccination. The Doctor said if you are prone to migraines the second dose could trigger migraines. They then did some tests and I was diagnosed with Amyloidosis.