Moderna

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

Right hand pain in center of palm. Started the very next day of vaccine. First three days was very painful and radiated up to just past the wrist. Now its just sore.

Day 0-2 - left deltoid soreness, vague malaise Day 4 - unexplained anger Day 6-7 - bilateral quadriceps soreness, headache --- No treatment sought for any of the above. Patient took acetaminophen for headache

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

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

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

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

Dizziness, HYPERtension, flushing, tingling on one side of the body- opposite side from injection Narrative: dizziness, tingling, flushing, on left side of head down to left foot immediately after injection at 1148. BP increased to 168/104 with HR of 103 at 1211.

WARM, REDDENED AREA ON ARM OF INJECTION. THE REDDENED AREA MEASURES ABOUT 4X5 INCHES AND IS LOCATED APPROXIMATELY 2 INCHES BELOW THE VACCINATION INJECTION SITE. THE AREA BECAME RED AND WARM 9 DAYS AFTER VACCINATION. PREVIOUS TO THIS REACTION, I ONLY EXPERIENCED PAIN IN THE ARM OF INJECTION ON DAYS 2-3 POST VACCINATION.

approximately 5 minutes post vaccine pt reported feeling tachycardia and bilateral hands tingling. HR noted to be 117 -122, BP 125/79 RR 16 NAD, Lungs CTA bilaterally no wheeze, neck: no stridor, no oral changes. Pt HR 92 after 10 minutes, and reported resolve of symptoms. Pt monitoring extended for a total of 1 hour, no recurrence or progression of symptoms. discussed use of Epi, pt has own epi pen on hand. Pt to discuss with allergist tomorrow, will use Epi if needed as discussed, and instructed go to the ED if any progression of symptoms

About 40 minutes after I received the injection in my right arm, my right arm began to tingle all the way to my fingertips. The sensation lasted for approximately 30-40 minutes, then subsided. No other reactions so far after that. No loss of mobility in my arm or hand.

PATIENT RECIEVED THE FIRST DOSE OF MODERNA VACCINE AT HOSPITAL, COVID CLINIC. RN OBSERVING NOTICE THE PATIENT STARTED GETTING ANXIOUS AND WANTED TO MOVE AROUND AND LAY ON THE FLOOR. PATIENT STARTED TO TURN PALE AND WAS COMPLAINING OF BEING WARM. RAPID RESPONSE WAS CALLED. PATIENT STARTED TO LEAN BACK IN THE CHAIR BUT WAS CONSCIOUS THE WHOLE TIME. RAPID RESPONSE TOOK THE PATIENT TO THE ER.

SkinRash, Rash, UrticariaPruritus, rash near site of injection,tingly, numbness between shoulder blades intermittently continues 1/4/2021

Bells Palsy approximately 24 hours after vaccination. I presented to the ER for evaluation. I was treated with steroids and antivirals for 7 days. Symptoms ave still persisted to date.

1414- 18min after injection Patient stated he was feeling funny. He reported feeling hot and discomfort to Left side of his neck. Upon evaluation he was mildly tachycardic HR 110. Symptoms began to worsen with redness spreading through his hands and upper torso and pt became diaphoretic. by 1420 Pt BP increased to 171/104. Pt was given IM Benadryl and Decadron per Dr. orders. by 1440 redness had completely resolved and Diaphoresis was gone, HR down to 144/82. by 1500 all Pt's symptoms resolved. Pt was able to be discharged from clinic without s/sx of distress.

After about 15 minutes, I began to feel lightheaded and experience a tingling in my arms/hands. I'd guess it was related to the nerves in the arms, because it specifically affected my pinky and ring fingers on both hands. I was also unsteady on my feet, but did not lose consciousness. The lightheadedness and tingling continued off and on for most of the day. The tingling appeared to go away the next day, but I still experienced periodic (though rare) feelings of lightheadedness. Perhaps 2-3 time the next day (Saturday) and experienced maybe 1-2 times the following day (Sunday). I did not take Adderall on the weekend. On Monday, I did take Adderall and returned to work, where I experience some tingling again and longer bouts of lightheadedness. Again, I have not lost consciousness.

Beginning at 6:30 am on 1/8, two days following vaccination, the individual was driving to work and began to experience nausea while at a traffic light. He pulled over and threw up. Once he got to work he vomited again. He drove to another facility for work and then threw up 3 or 4 more times. He began experiencing hot flashes at this time. He went to the hospital and was seen in the emergency room. He threw up several more times in the ER and stated that his heart was racing and that he had diarrhea. The emergency room gave him medications for the nausea and he stayed there for 2 or 3 hours. He began to feel better and was discharged to home.

soreness on arm with redness on injection side that still present a week after injection and start with pimple on 1/13/21, and small abscess with purulent discharge

Beginning night of 1/13 around 9pm, felt cold chills, nausea, headache, body & muscle aches, loss of appetite and fever. Tight chest and hard to breathe. Feels like asthma attack was triggered. Has been persistent symptoms since 1/13. Have been alternating Tylenol and Motrin. Using albuterol pump and vicks vaporizer, as needed.

Around 12hrs of first injection, I began to feel very cold. Left arm was very painful to move. Hands and feet felt like ice. I was shivering. Fever of 102. Could not sleep. I was up at 3am feeling like I was going to vomit and I couldn?t get warm. Whole body aches. Couldn?t go in to work the next morning. I had a terrible headache. Slept all day. Went to bed in the evening and woke again at 3am shivering uncontrollably. Hands have continued to stay cold. No appetite as well.

On 12/28 I had paralysis of the left side of my face and was diagnosed with Bell's Palsy. It took about 2 1/2 weeks for it resolve. The top of my face is at 100 percent while the bottom half is at 90 percent.

Sore shoulder started after a couple of hours and was moderate by evening. A general unusual feeling started within a couple hours of the shot. By 7pm I started to experience chills and joint fatigue in legs (knees, toes). Chills became severe and a low grade fever of 100.6 developed. Chills lasted about 1.5hrs. Fever broke overnight. By morning all previous issues were resolved and the only issue was a problem with equilibrium and balance (and sore shoulder) It was a general feeling similar to drunkenness. This issue persisted throughout the day and by evening I was experiencing mild vertigo when I closed my eyes. I went to bed feeling somewhat improved relative to all the symptoms but woke having experienced a cold sweat. My shirt was completely soaked. I noted several less significant sweating issues throughout this day with no other side effects. This was the final day with notable symptoms. At the time of this report I have minor shoulder pain as the only symptom that persisted throughout. The equilibrium symptoms were severe enough that I missed a day of work.

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

On day 2 and 3 had mild arm soreness and pink coloring around injection site. Skin color went back to normal and no pain on day 4. On day 9 I woke up and the place where the pink color had been had turned red and the skin is firm. No pain.

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

Shortly after the shot: - Dizziness - Weakness Later: - Sore left arm - Chest pain, left side - Fatigue - Anxiety, perhaps triggered by all of that.

Started with body weakness, pain, joint pain, headache, and feeling feverish the same night of the vaccination. This continued until about noon on 1/24/21.

Normally sore following the vaccine starting around 9:00 PM last night. Had shivers, nothing terrible. By 6:00 AM the chills were intense, weakness, having less coordination and depth perception issue. Closer to 9:00-10:00 AM felt like he had the flu 10 times worse than he should have. Had COVID in April/May but these symptoms worse. Got home at 11:15 AM was so cold, hands were ice cold, and took 2 hours of sleeping and all layers of clothing to feel warm. Took a few layers off and still shaking, feverish and feeling of worse flu to man. Pain all over the body, temperature at 3:30 is 99.5-100.4, above 98 is fever is fever for him, normal is 96-97. Sharp shooting muscle pains in extremities, top part of the hands, muscles, tendons, and also his legs and feet, but not fingers or toes. Pain is quite intense. All he wants to do is lay down in sleep. Thought he was going to freeze to death. Hands were so cold his kids were concerned. Ice packs on chest, and gloves and 10 layers on hands and arms. Had tremendous trouble breathing while having the intense chills. He is a responder for law enforcement. Symptoms have improved some, but still feeling feverish with shooting pains, depth perception issues, as well as pain. Headache in back of head, pressure type. Called off for work for today and tomorrow.

At first uncontrollable shaking for 10 minutes . Then inability to sleep, severe headache, nausea and rash at injection site

Onset at 14 hours - malaise, fever, arthralgias for 36 hours Onset at 36 hours - Facial burning, redness, swelling

Muscle spasm and tightness in shoulders, neck and back. Dizziness, Diaphoresis, elevate heart rate, nausea.

Initially, no immediate problems other than slightly tender at injection site. Approximately 48 hours later (evening 01/14/2021) started to notice increased inflammation about the size of a "quarter" on left side of chin. I did have a pimple/ingrown hair at this site prior to the injection which was mostly healed but not entirely healed. The next morning, 01/15/2021, I experience mild facial numbness to the left side of my chin and mild facial paralysis resulting in an asymmetrical smile, and mild swelling to the left side of my face. Two day later (morning 01/17/2021) with my symptoms not worsening but showing only a little improvement, I went to my local urgent care for evaluation. Provider was not 100% sure of the diagnosis but felt this could be a case of shingles or folliculitis. I was treated with a 7 day course of acyclovir and a 10 day course of doxycycline hyclate. The numbness subsided 2-3 days after treatment began. The facial paralysis and swelling showed much improvement (90-95%) after completing the acyclovir on 01/24/2021; however, I feel there is still a little more improvement to go.

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

Headache & arm soreness began 8 AM after 1st dose administered, Fever started around 12 and progressed from 100.6 to Tmax 102.7 for 6 hours with tylenol. O2 of 89-92, SOB, confusion, shaking chills, alternating between hot and cold, severe fatigue. COVID test performed 2 days after COVID vaccine and day after reaction and negative. Erythema at site on 2/1/21 w/o spread or cellulitis.

I woke up at 1am freezing w/Headache. All my joints are aching. And my nose is plugged. Pain scale for headache was about a 4-5. so it?s like I have a normal cold. The injection site hurts to touch. A teeny bit swollen.

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

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

Facial swelling and pain along the entire left face, on the same side as the injection site. Severe temperature of 101 degrees with intense chills and body aches.

Seizure activity, tx with ativan IM and sent to local ED. Febrile to 102.9, status epilepticus, given Fentanyl, Versed, and Keppra. RSI and intubation performed. Intubated and transferred for neurology care. History of similar events; had similar event when infected with COVID-19. Was extubated uneventfully and is recovering well. Currently on azithromycin and augmentin for aspiration PNA>

Received Moderna COVID-19 Vaccine EAU. Second round. Fine at time of injection until approximately 00:30 on Feb 3. Woke up restless and stiff. Feel back to sleep around 01:00 and awoke again at 03:30 restless and stiff. Unable to fall asleep. Soreness in back and shoulders began to increase with mild headache. Fatigue began to set in and feel asleep at approximately 07:00 on Feb 3. Work up to chills, muscle soreness throughout, no appetite or desire to drink, and extreme headache at 10:30. Restless periods of sleep while fighting body aches and chills continue through the entire day. Waking periods for remainder of the day occurred between 10:30 - 11:30, 12:30 - 15:00, and 14:00-18:30. Suffered from intense headache, muscle stiffness, no appetite, and chills during all of the waking periods. Upon awakening 05:45 on Feb 4 all symptoms had subsided but low energy due to lack of hydration and low food intake from previous day.

Body aches, unable to function and do anything. Chills and fever. Slight fever at 99.8. At times I feel so bad I want to go to the hospital. Horrific headache, feels like my head will explode.

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

Received the following symptoms starting 15 hours after the vaccine. Full body fatigue. Could not stand up for two hours from my bed. This was followed by body aches pains and chills. It also included heightened skin sensitivity. Physical touch and contact on anywhere but my palms in the pads of my feet was extremely painful. The best example I can give is, taking a shower was like getting shot at by multiple BB gun pellets. At 1450 PST, I experience shortness of breath and wheezing. Struggled to walk up 12 steps. Continued with migraine. Weakness in body. Pain and body. Skin sensitive until about 36 hours after the vaccine. Did not try walking up and down stairs again, but breathing was slightly challenged Until about 30 hour mark. Struggled with migraines from The 24 hour mark until the 48 hour mark.It was the weekend. I did not go in. I just graded it out. Fatigue lasted all the way until the 48 hour mark. Funny enough? I did not developed a sore arm symptom.

Had zero adverse effects from 1st dose, but 2nd dose I went to bend feeling fine then woke up at 01:30 a.m. burning up head to toe and extreme body aches. I had to take max dose of Tylenol and sleep on 6 six packs over my hold body just to take the edge off. I had to do this for 4 hours. After that I spent the next 24 hours with body aches and exhaustion.

Body wide rash with redness of the skin and petechiae on the lower extremities. Additionally, feeling flushed and fatigued.

Severe headache, Body Aches, Chills, night sweats, frequent urination and frequent stool. Slight fever at 100 degrees

Moderately severe tonic/clonic seizure of approximately 60 second duration observed by nursing staff at approximately 7:00am on 2/3/21. Patient was awake sitting at the dining table. Patient has no previous history of seizures. The only immediate treatment was continued observation, with no further seizures noticed to date. Patient visited his PCP later that day for follow-up, no treatment advised.

Feeling ache all over body, complained of pain in arm and spent the entire evening in bed. Vaccination sites sored. Normal temp.

09:18 complained of tingling feeling to body. Initial BP 140/100. States no other symptoms. No shortness of breath, no breathing difficulties, no throat tightening, no rash. Alert and oriented x3. Reports has had tingling feeling after flu vaccines. During course of assessment, tingling feeling dissipated. 09:33,BP 130/90. No complaints. Released at 09:34.

My are was sore for a week then my arm pit hurt for 3 days and a red rash/hive appeared at the injection site.

On Day 6, I started feeling tightness around the rotater cuff and inner arm muscle. On Day 8 I started feeling extreme fatigue and weakness. On Day 9 I started feeling extreme dizziness, as well as itchiness and raised rash on the injection site.

Patient had breakthrough seizure on 2/5/2021. Last prior seizure was 5/2020 before starting Keppra. It is not clear if seizure was related to vaccine.

Seizure lasting about 1 1/2 minutes with vomiting afterwards off and on for 30 minutes. He was very tired on the 24th.

Uncontrollable shaking; rise in blood pressure; hives; (stomach, back, face, injection site) high heart rate; swelling in face and neck; shortness of breath.

After receiving shot, patient reported feeling warm after sitting down in post observation area. Felt anxious and lightheaded. Vital signs taken x2 - stable. Offered and drank water and laid down. Feeling of warmth and lightheadedness resolved after about 10 minutes. Patient reported feeling better, conversing and laughed with clinic staff. Exited clinic after 40 minutes and observed gait was steady.

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

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

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

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

Patient had pain headache or migraine. Onsite EMS was called vitals BP 140/80 HR 80 100% O2. Patient refused evaluation and care released against medical advise.

Insomnia, muscle and bone pain, constipation, anxiety, tremors, changes in skin texture, migraines, headaches, change in emotions, memory loss, fatigue, confusion

2 hours after injection (Monday): fatigue, headache, sensitivity to light (migraine), sore arm, sore elbow (site of surgery three months prior), sore lower back muscles, some dizziness. Mild nausea. 1 day after injection (Tuesday): Increased dizziness and nausea. Fatigue about the same. Headache treated with ibuprofen and acetaminophen, responded well. 2 and 3 days after injection (Wednesday and Thursday): No side effect symptoms. 4 days after injection (today, Friday): Diarrhea.

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

Started feeling the arm really hot, and harder the area where the vaccine was received around 4:30pm. Then started having a fever of 100.9 and a headache (tried to keep it under control with ice packs) thru the afternoon onwards till today(Saturday) still have a fever and the arm is really sore.

Chills with VIOLENT shivering for several hours, strong enough to spasm chest and back muscles into charlie horse. mild headache for 30 hours, fever.

3-12-21: Lower back muscle pain/cramping. Slight fatigue. 3-13-21: Dull headache, fatigue, 3-14-21: Headache, chills, nausea, muscle fatigue, fever, night sweats.

It has been 6 weeks since my 2nd dose of the Moderna vaccine for Covid-19. For the first 3-4 days I had the usual moderate flu-like symptoms: dizziness, headaches, fatigue, chills, soreness at vaccine siteetc. Days 5-7 I seemed to gradually improve. On day 8 all of the symptoms returned with greater severity: this time I had a fever, the chills were much more intense, the headaches were excruciating, body and joint aches all over the place--I couldn't sleep or focus on anything cognitively taxing. Interestingly, my brother, who was vaccinated just after me, also had more severe side effects beginning on day 8 post 2nd dose. He improved after 3-4 days, but my recovery has been much much lengthier. By day 14 I was still feeling very ill, though the fever did subside. Sometime in the third week the pain in my arm at the vaccination site returned, then became intermittent, and still bothers me from time to time. I also started getting muscle spasms in the same exact locations that sent me to the ER after my probably bout with Covid in the spring of 2020. Thankfully these lasted only a week or so, though I began feeling muscle soreness in different parts of my body, ever changing. By the 4th week I was slightly better and down to 4 main symptoms: chills (by far the worst of the symptoms--to the point at which my skin would feel like it was being frostbitten by dry ice every time I changed sweaty clothes), occasional splitting headaches, and muscle soreness that included both the injection site on my arm and other areas. I had other symptoms as well, fatigue and brain fog, etc, but these were present before the vaccination, though not as severe.

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

Bells Palsy on March 7, 2021 (about 6 weeks after 2nd vaccine dose). Duration of condition is still on going 2 weeks post onset.

12:14 Post vaccination reports feeling dizzy, diaphoretic, color flushed and pale; medical monitoring w/vitals assessed: BP 93/53 P55 O2 sat 96%RA, rest w/feet elevated, po hydration provided, answering questions; 12:30 BP 101/71 P77 02 sat 98% RA , status improving, remains coherent; 1240 BP 107/78 P 72 reports "feeling better", stands w/no dizziness or reports of additional symptoms, color returns to normal; Released from facility w/self.

pt states he has sore left arm after getting covid vax but when he woke up he had fever, body aches, chills and headache. Pt as not taken any medication for these symptoms but still has them at this time.

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

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

Shortly after receiving the vaccine, the patient stood up from his chair and approached the pharmacy counter. He told the pharmacist he was starting to feel funny and immediately fell on his back. I ran out to around the counter and he was conscious and sweaty. He was responsive, knew his name and where he was. He described feeling very hot. He did not have any rash or swelling visible.

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

patient was seen at primary care provider's office on 3/29/21 - diagnosis Bell's Palsy (symptoms started 2 days after Covid vaccine). Prednisone and valacyclovir ordered by primary care provider. Follow up in 2-3 weeks. Will refer to neurology if not improving.

At around 6:30 pm patient felt very dizzy, lightheaded, and nauseous. He also felt hot, had cold sweats, pale face, and blue lips. He started shaking as well. At 6:35 pm his blood pressure was 126/78, his heart rate was 69, and his oxygen saturations were 95%. We called EMS and they arrived around 6:45 pm. He was already feeling much better by the time they arrived. They checked him out and said he was good to go and he left at 6:55 pm.

Patient reports extremely swollen, red, itchy arm at site of injection beginning 9 days after vaccination.

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

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

The differences started out with a sore arm that occurred the same day as my 2nd dose which occurred the next day after my 1st dose. The morning after my 2nd dose I awoke around 8AM to a 102.1 F temperature and then took 2 extra strength Tylenol (500mg) around 8:15 AM. I felt very groggy, tired, and still had the sore arm. I felt hot and cold spells over the next 6 hour time period. I measured my temperature around 12:30 PM and it was 99.5 F, and I later took another dose of 2 Tylenol (500mg) around 2:10 PM. I was still feeling groggy and tired but the hot and cold fluctuations seemed to be abated. Around 9PM I measured my temperature again and it had risen to 101.5F, so I took a shower then took two 200mg Advil/Ibuprophen and went to bed around 9:45 Pm . I awoke around 1AM that same night (03/25/21) and was sweating profusely in bed but was too tired to get up. I laid back down and went back too sleep. I awoke that morning around 7:50 AM feeling very sore in my muscles but no additional symptoms. My temperature was measured at 98.3F and I felt back to my normal self. No additional symptoms have presented afterwards.

2 days after receiving the 1st vaccine, I started getting night sweats and mild fever. Then a day later, I started getting an itch in my throat followed by a deep cough. I had to order Azithromycin and Prednisone to kill whatever what was going on. I was sick for 3 full weeks. Alternatively, my 76 father passed away only hours after receiving his 2nd moderna vaccine. We share the same number and I have to enter his information also.

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

Patient recieved the vaccine in the left arm and was asked to wait in the pharamcy waiting area for observation for 15 minutes (no previous hx of anaphylaxis). Upon returning to the main pharmacy floor a few minutes later one of the technicians alerted me to the patient had retrurned to the counter and was "feeling something". He was visibly struggling to maintain balance and I asked patient to take a seat to prevent any risk of falls and motioned to a chair. He took a seat on the floor next to the pharmacy counter and I rushed over to him to tend to him. I asked him if was having any other symptoms and he noted he was feeling lightheaded and having chills all over his body. His body was cold and clammy to the touch and had a difficult time locatiing a pulse on the radial artery. While talking to him his responses were shorter and he seemed like was starting to almost lose conciousness. Management had already called 911 and we offered water to the patient while we waited. Prior to the paramedics arriving I was able to get a pulse using a cuff and it was around 53bpm, the patient also seemed hypotensive.

Jaw numbness and tightness, dizziness. Patient vital signs assessed and found within normal limits. Upon further monitoring, patient reports symptoms subsided. Vital signs: 10:30am BP: 136/81, HR 110 bpm, O2 sat 98.8%, RR 12, Temperature 97.1 F, Lung sounds clear. 10:45am: BP 133/89, HR 78 bpm, O2 sat 98%, RR 12, Temperature 97.2 F, Lung sounds clear. 11:00am: BP 131/80, HR 81bpm, O2 sat 97%, RR 12, Temperature 97.1 F, lung sounds clear.

Didn't feel well this am 4/9/21, not able to eat lunch or take meds; approx. 3 pm started feeling weak, chills, headache, stiff neck, severe body aches, nausea. Presented to the unit clinic at 1600 and temp was 103 degrees, pulse 123, resp 18, b/p 161/97

- Day following the shot: headaches and dizziness. Difficulty to focus. - Whole week following the shot: cold feet and hands, Mild blood circulation problems (legs and arms slightly painful)

The following day after the first dose was administered, my left arm has been tingly and numb constantly. Time was 3/25 morning and continues today 4/12.

uncontrollable shivering/convulsions to the point that my muscles started cramping and were sore the next day difficulty breathing and hyperventilating night sweats, vomiting (1 time), confusion, body aches

On 4/8/21 awoke to intense pain in his left foot about 12 hours after receiving his 1st dose Moderna vaccine batch #038B21A. Over the next few days swelling and pain increased in the left foot moving around from the big toe, to ankle, to arch. His foot was swollen and extremely painful and he was not able to walk or put weight on the foot. On 4/18 he went to the clinic. The doctor took fluid from the big toe joint to test uric acid levels. Elevated levels of uric acid confirmed his condition to be Gout and Indomethacin was prescribed for pain and swelling. He has never had Gout or any kind of arthritis, joint pain or foot injury prior to the Moderna vaccine. As of 4/13/21 he is still unable to walk or sleep well due to pain and swelling in the foot. He is not able to work or resume normal daily activities.

My left thigh went numb. Like I had a few shots of novocaine in it. Its been numb for 2 days now. The nurse who gave me my shot told me I got Johnson and Johnson. Just found out today that I got Moderna apparently. Unless someone messed up.

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

Event: 3/10: itching, swelling, soreness, redness on arm ("COVID arm") around injection site. Treatment: Begin taking Zyrtec. 3/12: Itching, scratchy feeling spread to upper back. 3/12-3/15: Itching on back accompanied by tenderness, burning sensation like sunburn that spread to entire back, neck , head, and upper arms. Itching spread to legs, arms, groin, around eyes. Scratching raised occasional welts on legs and arms but didn't on back, just created more intense pruritus. Saw dermatologist 3/19 who recommended upping dose of antihistamine. Saw allergist 3/23 who gave similar direction. Treated with 1 Zyrtec twice a day until 4/12, then ceased because of excessive fatigue, and started treated with hydrocortisone OTC 3x/day. Outcome: Itching, burning, stinging sensation remains, especially on back, but also on neck and arms and legs.

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

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

Left parsonage turner syndrome shortly 3 days after left deltoid injection, persistent severe weakness post initial steroid Rx CT negative for exploratory compression. Hx of psoriatic arthritis

numbness and tingling front of arm, index finger and thumb Recommended to caller to contact PCP due to ongoing numbness/tingling L arm, index finger and thumb. Caller was not receptive of recommendations as he does not want to pay money for a visit if they can't do anything and possibly be sent to Ortho and pay more money. He doesn't feel he should be responsible for anything. Recommend increase ROM to left arm and hand as frequently as possible.

Patient stated prior to vaccination that he had a fear of needles. Once vaccinated patient seemed anxious so pharmacist continued to directly monitor the patient. He proceeded to feel nauseous and lightheaded. At this point, patient was laid on the floor on his side to prevent falls and 911 was called. Patient lightheadedness continued along w/ perspiration, and cold extremities. Cold compress was applied to patient's neck and face area. We maintained conversation until EMS appeared in which he disclosed he had been fasting. EMS proceeded to conduct patient well check and released patient --patient disclosed that this always happens when he receives shots or has blood drawn.

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

Day after receiving vaccine, left hand and left side of face to include the left side of inside of mouth started to tingle. Took Benadryl and it initially went away. The next day it came back and Benadryl did not work. Went to ER where they said it looked as if minor stroke had occurred.

Reaction to A-Fib medications Metoprolol and flecainide. Rapid heart rate, high blood pressure, body shaking, loss of apatite. extreme exhaustion.

Night sweats 4 random times in last month. Lower extremity aches, feet, and ankles, after waking up every morning. Typically lasts 10 min or less. Overall body soreness compared to usual.

Moderna COVID-19 Vaccine EUA caused diarrhea beginning morning after second dose and continuing for at least 3 days. Also caused brain fog, fatigue, sore arm, and chills beginning evening after second dose.

Flu-like symptoms for 24-36 hours. Chills, exhaustion, muscle aches, fuzzy head. Also sore arm persisted for 5 days

Entire left arm, all the way from shoulder to the fingers swelled up to 1.5 times the normal size. The left index figure and thumb started tingling and became numb. The pain is present in the front and back of the left shoulder as well. Saw a Dr and she told me to take 4 x 200mg Motrin every 6hrs for next 4-5 days. She also gave Tylenol 3. The pain was so acute that I asked my doctor to just chop off my arm. I couldn't sleep, I couldn't stand, sit or lay down. It hurt all the time. Lost all strength in the left hand and arm. Motrin and Tylenol didn't help with the pain. The swelling went down quite a bit in 3 days. Motrin caused a flare up of Crohn's. Saw another Dr 5 days later. She prescribed gebapentin, flexrel, norco, toradol, etc. It's now been almost 20 days since the injection. The pain has subsided but not completely gone. I am still unable to do much work and it hurts just to sit! I still have pain and still do not have my strength back. I am still unable to go back to work.

Husband received his second dose at work. The next morning he got up and turned on the shower and passed out. I found him in the bathroom after he regained consciousness in a cold sweat, extremely pale, saying that he thought he was going to throw up. He said it felt like food poisoning. I got him back into bed with a cool wash cloth and he slept off and on the rest of the day. He started feeling a bit better but struggled to comprehend simple questions and would just stare at me blankly as if he couldn't understand what I was saying. Even though he slept most of the day he was falling asleep in his chair by about 8pm. The paleness, waves of exhaustion, and inability to stay awake past 8:30/9pm has continued.

Became very ill with chills and body ache then the next day I had extreme pain in my shoulder down my back and in to my right arm. It got better after some stretching Ice and anti inflammatory I also noticed I could not press any weight over my head and my right scapula was winging then the pain came back about four days later. The pain was so bad I went to urgent care and was given muscle relaxers. The pain went away after a couple days but after giving it several weeks to see if the winging and weakness in my arm went away. When it didn't I contacted Orthopedics to have my arm looked at. The PA and was seen by noticed the scapular winging and believes its due to damage of my long thoracic nerve.

I had what I thought was "normal" pain at the injection site (left shoulder) initially however the pain spread from the injection site downward to my mid triceps by Saturday to Sunday afternoon. By Sunday night my shoulder mobility began to diminish (lifting the arm enough to comfortably shower was challenging). By Monday my shoulder and elbow radiated with pain originating at the injection site. By Monday afternoon I had lost virtually all mobility and strength in shoulder such that I could not raise my arm high enough to wash my left arm/hand enough to wash my hands in a kitchen sink/bathroom (which has NEVER been an issue). Since Monday, any activity that innervates the left shoulder to generate movement results in debilitating pain. By Tuesday the pain, immobility, and strengthless-ness had spread gradually to my left pectoral muscle, my left rear deltoids, my left elbow, my left forearm and slightly into my left pinky and ring fingers. Wednesday (today) all the symptoms from Tuesday are still present with the added symptom that maintaining proper posture through my left shoulder is also painful so now I'm hunching on my left side.

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

The day after taking vaccine, I started joints and muscles pain in whole body, felt like my body is transforming. Then on second day after taking the vaccine my left leg and lower back hurts. Since then, I am having left leg and back pain because of which I can't even stand. I have to lay down or sit all the time. When I stand, my left leg pain increases to extremely high level and starts feeling numbness on the feet.

Extreme fatigue and exhaustion. It is like my energy levels went down and can't come up, despite of food, water, and dietary supplement intake.

gave blood on April 8. On April 9, right above the blood draw area on my right arm, the muscle on my lower bicep started twitching. I looked up to see if loss of blood could cause it. This was about two weeks after my first dose of Moderna. I would occasionally get similar twitches on different areas of my body for the next week but didn't think too much of it. Upon my second vaccine on April 14, the twitches became much more frequent. Multiple times a day and more forceful in different areas of my body. Over the last weekend April 23, 24 and 25, the twitches were at their worst, occurring in my left arm, right shoulder, abdominal muscles, buttocks, thigh and calves at different times. Over the last several days, they have subsided somewhat and are occurring less forcefully and more sporadically. Today, only a few small twitches--similar to what it was prior to my second shot.

Nausea for roughly 6 hours, arm extremely sore and stiff for about 24 hours, headache for about 8 hours.

FOUND ON THE FLOOR OF HIS HOME UNRESPONSIVE, BY HIS SUOERVISOR, EMS CALLEED taken to hospital. HE REMAINS THERE TODAY AWAITING A LONG TERM ACUTE HOSPITAL BED UNABLE TO SPEAK, FOLLOWS SIMPLE COMMANDS, DOES NOT MOVE RIGHT ARE AND LEG

Had the moderns vaccine dose 1 april 21, 2021, only had a sore arm for about 2 days after. Around April 29, 2021 a big red perfect circle had formed around it, it is really tender and is sore. I'm just trying to make sure I do not need to go to the doctor or the hospital. Thanks.

Patient reported feeling sweaty and clammy while being observed after vaccine administration. Then he reported a headache and appeared pale. Patient vomited x1 and then reported feeling better after vomiting. Continued to monitor patient until he stated he felt well enough to leave.

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

Approximately 25 days post vaccination, patient (I) started to feel burning sensations in the right upper half of my body - areas affected were the back shoulder and chest. Approximately 4 days later, a rash appeared on my back shoulder and under arm areas. The burning sensation continued and the area was sensitive to touch. A telehealth doctor visit was done and I was diagnosed with Zoster without complications and I was prescribed valacyclovir for 7 days.

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

Helicobacter pylori; arm pain; a little bit cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included AMLODIPINE for Hypertension. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273, the report did not provide any causality assessment. The patient was prescribed to take lansoprazole 30 milligrams, amoxicillin 500 milligrams, and clarithromycin 500 milligrams for 14 days to treat Helicobacter pylori. 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.

When he received his second dose of Moderna he reported that after his first dose he had felt some pain immediately but then 2 days later he experienced a "twingy/numbness-like feeling" down his arm that comes and goes through out the day. Nothing makes it better or worse.He states he has never had any issues before with shots. Phone call to him5/5/21- he is still experiencing the same thing. It does not affect his work he says, it's just something he has learned to ignore.

During post-vaccination observation, Patient complained of feeling warm all over, slight nausea, and itchy rash on hands that progressed to upper arm during the next fifteen minutes; no angioedema, dyspnea, lightheadedness or other symptoms. Vital signs remained nominal at all times. 30 minutes following oral administration of diphenhydramine 50mg, all symptoms had resolved.

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

The patient got real dizzy and started to shaking (possible seizure). The patient was assisted to the ground and moved to a fetal position on his right side. 911 was called by the pharmacy technician. The patient slowly started to recover and he stated he started feeling better as paramedics arrived. The paramedics took the patient away to a nearby hospital.

Symptoms: vomiting, shakes, fever, body aches, lethargy, weakness, loss of appetite, migraine, chest pains, difficulty breathing, wheezing, shortness of breath.

Patient was nervous after Moderna vaccine. He felt dizzy and his hands felt cold. Patient laid on his side on the floor and felt better. He stated his throat was not swollen and he can breath just fine. I checked his blood pressure and it was normal. We called for the ambulance but when the paramedics arrived, patient felt a lot better and after their evaluation, they believed the patient did not need a trip to the ER.

Seizure lasting less than 1 minute occured within 1 minute of vaccination. Brought to ER by ambulance for approximately 2.5 hours, given fluids, blood tests, and discharged. Took 2 extra strength Tylenol before bed in anticipation of fever, elevated temperature by 5AM following day (98.8 F). 2 more Tylenol at 5AM. Very tired, sore throughout body, sluggish, lack of appetite. Another 2 Tylenol at 10:30 AM. Continuing...

A fatigue that lasted from 04/26/2021 to 05/02/2021. Low energy, very tired. I had to miss work on all scheduled days within that time frame. Quarantine at home. No irregular temperatures, no nausea. On 4/28/2021 to 05/01/2021, I did take one dose of Coricidin a day. I also took Airborne tablets. I eat chicken soup everyday. Lots of rest & naps.

101 fever, Headache, body aches - started 14 hours after shot, ended about 30 hours after. Sore left arm and swollen armpit lymph nodes - started 2 days after shot still subsiding 4 days later

Pt had vaccination and returned to lobby for 15 minute waiting period. While seated in lobby, became stiff and fell from his chair to the floor. Nurse responded, pt's jaw was clamped shut and pt appeared to be seizing. VS within normal limits, and pt returned to alert state within 2 minutes. EMS responded several minutes later and evaluated pt, who denied need for transport to hospital ER

Numbness started on Day 2 of the vaccine and has never stopped. Started with left ring and pinky fingers. Received Vaccine #2 on 5/11/2021 and now there is a line down my left arm from the point of the shot to my middle finger and it is entirely numb, leaving me with 3 fingers that are numb - left pinky, ring and middle finger.

Patient reports of vaccination site to be higher on his arm than last time. Reports pain in left arm and difficulty lifting hisarm

Severe muscle aches/cramps throughout the body once I (patient) went to bed at 11pm, followed by profuse sweating and fever that reached 102F by midnight; severe chills, nausea, headache, dizziness all began by 1:00am and continued throughout the next 8 hours. I was unable to leave bed during the night due to the aches and severe dizziness. By Monday morning at 8:00am the chills had stopped but all other symptoms remained along with severe fatigue. I was able to sleep until approximately 12:30pm and the only remaining symptoms were mild muscle aches, nausea, and severe dizziness/lightheadedness. Those symptoms remained until waking up at 8:00 Tuesday 5/18. As of 5/18, I have mild dizziness but all other reactions have stopped.

That evening I had chills followed by night sweats. My heart beat was racing over 130 beats per minute for over 8 hours. Headache, 104 degree fever, severe fatigue, pain at injection site, cough developed

Pt. received his 2nd Covid vaccine on 5/18/2021 at approximately 4:30pm. He stated in the informed consent form that he felt really dizzy on his 1st Moderna vaccine. I administered his 2nd vaccine and told him to wait in front of the pharmacy for 30 minutes. Approximately 30 minutes later one of the pharmacy technicians stated that the patient did not look like he was feeling well. I imediately went out as asked how the patient felt, and he stated that he was feeling really dizzy, had fatigue land a little tingley with a mild headache, nausea and some muscle aches. I offered to get him a wet towel and some water or anything he might like to drink. He stated he would like some water to drink. I asked him if he needed someone to come and get him. He called his mother and she came to pick him up at 6:35pm. I told him and her we would follow up with the patient tomorrow 5/19/2021 at the earliest possible time.

Patient observed to become unresponsive and slumped over in chair during observation at appros 15 minutes. He remained unresponsive to verbal and physical stimuli for approx 5 minutes. Once responsive, he c/o pain all over, abdominal pain with curling up as if cramping. no muscle spasms observed. Skin with mild tenting. vitals monitored, NS IV given, ~150 cc given prior to transfer to EMS. Lorazepam 0.5mg IV given for muscle spasms. Diphenhydramine 25mg IV administered Labs drawn. Oxygen saturation 99% initially with NRB, changed to NC and remained >94% on 2 lpm. patient remained somnolent, not answering questions, though conscious.

-Dark coloring (purple&blue) around knees -Severe migraine beginning at 12:30 AM Today -Severe joint pain hands & body. Can barely walk. Cannot work. -Mild shortness of breath -Mild Chills The last time I felt this type of pain I ended up in the hospital for 3-4 days with extremely high white cell blood counts. While I realize the vaccine may have side-effects, I'm also aware I have a weak immune system. So I'm taking extra precautions in the case things get worse. I'm sure I'll get better but I'd rather say something and be safe. When I get sick I tend to go down quick and I don't have any family closeby to rely on in case of an emergency. I'm completely played out on the floor hoping it will pass. Not an emergency now but it could turn the other way as it has before. Sorry for any inconveniences.

Thursday, day of 2nd vaccine dose: 1) Sore arm within a few hours of 2nd dose (9:00 AM), same reaction to 1st dose. 2) During fitness workout (5:30-6:30 PM), split second of dizziness. 3) At home (7:00) aggressive fever(temp unknown)/chills, dizziness; mild nausea 4) Bedtime (9:30) hallucination for about an hour Friday, day after 2nd vaccine dose: 5) Nighttime (2:00 AM) fever broke, no hallucinations 6) Remainder of day, fatigue (attributed to stress from issues 1-4)

I got Moderna vaccine #2 at around 11:30 am. That day, I felt tired and my arm was sore and felt really hot then really cold. That night, starting at around 11:30 pm, I woke up every hour and was unable to stay asleep, that continued through the morning. Toward the morning, around 3:30 am, I fainted in the bathroom and came to on the floor, luckily, I didnt get hurt on the way down. I felt crummy that next day and back to normal within 3 days.

I?m now 2.5 weeks out from my second dose and the side effects: fever, chills, muscle aches, night sweats are still occurring and still very bad. No end in sight.

Progressively got sicker and sicker. Vomit uncontrollably for a few days after. Dizziness. Tremors. Feels slightly off not sure if use to it or somethings changed.

Transverse myelitis resulting in bilateral leg weakness and urinary retention, weakness started 3 was after vaccine, mild abdominal pain started two weeks after vaccine. He was seen in the ED on 5/19 with abdominal pain and weakness, negative work up and sent home. Came again to the ED on 5/21, again with abdominal pain and weakness. Found to have urinary retention, required fully catheter for decompression which improved abdominal pain. Also significant weakness.

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

Patient reported left chest pain since 8:30AM 5/31, onset while driving, worse with movement such as moving his arms or neck. Later around noon he began having numbness in his left pinky and hand, thus presented to the UC. Diagnosed wtih costochondritis and discharged but high-sensitivity troponin came back elevated at 94 and was asked to present to hospital. Repeat trending down. Cardiology consulted, diagnosed with pericarditis.

Pt called on 6/3/21 to say he is still having arm pain. He still feels a hard knot at the injection site. He also described gradual decrease in range of motion of the arm. Patient also stated that he has had a headache almost every day since the vaccine.

tightness, pain in chest, shortness of breath, weakness, pain and tightness in left lower neck and shoulder and upper inner bicep area. Symptoms were 5-15 min duration at a time coming and going at all times of the day both with physical exertion and without. Resting pulse was around 120 with each event, symptoms came and went over the course of a week and have since subsided on their own.

Rec'd shot at 9:20 am. Onset at 9:29 am of "tingling and numbness" radiating from just distal of injection site down posterolateral arm to all fingers. No proximal radiation, no pain. No SOB, face/mouth swelling, rash, dizziness, lightheadedness. Neurovascular check left arm = pulses 2+, sensation intact, strength 5/5 all muscle groups. Ice applied to injection site at 9:33 am. No change in symptoms. Discussed sxs as side effect of injection with patient. Discharged home at 9:43 am with instructions for icing, use of OTC acetaminophen PRN, FU with PCP if symptoms worsen or persist longer than 24 hours.

Excessive aching especially when using his arm. He can raise arm above ahead but arm is still tender at rest even on June 9, 2021. He said it "hurts like hell" when he picks anything up. When he gets up in AM, he says it really hurts him and after about 1 to 1.5 hours after waking up the arm feelings okay.

First shot one month prior, no issues at all. Soreness at the injection site. Second shot: Next day, high fever, chills, severe muscle and joint pain. Two days after, violent vomiting. increased joint pain, fever, trouble thinking clearly. Three days after, numbness in my left hand, and loss of sensation in my entire right foot. As of 6-16, loss of feeling still continues. 1 week after, chest and lung pain, I think my heart is hurting, almost like random stabbing pains through it, random waves of muscle and joint pain. Issues sleeping. Issues with thinking clearly. I have felt run down since receiving my second shot. Loss of appetite and foggy brain.

Left Leg movement is painful and limited. The pain is in the thigh area and upper calf. The pain started 4 days ago and has gradually gotten worse.

About a week after the shot I noticed I was a experiencing some hypertension. I was having chest pains on the right side of my chest, as well as pain and numbness in my right arm around my bicep area. The chest pain is intermittent but the arm pain is pretty constant. My PCP ran a blood panel that showed high cholesterol. I also had an EKG, which was normal. He scheduled me for a stress test. I passed but was told that for a male my age and fitness level, I should have done better. I was prescribed aspirin and atorvastatin 10mg 1x/day. I had COVID in 11/2020, I was asymptomatic.

Vivid dreams and cant sleep, Insomnia, hallucinations, numbness, tingling, facial flushes, rashes, gut issues, heart racing and palpitations, high blood pressure, weight loss,

Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weird"; Weakness; pain in ankle; Gout pain; Feeling ill; Feels like he almost wants to fall asleep; Vaccination site bruising; Fatigue; headache; arm sore(left arm), muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 053621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia (Low oxygen), Mental disorder and Ankle operation. Concurrent medical conditions included Gout. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain) and FATIGUE (Fatigue). On 09-Jun-2021, the patient experienced ILLNESS (Feeling ill) and SOMNOLENCE (Feels like he almost wants to fall asleep). On 13-Jun-2021, the patient experienced GOUT (Gout pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PAIN (pain), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness) and ARTHRALGIA (pain in ankle). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout, at an unspecified dose and frequency and IBUPROFEN for Gout, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VACCINATION SITE BRUISING (Vaccination site bruising), PAIN (pain), GOUT (Gout pain), ILLNESS (Feeling ill), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), SOMNOLENCE (Feels like he almost wants to fall asleep), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain), ARTHRALGIA (pain in ankle) and FATIGUE (Fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications include unspecified mental health medications. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-215030 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated new events- Mental issues, physical issues, Loss of Consciousness, Gout, Arthralgia, Hypomania and feeling abnormal. Updated patient history and treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I was going to the bathroom and I got really hot. My heart started to race and I ended up passing out. I was transported to the hospital and admitted over the night for observation. Ten days later, I passed out again and was admitted to the hospital again. I've had a couple of mini episodes where I have had to lay down and elevate my legs to keep from passing out

Within 15 minutes of receiving vaccine, patient began to experience severe chest pain/tightness, elevated blood pressure and pulse and broke out in a cold sweat. EMS was called. Follow up 30 minutes after leaving facility - EMS was still monitoring the patient Follow up the next day (6/29/21) - patient was unable to be reached to get an update on status

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

Patient received 1st dose of Moderna, then started his 15 minute wait. 11 minutes into the wait period, patient got up and came to the pharmacy counter and said he was feeling real warm and "funny" to the pharmacy technician. The technician alerted the pharmacist and when the pharmacist looked over at the patient, he looked pail and started slouching. Pharmacist ran to patient and caught him as he started to pass out. Pharmacist laid him on the floor and by the time the pharmacist had him laying down, the patient came back awake. Patient was sweaty and very warm to touch. During this process, EMS was called. When they arrived patient was already back to normal cognition and said he felt fine other than being warm. EMS check stats and cleared him to drive home after another 15 minutes wait period. The pharmacist believes this was a vasovagal syncope reaction to this patient getting the Moderna vaccine. Patient was fully recovered within 30 minutes of the adverse reaction.

After several hours, extreme arm pain began. I was unable to move my arm without terrible pain for several days. By the time I went to get my second dose (5/5/21), the arm pain STILL occurred. I got the second shot in the same arm. My arm STILL hurts today (7/1/21) and I'm not sure what to do it about it. The pain is not as severe as the first month, but it is still painful and doesn't respond to traditional pain medications

Discovered a large rash/hives developed on right shin within 30 minutes of vaccination. Rash was dark reddish color initially and slightly itchy but not painful. Generalized joint point (left wrist/arm) and nausea also began within 30 minutes of vaccination. Went on a run later that day, much more severe fatigue than usual. Took a couple days off of exercise to rest. 3 days later, went running again and noticed an occasional sharp pain in left knee. The following day, left knee was in severe pain and was unable to walk normally or flex leg fully. Very little swelling, but pain was persistent and did not resolve with painkillers (Ibuprofen). Stopped all running activities indefinitely, and started short walks a couple days later. After 5 days of walking, left knee blew out with excruciating pain and swelling, like a rheumatoid arthritis flare up (I never had arthritis in my life). Now I was completely unable to walk more than a few feet without a cane and it was excruciatingly painful. Took vicodin for pain, but still not fully effective. Worst pain I've ever had in my knees, completely unable to sleep or even lie down. Any movement was horrible. After further rest, ice, and elevation, knee swelling slowly subsided but took many weeks to improve. Pain continued even without swelling, and is still not fully resolved today (over 2 months later). Left knee flexiblity is still limited and I can only do short walks with mild pain, no running or hiking. I am effectively disabled at this time.

I have Peripheral Artery disease and have had bypasses done on both legs. It has been managed fairly well with a several minor "tune ups" by angio. I was able to walk pretty well with minimal pain. About a week after my second dose I started noticing increased pain in both of my calves which has become considerably worse since then. I cannot walk 1/10 of a mile without taking a break. Also, around July 1st, my fingers went numb in my right hand, then I started getting pain in my right forearm and cramping in my hand. That pain has made it so the way up my arm. I saw my vascular surgeon and an ultrasound revealed a clot in the bend of my elbow. I was asked how I think I could have gotten the clot, the only thing I've done differently was get that vaccine. It's extremely obvious to me that the vaccine has caused a severe reaction in me. I have a surgery scheduled on Wed. July 14 to have the clot removed.

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

Four days post-vaccination, developed tingling in both feet, primarily big toes (sometimes slight numbness during heavy activity) Five days post-vaccination, developed tingling in right hand, primarily fingers - progressed to both hands 19 days post-vaccination Five months post-vaccination, symptoms remain and intensify - tingling progresses to all toes and balls of both feet, developed temperature sensitivity in both hands, both arms, both feet, and both legs. Developed scalloped tongue. Seen by primary physician in January, hematologist in April, and Neurologist in March and June. No active treatment so far. Symptoms remain. Diagnosed with small fiber neuropathy.

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

seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decreased level of consciousness; worsened Depression; Difficulty breathing/issues with breathing; worsened Anxiety; Feeling ill; felt really tired; felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar) and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (2 surgeries on other leg). Concurrent medical conditions included Bipolar disorder, Gout (In one leg), Penicillin allergy (reaction- nausea), Drug allergy (Revatio (reaction- nausea)), Drug allergy (Vicodin (reaction- nausea)), Seasonal allergy (reaction- congestion), Anxiety (worse with COVID mask use) and Depression (worse with COVID mask use). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 19-Apr-2021 to an unknown date for Depression, INDOMETACIN (INDOCIN [INDOMETACIN]) from 07-Oct-2020 to an unknown date for Gout, NAPROXEN SODIUM (ALEVE) from 24-Sep-2019 to an unknown date for Pain. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), ILLNESS (Feeling ill) and FATIGUE (felt really tired). On 14-Jun-2021, the patient experienced ANXIETY (worsened Anxiety). On an unknown date, the patient experienced SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work) (seriousness criterion medically significant), BIPOLAR DISORDER (worsened Bipolar) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DEPRESSION (worsened Depression) and DYSPNOEA (Difficulty breathing/issues with breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and OLANZAPINE (ZYPREXA) (oral) ongoing from 07-Jul-2021 for Bipolar affective disorder aggravated, at a dose of 10 mg. At the time of the report, SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ANXIETY (worsened Anxiety), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (worsened Anxiety) to be possibly related. No further causality assessments were provided for SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired). After getting the vaccine in the morning, the patient felt really tired. The patient went to the family doctor for a previously scheduled appointment regarding his condition. On the way there he couldn't keep the eyes open, and felt as if he didn't get enough sleep. The patient hadn't realized that he slept. The patient had assistance from his son because he felt like he could catch his train of thought. The patient told his O2 level was fine and was instructed to take Benadryl. The HCP reported that anxiety, depression and bipolar might be psychological and wondered why these had gotten worse. 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, history of bipolar depression and anxiety may remain as risk factors. This case was linked to MOD-2021-215030, MOD-2021-214836 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up contains New event , Medical history On 08-Jul-2021: Follow-up included: Medical history was updated, Patient weight, anatomical location of vaccine administered, Dose 1 details added On 14-Jul-2021: Case has been updated from non-serious to serious due to the addition of Serious events. New non-serious events also have been added. Patient's demographic details and reporter contact details were updated. Patient's medical history including allergies and current conditions, concomitant medications and treatment details were 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. However, history of bipolar depression and anxiety may remain as risk factors.

I started to have numbing on my right side especially on the back of my head. After that I had dizziness and confused. I felt like I could not breath. I was finally able to catch my breath. I am still not able to catch my breath. I went to the ER. They checked my pulse and took notes. They were just trying to rule out everything. They monitored me for a while. The did do an MRI. After that I followed up with my PCP, she ran labs, and they came back normal. They did a COVID test which cam back negative. I still experience irregular heartbeat. I am going to follow-up with my cardiologist at the end of month.

40 year old patient received second dose of Moderna lot number 026A21A. Began to complain of rapid heart beat, tingling, difficulty breathing, difficulty speaking. No physical evidence of allergic reaction. Vitals were normal except mild tachycardia. No rash or wheeze. Normal oxygen sat. Watched longer, offered food, but patient continued to state he did not feel right. At over 1 hour, asked if he would like to drive to ER, but said he could not drive. Called EMS. Gave Bendadryl IM (no po in kit).

Bells Palsy to the right side of the face. starting 03/06/2021 and continuing as of 07/28/2021 Pain control with medications

Patient completed 2nd dose of Moderna 07/29/2021, first dose was given 07/01/2021. After completed dose, patient was advised to sit and wait (MINUTES). After the timed interval was completed he would be free to leave. A few minutes after vaccination, the patient started experiencing dizziness and fainting. Objectively, the patient displayed fainting and minor seizure like activities. In addition, the patient was sweating all over the body. This happened over a period of 15-30minutes before EMT arrived to provide additional support.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had an event of syncope after the injection and fainted in the chair. I assisted the patient to the ground and had them lie flat and elevated their legs using a chair. Patient regained consciousness and was responsive within 1 min. I checked BP and heart rate (BP was 124/82 and Pulse was 76 b/m). Per store Policy EMS was called by store LOD. EMS arrived and took patient to local hospital. Pts was responsive when they left pharmacy.

The next afternoon on 12/30/20 I experienced a slight pain like someone scratched me on my chest, stomach, and back. The next morning (12/31/20) the pain turned into burning sensation like a mild sunburn all over my chest, stomach, and back areas. I am still experiencing the burning sensation today.

I work at a Hospital sterilizing surgical equipment. After I received the vaccine, the hospital staff observed me for 15 minutes to see if a reaction occurred. I felt fine, and they told me I could go. I was working that day (2-10:30pm) and had gotten vaccinated at the beginning of my shift. The rest of my shift went fine. Near the end, though, my arm began to feel sore. Driving home, I began to feel tired. By the time I got home, it felt like a cold was setting in. I ate a large bowl of chicken soup to try to feel better. I stayed up a little bit, but was feeling woozy by this point and went to bed. Bad chills set in and I began to shake I felt so cold. I used a heating pad to help with this. I tried to sleep, but my head was throbbing. The next morning, I tried to sit up in bed but my first attempt proved too difficult. I took it slower. I was able to sit up eventually. Standing was also difficult. I spent the day mostly lounging on the couch. I slept a little better that night, but my head was still throbbing somewhat. No chills this time. Getting up the next morning went a little better. I was able to sit up in bed without issue and walking around did not prove as much of a chore.

5 minutes post vaccine administration I started to feel palpitations, numbness on both arms and went up the nape/head, flushing, tingling in both arms dizziness, then dysphagia but able to talk. Hives at torso after 10 minutes. I was assessed by to physicians working at the site. Epi pen was given to me by a physician and taken by ambulance to hospital by EMTs who were there at the site. At the hospital I was given 40mg steroids by mouth. After observation for 4 hours I was feeling better, and was discharged home. Ordered to take 40mg of steroids for 2 more days. After one day post vaccination, I have significant pain at the site and body ache.

That night approximately 2300, started with minor chills and tiredness, 0430 with increased chills and body aches, headache, and took ibuprofen and Tylenol. Every 4-5 hours the body aches and chills came back, still taking the ibuprofen and Tylenol, napped later in the afternoon and woke up approximately 1630 feeling good. Laid in a recliner approximately 2000 and dozed off for about 30 minutes, woke up feeling worse with uncontrollably shaking chills, body aches, joint pain, fever of 101. Woke up the next day with minor body aches and joint pain. Sunday approximately 0730 had headache, joint pain flushed feeling/hot flashes/sweating, the body aches again.

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

Fever of 101 for the first 48 hrs, ibuprofen, fever went down Pain in the arm for first 24 hrs, ice, ibuprofen, pain went away

Employee received covid vaccine at 813am. At 830, he reported flushing sensation on his face. Vital sign at 830: BP 109/81, HR 80, O2 99%. He denies wheezing, sob, chest discomfort, sore throat, difficulty breathing, pruritic. Employee was provided fluids and reports symptoms gradually improved. On assessment, employee's face was flushed, mild erythema on the upper arm. No angioedema. Lung sounds clear. Heart sounds normal. No acute respiratory distress. Employee was observed closely in clinic. Symptoms improved. At 855, BP 107/79, Hr 72, O2 100%. Employee was discharged from clinic to return home. He was instructed to closely monitor his symptoms. If his symptoms worsen or persist, he needs to go to urgent care or go to ED. He stated understanding. He left in stable condition. No acute distress.

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

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

Light-headed, extreme cold in hands. Started approximately 2 hours after injection and lasted for about 4 hours.

Patient reports 01/09 and 01/10 feeling body aches, fatigue and a sore arm but the evening of 01/11 he developed full body hives after taking aspirin.

I felt a tingling in my middle, ring and pinky fingers of my left hand. This began about 30 minutes after. Approximately 24 hours after, I am noticing that my left hand is slightly tingling, as well.

Staff had his 1st vaccine yesterday 01/14/2021. Around 10 pm last night started having symptoms; bodyache, hot and cold. Staff had positive Covid test on 12/07/2020.

Developed shingles with symptoms starting on 1/10/21 including lesions along dermatome T5, neuralgia, and fatigue.

Started with flu like symptoms, chills, aches, etc. For about 12 hours. Then I rapidly spiked a 102.7 fever and became so physically weak I felt paralyzed. Oxygen saturation dropped into the low 90s and I began to have labored breathing. I made an attempt to stand up and urinate, then passed out and collapsed. Ems came to the house and checked me out. I declined their offer to go to the hospital because I broke the fever, was breathing better, and had no concussion signs from the fall.

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

Decreased overall energy and right calf muscle pain/soreness. These symptoms started the day after receiving the vaccine.

I received the vaccine at 11:50 am. First my arm started hurting and felt warm to the touch shortly after the injection. My arm started hurting more and more until I could barely lift it to the side more than like 20 degrees from my side. Then I got the worst headache of my life. I tried taking ibuprofen, but it barely seemed to make any difference. I also tried taking Bayer aspirin and it seemed to help a little bit. Plus the whole time I was feeling nauseas, and it was all I could do to eat a few crackers so the medicine wouldn't upset my stomach as much. By this time the muscle/body aches, and fatigue started setting in so I just tried to go to sleep around 8pm or so. I was able to sleep, but it wasn't a restful sleep. I was tossing and turning for a few hours. Then the chills set in around 10pm and I didn't want to get out from under the covers because I was shaking so bad. But I managed to pile enough blankets on to get warm, and I was able to get some sleep. Then next day, all of the previous symptoms seemed to get worse except for the chills seemed come and go. But my arm was hurting more in a larger area and up my shoulder. The muscle/body aches were more intense and the fatigue increased. Taking Ibuprofen every few hours only marginally seemed to help. My head was hurting so bad it hurt to open my eyes. And I felt like I was going to throw up all day. Plus I started taking my temp sometime in the morning of over 101. Sorry about to run out of time

41 y old M with post vaccine had a mild reaction had a low grade fever 99.5 x 8-10 hours occurred 6 days ago then resolved and a sore arm that resolved

Muscle aches, malaise, chills, 120 to 140 bpm heart rate and perfuse sweating which lasted from dinner, allnight until early morning. Drank a lot of water and stretched to help relax and tried to call back asleep. Heart rate did eventually go back down to 80 to 90 bpm. Still felt clamy and fatigued. Went to work with little energy.

Around 11:30 pm that evening I started feeling extremely warm in my face and thighs. Figuring it was due to the shot, I decide to try and lay down to sleep it off. A short time later, I awoke freezing with chills and uncontrollable shivering. My whole body hurt especially my lower back and pressure in my head. This continued throughout the night until the early morning. As the shivering and chills subsided, extreme fatigue, body aches and head pressure continued and it was difficult to get up at points. I had no appetite and forced myself to drink to stay hydrated. About 1:00 pm, I started to feel better, but that was short lived. Approximately 4:30 ? 5pm, the chills and shivering returned and I had 101 fever. I had some tea and toast and then went to bed for the night. When I awoke this morning, I felt a million times better. As of writing this email, I still have some slight fatigue, aches, and head pressure, but night and day difference from yesterday.

Patient states received MODERNA vaccine 1/14/2021. 1/16/2021 developed severe muscle pain and fatigue starting in bilateral calves moving superiorly to the neck. Edema of BUE. Loss of strength in BUE. Pain in Bilateral groin. All progressively worsening . Sought medical evaluation on 1/19/2021. Labs drawn. Given NSAIDS and Cyclobenzaprine for muscle pain and tightness. Encouraged hydration. Revisit on 1/22/2021. Sx improvement, not resolutions. Muscle weakness present. Quick to fatigue, example writing name of form, extreme muscle fatigue and hand edema developed. Repeated labs.

12 hrs after vaccine experienced typical adverse side effects of arm pain, fatigue, headache, myalgias and arthralgias. 24hrs after vaccination the initial symptoms persisted and also developed urticarial macular exanthem from scalp to waist along with decreased urine output, joint swelling, edema, Had intermittent tachycardia. Symptoms lasted for 72 hours.

swollen lymph node is axilla and sore arm. First noticed on 1/24. Have taken ibuprofen. Symptoms improving but still present. Will use warm packs and ibuprofen for symptom management.

Swollen lymph node in axilla and sore left arm. Started on 1/24. Took ibuprofen for symptoms. Has full ROM of shoulder. Symptoms persisting but improving. Pt to use ibuprofen and warm packs on site, will follow up with clinic if symptoms do not continue to improve.

Started with extreme pain in the upper are preventing the arm to lift laterally. Anterior/ Posterior lifting was performed with minor difficulty. Experienced chills in an indoor temperature of 80 degrees. Extreme fatigued experienced from 7:30a.m. and through this current time. Chills are coming and going as well as headaches.

Rash and burning feeling broke out on left arm around inner elbow area and growing to circumnavigate the arm

Jan 22, 2021 - 7:00pm - My housemates have notice my left mouth was barely moving when I speak. But dismissed it and didn't inform me. I personally did not notice it as at this time I have experience chills and my temperature rose to about 100.4 F Jan 24, 2021 - 7:00pm - I personally noticed that the left side of my face was paralyzed when I couldn't sip from a straw to drink tea Jan 25, 2021 -8:50am - I was diagnosed (through virtual consult) with Bell's Palsy by a Doctor and put on Prednisone 20 MG - 3 Tablets per day for 7 Days , Valacyclovir HCL 1 Gram - 3 Tablets per day for 7 days Jan 29, 2021 - 4:20pm - On-site checkup with Doctor and tapered my Prednisone for additional of 3 days - 3 tabs day, 2 tabs day 2 and 1 tab day 3. Valacyclovir HCL 1 Gram was extended for another 3 more days. Same dosage Feb 1, 2021 - 9:13pm - There is very little improvement

left arm around injection site was noted to be warm, red, and swollen ~23 hours after the injection for the second dose. There was mild pain and discomfort but the site did not itch. Applied ice when able without interfering with other activities and took cetirizine tablets.

Approximately 12 hours post-injection developed chills (around 10:30 pm). Went to bed and woke up with night sweats, aches, chills, fever (persistently over 100F, topped at 101.3F) and one of the worst headaches I?ve ever had (not hyperbole, truly a monster headache). Slept for small stretches of time, maybe 45-60 mins, before waking. Condition worsened until about 6-7am. Chills persisted but worst symptom was the headache, it was inescapable pain. At 9am, took 400mg ibuprofen and was able to fall asleep. Woke again around 10:30, soaking wet in sweat, but felt much better. Headache about 95% resolved, fever subsided (temp returned to steady 98.2). Felt generally tired the rest of the day, but overall much better than the overnight period.

pain on and around injection site. pain and discomfort with swelling in right arm pit. causes numbness if fingertips from time to time.

My shoulder was sore for several days after the injection. The soreness and tenderness has gone away for the most part. I now have a somewhat limited range of motion and my shoulder aches and becomes stiff. I am not able to move my arm up or back as far as my right arm. It is difficult to put a jacket on.

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

Left arm numbness lateral side of arm down to the wrist. Left side of face numbness, down left side of neck extending to left temple. Also tingling in areas previously addressed.

Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called. Was not transported to hospital per pt request.

2nd shot vaccine experience: - 3:30 shot -4:30 a little groggy no big deal -6:00 pm made/ate dinner -9:00pm walked on treadmill for a bit and felt a little off/tired -2:30am uncontrolled chills -3:30am had to go downstairs shivering with 3 blankets, pj?s & robe on. -6:30am uncontrolled shaking continues (3-4 hours), moaning with every breath, headache, fever 6:30am threw up and laid on random spaces of the floor throughout the house -7:30 am splitting headache, backache, etc. -9:30 am feeling better, back aches and laying in bed. -6:40 pm still lower back ache & mild headache. Temp is now 99.2

Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in chest, possibly lung. Shortness of breath, scanty urination/dark urine, problems with bowel movements. Days 2-4: dizziness, disorientation, gait changes, delay thinking, headaches, shortness of breath chest burning, whole body joint pain, neuropathy like sensations in arms, blood pressure spikes/ pulse rates dropped to 42.

Patient had warmth in face and flushing then itching and rash over upper chest then spreading down neck and chest and body

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

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

I had severe aches and pains that started the night of the 2nd dose of the Moderna COVID-19 Vaccine. The aches kept me awake, I took 4 baths during the night attempting to shake the chilled feeling. I did not vomit, but the best way I can describe the after effect was similar to a very bad flu. The next day I was understandably tired, but also very weak. I slept for somewhere in the neighborhood of 36 hours on and off starting halfway through the day after the vaccine was administered. After about a 48 hour period since the vaccine, I started to feel better, but not fully recovered for a few days.

Employee received second dose of COVID Moderna vaccine on 12/17/21 prior HX COVID positive on 12/8/20 ,came to work on 12/18/21 @ 12:08 pm c/o dizziness ,headache and ,numbness to both hand and feet. Employee awake ,alert and oriented able to follow verbal commands well. Blood sugar on scene 84 mg % with BP :140/80 , HR :74 /mt and 02 Sat's 96% Employee was triaged by RN and send out to outside hospital via AMR for further eval and treat @ 1233 pm .

Pt reporting chills, muscle stiffness, sore arm and feeling light headed. Pt's tympanic temp was 99.0

Very sore muscles especially shoulders and upper arms. Extreme fatigue. Initial arm pain subsided after day 2. Progressively been getting worse.

Extremely sore arm at site of injection , onset 12 hours after injection. Lasted 24 hours. Body aches onset 12 hours after injection, lasted 24 hours. Slightly felt amped up as well 12 hours after injection, restless. Lasted 24 hours. Urinated more then average. Onset 12 hours after injection. Lasted 12 hours.

Friday approx 12 hrs after vaccination adverse reaction began. Shaking and extremely cold, three blankets couldn?t warm me up. Oral temp did not register a fever. Severe body aches and muscle tightness especially lower back pain 5/10. Headache equivalent to migraine. 5/10 Saturday: headache persisted all day 4/10, muscle aches eased off late afternoon approx 4pm. Approx 120oz of fluids consumed during the day. Night time cold sweats, had to change clothes twice. No fever recorded. Sunday: no body aches, no headache

On Feb 14 developed Covid arm rash on left arm below site of injection. Rash spread over the course of 2 weeks and was red and hot to the touch. March 2nd left hand was achy and couldn?t open and close the left hand. March 4 rash spread to RIGHT upper forearm and is symmetrical with left arm. March 6 woke with swollen heel on right foot and painful and tender marking it difficult to walk.

Huge red rash that appeared about 8 hours after I got my second vaccination. It is painful to touch and itchy, and often feels like the skin is burning. The rash feel feverish. It started out smaller, but increased in size over the next few days. I received my second vaccination on 3/3/21 and I still have the rash today on 3/6/21. I have also had a very light fever that has come and gone, along with extreme fatigue and severe body aches.

Delayed reaction occurred 8 hrs. after receiving vaccine. Felt as if I was injected with the Flu, based on the symptoms that arose: chills, fatigue, nausea, dizziness, fever, body aches, weakness, no appetite or desire to hydrate(every single symptom was severe) These symptoms lasted 12 hrs. I chose to go in to work, instead of taking the day off. I truly believe that because I pushed my body through this painful ordeal, it helped me to overcome this Flu-like feeling that I endured for 12 hours: 10 of those at my job. I also experienced a swelling & pain in my right knee. The pain & swelling is finally subsiding as I type this report 4 days after the vaccine.

I felt a little discomfort in my left arm in the morning when I got up, 0900. By 1200, I was having some chills so I added a sweater. By 13:30, I was having more violent chills, so I grabbed a blanket and increased the room temperature. By 15:00 my fever was approximately 100 and then by 15:45 it was 102. I called my PCP and they suggested acetomediphine. I took two pills at 16:10 with some water and am waiting for my fever to go away it reduce.

So at 3hrs after second shot my arm hurt, 18hrs I felt really tired. 20hrs I was freezing. 24hrs chills and headache.

Cold sweats; headache; muscle and joint aches initially bilateral elbows still sore to date (3/12/2021)

Soreness and swelling in injection arm - 1/2 hour after shot continuing to present 1:00pm 3/17 (26 hours after shot): unexpected low blood sugar readings throughout the afternoon 7:00pm 3/17 (32 hours after shot): slight fever (100.1), muscle soreness, body aches

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

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

COVID Arm -- Painful rash that was symmetrical around the injection site in left arm. This lasted for 3-4 days and then faded. It measured around 5" diameter on average and was more or less a circle on my shoulder moving down my arm.

Patient reported "hard lump in center of right armpit", feeling "hot and sweaty," and having "swollen, irritated, tight muscles in groin." Patient used OTC Ibuprofen for symptoms.

Patient became flushed, sweaty, and experienced shortness of breath, per his report. This occurred approximately 1 1/2-2 hours after vaccine.

Beyond tiredness, weak muscles, mild to painful headache behind both eyes going to the back of the head, still have cramping/stabbing pain in left shoulder.

February 12 stareted developing a strong headache, numbness and tingling in arms and feet than it progressed to weakness on arms and legs in the next couple of days Got diagnosed with Guillain-Barre syndrome and was hospitalized form February 16 to February 23. Received 7 treatments of IVIG and am now recovering

blood pressure was 200/120; felt like it was hard to breathe; felt dread; felt a strange cold rush over his system; A spontaneous report was received from consumer concerning a 41 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a strange cold rush over his system/ feeling cold, felt like it was hard to breathe/dyspnoea, felt dread/fear, blood pressure was 200/120/hypertension. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On 8 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, less than a minute after receiving vaccine, patient felt a strange cold rush over hissystem felt like it was hard to breathe, he felt dread. Patient reported that the facility had checked and his blood pressure was 200/120. Patient was not sure if it was a panic attack, but he took antianxiety medicine. Treatment activities for event was done with antianxiety medicine. The seriousness criteria for the event hypertension was assessed as medically significant. The seriousness criteria for other event was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, and felt a strange cold rush over his system, felt like it was hard to breathe, felt dread, blood pressure was 200/120 were unknown.; Reporter's Comments: Based on the information provided which includes a STRONG temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded

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

Patient complained of headache, nausea and difficulty expressing self with periods of confusion. vital sighs obtained and stable. patient continues to be monitored for any worsening symptoms. patients skin color pale. patient administered tylenol that he brought with him, with water and orange juice. patient stated that symptoms have subsided and less headache comparing to initial incident.

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

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

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

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

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

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

The night of January 9th around 2330 I noticed that the left side of my face was acting a little funny. As the night progressed into the morning I noticed that it was starting to get worse and my face was drooping. By the evening of January 10th the left side of my face was really droopy. I had heard that a small percentage of the new COVID-19 vaccines had caused Bell's Palsy in a small percentage of the clinical trial patients. I did some research on Bell's Palsy and found what to do in the event of an onset. I took Advil 2 to 3 times a day for about a week and kept a close eye on it to make sure that it wasn't getting any worse. After about 2.5 to 3 weeks the symptoms of the Bell's Palsy went away on its own. I did not see any physicians for treatment.

Had covid in April 2020, which among other symptoms resulted in night sweats for weeks. After this vaccine had body aches, chills and low grade fever that lasted for 2-3 days and then resolved. I am still having persistent night almost 4 weeks later.

Shortly after 15 min observation post-Moderna immunization, pt complained of nausea. Pt went into safety room and was seated when first pharmacist arrived. Pt said they felt cold and were shaking. Upon touching forehead and hands, pt felt clammy. Pt then they did not want to lie down for fear of vomiting. Pt later said he had pain in left arm where vaccination given. When second pharmacist arrived, pt said his hip hurt but that was sometimes normal for him. Pt's BP was taken at approx. 5:38pm with a wrist monitor and BP shown as 69/57 with HR of 63. 1st Pharmacist called 911 while 2nd pharmacist wrapped pt in blankets and continued to rub his back and chest to keep pt warm. Pt's teeth were chattering and hands were extremely cold. Pt still complained of nausea and appeared lethargic. 1st Pharmacist continually monitored pt's BP / HR with upper arm cuff while on phone with 911. 5:41pm BP was 202/123 with HR of 63. 5:44pm BP was 185/125 with 63 HR. At approx 5:45pm paramedics arrived and took over at the scene. Pt advised he takes Lisinopril for Hypertension and Lyrica for neuropathy.

Pt started to becomes lethargic and was placed on cot. Pt was laying down and started to have seizures. She would become alert and more responsive between seizures. She was laying down to keep her safe and prevent a head injury. 911 was called and arrived. She did not want to be touched, not even for vital signs, she only talked by emergancy services.

Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported not having eaten since previous day in the afternoon, briefly experienced syncope and fell out of chair that he was seated in while waiting 15 min after given first dose of covid shot, patient waited full amount of time and felt fine after 15 min

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

Became violently sick to my stomach. High fever, throwing up, poring sweat but freezing cold, lasted about four hours. Next day I felt extremely sore and very drained with diarrhea.

Terrible pain in left shoulder. Could not move my left arm the entire next day & well into two days after shot. Pain lessened on day 3 & after, but still sore for about a week after shot. Still feel a little tinge if I move my left arm a certain way (12 days after shot) but no pain

20 minutes after shot, I went from feeling fairly normal to very suddenly had very severe problems including dizziness, confusion , significant difficulty breathing, significant difficulty staying conscious, tingling all over, loss of control of some body movements, inability to sit or stand, pulse dropped to 51 according to medic,. I believed I was dying. Medic indicated I turned "white". The symptoms peaked within 1-2 minutes after onset and stayed bad for several minutes. After a few minutes My pulse started to increase and all symptoms started improving. Within 10 minutes I was feeling well enough to sit, and within 30 minutes I was able to drive home.

Went to ED 3/30/21 Immediately after receiving the second vaccine 2/25 he developed chest tightness and joint pain. The chest tightness resolved within a few hours. He then had severe fatigue x36 hours-sleeping most of that time?followed by fever, chills, myalgias x2d. Those resolved but the arthralgias have persisted since then. Within 1 week he developed worsened joint hypermobility and has had multiple subluxations (fingers, ankles, knee, elbow) that has persisted. Within 1 week he developed joint swelling. He had diffuse pain and hyperalgesia with pain to minimal pressure. At 2 weeks he developed a pruritic popular rash on LE. Due to joint swelling and rash he was placed on a 5d prednisone burst that decreased the pain, swelling, and rash, but recurred when prednisone d/c?d. He was restarted on a 2 week taper which helped partially with pain and swelling but did not resolve them and the rash continued to spread. He still has the rash present now diffuse on legs and torso but it seems to have stopped spreading as of this week. The joint swelling has also seemed to plateau but has not resolved. The joint pain and worsened hypermobility is slowly improving but not resolved. 2 weeks ago (4 weeks after vaccine) he developed new neuropathic symptoms?tingling in his extremities with intermittent shock-like pain, followed by itching and burning along S2-S3 dermatomes (into groin) and back pain. The sacral sxs resolved w/in 1 week but the tingling in extremities has persisted.

Numbness in neck on left side, left side was side vaccination was administered. Started shortly after vaccine was given. Numbness in neck traveling to jaw line. Also reporting a headache.

pain in arm since shot slowly went away the 7 days after my arm swelled and is very tender and painfull swelled entire muscle shot was given warm to touch pain to touch

buckling and hyperextending; dislocated finger; all foot bones moving; every joint slipped out of place; can't bend; sacrum and buttock burning; light headed; Body tender; Felt jowly and loose; Migraine; headaches; Searing left knee pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (light headed) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A16M20 and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MIGRAINE (Migraine; headaches) and ARTHRALGIA (Searing left knee pain). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (Felt jowly and loose). On an unknown date, the patient experienced DIZZINESS (light headed) (seriousness criterion medically significant), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning) and MYALGIA (Body tender). At the time of the report, DIZZINESS (light headed), MIGRAINE (Migraine; headaches), FEELING ABNORMAL (Felt jowly and loose), JOINT HYPEREXTENSION (buckling and hyperextending), JOINT DISLOCATION (dislocated finger; all foot bones moving; every joint slipped out of place), JOINT RANGE OF MOTION DECREASED (can't bend), SKIN IRRITATION (sacrum and buttock burning), ARTHRALGIA (Searing left knee pain) and MYALGIA (Body tender) outcome was unknown. The patient received treatment with prednisone and sumatriptan. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-058046 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Suspected occipital neuralgia on the left side, mid skull starting approximately 12 hours post vaccination and sustaining for approximately 10 hours post onset. Symptoms were a sharp pulsating pain in the back of the skull, left side, approximately every 30 seconds followed by a corresponding twitching sensation in the left eye/jaw. Always possible it?s a coincidence / unlucky timing but woke me up and never experienced something like it - just reporting in case a pattern is later observed. By 10 am (7 hrs post being awoken by it, seemed to subside but was still intense in severity in the early active/awoken hours)

Approximately 10 hours after receiving the vaccine I started to feel extremely dizzy and light headed like I needed water really bad, but 10 fold more intense. I began to sweat profusely from my entire body and I began to get the trembles. I sat down and waited it out. The episode lasted 10-12 minutes. I felt drained physically afterwards, like I had just exercised intensely.

Overnight the night of the vaccine: severe chills, body aches, next day severe headache/migrane, mild nausea, weakness, winded, fatigue

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

11pm nausea and cold shivers started. I couldn't sleep and by 1am I had a fever of 100.9. I took 1000mg Tylenol at 4:30 am, and at 5:30am have a fever of 102.5. I still cannot sleep, and the fever keeps rising.

Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and vomiting. Assessment : Time of assessment 1005. Alert and oriented, Anxious, Tachycardia, Nausea, Emesis and left hand tingling. As soon as patient received vaccine and was getting ready to sit for his 15 minute observation, he started vomiting x 1 in the floor. He says he felt nauseated, lightheaded, and his left hand was tingling. He was assisted in the wheelchair and taken to the triage area. 1012: BP 148/100, P 110, denies nausea, lightheaded, but still has the tingling to the left hand. 1017: BP 138/100, P 102, denies hand tingling or any other symptoms. 1026 standing BP 120/88, P 108. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Ambulated prior to discharge home without symptoms. There were no vitals filed for this visit. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 20 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.

Around 10pm (9 hrs after injection) I experienced rapid onset of uncontrollable tremors and shaking in my upper body along with intense contraction of my chest and back muscles and significant loss of motor control in my arms and hands. This lasted for 5-10 minutes at which time the symptoms ceased nearly as quickly as they appeared. I have not experienced them since

Body aches, chills, starting upon waking the day after the shot and continuing until bed time Sore arm

Patient with persistent numbness to the contralateral thumb from the injection site 2 days after the injection and persisting for at least 3 days from the onset

Left thumb began twitching and spasming about 12 hours following injection. Thumb would "pull" into the side of the hand in an arthritic type motion. Symptom lessened as time has gone on but still occurs, though less frequently, 48 hours following injection.

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

First injection only had arm muscle pain. Second shot had severe cold chills all night with bad headache, muscle aches and mild fever of 100.8 degrees F. Very sore muscle at injection point and redness about 6 inches around three days later.

in the first couple of hours, felt lethargic, and run down, low energy and body aches and disoriented that lasted about 3 days. Continued to feel lethargic was able to return to work on the following Monday. Five days later, started with diarrhea, nausea, vomiting, fever, headaches. Vomiting stopped about 2-3 days later. On 04/13/20201 or 04/14/2021 started noticing a big patch of hair falling out on the left side, believes same arm as vaccine was given. Was Dx with bacteria called "Campy" on Monday. Client verbalized feeling better as of Monday 04/19/2021.

bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criteria medically significant and intervention required). 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by patient, within two weeks prior to the event, included cholesterol and blood pressure medications. Patient received his 1st dose of Moderna on 18Mar2021 and on 22Mar2021 he started having bell's palsy. He went to ER. Treatment included steroids. Patient was concerned regarding his second shot of Moderna vaccine which is due on 14Apr2021. 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.

Flushed feeling BP=110/62 HR=68 O2=97% Seen in medical screening by RN. Patient release at 12:15 p.m.

head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine. This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1

Severe body wracking chills beginning at 530pm CT, diminished temporarily with the use of Advil, but lasting until 8am CT the next morning (4/24/2021). Fatigue, lack of energy, lasting until 7pm CT on 4/24/2021. Body soreness lasting until morning of 4/25/2021.

WIFE CALLED AND SAID HUSBAND HAD NAUSEA, VOMITING, COLD, SHAKING DURING THE NIGHT , NEXT DAY STILL NAUSEA AND HAD RASH ON FACE, AND BACK . INJECTION SITE WAS RED BUT NO RASH. SHE IS PLANNING TO TAKE HUSBAND TO ER

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after administration of vaccine. patient was checked for responsiveness and flipped to the side. paramedics were called. patient regained conciousness upon tapping on shoulder. patient fell and hit the ground and had a few abrasions to the left head. paramedics arrived and patient was alert and oriented and declined ambulance. patient rested and left with cousin without any further issues.

Patient is currently in jail and that is where patient received the vaccine. He woke up the following morning with a full body rash and arm pain. He couldn't raise arm up and here a month later he still can't raise his arm.

THIS PATIENT HAS A SEIZURE DISORDER AND WAS MONITORED AFTER RECIEVING THE VACCINE. THIS PATIENT DOES LIVEIN A GROUP HOME AND IS MONITORED BY STAFF. THE STAFF EMAIED TO LET US KNOW THAT ONCE THE PATIENT GOT HOME HE DID HAVE "A RIDICULOUS AMOUNT OF SEIZURES TODAY." THE GROUP HOME SPOKE TO THE DOCTOR AND TOOK A PREFILLED SYRINGE OF ATIVAN.

Patient felt light headed. Put his head down on table. Responded to his name after repeating name once. Patient stated he was dizzy, light headed. Gave him a bottle of water and M & M's. Patient had forehead sweating and was pale. Patient drank the water, had a few M &M's, got cold. Patient finished M& M's and his color. Offered to call 911 or someone for patient. Patient refused. Patient remained seated for approximately 12 more minutes and left on his own accord. Patient stated before leaving he felt fine now and refused medical treatment or an offer to call someone again.

patient fainted and had a vasovagal response ... very clammy and sweaty but ended up being fine after several minutes

Weakness, muscular aches and pains, fatigue, headache, fever & Chills, nausea. Really sore injection site. Worse than the first dose. First dose gave me no side effects other than the sore arm.

After about 5 minutes I started getting hot and cold flashes and feeling light headed. If felt like I would faint, but I didn't faint. This lasted for over 30 minutes. I then left the store. For the next hour I felt lethargic and started feeling nauseous. After 1 hour I had severe uncontrollable nausaea and vomitting, this continued until I went ot sleep 3 hours later. After 2 hours I experienced dry heaves and could not hold down any liquids. After 3 hours I was extremely tired and needed to sleep, I slept for 6 hours until 11pm and then felt better. The following day I had a sore arm, felt sick and needed to rest, then felt better the day after that. My left arm was sore for 3 or 4 days.

He got the vaccine, had no reaction. The following morning around 4:00 he felt real dizzy and his arm real sore, and still feels nauseous and felt like vomiting but did once. He is trying to work with this continued reaction. He did run fever of about 100 for 2 nights, but most things seem to give him nausea. He has not taken anything for the reaction.

1) Fever, hot/cold sweats coming and going for about 60 hours, never broke 102. Tylenol already taking to keep sinuses open and in control assisted with this. ** 2) Sinus headaches that didn't seem to go away despite the Tylenol and Sudafed, which led to nausea and vomiting. As of 5/2 9 am EDT I believe I have an explanation: The Sudafed was doing too well, possibly due to the loss of water. Tried multiple variations to identify the cause: Increase water intake (no change), increase Sudafed (seemed to make worse), decrease Sudafed (seemed but help but then the drainage and discharge caused similar results). The current working solution has been to maintain the normal regiment but make sure to supplement moisture in the nasal passages with a saline nasal spray.

covid arm yes, expected that, dizzyness lasting 3 days, tired, flu like symptoms. chills, anxiety, that was no big deal but last night I had severe stomach pain and rushed to the bathroom , then had severe nautious, I had diarrhea, at the same time. I nearly blacked out. I got very hot and had to take off all my clothes, then when I got up to the toilet to diarrhea again I needed to vomit, I blacked out on my bathroom floor. when I woke up I went back to bed. at the time of the occurence I was too delusional to call for help. I barely ate that day because I felt so bad. I did notice the second day I felt worse after drinking 1,000 mg of vitamin C from one of those Emercencey Packets with lots of water. and the next day I took twice as much to (knock out) what ever I was feeling.

Fatigue which prevented in walking at normal speed on may 1 and followed by pain with stiffness in thighs on may 2 which prevented in walking normally. Nothing explains these unusual symptoms.

severe anxiety, nerve pain over body, GI Upset. Patient states it feels as if he has covid again but worse

First Shot April 20th of Moderna after facility cancelled my JJ, Second shot J&J in facility after facility cancelled my second appointment of Moderna. Could not make 2nd shot appointment. Going away for work in state and could not get second shot for three months so just got JJ. 102 fever, chills, chest pains, spasams, joint inflammation, no appetite, no bathroom. full body pain and some altered mental state. weakness. Going on 18 hrs now fever continues to rise.

Patient said about week after the shot, he didn't feel right and went to local urgent care, said the provider told him he had Bell's Palsy on left side.

I was standing at the toilet when I became dizzy and nearly collapsed. I called for help and my son assisted me to my bed where I collapsed and could hardly move while I broke out in cold sweats and my wife monitored my heart rate and placed an oxygen monitor on my finger. she said my pulse held steady and slow. The event lasted about 10 minutes and I felt I must return to the toilet for a bowl movement. I began having diarrhea and then began to throw up. After that i took a cool shower and laid in bed. I stayed in bed for about 48 hours.

An employee of the pharmacist (later told to me by the pharmacist to be an intern) injected me, my wife, and my father-in-law each with an expired Moderna vaccine dose, rather than the Johnson & Johnson dose we had ordered (note: the Johnson & Johnson dose and its lot number were written on our vaccination cards). Our vaccines were administered one after another by the same intern between 11:15am and 11:45am. We were unaware of the error until the pharmacist, called me after I had returned home and eaten lunch (around 12:40pm). The pharmacist explained that his intern had administered the Moderna doses from a stock that was supposed to be disposed of on 4/26/21, suggesting that the doses were expired. Unbelievably, those expired Moderna doses were apparently drawn from their vials into syringes on 4/26/21 and left, at room temperature, in a non-segregated area of the pharmacy, near the Johnson & Johnson doses. My wife, father-in-law, and I were completely distraught and unsure of what would happen. Each of us called our primary care physicians, but the advice was unclear given the uncertainty. Our online searches of Moderna and related vaccine studies also revealed no information on what we could expect to occur from receiving expired doses. In my case, my arm was sore on 4/29 and 4/30, and on 4/30 I was extremely fatigued. My wife and father-in-law experienced similar symptoms, although my wife's were more severe.

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

Injection site - severe itchy, swollen with "golf ball" size lump, redness, heavy "dead arm" with loss of sensation

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

Localized erythema/edema and pain with, urticaria without itching that initially was localized to the L upper arm then spread to the torso within an hour of noticing. No shortness of breath, chest pain or signs of anaphylactic reaction noted. I took OTC Benadryl 50 mg Q8H PRN , Pepcid 40mg Q12H PRN, and Ibuprofen 600mg Q8-12H for 3 days. I took 2 total doses of Benadryl, 2 doses of Pepcid, and IBU for 3 days (for pain/discomfort in arm). The "Hives" resolved in a little over 24 hours from the time I noticed them at 1600 the day of vaccination. I never felt the need to notify my PCP, or the Pharmacy administering the vaccination.

One week after the vaccine, 01/22/2021, very large inflamed lymph nodes. Under the arm, left breast tissue and left clavicle. The issue he went to the doctor, sore arm and fatigue. I saw the doctor, 01/25/2021. Determined an immune response to the vaccine. The inflammation was benign, the lymph nodes seem to be healthy during ultrasound exam. The patient has not recovered from the adverse event, I still have inflamed lymph nodes

Patient had no previous issues with vaccines in the past. Patient went to the post-vaccination chairs and about 2 minutes after giving the Moderna COVID-19 vaccine, patient's wife informed me he was not feeling well. Patient was sweating profusely, shaking, light headedness, and difficulty breathing. Site of injection looked normal. I brought him back to the immunizing booth, laid him down, gave him something soft to lay his head on and cover- up with. His sweating and shaking seemed to get worse. He wanted to sit in the chair since the floor was cold. We sat him up, gave him an ice pack, and gave him some orange juice. We called 911 and instructed EMS where to find us and the patient's symptoms. While waiting on EMS, his symptoms improved slightly. They arrived quickly and assessed the patient's blood pressure, heart rate, and blood sugar. He did not feel as if he needed to go to the hospital. I had the patient wait in the immunization booth a bit longer. He felt better, and color came back into his face. He went home with his wife. I gave them the V-Safe info, so he can report any issues while at home.

Patient reported difficulty breathing, dizziness/weakness, numbness/tingling and a fast heartbeat - and suicidal ideation - went to ED. CHIEF COMPLAINT: SUICIDAL IDEATION (pt. reports suicidal thoughts) and FEVER (pt. received 2nd Moderna vaccine approx 1100 yesterday approx 3-4 hours ago developed chills/fever/anxiety/visual hallucinations/generalized body aches) HISTORY OF PRESENT ILLNESS: HPI: Patient is a 41-year-old male who presents to the emergency department from home with his wife for chief complaint of suicidal ideation, anxiety. Nursing noted him to be hyperventilating in triage. Patient states these thoughts started about 4 hours ago after he started feeling unwell. Patient states that he got his 2nd moderna COVID vaccine at 11:00 a.m. yesterday. This evening after trying to go to bed he started getting fevers body aches and myalgias. He took Advil around 8:00 p.m.. After this, he started having increased thoughts of wanting to harm himself. He states he is having "hallucinations of himself cutting his arms and legs off". He called telemedicine who told him he needs to go to the emergency department. Patient originally did not want to wake his wife up and did not want to go in but he eventually woke his wife and she brought him here. Patient does have a history of PTSD and depression. He is on Cymbalta which apparently he has been taking. He has not been able to see a counselor since the beginning of the year because of his insurance. He does see physicians through the hospital. he has never had to be inpatient but has had to come to the ER a few years ago for suicidal ideation. He also tells me that he quit his job yesterday because he doesn't like seeing people be mean to other people. ED Course as of May 19 0613 Wed May 19, 2021 0339 Patient is a 41-year-old male who presents to the emergency department with suicidal thoughts. Patient has PTSD. Suicidal thoughts started about 4 hours ago. He did get his 2nd moderna COVID vaccine at 11:00 a.m. yesterday and now has a fever and generalized body aches and fatigue. I do believe this is a normal immune response to the COVID vaccine. We will give him Toradol. Patient is very tearful and anxious. I will give him some Ativan while we are waiting for lab work to return. Medical social worker will have to evaluate the patient. 0521 MSW is currently talking to the patient. 0611 Medical social worker and wife felt that patient could be discharged home with the safety plan. He will follow up with the hospital for mental health counseling services. Patient feels much better after fever subsided. He will continue to rotate between Motrin and Tylenol. ED Course User Index DO

Approximately 14 days after first injection I went to ER with Atrial Fibrilation symptoms. Had been feeling weak and tired for about a week before but ignored symptoms. Awoken early March 21st with NEW Apple watch alerting to high heart rate while sleeping over 150 bpm. Ran ECG and stated Atrial Fibrilation was occuring.

After about 8 hours I start having extremely high fever then I started urinating blood with burning symptoms

Friday after the shot was good, just a sore arm. On Saturday I developed a fever of 101 and chills and was very tired. I felt a little better on Saturday night and Sunday morning after some Tylenol 500 mg. My fever would break then come back for a bit By Sunday afternoon my back began to really hurt. I have some chronic back pain so didn't think too much of it just tried to massage it and stretch it out. However it just kept getting worse and the pain radiated into my chest around 9:00 PM Sunday night. It continued to get worse until about midnight, and I ultimately decided to go to the ER. The tylenol helped reduce the pain by the time I got into the ER but I went in anyway because I was concerned about the intensity of the chest pain I'd had earlier. I was tested for heart enzymes and they were slightly elevated, at .12. On this result, I was admitted to the hospital on suspicion of having suffered a heart attack. I was put on a heparin drip and my troponin levels were tested every 3 hours. They continued to rise to a high of .67. More testing was done, and the cardiology department concluded that I had not suffered a heart attack due to the low troponin levels but that instead I was dealing with heart inflammation. Every doctor and nurse there commented that there had been other patients coming in with cardiac inflammation from vaccines as well. Due to my family history of heart issues and my own existing risks, I was moved to the hospital where I was examined in the cath lab via angiogram. This found no blockages in my arteries, further confirming the cardiology suspicion of cardiac inflammation, and I was given a diagnosis of pericarditis and prescribed colchicine to treat the inflammation.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt recovered in less than 1/2 hr. Checked his BP and pulse- normal. Pt and his cousin said he fainted after getting the first dose on 4/24/2021. He promised he'll see his PCP.

He developed dullness and numbness in both feet followed by increasing subjective weakness, muscle twitching, intermittent in the legs. Dullness in feet has been constant. This contributed to increasing anxiety about the symptoms.

brain fog; left arm injection site was sore; fatigue; body aches; fever; chills; fatigued/Tired; body aches; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history per source document.). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced the first episode of VACCINATION SITE PAIN (left arm injection site was sore), FATIGUE (fatigued/Tired) and the first episode of MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (fatigue), the second episode of MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and the second episode of VACCINATION SITE PAIN (left arm injection site was sore). On 24-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) (seriousness criterion medically significant). On 27-Apr-2021, FATIGUE (fatigued/Tired) had resolved. On 23-May-2021, FATIGUE (fatigue), the last episode of MYALGIA (body aches) and the last episode of VACCINATION SITE PAIN (left arm injection site was sore) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Patient received both Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle. Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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

On 4/26 around 4pm 2 Moderna vaccine doses were drawn up for immediate administration to patients with the evening appointments that day. By 7pm the last 2 appointments did not show up. The pharmacist placed the 2 syringes in the fridge to report as waste the next day in inventory counts. This pharmacist did not work the next morning. On 4/28, the pharmacist working the afternoon shift thought the 2 drawn up syringes were from that morning and administered one to patient. Moderna manufacturer was contacted on 4/29 to advise on next steps and if re-vaccination was required. They advised that the reason for the 12 hour window after puncture of the vial is because it does not contain preservative and to avoid potential infection it should be disposed of after 12 hours, however the vaccine is viable for 30 days in the fridge at manufacturer?s temperature. The vaccine was within the 30-day window and remained in the fridge the entire time. The patient was called two times after their vaccination to check in for any adverse event or signs of infection. The patient reported only a sore arm for a few days, no signs of infection or other adverse reaction. The 1st dose was not re-administered. Pt was administered the 2nd vaccine on 5/26, 28 days later. The pharmacy updated their procedures for immediate vaccine disposal before leaving for the evening and other procedures such as clear labels and individual draws to avoid this same error. All staff were retrained.

Excessive fatigue lasting 2.5 days. Would get up to walk to the restroom and could only take steps that were about 6 inch strides and a walk that should only take 4-5 seconds would take 45 seconds each way. Inability to write legibly with a pen or open a bottle of Tylenol because of the protective seal. Convulsions while trying to breathe.

Starting about 2-3 weeks after my 2nd dose of the Moderna COVID19 vaccine, I started experiencing daily joint/nerve pain and swelling. It affects different parts of my body each day, but the usual targets are my fingers, wrists, knees, and ankles. Sometimes, it is a pure nerve pain. Other times, it is paired with swelling, especially in the knees and fingers. I've experienced pain like this in the past, but very infrequently (once every few months at the most). But the pain has been on a daily basis ever since late-March/early-April and still persists today.

3 weeks after injection, Pt still has a fever of over 100 or more, suffering from extreme fatigue, loss of appetite since the second shot now losing weight, has experienced some increase in the symptoms of his schizophrenia, night sweats, exhaustion

His reaction started on his first dose, but increased after his second dose. At first he had a sore arm. Then he started getting pains in his shoulder blade and down his arms. And if he lifted his head wrong it would hurt also. He went to the doctor, After about 3 weeks he started getting tingling in his right arm and hand all the way up to his elbow. Has continued on and was given prednisone and cyclobenzaprine. After a week on the meds the pain went away. He still has numbness and tingling.

Epilepsy; Device use error; Twitches; Generalized aching; This spontaneous case was reported by a physician and describes the occurrence of EPILEPSY (Epilepsy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis. Concurrent medical conditions included Seizures, Hypothyroidism, Sleep apnoea, Seasonal allergy and Non-tobacco user. Concomitant products included MONTELUKAST SODIUM for Allergy, LEVOTHYROXINE for Hypothyroidism, LAMOTRIGINE for Seizure. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Generalized aching). On 20-May-2021, the patient experienced EPILEPSY (Epilepsy) (seriousness criterion medically significant), DEVICE USE ERROR (Device use error) and MUSCLE TWITCHING (Twitches). In April 2021, PAIN (Generalized aching) had resolved. At the time of the report, EPILEPSY (Epilepsy) and DEVICE USE ERROR (Device use error) outcome was unknown and MUSCLE TWITCHING (Twitches) was resolving. 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 was an non alcoholic. No treatment medications were reported. Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.

High fever (102 degrees) for 36 hours starting 16 hours following the vaccine . Chills during fever (experience of feeling extremely cold, during entirety of fever). Muscle /joint pain during the 36 hour window. 1.5 inch swelling (golf ball sized) at site of vaccine on left shoulder. swelling peaked at 16 hours from time of injection, swelling receded by 24 hours from time from injection.

Started with bilateral proximal leg weakness, went to the LUE and LLE sensory symptoms and fasciculations which then decreased and went to the right side of the body with waxing and waning cramping of RUE and RLE.

Should/arm/deltoid is sore, there is a red slightly inflamed spot about 3 inches long and 1 in wide. Patient did see their provider and said it is nothing to worry about and should go away.

He had a severe pain in his right big toe, it was diagnosed to likely be gout. At first you did a telehealth appointment through 98.6 Clinic. They prescribed Prednisone and Indomethacin. His symptoms improved and then came back. He then went to urgent care where they gave him a cortisone injection in his toe. Which helped it get better, until second vaccine.

Developed severe pain in the big toe on the right foot. He went to the clinic and she prescribed prednisone and indomethacin. Symptoms slowly improved over the next few weeks.

Symptom 1: Pain and tenderness in the same arm of injection; time course: 24-36 hours; treatment: acetaminophen, hot/cold compresses, rest; outcome: symptoms subsided. Symptoms 2-7: Dizziness, numbness/weakness all over the body (beginning at lower extremities, radiating upwards), headache, fatigue, muscle/joint pain, fever; treatment: food, water, acetaminophen, hot/cold compresses, rest; time course/outcome: dizziness, numbness/weakness (2 days, dissipated), headaches (1-2x/daily for 4 days, worse at the beginning; better as time progressed), muscle/joint pain (same duration, pain level, and outcome as headaches), fatigue/fever (3 days, then improved/dissipated).

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

Paralyzed completely. Sent to ER. Transferred to another ER and completed spinal tap, MRI, blood work. Outcome: guillain barre syndrome

ABOUT 12 HOURS POST VACCINATION THE PATIENT PASSED OUT AT HOME. PATIENT HAD NO FEELINGS IN ARMS OR LEGS AND THOUGHT HE WAS HAVING A STROKE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND HAD TO BE PUT ON VENTILATOR AND REMAINED IN THE HOSPITAL FOR 3 DAYS. PT HAS MOSTLY RECOVERED BUT HAD SLOWER USE OF ARMS AND LEGS FOR 1-2 WEEKS

1/13/21: enlarged left supraclavicular lymph node 1/14/21: CT chest showed enlarged left supraclavicular lymph node with fat stranding 1/18/21: bloodwork done, unremarkable swollen lymph nose, left neck and shoulder pain continued 2/18/21: Excisional Biopsy of enlarged left supraclavicular lymph node, results were inflammatory/benign continued left neck pain and swelling 4/26/21: MRI neck soft tissue performed, results unremarkable May 2021: mid-may drenching night sweats started occuring with paraesthesias in left upper extremity 6/2/21: Orthopedic consult-normal exam, EMG LUE ordered 6/3/21: bloodwork done, unremarkable 6/4/21: CT chest, abdomen, pelvis performed with unremarkable results 6/9/21: EMG performed and showed mild carpal and cubital tunnel syndrome around 6/12/21 muscle fasciculations in both legs started to occur 6/18/21: MRI Brain, unremarkable 6/18/21: Neurology Consult at Clinic-normal neurologic exam 6/22/21: Primary Care doctor started me on buspirone for anxiety related to neurologic symptoms diarrhea and weight loss since first moderna vaccine 6/23/21: GI consult performed 6/23/21: Labs and stool studies performed that showed low b12, stool qualitative fat split, stool with enteropathogenic e coli, stool with norovirus 6/25/21: B12 injections started weekly 6/28/21: EGD performed 6/28/21: Azithromycin 500mg x 3 days to treat e coli 7/2/21: ER visit for worsening fasciculations, unremarkable work-up 7/12/21: More labs from GI ordered, unremarkable 7/14/21: Consult for counseling due to anxiety related to neurologic symptoms 7/19/21: PCP follow-up 7/23/21: Neurology follow-up 7/27/21: GI follow-up

Guillain-Barré syndrome; orthostatic light headedness; Difficulty in walking; didnot feel great; Itching; short term memory; chest tightness; Brain fog; Numbness; Tingling; Pain; swelling of hands; joint pain; fatigue; swelling at injection site; Injection site pain; headache; Nausea; rash; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided by the reporter. Concurrent medical conditions included Fruit allergy (Strawberries :Anaphylaxis + Angioedema), Seafood allergy (Shrimp) since 2012, Allergy to nuts (Walnuts[unsure]:Oral itching and jaw tightening.), Food allergy (Mushrooms[ nausea and vomiting]) since 1995, Anaphylaxis since 2012, Hay fever, Urticaria, Migraine, Diverticulosis since 2017, Connective tissue disorder NOS (Suspected), Eczema and Allergic rhinitis. Concomitant products included PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for Diverticulosis, SUMATRIPTAN for Migraine, TRAMADOL for Pain, CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication. On 28-Jan-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 POSTURAL (orthostatic light headedness), GAIT DISTURBANCE (Difficulty in walking), GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome) (seriousness criterion medically significant), FEELING ABNORMAL (didnot feel great), PRURITUS (Itching), AMNESIA (short term memory), CHEST DISCOMFORT (chest tightness), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), ARTHRALGIA (joint pain), FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (Injection site pain), HEADACHE (headache), NAUSEA (Nausea) and RASH (rash). At the time of the report, DIZZINESS POSTURAL (orthostatic light headedness), GAIT DISTURBANCE (Difficulty in walking), GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome), FEELING ABNORMAL (didnot feel great), PRURITUS (Itching), AMNESIA (short term memory), CHEST DISCOMFORT (chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling), ARTHRALGIA (joint pain), FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (Injection site pain), HEADACHE (headache), NAUSEA (Nausea) and RASH (rash) outcome was unknown and HYPOAESTHESIA (Numbness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Lab test include: Cardiovascular evaluation include tilt table test, Rheum workup, Ultrasound were known to cause Rheum. No treatment information was provided. This case was linked to MOD-2021-058060 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up Information received contains No New Information. On 14-Jul-2021: Updated Reporter address. Updated Patient demographics[Height, Weight, Race, Ethinicity ] .Added medical history include Allergies, current medical conditions. Added concomitant medications. Added Vaccine facility information. Added new Events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

The lot number for the first dose of vaccine that I received on 01/05/2021 is 026L20A, and the lot number for the second dose of vaccine that I took on 02/02/2021 is 028L20A. After I got both shots I has soreness but after the second shot the pain in the injection site never went away. my whole left arm is sore and the fatigue from my arm migrated over to my chest. My chest was very weak. the soreness or fatigue is also in my legs, thighs calves, hamstrings. and my arms and legs are still fatigued and I have a hard time moving around.

8.5 hours after vaccination, client altered sensation in skin at arm and chest. felt like a sunburn, with a dull itch, discomfort. Took OTC benadryl, but it did not offer relief. Went to ED that same evening and was given Solumedrol. No epinephrine received. Next day, taking 50 mg diphenhydramine PO. Next day, rash now at arms/legs /back . none at chest. Meds helping with discomfort.

Approximately 5 hours after the injection my left arm (injection site arm) became sore. The soreness ended on January 3rd. No treatment was needed. On January 1st I noticed tingling in both of my legs. Since then it has gotten worse. I have tingling in both legs, muscle twitching throughout both legs intermittently, muscle weakness specifically after muscle use, an abnormal skin sensitivity when wearing pants, and a consistent ache throughout my legs. The symptoms affect me 24 hours a day and create an anxiety that I have not felt before. It has also adversely affected my sleep.

Moderna COVID-19 Vaccine EUA Severe pain in injection site. Fever of 102.4, weak, lethargic, chills, achy all over.

Headache On Jan 1, 2021 10:00 had facial droop with headache, went to ED Narrative: went to ED Jan 1 after onset of facial droop with headache around 10:00am, diagnosed with Bell's Palsy, treated with Toradol, Acyclovir, Benadryl and 7 day course of Prednisone 60mg daily and acyclovir 1000mg q8 hours x 7 days

Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/itching/shortness of breath

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

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

Peripheral neuropathy. Needles and tingling from finger tips to shoulder - bilateral. More pronounced in left arm where vaccine was administered. Sensation lasted about 30 minutes and then subsequently subsided. No treatment needed. No further symptoms the following day besides injection site soreness.

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

I was covid positive one month prior to vaccine. I woke up the morning after the vaccine with a fever, chills, muscle aches and my injection site in pain. After one day I felt better, but my arm still hurt. I hurt for 4 days and spread down my arm and into my ribs.

Flu like symptoms the night of first dose. Woke up the next morning with migraine type headache, pain in hips and knees. Fatigue.

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

Painful, itchy rash over dorsal aspects of hand/fingers. Worse with heat. Some vasculitis/intraepithelial bleeding

15 minutes post vaccination starting with shaking, feeling hot and flushed, and sensation of throat closing. Brought to ER. Treated with IV benadryl and PO Tylneol. EE refused epi-pen injection. Discharged from ER aprox 3 hours post vaccination

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

Per patient: "I experienced some side effects approx 12 hours after receiving the vaccine. Symptoms included fever, chills, body tremors and labored breathing. These symptoms lasted 3-4 hours followed by general fatigue the next day lasting approx 24 hours after side effects appeared. On a side note, I did test positive for Covid Dec.10th and have had lasting side effects of no taste or smell but have recently had 3 instances of returned smell since getting the vaccine".

No allergic reaction. 12 hours after shot, I started to have a sore arm and painful when rubbed. 24 hours after shot, It hurts to move my arm, a little worse than getting the flu shots.

Patient received vaccination on 1/21/2021 @ 1511 and within 5 minutes of receiving reported to experiencing a tingling sensation through his body and feeling like he was not inside his body.

States about an hour after the shot went back to work-was sitting there-felt warm & fuzzy-the next thing he woke up-was on the floor-staff called 911-was taken to ER-states had coughing & couldn't catch his breath & apparently passed out.

At approximately 5 minutes after the injection, I experiences a short period of Rapid Heart Rate and a feeling of "Flush"\Warm. This lasted about 1-2 minutes. I did not receive any treatment for this. There was no further outcome to report. After 2 minutes it passed, I remained in the waiting area for an extra 5 minutes following my initial 15 minute observation period and left without incident.

Thursday I felt even worse and had a hard time getting out of bed. I had body aches, headache, felt weak, nauseous and couldn?t eat anything.

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

Mild sore or stiff neck on same day as shot. Sore arm in location of shot the day after the shot. Soreness in the size of a softball around the shot location.

Chills, body aches, 101.9 fever, cough, bad headache, extreme fatigue, arm sore to touch , 36 hours later feeling better but still lethargic and cough remains, no fever 36 hours later but may return in PM hours

Injection arm became sore about an hour after receiving the shot. The following morning when I woke up I had mild body aches, on the third I feel like a mild case of the flu and very tired.

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

Nurse alerted at 9:15 and client was taken from the observation area for further assessment. Client reported that he felt like "ants were crawling all over his body" and he was itching all over At 9:17 vitals were taken: BP 149/101, Pulse 75, O Sat 97% Client stated that he had no throat or tongue swelling, no difficulty breathing, and no shortness of breath At 9:23 EMT assessed client and vitals were taken : BP 151/98 Pulse 76, O Sat 97% Client exhibited redness around the chest and right arm, a small area of bumps (hives) on his right upper arm only Breathing was assessed: No strider, Breathing sounds clear Client reports that the itching is worse that when it initially began at 9:00. Client experiencing itching in the chest, arms, and the face Client is scratching his beard heavily At 9:28 vitals were assessed : BP 131/92 Pulse 77 O Sat 99% Client continues to report no difficult breathing EMT asked the client if he wanted to go to the hospital. The client stated that he does not want to be transported. EMT begins to talks to the client about self care regarding any further reactions since he has decided to go home and not be transferred. Client mentioned that he keeps benadryl in his car. EMT informs client that at any time he can see medical attention. Client states that Right arm is itching worse and that the itching is less in his chest. The left arm was unaffected. At 9:36 vitals were taken BP 146/96 Pulse 87 O Sat97% At 9:45 Client stated that he feels able to leave and feels less itching Client attempts to call his boss but is unable to reach him and is visibly frustrated. Client also noticed that his watch would not move further up his wrist as it normally does At 9:48 Client states that his hands are shaking and that this means his blood sugar is low. EMT took the clients blood sugar Clients blood sugar was 95. 9:54 Client stated that he would like to be transported to the hospital because his hands are shaking and since his BS is fine he knows that something is wrong and his wrist is bigger because his watch wont slide up and down his arm. Client transported to the hospital

Shot on Saturday. Chills\Sweats on Saturday Night and Sunday Night. Monday afternoon entire body weak and achy. Extreme Chills and sweating at night. Symptoms came and went, but were worst usually at night. Now 5+ days past vaccination and still feeling tired, achy and getting extreme chills. Sometimes have small amount of diarrhea and nausea. Bad headaches. Able to control by taking 2-3 advil but symptoms return after advil wears off.

Started out that night with chills and joint pains... then the next day (2/10), it was the nasty headache, tired, chills/ then was really hot (low grade temp) & then back to chills. Today 2/11, just a little tired and chilled and a slight headache but much better than yesterday.

PT WAS BEING MONITORED AFTER VACCINATION. I HAD A SMALL CONVERSATION WITH PT AROUND 3 TO5 MINUTES AFTER RECEIVING DOSE. I CHECKED ON HIM AT THE 7 TO 10 MINUTE MARK AND HE WAS FOUND NON-RESPONSIVE . PT WAS WARM TO THE TOUCH AND DID NOT RESPOND TO VERBAL COMMANDS OR PHYSICAL STIMULI. PT WAS ADMINISTERED 0.3MG EPINEPHRINE AND 100MG DIPHENHYDRAMINE.

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

Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis. The patient's medical history was not reported. Concomitant medication history was not provided. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient woke up to find that his face was paralyzed. The patient went to the urgent care center and they referred him to the emergency department at the hospital. After numerous tests they diagnosed him with Bell's Palsy. Treatment for this event included prednisone and doxycycline. Action taken with mRNA-1273 in response to this event was not reported. The outcome for the event, facial paralysis, 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

I received my first Covid-19 Moderna injection and felt slightly groggy and tired as the day progressed. Just before bed I noticed my arm was quite sore and I still felt tired and slightly light headed. The next day (Feb 4) I had a very sore left arm at the injection site but felt good otherwise. I came home from work and took one 200mg Ibuprofen as my arm was still quite sore. The following day (Feb 5) my arm pain subsided but I still felt light headed during the evening. I am writing this on Feb. 18th and each day I have bouts of being light headed and have difficulty concentrating. There is no real pattern to what time of day I get the symptoms. I do not have the classic headache but definitely feel pressure in my head and behind my eyes. I also find that I wake up after a full nights sleep and feel not well rested. I spoke with my doctor last week and he suggested I give it until this week to see where things are at. I plan on contacting him soon to schedule an appointment to discuss my symptoms more. Before getting the vaccine I did not have any of these symptoms as I describe.

My siatica flared up on its own but has not gone away as it typically does. Jt occurred 12hr after the vaccine Typically it goes away but i still feel the leg numbness and my eife confirmed three werks later anf my left glut is swollen

Difficulty breathing; Allergic reaction; Pain in the arm that radiated up to the neck; Hot and cold flashes; Hot and cold flashes; A spontaneous report was received from a consumer, who was also a 43-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, hot and cold flashes, difficulty breathing and pain in the arm that radiated up to the neck. The patient's medical history, as provided by the reporter, included asthma and allergies. Concomitant medications were not reported. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A; expiration date: 28 Jul 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, four hours after vaccination, the patient experienced hot and cold flashes and pain in his arm that radiated up to his neck. He had some food and went to bed. The next day, on 16 Jan 2021, the patient had an "adverse reaction, allergic reaction". This event was considered to be medically significant. treatments at home but had no relief. The patient still had trouble breathing so he went to the emergency room as his physician told him to. He was given three more nebulizers of ipratropium bromide (+) albuterol sulfate, steroids, diphenhydramine hydrochloride, and famotidine but he still had trouble breathing. Therefore, the patient was admitted into the hospital for observation. The patient was discharged on 17 Jan 2021 with two to three bags of normal saline and four bags of "lactose ringers". In addition, his physician put him on a steroid and inhaler. Action taken with mRNA-1273 in response to the events were not reported. The outcomes of the events, allergic reaction, difficulty breathing, hot and cold flashes, and pain in the arm that radiated up to the neck, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's significant medical history included asthma and allergies.

Resident became pale with c/o chest pain followed by emesis. Heart rate Tachy at 142/min. Resident indicates pain to mid-sternum radiating to right shoulder. States right arm has been sore since #2 COVID vaccine on 2/16/2021. BP 120/88, Pusle 142, Resp 20, Oxygen saturation 99% on room air, Aspirin 325mg given and supplemental Oxygen applied. Resident was subsequently transferred to the local ER.

Approximately 30 minutes after the administration of the dose I began feeling flush. I had intended to go back to work but instead my supervisor insisted on me being evaluated. It was determined that I was hypertensive. I felt a bit off and a bit strange. Even after lying on a bed in a dark room hypertension continued. I was transported by ambulance to the local emergency department where my BP continued to run high. The next day I was in bed the whole day feeling as if I had Covid all over again. I did previously had Covid but waited over 30 days to receive the vaccination.

Moderna covid-19 vaccine EUA At time of shot, full body flushing. At 2:45 next day chills, vomitting, headache.

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

THIS PATIENT IS A 42 YO MALE WHO STARTED TO COMPLAIN OF LIGHTHEADEDNESS/DIZZINESS/FEELING FLUSHED ABOUT 30 MINUTES AFTER RECIEVING VACCINE. PATIENT WAS INITIALLYVISUALLY MONITORED FOR 15 MINUTES WITH NO SIDE EFFECTS. PATIENT LEAFT THE CLINIC SITE, AND RETURNED ABOUT 15 MINUTES LATER REPORTING SYMPTOMS ABOVE. PATIENT A&OX4, GCS 15, NOMAL SKINS. PATIENT DENIES HEADACHE, CHEST PAIN, SHORTNESS OF BREATH. EKG COMPLETED, NO STEMI OBSERVED. PATIENT LED INTO QUIET/DARK ROOM TO REST AND FOR CONTINUED MONITORING OF BLOOD PRESSURE. DUE TO NO CHANGE IN ELEVASTED BP, RECOMMENDATION WAS MADE TO TRANSPORT PATIENT TO CLOSEST ED. PATIENT VERBALLY AGREED. PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO AMR UNIT AND PATIENT CARE WAS HANDED OVER TO UNIT PARAMEDIC. PATIENT TRANSFERRED WITHOUT INCIDENT. LAST NOTED BP ON SITE WAS 176/132 IN A SUPINE POSITION.

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

Brief seizure, patient came to consciouness within 30 seconds and was coherent and denied ambulance or any further care . Sat in chair for 30 minutes and said he was fine and apologized for event as he said he had seizures before but did not volunteer the information before shot.

Bell's palsy symptoms developed a few days after the vaccine. Received the vaccine on 2/18, started having facial droop on the night of 2/23, was seen in the emergency department on 2/24 with left facial droop, had a stroke code activation, imaging was negative, was treated with valacyclovir and prednisone x7 days. Was seen on 3/5 by neurology for follow up. Then was seen 3/11 in the ED again for severe headache and facial pain behind the left ear related to the Bell's palsy. His Bell's palsy symptoms have somewhat improved since the original onset but have not resolved. He continues to have facial weakness, facial droop, auditory changes due to the Bell's palsy. He was most recently seen on 3/16 in primary care to follow up on his symptoms after being seen in the emergency department. He did recently have COVID in October of last year. No other recent illness or vaccinations.

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

onset of dizzy spells, light-headiness, weakness, tired one hour after injection. Has persisted for 27 hours.

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

One day following, area of injection turned bright red and became hot to the touch, this resolved the following day. Also one day following stomach cramping and aggravated gastral intestinal activity, not diarrhea but very frequent stool passing. Headaches, fatigue, chills. 9 days following injection, headaches, cold sweats, chills, sudden random vomiting, and extreme fatigue. 12 days following injection, side affects persist, reported to Primary care facility and VAERS submission.

Body aches, chills, fever of 102, severe headache, stomach and gastrointestinal cramping. From approximately 9:30 PM on March 24, 2021 until approximately 4 AM March 25, 2021. Took 1000 mg of acetaminophen p.m. at approximately 9:30 PM on March 24 2021. Adverse event symptoms we?re better on the morning of March 25, 2021 with the exception of headache. Took an additional thousand milligram of Tylenol extra strength rapid release at approximately 7:00 AM on March 25, 2021. At the time of submitting this report at 11:30 AM on March 25, 2021 simply have a sore left arm from the injection

Felt a little nausea later in the evening of the injection (03/27/2021). No pain or tenderness the day of injection. The day after injection (03/28/2021) had back pain and muscle pain. Went through most of the day without taking anything for the symptoms. Later in the evening pt. had to take two Tylenol (325mg ea). Pt. went to bed about an hour earlier than normal do due to discomfort. Today (03/29/2021) pt. had to work, which pt. does from home. Pt. woke up for work around 7:00am and still felt the symptoms from the night before. Body aches, back pain, nausea but not vomiting, cold sweats. Pt. did not take temp and does not know if he had a temp. Pt.'s wife took temp later that night and reported no temp but cool clammy skin. Pt. once again went to bed an hour earlier than normal with the aid of Tylenol 2x (325mg ea).

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

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

11:34. Sudden onset of rapid pulse, anxiety, feeling cold all over. 11:36 - evaluated onsite by NP and EMS. EKG showed SVT with rate of 152; BP 183/117 - Vagal manuevers provided some decrease in rate but no appreciable change. EMS called and transported patient to Hospital. 11:45

Sore arm within 6 hours of vaccination. Fever, chills, and body ache after waking up at 5am the following morning (3/31). Fever rose to 100.8 as indicated with ear thermometer and lasted until the morning of 4/1. Mild body ache and discomfort lasted until morning of 4/2.

Slight dizziness began within minutes and ended within 30 minutes Arm soreness, muscle and body ache, fatigue, loss of appetite the next day for most of the day. Loss of appetite ended by the afternoon, soreness and fatigue continued the rest of the day. Arm soreness and some body ache still present after more than 36 hours.

My injected arm was mildly sore (enough that I didn't feel the need for a pain reliever), but after a long night's sleep, I woke up the next day feeling very drained. By 2 p.m. my partner noticed I was very warm and took my temperature. I had a 100.1 degree fever. So I took a single adult dose of Tylenol, napped for a few hours, and I felt much better afterwards. I didn't need any further doses because by late evening, all symptoms (except the mild arm soreness) were nearly gone.

Started on April 2nd, 2021, noticed that his left eye was drooping. He did a stroke test as he is a EMT, then 20 minutes later when he went to take a drink of something he noticed his facial droop on the left side. Saturday he went to the ER and was put on PRednisone, and Valcyclovir. Had follow up today with a provider and the medication has not improved anything.

When I received my first dose of the Moderna COVID vaccine (Lot # 010M20A) my arm was extremely sore and limited range of motion. I contributed it to just being sore like the literature had sad. When I received my second dose within 20 minutes my arm was extremely sore. It got to the point where I could not lift my arm at all and had no ROM in it at all. It was like my arm just was not working and I would have to move my arm around with my right arm. I was taking 600-800 mg of Motrin every 6 hours and alternating Tylenol 1000 mg and it was not easing the pain. It got to the point where the pain was so unbearable that I went to the Emergency Room on 4/3 where I was diagnosed with Shoulder Injury Related to Vaccine Administration (SIRVA). The gave me some Toradol and Decadron IM and sent me home with Naproxen and Prednisone with orders to follow up with my PCP

Dizziness, heart rate up and down between 62-118 while doing nothing physical. Had to sit down numerous times because I almost passed out. Heart rate would rave then drop and I'd break out in cold clammy sweat. Did not seek treatment tried to rest and had friends and kids keep an eye on me. Day 2 better but still times heart would race.

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

Wednesday night after gettting the shot, I started getting soreness in my left arm, and both shoulders and neck. It felt like I had been in a car wreck as I was very sore and by bones had been jarred. It went away almost exactly 24 hours after the shot around 1:30 pm on Thursday, and I felt fine until Saturday evening around 8:00 pm. At 8:00 pm, I felt the sudden wave of heat rolling through my entire body. It felt the same as I have had in the past when experiencing the flu. My temperature rose and my whole body started to ache, and every moment that went by it got worse. Around midnight my temperature was 103 degrees and I couldn?t stop writing in pain due to non stop body aches and fever. At 9 am Sunday, my temperature had fallen to 100 and body aches subsided to only minor, but my headache was massive, and this lasted 3 days.

On 01-14-2021 at about 8:00pm, I began to experience nerve inflammation. I had pain in my right arm, it was a fiery electrical pain that radiated from my right shoulder down to my right hand. The joints in my hands particularly my right index finger, ring finger and thumb felt incredibly painful. I could not pick up or grasp anything. It felt like I had intense rheumatoid arthritis and my symptoms lasted about 5-6 days before they started to go away.

Swollen at injection site approximately 3 inch diameter with soreness and fever. Difficulty concentrating. Tingling in fingers on left arm (arm that was injected. Symptoms began at 6am on morning following injection and continued for 36 hours.

Fatigue, headache, tinkling/numbness in hands. Went to urgent care, however, i got turned away and advised to come back after a few days if symptoms did not go away.

Within 24 hours I spiked a 101.2 fever and begin having digestive issues. Gas, bloating, and diarrhea. I was weak and had no energy for 5-6 days. Since my second dose I experience almost daily bouts of generalized weakness, dizziness, and shortness of breath.

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

Several hours after vaccine was given, had arm pain/numbness, intermittent dizziness. Chest pain, shortness of breath, anxiety.

At about 2 in the morning I let my dog outside and it was cold after that I had uncontrollable shaking for about 5 hours it was severe

42 y/o F with a history of uterine prolapse, GERD who is presenting with low back pain x4-5 days, about 2 weeks after receiving the Moderna vaccine on 3/28; she also developed a raised patchy erythematous rash on her L deltoid (site of vaccine injection) a few days prior to onset of the pain. Symptoms began Saturday, 4/10; pt was helping her mother around her house; was not straining excessively; however, later that day had a sudden burning sensation in her lower-mid back, which has since been recurring in paroxysms. At times it spreads into the posterior thighs but not into the feet; sometimes also spreads upward into the upper back and just below the chin. In between attacks, there is no pain or numbness. There has never been weakness. No urinary/bowel incontinence or saddle anesthesia; sphincter tone was normal. NIF/FVC normal -60, 2.3L. Paroxysmal pain controlled w/ 600mg gabapentin q8h since being hospitalized. There has been no development or progression or symptoms, still only pain and normal neurologic and physical exam.

Day 1- site pain Day 2- Fever 102.2 and chills, body aches and pain all over, focused pain in the spine and bottoms of feet, headache, nausea Day 3- Fever 100.1, severe GI pain and Diarrhea, loss of appetite, head ache, malaise

+3 hours after injection: severe fatigue +5.5 hours: Chills, Shaking/Shivering and body temperature 97.2 +7 hours: Severe joint pain in entire Right Arm, everything from shoulder to each finger joint +10 hours: Sore ribs, Right side, temp @97.4 +16 hours: Wake up in morning feeling relatively fine, Temp @97.4, joint pain in Right hand/fingers still present, chills and rib pain have subsided +20 Hours: Chills/Shivering returned worse than previous day, Fever of 100.6 Currently +27 hours: Chills, Shaking, Fever 100.8, and significant joint pain in right hand/fingers still persist Does not feel serious enough to warrant medical intervention at this time

The patient's right hand swelled up, including pain. This is on the opposite side of the injection site.

a little over a day after receiving the vaccine i started to have foot pain on my left food near one of my toes. It has progressively gotten worse and as of this week I could barely walk on my food. After doing some research COVID Toe is apparently a thing but I couldn't find as much info related to the vaccine and COVID toe.

Sore arm after which was worse after 12 hours, much worse than first dose. Began to get aches in entire body around 18 hours after second shot. Around 24 hours after, aches persisted with events of extreme cold chills then hot flashes almost flu like. Around 36 hours side effects have subsided and just tired body. No alcohol was consumed, with plenty of water and healthy foods.

Fever 101, joint pain, pain in the left arm and what caught my attention is a ball between the chest and the left armpit of half an inch in diameter when I touch it I hurt a little

A little over an hour after receiving my second dose I experienced a severe seizure that resulted in a trip to the ER.

Fever started Thursday 4/22/21 an hour after injection. Lasted til Sunday 4/25/21. Chills started 4/22/21 an hour after injection. Lasted til 4/25/21. Sweating started 4/22/21. Still experiencing on Monday 4/26/21. Diarrhea started 4/22/21 an hour after shot. Still experiencing 4/26/21. Shaking started 4/22/21 an hour after shot. Still experiencing 4/26/21. Achy body started 4/22/21 an hour after injection. Still experiencing 4/26/21. Sleeping problems, unable to sleep well. Started 4/22/21 still experiencing 4/26/21. Feeling of face falling asleep. Started 4/22/21 an hour after injection. Still experiencing 4/26/21. Arms, legs, fingers and toes have the feeling of falling asleep. Started 4/22/21 an hour after injection. Still experiencing 4/26/21. Headache started 4/22/21 an hour after shot. Still experiencing on 4/26/21. Overall feeling of being off or strange started 4/22/21 an hour after injection. Still experiencing on 4/26/21.

On 4/22/21, approximately 1 hr after the Moderna COVID-19 first vaccination injection, I started to encounter allergic reactions that I used to suffer about 20 years ago. My air intake decreased, and my skin began to become irritated. I formerly had environmental allergies that would reduce my air intake, and the first place I noticed the effects were on my skin and I would become irritable. Physicians told me that when my oxygen levels were low, the body would channel the air to where it was most needed, which is generally not the skin, so my skin would become irritated. When this used to occur, I would respond involuntarily with facial twitches and pulling at my face and hair. Physicians explained that these twitches and pulling actions would draw air to the surface of my skin where I was air depleted. When I took the Moderna injection, this happened again -- I found myself with low air, my face was twitching, and I was pulling on my face to draw air to the area. The result when I was 19 and dealing with allergies is that I would remove small patches of hair from my head or eyebrows or eyelashes, and this would happen almost unconsciously as I tried to stimulate the areas and draw air to the surface of my skin. I did the same thing on 4/22/21, and found later, when looking into a mirror, that I had removed a section of my eyebrow unconsciously. It all comes back to oxygen depletion. A different and more intense event occurred in the night of Friday, 4/23/21, and the early morning of Saturday, 4/24/21. I went to bed at about 11 p.m. or 11:30 p.m. Between that time and approximately 1:30 a.m., I had difficulty sleeping, and I dreamed of pain in my chest. I finally woke up about 1:30 a.m. and found the pain in my chest was real. I was having difficulty breathing deeply. It felt as if the lower part of my lungs (at least on one side) was solidifying or inaccessible. What I did was begin forcing myself to breathe as deeply as possible. Over a period of 30 minutes or longer, I was able to gradually reclaim the use of the deepest part of my longs. With every forced deep breath, I was able to chip away at the area that felt like it was freezing up. Finally, I felt that I could access the deepest part of my longs and breath normally. The pain and lack of use in my lower lungs were very concerning.

Hives after 10km run. 0100 following morning fever, intense pain on injection arm. Pain subsiding and fever subsubsiding a bit by 0300. Headache, aches, fatigue till evening the following day.

Per Patient report: Headache started within 1 hour of vaccination. the following day, Blood sugar and Blood Pressure rose to dangerous levels. Nausea and vomiting. Blood pressure 2??/185, Blood sugar so high unreadable >600?; Unresponsive, breathing labored O2 Stat was low and on oxygen, went by EMS to Medical Center. At ER Blood pressure and HR decreased to dangerous levels for approximately 6 hours. Patient stayed in the hospital for 7 days while he was monitored for continued changes in blood sugar and blood pressure as well as severe nausea and vomiting.

Hives, blisters, swelling, and itching, pain covering both feet, legs The problem is ongoing and has not resolved itself

Swelling about 3" in diameter at point of injection. Swelling is firm, slightly painful to touch, and has been present for more than 48 hours. Overall body is itchy.

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

First several days I had mild aches and pains and lethargy. Around the seventh day I had chills and night sweats, and severe aches and pains and lethargy. Around this time I started to notice swollen lymph nodes throughout my body ? five around my head and ears and three in the groin area. I also found lumps in my neck and rib cage, though I?m not sure if these are lymph nodes. Three weeks later the lymph node swelling has diminished, but they haven?t disappeared entirely.

Systemic: Fainting / Unresponsive-Medium, Systemic: fainted but recovered right away, hit back of head on the floor, ice applied-Medium, Additional Details: waited 45 minutes before leaving, wife picked him up so he would not drive, patient stated he had a history of fainting after vaccines or giving blood, his head felt better after applying ice, temp 94.6 before leaving and felt his breathing normalize after incident

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

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

Arm pain, then severe body pain and severe headache throughout the night of Friday 7, all day Saturday, Sunday I woke up well, only in small pain at the place of the vaccine. My wife had the same symptoms and also the feeling of disgust, the headache affected her the most, on Sunday the 8th the strongest reaction had passed.

Shingles. Symptoms began 3 days after 2nd Moderna COVID vaccine. These included waves of chills sensation through left leg and groin lymph node areas, as well as fatigue, achiness, and general flu-like symptoms. 6 days later (5/9), the first sign of rash/blister broke out. My doctor performed a house visit to confirm shingles and prescribed ValACYclovir. I am on my 2nd day of this medication.

No issues other than a slightly sore arm at the injection sight until about 12 hours after the shot: -Fever (101.5° at highest temp taken) for about 15 hours -Body aches (Joints hurt, skin hurt to touch, muscle aches) for 36 hours -Chills and difficulty getting warm for 1 to 2 hours then switching to hot flashes/sweating and difficulty cooling off (back and forth for about 24 hours) -Difficulty sleeping due to discomfort and fever for 24 hours -Heavy fatigue and difficulty moving and walking due to lack of energy for improving over 72 hours -No appetite for 24 hours

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

doesn't remember anything; muscle spasms in back and legs; very tired; very sore; fever; grand mal seizures; sweating and being soak and wet; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Epilepsy (The patient has a history of grand mal, petit mal and stress seizures. Patient stated that he has at least one minor seizure once a month and the last seizure he had with this great intensity was about 3 to 4 months ago.) and Drug allergy (aspirin). Concomitant products included MIDAZOLAM for Seizure, CLOBAZAM (ONFI), ESLICARBAZEPINE ACETATE (APTIOM) and TOPIRAMATE (TOPAMAX) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant). 04-May-2021, the patient experienced HYPERHIDROSIS (sweating and being soak and wet) and PYREXIA (fever). On 05-May-2021, the patient experienced MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired) and MYALGIA (very sore). On 05-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, HYPERHIDROSIS (sweating and being soak and wet), MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired), MYALGIA (very sore) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood test: unknown (Inconclusive) Result not provided. It was reported that the patient took midazolam and swiped his magnet across his vagus nerve stimulator (VNS) for treatment. Action taken with mRNA-1273 in response to the event was Not Applicable It was reported that the patient was asymptomatic after first dose and experienced symptoms on 04May2021 at midnight after second dose of vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of epilepsy was assessed as strong cofounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of epilepsy was assessed as strong cofounder.

Chest pain, left arm pain, numbness. Pt transported to ED with ST changes. ST changes subsequently thought to be early repolarization variant and not MI.

Patient was warm and having a racing heart. Tried relaxation and fan. Ended up receiving one dose of diphenhydramine 25mg and bottled water extended observation to 30 minutes. At the end of 30mins patient was feeling much better, no more racing heart.

Client presented to our clinic for his 2nd dose of Moderna vaccine. His wife called the call center to report the following: "His arm is immobile ? he?s not paralyzed but paralyzed by pain. Cannot change shirt, has never had pain like this with a vaccine and noticed something was wrong immediately. 'He could feel the liquid going in.' Fine with the first dose, arm was tender. No pain, swelling, redness, tingling with this vaccine. Very isolated, no unusual s/sx. Trying Motrin/Ice Pack. Didn?t know if he should be seen ASAP or wait it out." According to the caller, the vaccinator told the patient: "Pain at the injection site is normal after a vaccine, but if your husband believes the pain is unusual or concerning to him, he should follow-up with a PCP/provider." The call center representative told the patient the following: Suggested contacting 24/7 nurse hotline, as they can provide more assessment than we are able at this hotline and provide additional recommendations. Caller endorsed understanding but requested that we f/up with site to alert the nurse that she's administering the vaccine in the wrong spot. She said specifically that the site was much higher than the standard approx of 3 finger breadths. Call center note/addendum: Contacted caller and spoke with patient directly. Patient confirmed that information provided by his spouse was accurate and also stated "Caller noticed more pain than with a normal shot, but not a sharp pain. Described as a deep pain and like "fluid was distributing throughout the shoulder as it was going in." Patient has spoken with 24/7 nurse hotline and instructed to wait a few days and see if the pain resolves because there isn't much that can be done. Encouraged caller to check in with provider if issue doesn't resolve. Caller gave permission for this information to be shared with the vax site and for VAERS report to be completed. Explained that site wanted to assure event is documented in the event that pain doesn't subside, endorsed understanding.

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

On May 6, 2021, pt began experiencing topical pain on the left side of his head and forehead. Over the next several days, this pain turned into blisters and then scabs, and began to spread. On May 12, 2021, he was diagnosed with shingles at Urgent Care clinic.

He believes his veins was punctured, he was bleeding a lot; he believes his veins was punctured, he was bleeding a lot; sore arm for a couple of days; Very mild occasional cough on the day of the shot until he went to bed; Dizziness/ Mild lightheadness; Felt a little weird; Had really vivid cool dreams; may not have gotten the full dose; Shot was given in his upper arm, but not intramuscularly/shot was given in his veins (4mL in his muscles and 1mL in his veins); Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VEIN RUPTURE (He believes his veins was punctured, he was bleeding a lot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 06-Apr-2021, the patient experienced VEIN RUPTURE (He believes his veins was punctured, he was bleeding a lot) (seriousness criterion medically significant), PUNCTURE SITE HAEMORRHAGE (he believes his veins was punctured, he was bleeding a lot), PAIN IN EXTREMITY (sore arm for a couple of days), COUGH (Very mild occasional cough on the day of the shot until he went to bed), DIZZINESS (Dizziness/ Mild lightheadness), FEELING ABNORMAL (Felt a little weird), ABNORMAL DREAMS (Had really vivid cool dreams), UNDERDOSE (may not have gotten the full dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot was given in his upper arm, but not intramuscularly/shot was given in his veins (4mL in his muscles and 1mL in his veins)) and FATIGUE (Felt fatigue). At the time of the report, VEIN RUPTURE (He believes his veins was punctured, he was bleeding a lot), PUNCTURE SITE HAEMORRHAGE (he believes his veins was punctured, he was bleeding a lot), PAIN IN EXTREMITY (sore arm for a couple of days), COUGH (Very mild occasional cough on the day of the shot until he went to bed), DIZZINESS (Dizziness/ Mild lightheadness), FEELING ABNORMAL (Felt a little weird), ABNORMAL DREAMS (Had really vivid cool dreams), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Shot was given in his upper arm, but not intramuscularly/shot was given in his veins (4mL in his muscles and 1mL in his veins)) and FATIGUE (Felt fatigue) outcome was unknown and UNDERDOSE (may not have gotten the full dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown. No concomitant medications or treatment drugs were reported. Company comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-110191 (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.

- sleeplessness, headache and night sweats - 5/17/21 8PM - 6AM - passed out - 5/18/21 6:30AM - light headed and headache - 5/18/21 7AM - 10PM - shortness of breath when talking - 5/19/21 10AM - 6PM - headache has dissipated - 5/19/21 12PM

1135: Pt complained of dizzines and weakness. Patient was immediataly assesed by onsite NP and EMT. Vitals were taken BP 160/100, P 85, O2 99%, and blood glucose 112. Patient stated he was at work all night until the morning, and did not eat anything prior to getting his vaccination. Patient was given a breakfast bar and water, and started to feel better. 1145: Second set of vitals were taken. 149/98, P 81, 02 99%. Patient stated he was comfortable going home. He did not want further medical intervention

An expired vial was used in the administration of this vaccine. The vial was approximately 20 hours past the initial puncture date. I personally called patient today who reported NO adverse effects whatsoever, aside from arm soreness.

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

Moderna COVID-19 Vaccine EUA Left arm soreness in arm pit and around back of upper arm since soon after second shot and continuing for 3 months

Moderna COVID-19 Vaccine EUA, on my upper left back and middle front belly, burning- throbbing pain for days, which erupted as rash in defined circles or clusters 5 days later. Diagnosed as Herpes Zoster (Shingles) on 27-May-21. Still in throes of the rash and pain, currently being treated with valacyclovir 1000 mg po tid, for 7 days.

Strength less than half in his right hand; Paralyses started 72 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyses started 72 hours after vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Strength less than half in his right hand). In May 2021, the patient experienced PARALYSIS (Paralyses started 72 hours after vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralyses started 72 hours after vaccine) and ASTHENIA (Strength less than half in his right hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. Patient received covid vaccine on 15 May 2021. Per father son paralyses started 72 hours after strength less than half in his right hand. No treatment information was provided Company Comment : Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Patient said he lost feeling in his fingers. Can't sense hot vs cold, etc. Also, said he lost strength in arm/hand and drops things frequently. He said he got pretty sick the next day, but that the doctor attributed this to possibly having COVID previously.

Patient experienced facial numness/tingling, chest tightness, possible throat swelling, and shortness of breath about 10 minutes after administering Moderna Covid vaccine dose 1. Instructed patient to stay in consultation room for observation. I stayed with the patient and called 911. EMS arrived on scene about 5-10 minutes later. Took vitals, oxygen saturation within normal limits, elevated bp, normal heart rate. EMS monitored patient for about 15 minutes after which patient was still conscious and alert. EMS advised patient to go to hospital for further evaluation and patient accepted. EMS took patient to hospital. Patient generally seemed fine when he left the pharmacy which was about 30 minutes after receiving the vaccine.

Left leg weakness and numbness when woke up at 9 am 5/24. Had venous saggital sinus thrombosis on venous mri with contrast . Had bilateral lacunar infarcts acute on mri. Symptoms gradually subsided with lovenox snd warfarin. Residual weakness left leg but milder than initial presentation Bp very high in ED 5/24/2021 controlled with IV cardene

Pain in arm shooting and burning not able to use the left arm at all since the time of vaccine severe pain numbness burning shooting pain down from vaccine site to fingertips

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

Patient reports on 3/29/21, he had a seizure after visit on 3/27, he was admitted to the hospital where he was observed, and discharged on 3/29/21. Client reports the treating physicians at the hospital think it is unrelated to the vaccine.

PATIENTTWENT TO ER 06/06/2021 WITH FEVER, DISTENDED ABDOMEN WHICH WAS TENDER TO THE TOUCH & INCREASED BACK PAIN. PATIENT WAS ADMITTED TO HOSPITAL 06/07/2021

one week after 1st dose shoulder blade sharp pain . Fingers begin to go numb. Waiting for dr appointment.

Patient called to report a vaccine adverse reaction. He received the second dose of the Moderna on 05/07/21 and started to have mild fever (under 100F), body aches, headache, and weakness on 5/8 PM. He took once 600 mg Tylenol that day and symptoms felt better, but still some weakness at the time of call. ED precautions provided to patient

As per wife's account, patient died approximately 9 days after receiving vaccine on 4/21 of massive, unknown (suspected cardiac) event. Wife explained that patient was diagnosed with Wolff-Parkinson-White (WPW) syndrome prior to being vaccinated. PCP unaware of diagnosis, and patient did not disclose that on vaccine consent form. Patient reported to his wife that he was feeling unwell after receiving vaccine including unable to move legs well. Patient later diagnosed with thrush and supposedly treated by physician. Patient did not discuss concerns regarding vaccine or WPW with physician. Patient called his wife the day of death and asked her to bring him to the doctor the following day. Wife reported that patient experienced seizures but not concerned as it was similar to childhood seizure. Wife was done at work and drove home after phone call, arriving at house approximately 10-15 minutes after call. Patient supposedly dead when wife arrived. Wife performed CPR for ~15 minutes until EMS arrived, and EMS attempted for another 40 minutes for any electrical activity. Wife declined full autopsy from ME, suspecting that it was massive MI or clot. Wife and patient unaware that WCW could place patient at risk of clots and wondering if the vaccine was partially responsible.

Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-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 Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: heart attack

Received second dose around 3:30pm on June 11 2021. During the night woke up several times feeling ill. Developed symptoms that lasted all day on June 12th. HORRIBLE Headache, Fever of 100.7. Chills, body aches, stiffneck. Injection site was sore swollen warm and red. Symptoms faded on June 13th leaving me feeling weak. Developed sweats on and off on June 13th. It took 3 days for me to start feeling more like normal. Injection site took a week to get better. I used Advil to help relive symptoms but it did NOT help the headache.

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

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

I have no idea if this is even where I should ask or mention this but I can't find anywhere else to do so. I just wanted to find out if there have been any reports of people having previous ailments exacerbated after getting the vaccine. I've had various muscle or tendon issues the last 5 years and every single one of them have progressively gotten worse since the vaccine which seems odd to me. Ive had on and off gum infections in the same spot the last 4 years and I'm now getting them every other week and the periodontist has no clue as to why. My previously partially torn rotator cuff is now bothering me fairly regularly when it was non-existent before. I've had throbbing pain in my big toe for decades but it literally happened twice a year maybe and not this is the third bout I've had with it in the last 3 months. I've had extremely bad neck issues to the point of barely being able to move it. My knee has been an issue for years and it has gotten progressively worse as well. The last one is a wrist issue I've had for 5 years and as long as I didn't bend it back too far was never an issue and now it's throbbing on and off on certain days and a ton more sensitive. I'm aware I'm 42 and things in the body just get worse as time goes on but having all this happening at the same time out of nowhere just seems a bit off to me. I've done a little research on the mrna vaccines but have a very basic understanding of what they do. Just thought I would submit this in case it merits some inquiry about any possible connections. I'm assuming since there's no going back this is just stuff I'm gonna have to live with, which sucks, but I suppose maybe knowing why would make some sort of difference? I don't know. Anyways thanks for taking any time to read and possibly consider this. Have a nice day.

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

tingling in fingers and toes, low vitamin B12 requiring injections, then diagnosed w lupus nephritis by biopsy

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium

Patient felt cold and HR was elevating. Appeared clammy with an obtunded look. Head dropped to chest, diaphoretic. When name called - patient responded. No SOB or throat swelling. HR 105-124, BP 150-160's / 60-70s. Transferred to the ED. ED diagnosed with vasovagal syncope. discharged without complications.

After the vaccine 4 hours later I started to hyperventilate. Woke up next morning throwing up, diarrhea , extreme lethargy, muscle aches and absolutely no energy. I've missed 3 days of work and I can't get out of bed I'm so sick. I can't provide for my family in the shape I'm in. I truly need help. My medical doctor told me yesterday all my symptoms WERE VACCINE RELATED

Beginning On July 2, 2021, started to feel nasal congestion and had a hard time breathing especially at night. On July 5, 2021 (2M) I found him on our living room floor having a seizure. 911 was called and he was rushed to the hospital and was hospitalized for three days.

Severe chest and abdominal pain never felt before in life. Pain caused difficulty breathing lasting 4-6 hours, fading and remaining uncomfortable for 12-24 hours.

tonic-clonic seizures; Husband is now an epileptic; started convulsing; stop breathing; lots of blood coming out of his mouth; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (started convulsing), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 036B26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Appendectomy. On 25-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) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (started convulsing) (seriousness criterion medically significant), DYSPNOEA (stop breathing) and MOUTH HAEMORRHAGE (lots of blood coming out of his mouth). On 22-Jul-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) (seriousness criterion medically significant) and EPILEPSY (Husband is now an epileptic) (seriousness criterion medically significant). At the time of the report, SEIZURE (started convulsing), DYSPNOEA (stop breathing), MOUTH HAEMORRHAGE (lots of blood coming out of his mouth), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) outcome was unknown. Weeks after taking his second dose of the Moderna COVID-19 vaccine, on 24May2021, the patient started having convulsions, stopped breathing and his wife had to bring him to the hospital. Also started having lots of blood coming out of his mouth, at the hospital they said he could have bitten himself when having convulsions but they could not find signs of that. On 22Jul2021 the same thing happened, he started having convulsions, but there was no blood coming out of his mouth this time. The patient is now an epileptic and wife thinks he is screwed and she's scared that she may loose him. They said they're tonic-clonic seizures. Patient did not take any medications prior to this. Concomitant medications information not reported. Treatment information not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; 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, more information is required for further assessment.

I received the vaccine at 6:30pm on 12/27. I worked atb7pm and took lunch at 2:00am. After lunch, I immediately felt sick to my stomache and threw up. I went home after my shift and went to bed. After 5 hours, I woke up and went to the couch to lay down while kids watched TV. Next, I woke to several people in my house. I had a seizure and my son had called 911. I was taken to emergency department. I was admitted and stayed 2 nights in the hospital.

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

Employee received the Moderna vaccine in the left arm and noted numbness in the left finger tips approximately 20 minutes later. RN assessed patient and patient requested additional assessment by our Medical Assistance Team (MAT). The MAT team transferred the patient to the Emergency Department for further care. Patient released from ED. Contacted the following day and stated he had an elevated heart rate in the ED and when it returned to normal, they released him with instructions to follow up with his PCP if the arm pain and tingling did not subside in 1-2 days. He states his left shoulder is painful today (1/6/21 10:00 am) and his left fingers are still tingling. Patient instructed to call Occupational Health for further guidance.

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

At 23 hours after injection, fever began. The fever was followed by headache, tiredness, and soreness. The fever ultimately rose to 103.3 and stayed around there for several hours. I took Tylenol for the symptoms. I woke up in the night with chills and night sweats. Into the second day of symptoms, only a slight headache and tiredness remain. Continuing with Tylenol for treatment.

Headache, Myalgia, SkinRash & Rash Narrative: Employee reports arm soreness, redness at injection site and 2-4 inch raised "hive." Employee further reports headache, body ache, sweat and fatigue. She has taken Tylenol with relief, reports that condition is improving.

Initial shot did not even feel it. then a coldness in my shoulder. down my arm to wrist and up to my cheek behind my left eye, then over my sinus cavity to the right side behind my eye and to my ear. Got home from work and noticed my left side was kind of swollen. chest and back. It felt a bit like a bee sting. I slept on my left side. Woke up with numbness on my whole left side. face was numb. My wife said it was kind of like bells palsy. Face kind of twitched a bit. Hip was numb walking was slow and I was careful as I went to the grocery store . It kind of leveled out but stayed numb all of work. I was still swollen after work. Woke up on Sunday and my arm was hurting bad. numbness had dissipated. ate then suddenly felt flush and hot. fetal position on the bed for a half hour then I had to drag myself to work. felt bad the first few hours but as the night went on I felt better. I could always feel it behind my eyes. early on it felt like I was discharging a bunch of stuff from them. My body was literally numb on the left half. I could feel the middle of myself from my scalp to my toes.

Large raised Hive at injection site 1 week from injection, spread down upper arm for a few days. Discomfort, itching and heat. greatly reduced one week later but still present, no treatment sought. used Ice packs and topical cream to reduce itching.

Arm sore at site of injection for around 2 days Low grade temp 1 day some body aches 1 day flushed feeling 1 day

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

Day after the vaccine I awoke with a very sore left arm which was to be expected. Upon moving I experienced vertigo, dizziness, headache, and extreme pressure in the left side of my face to include sinus cavities and deep inner ear pressure. I had some episodes of loose stools, not diarrhea, but not formed stools. These symptoms still persist to today, 1/15/2021, except for loose stool, that has returned to normal. I had a Dr. appointment today and the doctor would not rule out post vaccine side effects. I was tested for COVID on 1/11/2021 as a precautionary measure as I was displaying symptoms, but the test result was COVID not detected.

The first day I was fatigued and achey for a few hours and wanted to go to sleep very early. The following two days my arm was sore at the injection site but that went away in a couple days. 3 days post vaccination, my right axilla and median and ulnar nerves were extremely sensitive for 3 days but that subsided. 6 days post vaccine I started to get extreme fatigued, low energy and feel like my nerves were hot. I got a covid test which was negative because I was not feeling well. Then 9 days post vaccine I started to feel very fatigued, achey, and I couldn?t sleep well and like my nerves were burning up all over my body. I had to call out of work due to brain fog, fatigue, nerve heat, difficulty concentrating. I took my temperature during all this and it was 97.7. My hands felt very hot and I could wash them under warm water because the water felt way too hot.

Severe joint pain. Started in hands, fingers, wrist day one. Day 2 ankles. Day 3 extended to shoulders.

@1710 Patient verbalized he was feeling dizzy. Patient appeared dazed and became nonverbal. Emergency Response team was notified. Patient was noted as diaphoretic and clammy. @1712 Bp 53/38, HR43. Epi 0.3mg IM was administered to patient left thigh. Patient was placed on oxygen via NonBreather mask and feet were elevated. @1716 patient became alert and responsive. patient verbalized he doesn't remember anything. EMS arrived on scene @ 1720. Patient verbalized to EMS he felt better. Patent was able to stand and walk on his own and denied any dizziness. EKG was performed by EMS and showed normal sinus rhythm. Phone consult was conducted between the patient and MD attached to the fire department via telephone. Patient verbalized to the MD he felt better and he declined to be taken to the hospital. Patient was able to exit the vaccination tent on his own and called a uber home.

On the day of the vaccination, I only had a little sore arm. But when I woke up the next day, around 4:30 am, I had a fever. I felt very cold and tried to sleep, but I could not fall asleep because of body aches and fever. So, I tried to get up and sit, but I could not and had to go back to bed with the pains and lethargy. I lied on the bed until around 8 am and realized that my fever was high. I took the temperature with my digital thermometer. It showed 108.7F. I could not believe it and retook it on my ears; it still showed 108.6F. My headache was really bad. So, I took 500mg Tylenol. The fever did not go away completely, and I had to keep sleeping the whole day. In the evening, before I went to bed, I took another 500 mg Tylenol and slept. I could not sleep well with the body aches. The next morning I still had 103F temp that slowly waned by the evening that day. Now I am feeling okay but have been struggling with a sleep problem.

Itchi in The L arm just below the site of injection which became severe (7-8/10) L arm pain. Pain comes in waves at rest. Pain increases with any movement which makes L deltoid contract. Applied cortisone for itchiness with relief but pain is still significantly bad.

Initial night difficulty sleeping due soreness at injection site, headache, and sore joints. Following Day: Flu-like symptoms: weakness, lethargy, headache, sore joints, sore muscles. Two days after: Symptoms eased up. Three days after: 8/10 back spasms, momentarily incapacitating. Reduced with NSAIDs and heat. *Patient had similar reaction to anti-malarial medication over a decade prior.

patient c/o chills, body aches(alot in legs and back), whole right arm pain, feels real weak like 2 days into when he had COVID 12/5/20, headache (2hrs after shot)

Chills (followed by heavy sweating), Aches, Head aches, sore throat, indigestion, fitful sleep/ dreams, increased heart rate. The big change from dose 1 to 2 is muscle twitching. The twitches coincide with the more extreme joint aches. Sore arm All started about 9 hours after vaccine. Sore arm was mitigated with movement and stretching (as compared to the first dose). Other symptoms have lessened since 7am (19 hours after shot), but linger. Ibuprofen seems to lessen, but not end eymptoms.

After receiving the COVID-19 Moderna vaccine on 21 Jan 2021 I have had tingling in lower left leg / ankle area. I waited the 48hrs to see if the effects went away it has not. I still have tingling in the lower left leg / ankle as of 27 Jan 20201. There hasn't been any increase or decrease in the intensity of the tingling.

Minor ache and soreness at the injection site starting about 4 hour after injection and lasting approximate 48 hours after. Similar soreness in the left elbow joint and shoulder starting around 24 hours after the injection and lasting to approximately 48 hours after.

Received vaccine at living premises by outside source on 1/22/21. On 1/26/21 caregiver called clinic (PCP) and appointment made. Noted to have rash on trunk, and back that he said was burning. Did not itch. No difficulty breathing or swallowing, or other symptoms.

Joint Pain, initially started primarily in pinky knuckle on Day 2 and each day progressed to additional knuckles on right hand until I could not make a fist at 4th day. Progressed to left hand and other joints (knees) by 4th day. Use of acetaminophen helped alleviate pain and permitted more movement. By day 6, pain reduced to no longer need medication. As of Today, joints are still not back to normal still slightly tight. Injection site was sore for 5 days.

I received my second dose of the Moderna vaccine at approximately 11:00am. At approximately 7:00pm, I began experiencing flu-like symptoms including fever, weakness, fatigue, severe body aches, a swollen axillary lymph node (on the side of the injection). 48 hours after receiving the shot, I still maintain a fever of greater than 100 and body aches.

Suspected Bell's palsy...MD felt symptoms were consistent (left side of face impacted, including ability to blink left eye)...treated by MD with prednisone and Valtrex.

Patient called pharmacy around 9:15 am complaining about side effect after receiving Moderna Covid 19 vaccine 2nd dose. Patient was advised to see doctor immediately. Patient stated that he didn't had any reaction after getting first dose of Moderna Covid 19 Vaccine (Lot - 027L20A - Site : LD - IM) on 01/05/2021. As per patient, on Wednesday 02/03/2021 around 3 am woke up with high fever( 102.7), chills, body sore, joint muscle pain and feeling tired. On Thursday 02/04/2021 around 2 am had fever (99.7), leg pain, low back pain and swelling in left armpit. Has appointment with physician at 10:45am.

Fever, chills, severe shakes. Began at 6:00 PM. Intensified at 8:00 PM (~ 12 hours after shot). Continued for 5 hours until 3:00 AM. Prevented sleep. Following day, minor chills, no major impact.

2-3 hours after receiving vaccine reported having a tingling sensation in face, head and arms, shoulders to fingertips. This has continued as of date and is intermittent lasting an hour and is not consistent in area.

Crawling soreness from left shoulder to neck and back started about 4-5 hours later, eventually extreme full body aches and chronic moderate headache lasting at least until current (4 pm, next day). Brain fog became concern at 8 pm. Mild Difficulty navigating grocery store. Extreme soreness has withstood 3 ibuprofen (x2 doses) and today took 1 hydrocodine in cabinet. Brain fog has continued and not improved. Moderate forgetting. Definitely not able to work today (Sunday) and doubt I will be able to work tomorrow. I am private practice dr. and will probably loose substantial income tomorrow. Completely NOT worth it and concerning with the brain fog. I strongly regret the second shot. No symptoms after 1st shot. The dose should be immediately reduced for 2nd shot. This strong of an immune response is not necessary.

chills,flu like symptoms. PT presents with burning sensation in chest with tightness and SOB x Saturday denies cough. Reports receiving 2nd moderna vaccine Tuesday prior to onset with hx of covid 10/2020. 43 yo m c/o acute atraumatic onset of substernal cp 'burning' sensation and difficulty breathing w/dry cough x24hrs states sx's feel similar to when he had COVID19 back in Oct2020; Pt states that then he was successfully tx'd w/hydroxychloriquine+azithromycin+zinc by civilian provider; initially dx'd w/covid and went in for tx after he woke up 'feeling like I was drowning' 48hrs s/p dx; Pt states burning sensation 'somewhat' similar to that episode; Pt recently received covid19 vaccine w/2nd dos

It has been 10 days and I am still suffering from aching pain mostly in my calves, but the rest of my body less severely. This happened after my first dose, perhaps more severely, but for only about 24 hours. This time it has not gone away.

My brother has epilepsy. His seizures can be triggered by low grade fever and exhaustion. He had covid in early October. His seizures are generally well controlled but he had several after the vaccine. I understand that the vaccine did not cause the seizures. The fever caused the seizure. I just think it?s important to neurologists to have this info to see how we can go about mitigating the seizures and if the 2nd dose is necessary. Keeping him hydrated may have helped and also giving him something immediately for the low grade fever. Just knowing these things may help others.

43 yr old male sitting in observation area after receiving 1st Covid vaccine injection felt faint and dizzy as well as nauseous. Pt appeared to be pale and skin cold,clammy, and diaphoretic and was moved to medical 2 for observation. Pt was placed in trendelenburg position and vs were taken. Pt bp was 102/62, hr 58, 98% ra and 18 reps. Led clear bil. Pt was allowed to rest for several minutes and vs were retaken and improved. Pt felt better and adverse symptoms subsided. Vs were normal at bp 110/70, hr 65, resp 18, spo2 was 100% ra. Pt felt like he can go home and doesn?t need t/p to hospital Er. Pt signed a refusal for transport and went back to observation room t rest.before returning home

Red rash at injection site approx 5 inches across, joint pain, fatigue, restless legs, arm pain in right arm

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

fatigue (24 hours) muscle weakness (1 day) headache intermittent (2 days) sore arm (3 days) muscle aches - lower back right scapula

The next morning after injection there was some discomfort at the injection site. At 3:30 am CST I woke with a 100.8 fever, muscle and joint aches, chills, and headache. I took acetaminophen and ibuprofen for the fever and pain throughout the day with rest. The symptoms cleared around 9:30 pm CST that evening.

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

Around 60 seconds after injection my left arm became heavy and tingly/numb, this then occurred in my right thumb as well. I had a heavy sensation on my chest and my heart rate increased rapidly to over 120. This would then resolve slowly and then the tachycardia would recur with the odd sensation over my whole body every ten-15 minutes. EMS was called to take vitals and monitor me. Very odd feeling. I was monitored over the course of 2 hours and when I finally stood up my legs felt heavy and weak as well. After going home and resting things seemed to resolve and I was even able to go out to dinner that evening. The following week I didn't notice much of anything but new symptoms arose around 6 days later on Friday. I would feel strange feeling in my legs and a heaviness. I had a strange dizziness but not vertigo. I felt like I was in slow motion at times. This worsened and I had weakness/fatigue that reached its peak on 1/20/21 and 1/21/21. I was unable to operate on Wednesday as an orthopedic surgeon and had to cancel cases due to this weakness. I saw my doctor that day and had a battery of tests run. CMP, TSH, T4, T3, COVID, COVID IgG, Epstein Barr, Brain MRI, Neruo Consult, ANA, CK, Flu A/B, Vit B12 level, ESR, CRP, Vit D level, EKG, CXR. The following day when I awoke in the morning I felt extremely lethargic and had to cancel clinic. Over the following weeks things have gradually improved but I occasionally get some dizzy/lightheaded moments.

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

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

Approximately 24 hours after dose, patient experienced lightheadedness, headache and lethargy, and was unable to stand or exert themselves without support. Patient suffered hot flashes, nausea.persisted for approximately 24 hours thereafter. No significant symptoms between time of vaccination and onset of symptoms 24h later.

c/o of bilateral wrist ache and pain following injection. Also pain in R side of spine, midway. No SOB, or other signs of allergy

2 days after vaccine had been given woke up with left sided face twitching , Headache, nausea. took motrin for Headache. Facial twitching lasted 2 days. and then went away on own. He did not go to dr. or hospital for treatment.

Chills @ T+12 to 13 hrs. (from time of injection). Severe nausea and resultant dehydration/dizziness/Low BP @ T+20 hrs. (lasted about 5 hrs.) Fever and body ache in the 102-103*F range throughout March 1. Overall lethargy throughout March 1. Night sweats night of 3/1 into 3/2. Laryngeal tissue damage from stomach fluids due to extremity of nausea/vomiting.

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

After an hour of receiving the moderna covid-19 vaccine on February 20th my left arm started burning, The burning sensation hasn't stopped since I got the first dose. In fact it has gotten worse, now my arm feels week, my fingers tingle and the burning sensation radiates to my neck and left ear. I been to the emergency room, VA clinic, and local clinic and nobody has helped me. Everyone just tells me to take ibuprofen, Tylenol, naproxen, use hot and cold compressions. Nothing has helped, If someone can call me and help me I will really appreciated.

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

"43M yo started with symptoms of for __3 _days. Pt states has very swollen left leg , and red. with mild pain in the groin area to the left testicle.. Leg pain is Very bad Symptoms started after biking pt denies injury. Pain in located in the left leg Pt describes pain as severe and is associated with groin pain to left testicle"

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

Prior to receiving vaccine, patient was nervous and diaphoretic temperature and o2 was within normal limits. Tolerated the administration of vaccine well. With in the 15 minutes of waiting after vaccine, became tachycardiac, SOB , and developed tremors. Sent to ED for further evaluation

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

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

I've lost 16 pounds in 1 month and 20 days without trying. Moderna killed my obsession for food. I was 268 lbs when I presented for the 1st dose of Moderna at the Robeson CRV. Within 24 hours I was weak, cold, aching all over, and nauseous. The nausea moved over to lack of interest in food. I've struggled with intense craving for food non-stop for 30 years. The cravings are gone. By my second shot in March I was down to around 260 lbs. Twenty days after my second shot, I am down to 252lbs. Food is more of a necessity now rather than a constant desire. I believe the vaccine modulated insulin/ghrelin or crossed the blood brain barrier and modulated the incessant dopamine reward signaling in the mesolimbic DA pathway when I eat food. I reach satiety easily now. I also have diminished need for Ativan. I use to drink close to a gallon of water a day. Now I have no real interest. I might drink a couple liters a day. To put things in perspective, before Moderna, I could eat 2 foot long Subway sandwiches, 3-6 cookies, 2-4 32 oz of soda and chips to stop my hunger for 2-3 hours. 2-3 hours later I would feel extremely hungry with a growling stomach. I could then consume 2-3 double cheeseburgers, a 20 piece nugget, 2 parfaits, and a chocolate sundae. After Moderna, now a half a Subway sandwich and maybe a cookie are enough to last for most of the day. The desire for food has diminished to necessity to eat and lack of interest in eating, even when my stomach is empty. If I have a soda or sparkling water, I might have 1 or 2 and stop. Moderna flipped some hormonal switch in my body. It's great. Food went from being an insatiable desire to a basic necessity. I've lost 16 pounds in 1 month and 20 days without trying.

Sore arm; Heart fluttering; Discomfort; More extreme exhaustion; A spontaneous report was received from a consumer, concerning a 39-year old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced extreme exhaustion, sore arm, discomfort, and heart fluttering. The patient's medical history was not provided. Concomitant was not provided. On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 015M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient began to experience extreme exhaustion, sore arm, discomfort and heart fluttering. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The patient received their second dose on 12 Mar 2021. The outcome of the events, extreme exhaustion, sore arm, discomfort, and heart fluttering, were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

At 16:05 this RN was called to evaluate a patient with a reaction after receiving his first dose of the covid shot. He stated that he had shortness of breath for 1-2 minutes and then Slight dizziness and tingling throughout his body that came and went every 4-5 minutes. Patient was brought to the nurse clinic for observation. I observed patient for 30 + minutes as his symptoms subsided and he returned to his baseline. See vital signs below. At 16:45, patient denied any further symptoms and stated he felt better. Dr. was called with a brief report of these findings and advised that patient was ok to leave and to follow up or to go to Urgent Care if symptoms return or become worse. Patient was provided with these instructions. He verbalized an understanding of information provided him. Patient left ambulatory with no distress noted.

No issues immediately following vaccine. About 11am, mild symptoms like 99.4 degree fever, muscle aches, joint pain, very mild nausea, fatigue began. Severe nausea began about 7:15pm. At 7:45pm, severe dizziness resulting in loss of consciousness and fall. Seizure Syncope event lasted 2 1/2 to 4minutes. Slow to wake. Trembling/shaking in extremities, cold sweat. Delayed speech. Paramedics were called. Went to ER at approximately 8:30pm.

About an hour after the shot I felt like I was getting the Flu. body aches, fever, fatigue, cold chills. I woke up the next day to go to my job and as I was standing at my closet to grab a shirt I felt like I was going to pass out. everything went black. The next thing I knew I was laying on the floor with a shirt in my hand but don't remember how I got on the floor or if I even fell. I asked my Girlfriend if she had heard me fall, She said no. I walked into the bedroom and layed back down on the bed still feeling "out of it". after what felt like a few minutes, I began Heaving like I was going to throw up but I felt like it was a dream and was very slow to react until my girlfriend told me to run to the bathroom. the whole time I was coughing up a foam.

Mild headache for two days Today: high pain in both elbows Delirium Exhaustion Dizziness Mumbling and garbled speech Uncoordinated movements

The day after the shot about 10:30 AM, started to feel very fatigued. Lasted throughout the day. on the second day after the shot around noon, started to have a pins and needles sensation in my ear and nose. Over the course of 2 hours, that sensation would stop and move to a different part of my body (fingers, arms, toes, back, hamstring, calves, etc). it would last for a while and show up elsewhere. Went to ER after it persisted for 2 hours. Total event lasted about 4 hours. On third day, woke up with slight tingling in toes but after moving around for a few minutes, that sensation went away. At the time of this report, i feel no tingling and no fatigue. Note: i marked unknown to whether i have recovered from averse event as the ER doctor told me this could come back over the next few days and that we needed to let the vaccination process run through its course.

Fever, chills, fatigue, muscle pain, aches, arm that shot was given in was very painful the day after getting the vaccine. Going on the second day after injection, fever broke and other symptoms are still present but beginning to resolve.

Started to develop weakness, muscle aches, and a bit confused, the next morning I had a fever all day of about 101. Took Tylenol and slept on and off as well as drank a lot of water. Could not eat solid foods, but only lasted a day. This morning I still have some left over soreness but otherwise ok and little exhausted

Arm soreness and fever for lasting at least 12 hours on the day 1 following vaccine. On Day 2 following the vaccine, in addition to soreness at injection site, swollen lymph node and tenderness in underarm of left arm where vaccine was administered. On Day 3 following the vaccine, lymph node still swollen with tenderness with additional tenderness in bicep and forearm. Today is Day 4 after vaccine and lymph node is still swollen and tender, along with tenderness in bicep and forearm. The swelling and tenderness seem to be improving slowly.

Received his 1st dose of the Moderna vaccine on 3/3/2021 Lot # 002A21A PCP: Dr. (name) Employee was alerted to the pt?s condition on 3/31/2021. Employee placed call for further information. On the same day of the vaccine the pt reported nausea and vertigo for about 7 days. Pt reports on day 4 his legs were hurting him. Day 10 his legs became weak and numb, day 17 pt reports losing all sensation in legs and losing sensation in his hands and arms. Trouble throwing a ball, using a toothbrush, etc. Pt went to the ED. Pt had a normal CT scan and MRI of brain and neck. Pt stated he recently started having some intermittent issues with swallowing, feeling like there was a lump in the back of his throat. Pt states his PCP is fully aware of all of his symptoms. Pt is scheduled to see a neurologist next week. Pt notes he experienced anaphylaxis to sulfa for the first time this past summer that required the use of an epi pen. Pt states he has a lung issue but otherwise is healthy. Pt reports no neurological symptoms prior to the vaccine. Patient was advised to continue to monitor his symptoms and keep his PCP up to date. Discussed precautions in great detail. Pt does not feel like he needs to seek emergency care again at this time.

Patient received Moderna vaccine #2 Left Deltoid at 1 PM. Notified First medical team at 1:05 PM reported left middle finger, left ring finger and left pinky numbness with digits flexed and numbness to left hand at 1:45. Grips = and strong. Has history of a 4 inch screw in the left arm that typically gets numb when the weather is cold. Had Hx Covid-19 positive in December. Had Moderna vaccine number #1 at 1 PM reports he had [pain, fever, numbness in left middle finger, left ring and left pinky when he awoke 4AM and lasted 12 hrs and resolved at 4 PM. Denies neck or shoulder medical problems. DTRs 2+ and = upper extremities. Pain 5/10. FROM neck/shoulders, wrist. Tenderness to olecranon. Arm easily irritated at ulnar groove and radial nerve. BP elevated 148/104 pulse 102. Pulse ox 97. Sensation decreased to light touch left hand and fingers, intact sensation right hand. Motor strength 5/5 b/l UE. He was instructed to take NSAID prn and report if symptoms do not resolve. Discussed Ulnar nerve irritation w/o possibly due to surgery post since he has had some symptoms of nerve irritation s/p 16 yr elbow surgery. Denies Headache, nausea, vomiting, throat swelling or other symptoms. Seen by Dr. and examined patient also with same findings.

Received his 1st dose of the Moderna vaccine on 3/3/2021 Lot # 002A21A PCP: Dr. (name) Employee was alerted to the pt's condition on 3/31/2021. Employee placed call to patient for further information. On the same day of the vaccine the pt reported nausea and vertigo for about 7 days. Pt reports on day 4 his legs were hurting him. Day 10 his legs became weak and numb, day 17 pt reports losing all sensation in legs and losing sensation in his hands and arms. Trouble throwing a ball, using a toothbrush, etc. Pt went to the ED. Pt had a normal CT scan and MRI of brain and neck. Pt stated he recently started having some intermittent issues with swallowing, feeling like there was a lump in the back of his throat. Pt states his PCP is fully aware of all of his symptoms. Pt is scheduled to see a neurologist at next week. Pt notes he experienced anaphylaxis to sulfa for the first time this past summer that required the use of an epi pen. Pt states he has a lung issue but otherwise is healthy. Pt reports no neurological symptoms prior to the vaccine. Patient was advised to continue to monitor his symptoms and keep his PCP up to date. Discussed precautions in great detail. Pt does not feel like he needs to seek emergency care again at this time.

Patient called and stated that they started developing what they described as spots/rash on different parts of their body. Stated that they rash was itchy, but not painful. They said they noticed the rash 3/30/2021, the day after their vaccination. This was reported to us over the phone, so was not able to see the rash in person. It was difficult to tell based on the description if it was related to the vaccine or not. Asked the patient if they were having any other issues/symptoms related to the vaccine. The patient stated other than a sore arm no. The patient was instructed that benadryl could be used to help with the itching, and that it was important that got in to a doctor as soon as possible to get the rash looked at.

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

Mild fever, body aches, arm swelling, cold sweats, shaking lasted about 8 hours. Full recovery was additional 18 hours later.

After second shot, I had the following adverse affects: tender/swollen testicles, burning sensation when I urinated . I had this after the first shot, too. I visited my local doctor. No UTI. Prostate was enlarged which I did not have before.

Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CARDIAC FLUTTER (Heart fluttering) and the second episode of CARDIAC FLUTTER (Heart fluttering) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) 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). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2020, the patient experienced PYREXIA (Fever). On 12-Feb-2021, the patient experienced the first episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), FATIGUE (more extreme exhaustion), DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm). On 13-Mar-2021, the patient experienced the second episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). At the time of the report, last episode of CARDIAC FLUTTER (Heart fluttering) outcome was unknown, FATIGUE (more extreme exhaustion) had resolved, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm) was resolving and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 103.3 (High) Fever for 103.3 degree. This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and non-serious expected pyrexia. Event onset on Day 2 after 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. Treatment medications included ibuprofen and acetaminophen.; Sender's Comments: This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and nonserious expected pyrexia. Event onset on Day 2 after 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.

1301. Patient noted numbness in front and back of hand, and down L arm. Thin patient - whose IM injection was given by 1" needle. No focal neurological findings. 1303: BP 121/85; 85 HR; Sate 98% on RA; 1307: 126/87; 73-98% Sat. Benadryl 25 mg po@ 1312. Cold pack applied to injection site. 1337. Patient reports symptoms have improved. discharged from clinic to home. Advised to follow up with PCP should symptoms return, worsen or has SOB.

Strong pain in left arm and left upper chest. Rapid heartbeat. Mild pain 10 minutes after shot then increasing intensity. At 10-12 hours after shot unable to lift arm. At 24 hours post shot pain only present in arm. Difficulty lifting even a cell phone. At 32 hours post shot arm still tender but can lift objects. Heartbeat still elevated but not as fast as day 1. Another side effect is tiredness which began 24 hours after shot.

Major pain throughout entire left arm, 7 on a 10 scale. Injection site pain, 9.5 on a 10 scale High, prolonged fever Nausea Major headache beyond 72 hours after injection, lingering headache and nausea ongoing. Minor paralysis in left leg.

AT 1:30PM, patient got first Moderna shot. Around 2:15pm, felt numb/tingling in the left arm then spread to the right hand. Monitored patient for 1 hour with no signs of improvement. Patient states pain level is 6-8 out of 10. At 3:15pm, referred patient to seek urgent medical care. Patient does not want to contacted.

After 12min started to get cold and shake, started to feel so slow even thinking, called my wife on the phone, walked slowly to the counter, and slowly started to have trouble talking, slow talking, neck felt like wierd muscles fighting to move. Then I sat down, monitored by people there. Then after 10 min felt better, but not a 100 percent since then, tierd, muscles. No hospital, Went home.

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

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

Two nights in a row, 04/07 and 04/08, woke up with rapid heart rate (fluctuating from 85-110 bpm) and felt dizzy, fatigued, feverish, sweaty, shaky and about to pass out. Could have been hyperventilating in sleep because of rapid heart rate. Required about 2 hours of attention to reading, yoga and relaxation to get to sleep. On morning of 04/08, heart rate was still high (78-95) for resting, which is usually in the 50s or 60s. GI disturbance led to frequent bowel movements and the whole condition resulted in malaise and feeling of impending doom. A feedback from acute anxiety as a result of symptoms could be involved. Also involved is the diphenhydramine I took at 9 pm on 04/07 to treat hay fever and acute insomnia. Night if 04/08 was more manageable. But it interrupted sleep with strong disturbances that felt like spasms in prefrontal cortex coming out of sleep. More likely it was movement in sinus congestion that triggered a startle response while exhausted from work. It was bad timing to have the shot during a very busy work week.

Pt had 1st dose of Moderna vaccine yesterday 4/9. Less than 5 min after vaccination pt had some jerking of limbs lasting about a minute per nurse & wife account. No LOC, no foaming at mouth, no incontinence. Did have eye deviation upwards & was groggy for about a minute but quickly was alert & able to answer questions & had a normal MSE. Vitals stable. Pt reports he is afraid of needles/blood. No hx of seizures & not on any meds. He also reported he felt faint after receiving vaccine. He was sent to ER by ambulance for further evaluation of possible seizure. Spoke to pt at home today 4/10, had ER evaluation - lab tests and heart studies; no radiological studies. All results normal. Pt reports he is feeling fine and has had no further symptoms or side effects. Recommended pt to discuss with PCP whether to take 2nd dose Moderna.

I was feeling fine directly after getting the injection. All of a sudden, after about 5 minutes, I felt a rush go through my body and managed to declare "I'm not feeling well" before I lost coherence and clarity. My wife called for help from the attendants as I started to convulse, get dizzy, start sweating, and feel like I was going to pass out. I then proceeded to throw up a couple of times and had to lie back for 30 minutes before switching to the passenger side of the vehicle for the ride home. I was completely worn out and weak, with flu-like symptoms and nausea for the rest of the day and for several days afterward.

On the evening of Friday 4/2/2021 around 9:30 PM, I was experiencing what felt like heartburn. It got better before I went to bed. At around 9:00 AM on Saturday 4/3/2021, I was awakened by intense pain and pressure that felt like the worst heartburn I'd ever experienced. After OTC heartburn treatments didn't help, at around 11:00 AM I went to the local ER where I was initially diagnosed as having a heart attack. After being given some baby aspirin and a nitro tablet, I started feeling better and was airlifted immediately to a nearby cardiology unit at another hospital. A heart catheterization and EKGs determined that I had not had a heart attack, but instead had takotsubo cardiomyopathy. I was admitted into the cardiac ICU overnight for observation, transferred to a non-critical room the next day (4/4/2021), and released on Monday 4/5/2021.

pt says a few days after taking the vax he had arm pain that moved into his lower back. He says his spine hurts around the waist and lower back area. He has severe lower back pain when he moves around. The pain will go away if he sits down but if he moves around it comes back.

left arm started to hurt pretty bad; patient felt flushed and hot; skin was red; shivering and shaking on left side of their body; left side numb, kind of Bells Palsy syndrome; feel cold in their shoulder; cold behind left eye then from wrist to behind both eyes; left side of the body was swollen, like swollen pecks, back and chest, like they had been stung; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical event). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes) and SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung). On 09-Jan-2021, the patient experienced FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) (seriousness criterion medically significant) and CHILLS (shivering and shaking on left side of their body). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm started to hurt pretty bad), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red). At the time of the report, FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome), PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes), PAIN IN EXTREMITY (left arm started to hurt pretty bad), SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung), CHILLS (shivering and shaking on left side of their body), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

without warning and approximatly 5 minutes after patient recieved vaccine patient passed out and fell face first onto floor. patient was approached lying face down on floor bleeding and sounds of gurgling coming from patient patient was unreponsive. When patient was brought around and returned to conciousness patient did not know where he was or what had happened. Patients pulse was very low at 58 and dropping to as low as 39. Patient pulse did not stabilize the entire time patient was under our care. Patient had about a inch and a half laceration about eye and possible facial fracture. It was noticed that patients face was swollen when leaving with ambulance to be transported to er.

Twitching up and down my left arm, where the shot occurred, and sometimes my eyes. I?m not sure about the eyes since that?s happened before, but the left arm is consistent, visible, and once every few seconds.

Fever seven hours after injection. Fever broke roughly 15 hours after injection. Migraines began 3 days after injection and have persisted through day 6. They are ongoing.

Arm pain, fever, chills, nausea, headache, body aches. Lasted about 12 hours, except for arm pain which continues.

Patient began experiencing pain in his right leg on 4/5, sought treatment at walk-in clinic on 4/12. Healthcare provider he saw sent him to ultrasound at a medical center, who then referred him to the emergency deptartment. Patient was diagnosed with a DVT and prescribed Eliquis 10 mg BID x7 days then 5 mg BID for 6 months.

Woke up morning after injection (6am 4/10) to low grade fever chills, headache and body aches. Symptoms lasted throughout the day, even after alternating between Ibuprofen and Tylenol . Woke up in the early hours of the morning (3am, 4/11) with severe shaking (no temperature) that lasted approx. 10 mins. No symptoms throughout the day but low grade fever retuned during the evening and lasted approx. 3 hrs. No symptoms as of 6am on 4/12.

Had first COVID-19 shot on 03/18/2021. 04/06/2021 started to have right lower leg pain. Was seen at urgent care were and xray was done that was negative. Urgent care doctor sent him for ultrasound right lower leg on 04/10/2021 which was negative. He was started on antibiotics and Prednisone. Was seen by PCP whom felt he needed to be seen by vascular. He was seen by Dr. on 04/16/2021 who felt it was a pulled muscle, but he want a repeat ultrasound of right lower leg done. 04/19/2021 ultrasound of right lower leg was done and showed a DVT. He was started on low does baby aspirin 81mg. A follow up ultrasound was ordered for 04/26/2021 to check status of DVT.

Pt. reports severe joint pain in arm that he did not receive the vaccine. He states it started about 3 hours to 4 1/2 hours after immunization. He reports it initially felt achy but by the next day got significantly worse. He reports that he does not have full strength in his arm and it is very painful to raise arm. Pt followed up with Primary Care doctor.

Moderna COVID-19 Vaccine Nausea, Diarrhea, Muscle Aches and Tightness, Fatigue, Flush/Low Grade Temperature, Pain in Neck and Joints

Today afternoon/evening I started to get sore and have a headache (which is normal from what I hear.) I could only sleep a couple hours Tuesday night into Wednesday morning because I kept tossing and turning. When I woke up Wednesday morning (4-21-21) around 6:00 am, I couldn't move as I normally could and when I tried to walk I found it very painful. The whole area between my knees and my shoulders were completely numb yet it felt as if it were on fire. I slept most of the morning and a little in the afternoon as it was very painful to move, talk, laugh, etc... Finally in the late afternoon (3:00-4:00ish) the numbness wore off but the burning sensation persisted. I felt progressively better throughout Thursday (4-22-21) and about the same time in the afternoon (3:00-4:00ish) the burning wore off as well. That evening I felt perfectly normal except for the typical achiness that tends to occur with vaccines. Today (Friday 4-23-21) I feel rested and back to my normal self.

Woke up next morning with 101 degree fever, aches, chills, headache, fatigue, weakness. Started around 3am day after dosage, recovery began around 3pm day after dosage. I still have a headache 46 hours after dosage, but no more fever.

swollen lymph node in armpit of arm where injection was received (lasted for 16 days after injection), sharp burning nerve-like pain to touch down arm of injection site onset 10 days afterward. Lasted about a week from there. Felt a lot like nerve pain. Got evaluated at Urgent Care for possible shingles. Diagnosed a negative.

Swelling and numbness in the right calf as well as purple spots around it. The numbness does not diminish and the purple spots have not faded. I need not to have movement so that it doesn't bother me.

Patient experienced left neuralgic amyotrophy. He got the 1st dose of the Moderna COVID-19 vaccine on Thursday 1/28/2021. He got the 2nd Moderna shot on 2/26/2021. Symptoms started on 2/1/2021. That morning, he awoke with severe localized left shoulder/shoulder blade pain. No weakness or numbness at that time. Left shoulder pain lasted for a week then resolved on 2/7/2021. However, that same day that the left shoulder pain resolved, he started to experience constant tingling paresthesias at the left digits 4-5 and the medial palm/hypothenar eminence. He was recommended physical therapy and went there for 2 weeks then went to occupational therapy who noticed some left hand weakness. He does notice some mild difficulty manipulating left digit 5. Since then, symptoms are present but improving.

Patient stated feeling dizzy after getting vaccination. than patient felt hot and ice pack and fan stated. Patient BP taken 104/68, 55 Pulse, 20 R at 10:08 am. Shortly afterwards patient black out and Nurse to get safely guide patient to floor, raised feet on chair and secured head up and continue to supply ice pack and fanning. Patient stated seizure activity and Nurse administered Epi injection to control seizure that last only 30-45 seconds and stop. BP taken after seizure and EPI injection 171/93, 65 pulse, 20 R, 98% sat. Patient stated talking and color stated coming back and 911 was called and patient remain on floor talking as we fan continue ice packs on him. Pulse ox 98%, R 18 and

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

Day of shot slight dizziness and weakness, second day minimal adverse reactions; slight chills, 3rd day (early morning) total body aches and pains, nausea and major dizziness; full body chills, extreme loss of strength; site of shot internal and external pain leading up to the back of neck, 4th day complete incapacitation uncontrollable shacking from chills; bones ached; constipation; nausea without ability to vomit; 5th day same effects if not worse; still unable to vomit but feeling of endless need to stuck in upper chest, 6th day chills begin to break and body pain subsiding; still weak and dizzy with major headaches, 7th day chills are almost completely gone, body (muscles, tendons, etc) ridiculously tight and aching from the constant shaking from chills and restless sleep over 7 days. Lots and lots of liquids from day 1; day 4 started taking minimal acetaminophen to ease pain and feelings of fever. Temperature never went above 96degrees. Small portioned meals to get nutrients, and constant liquids to stay hydrated. This did not relieve any symptoms, until night 7 when pain started to subside. Constant stretching now to release the constricting of all my muscles and tendons over the course of side effects. Still constipated and slight nausea, still weak in strength.

101.5 Temperature, chills for about 4 hours, then overheating, headache, loss of appetite, nausea, weak.

Extreme body aches, painful at site and painful swelling inside armpit. 24hr Fever 102 that won?t go away with Tylenol, Nausea, chills, headache and lethargy. Heaviness when breathing. Flank pain.

My wife and I had the same time and were vaccinated. She immediately had a sore arm but it took 24 hours for me to feel it. The following Monday (72 hours) I woke up with "the spins" and a mild headache. These symptoms have come and gone for over two weeks now. One day it will be better, the next worse, then even worse, then recovery, then almost gone, back to spins and dizziness. I read somewhere it may be cykotines affecting my inner ear. I also have a mildly stuffed nose but nothing out of the ordinary. This stuffiness is allergies (seasonal?) related perhaps. Today (4/29) it went back to "worse"

Sickest I have ever been for 12-24 hours. Aches, chills, bones and joints hurt. Mild fever, severe headache. Body felt like it was on fire. Fatigue, lethargy and weakness.

About 12 hours AFTER receiving my second dose, I've had a non-stop fever that continued for about 24 hours, with temperatures ranging between 99.8 and 102 degrees. I haven't had a fever for more than a year, and I haven't felt that bad in a long while. There was a little headache as well, which has continued into the third day (which is today), but I do not have the fever anymore. I have had used 5 Tylenol in about 30 hours, and not sure if I will need one for the current headache. Also, the second dose left the pain in my arm for much longer compared to the first, but that was nothing compared to the problem with the non-stop fever, which is the adverse effect I am mostly concerned about.

delayed cutaneous hypersensitivity - aka COVID Arm. Red rash at injection site with radius of 1 inch, hot to the touch, occasional hot flashes continuing 2.5 days after second vaccination, began 36 hours after second vaccination.

The first day I was fine until about 11:30p.m. I started to have fever and body aches. Then the next morning I started vomiting about 11:30am and again at 1:30pm. I became very weak and couldn't hold anything down. My wife took me to the ER and I was given iv fluids and nausea medicine, ibuprofen, Benadryl, and Toradol for my headache. I was then released after a bag of fluids . The following day my injection site had a red circle the size of a large grapefruit and was warm to touch and I still have a light red circle around injection site.

pt states he noticed he had a rash on the left side of his chest and stomach. He started getting a pounding headache with mild fever, body aches and chills. His headache was getting worse and no medicine he took helped with the pain. On 5/1/2021 he went to Urgent Care on in. He was diagnosed w/ Shingles. He had blood work that was negative. He was prescribed Valtrex and Ibuprofen and told to FU w/ PCP. He had a tele visit w/ his PCP on 5/6/21. He was prescribed more Valtrex and Ibuprofen and ordered more blood work. He still has a rash and still feels weak but is getting better.

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

Two days after the shot, my arm was bright right around the injection site, and the rest of the upper arm had red/bluish splotches - worst of all, the outer portion of my upper arm had gone partially numb/tingly. Expecting it to be temporary, I let it go. After a week, the redness around the injection site had faded, and the splotches were less obvious but still present - and the numbness had spread to most of my upper arm. I saw my family doctor, who ordered an ultrasound to rule out a blood clot - which it did. The symptoms persist, and the numbness is spreading further down my arm. It is currently from just below the shoulder joint al the way to just above my wrist. It remains on the outer side, with the inner side of the arm remaining pretty much normal.

Patient by 5/8/21 was experiencing fever to 103, lower back pain, palpitaitons, headache, nausea, left arm and neck pain and dizziness. He was taking Advil and Tylenol to assist with symptom managment. Left arm and neck pain persisted. On the morning of 5/11/21 he awoke with central chest tightness, left arm/shoulder/neck achiness, nausea and headache. During ride to hospital, he had palpitations for 30 minutes. He arrived at Medical Center where he was found to have a positive troponin I of 4.2 (ULN of <0.045). Echo done at that time showed EF of 59% with basal inferior, anterolateral hyokinesia, basal inferolateral hyokinesia, mid inferolateral hyokinesia, diastolic LV function normal function for age and trace mitral regurgitation. ECG showed non diagnostic ST elevations in leads II, III, AVF. The patient was transferred to another Medical Center for urgent cardiac cath based on resting chest, arm and neck pain, positive troponin and wall motion abnormalities seen on echo. Cardiac cath found normal coronary arteries that were free of disease. Troponin I at this medical center was positive 0.31 and 0.39. Further testing ordered is a cardiac MRI to assess for possible acute myocarditis.

PATIENT WAS UNRESPONSIVE ABOUT 5 MINUTES AFTER VACCINATION... PATIENT RED FACED AND NOT RESPONDING TO QUESTIONS... PATIENT THRUST BOTH ARMS DOWN TO HIS SIDE AND TRIED TO GASP IN A BREATH OF AIR... 911 CALLED AND 1 EPIPEN INTRAMUSCULAR INJECTION GIVEN INTO LEFT THIGH. PATIENT WAS TALKING AND ABLE TO DRINK WATER WHEN PARAMEDICS ARRIVED. HE DIDN'T REALIZE THAT HE HAD "PASSED OUT"... AS PARAMEDICS WERE LIFTING PATIENT TO GURNEY, PATIENT LOST CONSCIOUSNESS AGAIN... WHEN HE CAME TO, HE DID NOT KNOW WHERE HE WAS.

I have had muscle twitches on various portions of my upper right side (hand, arm, pec, abdomen) for the past three months daily.

Sunday morning (2 days after vaccine) slight pain on right palm led to discovery of swollen palm (one-third of the palm). Swelling has persisted until date of reporting. Contacted Moderna who took down information and issued a case number. Moderna stated someone from their company may or may not contact me. Indefinite as to the resolution.

Pt called call center on 5/7/21.pt states pt got 2nd covid vaccine Moderna 5/6/2021 (unknown site) and pt got rash with burning sensation on stomach and pt feels very tired and sleepy and body aches. Pt said he felt hot last night @11pm but pt didn't check his temperature. Pt is taking Aspirin for symptoms now. Noted pt also has ili symptoms:cough at this day. Pt was advised to go to ED for further evaluation

25 April - body aches and chills, no fever, these symptoms lasted for about 36 hours followed by general soreness throughout my entire body; 1 May - I woke up in the morning and was unable to urinate, I went to the ER and was given a catheter and sent home, I kept the catheter in place until Friday, 7 May when a urologist at hospital removed the catheter. I was able to urinate over the weekend but the symptoms returned 10 May. I returned to the urology clinic at hospital and I was given another catheter with instructions to follow up and conduct a hydroanalysis study with the urology clinic; Tuesday 11 May - I woke up with numbness and tingling in my hands, abdomen, and feet and pain throughout my entire body, scratching my chest made a burning sensation. I went to the ER and was admitted to the Neurology department at the same hospital. I stayed there for three nights and started to improve after receiving three daily doses of steroids, two days of IV steroids (1gram each), and one day of oral steroids (1 gram). I was discharged on Friday, 14 May and still had significant pain throughout my body and numbness and tingling in my feet, hands, and torso. I began to improve around 18 May with pain fading and numbness and tingling decreasing. As of 2 June, I still have some numbness and tingling in my hands, feet, and abdomen. It seems to slowly improve but not as quickly as it was in the aftermath of the high-dose steroids.

Patient was sent out to the hospital on Wednesday night (June 2) due to a decrease in oxygen saturation levels. He was admitted into the ER with a diagnosis for recurrent seizures. Patient has a history of seizures, but a facility worker mentioned that the seizures did not look like the ones he would have.

Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: PT REPORTS SHOULDER ACHE THROUGHOUT ENTIRE SHOULDER ARE SINCE 2 DAYS AFTER 1ST SHOT & PAIN & NUMBNESS DOWN ARM AS WELL

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

I received the first shot on 04/20/2021 Moderna 047B21A in the left arm around 04/23/2021 I had serve side effects. So much like the flu, I was very tired, nausea, fatigue, In my upper left chest the "vein" or "arteria" was in pain ( sending shocker's like electrodes ) it almost felt like having a stroke or heart attack ( never experienced one before though ) didn't want to move do anything I didn't continue working at restaurant hired part time there as a prep-cook. I didn't even show up. The second shot Moderna 024C21A I received 05/18/2021 it had the same effect and I also had the "veins" and "arteries" on my right arm and right leg calve same effect shockers and electrodes like I was having a heart attack.

Pain in leg presented several weeks after second shot. Symptom was dismissed until loss of consciousness/fainting occurred. Onlookers called 911 and after being transported to hospital CT scan revealed bilateral pulmonary embolisms and DVT blood clots were present. D-dimer blood test revealed a range 400 times the appropriate range. Number exceeded the scale. The number of clots on imaging were so numerous, the doctor that read the report said they would not even count them. Was treated on heparin IV and placed in cardiac ICU, prescribed Eliquis to thin blood allowing the body to not create additional clots. In process of establishing a medical team to treat.

Developed rough rash 2-3 days after vaccine, had arm soreness. Still has darkened skin underneath vaccine injection site. Denies other symptoms

The day folowing my first dose of the Moderna Vaccine, I began suffering from pretty severe Left Shoulder pain. I assumed that this was a normal side effect for the first day or two. Unfortunately, while the pain has subsided from what it was in the begining, I continue to have ongoing pain in my Left Shoulder. It makes sleeping on my left side difficult, and I have lost a significant amount of strength in that shoulder. Before the vaccine, I could easily do (10 - 12) push-ups without stopping. Now I can only do 1-2 becasue of the pain and weakness. I reported this condition to the pharmacy Location before receiving my second dose on June 1, 2021. The lady giving me the shot said that what I was experiencing was not common, and that she would report my symptoms and someone would be contacting me. As of 6/28/21, I have not heard from anyone, and the pain persists.

Oval , peanut size ball on left arm. Fever, headache , body ache , and weakness, and constipated . Had to get surgery to remove the oval ball from arm .

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

Swelling at injection site and extremely hot to touch and formed a hard mass for over one week and started within an hour of injection. 24 hours later, fatigue, fever, shakes, headache and aches set in. The second night all the previous mentioned symptoms continued but at an elevated state. This integrity lasted for three days. One week post injection, still suffering headaches, nausea, fatigue, shortness of breath, aches and sweats. Two weeks post injection, still suffering from previously mentioned symptoms.

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

Numbness in extremities. Primarily in legs and fee. Also rapid heart rate. Lasted for a few weeks. Some periodic numbness still

Patient had Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Patient had Bell's Palsy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. 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) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced BELL'S PALSY (Patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient had Bell's Palsy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was on oral medications to relieve the symptoms. She denied to provide the name of drug. Company Comment : Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.

Patient began experiencing extreme fatigue, increased frequency of urination, numbness and tingling in fingers and toes. He went to a nearby Urgent Care. Labs were drawn on 5/29/2021. When patient returned to that clinic for follow-up on 6/16/2021, he was given his results of glucose level of 300 and hemoglobin A1c of 12.0%. He was started on metformin 500mg twice a day. He was also started on empagliflozin 10mg daily and dose was tapered up to 25mg daily two weeks later. Patient had repeat labs done at our facility on 6/30/2021: glucose 94, A1c 10.2%. Patient purchased a diabetes monitor. His glucose levels from 6/30 to 7/13/2021 showed his average daily glucose was now only 89 and patient had 10 episodes of low glucose (<70). His highest glucose level was 147 and he did not have any levels above 180. Patient was taken of empagliflozin, kept only on metformin, and will be followed up in 2 weeks. Prior to vaccination, patient had no hospitalizations, illnesses, or any steroid treatments. He is a very healthy, patient with a BMI of 26 who works out 6 days per week.

After the first dose heart palpitations worsened, muscle pain, fatigue, chest pain (sharp pains), shortness of breath, pain and numbness in legs.

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

?Moderna COVID-19 Vaccine EUA Headache, fatigue, chills, weakness, dizziness, fever and R shoulder soreness. Last for about 18 hrs. soreness lasted 3 days

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

Had manageable bodyaches but following day triggered his Migraine headaches which is what patient came in for primarily. Symptoms managed with fluids, tylenol, reglan with improvement and was subsequently discharged from the ED.

Hospital on 1/2 - then again on 1/5, transferred and admitted to hospital, discharged 1/6 Abnormal reflex/weakness back pain paresthesia and weakness of legs abdominal pain evaluation for possible GBS post covid 19 vaccine

Fever, chills, body aches, pain on site, bruise on site after 2nd day. slight dizziness , flushing and increased Heart rhythm on day log administration for about a minute and resolved. Have been having mild to moderate pain on right kidney area.

1/6/21 Vaccine. 1/7/21 fever, severe migraine, aches everywhere, chills, vomiting, sore throat, tightness in chest

Foot pain. Bottom of the feet were painful to touch and walking became very painful for 2 days. Reaction occurred on 3rd day after receiving vaccination. Pain has subsided but took 2 days to stop.

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

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

Was perfectly normal until I laid down for bed. Got very dizzy and took blood pressure with a cuff and it reported 95/47. Hypotension, shakiness and mild nausea. I've never had this symptom in my life and have taken 3mg melatonin before bed for years. (3mg, not 4mg as reported on the previous page). I was back to normal after ~10 minutes and woke up perfectly normal. Also, minor shoulder pain.

chills that night and slight headache, then next morning had two occurrences of hot flashes and headache till 12 noon

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

"Tingly feeling all over, feels like pins and needles all through my body" within 5 minutes of receiving vaccine. Staff member with constant observation, no further adverse event. Approximately 15 minutes post vaccine, symptoms were gone. Staff member observed for full 30 minutes.

reports development of right arm redness and swellling related to covid vaccine administration. On 1/16/21, he reports having fatigue and body aches. On 1/17/21, he reported right arm redness, swelling, and warmth which increased throughout the day. He took 800 mg of Ibuprofen and ultimately sought care at a local emergency department, and was prescribed two oral antibiotics. stated the emergency room provider diagnosed the condition as cellulitis and informed patient the condition is a known side effect of vaccines. As of this writing, patient reports a decrease in redness/tenderness and no pain.

For Moderna COVID-19 Vaccine: the second shot led to significant issues at the 24 hour mark (post injection period). Symptoms were: full body aches, recurring chills with very cold extremities, extensive hyperalgesia, shooting pain from neck down to feet, and high fever of 102F. Symptoms lasted for a total of 12 hours.

The site was red the first couple of days then went away. Arm was a little sore like normal from getting any other injection. Yesterday evening the site was itching and then today it is bright red at the injection site and the size of the red spot is about 2 to 3 inches big. It is warm to the touch.

Moderna - left sided severe neck pain starting 1/8/2021 developing into shingles pustules appearing on left temporal and occiptal scalp progressing to left anterior neck. Started on Valtrex 1g 3x/day plus oral prednisone 20 mg bid for 5 days. Currently still have scalp tingling/pain.

Severe Headache within 1 hour of vaccination (01/20/21 @1330hours), followed by a slight fever within 6 hours and fatigue. Overnight, I experienced severe chills and body aches, and severe fatigue, which followed the rest of the morning (01/21/21) with general discomfort. By that early afternoon the chills subsided, and I continued to feel body aches with minimal joint pain. By 4 pm, I began to develop an itchy rash on my left wrist under my wristwatch, left hand and on my right forearm. I experience fatigue throughout the rest of the day. I used over the counter Benadryl Extra Strength Itch Stopping Cream to alleviate the itch. On the Morning of 01/22/23, I woke up to a itchy rash over my torso and my hands. I continued to apply the cream and I took an OTC Benadryl allergy pill, which seems to subside the rash. On 01/23/21, I woke up the the same rash over my feet and overall, the rash over my torso and hands had substantially subsided.

Feeling of numbness in left hand. Vital signs normal. Equal hand grip and strength. Normal capillary refill and range of motion. Symptoms resolved with time.

5 minutes after receiving vaccine I started feeling ?heavy ?. This progressed until I was diagnosed with Covid pneumonia and hospitalized on 1/17/21. I must have had asymptomatic case of Covid that was escalated by vaccine.

Myalgia, Fever, fatigue, facial flushing Narrative: Facial flushing, fatigue, myalgia, fever to 100.9, arm soreness; resolved in 48 hours.

pt had brief palpations 20 minutes after vaccine, pain in left arm spreading across the chest to right side 5 hrs later. Felt like someone had punched him repeatedly in the chest the next day and that night he was profoundly fatigued and couldn't take a deep breath, was winded with simple physical tasks ie walking across the room. The next day 1/24/21 the pain resolved but was easily winded. Improving since then

Immediate soreness at site of injection. Throughout the day soreness continued and increased making lifting of the arm painful and restricting movement. Felt fatigued the next day after vaccination and ?out of it?.

severe arm pain limiting range of motion, diffuse joint pain, chills, flushing, severe headache. last for 12 hours until 800 mg ibuprofen taken.

Employee complained of feeling hot flashes, sudden body chill and numbness tingling sensation to his arm where the injection was given. Blood pressure was elevated and employee says he has hypertension but its not usually that high. Employee takes Lisinopril.

Five minutes after COVID-19 Moderna injection I started to feel chest pains, tingling/numbness on my left hand (injection site limp) my blood pressure was higher than my normal range, pulse ox was 93%. I was observed in ED for over an hour. After wards at approximately 11:AM on Feb 1st 2021 I broke in fever 104.1, chills, severe joint pain relieved only with high dose Advil 800mg around the clock. Unable to get up from bed due to weakness. I was given a doctors note to be off work for 4-days.

At 15 minutes I felt flushed and a tightness in my throat. I was moved to private observation with nurse for an additional 30 minutes. After the additional 30 minutes, I started feeling better. I was released to go home.

It began with sudden fatigue around 5:15. By the evening I felt ?high? for lack of a better word. I was feeling odd. I woke up in the middle of the night with a fever, major chills, and a strong headache. I spent all of today dealing with what feels like the flu and that I was punched in my arm all the way to the bone. I think it is getting a little better but right now I?m lying in bed in the dark with a winter coat.

Pain and weakness in the left shoulder and arm. Onset was 1 week almost to the hour from injection of Moderna Covid vaccine. Symptoms still unresolved.

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

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

I received the dose on Friday 1/29. About 45 minutes after the left side of my face felt numb. Over the weekend I then thought I was developing acne (which is strange because I don't get acne). By Monday it was getting terrible on the left side of my face and by bedtime I thought it was shingles. I went to my general practitioner on Tuesday 2/2 and was diagnosed with shingles and prescribed Famciclovir 500 mg 3 x daily for 7 days.

Feb 2nd, experienced mild headache and hot flashes 10 hours after vaccination. On Feb 6, had chills, headache, and fever of 100.5. Went away without medication after about 6 hours.

Patient arrived to ED via ambulance Patient is a 44-year-old male who presents to the emergency department for evaluation of an allergic reaction. Patient reports that he is in EMS paramedic and that he had received his second dose of the COVID-19 Materna vaccine today at approximately 10 AM. Since noon he noticed that he felt his ears tingling and that his skin became beet red and he broke out in hives. He has a history of recurrent allergic reactions and anaphylaxis. He went back to his EMS facility. He noted that it was starting to get worse and so he was given IV with Benadryl and a dose of epinephrine and transported to the emergency department. He still complains of itchiness and redness to his skin but says he feels better. He denied having any tongue swelling or lip swelling or shortness of breath or wheezing or abdominal pain or diarrhea. In the ED he also received dexamethasone 10mg IV and 1L IV 0.9% sodium chloride

Severe headache, high fever(104.5), chills, body aches, joint and muscle pain. Onset of symptoms did not occur immediately. Mild (typical) post vaccination pain at injection site about 8 ot 9 hours after administration. Went to sleep without any systemic symptoms and woke up about 12 hours after administration with fever and chills. Temp approximately 101.5 at this point and chills body aches were moderate. Then woke up another 4 hrs later with severe headache, chills, weakness, joint and muscle pain and high fever(104.5). Symptoms have all begun to gradually improve, but still febrile with all other symptoms not being moderate and not severe, 26 hrs post vaccine administration.

Patient presents w/ PMHx of GERD presented to pain clinic by referral from primary care with new, sudden onset 8/10 sharp pain and tingling in lower extremities bilaterally terminating rostrally at the level of the coccyx. These symptoms began 3 days after receiving the first Moderna COVID-19 vaccine of the two-part series. The pain is refractory to acetaminophen and three sessions of physical therapy. The pain and numbness make it difficult for the patient to fall asleep. The b/l leg pain was so disturbing that the patient presented to the ED where she was noted to be ?slightly ataxic? and was treated by the ER physician for lumbar radiculopathy with one Norco that did not help.

Delayed reaction to the shot 8 days after. Soreness in arm hot, itchy , swollen and painful. 3 days later pain had stopped but right arm out swollen.

Headache, fever, muscle aches 12 hours after dose. Symptoms gone 12 hours later. 2 days later I woke up with numbness to my abdomen and upper quads. Day 3 the numbness was noticed throughout my body but worst in midsection, followed by legs. Muscle weakness started with spasms on occasion.

severe migraine, panic attack, sweats, chills, nausea, ocular aura most side effects lasted about 14 hours, completely miserable.

Low body temp on 2/20 followed by elevated temp on 2/21. Normal temp by 2/22. Soreness and lump at injection site evening of 2/22, with local burning pain. Left arm muscle soreness on 2/23 with red skin patch approx 3cm x 6cm at injection site.

Couldn't feel arm; Couldn't feel arm and had no range in motion; Pain in upper shoulder area by his neck; Thinks the administration was done incorrectly; Aching in legs as if he was getting sick; Aching in legs as if he was getting sick; Pain in upper shoulder area by his neck; A spontaneous report was received from a nurse concerning her son, who was a 44-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced couldn't feel arm and had no range in motion (hypoaesthesia, joint range of motion decreased), pain in upper shoulder area by the neck (arthralgia, neck pain), thinks administration was done incorrectly (product administration error), and aching in legs as if was getting sick (arthralgia, malaise). The patient's medical history was not provided. Concomitant medication included escitalopram. On 04 Feb 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030L20A) in the left arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, a couple of hours after the vaccination, the patient couldn't feel his arm and he had no range in motion. He also had pain in his upper shoulder area by his neck. The reporter thought the administration was done incorrectly but she "wasn't there to conform 100%." At night on 04 Feb 2021 and 05 Feb 2021, the patient had aching in his legs "as if he was getting sick." Treatment for the events included ibuprofen which helped, and the patient was feeling better at the time of this report. Action taken with mRNA-1273 in response to the events was not reported. The events, couldn't feel arm and had no range in motion, pain in upper shoulder area by the neck, and aching in legs as if was getting sick, were considered recovering/resolving at the time of this report. The event, thinks administration was done incorrectly, was considered recovered/resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 44-year-old male who experienced NS unexpected events of hypoaesthesia, joint range of motion decreased, arthralgia, neck pain, product administration error, malaise, and NS expected arthralgia. The events occurred 1 day after the first dose of mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-012275: US-MODERNATX, INC.-MOD-2021-012263:

Significant arm soreness for 4 days, fever of 102.2 for 24 hours, body aches/joint pain for 24 hours, severe headache for 24 hours, lingering headache for 5 days, nausea 12 hours, fatigue for three days. Have taken multiple doses of Tylenol 1000mg approximately every 8-10 hours for 5 days, ibuprofen 800mg every 8 hours for 1 day. All symptoms resolved after 5 days.

I have been experiencing some tingling on the left side of my face since receiving the first COVID-19 vaccination dose. It flare after receiving the second COVID-19 vaccination dose. The level of tingling varies throughout the day. It has not resulted in noticeable paralysis.

5 min after vaccination, patient complained of increase in heart rate to 133 BPM and feeling like his arm was tingling and numb. We propped his feet up and gave supportive care such as blanket and ice packs. Patients heart rate went back to normal (75-80 bpm) after 10 minutes. However, 35 minutes post vaccination, pt started having chills and shakes. Gave blanket and monitored patient for 45 min after vaccination. Pt declined 911. Wife took patient home 50 min past vaccination stating she felt he was stable and they would monitor at home.

5 days after injection I noticed a hive on my stomach. The hives spread to additional areas of body over the next 24 hours including the face, scalp, neck, arms, back, and additional hives on chest. This morning the majority are focused on my head and face area. I've double checked everything and haven't eaten or been in contact with anything out of the ordinary. Also want to point out I had Covid in October 2020. Also, I had a very sore arms for 2 days after shot along with exhaustion the 2nd day and a fever/chills (103 degrees) on my second night after injection.

Five minutes after injection heart rate began increasing and felt like it was racing. Left arm started feeling numb and tingling, then overall felt weak and dizzy. Got flushed/red in the face. Remained seated and propped up feet, applied ice packs. Heart rate was elevated again at 30 minutes after injection. Developed chills/shaking. Remained at pharmacy under observation another 30 minutes. Symptoms mainly resolved and felt generally better over the course of 2-3 hours.

Pt states that approximately 4 days after vaccine his 4th and 5th finger on the side that his vaccine was given started feeling numb, no rash or pain associated with it. States it comes and goes and is slightly better now.

Patient states began having "racing heartbeat, feeling of anxiety, sweating from scalp, cold feet, temperature of 100.1" at 4:30pm on 3/10/21, patient states took Ibuprofen 800mg and began to feel better. Patient states on 3/11/21 at about 4:30pm began having "racing heartbeat, feelings of anxiety" again, denies having temperature at that time, patient states "went away on its own", did not take medication. Patient states had "rapid heartbeat and feeling anxious" at 5am, no fever, no medication taken.

numbness/tingling in left arm after 1 hour, then similar feeling in right arm; then pressure in head after a 2 hours; seizure after 3 hours; I have not had a seizure for 6 years after being treated for it with Keppra starting in 2015

Sudden onset of severe dizziness (causing nausea), balance/standing/ walking issues. Complete weakness. Total loss of color/hue in complexion. Difficulty communicating. Feeling of things shutting down or not continuing to ?work.? Got to bed and passed out for over 10 hours. Woke up feeling mostly better.

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

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

Bells palsy; Soreness; Neck pain; A spontaneous report was received from a consumer concerning a 44-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness/ pain, bells palsy/ facial paralysis and neck pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced soreness, bells palsy , and neck pain. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, soreness, bells palsy, and neck pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Diarrhea about 9 times a couple of hours after I got home til midnight...36 hours later woke up with fever and sweaty at 2 a.m. but felt better by 10 am. Sore arm for 3 days.

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

12 hrs post vaccination on 3/17/21-Pt c/o onset of chest and arm pains, numbness to left arm, sever fatigue and headache. Went to the Hospital. Remained in ER for 10 hrs before released. Dx-cardio-vessel spasms. c/o continued migraines every 3 hrs for 10 days. Presented to ER again on 3/23/21 for the migraines.

Diagnosed with cellulitis; Diagnosed with sepsis; Temperature 102 degrees F/104 degrees F; Chills/Shivering; Discomfort; Difficulty breathing; Felt cold; Not feeling good; In a lot of pain; A spontaneous report was received from a pharmacist concerning a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnoea/difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 11 Mar 2021, the patient consulted wound care for his foot and was told to be fine. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their dose of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection. On 13 Mar 2021, within eight to ten minutes, after vaccination patient felt cold .The patient's temperature was noted to be 102 degree Fahrenheit. Also, patient reported a lot of pain and discomfort. Patient also complained about chills, cold and shivering and he was given an orange juice and blanket after five to ten minutes by the pharmacist. Pharmacist called patients wife and by that time patient developed breathing difficulty. Patient's temperature was raised to 104-degree Fahrenheit by that time and was taken by the emergency medical service to the hospital. The patient was hospitalised. On 16 Mar 2021, after 2 days, patients wife reported to pharmacist that the patient was diagnosed with sepsis and cellulitis and was given two antibiotics. The events sepsis and cellulitis were considered as serious (medically significant). The patient's wife reported that the patient was about to have an amputation in this past weekend. Treatment for the event included two unknown antibiotics. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnea /difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills were considered to be 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.

On day one after vaccine continuing for two days severe arm pain radiating from neck to fingertips with twitching in fingertips. Day 3 severe migraine for 14 hours, fever of 102, chills and body aches, sinus pain, minor cough, major fatigue. Day 4 migraine, sinus pain, fatigue Day 14 injection site swelling, itching, welt. Frequently since vaccine minor headaches, sinus pain.

Pt felt warm, hot , and dizzy 2 days after vaccine. This resolved spontaneously. He was given a dose of benadryl 25mg prophylactically.

Systemic: Fainting / Unresponsive-Mild, Additional Details: After awakening patient said he felt like he couldn't breathe but was. EMS came to take him to the hospital. His parents who were with him said he does have anxiety around needles and may have a hystory of fainting with shots.

Extreme fatigue and muscle cramps in legs, back and neck. Loss of appetite for 48 hours. Mild fever. Swelling and rash at injection site.

Patient complained of night sweats, crazy dreams with persistent palpitations, sweating when awaken from bad dreams from vaccine administration through 4/2/21 at doctor's appointment

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

ITCHING ON THE LOWER STOMACH AND HIP, FOLLWED BY COLD SWEATS AND FEVER FOR SEVERAL HOURS. BAD HEADCAHE AND EVEN SHORTNESS OF BREATH AND A COUGH. ALL SYMPTOMS WERE GANE AFTER 24 HOURS

Pain and burning both arms for last 8 hours. Fatigue and muscle pain. Pain at injection. Tachycardia

High grade fever that lasted for 32 hours total and peaked at 103.5. Severe cold chills that led to involuntary convulsions. Body aches that last for three days. Extreme fatigue.

Last night (04/10/2021) at around 8:30, I began having a dry cough, which I have now at 8:45 am on 04/11/2021. I also had a small fever last night, with my temperature up to 100 degrees F. I feel pretty weak.

Symptoms described as Covid arm. Woke up in excruciating pain that only subsided if in warm compress or tub. High intensity dull pain starting from shoulder through wrist. Pain epicenter seems to be slowly moving down arm from shoulder to wrist.

Soreness in arm. Leg pain. Legs hurt to touch. Sore joints. Sore knees. Chills. Inflammation. Red face.

Patient felt dizzyness, cold sweats, nausea, and paleness post vaccination while awaiting the 15 minute monitoring period. Pharmacy staff stayed with patient while ambulance arrived and took patients vitals. All was normal and patient began to feel better 10 minutes later. Patient went home. Followed up with patient later in the day and patient feeling much better/no pain in arm/no redness/etc.

Delayed (over 2 weeks after shot) arm pain. Low grade fever (between 99F and 100F). Fatigue, exhaustion. Runny nose.

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

Lost consciousness, Either a siesure or passed out. Cadiac events - Varied and Rapid Heart rate, Low Potassium and Low Magnesium

This is a 44 Years old male c/o right sided facial weakness for 3 days. Patient states facial weakness started 3 days ago. He complains of difficulty raising his right eye brow and closing his right eye completely. No changes in taste sensation or vision, no ear pain, no weakness in both arms or legs. He did not get sick recently prior to his facial weakness. He has no problem walking or his gait. He denies nausea, vomiting, or headache. Denies chest pain, palpitations, shortness of breath or dizziness. He was COVID-19 positive on 1/16/21 and received his first dose on 4/3/21. PMH: No chornic medication condition No hx surgery General: alert & orientedx3, no acute distress, cooperative, speech clear anbd coherent Neuro: cranial nerves intact EXCEPT CN VII mild right sided facial weakness w/ difficulty raising right eye brow and incomplete closure of right eye, positive numbness on CN VII V1-V3 Gait: normal tandem gait, negative Romberg Strength: 5/5 strength of both upper extremities, 5/5 strength of both lower extremities, no atrophy Sensation: intact to light touch both upper extremities, intact to light touch both lower extremities Cerebellar: no ataxia Reflexes: 2+ B patellar Head: normocephalic, without obvious abnormality, atraumatic Eyes: PERRLA, EOMI Ears: TM intact w/ grayish in color, no bulging, redness or discharge Nose: inferior turbinates pink and moist Throat: lips, mucosa, and tongue normal; teeth and gums normal Neck: no adenopathy and thyroid not enlarged, symmetric, no tenderness/mass/nodules Lungs:clear to auscultation bilaterally, no rales/rhonchi/wheezes, good air movement Heart: regular rate, regular rhythm, no murmur, normal S1/S2 Extremities: extremities normal, atraumatic, no cyanosis or edema Assessment/Plan 1. Bell palsy, Bell palsy -CN VII facial weakness/numbness sudden onset, difficulty closing right eye c/w Bell's palsy -PO Steroid and acyclovir for 7 days plus eye lubricant for 14 days -F/U PCP in 5 days -Consider ophthalmologist if no improvement with eye closure or facial motor

about 14 minutes after injection, patient stated he didn't feel well, then pitched forward and landed on face (was wearing glasses). Was unresponsive with possible seizure like activity. Neck was supported, patient became responsive again and alert. When tried to sit up again, became unresponsive again. Taken to ED. CT of head, face and c-spine done - all negative. CXR done - no acute disease seen. Given fluids and monitored for several hours in ED.

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

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

Pt called Call center 4/23/2021 regarding of covid vaccine side effect. Noted c/o dizziness, abdominal cramping and fever(pt didn't check temperature, but pt feels cold sweats and lots of chills) today. Pt got 2nd covid vaccine(Moderna) 4/22/2021. Pt said she felt fine yesterday however from this morning pt feels dizziness as long as pt has to lay down, abdominal cramping, fever, lump at left arm injection site. Pt is taking ibuprofen. Noted hx of anxiety, insomnia, depression per pt and no allergies. Informed pt to go to ED or call 911 d/t pt shows 3 parts of emergency side effects of covid vaccine. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED. Pt is educated of covid side effects. Pt verbalized understanding.

Patient reports back pain chronically, but worsened on the left side and felt "inflamed" for 24 hours. Patient also reported hand shakiness and was unable to write for 24 hours. Patient reports he had balance issues.

After the vaccination, the patient was asked to wait at the Waiting Area for at least a few minutes. He was with his father that time and they were seated at the Waiting Area. After a few minutes, the father saw the patient looking somewhat pale and he asked if he is doing okay and he seemed to become unconscious for a brief moment then he started shaking for a few seconds. While this happened, pharmacy called 911 and attended to the patient. His color came back after maybe 5 to 10 minutes, but still had sweats on his forehead. His palms were warm the whole time, no clamminess. 911 came and they attended to the patient and took him.

Found on floor in office at approx 0900. Was responsive and assisted to chair, minimally responsive. SM did not appear to have fallen, but to have laid down on purpose while feeling weak. Paramedics were notified and arrived at approx 0950. He complained of dizziness and tingling hands. CBG was checked on arrival and pt's blood glucose was 40, then 30 and 29 on rechecks. Was given sugary snack/drinks and iv fluids. Medics reported weak pulse and low BP. After initial treatment, pt was able to stand with minimal assist and transfer to stretcher for transport to ER at Hospital. Upon arrival to hospital CBG was still under 50, but was alert and conversational. However hand tingling

Both vaccines resulted in the same symptoms, which began about 12 hours after administration. It started with a migraine and then extreme cold chills, fever near 103, and nausea, which caused vomiting. In both cases, the vomiting was only during the fist night. In both cases the fever lasted about two days, on and off.

Bell's Palsy. Developed right-side facial paralysis 4/30/21 12:00PM involving forehead, eye and mouth. Evaluated in ED 4/30/21 6:00PM. Diagnosed with Bell's palsy based on physical examination and imaging. Discharged to home 4/30/21 9:00PM. Prescribed 60mg prednisone q.d. x 5 days; 1g valcyclovir t.i.d. x 7 days. Follow-up with primary care.

Consistently, Weak/exhausted/no appetite/constipated since 1 hour from shot on 4/27. Fever/Headache coming and going mostly in the 5 days following shot, better in the last few days. Headaches severe 3-4 days after shot.

Increasing headache and nausea through morning Chills and right shoulder & arm soreness beginning in afternoon 102 F fever in evening Right shoulder pain that night Symptoms subsiding through morning Still have headache, nausea, and right shoulder soreness

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

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

Moderna COVID-19 Vaccine EUA Woke up May 12 7 AM with chills, fatigue, full body aches including strong headache. Symptoms eased with migraine medication (2 tablets, each with 250mg acetaminophen, 250mg aspirin, 65mg caffeine). Symptoms came back 2-3 PM. Took just aspirin (3 tablets, each with 325mg aspirin), and symptoms got better after dinner at 5:30.

He says he got his second COVID shot (Moderna) on Saturday and says his lymph nodes in his neck and armpits got swollen and sore which was similar to when he once got bit by a black widow. His energy has been low, and he has been feeling dizzy with a fever on Sunday and Monday. He has not been able to go back to work since the shot. He says that on Sunday he wasn't able to get out of bed. He got the shot because his mother's nursing home required it in order for him to see his mother.

headaches and muscle aches and pain in my joints bell palsy symptoms fatigue nausea throat inflamation

Patient experienced facial flushing with a rash; immediately given 25mg of liquid siladryl and sent to ER for observation. Later released to home where he is extremely tired. He feels like he has been lifting and moving things all day. Muscle aches. No report of temperature.

Around 10am I was feeling a bit hungry and my stomach seemed 'sore'. I air fried some chicken for myself, but still felt hungry. I was feeling rather irritable, and an hour or two later I was violently vomiting. I tried to drink some water shortly after, and that did not help. My stomach was still rather upset and I vomited again an hour later. I laid down on the couch the rest of the day with my stomach feeling rather upset in way I've not really experienced before. I was able to sleep for a few hours and I was able to drink small amounts of water by midnight. I felt a bit cold but I don't remember anyone saying I had a fever. I was irritable, deep breaths kinda hurt, and I was a tad dizzy most of the day. I was able to eat and drink the next morning, but my abdomen was sore. It still is a bit sore, but I feel almost 100%.

Similar to a pinched nerve, but I don't recall doing anything that would "pinch" a nerve. The day after the second dose of moderna, my left arm ached at night. It has continued to fell numb, tingly, and achy, most predominant when I lie down. It has been steady pain for a week and 1/2 now. Worst pain occurs in the evening when lying flat on back. Can not lay on either side when in bed, has to be on back.

Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Patient fainted while seated after receiving vaccine. Fell on floor and hit head. Potential seizure may have occurred, patient mouth observed to be slouched and words slurred afterward. 911 called and full assessment performed by EMT.

high amount or arm throbbing and alot of hand / fingering numbness. this has taken place after both injections

Fever with distinct bone pain. A year earlier (Jan 2020) I was a bone marrow donor that required a heavy course of Filgrastim in preparation for the donation. As expected, the Filgrastim made me feel sick with a lot of bone soreness and pain, especially in my hips and legs. It lasted a few days after the donation and then was gone. Upon getting my second shot of the Moderna vaccine, the second day brought back the exactly soreness/pain that I felt under the filgrastim with distinct bone pain, especially in my legs/hips.

Could not control movements from waist up. Having spasms of muscles from waist to head. Could move legs and feet purposely. No seizure activity. BP 116/70, HR 72 Reg, R 18 Skin cold and clammy. Laid him down, elevated feet, covered with blankets. Unable to obtain O2 sat with pulse oximeter. He could not communicate orally. Only by blinking. Event started at 2:30 am about 13 hours after vaccine. Symptoms slowly resolved over 2 hours until he was able to rest. Administered ( 2) 325 mg Tylenol at 4:30 am. Able to communicate orally, squeeze both hands, awake, alert and oriented. All symptoms subsided. O2 sat 99. Next day only extremely sore muscles from waist up

had pain in left arm at injection site, but expected that. got sick after second dose (which is strange as I got really sick after the first one), that went away after roughly 36 hrs, however the injection site pain had radiated down the left arm. still, just assumed it'd go away, no worries. woke up the second day after shot, with feeling as if id maybe slept funny, as my shoulder on the left arm had a shooting pain thru to my arm, which was numb and tingly, and my hand felt like it was asleep...total pins and needles. shook it, didnt go away. mind you, I'm not a guy who thinks he's sick all the time, and is constantly at the doctor. I actually don't have a doctor, nor insurance, but I just usually ride whatever out..but this was becoming more than an annoyance. now its been three weeks or so, and the symptoms have just gotten worse. I'd say I've lost about 90% of the strength in my left hand. I can't make a fist, hold objects, pull up my pants, pick my nose, play my guitar, etc..my hand is never not buzzing with pins and needles, in a semi-claw shape, and its losing circulation as its noticeably purplish. yesterday, I called the urgent care that I use as a doctor if absolutely necessary, as I felt I had to do something. I asked if I could come down, described my symptoms, and they said all they'd do is tell me to go to the ER as it sounded not good..now numbness is going down my left leg and foot is swelling.

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

Seizure; Condition aggravated; This case was received via FDA VAERS (Reference number: 1036286) on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included seizure. On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SEIZURE (Seizure) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no known allergies has been reported. the concomitant medications not reported . the patient has the medical history of seizures. Company Comment: Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

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

He got his vaccine, the only thing that really hurt was that it felt like somebody shot him in the arm which lasted for a week. Then on Sunday he has had what he thought was a heat rash, and went and did laundry and when they dropped him off he has realized that he has a rash that has multiple little spots on his arms and legs, and they fester like a heat rash, and feels like somebody is pinching his skin with plyers. On his chest/torso he has the rash that is sensitive to the point that it bothers something rubbing against it. When they fester up he squeezes them to get rid of the pain and it's painful. He also has a dry skin rash on his right butt cheek, which also started when this started as well. He has not taken anything for this reaction. He called the pharmacist and they told him to call us and report it. The area of the shot looks like a state map shape rash area on his shoulder.

A fast heartbeat Dizziness and weakness Injection site pain Tiredness Helada che Muscle pain Chilla Joint pain Náusea Feeling unwell SEOLLEIM lymph nodes

The day after getting the vaccine he began to feel like he had the flu. He progressed each day to become weak and dyspneic. He became hypoxic with a pulse ox of 80%.

ON FRIDAY, 30 APRIL 2021, ABOUT TWO WEEKS AFTER GETTING THE FIRST COVID VACCINATION, I NOTICED A NUMBER OF SMALL PATCHES OF ECZEMA FLARING UP ON MY ANKLES, ELBOWS, AND HANDS. ON MONDAY, 3 MAY 2021, I VISITED MY GENERAL PRACTITIONER ABOUT THE ISSUES WITH MY SKIN AND HE WONDERED IF I HAD STEPPED IN POISON IVY OR POISON OAK. I EXPLAINED TO HIM THAT I HAD NOT BEEN HIKING AND THAT WE DO NOT HAVE POISON IVY OR POISON OAK IN OUR YARD. HE PRESCRIBED A .5 PERCENT CLOBETASOL STEROID CREAM. THE VISIT TOOK TWENTY MINUTES AND I WAS CHARGED $98.95. ON FRIDAY, 14 MAY 2021, AT 3:00 PM, I RECEIVED THE SECOND COVID VACCINATION. BY 9:00 PM, I NOTICED TINGLING AND NERVE PAIN ON MY HANDS...

1) Initially -30 mins after vaccine administered - "Electrical-like" tingling started in chest and face. then cascaded throughout entire body. 2) Following - Hives and rashes would appear randomly on neck, chest, inner thigh, inner forearm, and feet/ankles. Occurred nightly for about 2 weeks and was resolved by Benadryl, followed by having them every other night or so for several weeks. Reactions gradually reduced in frequency after about 6 weeks. 3) Currently, very infrequently, will experience random tingling/itchiness in different spots of body. Benadryl/Zyrtec will resolve.

Immediately felt abnormal. Later, left hip pain, feeling bad, sleeplessness, headache all night (severe), feeling hot and cold, difficulty walking, chills, shaking, hot flashes, painful left arm, teeth chattering, fatigue