Moderna

Presented as a pulled muscle in the left chest/lung area. No SOB, just pain and tightness in the chest. Began after the second vaccine and occurred on and off for about 2-3 weeks.

patient was not yet 18 years old. he will be 18 when his 2nd dose is indicated. no issues to report other than sore arm and back.

MEDICATION ADMINISTERED AS AN "OFF-LABEL" USE DUE TO PATIENT AGE. PATIENT ONLY EXPERIENCED MUSCLE SORENESS IN INJECTION ARM.

High fever of 102.5 that couldn't go down with ibuprofen or acetaminophen, achy joints, lethargic, loss of taste and smell.

Patient said he got dizzy within minutes of receiving vaccine and that resolved by 10 minutes after vaccine. Around 10 minutes after vaccine patient said both his arms felt heavy and numb but he was able to move them and his fingers. Patient had no other symptoms and walked out of pharmacy with his mother.

At the injection site a big blister ended up forming and is quite painful to the touch as well as the expected muscle pain, as well as the next day it felt like I had gotten hit by a truck, about every muscle was sore in my body and I was running a low fever

Soreness in arm the day of, and one day after, the injection. Starting two days after the injection: consistent fever, 100° F to 102° F, body aching in muscles (specifically legs), and chills throughout body. Most intense waking up and before bed (symptoms usually worsen around 8:00 pm).

After 2nd vaccine dose developed myalgias, fever, chills, chest pain and shortness of breath hours afterwards which persisted and continued to worsen. Initial work up so far in the hospital appears to be myocarditis and is he is being admitted to telemetry.

Patient experienced soreness at injection site, high fever (102 for 3 days), severe headache, muscle pain, nausea and vomiting, stomachache, extreme fatigue, palor. All these symptoms persisted for approximately 7 days. On the 8th day, patient developed strep throat as diagnosed by his physician and was given antibiotics.

The patient called and stated that upon ambulating this morning, his left leg "feels like it's going to give out on me when I stand on it." The patient claims that he has had no changes in his daily regimen, no new medications, and is not taking any medications that he can reasonably attribute to this possible side effect. I advised the patient to complete the CDC V-Safe form provided with his vaccine, and to contact his primary healthcare provider as soon as possible to seek guidance for assessment and treatment. Additionally, we will contact the CDC for further guidance and appropriate parties will reach out to the patient as more information becomes available.

Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)). On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well) (seriousness criterion medically significant), FEELING HOT (Feels hot) (seriousness criterion medically significant), MYALGIA (Achiness all over) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 10-May-2021, WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and lab values were reported. No treatment related information has been reported. This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. 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: This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

It is thought to be vaccine-induced myocarditis. Myocardial infarction was ruled out. Patient does now have a reduced ejection fraction of 45%. Here is the note from the ED today: "He indicates that he was awakened from sleep with chest pain this morning around 2:50 AM. He ended up trying to sleep longer to see if it would improve and ended up going to his mother's room. She recommended that he drink some orange juice and gave him some Tylenol. He states that the pain continued to increase since that time and he asked her to bring him to the emergency department. The patient states that the pain is on the left side of his chest radiates to his left shoulder and down his left arm. He denies that it radiates to his back. He has had lightheadedness. He does not feel short of breath. He does have some pain into his left jaw as well. He has not had any vomiting. He denies abdominal pain. He denies diarrhea. The patient did receive his second dose of the Moderna vaccine on Friday to his left arm. He has had fevers over the past 24 hours to 103 at home. His mother and he indicate that the go away with Tylenol though seem to come back when the Tylenol wears off. He did complain of some headache, myalgias, malaise and sore throat which she states were all worse when he would have a fever and seemed to dissipate when his fever resolved. He states he did not and has never had chest pain like this until this morning. The patient does not have a history of Covid infection. He is active and has run track in the past. He has not had any travel. He denies any pain or swelling to his legs or calves. He has had no sick contacts. His mother received her second dose of the vaccine on the same day that he did and has not had any similar symptoms. "

4/23/21 at around 1pm, felt pain in left shoulder blade and around left upper lung and ribs area. Felt like tissues around it was tearing and grinding. After an hour felt pain near heart area and experienced nausia and felt faint. Was taken to hospital around 3pm. Was screened and tested for Covid-19 - negative. XRay was taken - did not show any issues Was given strong anti-inflammatory via shot Was monitored for 2 hours. Sent home. Discomfort improved over the weekend and no longer experiencing any symptoms.

Patient is an 18 year old male with history of albinism and bilateral horizontal nystagmus. No other medical problems. He received the second dose of the Moderna vaccine on 6/15/2021. On 6/21/2021, he developed bilateral thigh/hamstring pain and bilateral pectoral pain that progressively worsened. On 6/24/2021 he noticed red-tinged urine. Patient does not take any medication or OTC supplements. He denies any recent major physical activity or time spent outside.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was administered vaccine in left deltoid. Patient was seated in chair when vaccinated. Patient walked about 5 or 6 steps to waiting room chair to sit down and wait post vaccination. About 90 seconds to 3 minutes post vaccination the patient was seated in chair and fainted forward. Was holding conversation with father in the next chair to him and fainted from chair to the floor. Patient was aware after about 5 to 7 seconds post fainting, arms and hands were rigid.

Pt "blacked out" & legs went stiff shortly (within 5 mins of receiving vaccination), pt reported feeling cold & seeing black spots, emergency personnel was called immediately, water was given & monitored until emergency personnel arrived on site. Patient reported waves of feeling better & worse throughout the course of waiting for emergency personnel. Emergency personnel evaluated patient & transported to local hospital.

Symptoms began 6/11/21, neck pain, intermittent stomach aches, chest pain described as "pressure". Treatment- colchicine 0.6mg BID x 3mo

Patient initially had muscle soreness in the left arm for about 4 days which did subside. 2 days later he developed an enlarged axillary lymph node which continues to be painful and a 3" x 2.5 inch erythematous patch at the injection site. All symptoms are slowly dissipating but do continue at this time. No constitutional symptoms.

I got the injection at 3:35pm on 1/20 in my left arm. Within the first 30 minutes, my shoulder around the injection site was incredibly sore, my left elbow had a lot of joint pain, and my left thumb and index fingers went numb within the first 30 minutes, I woke up at 8:00am on 1/21 and noticed that I had a light headache, felt extremely groggy, and was experiencing an uncomfortable amount of muscular and joint pain. I went to work at 9:00 and on the drive there, I began to feel dizzy and I felt as if when I turned my head, my vision would lag behind and take a second to process my surroundings. By 10:00, my muscular and joint pains were significantly amplified, my headaches were increasing in frequency and amplitude. I also began to have the chills, followed by periods of radiating heat from my body. Coworkers told me I looked very flushed, however, I never developed a fever. By 11:00, the muscular and joint pains, coupled with the headaches forced me to sit down and I almost broke down into tears. There were three sperate times where I began to get very lightheaded and thought I was going to pass out ( I did not). I went home at noon and noticed that my muscles felt like they were on fire. I took Tylenol and Advil whenever I could, which helped to reduce the symptoms. we had dinner at 7:00, however, I had no appetite, without eating since noon. On 1/22, I woke up at 8:30 with a pounding headache, muscular and joint pains still there, however reduced, and the same groggy feeling. This morning, I also noticed that I had a very sharp stomach pain in my abdomen. I also woke up with a severe nosebleed, which is extremely uncommon for me.

Began a few hours after second dose (4-5 hours). Left Arm pain, headache, and fatigue. 1-2 hours after developed chills, joint pain, weakness/fatigue, muscle aches, as well as the previous symptoms.

I was woken up at approximately 2AM January 28th due to the fact that I had sweat through my clothes sheets and was shaking. I had severe muscle weakness, a severe headache, and fatigue that has limited my ability to do daily functions. Since 2AM 1500mg of tylenol have been ingested, but my fever holds at 100-101 degrees. Time of writing this document is 11:20AM January 28th.

Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia. The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg. On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer. On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved. The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021. The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Woke up at 4:30 AM, felt feverish, got worse as the day progressed. Developed a headache, fast pulse, chills, muscle weakness, etc. took 1000mg Tylenol at 1 PM and 7 PM, symptoms got better each time.

Currently having it. I have a swollen face. Blurry vision. Difficulty standing. Shallow breaths. Headache. Chills. Body aches. 101 fever. Unable to sleep but very tired. Not able to breather through nose. Sore and numb right arm. Tingling of my limbs. Occasionally sharp pain in muscles. I got the shot at 11 and was just fine but I had work. I drove for a little over an hour and progressively my arm got weaker. I did physical labor until 10 pm and then started some school work, but found my arm almost unable to move and my mood was deteriorating. When I went to bed and lied down, it hit me. It is 4 am and it is still going strong.

Extreme fatigue, labored breathing, hyperventilation, numb fingers and toes, inability to speak, fever, backache, body aches. Was at work at time symptoms began and workplace was going to call ambulance, but instead called parents to pick him up to take to emergency room/urgent care.

Severe abdominal cramping, vomiting 2 days, lower back pain, elevated blood sugar (159 after 18 hours post-prandial and having vomited all night with no history of diabetes), diarrhea, Chills

Patient complained of dizziness immediately after walking to checkout station. We sat him down and he said he was only seeing black and he was got and his neck hurt. We called EMS to check him out also. His BP was 140/90 and his vision started to come back after a couple of minutes as blurry. Once EMS arrived, he was much improved and vitals were all good. He refused to go to the ER, but his roommate assured us that he would watch him today. Patient waited 30 minutes and said he felt totally fine when he left.

This patient received Covid19 vaccine. This PT has a history of Autism and was getting anxious post vaccination. PT's mother was accompanying him when he began feeling dizzy, sweaty, hard of hearing and tightness in his Left arm where the vaccination was administered. PT was immediately evaluated by EMS and Fire Rescue on scene. PTs condition began to improve. PT declined transport.

"Asyncope followed by apparent seizure activity. Palor, stiffness with jerking motion of muscles to extremities. Pt. lost conciousness multiple times (2 to 3). Patient was transported to hospital via EMS

Myalgias, chills, subjective fever and diffuse nonfocal abdominal pain without acute abdomen, N/V or D.

The patient's pediatrician believes the shot was given to high in the deltoid cause shoulder pain. The doctor believes the patient has sirva shoulder.

Patient had parked in the COVID vaccine waiting area, and was observed to fall forward onto his steering wheel within a few minutes of parking by 2 other participants waiting in the car next to him. One of them immediately notified one of the parking lot volunteers who came and got me within 1 minute of this observation. 2 students and I came quickly to the open drivers side door and began talking to assess the situation. Mr. Bannister appeared pale, mildly diaphoretic (sweating) and slightly confused as to the passage of time, but was able to state and spell his name and talk coherently about his circumstances. He stated that he was not allergic to anything that he knew about, and that he had no prior history of similar reactions to vaccines or medicines although he had not taken any shots in several years. He noted that he had not eaten anything since breakfast (now mid-afternoon). He described himself as initially feeling weak, faint, and nauseated with his vaccinated arm feeling heavy and numb. He also reported that he had a sensation of blurriness before passing out, but denied any spinning sensation, visual loss or ringing in the ears. There were no obviously visible abrasions or bleeding on his face or forehead. The nursing students brought a chair, and we elevated his legs and gave him some water to drink during the time we were monitoring his vital signs. He refused a cupcake because of the nausea, but as time progressed he gained facial color and was more comfortable in conversing. His hands had equal muscle grip and strength, visible fingernail beds were pink and his capillary refill was less than 3 seconds. Towards the end of our monitoring, he did accept some nuts and M & Ms to eat. A University Safety Medical Report was completed by the appropriate safety personnel. He was fully AAO x 3 at the end of our monitoring, and stated that if he felt better he would drive to his apartment (less than 5 minutes away) but would wait for his girlfriend to get out of class if he did not feel fully capable of driving. We encouraged him to eat something light when he got home, to use cool water/warm water soaks at his shot site, exercise his arm, and to take an NSAID for pain relief the next day. We recommended that he eat something light before his second shot (which had already been scheduled), that he bring someone with him the next time, and as a precaution to wait 30 minutes following the second shot. He left at 3: 15 pm driving his car without any apparent difficulties. An online report was completed for the incident 04/20/2021.

9:59 AM - Vaccine 2:39 PM - Stinging pain in left arm which slowly radiates out from the vaccine site over the next several hours 7:25 PM - Pain reaches base of neck 7:29 PM - Nausea 7:30 PM - Lightheadedness 8:09 PM - Pain reaches tailbone 8:13 PM - Entire back and both shoulders begin throbbing 11:25 PM - nasal congestion 12:15 AM - body temperature drops to 97.9 12:20 AM - shortness of breath, blood oxygen drops to 95% 12:32 AM - blood oxygen drops to 92%. 12:34 AM - blood oxygen rebounds to 95% 12:35 AM - blood oxygen stabilizes at 96%. I am usually at 97-98 while resting. 1:31 AM - one of the worst sore throats I've had in my life begins 2:05 AM - low grade fever 99.1, chills, severe shivering even when under three blankets with heater on full blast, uncontrollable muscle spasms in face, arms, fingers, and legs 7:32 AM - woke up with severe muscle and joint pain. Too bad to sleep through. Can't even walk from my bed to my bedroom door without collapsing. High grade fever 101.7.

Pt c/o discomfort in both calves; tingling in hands and feet; "hot feet" since receiving Moderna vaccine 1 week ago. Nothing abnormal noted on exam.

"Moderna COVID-19 Vaccine EUA" After I took the Moderna vaccine there was swelling and pain in my left knee. The swelling makes it difficult to walk and bend at that knee.

began with nausea, then chills, sweating, fever, headache, muscle and body aches and pain, loss of appetite -began around 8 pm and lasted until Wednesday, May 12, when awakening that morning.

5 days after Moderna Covid Vaccine, patient developed swelling, redness and tenderness over hands/wrists/knees/ankles and feet.

19 y/o male reported back to site after leaving post 15 minute wait period. Pt had redness/rash on L lower arm. Pt had received vaccine at 08:39 in the L deltoid. Pt returned to site at 09:00 with above symptom. Pt states itching as well as slight tightness of the neck with NO difficulty breathing. Pt states felt like a tight short collar. Pt vitals taken and were stable. Rash had progressed up the L arm by time of EMS arrival. EPI was not given in clinic due to no complaint of shortness of breath. Pt care given to EMS crew.

Joints felt sore and stiff, skin felt sensitive, almost like pins and needles- particularly along my lower back.

ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He told our staff this happens every time he has blood drawn or an injection? Dr. in office aware at time of vaccination and present and documented below. Came in for COVID-19 vaccine. 10 minutes after shot (L) deltoid. He was sitting and said to me he was feeling dizzy and immediately he had convulsion and became pale. We called 911. It lasted 1-2 minutes. Dr. came to see him, he had irregular heartbeat, feeling very tired and weak BP (L) arm 100/60 at 4:15pm. 2nd reading after 10 minutes (L) arm 112/78 p-64. He mentioned he has same reaction after injections, or blood draw. He did not want to be taken to hospital. Pt left at 5:00 with his aunt. He is visiting. When I entered the the patient was having convulsion, clonic phase, stiffening arms and legs. The consciousness came back in 1-2 minutus; he could communicate with me. He said he could breath fine. His heart rhythm was still irregular. Blood pressure was checked. He could not walk because he was too tired. 911 called. 911 cleared patient, BP and heart rate regular and stable per staff. Discharged with family member ambulating on his own, alert and oriented. Plan: must see PCP neurologist. NOT to receive second vaccine unless has complete diagnostic work up and clearance. Should have second injection vaccine in a monitored hospital setting with paramedics.

Developed acute onset chest pain and shortness of breath on 5/11 with nausea/vomiting x1. He didn't have any prior systemic symptoms, URI symptoms, rashes, and was in his usual state of health. Other ROS was negaitve other than longstanding right shoulder pain without weakness.

Fatigue during day and loss of sleep at night. Joint pain in knees the worst then back then pelvis/hip then neck. Fever of 100.4 Fahrenheit

Left sided chest pain, shortness of breath, exertional tachycardia, radiating chest pain to the back x 7 days. Treated with rest, Medrol Dose pack and improved over 3 days. Diagnosis from cardiolgist -myocarditis

While driving home from the vaccine chest felt weird. Got home told my mom, went upstairs and felt bad discomfort on my upper left-side and middle of chest. Sharp pain kind of on the left-side of rib cage below arm pit. Took a several days for it to go away.

It got progressively worse & got hives; Both arms started itching, mostly the left at first; Lethargy; Soreness in left arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), MYALGIA (Soreness in left arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced URTICARIA (It got progressively worse & got hives) (seriousness criterion medically significant) and PRURITUS (Both arms started itching, mostly the left at first) (seriousness criterion medically significant). The patient was treated with PREDNISONE on 05-Apr-2021 at a dose of 20 milligram and PREDNISONE on 14-Apr-2021 at a dose of 10 milligram. At the time of the report, URTICARIA (It got progressively worse & got hives), PRURITUS (Both arms started itching, mostly the left at first), LETHARGY (Lethargy), MYALGIA (Soreness in left arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported by reporter. On 05 Apr 2021, the patient went to the Emergency Room and was prescribed Prednisone 20 mg 2 tabs daily for four days. The hives went away after the 4th day but came right back. On 14 Apr 2021, the patient went to the dermatologist. At that time the hives continued and were spread on quads, calves, hands and back. The dermatologist prescribed Prednisone 10mg with titrating dose over two weeks. 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-2021-254133 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pt is a 19-year-old male with past medical history of hyperlipidemia, obesity who presents this hospital on 7/19/21 for chest pain and shortness of breath following administration of COVID-19 vaccination Moderna X 4 days. Patient noted to persistent substernal chest pain radiating to left upper extremity present upon exam at its worst 3/10 relieved with Advil and aspirin for which patient was taking daily following a COVID-19 vaccination Moderna first dose 7/15/2021. Patient stated pain persisted despite taking over-the-counter analgesics and had difficulty breathing today thus transported himself to the emergency department for further evaluation. Patient d admitted to subjective chills without recorded temperature, myalgias without rash, difficulty swallowing, palpitations, orthopnea, PND, increased weight gain, abdominal pain, nausea vomiting or diarrhea. Patient prior allergic reactions. Patient denied history of MI, TIA, CVA, thromboembolic events. Significant family history of mother MI and Graves' disease.

Patient developed mid to low back pain, followed by shooting pains down his legs that were 8/10 level of discomfort. generalized faitgue, low grade temp. But the shooting pain down the legs persisted for 3 days. This was accompanied by some numbness and tingling of the legs. Felt unsteady on his feet. Back pain resolved within 12 hours but the shooting pains persisted. Ibuprofen did help

Chills and bodyache following the #2 of moderna. Pt is tachycardic. Otherwise unlabored breathing. Steady gaits. 20 yo M w/ no known chronic medical conditions, p/w frontal HA, dry mouth, myalgias, fatigue, and nausea since last night. Received the COVID vaccine yesterday afternoon. No photophobia, vomiting, diarrhea, abd pain, cough/congestion, CP, SOB.

About 3d after shot, patient was at gym and noticed L arm had decreased strength and decreased grip strength. No improvement since. Now has noticed some intermittent L hand tremors and L leg weakness. This was all disclosed when patient returned for shot #2. Shot #2 not given. Patient advised to discuss with PCP first.

The above patient received a COVID-19 vaccine on 03MAR21 @ 1440. He came to the EH&S office on the morning of 04MAR21 complaining of left arm pain, fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting. He was evaluated by a healthcare provider who noted mild swelling and a small knot was felt in his left arm. He is to follow-up with our onsite nurse or his medical provider if his condition worsens.

Patient presented to the medical with a complaint of nausea/vomiting, diffuse muscle aches, fatigue, and headache which started the night after he received his vaccine. His vital signs were normal and his exam was unremarkable. He was provided symptomatic treatment with acetaminophen and ibuprofen and asked to follow-up if his symptoms fail to improve after two days.

Fever, chills, stomach pain, nausea, vomiting, tiredness, muscle aches/pain, migraine. Lasted about two days

chills and aching joints 2 and 3 days after shot. day 5 lymph nodes swelled on the same side of the body as the injection. chills returned.

After my second Covid-19 vaccination I immediately felt fine. There was minimal injection site tenderness. It all started to worsen approximately 8 hours after my shot. I lost the capacity to regulate temperature (not to the point of hospitalization), am experiencing muscle fatigue, have severe injection site soreness, and have a massive headache.

. He received his second Moderna vaccine on 04/15th. He did have localized pain in his arm and the following day, had some headache and neck stiffness. Yesterday evening around 5 o' clock he developed left chest pain that has persisted. It has waxed and waned, but not disappeared. It reached an intensity of 7/10 prompting him to get a ride to the emergency room for evaluation. He was found to have myocarditis, with troponin elevation to 37 ng/mL, and globally reduced ejection fraction 45%. His care is ongoing.

PATIENT RECEIVED VACCINE 9:58AM. AT TIME OF VACCINE INDICATED HE HAD NOT EATEN THAT MORNING, BUT THAT HE HAD NOT BEEN DIZZY FROM VACCINES IN THE PAST. WHILE SITTING IN POST-IMMUNIZATION AREA, PATIENT LOST PASSED OUT AND COLLAPSED FROM CHAIR TO FLOOR. REGAINED CONSCIOUSNESS SHORTLY THEREAFTER. BLOOD PRESSURE WAS TAKEN AND WAS 118/80 WITH PULSE OF 112. PARAMEDICS WERE CALLED AND UPON EXAMINATION, PATIENT'S BLOOD SUGAR WAS 62. PATIENT STABILIZED AND WAS ABLE TO LEAVE UNDER HIS OWN POWER. INDICATED THAT HIS NECK WAS A LITTLE BIT SORE

Patient had the common/expected fatigue/myalgia/low grade fever following the 2nd COVID vaccine. Then, once this resolved, he developed chest pain and shortness of breath. He was admitted to the hospital and found to have pericarditis with elevated troponin and mild/nonspecific EKG changes. He had echocardiogram, CT angio coronary, and cardiac MRI as part of evaluation. He was treated supportively with NSAIDs and discharged with only mild residual pain.

Patient has had swelling at site of injection for 10 days. For the last 3 nights he has been having chest pain, back pain and shortness of breath with dizziness.

Patient told us he already received first dose of Moderna covid vaccine at another location. He was overdue for his 2nd dose. We administered the shot. The next day he reported to us that he actually received the Pfizer covid vaccine (his error). He reported typical symptoms from the covid vaccine (tiredness, achy muscles) .

Injection site is really high my arm. I am experiencing shoulder pain and limited mobility in my arm. Dose was today so will monitor.

developed myalgia, chest pain, fever chills, came to Emergency department found to have Right bundle branch with elevated troponin

Patient complains of extended experience of pain, swelling, and redness in left unilateral axilla. Pain is significant enough to cause loss of sleep and significant alteration in daily lifestyle. Pain is described as most significant at site of axilla.

Swelling in both feet/ankles, joint pain in both feet/legs, red spots underneath skin in both legs, swelling in left hand

Chills, Restlessness, Nausea, Headaches, Shortness of breath, Dizziness, Muscle and joint pain, chest pain

Received first Moderna vaccination on 06/07/2021. On 06/23/2021- at approximately 9:00 pm patient developed a fever of 102* accompanied by muscle & body aches, chills, headache and fatigue. On 96/24/2021- 10:15 am- I I gave patient 2 Tylenol and liquids. Patient is now sleeping and I will watch his symptoms carefully.

The patient reported to pharmacy around 6:45pm with pain near his pectoral muscle that had begun around 6:30 pm. The pain was mostly in his armpit and was severe enough that he couldn't lift his arm without pain increasing. His vaccine occurred around 4:20pm and he then returned to work stocking shelves.

Just finished administering the Moderna vaccine and whilst still having a conversation with the patient I was about to start the clock on the timer to monitor the patient when his eyes rolled over, the patient slumped in his chair and fell to the floor. He jerked twice then his eyes opened and he looked very confused trying to figure out where he was. I let him stay on the floor for about two minutes and then I helped him get up and sit back into his seat. I monitored him for 30 minutes. There was no difficulty in breathing, shortness of breath or tightening of the airways. No swelling of the face or other sites of the body where observed. The patient was able to carry out a normal conversation. Once the 30 minutes where I released the patient and advised him to get in touch with his primary care physician, Dr.

Moderna COVID-19 Vaccine EUA adverse event started as localized myalgia around injection site started around 4:30pm same day as the injection then progressed into a headache and fever of 101 by 11pm that night. Myalgia spread to the entire body and interrupted sleep at 2am. Heart rate was 110 while lying in bed. Took Nyquil for fever and at 1pm on 01/08/2021 fever is down to 99.1.

Fever, chills/shivering, headache, nausea, difficulty breathing, myalgia, weakness, restlessness Pain at injection site beginning two hours after injection. All other symptoms experienced during the evening, night, and morning after injection. Sudden onset, lasting 12 hours. Constant. Acetaminophen and ice used to alleviate symptoms.

14 days post vaccination developed: chest pain, back pain, paresthesia of bilateral upper extremities. CXR, EKG and Lab work done. Symptoms not disabling yet present; musculoskeletal pain in upper extremities with paresthesia

W/i and hour of injection: Injection site soreness 10 hours post injection: chills, joint aches 15 hours post injection: headache, 101.4 degrees F fever

Severe Tension-Type Headache, Malaise, Myalgia, Insomnia, Chills, Sweating, Fatigue, Fever of 100.8 F, Mild Non-suppurative Cough. All tolerated with 600mg ibuprofen.

Patient had 1st COVID vaccine on 01-22-21. Had 48 hrs of typical reactogenicity symptoms including low fever, fatigue, dizziness. Felt well for post vaccination days 3-5. Then on post-vaccination day 6, he developed fevers, sore throat. Symptoms persisted x10 days and sore throat pain led to decreased appetite and 10lb weight loss. Due to fever, he was tested for COVID by PCR on 02-01-21 and was positive. He had no anosmia and Respiratory Pathogen Panel on 02-01-21 was negative for influenza and 17 other viral pathogens including negative testing to Coronavirus 229e, OC43, N163, and HKU1.

About 4 hours after getting vaccine, I started to get a headache and my injection arm started hurting. Then a couple hours after, my skin got sensitive and burning. My muscles started hurting. 10 or 11 hours after getting the vaccine, I got severe chills; migraine; fever; nausea; dizziness. Symptoms lasted through the night. Fever went away 24 hours after receiving vaccine. 14 hours after getting vaccine, headache, arm ache, and body soreness remains.

Patient tolerated vaccine fine with no immediate reaction or issues, waited normal 15 minutes and then left. Approximately 2 hours post vaccination the patient started experiencing leg numbness in her left leg. She stated it felt like "jello" and was weak. She declined the option to immediately return to the clinic for a provider evaluation. She stated no trouble breathing of any kind. She said she had consulted her oncologist and "healthcare team". She did mention her specialist was pausing some of her medications in order to receive the covid vaccine and that she had okayed her to receive it.

Started with pain in the abdomen then spread upwards into chest. Serve pain around ribs making it hard to breathe. Vomited and symptoms went away for ten minutes. Pain came back gradually in same spots. This was cyclical occurance and then just stopped.

Pain at injection site (began at 6pm 3/12, resolved around 8am 3/15) Fever (began at 11pm 3/12, peaked at 102.0F at 3am 3/13, and resolved at noon 3/14) Fatigue, muscle pains, nausea, chills (began around 3am 3/13, resolved around 5pm 3/14) Chest tightness / difficulty breathing (began 9pm 3/13, reduced intensity on 3/15)

While waiting the 15 minutes recommended after vaccination, the patient became very lethargic, started sweating profusely, and had muscle weakness. 911 was called, and the patient was given Benadryl 25mg by mouth. Paramedics also administered Epinephrine 0.3mg IM, and the patient was transported to the hospital.

low-grade fever, mild headache, significant joint and muscle pain, extreme fatigue, brain fog, nausea, chills.

Pharmacy staff was alerted by patient's girlfriend that he had passed out. I went to the waiting area where she was propping him up in a chair. Patient was not responsive and completely limp. Together we lowered him to the floor where he quickly began to regain consciousness and tried to sit up. Patient was fairly alert within 1-2 minutes. Patient was given water, ice packs for the back of his neck and forehead, and ED was called. Patient stated he was feeling much better and did not need EMS, but due to store policy they were called. Patient relayed a history of fainting after receiving tattoos, that was not notated on his form. Patient remained on floor until EMS arrived about 20 minutes later and checked on patient. Patient's heart rate and BP were taken by EMS laying down, sitting, and standing and was cleared by EMS to leave.

Severe nausea. Unable to keep down ANY liquids including water for the first 24 hours after the vaccine was administered. Uncontrollable sweating (no fever), muscle spams near vaccine site on left arm and in left shoulder blade. Headache.

Weakness, chills, sweating, nausea, dizziness, headache, restlessness, pain around injection site, joint pain, lower back pain

Severe body aches, fever, joint pain, headaches, fatigue. Began day of vaccine at night. Symptoms have worsened over time.

My body and spescifically back hurt a lot and was somewhat impossible to focus 2-3 day from the vaccine

Dizziness and Extreme weakness (to the point walking was difficult) Numbness Burns Muscle pains Mental foginess

21 yo male had the Moderna vaccine 1.5 weeks ago and 3 days ago he was lifting light and last hs he got pain and swelling to the left upper back above the scapula. He has 10/10 pain. he has been icing it. He did not lift heavy when working out and did not feel a pull or twinge. It was his first vaccine in the series. Physical exam: He has 4 cm area of tenderness and swelling to the left upper back, above the scapula. Pain with abduction of the left arm. No pain in shoulder joint or swelling.

6 days following 1st dose Moderna, developed chills, myalgia, shortness of breath, injection site arm pain

On 4/29/21 around 9 PM, I started feeling chills, fever, severe headache, muscle aches all over my body. I felt weak and tired throughout the night of the 29th. By morning most side effects subdued but still felt weak and tired.

Patent received the shot, was given a 15 minute timer until it was safe for him to leave, He went out and sat in the waiting room until his time was up. Approx, 10 minutes later I heard a noise and looked over at his and noticed he was started to fall out of his chair. He then became as stiff as a board and I held him in place until he came to. He was seemingly scared and not aware of his surroundings. He said that he was feeling better but was still light headed. He was given an icepack and water and took his mask off. He looked pale. He started to feel better and left approx 10 minutes after this happened. He told me that he was feeling dizzy before he passed out.

Moderna COVID-19 Vaccine EUA. Injection site pain lasted for 3 days. No symptoms for the next 3 days. On the 6th day after the shot, swollen armpit/armpit pain started. Not severe enough to justify seeking medical help. Lapse in arm pain to armpit pain was surprising.

This is a very pleasant and healthy 21-year-old with history of migraines with aura who presents to the ER 2 days after receiving his second Materna vaccine with complaint of chest pain, myalgias and fatigue. Patient reports normal postvaccination myalgias and fatigue for the last 2 days but had onset of left-sided chest pain that radiates to his upper back and is worse with deep inspiration, some positions and movement of his left upper extremity. He denies cough, shortness of breath or rash. He is low risk for pulmonary embolism with PERC score negative for PE. Screening EKG showed a sinus rhythm with elevated J point in anterior-lateral leads, ? ST elevation in 1 and AVL w questionable reciprocal changes in leads 3 and AVF. Patient went to CXR. Clinically very low risk patient for STEMI from CAD. ? Myocarditis or pericarditis? No hx of stimulant use or early CAD in family. Upon reevaluating the patient, clinically he seems to have musculoskeletal chest discomfort, worse with palpation and movement of LUE. Repeated EKG - showed more definative ST elevation through anterior and lateral leads with reciprocal changes in 2, 3, AVF. Slight ST elevation in AVL. ? Pericarditis vs myocarditis. Will call cardiac alert. Evolving EKG changes. Discussed with ED physician and Interventional Cardiology, we agreed, patient likely has acute myocarditis clinically. Very low risk for CAD. Gave aspirin and heparin. They will evaluate him. Labs coming back... wbc 17.4, normal chemistry. Sending off CRP, ESR. Troponin pending. Patient and family appreciative and understanding. 1710 - Follow up call from cardiology. Stat echo normal wall motion. With elevated CRP and mild trop 1.6, patient has myocarditis with pericarditis. Dr very appreciative for the detailed history and physical. CP free. Holding off on cath lab.

Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing. His muscles were tensed, tonic clonic, he was pale, hot to the touch, and excessively sweating. However, the fire department reported it as a syncopal episode. The fire department paramedics came and monitored him until his family came to pick him up. His pulse was 57, blood pressure was 102/54, respirations 20, glucose 116, pulse of 96. Patient denied treatment to the hospital and requested to go with his parents. His dad is a physician.

(05/11/21 - second dose administered) sore arm at point of injection. (05/12/21) sore arm at point of injection, fatigue, muscle soreness in upper back, headache, fever, cold chills, nausea, diarrhea. (05/13/21) sore arm at point of injection, fatigue, muscle soreness in upper back, muscle soreness in neck, headache, fever, cold chills, nausea, vomiting, diarrhea. (05/14/21 today?s date) sore arm at point of injection, fatigue, muscle soreness in neck, nausea, diarrhea.

He had Moderna vaccine #2 on 5/13/2021. The day after the vaccination he had fevers and chills. Two days after his vaccination (5/15/2021) he developed mild midsternal chest pain. This worsened and on 5/16/2021 he felt like someone was sitting on his chest. This pain was worse with deep breaths and radiated to his shoulders. He sought care at an urgent care clinic where EKG unexpectedly showed diffuse ST elevations. He was referred to the ED where he had an elevated troponin and there was concern for myocarditis. TTE done showed a normal ejection fraction and normal heart valves. He denies recent illnesses. He denies recent sore throats or skin infections. He works in the hospitality industry but denies known recent COVID-19 infection. Since admission he was seen by cardiology and was started on colchicine, indomethacin, and protonix. Telemetry has been reassuring. He reports feeling much better.

Pt experienced nausea, vomiting,, and heartburn after vaccination on 4/27. He awoke on 4/30 with chest pain, intermittent-radiating to his back at times. His troponin level was elevated, he was admitted for treatment of myopericarditis. He stayed for 7 days inpatient and was discharged home on 5/7/21.

Patient presented high fever around 5pm the day of the vaccination. He continued with high fever and joint pain all Friday. He then presented with respiratory difficulties and chest pain when lying down on Saturday morning. He noticed that pain was less intense if he was seated upright. Pain became more intense around 10pm Saturday night. He was taken to am Emergency Room and was determined after evaluation that a cardio evaluation was granted due to abnormal labs and EKG results. Patient was transferred to secondary hospital. He was admitted for further evaluation and treatment.

Pain and tenderness at injection sight almost imediately. Muscle pain within first hour. Dizziness, weakness, loss of consciousness, nausea, and vomiting approximately 10 hours after injection.

PERSISTENT SORENESS IN AFFECTED SHOULDER (LEFT) THROUGH 28 DAYS WHERE HE PRESENTED TODAY FOR HIS SECOND DOSE.

For the next few days after I received the second dose of the vaccine, I experienced muscle and body aces, fatigue, and a low grade fever. About 3 days after getting the vaccine I woke up at about 2 AM on the 18th with severe chest pain, the other side effects had subsided at this point. I ended up going to the ER after about a half hour of the pain not going away. They ran a Troponin blood test and foinf my levels to be high. They also tested me for Covid which came back positive. They ended up doing an ultrasound of my heart, using a catheter to take a look at my arteries, a chest xray, a CT scan, and an EKG. The final diagnosis was myocarditis of the heart. I had to stay in the hospital for a few days while my heart stabilized. I was given orders to only participate in light exercise and to take it easy for now. I have a follow up visit with the cardiologist in about a week frok now. It was also found out through testing that I may have Wolf Parkinson's white syndrome.

Fever rush(up to 38.2 Celsius for a night) with severe muscle pain and fast heart rate(110+ bpm). Began after the second dose from 01:00 to 06:00.

pt received #1 Moderna vaccine yesterday, pain on left arm, shoulder started around 3 pm, c/o dizziness and nausea*1, denies any blood in the emesis, denies any traumatic injury, last OTC Tyrenol 2 tabs taken at 2200 last night without any relief,

About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.

received Moderna COVID-19 vaccine on 6/28 and since 6/29 has had worsening chest pain with shortness of breath, but it was most notable yesterday. He went to urgent care , and had an EKG, with the results being abnormal. He reports it feels better when laying down and is exertional. He had chills, abdominal pain and myalgias, headache.. impression is myocarditis likely related to the vaccine.

sharp pain in left chest when breathing in and moving pressure in right chest low energy in whole body feeling of being overwhelmed shortness of breath pain under ribs and stomach that comes and goes hearing sounds in ear when swallowing

History: pt had 2nd Moderna COVID-19 vaccine yesterday at 10am and since yesterday evening, pt has had chills, headache, dizziness, low back pain, and nausea. Took Tylenol at 0030. Pt denies runny nose, overt fever, cough, sore throat, vomit, diarrhea, rash, sick contact, visit to Area II or contact with COVID-19 hotspot/cases in last 2 weeks and no co-morbidities.

Headache, muscle weakness (in entire body), muscle pain in shoulders and neck, chills, hot flashes. Treated with 400mg of Ibuprofen.

presented to the emergency room with symptoms of chest pain. He received Moderna covid vaccine on Tuesday and since then he has been having symptoms of myalgias and chest pain. He mentions that the chest pain is substernal, gets worse with deep breaths. It gets worse when he lays on his back. And feels better when he sits up. He also had subjective fevers. When he presented to the emergency room he was having crushing chest discomfort with a troponin level at 10 and was referred for an emergent coronary angiography with concerns for acute coronary syndrome. Diagnosis/Impression: Acute myocarditis after Covid vaccination: Based on positional changes and pleuritic nature of the chest pain. Given troponin level left hand and ongoing crushing chest discomfort he was emergently taken to the Cath Lab where he does not have any significant coronary artery disease or thrombotic occlusions. LV gram shows hyperdynamic LV systolic function. At this time his symptoms are consistent with myocarditis.

Blurred vision, difficulty breathing (pale skin/blue lips), profuse sweating, muscle fatigue, headache. This lasted about 15 minutes. Until severity went down. Followed by 20 minutes of profuse sweating and headache. I thought I was going to die

pt received vaccine at 1137 in left deltoid IM, started having acute right gluteal pain approximately 3-4 hours later after getting undressed. pain to put pressure on the buttocks, hurts to bear weight/transition from sit to stand. did not have this pain prior to the vaccine, did not do activity today to aggravate the gluteus, does not have a hx of this type of pain.

Day of 2nd Moderna vaccine Zizzo developed sore throat, loss of taste/smell, headache, myalgia, fatigue, fever/chills.

Body aches (lower back and legs mostly), Sore arm, fatigue all for a little over a day the day after the second dose

Sore left shoulder (2 days), Headache (2 days), Nausea (Yesterday), Fever (2 days), Rash around neck and around site of vaccination (Today), Congestion (2 days). I have taken ibuprofen the past 2 days in order to help reduce shoulder pain, and fever.

Stiff arm and slight pain from roughly 2 hours post vaccination till the following morning. Uncomfortable throughout the night

Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.

administered covid vaccine, answered no to all screening questions. Within seconds, while walking away after the shot, patient reported feeling dizzy, fell, bit tongue (bleeding), and appeared to be very stiff. It appeared that there may be troubl breathing, so the Pharmacist administer Epipen 00.3mg IM. Within 20 seconds, the patient became alert and oriented, was talking. Paramedics took to hospital. Update from parent said he was fine a few hours later.

Pt received the first of the two-series COVID vaccination at 1512. Once in observation area, pt became unresponsive shortly after sitting down. This provider was called over by staff to pt, which was noted to have become unresponsive while sitting in the chair. Pt remained in the chair, did not fall or injure self. Upon arrival to patient, he was noted to have severe diaphoresis, prominent pallor, with shallow, slow breathing, no cyanosis noted. His head initially fell back and head was aligned/adjusted to maintain an open airway. This provider was speaking to the pt and performed a sternal rub to elicit a response, pt remained unresponsive and with eyes closed. Pt remained in this state for approximately 10 seconds. Pt noted to suddenly have some muscular rigidity to arms and torso and in order to prevent injury upon possible onset of seizure activity, pt was lowered to the floor by this provider and RN . Once on the ground the pt was relaxed and opened his eyes. Pt was immediately verbally responsive and asked if he passed out. Pt was able to sit up and was assisted into the wheelchair. Pt moved to treatment area where vitals and blood glucose were obtained. (@1525 BG- 104 mg/dL, VS BP 116/72, HR bradycardic @51 bpm, O2 sat 95%). Patient responses/speech was clear and pt was oriented to self, place, time and situation. Pt stated that he felt nauseated upon sitting in the observation area and admitted that he only had a coffee today, nothing to eat all day and attributed this as the cause of his reaction. Pt verbalized that he would not respond to the hospital with the paramedics and was encouraged to at least call someone to take him to the hospital. This provider spoke with the patient?s mother and explained the events. The patient?s mother stated that the patient had febrile seizures when approximately 4 years old, associated with asthma exacerbations; but pt was evaluated with a neurologist and there were no abnormal findings. Pt admitted that he has a similar syncopal episode after washing a laceration and seeing his finger bleeding. Pt states this was a few years ago and witnessed by his father that told the patient he initially fainted and then became momentarily rigid before responding appropriately (similar to today?s events). Ambulance - arrival @1536 report given and pt stated he was feeling better and declined further evaluation in truck and also declined transport to ED ( departed at 1545). Pt?s overall condition, appearance, including color was much improved. Pt denied any allergies or medication history. Past medical hx of febrile seizures at approximately age three and four, childhood asthma and one syncopal episode as an adult. Pt girlfriend arrival and she agreed to drive patient from the vaccine clinic. Pt and girlfriend were both provided with an explanation of the many concerning causes of syncope and the necessity for further evaluation in the Emergency department to rule out any underlying conditions. Both patient and girlfriend verbalized understanding and although they still declined to respond to ED directly from the clinic, both did agree to respond to ED if any changes in mental status occurred. Pt lives alone, but agreed to stay with parents and family in order to have others watch him for any changes. Pt was advised to followup with PCP and made aware that an provider would contact him tomorrow to check on his status, understanding verbalized and agreed with plan of care. Pt in no acute distress, awake, alert and oriented. Color within normal limits for and departed facility with girlfriend at 15:56, steady gait noted. Patient?s appointment for second dose was cancelled and will need to obtain clearance prior to second vaccine dose.

Severe pain over entire upper body. However that subsided the next day and left my left arm still in severe pain and stiffness, despite pain pills, warmth compress, voltaren gel application, and rest.

Fatigue began around 12:30 pm, around 3 hours after shot and increased the next day. Pain around injection lasted about 3 days. Muscle aches and joint pain started on second day and continued mildly on third day. Chills experienced on second day, no fever.

Patient had his 1st dose of the Moderna vaccine & developed commonly reported side effects, sore arm & fatigue shortly after the vaccine was administered. As the week continued past 48 hours post injection period, he was experiencing extreme fatigue & muscle aches. On the morning of 3/29 his feet were tingling & his legs were stiff. When he woke up on 3/30 the stiffness in his legs & the tingling increased to the point where walking became difficult. Finally on the morning of 3/31 he could not walk without assistance. His PCP said to take him to the emergency room. Patient was admitted to Medical Center with the suspicion of Guillain Barre Syndrome. A lumbar puncture confirmed Guillain Barre on 4/1/21 and a 5 day course of IVIG was started immediately after confirmation of diagnosis.

Pain and Stiffness in left shoulder immediately, increasing to point of preventing/slowing movement the following day, especially when exercising. Nausea, fatigue, and minor headache the following after noon.

Around 3 pm on 4/14/21, I started to feel very tired and I started to get a headache. Around 6 pm, I started to experience lower back pain and my legs began to throb and my whole body became very sensitive to touch. I took tylenol or ibuprofen every 4 hours for the rest of the night. This went on until Thursday 4/15/21, when the dizziness and throbbing headache started. Every time I would stand up I would become off balanced and need to hold on to something. I was still experiencing the lower back pain, leg throbbing and skin sensitivity but the dizziness and headache became much more intense. Around 9:30 pm on Thursday, I felt like I was hallucinating and was experiencing euphoria along with a fever. I did not sleep the night of 4/15 into 4/16. I was sweating profusely with a throbbing headache that would cause spinning when I would stand up. Around 3 am on 4/16, I fell asleep until around 4:30 am when I woke up in a pool of my own sweat. The body aches, leg pain and skin sensitivity went away along with my fever. Throughout Friday 4/16, I had a throbbing headache and was dizzy with no relief. This continued into Sunday 4/18 when I started to feel some relief. My headache was pretty much gone but the dizziness is still very much there. I have also an experienced elevated heart rate and respirations throughout the last 5 days.

Muscle Pain (All Body) Sat. 1pm-Sun End of Day Fatigue (All Body) Sat. 1pm-Mon. 6am Cold Chills Sat. 1pm-Sun. 10am. Dizziness Sat. 1pm-Sun. 10am. Nausea Sat. 1pm-Sun. 10am.

Developed fatigue, back pain, chest pain, nausea and vomiting the morning after the vaccination. On Saturday 4/17, I awoke feeling some better. Performed my daily routines uneventfully other than just not feeling 100 percent. By that evening the chest pain returned. On 4/18, I awoke with severe chest pains. I then presented to the ER where was presumed I was having a heart attack vs. acute pericarditis/myocarditis.

Patient presented with severe chest pain x 2 1/2 hours, found to have EKG changes consistent with strain, dramatically elevated troponin to 13.2, ultimately peaked at 15. No pericardial fluid, diagnosed with myocarditis, treated in healthcare facility.

AFTER 10 HOURS OF ADMINISTRATION OBSERVED SEVERE ARM CONTRACTURE - 15 MINUTES OF BOTH ENTIRE ARM STIFFNESS AND FINGER CURL LASTING AT LEAST 15 MINUTES. PT LOST SENSATION IN HIS ARMS UP TO HIS ELBOWS AND BOTH HANDS. HE ALSO SUFFERED ARM SORNESS AT THE INJECTION SITE, HEADACHES, FATIGUE, VOMITING AND JOINT PAIN, AND RASH AROUND HIS EYES. UPON HIS REPORT TO ME A FEW HOURS LATER HE HAS RESUMED SENSATION IN HIS ARMS AND IS FEELING SOMEWHAT BETTER NOW.

Major depressive episode, severe arm soreness at injection site, redness and swelling at injection site, fever, chills, fatigue, headache, muscle aches.

* Tuesday, March 16th, I received my first Moderna shot. No immediate symptoms, felt fine. * Thursday, March 25th (9 days post-vaccination), I was sitting at my desk and experienced some kind of visual distortion (my computer monitor bounced up and down 4 times in quick succession, even though I was perfectly still). Got up from my desk and laid down, and it went away. * Tuesday, March 30th (two weeks post-vaccination), I started experiencing persistent dizziness/imbalance. It was manageable for the first couple of days, and I still went about my daily activities. * Thursday, April 1st, symptoms got noticeably worse. I had a really bad episode of vertigo/dizziness in the afternoon. This spell of bad symptoms lasted until Saturday evening/Sunday morning. I wasn?t falling down, but I would describe it as akin to being on a boat in rough seas or a plane flying through a storm. Pressure in head and ears was intense. I?ve had longstanding tinnitus, but pitch/volume definitely seemed to change somewhat. My neck was incredibly stiff, and my throat felt somewhat ?tight? (tonsils or lymph nodes in neck felt enlarged). Took ibuprofen and Benadryl on and off over next several days. * Tuesday, April 27th, symptoms are ongoing. Still having imbalance, dizziness, and non-spinning vertigo, though less severe than previously.

Patient was given their first dose of the Moderna COVIDvaccine. Within 1 minute, the patient began having a seizure (jerking, eyes rolled back in the head, head went limp, and his body stiffed up), and then went unconscious.

Following the shot I experienced severe inflammation and pain in my left shoulder joint, and loss of range of motion in my shoulder. Symptoms persisted for several days and I eventually had to seek medical care and physical therapy. The is some speculation the vaccine was inject a little bit too high. Treatment with physical therapy has been effective for regaining my full range of motion and reducing pain.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient waited in post vaccine area for 15 mins post vaccine. After about 10 minutes the patient fainted from where he was seated in his chair onto the floor and another customer described him as "rigid". He came to after less than a minute. Patient was kept for observation for 30 minutes and given water. He stated he has had fainting spells in the past and that he felt fine. His mother came to pick him up.

Headache; Chills; Vertigo; Nausea; He threw up for about 20 minutes; He feels odd here and there; Random onset on backpain now, in the lumbar area; He almost passed out; Heart beat was 130; Fever of 100.6; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (He almost passed out), HEADACHE (Headache), CHILLS (Chills), VERTIGO (Vertigo), NAUSEA (Nausea) and VOMITING (He threw up for about 20 minutes) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (He almost passed out) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), VOMITING (He threw up for about 20 minutes) (seriousness criterion hospitalization) and TACHYCARDIA (Heart beat was 130). On 20-Apr-2021 at 10:00 PM, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (He feels odd here and there), BACK PAIN (Random onset on backpain now, in the lumbar area) and PYREXIA (Fever of 100.6). At the time of the report, LOSS OF CONSCIOUSNESS (He almost passed out), HEADACHE (Headache), CHILLS (Chills), VERTIGO (Vertigo), VOMITING (He threw up for about 20 minutes), TACHYCARDIA (Heart beat was 130), FEELING ABNORMAL (He feels odd here and there), BACK PAIN (Random onset on backpain now, in the lumbar area) and PYREXIA (Fever of 100.6) outcome was unknown and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.6 (High) 100.6. On 20-Apr-2021, Heart rate: abnormal (abnormal) Resting heart rate was 130. Additionally irregular heartbeat reported.. Patient got to the hospital where he was given pain medication and medication for vertigo. He was in the hospital for 6.5-7 hours.When he was discharged nausea went away and it took him 48 hours after ER visit to feel normal. Concomitant medication information not provided. Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-114588 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-114588:dose 1

Presented with left neck, chest and upper extremity weakness, pain and burning that started on 5/1. Stroke protocol followed and alteplase given 5/2. By morning of 5/3 all symptoms had resolved.

Nausea, muscle pain throughout body for the first 12 hours Unusually delirious dreams Vomiting second night After vomiting and normal sleep, rapid recovery

Patient received a Moderna vaccine at another facility on 05/12/2021. On 05/13/2021, he had chills, fatigue, and myalgias. These symptoms resolved on 05/14/2021. However on 05/14/2021 at 10 AM he developed pleuritic chest pain. He was admitted to hospital on the evening of 05/14/2021 with dramatic elevations in high-sensitivity troponin to 1700 and EKG with diffuse ST elevations and PR depressions, concerning for myopericarditis. He was initially treated with ibuprofen and colchicine. We have ordered an echocardiogram and a cardiac MRI. Workup and treatment are ongoing.

my son had swelling in his throat and mouth , confusion and mild delerium after the second dose , fever of 101-103. vomiting , Muscle aches , migraine headache

Very serious aches and pains in my joints. Fever, sore throat, pain in arm. Swollen glands and stiff joints. All started around 9 Pm

He started with a fever within 24 hrs of vaccination. Then he woke up with severe pain on his right side by his kidney. He vomited from the severe pain. I thought it was a kidney stone, but once he urinated the pain went away within several minutes. He has never had this before.

extreme muscle weakness, difficulty breathing, swelling in chest/throat with a slow progression over a period of 5 days starting the day following immunization, did not seek medical attention

100+ fever for 24 hours gradually returning to normal temp, full body muscle aches that made laying down in any position very uncomfortable, very hindering headache, short of breath but lungs seemed to be fine mainly painful due to muscle aching and worsening the headache with deeper breaths.

Got the shot at 12:30PM on Thursday. Started feeling fever, chills, fatigue, muscle and joint pain, and slight headache at 3:10AM. Recorded temperature of 100.7 degrees with an ear thermometer. Took Tylenol, drank 32oz of cold water, put a cold wash cloth on forehead. After an hour my temperature dropped to 98.8. Felt less achy but still warm.

Patient is a 22 y.o. male with no previous cardiac history, no known cardiovascular risk factors, and no significant past medical history. 2 days ago he received his second dose of the Maderna Covid vaccine. Yesterday he reported flulike symptoms with fever to 102 degrees, generalized myalgias, and fatigue. He awoke at 2 AM this morning with sharp somewhat diffuse substernal pain unrelated to activity, inspiration, exertion, position, without radiation or associated symptoms. He took Tylenol which eventually caused the pain to decrease in intensity. He called his family, discussed it with his girlfriend, did some online research, and came to the ER for evaluation where his EKG demonstrated anterior T wave abnormalities and his high-sensitivity troponin came back elevated at 16,072. His pain is now fully resolved, he is being admitted to the hospitalist service, and cardiology consultation was requested. June 6, 2021

ABOUT 30 SECONDS AFTER THE SHOT WAS ADMINISTERED THE PATIENT HAD A SEIZURE WHILE SITTING IN THE CHAIR IN THE WAITING ROOM. FULL BODY TWITCHING AND EYES ROLLING FOR 15 SECONDES OR SO. LEFT ARM WAS ALSO SWOLLEN AT THE ELBOW WHICH WAS OPPOSITE ARM OF THE IMMUNIZATION. PARAMEDICS WERE CALLED AND PATIENT WAS EVALUATED IN THE AMBULANCE BUT CHOSE NOT TO GO TO THE HOSPITAL AND TOLD THE PARAMEDICS HE WOULD GO ON HIS OWN. STILL HAS NOT BEEN SEEN PER PATIENT.

Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: patient complaint of soreness/redness and extreme swelling in lymph node and trap muscle on arm.

Systemic: Dizziness / Lightheadness-Mild, Systemic: clenched fists----rigid muscles-Medium, Systemic: Shakiness-Mild, Additional Details: pt has anxiety w/ needles---possible panic attack

Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who he was, where he was; Chest pain; Stomach pain; Hand pain/feet pain; Shaky feelings; Knee pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Mentioned wanting to kill himself) and HALLUCINATION, AUDITORY (three voices in his head) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hydrocephalus, Down's syndrome and Convulsions. Concomitant products included OXCARBAZEPINE (OXCARBAZEPIN) for an unknown indication. On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SUICIDAL IDEATION (Mentioned wanting to kill himself) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (three voices in his head) (seriousness criterion medically significant), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (Mentioned wanting to kill himself), HALLUCINATION, AUDITORY (three voices in his head), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Scan brain: normal (normal) normal. Patient prescribed anxiety and sleeping pills that the physician did not recommend that he take. 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. Unlikely, that the events are related to the vaccine due to existing comorbidities. This case was linked to MOD-2021-235268 (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. Unlikely, that the events are related to the vaccine due to existing comorbidities.

At the end of April my left foot begun having arthrisit like pain. My foot was and still is tingly and I experience sharp shooting pains in my foot. After this began I was diagnosed with Bells Paulsy on May 3rd after I noticed on May 1st the left side of my face was weak and I could not blink my left eye.

sudden hearing loss requiring hear aids, ear canal swelling and itching, axillary gland enlargement and pain

Pt.'s grandmother states that after receiving the 2nd dose of Moderna 06/16/2021, started experiencing with extreme weight lost and slight cough. Primary visit (Blood work, X-rays, Chest X-ray) showing Thyroid levels elevated. Specialist seen 06/29/2021, Ultrasound continuing current medications. Follow-Up visit scheduled for 07/16/2021. Still experiencing extreme light-headness, weakness, loss of appetite.

I received the vaccine through my employer. 7 Days after the vaccination event, my left deltoid muscle became significantly swollen, stiff and tender. There was pain when I tried to elevate the arm laterally. The site was very warm to the touch. I experienced periods of malaise and fatigue at random intervals throughout the week after which I received the vaccine. On day 8, a red rash began to appear on the vaccination site. It was slightly itchy. The area was still stiff and swollen, and painful to move past a certain angle. This night I felt especially fatigued. On day 9 I woke up to see the swelling was mostly subsided, however the rash had spread down the arm to roughly the elbow. The site was no longer warm. It was still slightly irritable. As the day is progressing (this is written on day 9), the rash is starting to fade.

Approximately 6 minutes after receiving vaccine, patient experiencing left arm was feeling heavy. Patient felt like the arm was feeling "weak". May have had some tingling in the fingers. Initial BP 137/72 HR 95 O2=97%. Heaviness in the arm dissipating after 20 minutes. At 25 minutes, patient starting feeling a dull pain in forearm ascending to the left side of the neck with some intensity, but subsiding to a very dull pain. Tingling in the fingers subsided, but very mild at 30 minutes. At 5:35pm, BP 147/75 HR 91 O2=98%. At 5:45pm patient reports some mild tingling in fingers. Pain in the neck area and arms feel more like a stiffness than pain. Patient released from clinic at 5:50pm.

Approximately 10 minutes after receiving vaccine patient began to experience some mild discomfort on the left neck (mild "stiff neck"), heavy arm or discomfort, and mild tingling in the fingers. Initial BP 149/92 HR 91. Patient clinically stable at 30 minutes post-vaccination. Neck pain gone 30 minutes post-vaccination; patient only feels pain at injection site. BP 143/95 HR 86 O2=98%. Patient released from clinic at 2:22pm.

Early on in the day of 1/6/21, I felt very sluggish and spaced. My boss asked me early in the day if I was okay because she said that I seemed "out of it." It wasn't to the point that I was unable to work, but it was a noticeable difference from my typical state. At 11:31 AM, I texted my wife and said "I feel gross and weird today." When she asked me how so, I replied, "I just feel run down, my neck hurts, and I can't focus." My arm was more sore than it typically is from the flu shot, but it wasn't unbearable. As the day went on, I felt the cloudiness in my head start to dissipate a bit and I started to feel a little better. By dinnertime, I was feeling sick to my stomach and was not able to eat very much. I chose to head to bed around 9 because I was feeling pretty ill (my neck had really started feeling sore again and my stomach was very upset.) At 1:30 AM on 1/8/21, I woke up with a horrible headache. I get migraines from time to time, but this was unlike anything I had ever felt before. It felt like my head was in a vise and I was very close to asking my wife to take me to the ER. I never go to the doctor, but it legitimately scared me. My neck was extremely sore and my head hurt so bad that even laying it on a pillow hurt. I was extremely nauseous as well. I took a few extra strength Tylenol and laid my neck on a heating pad with an ice back on my forehead. The sound of our humidifier was too much for me, so I also out in earplugs. After an hour or so, I fell back asleep. When I woke up this morning, I still had a headache and I took an Excedrin. To this point, I have felt a little sick to my stomach, but the intense headache has been kept at bay. My neck is still sore but it is also somewhat better.

SM developed influenza-like illness with Fever, chills, myalgias, and HA 5 days s/p dose 1 of Moderna Vaccine. Pt previously infected with COVID 19 and diagnosed 12 days prior to vaccine administration

Arm Pain, Tenderness upon moving/touching. 2-3 hour onset after vaccination and continuous Severe Chills around 1:00am (l15 hours post injection) -- > uncontrollable shaking and tensing of almost all extremity (arms,legs, neck, and back) muscles. Sudden onset, lasted for 20mins

swelling at injection site, fever, and intense lower back pain following vaccination. treated with tylenol

Soreness in arm at injection sight. Muscular pain and general fogginess of thinking for the next 24 hours with intermittent migraines.

pt c/o of flu like symptoms after receiving 2nd COVID vaccine dose at 1100 02FEB2021. Pt reports fever (tmax 101F), chills, N/V, generalized body aches, h/a, sore throat, and dizziness. Pt states flu-like symptoms after getting 2nd COVID vaccine shot yesterday. Pt states fever, chills, n/v, dizziness, HA, sore throat, bodyache. Pt's left tonsil swollen. Pt states 1 episode of vomiting today 0100 without blood, 8/10 constant bodyache. Pt denies taking medication PTA.

Itchy skin accompanied with small red bumps, mostly on hands and arms, bilateral, not near injection site. Minor discomfort, treatment not initiated.

Moderna COVID-19 Vaccine Moderate to severe chills, fatigue, myalgias, and headache. Moderate to severe tension like pulling in posterior neck and posterior head. NyQuil and Advil therapy.

Fever at 7am at 2/20. Fever is 102.2. Extreme fatigue, sore muscles. Hard to walk and keep balance. Dry mouth. Head ache. Numbness in arms

Nothing at time of injection. In the evening, soreness in the arm (strong but on par for what I would expect). Next morning, I starting feeling sick, with flu symptoms. Aching muscles, sensitive skin, mild headache, sore eyes, and in the evening, nausea. Temperature gradually rose. ~99.7 at 6pm, 100.1 at 7pm, 100.7 at 8pm, 101.7 at 9:30pm. I took some Tylenol around 7pm, and then some theraflu at 10pm. Fell asleep at 11pm. Periodically waking up every 30min from 1am onwards. Muscle discomfort, sweating, and nausea continued until 3:45 AM, at which point I was feeling better and was able to sleep continuously. Feeling much better in the morning on March 4th. Temperature was 99.9, then rose to 100.0 at 11am. Now, at 3pm, feeling fatigue, exhaustion. No headache. Normal sense of taste and smell. No couch. Taking another day off from work. Temperature is currently 100.0. Taking more theraflu now, have not taken Tylenol today.

Patient received a COVID-19 vaccine on 04MAR21 @ 1400. At 1645, he returned to the vaccine room shaking and his eyes were tearing up. He complained of pain at the injection site, headache, nausea, abdominal pain, chills and joint pain. His temperature was 98.4 @ 1712. He also complained of increased saliva production. He laid down on a cot and an emergency rescue blanket was applied. He was reassured and monitored by our onsite RN. He was stable and left at 1755.

First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to resolve after 5 days, but continued to nap three times a day sometimes. No fever, but hot flashes at times. Booster given 2/23/21. Began to nap again three times a day or want to stay in his dark room. Began to have a lot of sinus drainage. Gagging at times. Pain over right eye area. Pain in right flank and stomach area. Severe headaches and possible body aches. No fever, but increased and more severe hot flashes that would wake him. 2/28 had a tonic clonic seizure after presenting with a distressed look throughout the day. Slept and upon waking began vomiting until 3am. Was at the ER and given many tests, pain meds and nausea meds. Ruled out kidney stones with CT scan and urinalysis. No fever, but hot flashing continued. ER visit lasted from 2/28/21 through 3/1/21 ER Physician suspects possible reaction to vaccine. Followed up with Neurologist and General Practitioner and both suspect reaction to vaccine.

pt initially developed hives the day after the vaccine, but on 3/22 he developed left groin pain. exam suggestive of epididymitis with no other known precipitating event other than recent vaccine

Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spontaneous report was received from a consumer concerning a 23 year old, male patient, who experienced faint (syncope), migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia). The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events, included allergy medication unspecified. On unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, after vaccination, the patient experienced faint, migraine, dizzy, fatigue, disoriented, joint pain, muscle pain, nausea and slight fever. Treatment for the event included Ibuprofen and Excedrin. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event of faint was considered recovered. The outcome for the events of migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Fever of 102.9 degrees developed at 4:00 AM, treated with ibuprofen and acetaminophen. Fever accompanied by muscle aches and severe fatigue. Symptoms began to subside around 5:00 PM.

Painful chills and muscle cramps. High-grade fever (101.5 degrees). Muscle aches. Fatigue and headache. All symptom appeared 11 hours after taking the first dose of the vaccine and are currently present.

4/6/21 Per, he felt two electrical pulses going to arm at the time he was vaccinated, noticed a change in dexterity of thumb, forearm feels heavy, a little pulsating in thumb, not numb, "dropped something", can use arm and hand, saw PCP on 4/6/21 who thinks is inflammation of nerve and will resolve.

23 YEAR OLD admitted to hospital with chest pain and elevated troponin (5000). Had received second dose of Moderna vaccine 4 days prior. Myalgia and fever from vaccine were resolving when chest pain and dyspnea started. Normal angiogram, no coagulopathy, normal platelets, normal echo. Pain resolved.

While monitoring post-vaccination a woman yelled from her car window that ?he? fainted. Upon arrival, it was noted that a young man in the passenger seat was slumped with his head on his chest and unresponsive. It was witnessed that the passenger stiffened and started shaking as if he was having a seizure. The nurse was called. It was noted that the shaking lasted just a few seconds and he then relaxed and opened his eyes. Once the RN, received call that there was a person having a seizure, 3 nurses went to the scene. Once RN arrived at the car the patient was awake and alert. The patient was assessed, and he was able to answer questions. History of the patient from the mother revealed that he has responded to other vaccines in the past by having a vagal response. RN noted that there were no signs of patient being postictal. Patient was alert, oriented and stated that he was feeling better. EMS arrived and assessed patient and noted that he was in no distress. Patient denied transport to ED. RN educated patient on importance of reporting this to nurse prior to next vaccination.

I took the FIRST dose of the Moderna vaccine this Tuesday on the 20th of April at 11:30 AM. Around 10:00 PM Wednesday I have been feeling short of breath. This feeling has persisted throughout the entire day of Thursday and I continue to feel the same way (I think it has slightly worsened). I can breath, but I am completely unable to take a full, deep breath. I sometimes can achieve a full deep breath but it's completely at random. I find myself trying to forcefully take a deep breath but can't seem to fully fill my lungs how I normally am able to. Additionally, my throat feels mildly swollen/sore, starting from the back of my mouth and down my esophagus. The lowest point of my esophagus at which I feel the soreness/mild swelling is near the center of my chest. I think my shortness of breath is progressively, and slowly worsening, but its hard to tell for certain. Some of the muscles around my back are beginning to feel uncomfortable due to me constantly trying to forcefully achieve a full and deep breath.

8/10 kidney and lumbar pain starting at 6AM the day after injection, mental fog, overall muscle weakness. Pain treated by moving around until found a position that hurt less. Pain reduced to 5/10 by 11am and 1/10 by 2pm. Tired feeling remains.

Arm soreness/aches started about 6hrs in (though injection sight was tender/sensitive to the touch pain became mostly localized around the armpit and shoulder area. Where the pectoral connects under the arm), then around 8hrs a headache and chills started. Chills and headache progressed and got significantly worse throughout the night. By around18hrs headache had progressed to a migraine and nausea started (likely due to the migraine). Simply sitting up in bed was enough to push nausea to vomiting at which the migraine subsided for about 30min-1hr. Chills and aching arm persisted. By 24hrs headache/migraine was nearly completely gone and chills had subsided. Arm pain persisted and got worse. Noticed around this time that there seemed to be mild swelling in the armpit. Around 48hrs in armpit area is still feels slightly swollen and causes a good bit a pain depending on how arm moves/rests. Injection sight still lightly tender. (currently the only symptom persisting)

Bilateral hand and wrist numbness, weakness and tingling. First onset lasted about 2 hours, has been returning intermittently for shorter episodes or longer but lessened symptoms

After receiving Moderma vaccine, pt came to 15 minute wait area. once here, pt stated he started getting a headache. The headache stopped , then pt began feeling extremely tired and shaky. Broke out into cold sweat. Never passed out. Pt his arms felt lie they were "asleep" and fingers on his left hands felt like he could not move them, stiffened . No respiratory distress listed VS taken

Moderna COVID-19 Vaccine EUA Symptoms: Muscle tenderness at vaccination site, general achiness, fatigue, occasional difficulty breathing (felt like someone squeezing on my diaphragm and made it uncomfortable breathing for short periods of time. Started in the evening time, lasted a minute max each time, and occurred around 5 times before ceasing). Symptoms ended around 9 pm the same day they began

Within hours of vaccine, patient reports dizziness, fatigue, neck and shoulder pain radiating down arm, headache. Symptoms have persisited since immunization 5/10/21.

Fever arm pain 24 hours after second shot 3 days after second shot: numbness, tingling in toes, some numbness, weak knees. Tight muscles These symptoms have continued now in 6th week. Now burning in toes at night waking him up.

The vaccine is affecting young people; My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something; The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; shoulder pain; On Saturday night he was feeling tired and cold; feeling cold; On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins; On Saturday his legs were very heavy and had pain; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) and ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included BUPROPION HYDROCHLORIDE (ZYBAN) for an unknown indication. On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) (seriousness criterion medically significant), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), FEELING COLD (feeling cold) and FATIGUE (On Saturday night he was feeling tired and cold). On 25-May-2021, the patient experienced ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) (seriousness criterion medically significant), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes) and ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (The vaccine is affecting young people). At the time of the report, THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins), ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something), VACCINATION COMPLICATION (The vaccine is affecting young people), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), FEELING COLD (feeling cold), ARTHRALGIA (shoulder pain) and FATIGUE (On Saturday night he was feeling tired and cold) outcome was unknown. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-182543 (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.

At approximately 3:30 a.m. on 04/19 I experienced strong pain in the chest, armpit, and upper back/shoulders accompanied by discomfort breathing that lasted 2.5 to 3 hours. These symptoms faded and altogether went away between 6:30 and 7:00 a.m. At 9:00 a.m. I went into prompt care and had the following tests and procedures as described in Item 19.

Myocarditis developed 2 days after second dose of Moderna Covid19 vaccination. Patient presented with bilateral arm pain, left shoulder pain, and left chest pain that had started at 2300 the night before.

Tingling and numbness in left pinky and ring finger, feeling of discomfort in elbow, lower arm like hit funny bone, left hand gets stiff and trembles when trying to extend. Mild symptoms first 2 days, but now significant and unable to type or use left arm without discomfort so have been resting it. Over 3 weeks with no improvement.

Began mild physical exercise 10 days after vaccine #2. Extreme muscle soreness even though hydrating and following an appropriate diet. Soreness continued for 4 days reaching a pain level of 9/10. On the 4th day began urinating dark brown, foamy urine.

Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: PATIENT'S MOM CAME TO THE PHARMACY AND REPORTED THAT PATIENT WOKE UP THE NEXT DAY WITH A SWELLING PAINFUL LEFF ANGKLE. PATIENT EVEN CAN NOT WALK. NO PAIN OR BRUISING AT THE INJECTION SITE

Patient was sitting in observation area immediately post vaccine and he suddenly lost consciousness and his head slumped back briefly. Within 3 minutes patient regained consciousness and was very sweaty and anxious. Provided patient cod compress and water and blood sugar boosting snack. Paramedics arrived.

Start 12/31/2020 tired, muscle tightness in upper back between shoulder blades, more energy, feeling more focused, tiredness

Solid red oval going 3cm laterally each way from injection site, and 5cm above and below injection site. Heat and minor swelling around injection site. Pain in armpit, almost unnoticeable while resting. upon raising armpit pain worsens. Swelling in the armpit as well. Headache. (NO fever).

Patient received the vaccine around 2:50PM; checked in around 2:46PM. He was seated during his monitoring phase when the nurse reported that the patient was complaining about: ? Dizziness ? Lightheadedness ? Weakness of extremities & general overall weakness ? Fast heartbeat ? These were noted to be part of the signs of severe allergic list for the vaccine. Upon assessment around 3PM, the nurse noted that the patient said he felt some of the symptoms were improving; no shortness of breath noted or facial swelling or rashes. Patient offered juice and crackers and advised to stay and continue monitoring. Patient compliant with plan. Around 305PM patient reassessed and patient started complaining of increasing weakness and dizziness and racing heartbeat. Patient also noted to have labored breathing, pale, clammy and tripoding. Vitals taken = 101/64; 100% in room air; HR = 80; RR = 32; lung sounds clear to auscultation. Patient kept on vital sign monitoring and noted that saturations started decreasing to 90%, then 80%, then down to 70% in a span of several minutes + HR = reduced to 55. Patient also stated he was feeling faint & started feeling very weak & stopped talking & having difficulty breathing. MERT called and patient placed in a wheelchair & oxygen administered. Patient continued to look worse and not as responsive. MERT arrived around 317PM and took another set of vitals and brought patient to ED.

Was fine for ~8 hours then started to feel ?off? after completing an upper body workout. I then felt nauseous and threw up, and my body began to ache. 12 hours post vaccination I began to develop a fever of 99.8 with the use of acetaminophen and had severe chills / muscle aches. The fever progresses to 101.1 about 36hours post vaccine and declined to 100.8 48 hours post vaccine. By 72 hours the fever was gone as well as all symptoms excluding fatigue and a slight headache.

Fever, chills, cold sweats, fatigue, dry cough, headache, muscle pain, and weakness lasting 12 hours starting at around 24 hours after vaccine administration. Patient took two Tylenol 500mg to some relief at 2pm and again at 7pm.

Headache, muscle aches, and fever reaching 101.8 started at around midnight of 1/9/2021, roughly 8 h after receiving the vaccine. The fever broke this morning (1/10/21) so a rough estimate of the time course is 32 h. The fever was also reduced with acetaminophen. The headache still persists, albeit milder. The muscle aches resolved with the fever, so a time course for that would also be 32 h. I recently had a COVID19 infection (symptom onset was 12/25/20), but had cleared my isolation date of 1/4/21. The symptoms from my COVID19 infection (headache, muscle aches, chills) had virtually resolved by 1/8/21 before I received the vaccine.

Left Axillary pain and mild swelling starting approximately 4 days after vaccination. The pain proceeded to worsen over the next week and moderate lymphadenopathy was also been noted. These lymph nodes are tender to palpation. Additionally some Parasthesias were felt down the left forearm into the hand possibly due to brachial neuritis or nerve pressure due to lymphadenopathy. The parasthesias lasted approximately 2 days. Lymphadenopathy is now present in the right axilla along with more severe adenopathy in the left axilla. - PA-S2

Site: Pain at Injection Site-Medium, Systemic: JOINT PAIN IN RIGHT THUMB , Error: Wrong Dose of Vaccine - Too High

Left shoulder soreness - still present Chills - approximately 5 hours Severe body aches - approximately 12 hours

A few hours after the injection, I started feeling severe joint and back pain. Around 5 PM is when I started feeling a tingling feeling in my hands, feet, and around the outside of my mouth. I still have a loss of feeling in my feet after returning to work today, 1/25/2021, and I was promptly sent home after informing my management. I still have some loss of feeling around the corners of my mouth, and most of the feeling has recovered in my hands.

01/21/2021 11:22am HCP #2 Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Contact #: Your concerns: Dept: Have you missed work? #shifts: today Did you seek emergency care? yes Date and Time of Vaccine: 1/20/2021 @ Age at time of vaccination, ____24____ years Sex: m Was the vaccine received at facility? yes Site of vaccine (LD or RD): LD Type of Vaccine Pfizer ( X) Moderna ( ) Other _______________ 1st or 2nd dose: 2nd When did your symptoms start? 1/20/2021 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain yes Tiredness yes Headache yes Muscle Pain yes Chills yes Joint Pain yes Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell yes Swollen Lymph Nodes (lymphadenopathy) no Other: Patient reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat swelling of the lower lip A fast heartbeat relates heart rate greater than 110 A bad rash all over your body no Dizziness and weakness If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: Plan: Consulted with HCP, patient sent to urgent care clinic for further evaluation. If patient was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. Patient verbalizes understanding and agreement with plan. VAERS report is completed electronically if vaccine given at facility. Signed by HCP on 1/21/2021 at 11:22am

Fever (100.9 F) from 3:30 PM - 9:30 PM, treated with ibuprofen and acetaminophen. Chills that coincided with the fever. Body aches and joint pain, starting at 8 AM and increased in intensity throughout the day, lasted until awakening the next day, ibuprofen and acetaminophen did not help.

Dizziness, nausea, backache soon after, but went to work 1/31/21 woke up and had palpitations, dizziness, vomiting, chills, body ache, headache, runny nose intermittently all day 2/1/21 continued to have palpitations into the evening 2/2/21 no further palpitations today

First dose: Fatigue, chills, muscle soreness, headache for three days after administration. Second dose: Fatigue, muscle soreness, headache for two days after administration. Itchy, red rash on right arm for 5 days after administration.

Moderna covid-19 vaccine EUA. Night sweats, body aches lasting 72+ hours, body shakes, hallucinations at night, headaches, dizziness lasting 72+ hours, extreme fatigue lasting 72+ hours, sore throat, joint pain, nausea , pain at injection sight lasting 72+ hours

Symptoms: malaise, fatigue, muscle aches, muscle cramps, sore throat. Time course: one day. Outcome: symptoms resolved.

soreness in the thumb joint; patient received 1 ml instead of 0.5 ml of the vaccine; A spontaneous report was received from a pharmacist concerning a 24-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose – patient received 1 milliliter instead of 0.5 milliliter of the vaccine and arthralgia – soreness in the thumb joint. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient received 1 milliliter of the Moderna COVID-19 vaccine instead of the recommended 0.5 milliliters. On 15 Jan 2021, the patient reported he had soreness in the right thumb. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, accidental overdose – patient received 1 milliliter instead of 0.5 milliliter of the vaccine, was considered resolved on 12 Jan 2021. The outcome of the event, arthralgia – soreness in the thumb joint, was considered unknown.; Reporter's Comments: This case concerns a 24 year old male patient who experienced a unexpected events of Accidental overdose and Arthralgia. The latter event occurred 3 days after first dose of the study medication administration. 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.

fatique, H/A, MUSCLE PAIN, JOINT PAIN, CHILLS, SLIGHT FEVER-99.3, PAIN/TENDERNESS AT INJECTION SLIGHT resting at home , have not gone to a Dr. or spoke to one yet.

fever, chills, headache, nausea, muscle aches, and SORE THROAT Treated with ibuprofen with mild improvement. Presented the following morning to COVID Testing Center with symptoms and was tested for COVID due to sore throat (not a "common side effect")

Painful swollen lymph node in left armpit. Tenderness in left pectoral. Onset was approximately 5 days after vaccination.

I was vaccinated on the afternoon of 3/5, then woke the next day with fever, chills, myalgias and headache. These persisted all day and into the next, 3/7. I was also very fatigued and slept most of these 2 days.

Loss of hearing in both ears; Fatigue; Joint pain; Headache; A spontaneous report was received from a Healthcare Professional concerning a 24 years old male patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced fatigue, joint pain, headache and loss of hearing in both ears. The patient's medical history was not provided. Products known to have been used by the patient were Tylenol and Ibuprofen. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events fatigue, joint pain and headache. On 28 Jan 2021, the patient experienced the loss of hearing in both ears. The patient was treated with Tylenol and Ibuprofen. No relevant laboratory details were included. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events include fatigue, joint pain and headache were unknown. The outcome of the event loss of hearing in both ears was not recovered.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Before going to bed, I had chills. Throughout the night I woke up feeling extremely cold multiple times. In the morning I awoke sweating. My temperature in the morning was 98.2°. Throughout the day on 03/13/21, I was extremely sore in my hips and legs. The arm where I was administered the shot was also sore. In addition to the soreness, I felt cold throughout the day, and I had a headache until I ate around 12:00pm, but I did not have much of an appetite.

I have a soreness in the short head of my bicep on the same arm I got the shot. At first I thought I pulled a muscle but I found out my coworker is experiencing the same thing after he got his shot and its already been 2 weeks for him and the soreness is still there.

after 5-7 minutes after the administration of the vaccine, patient approached the counter to report that he had fainted between the isles. in doing so, he fainted for and fell down. regained consciousness immediately. but patient was very warm and clammy to the touch.. patient complained that his skin felt burning and his right knee was hurting. Patient was tended until 911 personnel arrived.

T+4hr: Tenderness at injection site T+12hr: Tiredness, Ibuprofen 200mg T+24hr: Dizziness, confusion, drowsiness, fever (37.5C), Ibuprofen 200mg T+36hr: Neck stiffness

PATIENT FELT DIZZY AND NAUSOUS AFTER VACCINATION. PATIENT SAID HE LOST COLOR IN HIS VISION. PATIENT'S HEAD ROLLED AND THEN HIS WHOLE BODY BECAME STIFF BEFORE COMING BACK TO CONCIOUSNESS. PATIENT SAYS THIS HAPPENS WITH ALL VACCINATIONS AND DRAWING BLOOD.

Fever (up to 102F), chills, slight nausea, tension headache on upper neck, restlessness, joint pain, all beginning around 5pm. Went to sleep at 8-10pm (challenges sleeping). Woke up at 8am with 99.0F temp. Showered. Back to 97.6 by 10am.

Moderna COVID-19 Vaccine EUA Fatigue and pain at injection site starting at 8:25 PM. Fever developed over the course of the night; temperature 101.4 degrees when measured in the morning. Fever broke at around 2:00 PM. Moderate-to-severe headache, moderate joint pain, and fatigue lasting from waking at 7:15 AM until 4:30 PM. Some nausea.

Pain in right arm around injection site Muscle pain and aches in joints overnight and throughout the next day

Became extremely exhausted by the evening with slight back pain. At about midnight, woke up with fever of 102, severe back pain, and cold sweats. Did not sleep through the night. Woke up with vomiting, severe body aches, cold sweats, shivering, continued fever of 102. Took 2 tylenol every 6 hours and fever did not drop below 100 at any time. Had severe body aches mostly in the back. Slept for a few hours at a time the day after the vaccine. Constant shivers, sweating, vomiting body aches. Took Tylenol before bed, woke up the next feeling. Second day to present some brain fog, but not other side effects continued on.

At 3:15 PM, pt entered observation immediately after receiving his second dose of the Moderna CV 19 vaccine. Pt reported to the RN that he was feeling dizzy (Client reported feeling dizziness after receiving his first dose as well.). Pt also complained of piercing headache above his left eye and pain on the right side of his neck. The pain radiated down his entire left side of his body. The pt also felt tingling in the arm he received the vaccine in. Vitals were initiated and water was provided to the pt. Ice packs were applied to the patients forehead and nape of the neck where he felt the pain. Vitals NOT within normal limits. O2 saturation fluctuating and blood pressure was a bit elevated. Pt reports having a history of hypertension, but could not accurately recall having taken the medication that morning. EMS was activated at 3:35 PM because the pts O2 saturated was fluctuating dangerously and interventions were not successful in relieving the patients symptoms. Vitals were taken approximately 10 minutes apart. Vitals were not WNL. Pt continually reported that the pain was increasing and beginning to feel unbearable. It was noted that the patient had increasingly poor circulation in the arm he received the injection. O2 was taken on the opposite arm and saturation levels appeared normal. EMS at 4 PM. Vitals were taken, all WNL. Patient left with EMS at 4:05 PM and was transported to Hospital.

Severe vomiting (at least 8 times) and diarrhea in the evening. Elevated temperature (99.2-99.5°F) with chills and other fever-like symptoms. Muscle ache around injection site, but no redness or swelling. The morning after, experienced mild fever (temperature 100.3°F) and fatigue.

Day after receiving vaccine, patient notes progressive leg swelling, facial puffiness, and feeling of neck fullness. He estimates he has gained about 20 pounds. On 4/11, he was seen at an emergency room and diagnosed with new onset nephrotic syndrome.

The night of the shot, I began having symptoms: fever, shakiness, headache, nausea, neck pain, severe arm pain, and tiredness. My fever remained at 102 until the following morning when I began taking Tylenol every 6 hours for the fever. The tiredness, headache, neck pain, and arm pain lasted until 4/16/2021 (4 days).

30 seconds after receiving the Moderna Vaccine patient passed out; Fell to floor after passing out; Body was stiff when fell to floor; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Cephalexin). Concomitant products included VITAMIN B COMPLEX (VITAMIN B CO) for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out) (seriousness criterion medically significant). 03-Apr-2021, the patient experienced FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor). On 03-Apr-2021, LOSS OF CONSCIOUSNESS (30 seconds after receiving the Moderna Vaccine patient passed out), FALL (Fell to floor after passing out) and MUSCULOSKELETAL STIFFNESS (Body was stiff when fell to floor) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reported mentioned that ambulance was called after the events and paramedics monitored the patient in the ambulance, patient had stable vital signs and it was offered it take him to the emergency room, but patient declined.; 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.

Moderna COVID?19 Vaccine EUA Intense chills and muscle spasms. For approximately 15 minutes I felt cold, and my whole body was shaking. After the cold feeling subsided, the muscles in my legs and lower back locked up and I had to work very hard to get them to relax for several minutes. This event only happened one time and I have felt completely fine since.

rapid heart rate (almost always over 100) for entire day after vaccination, exacerbation of existing pains (neck pain, spasm of anal fissure)

Pain in arm at injection site started about 3 hours after injection. Full muscle pain and painful to lift or move arm for next 3 days. Dizziness/lightheaded starting around 7PM after moderate walk, then persisted for next 3 days. Fever of 99.5, strong chills and shaking, and mild nausea started at 10PM as I prepared for bed, persisted through the night, but chills and nausea gone in morning, and fever mildly subsided. Took NyQuil before going to bed to treat fever. Chills returned next night, but much milder than before and for shorter. Took ibuprofen, 2 tablets twice a day for next two days. Dizziness and mental fog persisted until 3 days after injection.

On Sunday April 25th 2021, I woke up with severe chest pain that went up to the right side of my neck, as well as having shortness of breath. I was admitted into the ER and they ran blood work, did a CT scan and x ray of My chest. When my bloodwork came back, it showed I had very elevated troponin levels. Because I was having continuous pain, I was given morphine but it didn't work. So they upped it and gave me dilaudid and that took the pain away. It was in the doctors best interest I get transported to a facility with a good cardiatric team. Upon arriving to the new facility, they further drew my blood and ran more tests. I got admitted as an in patient on the cardiatric floor. The cardiologists ordered for me to have an echocardiogram done, another CT scan with a special protocol to view my heart, and an MRI done of my heart. After my echocardiogram and CT scan came back fine, the doctors said they'd be surprised if the MRI DIDNT show something. When that result came back, it did reveal my heart was still inflamed. After ruling out all other possibilities they concluded that the 2nd Dose of Moderna COVID vaccination I'd received was the culprit behind my diagnosis. My diagnosis being, a case of myocarditis as well as a mild heart arrhythmia. For the next several months I am kn a medication called metoprolol 25mg, 2 half tablets a day, to correct my heart arrhythmia and relieve stress from my heart as well as minimize the amount of stress I encounter each day. No heavy lifting pushing or pulling of any sort for the next 3 months.

Experienced muscle pain, severe chills (3 hours), nausea and vomiting, and a high fever - I had contracted COVID-19 back in October 2020

A few seconds after shot, pt became pale and immunizer asked if he was ok. His muscles tensed and shook a little and he passed out, falling slightly to the right. The technician was able to place herself between him and the floor and slowly lower down, leaning against the wall of the pharmacy. By this point, about 30 seconds at most had passed, and pt was awake and cognitive, but had no recollection of passing out or how he had gotten to the floor. He did know his name and where he was, but was breathing heavy. We took his blood pressure at this point and it was 82/46 with a pulse in the 40's as well. Pt refused ambulance and we had him continue to sit on the floor. Patient mentioned he had this type of reaction in past to other vaccines (not stating what), though only telling us prior he had "slight dizziness once". He also stated he had not had anything to eat or drink that am so we got him a snack and some water. Patient continued to breath deeper as we suggested and stay on the floor as we called mgmt from the store. We took blood pressure about 10 minutes later and it had gone up to 117/71. and then again 10 minutes later and it was 121/69. After 30 minutes total, pt asked if he could stand and leave. He stood with no dizziness and said he felt "fine". We called patient approximately an hour later at his residence to make sure he got home ok and patient stated he had no other symptoms at that time and continued to feel "normal".

patient describes facial swelling for several days after vaccine administration, a diffuse rash that has mostly resolved on arms and trunk of body , and persistent joint pain to the shoulders, hips, and knees

Patient's mom called at pharmacy on 5/17/21 to report patient experienced side effects like muscle aches, headache, 101.8 fever at night on 5/15/21, spine and teeth ache and injection site was elevated and hot to touch. Mom said patient felt better after taking Tylenol and most side effects have subsided, but she just wanted to report about side effects. Patient feels much better today (5/17/21) so mom said they are not planning to make doctor visit.

Vaccination 5/6 5/7 generalized myalgias 5/8 felt improved / able to golf 5/9 admitted to local hospital / hospital transferred to another hospital acute pericarditis

PATIENT WASN'T FEELING WELL AFTER VACCINE (WAS A LITTLE NERVOUS) AND ASKED FOR SOME WATER. PATIENT SAT DOWN IN WAITING AREA WHILE I WENT TO GET HIM A DRINK. WHEN I CAME BACK PATIENT WAS RIGID AND LOCK JAWED AND NOT BREATHING. WHEN WE GOT PATIENT TO FLOOR HE WAS RESPONSIVE TO A STERNUM RUB AND HAD A PULSE. AT THIS TIME HE STARTED TO PRODUCE SNORE LIKE NOISES, CONVULSED FOR LESS THAN A MINUTE THEN CAME BACK TO. EMT'S CAME AND CLEARED PATIENT. PATIENT STATED HE HAS A VASOVAGAL REFLEX HOWEVER HAS NOT HAD AN INCIDENT IN MANY YEARS. IT IS UNKNOWN IF THIS IS WHAT PATIENT EXPERIENCED OR A REACTION TO THE VACCINE.

Moderna COVID-19 Vaccine Injection site pain and hardness. 100.4 degree Fahrenheit fever, chills, muscle pain. headache. body fatigue. By now, most symptoms have subsided. But, I still have injection site pain.

I felt really weak after my second dose. I was very sore and tender to even move. I was also stated to look puffy in my neck and chest area. I was diagnosed with Myositis and Rhabdomyolysis. I was hospitalized overnight to keep fluids flushing through me due to the muscle count found in my blood.

Patient was not vaccinated at our site, so I do not have information regarding lot number, etc. Vaccinated with dose #2 of Moderna vaccine 10 days prior to admission. Patient began feeling poorly, with fatigue and weakness the day following his vaccination. 10 days post vaccination, mother found him with right arm weakness, facial droop, and tongue deviation. Patient was severely encephalopathic with moaning, eyes deviated, unable to follow commands, diaphoretic. No focal deficits noted. CT head negative for acute finding. Platelet count low at 24,000. LDH elevated at 2856. UDS negative. Patient suspected to have aTTP and treated appropriately with high dose steroids, plasmapheresis, and rituximab.

24 year old otherwise healthy male presents to the emergency room with complaints of chills, myalgias, and mild headache beginning last night after receiving the second shot of the Moderna COVID-19 vacination. The patient denies fevers, abdominal pain, leg pain, weight loss, night sweats, worst headache of life, sick exposures, or recent travel. Symptoms consistent with expected post vaccination reaction following the 2nd Moderna COVID-19 vaccination. No evidence of life threatening pathology and doubt pneumonia, myocardial infarction, pneumothorax, meningitis, PE. Patient tolerating oral fluids and solids without difficulty. Will treat symptomatically, place on 48 hours quarters, and arrange follow up with primary care practitioner. The patient was given strict return precautions and was comfortable with the plan. Discharged to a safe ride home.

Extreame left arm pain. Tender to touch and movement. Unable to sleep at night due to discomfort and pain. Unable to lift arm above head due to pain level. Pain has not decreased at all.

Headache, fever, chills, fatigue around 18 hours after shot. Additionally, I woke up the morning after to pain in my toe, which spread to my foot and groin lymph nodes. I eventually went to the ER and was told my toe was infected. I had previously had a small cut on my toe and the doctor believes that the inflammatory response my body initiated from the vaccine exacerbated this infection.

Injection site pain starting evening of 1/8/20. Mild swelling and severe pain at injection site morning of 1/9/20. Moderate progressing to severe headache, and intermittent chills all day; no fever. Reduced appetite. Mild muscle pain/stiffness.

After receipt of the vaccine, I developed a low grade fever the next day (1/7/21) that persisted throughout the day until it progressed into a fever of at least 101.3 F at night. It might have been higher, but that was the best reading I could get. It felt like the fever came on extremely fast bc all of a sudden I started shaking vigorously with rigors and chills. I couldn't get out of bed without experiencing the most uncomfortable chills I've ever experienced. I previously had Covid in early November, and this fever felt worse than what I experienced when I actually had Covid. Also, I experienced moderate to severe pain in my left arm on 1/7/21 at the injection site, which was far worse than any other muscle soreness I've experienced from any other vaccine I've received. The hour preceding the sudden fever attack, my left arm was feeling blazing hot, looked a little red, and swollen. I also experienced a strange allodynia type pain, whereby parts of my body hurt from simply touching them. Although I did not develop a significant rash, I experienced pruritus all over my body, predominantly affecting the areas around my ankles and wrists. I have a hx of multiple dermal filler injections in my lips. I don't think I had any problems with my lips after the injection. But other symptoms that I developed included a tickle in my throat and some shortness of air. On 1/8/21, I woke up drenched in sweat so I presumed that I broke my fever while sleeping. I have felt much better ever since. I'm a nurse practitioner student, and I had to miss a day of clinical on 1/8/21 bc of this reaction to the vaccine. I used ibuprofen the morning on 1/7/21 and Tylenol at night on 1/7/21 to bring down my fever

Became pale and lightheaded. Vision faded to almost completely black, but was remedied by lying down. After lying down I heard a static/white noise sound in my ears that progressively got louder. It hit a peak volume then slowly started to get quieter until it went away. Muscle soreness in injected arm.

Headaches and fatigue onset the night after the injection, and have persisted through today. The morning after receiving the injection, I had a migraine, nausea, fatigue, severe muscle aches, and fever/chills. All symptoms except headache and fatigue resolved by the next morning.

One week following the vaccine: muscle aches and chills, fever to 101.3. The following morning no symptoms and no fever

Low grade fever presented about two hours after vaccination (99.7- 100.3) Fever went away by next morning, but by noon (15 hours after vaccine) pain in the low back started. No fever but intense pain in back. We believe the vaccine may have triggered a sickle cell crisis.

During the first night after receiving vaccine I started to have SEVERE shaking / full body muscle spasms-hypertonicity that lasted 60-90 minutes. Required 30 minutes hot shower to calm down shaking symptoms. Initially thought episodes were caused/triggered by cold temperature (still possibility) but now thinking its triggered by anxiety. Heart rate almost spikes to 120-130 BPM. No fever and normal blood pressure is noted when episodes happen. Occurrences is not routine and seem to be random. Very concerning considering symptoms lasted for 2 + weeks now. I do not have health care or ability to see PCP/GP without paying out of pocket. Now please understanding the severity of these episodes, to the point where it resembles severe Parkinson's symptoms. Along with those I still have the normal side effects, fatigue (extreme) , mood changes, joint aches, intolerance to cold off and on, and elevated HR.

Headache Chills Fatigue Muscle aches Arm pain All beginning 24hr after receiving dose throughout the day

I got the vaccine around 12:45 on a Monday - 1/4/21 4pm that day, started having a massive headache, laid in bed. Laid in bed all day, fell asleep around 10PM. 3:30AM woke up panicking with fever, tremors, chills, myalgia and very lethargic. Got out of bed to get tylenol and was shaking. Tuesday morning - woke up feeling the same as I did at 330 AM, plus no appetite on top of headache, chills, myalgia, lethargic and slept pretty much all day, felt fatigued. Wednesday was doing better, thought it was the end. Then suddenly about 7-8pm started having chills and shivering. I would say Thursday night is when I actually felt better and by Friday morning I was good with just residual ?brain fog/feeling dazed?

Received vaccine around 8am. At 10am noticed very minor aches. By noon noticed aches progressing but still minor. By 4pm noticed aches and fatigue. By 8pm had body aches, malaise, headache, and pain at injection site. Middle of the night had fever of 101F and body aches/muscle pain, chills, headache. Fever was gone by morning (99F at 9:40am on 01/29/2021). Body aches are slowly going away.

Vaccine given on 1/28/21 at 10:25 am. Mild muscle aches began later on in day, more than 6 hours but less than 12 hours from administration. At around 3am on 1/29/21 severe chills, headache, and fever of 104.3 F began. Chills, fever, and headache continued throughout the next day. At 7am, fever reduced to 101.1 F. Tylenol was taken at 7am. At 10am fever remained and Ibuprofen was taken. Around 11am fever was reduced to 98 F. Tylenol and Ibuprofen continued to alternate every 3 hours. Temperature has been controlled with alternating therapy, although waves of chills and heat flashes remain. Headache was never reduced with therapy. In addition, adequate amount of water was taken throughout the day beginning at 7am on 1/29. Muscle aches subsided around 7am on 1/29.

Patient received his 2nd dose of the Moderna vaccine prior to hospital admission at unknown site. Patient reported generalized body aches and that his whole body hurts and feels likes he's "being poked with a knife." He endorsed associated symptoms of fever, nausea, back pain, and shortness of breath. The patient denies any sore throat, headache, cough, or vomiting. His back pain is at the tip of his shoulders, in the middle of his spine, and near his kidneys. The patient adds the abdominal pain is worst in the lower left quadrant. Patient admitted for bilateral lower extremity weakness limiting him to ambulate and to rule out Guillain-Barré. During admission, had fevers, photophobia, phonophobia, and nuchal rigidity. On physical examination patient was able to minimally wiggle toes, had no plantar/dorsiflexion, unable to move hip joints or knee joints bilaterally, lift his legs against gravity.

24hrs after vaccination severe myalgia, chills, headache, nausea, diarrhea, swollen lymph nodes, loss of appetite, and fatigue continued into 02/02/2021

Almost 12 hours post-injection, I experienced a rapid onset fever, soreness, muscle aches, dizziness, high blood pressure, headache. Upon awakening the following day (today, 20 hours post injection) severe allergies around eyes. 24 hours post injection, all day today, fatigue, severe dizziness, soreness, headache, high blood pressure, loss of appetite, and labored breathing.

Received 2nd shot on 2/5/2021 at 5:20pm. Was fine until I woke up at 5:30am on 2/6/2021 for work. I experienced extreme aching joints (especially in my neck and back), muscle aches (especially on back), fatigue, exhaustion, headache and chills

Fever, chills, headache, muscle aches throughout body, sore at vaccination site with a short lived rash, fatigue. It was bad enough to halt daily activities (I canceled a phd interview because of how bad I felt). This occurred from late 2/4 through morning of 2/6. Taking tylenol seemed to help and I felt immensely better the two or three times my fever broke.

Fever of 101°F for over twelve hours, only slightly ameliorated by acetaminophen, body aches, soreness in shoulder, dizziness, trouble walking, hot and cold periods.

COVID-19 Vaccine EUA. Painful/sore at site of injection; left arm approx. 2-3 hours after injection. Also within 2-3 lower back pain/soreness. Night of vaccine, shortness of breath, full body aches/soreness, fever, fatigue, headache, chills, and nausea which followed into next day (today).

PT C/O FACIAL FLUSHING, FATIGUE, PAIN IN JOINTS AND A HEADACHE. VS @ 10:46 AM BP 124/93 HR 78 SpO2 98% PT REACTION RESOLVED WITH TIME AND HYDRATION WITH GATORADE.

Extreme fatigue; nausea and vomiting; 103.4 F fever; joint and muscle soreness; uncontrollable shivering

Delayed rash/swelling at injection site. Reaction began 9 days after vaccine. Pain, redness, numbness, itching, muscle weakness, pain in neck (also left side), fatigue. The rash/swelling is about 4x4 inches

Within 7 hours had mild headache low grade fever, mild myalgias; Next day fever to 102.4, severe headache, severe myalgias; Following day felt better but has maintained low grade fever to 100.4 for for 7 days since vaccination. 12th day still have headache, started to feel numbness in Left arm below elbow.

Injection site swelling, redness, and discomfort, fatigue, muscle soreness, chills and feverish symptoms (no fever, temperature never over 98.6)

Patient sat down to wait 15 minutes after the vaccination. other patients observed that he appeared to fall asleep then his eyes rolled back in his head and he went rigid and his body flexed straight out. another patient prevented him from falling out of the chair. i went out immediately to check on him and he came out of it. it lasted about 30-45 seconds. his color was not good so i instucted my technician to call 911. he was taken to the store directors office and the paramedics examined him and said everything appeared normal. he suffered no more reactions.

Tightness of right side of jaw. Difficulty chewing and pain when light pressure is applied. Pain extends along jaw to right ear

First dose: some arm soreness and little pain during this time Second dose: did not start off that bad, felt pain when moving arm around (lifting arm) around 3-4pm - felt feverish (about 12 hours after dose), couldn't sleep, felt chills and that lasted until next day - few hours after injection until the next day, felt generalized exhaustion, muscle aches and fatigue - few hours after injection felt nauseous and it went away after waking up from night sleep the next day - took ibuprofen 800mg around the time of injection and then took another ibuprofen 800mg in the evening

Started to experiment COVID-19 like symptoms the next morning after I received the vaccine. The symptoms included headache, nausea, muscle aches, joint aches, fatigue, fever, and chills.

Symptoms of mild COVID. Loss of taste, smell starting 4/10. Fatigue and muscle soreness starting 4/9, at approx 3 PM. Nasal congestion starting 4/9 early AM. Chills, fever 4/10.

Vomiting for 2 days, first day around 10 times, second day 4-5 times. Muscle weakness overall body 5 days, lower back muscle pain, ongoing. Nausea (bloating, gas, etc.) ongoing. Headache ongoing.

Arm pain after the shot. Last and worsen over a day. Very painful now. ~24hr after the shot Flu like symptoms: muscle pain all over the body, headache, skin very sensitive/irritable. Whole body is weak. Mild lower abdominal pain. Affected normal life by a large degree.

Patient is a 25 year old male A & O x4 with a chief complaint of a syncopal episode. Patient was sitting in a chair in the observation area approximately 10 minute post vaccine. Patient struck his head when he fell and presented with a small abrasion on the top of his head complaining of neck pain 1/10. Cervical spine immediately immobilized and EMS activated. Patient stated that he has had similar events in the past when he had his blood drawn. Patient denied any other medical history, no allergies and stated that he takes no medications. Vital signs obtained with all vitals within normal limits. Patient stated that he felt slightly dizzy but denied any other complaints. Negative chest pain, SOB, weakness, blurred vision, tinnitus, nausea and no sign of allergic reaction. Patient had equal grips and pushes with no signs of stroke. Medic Engine with EMT arrived and assumed patient care. Patient went via ambulance Hospital.

Vaccine (Moderna) given on 4/2 On 4/17, patient noted back pain radiating toward abdomen. Developed rash in same area of pain on 4/19- Seen on 4/20 and diagnosed with Herpes Zoster. Followed on 4/23 with same diagnosis.

I woke up with pressure on my chest and pain on my left arm around the elbow. After a couple of minutes, I began to have a lot of cold sweat, and both the pressure in my chest and pain in my arm began to increase. Then I began feeling a tingling sensation on my neck/chin. After that, I felt lightheaded and decided to go to the hospital. At my arrival to the ER, I was given aspirin and heparin. I got a couple of EKGs and a chest X-Ray, as well as some blood work. I was then transferred to the medical center, where I had some more blood tests and EKGs done. I was also treated with Indocin, Lipitor and Aspirin. At around 9PM, I began feeling the pressure on my chest again, although with decreased intensity. I was given morphine and the pain went away. This event repeated at around 10AM next morning with the same outcome. After that I got an Echocardiogram, and began to be treated with Metoprolol. No other pain events happened for the rest of my stay at the hospital. On the next morning, April 26th, I was taken to an angiogram to rule out Coronary Dissection. After the test, I was discharged with a prescription for Metoprolol.

Shortly after receiving the vaccination the patient began to feel light headed. He stood up and fell back to the floor, landing in a sitting position and not striking his head. He was helped into a chair by a bystander and I was alerted to the situation. He appeared pale and diaphoretic, then he became unresponsive with his eyes up and his arms tensing up. After about 10 seconds he became responsive again. EMS had been called earlier and arrived a few minutes after this and he was evaluated and left with EMS. It was unclear if he had simply passed out or if he had a seizure. He had no previous history of seizure, though the presentation seemed somewhat atypical for just passing out.

Symptoms: Fever, chills, joint pain, muscle aches, fatigue, headache Treatment: Acetaminophen Outcome: Reduced fever and pain after 15 minutes of 1000mg acetaminophen Time Course: all day 2021-05-06

Side Effects: Headaches, Dizzness/ Syncope, Opposite arm pain, wrist pain, (R) shoulder blade pain and stiffness. Painful non healing rash on buttocks, Rash on (L) arm, large lump on (R) side lower back of head DR's Visit ER Visit

Muscle aching and sometimes twitching. Dizziness of the head and stomach. Extreme nausea of head and stomach. Vomiting. Suppressed appetite. Great pain in head and stomach. Extreme fatigue and weakness. Symptoms peaked 24-36 hours after injection and were mostly gone after 3 days. Fatigue and weakness took a week to fully disappear. Seemingly no lasting symptoms.

Started to feel muscle aches and sore arm about 7 hours after shot. That progressed over the next 2 hours into a mild fever (99 degrees) with aches and body chills. Fever grade 100 by middle of night 12 hours after vaccination. 400MG of advil consumed, Fever went away for 3 hours and then came back (101 degrees). Fever, aches, and chills persisted until I was 28 hours post vaccination. The following night (Hours 32-42) patient experienced hot flashes woke up Sunday morning (42 post vaccination) with headache and sweats. The sweating persisted throughout the day and into the whole night where patient experienced profuse sweating enough to soak the mattress. At the time of submission, it is unclear whether the night sweats have resolved.

Pt developed upper body pain 5/17, then back and chest pain 5/18. + Troponin. CT showed LMCA and RCA SCAD. Cardiac MRI showed active myocarditis.

motion sickness in car; micro movement of the eye; lack of focus of the eye; prolonged dizziness; intense headache; Dropping blood pressure; Myalgia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOTION SICKNESS (motion sickness in car), EYE MOVEMENT DISORDER (micro movement of the eye), OCULAR DISCOMFORT (lack of focus of the eye), DIZZINESS (prolonged dizziness), HEADACHE (intense headache) and HYPOTENSION (Dropping blood pressure) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MOTION SICKNESS (motion sickness in car) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (micro movement of the eye) (seriousness criterion hospitalization), OCULAR DISCOMFORT (lack of focus of the eye) (seriousness criterion hospitalization), DIZZINESS (prolonged dizziness) (seriousness criterion hospitalization), HEADACHE (intense headache) (seriousness criterion hospitalization) and HYPOTENSION (Dropping blood pressure) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYALGIA (Myalgia). At the time of the report, MOTION SICKNESS (motion sickness in car), EYE MOVEMENT DISORDER (micro movement of the eye), OCULAR DISCOMFORT (lack of focus of the eye), DIZZINESS (prolonged dizziness), HEADACHE (intense headache), HYPOTENSION (Dropping blood pressure) and MYALGIA (Myalgia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg (Low) Dropping blood pressure. On an unknown date, Cardiac stress test: (Inconclusive) Inconclusive. On an unknown date, Magnetic resonance imaging: (normal) had a cyst but nothing that would cause symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication includes antibiotic for cyst, 25mg 3xday meclizine for inner ear, and Midodrine HCL 10mg for dropping blood pressure and 10mg Pregnisone for inner ear inflammation. Patient underwent VNG test had no inner ear inflammation and noticed micro movements of the eye No concomitant medication information were reported Caller wanted to report adverse event. Callers first dose was on 12apr21, LOT#040B21A, Expiration date 10/2/21. Caller said his life has been upside down since he got the shot. First week had intense headache and dizziness. Second week he had muscle aches and dizziness with limited headaches. Third week he is having a focusing and dizziness issue. Caller said he seen doctor and specialist. Caller had MRI and Stress test. Caller said MRI came back clean. Caller said they had a cyst but nothing that would cause symptoms. Caller said Brain scan came back negative. Caller said he was completely heathy. Caller said he also gets motion sickness now since he had the vaccine. Primary care doctor gave antibiotic for cyst. PCP thought had something to do with inner ear, 25mg 3xday meclazine, then the gave Midodrine HCL 10mg for dropping blood pressure. Caller said he got relief for 3 days then he started getting sick. Caller went to ER and they took him off the medicine. Caller when to a ENT doctor. Caller said took VNG test. He was prescribed 10mg Pregnisone for inner ear inflammation. The VNG test proved he didnt have inner ear inflammation. Caller said his symptoms have been going on for 32 days as of yet. CAller said he cant go to restaurants because of dizziness and sickness. Caller said during his VNG test they noticed micro movements of the eye. His ENT thinks this may be causing the dizziness and lack of focus. Caller said he will travel to anywhere to get help.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information regarding detailed medical history and diagnostics will help in assessment.

Patient was administered Moderna vaccine at 1744 and at ~1800, he was no longer seated in his chair and was lying on the floor. Appears to have a slight tremor to upper torso and stiff muscles viewed for ~3-5 seconds. Also patient had a blank face and stared blankly for less than 5 seconds. Patient was able to answer orientation questions as to name, date of birth and where patient current location was. Assisted patient to a sitting position on the floor. No physical injuries noted. Patient was steady when moving from a seated position on the floor to standing and then lying onto the gurney. Patient denied dizziness, lightheadedness. Patient reports he had been drinking alcohol the night before and had eaten one time today at 1300 and drank only 1 bottle of water. Beginning vital signs were HR 4; O2 sats 99%; BP 96/64. At 1820 vital signs were HR 57; 02 sats 99%; BP 110/70. Patient asked to consume 500 cc of water during last 15 minutes of evaluation. Patient did not want any further treatment and a friend took him home after monitoring completed.

The day after the vaccine, reported typical reactions including aches and pains, which improved the following day. The Monday after noted snoring, which was atypical but consistent with the ear infection and seasonal allergies. Sometime on midday Monday 5/24 Pt died. Was found in his bed at approximately 6pm with rigor already set.

Mild Chest pain began to occur roughly a week after vaccination. Two weeks after vaccination it had processed to severe bouts of pain accompanied with dizziness and fatigue. After about a week of severe pain, the pain began to taper off and seemed to move from my chest more into my armpit and arm. A swollen and painful lymph node occurred in my left armpit roughly 2 weeks after severe pain had started. The lymph node is currently still swollen but it's getting mildly better. Chest pain is not entirely gone but it's also getting better slowly.

In addition to CDC expected symptoms (swelling of the face, tiredness, headache, muscle pain, chills) I experienced nausea, coughing, sore throat, vomiting or gaging after food or coffee.