Moderna

soreness, stomach problems, constipated took prune juice, milkamagnesia, next day felt, bad chills, has not gotten out of bad, no energy, weak feeling in her legs, 3rd day hand were very hot, have no energy at night lots of chills, pain between shoulder blades, no apatite, pain in legs and still weak today.

Pt exam 2/25/2021 found swelling to left hand from wrist to fingers with discomfort in left arm which began 2/13/2021. No erythema noted. No clubbing, cyanosis. Treatment - Patient advised not to get 2nd vaccine.

Sudden extreme muscle weakness. Fell to the floor. Could not use arms or legs to get up. Was on the floor for several hours until someone came home and called for ambulance.

Started in her back and goes across her back, shoots down the middle of her back and both sides. Front in the ribs and around the breast - chest pains. Exhausted - energy is gone. Can't do normal activities that she was able to do prior to vaccine. Sharp pains. When I breath or cough/sneeze or laugh it hurts. Had some relief from heat and cold packs. Left knee has hurt a lot since this happened, too.

Within a couple days of second shot, legs became very weak, one was swollen and the other was atrophied. She can barely walk as a result. Can't keep eyes open, can't smile and trouble speaking. Back pain and all over pain.

patient reported to office on 1/26/21 complaining of SOB with lying down. Pain at sternum/shoulders/neck. She felt like she was being squeezed.

4/30/21 weakness and tremors in all 4 extremities, febrile 39.8*C, observation hospitalization 4/30/5/1/2021

Patient reported 'no problem with the first dose' administered on 4/09/2021. Approximately 3 minutes after administration of the second dose patient reported a sharp pain in the middle of her back that radiated down her spine to her 'tail bone'. Staff phoned 911 which arrived within about 5 minutes. Patient reported no other symptoms other than the excruciating pain in her back. Pain was subsiding somewhat by the time EMS arrived. Patient began feeling weak in a couple of minutes and was transported by EMS to local hospital for further evaluation.

The morning following vaccination, patient stated her right ankle was swollen. Over the next few days the rest of her right foot swelled, which is the current state. She described it as "pulling" feeling when asked to describe how it felt. (It looked slightly swollen compared to her left foot). Recommended she see her doctor, which she agreed to.

severe muscle aches in various locations and left shoulder pain with dose 1 of Moderna COVID vaccination on 3/3, which worsened after the 2nd dose on 3/31 and have continued to worsen to the present (6/2/21)

Patient described onset shoulder pain approximately 1 week after 2nd covid vaccine injection. Patient presented to PCP office on 4/5/21 for initial evaluation following pain with no resolve after trying exercises etc. At this time during evaluation PCP discussed possibility of vaccine related injury. Since this time, patient has undergone oral pain medications, PT exercises, and steroid injection, TENS treatment. Seen today 6/24/21 for continued evaluation. Major ongoing symptom is near constant pain. Bothers even at night, making it hard to sleep. Does not use arm because of the pain. Painful if tries to reach behind herself. Does not feel she is improving. PCP diagnosed as SIRVA, and next plan is MRI of shoulder.

1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was "cardiac event" according to death certificate.

patient states that last Thursday she had the COVID vaccine in her left arm. Friday night her back, hips and knees started hurting bad. she contacted Maderna who told her that no complaints have been made regarding this type of reaction and to see her pcp. her daughter states that on Friday the patient did a lot more walking than normal and she started hurting after that. patient states that the pain has not easeed up since and that it has gotten worse. pain described as throbbing. in both hips and across the lower back. pain level when sitting in office 7-8/10 while standing or walking 10/10 adds that the pain eases up slightly when sitting

Other meds; potassium chloride, VitD3, super B complex, Cal-mag-zinc. Increased neuropathy with increased pain, stiffness, myalgia, arthralgia, prickly skin feeling all over, sensitive. Criteria for reporting: states saw Dr. 1-18-21, prescribed steroids. Took prescribed pain meds and prevented her daily activity; Grade 3 for pain and fatigue, myalgia, arthralgia.

Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Additional Details: Pt experienced lower back pain, difficulty breathing, dizziness, light headed, shaking more than normal, cold, felt like she was fainting

-Right closed, same side as vaccine -Right side of neck distended and stiffness, same side as vaccine Symptoms relieved within 12hours Patients physician consulted, recommended if family felt uncomfortable receiving 2nd dose, avoid

24 hours after-headache- sinus type 48-hours -after- headache and body aches particularly left buttock 72- hours after- all of above plus 100.2 fever, extreme body aches, chills and could barely walk 96 hours after- symptoms going away, 120 hours after- only headache remained and red spot on left arm developed One week later all symptoms gone

extreme muscle fatigue confusion/disorientation patient fell out of bed and daughter was unable to help her get up; paramedics were summoned; patient transported to ER; next day patient had absolutely no memory of anything that happened; she was totally confused as to why she was in the hospital or how she got there; two days later she is absolutely fine except for being very tired

extreme pain in her chest and abdomen on the R side of her body (around the heart); had very high blood pressure; The vaccine worsened her constipation problems; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (had very high blood pressure) and CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension. Concurrent medical conditions included Constipation. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (had very high blood pressure) (seriousness criterion hospitalization prolonged) and DEHYDRATION (Dehydration). On 29-Mar-2021, the patient experienced CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) (seriousness criterion hospitalization). On 20-Apr-2021, the patient experienced JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore) and ARTHRALGIA (legs, feet, and ankles are swollen and sore). On an unknown date, the patient experienced CONSTIPATION (The vaccine worsened her constipation problems). The patient was hospitalized on 29-Mar-2021 due to BLOOD PRESSURE INCREASED and CHEST PAIN. At the time of the report, BLOOD PRESSURE INCREASED (had very high blood pressure), CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) and DEHYDRATION (Dehydration) had resolved and JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore), CONSTIPATION (The vaccine worsened her constipation problems) and ARTHRALGIA (legs, feet, and ankles are swollen and sore) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: 217/157 (High) 217/157. Concomitant medications include Vault to treat constipation. Treatment included amlodipine tablets. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Significant decrease in ability to function physically and mentally. Increased confusion. Unsteadiness resulting in two falls. Weakness of muscles. Facial numbness which lasted for several hours. These symptoms showed up within a few days of the second dose of the Moderna vaccine. The effects lasted for about one month. Since then, the person is back to normal functioning with no weakness, or confusion. She is doing well now but for one month following the Moderna vaccine was very debilitated and unable to function in normal activities of daily living.

Feeling tired, nauseated, vomiting. She fell and had to have assistance getting up, Afterwards, had some weakness in legs. She did have COVID in July. Still having some weakness. No pain.

Patient had complaints of joint and body aches and pains, generalized complaints of not feeling well and fatigue.

developed joint and body aches and pains, generalized complaints of not feeling well and weakness. She fell as a result of weakness. Physician ordered her to be sent to the ER

Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to ‘possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest

SWELLING AND PAIN IN HAND AND WRIST IN RIGHT ARM (WHICH IS THE ARM THAT WAS VACCINATED). PAIN AND HEAT AT SITE OF VACCINATION. INTENSE ITCHING, SORENESS AND REDNESS WHICH BEGAN 2 TO 3 DAYS AFTER VACCINATION OVER INJECTION SITE. THE PINK/RED, ITCHY, RASHY AREA HAS NOW DESCENDED TO HER ELBOW, IS SLIGHTLY SWOLLEN, 3 INCHES BY 5 INCHES (NO LONGER OVER INJECTION SITE)

Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.

Joint affected in left groin/hip area. Cannot put weight on left foot. Difficulty walking or standing. Using cane to take pressure off left foot.

Received the vaccine had no reaction, no temp, no headache. She felt a little funny, and possibly a week later she started getting reaction in her body, burning sensation in her chest, possibly thought related to acid reflux. She then had sensation down her leg nerve pains. Sometimes she also gets some hot flashes but they go away. She woke up early in the morning yesterday and had a pressure like sensation in her head, she still has that today. She still has burning sensation in her chest, and her legs and ankles are hurting still. She has taken some Tylenol for the aches and pains. Also has itchiness of her arm from the vaccine, as well as soreness.

Approximately 4 hours after receiving the Moderna COVID-19 vaccine (left-arm), my mother began to have moderate pain in her left arm, particularly in the left shoulder area. The pain continued to increase throughout the afternoon, until it became so severe (10 on a 10-point pain scale) by 8:30 pm on 3/10/21 , that she could no longer lift her arm. She took 500 mg of Tylenol to attempt to relive the pain and went to bed early. At 2:45 am on 3/11/21, she needed to go to the restroom, and I (daughter) had to assist her to get out of bed, as she had no use of her left arm due to severe pain in that arm. While seated on the toilet, she indicated that her arm was extremely painful and she felt that she was going to pass out and felt nauseated. Within a minute, she lost consciousness and I called emergency services. EMT arrived within 5 minutes and stated that her blood pressure was extremely low and she needed to be placed on the floor. They placed her on a gurney and took her to the ambulance, where they started an IV and took her to her local hospital. I followed shortly thereafter, where she was taken to the ER. She was admitted to the hospital for observation and given Ativan (she refused any opioids) She was ultimately diagnosed with vasovagal syncope due to the pain in her left arm. Two days later, the pain has subsided.

She started feeling poorly the day after vaccination. She had flu symptoms with body aches, headaches and joint pain and thought I had the Covid-19. Called ambulance and they did a test but it was negative but did not go to the Hospital. I felt fine the next day,

1st: Mild arm soreness with first shot that went away in a few hours. Loose stools beginning a couple days after shot and lasting three days. 2nd: Mild arm soreness X 1 day. Unformed stool beginning four days after shot and continuing four days to present. Uncertain how long it will continue. Severe whole body edema beginning day five. Particularly pronounced in L arm that received Moderna Vaccine. Also aches in Left shoulder, and whole body muscle aches. She has had some edema in her lower legs and feet, but NEVER in her hands, face and torso. In retrospect, we should have avoided using her left arm to vaccinate due to lymph node removal.

She got the vaccine, the first day it was very very mild until later. Then it started hurting in the back, but the arm did not hurt at all the first day. Four days later it started itching bad, and the 5th day it itched terribly bad. She stated it lasted a long time and stayed hard for several days. She states that she is still having some of the feelings. The 5th day was the worst by the 5th day,. It took a long time for the symptoms to go away.

On 1/14/2021 @ 0659, patient was noted to be weaker, arms were flaccid R>L. Unable to answer questions speech gargled. Unable to grasp hands. Pupils reactive, but sluggish. Probable CVA. Dr. and family were notified. Family wished to keep patient at hospital and provide comfort care rather than send to the hospital. MD was in agreement. APNP, assessed patient. Her tongue was red and swollen. Bite marks noted on right side of tongue likely d/t event. ST evaluation done to evaluate patient's ability to chew and swallow safely due to swelling of tongue. Hospice services were initiated. (Unsure if event was caused by vaccine administration)

vivid hallucinations lasting 48 hrs. saw clowns, ants on floor and crawling up walls, Piles of dirt on floor and furniture that must be cleaned. people sitting on furniture. Man sleeping on patio, people having picnic in back yard, backyard completely relandscaped. floor covered in snakes and lizards, then bedroom full of puppies. She became very agitated if you disagreed. Insisted on cleaning 'dirt'. slept 2 hrs first night. Second night finally went to bed at 4 AM. Woke up at 10 AM and was fine. She has bad knees, and they hurt from all the night's activities. She was combative at times, and insisted that you help clean, sweep, remove 'snakes', etc.

On 1/14/2021 resident began having a loose nonproductive cough. Lungs clear. Increased shortness of breath, Afebrile. Complaints of Left sided rib pain. Resident currently on hospice. Started Duonebs every 6 hrs. Resident also began having loose stools as well.

Sudden pain in left ankle joint about 8 days after vaccine, unable to stand or put weight on that leg for 3 days. Then sudden pain in big toe (inflamed) on left foot still continuing now. Elevating leg gave some relief also took Tylenol.

SOA, hives, anxiety started immediately after getting vaccine. Treated with Benadryl, methylprednisolone, Pepcid. Pt was in ER for one hour and discharged home.

pt has CTCL and has developed more intense itching than usual. Pt has dementia but has had more severe episodes of aggression, confusion and delirium. Her upper left arm is red and has developed more defined lesions around the injections site and on her lower back. Her arm pain and back pain seemed to be heightened more than usual and she also has some fatigue. Pt saw her cancer Dr. on 3/24/21. Dr. made notation in her chart about her symptoms and was instructed to continue the using the cream that she was currently using. Pts PCP is aware of the increased episodes of confusion and being argumentative since taking the vax. Pts daughter is her full time care giver and is dealing w/ her increased intensity of the patients symptoms.

Reports she has pain mainly in her left side. Her legs. She could not bend over as it hurt too bad in the lower back to bend. Could not walk, left side. As of yesterday started on the right side. Now in the ER and cannot raise her right foot up. Slowly worsening.

Patient presented to the ED on 2/19/2021 for gout of left ankle. Patient presented to the ED on 3/7/2021 and was subsequently hospitalized for fracture of right femur. These visits are within 6 weeks of receiving COVID vaccination.

When she woke up around 7:00 AM, she was so called. Around 9:00 AM she was very weak, hurting all over, had diarrhea. She did not take anything for it. Had fatigue, muscle pain, chills, nausea and vomiting. Today, 2/15/21 she is feeling better and is back to normal. Tried calling her doctor but could not get through to them.

Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site A feeling of heaviness in the arm Some Nausea 3 days after injection

Swelling, redness and resultant pain of both ankles, and lower legs worse at the end of the day, improved in the morning. Awakening with swelling of hands (moderate) and face (mild) resolving as the day goes on.

Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization

client had Right side severe joint and muscle pain. barely able to move. large bruise on leg; lasted 7-10 days; saw her provider who thought she should not take the 2nd dose of the vaccine

Patient reports a very sore/painful arm, which radiated up her neck and across to her back. After 3 days of rest, the pain has completely resolved.

Extreme pain in the back, hips and legs upon waking up lasting 3+ weeks. Unable to sit to go to the toilet. Weakness in legs causing a fall. Pain and weakness lessened as day went on only to reappear next morning. Also extreme fatigue lasting weeks.

Systemic: Chills-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Joint Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Fainting-Severe

death. Per son pt was not feeling well after the vaccination "like her legs were weak." Son found the mom in her bed 1am on 2/12/2021 unresponsive.

5 days after injection, had sudden onset of severe back pain, tingling and burning in hands and down legs into feet. Jerking extremities and seizure like activity. Facility staff called for ambulance to transport to ER. No treatment, observed overnight, prescription for Tramadol. Transferred back to facility. Extreme fatigue. Pain manageable with Tramadol. 4 weeks later: extreme fatigue continues.

Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, were considered as 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.

irritated her heart condition; Clot blood; weakness in legs, couldnt walk with legs; Coma; couldn't breathe; stroke/massive stroke in left side of her brain; Irritated her heart condition, rapid heart beat; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain), CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma) and MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disease, unspecified, Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Hypertension, METOPROLOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced CARDIAC DISORDER (irritated her heart condition) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criterion hospitalization) and HEART RATE INCREASED (Irritated her heart condition, rapid heart beat). On 15-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain) (seriousness criteria death and medically significant). On 16-Mar-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization prolonged) and COMA (Coma) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 13-Mar-2021 due to CARDIAC DISORDER, COMA, DYSPNOEA, MUSCULAR WEAKNESS and THROMBOSIS. The patient died on 17-Mar-2021. The reported cause of death was massive stroke in left side of her brain. It is unknown if an autopsy was performed. At the time of death, CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma), MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs), HEART RATE INCREASED (Irritated her heart condition, rapid heart beat), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested. This case was linked to MOD-2021-074814 (Patient Link).; Sender's Comments: This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested.; Reported Cause(s) of Death: massive stroke in left side of her brain

Four days side effect free. On the fifth day, woke with very bad headache which continues (1/27-1/30, so far). Acedaminophen (sp?) helps. Rarely have headaches. Two friends, one 105 and one 65+, developed severe backaches 4-5 days after covid vaccine.

Starting the following morning, significant nerve pain on the left (other) side radiating from shoulder up the neck.

Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.

Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI.

Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia

Flu symptoms, but most notably the loss of muscle strength in her legs. She collapsed and was unable to walk.

Left arm and left leg weakness following administration of the vaccine. She had similar symptoms with a stroke one year ago, but MRI reveals no new acute stroke symptoms. Her symptoms had improved over the course of the last year and worsened after the COVID vaccine.

COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Patient was hospitalized due to worsening condition. Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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 case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient was well 5/13/21 vaccinated 05/14/2021 with second Moderna COVID Vaccine and according to son pt rapidly declined with recurrent falls 5/15-seen in er 5/16 and sent home and cont to have worsening profound weakness presenting to the ER again 5/18 and admitted with Sepsis secondary to right lower lobe pneumonia, right 8th, 9th and 10th rib fractures, syncope/ rhabdomylosis and NSTEMI, profound weakness and new anemia with GIB needing 2 units prbcs. Pt was living independently alone pta with help from his son and was at his baseline up until getting his second vaccine. he was ultimately discharged to nursing home on 5/21/21. he was still too weak to walk or get out of bed at the time of discharge.

developed pain, redness and heat in her left wrist on 1/11/21. I saw her on 1/12 and evaluated it. It could be gout or pseudogout and just a coincidence but we need to fill out a VAERS report on it, just in case.

Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2