Moderna

Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF, A.Fib contributory.

On the evening of January 30 I began having chills and shaking. I then went to bed and had difficulty moving in the bed. I went to sleep. When I awoke on the morning of January 31, I was unable to sit up in bed and had been incontinent during the night. My wife called the paramedics to help get me out of bed and to change my clothing. At this time I refused to go to the hospital. The paramedics wheeled me to my lounge chair in the living room. About 1:00 p.m. in the afternoon I asked my wife to help me get out of my chair so that I could take a shower. I was not able to get out of the chair, stand or walk. My wife again called the paramedics and I was transferred . I was in the emergency room until 10:00 p.m. that evening. I was given some fluids IV. The ER staff had me walk to be sure that I was mobile before discharging me. They could not say for certain if this was a reaction to the Moderna vaccination, but thought it could be. Within a few days I spoke with my primary care physician, who concluded that I did in fact have a reaction to the vaccine. She has recommended that I not get the second shot at this time.

Early next morning he got in his vehicle and drove around (he does not know why).He ended up behind a shell gas station and police were called as a suspious person. His windows werte down and he could not remember how to close them. He had been there for hours and unrinated in his clothing. He told the police he was making sure the waitesses were doing there jobs correctly. Again this was a Shell gas staion and not a resterant. The police closed his windows and sent him home. He hit the side of the house with the truck. Then when he got to the garage he could not remember how to put it in park. He is still having memory issues today but he can carry a conversation. Tuesday he could not complete a sentance

Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021

Pt developed severe fevers, myalgias, headache, inability to take PO day after vaccine, developed significant AKI and required hospitalization - overnight observation. Was hospitalized 2/23 - 2/24 and had resolution of symptoms, improvement in AKI and was stable for discharge home.

Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.

Patient reported swelling of left hand and forearm started 2 days after vaccination. Was evaluated by PCP on 3/11/21. Noted swelling left hand, wrist, forearm. few small areas of patchy erythema. u/s negative for DVT. inflammatory markers elevated, uric acid elevated. Given prednisone burst and taper with some improvement in symptoms, but not full resolution. Seen by rheumatology on 3/24/21 with broad differential and plan to monitor/close f/u. recommended against second vaccine dose for now.

death Narrative: Patient received Moderna COVID #1 vaccine on 1/28/21. On 2/3/21, he was admitted to a facility for fever, weakness, chills and rigor. Noted history of B cell lymphoma not on chemotherapy at the time. He also had reports of productive cough with thick brown/green sputum. He was admitted to the hospital and given 1 round of methotrexate and Rituxan. Hospital course was complicated with bacteremia (given vancomycin and cefepime), A fib, AKI, HTN, neutropenia (received Neupogen), acute popliteal VT (unable to anticoagulated due to thrombocytopenia - platelets as low as 20). No bleeding issues noted. On 2/18/21, family opted to change his status to DNR with hospice/comfort care and he passed on 2/19/21. No autopsy results available. 22 days from date of vaccine to date of death.

death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death.

death Narrative: Patient received Moderna covid vaccine #1 on 1/22/21 and #2 on 2/24/21. On 3/4/21, he was admitted to a facility for shortness of breath x 1 week. Upon admission, he was found to be in heart block and was admitted to the ICU and placed on pressors. He did have a negative COVID PCR test on 3/4/21. He has a noted history of COPD, CHF and OSA. On 3/6/21, he underwent a new pacemaker placement. His course was complicated by the development of AKI, paroxysmal V tach and new aflutter and was initiated on apixaban. He was discharged on 3/18/21. No further records available and a date of death was recorded as 4/3/21. No autopsy results available. 38 days from time of second vaccine to date of death.

On 3/25/2021 POC alleges that the resident begin to develop fever and urine infection. He was transferred to the hospital on 3/26/2021 where he had white secretions in his mouth. On 3/28/2021 he died in the hospital from respiratory cardio failure.

swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms. Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case

Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.

Very painful arm.........Very weak whole body next day......had to urinate 4 times at night. (usually I only go once) vision weakened for 24 hours

Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020. Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure

'lost feeling of the left side'; still has some shingles; laid on his floor and went to sleep/passed out for 2 hours; got a stroke within 9 hours; got really tired; a small clot in the right side; lost feeling of the left side, couldn't walk, and couldn't do anything; lost control of his bladder/urinated in his pants; left arm went numb; the muscle was sore for about a week; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side) and HEMIPARESIS ('lost feeling of the left side') in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Injury, Back surgery, Gallbladder operation, Heart valve replacement and Heart valve disorders. Concomitant products included METHYLSULFONYLMETHANE (MSM 1000) for Joint disorder, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), CALCIUM, ZINC, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D3), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 10-Jun-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HYPOAESTHESIA (left arm went numb) and MYALGIA (the muscle was sore for about a week). On 11-Jun-2021, the patient experienced THROMBOSIS (a small clot in the right side) (seriousness criterion medically significant), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants) and FATIGUE (got really tired). On 11-Jun-2021 at 2:00 AM, the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours) (seriousness criterion medically significant). On 11-Jun-2021 at 3:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours) (seriousness criterion medically significant). On 22-Jun-2021, the patient experienced HERPES ZOSTER (still has some shingles). On an unknown date, the patient experienced HEMIPARESIS ('lost feeling of the left side') (seriousness criterion medically significant). The patient was treated with GABAPENTIN at a dose of 100 mg three times a day and LORAZEPAM at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side), HEMIPARESIS ('lost feeling of the left side'), HERPES ZOSTER (still has some shingles), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants), HYPOAESTHESIA (left arm went numb), MYALGIA (the muscle was sore for about a week) and FATIGUE (got really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: didn't find anything wrong (Inconclusive) didn't find anything wrong and patient mentioned the small clot in the right side.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 72 hours after receiving the first dose of the Moderna COVID-19 vaccine, the patient got shingles. He still had some shingles, and stated "it is leaving but still numbness in a belt from the stomach center to the back of the left side, front side is well, and back is numb". He was taking Gabapentin 100 mg three times a day for the shingles, which was the only prescription medication he was currently taking then. He was also prescribed pain medicine for the shingles which he no longer took as the pain had left. One of the pain medications is lorazepam. The patient received the second dose, and he stated his left arm went numb. The injection was in the top part of the shoulder, and it did not hurt up there, but the muscle was sore for about a week. In addition, the patient stated he "got a stroke within 9 hours" at 2AM on 11 Jun 2021 and lost feeling of the left side, couldn't walk, and couldn't do anything. He went to the bathroom and lost control of his bladder. He urinated in his pants and got really tired, so he laid on his floor and went to sleep at 3AM. He also described this as "passed out for 2 hours". At 5AM in the morning, he woke up and was fine. He went to the doctor on 18 Jun 2021, who told him that he had a TIS or a small stroke. The MRI didn't find anything wrong, and patient mentioned the small clot in the right side. He was never hospitalized. Prior medical history included spine injury, 2 back surgeries, gallbladder surgery, an artificial valve in his heart, and a clogged aortic valve in the patient's heart. He has taken vitamins and supplements daily for the past 20 years. 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-2021-231546 (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.

Patient is a 76-year-old male with a past medical history significant for dementia, CVA 5 years ago with right-sided hemiparesis, functional parapalegia/wheelchair bound, chronically aphasic, hypertension, type 2 diabetes which is diet controlled and history of BPH who presented to the emergency room on 1/26/2021 with diarrhea that began on jan 18th 2021 and was admitted to the hospital.. Patient spouse reported that the patient got his first dose of the Moderna vaccine on January 14 and then the patient began having a fever on January 18 of 103 degrees and then developed diarrhea which continued. He was started on Imodium by his PCP on 121 with minimal results and was encouraged to follow a brat diet. He was then encouraged by the PCP to come to the ER for further evaluation of dehydration or colitis. Patient was on trimethoprim 100 mg daily for chronic UTIs which was discontinued on admission and therafter. In the ER he tested positive for C. difficile and he was started on vancomycin p.o. 4 times daily. He was also noted to be hypotensive and dehydrated and was started on IV fluids. He remained in the hospital for 4 days and was discharged home on 1/30/21 on vancomycin orally for 10 days with improvement. . He returned back to the hospital on 3/17-3/19 for recurrent c difficile, sepsis and colitis and was discharged on a prolonged vancomycin taper with improvement. He returned back to the hospital from 6/26-7/2 for again c difficile colitis, ileus and sepsis and was seen by infectious disease and gastroenterology and was discharged home on vancomycin orally qid for a prolonged taper. If he again fails this treatment the plan will be for a fecal transplant. He was again admitted on 7/6/21 and remains hospitalized with severe c difficile colitis/diarrhea not responsive to treatment. Now having some streaks of blood in stool. Stool occult blood was neg on admission, however. Also now has concurrent Pseudomonas UTI. CT abd/pelvis 7/7 showed "Marked irregular thickening of the wall of the rectum demonstrating cystic changes. Findings extend into the distal sigmoid colon. Differential diagnosis includes severe protosigmoiditis and neoplasm." and "increased feces throughout the colon consistent with constipation." Pt has been having 2-3 watery BM's per day since admission. Infectious disease concerned about possible undiagnosed malignancy, which may be driving his clinical picture rather than C diff. Recommended colonoscopy and to continue PO vanc x 10 days then resume taper. -pt was transferred to hospital for GI involvement for a colonoscopy/sigmoidoscopy on 7/8/21 where he remains hospitalized awaiting further work up.

gross hematuria, painless, urinary frequency, urgency, started 6 am upon awakening 4.75 days following vaccine administration

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

Received first dose of Moderna vaccine on Friday 1/22 no acute reaction, no fevers or chills. On Saturday afternoon noted "very dark yellow" urine, which persisted despite increasing water intake. Sunday felt a little nauseated. Monday came for previously scheduled visit with me and found to have elevated bilirubin and transaminases No recent changes in meds. Carpal tunnel surgery approximately 3 months ago. No recent travel or unusual meals.

The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.

Began with extreme fatigue, some nausea and constipation that persisted and worsened to the point that patient saw PCP on Monday, January 25, 2021. Abdominal x-ray done on 1-25-21 showed stool in upper colon. Mag Citrate and Fleet's enema prescribed and administered on 1-25-21. Extreme fatigue and weakness continued. Patient called PCP on Tuesday, 1/26/21, but did not receive call back. Patient called PCP again on 1/27/21. Patient was told that abdominal x-ray done on 1/25/21, also showed possible left kidney stone on x-ray report that was read by radiologist. CT scan scheduled and completed on 1/28/21. PCP called patient and confirmed kidney stone lodged in lobe of left kidney that appeared spiked and possibly unable to pass. Presently unable to get immediate appointment with urologist, and pain medication prescribed. Please also not that patient has absolutely no prior history of any type of kidney stone. Still awaiting relief.

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021. Went to clinic where labs were conducted. Patient had an INR of 12. Previous INR results were normal prior to vaccination. Patient was also diagnosed with UTI and given antibiotics. Patient was encouraged to go to ER. Patient died on 2/12/2021.

The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure.

Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr

On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine. Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.

Excessive, frequent urination for a 24 hour period following the second vaccination. Lost 5 lbs in 24 hours. This is in addition to the more normal reactions mentioned on web sites

Reported via Nurse Triage / PCP: Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting. States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night. Symptoms worsened today and patient became weak and fainted. Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head. Is awake and alert now, but still weak and only able to take 1 or 2 steps. No chest pain or breathing difficulty and no fever. Feeling very nauseous. Caller requesting prescription for zofran. Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER. From Emergency Department: Patient presenting with chief complaint of syncopal episode which was witnessed by his wife. He reported the got dizzy and lightheaded and then passed out while seated. The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state. He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence. He has not been feeling well ever since receiving his 2nd COVID-19 vaccine. By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids. His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago. Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated. I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient. With negative testing and resolution of his symptoms he is stable for discharge home. Close return precautions were given.

He received the vaccine and after 2 hours he went home and was paralyzed from the waist down. He tried to stand up and then he passed out on the floor for about 10-15 minutes. He went to sleep and woke up around 5 hours later. He then tried it again and urinated on himself and he fell down on the floor, passed out without getting up until the morning. He did call his doctor who was not available, spoke to the nurse and advised to go to the hospital. He is weak and cannot drive so he did not go to the hospital. He slept the rest of that day and the following day. Then when he saw his doctor about 2 days ago, he described his reaction and told to report the reaction and that he would report it himself. He was advised not to take the 2nd vaccination. He is no longer having the heavy reaction, his muscles are aching and his vision is blurred, especially on his back and the shoulder. His doctor did do blood work at the office visit.

The day after vaccination (4March21) pt. slept all day, and had the chills. Got up next morning (5March21) feeling better. By noon felt lethargic and slept the remainder of day. He experienced incontinence while sleeping. He had trouble walking, and could not make it to the bathroom without support. While in the bathroom he went to the floor, (did not fall), could not get up. I had him crawl on his hands and knees to the living room. It's a though his muscles went soft. Remained lethargic the remainder of the day. Did not see a doctor. Stayed at home and waited for symptoms to pass.

UTI; Anemia; Colitis; A spontaneous report was received from a healthcare professional concerning a 77 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed anemia, colitis and Urinary Tract Infection (UTI). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 039k208) on 29 Dec 2020. On 26 Jan 2021, approximately 6 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 019K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient had a hospital visit for anemia and colitis for which patient was admitted and was discharged on 04 Feb 2021.The patient was again admitted to the hospital on 22 Feb 2021, for UTI and was at the hospital at the time of reporting. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Very limited information has been provided for this cases Although, a temporal association exist between the product use and the reported events of anemia and colitis, critical details such as the patient's medical history concomitant medication list lacking. Urinary tract infection is of an infective etiology as such a causal relationship is unlikely.

Patient presented to ED with complaints of severe fatigue and generalized weakness. He complains of chills as well. WBC found to be elevated. No electrolyte abnormalities found. Patient is suspected to have a urinary tract infection. Patient received ceftriaxone for UTI. Patient was admitted to the hospital.

Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for "flu b". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a "spot" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat "pneumonia". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was "atypical and abnormal" what was happening. It should not have happened. 180 degrees from normal.

77 yo male with past medical history of diabetes, stroke, aortic valve replacement, sleep apnea and hypertension. Admitted for COVID-19 infection, chest tightness, and acute kidney injury on 2/15/21. COVID was treated with bamlanivimab in emergency room (prior to acute kidney injury finding that led to hospitalization) and supportive care. Acute kidney injury was treated with IV fluids. Diagnosed with NSTEMI with cardiologist consult, outpatient stress test and conservative management. Patient discharged home on 2/18/21 with no change in home medications.

patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine

Patient came to pharmacy to report adverse events following 2nd Moderna COVID19 dose. Unable to determine if this was related to vaccine or not, but reporting as patient perceived event. The day after vaccine administration, patient felt weak and fell to floor when getting out of bed. He stated he was so weak that he could not lift his body up until someone came to help lift him. He said he felt shaky and could not control his bladder/was urinating uncontrollably. Pt reports that he only has 1 kidney and doesn't know if this may be relevant. Counseled patient and recommended consulting his physician/nephrologist and would report to VAERS.

Patient came to office for complaints of body aches, chills, hot flashes, sweating and lightheaded. Nausea and loss of appetite.

Gastro intestinal hemorrhage associated with chronic gastritis; Chronic gastritis; Nurse reports patient has fallen twice since being home; Abdominal pain; Acute Kidney Injury (found during hospital workup); Seven weeks and 3 days between shots; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was provided). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis) (seriousness criteria hospitalization and medically significant), CHRONIC GASTRITIS (Chronic gastritis) (seriousness criterion hospitalization), FALL (Nurse reports patient has fallen twice since being home) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) (seriousness criterion medically significant). The patient was hospitalized from 23-Mar-2021 to 02-Apr-2021 due to ABDOMINAL PAIN, CHRONIC GASTRITIS, FALL and GASTROINTESTINAL HAEMORRHAGE. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Nurse reported history of fall, non-compliant with cane use. Supra-therapeutic INR, watchman procedure was scheduled on 15-Apr-2021. Nurse reports patient had fallen twice since being home. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Patient was hospitalized due to pneumonia; Urinary track infection; Patient tested positive for covid at the hospital with a rapid test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia) and URINARY TRACT INFECTION (Urinary track infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included TORASEMIDE (TORSEMIDE), METOPROLOL TARTRATE (METOPROLOL XL), LEVOTHYROXINE, TAMSULOSIN, APIXABAN (ELIQUIS), METFORMIN, FENOFIBRATE and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Urinary track infection) (seriousness criterion hospitalization). On 18-May-2021, the patient experienced COVID-19 (Patient tested positive for covid at the hospital with a rapid test). The patient was hospitalized on 30-Apr-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient was treated with TAZOBACTAM (intravenous) at a dose of UNK dosage form and PIPERACILLIN (intravenous) at a dose of UNK dosage form. At the time of the report, PNEUMONIA (Patient was hospitalized due to pneumonia), URINARY TRACT INFECTION (Urinary track infection) and COVID-19 (Patient tested positive for covid at the hospital with a rapid test) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID at the hospital with a rapid test. Description: The patient was hospitalized on 30 Apr 2021 due to pneumonia and urinary tract infection. The patient was still in the hospital. 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 report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional information is requested.

Patient started experiencing nausea and vomiting per his appointment on 03/30/2021 since the day after vaccination. From the 03/30/2021 appointment, he continued to have more symptoms such as loss of appetite, fatigue, weakness, incontinence... Patient came in to see his provider on 06/07/2021 and informed him of his tremors, involuntary movements and jerking.

Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours. Very weak and shaky for another 24 hours.

Noticeable difficulty in urination. While I was eventually able to, starting was very slow and flow was low. My reaction is reminiscent of what I experience after a dose of a cold symptoms treatment like NyQuil and say Afrin spray.

Resident was desated, into the 80's, short of breath. We went him to the hospital same day as vaccine given

Awoke at 0500 with lower back ache assuming it was associated with flu like symptoms. Had my usual two ups of coffee and small orange juice. Took my meds at approx 0730 with small glass of water. From 0800 until 1030 I had frequent visits to the bathroom to urinate. My backpain was more associated with my Kidneys as the frequent urinating was causing mild pain. After 1030 I had one at aprox 1230 and did not pass any urine until aprox 1830 that evening. I did hydrate with water during that time. After 1830 I had no issues.

Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. Very limited information regarding these events has been provided at this time. Further information has been requested.

Chills, confusion, fevers, nausea, confusion Subsequent precipitous decline in kidney function, required a 4 day in-patient stay

3/7/21 ER to inpatient Admission (covid positive 3/7/21) 3/11/21 Transferred to higher level of care Date of Service: 3/8/2021 Chief complaint: Chest congestion HPI: Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19. Patient presented to ER brought in by EMS from local residence. Was complaining of chest congestion. Patient had been seen in ER earlier same morning complaining of cough. Was afebrile at that time. Oximetry 95%. Rapid COVID positive. Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1. Patient discharged home. Return later that evening per EMS with shortness of breath. Complaining that congestion was getting worse. Was now febrile & had fallen trying to get out of recliner. Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen 1000 mg IV in ER. Labs revealed mild leukocytosis white blood cell count 12.5. Glucose elevated to a 9 but patient had received Decadron previously. BUN 32 creatinine 1.8. D-dimer 1240. No CT chest obtained due to patient's renal status. Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene. Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20. Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB. Continued hydration fluids normal saline at 100 cc/hour. Started on IV Remdesivir with loading dose. DuoNeb nebulizers q.6 hours. Patient continued on home regimen less Plavix. Was started on Lovenox 40 mg subcu daily for DVT prevention. Patient maintaining oxygenation on 2-3 L. Had initially been on 2. Was increased to 3 this morning due to decrease in oximetry down to 92%. Patient continues with exertional dyspnea. Does have loose nonproductive cough. Is complaining of pain to the left lower chest wall with cough. Describes as sharp. Denies any actual chest pain. No nausea vomiting. Last BM yesterday described as normal. Blood cultures pending no growth at present. Is currently resting in bed. Is in negative air pressure room. COVID precautions observed. CASE DISCUSSED WITH DR

3/17/21 ER Triage note: "Pt c/o lips and and facial swelling. No sob, no problems swallowing. Onset this am. Denies pain."

bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bladder cancer. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

First Night, High Fever had to take PJs off to get cool, Next day, Cold,very Cold.Arm ached, had red colot going from injection towards elbow on outside for 6 inches. about 1-12 inch wide. Tired and slept except to get up for bathroom, eat a little, go to bathroom. Kidneys hurt, could feel pulse in Kidneys. Was weak. Back and legs ached. Legs felt almost numb. Hard time walking from back pain and had to sit ina chair for about 30 minutes to get relief from kidney pain. This continued until the 9th @ noon. Arm stopped aching then. Kidneys still hurt. Back strain started getting better. Bak and kidneys still hurt hen I first get out of bed. Have to sit in chair till it goe away. If the Kidney pain continues, I will se

dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided Treatment of these events included steroids. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Nursing home pt w/hx of dementia and recent hospital stay (5/1-5/7) for treatment of healthcare associated PNA, recurrent UTI, recent antifen CDiff+ but toxin negative. Pt p/w worsening SOB, generalized body aches, abdominal pain, chills and test positive for COVID (5/8) despite having received Moderna vaccine (1/18 & 2/15). Was admitted for additional management of acute hypoxic respiratory failure due to COVID complicated w/chronic hypoxic resp failure d/t COPD. Pt treated with dexamethasone and bronchodilators as well as diuretics for volume overload in setting of diastolic heart failure. Pt was ultimately discharged to nursing home on 4L of O2.

After having eGFR kidney readings of 54 to 60 over the past 5 plus years, my eGFR reading on March 5th, 2021 after taking the 2nd Moderna Covid 19 vacine on Feb 20,2021, my eGFR reading had plunged to 34.... But as of March 22, 2021, my eGFR reading had recovered to 43, and then my eGFR reading has further recovered to 52 as of June 22nd..... There is no other known issue which would be expected to have contributed to my low eGFR reading on March 5, 2021.

a history of Parkinson's who presented with generalized weakness as well as urinary frequency. Patient had a history of prior COVID 19 infection in 10/2020, was hospitalized. He had the first dose of COVID vaccine 1/19 and after that, he developed fever, increasing weakness and was unable to get out of a chair and therefore presented to the ED.

Five hours after no reaction to the vaccine chills commenced, nausea, vomiting, loss of appetite and severe muscle weakness; unable to ambulate even with walker; lost control of bowels and bladder functions; fatigue. Was bedridden for 36 hours . At about 28 hours upon recommendation from oncologist, took one Benadryl and within 2 hours started to improve. Took 1 Benadryl every six hours for next 48 hours and was feeling better except for residual whole body weakness. Would have been helpful to know about Benadryl before hand. Will take Benadryl 30 minutes prior to getting 2nd shot on March 5. Thanks. Hope this information is helpful to others.

Patient admitted and treated for respiratory insufficiency, CHF, hypotension, AKI, metabolic acidosis, and hyperuricemia

Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration

Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice. Patient passed away on 2/13/2021.

Patient had dark urine and high CK level and was diagnosed with acute rhabdomyolysis. Patient received IV fluids and nephrology was consulted. Patient was discharged home when stable.

patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful. Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.

By 3:00 he had a whole body chill. He was then incoherent, lost all control of all body muscles and was incontinent both bladder and bowel. He continued as such when Dr. said to give him Prednisone along with the Benadryl he was receiving every six hours starting at 3:30 p.m. 3/8/2021. He was given a Prednisone at 4:00 p.m. 3/9/2021 and again at 8:00 p.m. on 3/9/2021 along with his Benadryl. He was unable to ambulate or even turn his body over in bed. He was able sip water and sports drink but ate nothing since noon on 3/8/2021. It wasn't until early Sunday morning that he was able to move his legs and get to a walker and use the toilet. He slow, very slowly has improved since then. Late Sunday he was able to get up, and sit in a chair. Later he was able to take a sit down shower and shampoo and be an to feel "nearly human" again. He has slowly progressed since then and Monday morning was able to navigate by himself and to descend and ascend a 13 stair step to the basement. In discussing the 24 hours he spent in bed he was unaware of any of the things going on such as not being able to move, but knew he was in pain if he moved his legs. He also had a temperature of 102.3 which rose to 102.9 and then with cold compress on his forehead and time his fever dropped to 95.4 and the back up to a normal of 97.5. These are similar symptoms he had after the first injection of the Covid 19 Moderna vaccine and he had had a similar reaction in 2017 from the first flu shot he ever had in his life. He felt he needed to take this vaccine in order to be able to "have a life" even though we assumed he would have such a bad reaction. He is slowly improving and if it is like the first injection it will take him nearly two weeks before he can ambulate at the level he was before the vaccination. Still, he is grateful to Center for being so proactive as to have available the vaccine and it being more convenient for cancer patients than waiting in line at a mass inoculation center. He would appreciate an acknowledgement that this information has been received and could possibly passed along to help others in his situation. Thanks.

5 min after vaccination had abdominal pain, emesis x1, bradycardia, bigeminal PVCs, rigors, chills, fever 101.2, low Mg+ 1.3, SOB , ground glass opaque appearance on CT chest in lungs bilat, needing 2L O2, and normallly only needs room air. Admitted to hospital medical unit.

Chills 1:20 am Very stiff right arm 1:20 am Lethargy for 6 days Mild diarrhea days 1 and 2 Urine more frequently than usual

Patient became weak and unable to hold his head up one day following injection. Following day, low appetite. Day 2, had vomiting and unable to take in any PO. Day 3, was able to start eating. Day 4 and 5, he had improvement of neck pain. Day 5, had drop in blood pressure into the 70-80s systolic and 40-50s diastolic at home and then again in the clinic with no other signs of illness. Day 6, found to have Acute Kidney Injury on his CKD with creatinine rising into the 5's with baseline creatinine of 1.4-1.6. His liver function was abnormal also with elevated bilirubin to 6 (baseline normal 1), Alk Phos 522. He was hospitalized 2/25-2/28/2021 for these issues.

Patient advised Health Dept. (at time of 2nd dose) that approximately 45 minutes after 1st Moderna vaccine that he began experiencing blood in his urine. Patient contacted PCP and was admited to for further evaluation and treatment. Pt developed pneumonia while in hospital and spent a total of 4 days inpatient. Treating physician at hospital unable to identify cause of blood in urine. DR ADVISED THAT HE TREATED ANOTHER PATIENT WITH SAME SYMPTOMS AFTER INITIAL COVID VACCINATION but could NOT specifically attribute cause of blood in urine to COVID vaccination.

Patient came for vaccination in the morning, then went out to breakfast. During breakfast, the patient slumped forward in his seat and was unresponsive for about a minute. There was no incontinence or seizure activity. On regaining consciousness, patient seemed to quickly get back to his usual level of mentation. He was diaphoretic and nauseous. He denies any preceding lightheadedness, nausea, visual changes, chest pain or palpitations. He presented to the emergency room, also had nosebleed and UTI. Was admitted for observation overnight and discharged the next day.

Urinary tract infection; More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose). The patient was hospitalized on 02-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not reported. Treatment information was not reported. It was noted by the reporter that the event "urinary tract infection" was not due to the vaccine but due to something that the patient ate. 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.

Non-ST elevation (NSTEMI) myocardial infarction; Acute kidney failure, unspecified; Pneumonia, unspecified organism

Dyspnea and fatigue and low back pain starting 4/26. Seen at Urgent Care 5/1 and recommended to go to ED for ACS rule out. Declined. Followed up on 5/3 with persistent dyspnea, no hypoxia or tachypnea but visible increased work of breathing in office.

Patient has a history of simple Prostatectomy and Kidney Stone. He had the first Moderna Covid 19 vaccine on 2/3/2021 and the second dose 3/8/2021. 5 days ago He started with severe dizziness and next day he was admitted to hospital for severe Urosepsis.

Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506

Around 4:30am on the day after administration of the vaccination, patient went into ventricular tachycardia and his ICD attempted anti-tachycardia pacing (ATP). Per electrophysiology note after interrogation of patient's ICD: "Multiple VT episodes beginning around 4:30 AM, and continuing intermittently through 10:15 AM, approximately. There were 19 treated VT episodes, mostly terminated with ATP therapy. There was a single 24J shock delivered at 9:43 AM after a VT episode lasting 1 min, 4 seconds, with average ventricular rate 171 bpm. This appeared to be an appropriate shock after exhausting 8 ATP attempts. On 5 other occasions the patient required 4 or more ATP sequences to terminate VT. The remainder terminated with 1-2 ATPs. Reviewing the far field electrograms, there appear to be 2 distinct VT morphologies. Average ventricular rates for both are about 170-180 bpm." Patient presented to the emergency room, where he received amiodarone IV, and was admitted to an inpatient cardiology service. He was restarted on amiodarone and was noted to be hemodynamically stable and not in VT; however, he opted to leave the hospital AMA on 3/15. As noted previously (item 11), he has a history of VT and had discontinued amiodarone due to side effects about 6 weeks prior to this episode. As amiodarone has a half-life of around 45 days, it is thought that his rhythm control was suboptimal at the time of this vaccination, and there is no evidence that it was the vaccination that caused the VT episodes on 3/14.

Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11.

Began with about discoloration in my urine and then on the morning of the 6th, I was passing blood and I went to ER. They gave me an injection of something and a 10 day course of a different antibiotic. Symptoms were pretty much gone the next day. Have a dr visit scheduled next week.

Per records submitted by the hospital: Symptoms began 7/16, went to urgent care 7/19 with fever and cough, treated with albuterol and doxycycline. Hospital ED 7/22 after vertigo and a fall, hypoxic, placed on bipap. Diagnosed with CHF and pneumonia. Intubated 7/24/2021 and in ICU. Client had CABG 5/23/2021 and had post op complications with a-fib, AKI, hypervolemia and had 3 thoracentesis. Submitter does not have access to full medical record.

COUGH, RIGORS, NAUSEA, VOMITING, URINARY URGENCY/FREQUENCY, DYSURIA - FOUND TO HAVE LLL PNEUMONIA, CONCERNING FOR POSSIBLE CYRPTOGENIC ORGANIZING PNEUMONIA

Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue. The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue. On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included "significantly elevated" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and "slightly elevated" troponin of 0.079. On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care. Action taken with the second dose of mRNA-1273 in response to the event was not provided. The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021. The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin. Very limited information regarding these events has been provided at this time. Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.

Per neurology consult: "Patient was at his baseline until when he received his 2nd dose of SARS-CoV-2 vaccination. He complained of dyspnea and fear of impending doom after waking up the following morning with some disorientation. He was found to be in AFib with RVR after it was brought to ER the following morning and the rhythm was converted to normal sinus rhythm. Patient continues to have confusion after admission yesterday that seem to get worse today to the point where he did not know his own name or birthdate, and seemed to have global amnesia. Patient has been more drowsy this afternoon after receiving lorazepam 1 mg IV for potential seizure activity so no reliable neurologic exam was obtained. Patient remains afebrile with pulse ox in the low 90s on 4 L of supplemental nasal oxygen in the hospital. He had moderate decrease in kidney function upon admission that has improved. He has baseline anemia with hemoglobin at around 10. Incidentally patient had shingles in the right thoracic dermatome week ago for which he received valacyclovir.

SHORTNESS OF BREATH FEVER UTI (urinary tract infection) Systemic inflammatory response syndrome (SIRS) without organ dysfunction (CMS/HCC sepsis

Patient presents with multiple complaints. He complains of all of his symptoms started after his Moderna vaccine in 1/2021. He complains of fatigue, and in particular muscle fatigue, muscle wasting, urinary frequency, urinary urgency (but denies dysuria), myalgias involving his legs, leg weakness, unsteady gait, frequent falls, nausea without vomiting, dyspnea walking across the room. He is wheezing a lot this morning, it started after the Moderna vaccine.He had a recent heart cath that did not show any significant blockage. He had a recent MRI of his head that was normal. He reports his wife had covid 19 in the latter part of 11/2020. He never developed symptoms. He was not tested after she became ill. He admits to significant reaction his first covid 19 vaccine in 1/2021. All symptoms resolved except for his complaints as listed above. He is a very active 81-year-old. He states he was winning weightlifting contests. He would do 3 sets 50 pushups, bench press 150 pounds and do pulled downs with 160 pounds daily. He now experiences dyspnea and muscle fatigue walking across the room.

24 HOURS LATER HE BECAME RIGID, BODY BEGAN TO DISCHARGE URINE AND BOWELS WITH NOT CONTROL I CALL 911 AND HE IS STILL IN THE HOSPITAL.

Pt was admitted to hospital from hospice care with UTI on 4/16/21 after receiving 2nd dose of vaccine on 4/1/21. Patient passed on 4/21/21. Per guidelines, all hospitalizations are reported.

Pt received his first and second COVID19 MRNA Vaccine on 2/4/21 and 3/4/21, respectively. Patient was admitted to our facility on 6/17/2021 w/ symptoms of generalized weakness that had been worsening over the past few days. His first symptoms began on 6/14/21 w/ nasal congestion. He began to have cough and weakness on 6/16/2021. Patient tested positive for COVID 19 on 6/17 via PCR on nasal specimen. As of this report, 6/23/21, pt is admitted to a step-down unit at our facility requiring supplemental oxygen via CPAP. His current O2 requirements are 100 fiO2 and 60lpm w/ 15 cmH20 of PEEP.

Pain between shoulders in shoulder blades, frequent urination, dizziness/unsteadiness beginning evening 1/26/21 Followed on 1/27/2021 by increased dizziness/unsteadiness, more frequent urination and very frequent diahrea - lasting through the day/evening. On 1/28/2021 - pain between shoulders is slightly subsiding, unsteadiness remains along with frequent urination and diahrea

ON DAY OF VACCINE NO PRESENTATION OF SIGNS OR SYMPTOMS OF ILLNESS. PRESENTED WITH FEVER AND SYMPTOMS OF UTI ON 2/5/2021. PCR COVID TEST POSITIVE. SUDDEN HYPOXIA ON 2/6/2021. TRANSFERRED AND ADMITTED TO MEDICAL CENTER.

Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.

UTI, urinary/bowel incontinence Narrative: first COVID19 vaccine 1.11.21, ER visit with hospitalization 1.15-1.18.21 for SIRS/Sepsis, initially thought to be urosepsis but post discharge UA and blood cultures were negative; source was not identified. Beyond symptoms listed, patient just reported he "felt terribly bad" prior to spouse calling EMS. VAERS reported by hospitalist as well from the facility where he was treated. He was discharged home with Augmentin for UTI and Physical Therapy for strengthening. Patient follows local PCP and this facility PCP. Responsible physician listed on this form is this provider's facility Medical Director.

Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences] The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily. On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19. Patient was treated with 1 500mg Metformin and 2 500mg Tylenols. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue. Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Inability to urinate 12 hours after the shot, frequent bowel movements (not diarrhea) Severe bladder pain the next morning. Catheter relief at Urgent Care in early morning. Doctor prescribed antibiotic. Saw Urologist on March 8. No infection was found. Urologist believes that the excess bloating may have impacted my enlarged prostate which in turn restricted the bladder. arc u

45 minutes after the vaccine, daughter and pt. stopped at a restraint for breakfast. Pt. stated that he had to go to the bathroom and he felt limp and needed assistance with ambulation to the bathroom. Went home and sat in the recliner and said he felt like a limp noodle and was incontinent of urine. Pt. states that he had a fever (did not check it), brain fog and weakness.

3/24/21 ER C/o high blood pressure. States he got up to use the restroom this morning and "felt like my legs wouldn't hold me up & then I checked my blood pressure & it was high". Ambulates from waiting area to room without difficulty. Pt denies dizziness, shortness of breath or pain.

Close to "urea sepsis"; severe UTI; A spontaneous report was received from consumer concerning a 82-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe UTI/urinary tract infection and close to urea sepsis/sepsis. The patient's medical history was not provided. Concomitant medications was not provided by the reporter. On 16-Feb-2021, the patient received second of the two planned doses of mRNA-1273 (lot number: 006M20A) in the left arm for the prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient developed a severe UTI. Close to urea sepsis. Took antibiotics. Treatment medication included antibiotics. No lab tests were mentioned. The events severe UTI and close to urea sepsis were considered to be serious with criteria of important medical event. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events severe UTI and close to urea sepsis 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

Spinal infarct @ T 10-12, resulting in paraplegia. Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.

Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING

Patient complained of feeling unwell and having headaches after his second dose of Moderna vaccine on 2/2/2021. He became increasingly confused, paranoid and started occasionally refusing medications. On early March 2021, he started refusing all medications. Around 3/17/21, his increasing confusion and paranoia prompted suspicion for UTI which was confirmed with a urinalsis. Unfortunately, he refused antibiotic treatment. On 3/20/2021, nursing staff noted that patients right lower extremity was purple from toes to mid-calf, cold to touch and pedal pulse were not present. He complained of right leg pain. He was evaluated and diagnosed with probable thromboembolic event, since patient refused his oral anticoagulant for weeks prior to these event. Patient was sent to the local Emergency Department (ED) and diagnosed with acute critical right limb ischemia. At the local ED, he had a CTA which showed as per radiology: "Occlusion of the right superficial femoral artery beginning just beyond the origin. Occluded right popliteal, anterior tibial, tibioperoneal, peroneal, and posterior tibial arteries without reconstitution on arterial and delayed phases. Patent right deep femoral artery with minimal luminal stenosis in the proximal segment. Patent mid and distal right external iliac artery with up to mild luminal stenosis." Per discharge summary, "vascular surgery evaluated patient in the ED and did not feel operative revascularization with fasciotomy would provide any benefit; recommended continued anticoagulation with amputation/palliative management." He was admitted to the general medicine service which consulted orthopedic, infectious diseases and palliative care. Medicine Service also contacted patient's daughter who is his next of kin who opted for comfort care. He was discharged to facility on 3/25/2021 and started in the Comfort Care Program. He was pronounced dead on March 27, 2021 at 0807 hours. His autopsy showed that he also had thrombi on: 1. Pulmonary embolism, Left pulmonary artery 2. Left renal infarct

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.

At 5:30, started getting woozy in a fog. Could not remember what happened. For the next 2 days patient was in bed. The following morning patient went to bathroom, urine is red, which hasn't happened in years. Patient may think dizziness is from blood loss. The following days it slowly cleared. Patient contacted doctor. A few days after MD appointment patient was back to normal.

Renal failure; Horrible Headaches; Body ache; A spontaneous report was received from a consumer concerning an 83-year-old male patient, who was administered Moderna's COVID-19 vaccine and one week later, he had horrible headaches, body ache and hospitalized for kidney problem (Renal failure). The patient's medical history included diabetes and high blood pressure. Products known to have been used by patient, with in two weeks prior to the event, included apixaban, sitagliptin, carvedilol, furosemide, glipizide. Patient became COVID positive on 14-DEC-2020 while in the hospital and survived. On 02-Feb-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09-Feb-2021, approximately one week later, patient had horrible headache and body ache. Patient is better now but he is in the hospital because he has kidney problems (Renal failure) started on 14-Feb-2021. Patient's wife mentioned in call that this has never happened in past and she already asked MD not to give him the second dose. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was discontinued. The outcome of the events, he had horrible headaches, body ache, were considered resolved. The outcome of the event hospitalized for kidney problem (Renal failure) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Patient's elderly age and medical history of diabetes and high blood pressure may have been contributory for the event of renal failure.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.

death Narrative: Patient received COVID vaccine #1 on 1/13/2021. On 1/19/2021, notes from primary care indicate advancing dementia and a urinalysis suggestive of a UTI, he was ordered a course of cefdinir and PCP at that time suggested long term care. On 2/1/2021, he was admitted to a facility for acute kidney failure and was also noted to have frequent falls at home, no scanned records from that hospitalization are available. On 2/7/2021, he discharged from that facility with home hospice. On 2/11/2021 at 0140, Patient passed away at home. No autopsy results available.

but his liver had inflammation; jaundiced; dark urine; He did not receive second injection of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (but his liver had inflammation) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine). On 30-Mar-2021, the patient experienced CHROMATURIA (dark urine). On 01-Apr-2021, the patient experienced JAUNDICE (jaundiced). On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATITIS (but his liver had inflammation) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Liver inflammation, at an unspecified dose and frequency. On 27-Mar-2021, PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine) had resolved. At the time of the report, HEPATITIS (but his liver had inflammation), CHROMATURIA (dark urine) and JAUNDICE (jaundiced) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Biopsy liver: (abnormal) cancer free but liver had inflammation.. On 06-Apr-2021, Blood bilirubin: 36 (High) 36. On an unknown date, Blood bilirubin: 26 (Inconclusive) 26. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. On 30-Mar-2021, patient stated that his urine was getting dark and two days later, he started looking jaundiced. Patient saw the doctor on 06-Apr-2021. He was started on 20mg per day of prednisone. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.

Within three days of shot started with blurred vision, swerving while driving, progressing rapidly to unable to hold fork, falling down. Hospitalized since. Lost all motor skills, unable to walk, stand, feed self, control urine, slurring speech. No stroke. MRI found "lesions" in brain, spine/neck area, lung and stomach. Four Neurologists examined. They still are perplexed. One said she has not seen anything like this in her 20 years. Spent week in hospital, now in rehab center Minor improvement in ability to feed self (still can not hold fork), Receiving physical therapy.

patient developed progressive diffuse muscle weakness, altered mental status including excessive drowsiness, decreased oral intake starting on 1/31/2021. Symptoms continued to worsen overnight and he was evaluated in the emergency room on 2/2/2021 and admitted with dehydration and altered mental status. He was aggressively hydrated overnight, but showed persistent diffuse muscle weakness, altered mental status with decreased responsiveness progressing, but no focal neurological findings noted. CT scan of the head on 3/3/2021 showed no findings other than age-related diffuse cerebral atrophy. The patient did spike a fever to 103 on the morning of 2/3/2021. CBC, CMP, procalcitonin and lactic acid levels remained normal. He remains hospitalized in stable condition as of 2/3/2021 @1300.

Patient has been weak and having difficulty urinating for the few days. Was unable to urinate this morning and made an appointment. On the drive to the appointment, he felt the urge to urinate and urinated in a urinal he had with him. The urine looked like blood with clots. Patient admits that he has had some clots in his urine for past week, so he had taken plavix to break up the clots (plavix is not his medication). Given weakness, difficulty urinating, and gross hematuria, patient was sent to the ER. ER nurse was called and given report

Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021. Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis

Received call from doctor that labs drawn on 1/27/2021 showed low filtration rate and high creatinine. Was told to report to urgent care. Was admitted to observation unit and given IV fluids over 16 hours. Repeated labs until improvement and discharged. Was told cause of lab values was dehydration. I did not feel ill at any time prior to or after being notified by doctor.

Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin.

2/22/21 - achy/weak, nausea/vomiting with clear vomit taste like blood, no fever 2/23/21 to 2/25/21 - continues with weakness and developed joint pain and red rash on arm that had injection - rash lasted 4 days 3/12/21 - developed pain behind left knee and down to left foot 3/15/21 - knee/leg pain contiues and goes to urgent care - diagnosed with DVT 3/22/21 - developed chest pain, goes to ER, diagnosed with kidney stones

death Narrative: Patient received his COVID #1 vaccine on 1/4/2021. He is noted to be a dialysis patient and on 1/21/2021 was given a RX for treatment of a UTI. On 1/24/2021, he was admitted to a facility with a syncopal episode. He remained there until 2/2/2021 when he discharged to home. On 2/4/2021, notes indicate that he passed away in his sleep that night. No autopsy reports available. 31 days from time of vaccine #1 and date of death, does not appear that he received vaccine #2.

Patient received vaccine on 4/15/21 2nd dose of 2 dose series. He woke up the morning of 4/22/21 at 6:15am with vomiting. His temperature spiked to 104.2 and his O2 sat dropped to 98%. He developed shaking chills, and a loose wet sounding cough. He had chest xray and labs. Started on treatment for pneumonia with rocephin, zithromax and solumedrol. Declined throughout the day and had increasing requirements for O2 and patient passed away at 1355 on 4/22/21.

84 y.o. male who presents with chills, weakness and low back pain that had onset approximately an hour and a half ago. Upon presentation, the patient's temperature was noted to be 102°. Patient's states that he had a similar set of symptoms several years ago was found to have sepsis of unknown origin. He denies anorexia malaise generalized body aches headache cough dyspnea chest pain nausea vomiting abdominal pain diarrhea or urinary tract symptoms. The patient has been covered vaccinated and reports no known exposures. Of note, the patient has been on cephalexin for the past week due to a postoperative infection related to his recent carpal tunnel release. Transferred to a different hospital for Severe Septic shock, on dopamine drip; remains inpatient as of 5/17/21

One week after the vaccine, my dad noticed that his urine was darker than usual. Then over the weekend, he started having jaundice. He was seen by his PCP who ordered labs and then referred us to a GI specialist. He has had multiple labs and a liver biopsy.

could not urinated went to ER had Catheter put in, 24 hours later blood clots in Catheter bag and was in hospital for 10 days

Moderna Dose 1 2/25/21 (041L20A) Moderna Dose 2 3/25/21 (011M20A) COVID Positive 5/10/2021 5/10/21: Presented to ED. 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week ago with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. He was treated with Z-Pak but symptoms continued and he presented to the emergency room, found to be hypoxic requiring up to 6 L nasal cannula oxygen Patient also had fever no chills or rigors. Reports he has received both shots of COVID-19 vaccine. In the emergency room patient was hypotensive which was responsive to IV fluids and received levofloxacin. Chest x-ray showed bilateral pneumonia. WBC 15.5, lactic acid 2.8 and the creatinine 2 which is patient's baseline. 5/13/21: 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week prior to hospitalization with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Treated with dexamethasone and levofloxacin. With not a candidate for remdesivir based on poor renal function and ID consulted and did not believe patient qualifies for Actemra. Subsequently shortness of breath and hypoxia resolved and he was deemed stable for discharge and will complete 7 days steroid taper. Liver transplant team at pain clinic was consulted, recommended holding sirolimus while patient is on dexamethasone. I have clearly communicated to the patient and his wife to resume sirolimus after 1 week. On discharge patient was a febrile and hemodynamically stable. He was discharged home.

Patient presented to the emergency department on the morning of 5/25/21 with decreased ability to walk and increasing confusion (has mild dementia at baseline), as well as nausea, burping, stomach pains. The patient received 2nd dose of Moderna vaccine at 5PM the evening prior (5/24/21). Also noted to be febrile. Patient's son reports after receiving the second vaccine dose the patient started to take very short steps and took a long time to get anywhere. Had to be held up by his son. Normally he uses a walker to ambulate and get around most places. Also the patient's son reports that he was poor to respond when given directions and will instead stare straight ahead. Son also reported frequent belching with the patient occurring overnight. No vomiting or diarrhea. Patient did have AKI on admission (creatinine 1.7, baseline ~ 1.1) and had been on gabapentin 900mg TID outpatient (this was reduced inpatient) which could have contributed to confusion. The patient did not have any reaction to the first vaccine. Attending physicians attributed acute metabolic encephalopathy, gait abnormality, and fever to Moderna vaccine. Acute encephalopathy was noted to be resolved on 5/27/21. Patient discharge home with home health 6/1/21.

Patient suffered complete kidney failure despite no history of kidney disease. Acute tubular necrosis.

On Tuesday after receiving the vaccine Lowell fell out of bed and was unable to get up. I called 911 and the EMTs helped him up into his wheelchair. Since he has Parkinson's and has balance problems he is unable to stand on his own for very long. All day Tuesday he was incoherent and fell twice in the bathroom where on the floor he was incontinent of his bowels. Later in the day he was incontinent of urine while sitting in his chair and was unaware of it. Two days later he says he doesn't recall any of that but his cognition seems to be better now. I think this should be a warning for Parkinson's patients.

ER visit 1/25/21 patient walked into a prompt care and collapsed, witnessed and pulseless CPR with ROSC after 6-7mins, no shock no meds. Awake and speaking upon arrival to ER. 2 plus pitting edema ble ER diagnosis Anasarca, cardiac arrest, hypotension, elevated troponin I levels, Acute kidney injury and syncope. ER notes reveal a syncopal episode in the shower prior to collapse at prompt care. Central line placed and plan to ship to another facility, patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer.

Received 2nd dose of Moderna on 1/26/21. Went to the hospital and admitted 2/21/21-2/22/21 for UTI, weakness, and neck pain.

UTI; weakness; neck pain; A spontaneous report was received from a healthcare professional concerning an 85-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI (urinary tract infection), weakness (asthenia) and neck pain. The patient's medical history was not provided. Concomitant medications were not reported. On 26-Jan-2021, the patient received the second of two planned doses of mRNA-1273 (LOT/BATCH: 029K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient went to the hospital and was admitted for two days for UTI, weakness, and neck pain. Treatment for the events was not reported. 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 outcome of the events, UTI, weakness and neck pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure. The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital. Action taken with mRNA-1273 in response to the events was not reported. The seriousness criteria for all the events was hospitalization. The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

symptoms started 1/23/2021 Hard Chills, temp spike 103, nausea, frontal headache, and muscular aches, recurrent chills and fever, most of my difficulty came after midnight, I'm not sure exactly when I went to the Dr maybe 6 days later and admitted me to the hospital, I was fine until two weeks ago I had chills fever and a little nausea and abdominal pain, lab results largely returned to normal and showed the same problem, liver enzymes, 785 amylase. My physician did not want me to get second dose.

E83.42 - Hypomagnesemia R77.8 - Elevated troponin A41.9, R65.20 - Severe sepsis (CMS/HCC) R50.9 - Fever, unspecified fever cause A41.9 - Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC) R41.0 - Delirium N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC)

death Narrative: Patient received Moderna covid #1 on 1/9/21 and #2 on 2/8/21. On 2/24/21, he was sent to the ER at a facility from a nursing home where he was admitted for skilled nursing care. He was sent to the ER due to fever, decreased mental status, renal failure, possible UTI and possible pneumonia. He was admitted and received IV fluids, Zosyn and Solu Medrol. On 2/26/21, a consult was placed for hospice care and he was accepted for hospice care at a contract nursing home. Upon review of scanned records, it appears he had a stroke/intercranial hemorrhage on 2/10/21 and that is why he was admitted to the nursing home for skilled nursing services. A date of death of 3/18/21 is recorded. No autopsy results recorded. 38 days from vaccine #2 and date of death.

Patient was seen by an outpatient provided and was referred to emergency department due to hypoxis and respiratory distress on 4/27/21. He was found to by COVID-19 positive at that time. He was admitted to the hospital for further management. on 4/28/21, his condition declined. He was intubated and transferred to the ICU. Patient went into severe acute kidney injury and eventually into multi-system organ failure. He was placed on comfort measures on and was pronounced dead on 5/15/21.

Admitted for treatment of hematuria and altered mental status on 4/21/21 When we were preparing to discharge patient to nursing facility, he had a COVID-19 test that returned positive (PCR) even though he was vaccinated (3/5/21; 4/2/21) and had COVID-19 in January. The patient only stayed in the hospital because of the positive COVID test. Patient was placed on isolation however he never displayed any symptoms of COVID infection. Repeat COVID swab on 5/7 was negative.

Patient woke on 1/12 with violent shaking, nausea, fatigue and decreased appetite. Throughout the day on 1/12 pt became delirious, no longer recognizing people, not able to understand speech, incontinence of bladder and is unable to walk without falling.

Pt received Moderna covid vaccine on 1/11/21. Began experiencing "violent shaking" and decreased appetite yesterday morning, throughout the day yesterday became delirious and unable to recognize people, understand speech, control his bladder or walk without falling.

Had acute respiratory failure, dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day, ED by EMS @ 1745, respiratory distress, febrile 39.4 degrees C BP 150/105 RR 29

Patient was up at 6 AM on morning following injection. Temp 101.7. Difficulty mobilizing. Could straight leg raise. O2 sat was 94. B/P 170/70. Through out day has had some improvement. Incontinent (rare for Him) Achy. Sensorium unchanged.

got vax 13th woke up short of breath with 101 fever, headache, then had to use the bathroom every 20 minutes (urinate only). symptoms lasted about 48 hours. Only has 1 kidney due to renal carcinoma and doesn't want 2nd shot he is afraid to damage his only kidney and if side effects are worse the second time he doesn't want that.

Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17. He started c/o discomfort and appetite decreased. 2/18/21 had low grade fever. 2/22 fever and generalized weakness and abnormal labs (elevated potassium). 2/22 hydration was started. 2/25 antibiotic started for UTI for 7 days. Patient seem to improve except appetite. Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March. On 3/2/21, patient received 2nd dose of Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite. By 3/4/21, patient was noticed to have trouble chewing and swallowing. Speech was ordered. On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility. On 3/8/21, it was noted patient had intermittent confusion. By 3/10/21, patient was more alert. Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management. Then on 3/27/21 he became disoriented, wheezing, labored breathing, Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94. Oxygen started and sent to ER. Family reported patient is admitted to hospital with mild stroke and UTI. The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae. This seems similar to timing of actual COVID infection pattern when it is the actual virus.

One week after receiving the injection, patient went into complete kidney failure. Patient died on May 14, 2021

Patient began experiencing Shortness of Breath, which increased until he had to be transported to the ER on 3/26/2021. He was diagnosed with severe Congestive Heart Failure, with an injection fraction of 15% and kidney function below 30%. He was released to hospice care 4/5/2021 with Pleur-Ex drains to both lung areas. He continued to get worse, including TIAs, until he died on 5/31/2021.

Noticed that my urine was cloudy the night after the vaccination, then turned red with blood in urine, and very dark, also achy in shoulder joint.

He had the vaccine, everything was fine until he got up around 12:30 AM. He was shaking really, really bad with tremors. His wife got up and he had urinated on himself, and his wife felt his forehead and he did not feel hot. Went back to bed, he went to sleep and the next morning 2/13/21, wife got up and when he got up around 7:30 he was dressed, but not buttoned right and had his hat on and was confused. He sat in front of the fireplace not moving, and starting talking nonsense until 9:00 - 9:30 when he started talking to her. He could not differentiate between morning and night, and then slowly progressed back to normal. Did not eat much, and said that he could eat anymore. He was pacing back and forth and then finally cleared mentally and was ok around 10:00 AM. He is now back to his normal self today 2/16/21. She gave him 250 mg of Tylenol around 9:30 AM on 2/13/21 as his temp was 100.1. HIs blood pressure at that time was 103/59 and pulse 100. She then checked it in the other arm and it was 104/60, pulse 99. She then checked it again on Monday and it was 108/61 with 68 pulse rate which is normal for him.

Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine. Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.

Narrative: Patient and wife contacted telephone triage nurse today requesting advice. States patient did fine with the first covid vaccine, but after he got his second covid vaccine on 2/20/2021 he became ill, has not recovered yet. Patient is c/o nausea/vomiting, "he looks jaundiced" per wife. Some mild SOB, + epigastric discomfort, chills, increasing weakness. No diarrhea, "some constipation." + Dark urine. This nurse asked wife to check V/S. [B/P: 116/65, pulse 75]. Pt still able to getup and walk around to use restroom, etc. - some lightheadedness with ambulation. No leg swelling. Patient has been vomiting several times daily since 2/20/2021. Emesis x 4 since last evening. Recommended local ER. Wife states she will take him to ER now. Please follow up, thank you.

Possible pneumonia; Kidney stone; A spontaneous report was received from a consumer concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kidney stone and possible pneumonia. The patient's medical history included coronary artery disease, prostate cancer and skin disease - itching and eczema. No relevant concomitant medications were reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient developed kidney stone and was hospitalized on 19 Feb 2021. Patient's status of kidney stone was unknown. On an unspecified date, the patient experienced pneumonia. Second vaccine date was outside dosing interval. No treatment information was provided. Action taken with mRNA-1273 in response to the events kidney stone and pneumonia was not reported. The outcome of the events kidney stone and pneumonia was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home. Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%. He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI. Comfort care measures were implemented and he died 4/15.

ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours) Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance (CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021 Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA * (Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes Coronary artery disease with history of myocardial infarction without history of CABG Not Applicable Depression Yes History of aortic valve replacement Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia (CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA (transient ischemic attack) Not Applicable Dementia with behavioral disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury) (CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91] Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome status post pacemaker, aortic stenosis status post valve replacement.Coronary artery disease status post CABG, CHF, history of peripheral vascular disease, history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD, dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia 11/2020 was brought to the emergency room by the family due to worsening confusion and agitation, as per wife after the patient was discharged back in November in few weeks patient dementia started to get worse, more confused, more agitated and few times he was violent to his family members, well for the last few days patient's wife reported that his confusion was very bad so she decided to bring him to the ED for further evaluation management. Hospital Course -For the above presentation patient was admitted to the hospital services, patient was started on oxygen supplementation, Covid repeat test continue to be positive, started on IV antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8 patient was found without any spontaneous respiration, patient was pronounced dead by the RN and CRNP finished the discharge defecate, please refer to RN documentation for more details.

Admitted to hospital with sob upon exertion that started prior to vaccine. Hx COPD, HTN, CKD, hyperlipidemia, bladder cancer in remission. Stated he has been taking Eliquis and Xarelto between renal doctor and cardiologist Dr. Anticipating going home 2/5/21 but then turned blue and stopped breathing under a DNR. COVID test negative. Labs show acute on chronic renal failure with an elevated troponin likely from demand ischemia.

Having the feeling of a need to urinate, but inability to. A lot of pain in the groin area. High blood pressure. Diarhea all night.

Death Narrative: Patient tested positive for COVID-19 on 1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had made it through the COVID infection period but suffered complications including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen. He required readmission to hospital for the complications in 3/2021 but ultimately passed away on 3/24/21 likely due to the multi organ failure complication of COVID

After receiving Moderna vaccine, pt became increasingly tired, withdrawn, and confused, refusing to walk at home. He has begun to have mild memory changes after suspected COVID illness (covid testing negative) in November, but daughter of patient, with whom he lives, states that his memory and orientation now significantly changed- he seems to have forgotten the last "3 years" of memory. Presented to ER 1/16/21 as she checked his O2 and found him to be hypoxic in 60s. He is being treated for possible CAP with underlying perviously undiagnosed ILD vs post-covid lung changes (per pulmonology), and his energy and ability to walk have returned but memory is significantly impaired, confabulating and oriented only to self despite good oxygenation on 5L O2 by NC.

Patient stated he felt "funny in the head" on 02/19/2021 at 4:00 pm. His wife stated that the patient had seemed confused. Gave patient 2L of fluids and discontinued trazodone. Patient returned to baseline and was discharged after 24 hours.

Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization). Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR. Pt pronounced time of death was 2110pm. (Pt only reported a sore shoulder secondary to vaccine).

3/11/21 orthostatic hypotension, Fall and N-Stemi dx at a hospital -3/12 transferred to another hospital - 3/16 discharged to Swing bed at another hospital HPI: History of Present Illness: Patient is an 89-year-old Caucasian male with a medical history significant for atrial fibrillation on anticoagulation due to prior GI bleed, HTN, HLD, T2 dm, BPH who initially presented to outside facility following a fall. Fall was mechanical in nature and occurred whenever he slipped on water while walking with his cane out the front door. Primary point of impact was on his left leg in hip as well as possible head trauma. Preceding this event, patient denies any presyncope, syncope, chest pain, shortness of air, palpitations. An extensive workup was performed outside facility including CT scan of the left hip without contrast, CT scan of the head without contrast, lumbar x-ray, CT scan of the left knee without contrast all of which showed no acute fracture or abnormality. EKG showed normal sinus rhythm heart rate of 75 with incomplete RBBB. Labs are included below. Vital signs normal. Patient was getting ready to be discharged from facility and whenever they sat him up, he had an episode where he stared ahead and got diaphoretic as well as dizzy. Patient has recollection of this incident. Outside ER decided to get troponin at that time and came back elevated at 0.163. Patient continues to deny any chest pain. Denies other associated symptoms including fever, fatigue, chills, shortness of air, palpitations, abdominal pain, nausea, vomiting, diarrhea. CBC: WBC 9.2, HGB 13.4, HCT 39.3, PLT 223 BMP: Na 141, K 3.7, Cl 104, HC03 31, BUN 22, CRT 0.94, GLU 124. PT 10.5, PTT 24.7, PLT 1.07. Due to lack of Cardiology coverage at outside facility, patient transfer was requested for further troponin trending and possible cardiology evaluation should be deemed warranted. hpi 3/16 The patient is a 89 y.o. male with a past medical history notable for atrial fibrillation, CAD, diabetes, BPH, hyperlipidemia. The patient presents for evaluation of worsening issues of weakness status post recent hospitalization were patient was fainted and was found to have orthostasis. Patient had a cardiac workup which was negative for any significant cardiac disease. Patient's plan is to hopefully get stronger return home to more independent living. Patient was seen today in his room. Patient notes that he has done very well with therapy after his fall. Patient is hoping to get stronger. Patient has no issues with any bowel or bladder function. Patient denies any shortness of breath. Patient has had good intake. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite. on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue. on the evening of 3/4, he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD. he developed cardiogenic shock and renal failure. on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired.

Was not eating; Hematuria; became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion; weak/he could hardily make it to the grocery store door back to the car without total exhaustion; Pancytopenia; father who passed away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEATH (father who passed away), PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating), FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation and Heart failure. Concomitant products included RIVAROXABAN (XARELTO), FUROSEMIDE, PRAVASTATIN and CARVEDILOL for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced HAEMATURIA (Hematuria) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced DECREASED APPETITE (Was not eating) (seriousness criterion hospitalization). On 31-Mar-2021, ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) had resolved. The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating) and FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Full blood count: low (Low) lowplatelets, low wbc and low hemoglobin. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's advanced age and underlying medical conditions (Atrial fibrillation and heart failure) remains a confounder. Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death

Death 5/5/2021 Causes of death listed on death certificate: 1) cardiac arrest 2) unknown cause Other: COVID 19, CAD, AKI needing HD