Moderna

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

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

In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.

Patient presented to hospital on 4/9 with worsening dyspnea on exertion and fatigue and brown colored urine. Patient was diagnosed by hematology service with warm autoimmune hemolytic anemia (Evan's disease). It was refractory to high dose steroids, rituximab, cyclophosphamide and required splenectomy. He has required multiple blood transfusions.

After second dose 3/10/21 started having chills, myalgia. On 3/24/21 hospitalized with respiratory failure, kidney failure, heart attack, sepsis and liver malfunction. Had subsequent GI bleed

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

Stones in his Kidney; Badly dehydrated; Urine has been dark; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Stones in his Kidney) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark). On an unknown date, the patient experienced NEPHROLITHIASIS (Stones in his Kidney) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Stones in his Kidney), DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medication was reported. Patient states that these events were not related to vaccine and declined further follow up. This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. 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. Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up was received on 23-may-2021. New event "Kidney stone" was added.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. 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.

Patient presented to the ED on 3/29/2021 "for evaluation of right groin, right flank pain and gross hematuria." Patient presented to the ED on 4/4/2021 for UTI. Patient presented to the ED on 4/19/2021 for dependent edema. Patient presented to the ED and was subsequently hospitalized for alcoholic intoxication. Patient had second vaccination on 4/26/2021. Patient presented to the ED and was subsequently hospitalized on 5/19/2021 for atrial fibrillation. These visits are within 6 weeks of receiving COVID vaccination.

Patient is a 60-year-old gentleman with a history of tonsillar and skin cancer with mets to the lymph nodes status post chemotherapy and radiation, BPH, hypertension, hyperlipidemia, and CKD stage 4. Patient presented to the emergency department for complaint of dizziness x4-5 days with diarrhea x3 days and syncope today , pt noted hypotensive in ER but per ER physician not orthostatic, Dr spoke with pt oncologist and seems his Blood cell count close to his baseline, but his baseline creat 2.1 so does have acute on CKD and dehydration. pt noted COVID 19 positive and cxr suggestive covid pneumonia, his cxr was better couple of days ago when pt wasin ER as well. pt did recived his covid vacine 1st dose on Saturday. He finished his chemo on May 13th.

Delayed anaphylactic reaction. Evening of receiving injection he didn't feel well, oxygen dropped to 80s on pulse ox and patient self administered epi pen at home and went back to sleep. Later this happened again and he developed throat closing and gave himself a second shot. He went to the ER the following day 7/26/21 where he received treatment with dexamethasone, pepcid, and benadryl. He also had labwork completed, EKG, and Chest xray. He did well with treatment and was discharged home.

approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling

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

Fever, extreme aches, shallow breathing, dark urine, fatigue, joint pain. Patient had had Covid three months prior (mid-November). Vaccine side effects were the same as when he had Covid and lasted 36 hours.

I woke up with cold chills. Throughout the day I had fatigue in all extremities, irritability and sensitivities to the skin on my arms. I felt discomfort while urinating throughout the day. I had a low grade fever later in the day.

Patient received the first Moderna Covid-19 vaccine and a few weeks later he noticed jaundice and hematuria. He was admitted to the Hospital, and was noted to have dramatically elevated eosinophils (26.29 k/uL), elevated creatinine (2.36 mg/dL) and elevated LFTs (AST/AST/Alk Phos/Tbili all up, mostly direct). His eosinophils improved with pulse dose steroids and the diagnostic work up continues. There is diagnostic uncertainty about what caused this dramatic increase in eosinophilia, but it appears temporally related to getting the vaccination. Our working diagnosis is autoimmune vasculitis, but he is also being treated for possible parasitic infection, and will require very close follow-up. 61M with PMHx HTN p/w generalized fatigue, L flank pain, and decreased UOP. He was in his usual state of health until 5 days prior to admission with onset of general fatigue/sluggishness. This was followed by a few days of dull abdominal pain, watery bowel movements, and increased frequency which spontaneously resolved, though the fatigue persisted. Yesterday evening, he noticed new L flank pain, red urine, and decreased UOP associated with mild dysuria (he describes it as needle-like pain in his urethra) which prompted him to call EMS. Denies fevers/chills/night sweats, myalgias, respiratory symptoms, melena/hematochezia. He's never had pyelonephritis or kidney stones before, no recent urinary instrumentation, antibiotic use, or hospital stays. He recently received the first COVID vaccine and is due for the second COVID shot on Monday. He lives with his sister and works as a mechanic. He is not on any other medications or supplements. Not currently sexually active. ED Course Vitals: Temperature: 36.7 °C (98 °F) | Heart Rate: (!) 103 | BP: (!) 169/121 | Respiratory Rate: 18 | SpO2: 96 % | | FIO2 | Weight: 104.3 kg (230 lb) Exam: L CVA TTP Labs: Cr 2.34, bicarb 18, WBC 37, UA w/ 3+ blood, +1 LE, nitrates, >182 RBCs, 32 WBC, no bacteria, no casts Imaging: CT/AP with mild L hydrouretonephrosis, b/l periureteral and perinephric stranding, b/l urothelial thickening Interventions: CTX 1g, ketorolac, 1L LR, morphine ===================== Hospital Course 4/10-4/16 ===================== #B/l Pyeloureteritis with Eosinophilia c/f Eosinophilic Pyeloureteritis #B/l L Hydroureter/Hydronephrosis, B/l Perinephric Stranding and Pericystic Stranding #Profound Eosinophilia Pt presented with malaise, hematuria, decreased UOP and markedly leukocytosis with predominant eosinophilia to 26k and was found to have L hydroureter/hydronephrosis, b/l perinephric stranding and pericystic stranding on CT A/P (4/10). Notably has been afebrile and fairly well appearing. Symptoms were preceded by several days of watery diarrhea, cough with sputum production and subjective weight loss. Recently received moderna vaccine, and he was concerned it causes his symptoms. Underwent extensive workup as below with involvement of multiple services including Renal, Pulm, Rheum, Allergy, ENT, and Cardiology. Had one nasal lesion biopsied by ENT, which was non-diagnostic. Renal bx prelim without clear e/o vaculitis, although obtained after steroids. Negative testing for primary hypereosinophilic syndrome. Extensive w/u notable for ANCA positive at 1:80 with MPO only slightly elevated (20, uln 19) and PR3 wnl. cMRI with eosinophilic cardiomyopathy, for which cards was consulted as below. Additionally, toxacara ab positive and schistosoma ab indeterminate, although per ID both schistosomiasis and toxacara infection unlikely. Per rheum, overall felt presentation 2/2 hypereosinophilic syndrome, potentially the eosinophilic stage of EGPA (given low + ANCA, low + MPO) vs. End organ effects of idiopathic eosinophilia. Briefly received CTX 2g IV qd (4/10 - 4/12) until diagnostics returned. Treated with solumedrol 1g qd x3d (4/11-4/13) transitioned to prednisone 60 mg qd (4/14-) to be continued until rheum f/u, with rapid decline in eosinophilia. Received pre-treatment with PO ivermectin 20 mg before steroids. Treated with flonase nasal spray, symbicort and albuterol for respiratory symptoms. Deferred cyclophosphamide, with consideration of IL-5 or IL-5R targeted biologics as an outpatient. Treated with atovaquone for PCP ppx. Per ID, treated with praziquantel (for schistosomiasis) and albendazole (for toxacara) out of an abundance of caution, although low c/f visceral larva migrans given lack of compatible imaging findings and no known exposure to dogs and cats or schistosomiasis given remove travel history. Data - CT A/P (4/10): Mild L hydroureteronephrosis with b/l periureteral and perinephric stranding and b/l urothelial thickening. Pericystic stranding. - 4/11 CT Chest with parasinus mucosal thickening and sclerotic 1 cm lesion likely benign lesion or bone island - 4/11 CT Face with parasinus mucosal thickening and small fluid levels and sclerotic ovoid 1 cm lesion in neck of right mandible potentially representing benign fibro osseous lesion or bone island - PFT with severe obstruction and elevated FeNO c/w eosinophilic infiltration - Heme review of smear with normal Eos - Echo TTE with LVH nl EF 52% - Vitamin B12 >2000 - Urine Eos undetectable after steroids - SPEP with polyclonal hypergammaglobulinemia - Sinus Bx equivocal - ANA, ANCA (1:80; MPO 20, PR3 3), ESR (128), CRP (66), RF (<13), C3 (82, slightly low), C4 (10) - IgE 355 - Aspergillus IgG and IgE <19 - HIV non-reactive - RHP with CHIP mutation which will need f/u - FIP1L1 negative - Schistosoma ab equivocal - Strongy ab negative - Toxacara ab positive - Leptospira ab negative - Tryptase wnl - RHP notable for CHIP mutation as below - BCR-ABL negative - FIP1L1-PDGFRA negative - peripheral blood flow cytometry unremarkable #AKI on CKD #Nephritic syndrome #Urinary retention/hydronephrosis Cr 2.34 on admission. Baseline Cr unknown but Cr was 1.5 (OSH BI) and urine alb:Cr was elevated to 36 in 6/2018, at which time CKD was thought to be 2/2 untreated HTN. Now presented with persistent hematuria, HTN and proteinuria with UCx without e/o infection, all favoring nephritic process. Renal and urology consulted MALB/CCR 994.5. CT scan with hydronephrosis, felt to be eosinophilic pyelonephritis. Pt underwent uncomplicated renal bx 4/14 (after steroids) which showed preliminary very mild focus of interstitial nephritis with scattered eosinophils and immunofluorescence evidence suggestive of a mild immune complex-mediated disease without current activity. EM pending. He was treated with sodium bicarb 1300 mg bid. Hematuria improved but did not resolved by time of discharge. Cr on discharge 1.6, close to baseline of 1.5 in 2018. #Sclera Icterus #CBD Dilation on CT #Elevated LFT Sclera icteric and CBD dilation on RUQUS to 1.8cm with gallbladder sludge and small gallstones. MRCP with diffuse intrahepatic and extrahepatic biliary ductal dilatation to the level of ampulla, with associated ductal and gallbladder wall edema, complex material in the gallbladder lumen and CBD, and confluent periportal lymphadenopathy. No obstructing stone or discrete mass. Findings likely represent cholangitis such as eosinophilic cholangitis in light of severe eosinophilia.. No documented LFTs here, but OSH (BI) records indicate normal LFTs and viral hepatitis studies in 6/2018. Repeat Hep B non-reactive non immune, HCV non immune, HAV non-reactive. BIli remained stable and ALT and AST continued to rise after initiation of steroids. GI was consulted. RUQUS 4/15 with dopplers with persistently dilated CBD to 1.4 cm with sludge in CBD but with patent portal vein and hepatic veins. Anti smooth muscle ab positive on day of discharge; antimitochondrial ab pending. LFT uptrending at time of discharge, although patient declined to stay inpatient for further workup. LFT at discharge ALT 194, AST 114, ALP 262, TBili 6.3, DBili 5.3. ERCP to be considered as an outpatient. #HTN SBP on admission 160-180. History of HTN, not on any home anti-hypertensives. Per BI records, he was prescribed amlodipine 10/valsartan 160 in 6/2019, but pt reports self-discontinuation after ~2 doses. BP remains poorly controlled. Likely related to potential nephritic syndrome or renal infiltration by eosinophils, likely with contribution of high dose steroids. While inpatient, treated with hydralazine, labetalol, carvedilol, and amlodipine. BP regimen on discharge amlodipine 10 mg qd, carvedilol 25 mg qd. Avoiding ARBs and ACEI per Renal, although will likely need to add once AKI resolved. #Microcytic Anemia Patient with drop in Hct from 14.1 on admission to 11.4 4/14. Continues with hematuria, but denies current hematochezia. Suspect combination of blood loss and hypopoliferation given RPI 0.29, likely anemia of inflammation/acute illness given ferritin 1.010. Vitamin B12 >2000, Folate 11. Iron 151, unable to calculate TIBC. Noted to have persistently low MCV in low 70. Hemoglobin electrophoresis ordered. #Vitamin D deficiency #HyperPTH 25-OH Vitamin D 6. No e/o hypocalcemia. Phos slightly elevated on admission, but subsequently downtrending, likely iso renal dysfunction. Treated with ergocalciferol 50,000 U weekly x12 weeks #Right mandible lesion Sclerotic changes of the right mandible near the condyle noted on CT scan. Surgeon recommends outpatient follow-up, although patient declined. #Hematochezia #Hemorrhoids Patient with new bloody diarrhea 4/11. Some e/o hemorrhoids on exam. CBC stable. Treated with tucks pads, dibucaine ointment and hydrocortisone cream. #Little Medical Follow-up Pt reports that he has not seen a doctor in ~3 years.Cholesterol 124l LDL 73, HDL 10. HgbA1c 5.2. Will join Dr's panel on discharge #CHIP mutation RHP with DNMT3A mutation at low VAF. Will follow in cancer precursor clinic

Covid-19 J96.90 - Respiratory failure (CMS/HCC) N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC) U07.1, J12.82 - Pneumonia due to COVID-19 virus

kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass; very tired/very fatigue; urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body; sore arm; slept a lot after the shot; did not have any antibodies after the first vaccine of Moderna; very bad lower back pain both sides within a few hours of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after Shingles Vaccine.) on 24-Jun-2008. Previously administered products included for an unreported indication: SHINGRIX (First dose- Oct-2019 and Second dose-Feb-2020) from October 2019 to February 2021. Concurrent medical conditions included HIV infection since 18-Feb-1998, Renal agenesis (born without left kidney), Drug allergy (Fluroquine allergy), Contrast media allergy, Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhea (Improved with daily Morphine ER) since 10-Jan-1996. Concomitant products included AMLODIPINE for Blood pressure management, RITONAVIR, ABACAVIR, DOLUTEGRAVIR SODIUM (TIVICAY), DARUNAVIR ETHANOLATE (PREZISTA) and ABACAVIR SULFATE (ZIAGEN) for HIV infection, ACYCLOVIR [ACICLOVIR], MORPHINE, PRAVASTATIN and FINASTERIDE for an unknown indication. On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (very bad lower back pain both sides within a few hours of the injection). On 12-Mar-2021 at 1:30 PM, the patient experienced URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna). On an unknown date, the patient experienced DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue). The patient was hospitalized on 15-Mar-2021 due to URINARY RETENTION. On 13-Mar-2021, URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) had resolved with sequelae. On 22-Mar-2021, DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna) outcome was unknown. At the time of the report, DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue) outcome was unknown and BACK PAIN (very bad lower back pain both sides within a few hours of the injection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine: (High) Elevated creatine numbers.. On 22-Mar-2021, Antibody test: (Inconclusive) No antibodies were developed 10 days after 1st dose of vaccination.. On 22-Mar-2021, Blood creatine:. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported that he was born with only one kidney(Right). The patient was enrolled in a COVID-19 study for the last several months. Sequelae for the event of urinary retention included elevated creatine. No treatment was reported for the events. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event urinary retention was upgraded to serious. Seriousness criteria hospitalization was included for urinary retention. Lab data for antibody test and creatine test were added. Allergy (Fluroquine,contrast dye), historical vaccine(Shingles Vaccine), historical condition(Herpes Virus Infection) were updated in other relevant history. Current condition asthma, mitral valve disease and diarrhea were also added. On 12-May-2021: Additional information provided on 12-May-2021 included an additional event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

on 4/12/2021 found to have severe elevated BP 180/80 range which persisted despite BP medications. On May 12, 2021 found to have elevated creatinine, potassium and decreased E GFR. Duplex ultrasound on the left kidney demonstrated renal artery stenosis to 80%+. After renal parameters were improved with fluids, left kidney artery was stented (X2) with resolution of the high BP. No clear etiology for stenosis was noted (no plaque, no clot etc)

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

Kidney stones, 2 total, first the day after 2nd vaccination, 2nd the following day. Stones were moderate, blocking urine flow for about 30 minutes but passing with pain and very heavy bright blood. Self-treated with high fluid intake, blood dissipated reasonably. No recurrence. Also had a more usual and expected 2nd dose fatigue for several days. Kidney stone history - passed a tiny tiny stone some 5 years before, with brief sting and trace blood; microscopic analysis by my doctor confirmed trace stones; scan indicated no significant problem. Reduced my tea intake.

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

Patient came to the ED with SOB, kidney pain, weight loss, and disoriented. CT scan and MRI showed portal vein thrombosis. Patient is still inpatient at Hospital. Patient unable to give lot number or date of vaccination.

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

Patient is a type 1 diabetic that went into diabetic ketoacidosis. Patient has never gone into DKA and is requiring hospitalization because of this. Patient possibly had an NSTEMI as well.

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

Headaches, muscle aches, joint pain from 3/16/21 to present. Blood and residue in urine beginning 4/3/21 and continuing to present.

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

On day 4 following dose 2 of Moderna series, pt developed fever, chills, fatigue, malaise and self-medicated with ibuprofen and acetaminophen. After a "few" days of feeling unwell despite treatment, presented to ER and was found to have AKI, hyponatremia, and thrombocytopenia. Over the course of several days rapidly deteriorated and developed MSOF, including liver failure, DIC, respiratory failure requiring intubation, and shock requiring pressors. Workup for VTE, including V/Q scan, LE dopplers, and head CT negative for thrombosis. Ferritin was found to be highly elevated (12,000) suggestive of hemophagocytic lymphohistiocytosis (HLH). Per ER report, marrow positive for hemophagocytosis on smear. At time of report, transferred to Cancer Center for HLH treatment, currently in ICU, intubated, sedated, and on pressors. PF4 antibody pending.

Acute renal failure. Hospitalization for 7 days, hydration, medication change. Renal function returned to near normal.

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

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

Blood clot in urine (black in color) (described it as mucous like and black in color).; Blood in urine (Red in color)(described it as mucous like and black in color).; Aways thirsty; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) (seriousness criterion medically significant), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty). At the time of the report, HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported.. No allergy reported. No treatment done. Patient did not inform health care provider yet. 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.

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

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

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

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

Extreme difficulty urinating. Onset: 7 days after first dose, 24 hours after second dose Duration: 3 days after first dose, 1 day after second dose

Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure. The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported. On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection. On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had received his first dose. On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.

Dark urine post-vaccination on first void and on second void 2 hours later followed by severe bilateral flank pain that lasted approximately 48 hours following vaccination.

1/21 vaccination 1/22 pain at urination; possible dehydrated. Mild flu like symptoms. 1/23 subsided 1/24 By 4am I woke up in pain. The pain in urination came back very painful; blood in urine. I called immediately to clinic as it was painful. Drank a lot of fluids. The NP called back; 2 weeks of cipro. Might have been a particle; stone, low level. But was gone with hydration.

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

63 yo male received 1st dose of Moderna Vaccine on 3/31/21. Admitted to hospital on 4/6/21 then transferred to another Hospital on 4/12/21 for idiopathic pericardial effusion, acute kidney injury then released home on 4/23/21. He presented to hospital on 4/25/21 with acute respiratory failure, septic shock, cardiogenic shock, acute myocarditis and acute on chronic kidney injury. Transferred to different Hospital on 4/30/21

hemolysis aggravated; dark urine; diarrhea; fevers; vomitting; severe fatigue; This literature-non-study case was reported in a literature article and describes the occurrence of HAEMOLYSIS (hemolysis aggravated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria (diagnosed with PNH 30 years ago), Blood transfusion dependent (Transfusion dependence) and Dystonia (smooth muscle dystonia). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (hemolysis aggravated) (seriousness criterion medically significant), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 26u/l (Inconclusive) Pre-vaccination and 22u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood bilirubin: 2.4 (Inconclusive) Pre-vaccination and 3 (Inconclusive) Post-vaccination (after dose 2). In 2021, Blood lactate dehydrogenase: 305u/l (Inconclusive) Pre-vaccination and 342u/l (Inconclusive) Post-vaccination (after dose 2). In 2021, Haemoglobin: 11.9 g/dl (Inconclusive) Pre-vaccination and 7.1g/dl (Inconclusive) Post-vaccination (after dose 2). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (dark urine), DIARRHOEA (diarrhea), PYREXIA (fevers), VOMITING (vomitting) and FATIGUE (severe fatigue) to be possibly related. It was reported that the last dose of the concomitant medication ravulizumab, was given four weeks prior to dose 1 vaccination and seven weeks prior to dose 2 vaccination. PNH Clone was reported as 99% RBC, 99% granulocytes. A week following the second dose, labs showed >4 g/dL hemoglobin decrease from his baseline. No treatment medication reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's medical history and concomitant medications are required for further assessment. This case was linked to MOD-2021-151607, MOD-2021-151607 (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 event, a causal relationship cannot be excluded. However, more details regarding the subject's medical history and concomitant medications are required for further assessment.

I went to emergency and was hospitalized for 4 days due to rhabdomyolysis; Urine darkened; Chills; Slight fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pancreatic cancer. Previously administered products included for an unreported indication: Keytruda. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Pancreatic cancer. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired). On 22-Apr-2021, the patient experienced RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Apr-2021 to 26-Apr-2021 due to RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis), CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine (70-90): high (High) Patient reported a blood creatinine level should have been 70-90 but was 38,000, which then dropped over 2 days. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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

hemolysis aggravated; darkening of urine; total bilirubin rose to 7.1 mg/dL; fatigue; This literature-non-study case was reported in a literature article and describes the occurrence of HAEMOLYSIS (hemolysis aggravated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria (diagnosed with PNH 30 years ago), Blood transfusion dependent and Dystonia (smooth muscle dystonia). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (hemolysis aggravated) (seriousness criterion medically significant), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 26 u/l (Inconclusive) Pre-vaccination and 24 u/l (Inconclusive) Post-vaccination (dose 1). In 2021, Blood bilirubin: 2.4 mg/dl (Inconclusive) Pre-vaccination and 7.1 mg/dl (Inconclusive) Post-vaccination (dose 1). In 2021, Blood lactate dehydrogenase: 305 u/l (Inconclusive) Pre-vaccination and 312 u/l (Inconclusive) Post-vaccination (dose 1). In 2021, Haemoglobin: 11.9 g/dl (Inconclusive) Pre-vaccination and 10.7 g/dl (Inconclusive) Post-vaccination (dose 1). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CHROMATURIA (darkening of urine), BILIRUBIN CONJUGATED INCREASED (total bilirubin rose to 7.1 mg/dL) and FATIGUE (fatigue) to be possibly related. It was reported that the last dose of the concomitant medication ravulizumab, was given four weeks prior to dose 1 vaccination and seven weeks prior to dose 2 vaccination. PNH Clone was reported as 99% RBC, 99% granulocytes. A week following the second dose, labs showed >4 g/dL hemoglobin decrease from his baseline. No treatment medication was reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, more details regarding the subject's additional medical history and concomitant medications are required for further assessment. This case was linked to (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 event, a causal relationship cannot be excluded. However, more details regarding the subject's additional medical history and concomitant medications are required for further assessment.

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

Within 1 week, the following experienced severely inflamed: Colitis (Have had diarrahea for 5 weeks) Lower back (Received steroid shots) Prostrate (Was put on medication to reduce leaking and pain) Right risk (Received steroid shot)

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

The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d post-COVID vaccine (2nd dose, Pfizer). He presented to our hospital on 6/18 with these complaints and was found to have significantly altered mentation, acute kidney injury, and profound thrombocytopenia. Workup was positive for TTP and he was started on PLEX therapy x 5d. Hematologic parameters, renal function, and mentation have improved with PLEX therapy. ADAMTS-13 activity <5% c/w acquired TTP.

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

Patient was experiencing a high fever and was diagnosed with a urinary tract infection and COVID-19 at an outside facility on 7/18/2021. He was instructed to go to emergency department for further management on 7/21/2021. He presented with a cough and mild shortness of breath. He was treated with supplemental oxygen, dexamethasone, and remdesivir. His symptoms improved and he was discharged from hospital on 7/27/2021.

Developed severe myalgias with profound tremors. Severe lower back pain in the area of the kidneys. Minimal temperature elevation. Frontal headache. All symptoms lasted approximately 16 hours. Arm pain persisted for 4 days.

Day 1 headache progressing to migraine and nausea, injection site pain Day 2 - 3 continued migraine with aura, nausea worsening, runny nose Day 4 abdominal cramping , migraine subsided to dull headache Day 5 abdominal cramping worsening and muscle soreness (abdomen and lower back) hurt to urinate. Day 6 - 7 abdominal cramping subsided general soreness lessened Day 8 recovered

PATIENT HAD SENSITIVE URINATION, ALMOST FELT LIKE A UTI. IT HAPPENED THAT DAY OF THE VACCINE UNTIL ABOUT 24 HOURS. PATIENT DIDN'T TAKE ANY MEDICATIONS FOR IT

Medical Summary - Friday, April 9, 2021 Patient received 2nd Moderna vaccination at Care Center. (1st Vaccination at Care Center unremarkable.) Approximately five minutes after vaccination, seated in Observation area patient leaned forward with elbows on knees, when asked stated he felt light-headed, put his head between his knees, wanted to lie down. He lowered himself to floor, with help transferred to different chair, sipped water, given lollipop, suddenly unresponsive, eyes glazed and rolled back, teeth clenched on lollipop stick, leaning to left side, incontinent of urine, no abnormal arm or leg movements, duration ~ or under 1 minute. Lollipop removed by staff, vitals: BP 1 Additional information for Item 18: Lollipop removed by staff, vitals: BP 117/72, P68, SpO2 Room Air 96%: now alert and oriented x4, no shortness of breath, no chest discomfort, able to sit in chair without support, was surprised by incontinence. Stated he felt sleepy, tired, and with staff assistance walked to next room for observation where he laid down on carpeted floor. He had no further episode of LOC, remained alert and oriented but continued to feel "tired". No complaints of chest discomfort or shortness of breath. ~ One hour post-incident BP 94/58 with repeat BP 120/82. ~ Two hours post-incident BP 118/80 (his usual he said) sipped water and electrolytes solution. Patient verbalized several times this event much different from previous events associated with blood draws which he described like typical vasovagal reactions with recovery within ~ 15 minutes. Drs. spoke with patient via telephone: PLAN o Can go home today o Do not drive today o Son will pick him up and stay with him for about 24 hours until wife returns from out of town o Appointment scheduled with PA at PMD office for Monday April 12 @ 8:00am – Patient called the office and I listened via speaker, his PMD is out-of-office till later in month, this is first available at the practice o Dr. recommend PMD work-up to also include EEG and CT Scan o R/O vasovagal event v. seizure v. other etiology o Dr. will contact him by phone later today PA-C MD

Rheumatoid arthritis; kidney failure /dialysis; could not walk due to severe joint pains; fever; severe joint aches; severe body aches; extreme chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Rheumatoid arthritis). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills). On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criteria hospitalization and medically significant) and RENAL FAILURE (kidney failure /dialysis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT INABILITY (could not walk due to severe joint pains). The patient was hospitalized from 05-Mar-2021 to 15-Mar-2021 due to RENAL FAILURE and RHEUMATOID ARTHRITIS. On 15-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) outcome was unknown. At the time of the report, GAIT INABILITY (could not walk due to severe joint pains), PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 103 (High) 103 Fahrenheit. In 2021, White blood cell count: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient was prescribed Mobic at urgent care. In urgent care blood work was performed, white blood cells were elevated and inflammatory rate increased. Two doses of antibiotics ((product name not provided) were prescribed. Based on the information provided, a causal association between the event of renal failure and the administration of mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.; Sender's Comments: Based on the information provided, a causal association between the event of renal failure and the administration of mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.

After first shot on 3/1/2021 all I had was a sore arm for a couple hours and nothing else a breeze but after 2nd shot on 3/29/2021 My arm was getting sore and sorer and by 6:00 p.m. I started to get hot sweats and chills for the next 24 hours. I became very weak and developed diarrhea badly running to the toilet all the time and that lasted for four days. I also developed on day two burning urination for 3 days like a bad UTI which I have experienced being a diabetic. On day four hot sweats and chills stopped but burning urination continued but I was able to get diarrhea under control using some very good medicine I had on hand - The light green anti diarrhea medicine in the bottle -can't remember name but I can get. I also got very bad headace and there is still some there to day on top of back of head

Patient urinated blood clot in urine; Patient urinated blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lymphoma. Concomitant products included ACALABRUTINIB (CALQUENCE) for Lymphoma, CYANOCOBALAMIN (VITAMIN B-12), CALCIUM and FOLIC ACID for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) (seriousness criterion medically significant) and HAEMATURIA (Patient urinated blood in urine). On 10-Apr-2021, HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) and HAEMATURIA (Patient urinated blood in urine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient recovered (clarified as the patient's urine was clear and did not have blood clots) on 10 Apr 2021. Patient self treated by drinking lots and lots of fluids (not further clarified). Company comment: Based on the current available information and the temporal association between the product use and the start sate 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 sate of the events a causal relationship cannot be excluded.

Kidney failure; emergency dialysis; severe body ache unable to walk or move without assistance; bad chills; joint pain; muscle aches; sharp pain at the injection site; severe headache; 100-103 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) in a 64-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 Colitis (Have not been taking medications from 3-4 years). Concurrent medical conditions included Hypertension, Diabetes, Cholesterol high and Drug allergy (Allergic to NSAIDS). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (ONE A DAY ADVANCE ADULTS) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), PYREXIA (100-103 degree temperature), ARTHRALGIA (joint pain) and MYALGIA (muscle aches). On 20-Feb-2021, the patient experienced CHILLS (bad chills). On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (severe body ache unable to walk or move without assistance). On 06-Mar-2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criterion hospitalization) and DIALYSIS (emergency dialysis) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 14-Mar-2021 due to DIALYSIS and RENAL FAILURE. On 24-Feb-2021, PYREXIA (100-103 degree temperature) and CHILLS (bad chills) outcome was unknown. At the time of the report, RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) had resolved, GAIT DISTURBANCE (severe body ache unable to walk or move without assistance) had not resolved and VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), ARTHRALGIA (joint pain) and MYALGIA (muscle aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood test: high (High) WBC high Sedimentation rate elevated. On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 27-Feb-2021, a flu test was performed and results were not provided. On 05-Mar-2021, blood work and CT scan were performed and results were not provided. Treatment: Mobic and Hydrocodone for pain on 22FEB2021 Two Antibiotics and discontinue Mobic on 27FEB2021 Emergency Dialysis on 06MAR2021 IV Antibiotics and Steroids were given at hospital Patient was advised to follow up with Nephrologist and Rheumatologist. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Historical conditions added, Hypertension, Diabetes, High cholesterol, Colitis. Concomitant drugs added Lisinopril/HCTZ, Metformin, Atorvastatin, Baby aspirin and Men's one a day. The outcome of events changed to Recovered. The patient updated new adverse event as severe body aches unable to walk or move without assistance and was admitted to hospital and the outcome of the event is not recovered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

The patient is a 64 year old white male known with diabetes mellitus type II, hypertension, osteoarthritis of his knees, and abnormal liver enzymes. Patient is being seen today for a routine follow up appointment. Patient is experiencing no pain and expresses no new concerns. Patient denies SOB, NVD, cough, cold, etc. Recent labs reviewed A1c 6.9%, LDL 100, total chol 180, Trig 301, HDL 29, VLDL 51. TSH normal at 1.290, AST 39, ALT elevated at 52. alk phos 81 , bun 11, Cr 1.01, GFR 78 , WBC 5.4, Hgb 15.1, Plt 180 reviewed during visit. GM 5/19/21 Patient reports after second Covid-19 vaccine he had 3 weeks of diarrhea, got dehydrated and then had to pass 5 kidney stones. States several coworkers who also had Moderna had diarrhea but it did not last that long. He also had joint pain and headache. He states the headache was mild it was "not bad". He unfortunately did not seek care during this time. Headaches lasted 1.5-2 weeks. Did not hold him up. Had no other sick contacts. Diarrhea and headaches started the next day. He had diarrhea any time he ate anything "a straight shot". At times full watery diarrhea. No fatty or floating stools. He did feel a little warmer at times but when checked Temp was normal. We do have cases of Norovirus in community but symptoms lasted too long for that and no other sick contacts in household with similar symptoms. Did not have a COVID-19 test during that time. Did not notify our clinic. Had fecal urgency. Denies blood in stool.

Patient received vaccine on 4/26/21 and had mild fatigue and malaise, otherwise in his usual state of health. On 4/30/21 he was working in his barn and towards the end of his work he began to feel some palpitations and chest tightness. This did not go away despite resting causing him to come to the emergency department. No known history of cardiac arrhythmia, does not follow with cardiologist. No recent travel. No significant alcohol use. No new medications. No unusual events over the last few days. Found to have new-onset atrial fibrillation on EKG. He was given diltiazem to reduce rate.

The second day I woke up and my arm was on fire. That night I started with a fever. for 10 days I had a fever of 102-103. I had blood in my urine. I had a lung infection where I could not inhale.

Patient was vaccinated on 3/18/21. 1 to 2 weeks later patient reported fatigue and general malaise. Reported to PCP. PCP obtained CMP, CBC with differential. Patient was found to be hyponatremic with a serum sodium level of 110. Patient was admitted to hospital on 4.12.21. Workup showed that patient was in AKI and had DVT. Patient was treated with 3% sodium chloride infusion and was given diuretics. AKI resolved through his course of admission. Patient was treated with enoxaparin for DVT.

CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis

Began to experience UTI type symptoms, with uncharacteristically frequent urination, and some burning. Began to have a fever which over the 24 hour period went from my normal of 97.6 to 101.2 at 10:30pm the second night. Throughout the period I had a mild headache and significant fatigue. I woke up this morning at 12:30am with the sheets, pillow and pajamas very wet (from sweat). I checked my temperature and for the first time in 24 hours, it had dropped (to 99.2). When I got up at 6 this morning, my temperature was 98.6 (still a little elevated for me). My wife experienced practically the same thing 4 days earlier without the urinary symptoms and temp not quite a elevated. We had the vaccine at the same time(s). I'm still fairly fatigued at this time (and my wife a little).

unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "doesn't remember any of it", "unconscious", "near death experience", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; "difficulty breathing", "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "Moderna shot is killing him", and "he is dying". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". At an unknown time later he experienced "difficulty breathing", "lost consciousness" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "dying", unconscious for almost a week". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results "didn't find anything". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, "loss of consciousness", "headache", "feeling abnormal", "weakness" "decreased appetite", "insomnia", "amnesia", " aphasia", "dysarthria", "confusional state", "dyspnea", "fatigue", " myalgia", "arthralgia", "chills", "nausea", "vomiting", " pyrexia", "urinary incontinence", and "dizziness" were possibly related to mRNA-1273.

Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.

Date and time of vaccination: (list both if they received both shots): 2-2-21 10AM Moderna LOT # 038K20A 3-2-21 10AM moderna LOT # 025A21A left sided flank pain, went to ED. had Ultrasound done was told it was possibly a kidney stone, scheduled for a CT.informed them on 3-4-21 this was likely not related to the vaccine but sounds to be possibly issues with kidney stones and to continue with CT as scheduled. verbalized understanding.

65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.

Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29

Got the shot Saturday patients arm was hurting Saturday and the people at shot clinic told the patient to take Tylenol for pain, Sunday the patient was extremely tired and clammy told the daughter his joints and body was hurting so badly. Sunday the patient woke up with allergy symptoms so patient was waiting it out to see dr until his appointment. The patient finally woke up on 3-31-21 around 5 am and the patient had cold chills and clammy the patient put on his robe then told his wife that he was too hot shortly after. The wife was leaving for work at 6am and the patient was curled around toilet stating he felt nauseous, wife left for work around 6am and then she stated about 15-20 minutes later the husband called her asking her to come back home she stated he sounded very short of breath and just not right, she turned around and got home around 645am and found her husband pale and in his recliner with his mouth open and unresponsive. The wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR.

Patient had covid vaccine and then 1 day later, developed worsening PVCs. Patient has a history of PVCs and Vtach for which he has a pacemaker. Patient is historically very symptomatic with his PVCs. These worsened over the course of a week which lead to worsening substernal chest pain and he presented to the ER on 3/15/2021 and due to his history of CAD, was hospitalized for observation, discharged on 3/16/2021. He had labs, echocardiogram while in the hospital. His metoprolol was increased to help decrease symptomatic PVCs. On 3/9/2021, patient developed chills, difficulty swallowing and the sensation of his throat and tongue being swollen, along with some generalized itching. He presented to the ER 3/9/2021 due to these symptoms and these symptoms resolved without interventions and he was discharged home. He then developed lower lip swelling on 3/15/2021.

Approx 10 minutes after receiving vaccine, pt called out for help from his car in the waiting area. Was monitoring the area and went to assess patient. He stated he felt faint. O2 sat 94%, pt diaphoretic, pale, drooling, tongue protruding from mouth, eyes open, but difficult to arouse, unable to respond. Epi administered and EMS contacted. Pt then lost consciousness. Grossly diaphoretic, clammy to touch, in and out of consciousness, pupils small but reactive, BP 84/48, R16, pulse 68. Unable to obtain O2 sat as monitor wouldn't register values. Lost consciousness again. Not responding to sternal rub. Gave 2nd dose of epi and maintained airway with jaw thrust. Pt regained consciousness

Chills, Nausea, Entire Body Aches, Fever, No Appetite, No Sleep, Headache for36 hours, starting 15 Hours after 2nd vaccine, Home location throughout. Urine discoloration.

Patient states on 4/14/21 to the facility that he the following issues following his second covid vaccine that started around 22:00 on 3/26/21. Facial swelling, lymphnode swelling, severe malize and weakness, increased sleepiness, unable to urinate or with extreme difficulty. He called his PCP and was treated in the outpatient office.

Patient stated, " Sometime in February and has had some type of problems with his legs since then". He gets left ankle cramps and has noticed increased swelling in left leg. Patient is now in acute renal failure.

Prostate swelling; Unable to urinate/Zero flow/ haven't urinated since May 31st; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE and LEVOTHYROXINE for Thyroid disorder. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) (seriousness criterion medically significant). On an unknown date, the patient experienced PROSTATOMEGALY (Prostate swelling). The patient was treated with TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) and PROSTATOMEGALY (Prostate swelling) had not resolved. Treatment included pain medications. The patient went to the hospital and got a catheter inserted. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received added a new event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired.

Three months after I received a Covid-19 vaccine, I developed a urinary tract infection. I was admitted to the hospital with a fever and low blood pressure. Urine culture showed presence of E. coli. This was treated with IV fluids and antibiotics, followed by oral antibiotics. I am still taking Cefuroxime daily to prevent recurrence of the UTI. I had another UTI on March 18, 2021 - this was between my first and second Covid-19 vaccines. The first UTI happened one day after a cystoscopy. There is no evidence that either UTI was related to the Covid-19 vaccination.

Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021

New occurrence of gross hematuria 2 days after vaccination. Required hospitalization. Found to be related to papillary tumor of bladder via cystoscopy procedure.

31 hours after the shot all of a sudden I started to get very jittery and started having chills. I ate a banana and a glass of milk. The jittery feeling subsided in about an hour. The chills remained and I got flushed and felt like i had a temperature. My joints in my hands felt very sore and during the night my body muscles felt wore out. My left shoulder at the site of the shot was throbbing bad. For some reason I had to urinate every hour for the next five hours of the night without ingesting any more fluids. By 7:00 AM I got to feeling progressively better and by 9:30 AM I felt like I had just had a very poor nights sleep. No more chills, fever, being flushed and the pain in my arm subsided substantially.

He states that he began urinating every 2 hours at approximately 6 p.m. the day he received his second vaccine (approximately 4 hours after his vaccine) and this lasted until 8:00 a.m. the following morning (14 hours). He had no other urinary complaints to suggest an infection. He also had 3 episodes of diarrhea, fatigue, and joint pain following his second dose of vaccine.

Patient became very weak and sleepy about a week after the vaccine. By the following saturday, he couldn't even stay awake enough to eat. His blood pessure was very low and he had a fever , so I called paremedics, and they took him to the hosp. After many tests, they found blood in the urine, and his blood platelets had dropped to 121.( Now he had blood work done in June of 2020 and his platelets were 225.) After a few days, his platelets began to creep back up, and are now around 165, back to normal range. He is currently at a rehad facility for physical therapy to regain strength.

Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones). Patient also reported that patient was having a difficult time breathing. Treatment for the event included receiving oxygen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Soreness at left arm injection site on day 2. Day three Body ackes runny nose.Day 4 joint pain full flu like symtems,kidney pain,headake,coughing sore throat. These symtems continued for days 4 ,5,6,7. on day 8 all symtems were gone except for stuffed up nose that continues today But not as bad as days 4,5,6,7,

Patient was admitted to Medical Center with transverse myelitis, potentially caused by second Moderna vaccine received on 3/16/21

Patient had syncopal episode, urinated, became nauseous upon rousing. Placed in trendelenburg, left side lying for nausea. Patient bp 85/52, HR 110. Patient sent to ER via medics

weakness; inability to rise; frequent urination; lack of taste for food/loss of sense of taste; inability to produce a bowel movement; inability to walk/inability to reach bathroom; blood sugar higher than normal; blood pressure higher than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (inability to walk/inability to reach bathroom), ASTHENIA (weakness), DYSSTASIA (inability to rise), POLLAKIURIA (frequent urination), AGEUSIA (lack of taste for food/loss of sense of taste) and CONSTIPATION (inability to produce a bowel movement) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (10 day hospitalization and administration of oxygen therapy) on 01-Nov-2020. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (inability to walk/inability to reach bathroom) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSSTASIA (inability to rise) (seriousness criterion hospitalization), POLLAKIURIA (frequent urination) (seriousness criterion hospitalization), AGEUSIA (lack of taste for food/loss of sense of taste) (seriousness criterion hospitalization) and CONSTIPATION (inability to produce a bowel movement) (seriousness criterion hospitalization). In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to AGEUSIA, CONSTIPATION, DYSSTASIA, GAIT DISTURBANCE and POLLAKIURIA, and then from 03-Mar-2021 to 06-Mar-2021 due to ASTHENIA. On 06-Mar-2021, GAIT DISTURBANCE (inability to walk/inability to reach bathroom) and CONSTIPATION (inability to produce a bowel movement) had resolved. On 24-Mar-2021, ASTHENIA (weakness), DYSSTASIA (inability to rise) and AGEUSIA (lack of taste for food/loss of sense of taste) had resolved. At the time of the report, POLLAKIURIA (frequent urination), BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment History includes ER visit, hospitalization, IV fluids, IV medications, "injections for blood sugar", EKG, scope to check for blood clots, physical therapy. Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus; Sender's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus

Urination every 4 hours, fatigue, and dehydration after 1st dose. After second dose, on April 11 th, urination now every 2 hours, and same symptoms as previous dose. A1C levels detected as elevated on March 18,2021. Metformin dosage increased from 500mg daily to 2000 MG daily on April 30,2021.

Severe muscle aches and pain beginning in the large leg muscles and migrating to hips, shoulders, arms, neck and back

Approximately 30 minutes after vaccine resident c/o dizziness, right sided headache, blurry vision, weakness. Resident also talking but making no sense.

sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower stomach area; Health declined quickly; Heart issue after first shot of vaccine; Lungs have gotten worse since the first shot; grabbing and pulling at his chest; Unable to sleep; Foul smelling diarrhea; Terrible chest pain; Could not breath/Very difficult to breathe; Could not eat anything; didn't take the second dose of the Moderna COVID-19 vaccine; Sick as a dog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney's almost shut down both times), MYOCARDIAL INFARCTION (had 2-3 attacks) and ILLNESS (sick as a dog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Peanut allergy, Fruit allergy (citrus allergy was reported.), Milk allergy (Dairy allergy was reported.), Drug allergy (demerol), Kidney disorder (Kidney disease was reported.) since 2008, Chronic pancreatitis since 2012, COPD since 2001, Heart disease, unspecified since 2000, Drug allergy (tramadol), Drug allergy (lorazepam), Food allergy and Food allergy. Concomitant products included ONDANSETRON, PANTOPRAZOLE, BUPRENORPHINE and SALBUTAMOL SULFATE (PROAIR HFA) for Chronic pancreatitis, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension, FLUOXETINE HYDROCHLORIDE (PROZAC) for Mood depression, AMMONIUM BROMIDE, POTASSIUM BROMIDE, SODIUM BROMIDE (BROMIDES), TIOTROPIUM BROMIDE (SPIRIVA) and DIAZEPAM (VALIUM) for an unknown indication. On 03-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL IMPAIRMENT (Kidney's almost shut down both times) (seriousness criteria hospitalization, medically significant and intervention required), MYOCARDIAL INFARCTION (had 2-3 attacks) (seriousness criteria hospitalization, medically significant and intervention required), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine) and ILLNESS (Sick as a dog). On 06-Mar-2021, the patient experienced ILLNESS (sick as a dog) (seriousness criteria hospitalization, medically significant and intervention required), DYSPNOEA (Could not breath/Very difficult to breathe) and FEEDING DISORDER (Could not eat anything). 06-Mar-2021, the patient experienced CHEST PAIN (Terrible chest pain). On 19-Mar-2021, the patient experienced DIARRHOEA (Foul smelling diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST DISCOMFORT (grabbing and pulling at his chest) and INSOMNIA (Unable to sleep). The patient was treated with TIOTROPIUM BROMIDE (oral) on 05-Mar-2021 at an unspecified dose and frequency; SIMETHICONE ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at a dose of 10 mg and OXYGEN at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney's almost shut down both times) had not resolved and MYOCARDIAL INFARCTION (had 2-3 attacks), ILLNESS (sick as a dog), DYSPNOEA (Could not breath/Very difficult to breathe), FEEDING DISORDER (Could not eat anything), DIARRHOEA (Foul smelling diarrhea), ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST PAIN (Terrible chest pain), CHEST DISCOMFORT (grabbing and pulling at his chest), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine), ILLNESS (Sick as a dog) and INSOMNIA (Unable to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal other. On an unknown date, SARS-CoV-2 test negative: negative negative. On an unknown date, Troponin: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is on nebulizer treatment of tiotropium bromide and a lot of simethicone. Patient do not know if using either medication helped or not but that was my immidiate reaction. Now patient is on prednisone and feels like he's taking it just to breathe. Patient has had to go on 24 hr. oxygen since the first shot. Patient was negative for Covid-19 over the past 3 months at three different times. He continued to have terrible chest pain where he was grabbing and pulling at his chest, pain creeping up to his chest, could not breath or eat anything for 1 week after his first shot. Patient was in the ER on 10Mar2021. Caller stated he has chronic pancreatitis and breathing issues for which he was prescribed steroids, his doctor told him to decrease the prednisone to 10mg for 2 days prior and day of vaccination. Caller thinks he had a week long stroke since he had high Troponin level which resulted in visit to the hospital where the doctors thought he had septicemia. Caller stated he has not been able to sleep because he keeps having attacks of chest pains that last approximately 15 minutes in the middle of the sleep which occurs 4+ times per night. Kidney's have gotten worse since 1st shot vaccine. Doctors said "the kidney's took a shot" after the first shot of vaccine. Patient was admitted to the Hosp twice after the first shot because his kidneys almost shut down both times. Unexplainable, excruciating pain in chest and very difficult to breathe for approx. 10-15 minutes each attack. New, unexplainable pain in lower stomach area since 1st shot of vaccine. Doctors cannot explain. Patient is seeking legal action against Moderna. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021,included patient demography (Ethnicity, race, height, weight), allergy to peanuts, citrus, dairy, Demerol, tramadol, lorazepam. Current medical condition kidney disease was updated. concomitant medications were buprenorphine, pantoprazole, ondansetron, losartan, Prozac with product indications were updated. Laboratory information EKG was updated. Events Kidney's have gotten worse, unexplainable pain in lower stomach area, my health has declined, lungs have gotten worse was updated. On 23-May-2021: follow-up appended, conmeds added, NF added to events, new events added, new allergies coded, generated narrative.; Sender's Comments: This case concerns a male patient of unknown age who missed second dose due other adverse events experienced post first dose of mRNA-1273. The other events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. However, the patient has concurrent history that confounds the reported events to include chronic pancreatitis, COPD, kidney and heart disorder. Missed dose is assessed as not applicable

kidneys were at failure points; weakness like his running out of gas/lack of stamina; local arm tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of RENAL FAILURE (kidneys were at failure points) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0H0B21A and 0021321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site). On 17-Apr-2021, the patient experienced RENAL FAILURE (kidneys were at failure points) (seriousness criterion medically significant). At the time of the report, RENAL FAILURE (kidneys were at failure points), ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received his first dose of the Moderna vaccine on 15-Mar-2021 and had "zero side effects." The patient reported that his kidney function was normal before the second shot, but a week after the second shot, his kidneys were at failure points. No treatments were taken. Company comment: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. Further information has been requested.

Outcome: Patient Death CHIEF COMPLAINT in ER: chest pain, SOB History of Present Illness: Patient is a 66 yo with PMH of chronic afib on chronic anticoagulation who presented to the ER with a chief complaint of shortness of breath and increased fatigue over the past several weeks that has progressively become worse. Patient denies orthopnea or PND but does have some palpitations and occasional chest pain associated with increased fatigue with exertion. On evaluation emergency room patient was noted to be tachycardic consistent with chronic atrial fib, also acute renal insufficiency likely secondary to dehydration. Patient is admitted to the medical service for further treatment and evaluation. DEATH SUMMARY Date of Admission: 04/07/2021 Time of Death: 04/10/2021 at 0737 Final Diagnoses: 1. Sudden Cardiac Death 2. Acute Renal Impairment Secondary to Hypovolemia, A TN 3. Chronic Atrial Fibrillation w/ RVR, Resolved 4. Atypical Chest Pain, Resolved 5. Hypokalemia, Resolved 6. Obstructive Sleep Apnea 7. Chronic Diastolic Heart Failure Hospital Course: Patient is a pleasant 66yo admitted for acute renal impairment secondary to significant o hypovolemia resulting in ATN as well as atrial fibrillation w/ RVR after presenting to ER with complaints of chest pain, dyspnea, malaise, and anorexia that began after receiving his second COVID vaccine on 4/01/2021. Please see H&P for full details. Patient reported that on the day after his COVID #2 vaccine, he lost his appetite and was not able to eat or drink. He continued to take his home medications as prescribed including losartan, chlorthalidone, and meloxicam. After experiencing progressive worsening of symptoms for 5 days, patient presented to ER for further evaluation. Upon arrival to ER, patient was noted to be hypotensive and tachycardic. EKG showed atrial fibrillation w/ RVR. Routine labs were obtained and were remarkable for elevated creatinine and mild hypokalemia w/ normal BNP and negative cardiac enzymes. CXR showed enlarged cardiac silhouette, but no evidence of pulmonary edema or other acute abnormalities. Patient was subsequently admitted for further evaluation and medical management. He was staited on aggressive IV hydration for his hypotension and hypovolemia w/ PRN IV metoprolol as needed for HR> l lObpm. He was continued on anticoagulation. Serial cardiac enzymes were obtained and were negative. TIE report from Dr's office that was performed recently was obtained and showed EF of 55-60% with Grade 1 diastolic dysfunction. Patient's wife brought his CPAP from home and patient wore his CPAP while sleeping during his hospital stay. During the course of hospitalization, patient's blood pressure & HR improved, though he remained in atrial fibrillation. His creatinine continued to trend up consistent with ATN, but patient continued to produce adequate urine and he had no signficant electrolyte derangements. IVF were adjusted based on urine output and volume status. Patient had no recurrence in his presenting complaint of chest pain and he overall reported feeling better throughout his course of hospitalization despite reporting that he continued to have little appetite. Patient was monitored closely on telemetry throughout his hospital stay. On the morning of 4/10/2021, lab tech and nurse walked into the patient's room to obtain specimen for AM labs. Patient reportedly tried to get out of the bed independently, grabbed at his chest & pulled off his telemetry, and fell to his knees. Staff called Code 99 and patient was placed back in the bed. He was noted to be in asystole. ACLS was performed and despite maximal efforts, patient subsequently expired at 0737. I personally called the patient's cardiologist & personal friend, to discuss the events leading up to the patient's death. Upon review of the patient's course of hospitalization, it was felt that patient most likely experienced sudden cardiac death. Of note, Dr reports that the patient frequently contacts him via text message with concerns or complaints. He states that the patient did not message him during the hospitalization to report any chest pain or other concerns. Disposition: Patient Expired

Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737. Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death

Moderna COVID-19 Vaccine EUA Darker than normal urine for 2 days......I apologize if this is not considered an 'adverse event'. it is unusual for me.

Fever to 100.4 on day 1 after vaccine, to 101.9 on day 3 after vaccine. Acute kidney injury (creatinine rose from 1.73 to 2.43) requiring hospitalization.

Spouse woke at 3am got up for a drink of water and fainted - fell on a tile floor damaging lips and teeth. I got up to help, cleaning up blood and checking injury. After a while I got dizzy and fainted, got up too soon and fainted again. I fainted a third time, had convulsions and lost bladder control. Visited my PCP a week later. Now have a neurologist appt scheduled, a month out. Currently, I have no apparent issues.

2/26/21 @ 1150 Pt in 15min waiting area following administration of moderna 2nd dose. Approx. 5min into wait the pt wife reported something was wrong. Pt was pale, shaking, non responsive and urinated on himself during this event. Pulse was present. Within moments pt became responsive and answering questions. Ambulance arrived, preformed assessment, advised to go to hospital. Pt refused. Pt remained coherent and without complaints.

Day 1-body aches and lethargy, Day 2- same as above plus fever, Day 3-same as two above plus bad abdominal cramps with some gas and diarrhea resulting, cramps were bad enough to cause postural hypotension and cold sweats, had to wear a diaper and lie on floor by toilet till the worst passed during each episode, Day 4- symptoms subsiding, feeling better

The night of the second dose the wife reports that he experienced hallucinations, amnesia and incontinence. According to the wife, an ambulance was called and he was taken to the hospital.

Complete disfunction physically, Severe headache debilitating, No nausea or vomiting. Much difficulty with urination. Severe chills, Moderate fever. Duration in this state was at 32 hours. Tylenol (2) 500mg. every 4 hours, with minor results. As much ice water as possible

Treated for Pneumonia, has not yet fully recovered. Patient also has low back pain, very lethargic, collapsed while walking, legs painful, tingling in hands and feet, incontinence, headache, unsteady while walking and standing

Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and went into respiratory failure with sepsis due to COVID19. He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found. HE required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ failure. His level of cognition decreased until he was no longer responsive and he died on 2/24/2021.

low grade fever, headache, multiple body aches including neck, back, abdomen, hips and legs,mild diarrhea, frequent and painful urination and worsening of asthma.

Transverse Myelitis; Could not go to bathroom in spite his bladder was full; Could not get out of bed; Could not walk; Chest pain; Pain in middle back; Pain in both of arm; The blood pressure went high; Pain was intense that cannot be describe; Pain across shoulders; A spontaneous report was received from a consumer concerning a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events of chest pain, middle back pain, pain across shoulders/arthralgia, pain in both of arm/pain in extremity, pain was intense that cannot be described, the blood pressure went high/hypertension, could not get out of bed/asthenia, could not walk/gait inability, could not go to bathroom in spite his bladder was full/urinary retension and transverse myelitis. The patient's medical history as provided by the reporter included, quadruple bypass heart surgery, partial lung removal, back problem and neck problem. No relevant concomitant medications were reported. On 19 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 002A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient reported that after receiving the vaccine he was taken to the hospital for chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described and the blood pressure went high. On 21 Jan 2021, in the morning, he could not get out of bed, could not walk and could not go to bathroom in spite his bladder was full for which a catheter was installed to go to bathroom and he got hospitalized for three days. The physician diagnosed him having transverse myelitis which is a side effect from vaccine. 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, could not get out of bed, could not go to bathroom in spite his bladder was full were resolved on 24 Jan 2021. At the time of reporting, (16 Mar 2021), the outcome of the event, could not walk, was recovering/resolving as the patient reported he was able to walk a little and was on physiotherapy. At the time of this report, the outcome of the events, chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described, the blood pressure went high and transverse myelitis were 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.

The adverse reaction was an overwhelming feeling of impending doom. Chronological narrative: The morning after the 2nd vaccine I woke up with the typical general muscle aches and a very sore arm, what I considered to be the normal side effects; A slight feaver and chills. Later in the day there was only the muscle ache and low energy. At about 7PM I took two Tylenol tablets, 500 mg each. I soon felt better. At about 9PM I very suddenly felt extremely cold, as if I had been thrown outside naked in below zero weather. I began shaking very violently, more like muscle spasms than shivering. I felt an extremely urgent need to pee, but could not. Then I very strongly felt impending doom. It was not a feeling like

Onset variety of symptoms approximately 3/29, 10 days after 2nd covid vaccine: fever, chills swelling in his axilla, ear pain and discharge, headache, body/joint aches. Seen in clinic 3/31 and treated with augmentin for otitis, which he took with some improvement but return of drainage 3 days later. Intermittent urinary discomfort, which improved briefly then returned and culminated in passage of a small amount of blood. Was seen in ED for that, and confirmed to have RBC in urine, but CT abd/pelvis negative, CBC normal. Was told evaluation normal but may need to see urology. He thinks may have passed small kidney stone. Ten days later, continues with fevers (subjective - has no thermometer), chills, body aches, joint pain, headaches. Axillary swelling has decreased in size but he feels a pain deeper inside at that area. Pain & fever improve with tylenol but both return when it wears off. No further urinary symptoms. No rashes No recent travel Feels a little pressure in his chest to breathe, but no difficulty breathing. Never had cough No contact with COVID positive (or suspected positive) person - has only been at home. Was offered COVID test in ED but declined due to did not feel he was at risk of having come in contact with it.

Swollen left testicle, visible blood in urine. Urine culture negative. Ultrasound scheduled for 20 APR.

Chief Complaint Patient presents with ? Fatigue C/o feeling like he was going to faint since yesterday. Is feeling very weak. C/o still coughing and spitting up some green phlegm. Admitted to hospital

got shot at 10:30 AM. Felt fine , left 15 minutes later. That night we went to bed at 11pm. At around midnight I told my wife I can't sleep and don't feel right, hot. She turned on the light and i was bright red. took my temperature, it was 101.2. Took Advil to quell fever, .After 5 hours it was back up and I was still red as hell. Was urinating a full bladder every 1/2 hour. Was drinking water, but not that much. Also had a headache from hell, hurt to blink. While Advil was working I was able to get an hour or so of sleep. At about 5am that morning, I woke up soaked from sweating. Fever down to 100.1 to 99.8. Kept up with Advil all day .Fever normal by noon. Headaches persisited until next evening. REALLY bad feeling for 12 hours or so. Day two I still do not feel 100%, but ok. In the midst of all this I got a half hour of moderate chills

he couldn't pee; low appetite; he thought he may pass out; Chills; severe headache every time he got up; feel sick to his stomach but never vomited; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (he couldn't pee) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A2L1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced URINARY RETENTION (he couldn't pee) (seriousness criterion medically significant), DECREASED APPETITE (low appetite), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired). On 23-Apr-2021, DECREASED APPETITE (low appetite) had resolved. On 25-Apr-2021, URINARY RETENTION (he couldn't pee), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired) had resolved. The reporter stated, the patient had similar side effect from what he had from the 1st dose. Additional concomitant medications included Blood pressure pills, Cholesterol pills and maybe back pain pill. Treatment medication included Tylenol. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: An additional document received on 26 Apr 2021 has information Upgraded case to serious, updated suspect product details, concomitant medication, treatment medication and event details.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.

Acute renal failure, admitted to the hospital on 4/6/21. Underlying source never identified, died on 4/9/21.

I experienced a seizure. A family member told me I was "out" for 1 or 2 minutes, got very stiff, breathed very heavy then seemed as though I stopped breathing, involuntarily urinated. When I came to, my speech was slurred for a few minutes and my blood pressure was very low. The EMT's arrived, took my blood pressure, reported it was 85 / 58. After a few minutes, drinking some fluids, I began to feel more normal. I declined to go with the EMT's. That afternoon, I was extremely tired and slept most of the afternoon.

Went to ICU with 4 blood clots in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received the 2nd dose on 23rd or 24th of February 2021. Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; 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.

He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure, but he was being transferred to a larger hospital when he arrested and died (02/03/2021)

Pain and inflammation in left knee starting at about 7:30pm on 2/22/2021. Chills starting at 11:30pm on 2/22/2021 Knee was bright red by 12:00am 2/23/2021. Hydrocodone 5mg-acetaminophen taken at 8:30 pm. No relief. Oxycodone-Acet. 5mg taken at 11:30 pm pain worse, no relief. By 2:30am considering ER. 2:30am took 2 Prednisone 10mg tablets, and 1 Ketrolac 10mg. Pain relief within 20 minutes. By 8:00am 2/23/2021 knee pain was gone. Did notice burning urination at that time, but none since. by 12:00pm 2/23/2021 mild fatigue but no pain or inflammation.

Symptoms started within 3 days of getting the shot. As per Hospital : severe UTI - cleared up completely severe Pancreatitis - cleared up completely Severe diabetes - placed on high insulin severe kidney failure - placed on dialysis

Patient had vaccine at 3pm 1/22/21 at 5pm he had chills and fatigue, at 7pm urinary retention lasting 36 hours, almost went to ER but decided not to.

03/05/2021: Dark dense urine that sank to bottom of toilet bowl. 03/07/2021: Wide spread prutitis 03/12/2021: Acholic stool Other Sx: Jaundice/icterus, weight loss All symptoms abating over the course of 3 weeks.

Sore arm, then soreness went to both arms(shot #1 in other arm), also pain in hips, then knee. Urinary burn and slow stream and many urges. Worsen in last week approx 4-09-2021.

The morning after his first COVID19 vaccine, per wife, patient started with confusion, feeling of impeding doom, and disorientation. Wife had left him in the morning to go shopping and when she returned he had urinated on himself and was wandering around. He was taken to the ER that afternoon. Upon arrival to the ER, patient was noted to have mild confusion, tachycardia, and a mild fever of 100.8 F. Symptoms improved with Tylenol and IV fluids. His chest x-ray showed bilateral mid and lower lung interstitial airspace opacities, concerning for interstitial pneumonia and/or edema. However, it should be noted that patient was hospitalized due to pneumonia from COVID in November 2020. The ER doctor felt the chest x-ray findings were likely chronic changes from COVID, however, he was started on treatment for possible pneumonia. Patient was stable in the ER, so we was discharged.

Pt has a history of CVA and aspiration pneumonia in Feb 2021. Pt had been on olanzapine since 2/24 at Institute. He was given his second Moderna Covid-19 vaccine on 03/10/21. Per note on 3/12, pt had seizure like symptoms at 0545 for approx. 45 seconds (eye rolling, lack of response, increased confusion) Per staff, there was no flexing of limbs or loss of bowel or bladder control. No noted stroke like symptoms but he appeared more confused at neuro check. Pt was back to baseline at 15 min neuro check. Pt reported to have had additional seizure, of approx. 4 minutes duration, during morning report that day-but when MD got to his room, he appeared ?post ictal with a mildly agitated restless delirium? rolling back and forth on the floor, moaning, and not making eye contact. Pt did lose control of his bladder. Olanzapine was discontinued on 3/12, due to potential to lower the seizure threshold. Divalproex was initiated for seizures. Per note 3/22-no additional seizure type symptoms have occurred.

On second day after vaccination, blood in urine, which has continued to a lesser degree for the rest of the day. Nothing by nighttime. On third morning blood in the urine again but not as much as day before. This happened to a lesser degree after first dose one month before.

Day after vaccination, severe headache. On second morning after vaccination blood in the urine, quite a bit which reduced as the day went on. Third morning, blood in the urine again but not quite as much as second day.

First dose, extreme arm pain to the point I couldn't lift arm above my waist. Went on for three days. Second dose, extreme pain in upper body. Kidneys and liver pain included. Could not go to work on second day. Third day had heart issues, heart rate of 134 and BP of 170/90 which I have never been over 130/ 75 my entire life. Normal is 110/65 with an pulse of 60.

Approximately 24 hours after 2nd shot, patient couldn't breath good. He was admitted to hospital where patient reported to go into kidney failure and having pneumonia. He had an extended stay for 2 weeks in the ICU there. Patient does not remember treating physician, This was all patient reported.

On 5/6/2021- I noticed continuous bleeding in my urine for several weeks . I saw my doctor on 5/11/2021 and was referred to a specialist. I saw a urologist on 5/18/2021 and was diagnosed with bladder cancer. I did a CT scan to confirm the diagnosis. I am scheduled to have surgery on 7/1/2021. I did have a single episode of urinal bleeding last year 8/2020 after a bike ride. Dose 1 lot 010A21A Dose2 lot 045A21A

Moderna COVID-19 Vaccine EUA Patient received two doses of Moderna Vaccine at a Facility on the reported dates of 3/16/21 and 4/14/21. On 7/5/21 patient presented to ED with complaints of breathing difficulties and was diagnosed with multifocal pneumonia and COVID Positive with symptom onset of 7/1/21. Patient subsequently developed acute renal failure.Patient expired on 7/19/21 from complications of acute hypoxic respiratory failure due to COVID-19.

Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.

Inmate had two falls in a 24 hour period. Inmate complains of fatigue, dizziness, body aches and weakness. Inmate also reports increased urination and incontinent episodes. Inmate had a temperature of 102 F.

patient presented to ED with weakness, dehydration and fall, fever, UTI. Put into observation for IV antibiotics and fluids.

Patient and wife called in to report patient experiencing 7/10 constant stomach pain, uncontrollable shaking, and numbness and tingling bilateral feet. Patient reports receiving his first covid vaccine dose 2-17-21 and experiencing symptoms, today Patient states, "I can't feel the bottoms of my feet" and "it feels like I'm going to throw up". Patient denies difficulty breathing. Patient was able to check pulse will on phone with triage nurse with pulse 93 and blood pressure 147/107. Patient requesting to have triage nurse call 911-EMS; HPI The patient is a 69 year old male who states that he had the 1st dose of COVID vaccine yesterday morning. The patient states that approximately 24 hours later, he developed stomach cramping. He has nausea. He denies any diarrhea. He has not vomited. Patient denies any cough or shortness of breath. He complains of generalized weakness. The patient also has chronic back pain. Patient is noted to have a low-grade fever here, however, he does not report any fever. CHIEF COMPLAINT: WEAKNESS (per ems, pt got covid vaccine 24 hours ago, feeling weak and dizzy since 1500, tachycardia); Assessment/Plan DIAGNOSIS at time of disposition: 1. Hepatitis; The patient presents with a low-grade temperature, which isn't unexpected given that he received his COVID-19 vaccine yesterday. However, the patient complains of abdominal pain. Lab work does show elevated bilirubin, alk-phos, AST and ALT. The patient has no previous history of this. I did obtain both CT and ultrasound imaging of the gallbladder, which shows no pathology. Subsequently, the patient was reassessed. He is ambulated. He is steady on his feet. He does not desaturate. He has no subjective complaints while walking. I discussed the patient's lab abnormalities with him. The patient prefers to go home and follow up for lab retesting on Monday. Patient was given strict return instructions. He will return should he develop any new or worsening symptoms. He is going to have his labs redrawn on Monday and follow shortly with his primary care provider. Given the normal imaging studies, I do think that these findings are likely related to a reaction to his vaccination. This was discussed at length with the patient. Patient is discharged home in stable condition.

second day aches all day, severe chills lasted 1 hour then chills remainder of day and chills aches next. Day 3 chills and aches during day then 101 temp at night. Day 4 chills and aches stopped, unable to urinate sitting but could standing

The pt began to have chills, fever, body aches, followed by acute urinary retention. His history of benign prostatic hyperplasia was well controlled prior to retention. He required catheterization for 800cc urine and needed Foley cath for 7 days. He has now recovered.

Pt started with weakness approx. 14 hours after the vaccine. Pt said he was so weak he fell out of bed and was on the ground for approx. three hours until he was able to get up. He has had nausea, vomiting and diarrhea. He came into the ER complaining of shortness of breath and chest pressure. Pt has received Normal Saline fluid, chest x ray and is being admitted to the hospital for acute renal failure.

2/19/2021- PCP visit for 1-week history of constipation, malaise and bilateral leg weakness . Abnormal sCr and LFTs AKI: likely ATN from rhabdomyolysis. Requiring HD 2/23/2021 initial hemodialysis 2/23/2021 kidney biopsy 3/1/2021 second hemodialysis

69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology. Outside Hospital: Seen at ED where a stroke code was called for headache, RUE weakness, dysarthria with a CT and CTA that were negative for any acute changes. He he was febrile to 102.2, tachycardic to 130s, hypotensive with pressures in the 80s systolic unresponsive to fluids, leukocytosis to 15 and lactate of 3.5. He was started on vancomycin, ceftriaxone, ampicillin, acyclovir, and dexamethasone. Additional workup including an LP, UA, and CXR were all unremarkable. He was transferred here due to a lack of beds. Of note, the patient received his second COVID-19 vaccine dose on 3/10 and had been febrile since the morning of 3/11. Hospital ICU: Patient is hemodynamically stable and has been fully weaned off pressor support. His hyperglycemia is decreasing satisfactorily to insulin and is receiving IVF. Repeat lactate for PM of 3/12 and workup for TIA initiated. Assessment and plan : 69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology requiring vasopressors, antibiotics, and TIA workup. I have personally reviewed the daily labs, imaging studies, cultures and discussed the case with referring physician and consulting physicians. My assessment and plan by system for this patient is as follows: Neurology/Psychiatry: # RUE Weakness, headache, dysarthria Presented to Hospital with RUE, headache, and dysarthria with negative CT and CTA. The patient has a known hx of diabetes and hypertension with a recent elevated A1c. His hypotension as a result of sepsis may have revealed territories in his cerebrum particularly affected by his likely vascular disease. Will initiate TIA workup. Pending results, will consider Neurology Consult. Plan: - ASA 81 mg PO daily - Echocardiogram - Fasting lipid panel - Bilateral carotid artery ultrasound Cardiovascular: # Hemodynamics, Rhythm, Ischemia # Septic Shock Weaned off NE, still on Vasopressin 2.4. Monitor shows NSR in the 70s. Has now been weaned off vasopressors. Plan: - Weaned off pressors # History of hypertension Plan: - HOLD PTA lisinopril Pulmonary/Ventilator Management: # Airway, Oxygenation, Ventilation, Mechanics: No airway in place. Unlabored breathing on room air without assistance with sats in mid-90s. Plan: - Monitor GI and Nutrition : # BMs/Gas/Feedings: Reports having diarrhea. No enteral feeds. Plan - Monitor electrolytes Renal/Fluids/Electrolytes: # Electrolytes, Acid/Base, Volume Patient is septic and requiring pressors. He is also having diarrhea, so monitor electrolytes, creatinine, UOP. Glucose responding to insulin, most recently 159. If this afternoon's lactate and creatinine normalize this afternoon 3/12/21 and the patient continues to eat/drink ok (which he has been), then we can turn off his IVF. Plan: - HOLD Metformin given elevated creatinine and risk of metabolic acidosis - Lactated Ringers at 75 mL/hr continuous - Trend BMP - Monitor UOP - Venous Blood Gas - Electrolyte replacement per ICU protocols - Generally avoid nephrotoxic agents such as NSAID, IV contrast unless specifically required - Adjust medications as needed for renal clearance - Follow I/O's as appropriate Infectious Disease: # Septic Shock # Leukocytosis # Lactic Acidosis # Recent Covid-19 Vaccine Patient was tachycardic to the 130s, hypotensive with systolic pressures in the 80s, and febrile to 102.2 F. Worked up extensively at outside hospital with the following perfomed: Negative CT/CTA, unremarkable lumbar puncture, unremarkable CXR, and unremarkable UA. His pressures were not fluid responsive at that time, so we will continue some further workup here as below. In addition, there remains the possibility that this patient's current status may be a result of the Covid-19 vaccine and cannot be ruled out given its temporal relationship to his presentation. Will document this potential reaction with the Department of Health. Patient's most recent lactate returned at 6.5 and likely reflects his critical illness in combination with decreased clearance (given that his creatinine was 1.7, unclear baseline). Plan: - MRSA Swab, nares - Stool Ova and Parasite - CSF Culture - CSF HSV (from outside hospital, pending) - Continue piperacillin-taxobactam - Trend procalcitonin - Trend lactate - Report possible Covid-19 reaction with DH Endocrine: # Hyperglycemia # Recent Diagnosis of T2 DM not on Insulin Was found to be hyperglycemic in the high-500s on arrival. At least part of his hyperglycemia is a result of receiving dexamethasone at the hospital. However, his most recent A1c on 3/12 was 8.8 and his diagnosis of T2DM is recent. Plan - Diabetic diet - Nutrition consult - Insulin bolus 5 U - ICU insulin protocol with goal of BG <180 - HOLD PTA metformin Hematology/Oncology: # Hgb, Platelets Within normal limits. - Monitor as appropriate # Leukocytosis Leukocytosis to 15.4 here. Plan as above. Plan - Trend CBC MSKL/Rheum: # Right Shoulder Pain Reports having some right shoulder pain over the last few weeks, exacerbated by shoveling snow. Pain with right arm abduction. Pain is greater in arm and forearm than shoulder itself. Plan: - Tylenol PRN for pain - Outpatient f/u as needed. IV/Access: 1. Venous access - Left brachial PICC, left wrist PIV 2. Arterial access - None ICU Prophylaxis: 1. DVT: Hep Subq/ LMWH/mechanical 2. VAP: Not applicable 3. Stress Ulcer: Not indicated 4. Restraints: Not indicated at this time 5. Wound care - per unit routine 6. Feeding - Diabetic Diet 7. Family Update: Updated wife who was at bedside on AM 3/12/21. 8. Disposition - ICU pending further workup, treatment, and continuation of vasopressors.

Extreme pain in left shoulder, left knee, right wrist, left leg, left calf, "whole left side" Nausea, Vomiting, chills, sore throat, incontinent; Currently not ambulatory, "can't eat"; Went to ER Friday (3/19/21), prescribed Morpine and did not help the pain; RX Tylenol 3 for home - this has not helped. Reports has not seen any other doctor for these health issues.

Vomited once on 3/15. Then had left upper chest burning radiated up to his left jaw for few days that started 3/15. Since 3/16 he has had generalized weakness, fatigue, difficulty walking, and chills. On 3/17, he had one episode of urinary urge incontinence. Fever on 3/18 and 3/21. Imaging showed paraspinal myositis from suboccipital region to upper thoracic region. Main continued symptom now is generalized weakness and difficulty walking.

According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation.

Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure. Possible Rhabdomyolysis.

Teeth chattering chills off & on for two days. Now just chills. Upset stomach for 5 days. Fever , 2nd day bad; fever off & on since then. Upset stomach. Eaten 3 pieces of toast, saltine crackers, soup (just the broth). My stream is painful and weak but comes on me in seconds.having me rush to the bathroom. Small peeing accidents continue to happen.

N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC)" R79.9 - Elevated BUN R79.89 - Elevated serum creatinine

5:30 pm 3/29/21 received phone call from aunt that ems had taken dad to hospital because he was feeling unwell. he vomited prior before and just didn't feel right. ems showed up and observed him, glucose was 139..not out of range...vitals stable..2nd moderna vaccine 5 days prior...ems said that is was probably side effects...asked if he really wanted to go in...said yes, took him to hospital...5:45 daughter called hospital to get status check....she is poa for medical...er doc said he was intubated and on vent.....er doc said he was very sick...6:50 pm daughter got to er and room he was on vent and knocked out...he had antibiotics, sleeping meds..meds to rise bp in iv.....er doc came in daughter asked why he was on vent...asked about o2 doc said he was fine just unresponsive...labs were being done at time...had him on dextrose, propofol, dexmedtominine,..asked to have him transferred to own hospital..8:10 dr. comes in with lab results...kidneys and livers were showing multi organ failure...triponin was high as well..red flags were: creatine 9.93, gsr-5, hemoglobin-7, liver lft-500, triponin 14, covid test was negative, white count was in range, daughter mentioned vaccine again and doc said nothing nor did she mention heart being in trouble, no answers regarding what the cause of this was...for the record he only had kidney issues due to type 2 diabetes, was not at dialysis level...9:30 ems shows up to take dad to another hospital were not ready from him yet...9:41 dad heart started to drop on monitor withing 15 secodes iit flatlined in front of daughter......med staff did cpr...brought in epi pens and manual cpr for heart...a little after 10 heart was started it ran for 4 minutes then crashed again..10:05 continued cpr until 10:28, dr showed that walls i heart not squeezing very damaged, brought in echo during process, 10:28 time of death

NSTEMI; Septic shock; Hypoxic respiratory; Hyperkalemic; Bilateral pneumonia; Acute renal failure; Shortness of breath; Fever; Myalgia; Fatigue; Poor PO intake following the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) in a 69-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 concomitant product the patient had taken are Norvasc , vitamin D, Metoprolol , Dexamethasone , Levothyroxine, Lexapro ,Lisinopril. the patient had certain medical history : Renal Cell Carcinoma on Chemotherapy , Hypertension , Hypothyroidism and Type 2 Diabetes Mellitus. Concurrent medical conditions included Renal cell carcinoma (on chemotherapy), Hypertension, Hypothyroidism, Type 2 diabetes mellitus, Critical illness and Penicillin allergy. Concomitant products included AMLODIPINE BESILATE (NORVASC), METOPROLOL, DEXAMETHASONE, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and VITAMIN D NOS for an unknown indication. On 24-Mar-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEEDING DISORDER (Poor PO intake following the vaccine). On 25-Mar-2021 at 11:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue). On 26-Mar-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria medically significant and life threatening), SEPTIC SHOCK (Septic shock) (seriousness criteria medically significant and life threatening), RESPIRATORY FAILURE (Hypoxic respiratory) (seriousness criteria medically significant and life threatening), HYPERKALAEMIA (Hyperkalemic) (seriousness criterion medically significant), PNEUMONIA (Bilateral pneumonia) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criterion medically significant). On 26-Mar-2021, ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) outcome was unknown. At the time of the report, DYSPNOEA (Shortness of breath), FEEDING DISORDER (Poor PO intake following the vaccine), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Severe bilateral pneumonia. On 26-Mar-2021, Electrocardiogram: abnormal (abnormal) ST depression on V2-V4. On 26-Mar-2021, Troponin: 8.496 (High) High. On 26-Mar-2021, pH body fluid: 7.12 (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient expired with in hours of arrival to the ER despite full attempts at resuscitation. Treatment for the events included resuscitation. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events

On 6/18/2021 resident had received 2 nd dose of Moderna vaccination. 6/19/2021- no adverse reactions noted. None reported. On 6/20/21 resident around noon, reported to the floor nurse that he was unable to move right extremities both hand and leg. Resident refused to go to the hospital for further evaluation. Today, 6/21/2021 resident reported to this nurse that he still has no mobility to his right side. Resident had 2nd COVID vaccination (Moderna) on 6/18/2021 on his left deltoid. Mini neuro check completed. Resident's mental status is intact. Facial symmetry noted. When instructed to move right arm, resident was not able to pick up arm, unable to perform active ROM. Sensation is intact. Resident is able to discriminate pain, sensory stimulation is intact. Resident was asked to pick up and move right leg, resident was unable to perform the action. Sensation to RLE is intact. Resident was advised that he needs further evaluation but declined to go to the hospital. Resident stated his wife was made aware during visit yesterday and his wife had asked him to go to the hospital but he refused to go. Provider was made aware of findings. Provider advised for him to be sent out to ER for further evaluation however resident refused to go. Resident's urine output in his urinal was also noted to be dark colored, blood-tinged. Provider made aware of labs on 6/19/21 which were WNL.Orders obtained for blood culture, and UA with C&S. Resident is in agreement with lab orders. Orders were implemented and collected STAT. Lab results are pending as of writing.

Next day bladder infection, trouble urinating, went to urologist's office. They gave him medication (antibiotic), and problem cleared up within a few hours. Fine within 2 days.

on set ~6/21/21 moderate/sever weakness and fatigue. Went o hospital on 7/10/21 Dx Acute Kidney Injury

07/15/2021 patient became diaphoretic, nauseous and vomiting. Became hypotensive with BP 61/37. Sent to ED. Pt admitted to ICU for large subcapsular left renal hematoma with extravasation; large perinephric hematoma. Hematoma and inflammation extend into left pelvis; largest area of clot measuring 8.5 cm. No evidence of trauma or tumor. Pt also dx with Acute Kidney Injury. INR was 3.3. Pt treated with Kcentra, 2 units FFP and 2 units PRBCs.

Pts wife stated pt experienced feverish 99. 9, diarrhea, shortness of breathe, cough, and running nose/congestion on 07/05/21. Pts isolation expires on 07/15/21 symptoms resolved. On 07/05/21,Pt was admitted to hospital for shortness of breathe, choking and abnormal color of urine (Red) . At that time, Physicians performed exams and administrated a Covid test and found a positive result for Covid-19 at the hospital. Pts wife continues to share the call to 911 was for abnormal urine , shortness of breathe and choking. Pts wife stated they were not aware of the pt having covid and that there were no close contacts. Wife has been vaccinated. . Pt was transported to another Hospital on 07/06/21 and released on 07/16/21. Pt has not traveled outside/country/state within 14 days of illness.

Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital and treated for worsening AKI and hypotension.

Patient developed severe epigastric pain, nausea, diarrhea, urinary frequency 2 days after his Moderna vaccine. A medical assistant who saw him around day 14 said he looked jaundiced.

Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball The patient's medical history was not provided. Relevant concomitant medications were not reported. On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball. His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home. The patients temperature was 99.4. Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital. Action taken with mRNA-1273 in response to the events was not reported. On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown. At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

2nd dose of Moderna on 3/9/2021 at 8:30am. At 9:00pm started having upper respiratory distress leading to vomiting and diarrhea (every 10 to 15 min) on 3/10 at 10:00 pm. Went to ER on 3/11 at 1:00am. Admitted to ER with initial diagnosis (following lab work, x-rays, etc.) of Anaphylactic Shock. Symptoms were allergic reaction, chest pain, hypotension, acute kidney failure, diarrhea, DM2, hives/rash/itching. Multiple IVs of saline, antibiotics, steroids were administered. Remained In critical care/ER for ~12 hours until stable and transferred to hospital room. Discharged on 3/12/2021 at 11:00 am.

Presented with *acute sudden sensorineural hearing loss*, dehydration, poor appetite, and hypovolemic shock. Admitted to ICU for blood pressure support unresponsive to IV fluids. Given IV fluids and blood pressure support medicines in ICU, significant medical improvement after about 24 hours. His sensorineural hearing loss recovered after about 24 hours of rehydration. Workup for infection unremarkable.

Urinated far more than usual during the night. Went 5 times during the night, then again when I woke up at 9am. Shivering began at 1am and lasted until 6am. Upon getting up I got real dizzy after urinating, decided to go back to bed, but could not figure out how to get back in, so I stood beside my bed until the dizziness went away. At some point I must of figured I was ok as the next thing I know I'm on the landing of the steps upstairs, which is 6 steps, and my son is saying to my wife "I'm calling an ambulance". Upon arrival at Hospital. I heard them say he's severely dehydrated and his blood pressure is extremely low. I also had a fractured right clavicle. I was kept in the Hospital for 3 days.

discomfort; kidney stone pain worse and worse; kidney stone outpatient surgery with stent; warm at injection site; itching arm at injection site; red at injection site; A spontaneous report was received from a 70-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red at injection site, arm at injection site, itching arm at injection site, kidney stone pain worse and worse, kidney stone outpatient surgery with stent and discomfort. The consumer's medical history included kidney stones. No relevant concomitant medications were reported. On 18 Feb 2021, prior to the onset of the events the consumer received the first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, the consumer experienced red at injection site, warm at injection site and itching arm at injection site. On an unknown date, the consumer experienced kidney stone pain worse (the consumer did mention he had been having prior kidney stone pain for several weeks before the first dose but which got worse and worse after the first dose) and discomfort (he was referring to the pain and discomfort that comes with healing after surgery) . On 10 Mar 2021, the consumer was scheduled a kidney stone outpatient surgery with stent (the stent was removed on 14 Mar 2021). No treatment information for the events was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of discomfort was unknown and for other events were recovered.; 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.

Received 2nd dose covid vaccine around noon 4/1/21 and was standing in kitchen some hours later and suddenly felt weak. Eased self to floor. States "I was unable to move." Missed lunch date on Sunday, 4/4/21 and was found on his kitchen floor laying on R side. Arrived via EMS 16:30 weak, incontinent of urine with large, fluid-filled blistering R upper arm, sloughing of skin R ribcage, R axillary, and medial aspect R arm. Stage 2 and 3 pressure ulcers to R shoulder, hip, knee, ankle. Blanchable erythema on his back. Dry oral membranes, lips, tongue. Extreme weakness/pain. AOx4.

This is a follow up to an earlier report. Following the request for a key just took me in circles. Following the injection, and within 24 hours, I began experiencing severe vasovagal, with severe bloating, severe headaches, severe weakness and mental cloudiness. It is difficult, and at times virtually impossible to urinate and defacate. Any tissues with columnar linings are severely swollen, from the eustachian tubes to trachea and esophagus, including all intestinal organs. In fact all organ systems are involved. It is very painful, and has forced my retirement from practice, as I cannot provide the care that is needed for my patients. Severe fatigue continues, with severe headaches, cloudiness, inability to concentrate.

Patient became unconscious the evening of 4/14/21. This event occurred five days after his second Covid vaccination. Patient had just gotten up from a living room chair and was walking over to the stairs to go to the second floor when he became rigid, lost consciousness and fell backward. 911 was called by his girlfriend. He was unconscious for a couple of minutes. When EMT's arrived he was conscious but very groggy. His blood pressure was 250/157. He knew his name and year and SSN but did not correctly answer several other questions. He was taken to ER. After numerous tests over the course of several days, he was diagnosed as having a stroke. In the ER, they performed CAT scans, EKG, blood work, urine test and chest xray. Blood pressure remained high. Complained of headaches. Patient was also having trouble voiding urine in the ER so a foley catheter was inserted. He was admitted to the hospital. After admission, an MRI, echocardiogram and EEG were performed. The MRI showed three small blood vessels had burst in his brain. Echocardiogram showed functions were normal. The EEG showed some slowing but no signs of seizure. The conclusion was a stroke. Physical and occupational therapy examined patient. No need for further therapy. Blood pressure remains slightly elevated but he does not appear at this time to have lost any physical or mental functions. Patient does NOT have a history of high blood pressure or heart issues. Tests showed his heart was functioning properly. Per his family doctor, his BP ran approximately 124/64 when tested during the previous 12 months.

Patient presented to the emergency room for evaluation of shortness of breath and chest pain that started two days prior (one day after receiving first Moderna vaccine). Symptoms worse with exertion. Chest pain is described as a heaviness, does not radiate. EKG in the emergency room that showed ST elevations in III and aVF and his troponin was found to be 40.5 and so code STEMI was activated. Patient had cardiac cath on an urgent basis and that showed triple-vessel disease, with a very short left main as LAD and left circumflex were almost coming from 2 separate ostia, subtotal occlusion of the LAD and left circumflex and 100% occlusion of the mid RCA. Evaluated for CABG, which was declined. Patient's echocardiogram showed global hypokinesia with EF of 20 to 25%. Patient underwent high risk PCI procedure using Impella support with 2 stents to the subtotally occluded LAD and 1 stent to the subtotally occluded left circumflex. Patient's symptoms subsided following procedure, however patient suffered mild CHF on initial CXR secondary to ischemic cardiomyopathy, successfully treated with Lasix as displayed by downtrending BNP. Patient's labs also displayed shock liver with AST and ALT liver enzymes both above 1000 on arrival; hepatitis and HIV titers came back negative. Patient suffered from AKI on arrival secondary to ischemia, with an elevated BUN and creatinine; CKD suspected due to lab values showing chronic anemia.

71-year-old male with history of lymphoma on chemotherapy and heart transplant in 2011 on immune suppressants presenting with fever, fatigue, cough, shortness of breath x4 days. Patient is afebrile upon arrival with otherwise normal vital signs. He did desaturate to 88% while at rest and was placed on 2 L nasal cannula. He has clear breath sounds bilaterally without any focal findings. Work of breathing is not increased and very stable in my opinion. He appears clinically euvolemic and denies history of heart failure. No wheezing warranting treatment beta agonist. Patient will require admission given his acute respiratory insufficiency, will need to discuss appropriate Campus placement with the Heart Transplant Service and anticipate he will require transfer to Grand Rapids. Given his reported dyspnea, EKG ordered. Will obtain routine screening labs, COVID-19 swab. With his reported fever, although not objectively present during this visit, and current immunocompromised state, will treat via the emergency department sepsis protocol and collect blood cultures. Fri May 21, 2021 1059 EKG with a normal sinus rhythm, rate of 88 beats per minute, no acute ischemic changes are noted. Patient has a right bundle-branch block. EKG is unchanged from that of January 21, 2021. BNP is 404, no chest pain to warrant cardiac biomarkers. [SR] 1113 COVID-19 is detected. [SR] 1125 CMP was sodium of 128, chloride 95, glucose 303, creatinine 0.87. Magnesium is 1.9. Phosphorus 2.1. Urinalysis with trace blood, no urinary tract infection. Urinalysis without urinary tract infection. [SR] 1147 INR subtherapeutic at 1.2. [SR] 1149 Received a critical result from lab, white blood cell count is 0.04, patient is by definition therefore neutropenic. Platelets are 21 K without reported active bleeding. Hemoglobin is 9.3. Have a call out to Oncology to discuss need for IV cefepime given the reported fevers at home although etiologies presumably viral with COVID-19 test. Further, I do not know if IV Decadron is appropriate given his profound neutropenia, especially having recently finished a high-dose course of 100 mg prednisone orally x5 days. [SR] 1150 CXR: Airspace opacities are seen involving both the lungs, more prominent in the right lung, as described above. These are likely due to consolidation/pneumonia. Viral pneumonia can also have similar appearance. Correlate clinically. [SR] 1218 Discussed case with Dr. from transplant team who agreed with admission to his service . He did recommend that I broaden his antibiotic regimen to include both IV vancomycin and IV cefepime. He recommended that I do provided dose of IV Decadron despite the neutropenia to treat his acute respiratory failure secondary to COVID-19. Still awaiting call back from Oncology. [SR] 1454 After multiple pages, I have not been connected to Oncology. Patient was transported by EMS. He will need a formal oncology consult upon arrival to admitting facility. [SR]

** Began coughing in mid March after spending extended time in hot Florida sun. Coughing continued for approximately five weeks. Along with onset of coughing also developed a urinary-track infection. Visited Dr., my PCP, April 23. I would have seen him earlier, but he was on vacation. I did do a Tele visit with Dr., in late March, who prescribed medicine for the urinary infection. By this time the coughing had subsided, so I did not seek her help with that issue. Subsequently, coughing started again. When I visited Dr. in April, he felt that the coughing was triggered by an allergic reaction and possibly by acid reflux. He prescribed medication to treat the allergies. I also took an OTC drug for acid reflux. The coughing stopped a short time later.

Elevated fever (101); fatigue; elevated pulse and blood pressure; high blood sugar readings, excessive urination with very very limited fluid intake.

Cold chills throughout my whole body all night long, Getting up to urinate at least 15 times during the night on the evening of the shot. The next day I was tired and slept for the most part of the day, then that night I woke up twice with a wet bed from sweating. No appetite either day. I am feeling better today but still a bit weak.

nausea - couldn't hold down water or food for first day abdominal pain back ache blood in urine on third day after shot still in pain...haven't slept last two nights

At first I only had a sore arm. By early Friday evening, the night after the vaccination, I began having severe steady pain in my left kidney, along with sharp shooting pain at the same location. I also had the expected headache and fatigue. I took Tylenol during this time, and still am. I was pretty much totally bed-ridden for 4 days. I called my doctor on Wednesday, February 17th to report the severe reaction in my left kidney. The nurse told me that as long as I felt better each day then to weather it out and get the second shot (scheduled for March 11). Although I am feeling a little better, I am still taking Tylenol for the pain in my kidney. My exhaustion is lessening.

pt states the next day after he got the covid vax that he wasnt feeling well, he didnt feel right, foggy headed, felt disoriented and confused. He couldnt put words together to make a sentence. He got up to go into the kitchen and then urinated all over himself. He was worried about falling sleep, scared he would die in his sleep. The 3rd woke up and was feeling some better but still foggy headed. Pt went to the ER about 5 days later. They did a CT and blood work. He thinks the tests results came back negative. They wanted him to stay longer and maybe see a Neurologist but since there wasnt one available to see at that time the pt decided to go home. He has blood work and urine labs to be done at the facility on 2/23/2021. Pt states he is feeling better at this time.

71yo M received first Moderna COVID vaccine 5d ago. 24hrs following pt started having fatigue, vertigo, body and joint aches, intermittent runny nose, PND, throat irritation and gravely voice, decreased smell, loss of taste, chills, and fever to 104.2. Chronic dry cough which pt is unsure if has recently been worse. No ear or sinus pressure/pain. no respiratory concerns at present. +nausea, no vomiting, no diarrhea/loose stools, + decrease in activity, +decrease in appetite. Also yellow/rust colored urine x4d getting darker esp today w/ decreased urinary frequency. No burning or urgency. No urine blood clots. No BM for 4d w/ decreased appetite but did have BM today which was normal w/o blood, black, or tarry stool. Pt had heart stent placed 1mth ago and started on plavix along w/ his daily ASA and atorvastatin increased from 10 to 40mg. No CP or SOB. Pt found to have elevated LFTs, alk phos, and bili w/ hepatitis reaction.

Felt ill starting at 10:00 pm 03/12/2021 Body aches, muscle aches. Severe headache 03/13/2021 Frequent urination (every 90 minutes) starting at 12:30 am 03/13/2021. If I felt I needed to go to the bathroom, I was lucky I could control my bladder long enough to reach the toilet 20? away. Fever and chills. Fever measured 103 at 09:30 03/13/2021 Significant night sweats - soaked sheets requiring a change of sheets and pajamas. Basically slept from 10:30 pm 03/12/2021 until 07:30 am 03/14/2021 except to use bathroom Feeling of gout like symptoms in feet Blurry vision

Patient received vaccine, went home, had shortness of breath, was brought to ER, coded, intubated and brought to ICU for liver and kidney failure.

URINARY TRACT INFECTION; pink in my urine; Little bit of Pain after injection in left arm; A spontaneous report was received from a 71 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (urinary tract infection), pink in my urine (chromaturia) and little bit of pain in arm of injection (pain in extremity). The patient's medical history was not provided. The relevant concomitant medications were also not provided. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number:013M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, patient experienced little bit of pain in arm of injection. On 23 Feb 2021, patient experienced pink in urine. The patient subsequently visited the urgent care on 26-Feb-2021 and was diagnosed with a urinary tract infection. Treatment for urinary tract infection included ciprofloxacin 500 mg twice daily for 7days. No laboratory data was provided. Action taken with mRNA-1273 in response to the events was not reported. The event little bit of pain in arm of injection was resolved 03 Feb 2021. The event pink in urine was resolved on 01 Mar 2021. The outcome of the event urinary tract infection 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 (vaccination site pain) a causal relationship cannot be excluded. However, for the events - chromaturia and UTI, a very limited information has been provided at this time. Further information has been requested.

Fatigue, headache, rash and swelling upper leg, occasional high temp of 99, night sweats, dark urine, swollen lymph nodes(gone now)

Profound weakness the day following the shot, slide to floor unable to get up due to weakness, profound rhabdomyolysis with acute kidney injury

"MODERNA EUA requirement" hospitalization due to hypotension, malaise, fever, acute renal failure,

Intense pain in the left Kidney. It was equivalent to the pain I suffered when I had a compound fracture of my tibia and fibula. It was so intense that I thought I had a kidney stone or infection. We called the ambulance and the EMT, after checking my vital signs, thought it was from the vaccine. I also throw up quite a bit. It was the first time I threw up since 1985. The pain was hovering between a eight to 10 for about four hours. After applying heat to the left Kidney it subsided to a five. It was not until 4:00 am that I was pain free though still sore in the left kidney. The soreness continues.

Presents to hospital with c/o significant weakness since receiving first Moderna Covid vaccination on 3/26. Pt notes weakness started on 3/29.

My UTI, which was going away, developed into a raging UTI and then later into a bladder infection. I tried taking supplements from my chiropractor but they were not adequate. Even the Pads I wore were insufficient to stem the flow. There was bleeding as well. Then went to an Urgent Care facility and they prescribed an antibiotic which worked. It was both painful and embarrassing ( I have to stand and greet people in my position). I suffered for about 6 weeks through this.

About 22 hours after vaccine I started experiencing dizziness, balance problems, fatigue, low fever (99.8f), headache, muscles pains in both shoulders, pain at sight, VERY urgent urination,

Admitted to hospital in critical care; Kidney function issue; Liver function issue; He also gets confused about things.; Unbalanced on his feet/Standing up he losses balance; At least now he can stand on his own with help of a walker, that he did not need before.; Lost his voice; Lost sense of smell; Lost sense of taste; Wants to sleep 12 to 16 hours a day; Brain fog; He does not have energy at all; He also has extreme frequent urination; He lost all appetite. Not eating; If he eats he gets nauseas; Lost pounds; Cough; Low grade fever; Four hours later after second shot, he started not to feel quite well, and each day he got a little worse.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Admitted to hospital in critical care), RENAL IMPAIRMENT (Kidney function issue), HEPATIC FUNCTION ABNORMAL (Liver function issue), CONFUSIONAL STATE (He also gets confused about things.), BALANCE DISORDER (Unbalanced on his feet/Standing up he losses balance), DYSSTASIA (At least now he can stand on his own with help of a walker, that he did not need before.), DYSPHONIA (Lost his voice), ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), SOMNOLENCE (Wants to sleep 12 to 16 hours a day), FEELING ABNORMAL (Brain fog), ASTHENIA (He does not have energy at all), MICTURITION DISORDER (He also has extreme frequent urination), DECREASED APPETITE (He lost all appetite. Not eating), NAUSEA (If he eats he gets nauseas), WEIGHT DECREASED (Lost pounds), MALAISE (Four hours later after second shot, he started not to feel quite well, and each day he got a little worse.), COUGH (Cough) and PYREXIA (Low grade fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE, SOTALOL, Rosuvastatin Crestor, CLOPIDOGREL and RIVAROXABAN (XARELTO). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced MALAISE (Four hours later after second shot, he started not to feel quite well, and each day he got a little worse.) (seriousness criterion hospitalization). On 27-Apr-2021, the patient experienced HOSPITALISATION (Admitted to hospital in critical care) (seriousness criterion hospitalization). On an unknown date, the patient experienced RENAL IMPAIRMENT (Kidney function issue) (seriousness criterion medically significant), HEPATIC FUNCTION ABNORMAL (Liver function issue) (seriousness criterion hospitalization), CONFUSIONAL STATE (He also gets confused about things.) (seriousness criterion hospitalization), BALANCE DISORDER (Unbalanced on his feet/Standing up he losses balance) (seriousness criterion hospitalization), DYSSTASIA (At least now he can stand on his own with help of a walker, that he did not need before.) (seriousness criterion hospitalization), DYSPHONIA (Lost his voice) (seriousness criterion hospitalization), ANOSMIA (Lost sense of smell) (seriousness criterion hospitalization), AGEUSIA (Lost sense of taste) (seriousness criterion hospitalization), SOMNOLENCE (Wants to sleep 12 to 16 hours a day) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), ASTHENIA (He does not have energy at all) (seriousness criterion hospitalization), MICTURITION DISORDER (He also has extreme frequent urination) (seriousness criterion hospitalization), DECREASED APPETITE (He lost all appetite. Not eating) (seriousness criterion hospitalization), NAUSEA (If he eats he gets nauseas) (seriousness criterion hospitalization), WEIGHT DECREASED (Lost pounds) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization) and PYREXIA (Low grade fever) (seriousness criterion hospitalization). On 05-May-2021, HOSPITALISATION (Admitted to hospital in critical care) outcome was unknown. At the time of the report, RENAL IMPAIRMENT (Kidney function issue), HEPATIC FUNCTION ABNORMAL (Liver function issue), CONFUSIONAL STATE (He also gets confused about things.), BALANCE DISORDER (Unbalanced on his feet/Standing up he losses balance), DYSSTASIA (At least now he can stand on his own with help of a walker, that he did not need before.), DYSPHONIA (Lost his voice), ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), SOMNOLENCE (Wants to sleep 12 to 16 hours a day), FEELING ABNORMAL (Brain fog), ASTHENIA (He does not have energy at all), MICTURITION DISORDER (He also has extreme frequent urination), DECREASED APPETITE (He lost all appetite. Not eating), NAUSEA (If he eats he gets nauseas), WEIGHT DECREASED (Lost pounds), MALAISE (Four hours later after second shot, he started not to feel quite well, and each day he got a little worse.), COUGH (Cough) and PYREXIA (Low grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment drug information were provided. MRI in every inch of his body, ultra sound in all organs. Did a bone narrow biopsy and a lymph node biopsy. Results come back normal. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's comorbidities remains as confounders.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's comorbidities remains as confounders.

Fever for 10 days. Generalized weakness. Hospitalized 3/1/21 - 3/3/21 atrial fib, acute cystitis with hematuria, positive blood cultures

I am filing this on behalf of my sister, who feels it needs to be reported but she is too grief-stricken to do this herself. The morning after the second shot, my sister texted that her husband was up at least 10 times during the night, and five times the next night. He was agitated and hallucinating (swatting at bugs that weren't there.) For the next four weeks he had progressively more difficult breathing, and on 4/28 a liter of fluid was drained from his chest. He continued to have difficulty breathing and was taken by ambulance to Hospital on May 2 where they again drained his chest and diagnosed him with pneumonia. A nurse told him they were seeing a number of cases of fluid around the lungs (his fluid was around the lungs, not in them) after COVID vaccines. He was sent home May 4 and commented that it was strange his cardiologist hadn't visited. Almost immediately he was experiencing liver and gall bladder pain, even though tests for those showed the two organs were healthy. On May 8 my sister said patient woke up hyperventilating, which also became more frequent. On the 9th his daughter told me the labs were not trending well, and on May 10 he saw his cardiologist. He diagnosed him with congestive heart failure and got him an appointment at the Heart Hospital on May 17 - he explained congestive heart failure is scary but can be managed through programs at the heart hospital. He began sleeping outside because it made it easier to breathe. On May 15 he was advised to go to the ER/Hospital for tests the heart hospital would need and, once there, they discovered his kidneys weren't functioning and he was admitted immediately. He spent 17 days at Hospital- if the kidneys improved, the heart got worse. If the heart improved, the kidneys failed. He was released on June 2. On June 7 my brother took him to get blood work done - Patient was too weak to get in and out of the car by himself. The blood work came back bad, and on June 8 he was admitted to the Heart Hospital. On June 10 he was transferred to the Regional Community Hospital to be closer to his cardiologist. From there he continued to decline, and the doctors wanted to do surgery for a LVAD but couldn't. To help him get stronger, he had an impeller put in by catheter on June 19 and died that night. His own cardiologist said congestive heart failure is manageable. The symptoms started the night of the second vaccine and his illness wasn't gradual - he went off a cliff. With all the heart problems appearing in males, we don't think this was coincidence.

Developed rather sudden onset of neck stiffness and pain and then subsequent occipital and then frontal headache. Over next 6 hours became exceedingly painful as to prevent sleep or finding a comfortable position to rest my head. Went to Hospital ER at 2am on 12/31/2020. Had normal CT brain scan and labs. Given IV reglan, then ativan(1 mg) then 25mg benadryl and a liter of fluids. BP was slightly elevated 150/90 (?). Had oral temp of 99.1. When ativan didnt help they gave me a dose of dilaudid and zophran and additional dose of ativan. Then sent me home with instructions to take valium 5mg tid, orphenadrine 100mg Bid, Tylenol 650mg to 1300 mg q8hr prn and lidocaine patch on neck 5%(also started in ER) q 24hrs. Discharge diagnosis was headache, intractable neck pain and torticollis.

Patient admitted to skilled nursing, current diagnosis and symptoms before during and after vaccine is diarrhea, chills, shaking and fatigue. Unknown if side effect of vaccine or due to medical condition.

Patient presented with sharp right lower quadrant abdominal pain with associated nausea and emesis beginning the day he received the COVID vaccine, after vaccine injection. He had decreased appetite and pain was made worse by eating. He presented to the hospital 3 days (2/6/21) after receiving the vaccine/symptom onset. His vital signs were T 101.5, HR 78, BP 156/67, RR 20, SpO2 94 on RA. As discussed below, imaging showed acalculous cholecysitis. The day after presentation, pain was more localized to RUQ. He was treated with IV ceftriaxone and flagyl. He underwent percutaneous cholecystomy tube place on 2/7/21 with plan for delayed cholecystectomy following drain placement x 6 weeks. Bile fluid culture has been no growth. We are attempting to test bile fluid for COVID-19 via PCR. He tested positive for COVID-19 via nasal swab RT-PCR and developed a 3L oxygen requirement and mild dyspnea. He was treated with remdesivir and dexamathasone 2/6-2/10 with resolution of hypoxia and dyspnea.

1600 day after vaccine presented with N/V and chills. Small bowel obstr-partial. NG tube, fluids. resolved. Admit 3/3 DC 3/8

Patient presented to the ED on 3/8/2021 after being diagnosed with a UTI on 3/7/2021. Her reported feeling more weak and consistent fever. Reason for admission: UTI. Per EUA, all hospitalization must be reported after recently receiving a vaccine. This hospitalization does not seem related to the vaccine

24 hours after injection started with fatigue, shortness of breath, insomnia.shortness of breath continues 1 week later. winded even with conversation. some congestion in head on and off.

dark blood clot coming out of his penis; Gross Hematuria; dark urine; Redness arm; Sore Arm; Swelling arm; A spontaneous report was received from a healthcare professional who was also a 72-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness arm/ vaccination site erythema, sore arm/ vaccination site pain, swelling arm/ vaccination site swelling, gross hematuria/ hematuria, dark blood clot coming out of his penis/ hemorrhage urinary tract, and dark urine/ chromaturia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced the events redness, sore arm and swelling. On 20 Jan 2021, the patient experienced the events gross hematuria, with dark blood clot coming out of his penis. The patient had urine analysis (no results provided), and was still urinating dark urine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of the events, vaccination site erythema, vaccination site pain, and vaccination site swelling, were considered recovered on an unspecified date. The outcomes of the events, hematuria, hemorrhage urinary tract, and chromaturia, were 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.

headache, upper and lower back pain. neck pain. achy all over. Side affects were same for Vaccination 1 and 2. Number 2 more severe. Weird sympton though was that I had to pee every 30 minutes starting about 12 hours after the shot and contiuing for about 10 hours. All symptons over about 30 hours after the shots

Narrative: 72 yo M that received dose #1 of the Moderna COVID-19 vaccine on 2/26/2021 (Lot#:011A21A: Exp Date: 08/16/2021) and dose #2 of the Moderna COVID-19 vaccine on 3/26/2021 (Lot#: 007B21A; Exp Date:09/08/2021). Most recent A1C prior to COVID-19 vaccination 8.0% on 2/2/2021 and established on metformin 850mg PO BID and glipizide 10mg PO BID. Following non-fasting lab appointment on 3/1/2021, serum glucose=626; provider advised patient to go to local ED or fire station if develops symptoms of hyperglycemia. Note documented on 3/16/2021, Patient presented to the emergency department based outpatient clinic with increased frequency of urination, polydipsia, but no other signs or symptoms of hyperglycemia, found to have hyperglycemia with metabolic acidosis, acute kidney injury and pseudo hyponatremia. At this time patient admitted to hospital for further monitoring, evaluation, and treatment of hyperosmolar nonketotic hyperglycemic state, with mild ketoacidosis and AKI. Pt treated with IV fluid rehydration with normal saline, started on sliding scale insulin. In addition, pt started on basal insulin glargine 10 units every evening. Pt then subsequently discharged (incomplete records). On 3/22/2021, patient obtained non-fasting lab work with serum glucose=504 and A1C=12.5%. Pt has been consulted to endocrinology based on rurality of patient and subsequent management of diabetes.

Lost of Muscle Strength - Physical Therapy - recovery of most muscle functions after 1 month. Dizziness - recovery of ability to walk without wheel chair, walker, cane. Kidney failure - Dialysis

Patient had syncopal episode at home on 3/12/21, same day as second dose of vaccine, and fell. Was on floor for 8 days until admitted to hospital upon being found by family. Admitted with altered mental status and AKI.

Patient received 1st moderna vaccine on 4/13/2021. He then began to have urinary issues and diagnosed with a bladder tumor on 4/29. He then tested positive for covid 19 on May1st. He got his 2nd covid 19 vaccine on 5/11/2021 and was hospitalized on 05/20 with new onset rapid atrial fibrillation and NSTEMI. He reports he was healthy with no medical problems and took no medications prior to his vaccines. A pulmonary emboli was ruled out, no history or suspicion of sleep apnea.

COVID-19/ tested positive for Covid-19; loss of taste; loss of smell; loss of appetite; loss control of bladder; extreme weakness; Blood sugar decreased; Diarrhea; Vomiting; Nausea; fatigue/ tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19/ tested positive for Covid-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg amputation. Concurrent medical conditions included Diabetes mellitus, Atrial fibrillation and Hypothyroidism. Concomitant products included INSULIN ASPART (NOVOLOG) and METFORMIN for Diabetes, LEVOTHYROXINE for Hypothyroidism, METHOTREXATE, VERAPAMIL, HCTZ, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), SULFASALAZINE, ACETYLSALICYLIC ACID (ASPIRIN 81), FOLIC ACID and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell), DECREASED APPETITE (loss of appetite), URINARY INCONTINENCE (loss control of bladder), ASTHENIA (extreme weakness), BLOOD GLUCOSE DECREASED (Blood sugar decreased), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (fatigue/ tiredness). On 16-Apr-2021, the patient experienced COVID-19 (COVID-19/ tested positive for Covid-19) (seriousness criterion hospitalization prolonged). The patient was treated with OXYGEN at a dose of 2 liter and DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ tested positive for Covid-19), AGEUSIA (loss of taste), ANOSMIA (loss of smell), DECREASED APPETITE (loss of appetite), URINARY INCONTINENCE (loss control of bladder), ASTHENIA (extreme weakness), BLOOD GLUCOSE DECREASED (Blood sugar decreased), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (fatigue/ tiredness) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: unknown (Inconclusive) blood sugar levels tumble. On 16-Apr-2021, SARS-CoV-2 antibody test: unknown (Positive) Tested positive for Covid-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is due for his second dose i.e on 19apr2021. Company Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely for the vaccine and likely due to the COVID-19 infection.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely for the vaccine and likely due to the COVID-19 infection.

Hospitalized with acute kidney failure due to multiple renal infarcts. Symptoms began with GI tract issues, diarrhea, abdominal pain, weight loss. Work up extensive and still in process. Symptoms persist.

I had the 2nd dose on 01/23/2021 and on 05/15/2021 I started feeling very tired I saw my local physician, he did some lab work and they found out that I was anemic, Ultrasound of kidneys- normal, Urinalyses- microscopic blood . He prescribed Iron supplements. I am scheduled for some consults with specialists, one will be a kidney and one will be a GI.

FULLY VACCINATED WITH MODERNA - NO DATES DOCUMENTED ADMITTED TO FACILITY 7/6/2021 FOR RESPIRATORY FAILURE; PNEUMONIA DUE TO COVID-19; AKI

right after vaccine, eyes started itching and watery and drainage. They went to clean daughter's house, the more they cleaned, the worse he felt. After that, chills, achy, dizziness. sounded congested. Had vomiting and diarrhea later that night, arm was red and blotchy. Next day, urine had an awful smell and brown, chills, and dry heaves. Friday, finally was able to eat. Saturday and Sunday felt better. Today he's feeling good.

Patient had slow progression of kidney disease but since vaccine had unexpected acute kidney failure. He had to have dialysis and may need biopsy of kidney to confirm if he needs lifelong dialysis. He is still being hospitalized.

Moderna COVID?19 Vaccine EUA I received a Moderna covid-19 vaccination (Lot # 007M20A) at 10:20 AM on Monday 02-01-2021 at the VA Clinic . Between 3 and 4 minutes later I began to experience difficulty breathing, sweating and feeling warm, and then I passed out behind the steering wheel of my parked car, while sitting with my wife. I came to after few minutes as people were attempting to get me out of my car and into a wheelchair, but I had difficulty breathing, couldn?t move, and had to be pulled out. After being put in the wheelchair, I passed out again and came to after I had been taken out of the wheelchair and laid on my left side on the ground by Fire Dept. EMT?s. I then began to retch, but did not vomit. My wife said that one of the EMT?s pumped my chest a couple of times. They lifted me onto a gurney and put me in an ambulance, hit me with an EPI pen, and placed an oxygen mask on my face, as I was having great difficulty breathing. I was unable to move or lift my arms to help them place a blood pressure cuff on my arm, a pulse monitor on my finger, and lift my shirt to help them attach EKG pads. Atthat point I realized that I had also lost control of my bladder at some point. I continued to have difficulty breathing, and started to experience extreme shivering all the while to emergency Room. Once in the Emergency Room, I could not move myself off the FD gurney, and they had to lift the sheet that I was laying on in order to move me onto the hospital gurney. I had great difficulty helping the technicians remove my shirt so that they could administer another EKG and start an IV (LR 1,000ml bolus). I continued to have difficulty breathing and kept shivering and sweating for some time. I was advised that the EKG?s both appeared normal. After a lengthy period of I gradually reached a point where I stopped shivering and sweating, and returned to almost normal breathing. I was finally released around 1-1:30 PM.

Prostate bleeding for 3 hours 6 days post vaccination. History of bleeding but always with a known cause. Last INR before 2.4 and after event with hold of coumadin for 1 day was 1.7

It started with shaking and feeling cold. it lasted about an hour. I could not stop shaking. my temperature was 103.5. I had trouble walking, I had fatigue and tiredness. My arm hurt up to the base of my neck. I had pain urinating. my fever lasted about 12 hours. It did go away by 2/21.

Blood in urine and stool. Cleared up next day. No recurrence in 48 hours. Never had blood in urine or stool for over 10 years prior to vaccination.

extreme fatigue then patient passed away while asleep Narrative: Unclear if the vaccine is connected to his death. Chart reviewed. He has medical conditions which could have caused his death. Unclear who completed his death certificate. Death was close to a month ago. Whether he had an autopsy or not is unclear. We can report as a suspicious death after vaccination.

Approximately noon 2 days after vaccination 2/26/2021 patient began to experience weakness, vomiting, dry heaving, abdominal pain and muscle aches. At some point during the night he wound up on the floor and eventually yelled for help. He was unable to get up by himself and was down there for an unknown amount of time. His spouse believes a few hours. He then continued the same symptoms and wife gave him crackers, sprite and fluids. He slept Saturday night in his recliner, He was still unwell Sunday morning so she called an ambulance who took him to ER. He was then sent to another hospital. Initially thought he had kidney and liver failure as well as heart attack but she states the muscle damage is what cause the labs to look similar to a heart attack and his kidneys and liver were trying to expel toxins/waste from muscle damage and he was very dehydrated. His liver and kidneys recovered in about 2 or 3 days and he received IVF and spent 7 days at the hospital and is still in Rehab recovering.

4/4/21 ER HPI: 74 y.o. male who presents with complaint of brief priod of altered mental status associated with inability discussed on the phone was only able to say yes, then developed drooling without focal weakness, no drift of the extremities and no facial droop. Wife said patient on the way was grumpy and a bit agitated. Episode lasted about 5 min. Presently patient is alert and oriented x4, moves all the extremities with equal power and strength, speech is clear and no facial droop or focal weakness and no drift. No evidence of CVA at this time.

Gross hematuria for 48 hours beginning about 11pm on 3/30/21 until 11pm 4/1/21. Visited doctor. Urine sample & Complete blood count done, platelets were 31000. .. Observed no blood in urine since 4/1/21. CT Scan with contrast & Complete blood count on 4/7/21, Platelets 149,000. My platelets have not been this high since Ive been keeping track which started in 1992. How they bounced back so quickly is a mystery to me. I hope someone can explain.

4/2/2021 - 10:00a.m., felt weakness in legs, 10:30a.m. had problem climbing steep stairs, 12:00p.m. - legs felt heavy - landing heavily and flat footed going down steep stairs. 2.30p.m., walked to gang mail box in next block - shuffled and dragged legs in both directions , 3:00p.m. - felt extremely tired and lay down on sofa. Slept for about and hour. Awoke and felt I had to go to the bathroom - I could not feel or move my legs. Finally used my arms to swing legs over edge of sofa but could not feel or use them. I used the my arms to lift myself to standing position and lost control of bladder - not and accident - felt it totally empty at once. Feeling started to return to legs and I was able to walk to clean myself up. Slowly began to regain use of legs and to stop shuffling and dragging my feet. I was doing better by 6:00p.m. and the leg problem was almost gone the next day. No repeat of the bladder issue.

Patient reports progressive fatigue and lightheadedness beginning the day after vaccination (4/10/21). He also reports headache and nausea with decreased oral intake. Patient found to have AKI in ED and is being admitted to the hospital.

1. On 4/21/2021 at approximately 3:00 p.m., Patient experienced severe pain in his right side under his rib cage, followed by vomiting. The next bowel movement was abnormal in color (white). He has been experiencing pain day and night until last night when the pain subsided. 2. Pain in foot - He started having pain in his right foot on 4/21/2021 in the evening. The pain has become progressively worse as days go by. Last night 4/24/2021 the foot started to show pink color in the lower half of the foot. This morning, the foot showed swelling and pink on the top of the foot. By the end of the day the foot pain is so severe he can hardly walk on it. 3. Blood in urine - He started having blood showing up in his urine on 4/21/2021 in the evening.

Itchiness, Nausea and vomiting after injection. Admission to hospital for IVF and treatment of elevated INR.

At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital.

1. Fever 102.0 F 2. Heart rate increased by 30 BPM (55 to 85) 3. Blood pressure was at 90/52 4. Oxygen saturation was 79 % to 90 % 5. Difficulty breathing with minimal exertion 6. Chills, had to wear sweatshirt and jacket during 90-degree weather 7. Became dizzy and difficulty with balance 8. Dry cough 9. Nausea and loss of appetite 10. Muscle ache 11. Total joint pain 12. Headache 13. Redness and slight rash within a 2-inch area surrounding the injection site 14. Urinary incontinence

COVID + diagnosis & hospitalization of previously vaccinated patient (x2 - 2/26/21 & 3/26/21) HISTORY OF PRESENT ILLNESS: Patient is a 73-year-old male with past medical history of hypertension. The morning of 5/29 patient presented to the ER with complaints of loss of appetite, cough, and fatigue. He was found to be COVID-19 positive workup was benign patient was ambulated and did not go lower than 93% oxygen on room air and was discharged home Patient returned late evening of 529 due to continued nausea, fall from standing position due to syncope after getting up out of bed, and a laceration above his right eye. Patient states his symptoms started approximately 1 week ago after having a tubal he noticed decreased appetite and not wanting to drink much. He thought this was just due to the dental surgery. However this continued into body aches, fatigue, dry cough, dry mouth. ER course: Temp 38.2°, heart rate 74, blood pressure 134/55, respiratory rate 24, oxygenation 91% on room air with ambulation patient dropped to 88% on room air but stabilizes with rest. COVID-19 positive CT head and spine were obtained and showed no evidence of any acute injury or intracranial process. Chest x-ray was obtained and showed bilateral streaky infiltrates suspicious for bronchopneumonia. EKG is normal sinus rhythm with no ST changes, QTC 474 Complete blood count shows absolute lymphopenia and hemoglobin 13.3, platelets 101 Glucose 176, creatinine 1.45 GFR 48 No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider Cholecalciferol (VITAMIN D3) 2000 UNITS TABS take by mouth Daily. Historical Provider hydrochlorothiazide (HYDRODIURIL) 25 MG tablet take 25 mg by mouth Daily. for diuretic Historical Provider metoprolol tartrate (LOPRESSOR) 50 MG tablet take 50 mg by mouth Daily. Historical Provider Misc Natural Products (OSTEO BI-FLEX JOINT SHIELD PO) take by mouth Daily. Historical Provider Multiple Vitamins-Minerals (MULTIVITAMIN PO) take by mouth Daily. Historical Provider Omega-3 Fatty Acids (FISH OIL PO) take 1,200 mg by mouth Daily. Historical Provider ondansetron (ZOFRAN-ODT) 4 MG disintegrating tablet Take 1 tablet by mouth every 8 hours as needed for Nausea. 5/29/21 MD vitamin B-12 (CYANOCOBALAMIN) 1000 MCG tablet take 1,000 mcg by mouth Daily. Historical Provider Medical History Past Medical History: Diagnosis Date ? Hyperlipidemia ? Hypertension Past Surgical History Past Surgical History: Procedure Laterality Date ? HX COLONOSCOPY 1-9-14 Dr. ? HX HAND SURGERY 2011 thumb ? HX NASAL SURGERY 2008 Social History Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used Substance Use Topics ? Alcohol use: No ? Drug use: Not on file Family History History reviewed. No pertinent family history. Review of Systems Constitutional: Positive for activity change, appetite change and fatigue. Negative for chills, diaphoresis and fever. HENT: Negative for congestion, rhinorrhea and sore throat. Eyes: Negative for visual disturbance. Respiratory: Positive for cough. Negative for shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Positive for nausea and diarrhea. Negative for vomiting and abdominal pain. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for muscle pain and falls. Neurological: Positive for headaches and weakness. Negative for dizziness and light-headedness. Skin: Negative for rash. OBJECTIVE: BP (!) 170/48 | Pulse 82 | Temp 38.2 °C (Oral) | Resp 22 | Ht 1.753 m | Wt 77.3 kg | SpO2 94% | BMI 25.18 kg/m² Room air Physical Exam Constitutional: General: He is not in acute distress. Appearance: Normal appearance. Comments: Appears fatigued HENT: Mouth/Throat: Mouth: Mucous membranes are dry. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Dorsalis pedis pulses are 2+ on the right side and 2+ on the left side. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are increased. There is no distension. Palpations: Abdomen is soft. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Comments: Moving all 4 extremities spontaneously Skin: General: Skin is warm and dry. Neurological: Mental Status: He is alert and easily aroused. Comments: Patient is oriented but forgetful and poor historian Psychiatric: Attention and Perception: Attention normal. Mood and Affect: Affect is flat. Speech: Speech normal. Behavior: Behavior is cooperative. _________________________ ASSESSMENT/PLAN: COVID-19 Pneumonia with intermittent hypoxia - admit inpatient - chest xray shows bilateral streaky infiltrates - days of symptoms #7 - tested positive 5/29 - O2 requirements: drops to 88% with activity, back to 91% with rest - start decadron 6mg PO - start Remdesiver day #1/5 *Daily renal and liver function monitoring for kidney and liver toxicity due to Remdesvir is required. - trend CMP/CBC, check D-dimer and CRP (and trend as required) - pronation as tolerated, Incentive Spirometry, keep euvolemic - continue home Vit. D 2,000 units daily - PRN Tylenol, tessalon, albuterol Syncope Fall Laceration above right eyebrow - believe d/t #1 - CT head/spine negative - tele for now - laceration repaired via glue AKI - potentially on top of CKD, last Creat over a year ago was 1.23 - on admission creat 1.45 - give a 500ml NS bolus - hold home hctz - trend CMP HTN - continue home Metoprolol 50mg daily - hold hctz d/t AKI Diet: Adult general Code status: Full VTE prophylaxis: Heparin subq 6/1/2021 - Assessment/Plan COVID-19 Pneumonia - chest xray shows bilateral streaky infiltrates in right mid lung and mid/LLL no consolidations per read - days of symptoms #7 on admission - tested positive 5/29 - stable on room air - Continue decadron 6mg PO day 3/10 - Continue Remdesiver day #3/5 - trend CMP/CBC, check D-dimer and CRP - pronation as tolerated, Incentive Spirometry, keep euvolemic - continue home Vit. D 2,000 units daily - PRN Tylenol, tessalon, albuterol Syncope Fall Laceration above right eyebrow - believe d/t #1 - CT head/spine negative - does not report any repeat symptoms will DC tele - laceration repaired via glue HTN - continue home Metoprolol 50mg daily - hold hctz in the setting of acute illness AKI (resolved) Diet: Adult general Code status: Full VTE prophylaxis: Heparin subq Dispo: Patient is stable but would likely benefit from an additional day of steroids, remdesivir, and observation anticipate discharge tomorrow.

First shot: VERY painful around 1:30am next morning. Whole left arm to fingers. Couldn't sleep.....took 400mg Ibuprofen. Got back to sleep around 5:30am and woke at 9am feeling perfectly fine! Ouch it was painful. Second shot: Taken yesterday at 1:00pm. Difficult and painful night. Got worse around 2am. Whole body in pain! Dizzy, ears ache, dry mouth, difficulty urinating, slow, Slept on an off. Could not sleep on painful left arm (from shot). I stayed in bed until 9;15am. Feeling MUCH better. Lousy night! Sent email earlier to Dr. for suggestion on an aspirin or antidote. Now this form.....I had hoped for suggestions. Where's the help?

presents with wife today. Patient received covid19 vaccine on 06/11/21. he lost consciousness 24 hours after he received vaccine, lying on bed for 2 days, not understand wife's call, lost control of bladder, wet his pant, he did not know he wet the pants and did not felt his wife changing pants for him, needs wife to feed him during those 2 days. gradually recovered 2 days later. now he back to his previous condition.

Death LEG SWELLING N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism K92.2 - GI bleed K92.2 - Upper GI bleed

24 hours after presentation patient had developed high fevers 104. He presented to the emergency department with symptoms of severe sepsis and respiratory distress. He was intubated, suffered cardiac arrest with return of spontaneous circulation, requiring vasopressors.

Had all the listed side effects : headache, sore red arm at injection site, fatigue, fever to 100.2, body ache. Effects lasted 48 hours with arm redness and slightly sore lasting still through 2/6/2021, but subsiding. My main concern was that I experienced blood in my urine on the second day after the shot, Thursday, 2/4/21 at 3:30 PM. The blood continued in varying amounts until Friday AM, at which time I did not notice any blood (could still be microscopic).

Patient developed severe thrombocytopenia, consistent with ITP. He was admitted to the hospital with this condition on 2/1/21 after developing diffuse petechiae, ecchymoses, epistaxis, and gingival bleeding over the preceding few days. He required steroids, IVIG, and rituximab. Initial platelet count on admission 2000, dropped as low as undetectable to 1000. Normalized/improved to 164,000 after 9 days in the hospital and multiple treatments. NOTE: patient had a prior episode of ITP in 2011. Please note date of Covid-19 vaccine and manufacturer are not certain.

Generalized weakness, unable to walk. Chills. Temp 99.4 Admitted to hospital given IV saline and supportive care. Discharge on second day.

urinary incontance Narrative: Patient contacted telephone triage today requesting to speak with PCP clinic. States he had reaction to his first covid vaccine, which was given on 2/23/ 2021. States after the vaccine, he developed "massive, extreme headache - extreme sleepiness, weakness, no muscle strength, and I lost all control of my urine for about 3 days. I actually had to wear diapers for a few days." Patient states symptoms lasted approximately 3-4 days, prior to resolving. Feels better now, symptoms have resolved, but he is wondering if he should take the second vaccine, which is scheduled for 3/23/2021.

Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter. Symptoms of Covid started on Monday (2/15) early morning following shot. Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough. Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids. He went into kidney failure on Thursday (2/25) and put on dialysis. Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover. He passed away just before 4:00 p.m. on 2/26/21.

3/15/21 ER HPI - Transferred to Hospital, remains inpatient as of 3/16/21 74 y.o. male who presents with near syncopal episode. Patient states he was getting ready for his doctor's appointment this morning and when he started walking outside he fell dizzy.Wife states that before leaving for his doctor appointment this morning the patient complained of not feeling well, was sweaty and complained of upper chest pressure radiating into both arms. This symptoms have pretty much subsided on arrival to the emergency room. After initial dizzy episode, he almost collapsed, stood up, recovered and then felt dizzy again and was helped down by his wife and denies any injury except for some redness on his left knee. Patient denies chest pain or palpitations. He does not have any prior history of syncope. He is diabetic and hypertensive. Recently underwent bladder surgery due to cancer and now has a urostomy(ileal conduit). This was performed by Dr., urologist at Hospital He is on clindamycin postoperatively due to incisional infection on 03/08. 3/15/21 Hospital H&P: The patient is a 74 y.o. male with history of bladder cancer s/p open radical cystectomy resection with ileal conduit urinary diversion, type 2 diabetes, hypertension, diabetic neuropathy and chronic back pain presented to ED at Hospital because of dizziness and weakness in addition to chest discomfort. He stated that he was walking in the parking lot of his doctor's office when he suddenly felt dizzy weak and started falling on the ground. His son helped him and the ambulance was called. He stated that he felt pressure in his chest with radiation to the shoulders. He also felt short of breath. Stated that the symptoms lasted for about half an hour. He stated that he has never had any similar episodes in the past. He is not known to have any heart or lung disease. He was treated for bladder cancer and had open radical cystectomy with ileal conduit. He has been diabetic for the last 16 years. He has diabetic neuropathy. He stated that he gets out of breath walking a notice increasing swelling in the lower extremities

Presented for an office visit with PCP on 3/12/2021 complaining of dark colored urine, fatigue, diffuse itching without rash, and upper abdominal pain (RUQ>LUQ) which began 2-3 days after receiving the vaccine. Exam notable for jaundice. Labs significant for elevated AST, ALT, total and direct bilirubin. Started cholestyramine for pruritis. Had abdominal ultrasound which showed mild intrahepatic biliary ductal dilitation and surgically absent gallbladder. Had consult with gastroenterology the following week, diagnosed with likely immune-mediated hepatitis, liver function tests were trending down at that time, no further treatment required.

Moderna COVID-19 Vaccine EUA - 2nd shot March 10; Mar 11 to March 27: Fever on and off, muscled fatigue, bitter taste, unable to eat solid foods, chills, shaking when holding spoon, finally called ambulance to go to ER o March 28 after having difficulty breathing for 2 days. Admitted to ER on March 28. Gotten progressively worse March 29 to April 1 (intubated on April 1 or 2?) - Kidney / Liver failure. Transferred to ICU on April 2. Patient currently on life support (per ICU Doctors, Lung Failure, Kidney Failure, Liver Damage).

Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/1/21. On 3/17/21, he was admitted to a facility for a CABG. Per notes, after his CABG, he developed Pseudomonas pneumonia, AKI requiring dialysis and ultimately became oliguric. He required epinephrine, dobutamine, dopamine, amiodarone and went through two code blues prior to pronouncement of death on 3/25/21 at 2305. No autopsy reports available. 24 days from time of vaccine to date of death.

Patient received first COVID vaccine on 2/6/2021 and second vaccine on 3/6/2021. Patient presented to Hospital on 4/09/2021 for persistent nausea and vomiting, diarrhea, hematuria and jaundice. Patient reported a 1 month history of intermittent nausea and vomiting, generalized abdominal pain, feeling dizzy and weak, poor appetite. Patient had a colonoscopy ~2 weeks prior admission to hospital for cancer screening purposes which was unremarkable and labs done by his primary care at that time were all normal (per admitting physician's note). At hospital, patient was found to have evidence of hemolytic anemia thought to be autoimmune in nature with a positive direct antiglobulin. Patient was subsequently transferred to hospital on 4/11/2021 for further workup. Patient is still currently admitted to hospital. Oncology was consulted for workup of pancytopenia and suspected warm autoimmune hemolytic anemia. Throughout admission, the patient's platelets have ranged between 59-154 k/µL and hemoglobin has ranged 4.5-8.6 g/dL with no documented history of thrombocytopenia or anemia. Patient received methylprednisolone 125 mg x9 doses, prednisone 80 mg daily (1 mg/kg) x5 doses, prednisone 60 mg x1 dose, rituximab 740 mg (375 mg/m2) x3 doses, and immune globulin 40 g x3 doses. Patient has also received 4 units of packed red blood cells. Given the timing of anemia and thrombocytopenia and unknown etiology, immune response to his COVID vaccine is on the differential.

pt says he had fever, chills, cough, body aches and sweats. After being sick for almost 10 days he called his PCP and was instructed to go to urgent care. On 3/21/21 he went to an UTC. His vitals were checked, tested for Covid w/ negative results and blood test He was prescribed antibiotics. He says he was actively sick for over 2 weeks. He says he is feeling some better but still very weak and has night sweats.

Patient got his 2nd covid vaccine on 3/19 and has not been right since. wife reported a few days later to the pcp that his blood sugars are low and wife states he is suddenly having a hard time putting his thoughts together. Wife also says he his having a harder time breathing. was sent for blood work and chest x ray by pcp and placed on steroids. wife called back on 3/25 to pcp reporting no improvement in his breathing or condition. He was admitted to hospital on 3/31 for b/l pneumonia and UTI. treated with antibiotics. Hospitalization complicated by delirium. discharged home on 4/3. readmitted on 4/26 with acute/idiopathic pancreatitis. work up reveals no cause for the pancreatitis and is being reported as a possible immune mediated adverse side effect from his vaccination. He remains hospitalized in the ICU as of 4/28

encephalopathy with facial muscle weakness; facial muscle weakness; back pain causing inability to ambulate; dysarthria; Constipation; urinary retention; MSSA; extremity weakness; Severe refractory immune thrombocytopenia; ACUTE EPISTAXIS; DIFFUSE CUTANEOUS PURPURA; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness), ENCEPHALOPATHY (encephalopathy with facial muscle weakness), FACIAL PARESIS (facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. Journal of Blood Medicine. 2021;12:221-224 Previously administered products included for Influenza immunization: influenza in October 2020; for Pneumococcal immunization: pneumococcal in December 2020. Past adverse reactions to the above products included No adverse event with influenza and pneumococcal. Concurrent medical conditions included Hypertension, Gout, Hyperlipidemia and Cardiomyopathy. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (ACUTE EPISTAXIS) (seriousness criterion hospitalization) and PURPURA (DIFFUSE CUTANEOUS PURPURA) (seriousness criterion hospitalization). On 20-Jan-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia) (seriousness criterion hospitalization). On 31-Jan-2021, the patient experienced MUSCULAR WEAKNESS (extremity weakness) (seriousness criterion hospitalization), ENCEPHALOPATHY (encephalopathy with facial muscle weakness) (seriousness criterion hospitalization), FACIAL PARESIS (facial muscle weakness) (seriousness criterion hospitalization), BACK PAIN (back pain causing inability to ambulate) (seriousness criterion hospitalization), DYSARTHRIA (dysarthria) (seriousness criterion hospitalization), CONSTIPATION (Constipation) (seriousness criterion hospitalization), URINARY RETENTION (urinary retention) (seriousness criterion hospitalization) and STAPHYLOCOCCAL SEPSIS (MSSA) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to EPISTAXIS, IMMUNE THROMBOCYTOPENIA, MUSCULAR WEAKNESS and PURPURA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness) and FACIAL PARESIS (facial muscle weakness) was resolving and ENCEPHALOPATHY (encephalopathy with facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Platelet count: 10 10^9/L (Inconclusive) 10. On 01-Feb-2021, Blood culture: abnormal (abnormal) blood culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Culture urine: abnormal (abnormal) urine culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Platelet count: 21 10^9/L (Inconclusive) 21. On 02-Feb-2021, Cytomegalovirus test: negative (Negative) Negative. On 02-Feb-2021, Epstein-Barr virus test: negative (Negative) Negative. On 02-Feb-2021, HIV test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis B virus test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis C virus test: negative (Negative) Negative. On 02-Feb-2021, Parvovirus B19 test: negative (Negative) Negative. On 04-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) MRI revealed sever L1-5 stenosis with multi-level disc herniation and fluid collections within the lumbar, posterior and paraspinal musculature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Two months prior to vaccination, the patient had a platelet count of 224 x 10^9/L. No concomitant medications were reported. Treatment for the events included high-dose dexamethasone (400mg/kg/day), five daily doses of intravenous immunoglobulin (400mg/kg/day), three daily platelet transfusions, and two weekly doses of rituximab (375mg/m^2/dose). Immune suppression with dexamethasone (20mg/day) was continued after hospital discharge. Post vaccination day ten, TPO-RA eltrombopag (50 mg/day) was initiated. On post-vaccination day 14, he received one pheresis unit of platelets and an additional dose of IVIg of 80 grams. On post-vaccination day 12, he received high dose methyl-prednisolone (1 mg/kg/day) and (5 mcg/kg). The patient was given cefazolin for MSSA infection. On post-vaccination day 19, after the third episode of plasma exchange, his facial weakness improved. On post-vaccination day 22, his platelet count was 72*10^9/L, a second dose of romiplostim 5 mcg/kg was administered, and a corticosteroid taper was begun. He was transferred to a skilled nursing facility on post-vaccination day 25 with a platelet count of 173*10^9/L. 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.

About 12 hours (at midnight) after my second Moderna vaccination, I lost all bladder control and the use of both legs. I didn't have much pain but was very tired. Trying to get out of bed I fell, and my wife had to get me up. I decided not to call 911 but to wait until the following morning to go to the ER, which I now know was a mistake. By the morning the use of my legs was starting to return. I have been told by medical professionals (my wife being one, an RN) that it was the symptoms of either Transverse Myelitis or Gillian-Barre Syndrome. If it reoccurs, I am told to get to the ER immediately for a spinal tap. I had no adverse effects from the first vaccination, nor have I ever had any reactions from any other vaccinations or medications. I am not sure if this is the right place to report this. If not, please forward that info to me. Thank you.

COVID19 Vaccination EUA - unknown which vaccine. Patient did not have vaccination card with him. States that he got his COVID vaccines through the VA. Unsure of manufacturer. Unable to import any vaccination records. Patient states that he has completed the series and has received 2 Covid Vaccines. Patient hospitalized acute inpatient due to acute kidney injury with weakness, dizziness, and unsteady gait.

received Moderna COVID-19 vaccine on 2/21/21 and 3/20/2021 7/4/21: 75 y/o male with PMHx of emphysema, BPH, and recurrent UTI who presented to the emergency department via EMS due to concerns from family that patient appeared to have worsening dyspnea over the past 3 days. Workup in ED revealed positive COVID-19 status, WBC 12.9, BNP 4900, and CXR with infiltrates consistent with possible pneumonia. continued as inpatient: azithromycin and ceftriaxone prescriptions that were started on 7/3. Has COVID-19 viral pneumonia, acute respiratory failure with hypoxia, hypercarbia, hyponatremia, hyperkalemia, acute kidney injury, and sever sepsis. 7/5: patient admitted to the ICU. on BiPAP support. started remdesivir.

Two weeks after the vaccine, patient had an unusually strong Myasthenia Gravis reaction. He was unable to shallow, choked on his food and violently vomited. Because of that, his doctor told him not to get the second dose. SECOND POSSIBLE SIDE EFFECT: Patient had left hip surgery on July 8th. On July 20th, he presented with low blood pressure. He usually has high blood pressure, hence, the BP RX. Lovelace Heart Hospital found a UTI and blood clots in both legs! He had no symptoms of the blood clots. (None in lungs) His doctors are stumped. Usually with blood clots the BP would be high, not low. He had no redness, no pain, no throbbing, no symptoms of blood clots. Also, his doctor said it is very rare to have clots in both legs. It is possible they were there before the surgery. He is still struggling with low BP and they can not determine why.

Other than sore arm after vaccine, developed weakness and melena 2 days later on Friday the 22nd and intermittent for next 3 days. He saw cardiologist the following Friday (29th) who advised blood work. The next day sent to ER as hgb was only 5.2. EGD. He received 3 units of PRBC and a gastric AVM was cauterized. He has had a Type 2 MI and is still hospitalized.

swelling in face Pain around both sides around Kidneys Minor Rash Cold Sores General weakness and aches

Had the vaccination, dose #1 on January 26th and 12 days later had sharp abdominal pains just below the breast bone and they lasted for about 4 hr. After that I had soreness in the abdominal area and back for several days. The day after the pain I was shocked to see my urine was brown. The was Saturday so saw by PCP on Monday February 2nd for testing. My ALT liver test came back at 124 ul (normal range is 0-30). Since indicates liver problems liver follow-up testing is being scheduled.

chills, fever, severe weakness, nausea, incontinence - began approcimately 12 hours following the vaccine and were severe for approximately 20 hours

Shortness of breath, jaundice, chest pain, vomiting, O2 sat dropped to 87-95%, bilirubin 16, Hgb 6.7, Hct 15, elevated BNP and troponin, required 2.5 L of O2, and 2 units of blood, 3 night hospital stay, discharged 2/26/21.

1. Woke up following morning , I had difficulty urinating. 2. 99.3 fever the following day around 4 pm. Took 2 tablets of tylenol. 3. Fever gone after a few hours. 4. Still had difficulty urinating whole day up to evening of the 2nd day.

Patient said he had a headache, indigestion and blood in his urine the day after his second Moderna vaccine. He came in today and said the symptoms only lasted the one day but he wanted them to be reported.

Patient had emergency department visit at Medical Center on 3/11/2021 with a chief complaint of back and chest spasms on the right side. Symptoms started around 5 or 6 p.m. on 3/10/2021 and slowly worsened per patient. No abdominal pain, shortness of breath, fever or chills. No pain with chest palpation. No recent leg swelling or pain.

75 y.o. male who presents with LLQ PAIN INTERMITTENT FOR 3 WEEKS. PT STATES HIS "BOWELS HAVE NOT BEEN RIGHT" MEANING HE DOES NOT HAVE A STOOL EVERY DAY. HE SAYS HE HAS BEEN TAKING A STOOL SOFTENER AND PROBIOTIC AND NOW STOOLS ARE "RUNNY" BUT PAIN PERSISTS AND IS WORSE WITH DEFECATION. DENIES FEVER, CHILLS, NAUSEA OR VOMITING. PT STATES HAS HEMORRHOIDS AND HAS HAD SOME BRIGHT RED BLOOD OCCASIONALLY WITH STOOLING.

Initially after the second vaccine he had typical myalgias/arthralgias, especially shoulder/neck. On 3/19 he got acutely worse with severe pain both shoulders/wrists/hands. He came to ER 3/24 with symmetric inflammatory arthritis involving shoulders/wrists/hands and edema of the hands-pitting edema on dorsum of right hand. He was in such pain that he couldn't take off his shirt without assistance, couldn't bend the wrists, couldn't make a fist. Clinically, this looked like RSP3PE and resolved within 24 hours on prednisone 20 mg bid which is tapered down today. Patient returned to the ER today 3/24 with nausea/vomiting and that is currently being worked up. If it appears that this has anything to do with the vaccine, I will file a second report with the new symptoms.

pt states he did not sleep well the night after taking the vax and when he got up next morning he was very dizzy and nauseated. He had to hold on to furniture to get to the restroom and then vomited. He feels like he is having a vertigo episode. He is also urinating a lot more than usual and has a pain in his kidneys. Pt has contacted his PCP but they not have returned his call yet.

Patient presented to the ED with weakness and shortness of breath. He reports needing assistance with activities of daily living due to weakness. Patient reports the shortness of breath has been ongoing for approximately 2 weeks. Patient was found to have hemoglobin of 4.4 with a suspected GI bleed. The patient will be admitted to the hospital. Patient is to receive 3 units PRBCs.

My specific adverse effect that other people I know didn't report is the amount of urination I had to deal with over a 2 day period. There were times I didn't make it to the bathroom even though I had just finished going. My Pharmacist recommended I report yhis to you.

The patient has acute vasculitis with biopsy + purpuric leg rash, microcytic anemia, acute renal insufficiency with hematuria, He has been responding to oral prednisone, tapering dose.

POC alleges that she observed that resident began to swell and retain fluids and the nurse noticed that he was not urinating, felt a lot of tiredness and had swollen legs. He was evaluated by the doctor and sent for several studies (EKG) and his heart was weakened. He was sent to do another study, because snoring was heard. He was transferred to the hospital to the ER, he had the fluid in his lungs. He is placed intensive and dies on 3/23/2021 from heart failure.

Almost exactly seven days after my second Moderna shot, I had a urination which was dark blood red. It included a small blood clot, which by my estimate was at most 1/2" long by 1/8" in diameter. There was no pain or burning on discharge, either with that urination, or before, or after. My next urination after that had a very small amount of dark red discoloration; and there has been no dark red in my urine after that [now six days]. Following that bloody urination, I did have a slight discomfort in the area below my belly button for several hours, but then it stopped. Since that incident, I have increased my intake of water and decreased my intake of acidic and carbonated drinks. I have not smoked in more than 45 years; and the occasional urinary dribbling I had experienced for some years before that incident has decreased noticeably. All else is OK. As a non-healthcare professional, I concluded the outcome to date is good. I have an appointment to see my doctor, on April 22.

75 year old man with Afib on Pradaxa, CAD (PCI 8/2019), HFrEF (30-35% 10/2019), DM2, CKD (baseline 1.35-1.66), COPD, Hx of Stroke with left sided deficits, Alzheimer dementia, AAA and aneurysms of the bilateral common iliac arteries, who presented 3/5 with chronic back pain, myalgias, fever to 101, after 2nd covid vaccine (?Moderna) on 3/4. Found to have a LA of 4.5. Briefly on vancomycin for 1/2 bcx with gpc's however discontinued one day later for contaminant. Other home meds were restarted. Lactate cleared. Symptoms thought possible related to second COVID vaccine and he remained otherwise stable throughout his hospitalization. On 3/8 he was discharged home with home health in stable condition. #2 COVID shot (thinks Moderna) yesterday on 3/4, from the care center

acute renal failure; again he lost control of his legs in the middle of the night; elevated CPK; pretty bad chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE KIDNEY INJURY (acute renal failure), LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044A21A) 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). Concomitant products included ALLOPURINOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) (seriousness criteria hospitalization and disability) and CHILLS (pretty bad chills). On 08-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (acute renal failure) (seriousness criteria hospitalization and medically significant) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) (seriousness criterion medically significant). The patient was hospitalized from 08-Apr-2021 to 11-Apr-2021 due to ACUTE KIDNEY INJURY and LOSS OF CONTROL OF LEGS. On 11-Apr-2021, ACUTE KIDNEY INJURY (acute renal failure) outcome was unknown, BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) had resolved. At the time of the report, LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and CHILLS (pretty bad chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood creatine phosphokinase: 22,000 High. On 10-Apr-2021, Blood creatine phosphokinase: 10,000 High. On 11-Apr-2021, Blood creatine phosphokinase: 6,412 High. Acute renal failure was due to something in the vaccine that attacked the muscles in his legs. IV saline was given as a treatment HCP appointment is on the 19/apr/2021 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-2021-080270 (E2B Linked Report).; Sender's Comments: MOD-2021-080270:first dose

presented to ED with RUQ pain and temp of 102., borderline SIRS found to have segmental and subsegmental PE's on CT. Additionally diagnosed with UTI

fainting; fall; Dehydration; itchiness; frequent urination; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history reported. Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and LATANOPROST for an unknown indication. On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever). At the time of the report, SYNCOPE (fainting), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever) outcome was unknown. Treatment of the events were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-089270 (E2B Linked Report). Reporter did not allow further contact; 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 MODERNATX, INC.-MOD-2021-089270:Wife case

# Post-obstructive AKI complicated by hyperkalemia/metabolic acidosis and uremia, improving # BPH-induced obstruction # Moderate right hydroureteronephrosis with a 4-5 calculi(the largest 5mm) in the right distal ureter # Sepsis 2/2 Complicated UTI # Severe protein-calorie malnutrition (Present on admission) # Severe deconditioning # Unintentional weight loss

NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified

3/24 medical facility, admitted day after covid vaccine with syncope. Male with a history of PVCs who is coming into the hospital after a syncopal episode; patient reports in usual health, he had a second covid vaccine on 3/23, and start getting dizzy especially with movement on 3/24. On 3/24, he woke up and was going to the bathroom and then turned around to walk out of the bathroom and all of a sudden became lightheaded and dizzy. He said he ended up falling onto the ground not sure exactly how long he was out for but did not lose control of bowel or bladder function he had no chest pain. Stable course in the ER vital signs reviewed slightly elevated blood pressure. Extensive work-up was done. Normal saline bolus given. Chemistries unremarkable save for creatinine 1.32. Rest labs reviewed. He did meet gap alert criteria so CT C-spine CT head done no acute findings. EKG sinus tachycardia as ventricular trigeminy. No ST elevation. Discharged in stable condition.

75 year old male who presents with Weakness and altered mental status after second covid vaccine. Patient with advanced dementia, at baseline ambulatory , follows some direction and able to feed himself , but since second vaccine worsening weakness, stopped walking and communicating and today was too lethargic for family to wake him up, thus 911 called. Patient had similar but less severe reaction after first vaccine, and had covid disease earlier this year . Normally cared for at home by wife and son . Patient unable to give any history , awake but not coherent.

We report an event of transverse myelitis occurring one week after second dose of COVID vaccine in a seventy-five-year-old previously able-bodied gentleman with HTN and DM2. He developed a painless, distal greater than proximal, subacute onset weakness of the right greater than left upper and lower extremities with bowel and bladder retention. He was treated with methylprednisolone IV q24h for 3 days and IVIG (divided over 3 days). At one month from symptom onset, he was able to walk, but continued to have urinary and fecal retention. By 60 days since symptom onset, he had near resolution of symptoms.

Patient presented to the ED on 5/11/2021 and was subsequently hospitalized with UTI and severe sepsis within 6 weeks of receiving COVID vaccination.