Moderna

Client's care giver stated she was not as talkative following vaccination, was dizzy and lethargic (Client was in a wheelchair in her van in the 15 minute waiting area from the drive thru event) VSS and not recorded. No LOC for client. Due to extensive list of allergies, client was transported by EMS to ER.

Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.

1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.

Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive urination....for over a week

Second Covid Response to Moderna I had a very severe reaction to she second Moderna shot (3/4/2. I went grocery shopping the afternoon after I had my shot at about 11am. Everything seemed normal, but after 20 minutes I was in an episode of the Twilight Zone . I bought the wrong products, I also bought several of the same thing. I bought products I never would have bought and had never purchased before. Then I got home and was feeling still like I was in the Twilight Zone. (nothing seemed real). Soon after I fell on the floor and could not get up. My leg and back would not work. Then I started to urinate and could not stop. Buckets came out and every time I tried to get up, I fell completely flat again. The urination lasted from early afternoon till about 6:30 pm. Then I went to bed and stayed there till morning when I could get up and walk. Meantime I had to wash my bedding, 3 pairs of pajamas and seven pairs of under pants. One of the times I fell, my foot (which was recovering from a burn across my toes) and I jammed it between the wall and the bed, causing a break. Also the first night I took the shot, I could not get to sleep until 4am (my cat and I were stuck watching Robo Cop till it ended at 4am. I?m now in a boot-cast, and will get an x ray tomorrow. I should let you know I take Sartaline HC, 100 mg once a day and Clonazepan, 1 mg 3 times a day.

Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/2021 she complains more than usual with fatigue, a lot of fatigue so they make the decision to transfer her to the hospital. In the hospital she was informed that the pain was from a gallbladder stone, also that she has a lung condition and a compromised kidney. A Dr. from Hospital tells POC that the patient was not responding to treatments and was compromised thus prolonging the hospital stay.

Patient received the first moderna vaccine. She was waiting the 15 minutes after the vaccine, at about 8 minutes I checked up on her again and asked if she was doing okay. her eyes were open but she was not responding. I ran over there and tried to get her to respond to my touch and voice. She was breathing but was non responsive. She also had incontinence and when she came to she stated that she was asleep. We called 911 at this time and the paramedics came and took all her vitals, all of which were within range. The paramedics came within 10 minutes and at this time she was already responsive. She kept stating she was just asleep and told us she does sometimes have incontinence and has to wear pads. She refused further medical care and I contacted her when she was at home, where she stated that she would rest up but overall feels fine.

Had kidney stone problem; Urine test showed bacteria; Sore arm; A spontaneous report was received from a consumer concerning a 76-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm / pain in extremity, had kidney stone problem / nephrolithiasis and urine test showed bacteria / urinary tract infection bacterial. The patient's medical history was not provided. Concomitant medications reported included potassium and nebivolol hydrochloride administered half a pill. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient experienced sore arm. On 13 Mar 2021, the patient had kidney stone problem and urine test showed bacteria. The event kidney stone was found to be medically significant. Treatment drug administered was amoxicillin and clavulanate potassium on 18 Mar 2021 and on 19 Mar 2021. On an unspecified date, treatment drug was switched to ciprofloxacin. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, sore arm, had kidney stone problem and urine test showed bacteria 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 event of sore arm, a causal relationship cannot be excluded. Very limited information regarding the events of nephrolithiasis and urinary tract infection bacterial has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea. The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate. On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.). On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F. In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2. The outcome of the events, pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.

Kidneys not working properly; Elevated Blood pressure 170/? mmHg; Feeling of being Wiped-Out; Creatinine Clearance Levels went up to 2.2 mg/dl; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL IMPAIRMENT (Kidneys not working properly) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension and Kidney function abnormal. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RENAL IMPAIRMENT (Kidneys not working properly) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out). On an unknown date, the patient experienced BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl). At the time of the report, RENAL IMPAIRMENT (Kidneys not working properly) and BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl) had not resolved and BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (100/70-140/90 mmHg): 170/?? mmHg 170/??. On an unknown date, Creatinine renal clearance increased (0.6-1.1 mg/dl): 2.2 mg/dl 2.2 mg/dl. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications not reported. Treatment was not reported.; 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.

Fainting; frequent urination; MODERNA toes/dots on her foot which still persist; itchiness; Dehydration; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the reporter. Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, 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), POLLAKIURIA (frequent urination), VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist), PRURITUS (itchiness), DEHYDRATION (Dehydration) and PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting), POLLAKIURIA (frequent urination), DEHYDRATION (Dehydration) and PYREXIA (Fever) outcome was unknown, VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist) had not resolved and PRURITUS (itchiness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment medications were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-089293 (E2B Linked Report).; 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. MODERNATX, INC.-MOD-2021-089293:Husband case

Pt received dose #1 Moderna COVID vaccine 1/19/21 @ LPH Vaccine clinic. Overnight some nausea, malaise. 1/20/21 experienced a syncopal episode at home and BIBA to PVH ED. Vomiting, incontinence in route. Workup negative, given IVF and zofran, discharged. Per ED provider "Likely vasovagal syncope. Possibly related to reaction to vaccine. No worrisome findings in the evaluation today."

Starting 6/2/21, pt felt like her kidneys "were not working properly." She states she isn't urinating much and when she does urinate, her arms tingle. Symptoms have persisted throughout yesterday and today 6/3/21.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first time occurred on 03/09/2021 for severe sepsis, tachypnea. The second time occurred on 3/22/2021 for Acute cystitis without hematuria.

Pt was admitted to hospital from the ED with acute cystitis without hematuria on 4/16/21, after receiving the second dose of vaccine on 4/5/21. Per guidelines, all hospitalizations are reported

Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.

March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital

pts daughter states she has severe confusion with slow speech with difficulty speaking and slow movement Also has extreme muscle pain and double vision. Pt had urge to urinate but could not. Pts daughter states she is still having some symptoms but is improving and will see her doctor next week for a regular scheduled appt. Pt started the medicine Cymbalta in November 2020 for her Fibromyalgia but had developed confusion from it so the doctor took her off of it on January 11th 2021 and was doing well until the day of the vaccination.

Pt was admitted to her local hospital for less than 7 hours for fever, chills, fatigue, intense body aches, nausea and vomiting.

I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to the point that all I wanted to do was sleep. So I went to bed, but just as I would be close to falling asleep I'd have to get up to empty my bladder. This was happening almost every 15 minutes for a few hours. I knew I probably should hydrate, but I chose not to because I wanted to get some uninterrupted sleep which I finally did at about 4:00am which only lasted a couple of hours. Then up at about 6:30am when I took some acetaminophin and went back to sleep. I was in bed all day, sleeping most of the time. When I'd wake up I'd take my temperature and most of the time I'd hydrate. I haven't had anything to eat because I wasn't feeling strong enough to even heat water for soup. My normal temperature is about 97.6 give or take. The highest temperature I had was 100 when I took another dose of acetaminophin. But one time it was 94.3!!! I started feeling better at about 8:30pm (3/1/21) and was able to make myself some chicken noodle soup and had some cereal and cottage cheese with it. I finally felt "normal" on Tuesday morning (3/2/21) after getting a good night's sleep.

Immediately, sharp shooting pain from injection site ( the back of my arm, not the middle) when all the way down my arm and was severe in my pulse side of my wrist. I reported it. The pain resolve mostly after 30 minutes. Either Feb. 28 or March 1 woke up with my left eye being red from broken blood vessel. March 3, slight burning with urination. 1X March 4 no burning until about 4:30 pm, and then also much blood. 15 minutes later, the same.

"Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, increased swelling,

Body was extremely hot and red, and I also had chills. Arm was very hot and sore and swollen. Entire body ached (like I have never had before) , nausated, bad headache, very weak. My urine was a different color (kinda of peach/pink). I took Tylenol to help with fever etc., for a couple of days. I still fatigued from the ordeal.

Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; A spontaneous report was received from a consumer concerning a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19. The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided. On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up. On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic. On an unknown date post hospitalization, the patient tested positive for Covid-19. Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-033912:

3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort. Patient reports a 2 day history of increasing cramping and pressure in the suprapubic area. Patient reports she felt this way when she had urinary tract infections. However, patient denies any current urinary frequency, dysuria, hematuria, or urgency. Patient does report some minor dribbling which she states is common for her. Patient denies any fevers but does report an occasional chill. Patient does report pain across her low back. Patient denies any nausea, vomiting, constipation, diarrhea, melena, hematochezia. Patient does have an extensive abdominal surgical history including colon resection, cholecystectomy, appendectomy, and hysterectomy

Urinary Tract Infection - severe lower abdominal/bladder pain, burning sensation during urination; then, unable to urinate.

I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination. No medical advice was sought and acetaminophen was taken on an as-needed basis. What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first

Toilet bowl full of blood in pee. Shot was given on Saturday April 10 blood on toilet on April 12. Same thing happened after first shot on March 13. March 16 toilet bowl full of blood.

Patient received the vaccine on 2/8/21. There was a continued gradual weight loss and decrease of appetite after vaccine. On 3/2, patient had unknown reason for elevated blood sugar of 303. On 3/4, patient had oxygen of 78% on room air, Pulse 127, RR 22, BS 158. Oxygen started. Lethargic, hypoxic, tachycardia. Transfer to hospital. Patient readmitted on 3/12/21 with community acquired pneumonia, bacteria in urine acute kidney injury. Treated with antibiotics and hydration.

on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking medications as prescribed. Documentation from MD in ED uncertain if pt. taking her amiodarone, torsemide and elquis. Noted to have O2 sats on RA of 81%. Pt. was in respiratory distress upon arrival to ER. Pt. was transferred to higher level of care, another Hospital on 4/15/2021 placed on Bipap.

FEVER, Wheezing, Shortness of Breath DX Fever, unspecified fever cause R50.9 Pulmonary infiltrate R91.8 New Prescriptions DOXYCYCLINE HYCLATE (VIBRAMYCIN) 100 MG CAPSULE Take 1 capsule by mouth 2 (two) times daily for 10 days.

Urinary tract infection; sciatic nerve; stressed; can't walk; Cancelled 2nd dose because sick in hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed), GAIT DISTURBANCE (can't walk) and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital). The patient was hospitalized on 17-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed) and GAIT DISTURBANCE (can't walk) outcome was unknown and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment includes IV Antibiotics Bactrim Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis.

(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of "just not feeling right" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed "water pill" and told to "lay off salt,". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter "water pills" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative.

Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified

ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED IN ICU PER DAUGHTER FOUND have 2 ANEURYSMS.

Patient had COVID-19 with pneumonia at the end of December 2020 and recovered. Received vaccine in mid February and 2nd dose of vaccine on March 3rd. Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.

weakness in legs, collapsed onto floor, unable to control bladder, headache, Legs continued to give out while walking, fatigue

Moderna Covid Vaccine EUA: Sent to ED from adult care facility (resides at home; PACE program participant with care center attendance multiple days per week. Received vaccine on 2/3/21 at care center. On 2/5/21 care center staff sent patient for ED evaluation due to decreased oral intake and activity, general weakness and lethargy, and fever. Cannot determine exact onset of symptoms but ED presentation was 1 pm on 2/5/21. Fever on ED presentation recorded as 101.9 F. Patient noted to be very sleepy/lethargic; appropriately responding to questions but requiring nearly constant stimulation to stay awake to answer questions. Workup revealed procalcitonin 0.08, serum creatinine 1.3 (baseline 1.0 to 1.1). Blood cultures and urine culture negative. CBC not available due to refusal of additional blood work. Received IV acetaminophen with improvement in fever and mental status. Discharged home.

pt had 2nd dose of covid vaccine on 03/16 went home got something to eat laid down- does not remember anything else for 2 days was found on the floor by her bed must have fell off of the bed has lost urine neighbor found her- call paramedics declined to go to hosp thinks she passed out for 1.5-2 days daughter came to take care of her had to drink from straw couldn't eat brain fog feeling better now

on 4/24 noticed very small drop of pinkish blood in urine stream. 4/30 went to dr, he tested urine for blood,tested positive. Scheduled a CYSTO for 6/3/2021. (scope prostate, bladder). Evening of 4/30/2021 noticed small blood clotting of blood in urin streem. same thing the morning of 5/1. Looked up Bladder Cancer, said that DNA can cause changes ib bladder related to blatter cancer. Dr now on vacation, but if the blood clotting in urin stream continuse will contact DRs Office.

She had labored breathing in her chest and rib cage hurt for 36 hours post vaccination. She also had a urinary tract infection at the time and felt her heart flutter. In the past, she reported a history of reaction to any vaccine, including polio.

Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure

Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.

Severe weakness in both legs. I couldn?t walk. Dizziness and mental confusion. I was taken to the ER. Blood and urine samples taken, chest X-ray, ECG, and was told I had a UTI and was prescribed a course of antibiotics for 10 days and discharged.

Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna

Increased problems with speech, finding words, and confusion. Cannot answer the phone anymore. She seems to be more needy, shuffles (new onset), and incontinence problem has returned. Did not have an office visit as a result of adverse event.

- stye on left eye - uncontrollable diarrhea - diagnosed with lymphocytic colitis - shortness of breath - blood in urine - hematuria

The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vaccine yesterday. Now displaying increased weakness, blood in urine, increased confusion and urinated on herself today. Fever of 101.9 ) 79-year-old female presents to the emergency room with fatigue. The patient states yesterday she had the Moderna COVID-19 The patient states today she had a temperature 101.8° prior to arrival. Her son noted that she was having episodes of urinary frequency and also that she was profoundly weak and fatigued. They denied falling or hitting her head. The patient also states she been having nausea vomiting with diarrhea.

Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.

2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with severe leg weakness, inability to walk, urinary incontinence

Patient received second dose of Moderna Covid vaccine at 0930 on 3/4/21 and presented to ED at 1800 on 3/4/2021 with complaint of weakness and not being able to get out of recliner. Patient was admitted to hospital under observation stay. The following meds were started: pantoprazole 40 mg IVP once and normal saline at 100 mL/hr (ran for 7.5 hours = 750 mL). Patient returned back to her baseline by approximately 1400 on 3/4/21.

Pt became encephalopathic, developed afib, and urinary retention. Admitted to the hospital for 2 week stay until encephalopathy resolved. Afib broke spontaneously. Required foley catheter placement.

Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/2021. Since then her stomach started hurting and pt. is lethargic. Pt. did not open eyes when asked questions and was quite pale. Son reports increased confusion last day or two. Pt. reports that she started feeling ill immediately after receiving the injection. Complains of generalized weakness and fatigue. Denies dizziness or lightheaded. C/o abd. pain. Denies nausea, vomiting, but admits to diarrhea. Denies fevers, cough congestion. She is alert to place and name, but unsure of date at time seen in ER. When seen in ER she was afebrile, but hypoxic and hypotensive. Initial saturations were in mid 80's, but dropped to low 60's. With a non-rebreather mask she maintained at 90%. BP 60's systolic but with fluids increased to 90's . No rectal bleed or hematemeis. Diagnosis of septic shock, anemia, elevated LFT's, pneumonia, and UTI.

Had a type of E-coli; Fever; UTI; A spontaneous report was received from a consumer who was also a 79-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who fever/ pyrexia, UTI/ urinary tract infection, and had a type of E-coli/ enterococcal infection. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 27 Feb 2021, prior to the onset of the symptoms, the patient received a dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date the patient developed a type of E-coli infection, Urinary tract infection and fever. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: This case concerns a 79-year-old female who had a medically significant and serious unexpected event of Enterococcal infection along with NS events of unexpected urinary tract infection and expected pyrexia. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

To er for eval of seizure activity at hospital . Nurse reported that seizure activity lasted 1.5 min and took approx. 30 minutes for her to start " coming around" to her self. Patient was bradycardic en route to hospital. er hpi: "79 y.o. female who presents with seizure activity. Patient is brought to the ER via EMS from nursing home with new onset seizure. Nursing home staff reports patient had tonic-clonic seizure which lasted approximately 1 min. Patient was apneic. Patient is slightly postictal but no urinary incontinence. Patient has no known history of seizure disorder. Patient is resident of nursing home and is a DNR comfort care. Patient with underlying dementia. In speaking with patient she denies any current headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers, or chills. She is alert only to name." Inpatient admission to hospital 3/24/21 dx acute hepatic encephalopathy, new onset seizure without head trauma

Patient reportedly recevied COVID vaccine on 2/25/21 but unsure of manufacterer or lot number. Patient admitted to hospital on 3/17 for altered mental status and suspected UTI. COVID screen test on 3/17 resulted positive. Patient was asymptomatic for COVID. Patient was discharged on 3/21/21 with no clinical deterioration from COVID.

Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into afib.

Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.

This 79 year old black female received the Moderna Covid shot on 1/30 /21 and went to the ED on 2/8/21 and was admitted on 2/9 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (HCC) N17.9 - Acute kidney failure, unspecified

ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD

Transient ischemic attack; Bad urinary tract infection; Missed her second dose of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg operation and Knee surgery NOS. Concurrent medical conditions included Anxiety, Fibromyalgia and Wheelchair user. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Bad urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination). The patient was hospitalized on 26-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK and URINARY TRACT INFECTION. The patient was treated with Rehabilitation therapy (Sent to rehab for 2 weeks) for Transient ischaemic attack and Rehabilitation therapy (Sent to rehab for 2 weeks) for Urinary tract infection. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Magnetic resonance imaging: abnornal (abnormal) Confirmed TIA. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications or treatment information has been specified. The symptoms resembled having a mini stroke. The doctors did not state that the events happened due to the vaccine. The patient was sent to rehab for 2 weeks and consequently missed her second dose. 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.

5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.

After the shot ended up in the hospital with kidney failure...a week later ended back in the hospital after falling, little use of right hand, has become very weak

interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; shaking and teeth chattering; impossible to eat w/out vomiting / She couldn't eat or; she had all over excruciating pain; UTI; extreme back pain; weak legs and unsteady/ very unsteady; arm was sore at the site; aching head to feet, body that had ever been in pain was more painful; rigor chills, teeth chattering; Nauseated; cytokine reaction; headache; sick to her stomach; dizziness/; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (cytokine reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cystitis interstitial from 1996 to 1999. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (cytokine reaction) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), HEADACHE (headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), MYALGIA (aching head to feet, body that had ever been in pain was more painful) and CHILLS (rigor chills, teeth chattering). At the time of the report, CYTOKINE STORM (cytokine reaction), CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), HEADACHE (headache), MYALGIA (aching head to feet, body that had ever been in pain was more painful), CHILLS (rigor chills, teeth chattering) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 degree Celsius (High) 100.6 and 99.1 degree Celsius (High) 99.1. Relevant concomitant medications were not reported. Treatment information was not provided. Patient visited her cardiologist and primary care doctors and they reported good strong immune response. Patient also visited oncologist; he reported cytokine reaction. Patient also had a medical history of interstitial cystitis for 3 years but again she developed interstitial cystitis after the 2nd dose. 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. Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Additional information received on 10-JUL-2021 regarding the 2nd Dose events and lab data. On 12-Jul-2021: Follow-up information received on 12-JUL-2021 contains updated event onset date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.

Left deltoid began turning blue evening of 01/13/2021. After awakening on 01/14/2021, left upper arm was blue and red to elbow. Voices that "head felt like it did when I had covid, light-headed, dizziness", hallucinations, urinary incontinence, weakness, memory loss.

Morning after receiving vaccine (01/14/2021), woke up and was having chills, weakness, "head felt like it did when having covid, dizziness, light-headed". Urinary incontinence and memory loss, and hallucinations on 01/14/2021. Blue color to left deltoid started 01/13/2021 in PM and on 01/14/2021 when waking up, left upper arm was blue and redness noted down to elbow. "I have laid on the couch and that's basically all I've done since getting the shot."

No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia. The patient's medical history was not provided. concomitant product used not provided by reporter. On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak). On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body). On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs). The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported. The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities

Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsions; terrible contractions of muscles; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Convulsions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) and PYREXIA (fever). On 09-Apr-2021, the patient experienced URINARY INCONTINENCE (Loss of control of bladder). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) had resolved. At the time of the report, SEIZURE (Convulsions), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), URINARY INCONTINENCE (Loss of control of bladder) and PYREXIA (fever) had resolved. No relevant concomitant medications were provided. No treatment information was provided.; 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.

80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021

Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination

Patient was referred to emergency department by primary care physician for concerns of sepsis. Patient UA outpatient that showed a urinary tract infection and was experiencing hypotension. During screening for admission, was found to be COVID-19 positive. Patient was asymptomatic for COVID-19 infection at presentation and was only recieving supportive care. She does not require antiviral, steroid, or supplemental oxygen at time of writing. Patient is currently admitted at time of writing.

Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis

I had some diarrhea - but I do get that quite often even before the shot. Noticed blood in the Urine at home and I called for an appt. Doctor at Kaiser.

Twice the first night I lost bladder control. Today I have sores inside my lower lip. Not serious but not a mention of the possibilities

Per patient's daughter: around 1 pm patient started acting confused. At one point, patient thought it was Valentine's Day. Daughter also stated that patient ate a Kleenex. Patient was treated with 2 L of fluids and cardiac monitoring. Patient's AMS resolved by next morning. Patient returned to baseline and was discharged after 36 hours of observation.

fever, chills body aches, shortness of breath, urinary frequency, factigue, headache, body aches, water does not taste good.

81 y/o otherwise healthy female on no prescription medications Received Moderna Covid 19 vaccine on 2/25/2021 at 11:30 am -- > no problems following administration of vaccine About 15 hours later, on 2/26/2021 at around 2:30 am, pt went into the shower and suddenly felt acutely weak in lower extremities; unable to bear weight, so sat down on floor; no fall or injury; no focal neurologic sx at that time. Patient was able to crawl out of bathtub and call family member - total time down about 3 hours. Patient denied any associated fever, chest pain or upper body weakness. Due to extreme lower extremity weakness, pt taken to ER -- > dx: nontraumatic rhabdomylolysis She was treated with IVF, Tylenol and discharged home. Since discharge, she has been steadily improving. Three days after ER, pt is able to bear weight, ambulate but still with mild bilateral upper thigh pain and weakness (unable to get up from low seated position or squat).

On 3/7/2021 the patient presented to the ED with generalized weakness and altered mental status. She was admitted for hyponatremia and found to have a UTI. Per EUA, all hospitalization must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.

patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she was hospitalized for 2 days.

chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.

stated a little of everything going on, not feeling good, UTI and sinus infection, had last covid vaccine on March 4, was on 4 different kinds of HTN meds that were being adjusted, woke up Thursday AM 6/03 with dizziness, went to ER, Stated concern about symptoms after taking covid injection 5 wks after second dose, had second dose March 4 of Moderna injection for covid, received in left arm, soreness in muscle very little that lasted one day, stated on April 18 LLE cellulitis and went to urgent care, rash to chest 3 days after taking tetracycline, was told she had statis dermatitis by doctor, stated went away after 1-2 days of using hydrocortisone and compression stocking, HTN meds changed one week before rash

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management

admitted for further management of a PNH flare; severe hemolysis; heme pigment-associated acute kidney injury; Condition aggravated; Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms; One day after dose 2, she developed dark urine; One day after dose 2, she developed generalized weakness; One day after dose 2, she developed abdominal pain; One day after dose 2, she developed odynophagia; This literature-non-study case was reported in a literature article and describes the occurrence of PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury), HAEMOLYSIS (severe hemolysis), and CONDITION AGGRAVATED (Condition aggravated) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Autoimmune- and complement-mediated hematologic condition recrudescence following SARS-CoV-2 vaccination. Blood Adv. 2021;5(13):2794-8 Previously administered products included for an unreported indication: SHINGRIX (Flare 2 years earlier which was triggered by her second Shingrix vaccine. She had never been treated with terminal complement inhibition.). Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria (long-standing history of steroid-responsive granulocyte clone size, 98%). 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 PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare) (seriousness criteria hospitalization and medically significant), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury) (seriousness criteria hospitalization), HAEMOLYSIS (severe hemolysis) (seriousness criteria hospitalization), CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia). The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of 1 gram; ECULIZUMAB (intravenous) for Adverse event, at a dose of 600 milligram and RAVULIZUMAB for Adverse event, at an unspecified dose and frequency. At the time of the report, PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury), HAEMOLYSIS (severe hemolysis), CONDITION AGGRAVATED (Condition aggravated), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) Negative. In 2021, Blood bilirubin: 1.8 mg/dl (Inconclusive) 1.8. In 2021, Blood creatinine: 0.91 mg/dl (Inconclusive) 0.91 and 1.69 mg/dl (Inconclusive) heme pigment–associated acute kidney injury (baseline: 0.79 mg/dL). In 2021, Blood lactate dehydrogenase: 1272 (Inconclusive) 1272 U/L and 3282 (High) On day 2 after admission to the emergency department. In 2021, Haematocrit: 30 percent (Inconclusive) 30. In 2021, Haemoglobin: 10.0 g/dL (Inconclusive) 10.0. In 2021, Laboratory test: demonstrated severe hemolysis (abnormal) demonstrated severe hemolysis. In 2021, SARS-CoV-2 test: negative (Negative) after admission to the emergency department. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), CONDITION AGGRAVATED (Condition aggravated), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia) to be possibly related. Concomitant medications were not provided. The patient received a transfusion of 2 U red blood cells (RBCs) as a treatment and received a transfusion of 1 additional unit of RBCs after admission to the emergency unit. On day 2, the patient received a transfusion of 1 additional unit of RBCs to suppress erythropoiesis. The patient received meningococcal prophylaxis with meningococcal B and ACWY vaccines without complications and was discharged on day 6 and continued on terminal complement inhibition with ravulizumab in the outpatient setting. This case was linked to MOD-2021-263889, MOD-2021-263970, MOD-2021-264203 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of paroxysmal nocturnal haemoglobinuria (including flare ups) is a confounder.

Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.

3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey

Patient had a sharp decline in her health following her second vaccine. Leg pain, lower ext claudication, acute renal failure and acute congestive heart failure

Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine­ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.

The patient started running a fever of 101 within 12-24 hours of receiving her second covid vaccine and was suffering from altered mental status. She was transported via EMS where she was admitted until her d/c home on 2/20/21.

x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2/16/21; admitted 3/18 swg bed for physical deconditioniong. 3/18/21 Swg Bed admission HPI: 82 y.o. female presents for direct admission to swing bed. Back in the middle of February the patient had a high-grade small-bowel obstruction ended up with laparotomy and lysis of adhesions. She was extremely deconditioned. She came to swing bed here and states here for about 2 weeks. She thought she was ready to go home and be successful at that time. Unfortunately, she has gotten home and found that she can barely take care of herself. She is extremely deconditioned. She thinks she just needs to be built up for another week or 2 and then could be very successful at home. She does have a friend that is helping her, but is worried about getting so weak that she end up hurting herself. I saw her yesterday in the office and thought that another swing bed stay a might be in order.

Pain and swelling commenced on day 6 as reported to V-Safe- itchiness rash and frequent urination....unable to sleep throughout night on day 7 and an ER visit confirmed shingles.

Resident showed signs of a stroke at 8:30am on 4/1/2021; transferred to hospital; 4/1/21 12:22 pm resident admitted to hospital with symptoms of stroke; UTI; and elevated cardiac enzymes

Fatigue the day after increased and progressed to weakness and confusion for the week following the vaccine, culminating in Emergency Department visit with hypercalcemia and acute kidney failure and subsequent 9 day hospitalization.

She got the vaccine and did not get an immediate reaction, and on Thursday morning she was tired and couldn't get out of bed. So her husband kept her in bed all day and by Friday morning things didn't get any better, and he helped her to get to the end of the bed and went into the kitchen to get breakfast and he heard her fall, and she fell off the bed and was semi-consciousness, and was able to get her back into the bed and called the ambulance. She was taken to the hospital Friday morning and she's still in there. She has been diagnosed with hydronephrosis, and they keep going back and forth on her diagnoses. At first they said that she had a UTI, and then they said she didn't, and then said that she did. The son feels that all three of the doctors feel that it was some sort of reaction to the vaccine. They did give her steroids at one time, and she developed severe tremors when she moved which have subsided. She also has had fever, in a weakened state due to this condition. She is still being treated for this still and said that she will be having to go to rehabilitation before going home.

Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia

From 3/11/2021 until 3/29/2021 the patient was in the hospital due to lack of appetite and kidney failure. The doctor certifies that the cause was more natural

The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak. Patient presented with a fever and hypotensive. Patient also reports a UTI. Tested for COVID has a part of hospital admission guidelines. The test returned positive.

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC)

Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/21 PCR positive for COVID-19 virus. Admitted inpatient 4/14/2021.

2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function failed. and Acute Hypoxic Respiratory Failure and Cardiogenic Shock were listed as cause of death on 3-3-21

Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included acetaminophen. Company Comment There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded

On 6/4/21 at 10:40, res became unresponsive with agonal/snoring respirations, no palpable pulse, but audible apical pulse with irregular rhythm, general pallor nd cyanosis, cool and clammy skin. BP92/58 manual, R 4 initially sats low 90's. Accucheck 181. required heavy tactile sternal rub; Res vomited large amt of yellow/white vomitus and had large diarrhea episode. She became responsive after sternal rub but shortly thereafter became unresposnive again. MD notified with new orders for labs and head CT.

Daughters report that mother, pt., was sleepy with a possible fever the day after the 1st Moderna COVID-19 vaccine which was administered on 5/5/2021. On 6/2/2021 she received the 2nd Moderna dose. The following morning, 6/3/2021, at 7am she was awaken by her daughter and had a fever of 101 degrees F, began vomiting shortly after and whole body was shaking. Ambulance was called and transported her to Hospital ER where she was admitted. Several tests were performed. Diagnosed with a UTI, treated and released on 6/7/2021 to Rehab center for therapy for 3-6 weeks.

ER HPI: 82 y.o. female who presents with altered mental status. Patient is transported to ED via EMS from local nursing home because of increased confusion. Patient is unable to give any pertinent history. DX: Cerebral infarction due to embolism of cerebral artery

"Patient with seizure this am during 1 assist transfer, resident passed out, lowered to shower chair next resident with incontinent episode and was sent to Emergency Department emergently and currently under evaluation with possible admission. "

Patients states within 12 hours of vaccine administration she had urinary incontinence and butterfly rash developing into full facial rash and ear flushing. Incontinence resolved after 10 hours and facial flushing continues to improve 2 days later. Other more common symptoms included myalgias and fatigue. NO oral swelling/symptoms or difficulty swallowing

Patient noticed what appeared to be severe rash mostly on lower extremities (legs). It did not itch and she is not sure the onset except that it appeared sometime after her Moderna vaccine (only had one shot). She ended up at Emergency Department per her doctor's orders and was diagnosed with thrombocytopenia (platelets 130). They also found stage three kidney failure. She was not aware of these conditions prior to vaccine although it sounds like there were prior labs suggesting some issues. She was advised to not get the second vaccine as it could potentially further lower platelets. Apparently, other pts have been in their hospital with severe platelet issue post second Moderna vaccine.

Stage 4 kidney failure; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stage four renal failure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011L20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was diagnosed with Stage-4 Kidney Failure. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The relatedness of the event (Kidney Failure) to the suspect drug is unknown. At the time of this report, the outcome of the event reported (Stage-4 Kidney Failure) was not resolved.; Reporter's Comments: This case concerns a 83-year-old, female patient, who experienced stage four renal failure. Very limited information regarding this event/s has been provided at this time. Further information has been requested.

3/5/21 emergency roomHPI 83 y.o. female who presents with Complaints of nose bleed reports that she had a nose bleed this ongoing now for the past hour she could not stop at home and came for help she reports her symptoms are mild-to-moderate better with putting pressure on her nose worse without pressure denies any injury FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Hypertensive urgency I16.0 401.9 2. Epistaxis R04.0 784.7 2/22/21 Emergency room HPI 83 y.o. female who presents with SHORTNESS OF BREATH ONSET BEFORE ARRIVAL. EMS GAVE PT A DUONEB AND NOW SHE STATES SHE FEELS FINE. DAUGHTER STATES THAT PT HAD A YELLOW STOOL YESTERDAY. PT STATES THE SHORTNESS OF BREATH IS WORSE WITH LAYING FLAT. NO OTHER EXACERBATING FACTORS. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Acute urinary tract infection N39.0 599.0 2. Shortness of breath R06.02 786.05

Fever 101, chills, tiredness, urinary incontinence Went to ER early morning of 3rd day 3/6, ,given 1000 mg. ascetaminaphen, urine culture taken, blood work done, CT scan. Stayed there only about 2 hrs. and released 3/6

My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th.

The morning after her shot she felt unwell and did not get up for any meals. She said she couldn't lift her legs and she could not tell when she had to go to the bathroom. Prior to this shot she was able to walk with a walker ; she knew when she had to go to the bathroom and she got up by herself in the morning and knew what her routine was. Now she is unable to walk and is totally incontinent. She does not know her routine anymore and is waiting for directions from her caretakers on when to get up, when to go to the bathroom and sits in bed all day or is moved to a chair by caretakers. She needs pillows propped around her in order to sit upright.

Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI

This 83 year old female received the vaccine on 2/26/21 and went to the ED on 4/22/21 and was admitted with Thrombocytopenia, acute renal failure, fall with subdural hematoma, clavicle fracture, anemia, head injury, anascara, hyperkalemia and died on 4/27/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Started not able to eat or drink, then started throwing up and not sble to keep anything down. Then had diarrhea somewhat also had a headache. Then wasn't voiding at all either one. Turned into kidney failure. Shut down her kidneys.

I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.

2:15 - Altered mental status, responsive to verbal, c/o and pain and "indigestion" 2:16 - Loss of consciousness & urinary incontinence, EMS activated 2:17 - Transported via wheelchair to treatment room 2:20 - A&O x 3, EKG (Normal sinus rhythm) 2:25 - EMS on scene, Patient signed Against Medical Advise form. EMS released patient to friend to be transported home via POV

2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m.. Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member. Family member says she was out for about 10 min and then came around. The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath. Patient has not been eating or drinking because she has and lost some. Has some food after this episode but was brought in because of continued dizziness. 3/15/21 84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival. Patient states she has mobility issues and normally uses a walker but she did not. Patient is on home oxygen. Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke. She does have a pacemaker. Patient denies any other injuries..

During the last month she was losing weight, reflux due to having PEG, low blood pressure, lack of tension. They notified relatives and hospice, she lost mobility, stopped urinating. Respiratory cardiac arrest and end-stage Alzheimer's certified

MODERNA COVID-19 Vaccine EUA Patient received first dose of Moderna COVID vaccine on 1/20/2021, presented to Emergency Department on 1/29/2021 with complaints of left-sided chest pain below her breast, with an onset 1/26/2021. In ED diagnosed with Pulmonary Emboli in lower branches of left lung, and a urinary tract infection. Pulmonary Embolism diagnosed with CTA of Chest. Patient treated with Apixiban 10 mg BID with anticipated duration of therapy for at least 6 months. Patient subsequently received second dose of Moderna COVID vaccine on 2/26/2021

Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing quite well between mid December and mid January. Patient was hospitalized with congestive heart failure in late January 2021. Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date). Patient was feeling well at that time. Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021. Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease. Congestive heart failure rapidly worsened and previously stable leukemia flared up. Patient was discharged from hospital February 19 and was placed in quarantine at Care Center. Patient was considered terminal and was to go into hospice care. Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.

Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen levels went down, she sweated profusely, her eyes were rolling out, she was also congested and had gurgling sounds and started foaming at the mouth. Hospice care and Medical workers came through to help. X-rays were performed along CT scans of the brain and lungs at Hospital. X-rays of the chest showed ammonia and with lab work performed showed she also had an UTI infection. A Covid test was done which was negative. She was given Tylenol at Hospice Care. After her second dose she also went through the same symptoms but overall is doing well now and is stabilized.

Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen. COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI. Pt recovered and ultimately was discharged on 5/11 with followup.

Patient received both doses of COVID Moderna vaccine (2/13/21 and 3/13/21). She presented to the ER on 7/7/21 after a fall at home. She was noted to have altered mental status/confusion and claimed she was dizzy. CT brain was negative, as well as chest X-ray and pelvic X-rays (also negative). Pt was tested for COVID per protocol, and was found to be positive on 7/7/21, despite being fully vaccinated and being asymptomatic. Patient was admitted for Neuro work-up and was started on ceftriaxone for presumed UTI. COVID treatment has not bee started since pt is asymptomatic and is not hypoxic.

Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine. She has red and itchy bumps. She saw a primary care doctor who diagnosed scabies. She was treated medically and it did not work. She saw a dermatologist who twice biopsied. A skin inflammation was diagnosed and Sarna was advised. Her primary care doctor prescribed prednisone: it made her puffy but did not help much. Her primary care doctor gave her a sulfa antibiotic and she completed it without benefit. She has an ointment to mix with Sarna and it helps. She cannot sleep. She has used Zyrtec: it does help her to sleep but nothing else. Allegra did not help. Individual lesions can last a week at a time. She has a history of ?swellings? of her bones. She has had problems of her knees and heels. She has had injections of her knees, shoulders and heels. Her fingers sometimes hurt, and they have been injected. She denies any other swellings. She started Edarbyclor and Bystolic last year. She started Diltiazem in March or May. Baby aspirin was started in the early 2000s. Simvastatin in about 2003. She recently completed a week of sulfamethoxazole-trimethoprim.

urinary retention, hypertensive urgency, went to ER and was told it was probably not related to the vaccine.

Patients husband called office on February 3rd wanted to let us know his wife was in the hospital and my not be out to get her 2nd Moderna COVID-19 vaccine on Monday February 8th. I talked with the husband briefly about why his wife was hospitalized. He reported she got sick 2 days after getting her first COVID-19 vaccine. He states she had pneumonia, had a urinary tract infection and had to have a heart catherization with stent placement. We moved her second vaccine appointment to February 17th. The spouse came in on February 8th for his 2nd dose. He told me the doctors did not believe his wife's hospitalization was related to the first COVID vaccine and he said the doctor's told him that she needed her 2nd dose.

Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and loss of appetite post vaccine. Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home. Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21. In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated. Patient was sent back to ED for further evaluation. Patient admitted and consults made to Hematology and GI. Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced. Acute renal failure present on admission resolved with IVF. Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim. CBC improved and patient was discharged to follow up with heme/onc. Her methotrexate and eliquis was held.

paralysis, hallucinations, lack of speech, no bowel control, slept for 2 days straight, no mental reasoning or control of bodily functions

On 2/22/2021 My mom felt very tired. On 2/23 EMS was called at 530 am to report that my mom could not walk or stand. My mother is not incontinence but she had urinate her bed. EMS took her to ER they kept her for 24 hrs released her on 2/24/2021 around 2:00 pm. still could not stand right. On 2/30/2021 EMS called again patient could no longer stand went back to ER there until moved on to Rehab on 2/24/2021. Her Dr reported to the family place her for couple of weeks to get her strong. Patient is still no longer walking.

Generalized weakness to the extent she could not walk unassisted or speak clearly. Fatigue Incontinence (perhaps as result of weakness and fatigue) bowel and bladder not usual in this individual.

I woke up on 3/02/21 totally incontinent. I could not control my urine. The flow was bright red, filled with blood. I called my healthcare provider and the doctor at that clinic gave me a urine test. He found nothing. There was no pain, only blood for about six bouts of irination. He sent out to a clinic and they said I had an infection caused by E-coli. (The vaccine had obvioiusly lowered my resistance to infection because I had none before at all.) Also, he found that I was in heart failure - about 30% function. They recommended I be hospitalized. My daughter and I drove back to my home state and primary care physician, who concurred. I was hospitalized for heart failure at the hospital in my home state. This was the first time ever my heart had been compromised. I have now to see a cardiologist, take meds, and do cardio rehab. They found my heart was enlarged and I had fluid build-up around my heart also.

AKI (acute kidney injury) Hyponatremia NSTEMI (non-ST elevated myocardial infarction) ABDOMINAL PAIN VOMITING DIARRHEA NAUSEA

Patient presented to the emergency department with weakness, was found to have acute rhabdomyolysis and acute renal failure with generalized muscle aches and pains all 4 extremities.

Incontinent upon awaking 3/02/21. Blood in urine (quite a bit). Called out-of-state clinic, had tests: showed heart failure (20-25% of heart function), E-coli urinary tract infection. Told to enter the hospital.

2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme confusion and weakness in arms and legs. unable to do usual daily activities. unable to self-transfer. Taken to ER and diagnosed with UTI. 2.18 - resident complained of headache and being unable to sleep previous night. VS: temp 101.8; BP:135/63; P:93; R:20; SP02:79-80%; HOB elevated. Resident send to ER via ambulance. Diagnosed with pneumonia. hospitalized for 5 days.

Sudden presentation of Ecoli bladder infection with numerous clotting and emergency catheterization. Have not had prior UTIs that I am aware of. Urologist doesn't see any possible correlation but I am now on a third round of antibiotics. Three days after my second shot on 3/12/2021 bleeding again started so now am now back on antibiotics.

See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she was taken to the hospital. She died in the hospital due to kidney and heart failure.

She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on the 19th of Feb and I did not get a call back. She was sick to her stomach, really tired and lost her appetite. On the 22nd I called her doctor again... no response, on the 23 I called again. On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her. They are suppose to call me, my mom could not remember by the time she would hang up. They said to let her rest and give her electrolytes and Vit. B6. On the 26th when I called the doctor and said she is lethargic they said to take her to the ER. She flat lined at the hospital and her body went into shock. She ended up having Kidney, Heart and Liver Failure. She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th. She died on March 5th.

Fatigue, hypersomnolence, gait instability, anorexia, apathy, urinary urgency/incontinence, "brain fog"

This 86 year old black female received the Covid shot on 1/20/21 and went to the ED on 2/20/21 and was admitted on 2/2/21 with the diagnoses listed below. D69.6 - Thrombocytopenia, unspecified J12.82 - Pneumonia due to Coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified

Encephalopathy; Non-convulsive focal status epilepticus; visual hallucinations; acute confusion; left frontal headache; urinary tract infection; This case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diastolic dysfunction, Type 2 diabetes mellitus, Phacoemulsification and Lens implant. Concurrent medical conditions included Chronic kidney disease stage 3, Glaucoma and Cataracts. Concomitant products included PREDNISOLONE for an unknown indication. 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 ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization prolonged and medically significant), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus) (seriousness criteria hospitalization prolonged and medically significant), HALLUCINATION, VISUAL (visual hallucinations) (seriousness criteria hospitalization prolonged and medically significant), CONFUSIONAL STATE (acute confusion) (seriousness criterion hospitalization prolonged), HEADACHE (left frontal headache) (seriousness criterion hospitalization prolonged) and URINARY TRACT INFECTION (urinary tract infection). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CONFUSIONAL STATE, ENCEPHALOPATHY, HALLUCINATION, VISUAL, HEADACHE and STATUS EPILEPTICUS. The patient was treated with CEFALEXIN MONOHYDRATE (CEPHALEXIN [CEFALEXIN MONOHYDRATE]) for Urinary tract infection, at an unspecified dose and frequency; CEFTRIAXONE for Adverse event, at an unspecified dose and frequency; LORAZEPAM for Adverse event, at an unspecified dose and frequency and FOSPHENYTOIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion), HEADACHE (left frontal headache) and URINARY TRACT INFECTION (urinary tract infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: negative (Negative) Negative. In 2021, Blood folate: normal (normal) normal. In 2021, Blood gases: normal (normal) unremarkable. In 2021, Blood glucose: high (High) 394 mg/dL with an osmolality of 308 mOsm/kg.. In 2021, Blood thyroid stimulating hormone: normal (normal) normal. In 2021, C-reactive protein: borderline (Borderline) 1.2 mg/dL and high (High) 4.0 mg/dL. In 2021, CSF culture: negative (Negative) Negative. In 2021, CSF test: negative (Negative) meningitis/encephalitis panel NAAT, oligoclonal bands and Lyme antibody were negative except for West Nile virus IgG but no IgM antibodies with minimal protein elevation. In 2021, Chest X-ray: normal (normal) unremarkable. In 2021, Computerised tomogram: normal (normal) no acute findings. In 2021, Culture urine: negative (Negative) Negative. In 2021, Electroencephalogram: abnormal (abnormal) non-convulsive focal status epilepticus. In 2021, Magnetic resonance imaging head: normal (normal) with and without contrast showed no acute findings.. In 2021, Metabolic function test: normal (normal) normal. In 2021, Physical examination: abnormal (abnormal) Word finding difficulties and slow mentation. however, no focal neurological deficits noted. No suprapubic, abdominal nor costovertebral pain was noted.. In 2021, Procalcitonin: borderline (Borderline) 0.14 ng/ml. In 2021, Red blood cell sedimentation rate: high (High) 107 mm/hr. In 2021, Respiratory tract infection: normal (normal) normal. In 2021, SARS-CoV-2 test: normal (normal) normal. In 2021, Treponema test: negative (Negative) Negative. In 2021, Urine analysis: negative (Negative) Negative. In 2021, Vital signs measurement: borderline (Borderline) Body temperature: afebrile, Pulse 61, respiratory rate 20, oxygen saturation 99% on room air Blood pressure 150-170/66-75. In 2021, Vitamin B1: normal (normal) normal. In 2021, Vitamin B12: elevated (High) above 2000 pg/mL. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) to be possibly related. No further causality assessment was provided for URINARY TRACT INFECTION (urinary tract infection). Patient was at baseline neurological function. Patient had no evidence of cognitive dysfunction at baseline and no known neurological or psychiatric history. Patient had never used tobacco, alcohol nor any other illicit drugs. Their was no evidence of giant cell arteritis. Patient had no family history of seizures. Patient was seen in outpatient neurology clinic one month post hospitalization with baseline neurological status. Patient also reported she received 2nd Moderna vaccine 2 weeks post hospitalization and only experienced local injection soreness. 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 is a literature case. This case was linked to MOD-2021-256855, MOD-2021-256858 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is a literature case.

After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid response was called and pt was sent to emergency room for further workup.

On Saturday while getting your night medicines from the shelf, and started feeling dizzy, tried to reach the shelf and said to herself that "i can't do it, I just can't do it". She staggered back and sat down on a towel hamper and apparently fell off of that onto the floor, lost kidney function. Tried to get up and managed to get her phone out and called her husband (he's hard of hearing - was downstairs). She said when he got there her head was towards the bathroom door and felt that he could not get in and could not get her up so she tried to get up. She did not have any strength. Finally she got up to get on her elbow and crawled into the vanity area and raised up and pulled herself up. She did not enough strength to walk to the bed. She got to the bed and then started with chills, turned on her electric blanket. She felt better Sunday, 1/7/21, and is real shaky today. She feels a little stronger but is not back to where she wants to be. Yesterday evening she felt her arm itching a little bit, and looked at it and it was swollen and red, and had an area about the size of her hand. Her husband felt of it and said that he felt she had fever in it. The arm was sore to touch. It is itching a little bit this morning. She had a headache for a couple of days as well, took a Tylenol one night and her head felt real weird. It was not real severe, and it hurt more times than it did others. It would come and go. Has not taken anything else for these symptoms. Her husband checked her BP, Friday was 108/62, and last night 106/67.

Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death

blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs. Treatment details were unknown. Action taken with mRNA-1273 was unknown. The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 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.

Approx onset 24 hrs after vaccination w/ weakness in legs and generalized malaise/myalgia, fell and diminished ability to ambulate -- > approx. 48 hrs after vacc was brought by EMS to ED for evaluation (2/19). Admitted to hospitalist service w/generalized weakness/ambulatory arrest, developed new onset urinary retention night of admission requiring straight cath intermittent. Increased weakness of leg, progressed to right arm/leg weakness > left leg weakness, so TELENEURO Consult initiated, hMRI w/o gado (2/21) checked, no CVA; recommendation for possible LP and EMG. Progressed to apparent areflexia ; seen by NEURO consult onsite (2/23) -- > felt to toxic encephalopathy due to COVID vaccination, motor predominant and detrusor involvement. Bladder atony resolved completely over approx. 3-4 days. Leg strength recovered somewhat over 4-5 days, and patient was referred for SNF rehab discharge. Developed low grade fever and pyuria on 2/24, urine cx grew ecoli ; initially treated with empiric ceftriaxone. Then patient developed left elbow and left knee pain/erythema/edema/tenderness (2/25) and was seen by ID in consultation. Got vancomycin empiric, and had aspiration of left knee joint effusion, revealing no crystals, 500cells monocyte predominant consistent with pseudogout. Vanco d/c'd; NSAIDs contraindicated for frail elder so patient was treated with prednisone short course. Ceftriaxone iv transitioned to po Keflex for ecoli uti to complete 7d course. Patient was discharged to SNF for rehab

great fatigue and then weakness (2 days) Head feels full (1 day), Lower abdomen tenderness, urinary frequency, less tenderness the next day on the next , No fever at all,

09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this past Friday. For the previous 2 to 3 days she has had increasing fatigue and generalized weakness. Anorexia and nausea have been noted as well. Apparently has not been eating or drinking well at all. No vomiting or diarrhea. No new medication recently. No fever or chills. Patient was seen and evaluated in the ER tonight by the ER physician. Significant acute renal failure was noted. Urinalysis was unrevealing. Mild hyperkalemia and moderate metabolic acidosis were noted as well. Initial treatment in the emergency room included a 1 L bolus of normal saline and antiemetic therapy. The hospitalist service was then consulted for admission." Discharge Summary Written 20MAR2021-Patient was admitted and started on IV fluids. Nephrology was consulted. She was started on a bicarb drip for metabolic acidosis. Renal US was negative for hydronephrosis but with incidental biliary ductal dilatation which was stable compared to a previous imaging study in 2011. Unfortunately her renal function continued to worsen and require dialysis. She had a temporary dialysis catheter placed on 3/12. She had RRT started on 3/12 and again on 3/13. Her urine output, electrolytes, and azotemia started to improve slowly. Renal function continued to improve and she no longer required any RRT. Her temporary dialysis catheter was removed on 3/19. Her Foley catheter was also removed on 3/19 and she was urinating well prior to discharge. She will go home with oral Lasix. Patient felt much improved and is agreeable for discharge on this date- 20MAR2021 Second Admission- 02APR2021-05APR2021- INDICATION FOR ADMISSION: This is an 87-year-old female with history of COPD, hypertension, and chronic lung disease, who presented to the Emergency Department on April 2, 2021 with a chief complaint of shortness of breath.. Three days prior to this admission the patient had increasing shortness of breath. The patient also had a nonproductive cough but denied any fever or chills. The patient was started on IV Lasix and IV steroids in the ED. She also had elevated BNP. She was admitted to the hospital for further medical management. Discharge Summary Written 05APR2021- She was started on IV steroids, IV Lasix, nebulization, and she was monitored closely. The patient also had HGB dropping to 8.8 from 11.3 back in March 2021. The patient was started on proton pump inhibitor. Gastroenterology and cardiology eventually were consulted to see the patient. She did have an EGD done at this time which showed gastritis. She will continue Protonix for now. She was started on IV Lasix and she improved with the treatment. Now she remains on room air. She denied any respiratory issue. Her renal function still remains at baseline. Today creatinine is 1.5. The patient can be discharged home today and continue oral Lasix at home daily for now. She was instructed to follow up with her primary care physician and also her cardiologist as outpatient in 1 to 2 weeks.

urinary tract infection; passed out; foggy; missed her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urinary tract infection (She was given some medication and has significantly improved with her urinary tract infection.) on 05-Apr-2021. Concurrent medical conditions included Stomach cancer. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (foggy) and PRODUCT DOSE OMISSION ISSUE (missed her second dose). On 05-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed her second dose) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) was resolving and FEELING ABNORMAL (foggy) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Her doctor and oncologist have told her to get the vaccine 1 week from today. 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.

Patient had an undiagnosed/unknown UTI at the time of her second vaccine on 3/2/21. She was admitted to Hospital on 3/3/21 with organ failure; she passed away on 3/5/21. Her cause of death is listed as Sepsis, and UTI. The vaccine was not listed as a cause of death, but might have been a "tipping point" in her inability to recover with antibiotic treatment.

patient was unconscious; patient was unconscious; UTI; Bedridden; Patient began to vomit; This case was received via FDA VAERS (Reference number: 0967119) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Syncope (granddaughter states patient has episodes of syncope) and Wheelchair user. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient was unconscious) (seriousness criterion medically significant) and SYNCOPE (patient was unconscious) (seriousness criterion medically significant). 22-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit). At the time of the report, LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) had resolved and URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After administration, the patient remained in waiting area for the recommended 15 minutes observation time. Approximately 20 minutes after vaccination, patient was unconscious and appeared not to be breathing, but pulse was palpable. Pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. The patient quickly regained consciousness, spoke to family, said she did not feel well. Emergency medical services (ems) arrived. The patient began to vomit, was placed on stretcher and left with ems. A few hours later the granddaughter reported that the patient had a urinary tract infection (UTI) and physical exam by emergency room (ER) attributed her experience to untreated infection.; 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. Vomiting is consistent with event safety profile.

Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died.

She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, emesis,and fatigue. She was sent to ER @ Hospital. Continues with confusion and weakness as of 3/4/2021.

3/13/21 ER HPI -> transferred to hospital 88 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. Apparently, the patient has a 2 day history of intractable nausea and vomiting. She states she has vomited more than 5 times over the last 2 days. She has become more and more weak. She states she has been having coffee-ground emesis. No definite fever. The patient had a similar episode to this a few months ago. The patient does take nightly ibuprofen. She also take iron on a daily basis because of chronic anemia. She is not on any blood thinners. When the patient did get to the ER she had an episode of vomiting and it did appear coffee-ground. She is having a little bit of epigastric abdominal pain. No history of GI bleed in the past 3/16 note from Hospital Hospital Course: 88 y.o. female with a past history significant for hypertension, renal artery stenosis, arthritis, skin cancer presented to hospital with nausea/vomiting and transferred to another hospital on 3/13/2021 for GI evaluation. Patient developed coffee ground emesis and had NG tube placed, yielding 1800 cc of coffee-ground emesis. She was also noted to be hypertensive. A CT done at the outside hospital revealed a large hiatal hernia with a significantly distended herniated portion of the stomach and a portion in the left upper quadrant compatible with a gastric outlet obstruction. Transferred to another hospital and GI consulted. Underwent EGD on 3/14 with results as noted below. Recommended to continue PPI, avoid NSAIDs if possible and repeat EGD in 8 weeks as outpatient. NG-tube removed and tolerated diet. No further bleeding noted. Hgb remained stable. Medically stable for discharge. Counseled on medication use and diet. Patient or daughter had no further questions or concerns on discharge.

5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked "ashen". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.

3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed

Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.

Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.

pt stated after she got her vaccine she had to use the bathroom right away. she went home and went to straight to the bathroom. When she urinated it was dark gold color. She thinks the vax medicine went straight to her kidneys. She has urinated since this episode and said her urine was back to normal. Pt has not contacted her PCP at this time since he urine returned to normal color.

Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia). The patient's medical history included Parkinson's Disease. On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection. Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli. The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 °F (36.7 °C) Height: 5' 8" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM

Patient's daughter states worsening dementia and bladder control. Patient can normally care for herself, but peed her pants more than once between 3/13 and 3/15. Unable to remember to take her medications by herself. Unable to cook for herself. Seems to be letting up as time has passed. Patient's daughter is taking her to see her primary care provider.

The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence and her daughter told her to rest and then she insisted on getting into the shower because she was upset about the incontinence 9:15 am she had gotten in the shower and her other daughter was close by when she had bowel and urine incontinence again and then lost consciousness and then she came to and had bowel and urine incontinence for a 3rd time. The bowel movements were massive diarrhea. Reporter believes she had a TIA event (Mini stroke). She was cared for at home by her daughter who is a nurse. In the past, when she has high fever and chills she tends to have TIA events.

Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; 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. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high

Died in the hospital. Was admitted due to respiratory problems, had urinary tract infection, had complications with medications administered at the hospital ( did not specified which ones).