Moderna

I began to feel very tired and weak the same day slept through the night and all day the next day And all night the second night till 10 o?clock in the morning on the 13th. Within 12 hours my kidneys were working overtime I was running to the bathroom constantly. Couldn?t hold It at all. Made me incontinent for at least 24 hours up three or four times to go to the bathroom. Lack of appetite. Arm is aching at site of injection and a little red.

Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.

extreme weakness, shaking extremities, diarrhea, loss of bowel/bladder control, mental disorientation, unable to walk

sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; 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.

Hallucinating; Urinary tract infection; A spontaneous report was received on 22 Feb 2021 from a consumer concerning a 90-year-old female patient who received Moderna's COVID-19 vaccine and developed a medically important event of hallucinations, and in addition urinary tract infection. The patient medical history was not provided. Relevant concomitant medications provided included acetylsalicylic acid, vitamin d3, unspecified vitamin b12 , donepezil hydrochloride, levothyroxine, melatonin, omeprazole, permethrin and hydrocortisone. The patient received their first of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 032L20A) on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 12 Feb 2021, patient received their second of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 013M20A) in the left arm for the prophylaxis of COVID-19 infection. On 20 Feb 2021, in 9 days of receiving vaccine, patient started hallucinating, and has urinary tract infection manifested by an odor and painful urination. Treatment for events were not provided. Patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable. The outcome of the events, hallucinations, urinary tract infection, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

3/12/2021 Presented to the hospital with altered mental status, and was ultimately diagnosed with a urinary tract infection. The patient was admitted for IV antibiotics with resolution of the patient's mental status.

Caused extreme dehydration. 3 days after shot her Kinsey?s went into failure and she never recovered despite all the efforts of the doctors / staff. She was never advised not to get shot if she had kidney issues. She diesels eight days after getting shot

As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak.

Swelling and confusion advised to the ed call 911 Sister calls for 91 year old sister that caretaker called and stated patient more confused today and is swollen face arms legs abdomen. advised to call 911. sister had little info , list given of information needed to complete adverse event chart Taken to Hospital, diagnosed with a UTI, on antibiotics. Feeling much better an symptoms resolving per sister. Taken to Hospital, diagnosed with a UTI, on antibiotics. Feeling much better an symptoms resolving per sister.

severe diarrhea; Two urinary track infections; severe vomiting; Second dose was given more than 36 days apart from first dose; Minerals were very low; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low) and VOMITING (severe vomiting) in a 91-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 information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Two urinary track infections) (seriousness criterion hospitalization), MINERAL DEFICIENCY (Minerals were very low) (seriousness criterion hospitalization) and VOMITING (severe vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose). The patient was hospitalized on 19-Mar-2021 due to DIARRHOEA, URINARY TRACT INFECTION and VOMITING. The patient was treated with Rehabilitation therapy for Diarrhoea; Rehabilitation therapy for Urinary tract infection; Rehabilitation therapy for Mineral deficiency and Rehabilitation therapy for Vomiting. At the time of the report, DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low), VOMITING (severe vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood electrolytes: severely (Low) severely. Patient called in to report an adverse event on behalf of her mother. Mother received the Moderna COVID 19 vaccine 2 dose series on 6 February and 18 March (left arm). On March 19 patient suffered from severe vomiting and diarrhea which led her to have 2 different urinary tract infections. Additionally, her minerals and electrolytes were very low. Patient was hospitalized as a result of this on March 19th. She was currently in rehabilitation. Patient has gone through IV antibiotics, oral antibiotics, and IV electrolyte supplements. Treatment medications included: IV antibiotics, oral antibiotics, and IV electrolyte supplements. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics

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

Patient was not tested for COVID prior to the vaccine; one month after being fully vaccinated, the patient was admitted for pneumonia, altered mental status and reduction in ability to do ADLs. Upon admission, the patient was tested using the Abbott-ID NOW rapid COVID test and patient tested positive on 04/04/2021. Patient clinical presentation consistent with COVID per lung changes on chest x-ray and symptoms, positive for UTI.

Patient presented to the ED and was subsequently hospitalized on 3/18/21 with atrial fibrillation. On 4/1/21 patient had their second dose of Moderna. On 4/9/21 patient was hospitalized for paroxysmal atrial fibrillation. On 4/12/21 Patient presented to the ED and was subsequently hospitalized again for atrial fibrillation. On 4/18/21 Patient presented to the ED and was subsequently hospitalized for acute cystitis. These visits were all within 6 weeks of receiving COVID vaccinations.

Pt had a sudden severe escalation in hepatic and renal function testing within 1wk of receiving vaccine dose #1.

Total disorientation, fatigue and not moving, used bathroom in bed peed and pooped on herself, chills, slight fever, extremely nausea, vomiting and 24 hours later diarrhea.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt was not responding well, urinated on self and felt nauseas. Pt is on hospice and felt dizzy even before the vaccine.-Mild, Systemic: Nausea-Mild, Additional Details: Pt was dizzy and fell 02/21/21 at the site; paramedics called; refused to be hospitalized. Pt vaccinated 02/22/21, was dizzy and urinated on self, paramedics called, refused to be hospitalized. Staff told vaccinators then that pt was hospice and own guardian, so nothing could be done.

pneumonia; urinary tract infection (UTI); talking nonsense and not being clear; The reason the patient did not have the second dose one month from the first dose is because she got ill; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)) and COMMUNICATION DISORDER (talking nonsense and not being clear) in a 94-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 No adverse event (No medication history was provided). Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD), CLOPIDOGREL and DULOXETINE for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN 81). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (urinary tract infection (UTI)) (seriousness criterion hospitalization), COMMUNICATION DISORDER (talking nonsense and not being clear) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill). At the time of the report, PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)), COMMUNICATION DISORDER (talking nonsense and not being clear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. While hospitalized she was diagnosed and treated for a UTI, with intravenous fluids and antibiotics. Patient was discharged from the hospital with Foley's catheter and rehabilitation was advised. While hospitalized she was due for her second dose but she got pneumonia, so she was not given the second dose. The reporter assumes the pneumonia was bacterial, because the patient was treated with antibiotics. Very limited information regarding the events has been provided. Further information was requested.; Sender's Comments: Very limited information regarding the events has been provided. Further information was requested.

Large unusual swelling with non puss pinnacle and black subdermal discoloration. Very dark yellow urine. Itchy non painful swelling on top of left shoulder. Never had anything like this before.

About an hour after receiving her 2nd dose, she went to a restaurant and ordered her favorite shredded beef burrito. After only a few bites, she experienced non-stop "burping" and swallowing any liquid became impossible. We were at a useless ER hospital from 2-6 pm when they finally saw her and said they did NOT have any means of looking down her throat. Long story short -- the next day I drove her to another Hospital. We were there from 2-8 p.m. The Dr. removed a bolus at 7:15 p.m. - 7:45 p.m. and he said "everything looks good". HOWEVER -- my mom continued having "esophagus" issues from that time on. And ALSO, on April 4, she told me, "I don't feel good" and she proceeded to fall asleep on her couch and did NOT WAKE UP for about 6 weeks except to use the bathroom, take her morning and evening pills and eat a tiny bit of soft foods. I can't think of any other reason for this bizarre "sleeping" except for that 2nd Covid shot. I've taken her tour GP 2 times since then and all blood work comes back normal. And a few visits to the ER within the last 3 months only showed she's had another UTI within 6 weeks and her swollen lower legs/feet can only be cured with lack of gravity. Weeks ago I took her to her annual checkup with her heart doctor and he said her blood pressure was on track. So as of today, I am waiting a call-back from hospice to see if I can get someone to help me with her bathing, etc. at home. Just wanted to tell somebody that since her second dose of Moderna Covid vaccine, it's been downhill for her and it's hard for me to believe the cause can be anything other than that 2nd vaccine.

Resident became hypoxic and supplemental oxygen did not bring oxygen saturation up to normal levels. The physician ordered resident be sent to the emergency room for evaluation.

Pt. received first dose of Moderna without incident. Received second dose on 6/8 and experienced extensive weakness. Son describes significant decline in cognitive function over the next ten days, as pt. became increasingly altered. She also switched from using a mix of language to communicate to only being able to use one. Pt. also became incontinent of stool and urine during this period. Pt. proceeded to have significant fall on 6/10. She was ultimately BIBA to the ED on 6/19 with concerns for altered mental status and failure to thrive. She was found to have a significant saccular aneurysm of the descending thoracic aorta. Ultimate outcome of aneurysm is still pending, as this is a life-threatening disorder.

Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.

Resident complained of feeling "hot" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021

03/15/2021: Presented to the emergency department with shortness of breath and not feeling well. The patient was admitted with pulmonary vascular congestion on imaging and UTI. The patient is currently still admitted.

Pt. had hx of SOB prior to vaccination and Dx with hear failure Woke up day after vaccination with being very tired. Admitted to hospital with UTI, Sepsis

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

3 days ago patient was started on Cipro for a UTI. Patient received the ModernaCOVID vaccine 2 days ago. The past 48 hours patient has had increased confusion, decreased p.o. intake. Patient was sent to emergency room for evaluation. Patient was found to have a low sodium, 112, high potassium 6.9 with corresponding EKG changes. Patient was bradycardic with a rate between 30 and 40. Patient was also found to be in acute renal failure with a creatinine of 5.6. In ER pt was confused, unable to tolerate PO fluids. Due to severity of illness patient's family has elected to avoid aggressive medical care. Patient has poor prognosis. Patient was returned to nursing home for comfort care only.

in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI). The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.

Presented to emergency room for symptoms of urinary tract infection and was found to be positive for COVID19 during screening for hospital admission on 2/4/21. Patient did not experience any symptoms relating to COVID during hospitalization. An additional COVID test was ordered on 2/7/21 as patient did not have symptoms and was also positive. Patient was hospitalized from 2/3/21 to 2/15/21 for urinary tract infection.