Moderna

Patient seen by physician for weakness, tired, increase SOB, falls, increase confusion and then subsequently hospitalized . Patient then expired on 3/7/21.

He came home, laid down and went to sleep and slept all day long. He had incontinence or urine, and could not put any weight on his legs, could not stand on his own and confused about what was going on. His wife was able to get him up after pulling and tugging on him, and mentally confused. He was able to go to the bathroom, and got him back to bed. He had a urinary accident and slept until the evening. She could tell he was better and walked with a walker. She said the symptoms resembled a stroke, but he got better. He did not take anything, did not want anything for the symptoms. She does not think that he ate anything that night. He says that he's fine now.

Received Moderna Vaccine 1st dose on 2/24/2021. Went for a cystoscopy and biopsy on 3/8/2021. On 3/9/2021 was sent to the ER and admitted for acute renal failure, UTI, and dehydration.

Acute renal failure; Dehydration; Urinary tract infection; A spontaneous report was received from a nurse concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed acute renal failure/acute kidney injury, urinary tract infection, dehydration and vaccine administered intramuscularly in the right thigh. Medical history or concomitant medications were not reported. On 24 Feb 2021, the patient received his first planned dose of mRNA-1273 (batch number: 029K20A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection. On 08 Mar 2021, he went for cystoscopy and bioscopy with unknown results. On 09 Mar 21, he was sent to the ER for acute renal failure, dehydration and Urinary tract infection (UTI). He was admitted to the hospital. The events acute renal failure and urinary tract infection were considered to be medically significant. The action taken with mRNA-1273 in response to the acute renal failure, dehydration and Urinary tract infection was unknown. The outcome of the events acute renal failure, dehydration and Urinary tract infection was not provided. The outcome of the event, vaccine administered intramuscularly in the right thigh, was considered resolved on 24 Feb 2021. The reporter did not provide any causal relationship between mRNA-1273 and the events acute renal failure, dehydration and Urinary tract infection.; 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.

Urinary incontinence, weakness, loss of speech, loss of mobility (couldn't walk), fever for almost 12 hours. Still has loss of cognitive function from before the second shot almost 2 months after. Alzheimer's worsened. Needs more help around the house.

Patient admitted to Inpatient on 1/13/2021 after receiving vaccine on 1/6/2021. Diarrhea and dizziness. Since Sunday, corona vaccination last week. No headache, abdominal pain, nausea or vomiting, loss of taste or smell, muscle aches or general malaise. Patient was hypoxic at clinic visit, 84% on room air, transferred to ED for evaluation.

Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.

On 1/6/21, 91 yo M amb to ER with c/c of allergic reaction to COVID x 1 day. Pt receive COVID vaccine Moderna Jan 3, 2021. Pt c/o fever, n/v, lower back pain, SOB, dark colored urine. Jaundice noted to bilat sclera and generalized skin. Patient hospitalized and discharged on 1/17/21. Admitting diagnosis was pneumonia, hepatitis, acute repiratory failure with hypoxia and acture renal failure. Patient was treated for sepsis due to acute cholangitis and completed 10 day course of IV zosyn

Open 24 hours of receiving the vaccine, the patient was noted to be fatigued and increasingly confused. Had some response to IV fluids but within 72 hours became progressively hypertensive and transferred to hospital

Patient with severe muscle weakness with tremulousness 3 days post-vaccination, and subsequently patient developed new onset seizure like activity on 2/20/2021 around 3:30 pm requiring admission to the hospital for further evaluation and monitoring. All events occurred within the 14-day period post vaccination.

Hospitalized February 28, 2021 with acute cerebrovascular accident with left hemiparesis, 4 days after vaccine

48 hours diarrhea and weakness, unable to keep fluids down, admitted to hospital through ED for diarrhea, stool culture, IV fluids. Discharged after 4 days diagnosis gastroenteritis/norovirus, dehydration and hypokalemia

pt became confused a few days after receiving the vaccination. he began having hallucinations. family took him to ER on 1/19/21

Patient is a 93 y.o. male patient who originally presented to the hospital on 4/6/2021 due to generalized weakness. Patient found to have COVID infection as well as UTI. Patient was started on remdesivir and IV antibiotics. Patient did not requiring oxygen. Patient did have decreased appetite which did slightly improve upon discharge. Patient did not require oxygen throughout hospitalization. Clinically stable for discharge home. Will discharge on oral antibiotics to complete course of therapy. Advised to follow up with PCP as outpatient in 1-2 weeks.

Low Back Pain - Assessed by, PA on 1/19/2021 and treated for UTI with Doxycycline 100mg, po, bid X 10 days.

started having generalized weakness on 1/21/21, fatigued., nausea/vomiting. went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested. Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting. started on oxygen for sats of 87%. admitted on 1/25/21. On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated.

2/14 Emergency room HPI Patient is a 94 y.o. male who presents with complaint of cough that started about a week ago, and was seen by primary care provider on the 9th February 2021. Patient was started on Augmentin and has taken it for about 5 days but said the cough is worse and productive of clear sputum. Patient in ER to get checked for pneumonia. Patient denies a fever or chills, shortness of breath, chest pain, nausea vomiting and no headache or dizziness. Transferred to another facility h&pHistory of Present Illness: 94-year-old former smoker with a history of paroxysmal atrial fibrillation not currently on anticoagulation, coronary artery disease, insulin-dependent diabetes, CKD 4, prostate cancer on surveillance, TAVR 2/17, with a son who is a doctor and a caregiver who is a Radiology NP by his report, who presents in transfer from previous Hospital due to a large right pleural effusion. He has had a cough for some time now, but thinks it may have worsened, at least per his caregiver, over the last 4-5 days. He was seen by his PCP on February 9th and placed on Augmentin, but nothing changed. He himself denies being short of breath, having any chest pain, fevers, chills, sweats, change in appetite, abdominal pain, nausea, vomiting, dysuria, diarrhea. Of note, on a chest x-ray in June he had bilateral pleural effusions, and on an MRI in July to investigate a renal mass, he was noted to have a small right-sided pleural effusion. On arrival to facility this morning, he was afebrile, normotensive, had a normal heart rate, sometimes mildly bradycardic, normal respiratory rate and saturations of 97% on room air. Labs demonstrated chronic anemia and thrombocytopenia, stable stage 4 kidney disease creatinine of 2.6, BUN 64, glucose 187. Chest x-ray demonstrated a moderate right pleural effusion, noting that underlying consolidation cannot be excluded. He was also felt to have bibasilar atelectasis. CT of the chest without contrast showed a large right pleural effusion with most of the right lower lobe being collapsed. Superimposed infection could not be excluded. He had a small left pleural effusion with adjacent atelectasis and a small pericardial effusion as well. EKG and procalcitonin were not performed. He was sent to our facility for thoracentesis. On arrival here, vitals remained stable. His bedside RN informed me that upon returning from the bathroom, he appeared to be a bit dyspneic, but the patient himself denies any shortness of breath or ?huffing and puffing?. 2/25 admEd to hospital admission

low grade UTI; collapse; been kind of weak; A spontaneous report was received from a consumer, who was the caregiver of a 94-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI), collapse (syncope), and weak (asthenia). The patient's medical history was provided. Concomitant product use was not provided. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient was hospitalized for a UTI from 10 Feb 2021 to 12 Feb 2021. The reporter stated, "after that, he's been kind of weak and everything". The reporter indicated it was a "low grade" UTI and the patient didn't show any symptoms but then stated "it actually had him collapse and he did that in between the two vaccines and spent two days in the hospital." On 17 Feb 2021, the patient received his second of two planned doses of mRNA-1273 (batch number 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient received both planned doses of mRNA-1273; therefore, the action with mRNA-1273 in response to the events was not applicable. Treatment for the UTI included nitrofluorine. The outcome of the events 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 these events, a causal relationship cannot be excluded

He developed DRESS syndrome confirmed by labwork (elevated WBCs, elev eos, AKI, ) and biopsy (superficial and perivascular interstitial dermatitis with eosinophils) and clinically (diffuse rash, swollen face, multi morphologies - vasculitic, targetoid, erythema)

After second dose, individual became weaker and needed to use of cane to walk around. Became progressively weaker over course of a few weeks, then on May 14th had chest pressure, nausea, and dizziness. This continued, Wednesday May 19th complained of trouble breathing, shortness of breath, but felt better Friday, May 21st, until Saturday May 22nd at 6:00 AM individual complained of more severe chest pressure. Taken to hospital, determined heart attack and kidney failure.

Death Narrative: 95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported.

Patient states that he woke at 01:00AM on 03/02/2021 to go to the bathroom. He reports that he was unable to move his arms or legs and had to call out to his daughter to assist him. His daughter had to physically assist him with sitting up on the edge of his bed. Symptoms lasted approximately 15 minutes. When he regained use of his arms and legs he was unable to void or have a bowel movement. Patient states that his symptoms have resolved and that he currently reports feeling fatigued.

DEATH Narrative: PRIOR TO DEATH, spoke with pt's daughter and she reported that pt is unable to keep his appt for the second Covid vaccine appt because is sick today. Per daughter, pt has been lethargic, not enough sleep last night because of frequent urination at least every 30 to 45 minutes looks exhausted and with poor appetite. Pt has not been drinking fluids at least 6 to 8 glasses a day and daughjter tries to make sure pt drinks fluids, the best he can. Per daughter, pt's vitals signs are as follows: BP: 93/48mmhg PR: 93/min. Temp: 98.1 F and O2 sat: 95%.

Patient received both doses of the Moderna COVID vaccine on 02/02/2021 and 02/26/2021. Patient tested positive for COVID on 03/25/2021 and was admitted to hospital 03/25/2021 - 04/23/2021. Patient was readmitted on 04/27/2021 for UTI. Patient died on 05/07/2021, suspected cause of death was multi organ failure.