Moderna

Caretaker at Facility contacted me to tell me that this morning, patients left arm is red and raised all the way to the elbow and very painful. Patient gets scheduled ibuprofen for arthritis which is helping. She has had no other problems with other vaccinations including flu shot Fall 2020. Denies SOB, swollen tongue or throat, or rash/red areas anywhere else on body. Wondering if getting vaccine 3-1/2 months after getting COVID may be reason she is reacting. Caretaker anticipates she will recover just fine but is concerned about giving 2nd shot of series.

Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow up. patient reported arm soreness. Patient received COVID vaccine on December 31.

Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow-up, patient reported arm soreness. Patient received COVID vaccine on December 31

10:10 am received Moderna vaccine; observation time 30 min due to previous allergies stated (shrimp-throat closure); 10:37 am RN was observing/talking to pt & mid-sentence pt. reported "I'm feeling funny." Resident's eyes appeared glazed over and she reported "feeing out of it. Like I'm in another world." Resident unable to provide any further specific descriptions of how she felt. Resident's radial pulse felt regular. No loss of consciousness. Resident remained in seated position. 10:39 am Resident reported no improvement & stated, "I feel week". Rn paged for assistance. 10:45 am another staff member arrived with bp cuff. L upper arm blood pressure was 136/72. Heart rate remains regular. Lungs sounded clear. Resident was able to drink a 1/2 glass of orange juice. 10:49 Resident reported feeling " a little better." 10:51 am We noted resident's face appeared flush. No baseline observation of what her cheeks looked like prior to vaccination due to mask, but questionable mild facial swelling present. 10:53 asked resident if she was able to swallow normally. Resident wasn't sure, so RN asked if she felt like she had a lump in her throat or like she needed to clear her throat, but couldn't and she confirmed that her throat felt different than normal. 10:55 am Epi pen administered to L outer thigh by RN. Call placed to EMS. Discussed expected side effects of Epi administration. 10:57 am Resident started to feel anxious and visible shaking present. 11:05 am Resident reported felling slightly better, perked up a bit. 11:08am EMS arrived. 11:10 Ambulance crew arrived. Resident was able to walk to stretcher with assist of 1. 11:17 am Ambulance left with resident. Resident was still reporting "feeling weak".

began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead

soreness, stomach problems, constipated took prune juice, milkamagnesia, next day felt, bad chills, has not gotten out of bad, no energy, weak feeling in her legs, 3rd day hand were very hot, have no energy at night lots of chills, pain between shoulder blades, no apatite, pain in legs and still weak today.

Thursday - day of shot after dinner she began to not feel good. Her stomach was upset & vomiting, increased mucus, and a slight headache we gave her Compazine suppository and she went to bed. Said she rested well that night. Friday all day her stomach was upset but was able keep down tea/toast and have some broth. Friday Night/Saturday Early AM she became mentally unstable, confused and knew she was confused, felt like she was going to die, had a hard time breathing, her chest was tight and had shortness of breath. Later that morning she was weak, shaking, vomiting. After a good bowel movement and a 4-hour nap she started to feel better. 1/28/21 PCP Televisit - reaction do not take 2nd sho

Patient was showing signs of weakness, lethargy, change in LOC, and complaints of pain. She experienced a fall. Sent to the ER for evaluation.

left arm pain and Malaise immediately after, followed by sweling in both feet and purple discoloration in feet that resolved spontaenously over the next 4 days. Erythema and swelling to bilateral upper arms with associated skin tenderness, Malaise / intense fatigue both not yet resolved at time of this writing on 2/3/2021.

On 1/17/2021 patient woke and began her day as usual, was found down by family member 1 hour later conscious but unable to speak and unable to move her R side. She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended). CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy. Unfortunately the patient had persistent severe neurological deficits after thrombectomy. Was discharged home on hospice care and expired on 1/23/21.

PT OBSERVED FOR 15 MIN AFTER ADMINISTRATION OF VACCINE. SON-IN-LAW STATES THEY WERE AT THE STOP SIGN WHEN PT BEGAN TO FEEL HER FACE FELT VERY WARM AND FLUSHED. 1400 : BP 200/92 P 80 R 16. IN NAD. BS CLEAR & EQUAL. EMS PRESENT ON SITE AND ALSO ASSESSED PT AND RAN AN EKG. PT DID NOT DESIRE TRANSPORT. DOES TAKE BP MED. PT AND HER DAUGHTER BOTH STATE SHE TOOK HER MEDICATION THIS AM AND BP IS WELL CONTROLLED. REPORTS RECENT CARDIOLOGY CHECKUP WAS NORMAL. 1445 : 205/84 P 79 R 14. 1450 : 205/83, 72, R 14. 1500 : 180/90, P 72, R 14. 1505 : 180/82, P70M R 14. 1510 : 170/84, P 70, R 14. 1515 : 158/80, P 78, R 14. PT DRINKING WATER AND STATES SHE FEELS MUCH BETTER. DISPOSITION : HOME W/DAUGHTER.

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.

Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36. Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness. Her pulse ox improved to the 90s. BP 92/55. Her only complaint was that her hands were cold. Medical Director believes it was vasovagal syncopy due to receiving the vaccine. Patient died on 1/28/2021, due to progressive dementia.

2 days after vaccination in left deltoid, patient developed erythema, swelling, and firmness circumferentially proximal to elbow and distal to, but sparing, the injection site. She felt mild pruritis and tingling sensation. 4 days after vaccine, she felt nausea without emesis. No throat closing, shortness of breath, chest pain, fevers change in arm's range of motion or strength. Likely represents hematoma (patient is on anticoagulation) vs local injection site reaction.

Severe, total body shaking. Sudden onset, occurred while lying in bed. Approximately 20 minutes duration. Eventually subsided.

Patient complained about pain in arm after shot. Diarrhea in the morning, approx. 20 hrs after injection. Patient unable to leave bed and complains of pain in stomach. Currently, at 11 a.m., still in bed.

AFTER 5 MINUTES AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF BEING WEAK. ONSITE EMS RESPONDED. SHE WAS EVALUATED BY EMS AND TRANSPORTED TO A LOCAL HOSPITAL FOR FURTHER EVALUATION. VITALS BELOW

Patient became incoherent for a few seconds while sitting in a chair in the observation area. Pharmacy manager went to observe patient and ask how she was feeling. Patient's head started to droop to the side for a few second and her shoulders made shrugging movements for a few seconds. During this time I called 911, while individual waited with the patient seated in the chair. Patient became more coherent in a few seconds and could speak and smile normally. Ambulance came and patient went with paramedics.

I woke up with tingling on entire left side of body; Dr. ordered MRI; done on the 10th; showed no change in brain; Today, 2/26/2021, I still have some tingling; with left hand and fingers more so.

Warm to the touch; Tender; Swollen; Red spot; A little off from deltoid muscle; A spontaneous report received from a consumer concerning, 90-year-old, female patient who received Moderna's COVID-19 vaccine a little off from the deltoid muscle and experienced redness, swelling, warm to the touch, and tenderness. PT: [Product administered at inappropriate site, injection site erythema, injection site swelling, injection site warmth, and tenderness]. The patient's medical history was not included. Patient's concomitant included calcium, vitamin D, levothyroxine sodium, atorvastatin, citalopram hydrochloride, amitriptyline, triamterene/hydrochlorothiazide, acetylsalicylic acid, and lorazepam. On 02 FEB 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: 007M20A) for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient received the vaccine 'a little off from the deltoid muscle' as described by the patient's daughter (nurse). Approximately 9 days later, the patient developed a red spot on her arm and it was swollen and warm to the touch. At the time of the report, the patient's arm was still swollen. The redness was fading and her arm was tender. Treatment for this event included paracetamol. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, vaccine administered at inappropriate site, was considered recovered/resolved on 02 Feb 2021 The event, redness was considered recovering/resolving. The events, swelling and tenderness, was considered not recovered/not resolved. The outcome of the event, tenderness, was unknown/ not reported.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273, (lot # 007M20A) with associated injection site erythema, swelling, warmth, and tenderness. Based on the current available information and temporal association between the use of the product and the start date of the injection site events, a causal relationship cannot be excluded.

nausea next day on second day 3 pm shaking, shot of breath then - had chill then fever, 3 day another chill and fever - lose of appitite

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

2/12 Patient presented with palpitations, sensation of heat with no chest pain. Of note patient had covid diagnosed 11/20. Work up showed saddle PE and had SVT treated with adenonsine. Treated with IV heparin. Patient on 2L O2 weaned to room air before discharge. Patient transferred to CIRS 2/17. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

Left lower leg and calf: severe nerve pain; skin sensitive to touch; sharp stabbing pain with slightest touch.

Patient is a 90 y.o. female who presented to ER complaining of generalized shivering which began late last evening (3/3/21). Patient states she received her 2nd dose of her Moderna COVID 19 vaccine yesterday (3/3/21). She states she went to bed, woke up in generalized shaking which has yet to stop that she came to the ER (on 3/4/21). In ER patient's initial blood work was unremarkable which include CMP and CBC. CT brain was done to rule out any underlying neurological deficits or acute CVA which was unremarkable. She denies any numbness tingling no blurry vision no headache no sensory motor deficits. She denies any recent falls.

On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/ , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.

Started in her back and goes across her back, shoots down the middle of her back and both sides. Front in the ribs and around the breast - chest pains. Exhausted - energy is gone. Can't do normal activities that she was able to do prior to vaccine. Sharp pains. When I breath or cough/sneeze or laugh it hurts. Had some relief from heat and cold packs. Left knee has hurt a lot since this happened, too.

Within a couple days of second shot, legs became very weak, one was swollen and the other was atrophied. She can barely walk as a result. Can't keep eyes open, can't smile and trouble speaking. Back pain and all over pain.

This was the Johnson and Johnson one shot. My mother received it and today is in the hospital with acculsive blockage in left brain, paralyzed from stroke and is being operated on. I believe it is a blockage from the vaccine. She was old but extremely cognizant, independent, healthy, strong of sound mind. This is why I am reporting it. If she dies I will report again.

Extreme fatigue, headache, brain fog, weakness, lasting one month. Extreme in beginning, fading over-time.

4/30/21 weakness and tremors in all 4 extremities, febrile 39.8*C, observation hospitalization 4/30/5/1/2021

Patient reported 'no problem with the first dose' administered on 4/09/2021. Approximately 3 minutes after administration of the second dose patient reported a sharp pain in the middle of her back that radiated down her spine to her 'tail bone'. Staff phoned 911 which arrived within about 5 minutes. Patient reported no other symptoms other than the excruciating pain in her back. Pain was subsiding somewhat by the time EMS arrived. Patient began feeling weak in a couple of minutes and was transported by EMS to local hospital for further evaluation.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Pt developed GI upset and weakness on 6/2, followed by chills and emesis 6/3. Was found deceased on the toilet on the morning of 6/4/21.

Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.

Noted increased weakness on R side compared to L side - appears drowsier than baseline. HEMIPLEGIA, UNSPECIFIED AFFECTING RIGHT DOMINANT SIDE

1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was "cardiac event" according to death certificate.

A 91 Y.O FEMALE RECEIVED COVID-19 VACCINE ON 01/05/21 AT 11:30AM. FOUR DAYS AFTER THE VACCINATION ON 01/09/21 AT 3:15 PM, SHE CALLED HER DAUGHTER AND TOLD HER THAT HER MOUTH WAS NUMB, LEFT SIDE OF THE MOUTH WAS DROOPING, SO AS HER EYLID. AT ABOUT 5 PM THAT DAY, PATIENT ARRIVED IN TMH ER VIA AMBULANCE. ER DOCTOR RULED OUT HEART ATTACK OR STROKE. PATIENT WAS DIAGNOSED WITH BELL'S PALSY. WAS SENT BACK TO WESTMINSTER OAKS THAT DAY WITH CORTICOSTEROID AND EYE OINTMENT THAT WAS PRESCRIBED BY THE DOCTOR. (INFORMATIONS REPORTED TO ME BY THE DAUGHTER AND THE PATIENT HERSELF) AS OF 01/19/21, PATIENT IS STILL RECOVERING. SPOKE WITH THE PATIENT TODAY 01/19/21, PATIENT STATE SHE STILL HAS THE SIGNS AND SYMPTOMS OF THE BELLS PALSY, BUT SHE SAID SHE'S GETTING BETTER. SHE ALSO STATES THAT TODAY IS THE LAST DAY OF HER CORTICOSTEROID TREATMENT.

Other meds; potassium chloride, VitD3, super B complex, Cal-mag-zinc. Increased neuropathy with increased pain, stiffness, myalgia, arthralgia, prickly skin feeling all over, sensitive. Criteria for reporting: states saw Dr. 1-18-21, prescribed steroids. Took prescribed pain meds and prevented her daily activity; Grade 3 for pain and fatigue, myalgia, arthralgia.

Resident reported soreness to left arm and began having diarrhea and chills at approx. 0900 the day after receiving the vaccine. No treatment at this time.

Woke up skaking all over body-very violent. Could not control. Arms, legs everywhere. Continued for all day but did decrease a little bit toward evening. Doctor said nothing to do. Called 911, they checked. Blood pressure, heart etc seemed normal. Did not go to hospital because of virus cases being there. Vomited 1 time about 3 hours after I woke up. Second day was much better but extremely tired.Third day was back to normal but body very tired. Back to normal now. Will I have this with second shot???

Patient experienced weakness; BP 159/91, HR 102. Gave water - patient did not take BP medications. After water, patient felt better, and was safe for home discharge. MD speculated about vasovagal reaction.

4 days after injection, I experienced chills, slight fever (99.1), drop in oxygen level (96), aches all over, intestinal distress, extreme fatigue, lasted over 12 hours. Temperature and oxygen level back to normal, but am still shaky this morning, so I'm returning to bed.

Started 8 p.m.-ish last Sat. Injection arm (right) very swollen, painful, tingly to fingertips. Fever 101. Unable to move arm or sleep for pain. Symptoms bad through Wed. a.m., when fever broke, swelling/pain started to subside. It's now Thurs.: She's still symptomatic but slowly getting better. Tried inserting Julia's current meds/supplements in Continuation Page but wouldn't accept copy so putting here: Aspirin 81 mg/day; clopidegrel 75 mg every other day; hydrochlorothiaziada 12.5 mg/day; amlopidine besylate 5 mg/2x day; losartan potassium 50 mg/2x day; rosuvastatin calcium 41 mg/day; nexium/2 per day; esomeprazole magnesium 20 mg/2x day; vitamin d3 1000 iu/day; calcium carbonate 1200 mg/day; multivitamin Centrum

1055 S/p vaccination reports "feels anxious" w/associated palpitations and "feels like sugar is going down" Medical monitoring begins x 30 min, vitals assessed; BP 140/85 P137 RR 19 Po hydration offered/ given; symptoms improve during this time 1115 BP 145/80 P89 RR 18

Date and time adverse event started: 2-12-2021 at 8:15am with confusion, slurred speech. daughter had her rest and reports she is now okay. followed up with daughter, states she did not take the patient to the ER. had her rest and is now at baseline. Informed her of potential risks of waiting, went over life threatening reactions to look out for and call 911. verbalized understanding, states if symptoms occur again she will then go to an ER.

The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been "feeling generally poor and then suddenly collapsed." Daughter described "gurgling respirations" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.

vaccine given at 1532, symptoms started about 1545, client started coughing, said she felt funny, felt faint, pale, skin to touch was very cold, she said she was cold, BP 182/94, Resp 28, O2 99% on room air, HR 64, she was short of breath, was not tracking, would stare off looking at the ceiling, at 1552 0.5mg Epinephrine was given IM, EMS was called at 1553, EMS arrived at 1558, no relief in with the Epi, left via ambulance at 1605

Trigeminal neuralgia pain on right side of face occurred next day after vaccination. Became very severe without being able to talk, drink or eat on 2/11. Went to ER on 2/12. Discharged on 2/14. Still be in pain and unable to eat solid food.

91 YEAR OLD FEMALE FELT TINGLING AND NUMBNESS IN BOTH HER LEGS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. BP 180/90. SHE STATED THAT SHE DID NOT TAKE HER MEDICATIONS THIS MORNING. IT WAS RECOMMENDED FOR HER TO GO TO HOSPITAL FOR FURTHER EVAL AND SHE REFUSED. SHE WILL GO TO E.R IF SYMPTOMS PERSIST BUT FOR NOW, SHE WILL GO HOME HAVE BREAKFAST AND TAKE HER MEDICATIONS.

Dizziness/vertigo, nausea, vomiting, chills started at about 7:30 am on 2/20/2021. This was the day after I received the vaccine. Nausea and vomiting subsided around noon. Chills were ongoing through out the day. On and off vertigo episodes continued through 2/23/2021. All symptoms subsided by 2/23/2021. Also had a very sore left arm.

Patient developed COVID 13 days after vaccine administration presenting with shortness of breath and generalized weakness.

Injection site sore the day of the injection. Soreness went away the next day. Eight days after receiving the vaccine, the patient's arm became sore (2/26/2021) and is still sore today (2/27/2021). Called "Ask A Nurse" was told to apply heat or ice for about 20 minutes.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Additional Details: Pt experienced lower back pain, difficulty breathing, dizziness, light headed, shaking more than normal, cold, felt like she was fainting

About 20 minutes after the vaccine was administered my Mother's speech became garbled and she was unable to speak understandably. I thought she was having a stroke so rushed her to the emergency room. They examined her and her speech returned to normal in about an hour. They kept her overnight for tests and after an MRI they said she had a TIA. We wanted to report it in case there were others who had a similar adverse affect. No one can say for sure if the vaccine caused it or not but we wanted to let you know what happened to her.

Administered 0.5 ml of Moderna Covid EUA vaccine IM to patient's left arm. Patient went out to waiting room after told to wait 15 minutes before leaving store. Approximately 2 minutes later caregiver and patient approached register and stated patient wasn't feeling well. Brought patient back into consultation room. Patient was slouching and not responding to questions. "Are you okay" & "Can you sit up" Patient continued to slouch. Administered EpiPen 0.3mg to patients left thigh and called 911. Patient then began to respond to questions. Paramedics showed up and assessed patient. Paramedics took patient to emergency room after their evaluation of patient.

Developed Shingles; This morning had a lot more burning; Itching and Burning; A spontaneous report was received from a consumer concerning a 91 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Shingles, itching and burning, this morning had a lot more burning and it was running down the leg. The patient's medical history was provided not by the reporter. No concomitant medications were reported. On 28 Jan 2021, about seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: probably 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, a week later, the patient developed shingles and an itching and burning. On 05 Feb 2021, this morning had a lot more burning and it was running down the leg. Treatment included anti viral drug for shingles and lidocaine for itch and burning and pain. Lab details were not provided. The seriousness criterion for all the events was reported as other without a rationale. The event is serious meeting Medical Significant criteria due to the necessity of treatment. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, developed shingles, itching and burning, this morning had a lot more burning and it was running down the leg was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Woke up at 8 am drank some orange juice and immediately threw up several times and began having hot flashes for a couple hours. By 10 am , she seemed to settle enough to try and drink some slim fast. She feels weak and tired.

Her rectum was bleeding, it was bright red blood; Her arm was also sore the same day she received the vaccine; A spontaneous report was received from a consumer concerning a 91-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea and pain in extremity. The patient's medical history was not provided. Concomitant medications included warfarin. On 16 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Mar 2021, the patient experienced arm was sore the same day she received the vaccine, but it went away the next day. On 19 Mar 2021, the patient experienced rectal bleeding, which was bright red blood and one bout of diarrhea. No treatment information was provided. Action taken with the drug in response to the events was not applicable. The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

VIIS ID: 7827510; Moderna COVID-19 Vaccine Vaccine Lot Number: 025B21A second dose. Vax clinic. Pt received vaccine in vehicle-unable to walk inside-family member stated that about 10mins after vaccine she began nodding off and was difficult to wake. 16:10: 123/80 POX 80% CPR not indicated. EMS On-site. S/S hypoxia, altered mental consciousness, unresponsive then alert. Family stated that she has been exhibiting similar symptoms recently-today is a 'bad day'. Son stated that it has been a difficult day for her. She has had to stop to "catch her breath' numerous times. "nods off' frequently. Assessment completed by EMS; transported to Hospital (doctors).

Felt weak; Neuropathy; hot skin all over; skin burning; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak) and NEUROPATHY PERIPHERAL (Neuropathy) 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. The patient's past medical history included No adverse event (No reported medical history). On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt weak) (seriousness criterion hospitalization), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Felt weak), NEUROPATHY PERIPHERAL (Neuropathy), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness) had not resolved. Treatment Medication was cortisone cream, cerave, and Citalopram. This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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.; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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.

Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke. Patient passed died on 3/17/21.

Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history was not reported On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm. The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant were given No lab details was provided. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case

48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well. Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. 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.

extreme pain in her chest and abdomen on the R side of her body (around the heart); had very high blood pressure; The vaccine worsened her constipation problems; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (had very high blood pressure) and CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension. Concurrent medical conditions included Constipation. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (had very high blood pressure) (seriousness criterion hospitalization prolonged) and DEHYDRATION (Dehydration). On 29-Mar-2021, the patient experienced CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) (seriousness criterion hospitalization). On 20-Apr-2021, the patient experienced JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore) and ARTHRALGIA (legs, feet, and ankles are swollen and sore). On an unknown date, the patient experienced CONSTIPATION (The vaccine worsened her constipation problems). The patient was hospitalized on 29-Mar-2021 due to BLOOD PRESSURE INCREASED and CHEST PAIN. At the time of the report, BLOOD PRESSURE INCREASED (had very high blood pressure), CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) and DEHYDRATION (Dehydration) had resolved and JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore), CONSTIPATION (The vaccine worsened her constipation problems) and ARTHRALGIA (legs, feet, and ankles are swollen and sore) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: 217/157 (High) 217/157. Concomitant medications include Vault to treat constipation. Treatment included amlodipine tablets. 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.

91 year old female was sitting across the table from her husband while eating lunch when she passed out. She had slurred speech. 911 was called. She was taken to the ER and was diagnose with acute stroke. Her symptoms subsided on presentation to the ER. She was started on Plavix. Had negagive carotid duplex. MRI brain showed suspected subtle nonhemorrhagic punctuate left frontal lobe, Cortical 2-3mm acute -subacute vascular insult vs image artifact.

after first dose of the Moderna vaccine she became very ill and was hospitalized on 3/13 - 3/23. After 2nd dose of the vaccine she seemed to be doing ok but gradually declining and less and less to be able to do for herself, it slowed down greatly after the vaccine. There was a gradual decline, but on May 2 she woke up and was semi conscious and said she thought she was dyeing and was in pain and discomfort and was taken into the ER and she was DC'd and started hospice and two days before she passed she got the hospice care. My mother was in a semi coma and could not communicate properly. Many test were done at the hospital during her stay even though they never identified what the cause was. At the last ER visit they diagnosed her with pneumonia

Son states that on February 7th his mother developed shingles. On February 12th developed Bell's Palsy. On May 15th at 9:00 PM his mother had a heart attack. Is recovering at healthcare facility.

Reports about 3 days after the shot she developed a headache, was cold, felt like a "dishrag", tired. She went to her family physician. He sent her to the hospital as she said he told her that her heart was hardly beating. At the hospital she had to have a pacemaker placed. She had no history of any heart issues. She reports being healthy before the vaccine.

Patient is a 91 year old female who presented with a chief complaint of aphasia. Patient with increasing frequency in confusion episodes over the past few months. Patient presented in no acute distress, normal neurologic exam. Vitals stable, afebrile. Asymptomatic. CT Head without acute findings, but chronic microvascular disease consistent with age which may explain patient's symptoms. TIAs cannot be ruled out however at this time. Recommend patient be evaluated by neurology. Discussed with patient who is in agreement with plan. Incidentally, patient with CXR findings consistent with pneumonia. Patient treated with antibiotics for CAP in case this is contributing to symptoms. COVID is positive but patient states that she tested positive in March and has received both vaccines. SpO2 94% on RA.

5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)

April 1, 2021 a rash occurred on both legs from above her knees down to her toes. Legs began swelling, experiencing nerve pain. Received one shot of prednisone in the shoulder. June 28, 2021 legs are still swollen.

Significant decrease in ability to function physically and mentally. Increased confusion. Unsteadiness resulting in two falls. Weakness of muscles. Facial numbness which lasted for several hours. These symptoms showed up within a few days of the second dose of the Moderna vaccine. The effects lasted for about one month. Since then, the person is back to normal functioning with no weakness, or confusion. She is doing well now but for one month following the Moderna vaccine was very debilitated and unable to function in normal activities of daily living.

Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib. 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. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; 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.

The day after vaccination EMS was called to the patients home EMS States: Pt had right sided gaze noted possibly for the past 2 days. upon EMS arrival pt had tonic clonic seizure activity x3, family denies history of seizures. 12 lead EKG showed afib RVR. Pt was stoke activated and transported to the hospital.

Day 8 following 2nd Moderna vaccine shot, patient began experiencing heaviness, dull pain in chest. She layed down which seemed to help alleviate the chest issues. Day 10 after receiving the second Moderna shot, patient died suddenly while sitting in her recliner of cardiac arrest. There were no symptom s leading up to the event.

At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.

1/8/2021- 1/12/2021- complaints of intermittent L thigh pain 1/8/2021- Moderna Vaccine given 1/12/2021- continued c/o pain to Left hip/thigh, Rash noted to L inner thigh/groin. 1/13/2021- VS: 97.1-69-18-110/70-SpO2 97% on RA. Notified PCP regarding rashes/lesions with vesicles to left inner thigh and left posterior leg and left lower back. With orders to start on contact/droplet precautions. Famciclyclovir 500 mg tab PO QD x 7 days. Dx. Shingles. 1/13/2021- Medical director advised reporting to VAERS.

Redness, warmth, pain, RUE measuring 9.5cm x 15.0 cm noted on 1-17-2021 continues with redness (fading) on 1-21-2021 warmth. Denies pain unless bumped. Resident afebrile. Size remains unchanged

Approximately 15 minutes after receiving the vaccination the patient began to feel a tightness in the throat and difficulty speaking with a sense of anxiety and fright. The EMT and paramedic summoned me and after arriving at the observation area and ascertaining the patient's symptoms i asked the medic to administer the .3ml of epinephrine via EpiPen which he then did. Responding paramedics then arrived and took over assessment and treatment of the patient. An ambulance had previously been called and the patient remained stable with slight improvement in the sense that she became less anxious and frightened. She exhibited no urticaria or angioedema. Vital signs included initial B/P of 183/95 with improvement to 176/76 and 99% pulse ox . Patient was transported to hospital and per daughter was released about 2 hours later.

Client received vaccine on Monday January 25 in the am Phone call from daughter client started fever and weakness late on Wednesday afternoon. coughing but had been coughing prior to vaccine Daughter called MD started client on her standard dose of Predinisone No respiratory distress experienced at this time. Family will continue to monitor client for any changes MD aware of status at this time . MD not sure related to Covid 19 vaccine but felt it needed to be reported.

Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea

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

Reaction to second dose of moderna (no reaction to first dose; Ten hours later, had sharp pains in lest side of my head (thought I was having a stroke). Before I called 911, I got extreme shakes. after that, no pain - nothing. Shakes lasted 5-10 minutes.

SWELLING AND PAIN IN HAND AND WRIST IN RIGHT ARM (WHICH IS THE ARM THAT WAS VACCINATED). PAIN AND HEAT AT SITE OF VACCINATION. INTENSE ITCHING, SORENESS AND REDNESS WHICH BEGAN 2 TO 3 DAYS AFTER VACCINATION OVER INJECTION SITE. THE PINK/RED, ITCHY, RASHY AREA HAS NOW DESCENDED TO HER ELBOW, IS SLIGHTLY SWOLLEN, 3 INCHES BY 5 INCHES (NO LONGER OVER INJECTION SITE)

Red spot about 2" diameter, itchy and itchiness in wide area around injection site., slight ache in right arm

Patient son stated today that 4 days after vaccine patient arm sore between shoulder and elbow and still is in pain/sore today 27 days later.

Chills, fever (101); arm sore all night; could not sleep; took Tylenol to bring temp down; nose was running; did not feel like eating; feeling much better today; no fever, chills, temp normal

Experienced generalized mid weakness 20 minutes after receiving the vaccine. BP 112/51, HR 71 O2 sat 97%

Joint affected in left groin/hip area. Cannot put weight on left foot. Difficulty walking or standing. Using cane to take pressure off left foot.

92 yo female who received her first dose of Moderna vaccine on 1/11/2021 with no known adverse effects. Admitted to the hospital on 1/17/21 with a spine compression fracture. Discharged and readmitted on 1/19 /21 with nausea and vomiting. Found to have new atrial flutter and elevated troponin attributed to NSTEMI. Discharge on Aspirin and Plavix. No cath. Second dose of Moderna vaccine 2/25/21. No immediate reaction. One hour later began to feel progressively weak. EMS called shortly after getting home. Intubated in the field. Died at 0658 on 2/26/21 s/p PEA arrest without ROSC.

Patient woke up the night of the shot and experienced let crams, she was gasping for air, and had shortness of breath. She also experienced leg cramps. This lasted for 3 days.

pt states she started having pain in the right arm. Her arm has limited movement. Pt has extreme fatigue and has slept the majority of the time after getting home from receiving the vax. Pt still has these symptoms.

Received the vaccine had no reaction, no temp, no headache. She felt a little funny, and possibly a week later she started getting reaction in her body, burning sensation in her chest, possibly thought related to acid reflux. She then had sensation down her leg nerve pains. Sometimes she also gets some hot flashes but they go away. She woke up early in the morning yesterday and had a pressure like sensation in her head, she still has that today. She still has burning sensation in her chest, and her legs and ankles are hurting still. She has taken some Tylenol for the aches and pains. Also has itchiness of her arm from the vaccine, as well as soreness.

Approximately 4 hours after receiving the Moderna COVID-19 vaccine (left-arm), my mother began to have moderate pain in her left arm, particularly in the left shoulder area. The pain continued to increase throughout the afternoon, until it became so severe (10 on a 10-point pain scale) by 8:30 pm on 3/10/21 , that she could no longer lift her arm. She took 500 mg of Tylenol to attempt to relive the pain and went to bed early. At 2:45 am on 3/11/21, she needed to go to the restroom, and I (daughter) had to assist her to get out of bed, as she had no use of her left arm due to severe pain in that arm. While seated on the toilet, she indicated that her arm was extremely painful and she felt that she was going to pass out and felt nauseated. Within a minute, she lost consciousness and I called emergency services. EMT arrived within 5 minutes and stated that her blood pressure was extremely low and she needed to be placed on the floor. They placed her on a gurney and took her to the ambulance, where they started an IV and took her to her local hospital. I followed shortly thereafter, where she was taken to the ER. She was admitted to the hospital for observation and given Ativan (she refused any opioids) She was ultimately diagnosed with vasovagal syncope due to the pain in her left arm. Two days later, the pain has subsided.

Sore arm; Passed out; loss sense of time for 36 hr; so weak to get up; Vomiting for several time; A spontaneous report was received from a consumer, who was a 92 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, lose the sense of time, vomiting for several time, so weak to get up and passed out. The patient's medical history included cancer, restless leg syndrome, allergies to shellfish and currently living in hospice. Concomitant products included rivaroxaban, digoxin, diltiazem, omeprazole, pramipexole, vitamin D3, budesonide and paracetamol prn. On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date after receiving the vaccine, the patient experienced sore arm. One night, she lost the sense of time for 36 hours. She got up in the middle of night and went to bathroom and was vomiting for several time. She then got back to bed with waste basket and was so weak to get up. She called the nursing home next door and she believed that they may have called 911 but was not full sure if they did or did not. The next day morning, one of the neighbors came to check on her at 11 am. When the neighbor tried to wake her up, she was passed out therefore the nursing home called 911 again. Patient believed that nurse gave her a shot to stop vomiting but do not clearly remember. She was not planning on getting the second dose of the vaccine. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, sore arm and so weak to get up, were unknown. The outcome of the events, lose the sense of time and passed out, were considered resolved on 22 Feb 2021.; 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.

Patient c/o feeling flushed, color pale pink, warm, dry. Radial pulse strong, steady. Breathing unlabored.Patient given bottle of cold water to drink, no swelling to face or lips. Patient stated she did eat breakfast that morning. Patient states water helping, then has some coughing after a drink. Patient states she often coughs after drinking things, denies difficulty breathing or swallowing. Patient c/o head throbbing after drinking. C/o nausea and has dry heaves x 1 but no emesis. Patient states has some chronic breathing problems and heart problems. Family member at side. BP 146/90 left arm sitting automated cuff, pulse 84. Respirations even and unlabored, O2 sat 88% on RA, Patient remains alert and talking, nausea subsides. Patient assisted to stand and ambulate with walker to be dismissed at 1053, but is dizzy so sat back down and dizziness subsides. Patient remains sitting and alert, talking to volunteer medical staff member. BP decreases to 132/86 and pounding in head decreases. Patient reports feeling okay to leave and at 1107 ambulates out with her walker and stand by assist from volunteer member and patient's family member.

1st: Mild arm soreness with first shot that went away in a few hours. Loose stools beginning a couple days after shot and lasting three days. 2nd: Mild arm soreness X 1 day. Unformed stool beginning four days after shot and continuing four days to present. Uncertain how long it will continue. Severe whole body edema beginning day five. Particularly pronounced in L arm that received Moderna Vaccine. Also aches in Left shoulder, and whole body muscle aches. She has had some edema in her lower legs and feet, but NEVER in her hands, face and torso. In retrospect, we should have avoided using her left arm to vaccinate due to lymph node removal.

On 3/29/21, resident laying in bed and began on convulse . Sent out to ER and DX with new onset seizure disorder,

Patient presented to emergency department on 3/27/21 with weakness, lightheadedness, decreased appetite and vomiting. Patient tested positive for COVID-19. Chest xray was negative for acute process. Patient was saturating 92% on room air. Patient received remdesivir and steroids. Oxygen was weaned off prior to discharge. Patient was discharged to a rehab facility.

She got the vaccine and started out with nausea below the vomiting point, and she could not eat much and had stomach upset. She did not feel well. She went to bed for a whole day and then slept the following day. It is still going on but not quite as bad, very tired. The arm was a little sore the night of the vaccine, but when she started using the arm the feeling left. Did have some soreness for a couple of nights. She can still hardly eat, but her stomach feels better. She has the bad feeling where she cannot eat but a few bites as she gets nauseated then. She has not taken anything for her symptoms. She is just not feeling well at all as if you don't want to be out of bed. It's a big struggle for her to get up and get her something to eat. Something that she doesn't have to cook.

5/18/21 9:20pm - c/o general aches & soreness right arm 5/19/21 6:10pm - c/o general aches, sleepiness, soreness to right arm temp 99.8 5/20/21 11:21pm - redness adminstration site, redness & puffiness to eyes & face, arm very sore 5/21/21 11:02am - c/o pain at injection site, red, warm, swollen, afebrile 5/21/21 10:03p - arm red, warm, swollen at injection site, afebrile, states feels better today 5/25/21 4:27am - lethargic, tremoring, nausea, diarrhea, temp 103.4 pulse 128, SPO2 82%, sent to hospital

2/18---dizziness/weakness (CMP, CBC, troponin, TSH, urine, EKG, chest xray)?ED visit. 2/24 traumatic hematoma (possibly from blood draw on 2/18)---xray, Doppler done 6/12 Nausea/vomiting hemocult + blood, maroon/coffee ground consistency, RUQ pain, diarrhea, colorectal enteritis, heparin given as prophylaxis against DVT. Hemoglobin trending down (14.1 to 11.5), type and screen done in case blood transfusion is needed (when hgb <7), endoscopy; CT scan showed the following: 1. Multiple regions of small bowel wall thickening and to a lesser extent large bowel wall thickening concerning for a coloenteritis. Differential includes infectious, inflammatory, or ischemic coloenteritis. Recommend correlation with lactic acid levels. No pneumatosis or free air. 2. Small volume ascites. Mesenteric edema. 3. Advanced atherosclerotic change of the abdominal aorta and side branches.

The history is notable for 92F well known to dept p/w generalized malaise, fatigue, weakness--received 2nd COVID vaccine day prior. Has been trying to eat/drink normally, but admits to me probably less than normal. No focal weakness, pain, rash.. Exam is notable for On my eval after initial interventions by PA, pt is ambulatory, tolerating PO, well appearing, normal complexion, normal/stable VS.. Patient at risk for Vaccine reaction, dehydration, ACS, AKI. Our plan is Workup unrevealing of acute pathology. Pt feeling well after tylenol and IVF, ambulating well. Discussed by phone with her son, agreeable to bringing her back home if she's up and moving about okay. Understanding about her symptoms mos

Rash and itching developed over arms, legs, neck, trunk, stomach, crotch, scalp. Persisted for weeks and would not abate with several prednisone treatments. Blisters arose at each point of irritation along with red splotches. Begins with burning, then itching, followed by visual eruption. Inflamed sites are hot and swollen. About 15-25% of body affected at any given time, mostly upper body and arms. Rashes moved over time to various locations. Patient began to feel badly around June 15 2021, with symptoms including: extreme weariness, novel tinnitus, severe itching an burning at night, novel severe brain fog and confusion, inability to drive or accomplish household tasks, novel ocular migraines/loss of vision, headache, loss of appetite.

7.11.21: Patient presents to the ED with fatigue, dyspnea, cough, and malaise. found to be COVID-19 positive. has a history of receiving both doses of Moderna COVID-19 vaccine. diagnosed with Pneumonia. Found unresponsive during CTA of chest. Then coded in the ED. transferred to the ICU. 7.12.21: rapid response called for respiratory distress. intubated. started remdesivir. received 1 dose of tocilizumab. 7.16.21: patient still admitted as of today - the day of report submission. still intubated. completed 5 day course of remdesivir.

On 1/14/2021 @ 0659, patient was noted to be weaker, arms were flaccid R>L. Unable to answer questions speech gargled. Unable to grasp hands. Pupils reactive, but sluggish. Probable CVA. Dr. and family were notified. Family wished to keep patient at hospital and provide comfort care rather than send to the hospital. MD was in agreement. APNP, assessed patient. Her tongue was red and swollen. Bite marks noted on right side of tongue likely d/t event. ST evaluation done to evaluate patient's ability to chew and swallow safely due to swelling of tongue. Hospice services were initiated. (Unsure if event was caused by vaccine administration)

About an hour after receiving the vaccine my heart starting beating really hard and loud. You sweating, weakness and runny nose. The symptoms have been on and off since then. But the last 5 hours they have been steady. It feels like my heart is in my lungs. I do have a pacemaker and my Doctor just prescribed Lasix for swelling in my legs. I have not received it in the mail yet. Does not have the lot number.

Does not have lot number. About an hour after getting the vaccine started with fast heart beat, felt like my heart was like "boom boom boom" and was really loud, sweating, weakness, runny nose. Symptoms since then have been on and off and steady for 5 hours today. Today it feels like my heart is in down in my lungs.

pt stated within 10 minutes after receiving vax she became flushed, had chills, cold sweats and palpitations. Pt stated her vitals were taken and her BP was 215/104. After about and hour it came down to 160/?. Pt stated that 2 weeks after the vax she developed a 6" red, warm, swollen, itchy area around injection site. Pt stated her symptoms have subsided but she has contacted her PCP about getting second dose and was advised not to take it.

Pt received Moderna COVID vaccine at 0850. RN responded when pt c/o dizziness at 0905 while sitting in observation area. Pt pink, warm and dry. RR easy and regular. Radial pulse 100, BP 174/108. Pt stated she took her morning meds including antihypertensives this am at 0800 on an empty stomach and then did not eat breakfast. Pt given water to hydrate and crackers. At 0910 pt denied dizziness. At 0910 BP 200/76 and pt stated I feel better. Both nurses remained with pt at all times. At 0918 BP 208/88. Pt encouraged to go to ER or her PCP for further evaluation. Pt's niece was in attendance and made an appt with pt to go to her PCP at 1215 today. At 0930 pt stood and ambulated and stated she felt fine to go to her doctor. Pt escorted by wheelchair to her car per volunteer staff. Pt discharged with her niece in attendance.

Health RN administered vaccine. At the time PHN withdrew the needle from the arm, the needle was left in recipient's right arm and a unknown amount of vaccine ran down recipients arm. Followed up with recipient the following day 1/31/21. Recipient verbalized arm soreness from the vaccine.

In the morning following the shot, she could not get out of the bed without assistance. She was very weak and could not stand by herself. She did not want to eat very much. Then by lunchtime, she was running a fever of 102.5 fever for many hours. We put her to bed. On Sunday morning she was much better with a better appetite and no fever. She also had normal amount of energy. She had a rash on her arm that received the shot and it ran from her spot of injection to her elbow. It was hot with the rash for about 5 days.

Patient's daughter reported at 2/20/21 (next day after her shot) that her mother was experiencing chills, fatigue, sore arm and fever (peak 101F). The patient's daughter gave her a Tylenol when she found out she had a fever and this resolved the fever and the patient was feeling back to normal around midnight that same night.

pt has CTCL and has developed more intense itching than usual. Pt has dementia but has had more severe episodes of aggression, confusion and delirium. Her upper left arm is red and has developed more defined lesions around the injections site and on her lower back. Her arm pain and back pain seemed to be heightened more than usual and she also has some fatigue. Pt saw her cancer Dr. on 3/24/21. Dr. made notation in her chart about her symptoms and was instructed to continue the using the cream that she was currently using. Pts PCP is aware of the increased episodes of confusion and being argumentative since taking the vax. Pts daughter is her full time care giver and is dealing w/ her increased intensity of the patients symptoms.

Patient felt very severe generalized weakness 24 hours after 2nd COVID Vaccine and had to be transported to local ER via ambulance

Unknown if she had any symptoms or adverse reactions. She apparently was stubborn and kept to herself.

Pt reports feeling shaky after receiving this injection of vaccine. EMT stayed with patient and spoke with her, offered her a cookie and some juice and patient reported feeling better, no concerns. Was sent home with her friend, who drove her to the clinic.

resident was hospice she was afebrile day of vaccine on 4/20. on am of 4/21/21 0600 nurse stated no c/o of pain or discomfort. Resp were even and unlabored. That morning at 1145 charge nurse stated she was extremely hard to rouse. Vs were ok. SHe had some weakness in right side. they notified hospice. She had labs done. She was diagnosed with PNA and started on Abt. That night she was unresponsive to verbal commands and couldn't get po med. she received gentamicin im. on 4/22/21 charted she was vommiting small amount. She expired late that night. MD doesn't believe the vaccine caused the death, but thinks it has the potential.

Patients dementia symptoms got worse after getting vaccine. Patient became nonverbal, would not eat, and started having falls. Patient was hospitalized and eventually went home with hospice.

very agitated, unusually low blood sugars, feeling of something crawling under her skin, picking at and cutting fingers

Nurse: the resident received her vaccine at 09:25 am and immediately began to feel cold. This nurse was notified at 0945 at which time the resident complained of nausea and dizziness. The resident was also emotional, confused and experiencing high blood pressure (170/78) .

Person received vaccine at approximately 2:00 pm on 1/13/21. Person has been on hospice but had been able to talk/communication. The evening of 1/13/21 person declined to where they would no longer wake up and/or respond. Restricted to bed. We are unsure if this decline is just a progression of her disease or is a reaction to the COVID-19 vaccine received.

Client noticed on 1/27/21 that arm was itching, then noticed on 1/28/21 that arm was red and warm to touch. redness progressed to lower arm by 1/31/21. Saw MD on 2/1/21. Advised she was ok and client was ok to get 2nd dose. Client started using Benadryl and cool compress on 1/29/21 or 1/30/21.

When she woke up around 7:00 AM, she was so called. Around 9:00 AM she was very weak, hurting all over, had diarrhea. She did not take anything for it. Had fatigue, muscle pain, chills, nausea and vomiting. Today, 2/15/21 she is feeling better and is back to normal. Tried calling her doctor but could not get through to them.

Received influenza vaccine 1/29 at PCP clinic. Received Moderna vaccine on 2/6 by pharmacist at her place of residence. She was taken to the ER on 2/9, unresponsive. Staff reported she wasn't acting normally since 2/7. During her hospital course (2/9-2/13) she was only able to open her eyes. Unable to follow any commands. MRI showed large right MCA stroke. She was discharged from the hospital on hospice.

Per patient's daughter, the patient told her that she "passed out" while she was on the toilet the day following vaccination. States she felt weak. Per daughter the patient is doing fine now.

Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site A feeling of heaviness in the arm Some Nausea 3 days after injection

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.

Patient was awakened by itchiness on left arm from elbow to wrist. Increased in severity to feeling as though on fire and being bitten by a thousand mosquitoes. Spread to other arm, both becoming bright red and blotchy. Some areas became raised. The itchy red began to creep up to injection site. Next day, February 21, legs began to ache, swell, and itch. Developed bright red, splotchy hives similar to arms spreading from knees to ankles before creeping up thighs. Large, hard, itchy area behind both ankles, and navel also became inflamed and itchy. Today (March 1) arms and legs are still red, though it has faded in some areas, and the itchiness is persistent but has subsided.

Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer

Systemic: Patient was unresponsive after the vaccine and then started vomiting. She went to the ER and then perked up for a few hours and they sent her back. She was fine after leaving the hospital.-Severe

Hypoxia on 3/12/21 in afternoon around 3pm. New Right lower lobe Infiltrate on Chest Xray 3/12/21. Cough 3/13/21. Worsening generalized weakness 3/12/21 7am, Nausea 3/12/21 7am, No appetite 3/12/21 7am. Malaise 3/12/21 7am. Encouraged fluids. Placed on oxygen via nasal canula. Started Levaquin antibiotic. Started on Guaifenisin cough syrup. Patient is still on Oxygen and antibiotic as of this report. Incentive spirometer ordered 3/15/21

Blood clot in blood vessel in the left hand at the base of the middle finger causing darkening in the lower part of the finger and numbness in the whole finger.

Patient reports a very sore/painful arm, which radiated up her neck and across to her back. After 3 days of rest, the pain has completely resolved.

Resident had acute onset of confusion with difficulty following directions, severe decrease in safety awareness, and significant weakness x2 days leading so several falls.

Extreme pain in the back, hips and legs upon waking up lasting 3+ weeks. Unable to sit to go to the toilet. Weakness in legs causing a fall. Pain and weakness lessened as day went on only to reappear next morning. Also extreme fatigue lasting weeks.

Patients caregiver states that patientcan't move her arm. Said it not just a sore arm but can't move it. Caregiver said went to hospital but did not mention vaccine adverse effect. I advised caregiver to seek healthcare, hospital or primary care, since she can't mover her arm.

Patient experiencing legs numbness upto the knee. Symptom occurred about 5 mins after receiving vaccine

Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital.

death. Per son pt was not feeling well after the vaccination "like her legs were weak." Son found the mom in her bed 1am on 2/12/2021 unresponsive.

patient complained stomach pain, responsive but lethargy and slightly clammy. Vital Signs: BP 112/45; pulse 41; O2 Sat 99 - 100%. Bradycardia patient put on gurney, heart monitor, started IV lock. transferred to ED for further evaluation.

5 days after injection, had sudden onset of severe back pain, tingling and burning in hands and down legs into feet. Jerking extremities and seizure like activity. Facility staff called for ambulance to transport to ER. No treatment, observed overnight, prescription for Tramadol. Transferred back to facility. Extreme fatigue. Pain manageable with Tramadol. 4 weeks later: extreme fatigue continues.

Pt received 2nd dose of Moderna too early. On 03/12/2021 when health dept nurse learned of the error, the patient was called to assess for any problems and to determine if the doses were given too early. RN said the patient was hard to understand and a poor historian. Pt could not give names of caregivers. RN had EMS go by to provide a welfare check. EMS reported pt was at baseline health status. EMS staff spoke with nephew who reported pt has only had one vaccine. On 03/15/2021, RN received calls from step daughter-in-law and Nephew, both advising pt did get both vaccines. Per family, the patient?s vaccine appointments were not communicated well between the family caregivers. One caretaker thought the 2/24/2021 trip to health dept was just to register and the second trip on 03/05/2021 was when the actual vaccine was to be given. Registration forms were completed at each visit, with both showing no previous vaccine administered. Pt and family report no side effects after the 1st vaccine, the nephew did report noticing that the patient was lethargic and weak 3 d after the 2nd vaccine. Family was advised the patient does not need another dose of COVID vaccine at this time, 2 dose series complete.

Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Both arms hurt, but left arm became so painful and numb to wrist, cannot move it without extreme pain. Sleeping is very uncomfortable . Making feeding herself is very diffuicult. Pain is impossible to control. Using Voltairen cream and Tylenol all day with little to no help

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.

On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.

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.

Res not feeling well this shift, very weak and tired. Res having minimal output and has been to the bathroom x1 today.

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

Fever of 104.5 at 330am. Reduced to 101.5 by 500am with Tylenol. Collasped at 830am on the floor unable to verbalize or move, 02sat =72. EMTs were called, checked vitals and transported to the ER.

Starting the following morning, significant nerve pain on the left (other) side radiating from shoulder up the neck.

Pt complains of experiencing bilateral burning from toes to ankles 2 days after receiving 2nd dose of Moderna. Plan per MD: trial 100mg gabapentin at bedtime; consider lab draw, B12 supplementation d/t low levels from previous blood draw

Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.

Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI.

Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia

Could not move their legs; Legs were shaky shaky shaky/Hands were trembling and shaking; Tender arm; A spontaneous report was received from a consumer concerning a 96-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her legs, legs were shaky, hands were trembling and arm was tender. The patient's medical history included dementia. Concomitant medications were not mentioned. On 04 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 031120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Mar 2021, approximately a day prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, prior to receiving mRNA-1273, the patient could not move her legs and noticed her legs were shaky. Patients daughter had to help her to get up. Hands were trembling and shaking (could not drink from a glass of water and had to use a straw). it affected her muscles; her legs were like jelly. She is in mild mid-stage of dementia but it had no impact on that level. She only had a tender arm after the first dose. Treatment for the events was not mentioned. Action taken with mRNA-1273 in response to the events is not applicable as both doses of the vaccine have been taken. The events, legs were shaky,hands were trembling, were considered resolved on 08 Mar 2021 and outcome of arm tenderness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20

1. Double vision. Saw opthalmologist. Diagnosed as Left 6th Nerve Palsy as a result of the vaccine. Started using eye patch. Condition unchanged. 2. Weakness in legs, difficulty controlling movement which started 48 hours after vaccination. Saw neurologist. Diagnosed as Ataxia. Conditioned worsened daily to a point. Presently neither improving nor worsening. Currently conditions have reached a plateau, neither improving nor worsening.

Flu symptoms, but most notably the loss of muscle strength in her legs. She collapsed and was unable to walk.

Very weak; Patient received 2nd dose day 42 after the 1st; Diagnosed with Colon cancer after the 1st dose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of COLON CANCER (Diagnosed with Colon cancer after the 1st dose) in a 96-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 Blood transfusion on 11-Feb-2021 and Surgery on 19-Feb-2021. Concurrent medical conditions included Colon cancer on 13-Feb-2021. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced COLON CANCER (Diagnosed with Colon cancer after the 1st dose) (seriousness criterion medically significant). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose day 42 after the 1st). On 18-Mar-2021, the patient experienced ASTHENIA (Very weak). The patient was treated with Surgery (Transfusion on 11 Feb 2021 and surgery on 19 Feb 2021) for Colon cancer. On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose day 42 after the 1st) had resolved. At the time of the report, COLON CANCER (Diagnosed with Colon cancer after the 1st dose) and ASTHENIA (Very weak) outcome was unknown. The patient's medical history was not included. Concomitant products were not listed. This report refers to a case of a 96-year-old female patient who experienced non-serious event received 2nd dose received day 42 after the 1st (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # -unknown) and very weak and serious event of colon cancer. Based on temporality, the event of very weak cannot be excluded with product use. Colon cancer is assessed as unlikely due to latency to diagnosis and inappropriate schedule of vaccine is assessed as not applicable.; Sender's Comments: This report refers to a case of a 96-year-old female patient who experienced non-serious event received 2nd dose received day 42 after the 1st (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # -unknown) and very weak and serious event of colon cancer. Based on temporality, the event of very weak cannot be excluded with product use. Colon cancer is assessed as unlikely due to latency to diagnosis and inappropriate schedule of vaccine is assessed as not applicable.

Became lethargic. Wasn't answering simple question. Did not have trouble breathing. Looked as if she was falling asleep. Son was with her and said this was very unusual for her.

Arm turned bright rosy pink/red in a 2? area, then extreme pain, throbbing, heat, fever, and then area extended down and around arm. At this time it was lighter: spreading out. Began to itch. Still hurting somewhat at varied times but not nearly as bad.

Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms except feeling weak and she had a decrease in her appetite. She already had a poor appetite prior. She died on 2-2-21.

Around the 30th my mother's left breast was a little bit swollen, we didn't think nothing of it. It is has gotten worse and starting to hurt her.

Resident became unresponsive after bath. unable to get O2 stats P76 B/P 116/70. Very lethargic all am did not get out of bed all day continued to be very lethargic all day.

COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Patient was hospitalized due to worsening condition. Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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 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.

RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE ON 01/05/2021.

Swollen arm, lymph nodes, neck, sinuses, and chest on left side; redness and pain in arm; difficulty breathing and heaviness in left side of chest; chills; loss of appetite; fever (her normal is 96.5 and she had 101 degrees); lethargy; aching all over

Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite

Narrative: Patient received dose 1 of Moderna COVID-19 vaccine on 3/11/21 from clinic. Vaccine was administered to patient without complications and patient was observed for 15 minutes post-vaccination without any adverse effects. No documentation as to any adverse effects following the 15 minutes post-vaccination. 11 days later on 3/22/21, EMS was dispatched to patient's home and patient was found lying supine, unconscious, and unresponsive to stimuli. Patient was noted to have shallow breathing per EMS staff, and was subsequently brought to the hospital. Per family, patient lives alone and was feeling well - they had spoken to her two days prior to the event. Per family patient did not have recent fevers, vomiting, diarrhea, or cough. Also no recent medication changes or trauma. PMH includes stroke approx. 8 years ago, gout, HLD, HTN, and RLS. BP upon admission was 126/93, HR 123, temp 37.1 degrees Celcius, RR 28. Patient noted to smell of urine. CT showed large completed right sided infarct consistent with MCA stroke. Per neurology the lesion was not recoverable and patient would be unlikely to regain any function. Family was notified and poor prognosis was discussed. Patient has been very clear in the past that she would prefer "to go when her time came". She had a DNR And DNI as well. Daughter requested to pursue comfort measures for patient, therefore she was transferred to hospice care. Patient passed away the following day on 3/23/21. Death very unlikely due to COVID-19 vaccination since CT imaging clearly showed cerebral infarct and patient had a PMH of stroke.

On 2/26/21 patient had tingling and numbness in legs. Legs wouldn't move. Patient fell. provider not contacted 3/27/21 called 911, patient had maybe had seizure couldn't talk. Patient had EEG,MRI and CAT scan- all came back negative for stroke or seizure.

patient woke up on 04/22/2021 with shortness of breath and weakness. On exam, she was hypotensive, tachycardic and edematous

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

Patient developed lightheadedness and extreme shaking in the extremities such as the hands. It slowly progressed worse over a period of 20 minutes. Patient had no nausea or vomiting.

Patient complained of tingling in her arms and extremities. She said it continued to get worse and she was unable to lift her arms. She was able to squeeze my hands. She said she was having trouble swallowing, but did not have any issues with breathing. I gave her 2 diphenhydramine 25mg and her symptoms seemed to get better. She said she felt a little pressure in back of her neck.

developed stroke (unresponsive, unable to express herself or her needs, lethargic, unable to swallow)

Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product were not provided. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.

Generalized decline in status: increased lethargy, increased weakness, decreased oral intake of food and liquids, alert but decreased socialization all of which have progressively gotten worse but was first noted the early morning of 6/18/21 which was about 12 hours after administration of the vaccine. Currently, resident is not exhibiting s/sx of generalized pain. Zoloft was d/c'd on 6/25 to see if the start of this medication induced residents symptoms. Since d/c of medication, residents status continues to decline with only new item in regimen being the second administration of the MODERNA vaccine.

Vomiting the night of the vaccine. Low oxygen and high fever next morning. Has been on palliative care Was hospitalized, but section 21 will not let me fill the info. Hospital Admitting Dx: Sepsis, likely biliary cause; Acute on chronic encephalopathy likely sepsis related Returned 1/12 on hospice

Chills, nausea and vomiting on days 1 and 2 post vaccine. Days 2 and 3 post vaccine developed burning sensation in esophagus and dehydration. Given GI cocktail (Maalox and viscous lidocaine), IV protonix, and 500mL fluid bolus in ER on evening of 1/23 and discharged home feeling significantly better.

Onset of event approximately 12:30 pm on 3/4/2021 with duration through approximately 4:pm on 3/5/2021. Patient described extreme fatigue and weakness, disorientation/lethargy, vomiting x 1.

developed stroke with generalized body weakness, unable to speak or respond to command. Continues at this time with weakness/inability speak/feed for herself.

Approximately 15-20 minutes after receiving injection patient complained of "weakness", numbness of right side of face; patient denied shortness of breath; denied chest pain; vital signs were stable BP 126/69; Pulse 75, Respirations 20 ; Pulse Ox 99%. Patient denied itching; denied difficulty swallowing; neuro exam within normal limits. Patient was evaluated by Doctor; patient given Benadryl 12.5mg; symptoms resolved. Patient left office at approximately 2:00 pm. Phoned patient the following day (1/27/2021) and spoke with caregiver; caregiver (daughter) reported no symptoms

Moderate energy, numbness, funny breathing sounds on February 7th, 2021. Forgot to do vsafe on February 7th, 2021.

Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.