Moderna

Client had emesis x2 and multiple episodes of diarrhea. Client seen in ER and received bag of Nacl and ABX d/t ER staff finding a UTI while client was in the ER.

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

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.

Nausea, vomiting, diarrhea, chills and fever, fatigue, PO2 dropped into high 80's. Diarrhea lasted about 24 hours, N/V about 48 hours. Chills ("teeth clattering") lasted 36 hour and fever (subjective, temp not taken by patient) lasted about 48+ hours. At 5 days post vaccine, PO2 is back up to 97 and she has only fatigue.

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.

Client had pressed her call pendant this morning (2/18/2021) at 0750, LPN found client in her bed unable to stand. Client reported she had to use the restroom, upon standing client, LPN noticed blood on client's pillow. After assisting with ambulation to her bathroom, LPN noticed blood covering the floor near her shower. After further assessment, blood appeared to me coming from the back of client's head. Vital signs assessed while she sits on the toilet. BP: 128/92 O2: 89% on RA RR: 18 HR: 69 T: 99.1 Client reported significant dizziness, lightheadedness, and nausea. She reported unsteadiness when standing. Quarter sized lump with dried blood noted on the back of client's head. She does report left arm soreness, likely from where vaccine was administered. Ambulance was contacted while LPN assisted dressing client. Client was unable to recall the incident that occurred overnight, she did not utilize her call pendant during initial fall. Time of fall/incident unknown.

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.

Patient presented with hematochezia and bright red blood per rectum. Platelets were severely down to 1k. This was about 2 weeks after receiving the moderna COVID-19 vaccine first dose. Patient also with extensive ecchymosis on upper extremities and petechial rash on legs. Concern for ITP related to the drug. Patient received IVIg, Platelet transfussion, and steroids. Platelets slowly increasing, patient received NPLATE. The patient remains hospitalized with platelets up trending from 1--- >4--- >6--- >5--- >9--- >11.

arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies. On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection. On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot. Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported. The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.

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

Patient received her first dose of the COVID-19 Moderna vaccine. After vaccine administration, it was brought to our attention that patient received monoclonal antibodies 71 days prior to vaccination. Patient did not have any adverse reaction after vaccination. The next day, 3/11/21, Patients daughter was contacted and reported no side effects. Advised to call back if side effects occur. Patients daughter was also contacted 1 week later on 3/17/21 and said patient was doing well, had some diarrhea but that was it.

Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine. The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal. Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific. Action taken with mRNA-1273 in response to the events was not provided. The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments: MOD-2021-047223:Crosslinked case

One week after second Moderna shot, patient began low-grade fever, loss of appetite, foggy thinking, fatigue, general malaise. She was treated with three different meds for a possible UTI. All symptoms except fever continued for 10 days, and on March 25, she suffered a TIA. She went to the ER and stayed in the hospital for 36 hours. MRI showed no lasting damage. She is improving but is still fatigued.

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.

She became so dizzy that she could not stand. Also experienced nausea. Took to ER. Administered numerous tests and determined reaction was likely to vaccine. Took several days to recover.

FIRST THING WHEN GETTING UP IN THE MORNING, FELT DIZZY, NAUSEA AND VOMITED 3-4 TIMES, Increase in Blood Pressure; Treated with Phenergan for N & V; and rest, fluids. Lasted just this day, but wasn't back to normal for 2 days.

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???

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.

Diarrhea, nausea with dry heaves which resulted in light headedness. Resolved with fluids and rest later on in the day.

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.

Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement. The patient's medical history included constipation. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection. On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as "Intestines were blocked". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now). The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

I felt fine the day I received the shot and the following day until that evening. when I started feeling indigestion followed by very painful abdominal cramps and vomiting several times over a period of several hours. The following days I felt some indigestion and was alright after that..

Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.

26 hours post-vaccination, patient experienced vomiting, abdominal pain, and diarrhea. All of which she continues to experience which makes it 3 days now. Patient is taking zofran for the vomiting, pepto bismol for the abdominal pain, and imodium and pedialyte for the diarrhea. Vomiting and diarrhea improved with medication, but continues to persist.

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

She found passed out on the floor by a friend. The ambulance was called. She was hospitalized for 24 hours and treated for dehydration. She had fever and diarrhea.

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.

Systemic: blood clots-Medium, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Stroke-Severe

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.

Lethargic/ felt extremely weak lethargic/m body shut down; sleepy; lost appetite; couldn't use bathroom, open her eyes, or eat; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history provided). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down) (seriousness criteria hospitalization, disability and medically significant), SOMNOLENCE (sleepy) (seriousness criterion hospitalization), DECREASED APPETITE (lost appetite) (seriousness criterion hospitalization) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) (seriousness criterion hospitalization). The patient was hospitalized on 09-Mar-2021 due to DECREASED APPETITE, FATIGUE, FEELING ABNORMAL and SOMNOLENCE. At the time of the report, FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of fatigue, somnolence, decrease appetite, and feeling abnormal. Event onset Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

About 16 hours after the shot, she had a fever of 100.0, she felt very sick, nauseous, feverish, didn't eat breakfast like normal, didn't sleep last night as well. The fever broke and she's starting to feel better but it's making everyone concerned about the second shot.

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.

severe diarrhea; Two urinary track infections; severe vomiting; Second dose was given more than 36 days apart from first dose; Minerals were very low; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low) and VOMITING (severe vomiting) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Two urinary track infections) (seriousness criterion hospitalization), MINERAL DEFICIENCY (Minerals were very low) (seriousness criterion hospitalization) and VOMITING (severe vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose). The patient was hospitalized on 19-Mar-2021 due to DIARRHOEA, URINARY TRACT INFECTION and VOMITING. The patient was treated with Rehabilitation therapy for Diarrhoea; Rehabilitation therapy for Urinary tract infection; Rehabilitation therapy for Mineral deficiency and Rehabilitation therapy for Vomiting. At the time of the report, DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low), VOMITING (severe vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood electrolytes: severely (Low) severely. Patient called in to report an adverse event on behalf of her mother. Mother received the Moderna COVID 19 vaccine 2 dose series on 6 February and 18 March (left arm). On March 19 patient suffered from severe vomiting and diarrhea which led her to have 2 different urinary tract infections. Additionally, her minerals and electrolytes were very low. Patient was hospitalized as a result of this on March 19th. She was currently in rehabilitation. Patient has gone through IV antibiotics, oral antibiotics, and IV electrolyte supplements. Treatment medications included: IV antibiotics, oral antibiotics, and IV electrolyte supplements. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

States got nauseated/vomited 24 hours after the vaccine Client went to her primary physician to be checked out on 1/20/21 at 1:00pm with her son who reported her adverse reaction to her doctor and the health department.

Feeling tired, nauseated, vomiting. She fell and had to have assistance getting up, Afterwards, had some weakness in legs. She did have COVID in July. Still having some weakness. No pain.

Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to ‘possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest

On Saturday the 30th well I started off I didn't feel good. I noticed that I had a temperature of around 99.6 and I normally don't get a fever. As it got later I aching, a bad cough and diarrhea. During the night I temperature of around 101. The next morning I called my son and he came over and he called an urgent care who advised him that is was probably a reaction to the vaccine and to give me Tylenol. I got better and my temperature went down yesterday (Monday). I still didn't feel good on Monday and slept all day. I still feel a little washed out today.

Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death. Prior to her death, she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed. Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death.

Present to ED for chest pain, nausea, chest heaviness, mild headache and slight SOB with lower extremity swelling, Hospitalized starting today 2/5. EKG shows Afib with RVR (new oneset). Still in hospital at this time

Symptoms hit suddenly around 2pm on 2/112021( approx. 25 hours after vaccination) Soreness in right arm, Stomach cramping, Severe Chills, Low grade temp 99.8, Nausea. Pt was given Tylenol at 530pm and again at 2 a.m. on 2/12/2021. Symptoms subsided by the morning of 2/12/2021 but patient remained fatigued and "drained." She did not seek medical attention for this

Felt nauseated afteR Receiving vaccination. Did not eat or drink afteRwards. Stated had small emesis. Found on flooR in Bathroom with walker on top of heR 1230 AM 2/14/2021. Stated had lost consciousness. Side effects are as described to attending nurse.

VOMITING POST ARRIVAL TO OBSERVATION AREA LASTING 10 MINUTES. 130/98 84 24 X4 ACCOMPANIED BY DAUGHTER VOMITTING STOPPED AND PATIENT WAS STABLE AND WENT HOME WITH DAUGHTER

Signed ? Encounter Date: 2/18/2021 Vaccination site 02/18/2021 REACTION AFTER MODERNA VACCINATION patient vomited after 1st moderna vaccine Patient vomited post Moderna Vaccination lot number vomited for 10 minutes denied any pain/discomfort a ox4 mae vs 130/98 84 24 Patient stopped vomiting and went home with daughter and will be with other daughter Occurred at Vaccination Site Pt was stable and DC'd home with daughter

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

Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later

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.

Severe intestinal cramps...very sharp, caught my breath a few times! Went away by the next night. About 24 hrs.

Severe Dizzy, Nausea, vomited x5, elevated HR and Elevated BP . No short of breath, no fever. Day 4 still dizzy, nausea but vitals stable

He was going to be discharged from Hospice on Monday 2/15/2021. The patient was in Hospice due to a stroke. The nurse indicates after the vaccine she started with stomach pain and vomiting. Hospice evaluated her, she was given Pedialyte and then she died on 2/19/2021

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.

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.

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

Patient presented to the ED on 3/29/21 for epigastric and chest pain. Patient presented to the ED on 4/22/21 with common bile duct stone and was admitted to the 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.

Two weeks after the vaccine I had symptoms of a Stomach Virus with vomiting and diarrhea. My daughter had the same symptoms for two days on the two days before mine. I was given medication and recovered. About four weeks after the second dose I was experiencing constipation. After four days of abdominal pain we went to the ER. I was diagnosed with an impacted bowel. We don't know if was caused by the previous medication for the stomach problems. I was discharged after a few hours and it resolved at home.

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.

On 1/14/2021 resident began having a loose nonproductive cough. Lungs clear. Increased shortness of breath, Afebrile. Complaints of Left sided rib pain. Resident currently on hospice. Started Duonebs every 6 hrs. Resident also began having loose stools as well.

94 yo Female patient reported dizziness and stomach pain 7 minutes post vaccination. v/s taken BP 156/76, HR 101, SPO2 97%, RR-21. T 98. Patient stated no PO intake. Water given for rehydration + tolerated. Patient observed and RRT responded and took over. Patient taken to ER for further evaluation with s/o Pt v/s retaken BP 142/72 HR 86 SpO2 98% on room air. RR 21 T 98

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.

Moderna COVID-19 Vaccine - Pt reported dizziness, nausea, chills and red and swollen arm after receiving her first dose of the moderna covid-19 vaccine. Pt stated that she rested and stayed hydrated and symptoms went away after a couple of days. She decided to forgo her second dose until she has talked to her doctor.

4/3-was feeling unwell and didn't eat much 4/4-could not get out of bed without assistance in the am; vomited mucus and could not eat; refused Easter dinner. 4/5-woke up and had trouble breathing; ambulance called "she had no pulse, and had trouble breathing" Throughout had no fever or chills.

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

pt says her throat started burning immediately after taking the vax and she had some difficulty swallowing. her PCP came and checked her vitals. She was observed for about 30 minutes and was able to leave. About 4 or 5 days later she noticed her vision declining. She already has poor vision but seemed to be getting worse. She has a varicose vein on her right leg and her upper right leg is swollen. She will contact her doctors.

4/16 515am Itchy at vaccine area, nausea, used Sarna itching lotion, tylenol 230pm more itching lotion 315pm redness the size of baseball, hot to the touch, went to urgent care, icing 4/17 physical aches throughout, continued icing and tylenol 4/21 4am nausea and aching all throughout the limbs, couldn't walk due to pain in thighs, short of breath, tried to rest. the pain continued for over an hour till fell asleep.

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.

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) .

Nausea, vomiting, headache, fatigue, diarrhea that started about 24 hours after the vaccine and lasted about 3 days

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.

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.

nausea; takes an anticoagulant; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and contraindicated product administered. The patient's medical history was not provided. Concomitant medications included warfarin. On 24-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot unknown) in the right arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, the patient experienced nausea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, nausea, was unknown. The outcome of the event, contraindicated product administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 94-year old female patient who received mRNA-1273 and experienced non-serious event nausea and contraindicated product administered. Based on the current available information and temporal association between the use of the product and the start date of nausea, a causal relationship cannot be excluded. The event contraindicated product administered is assessed as not applicable.

Mania lasting 2 days ( not sleeping or eating, constant talking, constant activity, hearing things that weren't there.

On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.

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

Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21.

Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23

My mom received her first Moderna Vaccine on 1/22/21. Late on 1/23 her face began to swell so the staff called the ambulance to come take her to the hospital for what they thought was an abscessed tooth. ER doctor said there was an infection and that she needed to be seen by an oral surgeon. On 1/25/21 I took my mom to Dr., her oral surgeon and after the examination he advised that there was no abscess but an allergic reaction to the Moderna vaccine. He suggested Benadryl. I gave her benadryl and the swelling started subsiding. From this point on her gums and teeth hurt. Her eating habits started to decline. She received her 2nd Moderna vaccine on 2/19/21 and from that point on she could no longer chew or brush her teeth because the pain was so severe. She passed on 3/19/21.

Patient's family called us on 03/18/2021 to report vomiting for 3 days starting after her vaccination. They took her to hospital where the family reports she was diagnosed with bowel obstruction. She declined surgery because of her age and underlying comorbid conditions including breast cancer and diabetes. She passed away on 03/22/2021.

Clinic appointment for RUQ abdominal pain and emesis. Admitted to unspecified hospital, treated with IV protonix and IV fluids with K+.

Resident began coughing then complained of abdominal pain and was taken to the Hospital. He began to vomit and breathed in. Had a heart attack

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

Shortly after being vaccinated patient started vomiting. Staff was able to help her and stop vomiting. Later she started vomiting again. Vomit was black and was also passing black stool. This was reported by director of FACILITY.

Systemic: Chills-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Joint Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Fainting-Severe

nausea, vomiting, insomnia, runny nose--started 1:00 AM 21. /Left arm sore at injection site. Still have runny nose

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.

RN administered vaccine in drive through setting and asked pt to park and wait for 15 min. following vaccination. She done so and after 15 minutes she left the facility. Right after that, on her way home, she began to have trouble swallowing, her lips were numb, and her tongue was tingling. She was brought back to the clinic by her caregiver and evaluated by EMS. She was given oral benadryl per patient and held for monitoring. After this, patients symptoms began to improve and everything went back to normal. She was released from EMS care back home.

fever 100.4 (2 days duration), diarrhea ( on day 4), extreme fatigue ( durated 2 days commenced on day 4), erythema and swelling of right arm where injection administer( commenced day 1 , fading but not gone on day 8).

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.

Loss of apatite to the point of no ingestion through mouth. During hospitalization, the medical staff identified a mass at the abdomen.

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.

Resident reports that she is not feeling well this morning. Reports cold chills, nausea. Stated that she vomited around 4am.

Pt receieved her first dose of the Moderna COVID-19 on 12/29/2020. Lot number, route, and site not specified in medical record. No record of 2nd dose was found on medical record review. Pt was admitted to reporting hospital 2/2/2021 with an admitting diagnosis of failure to thrive/poor oral intake. Pt was reported in ER to have a sore throat, cough, shortness of breath, and general recent decline. Reported that pt and others in family had GI like illness about a week ago. Admission test for COVID was positive per PCR NP swab on 2/2/2021. Pt still currently admitted.

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

After the pt received her 2nd dose of the COVID19 vaccine while sitting in observation she reported feeling "queasy." Also reported feeling like her heart was beating fast. Pt was evaluated by RN and EMS paramedic. BP 195/83 and repeat 175/129. HR 76 and 83. Per RN and EMS pt seemed to be in a-fib. Pt states her MD recently took her off of medication for a-fib. Pt was advised to go with EMS to the ED. Pt refused despite counseling and encouraging her to go an be evaluated. Pt signed refusal for transport with EMS. Pt's daughter came into clinic to walk her out. RN discussed with pt's daughter and reiterated the recommendation for ED eval. RN also advised both the pt and her daughter to call her PCP and speak with the oncall MD for further recommendations since she is refusing transport to ED. Pt and her daughter verbalized understanding.

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.

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

esophagus is severely inflamed; unable to eat or hold down fluids; nausea; vomiting (thick mucusy stomach fluid); Fluid at bottom of lungs; Acites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed), FEEDING DISORDER (unable to eat or hold down fluids), NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PLEURAL EFFUSION (Fluid at bottom of lungs) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting (thick mucusy stomach fluid)) (seriousness criterion hospitalization). On 21-Mar-2021, the patient experienced OESOPHAGITIS (esophagus is severely inflamed) (seriousness criterion hospitalization) and FEEDING DISORDER (unable to eat or hold down fluids) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to FEEDING DISORDER, NAUSEA, OESOPHAGITIS, PLEURAL EFFUSION and VOMITING. At the time of the report, PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed) and FEEDING DISORDER (unable to eat or hold down fluids) had not resolved and NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) blood work done shortly before getting COVID vaccine and everything came back normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional information: Patient was admitted to the hospital 10 days ago on 21Mar2021. Nausea and vomiting was continuing, patient's esophagus is severely inflamed, patient is unable to eat or hold down fluids, had to start TPN, has had Gastro-Intestinal biopsies performed, Computed Axial Tomography scans, endoscopy, esophagram, oncologist consulted-nothing showing up, fluid in bottom of lungs, ascites-pulling fluid off abdominal cavity with paracentesis (first on 5Mar2021, second paracentesis scheduled for today.) Doctors have been in touch with another facility.; 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.

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.

Approximately 10 minutes after receiving her vaccination patient fainted, then once she gained conciousness she vomitted a small amount of water. Family that was present, said that this is a somewhat common occcurence as she's had several episodes similar to this within the past year.

Extreme fatigue, shortness of breath. Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well. Death occured on mon, Feb 8 2021.

We were told by the administering healthcare worker that approximately 20% experienced symptoms, and someone of her advanced age would probably only experience a sore arm. Nearly everyone in the retirement home was extremely ill after the second dose; most of the administrative staff went home sick; skeleton crew pulled double shifts caring for residents with extreme "blow-out" diarrhea and debilitating nausea. One patient reported temporary paralysis. Men complained of sore arms but women couldn't get out of bed. We were prepared with prophylactic anti-emetic meds and avoided diarrhea. However, patient had headaches and nausea for a week; refusal to eat/drink put patient at risk for dehydration and kidney issues; fasting exacerbated confusion and put patient at risk of harm (wandering, falling, etc.) Patient is still lethargic and confused, has started eating again but only minimally, a few bites. Strongly regret vaccinating.

resident received 1st dose of Moderna at hospital on 2/21/21. Patient admitted to nursing home on 2/22/21, the day of our first clinic- transition of care did not identify covid vaccine having been given from day before. our state did not have the hospital dose entered when we entered our 1st dose. Patient received 2nd Moderna dose. on 3/24/21 from our clinic which at that time of documenting in our state of the 2nd dose did we see it actually was her 3rd dose.

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.

This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.

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

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

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 became lethargic, extremely tired, unable to care well for self. Patient had no appetite, refused most food and spent many hours simply sitting in her chair. She felt that she was having a heart attack and called 911 using her emergency response button on 2/21/2021. Doctors indicated that the patient's life was in serious danger, but because of age they were hesitant to try to remove the clot pressing on her heart. She was only allowed to go back home because we utilized Hospice. When asked about her life expectancy, we were told she could die any minute or might live a few more months, but that she was not expected to live much longer. SHE WAS IN GOOD HEALTH PRIOR TO THE IMMUNIZATION!

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)

A little delirious; Very tired; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (A little delirious) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided.). On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DELIRIUM (A little delirious) (seriousness criterion medically significant), FATIGUE (Very tired) and VOMITING (Vomiting). At the time of the report, DELIRIUM (A little delirious), FATIGUE (Very tired) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

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.

These side effects lasted about 24 hours: fever-101, chills, pain ,swelling and redness at injection site, swelling/ knot the size of orange, throwing up, very tired. The pain and swelling of injection site/ arm lasted about a week. My mom tested positive for covid=19 on 1/15/2021. She had a negative covid test on 1/22/2021. She received the 1st Moderna vaccine on 2/24/2021 in which she had the above side effects. the 2nd vaccine is supposed to be given on 3/24/2021.

On 02/16/2021 at approximately 6 PM, patient, who usually uses a walker, fell while returning to her chair. Although she reports that she is not in any pain, since then she has been unable to walk more than 1-2 steps. She has also lost her appetite.