Moderna

Localized swelling, redness and itching 6 cm in diameter at injection site. it developed about 7 days after the injection

Began having a local reaction. Spread to current size of 6 in by 4 in. Warm to touch, area swollen. Has not progressed in size over past two day. Somewhat sore, very itchy. No other symptoms except for the local reaction.

Pt started wtih peripheral edema around 1/1/2021 which progressively worsened and then signifcantly worsened overnight after 2nd dose. Complete work up in ED with normal CBC, CMP, UA, negative LE doppler, negative chest CTA, normal ECHO.

Swelling, redness,itchy rash. Very hard swelling at the site of the injection. Has been taking oral benedry and applying ice to the site. Today,01,21,2021, the redness is spreading

Raised red bumps in a rash all over the abdomen, arms & legs. First noticed at 6 pm, majority of rash gone the next morning except. Under arms and upper legs.

Caller had vaccine at 2:30 pm today. Vaccine given in left arm. Now states he has quarter size swelling on his left side of his face starting from his left eye to his mouth with redness and itching. Advised to call his PCP. 24 follow up will be done.

PATIENT WOKE UP WITH RIGHT EYE REALLY RED SWOLLEN. ALSO FACE WAS SWOLLEN. TOOK BENADRYL WHICH HELPED TO ALLEVIATE AND BRING DOWN SWOLLEN FACE.

Almost two weeks after the shot, i noticed itching on my left arm. After showering the next day I noticed a red area about 4 inches wide and 8 inches long with slight swelling and itching. The swelling and itching was not noticed in the days immediately following the shot. I will contact my doctor about the situation and follow up with them if the condition gets worse or does not go away.

Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache and fatigue following receipt of the Moderna vaccine 10 days prior. Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.

Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF, A.Fib contributory.

The left hand/fingers (injection site was left deltoid) became very swollen which lasted for about 3 days. Initially the hand was very warm but that dissipated after day #2. There was no pain or loss of function at any time.

Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021

Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000. He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25. About 4-days later he developed diffuse dermititis and severe fatigue. He had an ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin (completed Feb-15). CBC was NOT done at that ED visit. He called HEME clininc on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling well in general with increased fatigue and DOE. He noted that the dermatitis was mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that indicated ACUTE LEUKEMIA. Presents to the MC with MDS on FEB18.

Received 2nd dose of Moderna on 1/26/21 and was admitted to the hospital (IVCH) for septic right knee on 2/17/2021

Received1st dose of Moderna on 12/30/2020 and was in the hospital on 1/19/21-1/25/21 for a neck mass.

pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.

2/19: left arm, red spot approximately 2" in diameter at site of shot; itchy 2/20: left arm, redness increased to 3-4" in diameter; itchy; by evening increase to approximately 5" in diameter 2/21: left arm, redness area no change; itchy; swelling increased after physical exertion; tender and warm to touch; 9:30pm took 1 tablet Benedryl; 11:00pm took 2nd tablet Benedryl 2/22: left arm, redness and swelling increased; approximately 5-6" in diameter11:00pm took 1 Benedryl tablet 2/23: left arm, redness and swelling diminish slightly, approximately 5" in diameter; 11:00pm took 1 Benedryl tablet 2/24: left arm, swelling diminished; red area unchanged; 11:00 pm took 1 Benedryl tablet 2/25: left arm, swelling further diminished; red area unchanged - 5" diameter 2/26: left arm; no swelling; red area smaller - color changed lighter, more pinkish, area 2-3" in diameter at shot site 2/27: left arm; pink at injection site; approximately 1-2" in diameter; slightly itchy

Neck mass; A spontaneous report was received from a health care professional concerning a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck mass. The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 12 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On the 19 Jan 2021, prior to receiving mRNA-1273, the patient experienced neck mass. Patient was hospitalized from 19 Jan 2021 to 25 Jan 2021. No treatment details were provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, neck mass, is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Noticed left arm began itching last night. This morning, my arm was hot, red, swollen with a red streak across my upper arm.Put cold compress on arm around 2:00 pm as my wife was concerned. She called her nurse on call line and they told her to watch it and try to have it looked at in 24 hours if not better..

Approximately two weeks after receiving my first dose of the vaccine, I started experiencing upper body bilateral joint pain, primarily in shoulders and wrists. This pain has continued since then for approximately six weeks now. In addition, my right arm, hand, and fingers are swollen, and the tips of my fingers on the right hand feel slightly numb. I have been taking acetaminophen, ibuprofen, and naproxen, but still have the symptoms described above.

Moderna COVID-19 Vaccine EUA 3-March to 7-March: sore left arm, then later sore neck, chills, aches all over body and general blahs. Took Tylenol Extra Strength 500 MG as needed 8-March to 15 March : forehead and left side of upper face swollen, red and slightly itch . I Put some Polysporin ointment on and it seemed to help a little. Called my doctors office on 12-March, they these symptoms were due to the Moderna shot and that I should ride it out until they went away.

Approximately 8 hrs after the second Moderna vaccination I starting having chills. These continued and increased in intensity along with the onset of fever. I did not have an accurate means of taking my temperature at the time. Over the course of the night on the 17th/18th of February the chills and fever never subsided, even with two doses of Tylenol. The day of the 18th, fever and chills continued along with a feeling of intense malaise. My sternum was very sore and it hurt to breathe as a result of the prolonged shivering. I had no appetite and ate absolutely nothing the day of the 18th. In the early morning hours of the 19th my fever broke as did the chills. However, later in the day, a thermometer was obtained and my fever was 101.4 degrees. When taken at bedtime, it was down the 99 degrees and returned to normal later with no future spikes. On the morning of the 20th when I awoke, I noticed a stinging soreness in my mouth and lip area, followed later in the day with my nostrils and inner nose. This turned out to be an intense outbreak of Herpes. The roof of my mouth, gums, upper surface of my tongue, lips, nostrils, and inner nose ultimately became covered and extremely painful. These lesions were not typical blebs, but were tiny, albeit most painful. After five days they resolved and I have had no further issues. As a possible area to investigate - I had had the second Shingles booster 14 days prior to my first Moderna COVID vaccination. I understand Shingles is also a Herpes family virus.

SHORTNESS OF BREATH ISOLATION-INFECTIOUS DISEASE SIRS (systemic inflammatory response syndrome) Hypokalemia Hypomagnesemia Lactic acid acidosis Hypoxia Transaminasemia Generalized weakness Abdominal pain, unspecified abdominal location Suspected COVID-19 virus infection

Patient reported swelling of left hand and forearm started 2 days after vaccination. Was evaluated by PCP on 3/11/21. Noted swelling left hand, wrist, forearm. few small areas of patchy erythema. u/s negative for DVT. inflammatory markers elevated, uric acid elevated. Given prednisone burst and taper with some improvement in symptoms, but not full resolution. Seen by rheumatology on 3/24/21 with broad differential and plan to monitor/close f/u. recommended against second vaccine dose for now.

Itching after 30 minutes. Full body hives after 45 minutes. Facial swelling and itching. Racing heartbeat. Took Tylenol at the one hour mark. The hives itching lessened after three hours. The facial swelling and under skin full body itching, extreme tinnitus and racing heart lasted at least 10 days. Two blood pressure readings during the first week confirmed higher blood pressure. Everything was normal after 14 days. My allergist recommended not taking the 2nd Moderna shot. I am now seeking his guidance on getting the J&J shot - hopefully a test on whether I can tolerate its polysorbate.

couldn't stand on feet; has a large swollen area/swollen twice the normal size/hardness belowhis elbow; has a knot in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) and DYSSTASIA (couldn't stand on feet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) 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 reported). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced MUSCLE MASS (has a knot in his arm). On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSSTASIA (couldn't stand on feet) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DYSSTASIA and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow), DYSSTASIA (couldn't stand on feet) and MUSCLE MASS (has a knot in his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. 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. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email address of primary reporter was added, peripheral swelling was updated as serious due to hospitalization, new event "couldn't stand on feet" and duration of hospitalization was updated.; Sender's Comments: This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. 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.

swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) in a 76-year-old male 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details include prednisone, Benadryl and oxycontin. Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

Per patient and spouse: 2nd dose of Moderna received on 04/01/2021. (This facility does not have record of administration). Patient seen in ED 4/11 after 5 days of bilateral lower extremity weakness, gait problems and numbness. Patient admitted and evaluated. Neurology consulted and on 04/13/2021 diagnosed with likely acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barre syndrome.

death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death.

Leg swelling and discomfort. Saw primary care provider who thought this was varicose veins and referred to vascular surgery. Venous duplex revealed DVT involving left leg. Patient treated with at least six months of apixaban.

swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) in a 76-year-old male 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 medical history reported.). On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms. Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or 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. This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or 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. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case

Patient presented to hospital evening of 1/27/21 with acute onset weakness and buckling of knees, admitted to medicine service and neurology consulted. Patient diagnosed with acute motor axonal neuropathy, a variant of Guillain Barre Syndrome. Patient received IVIG 1/28-1/31. Despite IVIG treatment, patient with progressive worsening of motor weakness, resulting in diaphragmatic weakness requiring intubation on 1/29. Patient has remained ventilator dependent and is now s/p tracheostomy.

Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020. Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death.

PATIENT STATES HE GOT THE 1ST DOSE . HE GOT RASH AND SWOLLEN ON BOTH HANDS. IT WENT AWAY AFTER A WEEK OR SO. HE GOT THE SECOND DOSE AND SAME THING HAPPENED. HOWEVER AFTER A FEW WEEKS IT RESOLVED. NOW IT CAME BACK AGAIN. HE ALSO HAD ULCERS IN HIS MOUTH

Received the first and second doses at Pharmacy. Second vaccine shot was on Friday, May 14, 2021, in the left arm. On Saturday, May 15, 2021, I wasn't feeling well. Then later in the evening I developed a bulge under the left arm. The lympth node increased in size; my left arm would ache, especially if I would stretch to reach for something. I have been applying cold packs. This situation has now continued for two weeks.

rom: To: Cc: Subject: Patient Concerns Date: May 29, 2021 6:42 PM Dear Sir/Madam, I would have liked to include her in this message but am not in possession of her official email address. To recap the encounter on April 29, 2021 : I went with my friend to the clinic,where we spent 12 most frustrating hours I expressedly told the staff with my friend present, that I have been an extremely healthy individual, who has never seen a doctor,/ER/hospital in over 40+ years. I am happy to give you my previous employers contact info to verify that I never missed a day`s work. I told the staff I suddenly fell very ill 2 days ago 2-3 weeks after my 2nd CVID 19 vaccination. with sudden massive bilateral leg edema up to the groin and extensive lower leg blood staining and mottling of my skin. The attending dr just called it Pedal Edema. He was not interested in my history (present and past), no examination, had to remove no clothes. My friend and later neighbors in the community where flabbergasted that he did not see the state of my legs. Obvious other symptoms such as abdominopelvic ascites was also present. Further tests were done and inexplicably suddenly pulmonary atelectasis and cirrhosis of the liver become important. Could that really make me so sick in two days? Absolutely incomprehensible. there was an avalanche/cascade of blood destruction with destruction of RBCs, hemolysis, loss of platelets, obvious very high total bilirubin, hypoalbuminemia and ascites. My bed sheets still show numerous blood stains where I bled from many of the skin lesions and scabs Those were all results due to one common denominator:: reaction to COVID vaccination. Forget about pulm atelectasis or liver cirrhosis making me so sick in 2 days i AM INTERESTED TO SEE YOUR EXPLANATION A quick comment for her and her comment about compassion, She is probably unaware, that are quite a few nations in this world, where medical colleagues do not charge their colleagues/family and the pastor/family of their church, I lived/worked for a for a few years in another country. One night I was called to drive into one of the park's camps to attend to a colleagues wife who had an incomplete miscarriage and bleeding, This was quite a drive through the night back to the hospital, doing a D&C and the couple could happily continue their journey that afternoon. No charge by the hospital or me. That is compassion. Dr.

Rheumatoid factor elevated at 45, CRP 122 Patient was in good health, with distant history of Graves Disease until April 5 when he presented to Hospital with complaints of chest pain, worse with sitting up. CAD was ruled out with troponins and he was taken to the cath lab and found to have essentially normal coronary arteries. He was started on colchicine with improvement in chest pain. On April 30th he presented to Hospital with low grade temps, cough and right sided chest/abdominal pain. He was found to have moderate pleural effusion. Because he was on Eliquis, for episode of afib thought related to pericarditis, pleurocentesis was delayed until May 3 when 1.5 L of fluid was removed from his pleural space. He continued on colchicine and 3 days later reported feeling essentially normal. Blood and fluid cultures were negative. Pleural fluid cytology showed predominantly chronic, inflammatory lymphocytes and macrophages/monocytes, reactive mesothelial cells. There was no overt morphologic evidence of malignancy. Patient was feeling well. Dr stopped Eliquis, Cochicine and patient did well until May 17 when he again reported aches, chills and pleuritic chest pain. Pleural effusion recurred and patient restarted cochicine with improvement

Developed Guillian Barre Syndrome. Lost mobility in legs and unable to walk, shortness of breath, heartburn, severe burning in the chest.

Patient is a 76-year-old male with a past medical history significant for dementia, CVA 5 years ago with right-sided hemiparesis, functional parapalegia/wheelchair bound, chronically aphasic, hypertension, type 2 diabetes which is diet controlled and history of BPH who presented to the emergency room on 1/26/2021 with diarrhea that began on jan 18th 2021 and was admitted to the hospital.. Patient spouse reported that the patient got his first dose of the Moderna vaccine on January 14 and then the patient began having a fever on January 18 of 103 degrees and then developed diarrhea which continued. He was started on Imodium by his PCP on 121 with minimal results and was encouraged to follow a brat diet. He was then encouraged by the PCP to come to the ER for further evaluation of dehydration or colitis. Patient was on trimethoprim 100 mg daily for chronic UTIs which was discontinued on admission and therafter. In the ER he tested positive for C. difficile and he was started on vancomycin p.o. 4 times daily. He was also noted to be hypotensive and dehydrated and was started on IV fluids. He remained in the hospital for 4 days and was discharged home on 1/30/21 on vancomycin orally for 10 days with improvement. . He returned back to the hospital on 3/17-3/19 for recurrent c difficile, sepsis and colitis and was discharged on a prolonged vancomycin taper with improvement. He returned back to the hospital from 6/26-7/2 for again c difficile colitis, ileus and sepsis and was seen by infectious disease and gastroenterology and was discharged home on vancomycin orally qid for a prolonged taper. If he again fails this treatment the plan will be for a fecal transplant. He was again admitted on 7/6/21 and remains hospitalized with severe c difficile colitis/diarrhea not responsive to treatment. Now having some streaks of blood in stool. Stool occult blood was neg on admission, however. Also now has concurrent Pseudomonas UTI. CT abd/pelvis 7/7 showed "Marked irregular thickening of the wall of the rectum demonstrating cystic changes. Findings extend into the distal sigmoid colon. Differential diagnosis includes severe protosigmoiditis and neoplasm." and "increased feces throughout the colon consistent with constipation." Pt has been having 2-3 watery BM's per day since admission. Infectious disease concerned about possible undiagnosed malignancy, which may be driving his clinical picture rather than C diff. Recommended colonoscopy and to continue PO vanc x 10 days then resume taper. -pt was transferred to hospital for GI involvement for a colonoscopy/sigmoidoscopy on 7/8/21 where he remains hospitalized awaiting further work up.

Developed hives; Extremely itchy; It worsened and spread over the entire body; Rash on the shoulder near the injection site; Anaphylactic reaction; Red Bumps; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced RASH MACULAR (Red Bumps). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red blotches, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), RASH MACULAR (Red Bumps), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. According to the report it started as a rash on the shoulder near the injection site in the evening of the 1st dose. There were tiny dots which were extremely itchy. Skin like scabs would fall away on scratching them. The next day, it worsened and spread over the entire body. Patient called an ER doctor and he was told that he was having an anaphylactic reaction to the propylene glycol component of the vaccine. He then visited a dermatologist and received a steroid shot and he was put into an oral steroid regimen where the dose tapers every day. These calmed the symptoms down but by the 10th day though they were still visible. It took several months for the events to resolve. He was advised not to take the 2nd dose of any COVID-19 vaccine. No relevant concomitant medication information 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 Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received on 14 Jul 2021 as a Telephone Contact Report wherein events anaphylactic reaction, pruritic, injection site rash, urticaria, rash were added. Event outcome updated as recovered. Action taken updated to withdrawn. This case was upgraded to serious as event anaphylactic reaction was added.; 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

Right elbow swole vup to two to three times its normal size. Both feet swole up and was so sensitive I could not touch the floor or stand. Was hospitalized for a total of eleven days.

Upper lip, left cheek, part of right cheek swelled up. We have pictures with times pictures were taken from different angles. Ice was applied and generic Benadryl was given, 2 tables. Swelling started at 5 pm, continued to increase until approx 8:30 pm. Upon waking face was still swollen the next day. Swelling started to decrease noticeably approximately noon on the 9th. By 7pm on the 9th most swelling had decreased, except for left lower cheek and upper lip still had noticeable swelling. This report is being filled out at 7:10pmon January 9, 2021.

not much sore ness from the shot at all. on the 1-11-2021 I felt a little flue like symptoms. head ace, low temp 97degres, aches in shoulders, small lymph node under left arm solen , I went to bed and the next morning it was gone. Tonight I feel a little of the aches. not bad but wanted you to know. Im ready for the next shot on the 1-28-2021.

Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

Noticed today that left arm is a bit swollen . Has a pinkish color and slightly warmer than corresponding area on right arm. Slight soreness when area pressed.

The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.

Swelling and pain in arm for several days. About 1 week after the vaccination, I developed chills, headache, muscle aches,fatigue, swelling of the knees and difficulty walking. I began to improve after 2 days, but recovery was slow.

Leukocytosis with blast cells - concern for heme malignancy Jaw swelling with lymphadenopathy, confirmed with CT - ?2/2 to new heme malignancy vs adverse reaction to vaccine

morning after vaccine woke up with the worse headache and left are soreness. The following morning headache and body aches from the hips and both legs. In the following days pain got progressively worse until it was very difficult to walk. After a week of this the pain settled into my left hip. On the 9th day of pain and difficulty walking went to see my PCP. Treated me for bursitis of the left hip with a steroid injection to the left hip joint. Pain has gotten better but still painful. The vaccine was given at Urgent Care. Post vaccine visit was with PCP

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

Feeling of impending doom. Felt like I was going to die. Symptoms of Anaphylaxis but did know that was what it was. Failed to call paramedics which I should have . Kept getting worse all night and the onset of vomiting, diarrhea, fever, which lasted three days.

Had muscle and joint pain and low fever for 2 days after vaccination. Stayed in bed. 4 days after vaccination a bubble the size of 3/4 of a golf ball popped up on the tip of my left elbow, Olecranon Bursitis. The pain was minimal but I could not put the elbow on a table or the arm of a chair without sudden pain. Bubble stayed the same for 4 weeks and then slowly went down over 10 days. Elbow is still sore when hit or put on a table. Got vaccinated 2nd time in the right arm on 02/22/2021. Right knee started hurting after 4 days. Could only walk by keeping the leg straight. Went away as suddenly as it came after 4 days.

He had the injection, had the sore arm and approximately 3 hours after the vaccination he began to experience severe chest pain across his entire chest and into his jaw, which was exacerbated upon taking a deep breath. He called his cardiologist who advised him to go to the ER. He was worked up, subsequently admitted from 2/8/21 to 2/11/21, a lot was ruled out but no specific diagnosis made at that time. They did note some pleural effusion and pericardial effusion at that time. Upon discharge on 2/11/21, starting Thursday evening he continued to have pain in the chest, but not as severe as when he entered into the hospital. Every evening including last night has began with severe night sweats, low grade fever and the chest pains have continued. Went to see his PCP, Cardiologist and his Electrophysiologist several days later the following after discharge, he does have a pacemaker, and was told by all three of them that he has pericarditis and that the reaction could have been related to the vaccination. It seemed more than coincidental that the symptoms did not appear until 3 hours after the vaccine. Was put on Colchicine to treat the pericarditis and then received a 2nd opinion and has reinstituted the colchicine. His low grade fever has finally dissipated. During the day he feels okay, but still continues with the chest pains and the night sweats. His hemoglobin dropped in the hospital possibly related to the heparin and then put on Eliquis postop, and now discontinued, and received an iron infusion to boost his hemoglobin. He is scheduled for another iron infusion this Wednesday. He went to see GI physician and feels that he may have a bleed due to the infusion. He has had an anastomosis due to Crohn's disease and feels that's where the bleed may have been coming from as he did have an ulceration at last colonoscopy. He did have atrial flutter due this and was advised to have an ablation, and trying to reduce the pericarditis and FU later with other heart related problems.

foot and lower leg on leg with torn miniscus in knee, swelled up next day after 2nd dose of moderna. today ,almost month later they are still swelled up

Patient presented to ED with complaints of severe fatigue and generalized weakness. He complains of chills as well. WBC found to be elevated. No electrolyte abnormalities found. Patient is suspected to have a urinary tract infection. Patient received ceftriaxone for UTI. Patient was admitted to the hospital.

Blood clot running from ankle to groin; entire leg swollen; still swollen after 6 weeks; received shot of heparin and put on Xarelto; blood clot was just short of where it could break off and go to heart or lungs.

adverse events: multiple joint swelling, redness and pain, plus bilat led edema Treatment: steroids oral and injected, Outcome: improvement at first but wrist pain and swelling came back requiring injections

About 1-2 weeks after first COVID Vaccine, he started to experience breast and axillary tenderness + swelling which are still present.

patient started experiencing swelling in the face and arm, arm is red, hot to the touch just below the injection site

Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for "flu b". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a "spot" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat "pneumonia". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was "atypical and abnormal" what was happening. It should not have happened. 180 degrees from normal.

Hospitalized for 8 to 9 hours; Could not walk; Whole body shutdown; Swollen arm; nostalgic; A spontaneous report was received from a consumer concerning a 77 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nostalgia, could not walk, swollen arm and whole body shut down, and hospitalized for 8 to 9 hours. The patient's medical history included allergies to bee stings. Products known to have been used by the patient within two weeks prior to the event include: unspecified cholesterol medication, aspirin and unspecified hernia meds. On 08 March 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 036a21a) intramuscularly for prophylaxis of COVID-19 infection. On 08 Mar 2021, the patient experienced nostalgia, could not walk, swollen arm, whole body shutdown and was hospitalized for 8 to 9 hours. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of the report, the outcome of the events, nostalgic, could not walk, swollen arm, whole body shutdown and hospitalized for 8 to 9 hours, were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine

Patient came to office for complaints of body aches, chills, hot flashes, sweating and lightheaded. Nausea and loss of appetite.

Patient had COVID infection in 12/2020. Had 1st moderna vaccine 1/31/21. developed new headaches 2/12/21. 2nd dose of moderna COVID vaccine on 2/25/21. on 3/18/21 admitted to the hospital with right sided weakness, expressive aphasia, left gaze preference and right hemineglect found to have a left posterior parietal intracranial hemorrhage with vasogenic edema and extensive venous sinus clot involving the superior sagittal sinus, bilateral transvere sinsu and sigmoid sinus to the level of the jugular veins. He stabilized and was airlifted from one place to another to have hospice care.

Was in good health. Received 2nd dose of COVID19 vaccine on 4/7 with progressive weakness and confusion following vaccination. Admitted to hospital on 4/18 with confusion, fevers, thrombocytopenia, mediastinal adenopathy and elevated LFTS and inflammatory markers. Workup has been negative but ongoing fevers and confusion. Labs have improved without treatment.

Patient developed fever after second COVID-19 vaccine and over the next two weeks became increasing encephalopathic before presenting on 4/18 and being admitted for encephalopathy and persistent fever. He was found to have mediastinal lymphadenopathy There has been no cause for fever through infectious, rheumatologic, and hematologic evaluations.

77 y.o., male come to ED on 12/24/20, with complaint of SOB and neck swelling. Per ED notes, PE: Large left side neck mass (Erythematous, warm and tender). Possible abscess vs gland infx vs lymphadenitis , which started 4 hours PTA. Pt stated he woke up with the symptoms after having his COVID vaccination yesterday (12/23/20). Patient was given clindamycin in ED, had an anaphylactic reaction (neck, tongue and epiglottis swelling), developed progressive respiratory distress requiring intubation. Noted to develop complete heart block, had 2 cardiac arrests with preceding bradycardia, had transvenous pacer and and tolerated procedure well. He was discharged back to SNF on 1/02/21. Patient noted to have a subclavian DVT on DC, and will start Eliquis.

After a couple days, the patient because nauseous for a day or two and then developed stiffness in his arm, neck, back, and clavicle area. He has had these symptoms for about 5 weeks. Suspected administration being too high and accidental injection into the shoulder joint resulting bursitis.

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

21 days later i was out walking my oxygen level began dropping down to 80 and I started throwing up. then i and took my blood pressure it was 125/80 and I tried to eat a cookie and I threw up. I went straight to ER. He gave me EKG, and he sent me straight to the Operating Room. 10 minutes after I saw the doctor he started the stint and that's when the oxygen dropped to 0, They knocked me out completely and I was in surgery and that is all I remember. I had a full blown heart attack on the table, called a widow maker- means the main arteries shut down completely, and my oxygen dropped to 0. The doctor put a stint in. Since then I started taking baby aspirin and brilinta 90 mg - 2x day, both are blood thinners. I took the 2nd Moderna shot on 5/18/21, which was advised by my doctor to wait 90 -100 day. I didn't have AE just a little swelling in the arm. I'm recovered from the AE from the 1st Dose, but my arms and legs are still a little. Not able to build up the muscles to were they were.

Patient was diagnosed with Guillain Barre Syndrome in late May. Symptoms began in early May. Lower extremity weakness and paresthesias. He did not have any other proceeding illness that might be expected to cause GBS. I do not necessarily believe the COVID vaccination he received in Jan and Feb caused his GBS. On the other hand I don't have another explanation and thought it should be reported to VAERS

2 days after vaccination the lymph nodes started to swell bilaterally, and then the right side nodes had returned to normal after a couple of days. The main swelling of lymph node continues to be on the left side of the body on the upper neck, behind the jawline behind the ear.

Patient came into the clinic today to report the following: He states he received his first Moderna injection on 1-26-2021 and the second on 2-23-2021. One week after the second shot he began to have severe joint pain in his hands, knees and shoulder. 2 nd week after the last shot he had the shingles. The 3 rd week after the shot he was diagnosed with blood clots in both lungs and was hospitalized for 3 days. They gave him blood thinner in the hospital and sent him home with more to take. States as of today (6-4-2021) he is still having problems with fatigue and swelling/ pain in his hands, knees and shoulders.

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

Pt experienced abdominal pain, emesis, leukocytosis. Admitted to hospital on 5/25/2021 and was diagnosed after workup with small bowel obstruction due to a single abdominal adhesion, which was lysed on 5/28/2021. No prior history of abdominal surgery. Discharged from hospital on 6/7/21 in stable condition. On 6/12/2021, pt developed further abdominal pain. Workup revealed SBO with multiple abdominal adhesions that had redeveloped.

was admitted to hospital with symptoms of pericarditis, chest pain, on 3/25/21; chest CT and echo showed moderate pericardial effusion; no tamponade; improved with ibuprofen and discharge on 2nd day 3/26/21; DDimer was positive and sed rate and CRP were elevated; chest sxs all resolved by 2nd day of hospital and felt well; repeat cardiac echo 4/26/21 normal, no effusion; no recurrence of sxs after 3/26/21 and doing well as of 7/18/21

I received my second shot on 02/05/2021. About a month later I developed muscle pains. These progressed over the course of the next several weeks. On June 30, 2021, I visited my physician and was diagnosed with polymyalgia rheumatica. I was put on a small dose of prednisone, and my symptoms subsided promptly.

Rash at injection site, on lower back, left hip, chest, arms, inner thighs, armpits, Swelling, itching, burning on both hands and fingers. Itching and burning on lower back. These symptoms began a day following injection and grew much worse on the second day after injection. Prescribed a prednisone steroid, zertec, over the counter Benadryl, and an epipen

Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours. Very weak and shaky for another 24 hours.

Fever and sore arm at shot site. Ibuprofen took care of the fever that day. No fever the next day. Sore arm with some swelling persisted for 2 days thereafter and subsided.

LEFT HAND SWOLLEN, MILD BODY ACHES, FATIGUE, CHILLS, 99.5 TEMPERATURE. ALL OCCURRED ONE DAY AFTER SHOT AND ONLY LASTED FOR ONE DAY. EVERYTHING BACK TO NORMAL 2 DAYS AFTER SHOT.

Patient had a sore arm on the evening of vaccination. The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb. He was transported by ambulance to the ER and admitted. He received IV therapy and acetaminophen. He states he vomited February 4th. An X-ray was performed on his abdomen and he was given a diagnosis of Ileus. The next day, February 5th, he was able to have a BM and eat. After he was able to eat, he was released from the hospital. Shortly after being released from the hospital his lips started breaking out in fever blisters. He estimates he had 50 or so cold sores and his lips were extremely swollen and red. After seeing his regular health care provider, he started a round of Valcyclovir. On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.

2nd shot 10th @ 1115 , 1st shot 1/13/2021 lymphedema, red, itchy, fatigue lump under arm that has moved to breast.

Developed a fever of 101, pain and swelling in my shoulder, sluggish feeling. Fever was gone the next day. The only residual was pain in the shoulder.

Arm red, warm, and swollen from shoulder down to hand. Right side lymph nodes also enlarged. Some tightness, pain, and itching. Arm warm to touch. Today is 15 days after injection. Arm swelling has reduced every day, but still persists.

He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk. On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine. Next day, he started having jaw stiffness and had difficulty in brushing his teeth. He was complaining of blurry vision in both eyes. He denied any double vision. He stated he could not read things which he was able to read 2 days ago. A day before he presented to Hospital, he was not able to walk at all and he required walker. According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center. Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis. pt underwent imaging of CNS, LP and extensive laboratory testing.

3/7/21 ER to inpatient Admission (covid positive 3/7/21) 3/11/21 Transferred to higher level of care Date of Service: 3/8/2021 Chief complaint: Chest congestion HPI: Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19. Patient presented to ER brought in by EMS from local residence. Was complaining of chest congestion. Patient had been seen in ER earlier same morning complaining of cough. Was afebrile at that time. Oximetry 95%. Rapid COVID positive. Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1. Patient discharged home. Return later that evening per EMS with shortness of breath. Complaining that congestion was getting worse. Was now febrile & had fallen trying to get out of recliner. Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen 1000 mg IV in ER. Labs revealed mild leukocytosis white blood cell count 12.5. Glucose elevated to a 9 but patient had received Decadron previously. BUN 32 creatinine 1.8. D-dimer 1240. No CT chest obtained due to patient's renal status. Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene. Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20. Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB. Continued hydration fluids normal saline at 100 cc/hour. Started on IV Remdesivir with loading dose. DuoNeb nebulizers q.6 hours. Patient continued on home regimen less Plavix. Was started on Lovenox 40 mg subcu daily for DVT prevention. Patient maintaining oxygenation on 2-3 L. Had initially been on 2. Was increased to 3 this morning due to decrease in oximetry down to 92%. Patient continues with exertional dyspnea. Does have loose nonproductive cough. Is complaining of pain to the left lower chest wall with cough. Describes as sharp. Denies any actual chest pain. No nausea vomiting. Last BM yesterday described as normal. Blood cultures pending no growth at present. Is currently resting in bed. Is in negative air pressure room. COVID precautions observed. CASE DISCUSSED WITH DR

Difficulty breathing. Inhaling and exhaling. Two visits to the ER. Swelling arm, ankles, swollen arm , very red. Breathing treatment, inhaler, antibiotics. I have a Dr appointment Monday to see my primary. Still struggling to breathe

Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying. Really bad. The arm is swollen up like a balloon, black and blue from the injection. Took aspirin, and still having the chills and he can hardly move his arm.

8 minutes after the vaccine was administered, he started to act funny. At first, he looked like he was having a vasovagal/ syncopal episode: he became non-responsive, stared straight ahead. then shortly thereafter he started to take be gasps for air, his lips turned blue. It soon became clear that he was having an anaphylactic reaction. we called for an ambulance, we administered one dose of an Epipen, and administered oxygen. His pulse ox was in the low 80's. within a minute or two, he started to react and started to moan, breathe more normally, then began to speak to us. His BP was checked and was 118/83. His oxygen sat went up to 100%. after a few minutes, We took the oxygen off and his sats dropped into the 80's so we restarted the oxygen. We are rural, so it took the ambulance 30 minutes to arrive. He was very stable at the time that he was taken to an emergency room for further evaluation.

After vaccination that evening I started vomiting, the fatigue started the next day and it was mild. Day 6 or 7 in the middle of the night I had an itchy arm that woke me up,went back to sleep, woke up the next moring my arm was blown up like a balloon and I was worried about cellulitis, but this lasted about 4-5 days and I was back to normal.

3/17/21 ER Triage note: "Pt c/o lips and and facial swelling. No sob, no problems swallowing. Onset this am. Denies pain."

Subacute fevers, cough, dyspnea for 2-3 weeks, found to be hypoxemic requiring up to max 5L nasal cannula, not responsive to coverage of community acquired pneumonia with 2 courses antibiotics. No bronch performed based on goals of care, empirically trialed on high dose steroids (soluemdrol 1000mg x3 days, then 500mg x1 day, transition to PO prednisone) as well as cefepime x7 days. Improvement to room air while continuing on steroids currently.

Severe pain in abdomen; pancreatitis; Swelling in gallbladder; Swelling in kidney; weakness; A Spontaneous report was received from a Consumer concerning a male patient of 78-year-old who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis. The patient's medical history included heart problems, 13 stents, high blood pressure, high cholesterol, borderline diabetic, thyroidectomy (28 years), bilateral knee replacement, and arthritis. Allergy history included sulfa. Concomitant medications included metformin, metoprolol, lisinopril, levothyroxine, clopidogrel for unknown indication. On 25 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023M20A) on left arm for prophylaxis of COVID-19 infection. The patient had experienced difficulty in exercise and weakness, after first dose of vaccination. On 17Mar2021 he had severe pain in abdomen and hospitalized for seven days until 23 MAR 2021. The patient was diagnosed with pancreatitis and the patient also had swelling in gallbladder and kidney. The patient was treated with intravenous fluids but other meds were not reported. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

3 days after injection developed left arm pain, swelling. persisted when presenting for second injection 4 weeks later which was deferred. evaluated next day in clinic. reported feeling feverish, left arm pain weakness which was in a sling. noted have swelling with moderate edema in hand. tender left lateral shoulder, hand. decreased strength in arm, hand possibly due to pain. no lymphadenopathy. afebrile. WBC normal.

Rash with red lumps. First appeared on arms! Then included back , the a few days later, upper chest. Lumps were very itchy. Put anti itch ointment on rash areas. Condition did not improve. Sought medical help. Dr. Prescribed Prednesone and Claritin generic pills. Itching de teased significantly. Rash and bumps are still visible, but appears to be healing. Course of medication is continuing. Itching has mostly subsided.

Patient received 2nd dose of vaccination on 03/01/2021 and developed symptoms on 03/03/2021. He presented with bilateral numbness in feet ascending to his mid shins and weakness complicated with multiple falls due to severe ataxia. He did not report any head injury or loss of consciousness. He also reported mild dysphagia, changes in voice and left arm weakness. Neurological examination showed bilateral leg strength 4/5 and numbness. The patient was admitted to hospital and given IVIG for 7 days before transfer to an acute inpatient rehab facility. The patient was discharged from rehab facility on 04/05/2021 and still has some residual weakness and numbness.

2/16/21-NOTICED SWOLLEN CHEST ON LEFT SIDE ALONG WITH PAINFUL AXILLARY LYMPH NODES LEFT AXILLA 3/4/21-WENT TO PREVIOUSLY SCHEDULED DR APPT AND MENTIONED TO DR. --GYNECOMASTIA LEFT SIDE. 3/11/21- ULTRASOUND AND MAMMOGRAM PERFORMED 3/12/21-NEEDLE BIOPSY COMPLETED ON LEFT SIDE OF CHEST. BIOPSY NEGATIVE. 4/14/21-BLOOD TEST FOR ABNORMAL HORMONES NEGATIVE 4/19/21-LEFT CHEST AREA STILL SWOLLEN

patient's both legs and ankles started to become swollen; patient's both legs and ankles started to become swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event (Relevant medical history not reported). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen). At the time of the report, PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) outcome was unknown. Not Provided Patient reported concomitant medications which include diabetic medication and goat (gout?) medications. No further detail was provided. No treatment information was provided for the events.; 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.

Guillain Barre Syndrome. received treatmetn with IVIG. symptoms improved, discharged to rehabiliation center at time of form submissions.

Vaccine site left arm. Left hand joints at pointer finger and thumb are swollen and have sever pain. Right arm elbow pain. Can not lift right arm to even shave. Symptoms started 2 days after vaccination. Three weeks later with no improvement.

dvt ER despense blood thiner Left arm swelled to twice its size from shoulder to tinger tips.

Within minutes of receiving vaccine, there was an emergent swelling black and blue spot on his right hand, followed by black and blue marks on both his hands and arms.. As he was waiting the 15 minutes after receiving the vaccine, he saw this swelling .The black and blue areas lasted for over 2 weeks. No pain, just the discoloration.

2 days after vaccination, patient developed 10/10 pain, and arm swelling. Entire hand and part of lower arm was also so swollen that he could not make a fist. Pain was worst in 3rd and 4th left fingers. Patient is a farmer and did use are for his normal heavy work after vaccination. Patient also developed numbness in 1st-4th fingers in hand, worse in 3rd-4th fingers most consistent with carpal tunnel

Sudden inability to move and delirious and hallucinating. Hospital ran numerous tests to find problem without being able to determine.

Approximately 75 days later I awoke with swollen hands and could barely close my fingers to make a fist. Knucles were painful and swollen.

Reports he had muscle tenderness, swelling and redness after shot was given. Reports he still has muscle soreness and some limitation of movement if he moves his arm a certain way

Pt had vaccination at city site. Waitied 15 min after shot and was cleared to go. Reported to wife that he was very thristy, so they stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and defib, he had ROSC. Was taken to cath lab for intervention (stents) and is now in ICU.

swollen tender lymph nodes requiring CT chest with contrast and then Ultrasound and 2 different antibiotics

I had Moderna COVID-19 Vaccine on Wednesday February 3 at 11:30 AM . After the vaccine I went home and had virtually no pain. Around 10PM that night I felt some pain in the toes on my left foot. When I looked, I noticed that my toes were red and appeared slightly swollen. My big toe was the worst. It was sensitive to the touch and very red. I also felt a short intermittent sharp pain that would last a second or two. It would happen every 3-4 minutes. The next day the redness was gone on all but my big toe. As I write this today Saturday February 6 at at 11 AM. My big toe is still sore, but does appear a bit better. I have had gout once in the past. So, gout or Covid ? The people at were great.

Pt developed pain and swelling in his leg on 2/8/21. Sent to the emergency room on 2/10/21 and found to have DVT. No history of clots in the past.

2/10/21 Vaccine 6 pm. 2/11/21 10pm swollen hand, extremely painful inflamed right hip. 2/12/21 1 am recurring inflamed hip and right upper leg. 2/13/21 same issue as 2/12/21.

79 Yr old pt had Covid Vaccine 2nd injection on Tuesday. Pt became ill on Tuesday noc with generalized bodyaches and loose stools. No fever. No cough nor HA. No redness nor swelling of arm. Injection was the Moderna. Last voided this evening. Last normal meal was AM of vaccine injection. 2. Increased dependent lung base atelectasis 3. Mild gallbladder wall edema suggesting choleycystitis. No biliary ductal dilitation or calcified stone. 4. Mild pancreatitis without abscess or necrosis 5. Colonic diverticulosis without diverticulitis. Impression: 1. Mild-Moderate Dehydration 2. Reaction to second dose of Covid -19 Moderna vaccine 3. Elevated LFT's suggesting CD Obstruction 4. Elevated wbc most likely related to #3 or #5 5. Bibasilar atelectasis with low lung volumes and accounting for Hypoxia; suspect related to #6 6. Acute Pancreatitis with Amylase 348 and Lipase 1109 7. Elevated D Dimer ; DISCHARGE SUMMARY Date of Admission: 2/11/2021 Date of Discharge: 02/12/2021 Admitting Diagnosis: Acute pancreatitis, acute cholecystitis Discharge Diagnosis: Acute pancreatitis, acute cholecystitis, sepsis History of Present Illness: Pt presented with 2 days of generalized malaise, abd pain, and diarrhea, starting shortly after his second Moderna COVID-19 vaccination. In the ER, he was found to have acute pancreatitis and cholecystitis as determined by CT scan and U/S without biliary tree involvement. Given new O2 requirements, CT chest performed and was negative. Labs showed elevated amylase/lipase, elevated bilirubin, AST/ALT/alk phos. Disposition: Transfer to Medical Center for further management Condition: Fair

swelling;redness; rash; infection: Treated by Family Doctor. antibiotic Doxycycline, Allegra,Prednisone. Condition cleared the following day after meds.

Patient recieved 2nd dose COVID vaccine and had unresponsive episode in car after monitoring period, staff assessed in car and patient had recovered, staff encouraged family to take to ED for evaluation. From ER MDs note: EKG was normal sinus rhythm, narrow QRS, delayed transition, minimal lateral st depression V4. Patient IV access on arrival, would Brady down to the 40s 1 time as low as 27 but remained alert, blood pressure is not dip. Troponin was mildly elevated and decision was made to transfer the patient. Prior to transfer is necessary to rule out pulmonary embolism, intracranial injury Patient wished to proceed with CT angio chest and noncontrast CT of head which were without acute findings. Patient given aspirin 81 mg to supplement the 81 mg he had earlier today. Discussed with hospitalist, patient was accepted in transfer. Suspect this is combination of patient's beta blockade with underlying sinus node dysfunction. Patient does have prominent lower extremity swelling and suspect pulmonary hypertension despite treatment with CPAP but cannot exclude valvular heart disease. Patient was went to Hospital. Symptoms thought to be unlikely from seizure. Doubt CVA, ongoing cardiac ischemia.

Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful. Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.

Within 4 hours of vaccination my arm swelled up noticeable, became very stiff and sore and made it painful to move my left arm. By 8:00pm I began to feel weak, tired and poorly. By 11:pm I had developed a fever and aches and pains in most joints and muscles which mimicked flu symptons. During the night I became chilled and found it hard to sleep from all of the discomfort. Most of these symptons were almost gone by the next night except for the swelling, which took another 2 days to go down. I have had no other symptons since then.

KEY POINTS Had the first dose of the Moderna vaccine on Mon. Jan 11. Symptoms started Tuesday, January 19, 2021 1st hospitalization, January 27, 2021 o Discharged, January 29, 2021 o Diagnosis: High leukocytes, inflammation. Diagnosis, acute pancreatitis. 2nd hospitalization, February 2, 2021. o Discharged February 4, 2021. o Diagnosis: Diagnosis, Deep vein thrombosis (DVT) of popliteal vein and pneumonia Details in notes section. NOTE This is an updated and correctly filed version of a form that I attempted to email to the regulatory authority. No evidence that it went through. Use this version if you have the earlier version. DETAILED DESCRIPTION OF EVENTS AFTER VACCINATION PROGRESSION OF SYMPTOMS TUES. JAN 19: At night, felt like hunger pangs – but not really relieved by eating. In the morning tried 2 Tums. Had temporary relief for about an hour. Had symptoms for the last three days. Chronic, varied between almost negligible to mildly annoying. Bowel habits usually very regular. WED. JAN 20. Had major bowel movements in the middle of the night THUR. JAN 21. Had major bowel movements in the middle of the night FRI. JAN 22. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SAT. JAN 23. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SUN. JAN 24. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) MON JAN 25. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) TUES. JAN 26. Problems persisted and got worse. On Jan 26, Daughter GP suggested getting blood analysis to test for inflammation. WEDS, JAN. 27. Hospitalized. Findings: High leukocytes, inflammation. Diagnosis, acute pancreatitis. THURS. FRI. JAN 28. Hospitalized. FRI. Jan 29. Discharged. Wt 193 lbs! Usual, ~176-183. MONDAY FEB 2. Readmitted to hospital. Felt feverish, easy fatigue, bilateral stiffening of the calves, some edema. Diagnosis, DVT of popliteal vein and pneumonia. Given an iv bolus of a broad spectrum antibiotic. Started on Eliquis two 5mg pills twice a day for one week and the one tablet am and one pm. Given Lasix bolus and then started on 5 mg Lasix/day. Swallowing tests more or less OK WEDNESDAY FEB. 4. Discharged. MONDAY, MARCH 8, Check up with GP, Blood pressure 127/76. Lasix discontinued. THURSDAY, MARCH 11, Check up with GI doctor, Blood pressure consistently 150/90. Sent to adjacent cardiologist's office (next door). High BP reading confirmed and reconfirmed the next day. Dose of Metropolol succinate increased to 5 mg 2xday. Note 1: Still have the DVT. Note 2: Received 2nd dose of Moderna vaccine on Feb 11. Note 3. All medical records available either through hospital, GP or by contacting me. Note 4: This is not a crank report. I have had 50 years teaching and doing funded research in 3 medical schools rising to the rank of full Professor in each.

Chief Complaints: Progressive weakness with respiratory difficulty and severe shortness of breath Diagnosis: Guillain-Barre supported by progressive weakness, albumincytologic dissociation of cerebral spinal fluid, vocal cord paralysis, speech apraxia resulting in aspiration pneumonia Treatment: Guilain-Barre: Plasmapheresis requiring critical care management Pneumonia: Antibiotics

Swelling and erythema of the right forearm after second COVID-19 vaccine along with shoulder pain. Symptoms started on 3/14/21.Pt was admitted to the OBS Unit and subsequently diagnosed with Right Upper Extremity Cellulitis.Tx in hospital was Rocephin IV for failed po Keflex tx. and subsequently discharged home on Doxycycline 100mg po BID x10 days .Pt. was also in the ED on 3/17/21 for same c/o and discharged on po Keflex.

Swelling of cheek and eye area. No hives or difficulty breathing. Patient stated it lasted about 3 days then stopped.

rash from the elbows to the wrists in both arms; Moderna arm; a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021. This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH (rash from the elbows to the wrists in both arms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 reported. ). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash from the elbows to the wrists in both arms) (seriousness criterion medically significant), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching). At the time of the report, RASH (rash from the elbows to the wrists in both arms), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days 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.; Sender's Comments: This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days 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.

Approximately 3 hours after vaccine administration, patient experienced the following: Nausea, Vomiting, Abdominal pain, and the following day: Bloody Bowel Movements. Patient went to the emergency department the day after vaccine administration. Patient was made NPO, started on IVF and Zosyn. Patient was seen by GI who agreed with supportive management of ischemic colitis. Around 1730 on 2/6, patient unresponsive and rapid response was called. Patient responded to Narcan. On 2/8/2021, 0358, patient was seen as not breathing and code blue was called. Interventions were unsuccessful and patient was pronounced dead at 0439am.

About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.

Admitted to hospital with COVID-19 pneumonia. At time of admission, reports 2 weeks of dry cough with 4 days of progressive dyspnea on exertion. Required supplemental oxygen at presentation to ER.

Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021.

Heart problems; Breathing problems; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems), DYSPNOEA (Breathing problems) and LYMPHADENOPATHY (Lymph nodes swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 029I20a) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Lung cancer (in remission since November) and Liver disorder (liver problems). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced CARDIAC DISORDER (Heart problems) (seriousness criterion death), DYSPNOEA (Breathing problems) (seriousness criterion death) and LYMPHADENOPATHY (Lymph nodes swollen) (seriousness criterion death). The patient died on 15-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were provided. Daughter of the patient reported that the patient passed away after his lymph nodes swollen, had breathing problems, and hart problems. She stated that the patient was in remission of lung cancer since November, and that he was diabetic and had liver problems. They wanted to be part of the trials for the vaccine. She wanted his cases to be research because his lymph nodes were swollen, and that for her means there's a correlation between the vaccine taking and his demised. No treatment information was provided. Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Reported Cause(s) of Death: passed away

Patient has a history of simple Prostatectomy and Kidney Stone. He had the first Moderna Covid 19 vaccine on 2/3/2021 and the second dose 3/8/2021. 5 days ago He started with severe dizziness and next day he was admitted to hospital for severe Urosepsis.

11X6 cm mildly erythematous, slightly raised, warm ovoid lesion. Became apparent 6 days after vaccination, has been unchanged for past 2 days.

redness, swelling and itching beginning at shoulder and extending downward past elbow first noticed on 1/19/2021 and worsening on 1/20/21. no reaction noted at injection site.

Client developed a mild covid infection 12/8/21 and recovered. He was admitted 12/25 with hypogycemia and mild weakness and sent home He was given his first dose of the Moderna vaccine 1/4/21 at approximately 9AM covid vaccine clinic He developed weakness the next day (1/5) prompting admission to a hospital and then transition to subacute rehabilitation briefly Work up at hospital revealed progressive respiratory failure and pneumonia requiring intubation and progressive ascending weakness and sensory loss without upper motor neuron changes. MRI : nerve root enhancement LP : protein 40, +/- 80 lymphocytes, cultures negative B 12 and B6 normal extensive CSF testing still pending campylobacter and Musk antibodies negative Neurology diagnosed likely AIDP (Guillain-Barre) and an EMG is planned for the near future. Neurology felt the cause of his GBS was likely his covid infection verses his Moderna vaccination He was treated with plasmapheresis. Client received dexamethasone, remdesivir, and zosyn and doxycycline when progressive leukocytosis and procalcitonin elevation was noted. Candida was cultured from tracheal aspirates but felt most likely d/t colonization with an option to treat further if he did not continue to improve. He is now extubated, unable to swallow and has profound weakness and distal sensory loss. He will transition to Acute rehab in the near future. Comorbidities:as described in the above section and... DM2, CKD3, HTN, DJD, BPH ( h/o prostate surgery), h/o Lumbar surgery and hernia repair, GERD, hypothyroidism, hyperlipidemia. Possible etiologies of his AIDP ( GBS) would include his recent covid infection, the Moderna Vaccine, or other undiagnosed infection. He got his flu shot 9/25 ( fluzone sanofi) so this is not likely to be the culprit

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

NURSE WAS CALLED TO FACILITY. PT WAS NOTED TO BE MORE CONFUSED THAN USUAL. HE TOLD NURSE THAT THINGS WERE "FLYING THROUGH THE AIR". HE DID HAVE 2+ PITTING EDEMA TO BLE(NEW TO HIM). HE DID THINK THE DATE WAS MARCH 4, 2091. LEFT EYE ALSO SLIGHTLY RED/SWOLLEN. VSS AT THIS TIME. MD NOTIFIED. CG INSTRUCTED TO MONITOR FOR WORSENING EDEMA, INCREASED SOB, INCREASED CONFUSION/HALLUCINATIONS.

Pt presented to ED 1/25/2021 with 1 week history of bilateral shoulder pain, started on right, left involved later, wore with movement. NKI. He was given IM ketorolac 30 mg and seen in Clinic by chiropractor with some relief 1 day. PT consult placed and is still pending. Known hx osteoarthritis right shoulder by x-ray 12/10/20 Pt returned to urgent care/walk-in clinic 2/8 with worsening bilateral shoulder pain. ROM of both shoulders quite limited. NKI. Treated for PMR.

Patient with achiness that eventually progressed to severe muscle pain with movement and experienced elevation of CK to 6546 on 2/14 and required hospitalization.

Rash/ hives on entire body from the neck down. Concentrating especially on the back and stomach completely encompassed in splotches and running down both legs. Swollen hands and sanative to the touch.

Approximately 15 minutes after injection, patient developed a severe headache, dizziness and swelling of the face with red rash across cheeks and nose. Profound fatigue - needed to lay down rather than sit up. Was admitted to the Emergency Room for observation and benadryl IV was administered. Patient experienced the profound fatigue for seven days after the vaccine.

one episode of heavy sweating...followed by 5 days of not being able to walk in my home more than 10 feet without having to sit due to severe pain and cramping in upper part of both les. Also unable to lift either or both arms above my waist without sever pain or cramping. this lasted for 5 days before subsiding. three days later both ankles and my lower left leg became swollen. this has presisted for 10 days.

Around 4:30am on the day after administration of the vaccination, patient went into ventricular tachycardia and his ICD attempted anti-tachycardia pacing (ATP). Per electrophysiology note after interrogation of patient's ICD: "Multiple VT episodes beginning around 4:30 AM, and continuing intermittently through 10:15 AM, approximately. There were 19 treated VT episodes, mostly terminated with ATP therapy. There was a single 24J shock delivered at 9:43 AM after a VT episode lasting 1 min, 4 seconds, with average ventricular rate 171 bpm. This appeared to be an appropriate shock after exhausting 8 ATP attempts. On 5 other occasions the patient required 4 or more ATP sequences to terminate VT. The remainder terminated with 1-2 ATPs. Reviewing the far field electrograms, there appear to be 2 distinct VT morphologies. Average ventricular rates for both are about 170-180 bpm." Patient presented to the emergency room, where he received amiodarone IV, and was admitted to an inpatient cardiology service. He was restarted on amiodarone and was noted to be hemodynamically stable and not in VT; however, he opted to leave the hospital AMA on 3/15. As noted previously (item 11), he has a history of VT and had discontinued amiodarone due to side effects about 6 weeks prior to this episode. As amiodarone has a half-life of around 45 days, it is thought that his rhythm control was suboptimal at the time of this vaccination, and there is no evidence that it was the vaccination that caused the VT episodes on 3/14.

One day after the first Moderna vaccine, this gentleman developed hand and wrist pain. There was then hand numbness and swelling across the right wrist and MCP joints. He had pain in the hands, wrists, shoulders, and hips. He felt weak in hands and with rising from a chair or climbing stairs.

Patient called the office stating that his arm is red and hot and his arm is swollen all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0. Patient was also having arm pain. Patient was advised to go into UC.

You probably after using my time will have some reason for not allowing me to report this field 18. Why have you been keeping me from reporting it? Four four weeks after the second Moderna Covid 19 vaccine I gained five pounds a week with no change in diet except I may have eaten less. Finally, I was wheezing one morning . I told a friend of mine who is also a retired Doctor. He checked me over and told me I was retaining water and was carrying at least 15 pounds of water in my legs alone. i was also carrying excess water in my abdomen. He took me to my doctor, but I was not allowed to be seen until they shove a stick up my nose until I gagged. After I received the negative results I was allowed to see my doctor. Should have never told them I wheezed. Anyway, after seeing me x-rays were ordered and the next day my doctor contacted me. I am retaining water, IMHO, as a result of the second Mocerna Covid 19 vaccination. I am now on a water pill. Weight has come down about 15 pounds in one week. Only 7 pounds more than what it was when I received the second Moderna COVID-19 vaccine. I feel I will be able to shed the rest of the water being retained as a result of the second Moderna COVID-19 vaccine. Cordially, patient Wonder if I will be allowed to report this or be stopped as before.

Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11.

Left arm swelling, shortness of breath, leg pain, generalized discomfort 4/5/21 - was seen at Urgent Care - no orders 4/6/2021 - seen at Hospital ER - CT showed blood clots/pulmonary embolism of left arm and lungs and lymph nodes. Received IV fluids in ER. Kept overnight for observation and discharged from hospital next day. Sent home on Eliquis and Prednisone

Reports soreness to injection site since 5/24/21 however developed increased swelling and warmth at the injection site on 5/26/2021. On 5/27/2021 the swelling and redness began to spread down his arm and he started to not feel well with chills and nausea. The patient was then seen by primary care this a.m. on 5/28/2021 who obtained blood work and an ultrasound. The patient was then instructed to present to the emergency department for IV antibiotics. He reports the arm is painful however declines need for pain medication. The patient does have a scabbed over area to the right hand which he reports is from his daughter's puppy that happened approximately 3 weeks ago. He has been applying bacitracin to this at home.

04/28/2021: Patient transferred from Hospital with shortness of breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated episodes of hypoxemia and hypotension - was intubated on mechanical ventilation, eventually switched to pressure control inspiratory pressure, extubated, had to be reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00 Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable bacterial superinfection, Atrial fibrillation with rapid ventricular response, Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida tracheobronchitis, Previous history of prostate cancer status post radiation, dyslipidemia, hypertension present at admission.

FACIAL SWELLING, RASH, ITICHING OF EYES & FACE. STARTED 3 DAYS AFTER INJECTION. METHYLPREDNISOLONE 4MG TABLETS GIVEN.

Covid-19 arm - raised rash type swelling, itching, light redness. Currently treating with generic Benadryl, which seems to be resolving issue.

After vaccine I had a headache and was lethargic and took Tylenol, next day I took Tylenol and Movic and started feeling better but yesterday I got this nodule on my neck that I can move around. My lymph node is enlarged

On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.

2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017. Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.

The pt reports having swollen hands three days after the first vaccine (1/22) so started to have symptoms 1/25. PCP did not think this reaction was due to the covid shot. Pt then got second dose 2/19 and now both hands are swollen and some back pain is noted.

arm could hardly be raised in evening and had large lump at injection site, woke up around midnight with bad chills, felt feverish and dizzy. Stayed in bed and slept pretty much until 2:30 when was woken up by wife. around 11:00am on 03/05/2021 face looked swollen and still feverish and dizzy. Wife called the hospital and spoke to a nurse who wanted him to be woken up to check facial swelling and advised going to a walk in clinic or emergency room. face looked better so did not go, he went back to bed around 7:00 p.m and the next morning on 03/06 still felt light headed and not normal. Today 03/10/2021 still doesn't feel right still some light headedness, just not normal at all.

went to the hospital for 5 days and had 5 infusions, one each day. He was diagnosed with Guillain Barre Syndrome. currently in rehab going on 3 weeks now.

ANAPHYLACTIC NEUROLOGIC SYMPTOMS INCLUDING HALLUCINATIONS DEVELOPING WITHIN 7 DAYS OF VACCINATION, SECOND DOSE NOT ADVISED BY CDC, SECOND DOSE DUE 3/12/2021, SECOND DOSE NOT ADMINISTERED AND DOCUMENTED AS ANAPHYLACTIC REACTION TO FIRST DOSE

reaction vs. septic shcock oncologist worried about delayed anaphylactic reaction. on keytruda. never on chemotherapy.

SHORTNESS OF BREATH FEVER UTI (urinary tract infection) Systemic inflammatory response syndrome (SIRS) without organ dysfunction (CMS/HCC sepsis

Red, swollen ,hard, itching , sore area from deltoid to elbow at site of injection. Swollen and tender lymph nodes under left arm

APRIL 9 EVENING LUMP IN RIGHT LEG, PAIN TENDERNESS AND REDNESS, SITE IS HOT AS WELL. SWELLED OUT, RUNS 2 INCHES, RIGHT ON INNER PART OF LEG, BELOW KNEE LEVEL, HAS HAD 2 NEW KNEE IMPLANTS ON RIGHT LEG.

passed away(death); temperature 99.7F; tired; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away(death)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Asthma ((but everything was under control).). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and FATIGUE (tired). On 31-Jan-2021 at 10:30 AM, the patient experienced PYREXIA (temperature 99.7F). The patient died on 25-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PERIPHERAL SWELLING (left arm swelling), PYREXIA (temperature 99.7F) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 99.7 f (abnormal) elevated. On 31 Jan 2021, the patient was tired and went to bed early. At 10:30 pm, the patient's wife reported the patient's temperature as 99.7 degrees Fahrenheit and was given acetaminophen. The patient's left arm had swelling. The patient's son (doctor) prescribed antibiotic for treatment. On 01 Feb 2021, the patient was taken by ambulance to hospital. He was at hospital for 24 days and was on a ventilator. Treatment included Tylenol antibiotic. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested..; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested..; Reported Cause(s) of Death: Unknown cause of death

passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

3 weeks post Right deltoid Moderna Vaccine the patient developed lymphadenitis. Infectious Disease physician was consulted. Patient to take naproxen 550mg po bid for 5 days and Prednisone 20mg po daily for 5 days Patient was instructed that he may proceed to 2nd dose Moderna but would defer administation until lymphadenitis has resolved and he is not taking prednisone

Pt received his first and second COVID19 MRNA Vaccine on 2/4/21 and 3/4/21, respectively. Patient was admitted to our facility on 6/17/2021 w/ symptoms of generalized weakness that had been worsening over the past few days. His first symptoms began on 6/14/21 w/ nasal congestion. He began to have cough and weakness on 6/16/2021. Patient tested positive for COVID 19 on 6/17 via PCR on nasal specimen. As of this report, 6/23/21, pt is admitted to a step-down unit at our facility requiring supplemental oxygen via CPAP. His current O2 requirements are 100 fiO2 and 60lpm w/ 15 cmH20 of PEEP.

Narrative : Symptoms: SkinRash& SWOLLEM GLANDS UNDER JAW-SORE. BLISTERS DEVELOPED WHERE THE RASH WAS ON PTS KNEE Treatment:

Ten hours after I had a Severe allergic reaction. My eyes were itching and watering. I was incredibly nervous and anxious. I couldn't relax or sleep. NO SHOULDER OR ARM PAIN. Swelling and puffiness in my face ( eyes, nose, and sides of my head). I was fine the next day.

Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.

I received my Moderna shot on Saturday 1/23/21 around 4PM. On Tuesday -- 1-26/21 -- AM I woke up with a slight pain on the side of my left foot. In the middle of the pain there was a small black dot . I am an unusually healthy 83 y.o. physical active, ex Marine, with a high tolerance to pain. So at first I paid no attention to this and went and played pickleball that very day. But the next day I awoke to find that the foot was not only bright red and swollen, but painful. I immediately called my doctor and the next morning I had a telephone conference with him. We discussed the possibility of what could have caused this problem. Although I am pre-diabetic (111) he ruled out diabetes. He also ruled out gout. This only left the possibility of an infection. But since I had not stepped on any nails, etc. the only possibility was a bug bite. So he prescribed an antibiotic, which I started taking that very day. After several days the foot got progressively worse and turned into a ulgy, oozing sore and redness grew to the whole left side of my foot. So I made an appointment with my doctor for a physical visit, however this was delayed until 2/5/21. By then the swelling and redness had subsided considerably and the wound was healing. He ordered lab tests to rule out the possibility of diabetes and gout. He also gave me a prescription for stronger antibiotic and antibiotic ointment. Unfortunately the lab was by appointment only and I did not get the tests done until 2/12/21.I would not even be writing this except for the fact that on 1/27/21 I also developed a rash all over on my back that was very itchy. This is when my attention turned back to my vaccine shot, and the reports that Maderna had a track record of rashes from their shots. So I thought I had better write to see if it would be safe for me to get my 2nd Maderna shot which is scheduled in just 6 days (2/20/21).I do have a history of occasional painful rashes since childhood and I am wondering if the Moderna shot could have possibly triggered one, or both, of these problems? If it will help I did have photos taken of my foot during this episode and will be happy to send them to you if you feel it necessary?Thank you for your immediate consideration and response.

UTI, urinary/bowel incontinence Narrative: first COVID19 vaccine 1.11.21, ER visit with hospitalization 1.15-1.18.21 for SIRS/Sepsis, initially thought to be urosepsis but post discharge UA and blood cultures were negative; source was not identified. Beyond symptoms listed, patient just reported he "felt terribly bad" prior to spouse calling EMS. VAERS reported by hospitalist as well from the facility where he was treated. He was discharged home with Augmentin for UTI and Physical Therapy for strengthening. Patient follows local PCP and this facility PCP. Responsible physician listed on this form is this provider's facility Medical Director.

Patient states that 5 days after getting the vaccine he developed severe diarrhea which has persisted. He has not been able to eat much as every time he eats he has diarrhea, sometimes to the point he can't make it to the toilet. He has not sought medical attention. Upon arrival for 2nd vaccine dose today he asked to speak with someone and it was noted he had lost 30 lbs in the last 4 weeks. He was advised to contact his regular physician immediately for complete evaluation and told this may or may not be vaccine related. Second dose was held today as precaution and once cleared by regular physician he can call us to get the 2nd dose. Patient did admit to history of "bacterial infection" causing diarrhea many years ago from drinking well water but doesn't drink well water currently. He also had body aches, headache after vaccine but these resolved and also complained of his hands swelling up like arthritis.

vaccine rec'd 2/11, and 5 days ago there was a swollen area, warm to touch and red, if I tough it, it itches.

Presented 2/25/21 with right arm swelling, redness, warmth to palpation, most apparent around right elbow. Normal range of motion of right arm without pain. No pain to palpation of right arm. Also had pacemaker surgery 2/11/21. Patient was referred to healthcare facility for further evaluation.

I noticed a long raised red bump on my left arm (3/21/2021) from the vaccine 1st dose received on 3/5/2021. Feel okay other than the red bump.

Close to "urea sepsis"; severe UTI; A spontaneous report was received from consumer concerning a 82-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe UTI/urinary tract infection and close to urea sepsis/sepsis. The patient's medical history was not provided. Concomitant medications was not provided by the reporter. On 16-Feb-2021, the patient received second of the two planned doses of mRNA-1273 (lot number: 006M20A) in the left arm for the prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient developed a severe UTI. Close to urea sepsis. Took antibiotics. Treatment medication included antibiotics. No lab tests were mentioned. The events severe UTI and close to urea sepsis were considered to be serious with criteria of important medical event. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events severe UTI and close to urea sepsis was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

82 year old male with history of hypertension, hyperlipidemia, mild dementia presented with progressive worsening weakness over the past 2-3 weeks. Patient reported that he has noticed whole body weakness that has progressively worsened over the past few days. Reported that he has noticed feeling weak, fatigue and requiring more energy to do his daily activities over the past few weeks. He went to his PCP's office yesterday and had laboratory tests for further evaluation. Initially his PCP thought he might have PMR since he had bilateral UE soreness. However, the labs returned reassuring and does not seem to suggest the diagnosis of PMR. Since yesterday, he has noticed worsening of his weakness. Reported that last week, he was still able to play golf. Today, he was unable to get out of his car or get up from a sitting position without help. Associated with unsteady and poor gait. And reported that he has numbness in both hands and feels like his grip is weak. Denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, headache, vision changes, no urinary/fecal retention or urinary/fecal incontinence. Primary Discharge Diagnoses 1. Guillain Barr syndrome., 03/16/2021 Secondary Diagnoses: Guillain Barre Syndrome (AIDP) Hypofibrinogenemia Thrombocytopenia and Anemia, have been fairly stable for more than a week Hypokalemia Hyperlipidemia Hypertension, BPs controlled Mild dementia

Inflamation at site and progressively down the arm over three days with simptons of swelling and itching as well as some pain and stiffness. Took some pain killer - one ibuprofen per night. And when itching severe enough used Sarna lotion sometimes twice over the night

Client reports feeling fatigues day after vaccine. however, on 3/28 he reports his face bilateral near the nose is firm swollen and red. he reports no relief with gels or antihistamine. He sought dermatology assistance and is seeking allergy evaluation and is contacting his primary MD.

soreness at the site for about 2 days gout at the right toe, swelling, redness, burning, tenderness, pain. took (1) motrin every 4 hours four times. pain subsided by 75% in 2days.

82YM Admit 3/18/21 to hospital for small bowel obstruction within 1 week of second vaccine dose. PTA bowel obstruction led to a syncopal episode following use of laxative, and several episodes of vomiting in the days prior . Upon admission Patient was receiving conservative therapy for a partial obstruction when he developed increasing shortness of breath. The patient was transferred to the ICU for worsening respiratory status and eventually developed significant hypercapnic and hypoxemic respiratory failure requiring intubation. Neurology was consulted for altered mentation in the setting of respiratory failure. Patient with ascending paralysis. MRI of the head and neck as well as CTA were obtained x2. Patient was ultimately diagnosed with Guillain-Barre, variant and received 5 days of Intravenous Immune Globulin therapy. Patient's small bowel obstruction resolved and ultimately patient required percutaneous tracheostomy tube and gastrostomy tube placement for prolonged respiratory failure and neurologic compromise. The patient had uneventful ventilatory requirements and ultimately was performing intermittent spontaneous breathing trials; however, still had episodes of apnea, but improved. He was tolerating tube feeds at goal with resolution of his small bowel obstruction, which was thought secondary to his Guillain-Barre. The patient did develop abnormal LFTs which were thought secondary to cholecystitis not requiring operative intervention, with improving LFT findings on antibiotics. The patient had a nonobstructive cholecystitis. The patient's mentation was improving to the point where he was able to communicate and open his eyes upon discharge, as well as was working with Physical Therapy for strengthening. He was able to move his upper extremities and followed commands and lower extremities were improving in strength as well. Patient was discharged via private air flight to acute care ICU facility.

Pt presented to my office on 4/30 after being vaccinated on 4/20 with left arm swelling. Outpatient stat DVT study in LUE showed extensive thrombosis in veins of LUE and subobcclusive thrombosis in BL Internal Jugular veins. I referred pt to hospital for inpatient admission.

Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING

Swelling on left and right side of temporal areas of the face; High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition; Diagnosed him with temporal arthritis; Double vision in both eyes; Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face) and DIPLOPIA (Double vision in both eyes) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol total abnormal NOS (Patient takes Lipitor for cholesterol). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (Swelling on left and right side of temporal areas of the face) (seriousness criterion hospitalization) and DIPLOPIA (Double vision in both eyes) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition) (seriousness criterion hospitalization), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis) (seriousness criterion hospitalization) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to DIPLOPIA, GIANT CELL ARTERITIS and INFLAMMATION. The patient was treated with PREDNISONE at a dose of 60 mg and PREDNISONE on 25-May-2021 at a dose of 40 milligram. At the time of the report, INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face), DIPLOPIA (Double vision in both eyes) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. On 17Mar2021, the patient began to experience double vision in both eyes as well as swelling on the left and right side of the temporal areas of the face. The patient underwent a biopsy of both sides of the face, results were not provided. Ultimately, the patient was diagnosed with "temporal arthritis" along with "having high levels of inflammation in his body" by his rheumatologist. On 16Apr2021, the patient was admitted in the hospital for four days until 19Apr2021 for observation. The patient received high doses of steroids/prednisone for treatment including 60 milligrams for one month and then 40 milligrams starting 25May2021. It was recommended by the patient's physician that he not receive his second Moderna COVID-19 vaccination which was originally scheduled for 07Apr2021. Further clinical course is unknown/not reported at this time. 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 25-May-2021: Non-significant follow-up received. Follow-up contained no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient had COVID-19 infection in October 2020, then received 2 doses of COVID vaccines. On 6/1, COVID-19 tested positive, but patient denies any COVID related symptoms. Subsequence COVID tests on 6/2 and 6/3 all showed negative. On 6/1, patient presented initially to his PCP for evaluation of groin swelling. The patient had noticed a left groin swelling since last fall and had not previously bothered him over the last 2 days he noticed the swelling had increased in size and was uncomfortable with walking. Then he was instructed to ED and CT showed left inguinal hernia, so admitted at hospital for left inguinal hernia repair.

rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel

Resident became increasingly somnolent and short of breath with bilateral lower extremity edema. He was sent to the hospital for evaluation and treatment on 5/26/2021 where he was tested for COVID 19 and found to be positive. Resident had a previous negative COVID 19 test 5/23/2021.

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was 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 request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; 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 request.; Reported Cause(s) of Death: unknown cause of death

Patient is a surgeon, developed pain and swelling right palm and 5th finger with swelling, gradual development of pain and decreased ROM right shoulder and neck. He believes this is a manifestation of post vaccination arthropathy with tenosynovitis as reported.

One week post vaccination, the patient developed bilateral lower leg rash - described as small pinpoint dots around the ankles feet and anterior and posterior calves in a stocking like distribution He awakened one morning with this development . No injury reported no tight clothing noted

On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it. He got up and got dressed, went about his day. Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind. At that time, his speech became slurred. They got a neighbor, who is a nurse, to come over. She recommended medical attention. They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred. There were no cognitive issues. Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke. Bell's Palsy was diagnosed. He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home. As of today, Monday, February 22, his symptoms are improving.

Patient reported swelling in his legs, knee trouble (making walking difficult), dizziness, headaches, temporary memory loss and tired. These were all experienced for about 2 1/2 weeks post 2nd dose of Moderna vaccine.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

Went to the ed on saturday about pain at the injection site. They did an ultra sound and it was neg, some swelling was noted. Was given meloxicam 15 mg, after calling md thursday.

shortness of breath Hypokalemia Metabolic acidosis Pneumonia Chronic atrial fibrillation (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Multiple myeloma not having achieved remission (CMS/HCC) Severe sepsis (CMS/HCC) ST segment depression

CLIENT DEVELOPED RED RAISED RASH WITH ULCERATION WAS SEEN BY PRIMARY CARE MD X2 VISITS. RECEIVED PRESCRIPTIONS FOR CEPHLAHEXIN 500MG AT FIRST VISIT AND BACTRIM DS AT FOLLOW UP

Patient was admitted to the hospital with pneumonia the evening after her received the vaccine in the morning. He had been struggling with his COPD/ pneumonia since 3/1/21. He was hospitalized and died 8 days later

Need to be able to attach photos of patient's arms and hands. Left arm became inflamed, colored, pustules, swollen, blackened fingers, swollen knuckles, five days after vaccine. Three weeks later, right arm did same thing. Patient continues to live with this condition, without pain, some minor itching, but much discomfort and embarrassment for people to see arms. He has seen multiple doctors, including primary care, dermatologist, urologist, cardiac specialist, oncology doctor, been in a rehab facility for two weeks after fall and L-1 fracture, and no one knows what it is, or what caused it. Very frustrating. Suspicious of Covid vaccination. Pt stopped taking amiodarone a couple of months ago, with no change.

Patient had lymph node swelling within a couple of days after first shot (1/28/21) and rash or hives on his body and head. He has continued to have this rash even after the second shot (2/26/21). It looks real bad on one day then not as bad the next. It is random where he breaks out from his legs, arms, back, abdomen, etc...not staying in any one particular area. Could not get him to go and see a doctor yet. Pictures available if required. BIRTH DATE IS (disclosed) BUT PROGRAM KEEPS CHANGING IT TO THE 9TH INSTEAD OF THE 10TH.

Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. 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. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; 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, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

"blood pressure went nuts"; "soreness only when you touched it"; "arrhythmia skipping beats 1234 skip 1234 skip"; "a bump like the muscle was puffy"; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ("blood pressure went nuts") and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included NADOLOL, CLONIDINE and FINASTERIDE (PROSCAR) for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING ("a bump like the muscle was puffy"). On 23-May-2021, the patient experienced BLOOD PRESSURE INCREASED ("blood pressure went nuts") (seriousness criteria hospitalization and intervention required) and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY ("soreness only when you touched it"). On 24-May-2021, PERIPHERAL SWELLING ("a bump like the muscle was puffy") had resolved. On 12-Jun-2021, ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") had resolved. At the time of the report, BLOOD PRESSURE INCREASED ("blood pressure went nuts") outcome was unknown and PAIN IN EXTREMITY ("soreness only when you touched it") had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: skipping beats 1234 skip. (Inconclusive) skipping beats 1234 skip.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Patient had call on 14Jun2021, with symptoms following his first dose of the Moderna COVID-19 Vaccine, which he received on 19May2021 in his left arm, lot#027C21A, expiration 10Oct21. He states that he had felt really good for a day or so and then he developed soreness on his arm only to the touch, "a bump like the muscle was puffy," and "blood pressure went nuts." He had states the puffy muscles and soreness on his arm lasted about 2-3 days. He also states he was hospitalized for his blood pressure and was told by the doctors in the hospital that he had "arrhythmia skipping beats 1234 skip 1234 skip" that was seen on an EKG they performed. At the hospital, doctor "loaded he up with meds and sent he home" and his arrhythmia went away around 12Jun2021 but he is still dealing with the blood pressure. He states he has been dealing with blood pressure issues since before his vaccine and has seen his cardiologist and primary care since hospitalization. Consents to follow up with Safety. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.; 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.

Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear

Rash on upper arm that has spread to both arms, legs, back of the neck and cheeks. Itchiness, redness, swelling. Joints swollen - particularly left elbow. No other symptoms (no difficulty breathing or other issues).

Initially, red rash with severe itching at injection site on left arm, spreading down arm with increasing swelling, itching, and discomfort. Treated with Benadryl cream locally, Benadryl and Tylenol orally for 4 days with improvement. MD visit on 5th day of reaction for evaluation and prescribed Keflex for possible cellulitis. Swelling remains after 7 days but itching and redness decreased.

Arm was sore after initial injection-but soreness increased and our first sighting of swollen redness was this morning-2-8-2021. NO fevers-just sore and swelling-about 3" by 3" and reddish in color-currently no itching or signs of rash.

SWELLING, REDNISS, MILD PAIN, ITCHING. TREATMENT: TOPICAL STEROIDS. Symptoms started 1 day after injection' Had similar episode after first vaccination, but onset was in 2-3 days, discomfort was less; first event lasted between 2 and 3 weeks duration.

Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021. Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis

Developed ascending bilateral symmetric weakness ~under one week after receiving second Moderna shot. MRI negative, LP with elevated protein, low cell count. Guillain-Barre suspected, neurology consulted likewise agrees, has been started on IVIG and is hospitalized presently

Patient received 2nd dose of Moderna vaccine on 3/5/21 to his left deltoid. On 3/14/21, he began to develop tender, swollen, and erythematous area of lymphadenopathy to his left axillary region. He presented to clinic on 3/16/21 with concerns for infection and was noted to have area of induration with surrounding erythema and swelling. Was treated for possible underlying cellulitis.

Death Narrative: On 2/12/21, patient was hospitalized at Medical Center with "leaking and swollen legs." Patient was transferred to hospital 2/13/21 for a vascular surgeon consult, where patient was diagnosed with lower extremity ischemia and acute diastolic heart failure. A bilateral, common endarterectomy with bovine angioplasty and bilateral iliac stent placement was performed on 2/17/21. Patient was discharged to a skilled nursing facility on 2/26/21. Patient had received first covid vaccination on 1/29/21. He was due to receive his second dose on 2/26/21, however, the appointment was moved to 3/10/21 since patient was hospitalized. Patient received his second dose on 3/10/21. Patient was hospitalized again (reason for hospitalization unknown) where he passed away 3/11/21 at hospital.

Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin.

Hospital Course: Patient was admitted 2 days after having received his COVID-19 vaccine and had SIRS including hypotension. Was believed to be a possible reaction to the vaccine. He was admitted to the ICU and briefly he needed vasopressors. The hypotension resolved and did not recur. An echocardiogram showed that he had a moderate pericardial effusion, cardiology saw him and does not believe that this contributed to the hypotension. He also thought his stools were dark however he has had quite dark stools for many years he told me, ever since he was started on iron pills. He could not confirm whether or not the stools might be a little darker than usual for him and he also had 1 out of 3 stool occult blood test that were positive. He has chronic anemia with the hemoglobin slightly lower than his baseline, so GI was consulted and an EGD was performed. He does have Barrett's esophagus and GI discussed with him how he will need follow-up EGDs, and I reminded him of that as well. Warning signs and alarm symptoms were discussed. He was placed back on his Eliquis however he will not be taking the Effient medication. This was based on recommendation from cardiology. He will have lab work done and see his primary care provider within several days. He will also have a video capsule test done and pick this up either today or tomorrow and follow-up in several days with GI. Discussed going back on his low-dose Eliquis with GI. Discussed with cardiology and GI and discussed with the patient the risks, benefits and alternatives. He will watch for any signs of bleeding and stick with a low dose of Eliquis.

Became febrile, poorly responsive. Taken to the MGH ED. En route while in ambulance, he experienced a convulsion with rhythmic shaking in all limbs lasting several seconds. He had a second episode requiring midazolam and levetiracetam. On arrival to MGH ED, the patient was afebrile, heart rate 133, blood pressure 173/93, oxygen saturation 99% on a nonrebreather. He was found to be severely encephalopathic, mute, and not answering questions or following commands. He was admitted to the neuroICU and intubated for airway protection given his poor mental status. He was started on broad-spectrum antibiotics for empiric treatment of meningoencephalitis, but these were discontinued after his CSF was not concerning for a bacterial infection herpes simplex encephalitis. Antibiotics were discontinued. He was extubated on hospital day 2. After extubation he had persistent mixed receptive-expressive aphasia that was slowly improving over time. At discharge from the hospital, he was able to occasionally say a simple sentence, could repeat simple phrases, and could follow simple commands. He was discharged to Rehab

Adverse events: Weakness in legs (had a fall), feeling of pins and needles in legs, feet and hands, loss of normal leg activity and strength, numbness in fingers, loss control of walking abilities Diagnosis: Guillain Barre Syndrome Treatment: 5 days of intravenous immunoglobulin Outcome: Don continues to slowly progress at home with therapy

Patient has long standing COPD and asthma. He has been stable on his home medications for years. No hospitalizations for these issues in the past. During Covid times he has been very restricted to his home with no visitors. Approximately 5 days after receiving the 2nd Moderna Covid-19 vaccine, he started having increased difficulty with breathing. Over the next few weeks he continued to get worse and required home oxygen and an adjustment with his medications. He was started on steroids and antibiotics about 3 weeks after the vaccine and then hospitalized on 3/16/2021 with COPD exacerbation and pneumonia. He tested negative for Covid at that time. He was in the hospital for 9 days and discharged home on steroid taper and home oxygen. A few days after being at home, he had gradual onset of subacute dementia/delirium. All workup has been negative. MRI/MRA normal. He is currently continuing on oxygen and again on steroids and mental status may be starting to improve. The concern here is that patient was stable and had been stable on his medication regimen for years. He was doing well until approx 5 days after his second Covid vaccine when he started having worsening pulmonary complaints and eventually ended up in the hospital. He continues to be on oxygen at home and was recently started back on steroids. There has been no explanation for his subacute onset of Dementia/Delirium. MRI/MRA normal. This has been discussed with both Pulmonology and Neurology specialists.

Rash, red and raise , intense itch on arms and legs and the body. Pt was prescribed zyrtec and used steroid cream. It has been continuous since the first dose on 2/27.

Patient received vaccine on 4/15/21 2nd dose of 2 dose series. He woke up the morning of 4/22/21 at 6:15am with vomiting. His temperature spiked to 104.2 and his O2 sat dropped to 98%. He developed shaking chills, and a loose wet sounding cough. He had chest xray and labs. Started on treatment for pneumonia with rocephin, zithromax and solumedrol. Declined throughout the day and had increasing requirements for O2 and patient passed away at 1355 on 4/22/21.

84 y.o. male who presents with chills, weakness and low back pain that had onset approximately an hour and a half ago. Upon presentation, the patient's temperature was noted to be 102°. Patient's states that he had a similar set of symptoms several years ago was found to have sepsis of unknown origin. He denies anorexia malaise generalized body aches headache cough dyspnea chest pain nausea vomiting abdominal pain diarrhea or urinary tract symptoms. The patient has been covered vaccinated and reports no known exposures. Of note, the patient has been on cephalexin for the past week due to a postoperative infection related to his recent carpal tunnel release. Transferred to a different hospital for Severe Septic shock, on dopamine drip; remains inpatient as of 5/17/21

Moderna Dose 1 2/25/21 (041L20A) Moderna Dose 2 3/25/21 (011M20A) COVID Positive 5/10/2021 5/10/21: Presented to ED. 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week ago with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. He was treated with Z-Pak but symptoms continued and he presented to the emergency room, found to be hypoxic requiring up to 6 L nasal cannula oxygen Patient also had fever no chills or rigors. Reports he has received both shots of COVID-19 vaccine. In the emergency room patient was hypotensive which was responsive to IV fluids and received levofloxacin. Chest x-ray showed bilateral pneumonia. WBC 15.5, lactic acid 2.8 and the creatinine 2 which is patient's baseline. 5/13/21: 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week prior to hospitalization with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Treated with dexamethasone and levofloxacin. With not a candidate for remdesivir based on poor renal function and ID consulted and did not believe patient qualifies for Actemra. Subsequently shortness of breath and hypoxia resolved and he was deemed stable for discharge and will complete 7 days steroid taper. Liver transplant team at pain clinic was consulted, recommended holding sirolimus while patient is on dexamethasone. I have clearly communicated to the patient and his wife to resume sirolimus after 1 week. On discharge patient was a febrile and hemodynamically stable. He was discharged home.

Pt showed up to the ER via EMS on 6/5/2021 with low back pain and weakness, bilateral leg swelling, shortness of breath. On 6/6/2021-developed bilateral upper and lower weakness that progressed to dysphagia and dysphonia. Transferred to ER on 6/8/2021 for Gillian Barre Syndrome On 6/11 had bilateral DVTS He was placed on palliative care and passed away on 6/19/2021

swelling in my neck threatening ability to breathe as well as in ankle and face the threat to breathing most alarming to me and with all my allergies I have not gone back for second shot

PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.

Noted left arm soreness without swelling or redness. Shoulder was sorer the next day. Upon arising noted BL facial swelling/tightness similar to past reaction with lisinopril. 0 lip/tongue swelling. Swallow and breathing is normal.

I woke up at 10:30 pm Wed. night with severe chills, headache, aching joints & a big lump in my right lymph node in the neck. I took 2 Tylenol 650 mg. & it helped with the joint pain & headache. I still have a big lump on my right side neck where the lymph node is at. Other than that I feel fine.

1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours.

Patient got Moderna vaccine on 02-08-2021. Around 5:00 PM his arm was getting sore and was sowllen ( he said it was like a bump). He stated his temperature was 100.8. He denied any other symptoms. RN reviewed taking Tylenol or Advill, keep hydrated, monitor his temperature. RN reviewed moving arm, using cool compress on it. RN stated will follow up with him the next day.

Symptoms started approximately 1 week after vaccination, symptoms include fatigue, shortness of breath, water retention, swelling in feet and lower legs, high blood pressure, cough.

Patient presented to the ED with worsening dyspnea and lower extremity edema. Patient was found to have an elevated BNP with chest x-ray showing pulmonary edema. Patient has been treated with IV diuretics. Nephrology was also consulted due to worsening BUN/creatinine. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

One week after I received the second MODERNA dose, I experienced swelling of my upper lip and tenderness of facial muscles left side of my face. The symptoms are similar to the sensation I feel after a dental procedure when I have an injection. I have experienced side effects for one week. ( , ,

Around mid-day the day after vaccination the patient started to experience chills, muscle aches, and flu-like symptoms. Throughout the day, he developed edema in his legs and feet. The following day, he noticed a rash on his feet, which resolved after about 24 hours. He had severe pain through the right side of his body, and some tenderness at the vaccination site.

Pt reported "chills and aches all over the body for a couple of days", he also had a red and swollen arm from shoulder to elbow. The arm is still red, but the swelling went down.

Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure. The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital. Action taken with mRNA-1273 in response to the events was not reported. The seriousness criteria for all the events was hospitalization. The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure 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 event, a causal relationship cannot be excluded.

Patient admitted to the hospital 3/16/21 2 weeks post #2 Moderna COVID-19 vaccination with sepsis, atypical pulmonary infiltrates, and hypoxia. Patient treated for pneumonia and discharged home 3/19. Patient readmitted to hospital 3/31/21 with dyspnea, CT with worsening miliary appearing pattern.

E83.42 - Hypomagnesemia R77.8 - Elevated troponin A41.9, R65.20 - Severe sepsis (CMS/HCC) R50.9 - Fever, unspecified fever cause A41.9 - Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC) R41.0 - Delirium N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC)

Received Moderna Dose #2 on 3/10/2021. About 1-2 weeks after, he started experiencing swollen leg (unsure if left or right), had shortness of breath, and looked pale on 4/22 he was seen by a provider and was prescribed oxygen, later that night he passed.

Declining health condition; Hand swollen; Cannot lift the arm; Physical activity significantly decreased; Infection; Inflammation; Arm pain/pain got worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) in an 85-year-old male 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 Stent placement (stent placed before receiving the vaccine.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) (seriousness criterion medically significant), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. The patient developed arm pain for his father couple of months back next day after receiving the first dose. The pain got worsened from then making the hand swollen and physical activity significantly decreased. The reporter contacted 3 doctors to address the concern and none could figure the reason. The reporter was concerned about his father's declining health condition and mentioned that he cannot his arm. The physician recommended not to have the second dose. First Health care provider considered as Arthritis, Second now considered as Gait and third doctor diagnosed as Infection and Inflammation. Treatment medication include Prednisone. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient appeared to have had suffered a stroke. Admitted to hospital, tests determined no stroke. Patient had pneumonia, and severe inflammatory response. Sepsis.

The day after 2nd Moderna vaccine: Syncope (suspect seizure) shortly after wife got him up from bed, minutes later saw him slumped over in chair, pale, prolonged loss of consciousness about 20 min, EMS called and took him to ER. Had bowel incontinence with this; no tonic/clonic activity, no tongue biting.

Swelling under left armpit. Small 1/30/2021, enlarged to 2? diameter today2/1/2021. No pain, but mild discomfiture when I lift arm, or press on it.

Patient awoke at 1:00 AM on 2/10/2021, five days after his Moderna COVID-19 booster, with chest pain radiating to the back and worse with deep inspiration. Patient arrived in our office on 2/10/2021 at 9:30 AM for an evaluation. Patient was noted to have new EKG changes with new concave-up ST elevation across the precordium. Bedside echocardiogram showed no pericardial effusion and no pericardial friction rub was appreciated. Due to ongoing chest pain, patient was transported to Emergency Department by medics for further workup and evaluation for possible pericarditis. Formal echocardiogram in ED was normal. Acute myocardial infarction ruled out. ST changes improved. Patient now being discharged in stable condition 2/11/2021.

Right arm swelling and pain(not arm injected), difficulty walking, very weak, some dyspnea, elevated blood sugars, total body aches, subjective fever, patient report fever 102 deg F. S/S lasting >4 days. Sent by nurse to PCP for covid-19 rule out. Tested at clinic for covid 19, then sent into hospital for CXR and labs that were all "normal" No other treatment reported. Patient not admitted, sent home and remains a little better but still weak.

He was brought into the ER via EMS for altered mental status. He does have an underlying dementia but is normally able to hold a conversation and take care of himself. He was standing at kitchen sink staring off and drooling from his mouth. He was not able to answer questions, unable to find the words, and was weak. Admitted to hospital.

Woke up March 12th at about 8 am with severe welling in left hand and arm - ballooned up - and right eye. Started to subside after a few hours. Did telehealth visit, who recommended urgent care. No medication was given; advised to wait and watch. By afternoon, swelling had eased considerably; completely disappeared after 48 hours.

Prior to the vaccine patient was active, Driving car, tutoring kids math as volunteer. Started with sever upper back pain between shoulder blades. Used diclofenac gel, Advil ones a day - pain went away in this area within two weeks. Debilitating pain transferred to lower back pain and it continues for over two month. Tried to apply heat, any possible over the counter remedies for lower back pain such as lidocaine patches, Bungay cream, heat patches. Tired physical therapy. Got cortisone and Novocain shut in facet joins in lumbar area. Still conditions did not improve. Now patient has to walk with walker, lost 20 pounds and in the addition patient has swollen legs.

fluid overload; fatigue; Swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUID OVERLOAD (fluid overload) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia. Concurrent medical conditions included Allergic reaction to drug, Chronic lymphocytic leukemia, Blood pressure high, Swollen lymph nodes, Swelling, Fatigue, Allergy to chemicals and Fruit allergy (Cantaloupes). Concomitant products included ATENOLOL for Blood pressure high, COENZYME Q10 [UBIDECARENONE], TURMERIC [CURCUMA LONGA RHIZOME], SELENIUM, VITAMIN D3, VITAMIN B COMPLEX, CALCIUM and FISH OIL for Supplementation therapy. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 03-Apr-2021, the patient experienced FLUID OVERLOAD (fluid overload) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to FLUID OVERLOAD. At the time of the report, FLUID OVERLOAD (fluid overload) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: 182 pounds 182 Pounds. On an unknown date, Weight: 194 pounds 194 Pounds. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter stated, the patient had been taking Imbruvica for the treatment of chronic lymphocytic leukemia for almost one month, but he complained that the drug had not helped to reduce the swelling, which might be caused by swollen lymph nodes. The swelling started before he started to take Imbruvica. The patient also said that the Imbruvica had not helped with his fatigue. He emphasized that he had no side effects from Imbruvica. On 03-Apr-2021, the patient was hospitalized for fluid overload, and 4.9 liters of fluid was removed from his body. He was discharged on 05-Apr-2021 to go home with a prescription of furosemide, to be taken orally daily, for the treatment of fluid overload. When he was admitted to the hospital, he weighed 194 pounds. When he was discharged from the hospital, he weighed 182 pounds. 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 chronic lymphocytic leukemia is a cofounder; 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 chronic lymphocytic leukemia is a cofounder

COVID vax#1 (MODERNA) given on Jan 23, 2021. COVID vax#2 (MODERNA) given on 2/23/2021. Started having waxing and waning L axillary adenopathy after 2nd vax. 6/8/2021 Biopsy is consistent with an aggressive lymphoma.

White blood cell count almost doubled one month after the second vaccine and nearly tripled 6 weeks after the second vaccine. Patient was placed on hospice on April 23rd and passed away on May 8th.

Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine. Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.

Patient was admitted to hospice services on 2/11/21. Patient received vaccination on 3/2/21. On 3/16/21, patient developed severe ineffective breathing and is requiring palliative management of respiratory symptoms. Patient also suffered swelling to jaw and fever of 102 F. Patient is a DNR and appears to be approaching end of life. Patient was on the following medications prior to the current event: Citalopram, Quetiapine, Simvastatin, Furosemide, Miralax, Potassium Chloride PO, Vitamin D3, Zinc, Tylenol.

Itchiness w/ in a few minutes of injection. Developed indurated lump of 3inches, hot to touch. As of 03-30-21 site still indurated 2 inches, warm to the touch and ongoing itchiness.

Swollen hand starting on 3/26/2021, his hand and fingers were swollen with decreased ROM to extremity. 4/8/2021 presented with persistant elbow pain/swelling with continued limited ROM and ADLs.

Patient presented to the ED and was subsequently hospitalized with sepsis, respiratory failure and pneumonia on 3/2/2021. Patient presented to the ED and was subsequently hospitalized with pneumonia on 3/22/2021. Patient presented to the ED and was subsequently hospitalized with sepsis on 3/31/2021. He died on 4/4/2021.

ED to Hosp-Admission Discharged 5/21/2021 - 5/28/2021 (7 days) DO Last attending ? Treatment team E coli bacteremia Principal problem Discharge Summary , DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/28/2021 DOB: Admission Date: 5/21/2021 PCP: , PA-C Length of Stay: 7 Days Discharging provider: , DO Discharge Date: 5/28/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) E coli bacteremia Yes Atrial fibrillation with RVR (CMS/HCC) Yes Mitral and aortic valve disease Yes Overview Signed 11/4/2020 5:08 PM by , LPN Note: Moderate AR, MR & TR 1'15 Note: Moderate AR, MR & TR 1'15 Type 2 diabetes mellitus (CMS/HCC) Yes Dementia due to Parkinson's disease without behavioral disturbance (CMS/HCC) Yes Acute metabolic encephalopathy Yes Chronic systolic CHF (congestive heart failure) (CMS/HCC) Yes Sepsis (CMS/HCC) Yes Anemia Yes COVID-19 Clinically Undetermined Overview Signed 5/28/2021 12:11 PM by, DO Asymptomatic, had been positive back in January, tested negative on admission then tested positive when planning for discharge. May just be persistent viral shedding from previous Covid infection Hospital Course HPI:I refer you to the history and physical for completeness. Briefly, patient presented to the emergency department with his family stating that he is a little bit more confused, not as alert, and little bit more short of breath and shaky. Noted to have an elevated white blood cell count lactic acidosis. Hospital Course: Patient was cared for in hospital. Placed on broad-spectrum antibiotics. Blood cultures revealed gram-negative bacteremia most likely due to to possible mild diverticulitis. Throughout the course of his hospitalization he steadily improved. Was transition to oral antibiotics. His cardiac issues were continue to be managed during his hospitalization. He did have some mild encephalopathy associated with the bacteremia and as his infection cleared that improved. Adjustments were made in his home medications. He is started on therapies. Due to his severe deconditioning associated with acute medical illness will need some higher level care and increased rehabilitation. Arrangements were made for him to receive ongoing care at . When he presented to the hospital he tested negative for COVID-19. In preparation to going to the he tested positive. He was completely asymptomatic as far as COVID-19 symptoms are concerned. He was previously positive in January 2021 for Covid. This could just be a prolonged positive testing from his infection in January. Nondetected COVID-19 test on 5/21/2021 could potentially be a false negative. At this point would recommend isolation for 10 days from 5/26/2021. Otherwise his vital signs are stable. Improved the point where he no longer requires hospital level care and can be discharged to

Patient presented to the emergency department on 6/15/2021 with weight gain, peripheral edema, and worsening dyspnea. Patient has a history of CHF. Upon admission screening, he was found to be COVID-19 positive. He was treated for COVID-19 infection as well as CHF exacerbation. He is currently admitted at time of writing.

fatigue, stayed in bed most of day after vaccination and during therapy oxygen sats dropped to 82 % on Room air, needed to start oxygen, HR 101, R 36, mild non productive cough, mild SOB, T 99.5 Oxygen administered at 2 liters from 1/7 at 220 pm til 1/8 0930 off oxygen sats 95%, guaifenisin 5 ml given 1/7/21 at bedtime _history of taking this in evening already GNP updated and ordered labs and CXR and oxygen via email/phone communication Back to baseline 1/8 by mid morning, oxygen off and performing in therapy per prior (1/6 level and has since shown steady improvement in therapy as expected with rehab stay.

Inpatient admission for the treatment of sepsis (peptostreptococcus suspected) source of the infection unknown.

Severe headaches, loss of appetite, jaw claudication, tongue discomfort, difficulty swallowing, elevated CRP. Treated with prednisone 20mg, 1 tablet by mouth three times daily. Continued headaches and jaw discomfort. Still treating with steroid.

Increased edema/fluid accumulation to lower extremities, increased dyspnea, requiring supplemental O2 use.

After I received the vaccination that evening I went to bed and woke up about midnight felt water in the bed and it was coming out of my arm, I dried it off went back to sleep. The next morning my arm was swelling, and it?s gotten worse and worse, the top of my had is so swollen I cannot make a fist. My doctor sent me to the hospital and blood work was alight the echocardiogram showed heart is alight no blood clot and there?s no other reason. My doctor thinks it?s because of the vaccination.

Patient presented to office today for complaints of red hot swollen arm. Onset 02/06/2020 started with intense puritis. Patient then reported gradual onset of redness, warmth, and swelling from deltoid to forearm. Patient has a hard indurated lump on deltoid measuring 4x5 cm, with extensive redness, swelling, and fluid collection due to gravity from deltoid to mid forearm. Involving the entire circumference of patient arm.

caller stated the pt had some swelling in the right arm the day of the vax and has been really cold at night. Three days later he developed extreme swelling in his right breast. Caller states he looks like he has had a breast implanted. Pt has not contacted his PCP regarding his symptoms since the swelling seems to be better today.

Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization). Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR. Pt pronounced time of death was 2110pm. (Pt only reported a sore shoulder secondary to vaccine).

I did not see it but the patient describes initially discomfort, itching and redness below the injection site and then arm swelling that progressed down to the fingers. There was pain initially but that improved before the swelling progressed down the arm. (I spoke to him on 3/3 about the symptoms - the pain was gone - swelling continued)

Patient received covid vaccine at local health department clinic on 02/25/2021 and presented to this reporters facility ED on 03/01/2021. Patient with multiple comorbidities and newly diagnosed COPD presented after SOB not relieved by new rescue inhaler. Admitted to hospital with pneumonia/sepsis. Treated, improved and discharged to home

3/11/21 orthostatic hypotension, Fall and N-Stemi dx at a hospital -3/12 transferred to another hospital - 3/16 discharged to Swing bed at another hospital HPI: History of Present Illness: Patient is an 89-year-old Caucasian male with a medical history significant for atrial fibrillation on anticoagulation due to prior GI bleed, HTN, HLD, T2 dm, BPH who initially presented to outside facility following a fall. Fall was mechanical in nature and occurred whenever he slipped on water while walking with his cane out the front door. Primary point of impact was on his left leg in hip as well as possible head trauma. Preceding this event, patient denies any presyncope, syncope, chest pain, shortness of air, palpitations. An extensive workup was performed outside facility including CT scan of the left hip without contrast, CT scan of the head without contrast, lumbar x-ray, CT scan of the left knee without contrast all of which showed no acute fracture or abnormality. EKG showed normal sinus rhythm heart rate of 75 with incomplete RBBB. Labs are included below. Vital signs normal. Patient was getting ready to be discharged from facility and whenever they sat him up, he had an episode where he stared ahead and got diaphoretic as well as dizzy. Patient has recollection of this incident. Outside ER decided to get troponin at that time and came back elevated at 0.163. Patient continues to deny any chest pain. Denies other associated symptoms including fever, fatigue, chills, shortness of air, palpitations, abdominal pain, nausea, vomiting, diarrhea. CBC: WBC 9.2, HGB 13.4, HCT 39.3, PLT 223 BMP: Na 141, K 3.7, Cl 104, HC03 31, BUN 22, CRT 0.94, GLU 124. PT 10.5, PTT 24.7, PLT 1.07. Due to lack of Cardiology coverage at outside facility, patient transfer was requested for further troponin trending and possible cardiology evaluation should be deemed warranted. hpi 3/16 The patient is a 89 y.o. male with a past medical history notable for atrial fibrillation, CAD, diabetes, BPH, hyperlipidemia. The patient presents for evaluation of worsening issues of weakness status post recent hospitalization were patient was fainted and was found to have orthostasis. Patient had a cardiac workup which was negative for any significant cardiac disease. Patient's plan is to hopefully get stronger return home to more independent living. Patient was seen today in his room. Patient notes that he has done very well with therapy after his fall. Patient is hoping to get stronger. Patient has no issues with any bowel or bladder function. Patient denies any shortness of breath. Patient has had good intake. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

Arm swelling and visible bruising all up the right arm on 2/15/2021. Bruising all along the armpit down to waist started three days prior to the second shot on 3/9/2021. Contacted his cardiologist who stated it was a spontaneous bleed and not related to the vaccine. Received 2nd vaccine on 3/12/2021 in the left arm this time. The swelling and bruising on the left arm started the next day. Called ems on the 17th after a fall and was unable to get up.

Tested positive for COVID on 5/24 after exposure to family member. Presented to ER with increased weakness, confusion, fevers and fall at home. Patient admitted to hospital for suspected superimposed bacterial pneumonia and treated with IV antibiotics then subsequently discharged on oral cefprozil to complete 7 days.

Crticial illness; He couldn't dress himself; The elbow on his left arm was killing him; he had a lot of pain in his left arm; Warmth of hands; swelling, pain, and the heat in his hands; Couldn't move his right arm; Both of his hands and fingers swelled; Pain in elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Crticial illness), MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0A) for COVID-19 vaccination. The patient's past medical history included Lyme's disease (4 years ago) and Paralysis (Both legs and one arm). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't move his right arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Both of his hands and fingers swelled) (seriousness criterion medically significant) and ARTHRALGIA (Pain in elbow) (seriousness criterion medically significant). On 17-Jan-2021, the patient experienced ERYTHEMA (swelling, pain, and the heat in his hands) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ILLNESS (Crticial illness) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself) (seriousness criterion medically significant), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm) (seriousness criterion medically significant) and FEELING HOT (Warmth of hands) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to ILLNESS. The patient died on 04-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. on 17-Jan-2021. There the patient underwent bloodwork, ultrasound, and x-rays to rule out blood clots or anything else. Treatment included a steroid shot, antibiotic shot, and medication, steroids and antibiotics and 4 pain pills on 17Jan2021. No concomitant medications was provided by the reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added reporter's email address. On 06-Jul-2021: F/U-1 : Case upgraded to serious: Patient has died on 04-Jun-2021.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death