Pfizer

Patient remains hospitalized but respiratory symptoms are improving, AST/ALT are down-trending, & PT/INR returned to normal. Symptoms: Bleeding, Abnormal INR & ElevatedLiverEnzymes

Sunday Morning (2:00 AM) 01/24/2021 woke up with severe chills (body hot), breathing hard. Lasted about 45 minutes. took Advil and used the CPAC to calm my breathing down. Then slept until 9:00 am. But after I woke, I felt tired the rest of the day. I am doing fine now. I am not sure if this was a side effect of the covid vaccine or not. But I thought I let you know.

Difficulty breathing, throat swelling. Called 911 and treated with EpiPen at 2:45PM. Patient was improving and was taken by EMS to local hospital for further treatment/monitoring. We attempted to contact the patient on 1/19 and 1/20 but did not receive a return call.

Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns to bed at least two times per day, feel rested but upon rising to side of bed becomes weak again. Complaining of shortness of breath. Concerned about COVID infection; states had three negative tests with last test being in December. Was evaluated by Dr. with Family Medicine (his primary care provider was not available) and was prescribed Prednisone 20 mg QD x 5 days and Erythromycin 250 mg QD x 5 days; both have been completed. During office visit lungs were evaluated and reported as clear; physician mentioned a COVID test but none was obtained. Has continual cough with asthma, but feels symptoms have gotten worse since the COVID vaccine; "can't get his strength back". States the weakness, cough, shortness of breath, and joint pain have remained the same since first day noticed and has not seen any improvement since completing Prednisone and Erythromycin. Not on O2; states O2 sat is around 98 - 99%; uses a C Pap Machine. Wished to schedule a COVID test; appointment given for 2/3/2021. Denies dyspnea beyond usual SOB; instructed to seek emergency care if symptoms worsen; indicated understood and would do so if needed.

Patient presented for second COVID vaccine (1st dose given 1/21/21). While in observation, patient started feeling chest & throat tightness. Nurse in observation reports pt looked anxious. EMS was called over. EMS assessed patient and advised transfer to emergency department. Patient was taken to ER. At the ER, patient was diagnosed with chest tightness and shortness of breath. He received 325 mg of aspirin. EKG showed rate 63, no ST-T changes, no ectopy, normal PR & QRS intervals with rhythm atrial fibrillation. No epinephrine was given in the field (at vaccination site) or while in the ER. Patient was in NSR at time of discharge with recommendation for close cardiac follow up.

2 days after vaccination, at about 8pm, I felt a shortness of breath. A very uneasy, scary feeling. Slept through the night and have not had any problems since that incident.

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left deltoid on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 26Jan2021. When he came home that day his left arm swelled up and had a knot at the injection site. States he went right out, clarifies he went to sleep for hours. The next day (27Jan2021) when he woke up, he rubbed the area and it was sore. Three days ago (30Jan2021), he started running out of breath, he would walk to the mailbox and have to stop since he was out of breath. He never had that happen before. He was not sure what it was or if something else going on. He would have no breath whatsoever if he gets up to walk. When he was sitting still he was ok. If he gets up to walk to the bathroom, he was out of breath by the time he gets to the bathroom. States he was not short of breath as long as he was not doing anything. States it was crazy though when he starts walking and he gets out of breath. This has never happened to him before. He does not know if it was the vaccine or something else. He saw the shortness of breath was one of the side effects. He wants to find out what he should do and if he should go to the hospital. Advised to contact hcp. He asks if he was supposed to go back for the second shot. He has an appointment with his doctor in the next two weeks for all the medications he takes. The outcome of the events was unknown.

0945 Client related he is having difficulty breathing and is showing signs of cyanosis within 2 minutes of receipt of 2nd dose Pfizer vaccine. Epinephrine 0.3mg administered per auto inject pen IM to left thigh. Ambulance called. Nursing staff and medics on site. SPO2 55 pulse 133 client has Ventolin inhaler 2 puff administered .0949 BP 76/52. 0952 Sp02 64 Pulse 104. Client relates improved breathing. Audible wheezes. 0956 ambulance arrived Pulse 103 SpO2 76. Client remained conscious and continued to communicate. Client taken by ambulance to Hospital. Wife is with client.

77 year old male presents with SOB x "2 minutes" after vaccination. Pt has multiple comorbidities and poly pharmacy. Pt. is accompanied by 2 daughters who states that he is late with taking medication. Pt is currently "feeling better" and has refused emergency medical transport, .

Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered

Shortness of Breath; Asthma; Cough; he is experiencing asthma, shortness of breath and a cough/he has had these symptoms previously but it was cleared up and then he had the shot and it hit him again last night; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on the left arm, on 28Jan2021 08:10, at single dose, for COVID-19 immunization, at the hospital. Medical history included cholesterol, blood pressure, coronary artery bypass in 2008, asthma, shortness of breath and cough which the patient already had before receiving the vaccine. Ongoing concomitant medications included rosuvastatin calcium (CRESTOR) for cholesterol and losartan for blood pressure. The patient did not receive any prior vaccinations within four weeks. On 01Feb2021, the patient experienced asthma, shortness of breath and cough. The patient stated that he already had these symptoms before receiving the vaccine and clarified he has had these symptoms previously, but it was cleared up and then he had the shot and it hit him again. He added that last night, on 01Feb2021, he had to sit in a chair all night due to the coughing. He did take some albuterol in his nebulizer and he was better on 02Feb2021. He was asking if he can take prednisone between doses of the Pfizer COVID 19 vaccine. His second dose was scheduled on 19Feb2021. The events did not require visit to a physician or emergency room. The outcome of the events was recovering.

history cancer on chemo, DM2 non insulin dependent 10 min s/p vaccine adminstered pt developed Chest pain associated with shortness of breath. chest pain resolved after nitro SL and asa. pt was evaluated by cardiologist and discharged home. Denies cardiac history similar reaction with 1st COVID vaccine dose

chest pain Narrative: 6yo man received first dose Pfizer Covid vaccine on 3/1/21. Patient subsequently presented to the ED on 3/13/21 with a one day history of atypical chest pain and shortness of breath with walking and lying down. It is very unlikely that the vaccine is related to the patient's episode of chest pain. From a vaccination standpoint, it is safe for the patient to receive his second COVID vaccine as scheduled.

Received vaccine on March 18th. Was very tired that day. March 19th slept most of day, had muscle aches. Saturday, March 20th had fever, muscle aches, headache, fatigue. March 21 had all the above but short of breath. March 22, in the hospital with fluid in the lungs, very high blood pressure, short of breath, on oxygen.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

1st shot, none. 2nd shot, 22Feb21 fatigue joint and wound soreness. Soon diminished.. But, I got shot through my throat and shoulder in RVN ?68 and a deep gash to my inner right forearm 11Sep01 exposing my bones and severed arteries. 2 months later I still feel tightness/constriction, soreness in my lower throat and upper lungs when I breath deeply such as running, exercising or sex to the point I have to slow down. Also my right forearm is no longer sore but still feels a little swollen.

Diagnosed with Covid-19 via Rapid Test on 04/30/2021. Received Pfizer vaccines in Feb 2021. Took Covid Rapid Test (NEGATIVE) on 04/18/2021 prior to leaving for vacation home. Arrived in 04/22/2021 and only went out in public twice, both times masked and social distancing. On 04/26/2021 I started having flu like symptoms, cough, fever (99-100 degrees F), headache, body aches, shortness of breath. 04/27/2021 I lost my sense of smell and taste. 04/30/2021 since I was still feeling unwell, I went to Urgent Care in for evaluation. Rapid Covid test POSITIVE for CV-19. Prescribed rest, fluids, Tylenol for fever and monitor breathing. Returned home 05/07/2021. As of today, 05/13/2021 I continue to have cough, lack of taste and mild shortness of breath and feeling generally lousy.

developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are swollen; burning pain in left lung, and it goes up to the breast and lymph nodes/ discomfort on left side Lung; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; has tenderness near the wrist and elbow, clarifying the inside of the elbow; felt numbness in the left arm; hot flashes; This is a spontaneous report from a contactable consumer (patient) and physician. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart conditions, he has had 2 heart attacks in the past, the first one was 21 years ago, and the second was 2 years ago. Concomitant medications included all his regular medications, nothing new; (also reported as No other products). Patient previously received BNT162B2 first dose on 13Feb2021 administered in left arm for COVID-19 immunization. Patient developed varicose veins a month after he received both his shots for Pfizer's COVID vaccine. Caller stated veins are swollen. It's coming down some, but patient need to know what medications could take or not take. On the left arm right inside of his elbow, he started getting some pattern of varicose veins. It was tender to some degree and people told him to massage it and put a warm pad on it. Seems like the veins were going to pop out. Patient stated he received his vaccine at a hospital. On 03May2021, reported patient was calling in regards to a covid vaccine. He developed a thrombosis on the left arm, it was varicose veins on the arm and the whole arm is swollen, it was still swollen but it was coming down. He had been using a heat pad. Initially after 2 weeks from when he got the shot he wasn't concerned, he went to the doctor and they gave him Cat scan, Ultra sound, and blood test and did not find a blood clot. He added that he had discomfort on left side Lung, but he had discomfort several years ago, an MRI in the past that showed he has a spot in the lungs, but they didn't think it was progressing. With this thing in the past 3-5 weeks he has burning pain in left lung, and it went up to the breast and lymph nodes, it is sensitive there, he has no idea what it is. Caller was asked to clarify since he stated that he had a thrombosis but all tests show no blood clot. Caller stated that he thought Thrombosis meant when the veins are popping out and gives impression of varicose veins. He had tenderness near the wrist and elbow, clarifying the inside of the elbow. If looking at the arm from the elbow up little, it looked like worms coming out, it was veins or arteries showing. The varicose veins appearance was more pronounced close to surface initially but is now minimizing. First dose date on 13Feb2021. He was not concerned after the first dose, he was fine, he thought it was a good product and it still is. Second dose date on 10Mar2021. After the second dose he felt numbness in the left arm and hot flashes, he looked down and saw the varicose veins. He did go see the primary care doctor. He also saw his heart doctor but that was an already scheduled appointment, he did not schedule it because of this situation. the heart doctor said to put a warm pad on the arm and lift the arm up over the head every so often. Caller did not have his covid vaccine card, caller stated that he has miss placed it. He found some paper but it only has his ID number and "LHDSER" on it. He received the vaccine in the left arm both times. All symptoms occurred on the left side. He recieved the vaccine in a hospital. Patient asked to refer to his primary care doctor as he has all the results for the tests. Investigation included CAT scan normal; Ultrasound normal; Blood test normal and MRI abnormal which showed spots in the lungs on unspecified date. The event outcome for all events was unknown. Information for batch/ lot number has been requested.

Exacerbation of asthma, unspecified asthma severity, unspecified whether persistent Acute bronchitis, unspecified organism

Chief Complaint Patient presents with ? Cough ? Shortness of Breath HPI is a 76 y.o. male presenting to the ED for assessment of approximately 2 weeks of shortness of breath and cough that has been progressively worsening. Patient's wife did test positive for COVID-19 2 weeks ago. At this time patient has been taking over-the-counter cough and cold medications with no relief of symptoms. Patient does have a history of atrial fibrillation. Patient does take Lopressor daily. At this time patient denies any headache dizziness confusion chest pain nausea vomiting diarrhea abdominal pain dysuria rashes leg pain leg swelling. PCP: , DO

ED to Hosp-Admission Discharged 5/4/2021 - 5/10/2021 (6 days) Treatment team COVID-19 Principal problem Hospital Course HPI: Please see H&P for details Hospital Course: 76-year-old gentleman was admitted to hospital because of COVID-19 pneumonia and respiratory failure with hypoxemia secondary to it. He was placed on oxygen which was titrated. He was started on remdesivir and finished the course. Initially his condition got worsened and ID was consulted and he was given Tocilizumab. He also was started on dexamethasone from day 1. His condition has improved significantly. He is requiring 2 L of nasal cannula. At this point he is going to finish his course of dexamethasone as outpatient and he will be discharged home with oxygen. He was also educated about proning and he is very good at this. He also had remote patient monitoring arranged. He is going to follow-up with his PCP. Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Depressive disorder Yes Type 2 diabetes mellitus (CMS/HCC) Yes Chronic lymphoid leukemia in remission (CMS/HCC) Yes Pneumonia Unknown Acute respiratory failure with hypoxia (CMS/HCC) Yes

3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.

Patient experienced extreme shortness of breath 16 days after the second Covid-19 vaccination. Treatment was rest and reduction of physical activity. Patient has recovered about 80 % of conditioning level over 3 month period.

started having events of asthmas and coughing type stuff; started having events of asthmas and coughing type stuff; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 28Jan2021 as 1st dose, single for covid-19 immunisation (76 years old when vaccinated). The patient medical history included asthma and chest congestion. Concomitant medications were not reported. On 01Feb2021(patient reported as last night) he started having events of asthmas and coughing type stuff. The patient reported that he would normally get Prednisone for this but asks if it is contraindicated between the vaccine doses. The outcome of the events was unknown. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labored breathing and triggering of bowels.

Patient tested positive for COVID-19 on 07/09/2021. Sx onset 07/04/2021 (SOB, cough, loss of taste/smell, fatigue, body aches, subjective fever; afebrile at time of testing). CXR has been ordered, pending. Lab contacted to request specimen be held, and requested they contact TN DOH to coordinate with CDC to discuss the case further. Attempting to coordinate monoclonal antibody infusion for this patient.

7/3/2021 7:23:41 AM > phone call from Officer pt deceased. discussed with wife. she heard him make a loud breathing noise at 3am and then could not wake him. had been feeling well with no complaints. planned to run a road race this Sunday. offered support. pls mark chart and then FYI to Dr.

Received his Pfizer vaccinations 1/26/21 and 2/16/21; he started to have a dry cough on 7/15/21 which has progressed to shortness of breath. He does admit to eating with friends who were not vaccinated while on vacation sometime prior to this. He had a positive COVID test at his PCP office on 7/18 and another positive COVID PCR at our hospital 7/22

Cough, congestion, shortness of breath, diaphoretic, Temp of 99 degrees F, nausea, oxygen saturation dropped to 88% on room air

Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest

I had my second Covid-19 vaccine last Friday at noon, January 29, 2021. I felt fine until late Friday evening. I woke up around 3am violently panting and trying to get his breath. After what could have been a minute or many minutes, I started breathing normally. My Friday night sleep was terrible. I woke with a temperature around 101. After taking Acetaminophen, my temperature went back to normal. Towards evening my temperature went up to about 101 and I was achy all day. Saturday evening was a good evening and I woke up feeling fine on Sunday.

6 days ago he got his first COVID-19 vaccination. 5 days ago he started to feel ill. Generalized body aches. Progressive shortness of breath. More recently dry cough. Diminished sense of taste and smell. His symptoms progressed and today, due to shortness of breath, he presented to the ED. In the ED he was found to be hypoxic and have tachypnea. COVID-19 test was positive. He was given intravenous dexamethasone and is referred to the hospitalist service for admission. Patient denies ill contacts. He denies diarrhea. No nausea or vomiting. Since arriving to the ED and getting on oxygen he feels significantly better.

Narrative: See "Other Relevant History" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of "There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib

He felt like he was having an asthma attack; Blood pressure became elevated; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283), via an unspecified route of administration at right arm on an unspecified date at 77 years old at 09:30 AM at single dose for covid-19 immunization. Medical history included diabetes, sarcoidosis, hypertension, asthma, Idiopathic thrombocytopenic purpura, sleep apnea, arthritis. Known allergies included X-ray dye and statin medications. Concomitant medication included insulin, amlodipine, folic acid, nebivolol hydrochloride (BYSTOLIC), eicosapentaenoic acid ethyl ester (VASCEPA). No other vaccine in four weeks. No covid prior vaccination and Covid tested was not post vaccination. He felt like he was having an asthma attack and his blood pressure became elevated. He had to wait in the ER until they gave him his blood pressure medicine (Norvasc), a diuretic and an antacid (Pepcid). Adverse event start date was 22Jan2021 10:00 AM. The events resulted in: Emergency room/department or urgent care. Outcome of the events was recovering.

Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).

Patient referred having persistent cough and slight shortness of breath that started the day after the immunization which slowly faded week and a half after the immunization.

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

Shortness of Breath causes by multiple large blood clots, put on blood thinners, seems to be fine, but has follow up appointment in March

1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

Moderate pain in chest behind sternum when breathing. Admitted to Hospital on 1 February 2021. Diagnosed as pericarditis. Treatment: Ibuprofen 600 mg 3x/day for 2 weeks, and Colchicine 0.6 mg 2x/day for 3 months.

77-year-old male with history of coronary artery disease must CHF brought in from home for worsening shortness of breath, per EMS saturation found to be in the 50s that improved on CPAP, apparently patient received his COVID-19 earlier today. Denies fever, chills, nausea, vomiting, chest pain, abdominal p

Patient complains of shortness of breath, difficulty breathing, decreased o2, chest congestion 3 days after receiving vaccine

2 days after 2nd dose of Pfizer vaccine pt developed stuffy nose, SOB, but no cough, fever, or chills, then developed an itchy rash on Rt foot that spread to arms and legs resulting in a peticheal rash/lesions on dorsum of feet, shins, thigh, mid abdomen, medial arm and back. Dermatology consult felt due to allergic purpura, and vasculitis possible but less likely. Platlet count in the normal range.

48 hours after the 2nd dose of the COVID-19 vaccine, he had generalized body aches that had worsened, chills, agitation/anxious, dizzy, and hyperventilating/ shortness of breath. He went to the hospital with his wife on 3/1/2021. He stated "I think I'm going to die". Patient had been off Cymbalta for 3 days completely- treating neuropathy (previous daily medication that his primary physician advised him with weaning down the dose). The patient was manic and had tangential thoughts- from crying/angry to laughter. It is believed that the agitation could be due to medication withdraw.

had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

Two days after receiving the vaccine the patient began experiencing shortness of breath. One week after onset of symptoms he presented to the hospital and was diagnosed with submassive pulmonary embolism. He underwent IR suction thrombectomy which removed 30% of the PE burden and spent two days in the ICU. He has now been transferred to the floor.

Patient received the first shot on 2/17/21. Nothing seemed unusual during the following days; no complaining of soreness or anything. He hadn't introduce any new medicine or food into his routine. On the morning of 2/21/21, he woke up around 5 AM as usual. He spoke with his wife for a bit. Around 7:00 AM, he started having trouble breathing. He asked for help from family members. 911 was called. EMT's preformed heart compressions for about 45 minutes before pronouncing patient deceased. During EMT's initial encounter, EMT's struggled getting a tube down patient's throat due to his tongue being swallon

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

The patient is a 77-year-old male with T2DM (not on medications), gout, and HTN who received the first dose of the Pfizer COVID-19 vaccine on 2/14. On 2/17 (three days after vaccination), he sought care in the emergency department for chest pain that worsened when he was supine and shortness of breath. EKG in the emergency room showed STEMI and troponin levels were normal. He was transferred to a different facility for cardiac catheterization. Cath showed mild circumflex disease and a stent was placed. He was diagnosed with pericarditis at that time (elevated inflammatory markers ESR/CRP). He was discharged home post cath on Plavix/ASA. He had an echocardiogram at his PCP?s office on 2/25, results still pending (as of 3/10). 2/25 ? televist with cardiologist who concurred with pericarditis, maybe mild coronary artery disease (follow-up scheduled 3/11). 3/3 chest pain symptom improved further, no cough, improved shortness of breath. Medications at home: statin, previously colchine for gout, likely BP medication (PCP will send records) Allergies: None known. Vaccine Indication: Age >75

dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.

Receive vaccine at approximately 0855 at off site location. Waited 15 minutes in post vaccination waiting area and left clinic. He drove to medical office at 0920 to report "throat swelling" on the left side that started 10 minutes post vaccination that progressed to bilateral. He reported difficulty swallowing. No respiratory distress. EMS called and he left per EMS at 0928. Attempts to contact later in the day on 3/18 not successful

He was having trouble breathing; His heart is working at 25% capacity; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Lot number: was not reported) (at the age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included wears a heart pacemaker and cholesterol issue, both from an unknown date and unknown if ongoing. On 09Mar2021, the patient experienced trouble breathing, it was reported that his heart was working at 25%. The patient was admitted to emergency room and subsequently he was hospitalized for 3 days, the events were life-threatening. The patient outcome of the events was not recovered. Information about lot/batch number has been requested.

Death Narrative: Patient received first COVID vaccine does on 3/13/21 at 07:53 without complications. Home telehealth nurse informed by family member on 3/18/21 the patient passed away on 3/13/21 at approximately 1300. Per medical record documentation, "Patient had been at facility getting COVID vaccine that morning at 0800, came home and was taking out his garbage when he started to stumble and fell to his knee, a neighbor saw and assisted patient up and was walking with him back to the apartment when "...he stopped breathing and feel over, dead." Per medical record review, patient had several co-morbidities including hypertension, hyperlipidemia, chronic hyponatremia, alcohol abuse, alcoholic fatty liver, chronic thrombocytopenia, and GERD.

Pfizer-BioNTech vaccination given on 2/26/21 and 3/19/21. Presented to ED on 3/27/21 with generalized body aches, shortness of breath, and cough. Was admitted to hospital for COPD exacerbation and COVID-19 infection without hypoxia.

Patient's chief complaint was feeling tired and shortness of breath. Patient was hypertensive. Denied dizziness and chest pain. Patient was offered oxygen supplementation but refused and stated that he felt okay. All symptoms resolved except fatigue and blood pressure remained slightly elevated.

Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.

Significant drop in blood pressure, couldn't walk more than 1/2 block, shortness of breath. This happened about 5 weeks after the 2nd dose of the vaccine. Had blood work, showed very low blood counts to the point of maybe needing a transfusion. Had GI work up today, no bleeding. Could this be an autoimmune reaction to the vaccine. His blood counts were fine prior to the vaccine.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new. Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.

Patient had COVID-19 exposure and reported having a very bad cold with cough on 4/12/21 to his primary care physician. He was tested and found to be COVID-19 positive at that time. He presented to emergency department on 4/19/21 with worsening shortness of breath. He was admitted to hospital for further management of infection. Patient admitted from 4/19/21 to 4/24/21 and discharged to a skill nursing facility for further care.

It started with stills, nausea, aches for about 24 hours. Then more and more trouble breathing for 8 weeks. In the past week it has been somewhat better.

Patient received both doses of Pfizer vaccine (#1 on 2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on 5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with Hypoxia, Pneumonia due to COVID-19.

vaccine failure -- despite 2 weeks having elapsed since 2nd vaccine, he was hospitalized for COVID pneumonia with hypoxemia 4/24/21 through 5/4/21, treated with oxygen, remdesivir, dexamethasone

Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.

Shortness of breath because extreme in late March/Early April. X-Ray and Cat-scan showed serious new inflammation in lungs and expanded bronchiectasis. Sample taken by bronchoscopy showed pseudomonas infection not susceptible to oral antibiotics. Treatment was a week of Cefemime injections three times a day.

Pt w/no significant PMH p/w worsening symptoms over 10 days of cough, general malaise, nausea, poor oral intake, and sore throat. On admission, was hypoxic on RA & generally ill appearing. CXR showed poss viral pneumonia consistent w/COVID-19 and COVID test was positive despite having received Pfizer vaccine on 01/15 & 2/8/21. Was admitted for acute hypoxic resp failure secondary to COVID and given 3L O2, dexamethasone and remdesivir. Was ultimately discharged 3 days later w/follow-up.

Patient received Pfizer COVID-19 vaccine on 1/24/21 (first dose) and 2/5/21 (second dose). Patient tested positive for COVID on 5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and passed away on 5/29/21: Preliminary cause of death: Respiratory failure with hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19 vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on methotrexate Anemia Hypertension Obesity

Rash; Itch all over my body - second dose; Hard time breathing through mask - second dose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 21Apr2021 12:15 as single dose for covid-19 immunization. Medical history included Broke femur of right leg from 09Nov2020 to 09Nov2020 (he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), Surgery to repair broken right femur from 12Nov2020 to 12Nov2020, ongoing COPD (Chronic obstructive pulmonary disease) (Chronic COPD, he was diagnosed with chronic COPD at least 13 or 14 years ago), ongoing Asthma, on-going bronchitis, he's been in either a walker or a wheelchair (he is still not fully recovered), hospitalized for the broken femur on 09Nov2020 (reported that he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), rehabilitation from unknown date to 14Dec2020 (reported that he had rehabilitation following his hospital discharge and got out of the rehab facility on 14Dec2020). Concomitant medications included apixaban (ELIQUIS) taken for Blood clots in leg after surgery from Apr2021 and ongoing as 5 mg, 2x/day (one in the morning and one at night). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number CR2613, expiration date unspecified), via an unspecified route of ad-ministration, administered in arm left on 30Mar2021 as for covid-19 immunization. No additional administered vaccines. No prior vaccinations (within 4 weeks). No family medical history relevant to adverse events. He reported that what was happening was that he itches all over his body. He reported that he had little bumps and he itches all the time. Her reported that he got some anti-itch stuff and he's been putting that on it.He reported that he just did what he thought was necessary for the itching. He reported that he thought he could take anti-itch stuff and try to correct it that way, but he was still itching. He stated that naturally you say not to itch, but he still itches and he scratches. He reported that he guesses the scratching makes it worse. He reported that his children recommended that he take Benazine or something so that is what he has been doing. He reported that he just got out of the hospital anyway because he broke his femur.He reported that he's been in either a walker or a wheelchair and that he is still not fully recovered from that, so that was one of his deals. He reported that he also has blood clots. Reported that the itching seems a little better but right now it was on his back and it was difficult to put the cream on there. The rash started on the second day, he started itching on the back of his head, he thought it was dandruff or something, so that happened the first day after, and the following day he got itching all over. Was using some itching stuff they get from the pharmacy, they said take certain meds, so he talked to the pharmacy about that, his wife did, and he started doing that, but it's continued on for a week, he did not know if he was doing ok, or if he should be doing something else, or continuing doing what he is doing. Trouble breathing through mask: He reported that he received the Covid-19 vaccine at 12:15 PM on 21Apr2021 and he had physical therapy at 3:00 PM following the vaccine. He reported that he then had a hard time breathing through his mask at physical therapy. He reported that he always has a hard time breathing one way or the other, and that the difficulty breathing through his mask was present before he received the Covid-19 vaccine. Blood clot in leg: reported that after he was discharged from rehab, he went to his own family doctor because his ankle and leg were still swollen. He reported that his physician sent him to (place name) to have a vascular done. He reported that the physician in (place name) determined that he had blood clots in his leg. He reported that he was sent to the emergency room and he started that stuff for about a week until he went to a regular vascular doctor and the physician determined what the caller should be doing. He reported that he was diagnosed with the blood clots after he got out of rehab at (place name). He reported that he went to see his regular doctor on 30Mar2021 and that it had to be after that that they sent for vascular. Rash: His wife reported that the caller has been scratching himself bloody. His wife reported that the rash came out on Friday, 23Apr2021. He reported that he was in a wheelchair. He reported that he has been using anti-itch products but is still itching. His wife provided product details. His wife reported that the patient has already used one tube of the Benadryl Anti-Itch cream. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets; Lot Number: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets; Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube; Lot Number: 3290LZ-1; Expiration Date: Oct2022. There was product complaint. Patient was using Benadryl tablets, Benadryl Anti-Itch Cream, and Benadryl Liquid Capsules and is still itching. The imprint with lot number and expiry date on the Benadryl Extra Strength Itch Stopping Cream was little hard to read. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube. Additional lot numbers: Benadryl Anti-Itch Cream (second tube): Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Lot Num-ber: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Lot Number: 3290LZ-1; Expiration Date: Oct2022. Sample of the product available to be returned, if requested. Packaging sealed and intact. The outcome of breathing difficult and itchy was not recovered, rash was unknown. No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021479091 same patient, different dose/event

77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI

Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS.

very bad flu like symptoms, couldn't breathe, congestion . stiil down , been 1 1/2 weeks .see dr. on thur ,6/24 follow up .

Death 5/30/2021 Causes of death listed on death certificate 1. respiratory failure 2. covid pneumonia

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Pfizer COVID Vaccine EUA Pfizer Vaccine Dose 1 2/5/2021 (lot # not in state registry) Pfizer Vaccine Dose 2 3/6/2021 (lot # not in state registry) COVID Positive 3/27/2021 Hospitalized 3/27-4/2/21 Hospitalized 5/19-5/24/21 6/15/21: Presented to ED. This is a 77 years old gentleman with a history of COPD presents to the emergency department because of shortness of breath and chest pain. Patient states that he was in his usual state of health and suddenly developed shortness of breath and chest tightness. By the time of my evaluation he no longer has chest tightness. He was recently in the hospital and treated with antibiotics for Pseudomonas pneumonia. He is reportedly compliant with his COPD medications at home. He normally wears 2 L nasal cannula at home. Currently he is on the BiPAP and reports feeling better after treatment in the emergency department. He was given IV steroids, bronchodilator therapy. He was also given IV antibiotics given recent history of Pseudomonas pneumonia. Of note patient states that for the past week his bilateral ankle appears to be more swollen and he is on Lasix started by Dr. from pulmonology for this. 6/21/21: This patient with a history of COPD, atrial fibrillation on anticoagulation and chronic dementia, was again admitted 6/16 with increasing shortness of breath and chest pain. It was noted that his COVID 19 test was positive. He was started on IV Remdesivir, but since his COVID 19 test has been positive since March of this year was felt that he did not require additional treatment. We are treating him for an exacerbation of COPD. His chest x-ray was actually normal with COPD but no signs of infiltrate, heart failure or effusions. He is on apixaban for atrial fibrillation and should not have a pulmonary emboli. He was getting IV Lasix, but the BUN and creatinine were rising. We have obtained an echocardiogram to see if there is a degree of systolic heart failure. We will continue the IV antibiotics and steroid therapy. The patient seems comfortable at rest but is on 5 L nasal cannula. The patient reports that he is on 3 L of oxygen at home all the time. I called to talk to the good friend who is listed as the 1st contact and reviewed the situation. He does live by himself but has 24 hour a day care. We discussed that our goal was to get him back down to 2-3 L of oxygen. There seems to be some improvement but if still requires 5-6 L of oxygen, we will ask for a pulmonary consultation. I have talked to the pulmonary team several times unofficially for advice and they seem to have nothing else to offer at this time. Again today the patient seems comfortable and is warning why he can go home.Admitted and treated with bronchodilators, steroids, BiPAP and levaquin. Echocardiogram repeated. By the time of admission, chest pain resolved. Oxygen requirement stay high at 5 liters. Today improved to baseline 2 L. Discharged home.

Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

On 1/18/21, received the vaccine at 1007. At 1035 while working with PT, he became very fatigued and short of breath. Pulse ox was 96%. At 1105, he began shaking uncontrollably and projectile vomiting. BP 100/62, P-100, temp 96.0. 1230: temp 99.0 and still shaking. 1315: temp 100.1, shaking less. 1500: temp 102.0 no other symptoms. 1600: Temp 101.3 no other symptoms. 2000: Temp 99.3 no other symptoms. Temp continued to normalize through the night. Doing well and back to baseline on 1/19/21.

Stated since Xmas he has not feeling well after a family gathering. His wife in hospital for Covid-19 pneumonia. He reports for about 1 week, his SOB worsen, not eating well at all for the past 3 days. Which prompt him to visit the ED. Admitted to Hopital for Dehydration; Dyspnea; Pneumonia due to COVID-19 virus; COVID+ 1/10/21; still admitted

Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure

site soreness; nasal stuffiness; difficulty breathing; throat began closing up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient (also reported as age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration on 14Jan2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. Medical history included two recent right shoulder surgeries. Concomitant medication included oxaprozin. The patient previously took oxycontin and experienced allergies and an unspecified allergy shot last 06Jan2021 on the left & right arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021 at 01:30, the patient was having difficulty breathing and throat began closing up. Patient's wife was going to call 911 but after about an hour, incident appeared to be getting better. On the next day (16Jan2021), the patient felt better with minor site soreness and nasal stuffiness. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.

Patient presented with night sweats and shortness of breath the day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.

After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath. Stopped for errand & had same experience. No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106. Went to ER. Had EKG, check xray,troponin levels checked 6 hrs apart. All were negative. Released. Since that time, I continue to have: chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea. Went for Covid test 02/04/21 Results were negative. Just began feeling more normal today--2 weeks after innoculation.

Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.

Pt received vaccine on 1 Feb and presented to the ED on 3 Feb with Abdominal pain, epigastric; Acute pancreatitis without infection or necrosis, unspecified pancreatitis type; Hypertension, unspecified type; SOB (shortness of breath). He was discharged on 6 Feb 2021

Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.

First dose given 01/21/21, 2nd dose February 11th 1:30 pm Both first and second dose, first dose only soreness at injection site, second dose had soreness, nausea, cramps in stomach, wheezing, fatigued, chills, vomiting,, diarrhea Symptoms have mostly subsided, just a little stomach craming and fatigue

The evening of the day of vacination, I had bad headache, body ache, chills and body shivers. By the time I went to bed, I had coughing and wheezing. Took atomizer for that. During the night every joint in my body starting to hurt. Took more tylenol and CBD rubbed on hips, shoulders, knees and wrists. By morning I felt better, but some body aches and headache. Lsted for the rest of the day. Ok by the evening.

Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He started with sx ~13 hrs later - He started drifting out of consciousness, then had labored breathing through night rendering him unable to sleep. After getting up in the morning, his breathing was better but he felt lightheaded/weak through the day. By the next morning (Friday 2/12), he was so bad next morning that wife called 911 - He reports that he was there and then not there and was losing track of train of thought. He was taken to ER via EMS, where his HR was initially 15 - He was admitted to hospital - initially a temporary pacer was placed, then a permanent one on Monday, 2/22. He has had other episodes like this in past 13 mos. PCP referred him to neurologist and EENT. Neurology work-up, including MRI and 72 hr EEG were unremarkable, although he learned retrospectively that there was a time during EEG where HR was only 35. EENT found no auditory or other issues . *MD in ER told him that if issues were not neuro in nature, they were probably cardiac.

My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.

Patient stated a history of allergic reaction to the influenza vaccine in the past. Patient insisted on receiving Covid vaccination. Patients primary care provider was called and gave approval for patient to receive vaccination. About 10 minutes after receiving vaccination the patient stated sinus pressure which quickly proceeded to complaints of his throat feeling "funny and tight". ERT was called and patient was given a dose of Epinephrine and transferred to the emergency department.

Developed malaise, runny nose and productive cough with wheezing on day 3 following vaccination. Cough persisted for 5+ days. No fever.

Patient received second dose of Pfizer vaccine on 02/26/21. Starting having a fever from 02/27 and shortness of breath from 02/28.

patient began to have left sided chest pain which radiated to left arm. stated sharp pain but also belt like pressure. does not have history of similar chest pain. he also described dizziness and SOB, but additional questioning suggests this is his baseline. 12 lead showed a fib. patient denies history of similar. patient given ASA and transported to ED for additional work-up for his chest pain

On evening of vaccine, he began to run high fever of 101.5. next day 102. 3 with extended chills, Doctor was called and patient was told to take Tylenol, On second time Doctor was called, he was told to alternate Tylenol with ibuphrofen. Fever came down on 2/28 started back up on 3/2 , went to Er ON 3/4 FOR BREATHING ISSUES, a blood infection was found, went back to ER ON 3/8 FOR ANTIBIOTIC,( DOCTOR HAD WANTED HIM ADMITTED,THIS WAS NOT COMMUNICATED) , next day was admitted to Providence Hospital for IV antibiotics, dismissed from Providence on 3/13, with antibiotics infusion to continue at home.

Patient passed away unrelated to covid vaccine Narrative: The patient had new onset of CHF,A.fib and hx f COPD. Patient was admitted to hospital on 1/21 and Patient discharge against medical advise on 1/22. Patient aware of risk including early death and increased morbidity but patient still wanted to leave. Patient received the first dose of Pfizer vaccine on 1/19 and no adverse reaction was reported. Patient presented to ER for shortness of breath and chest pain and was admitted on 1/29. Patient passed away on 1/31. No indication that death was related to COVID 19 vaccination.

Case tested positive for COVID-19 on 3/1/2021 by rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on 3/3/2021 for shortness of breath and occult infection. Case was previously admitted and discharged from hospital on 2/22/2021 after a lumbar compression fracture. Case had monoclonal antibody infusions; was afebrile and denied chills, but had a dry cough. Case was a previous smoker, quit 2 years prior. Case developed pneumonia. Case required supplemental oxygen.

Patient is a 78-year-old male with history of COPD, paroxysmal atrial fibrillation, ischemic cardiomyopathy, type 2 diabetes mellitus, status post mitral valve replacement with metallic valve on Coumadin, stage II: CAD status post LAR. Presented to Hospital campus on account of severe shortness of breath in a patient with significant weakness. Patient has had significant shortness of breath progressively worsening. Patient was just discharged from this facility on 03/17/2021. The patient was admitted on 03/05/201 on account of shortness of breath. During the admission, patient had a multiloculated right-sided pleural effusion requiring video-assisted thoracoscopy and evacuation of hemothorax. Associated with chest wall mass. Subsequent biopsy revealed evidence of small cell carcinoma. The patient was seen by oncology during that admission with a Mediport put in place. With plans to follow-up with oncology outpatient for continued management and to hopefully initiate chemotherapy. There was also concern for acute congestive heart failure and required diuresis. Echocardiogram was showing EF of 40% at the time. Now, patient is presented to the emergency room on account of significant weakness in the patient well developed worsening shortness of breath over the last couple of days. Patient was still short of breath and weak he could not even get up the toilet seat. When EMS saw the patient he was satting 80% on room air and required 6 L via nasal cannula. Did not complain of any chest pain or cough with this finding. Neither did he complain of any fever. In the emergency room, patient was tachypneic and slightly tachycardic. Lab work shows lactic acid of 2.3 glucose of 302 and creatinine of 1.90. The patient's BNP was 1170 with GFR of 34. Patient INR was 4.5. Chest x-ray shows Trace right pleural effusion. No pneumothorax. With concern for pneumonia patient was given azithromycin and Unasyn. Also with concern for possible CHF patient was given Bumex.

Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.

Presented to ER - somnolent and lethargic. After morning do dose of inhaler for COPD started to feel congested and short of breath, prompted him to ER. Did not have fever, chills, HA, rashes or allergic reactions. Started on BIPAP. No definitive evidence indicating that this was or was not an ADR to vaccine

Multiple pulmonary embolism 100 degree fever Chills incontinence Gout Blood Uric Acid Increase Shortness of breath

Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure

Presented to hospital with shortness of breath for one week on 4/13/2021. Additional symptoms reported include productive cough with blood tinged sputum, diarrhea, and food tasting like salt. Supplemental oxygen, tocilizumab and remdesivir treatment initiated

Pt presented with SOB and leg swelling and found to have RLE DVT. He was admitted and started on anticoagulation

After receiving the injection, patient had not been feeling well. Low appetite, lightheaded, fatigued, difficulty breathing. They had been traveling and returned on 3/7. He was tested for covid and the test was positive. He presented to the ED on 3/25/21 and was subsequently admitted to the hospital for 4 days with pneumonia.

ED 3/7/2021 MC MC Source Organization Encounter Summary 78 y.o. Male; born Jan. 03, 1943January 03, 1943Encounter Summary, generated on Apr. 02, 2021April 02, 2021 Reason for Visit Reason Comments Shortness of Breath Fever Encounter Details Suspected COVID-19 virus infection (Primary Dx) ED Provider Note Patient Chief Complaint Shortness of Breath and Fever History of Present Illness 78-year-old male, PMH is documented below, presenting to the emergency department with fever, cough and shortness of breath. Patient reports that he has been ill since Tuesday. He developed a productive cough bringing up some clear sputum. States he has some shortness of breath with exertion. He denies any chest pain. He denies any palpitations, lightheadedness or syncope. No headache or neck stiffness. States that he has been afebrile until today. Patient had a temperature of a 101° for EMS he has also been having some diarrhea. States he has no loss of taste and has chronic loss of smell. He has not come into contact anybody with COVID-19. Denies any history of DVT or PE. No lower extremity pain or swelling. Patient had his 1st Covid vaccination, but has not received his 2nd. Office Visit 5/7/2021 Family Medicine Cough +1 more Dx Cough Reason for Visit

ED to Hosp-Admission Discharged 3/28/2021 - 4/2/2021 (5 days) Treatment team. Acute hypoxemic respiratory failure due to COVID-19 Principal problem Discharge Summary (Physician) Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 3/28/2021 PCP: (doctor) Length of Stay: 5 Days Discharging provider: (doctor) Discharge Date: 4/2/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 Yes Cardiomyopathy Yes Obstructive sleep apnea syndrome Yes Essential hypertension Yes Type 2 diabetes mellitus Yes Presence of automatic (implantable) cardiac defibrillator Unknown Pneumonia due to 2019 novel coronavirus Yes Stage 4 chronic kidney disease Yes Pneumonia of both lungs due to infectious organism, unspecified part of lung Yes Atrial fibrillation with rapid ventricular response Yes NSTEMI (non-ST elevated myocardial infarction) Yes Hospital Course: Patient is a pleasant 79-year-old male admitted due to acute hypoxic respiratory secondary COVID-19 pneumonia. He was continued on dexamethasone for the COVID-19 pneumonia however the medicine was relatively contraindicated due to renal failure. Patient was seen by cardiology continued on aspirin beta-blocker and statin for non-STEMI and already was anticoagulated with Xarelto which is continued. Patient's oxygenation requirements did improve and he was set up for home oxygen prior to discharge. Patient was continue with PT and OT and slowly did well he was doing well clinically at this time may be discharged home for convalescence as per protocol. Patient may follow-up with PCP and specialist as noted

PT WENT TO ER AFTER INJECTION AFTER 2 DAYS DUE TO SHORTNESS OF BREATH. HOSPITAL FOUND INFLAMATION AROUND THE HEART (SIMILAR TO CONGESTIVE HEART FAILURE), CLOTTING, ARRYTHMIA.

Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.

ED to Hosp-Admission Discharged 4/16/2021 - 4/19/2021 (3 days) Hospital Doctor Last attending - Treatment team COVID-19 Principal problem Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Hypercholesterolemia Yes Hypertension Yes Type 2 diabetes mellitus Yes Major depressive disorder Unknown Acute respiratory failure with hypoxia Unknown Hypertensive urgency Unknown Presenting Problem/History of Present Illness/Reason for Admission COVID-19 Hospital Course (Patient) is a 78 y.o. male with medical history of hypertension, type 2 diabetes on insulin, and hyperlipidemia presents with SOB and she was admitted for acute hypoxic respiratory failure with sepsis .Patient was diagnosed with Covid on 4/15 and repeat COVID-19 was positive on admission. Acute hypoxic respiratory failure likely from COVID-19-improving o On admission satting low 90% ,required supplemental oxygen, normal lactic acid & CRP, elevated LDH 263 o CXR (4/16/21): mild basilar atelectasis. o Continue remdesivir (4/16-4/21, Day 4) and dexamethasone (4/16-) since O2 sat <94% on room air, requiring supplemental oxygen o Patient currently satting 95-97% on 2 L nasal cannula. Bedside study does not qualify patient for home oxygen while resting and/or ambulating. PT recommends safe discharge home. Patient clinically stable to be discharged home today. Patient to follow-up with PCP. Sepsis likely from COVID-19 -resolved o On admission HR >90, RR >20 + source of infection COVID= sepsis, procalcitonin neg- antibiotics not indicated Elevated D-dimer likely from SARs-COV-2 o On admission D-dimer elevated 0.59, patient was tachycardic o CTA significant for No pulmonary embolism. No lung consolidation. Hypodense renal lesions. Hypertensive urgency - resolved Essential hypertension o On admission BP >180/120 o Continue home losartan and amlodipine. Diabetes mellitus type 2 o A1c (11/18/20):7.9, repeat A1c 6.7 (4/17) o Home meds metformin 500 BID, Novolin 70-30 : 40 unit AM, 75 unit PM. Home novolin 70-30 = lispro 34 units, glargine 80 unit approximately o Started SSI, lispro TID 5 units, Glargine 10 units BID, confirmed dose with pharmacy based on his home Novolin 70-30 conversion. Patient to continue home medications and follow-up with PCP. MDD-Continue home paroxetine, venlafaxine Hyperlipidemia - Continue home statin Treatments: steroids: Dexamethasone 6 mg and remdesivir 100 mg, benzonatate capsule 100 mg Procedures: None Consults: pulmonary/intensive care Pertinent Test Results: CXR: There is mild atelectasis at the lung bases. There is no effusion or pneumothorax. The cardiac silhouette is normal size. The trachea is midline. The osseous mineralization is normal. CTA: IMPRESSION: 1. No pulmonary embolism. 2. No lung consolidation. 3. Hypodense renal lesions as described above. ED to Hosp-Admission Discharged 4/26/2021 - 5/6/2021 (10 days) Hospital Doctor Last attending ? Treatment team Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Principal problem HPI: (Patient) is a 78 y.o. male with past medical history of T2DM, HTN, HLD, and depression/anxiety who presented to the ED on 4/26 with COVID pneumonia and acute bilateral PE. Orthostatic Hypotension. Improved with IV fluids. No orthostasis this morning. TTE done yesterday showing preserved EF. Acute hypoxemic respiratory failure secondary to Covid 19 Pneumonia with some contribution from PE. Patien.t now on room air. Patient completed Remdesivir. Completed 10 days of Dexamethasone. He will be transitioned to prednisone 20 mg daily for 7 days, 10 mg daily for 7 days then 5 mg daily for 7 days. He was givenTocilizumab: 8 mg/kg, 4/29. He is not a candidate for convalescent plasma. Acute bilateral PE: Mild clot burden without evidence of RV strain. Was initially started on therapeutic Lovenox, transitioned to Eliquis 4/29. Eliquis priced and affordable to the patient. T2DM: On lantus 23 units nightly and Humalog to 10 units with meals HTN: Continue losartan and amlodipine with holding parameters HLD: Continue statin Depression with anxiety: Continue paroxetine and Effexor BPH: Continue Flomax Suspected OSA: Per his daughter concern for OSA. Will need outpatient sleep study.

difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

78y.o. male with a past medical history of COPD, DM II, and HTN who presented to the hospital's emergency department from an extended care facility. Patient was recently hospitalized and treated with IV antibiotics for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for ischemic signs but patient had an elevated troponin. CXR showed right pleural effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory failure. Patient's oxygenation continued to deteriorate despite Remdesivir, decadron and lovenox. Patient went into respiratory failure and expired from progressive respiratory failure.

Patient was Positive for Covid-19 in September 2020, repeat testing in October showed negative result. Patient was vaccinated on 2/24/21 and 3/17/21 with Pfizer-BioNTech COVID-19 vaccine. Patient developed COVID 19 on 6/20/21, and was hospitalized for acute respiratory failure. Patient was intubated and required pressor support with norepinephrine and an IABP.

Chest pressure left of sternum. Reported to family primary care doctor nurse told him and was dismissed as it only occurred twice. It never happened before and has not occurred again since the beginning of April. Second symptom which was not reported was a raw feeling in the center of the chest between the lungs. This had never occurred before and started April time frame and as of late June has disappeared. Third symptom is getting out of breath with what I would consider minor exertion. Discussed with primary care and heart doctor both considered it to be age-related. But walking 200 yards and being out of breath for someone that is not overweight seems unlikely.

Pfizer COVID vaccine EUA Pfizer Dose 1 2/13/21 (EN6201) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 5/24/21 5/24/21: 78-year-old man brought to the emergency department for further evaluation of worsening shortness of breath and cough. He was in his usual state of health until approximately 11 days ago when he started to have upper respiratory symptoms characterized by congestion, rhinorrhea, sneezing episodes. Symptoms gradually worsened until 5 days ago when he started to have for productive cough accompanied by shortness of breath. He denies accompanying fever, chills, nausea or vomiting. His sister who accompanied him has been checking on him daily and has noted worsening bouts of coughing as well as shortness of breath, unable to keep up with ADLs. Upon checking on him today she noted that his lips were blue, brought in to the emergency department by private passenger car and in trial urge his oxygen saturation was noted to be 64% on room air. He was immediately started on supplemental oxygen via OxyMask, nebulizer therapy. COVID-19 rapid antigen test was subsequently positive, CT pulmonary angiogram was done which is negative for PE but also did not demonstrate any evidence of pneumonia. He is fully vaccinated against COVID-19 since March, denies any known contacts being treated for or with symptoms suggestive of COVID-19 infection. While in the ED continued to deteriorate requiring increasing amounts of oxygen via OxyMask, desaturating to 82-85% on 15 L OxyMask. Has been started on NIPV and will be admitted to the ICU for further treatment and evaluation. Of note, he reports that he and 5+ of his family members were all fully vaccinated and all tested positive to COVID around the same time. 6/14/21: The patient presented to the hospital on May 24 with cough and shortness of breath, COVID-19 test positive, initially he was hypoxic requiring 6 L of oxygen then his oxygen demand increased until he require to be on BiPAP and high-flow nasal cannula, then on May 29th require endotracheal intubation the ICU and started on Remdesivir, Decadron, but he was not candidate for Acterna, on June 3rd the patient had a fall with dislodged endotracheal tube require immediate re-intubation and his CT show simple nondisplaced skull fracture and subgaleal small hematoma without intracranial hemorrhage. Patient extubated on June 6 to BiPAP then the oxygen requirement taper down. The patient post extubation kept having shortness of breath and cough, sputum culture grow Klebsiella pneumonia and he was on Zosyn which cover it and will complete the antibiotic on June 15th. The patient is hypercoagulable with elevated D-dimer 2 to COVID-19 infection and will continue Lovenox b.i.d. with his aspirin and Plavix for CAD with pantoprazole. Will continue his chronic steroid. The pulmonologist recommend to keep the patient in isolation due to prolonged virus shedding. On per oral Vanco for C diff prophylaxis due to history of recurrent C diff infection and he is currently on antibiotic. Echocardiogram showed normal EF without significant valvular disease. Patient had episodes of dysphagia and swallow studies show some aspiration and he placed on pureed diet/dysphagia level 1. Sign-out given to SELECT LTAC team, they will follow on management.

Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21

This is a patient who presented to the ED with a cc of dyspnea and was found to have left central main pulm artery/left upper lobe/left lower lobe PE's and also has a large clot in transient in his RV. There is no provoking risk factor that I can clearly identify (no recent surgeries, trauma, immobilization, or active cancer). He does have a remote cancer hx of bladder cancer in 2015. He is a former smoker 20+ years ago. However, he is at risk for VTE events by being a ERSD patient and also there's increased risk for VTE for pts >70yo. His COVID vaccination a few months ago is a potential contributing risk factor, will report to VAERS

MULTIPLE visits to clinic and ED for breathing issues Most recent visit--diagnosis of eosinophilic asthma, persistant asthma, SOB, asthma exacerbation

Pt. states after receiving the 2nd dose of Phizer 02/25/2021, started experiencing racing and pounding heart rate, hospital visit 03/22/2021 EKG preformed. Still experiencing mid-night heart palpations and shortness of breath.

Presented to ED with SOB/fatigue, symptoms started 2 days prior. Was hypoxemic on NC so was placed on NRB, titrated to HFNC 40 L at 90%. over 48 hours and subsequently required intubation. Remains intubated. Received tocilizumab/steroids/remdesivir. Remains intubated but off CRRT.

chest was congested; kind of hard to breath; spitting out crud; This is a spontaneous report from a contactable consumer. A 78-year-old male patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm left on 19Feb2021 11:00 AM (age at vaccination: 78 years) as dose 1, single for COVID-19 immunization at Heart hospital. The patient medical history included COPD diagnosed a few years ago, high blood pressure, allergic to penicillin and iodine. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient Concomitant medications included Lasix for Blood pressure (His dose is either 10mg or 20mg, but he is not sure. He takes one tablet per day. He has been on it for a while). It was reported that, the patient got COVID shot on Friday and was good all day on Friday. He woke up on Saturday and was all congested. He started spitting out crud on Saturday. It was kind of hard to breath. Caller clarified that it was hard to breathe because his chest was congested. It was reported that he goes to a clinic and change the doctors frequently and he also goes to heart hospital. He has not been to the ER or to his physician's office. He goes back in two weeks for the second shot. The breath sounded like a popcorn. The patient woke up with congestion between 8:30AM and 9:00AM. The patient Wanting to know if difficulty breathing due to chest congestion is 'supposed to happen'. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

fluid build up in lungs; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Mar2021 15:30 (Lot Number: ERZ2613) at the age of 78-year-old as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had no COVID prior vaccination and had no allergies. The patient has other medication (unspecified) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EN6202) on 26Feb2021 15:30 PM at the age of 78-year-old for covid-19 immunisation and experienced low energy, loss appetite & weakness 3 weeks after initial injection, although no pain in arm. In Mar2021, within the first week of the second shot, he was admitted to the hospital with fluid build up in the lungs. Within two weeks of his second injection he was diagnosed with Guillain-Barre syndrome. These events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was in hospitalization for 12 days. The patient had COVID test type post vaccination: Nasal Swab with unknown results in 2021. The patient received plasma exchange for events. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.

Systemic: SOB, difficulty breathing, chest pain, Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days

Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.

Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms

Facility manager called on 1-29-21 to inform me that patient had shortness of breath upon awakening at 6 am on 1-29-2021. Emergency Personnel were called and patient was taken by ambulance to the ER.

Patient admitted to hospital with COVID-19 virus infection; Cardiovascular disease; Dyspnea, unspecified type; SOB (shortness of breath). Still admitted.

COVID(+) Narrative: Patient developed COVID-19 symptoms on 1/16, approximately 2 days after receiving dose #1 COVID vaccine. He was admitted on 1/30 with worsening symptoms of fatigue, low grade fever, myalgias, dyspnea, and productive cough and found to be COVID(+) via Cepheid test. Patient was treated with supplemental oxygen and oral dexamethasone therapy.

STOMACH CRAMPS LOWER BACK AROUND KIDNEY AREA ( NO KIDNEY MALFUNCTION) DIFFICULT TAKING A FULL BREATH FEELS LIKE A BALL BAT TO MY CHEST PAIN STARTED ON 02-05-2021. TODAYS DATE IS 02-08-2021. BLOOD PRESSURE IS 124/68 HEART RATE IS 51. OXEG IS 99.1 RIDE MY ROAD BIKE 30 MILES EVERY OTHER DAY.

I woke up around 2:00am with pain when I inhale. It feels like pleurisy. I can feel the pain in my lungs, upper back/shoulders and neck. I have asbestosis so shortness of breath is always an issue. The pain is not. I am assuming it will pass in the next 24 hours or so.

Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing. He was hospitalized from February 5 to February 23. Patient died in the hospital on February 23, 2021

Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain. He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism. He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued. He notes that he has not been very active since receiving the vaccine. CT PE study showed an increased RV to LV ratio 1.2. He had no elevation in his troponin or BNP. His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time. He will need a 6 month course of Eliquis. Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus. Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated.

wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.

Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,

HPI: Patient is a 79 y.o. male who presents with the chief complaint of progressively worsening of shortness of breath associated with cough and fever which has a started 2 days ago. Patient states that he has been otherwise in his usual state of health. In the past he used to use oxygen supplement therapy at home but he has not been using any oxygen recently since his respiratory condition had improved. Patient has followed up by pulmonary consult as an outpatient but he has not seen any physician recently. By the time EMS arrived at home patient was noticed to be hypoxic and started on CPAP. On the way in the hospital hospital but he had 2. Patient on nonrebreather mask and in the ER patient was initially started on BiPAP ventilation which was switched to Patient denies any loss of consciousness no nausea vomiting abdominal pain no diarrhea no constipation. Patient denies any coffee-ground vomiting no rectal bleeding no flank pain no hematuria no dysuria no frequent urination.

history of hypertension, mild cognitive impairment. Prior COVID pneumonia treated as an outpatient November 2020. Completed dose 2 of Pfizer vaccine 4/11 with progressive fatigue low-grade fevers and white count of 14 CRP elevated at 4 (see this would equate to a CRP of 40 with most other lab references) on 04/27. He was admitted and treated for community-acquired pneumonia with ceftriaxone and azithromycin. He was discharged 04/30 and then presented again 5/5 with progressive right greater than left consolidative ground-glass opacities and hypoxemic respiratory failure requiring up to FiO2 80% of high-flow nasal cannula. Infectious workup has been negative. He has been too unstable to bronch. COVID-19 testing has been negative. He was started on high-dose steroids 5/8 with stability and slow gradual improvement.

Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Inpatient Discharge Summary Admission Date: 3/22/2021 Discharge Date: 3/27/2021 Principal Problem: COVID-19 virus infection Hospital Course s a 79 y.o. male who presented to the hospital with a complaint of 1 week of shortness of breath and fever. He was managed for- COVID19 pneumonia with acute hypoxic respiratory failure, POA - CTA negative for PE; there is evidence of COVID19 pneumonia - given a unit of convalescent plasma - Remdesivir daily x 5 days (last day 3/26) -Will be sent on 4 days of Decadron to finish total of 10 days of Decadron. - inflammatory markers have improved - procalcitonin is negative x 2 - Mucinex/is/opep - wean oxygen as able, encourage patient to prone. - patient weaned down to room air. Home oxygen evaluation was done he did not qualify for O2 at home. AKI - Cr 1.36 upon presentation, improved to 1.0. - avoid nephrotoxic agents- d/c mobic. Did get contrast on 3/23 - continue to monitor renal function 5 beat run vtach - Patient does have hx of osa and was using CPAP machine - electrolytes were normal - continue telemetry monitoring - discussed outpatient ECHO Transaminitis - ?secondary to remdesivir vs covid virus Commend to repeat the LFTs in 3 days and follow the results with the PCP.

Chest pain; Pleurisy; discomfort in his chest (not in the lung) in the bone muscle around the lung, it feels like he has been punched right in the cardiac plexus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 79-years, on 07Apr2021 10:20 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included ongoing moderate to mild asthma that sometimes bothered him when he tried to sleep and maybe wheezed a bit and he had to use inhalers during the day as he cannot go to sleep if he got a wheeze; diabetes 8 or 10 years ago and he took Insulin for it; he was allergic to aspirin. Family History included that his mother had rheumatoid arthritis. The patient's concomitant medications were not reported. No additional vaccines administered on the same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021, next day (08Apr2021) he started to have discomfort across his chest like a hernia starting on the left (he started to have chest discomfort, like a hurting across the chest starting on the left and now on the right), after being checked on a medical place he was informed that he has Pleurisy, they did a chest X-ray and then they sent the information to the hospital to have a doctor look at it so he had to wait a half hour. Mentioned they wanted to put him on pain medication but he declined because he was allergic to aspirin and he only took Tylenol. He described the sensation as: a discomfort in his chest (not in the lung) in the bone muscle around the lung, it felt like he has been punched right in the cardiac plexus, now was a minor discomfort that won't go away. He cancelled his appointment to receive the second dose of the vaccine (due tomorrow) and wanted to know if he should receive the second dose at all. The patient also experienced Chest pain that started on 08May2021, but now it had shifted, and it was more on the right side. First he noticed it on the left then it moved under his sternum and now almost all of it is on the right side. The pain got up to a certain point and then it had stayed the same. Sitting he isn't feeling it but when he got up out of the chair it was worse. Seemed to be worse when he moved from a relaxed position like getting out of bed. Events of Chest discomfort and Pleurisy resulted in "Physician Office Visit". Events outcome was not recovered.

Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were: Severe sepsis (HCC) due to pneumonia causing acute on chronic hypoxic respiratory failure and hypotension that resolved with fluids. He also presented to the ED on 5/13/21 and was subsequently hospitalized for sepsis secondary to UTI.

Pt received vaccine 3/3/2021. Pt began with congestion and shortness of breath 03/17/2021. Pt admitted to hospital 3/23/2021 with DVT and PE. Pt was fully ambulatory and no recent procedures prior to this

pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by heart palpitations on day four. Palpitations continued for several weeks and then slowly cleared. BP, heart beat all normal. Palpitations were infrequent, then increased in frequency and the slowly diminished.

Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling like they are burning, experiencing shortness of air when walking thirty to forty feet, and elevated blood pressure at times of episode. Wife reported she has called primary care provider to let doctor know. Doctor referred client to see his lung doctor as soon as possible. Wife reports they are in another state working on their farm and is having trouble getting client to cooperate to go to doctor. Clients wife reported primary care provider recommended going to ER as soon as client experiences any of those symptoms again. Educated wife the importance of listening to providers recommendations. Clients wife reported client using his own CPAP machine when episode occurs and it does bring some relief to symptoms.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

Short of breath; I am having difficulty is shortness of breath; It's nauseating pain that I am having in my stomach; It's nauseating pain that I am having in my stomach; Very strong stomach discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9261) as dose 1, single (age at vaccination: 79-year-old) for covid-19 immunization. Medical history included Blood pressure high from an unknown, knee surgery from 25Jan2021. Concomitant medication included clonidine 0.1 mg, taken for hypertension, start and stop date were not reported. On unknown date in 2021 (reported as couple days after I got my shot), the patient experienced "short of breath; I am having difficulty is shortness of breath, it's nauseating pain that I am having in my stomach, very strong stomach discomfort, And I can't shake it". Consumer stated, he had his COVID 19 Shot, first one and he think it was done last month on the 28th he believes (clarified as 27Jan2021). Because his next follow-up shot was going to on the 19th of this month that will be on 19Feb2021. And his symptoms were that he was short of breath and he was also having very strong stomach discomfort. And its nauseating pain that he was having in his stomach. And he could not shake it. And he doesn't know if there was something to do with the vaccine or something completely different. So, he was just wondering. He had gone through some lab test in last 2 weeks because he just had knee surgery, he had a knee surgery. And he that, his knee surgery was on the 25th of last month, it was 25Jan2021 when his knee surgery done. Lab test were apparently well, they were good, there was no reason for him not to have his knee surgery. He did pass COVID 19 nasal test for negativity, before the operation. And so, he had his blood work done and everything else was done before the surgery. Patient told the events were started couple days after he got his shot and was still experiencing. Patient did not take any medication for treatment because he doesn't know what it was. The only thing that was recommended to him was to eat some yogurt. The only other thing that he was having difficulty in shortness of breath, also that he noticed after getting the shot. The patient underwent lab tests and procedures which included blood test: unknown result, Lab test: they were good, sars-cov-2 test: negativity on an unknown date in 2021. The outcome for all events was not resolved. Follow-up attempts completed. No further information expected.

Being winded; Heart rate has dramatically increased during any type of exercise (125 plus); Rapid breathing; This is a spontaneous report received from a contactable consumer, the patient. A 79 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6200] via an unspecified route of administration in left arm on 19Feb2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. The patient medical history included allergy to Zocin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. No concomitant medication was reported. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: El9262] via an unspecified route of administration in left arm on 29Jan2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. On 28Feb2021, the patient noticed that his heart rate had dramatically increased during any type of exercise. The patients resting pulse was 74 and he was exercising on a treadmill for weeks before the second shot. The patient experienced being winded after a very short time on the treadmill with his heart rate reaching 125 plus after a very short time. This was out of patient target range and he stopped before getting to that heart rate that patient knew that something was definitely wrong. The patient also got rapid breathing when the heart rate increased. The clinical outcome of events heart rate increased, being winded and rapid breathing was not recovered. No follow up attempts are needed. No further information is expected.

Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines (replaced 4 pints of blood), shortness of breath.

Patient hospitalized due to hypoxia, shortness of breath and dry cough. Arrived on 15L and put on BiPAP at 100%

Patient admitted on 15L of O2 and placed on BiPAP at 100%. Shortness of breath with dry cough. Hypoxic on room air

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

Nausea, H/A, took 2 Tylenol. At 10pm started feel ill, achy, Had trouble breathing over night. The albuterol didn't help. Heart beat was fast. 1/13/20 in the am had a H/A, took 2 Tylenol. The breathing got better around noon.

80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE "Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain." "Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative

Received vaccine on 1/16/21, on 1/17/21 started with coughing, white phlegm, SOB and on 1/18/21 developed fever to 101 and increased need for oxygen. Home requirement increased from 3L O2 to 6L O2. On 1/18/21 presented to hospital. Quickly defervesced with steroids and cefepime. Possible post-obstructive pneumonia vs immune response to vaccination.

Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted

Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30.

COPD exacerbation; SOB (shortness of breath); Shortness of breath; Suspected COVID-19 virus infection

trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.

At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

Resident with acute onset of SOA this AM with Sao2 of 65%. Transfered to ER with diagnosis of bilateral pulmonary embolism

SOB, Diaphoretic, Tachycardia, hypotension, Decreased Heart Rate, Decreased oxygen saturation. PT was taken to the ER.

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

Admitted to hospital on 2/28/21 for covid pneumonia and acute hypoxic respiratory failure, covid test positive. receiving dexamethasone 6 mg BID and received 1 dose of actemra. concern for bacterial infection.

pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed. information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for cardiovascular diseases. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain

patient presented to ED with chest pain, gone upon arrival to ED, dyspnea on exertion, shortness of breath. no congestion, no cough. Nausea present. patient tested for covid and found to be positive. Received 2nd covid vaccine on 2/3/21

the night after receiving this 2nd COVID vaccination, I returned to active Afib and started in active Afib status for 9 1/2 days. Since then I have had 2-4 days where no Afib (irregular heartbeat) was recorded, but the past week irregular heartbeat has been recorded each time I took my blood pressure (using an Omron series BP monitor).I can feel my heart flutter often and I am very short of breath, where I cannot walk over a block without getting out of breath.

mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Went to the Medical Center for chest pain, fever, shortness of breath one day after receiving the vaccine.

Fever for 3 days, Shortness of breath and Weakness increasingly, Dizziness, became very pale, and so on... Visited PCP on March 24, 2021 . Blood work showed 4.8 Hemoglobin. Was hospitalized on March 25, 2021. Diagnosis - Autoimmune Hemolytic Anemia due to IgG.

not feeling well and short of breath on 2/11/21, 2/12/21 more short of breath ambulance came. Went into PEA in ambulance with CPR. They gave TPA for suspected blood clot. He initially improved. He did not recover and died 4/4/21. He spent the entire time in hospital or TCU with complications. We brought him home 4/2 to die at home.

Pfizer-BioNTech COVID-10 Vaccine - case of COVID-19 resulting in hospitalization. Pt presented to ED of facility on 4/20/21 with dry cough, malaise, altered sense of taste/smell and worsening dyspnea. Afebrile (T=98.6 F). Symptoms began approximately 4/13/21. Reportedly was hypoxic at PCP's office prior to presentation to ED. S/P 2 doses of the Pfizer-BioNTech COVID-19 vaccine - 1/29/21 and 2/19/21 (dates obtained from database). Admitted to inpatient unit 4/20/21. Treated with dexamethasone 6mg po daily, remdesivir (x2 doses prior to discharge). Transiently required increase in oxygen by nasal cannula but remained on baseline of 3L oxygen majority of admission. Discharged home 4/22/21.

shortness of breath; body aches; weakness in arms and legs; headaches; chills; This is a spontaneous report received from a contactable consumer. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shortness of breath, body aches, weakness in arms and legs, headaches, chills on 03Apr2021 with outcome of recovered on 06Apr2021. Therapeutic measures were taken as a result of events included Acetaminophen and Ibuprofen. No follow-up attempts are needed. No further information is expected.

First dose covid vaccine given 1/28/21, second dose given 2/18/21. Admitted for bilateral pulmonary emboli to hospital on 4/25/21. From H&P "He reports that he woke up this morning and then subsequently started developing left-sided chest discomfort, it was pleuritic in nature. It is sometimes worse with position. He traveled to the Emergency Room where he was found to be mildly hypoxemic. He underwent workup to include a CT angiogram, which revealed multiple predominantly small peripheral bilateral pulmonary emboli with borderline dilation of the main pulmonary artery and slightly greater than 1:1 right to left ratio. He subsequently was felt to be appropriate for admission because of his underlying hypoxemia. He denies any unilateral weakness or stroke symptoms. He does have a patent foramen ovale. He also reports no history of calf discomfort. With the exception of being sedentary because of the pandemic, he has not traveled anywhere in a car or in a plane in the last 6-12 weeks." treatment: enoxaparin 1mg/kg SQ Q12h starting 4/25 @1659, changed to apixaban 10 mg PO Q12h 4/26 at 1756.

4/30/21 Patient presents to the ED w/complaint of SOB x 2 days. He had rales on exam and RA pulse ox was 88-90%. Troponin was elevated and EKG showed lateral ST-T wave changes. Pt was admitted for COVID and NSTEMI. NSTEMI Hx of CAD sp CABG Presented with dyspnea, Trop of 382, trended up to 859, now trending down CXR with findings of pulmonary edema Started on lovenox, aspirin, coreg, statin Cardiology consulted TTE showed EF 50 %, normal diastolic dysfunction, moderate AV stenosis S/P Cardiac cath 5/3 with severe disease of SVG to Diag with successful PCI Continue aspirin, plavix, statin, coreg Follow up with cardiac rehab once he has completed quarantine 10 days after 4/29 Pulmonary Edema Acute HFpEF CXR with findings of mild/early bilateral pulmonary edema. NT ProBNP of 3081 Started on IV lasix and improved Lasix stopped 5/3 due to improvement in symptoms and worsening Na TTE as above Monitor intake and output COVID 19 infection Symptoms of exertional SOB of 2 days Diagnosed on 4/29 Has received two doses of Pfizer Vaccine, last dose 1 month ago per patient CXR Low lung volume examination with findings suggestive of mild/early bilateral pulmonary edema. Was on 2L oxygen, now on RA after diuresis Doubt symptoms are due to COVID-19 and suspect more likely cardiac in origin given rapid improvement of oxygen status with dose of lasix Inflammatory markers also not elevated held off on decadron and remdesivir due to patient not requiring oxygen Complete 10 days of quarantine Patient was discharged home on 5/5/21

dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms

COVID-19 - patient admitted for 5 days of shortness of breath. Tested COVID+ upon admission, Received vaccine in March. Patient admitted 5/25, still inpatient but improving. Allergies (drug/food and reaction):NKDA Date of Vaccination:02/03/2021 and 02/25/2021 Dose: 1 and 2 Vaccine Manufacturer: Pfizer Lot #: 1st dose 2/3 Lot # EL9269 2nd dose 2/25 Lot # EN6203 Clinic Administering Vaccine: Healthcare Injection site: L deltoid Description of event/reaction: Pt was hospitalized for COVID-19 after receiving vaccination Date of Clinic Visit or Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: hypoxia COVID-19 positive test result: Yes ; if Yes, date 5/22/2021 Plans to monitor (include medications if prescribed):Treatment with dexamethasone, remdesivir, tocilizumab

Patient presented to the ED on 5/5 after being sent by his PCP after an ultrasound in the office showed a DVT along with patient's complaint of shortness of breath. Patient denied history of DVT/PE. In the ED, CTA-PE showed bilateral pulmonary embolic disease and Ultrasound confirmed acute right lower extremity DVT. Patient was started on a heparin drip and then switched to enoxaparin 1 mg/kg every 12 hours per pulmonary. Hematology/Oncology was consulted and determined that acute bilateral PE likely provoked by recent vaccination with the second dose of the Pfizer vaccine. Patient was switched to rivaroxaban 20 mg daily prior to discharge for planned duration of 3 months.

Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath , "pins and needles" in bothe hands at the same time as each other, loss of balance when walking, stomach pains only in the evening after eating a Small amount of food as I have put on weight recently even though I am eating the same amount ( less recently as above) as normal for the last 70 years.

81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness. Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride). He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms. Of note, pt is 3 days post op from left upper extremity AV graft placement. Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing. He had lung infiltrates. He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist., Diabetes management, vascular surgery, Pulmonology. Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack.

shortness of breath; The shortness of breath has continued and has gotten a little worse; Nasal congestion; Coughing; heaviness in chest; It was like lumps; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 12:10 (at the age of 80 years old) (Batch/Lot Number: EL9269; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (at the age of 80 years old) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. Medical history included Heart bypass, it was 18 years ago. It was a aortic valve replacement, ongoing lymphoma cancer, and it is gone at this point, had shingles on the right side in 2015, skin cancer in both ears in 2016. Concomitant medications included ongoing warfarin sodium (COUMADIN), ongoing warfarin deanol, ongoing carvedilol, ongoing atorvastatin calcium (LIPITOR ORIFARM), ongoing atorvastatin, ongoing hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), ongoing gabapentin (GABAPENTIN) taken for restless legs syndrome, ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing turmeric and bromelain, ongoing ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) taken for macular hole, ongoing loperamide hydrochloride (IMODIUM) taken for diarrhoea, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), ongoing potassium, ongoing Calcium citrate magnesium zinc all in one pill 80mg Magnesium, 500mg Calcium, 10mg Zinc, 20mg B6 taken for restless legs syndrome. Has been on his normal medications for years and nothing has changed. Has been on all of these medications at least 15 years, or more than that, maybe 18 years. The patient experienced shortness of breath since Feb2021 (at the age of 80 years and 6 monthes). He received both doses of the Pfizer Covid-19 Vaccine and received his second dose 13Feb2021. He has been to his doctor and has been treated with antibiotics and Prednisone. He wanted to know what he should do about it. Caller's shortness of breath began a couple of weeks after his second dose in Mar2021, where it became noticeable, and it continues. The patient would like to know if others have reported shortness of breath after receiving the Pfizer Covid-19 Vaccine. He has been experiencing shortness of breath since Feb2021. Maybe it is a side effect of the Covid vaccine, he does not know. First stated that it was around 15Feb2021 or earlier, when he first went to the doctor. He stated that he did start experiencing it before then. He wouldn't of went to the doctor if he didn't have that. Wife was brought on the phone to describe the event further. Stated that 01Mar2021 is when he first went to the doctor. They went on vacation on an unspecified date in Mar2021 and his wife had to take him to a clinic there that it was around 09Mar2021. He has had 4 series of antibiotics and prednisone since that first visit in Mar2021. When he got home, he went to the doctor again and they gave him more antibiotics and Prednisone. Then again in May, he had another round of it, and is still experiencing shortness of breath. He had also had other symptoms at that time. He had a lot of congestion. It did not stop but that has kind of subsided. The shortness of breath has remained. He had heard a news report stating shortness of breath symptoms have been reported regarding the COVID vaccine. He had his last shot 13Feb2021, he thinks it was. Soon after, he started having the shortness of breath. At first, he didn't relate it to the Covid shot. He does have heart problems. The first antibiotic was Azithromycin, it was with the Prednisone, It was the ZPack. He took it for 6 days and then tapered one every day. In Mar 2021 he took Medrol pack, which was 4mg tablets. They were different Prednisones and different antibiotics each time. The last one he took was Doxycycline, which was 40mg and he took it for 4 days. Can't remember what the other one was. Caller states that he had the Zpack from the clinic and his doctor gave him Doxycycline after he came home. It was a different amount of Prednisone each time. He had a lot of allergy like symptoms with nasal congestion and coughing. States that it was clear congestion and was probably 3 times as thick as with normal nasal problems. It was like lumps, was clear and was coughing it up. The congestion started when he was coughing up stuff. The last time his doctor gave him nasal spray, Azelastine HCI, which was in a spray bottle with 30ml. He stopped it after a period of time. He still has some congestion every day, but it is not near what it was before. The Prednisone and antibiotic lessened the problem along with the nasal spray and really helped. The shortness of breath has continued and has gotten a little worse. He used to be able to walk 3 quarters of a mile every day but now he probably can't walk 4 blocks. Sometimes, just sitting on the couch, watching TV, he gets heaviness in his chest. He has to breathe really deep to get it fixed. When he had his oxygen level tested, at the doctor's office, it is always 98, 99 or 100 percent. The doctor listens to his lungs and he doesn't see or hear anything that is going on. He had an X-ray for his lungs they didn't see anything there either. Had a chest X-ray, blood tests by his primary care physician and heart doctor. Had blood tests by his oncology doctor. All of those came out normal, with no problems. Feel free to ask for those results. No other additional vaccines were administered on Same Date of the Pfizer Suspect. The patient has not received any other vaccines within 4 weeks prior vaccinations. The adverse event shortness of breath resulted in visit to urgent care and physician office. The patient underwent lab tests and procedures which included chest x-ray: normal on an unspecified date. Therapeutic measures were taken as a result of the adverse events. The outcome of the events was unknown.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events "Dyspnoea, Nasal congestion ,Cough, Chest discomfort " and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Heart rate slowed significantly down to 32bpm Tightness in chest, trouble breathing Elevated blood pressure

The day after I received my shot, Jan.16, at about 7:00 pm I began having pain breathing when I inhaled. I was laying down on the coach watching TV. I did not have any pain exhaling (only inhaling). The pain was on my left ribs. The pain was a 2 out of 10. If I stood up the pain subsided to a 1. I did not have any pain when I laid on my right side. The pain occurred when a laid on my back and on my left side (the side of the shot in my left arm). I slept that night on my right side with no pain. Upon waking on April 17 at about 7 am the pain was about a 1 on my left side. The pain stopped completely at about noon that day.

Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021

EMS brought patient to ED stating patient was bright red and tachypneic with oxygen saturation of 81-82% on RA. Failed on CPAP. Given Benadryl 50mg IVP, Solumedrol 125mg IVP, 0.3mg of IM Epi and a duoneb with no relief. Was RSI'd and intubated and transported to the ED.

The patient began experiencing trouble breathing and weakness a few hours after administration of the vaccine. He was recovering from a kidney infection, so it is unknown what the cause of the symptoms originated from. It was determined to involve EMS, and they came and picked him up at the Long Term Care facility and took him to the hospital.

Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x 5 days, Augmentin 875mg 1 tab po bid x 10 days.

Herpes zoster on right side; shortness of breath after vaccination. Seen in office 2/9/21. Chest x-ray completed, patient prescribed valacyclovir, prednisone, tramadol. Patient reports improved breathing and pain 2/10/2021 since beginning treatments

lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.

Anaphylaxis symptoms began approximately 6-7minutes post vaccination with patient having difficulty breathing, palor, lethargy, sweating, and stating throat was closing/tightening-patient immediately given epi and ems called...patients symptoms improved significantly in about 2 minutes post epi and ems arrived within 11 minutes and took over patients care..patient transported to local ER per EMS for further evaluation and treatment

Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors in his hands. Had a syncopal episode and chest pressure. Went to ER on 2/20/21

Severe nausea and vomiting General body aches, but more severe lung/chest area pain, but with NO shortness of breath Overall fatigue

1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.

Patient has history of COVID19 infection on November 2020. He received first dose of pfizer COVID 19 vaccine on 2/2/21. Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting. Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia. Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy. Throughout the patient's stay, his respiratory function was stable on room air. Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE. Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19. Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.

Patient received second dose of Pfizer vaccine 2/21/21. Patient is unable to recall the name of facility that he received the vaccine, but states that it was at a clinic. Patient's vaccination card was left at home. Patient developed symptoms of shortness of breath on 2/24/21, which were mild at first but progressed to severe and resulted in him coming to the hospital on 2/26/21. Patient had a thorough cardiac work-up and it was found that patient has severe aortic regurgitation. Patient is still hospitalized waiting for a TAVR on Monday, 3/8/21.

Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.

shortness of breath Hypoxia Pneumonia of both lungs due to infectious organism, unspecified part of lung History of COVID-19

Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt was experiencing SOB at approx 811am . Upon questioning Pt stated this was his normal breathing and needed to use inhaler. Pt stated he has been experiencing this SOB for several weeks. Used inhaler was stared was feeling better. RN went to get grandson from parking lot, he stated that pt was SOB this AM when he picked him up. Pt was being questioned by RN when he became diaphoretic and less responsive. 911 called at 819am. VS attempted difficult to get BP via dianamap. Pulse was present. 4L O2 placed on pt . Pox per dianamap was in the 60's. Paramedics arrived at approx 823 am and left at approx 826am . Pt opened eyes and responded to name on way out to ambulance.

Lung blood clot found after emergency room visit experiencing shortness of breath 03/04. Tennis ball size neck lymph node swelling starting 02/25. Joint pain and swelling starting 2/22

Janssen COVID-19 Vaccine EUA; patient reports intermittent blurry vision and fatigue after vaccination. Presents to infusion center for chemotherapy, experienced blurred vision, found to be hypotensive and bradycardic, and transferred immediately to emergency department (ED). In the ED diagnosed with acute left lower lobe segmental pulmonary embolism and thrombocytopenia. Admitting to hospital for further management.

difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown. Information on the lot/batch number has been requested.

difficulty swallowing; difficulty breathing; a little swelling in the throat; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 16:30 as SINGLE DOSE in Arm Right for covid-19 immunisation. Medical history included He has seasonal allergies and sneezes. He does not take medication for it. It has been diagnosed 3-4 years ago. It is not real bad. Concomitant medications included atenolol taken 10-15 years, amlodipine taken for 10 years, both for high blood pressure. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was None. Vaccination facility type was Clinic. After 5-6 hours after the first injection he developed difficulty swallowing, a little difficulty breathing and a little swelling in the throat on 11Mar2021. When he took first shot, there was no reaction until 5-6 hours later. He had trouble swallowing at 21:30-22:00. He was concerned about these side effects and whether he should receive the second shot. NO ER or physician's office required. The outcome of a little swelling in the throat was recovering, of other events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Acute respiratory failure due to COVID-19 (CMS/HCC) SOB Severe sepsis (CMS/HCC) Hyperlipidemia IV remdesivir IV dexamethasone

This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21.

Patient developed chest pain late March. Duration of 1-2 days. No medical follow-up. Patient developed chest pain and difficulty breathing 26 Apr. He reported to a facility like Urgent Care. HCP recommended CXR which revealed questionable findings. HCP recommended hospital visit but patient did not go that day. Instead patient called ambulance to home the next morning and was transferred to the local hospital. Chief complaint chest pain and difficulty breathing. Bloodwork ruled out myocardial infarction. Various other assessments done over the first three days of hospitalization, including a CT scan which purportedly showed about a pulmonary emboli. Most (if not all) of the emboli were in the right lung and were small and fixed/immobile. At least one was larger. Patient was started on heparin . Echocardiogram workup ruled out presence of DVT in the legs. Patient was discharged after 13-14 days in the hospital.

admitted 5/5/21 with increased sob/cough/aches and pains. Dx with COVID 19 pneumonia on 5/1 . temp 98.3

Resident received vaccine at 10am and was observed for 15 minutes post vaccine with no reaction noted. Pre and post vitals were at baseline. Upon rounds at 12pm, nurse noted resident with increased respirations and an elevated temperature (Resp 40, Temp 103.5). Nurse notified nursing supervisor and MD called. Patient was transferred via 911 to Hospital at 12:25pm.

About 2 weeks after receiving the vaccine, the patient started developing progressive shortness of breath. He obtained a CT chest which showed bilateral pleural effusions and congestive heart failure. Patient was evaluated in emergency room at hospital and treated with IV lasix for acute on chronic heart failure. However, his symptoms were progressing. Currently, he is hospitalized with suspicion of myocarditis / cardiomyopathy.

February 9,2021 I went see my caediologist complaining shortness of breath and little energy. We laid rhis off to lack of excercise due ro quarantine from Covid. By April 6 I was so short of breath,my wife insisted that I see my PCP. He found that my O2 was at 77%, he immediately called my cardiologist and explained my symptoms which resulted in my hospitalization. After six days of testing, the diagnosis being "Acute respiratory failure with hypoxia (HCC) J96. and Diastolic dysfuntion (151.89)

Fully vaccinated patient hospitalized with positive COVID PCR. Patient admitted from ED after a fall at home on 05/20/21 which patient attributed to weakness. COVID swab in ED for admission testing was positive for COVID. Weakness only notable symptom at that time. Patient d/c'd home and readmitted on 05/28/21 per recommendation of Homecare due to increased shortness of breath and O2 in 70's. Chest X-ray showed PNA. Patient discharged with Homecare on 06/02/21.

81 yo male patient with a history of leukemia, diabetes, renal failure, htn, hyperlipidemia, and nephrolithiasis presents with increasing weakness over the last several days. The patient states that he received his second pfizer covid vaccination on Monday. Since then has felt weak and tired. Has been short of breath with any exertion. No fever or chills. No chest pain. Has had a cough when he breathes through his mouth. He states he is only short of breath when he breathes through his mouth. No nausea or vomiting. Had one episode of diarrhea. No blood in the stool or black stool. No abdominal pain. No urinary symptoms. Has been eating. Has been exposed to a known covid positive contact at home between

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Patient is a 82 y.o. male presenting with shortness of breath and nausea and vomiting. Patient has a past medical history of bladder cancer, COPD on no home oxygen, hypertension, chronic UTI, BPH, and Pfizer vaccination from COVID-19 on 1/4/21 and 2/5/21. Patient was symptomatic with shortness of breath and nausea and vomiting since 07/13/2021. Patient went to urgent care and tested positive for COVID-19 on 07/19/2021. Patient went to the ER and received a fluid bolus as well as Zofran; the wife states that the Zofran does not help with the nausea and vomiting. At home, patient denies fever, muscle aches, chills, chest pain, abdominal pain. Patient admits chronic cough, chronic headache, and pain with urination, most likely due to BPH. Patient denies known history of sick contacts. COVID-19 pneumonia, tested positive 7/19/21, currently requiring 1-2 L of oxygen, baseline room air

Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath)

increased heart rate; breathing difficulty; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2(lot number=EK5730), via an unspecified route of administration on 15Jan2021 13:45 at single dose, left arm for covid-19 immunization. Medical history included partial obstruction in coronary artery, arthritis, allergies to pregabalin (LYRICA), levofloxacin (LEVAQUIN). Concomitant medication included cortisone. The patient experienced increased heart rate and breathing difficulty on 15Jan2021 13:45 with outcome of recovered in Jan2021. The events were non-serious. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Given vaccine in AM, had adverse reaction around 1430 when he was found unresponsive and in respiratory distress

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

2/25 - loss of taste 2/26 - dizziness/woozy, severe flu like symptoms all day (no energy, ache) 2/27 - continuing dizziness, minimal energy 2/28 - continuing dizziness, wheezing/trouble catching breath (needed oxygen to calm)

Presented to the emergency department on 2/28/21 with exertional shortness of breath and upper abdominal discomfort for the past 2 days. Patient was admitted to the hospital, and pulmonary edema was contributed to right-sided heart failure from his mild COPD and suspected underlying interstitial lung disease. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.

Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Patient presented to ED for on/off SOB the past few days. Required O2 60% FiO2. Acute on chronic CHF exacerbation. Treated with Lasix. Patient is currently improved and planned discharge.

started with a sore arm, Tuesday pain radiated to chest. Pain pressure in chest come and go. Wednesday pain got worse. Thursday I felt dizzy and I felt short of breath. Chest area felt like bruised pain

Severe shortness of breath, and decrease in oxygen saturation to 61%, 2 weeks after second Covid Vaccine dose. He was rushed to the hospital and was diagnosed with pulmonary embolism and received oxygen therapy. He also received Lovenox injections and then apixaban orally.

Seizure followed by Acute encephalopathy a few hours after receiving 2nd dose of Pfizer COVId-19 vaccine. COPVID-19 PCR testing positive on admission. Ongoing encephalopathy and patient made Comfort care. EEG showed no overt siezures.

Patient received Pfizer Covid 19 vaccine dose #1 on 02/02/2021 Lot # EL9264 in left deltoid IM. Dose #2 as listed above in item 17 administered on 02/23/2021. Patient presented to ER with family on 03/15/2021 with breathing difficulty. COVID PCR Positive. Specimen sent to State Lab for genetic sequencing and reported to VAERS as required.

1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

83 yo F presents to the ER on 1/30/21 with complaints of worsening SOB and weakness. She was diagnosed with COVID-19 in 1/22/21, 7 days after receiving the first dose of COVID-19 vaccine. She had a fall on 1/25/21 and was evaluated in the ER, where she was placed on steroids and oxygen at home. She was admitted on 1/30/21 for hypoxia, generalized weakness, and A-Fib with RVR. Patient required oxygen supplementation and was treated with IV dexamethasone and inhaled budesonide. She also received treatment for afib/RVR with improvement upon treatment. Patient was discharged on 2/1/21 with recommendations to transfer to skilled nursing facility.

Rapid COVID test was positive/Next day long test came back negative and was quickly moved out of the COVID-19 unit; Hemoglobin Anemia; difficulty breathing; fast heartbeat; dizziness; weakness; tiredness; over all feeling of unwell.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization. Medical history included lower left lung lobectomy in Mar2019 and cancer in May-Jul2019 treated with chemotherapy 4x. The patient previously had first dose of BNT162B2 in the left arm on 26Feb2021 10:00, lot number: EN5318 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 06:00, 1 day later had side effects of tiredness and over all feeling of unwell. On 22Mar2021, 3 days later, the patient had additional side effects of difficulty breathing, fast heartbeat,dizziness and weakness. On the 6th day, the patient went to ER 26Mar2021, the patient was admitted to the hospital. Rapid COVID-19 test was positive and sent to COVID-19 unit. Next day long test came back negative and was quickly moved out of the COVID-19 unit. The patient was diagnosed with hemoglobin anemia. Over all, hemoglobin dropped from normal base line of 14 to 6.1. The patient was given 2 units of blood, was given a shot of prednisone and then put on 60 mg of prednisone daily. Release from hospital after 6 days with hemoglobin of 9.9. Still being followed by doctor and follow up blood work. Continuing 60mg of prednisone daily until hemoglobin reaches normal range. If prednisone does not work, next step is an infusion of Rituxan. The patient underwent lab tests and procedures which included haemoglobin: 9.9 on unspecified date, haemoglobin: dropped from normal base line of 14 to 6.1 on 27Mar2021, long test: negative on 27Mar2021 and Nasal swab/Rapid test: positive on 26Mar2021. All events were reported as life threatening. The outcome of the events was recovered with lasting effect

Patient began to experience breathlessness after receiving vaccine. His SOB continued to worsen. On the 13th, the patient reported to the ER. The patient was discharged from the hospital with a diagnosis of CHF exacerbation

received second covid vaccine on 3/2/2021. Admitted to hospital on 3/27/21 with shortness of breath and expired on 4/12/2021.

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

COVID-19 SOB (shortness of breath) Cough Suspected COVID-19 virus infection Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file): 5/8/21 Start of Symptoms Date: 5/6/21 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease ED to Hosp-Admission Discharged 5/10/2021 - 5/18/2021 (8 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Discharge Summary Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 5/10/2021 Discharge Date: 5/18/2021 Discharge Diagnosis Medical Problems Hospital Problems POA * (Principal) Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Yes Overview Signed 5/14/2021 10:50 AM 05/11/2021 Dexamethasone 05/11/2021 Remdesivir Essential hypertension Yes CLL (chronic lymphocytic leukemia) (CMS/HCC) Yes OSA (obstructive sleep apnea) Yes Persistent atrial fibrillation (CMS/HCC) Yes DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 82-year-old male with past medical history significant for CLL, obstructive sleep apnea, obesity and persistent atrial fibrillation who presented to the ER on 5/10 for evaluation of progressively worsening shortness of breath after recently being diagnosed with Covid?19. ER work-up concerning for severe sepsis with acute hypoxic respiratory failure for which he was admitted to the PCU under the hospitalist service. Hospital Course He was treated with dexamethasone and remdesivir but remained hypoxic requiring alternating trials of high flow nasal cannula and BiPAP for which pulmonology was consulted on 5/12. Unfortunately, he did not tolerate prone positioning. Despite his advanced age and several risk factors, he slowly but surely progressed from a pulmonary standpoint. He was weaned off high flow oxygen 2 days ago and deemed stable for downgrade to MedSurg with telemetry at that time. Since then he has continued to recover well, now requiring 6 L of oxygen with activity and 4 L at all other times. He is anxious to be discharged home and appears medically stable to do so with home health care services, remote patient monitoring and outpatient pulmonology follow-up with PAL as prior to hospitalization. Prior to discharge, all questions were answered and patient and his son expressed understanding, appreciation and agreement with the discharge plan at this time. Treatments: IV hydration, analgesia: acetaminophen, cardiac meds: metoprolol, furosemide and aldactone, anticoagulation: eliquis, steroids: dexamethasone, respiratory therapy: O2 and remdesivir

never had difficulty breathing like he did 3 days after the vaccine; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 01:45 AM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history included High Blood Pressure (hypertension); COPD (chronic obstructive pulmonary disease) and drug hypersensitivity from an unknown date and it was unknown if ongoing. Concomitant medications included lisinopril; felodipime; XARELTO (rivaroxaban); hydrochlorothiazide; zinc; folic acid; Vitamin C; pravastatin sodium; ALLEGRA (fexofenadine hydrochloride); VITRN C (ascorbic acid, ferrous fumarate); atropin; TIMOPTIC (timolol maleate); REFRESH PLUS (carmellose sodium); REFRESH PM (paraffin, liquid, white soft paraffin); BREO ELLIPTA (fluticasone furoate, vilanterol trifenatate ); FLONASE SENSIMIST ALLERGY RELIEF (fluticasone furoate) taken for an unspecified indication, start and stop date were not reported. The patient's allergic conditions included Penicillin, Tetracycline, NSAID eye meds (drug hypersensitivity). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid 19 and was not tested for COVID-19 prior vaccination. On 25Jan2021 at 12:00, the patient reported that he "never had difficulty breathing like he did 3 days after the vaccine". The patient was treated with Prednisone 10 mg, Azithromycin 250 mg, Clonidine HCL .2 mg, Albuterol Sulfate 4 mg. On 04Feb2021, the patient underwent lab test for sars-cov-2 antibody test with nasal Swab which was revealed to be negative. The outcome of event was not recovered. No follow-up attempts are possible. Information about batch number cannot be obtained.

Breathing issues; COVID positive with mild infection; COVID positive with mild infection; Nosebleed; This is a solicited report from the marketing program, marketing program not available received from a contactable consumer (patient's wife). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose on 16Feb2021 (Lot number and expiration date was not reported) at single dose, via an unspecified route of administration first dose on 26Jan2021 (Lot number and expiration date was not reported) at single dose for COVID-19 immunization (age at vaccination 82 years old), treprostinil sodium (TYVASO, inhalation gas, strength: 0.6 mg/ml), resp inhalation from 07Aug2018 to an unspecified date, at unknown dose and frequency; then from an unspecified date (Lot Number: 2101911; Expiration Date: 31Oct2021) to an unspecified date, at 4x/day (18-54 mcg, qid) for pulmonary arterial hypertension and treprostinil, resp inhalation from 07Aug2018 to an unspecified date, at 0.6 mg/ml; then from an unspecified date (Lot Number: 2101911; Expiration Date: 31Oct2021) to an unspecified date, at 4x/day (18-54 mcg, qid) for pulmonary arterial hypertension. The patient's medical history included ongoing pulmonary arterial hypertension. The patient's concomitant medication included tadalafil. On 13Mar2021, the patient experienced COVID positive with mild infection, difficulty breathing, and nosebleed. On 31Mar2021, 2 years 7 months 25 days after initiating IH Tyvaso, the patient was readmitted to the hospital for breathing issues. The events COVID positive with mild infection, difficulty breathing was assessed as serious (medically significant and caused hospitalization). The events nosebleed and breathing issues was serious (caused hospitalization). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 13Mar2021. The action taken for the suspect drugs treprostinil sodium and treprostinil in response to the events was unknown. The outcome of the events was unknown. The reporter did not provided causality for events. Case Comment/Senders Comment: The company has assessed the serious adverse event of COVID-19, epistaxis and dyspnea as not related to IH treprostinil and TD-300/A device. COVID-19 was likely due to infection with SARS-CoV-2 virus infection during the ongoing COVID-19 pandemic and epistaxis and dyspnea was likely a clinical cascade from COVID infection in setting of underlying PAH in this elderly 82-year-old patient. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on the lot/batch number has been requested. Follow-up (07Apr2021): New information received by Pfizer via United Therapeutics (MFR report #: UNT-2021-004686) from the same contactable consumer (patient's wife) includes: suspect product details (new dosing regimen for treprostinil sodium (TYVASO)), new event (breathing issues) and clinical course details. Information on the lot/batch number has been requested. Follow-up (19May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the available information, the Company cannot completely exclude the possible causality between the reported COVID- 19 positive with mild infection, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2 vaccine. The Company considers the reported events Nosebleed and Breathing issues as unrelated to BNT162B2 vaccine, more likely being inter-current medical conditions.

couldn't movelower extremities. Some weakness inarms; No involvement with breathing; This is a spontaneous report from a contactable/non-contactable None[C.2.r.4 (Reporter Type)]. A 82[D.2.2a; age]-Year(s)[ D.2.2b; age unit]-old Male[D.5; gender] patient received BNT162B2[G.k.2.2; suspect product(s) generic name(s) BNT162B2[G.k.2.3.r.1] 1[dose number FDA.G.k.4.r.13] dose:,None[ G.k.4.r.1a; G.k.4.r.1b], None[route(s) of administration or unspecified route G.k.4.r.10.1], administered in Arm Left[add the anatomical location G.k.4.r.11.x1] on 202103171430[G.k.4.r.4; start dates or unspecified date; and time if provided], ER8727[G.k.4.r.7 batch/lot number [Lot #], Expiration date [EXPIRATIONDATE Expiration Date or indicate if they were not reported], [for vaccine indicate the following information] at the age of vaccination 82[FDA.D.2.1a]; as dose(s) with unit] single[DRUGDOSEFREQUENCY], for Covid-19 immunisation[G.k.7.r.1; indication(s). Medical history included [any information regarding past medical history, concurrent conditions, social history, and family history]. Concomitant medication(s) included Suspect[G.k.1 with value of 2: all concomitant medication names] taken for [indication(s) (if provided)] from [start dates] to [stop dates]. The patient previously took [D.8.r.1; past product] for [indication] and experienced [past event]. The patient experienced couldn't move lower extremities. Some weakness in arms,No involvement with breathing[E.i.1.2; AE(s)] and [indicate the appropriate seriousness criterion at the appropriate point in the description] on 202103171630[E.i.4; AE(s) onset date(s)]. The patient underwent lab tests and procedures, which included [F.r.1 ;any information regarding laboratory tests and procedures]. [He/She] was diagnosed as having [provisional/differential/definitive diagnoses]. The [non-vaccine suspect product(s) only do not add this statement for vaccines products] was/were [action taken] on[date of temporary interruption/withdrawn to be included if applicable]. Therapeutic measures were taken as a result of [AE] and included treatment with [treatment product(s)] from [start date(s) of treatment product(s)] to [stop date(s) of treatment product(s)]. The patient recovering/resolving[E.i.7: outcome(s) of the event(s)]/died] on [E.i.5; AE(s) stop date(s)].

presented with a cough, difficulty breathing, sinus congestions and headache on 2/7. tested positive for COVID-19. admitted to the hosp. completed 5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21

Death 4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week) 2) COVID Pneumonia (onset interval 1 week) Other: acute on chronic congestive heart failure

Very lethargic for 3 days followed by headache, dizziness and shortness of breath. Has continued up to today but the symptoms have lessen each week. Most common is headache and dizziness. Went to emergency in May thinking I was having a heart attack but they could find nothing wrong.

Dx: Pericarditis s/s: Dyspnea on exertion, edema, fever/chills unknown symptom onset date, patient poor historian. diagnosed with pericardial effusion, suspect pericarditis. viral panel negative. etiology not defined defined as acute on chronic dyspnea and acute CHF

issues with his memory and being more confused/Confusion; tiredness/Fatigue; He feels like he is not getting enough oxygen, has had a cough, runny nose, issues with his memory and being more confused; cough; runny nose; Having problems with memory; Not Feeling Right; Muscle pain; Pain areas have been more painful/pain; Sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1685 then says someone changed the 5 to a 6), via an unspecified route of administration in left arm (left shoulder) on 05Jan2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included he had two ablations, close together 4 years ago, blood pressure issues from Dec2020 and ongoing, ongoing thyroid condition from several years, ongoing acid reflux, has been on medication on and off for this condition for 5-10 years. Concomitant medications included levothyroxine sodium, 75 mcg once a day for thyroid disorder taking this medication for several years; losartan, 0.5 mg once a day per for blood pressure abnormal from Dec2020 and ongoing, he used to take half a tablet; started taking a full tablet 08Mar2021; omeprazole, 40 mg twice a day for acid reflux, he has been on and off this medication for 5-10 years. Started taking it regularly in the past year. Also increased it to twice a day in the past year. He was on Eliquis for blood thinning. He was started it 01Mar2021. He had been on hit previously for quite a while and had an ablation and was able to stop taking it. Blood pressure went up so he was put back on it in Mar2021, before then he had taken it about 2-3 years ago. He currently takes 5 mg twice a day. Caller also mentions unspecified vitamins and herbs; no further information provided by the caller. The patient previously received flu and tetanus vaccines in Oct2020 and shingles vaccine in Aug2019. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The month ago (or more) he has been experienced tiredness, fatigue, pain, although he stated that he always has some kind of pain because he was 82 year old but it has been worse in the past 2 weeks. He felt like he was not getting enough oxygen, had a cough, runny nose, issues with his memory and being more confused. He stated that the tiredness and fatigue started out as intermittent about a month ago and said that it would "come and go" but now in the past couple of weeks it has been much more frequent. He also stated that he has been experienced a runny nose, cough and congestion for the past couple of weeks. He stated that since he got it; and for about a month or two, he has not been feeling right. He has tiredness, fatigue, all of his pain areas have been more painful, muscle pain. He doesn't seem to be getting enough oxygen; he really has to suck in air. His overall biggest problem was the fatigue. He stated that right after the shot he had no issues other than soreness in his arm on Jan2021; he has been going down hill since then. Tiredness and fatigue it has gotten worse gradually. It started a month or more ago. It has gotten worse over the last 2-3 weeks. He has pain all the time, he was 82 year old and something that always bothering him. Increased in pains started along with the tiredness and has also gotten worse over the last 2-3 weeks. He stated that his tiredness and fatigue was intermittent, but now it was more frequent. Before he had more good days than bad days. Now he has more bad days than good days. His feeling of not getting enough oxygen also went along with the tiredness. It has also gotten worse over the last 2-3 weeks. Cough and runny nose seem like it started in the last few weeks and has gotten worse. He has difficulty in answering the questions because his memory has been giving him problems and he's been confused more for about a month or so. It was gotten worse. The patient received second dose of the Covid vaccine (Lot Number: EL3249) on 26Jan2021, He was pretty sure that it was given in his left shoulder. He would like to know if he should go back to the VA where he received the Pfizer COVID-19 vaccine to be evaluated for these symptoms. The patient did not visit to emergency room or physician office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of sore arm was recovered on an unspecified date in Jan2021, while with other event was not recovered. Information about Lot/Batch Number has been Requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB on 1/14/2021 at 1325

When given vaccine patient felt a moment of shortness of breath, advised the staff also had flushing Benadyl 25 mg given to patient. Patient waited 30 minutes. all vitals were normal patient escorted to his car, drove home.

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.

Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436

Patient reported to emergency room on 2/20 with increasing of shortness of breath, quantitated unable to walk from room to room in his house. Patient was admitted.

Patient was vaccinated approx 9a. Later that evening, patient was having trouble breathing so they called son who lives down the road to come, 20 mins after the call the patient has passed. Per medical examiner, pt died due to possible PE, MI, or his aortic aneurysm ruptured.

He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful.

9 days after receiving vaccine, pt developed rapid onset of ascending paralysis. No use of legs, minimal use of right arm. Limited use of left arm. Repiratory difficulty/failure.

severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin. The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.

Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.

Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism

Pt developed dyspnea and decompensated due to underlying metastatic adenocarcinoma of lung and large pericardial effusion which caused cardiac tamponade ultimately causing him to succumb.

PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday. 03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.

Positive COVID + 5/2/2021 Admitted with extreme lethargy and syncopal episode, hypoglycemia, increased dyspnea with hypoxemia

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

Pt states he had his 2nd Covid vaccination at his County Health Department on 6/10/21 and later the same day he began having significant difficulty breathing. He did not seek treatment and it resolved 24 hours later. he also claims he had significant pain in arm that vaccination was given in. Both symptoms have resolved.

Costochondritis/ chest area quite painful/ lower left ribcage; Taking my breath away as I moved; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9809) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), glaucoma, hypertension, and gastrooesophageal reflux disease, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included amlodipine, dutasteride, esomeprazole, and brimonidine tartrate (ALPHAGAN), all from unknown dates for unknown indications. The patient previously received sulfur from an unknown date for an unknown indication and experienced drug allergy; unspecified beta blockers from unknown dates for unknown indications and experienced drug allergy; and the first dose of BNT162B2 (lot number EL3247) in the left arm on 15Jan2021 (at the age of 83-years-old) for COVID-19 immunisation. The patient reported that on days 3-5 following the second shot, his entire chest area was quite painful, taking his breath away as he moved. On days 6 and 7, it was in the left side only, and on day 8 it settled in his lower left ribcage. The patient stated that over 3 months later, it was still there, some days were worse than others. He reported it was diagnosed as costochondritis, stating he visited urgent care, emergency room, two pulmonologists and his primary care physician. No treatment was received for the events. The clinical outcomes of costochondritis and taking his breath away as he moved were not recovered. It was also reported that on 29Mar2021 the patient was tested for COVID-19 via nasal swab, the results were not reported.

Pt w/hx significant for B-cell lymphoma & interstitial lung dx (on 4L O2 at baseline) p/w 5 day hx of SOB, cough, congestion, and diarrhea. COVID test was positive (6/15) despite receiving Pfizer vaccines (1/15 & 2/6). Was admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. Received dexamethasone, plasma, and tocilizumab during admission with improvement, however, pt is still hospitalized and feels SOB w/any exertion and desaturates w/cough.

This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an unspecified route on 19Jan2021 at 11:15 (at the age of 83-years) as 1st dose, single dose in the right arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing and went to Emergency room and diagnosed has pleurisy. The patient received treatment for events with steroids, pain meds and muscle relaxers. The patient underwent lab tests and procedures which included nasal swab, COVID test was negative on 19Feb2021. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Patient is an 83 year old male admitted with COVID respiratory failure who has end stage COPD. His condition declined throughout hospitalization and expired 7/2/2021.

~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home.

Fully vaccinated 83 year old male admitted with Covid-19 pneumonia. Symptom onset with cough, dyspnea, fatigue, lethargy on 6/5.

Presented to hospital for increased SoB and weakness. Diagnosed with COVID-19 on 7/8. Discharged home on 2L O2 and dexamethasone. On 7/12 presented again with hypoxia, elevated WBC/ D-dimer. O2 titrated to 5 L NC and transferred to our facility on 7/12. Oxygen requirement continued to increase and patient admitted to ICU on 7/14. Currently receiving dexamethasone and received tocilizumab 7/13. Received remdesivir initially but was discontinued on transition to HFNC> Currently on HFNC w/NRB 50 L at 90%

83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath. Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress. The patient had recent angiogram with 2 stents placement. The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention. Critical Care, Cardiology, and Infectious Disease were consulted. Urology was consulted for the patient for urinary retention. The patient went to the OR for urinary retention and urethral stricture. The patient had transurethral incision of the vesical neck contracture. Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection. Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids. The patient was seen and examined on June 15. At that time, Neurology was consulted for patient's seizure. Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation. Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%. The patient was on aspirin and Plavix. The patient had a recent stent placement. The patient was seen and examined on June 22, 2021. At that time, the patient was successfully extubated to nasal cannula. The patient was improving. The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia. Infectious Disease was following the patient. The patient was seen and examined on June 28. At that time, IR was consulted per Pulmonary request for thoracentesis. IR requested to hold Plavix for the procedure. The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021. At that time, the patient was lying down in the bed, no acute distress noted. The patient denied any chest pain or shortness of breath. The patient was status post thoracentesis. Infectious Disease was following the patient and IV antibiotics recommended. The patient was status post pneumococcal pneumonia with septicemia, bronchitis. At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days. The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.

Difficulty breathing and shortness of breath lead to hospitalization. Daughter said PUI's health is not improving.

1 week of nausea, vomiting, and diarrhea and worsening dyspnea. His respiratory status decompensated since admission. He was initially on 2-3 L nasal cannula and then worsened to needing BiPAP at 100% FiO2. Even with that, his SpO2 was between 88-90%. He was transferred to another hospital for further management.

Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.

Paroxysmal atrial fibrillation 4 hrs after vaccine administration. Symptoms: palpitations, dyspnea, throat tightness, fatigue

CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit "like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm.

admitted 21 Jan 21for Chest pain; Elevated troponin; Hypokalemia; SOB (shortness of breath); Shortness of breath; Volume depletion Dishcarged on 23 Jan 21

Resident had a rash all over his body about 12 hours after 2nd dose of Pfizer vaccine. He started becoming SOB even with oxygen applied. On-call provider was notified and resident was treated with benadryl 25mg by mouth once. Symptoms resolved about 2 hours post benadryl dose.

Shortness of Breath, Continuous Coughing with blood tinged spit, Blood Pressure 200/100, Oxygen level 84 began around 5:00 am with paramedics arriving and transporting to the hospital around 7:00 am.

Development of chest pain and dyspnea. Large pleural and pericardial effusions requiring drainage. No evidence of CHF by echo or BNP. Fluid was found to be exudative rather than transudative. No growth of infectious agents found to be causal. ESR and CPR extremely elevated. All self resolving after thoracentesis and pericardiocentesis.

Per patient, the evening after dose 1 he developed throat discomfort, difficulty swallowing, and shortness of breath. The pain was moderate but main issue was difficulty swallowing. He did not seek medical attention but took tylenol. Symptoms self-resolved.

Patient was observed post Covid-19 immunization for 15 minutes and during that 15 minutes at 0915a reported to RN that he was feeling dizzy/lightheaded at 0915a. Bp was 134/81, RR 18, p 75, t 96 oral and 02 sat 96 on RA. Patient states he is tired as well and has history of COPD, sometimes wearing mask can increase SOB. Patient given water and offered crackers, which declined. Removed coat and hat and continued to monitor with wife at side. T 0934 BP was 135/64, O2 sat 95 on RA, RR 20, t 96.5 continue to monitor for another 10 minutes. At 0934a, pt states still feeling lightheaded but slightly better. Had patient stand and stated he was dizzy, EMS at side and assessing at 0934. EMS continued to monitor patient and at 1000a, pt stated he was "much better" and EMS released. Walked short distance without any dizziness or lightheadness. Encouraged wife and patient to notify PCP of events and if symptoms return

On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.

Received 2nd dose of covid19 vaccine on Wednesday 3-24-2021, felt fine Thursday, Friday loss of appetite tired, Saturday lethargic could barely function on his own. Sunday morning lethargic, weak, could not walk very well, complained of shortness of breath. Called 911 and took to emergency room. White blood count off, platelet level low, 14,000

Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.

Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics

Patient arrived to ED via EMS after wife called reporting the patient became acutely dizzy, diaphoretic, and short of breath during a bowel movement. Patient was found to have COVID-19 via rapid swab with basilar opacities and effusions noted on X-ray. The patient had an elevated lactate of 3.9 and was in AKI with a serum creatinine of 2.36 (baseline 1.5 on 3/26/21). The patient will be admitted to the hospital. The patient has received azithromycin and ceftriaxone in the ED, as well as a fluid bolus of 500 mL NS. Patient is not hypoxic.

Patient is an 84 year old male with a PMH of psoriasis, DM2 on insulin, HTN, HLD, who was admitted on 2/9/2021 with COVID-19 pna, weakness, and AKI. Pneumonia due to COVID-19 likely had concurrent bacterial infection present. Patient received 5 days of IV dexamethasone and ceftriaxone during admission. He was not a candidate for remdesivir. On day of discharge, chest x-ray showed persisting infiltrates and pt was discahrged with additional 5 days of oral dexamethasone. Patient discharged to home on 2/16/2021

WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.

Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures.

3/30- Resident was sent to ER was found to have acute CVA, R vertebral occlusion, carotid stenosis, 17mm lung mass suspicious for malignancy, family opted for palliative and or Hospice. 4/03-re-admitted to the facility. 4/14 Admitted to Hopsice. Resident deceased on 4/16.

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

Patient developed shortness of breath and "barky cough" 5 days after first COVID 19 vaccination. Chest imaging revealed pulmonary embolism. Patient was hospitalized for 4 days and discharged on anticoagulation.

Hospital admission on 03/22/2021, dx COVID+ with acute respiratory failure, acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity.

Hospital 5/22 thru 5/24/2021 Dx: UTI/ Weakness/ Right Pleural Effusion Covid Positive (5/22/2021) ED to Hosp-Admission Discharged 5/22/2021 - 5/24/2021 (2 days) Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List Generalized weakness Resolved Pleural effusion on right Resolved UTI (urinary tract infection) with pyuria Resolved Lack of appetite Resolved UTI (urinary tract infection) Resolved Constipation Resolved Intractable vomiting with nausea Resolved

Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021

Patient presented to the ED with shortness of breath and was subsequently hospitalized for elevated troponin, pneumonia and palpitations. She was in the ICU for 9 hours before being transferred to the cardiology floor.

2 days after 2 shot severe shortness of breath; This is a spontaneous report from a contactable consumer (Patient). An 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: ep7534), via an unspecified route of administration administered in Arm Left on 23Mar2021 as 2nd dose, single dose for COVID-19 immunization. Age at the time of vaccination was 84 year. Medical history included atrial fibrillation (afib) and allergies (unspecified). The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: en6203) via an unspecified route of administration, administered in Arm Left on 02Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested with covid post vaccination. 2 days after 2 shot, the patient experienced severe shortness of breath (dyspnoea) on 25Mar2021. Event resulted in Doctor or other healthcare professional office/clinic visit and was treated with prescribed drugs for heart failure. Therapeutic measures were taken as a result of shortness of breath. Seriousness of the event was reported Disabling/Incapacitating. The outcome of the event was recovered with sequelae.

Death: 4/22/2021 Causes of death listed on death certificate: 1) Respiratory failure 2) Emphysema Other: Covid-19 pneumonia, diabetes

Death 4/21/2021 Causes of death listed on death certificate: 1) respiratory failure 2) covid 19 pneumonia

Patient presented to emergency department with complaints of worsened shortness of breath and lower extremity edema on 6/22/2021. He was admitted for further management of CHF exacerbation. During screening for placement to post acute rehab facility, patient was found to be COVID-19 positive on 6/29/2021. He was treated for COVID-19 infection in April of 2021. He is still admitted at time of writing.

From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of COVID-19 illness on 06/13/2021

Patient presented to emergency department 7/20/21 with shortness of breath beginning several days prior to admission and progressively worsening. Diagnosed with COVID-19 pneumonia with superimposed bacterial pneumonia. Treated with dexamethasone, vancomycin, cefepime. Currently on day six of hospitalization requiring 15LPM of oxygen.

Patient admitted to hospital 7/28/21 diagnosed with COVID-19. Symptoms started 7/18/2021 and positive Covid-19 test 7/21/21. Repeat Covid-19 test on 7/28/21 to confirm diagnosis. Patient reports symptoms of nausea, nasal drainage, cough with yellow-green sputum, increasing SOB, generalized weakness, dry heaves.

vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.

REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED. PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.

Swelling of face. Denies difficulty swallowing, shortness of breath, rash. BP 136/68, RR of 16, HR of 84. Benadryl 25mg PO given at 1625 and was observed for an additional 15 minutes. No worsening of symptoms and slight improvement. He is here with his daughter who is an RN and feels comfortable taking him home. No further treatment initiated.

ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.

DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing

Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation, elevated lactate, anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom. Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM.

DEATH Narrative: Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21

Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

The patient had possible syncopal episode and an increased white blood count with lactic acidosis on admission. He is currently still in hospital and had delirium and acute hypercapnic respiratory failure requiring BiPAP ventilatory support.

Patient passed away unrelated to covid vaccine Narrative: The patient had Alzheimer dementia and acute on chronic renal failure. Patient received first dose of Pfizer vaccine on 1/13/2021 and second Pfizer vaccine on 2/2/2021. No adverse reaction was reported. Patient was recently admitted for LE edema and increasing SOB. Patient passed away on 3/8/2021 in hospital. No indication that death was related to COVID 19 vaccination.

about 15 hours after dose of vaccine his daughter could hear him carrying on, and was standing but not responding to verbal cues. He was confused, wet himself, and still doesnt remember anything about the event or the ambulance ride. He would not and could not walk, and was sweating, breathing labored, they called 911. went to hospital and was admitted friday morning and was released monday. patient states his body was in pain from head to toe. His daughter stated he received antibiotics and fluids and is not sure what else. Patient is home now and is doing better.

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.

Pt presented to ED at the recommendation of the PCP for low hemoglobin where he reported having increased generalized weakness for the past month, dyspnea on exertion, occasional lightheadedness. On arrival to ED was found to be hypotensive, with elevated WBC count, mildly elevated lactic acid level, and anemic at Hgb 7.5. An incidental finding of a positive COVID-19 nasal swab was found despite receiving Pfizer COVID vaccinations on 1/30/21 and 2/20/21. Pt admitted for additional management of sepsis, hypotension potentially secondary to COVID-19 infection and/or RLL developing pneumonia. Pt currently still hospitalized with worsening acute respiratory failure due to COVID and acute pulmonary embolism.

As per nursing notes documented on 4/22/21 at 6:17 am, resident observed in bed with no respirations at around 5:10 am. Patient completed a 7 days course of Levaquin for UTI. Patient was on Vancomycin IV 750 mg every 12 hours and Zosyn 2.25 mg every 6 hours for possible pneumonia.

HEART... SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not provided) via an unspecified route of administration, administered in left arm on 02Feb2021 as first dose, single dose for covid-19 immunisation. Medical history included diabetes, bipolar, seizure disorder and COPD (chronic obstructive pulmonary disease), all from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medications reported as patient received within 2 weeks of vaccination. The patient previously took buproprion hydrochloride (WELLBUTRIN). Patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. Prior to vaccination, the patient was diagnosed with COVID-19. On 10Feb2021 10:00, the patient experienced heart (also reported as sudden death 20 days after), and immediately had breathing issues, no arrhythmia, no adverse defibrillator reading recorded. Family saw decline immediately after injection, did not request autopsy and adverse medical decline reported to doctor following injection. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment receive in response to the events and treated with cardiologist. The patient died on 10Feb2021. The causes of death were heart (heart disorder) and breathing issues. An autopsy was not performed. Since the vaccination, the patient has been tested for COVID-19.; Reported Cause(s) of Death: HEART... SUDDEN DEATH 20 DAYS AFTER; BREATHING ISSUES

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45.

Severe cough, shortness of breath, exhaustion leading to emergency room visit followed by hospitalization wherein it was discovered Pt was diagnosed with acute congestive heart failure. Prior to this vaccine he was living alone, preparing meals, driving to errands, etc. Over the following few weeks after release he became unable to live at home so he was moved to an assisted living facility where he rapidly declined and was put on hospice less than 2 weeks after his second Covid shot on 3/2/21 (Lot EN9581) (which he only took because his doctor pressured him). He died on 6/2/21 of heart failure.

Patient diagnosed with COVID on 6/6/21. Patient was fully vaccinated. Patient admitted to our hospital with respiratory failure and COVID-19 pneumonia on 6/9/21. Patient was treated with oxygen, remdesivir, dexamethasone, and antibiotics. His pneumonia progressed, oxygen requirements increased, and chest xray showed worsening airspace opacities and decreased aeration. Patient's code status was updated to DNR/DNI per family request. Patient's condition continued to deteriorate and patient expired on 6/13/21.

having difficulty breath; too much stress for the heart; Having problems swallowing was reported as worsened; He is not able to eat or drink; swelling; She stated patient's weight has fluctuated; Fluid retention/ Fluid retention and high level of CO2 in blood system; CO2 was high/ Elevated CO2 levels and unable to arouse; This is a spontaneous report from a contactable consumer (patient's daughter). A 85-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single (at the age of 85-years-old) for COVID-19 immunization; tafamidis (VYNDAMAX, 61mg once daily by mouth), via an unspecified route of administration from an unspecified date for amyloidosis. Medical history included amyloidosis, sleep apnea which was diagnosed before he was taking either Vyndamax or Vyndaqel. There were no concomitant medications. Previously patient received first dose of BNT162B2 as 1st dose, single (at the age of 85-years-old) for COVID-19 immunization. Patient was on Vyndaqel 4 times a day and had some diarrhea. He was switched to Vyndamax about 3 months ago and in the last month, he started to have problems with swallowing. He was hospitalized and had to be intubated because he was having difficulty breath and his CO2 was high and the doctors thought it was too much stress for the heart, so they intubated him. While in the hospital, a feeding tube was put in because he could not pass the swallow test and they gave him one Vyndamax through the feeding tube but no more. He has been in the hospital twice and since then, has had difficulty swallowing food and pills. She has read on social media that other people on Vyndamax have had difficulty swallowing. The swallowing issues also started after having received his second dose of Pfizer's covid vaccine. Maybe about a month and a half ago, he started having problems swallowing and realizing it was possibly a side effect from it. He was having problem with the pills. He is currently in the hospital. He ended up where they had to intubate him and now extubate him. He is not able to eat or drink. Because of him being intubated, they were not able to continue giving him the medication. He has not taken it for 7-8 days. If the swelling is partly from being intubated, she is guessing that was part of the problem before, once they have been off the medication for a while, if that occurred with the swelling, would that go down after a while. She stated patient's weight has fluctuated. This occurred during the whole time, off and on. He was on Vyndaqel before this and does not know how long. It has been over a month that he has been having issues swallowing. He actually came home from the first hospitalization on 05Jun2021 and was only home for a day and a half before they had to take him back. He was again experiencing effects of CO2 where he was sleeping and they could not wake him up. On an unspecified date in May2021, the patient experienced having difficulty breath, too much stress for the heart, fluid retention/ fluid retention and high level of co2 in blood system, having problems swallowing was reported as worsened, have problems with swallowing, on 07Jun2021, the patient experienced co2 was high/ elevated co2 levels and unable to arouse, on an unspecified date in 2021, the patient experienced he is not able to eat or drink, swelling, she stated patient's weight has fluctuated. The patient was hospitalized for all events. Reporter seriousness for Having problems swallowing was reported as worsened, reporter seriousness for Fluid retention and high level of CO2 in blood system was hospitalization from 22May2021 to 05Jun2021, reporter seriousness for Elevated CO2 levels and unable to arouse was Hospitalization from 07Jun2021 to Ongoing. The patient underwent lab tests which included CO2 with high, swallow test which was not pass. Patient received treatment for having difficulty breath, co2 was high/ elevated co2 levels and unable to arouse, too much stress for the heart, having problems swallowing was reported as worsened, have problems with swallowing. The outcome of events (having difficulty breath, CO2 was high/ Elevated CO2 levels and unable to arouse, too much stress for the heart, Fluid retention/ Fluid retention and high level of CO2 in blood system, He is not able to eat or drink, swelling, She stated patient's weight has fluctuated) was unknown, the outcome of events (Having problems swallowing was reported as worsened, have problems with swallowing) was not recovered. Information about lot/batch number has been requested.

Patient received Pfizer vaccines on 1/28/21 and 2/18/21, tested positive for COVID by PCR on 7/9/21. Admitted to hospital due to dyspnea on exertion on 7/9/21 and diagnosed w/ presumed COVID-19 pneumonia, received remdesivir. Patient has underlying h/o of relapsed CLL and lives in an assisted living community.

Patient presents to ED with 2-3 weeks of weakness, fatigue, anorexia. No known Covid exposures. Cough, productive at times. CT scan shows extensive lung infiltrate consistent with COVID per note.

the evening after the vaccine, I had difficulty breathing and headache. Took me 5 minutes of trying to breath to get enough air and did not lay back in bed, I sat up and didn't have any other issues. the headache is out of the ordinary for me as well

RN received a phone call from patient. Patient was found by home health physical therapy assistant to be extremely short of breath, dizzy, hypotensive and tachycardic at home following 1st dose of covid vaccine today. Blood pressure on initial check was 58/46 and 66/52 on recheck. Heart rate (on pulse oximeter) was initially at 130-142 but came down to 72, irregular. After resting and hydrating, patient denies shortness of breath, but is still dizzy. RN advised 911

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.

SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH

Patient's wife noticed red blotches on his arm and suspected hives. Patient brought back to Med OBs at 2:55, he was alert and vital signs were: HR: 63, BP: 134/51, SPO2: 99. denied itchiness, SOB, throat tightening, palpitations. Scattered dry, red blotches on bilateral arms. Examined legs, back, and chest, no other blotches noted. Had patient wait with us for observation. At 1545 rechecked vitals: HR:65, BP:128/55, SPO2:98, patient had no further redness and continued to deny any symptoms. he felt he was ready to go home. discharged to home with wife. consulted patient and wife he could take Benadryl.

86y.o. male with history of hypertension, Diabetes mellitus type II, OSA (uses 2L of O2 at home), CAD, cardiomyopathy, CVA with right hemiparesis, gout, GERD, and depression who presents to the hospital on 4/27/2021 for shortness of breath that has been worsening over the past week. Patient positive for COVID on 4/26/21 when he presented to the ED with fever, cough, and chronic toe infection. Patient had no hypoxia or increased work of breathing and was discharged from ED with doxycyline for his toe infection. Patient reports that he returned to ED due to family concern over symptoms. In ED, patient became hypotensive and was given 30 mL/kg bolus by ideal body weight. Patient remained hypotensive and central line placed in ED for possible vasopressors. Patient is on his home oxygen of 2L and has no increased requirements. Patient in ICU for sepsis and hypotension that responded to IV fluids.

shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough

Pfizer Dose 1 2/19/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6207) COVID Positive 4/29/21 5/3/21: A is a 6-year-old male past medical history significant for COPD with chronic bronchitis, AAA, pulmonary embolism chronic heart failure, OSA and previous smoker was referred from infusion center for hypoxia on room air of 88%. Patient endorses that since field note Will with some shortness of breath; contacted PMD and COVID test was done and was found to be positive. Patient was then referred to infusion center and was found to be hypoxic on room air 88% and referred to the emergency room. Patient endorses that progressively has been feeling short of breath with generalized malaise otherwise denies any fever chills or rigors. Patient had 2nd COVID-19 vaccine X2 doses in March. Patient was found to be hypoxic in the emergency room requiring 2 liter/minute to bring saturation to acceptable level. Chest x-ray shows mildly cardiomegaly with pulmonary vascular congestion and grossly scatter bilateral pleural plaques. CT angio of chest to rule out PE was done and was unremarkable for pulmonary embolism; however shows right lower lobe airspace disease that might represent pneumonia; intervals catheter bilateral calcified pleural plaques stable as prior. 5/11/21: Patient is an 86-year-old male was admitted with COVID-19 pneumonia with superimposed bacterial pneumonia. Patient had been vaccinated in March 2000 in 21 for COVID-19. Patient was started on remdesivir received Actemra as well. Patient was covered with IV Zosyn for possibility of superimposed bacterial pneumonia. Blood cultures x2 were negative for the patient. Pulmonology team was following the patient and we were able to successfully wean the patient down to room air. Pulmonology cleared the patient for discharge. Patient was discharged to skilled nursing facility with a prednisone taper as recommended by pulmonology. On 05/10/2021 patient had a sinus tachycardia and EKG revealed right bundle branch block which was discussed with Cardiology. Patient was asymptomatic and Cardiology did not recommend any further workup for right bundle branch block. Patient's electrolytes were in the normal range. Patient was in sinus rhythm upon discharge from the hospital on 05/10/2021. Patient was discharged to skilled nursing facility in a stable medical condition on 05/10/2021

presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital

Developed dizziness. Had several episodes a week or so after the shot getting progressively worse. On April 10, 2021 three bad episodes - last one resulted in fainting and splitting head open. EMT's came took me to the hospital and on April 12th I had a pacemaker installed. Breathing problems improved after pacemaker.

Developed symptoms of SARS-CoV-2 infection including shortness of breath, cough and was tested due to persistence of symptoms despite antibiotic treatment. Antigen testing was positive. Approximately 1 week after symptom onset patient was noted to be lethargic and confused by family who contacted EMS. Patient was hypoxic in ER and required 8 L of O2. Was admitted with COVID-19. Subsequently did decompensate on the floor and required intubation. Currently intubated receiving remdesivir, dexamethasone, and antibiotics.

86 year old pleasant gentleman with a history of coronary artery disease (noted on MPS in 2003, unclear if prior intervention), hx of SSS with PPM, type 2 DM, ischemic CM with EF of 41%, chronic kidney disease with a baseline Cr 1.5 - 1.9, hx of popliteal artery embolism felt to cardioembolic in origin (in setting of cardiomyopathy) on lifelong coumadin, and chronic thrombocytopenia with baseline plts of 100s. He has been admitted for acute respiratory failure due to COVID pneumonia. There may also be a component of pulmonary edema given elevated BNP. Plan: 1. Acute Resp Failure/COVID-19 Disease - - Symptom onset on 07/15. COVID positive on 07/17. Last fever on 07/15 o Pt has been started on Remdesivir on 07/20. He is to have a 5 day course. o Continue decadron 6 mg daily - started on 07/20, will continue for 10 days o Trend LFT's and chemistry daily as he is on remdesivir. Hold Remdesivir if ALT >10xULN or CrCl<30 o Continue awake proning: 2 hrs prone, 1 hr left, 1 hr right and back to prone. Limit the hrs supine. Explained in detail to patient who understands and is agreeable. o May use MDIs as needed for bronchospasm o Check d-dimer, ferritin, ESR, and CRP every other day. If rising will need to consider CTA/LE doppler o Monitor I/O and make sure patient is net negative. Continue bumex home dose for now per patient request. Will increase tomorrow UOP not adequate. o Continue Coumadin for prophylaxis active bleeding o Nasal Cannula 3 liters. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% o Pepcid for GI prophylaxis o Continue isolation in hospital per Regional/Local ID guidance.

Patient received both doses of Pfizer vaccine. Patient reports around 5 days after the vaccine, experienced shortness of breath, generalized weakness. On admission (about 10 days after completion of vaccination), patient is diagnosed covid-19 pneumonia with covid pcr positive and chest x ray consistent with pneumonia.

Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021.

On 3/15/21, patient called the pharmacy and stated he was short of breath and possibly had a rash. Recommended patient to be seen by a doctor. On 3/17/21, patient informed us that he did go to the ER, but they were unable to diagnose him with a cause for the SOB and were unsure if it was related to the vaccine or not.

Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.

FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital with multiple complaints. He was reporting falls, chest pain, his wife was diagnosed with Covid. While he was there, he was found to have hemorrhagic contusion in the right frontoparietal region with minimal surrounding edema, Covid, pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and arrives with no complaints. 2/26/2021 Patient died after code blue was called Death Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per initial CT - serial CT head showing stability Acute hypoxic respiratory failure secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain, improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan with intermittent probability PE Acute kidney injury on CKD, improving unlikely that vaccine contributed to patient's death.

an 87 year old male with ESRD on PD, pAfib, CAD, HTN, HLD, hypothyroidism, who was brought in after a witness cardiac arrest. Patient apparently received the first dose of the Covid vaccine (pfizer) at around 11 am. He was doing fine the rest of the day until later in the evening when he had shortness of breath without chest pain, abdominal pain, nausea, vomiting. Upon EMS arrival, the patient appeared to have some agonal breathing and then went down, was in PEA arrest, received CPR with 1 dose of calcium, 1 dose of bicarbonate, and 3 doses of epinephrine with return of spontaneous circulation. Upon arrival in the ED, patient had an intraosseous line, on dopamine for soft blood pressure. Patient has been successfully intubated.

The patient was admitted to the hospital on 4/25 c/o fatigue, hypoglycemia, and poor oral intake. He also complained of shortness of breath, which was an indication for a COVID-19 test. The specimen was collected and came back positive on 4/25. After a day at the hospital, the patient developed increased shortness of breath, had 80% oxygen saturation on a non-rebreather mask with subsequent upgrade to BiPap, and was using accessory muscles of respiration. His CXR on 4/25 on admission showed patchy b/l infiltrates. CT confirmed findings of CXR and was found to have ground glass opacities. The patient's ABG showed hypoxemia. On the morning of 4/27, the patient was found to be severely hypoxic and was electively intubated. As this form is being filled out, the patient is in the ICU on a ventilator due to COVID-19 pneumonia.

3/26/21 Patient presented to the ED w/several days of fever, chills, body aches, SOB, and fatigue. He had a + COVID-19 test several days prior. His RA pulse ox was 83%. He was started on BiPAP, decadron and remdesivir. Acute Hypoxemic Respiratory Failure ARDS secondary to COVID-19 pneumonia Oxygen requirement improving, Antley on 4 L of oxygen Status post 10 days of dexamethasone. Status post remdesivir. Continue incentive spirometer use. Breathing treatment as needed. Ct chest- CT chest images personally reviewed and notable for chronic changes consistent with evolving ILD/fibrosis + areas of consolidation which are consistent with a bacterial pneumonia Agree with pulmonology starting patient on IV Zosyn and IV vancomycin Agree with MRSA PCR from and starting Steroids and plan on a 6 week taper. Repeat OP imaging. Patient desaturates with activity Patient was discharged on 4/21 and was readmitted on 4/22 Patient is a 87 y.o. male patient with a history of hypertension, hyperlipidemia, CLL GERD, vitamin D deficiency, with a history of TIAs who was recently admitted to Hospital with COVID-19 pneumonia requiring remdesivir and steroids. After a protracted hospitalization the patient was deconditioned and on 4/21/2021 the patient was admitted to hospital for aggressive rehabilitation. The patient had been doing well over the past week and was making good progress however today during her visit the Daughter noticed at 11 AM when she came to visit him that he is unable to speak and that his gaze is to the right and there is left facial droop. Nurse confirmed this finding had a stroke alert was called. A CT scan was completed and patient is moved to emergency room department. Upon the virtual neurologist's evaluation, patient is alert and oriented without any aphasia or dysarthria. There is no gaze deviation. Extraocular movements are full. There is no facial weakness. There is no drift in any of the extremities and there is no reported sensory loss and there is no appendicular ataxia. The neurologist reviewed the images of CT head and it showed no acute intracranial abnormality.

My Dad received dose 2 of the vaccine on 3/22/21. On 3/29/21, he woke up to extreme shortness of breath and excessive bowel movements. Both are still continuing to date. He has been to his infectious disease doctor, his cardiologist, and to his nephrologist. Shortness of breath continues. He has also developed edema in his legs. His heart condition worsened suddenly after the vaccine. He will be having a heart procedure on 6/1/21 to address one of the issues. At this point, there has been no improvement 10 weeks post vaccine. As I type this report, I am sitting next to him as he helps me with the information and I can hear his breathing which is very labored.

Patient admitted to the hospital with shortness of breath and cough after being diagnosed with pneumonia in the clinic. He was found to have Covid pneumonia and was treated with maximal support but unfortunately became profoundly delirious and developed worsening hypoxia associated with Covid pneumonia. Family was called to the bedside due to progression in his illness and concerns for cardiac dysrhythmias occurring in the setting of worsening hypoxia on maximal support. Decision was made to transition to comfort care and aggressive life-prolonging interventions were discontinued for primary focus on comfort. Patient subsequently expired at 1810 on 04/18/2021. Patient was vaccinated against COVID 19. Death Certificate Information: Part 1: Cause of Death: A. COVID B. SARS COVID 19 Part 2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia

when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe; my platelets go way down; my red blood cells go way down; when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8720), via an unspecified route of administration on 04May2021 (at 87-years of age) as single dose for covid-19 immunisation. Patient received first dose of BNT162B2 (lot Number: EN6208, not sure it 8 or B as in boy) for Covid-19 immunization. Medical history included myelodysplastic syndrome (cancer patient and over a last 2-3 years). Concomitant medications included Dacogen, Zarxio, Procrit 40000 units/ml and Promacta 50 mg. It was reported that patient had no prior vaccination. The patient receive medication to get platelets up, after a few days he does not feel well and can hardly breathe, his platelets go way down and my red blood cells go way down. Patient stated that after taking of second dose of vaccination, patients doctor had a lot of trouble trying to control his blood characteristics, his platelets go way down and his red blood cells go way down. Patient stated that from past two weeks after 04May2021 that he could not control his red blood cells and platelets, it was both of these were blood products and if he could not get his platelets down, he would break to death. Patient added, three transfusions needed to get his platelets up. when patient took medication to get platelets up, after a few days he did not feel well and could hardly breathe. The patient underwent lab tests and procedures which included full blood count (CBC) which was good record on 06Jul2021 at 8 O'clock. All his blood as the result indicated a very good record graphical and numerical, platelet disorder and red blood cell abnormality go way down, transfusion: unknown results on 06Jul2021. Patient reported that he has been taking a lab test for the last two years every Saturday or Monday, every week for one time he had a very good record. Patient had not recovered from the events my platelets go way down and my red blood cells go way down while the outcome of event when he takes medication to get platelets up, after a few days he doesnt feel well and can hardly breathe was reported as unknown. Follow-up attempts are completed. No further information is expected.

Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.

Patient presented to the ED with SOB and weakness for the past 1 month. He reports seeing his PCP twice and given antibiotics and steroids. His son also had similar symptoms to both were advised by PCP to get tested for COVID. The patient initially tested negative however, his son, who he lives with tested positive. In the ED, the patient did test positive for COVID and is assumed to have got this from his son. Patient remains hospitalized receiving remdesivir and steroids. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.

Wheezing, ugly cough, no phlegm. Began two weeks after 1st vaccination, lasting until now (22 March, 2021) and who knows when it will subside?

Patient vaccinated with first dose of Pfizer with subsequent infection and hospitalization due to COVID-19 infection. Initial H&P reads in part as, "Patients symptoms began on or around Thursday 3/11 when he began to feel fatigued. After two days of fatigue, he presented to an urgent care facility on Saturday 3/13. He was noted to have a fever there and was diagnosed with a presumed UTI, though patient reports at bedside that he has not had any dysuria. He was treated with nitrofurantoin and increased his furosemide temporarily per urgent care's recommendations. He then presented to the ER on 3/15 with continued fatigue and a low blood pressure at home. We were unable to clarify the method by which the blood pressure measurement was obtained and/or if it was repeated. Antibiotics were changed to cephalexin at that time despite a relatively clear UA. His daughter brought him back to the ER today (3/18) due to persistent issues with low grade fevers in the 100-100.5 range, significantly worsening fatigue, anorexia, and oxygen levels of 92-93% on nonproductive cough. Does not have a home O2 requirement. In addition, he endorses feeling chilled during the admission evaluation. Denies any chest pain, nausea, vomiting, fevers, diarrhea, constipation. # Fever Progression of symptoms from Saturday 3/13 may constitute original presentation of Covid-19. Presentations on 3/13 and 3/15 with dyspnea and fatigue. Initially thought to be UTI and was treated with nitrofurantoin and cephalexin. UA on 3/15 in ED was negative for leuk esterase and nitrites. Tested positive for covid-19 on 3/18 with lymphopenia, 90-92% on room air. No home O2 req. Given duration of symptoms and worsening fatigue and fevers, will admit for treatment of Covid- 19. Also considered CHF exacerbation, COPD exacerbation as explanations for dyspnea. Possible CHF exacerbation as well given 1+ bilateral pitting edema to mid-shin and JVD to ear lobe. Suspicion for COPD is low given no report of increased sputum production and questionable history in chart to begin with. Would be beneficial to clarify history with collateral history 3/19."

Patient was a 88 yo M who presented to hospital on 2/19/2021 with acute onset unsteadiness and trouble swallowing. The patient noted that these symptoms began on day of admission and receiving his vaccine 7 days ago in which he noticed he had increased malaise and increasing DOE/SOB. Patient was noted to be hypoxic with SpO2 in 80s increasing to 90s on 2L NC and in atrial fibrillation on admission. Patient tested positive for COVID-19 on admission and was placed on dexamethasone 6 mg daily for 4 days, ceftriaxone 2g qd for 4 days, and doxycycline bid 100mg for 4 days. Patient improved over the 6 day stay until he was stable on room air at rest and upon ambulation at which time he was discharged home on 2/25/2021.

This is a 88 yr old male pt with a hx significant for -stage renal disease on hemodialysis, hypertension hypertensive heart disease and kidney disease, CAD, history of acute MI, dementia, GERD, gout, prostate cancer who is admitted with complaints of chest reviewed and back pain. Pr records patient was noted to be grunting and hyperventilating while in the emergency department. Imaging done was negative for a pulmonary embolism, showed minimal interstitial upper lobe and peripheral lower lobe interstitial and groundglass lung opacities which are nonspecific. Patient was tested for COVID-19 and has tested positive.

4/14/2021 at ~8am, Patient was out of bed and in his wheelchair and consumed 100% of his breakfast. During lunch time, he only consumed 25% of his meal. At ~2pm, patient was noted to be unresponsive. Oxygen saturation was 88% and B/P was low and oxygen was administered and Oxygen Saturation increased to 92%. The patient was placed in bed and Dr and the family were notified. The resident was continuously monitored by the Hospice nurse, who happened to be on-site and the primary nurse. At ~6:30pm it was noted that patient was having labored breathing so 0.25 ml of Morphine Sulfate Solution 20mg/ml was administered with releif. At 8:30pm, patient expired.

88 y.o. male with medical history of hypertension, dyslipidemia, sinus bradycardia, COPD ,OSA on CPAP night and AFib on Xarelto. Patient presented to the emergency room with a complaint of chest pain and worsening shortness of breath.Initial vitals in the ED showed temperature 36.1° heart rate 83 respiratory rate 20 blood pressure 150/89 SpO2 96%. CBC within normal, PT 18.8 APTT 39 D-dimer 1111, CMP showed bicarb 32 creatinine 1.39 E GFR 45 and lipase 146. Initial troponin is 53 with indeterminate to our delta, will follow-up on 6 hour delta. ProBNP 1663 with no baseline available. Patient tested negative for COVID-19. VBG showed pH 7.33 and pCO2 of 61 no baseline pCO2 available. Chest x-ray as per report no acute abnormality, personal impression increase interstitial reticular opacities suspicion of fluid overload/pulmonary edema. CT PE as per report filling defect left descending pulmonary artery consistent with acute pulmonary embolus. Patient admitted to the ICU for further monitoring and evaluation. Patient started on heparin drip, rivaroxaban factor Xa antibody sent, as per patient he was compliant with Xarelto. Vascular medicine consult done recommended to bridge with warfarin versus start Lovenox. Discussed with the patient, patient prefers warfarin. Patient was started on warfarin INR 2-3. Resumed CPAP for OSA. Venous Doppler lower extremities negative for acute DVT. TTE showed Normal left ventricular chamber size. Estimated LV ejection fraction range 55-60%. No regional wall motion abnormalities. Mildly enlarged right ventricular chamber size and mildly reduced RV systolic function. Estimated RV systolic pressure 46 mm Hg. Moderately enlarged inferior vena cava size with reduced inspiratory collapse (<50%). No hemodynamically significant valvular heart disease. Patient was started on Lasix IV; converted to oral upon discharge. Patient discharged on Lovenox and warfarin. Patient medical condition improved with medical treatment

Admitted to ICU on 4/29/21 with shortness of breath, requiring bipap. Tested + for covid on 4/10/2021. Last vaccine dose given 2/10/2021. Discharged home on 5/3/2021 and doing well currently.

88-year-old male with lymphoma that received a transfusion of 2 units of packed red blood cells prior to admission. The patient has a history of pleural effusions and he states after the blood transfusion, he became increasingly more short of breath and could not catch his air. He was dyspneic at rest and exertion. There is no cough. No fevers. He also has a history of cardiomyopathy and chest x-ray is suggestive of increasing sizes of his pleural effusions. Tested positive for COVID on 4/20/2021. Moved to hospice and expired on 4/22/2021.

ED to Hosp-Admission Discharged 4/28/2021 - 5/1/2021 (3 days) Last attending ? Treatment team Acute respiratory failure with hypoxia Principal problem Hospital Course Admission HPI: (patient) is an 88 y.o. male come to emergency room for evaluation of cough with thick yellow sputum which is going on since past 2 days. Which is progressively getting worse. Associated with some shortness of breath. On arrival of EMS patient found to have significant hypoxia with 70% at room air. He was placed on nasal cannula. Did bring him to the emergency room. Patient had a dose of Covid vaccine and is due for second dose soon. In emergency room, he was thoroughly evaluated. He found to be septic. He was given dose of IV Levaquin and Covid swab come back positive. Hospitalist service requested to admit the patient. Asking patient, is feeling little better after coming to emergency room. He is having shortness of breath with significant cough with sputum production. He felt wheezy. Denies any fever but had chills. He feels nauseated. Hospital Course: Pt was admitted to the hospital for management of acute hypoxic respiratory failure secondary to COVID-19 virus pneumonia. His breathing improved precipitously. He had resistant hypertension this admission and was started on amlodipine. He did have mild hyponatremia this admission but did not appear to have any volume overload. TSH elevated at 13.8. Will need repeat study. He did also have rising procalcitonin and received few doses of antibiotics. Lipid panel was benign. ED Discharged 5/9/2021 (58 minutes) Hospital ER Treatment team Thrush, oral Clinical impression Sore Throat Chief complaint ED Provider Notes (Physician Assistant) Emergency Medicine Cosigned by: (Doctor) at 5/9/2021 6:45 PM Attestation signed by (Doctor) at 5/9/2021 6:45 PM The patient was seen and treated primarily by the PA-C. I did not independently evaluate the patient. Chief Complaint Patient presents with ? Sore Throat HPI Patient is a very pleasant 88-year-old male with recent COVID-19 infection diagnosed on 4/28/2021 on oxygen 4L NC, who presents to the emergency department complaining of sore throat x 1 day. He states that he started yesterday with a sore throat, painful to swallow, then noticed this morning that he had twice patches on his tongue and mouth. He states he is able to tolerate food and liquid, but that it hurts to do so. He denies any fevers or chills. From a Covid perspective, he states that he would not be here if it were not for the pains and sores in his mouth/throat. He feels that his breathing is stable and he is doing well on 4 L of oxygen nasal cannula as prescribed. He has finished a course of Decadron and states he is currently on no further treatment for COVID-19. ED to Hosp-Admission Discharged 5/10/2021 - 5/13/2021 (3 days) Hospital (Doctor) Last attending ? Treatment team Aspiration pneumonia Principal problem Hospital Course Patient come to the hospital with complaining of abdominal pain and hypoxia and cough. Patient found to have a right middle lobe pneumonia. We are believing that it is aspiration pneumonia which is improving at this time. He had a recent COVID-19 infection which is resolving at this time. During course, GI, pulmonology, urology and oncology consultation obtained. Patient continued to improve clinically. Patient had a urinary retention because of the constipation. He is able to void now. Today morning, I am seeing him. He is feeling better. Is agreed to go home. I discussed with the patient's wife regarding plan. Once he fully recovered from pneumonia he need to have colonoscopy and possible biopsy of colon mass.

Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice

Intermittent SOB for several weeks, progressively worsening over three days prior to presentation to ED. Presented with SOB, bilateral leg swelling. CXR obtained in ED showed perihilar and RUL opacities consistent w/ multifocal pna or pulmonary venous congestion. SARS-Cov2 PCR resulted as positive. CT of chest showed bilateral pna, began treating as COVID pna with dexamethasone, lovenox. Treated for CHF exacerbation with aggressive loop diuretic therapy. Required 2Lpm O2 via nasal cannula. Discharged home after 6 days in hospital.

loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.

Pt called son to let him know he couldn't breath around 2 AM. Pts son showed up at his house 10 minutes later and ambulance arrived with in 20 minutes at 2:15

Administered Patient vaccine 01/21/21. Went to ED and diagnosed with the following: 1. Shortness of breath 2. Peripheral edema 3. Hypertensive urgency 4. Weight gain 5. Hypervolemia, unspecified hypervolemia type 6. Atypical chest pain Admitted to inpatient to hospitalist but then signed AMA and left hospital.

Dose #1 on 12/21/20 Dose #2 on 1/11/21 On 1/12/221 He states over the last 24 hours he has developed shortness of breath, chills, extreme fatigue. Patient states he went to sleep fine last night using his BiPAP which she always does for obstructive sleep apnea and woke up today around noon. He states upon awakening he had extreme fatigue and chills and felt short of breath. He states he was breathing "60 times a minute". Patient has not had fever since. Patient states he did have coronavirus in October and had pneumonia with this, states that his pneumonia improved and his symptoms resolved. Patient initially requiring 2 L of supplemental oxygen. Afebrile throughout admission. Was able to be weaned to room air. Patient symptomatically improved in terms of shortness of breath as well as myalgias. Likely the symptoms were secondary to vaccine reaction. Patient stable to be discharged home. No changes made to home medications.

2/14/2021 Resp panel: COVID19 + Started on 2/14/21 Dexamethasone 6 mg po daily and on 2/15/21 Remdesivir 200 mg IV x1 dose then 100 mg IV daily x 4 doses. 89-year-old male presents to the emergency room with epigastric abdominal pain and shortness of breath and was found to have acute pancreatitis and COVID-19 pneumonia.

respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from

Face and throat swelling; wheezing loudly; labored breathing. 3rd morning post 1st injection, lasted 24 hours face swelling from onset; wheezing lasted 72 hours from onset (being 3rd day post 1st injection). No medical treatment received because patient and caregiver were not warned that a DELAYED reaction to the vaccination could occur Caregiver contacted primary doctor to report severe reactions, was asked if we sought epinepherine /ER which we did not thinking patient had allergies, talked with cardiologist who thought patient was breathing like "an almost 90 year old".... PCP advised patient to not receive 2nd shot given 1st shot reaction.

2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID. + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19. He was discharged 2/20.

12/31/2020: vaccine given 1/17/2021: symptom onset and subsequent hospital course: dyspnea, hypoxic, tachypnea, afib w/RVR, septic, NSTEMI

Chief Complaint Arrived via EMS- per wife pt has been more confused than BL, febrile, incont of bowel and bladder. Denied pain. +cough, SOA. Got first dose of COVID shot wed.. A&Ox1. Has left sided weakness from prior CVA History of Present Illness 89-year-old male who presents to the ER via EMS with confusion. He has also reportedly had a cough and some fever. There has been some report of incontinence of both bowel and bladder. He received his first dose of the Pfizer Covid vaccine on Wednesday, 3/17. He and his wife have returned to the home after wintering in another state. According to his wife, with whom I have spoken this evening, last night he suddenly became confused. The confusion continued throughout the day today, thus prompting the EMS called to the house and the subsequent journey to the ED for further evaluation. In the ER this evening, a battery of testing was completed. A Covid swab is indeed positive. His wife is uncertain of any positive contacts. He had some vascular congestion on chest x-ray. He has a prior history of pleural effusion which is thought to be resolved. He does have a history of lower extremity edema. He had some urinary incontinence and his wife held his Lasix Saturday morning. He was noted to be slightly hypoxic around 88% on room air. He was around 85% or so on room air at home with their home pulse oximeter device. He has been placed on 2 L of nasal cannula.

CHEST PAIN SHORTNESS OF BREATH Shortness of breath Pneumonia Elevated troponin Elevated CK Acute chest pain Elevated lactic acid level Pneumonia of both lungs due to infectious organism, unspecified part of lung Ground glass opacity present on imaging of lung Leukocytosis, unspecified type Hematuria, unspecified type Sepsis

Shortness of breath; bradycardia; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EN6200), intramuscular in left arm on 24Feb2021 12:00 PM (received at the age of 89-years-old) at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within the four weeks prior to receiving BNT162B2. Medical history included known COPD (chronic obstructive pulmonary disease), hypertensive heart, CKD 3 (chronic kidney disease stage 3), and history of breast cancer. The patient had no COVID prior to vaccination. He had no known allergies. Concomitant medications included multiple unspecified medications. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number: EL9265), intramuscular in left arm on 02Feb2021 at a single dose for COVID-19 immunization. It was reported that the patient developed shortness of breath (SOB) and bradycardia 3 days after vaccination, on 27Feb2021. 1 day after that, 28Feb2021, it worsened, and the patient was admitted with SOB and bradycardia. Has known COPD, not on any negative chronotropic medication. The patient was cleared after a day in the hospital. The reported adverse events resulted in an emergency room/department or urgent care visit and hospitalization. The patient was hospitalized for 2 days (28Feb2021 to 02Mar2021). As corrective treatment, the patient received oral steroid. The patient recovered from the events on an unspecified date. The patient underwent Covid test post vaccination: Nasal Swab on 28Feb2021 with result of negative.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

The patient presented to the Emergency Department with cough for 3 days, nausea, vomiting, fatigue, decreased appetite, and chest congestion. Upon admission on 03/25/21, the patient tested positive for COVID-19. The patient received levofloxacin followed by ceftriaxone/azithromycin, dexamethasone, remdesivir, and convalescent plasma.

5/2/21 Pt was hospitalized for 2 days for COVID is a 89 y.o. male patient of , MD with history of steroid and oxygen dependent COPD with chronic hypoxic respiratory failure on 6 L, coronary artery disease, gout, hypertension, hyperlipidemia, BPH, and recent exacerbation of his COPD who presents with fevers, body aches, generalized weakness for 5 days found to have COVID-19 infection Acute on chronic hypoxic respiratory failure Due to COVID-19 infection. On home requirement of 6L NC. Expect he may have a milder course given vaccinated status (though not fully vaccinated until 5/7/21). Update 05/4/2021 Patient stated that he feels that he is back to his baseline Currently on 6 L nasal cannula oxygen His sats was~98 %t rest, with no evidence of respiratory distress Covid-19 Virus Infection Date of onset of symptoms: 4/28/21, Symptoms present on admission: fevers, myalgias, dyspnea, weakness Date of covid positive test: 5/2/21 Vaccination status: vaccinated on 4/1 and 4/23/21 but had exposure on 4/22/21 Imaging: CXR with low lung volumes with bronchovascular crowing and strandy bibasilar pneumonia with small pleural effusions Oxygen requirements on admission: 6L Current oxygen requirements: 6L Medical therapy: Received x3 doses of remdesivir while in the hospital, will complete total 10 days of dexamethasone treatment Consultants following: pulmonary Anticipated special isolation end date: 5/8/21 Generalized weakness Due to above issues -PT/OT consults COPD with chronic hypoxic respiratory failure GOLD grade 3, group D, follows with Dr. as an outpatient and recently completed a course of prednisone taper and augmentin on 5/1/21.Chronically declines PFTs in the past. He is on chronic prednisone at 5mg daily and uses 4-6L NC continuously at home. Pneumovax 2010, prevnar 2015. -Continue home spiriva, symbicort, singulair, and albuterol MDI 4x daily -ST consulted, recommended chopped/NDD 3, thin liquids -Discharge home to complete total 10 days of dexamethasone -Can restart his home prednisone afterwards

Death 3/30/2021 Causes of death listed on death certificate: 1) Respiratory distress 2) ITP 3) COVID 19 4) Dementia Other: acute cardiopulmonary failure