Pfizer

mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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.

1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process

On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or something. It eventually radiated over up into the left quadrant of his chest where he could not push down on it. It was extremely painful by Monday. He has a history of esophageal spasms and exacerbated them to where he thought he was having a heart attack. He called his Cardiologist and told him to go to the ER. He went to the hospital Monday evening, he had two EKG's, had blood drawn 3 times, did sonograms looking for blood clots. He did inform them that he had the vaccine on Friday and they told him it was due to that. He went to nuclear medicine to get his lung checked for blood clots as well. All tests were negative. He saw his PCP today who told him that the lymph nodes were affected due to the vaccine. He has improved greatly, still has some slight discomfort which his PCP said would go away in time.

Patient received initial COVID vaccine on 2/11/2021 at Clinic. Direct observation for 15 minutes and no documentation noting an adverse reaction. On 2/14/2021 was diagnosed with Sepsis secondary to pneumonia, started on antibiotic therapy, cardiac arrested, and expired on 2/14/2021 while at Hospital.

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.

BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT. I DID NOT SEE A DOCTOR .

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.

Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation

Swelling of the right foot; joint pain in the right big toe; 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 MRNA VACCINE, Lot number EL9265), via an unknown route of administration on 01Feb2021 at 08:30 (at the age of 76-years old) as a single dose in the right arm for COVID-19 immunization). Medical history included arthritis from an unknown date and unknown if ongoing. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included tizanidine hydrochloride (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) from an unknown date. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 02Feb2021, the patient experienced swelling of the right foot and joint pain in the right big toe. Therapeutic measures were not taken for the events. The clinical outcome of the events peripheral swelling and arthralgia was recovered on an unknown date in Feb2021.

Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.

Non arteritic ischemic optic neuropathy in one eye; swelling/joint inflammation in one hand. Started several days after 2nd Pfizer Covid-19 vaccination.

sore left arm, little bit swollen; sore left arm, little bit swollen; covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid; This is a spontaneous report from a contactable other hcp (Nurse). A 76-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm on an unspecified date (Batch/Lot Number: EM9809) as 0.3 mL, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EL3249) via intramuscular in left deltoid on 18Jan2021, unknown time as single dose for covid-19 immunisation. On 08Feb2021, covid vaccine was administered in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid and on 09Feb2021, sore left arm, little bit swollen. Clinical course of the events includes, someone at a vaccine clinic, the second dose of the covid vaccine was administered very low in the arm. States the injection probably did not go into the deltoid, probably went in the bicep. She is asking if the injection would need to be repeated. She wants to know if the vaccines will need to be repeated. She also had a sore left arm and it was little bit swollen which started on the morning of 09Feb2021. The outcome for the event covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid was unknown and for the events sore left arm, little bit swollen was not recovered.

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.

Increase in white blood cells with peripheral blasts suggesting progression to acute myeloid leukemia

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.

ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) CRNP Last attending ? Treatment team COVID-19 virus infection Principal problem HPI: For complete history and physical see the H&P dictated by Dr. on 4/28/2021. This is a 76-year-old male who presented to the emergency department with upper respiratory symptoms for three days. He reports having cough, sneezing, runny nose and poor appetite. His caregiver had Covid recently and he was exposed. He was admitted for further evaluation and treatment. Hospital Course: Patient was admitted inpatient to the medical surgical floor. He was not on telemetry. Patient reports that his caregiver had recently tested positive for Covid and he was exposed. He has been having upper respiratory symptoms including cough, sneezing, and runny nose. His COVID-19 test was positive. He was started on the COVID-19 treatment protocol which included IV remdesivir and IV dexamethasone. He underwent a CT scan of the chest which showed small patchy areas of groundglass infiltrates in the peripheral portions of the left and right upper lobes and also the posterior aspects of the right lung base. These findings are probably due to pneumonia. Hospital course consisted of gentle hydration with IV normal saline. He was also started on antibiotic therapy oral azithromycin and IV Rocephin. He had completed the course of antibiotics while on the unit, therefore, at the time of discharge no antibiotics were prescribed. He initially was hypoxic and started on nasal cannula oxygen to maintain pulse oximetry greater than 92%. Eventually, oxygen was weaned and pulse oximetry on room air has remained in the 95-96% range. He has a history of diabetes mellitus and while on the unit blood glucose levels have fluctuated. His point-of-care glucose have been in the 80-500 range. He has had numerous episodes of hypoglycemia and insulin has been adjusted. The fluctuations of the blood glucose levels may be secondary to IV dexamethasone. At the time of discharge he will continue dexamethasone 6mg daily for the next three days. He was advised to increase insulin 70/25 insulin five units daily for the next thre days. After that time he can return to his normal dose of insulin. He also had been treated with IV remdesivir and had completed the 5-day course. On examination today he has been asymptomatic. He denies any chest pain, dyspnea, abdominal pain, nausea, or vomiting. The initial lab studies showed an elevated creatinine level, although he has a history of chronic kidney disease. At the time of discharge the creatinine level trended downward and he was advised to follow-up with the primary care provider for possible repeat BMP in 1 to 2 weeks. All other lab studies have been within normal limits. The systolic blood pressure has been in the 120-150 range. The most recent systolic blood pressure was 151/66 mmHg with a heart rate of 66 bpm. He denies any lightheadedness or dizziness. He was advised to continue all of his current medications. While on the unit he was in isolation secondary to COVID-19. At the time of discharge he should maintain social distancing/isolation, mask wearing and good handwashing. He will will need to follow-up with the primary care provider. He was also advised if the oxygen level dips below 89% he will need to return to the emergency department. At this time he is resting comfortably, offers no complaints and is stable for discharge. Patient is alert, oriented answering all questions appropriately. He is continent of bowel and bladder. Heis able to make his own decisions. He is able to performhis own ADLs. . At this time he is in agreement with the plan and feels comfortable to be discharged home. Thank you.

Patient received what he believes was both Pfizer covid-19 vaccines in February 2021. He was admitted to hospital on 5/5/21 with leg edema. Found to be covid-19 positive x 2 on nasopharyngeal PCR testing. He had no pulmonary symptoms. Normal oxygen saturations. He seemed to have an asymptomatic infection after covid-19 vaccination.

Lymphadenopathy under left arm more 5 cm diameter; This is a spontaneous report from a contactable consumer. A 76-year-old male consumer (patient) reported for himself that he received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 26Feb2021 10:45 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications were none. The patient was not administered with any other vaccine in four weeks. On 28Feb2021 the patient had lymphadenopathy under left arm more than 5cm diameter. The event was non-serious. Outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Developed Covid Foot; feet were swollen and red and typically for Covid toes; Developed Covid Foot; feet were swollen and red and typically for Covid toes; This is a spontaneous report from a contactable physician. This physician reported for a 76-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, expiration date: not reported) via an unspecified route of administration on an unspecified date in Jun2021 (Exact date of the first vaccine unknown, it was about 7 days ago) as dose 1, single for COVID-19 immunisation (at the age of 76-year-old). The patient medical history and concomitant medications were not reported. The patient got the PFIZER COVID 19 VACCINE, and after about 24 hours on an unspecified date in Jun2021, developed pink-red feet with swelling, especially toes and especially great toes, very similar to Covid foot- toes that been seen with the actual disease, had improved significantly since then, now the question was he needed the second vaccine and were worried about the above reaction to the first dose of vaccine. The patient's feet were swollen and red and typically for Covid toes (start date: Jun2021). The patient had Covid feet (start date: Jun2021), and the toes were involved. It was reported that slowly it had improved significantly, but the patient was due for his second shot and he was worried about if he will have more issues with the second shot. The patient had significantly improved, about 90% improved and could get the information about the Covid vaccine later if needed. The patient wanted to get some help and information with how to proceed with the second vaccination. Reporter's seriousness for the events was medically significant. The outcome of both the events was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relationship, the association between the events of swelling of feet and redness and the suspect product of BNT162B2 cannot be completely ruled out. 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.

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

Itching; Scaliness of the skin, Similar to eczema; Scaliness of the skin, Similar to eczema; swelling of the right leg, Now also swelling in left leg.; dryness of skin; chills; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route, administered in Left Arm on 04Mar2021 at 13:30 (76-year-old at time of vaccination) as a Dose 1, single for Covid-19 immunization. The patient's medical history included diabetes mellitus, blood pressure. The patient received diabetic medication and blood pressure medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 infection. On an unknown date in 2021, the patient had experienced itching, scaliness of the skin, similar to eczema, swelling of the right leg, dryness of skin, chills. Now also swelling in left leg. The adverse event resulted the patient to visit Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19 infection. The patient received antibiotics, benadryl, lotion for skin as treatment medications for the resulted events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

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

Narrative: See "Other Relevant History" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:

Ipsilateral lymphocyl in the left axilla, 5 cm in diameter, about 1 cm in thickness. Tender, painful with movement, mild, without discrete palpable lymph node enlargement.

2-3 weeks after COVID vaccination, patient presented to hospital with anemia and thrombocytopenia and intracranial hemorrhage. L axillary mass (same side as Pfizer vaccine admin site) found on exam. Bone marrow biopsy demonstrated Burkitt's Lymphoma. He is undergoing treatment at hospital

Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.

Patient described the event as "severe anaphylaxis" that included redness all over the body and a rash on the face, with a strange feeling in the esophagus but no trouble breathing. The patient self-medicated with prednisone and did not seek medical care. Symptoms resolved later the same day they appeared. The patient indicated he had an appointment unrelated to this event scheduled with his primary care physician on March 3, 2021, and was advised to discuss the reaction with the physician at this appointment.

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.

Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick. Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly. Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck. Size of swelling was easily visible to the eye. Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting. Mass remains soft to the feel, but easily defined in size and location. I have taken OTC pain killers to help with the discomfort. Will continue to monitor its progress, unless notified otherwise. Do not anticipate seeing my physician at this point. Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site. Thought I should report this side effect only because of the size of the swelling that occured.

3-3-21 unable to open jaw, sweating (sweating resolved). 3-4-21 swelling to chin area with redness. took tylenol reports it helped him. asked if he had any fever, wife reports "no". called PCP spoke with his nurse, pending further instruction from PCP and or nurse. Wife called back states her Husband has abscess tooth, so feels maybe related to that. Wife states he was given Amoxicillin yesterday at MD office. She states he is feeling better today, eating slowly.

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

On 2/25 he started having severe itching all over for the knees up. On Friday he had facial swelling and swelling with both hands and puffy fingers. Between his fingers he became very red and his face was red.

After Does 1, I broke out into hives, I was given prednisone and the swelling and itching did go down. After dose 2, The hives returned and I developed plaque psoriasis all over my body in perhaps 20 locations. I was given prednisone again, the itching stopped but The psoriasis remains and is getting worse. As a note, I have had psoriasis for most of my life on my hands and feet, but after this experience I have psoriasis all over my body.

Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.

72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.

weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; 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, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration, in left arm on 09Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) at single dose for covid-19 immunization. Medical history included diabetes mellitus from 2004. There were no concomitant medications. The patient said yesterday morning he had whelps on his left and right legs with some swelling, also whelps to upper left arm and left elbow. He clarified that he had slight swelling to his legs, with little whelps or hives to his legs and calves. He had done no treatment, though last night before bed he put alcohol, clarified to being Swans 70% rubbing alcohol with a swab where it was itching, it seems to be getting better, it doesn't itch as much. Swans 70% rubbing alcohol LOT: 0501407, EXP Sep2023, UPC: Number. Outcome of itching was recovering, and outcome of other events was unknown.

4/14/21: onset of right leg swelling from the knee down that was painless. Calf circumference of the right leg had increased to 2cm greater than the left. No fever, chest pain, or difficulty breathing.

This 77 year old male received the Covid shot on 1/27/21 and went to the ED on 2/1/21 and was admitted on 2/2/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome) Pneumonia, unspecified organism Acute kidney failure, unspecified

Severe clots on right thigh rushed to urgent care and urgent care referred me to emergency Hospital. Was hospitalized for 5 nights with severe swelling on right thigh. The swelling has since abated but has still not subsided. Feel still very heavy on right thigh.

flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

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

Patient presented to the ED on 6/7/21 with worsening redness and swelling of his legs. He had presented to the ED with the same complaints on 5/29/21 but was discharged back to his group home. On the 5/29 visit, he was tested for COVID as part of standard protocol, and was found to be COVID positive (asymptomatic) despite receiving 2 doses of Pfizer vaccine (1/15 and 2/5). On the 6/7 ED visit, pt was initially found to be hypoxic (89% on room air) in the ED, but once he was admitted and transferred to the COVID floor, he was found to be 95% on room air and supplemental O2 was discontinued. Patient has remained asymptomatic for COVID during his hospitalization, and has not required COVID treatment.

muscle pain in the right shoulder and its getting worse; muscle pain in the right shoulder and its getting worse; Swelling; Little sensation; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, NDC number and expiration date: unknown), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 (last Thursday) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing arthritis (probably started off 6 years ago, little by little and got worse over time). Concomitant medication included paracetamol (store brand of TYLENOL 8 HR ARTHRITIS PAIN) taken for arthritis pain (Expiration Date: Jul2022; Lot Number: 81830065M; Count size: 225 tablets, start and stop date were not reported) and CBD oil which helped out with the knees. Patient did not receive any prior vaccine within 4 weeks. The following day on 19Mar2021, patient didn't feel anything but the day after that on 20Mar2021, patient began to have a little sensation and swelling. Patient reported that the little sensation occurred where the Covid-19 vaccine was injected, below the shoulder where they put a shot on a person's arm, and the sensation then moved to the shoulder muscle. Swelling was gone after a couple of days. On 25Mar2021 (from last night), the patient experienced muscle pain in the right shoulder and it was getting worse (myalgia/condition aggravated). Patient was normally hurt everywhere anyway because of arthritis, but the pain in his right shoulder was different now. It was in the muscle not the joint. Patient's second dose was scheduled on 08Apr2021 and he wanted to know should he not take it. Outcome of the events myalgia and condition aggravated was not recovered. Outcome of the event sensory loss was unknown while event swelling recovered in May2021. Investigation Assessment: No No follow-up attempts are needed. No further information is expected.

spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

Chills, fever (99-102), and overwhelming fatigue lasted 22 days. Then the general fatigue became localized in my legs. Whenever I try to walk up a sloping street my legs, esp. the calves, become fatigued and it is difficult to continue. Once I am on level ground or walking downhill normal feeling returns. This is now the fourth month of this condition. Blood test on 03/31/2021 indicated the following values: C-Reactive Protein 93.6; Red Blood Cell Count 3.89; Hemoglobin 11.3; Platelet Count 610. White blood cell count was normal (7.9). A CT scan on 04/17/2021 was normal. Am waiting insurance approval for a cardiac catheterization to determine blockage of the arteries to the legs.

Overnight I developed very significant headaches (hardly ever had a headache before); in a few days I developed edema of my ankles and feet; checked blood pressure after a few days and it was very elevated; Took Tylenol for headaches (not very effective); Doctor had me move from 20mg Olmesartan to 40mg Olmesartan with 25mg hydrochlorothiazide which controlled my blood pressure and eliminated the lower extremity edema. When my blood pressure became dangerously low, I was moved back to just 20mg Olmesartan. Atrial fibrillation had been controlled prior to the vaccination with Multaq. For two days after the vaccination I had A-fib, then it went away. I have been monitoring my blood pressure and EKG since and the A-fib is becoming increasingly common, so that now I seldom had sinus rhythm.

Swollen Cheek; Swollen lips; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration in the left arm on 25Jan2021 at 12:15 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 at 15:15 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 (after receiving the first dose of COVID-19 vaccination), the patient experienced swollen cheek and lip. On an unknown date 2 weeks and 4 weeks, (after second dose of COVID-19 vaccination) the patient experienced swollen cheek and lip. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with prednisone and anti-histamine for the events. The clinical outcome of the events swollen cheek and lip was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Feb2021 at 13:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart attack and bypass surgery. The patient had a history of allergy to ciprofloxacin (CIPRO). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), montelukast sodium (VICTOR) and metoprolol succinate (METOPROLOL) all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 14:00(at the age of 77-years-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the vaccination. On 24Feb2021, the patient experienced slight headache for a month which was still continuing, muscle cramps for 2 days and had lymph node pain under arm when lying on side with arm under body which started two weeks after shot and continued for several weeks. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle cramps was resolved on 20210226. The clinical outcome of the events slight headache and lymph node pain under arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Extreme pain in joints, reduced mobility, inability to move legs, arms, hands; increased white blood count. Was hospitalized four different occasions for 2-5 days each. Various tests and medicines were tried. Pretizone was used for 4 months.

Sore arm; slightly swollen two months after second vaccination; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and cholesterol. The past drug included ALEEVE for unknown indication, from an unknown date. The patient received unspecified medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 1900, the patient experienced sore arm and slightly swollen arm. The patient was concerned with length of time, since it continued to the present -May1. The events resulted in doctor or other healthcare professional office/clinic visit. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the event sore arm and swollen arm was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

Patient called at 12:13PM and reported swollenness to the face and neck area after receiving his first dose of the covid19 Pfizer vaccine today. Patient was advised to go to the ER and take his vaccination card with him.

He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; This is a spontaneous report from a contactable consumer reporting on behalf of the husband. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE, lot number: EL9262), via an unspecified route of administration on 20Jan2021 at about 9am at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first Pfizer vaccine on Wednesday (20Jan2021) morning at about 9am. And he woke up this morning everything was fine until this morning, Saturday morning (23Jan2021) and he woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen. They didn't do any lab work or blood. The patient did not receive any treatment. The only other question was whether he should go to the emergency room. He could breathe, he could swallow. The event outcome was unknown.

His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261 with Expiration Date 31May2021), via intramuscular, on 22Jan2021 (at 09:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing restless legs syndrome and ongoing acid reflux. Relevant concomitant medications included omeprazole ongoing from an unknown date for acid reflux and gabapentin ongoing from an unknown date for restless legs syndrome. Her husband had the injection on Friday 22Jan2021. The next morning his left foot was swollen up really bad, red and tender and he could not walk on it. He has had problems like that before and he had it checked and was told it is not gout. It did not go away and she called the nurse on Sunday morning, and the nurse did not think it was a reaction and told her that a lot of times it is swelling in the lymph nodes. He was advised to go and see a podiatrist on Monday. He saw the podiatrist yesterday morning and the podiatrist gave him a one injection that contained Lidocaine, dexamethasone, and depomederol. After injection, the swelling right down and his foot was ok. The patient went to go get the Moderna injection and she asked those giving the injection if it was ok for her husband to get that injection from the podiatrist. She was told that people are not supposed to take paracetamol (TYLENOL) or ibuprofen. She was told that they did not think it was a good idea for her husband to get that injection from the podiatrist and it may have wiped out the benefit of the Pfizer COVID VACCINE. His foot was 95% recovered, he could walk on it and the swelling was down. The patient was recovering from the events.

severe edema lower extremities Both feet red and swollen pustular rash all over the abdomen, back,legs, and arms severe itching

Increase in size of lymph nodes. This was detected the day before my second shot based on self exam suggested by my spouse.

There was a significant drug interaction with Efudex Cream that I was applying topically to a pre-cancerous 2-cm-diameter lesion on my left shin. On the day of my first Pfizer shot, the Efudex treated lesion was progressing normally from the desquamation (scabbing and shedding of epithelial scales) to the erosion stage (starting to form a shallow 2.5-cm-diameter ulcer). Starting about Saturday 30 January (three days after the first Pfizer shot) and slowly increasing for the next four days, the Efudex-treated ulcer became deeper, the peripheral 12-cm-diameter skin became redder, and the left foot and ankle became increasingly swollen. My RN-wife and I (a former medical-research physicist) began research andChronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral. Chronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral.DVERSE EFFECTS, TREATMENT, AND OUTCOME: discovered that Efudex should not be given concurrently with any of a long list of immunizations. This is an Efudex problem that should gain another immunization onto that list. Being within a week of finishing the Efudex regimen, we monitored the Efudex-treatment area and the peripheral area carefully. On Thursday 4 Feb (eight days after the first Pfizer shot), the ulcer began unusual drainage, the 12-cm-diameter peripheral area became inflamed, and swelling of the left ankle and foot increased to almost skin-tight - I can upload photos if you need. Time for immediate action. My excellent Dermatologist stopped Efudex and started me on Bactrim by mouth for 10 days, and Gentamicin topical antibiotic on the ulcerated central area and Triamcinolone topical corticosteroid on the peripheral and swollen areas for three weeks. Good choices. Improvement was immediate and continued improving for the next three weeks. By the time of the second Pfizer shot on 24 February, the central area was healing well, in the late-reepithelialization stage (regrowth of epithelial tissue that now formed a completely-covering scar tissue with no oozing), and with all inflammation and swelling completely gone. After the second Pfizer shot (taken 20 days after stopping Efudex), there were zero adverse effects of any kind. NOTE: There were absolutely zero other adverse effects of any kind throughout the entire series: no chills, fever, headache, nausea, vomiting, diarrhea, change in pulse or blood pressure (120/70 range), loss of taste or smell, sore throat, cough, lung congestion, fatigue, feeling of being unwell, shortness of breath, injection-site swelling or redness, hives, swelling of face, decreased kidney function, or other adverse cardiovascular, neurological or pulmonary effects. There was no additional joint pain above my normal osteoarthritis. After both shots, I felt a slight normal-range injection-site soreness for the next few hours, but no site swelling, rash, redness, or other problem. We recommend that this immunization be added to the Efudex ‘proscribed or warned' list.

Noticed a small lump in right armpit 2 weeks after 2nd Covid vaccine. Appears to increased in size, currently is approximately .5 inch

Developed what appears to be an olecranon bursitis in the same arm as the one he received the Covid-19 vaccine in.

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.

Dizziness following vaccination, swelling of eyes, slight facial swelling around cheeks and eyes. without resp distress. BP 138/94, 76, 18, 98%, BS 135

H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods, 9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities

3 days after second Pfizer shot right foot swelled up with pain. Two days later pain shot up right leg and to hip. Intense pain for about 5 days similar to when I had back surgery about 27 years ago. Since then leg and hip pain subsided but my right foot still feels swollen and painful at night and in the morning. Gets better temporarily walking on it during day but feel like there is a stiff pad below the skin on my foot . Had a similar reaction with second pneumonia shot in October where I got spasms in lower back and then right leg started to collapse but only lasted then for about 5 minutes with no long term effects/

Swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EM9810, Expiration date unknown), via an unspecified route of administration, anatomical location- Left Arm on 05Feb2021, at single dose for Covid-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL8982, Expiration date unknown), via an unspecified route of administration, anatomical location- Left Arm on 15Jan2021 03:30 PM , at single dose for Covid-19 immunization. The patient medical history included allergies: lime, Benign prostatic hyperplasia (BPH), arthritis, microhematuria Concomitant medication include terazosin, Finasteride, supplements. On Feb2021 patient experience swollen lymph node in left armpit patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any treatment for the event Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not tested for COVID-19. The outcome of event was not recovered.

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

Enlarged lymph node on lower right side of face which continues to get larger by the day, after 3months it is passing the size of a golf ball. A needle biopsy pulled off 20 cc of turbid blood tinged fluid. Local physicians are suggesting the lymph node should be removed. I would never recommend anyone taking a covid vaccine shot. I do have an overactive immune system.

Patient came back to Mass vaccination site to report that after he received 2nd dose of Pfizer COVID vaccine, he had angioedema with Left eye swelling completely shut. T99.3 He reports he did not notify his PCP, did not go to urgent care or ER for treatment as he does not believe in doctors. He reported to his cardiologist who instructed him to come back to vaccination site to let us know of his reaction. Patient states he is a doctor himself. At time of patient report, on 4/29/21, symptoms had resolved.

Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears that patient has had a progressive course of this problem over the last 1 week. His symptomatology is mostly consistent with gait ataxia with some lower extremity weakness. He mentions that his weakness of the lower extremities became more and more pronounced towards the end of the week when he would start trembling in his legs whenever standing for some time. Although he had some numbness and tingling few days ago but that does not seem to be the predominant symptoms. There was no preceding symptoms of any viremia prior to this. Although he has Covid in January, however he did not have cough expectorations upper respiratory infection or any diarrhea in the last 1 month. He has not been exposed to any new pets or any new medications. His clinical exam suggest a lower extremity weakness more proximal than distal although there appears to be some sensory sparing. He has diminished reflexes all over including absent reflexes in his lower extremities and many of the upper extremities. His imaging study did not show any specific etiology for the cause of his problem. He does not have any spinal etiology and his exam does not show any upper motor type of involvement. His spinal fluid shows a high protein with no cells consistent with cytoalbuminogenic dissociation. So he definitely fits with the diagnosis of acute immune mediated demyelinating polyneuropathy or Guillain-Barré syndrome. On IVIG therapy. Overall appears to be some improved however not still able to walk.

A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barré syndrome, a debilitating condition where the body?s auto immune system attacks the nervous system resulting in peripheral numbness in one?s hands, feet and legs. This condition was diagnosed by a neurologist. Following his diagnosis, I spent 8 days in the Hospital and was treated for 5 days with a daily dose of 400ml of immune globulin (IVIG) to rebuild the damage to my nervous system. On April 10, I began to feel the onset of Guillain Barré syndrome as the bottoms of my feet suddenly began to tingle and feel numb. The next day I tripped while returning our waste management garbage cans to our garage. Fell face forward onto the driveway and was bruised pretty bad. The next day my BP zoomed to 224/160. 911 was called and I was taken to our local hospital fearing and thinking that I was having a heart attack. I spent 4 days in the hospital being checked for a possible heart attack and all the while my Guillain Barré syndrome was progressing undiagnosed. I was discharged and instructed to see a neurologist for the tingling and numbness in my hands, legs and feet. Within 15 minutes of the neurologist consult, a few days following my discharge, I was told I had Guillain Barré syndrome and get to a hospital. I left his office and went straight to the emergency room and I spent the next 8 days there and was discharged Tuesday, 4 May 2021. Several hospital neurologists treating me believed the vaccination triggered the syndrome as do I. It's not being widely reported even though there have been several Facebook postings of people saying the same thing as me.

Pt had covid19 in 11/2020, now with immediate onset of sepsis of unclear source after 1 dose Pfizer vaccine as well as rapid atrial fibrillation and heart failure

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

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

first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.

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.

Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.

Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis

Legs and feet swelled suddenly and dramatically. Cardiologist described it as possible myocarditis and congestive heart failure.

Blood work done every three months showed a significant increase in C-Reactive Protein. Since 2005, C-Reactive Protein levels have been <0.8 mg/L. Forty-Six days after my second vaccination dose of Pfizer vaccine, my scheduled blood work showed a C-Reactive Protein level of 3.4 mg/L, which is a significant change from the normal <0.8. No other parameter of my normal blood work testing showed any significant changes.

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.

Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.

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.

whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety. Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.

Right Hand swollen and fingers tingle. Unable to hold fork for the past 4 days. Plenty of pain. 1st shot 3 weeks ago attacked my upper leg muscles - front and back- and shoulders - both sides. Even though rules say not to get 2nd shot if an allergic reaction is still viable, I didn't know this was an allergy reaction. Thusly, I got the 2nd shot. Sorta wish I hadn't. My original e-report # is 327694

Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.

I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown. Information of lot/batch number has been requested.

I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play I have gone from being active and strong to being totally depressed because of the constant pain that I am in

Pt began experiencing metallic taste in mouth after 1 st shot on 3/31/21. Pt worked the rest of his shift that night. Pt spouse called in to work on 4/1/21 stating pt felt crummy, arm swollen, and headache.

Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis

swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip; swollen gland he noticed on the left side; the swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days,his upper lip irritated on inside for a day or 2,; swelling that occurred in his mouth/1st occurrence of swelling was like golf ball size, it was visible; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at 79-years age) as single dose for covid-19 immunisation. Medical history included diabetes and hypertension (he was diabetic and was on blood pressure medication, but both his hypertension was under control, and his diabetes, sure his A1C is higher than it should be but was under control with oral medication), root canal infection (though this was contributed to the root canal which he had on 29Jan2021, the root canal was on the lower left of the mouth, tooth number 20). Patient provided relevant Family medical History of Hypertension. Concomitant Medications: He was just taking his general medications, like his maintenance medication, nothing out of the normal. He had no other vaccines on the same day as the covid vaccine or in the 4 weeks prior. He had no positive covid or antibody test prior to the first dose (he had never had a test).On 08Feb2021, the patient had the 1st occurrence of swelling was like golf ball size, it was visible, but it went away after 3-4 hours and he didn't have to take anything. Then on the 11Feb2021, the patient woke up at 4:30AM, experienced the swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip, it gave him a distorted appearance, it was severe. The swelling in the mouth, that wound up settling in upper lip which was the 2nd occurrence in a 3-day period. The first occurrence was swelling, not as severe, in the lower inside of the mouth in the lower right inside of the gum, the swelling appearance from the outside, though this was contributed to the root canal (had on 29Jan2021). The swelling in the mouth from 08Feb2021 subsided for him in 3-4 hours. He called endodontist, and told her about the second swelling, she said to come in and look at it, that was on 11Feb2021, she took X-rays and result was normal, she said it was not connected to the root canal and told him to contact his Primary and go from there, he agreed with her because he did not feel any type of sensitivity. On 11Feb2021, patient then called the Primary Care doctor, told how he developed the swelling, and the primary care said that he would rather see an ENT specialist and he got an appointment with the ENT that same day 11Feb2021 at 15:00 in the afternoon. The patient went to see him, the ENT checked his mouth out, checked his nose and throat, he did not know what it was stemming from, and said he will put him on an antibiotic. On 11Feb2021, the ENT said that the patient did had a swollen gland he noticed on the left side. The swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days, his upper lip irritated on inside for a day or 2, but it lasted till about the 13Feb2021. On 11Feb2021 (5 days ago), the patient was put on an antibiotic for swelling that occurred in his mouth which was Clindamycin HCL 300mg, 3 pills a day with his last 2 pills of antibiotics falls same day (18Feb2021) as his second vaccine dose was scheduled on Thursday (18Feb2021; appeared to be scheduled outside of the 21-day recommendation). Patient felt like he was sort of on edge for another occurrence possibly happening. Being on the antibiotic, maybe this was some type of infection. The ENT told honestly that he didn't know why this happened, but if it happened again, he might have a CT scan for the suspect salivary gland, maybe it was clogged or there was an infection in the gland. He asked if he should take the pills or reschedule the vaccine dose and if it was ok to receive the second shot while on this antibiotic (his prescribing doctor couldn't give an answer). On 18Feb2021, the patient was due to have booster. Patient would have 2 pills left on the 18Feb2021, after that he was finished. Therapeutic measures of antibiotic were taken as a result of swelling that occurred in his mouth (mouth swelling). He did not have to go to the emergency room for the mouth swelling but he has visited the physician's office. The outcome for swelling in the mouth and lips was recovered on 13Feb2021 (Duration 5 Day); outcome for swollen gland was unknown. Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported patient information, new event information.

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.

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.

right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpal tunnel; feeling anxious; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap/ was hotter than a firecracker; arm was so sore he couldn't pick it up straight in the air; trouble walking; right shoulder was swollen; left knee is swollen real bad; right shoulder was pretty sore and is getting worst all the time; left knee was "sore"; right wrist twice as thick as [his] left one/left wrist then "started swelling and being painful"; This is a spontaneous report from a contactable consumer, the patient. This 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in Apr2021 (at the age of 79-years-old) as a single dose for the corona virus, to get rid of it/ it's supposed to be sure he didn't get it. Patient had no medical history. There was no relevant family medical history. There were no additional vaccines administered on same date of the COVID-vaccine. Patient had no adverse events following prior vaccinations. He remembers his first polio shot he got that back in the early 50's and his second shot was a cube of sugar, called the salt vaccine. Stated he's been getting vaccines for a long time and he never had any trouble with any of them. The patient previously received the initial dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in 2021 (March or April) in the left arm which was deemed invalid by the vaccination provider due to temperature related issues (i.e wasn't cold enough). He explained he received a letter informing him of this incident and recommending a replacement dose (which he thinks was on 06Apr2021). About 2 to 3 weeks before he got his first COVID shot, he got a flu shot in his left arm, about 4 or 5 inches above where he got his COVID shot. The patient's concomitant medications were not specified. He reported that the second vaccine (BNT162b2) caused him problems. On 06May2021, he woke up with his right wrist twice as thick as his left one, it was swollen real bad. The right wrist was quite sore and painful. He didn't know if he was getting carpal tunnel or what it was, so he went to the ER about it and they gave him three different kinds of pills, two of which included tramadol 50mg one every day and ibuprofen 400 mg. The ER couldn't determine the cause for his reaction. About 3-4 days after taking the prescribed medication, his reaction subsided quite a bit and was not nearly as hurtful, but his left wrist then started swelling and being painful/sore. Therefore, he continued to take his medication and it improved. It was like that for a couple/ three days, and it calmed down. He thought he was okay 2-3 days ago, but this morning (14May2021), his right shoulder was swollen and pretty sore and was getting worse; he was in so much pain, so sore he could hardly even move his arm, he couldn't pick it up straight in the air, couldn't get his elbow up past his ear. The patient also reported that when he got off his bed, his left knee was sore and it felt like a fire underneath his kneecap and he was having trouble walking. The left knee was swollen real bad and was hotter than a firecracker. Thus, he went back to taking his pill again. The knee pain started the morning of 14May2021 about the same time it seemed and has worsened, and he took a 400mg ibuprofen and the other pill he's taking, "100 mg doxycycline or something". Patient hadn't been doing much since, he was feeling kind of laid up, he had thought it was all done with yesterday (13May2021). He stated he's been hearing things about allergic reactions to this COVID shot, was sure that a lot of people are having complaints of allergic reactions, and was sure he's not the only one who has had a problem like this. He asked if there was anything he can take to block it because he is sure when this calms down after a week or whatever, it will be his in his right knee or left shoulder or wrists or ankles and he's 100% it's about that COVID shot. He stated he's never had arthritis before. He stated that he has never had any problems like this before. He is supposed to go see his doctor in a week or two. He tried to call the doctor to make an appointment, but he figured he would wait a couple days, but he is hurting bad today (14May2021), and he hasn't been to anybody yet except for the ER. The patient stated it looks like the vaccine is methodically causing this spread into his body. He also reported that it feels warm outside of his left wrist, towards the edge of it and all the way to the joint of the little finger and he thinks the swelling will start again. He expressed feeling anxious about his reactions. He asked if there were any kinds of pills he could take to block the effects of the vaccine from working in his body. He stated it seems like it's going from one area to the next and it seems like it's going through his joints and he doesn't like that. His left wrist still got a little bit of soreness in the back near the joint, but doesn't appear to be swollen. Regarding the right wrist, he has recovered completely, it feels better; doesn't feel any soreness in any place and doesn't look swollen. The clinical outcome of right wrist twice as thick/left wrist started swelling recovered on unspecified date; left wrist painful/sore not recovered; right shoulder is so sore not recovered; left knee was sore not recovered; anxious was unknown; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap was unknown; left knee is swollen not recovered; arm was so sore unknown; carpal tunnel unknown; trouble walking unknown; right shoulder was swollen was not recovered. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551521 same patient/reporter/drug with different AE/time gap.

Burkitt's Lymphoma, Pain in Abdomen, Lethargy, Weight Loss, PET Scan, Chemotherapy, Mass discovered in Lymph Node in abdomen CT Scan - May 18, 2021 Blood Work - May 19 and 27, 2021 Tissue Culture and Biopsy - May 19, 2021 PET Scan - May 27, 2021 Echocardiogram - May 28, 2021 Chemotherapy start date - June 2, 2021

On 03/27/2021 I had the second dose and 3 weeks later I started to have a swollen hand and painful wrist and hand and I was unable to pick up things. I decided to go to the doctor and he gave me injections in the wrist and they did some x-rays. The second time I visited the doctor they diagnosed me with Rheumatoid arthritis in the hand and wrist in the same arm I had the injection. And they put me on prednisone.

Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug 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 response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology.

Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.

Ipsilateral axillary node swelling and tenderness beginning day 2; treatment - watchful waiting,; outcome - slowly improving tenderness, size unchanged on day 3 No reaction to first shot inseries.

sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or lift right arm and no strength to lift object. Felt swelling in nymph node area under arm and in neck. Totally immobile arm on day 8; improvement and dissipation on day 9. Today, day 10 no after effects; back to normal. Treated the pain and discomfort with Tylenol extra strength.

Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)

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.

Patient woke up in the morning to swelling of the entire face, around the eyes as well. Was given a dose of Benadryl and a cool compress to face and eyes. Swelling subsided and face returned to normal.

1 day after taking vaccine, noted stiffness on left side of the body, beginning on left buttock down left leg to the left foot; leg was swollen and stiff

weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.

Rash/hives all over his body and large swollen lump on the back. Itchy and irritable. Doctor prescribed Benadryl and Prednisone 10 mg.

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.

Patient started having rash on his feet the same day and it was getting all over his body and also started swelling. he was even hospitalized. dr recommended not to get the second dose of covid vaccine

Pt developed rash/hives to neck/chest/back/ head & scalp/ Left arm & Left hand. L arm/hand swelled up & open, draining wounds developed. OPen areas to neck/back developed. UNresolved with Rx & OTC TX

4/12 Patient was brought by family to ED for excessive fatigue, dry cough and poor PO intake. He was positive for SARS CoV-2 and had some hyponatremia. Date of onset of symptoms: ~Approximately 5 days Date of covid positive test: 4/12/21 Symptoms: dry cough and fatigue Imaging: Chest x-ray?No significant abnormality Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Of note it has been reported the patient is approximately 2 weeks out from second Covid vaccine injection. His son reports that one day about 2 weeks ago he escaped out of his home into a crowded bar and apparently there were 7 others there who tested positive. . Appreciate Dr's assistance - reswab sent for CT value. CT values were 18.5/19 which are consistent with concern for active disease. He was given monoclonal antibody in-house on the day of discharge

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.

left cheek was swollen and red; left cheek was swollen and red/red dots on the skin near his left eye; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not provided), via an unspecified route of administration, in last week Tuesday, on 06Apr2021, as a single dose for COVID-19 immunisation. Patient medical history included hernia and relapsing polychondritis. Concomitant medications were not reported. Upon call E-transferring to unit the patient mentioned that his symptoms started last week and he was able to notice a couple a days ago that his left cheek was swollen and red and he thought that it was sunburn but it started to itch a couple of days ago and his cheek was swollen to about the size of a softball in circumference and about 1/8th to 1/16th of an inch thick which takes up the whole check. He further stated that he also had red dots on the skin near his left eye. He mentioned that he will be seeing his Cardiologist shortly for a hernia that appeared. The patient has an extremely rare condition called Relapsing Polychondritis in which his ears bleed from and takes steroids for it. He is asking for what to do with his swollen cheek and should he proceed with his Hernia operation. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

S/P pfizer vaccination for COVID-19 about 6 weeks ago with progressive confusion, new fevers and encephalitis with parkinsonism Appears to be consistent with inflammatory encephalitis

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.

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

Skin rash on his whole body; Urticaria; Right mouth swelling/left mouth swelling; Swelling face; Lower lip is swollen; Touches his face, the skin feels thicker; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that about 13 days ago, on 22Apr2021, he had the Pfizer Covid-19 Vaccine. He thinks that about one week or 8 days later he had a skin rash on his whole body. Treatment of skin rash on his whole body was applied. The patient added that he took Benadryl 25 mg only once and and a few hours later the rash faded. One day later, it was completely gone and was no more (as reported). Today, this morning (as reported), the patient woke up and his right mouth right below the chin to the mouth area to the lower lip is swollen. The patient adds that his body had urticaria. He took Benadryl, another one, 25 mg and one or two hours later his body urticaria disappeared. Right mouth swelling: the patient adds that his face was swollen below the cheek to lower the lip line and it is not disappearing but seems a little bit smaller. It used to be a bump and now it feels like skin is still thick but he feels better on the right side. Left mouth swelling: the patient adds that he thought probably he would caller interrupts statement and says he does not know why but it turned to the left side, the left lower lip and it became swollen again (as reported). The right side has come down a little more but still feels like the inside of his mouth on the right side, he does not feel anything now, except when he touches his face, the skin feels thicker (as reported). Now, it has become to the left side left lower lip area, and lower chin. He does not know what to do. The patient confirms that this was his first dose of the Pfizer Covid-19 Vaccine. The outcome of the event "Skin rash on his whole body" and "Urticaria" was resolved, the outcome of the other events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-events temporal association and considering the nature of the reported events suggestive of a possible allergic reactions (the events urticaria and skin rash are also mentioned in the safety profile reported of the suspect product), the company deems there is a reasonable possibility that all the reported events are related to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration. The impacts 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.

Pt received 2nd Pfizer vaccine in right arm at 1439. Pt complained of swollen tongue and left side of face at 1515. Pt immediately transported to ED via wheelchair for further evaluation and care. LPN called ED Charge RN to give report

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.

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

patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.

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.

Swelling, redness, warm-to-the touch on vaccinated arm beginning 7 days after vaccination. Reaction occurred on entire upper arm and did not begin at injection site. Pt did not experience any initial swelling or soreness at injection site.

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.

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

Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.

Day after vaccine given, large red bump appears over RIGHT eye. Then non stop throbbing headaches (still up til today), teary eyes. Then on 2/25/2021 very large (size of half dollar coin) red bump appears over LEFT eye. VERY swollen shut. Hurts, throbs and itches. Took photos and having tele med call with physician today at 1:50 pm. More bumps appearing higher up on scalp and skin on bump is red and pealing. Very swollen L. eyelid and swollen under eye as well. Hot to the touch. Bumps coming and going behind left ear.

2 days after receiving his first vaccine, he developed muscle and bone pain. Symptoms continued and he did get his second vaccination. These were done in in his home state. I am in a different state. I saw him last week and he had muscle pain and arthritic symptoms. Sedimentation rate was elevated. Started on prednisone with some improvement.

4 days after second short arm of shot ballooned such that no features can be distinguished. Visited Doctor twice but they had not seen anything like this. They ordered scan on left arm for possible blood clots; negative. Prescribed Benadryl every 8 hours, taken for thee days but no relief from sever swelling. It is now 7 days since the arm first swelled up.

My RA began to really act up. My whole body stiffened up-(legs, hands, hips, back). Lower back made it hart to bend over, Rt shoulder had a swelling and hurt at a pinch point in shoulder, my rt hip hurt when I walked more than 0.25 miles, my hands swelled and could not use hand well. Did not initially link to Covid shot, so called my Rheumatologist on the sixth day that the symptoms continued. Received prescription to reduce muscle tension and an anti inflamatory. However, a couple of days after talking to my doctor and before taking any of the prescribed meds, the symptoms went away and since that time, my RA is back to typical old symptoms and pain level.

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

Multiple blood clots, bleeding, hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital.

history is a bit complex. I had had occassional r shoulder pain in the past without a diagnosis or specific Rx. 2 days before 2nd dose, i b raised upper L ulna. 2 days post 2nd dose, rather severe olecranon pain developed dwith expuisite tenderness and mild swelling, but no fever. Subsequently over a period of days and weeks, I developed worsening right and then left shoulder and some neck pain and some additional hip and other pain. Shoulder tyenderness was diffuse and mostly muscular, Siginficant limitations of ROM withinability to raise arms. Pain was worst at night and on awakening with some relief with acetaminophen (no NSAIDS as on Xarelto).

Got worse and the leg swelled and was also having foot swelling because blood flow wasn't there; sore arm; blood clot; pain behind left knee; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right shoulder on 23Feb2021 (Batch/Lot Number: EN6202) (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, stage 3 renal failure (was not bad, was in stage 5 couple of years ago, was a month or so away from full failure, was in the hospital and had dialysis, was able to get reversed with medication and diet), high blood pressure, and blood cholesterol increased/high cholesterol. The reporter stated that with regards to patient's height, he shrunk a little. Patient had no prior vaccinations within 4 weeks, didn't get flu shots. Concomitant medications include about 12 other unspecified drugs, takes statins, has high blood pressure and high cholesterol. Patient started experiencing pain behind his left knee about 6 or 7 days later in Mar2021 (also reported as 04 or 05Apr2021, pending clarification). By that Sunday, it had gotten worse. The leg swelled and was also having foot swelling because blood flow wasn't there. There was no TIA's no stroke, no heart racing, no sweating, was all pain. Got leg up and kept elevated until they could get to the doctor and get imaging. Patient went Monday 08Mar2021 to see the doctor. Patient was brought to the doctor and was then sent to the imaging place. Radiology read the imaging around 5:15pm on the Monday, 08Mar2021. The radiologist said there was 2.5" blood clot behind the left knee. He had never had a blood clot before. Patient was then sent to the Emergency Room at (Name) Hospital, in (Name) where they live. Was kept there several hours. Did a lot more blood tests. He was immediately put on 10mg ELIQUIS 10mg, once in the morning, and once at night. He is now taking 5mg Eliquis in the morning, and 5mg at night. He has not had any of these problems before the Pfizer shot. The reporter knew that not a lot had been reported. It seemed it should be safe. The correlation and timing having the shot on 23Feb2021 and all of a sudden a week and a half later this happened. It was 10 days later. There was nothing they can do about it. Just continuing with the ELIQUIS, trying to dissolve the blood clot, will be staying on it for 4 to 6 months. It was a pretty big blood clot and were worried about it breaking up and traveling. The patient had no other symptoms, had a sore arm, that was it. Patient going back to (Name) 01Jun2021 and he will have another CT scan or ultra sound when they get back. The reporter did not want to need to get the leg amputated. Patient was only in the ER, was not admitted to the hospital. Patient was concerned because of his age. If it doesn't dissolve, they know there will be a lot more trouble. The event of pain left knee, blood clot and sore arm required a visit to the emergency room and physician's office. The patient received the second dose of BNT162B2 on 01Apr2021 (lot number: ER8730) in the right arm. The outcome of events was unknown.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

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

1) I had L elbow injury a few days before 2nd injoction (ind 02/26/2021. 2) Some hast history of vague R shoulder pain- intermittent 3) Severe L elbow pain, swelling, tenderness a few days post 2nd shot. Probable olecranon bursitis and bone bruise. 4) Severe bilateral shoulder, neck, arm pain 8/10 most severe at night interfering with sleep and morning. Inability to raise arms. Significant malaise. Some improvement w acetaminophen. Saw dr. Elevated CRP and ESR . Began Prednisone 20mg/day with dramatic improvement within hours.

This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.

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

Patient had fall x 2 with or without sycnope (conflicting documentation) with humeral fracture after recieving the vaccine. Workup demonstrated PE and DVT (appears PE was not submassive/massive, unlikely it directly precipitated fall/ syncope)

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

Patient received vaccine and after approximately 15 minutes he reported that his face felt swollen and was red. Reported that he has had this reaction before if allergic to something. Medical response called. Patient transported to ER via wheelchair by Medical Response team.

Discussed with ER provider last night about this patient. The abdominal findings and mild elevation of WBC gave us a hope to manage it with antibiotics alone because of his age, COPD, AAA. He was admitted to be kept NPO, and IV Zosyn was started. The understanding was to reassess the patient this morning and make appropriate decision Surgeon's H&P 1/10/21, Admitted from ER: Admitted with sudden onset of right lower abdominal pain started yesterday morning. Not associated with vomitings, diarrhea, fever Was seen in ER last night WBC 13K and CT scan showed appendicitis with multiple appendicoliths. This morning he is having pain, slightly worse. Not hungry WBC 11.3K. Afebrile

Diagnosed with CML few months ago and taking Dasatinib daily with great response and normalized WBCs. Had second dose of Pfizer vaccine 2/2. Blood work on 2-5 WBCs 150K and 2/6 bilateral blood clots in legs which then became pulmonary blood clots.

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.

Woke at midnight the following day with chills headache and shaking.Very fatigued. No fever. Rested the next day .felt better no fever.but still tired.Next day. (Fri) woke up with swollen neck gland on the left side.Still tired but improving

After vaccine, the next day I got up and my feet were red and swollen from ankle down with small blisters on top of my feet that lasted from 3/10 through 3/14, it's not 100% gone but most is gone today. I went to the Urgent Care Clinic and the doctor said it will go away, I took Benedryl. They tested me for Coronavirus and it was negative.

seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling symptoms worsening each day per patient suspect rheumatoid arthritis even with negative rheumatoid factor will recheck labs today and refer patient to rheumatology for further work up patient to start prednisone 7.5 mg every day x 30 days used in the decision making process Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness pain since administration of Pfizer covid vaccine in January patient agrees to steroid injection to area patient reports improvement post injection used in the decision making process Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects will check lab today continue current treatment used in the decision making process Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process hyperlipidemia denies side effects continue current treatment used in the decision making process celiac disease denies worsening symptoms continue current treatment neoplasm of prostate followed by oncology--reviewed records congestive heart failure followed by cardiology--records reviewed overweight BMI 27.8 + hypertension, hyperlipidemia, CHF weight maintained since last visit continue current efforts--diet and exercise History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking established pt pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free

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.

Fever Cellulitis Elevated troponin Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present"

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

bilateral shoulder pain/iliac crest pain started 3 weeks after 2nd COVID-19 vaccine. Noted to have elevated ESR (47). Symptoms improved immediately after starting prednisone. Suspect polymyalgia rheumatica -- ?vaccine related.

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

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.

Shortly after receiving the vaccine, the patient's spouse reported redness and swelling to the patient's face. The patient denied sensing any new symptoms. Vital signs within normal limits. He felt fine and declined urgent care.

Day 1 after receiving vaccine he started to notice redness on face and fatigue. Day 2 woke up face was swollen and eyes almost swollen shut and hot, started taking benadryl and sleep most of the days. Denies SOB. Day 3 continue benadryl, zyrtec and pepcid. Day 4 came to PCP as it's gotten worst. Swelling of bilateral ears, face, and forehead.

Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

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.

Feb. 26, 2021, swollen and tender lymph gland on left side of throat. Feb. 27, 2021, swelling and tenderness is reduced. No other symptoms.

Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

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.

Awoke feeling achy, tired, warm, chills, headache on 3/2/21 Bright red rash down right arm , warm to the touch, swelling of arm and hand on 3/4/21 Arm Itchy and swollen, slowly dissipating since 3/4. Minor symptoms of arm and neck still today 3/8/21

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

Swollen glands in face and neck for entire time since shot. whole body rash and itchiness that has become worse over time

Patient presented to the ED and was subsequently admitted for TIA on 2/21/2021. He also had an ED visit on 3/10/21 for peripheral edema.

This 83 year old black male received the Covid shot on 03/22/2021 and went to the ED on 4/5/21 and was admitted on 4/8/21 with CHF, bilateral lower extremity edema, chronic kidney disease and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021 Active Hospital Problems Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment. In the emergency department the patient's vital signs were stable. Labs revealed a potassium of 3.3. AST was 52 and ALT 61. White blood cell count was 11.13. Troponin was negative and BNP was within normal limits. Lactic acid was 1.5. UA showed trace blood. EKG showed normal sinus rhythm with PACs. CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes. There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl. Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available. He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months. He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months. He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day. His daughter was updated over the phone.

Swelling face; Chills; Face is deep red; following day my face started getting red; Swelling is going down a little bit now, but it itches; Swelling is going down a little bit now, but it itches; I have been sleeping for 2 days; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history included Blood pressure. Concomitant medication included VITAMINS NOS. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1686; Expiration Date: unknown) on 21Jan2021 for COVID-19 immunization. The patient experienced swelling face, chills, face is deep red; following day my face started getting red swelling is going down a little bit now, but it itches, I have been sleeping for 2 days. The patient underwent lab tests and procedures which included blood test and results was unknown on 21Jan2021. The outcome of events swelling face, chills, face is deep red; following day my face started getting red, swelling is going down a little bit now, but itches was unknown. The swelling is going down a little bit now was recovering. The outcome of event I have been sleeping for 2 days was recovered on an unspecified date.

Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction ABNORMAL LAB BACK PAIN

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.

Arm soreness Joint pain shoulder pain stiff neck involantary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor appmt. Went to ER because of hand and foot swelling. Diagnosed with Poly Myalgia rheumatica or PMR. Being treated at this time by Dr.

4 days after receiving the vaccine the patients arm swelled up and was painful. Arm is bruised from deltoid to above the elbow . Purple and yellow bruises are still visible 3 weeks later. Patient did see physician and physician advised patient to receive the second dose

R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

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.

Face swelling/ face is still swollen/ swelling on the face; This is a spontaneous report received from a contactable consumer (daughter of patient). An 83-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route in the arm on 28Jan2021 (LOT: EL9265) and the second dose on 19Feb2021 (LOT: EN6198) in the arm, both as single doses, both at the age of 83-years-old, for COVID-19 immunization. Medical history included kidney condition, heart issue, liver problems, hard of hearing, and he's getting older and shrinking. Concomitant medications were not reported. The patient experienced swelling on the face right after receiving the first dose of the vaccine, since Feb2021. It's been 4-5 months and it's growing bigger and bigger. Reporter described that if she put a big plate on patient's face, his face would look like that, it's huge. She reported that the swelling is so much to the point she can't even see his eyes; his eyes are so small right now, she can hardly see his eyes. The lady who took the patient to get the second vaccine, saw his face was a little bit bigger, but she thought he had gained weight. The patient has seen the doctor and per doctor he is fine, doctor told him there's nothing wrong, it's normal. Reporter added that patient didn't tell the doctor about the vaccine. The reporter (daughter) stated that her dad was normal, his body was fine until he got the (company) vaccine and time after time he is starting to get worse. The clinical outcome of face swelling was not recovered.

patient arm hurt/very sore; swollen very hard; arm hurt and it was warm; very painful for him to touch where the injection went in; not comfortable; This is a spontaneous report from a contactable consumer (patient wife). An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, patient arm hurt, started to feel pain on 22Jan2021 and in the morning his arm was very swollen and very sore. He got up in the middle of the night and he said that his arm was swollen, and it was warm and swollen very hard, and 5 days later, the arm was still hard and warm and it was still very painful for him to touch where the injection went in. Caller was very concerned that this point that 5 days later could the shot gone in and then not gone anywhere just be sitting in that muscle. Patient can't touch it because it hurt too much. It was reported patient was not comfortable. Outcome of events was unknown.

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.

Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient taken to emergency medical facility.

Severe weakness 3 days after vaccine (3/5), to the point I which patient could not stand. Presented to hospital 6 days after vaccine (3/8). Hospital workup notable for CPK 45,720 U/L with CRP 109 (3/8) and low-grade fever (3/9). Negative infectious workup so far (BCx, Biofire, COVID PCR, UA without WBCs, no leukocytosis). He also had new thrombocytopenia to 84 (3/8), but possibly due to rifampin for LTBI. He remains admitted at this time, receiving fluids for rhabdo, undergoing further infectious and rheumatologic workup.

Caller is a 54 y/o M reporting that he, his 53 y/o F wife and 84 y/o F all received the Pfizer COVID-19 vaccination and have developed symptoms after vaccination. None have ever had adverse reactions to vaccinations. A 400. Advised can have injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever. Swollen lymph nodes and nausea have also been reported. Advised to seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. Cough, shortness of breath, runny nose, sore throat, or loss of taste or smell are symptoms of SARS-CoV-2 or another infection and not consistent with post-vaccination symptoms. Advised PC is available as needed. TR

Progressive ascending paralysis consistent with Guillain-Barre Syndrome. At time of hospitalization, patient was unable to walk. Diagnosis confirmed by spinal tap. IV IG therapy administered for 5 days post diagnosis with significant alleviation of symptoms. As of the date of this filing patient is near completion of at-home PT and has regained the ability to walk using a cane, but recovery is ongoing.

He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12). Both shots were given into the left arm. He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees. Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees. Some soft tissue swelling was noted around the hand. Simvastatin was discontinued with no improvement in symptoms. Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L. Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare. He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms. Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.

I didn't feel anything the rest of the day, but the next morning I felt that feeling tingling through my arm and it was there every day and wouldn't go away, it was the feeling like when you hit your elbow and it tingles but this was constant. The last few days it's moved up to around the shoulder, and I did have a lump that would come up for a few days but it's gone down.

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

Leg swollen; Foot swelling; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 (Batch/Lot Number: ER8736, Expiry Date: 31Aug2021) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. NDC and UPC number of vaccines is unknown. On 20May2021 patient experienced leg swollen- peripheral swelling, foot swelling 2 days after taking shot. The outcome of the events was unknown. The outcome of events unknown.

pain in his left wrist; arm pain and swelling to left arm; arm pain and swelling to left arm; swollen under side of his arm where he got the vaccine injected; pain in his left wrist, which was the same arm that he received his injection; This is a spontaneous report from a contactable consumer, the patient. A 84-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, occasionally rapid heart beat, blood cholesterol abnormal, cardiac operation (9 years ago, macular degeneration (in each eye and puts eyedrops in and occasionally they give him injections). Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]; 10mg everyday) taken for blood cholesterol abnormal; estradiol (ESTROGEN; 10mg everyday). The patient did not have any other recent vaccinations or started any new medications. The patient reported practically had no symptoms with either shot. After his first dose he had one day where his blood pressure went very low but by the time he talked to his cardiologist it had gone back to normal and was taking pills, it was under control. Yesterday afternoon he experienced pain in his left wrist, which was the same arm that he received his injection, and describes the pain as not too bad. He states that when he uses his wrist in certain positions, the pain "shoots up." This morning on the lower part of his left arm ("not the top where I got the injection") he has "slight pain." He says this morning his upper arm on the underside where he got it on the left side is swollen. He says he would like to know can it be from vaccine, though maybe he could have strained his wrist, it happened yesterday evening, he had wrist pain and swollen under side of his arm where he got the vaccine injected. He says yesterday late afternoon was the first time, it could be something else, it was the same arm this morning he has a little pain to his upper arm that was not on injection side but below, under it. The patient did not received any treatment, it was not serious pain, it was low level pain, when he uses his wrist and turns it, it comes in more prominent. He says it was not pain that bothers him, if it was not related to the vaccine then he most likely strained his arm. No follow-up attempts are possible. No further information is expected.

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 got his vaccine on 5/29/21 and then received his normal chemotherapy treatment a few days after receiving the vaccine. He had red blotches all over his body and his left leg swelled. He didn't have any problems with his first vaccine. He was and is currently taking a prednisone taper. He's still experiencing these blotches and it doesn't seem to be getting better so he wanted to make sure the pharmacy was aware.

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.

Patient received Pfizer-BioNTech Covid-19 vaccine, first injection, in the afternoon of Tuesday, 1/19/2021 - administered by pharmacy staff. All residents and staff of the facility were vaccinated (except one resident). Wednesday afternoon (1/20/2021), patient was noted to have a open area on his 3rd left toe with digital edema and blackening of toe, 2nd toe had a fluid filled blister as did area superior to left medial knee. There was also an open area inferior to left medial knee. Bruising or blackened areas to 3rd left toe and bottom of left foot (pad below toes 1-3). Patient was placed on Keflex 500 mg BID for 10 days, Clotrimazole 1% topical cream for ring worm middle of left foot, and ammonium lactate 12% lotion for dry skin. By Saturday, 1/23/2021, multiple blisters had erupted on patient's left medial knee area and 4th left toe. Some of the prior blisters were now gone, but new blisters were larger. On Thursday, 1/28/2021, patient now has blisters and open areas on bilateral feet, legs, and hands. He has a red rash on his right lower leg just superior to the medial ankle. Patient was placed on a 10 mg Medrol Dose Pak. There have been no changes to the patient's diet or medications. Patient is confined to the facility due to dementia. He goes from his bedroom to a sitting area, right outside of his bedroom door. He ambulates with assistance using a cane, only to the bathroom in his room. He has a private room.

his lymph nodes to his neck are swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 19Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's lymph nodes in his neck were swollen on 19Jan2021 at 17:30. It was more on the left side. The patient has not recovered from the event. Information on the batch/lot number has been requested.

swelling of left index finger; This is a spontaneous report from a contactable (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 23Jan2021 16:00 at single dose for Covid-19 immunization in a facility. Medical history included recent finger injury. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 16:45, the patient experienced swelling of left index finger in area of recent injury. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the event. The outcome of the event was unknown. The patient informed that this may not be related to the vaccine but thought it should be reported. The reporter considered the event non-serious; did not results in death; not life threatening; did not caused/prolonged hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.

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.

Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.

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

Facial swelling; I have got Vitallium Partial, there was a pinching, it was very uncomfortable; Gum swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E79262) via an unspecified route on an unspecified date (at the age of 85-years-old) as a single dose in the right upper arm for COVID-19 immunization. Medical history included unspecified health issues. Concomitant medications included unspecified regular medications he took several in the morning and at night. The patient also took vitamins "and different things like that" from unspecified dates for unspecified indications. The patient experienced facial swelling and gum swelling on an unspecified date. The patient had a Vitallium partial. The metal and the partial denture were pinching him; it was very uncomfortable. The patient stated it was not a life or death situation but he was ready to go to the dentist for an adjustment in the partials so it didn't hurt. The patient did not undergo any lab tests. The patient did not receive treatment for the events. The outcome of facial swelling and gum swelling was unknown. No follow-up attempts are needed. No further information is expected.

85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22. Again admitted and had further rheumatological and infectious work up with negative results He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and thought to have viral pericarditis. Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION. He was started on celebrex in addition to the the colchicine as an anti-inflammatory. After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased. He was monitored for another days and was feeling better. He is therefore being discharged home. In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.

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.

Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21.

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.

1/2/2021 vaccination couple days later, developed swollen lymph nodes. No other symptoms. Lasted a couple days. *PCM to monitor

for several hours my balance was much worse. By morning i was okay. Also, the next morning my right for arm was swollen and my skin had a reddish color. This has continued as of this moment

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.

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

This 85 year old white male hospice patient received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/22/21 with altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Starting on 3/15/21 developed painful rash with raised bullae. Seen by dermatology on 4/6/2021 with biopsy confirming bullous pemphigoid. Was prescribed prednisone and when seen again on 4/15/21 rash was improved and resolving.

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.

Vaccine was administered on 1/12/21 at Memory Care. On 1/15/21 at 12:30 he developed slurred speech at his facility and slumped to his left side. Out of concern for stroke he was sent by ambulance to Hospital. There he was found to have no evidence of stroke on MRI or CT angiogram. He was admitted to the hospital due to fever and elevated inflammatory markers (ferritin, CRP) and transaminases. He was found to have a positive SARS-CoV-2 PCR and IgG. His symptoms resolved the following morning and may have represented a TIA. He had many markers consistent with COVID-19 and his CT pulmonary angiogram did show ground glass opacities but no pulmonary embolism. It was difficult to assess if this was a reinfection with COVID-19, persistent PCR positivity from November, or an adverse event to the vaccine.

right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, "Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema." He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), "It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear." Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)

Pt on 6th day post vaccine and is having swollen glands hard to eat and drink that is more painful on one side; Diarrhea; Body aches; Chills.

covid shot estimated at Feb 1st between 1-2 PM, first shot, and then had a trip and fall that day. 3-5 days later noted cellulitis on his leg with redness, swelling, pain, edema and went to urgent care on the 10th, given some antibiotics which he is currently taking and the site is looking much better. Patient notes also painless nodules going down his bicep, but not where lymph nodes are (more in the middle of the arm from the site, not near elbow or armpit). Pt also noted some bruising initially at the injection site which is better. Should he still get his second shot even with the abx and cellulitis? Adv cellulitis on the leg more related to the fall than the shot. The nodules could be from the shot but as they aren't where I would typically expect to see lymphadenopathy would rec FU with PCP if the nodules persist or worsen. None of this is a contraindication to getting the second dose of the vaccine, but inform the vaccine providers that you are on elliquis so they can be aware to watch for additional bruising/bleeding, which is common after the shot. Discussed also Q518.

I had redness, warmth, tenderness and swelling of my right leg. I was hospitalized to received IV antibiotics.

03/22/21: Patient presented and was admitted through ED for pain, redness and swelling to his left lower extremity which began 2 weeks ago. Patient had left leg ischemia with rest pain and foot ulcers. patient was on outpatient antibiotic treatment for same problem. Per the EUA, hospitalization are to be reported irrespective of attribution to vaccine.

pt came into the office with symptoms of left lower extremity swelling/edema. Ultrasound was done that determined patient is Positive for acute deep vein thrombosis of the left femoral and left popliteal veins. Pt placed on Eliquis right away.

He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.

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.

Vaccine 3/9, 3/30. Admit 5/3. Admit for COVID PNA, DKA. Treated w/ abx, steroids, remdesivir, zinc. CXR shows bilat opacities. Elevated WBC and procalcitonin. He was found to be COVID-19 positive and pulmonology was consulted. Required increasing amounts O2, tfer to PCU. Some clinical improvement but none for worsening confusion. Family opted for DNR and hospice. DC to IP hospice.

This is a spontaneous report from a contactable consumer. A 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164 and Expiration Date not reported) via an unspecified route of administration, administered in Arm Left on May 2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no family medical history relevant to Adverse event. The patient had no history of all previous immunization with the vaccine considered as suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient reported that, he took one shot. The patient took the first shot about 2 weeks ago. The patient reported that in the last day or so he noticed a little lymph node swelling in the left chest area and stated that, it was not bad, it was not something that the patient cannot live with. The patient stated that the swelling came up about 3 days ago and it was just tender when he pressed on it. The patient was due to get his second shot next week. The patient was wondering if he should take it as scheduled or wait a few days for shot. The patient mentioned later should he take it in the right arm this time instead of the left arm. The patient denied medications, medical conditions, labs, testing, or treatments relevant to event. The patient did not visit emergency room and physician office. The outcome of little lymph node swelling in left chest area was not resolved and the outcome of event asking about postponing second dose of the vaccine was unknown. Information on Lot/Batch number was available. Additional information has been requested.

The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported.

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.

Patient called our clinic to report swelling and redness of the left hand. He said this symptom started several days after receiving the vaccine at an outside location. Symptoms gradually worsened over the last few days until his hand became so swollen that it became difficult to make a fist and is impairing his activities of daily living. Reaction seems to be localized to the hand and patient reports no other symptoms.

a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient). An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown). No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.

On 3/5/2021 patients left elbow showed extreme swelling, while the injection was done on the right arm. On 3/14 patients 2 knees down to the ankles showed extreme swelling. By 3/18, patients neck was stiff, and sore created an inability to move and nighttime sleeplessness due to pain/discomfort. By 3/22 patient experienced swelling in the buttocks. Patient visited ER on 3/16/21, Internist on 3/17/21 and internist again on 3/23/21. On 3/23/21 internist referred patient to rheumatologist.

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.

Symptoms started with headache and fatigue. After a couple of days, developed fever that lasted 3 days. On the last day of the fever, rash developed all over body and pain around the parotid gland. Two days ago, developed swollen hands and ankles. Was given antibiotic and told to take OTC allergy medications.

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.

Approximately 1 week after vaccination patient developed swelling and blistering rash overlying left arm. Subsequently developed significant pain and weakness in his arm, with contractures present.

Pt. tested positive for SARS-CoV-2 on 2/3/2021 and required hospitalization for associated diarrhea and dehydration with mild acute kidney injury. Of note, he has not been hypoxic and has not required supplemental oxygen to maintain his SaO2 as of 2/6/2021.

Facial flushing and warm to touch day after injection with slight swelling and painful to touch. Physician called and Treated with Benadryl orally and Tylenol. The next morning his face was extremely swollen and small blisters present and weeping. Face extremely painful. We went to hospital and diagnosed with allergic reaction and cellulitis. Treated with oral steroid taper,Pepcid and cephalexin. He continues to treat currently for both. Instructed by healthcare provider not to get the next injection. On second steroid taper currently.

Cellulitis; face was weeping serous fluid; sores; Swelling; face was so swollen; swollen cheeks; Pain in face; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), intramuscular in left arm, on 25Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included Alzheimer's and other conditions, but family did not disclose. The patient was taking unspecified concomitant medications. The patient previously took piroxicam (FELDENE) and experienced allergies. The vaccine was administered in a public health clinic or Veterans administration facility. On 25Feb2021, the patient noticed pain in face in the evening of day he was vaccinated and then the patient developed swelling by the next morning (26Feb2021). On 27Feb2021, the patient's face was so swollen that his face was weeping serous fluid and family took him to the ER. The swollen cheeks bilaterally progressed to cellulitis (27Feb2021) requiring oral steroids, famotidine (PEPCID), and antibiotics including cefalexin (CEPHALEXIN). The patient remains on steroids and creams to treat swelling and sores. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cellulitis due to temporal relationship. Case will be re-assessed upon the additional information provided. 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 Sunday afternoon, March 14, I received the first dose of the Pfizer vaccination. On the morning of March 16 I had a sudden hit of fatigued and my left leg started going numb while doing some menial work in the yard, The numbness cleared when I went inside and laid down but some form of the fatigue persisted for several days. Then, on March 28, two weeks after the vaccine, I woke up to a leg severely swollen from toe to hip. I waited two days to see if it went down but it only got worse, swelling to double the size by volume. I went to the doctor and they sent me to the hospital for ultrasound, suspecting a blood clot. No blood clot was evident but there were multi swollen limp nodes in the upper leg area. The problem worsened and two days later I was sent in for a CTscan which now showed multi blood clots near the swollen limp nodes. I was barely able to walk as major pain persisted with no signs of decline. I am now on blood thinner. It has been 2 months since the vacination and my leg is still swollen the same amount (2X by volume).

Went to ER on 4/27 with c/o chest pain (~3 day history), resolved. Returned to ER on 4/30 for chest pain- diagnosed with a small LEFT lower lobe segmental and subsegmental pulmonary embolus on CT 4/30/2021, hospitalized until 5/2/21, discharged on Eliquis, metoprolol, pantoprazole, keflex (for sore throat, negative throat cultures), metoprolol, atorvastatin, amlodipine.

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.

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.

1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.

FEVER BLISTER TO UPPER LIP Narrative: PATIENT STATED THAT HE DEVELOPED FEVER BLISTERS TO TOP LIP X 1 WEEKS, DENIES PAIN

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.

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.

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

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

fever and generalized weakness bilateral pneumonia secondary to COVID-19 infection Failure to Thrive, Severe Sepsis antibiotics: Levaquin, ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2

Incredibly weak; unsteady on feet; 6cm mass on neck; rash on legs; now food all tastes metallic; This is a spontaneous report received from a contactable consumer, the patient. An 89-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route in the right arm on 11Feb2021 at 09:00 as a single dose (at the age of 89-years-old) for COVID-19 immunisation. Medical history included benign prostate hypertrophy. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 after vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and prostate pill (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. On 19Feb2021 at 14:00, the patient experienced incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic. It was reported that the patient was perfectly healthy prior to vaccine and had a great appetite prior. The events resulted in emergency room visit twice and the patient was treated for these events. On an unknown date, the patient underwent lab tests as treatment for events which included blood work, EKG, chest X-ray, urinalysis, CT scan all with normal results. All the testing done in emergency room had been normal except for mass on neck, it was scheduled to have biopsy of neck on 23Mar2021. The doctors suggested that it was all from the vaccine. The clinical outcome of the events incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.