Pfizer

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

Right arm moderate swelling entire arm No lymph nodes in that arm from mastectomy more than 3 years ago No apparent adverse reaction at injection site

Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI.

Left Hand began swelling the first night and continued daily until hand very swollen. Tried cold pack and used Ibuprofin several times especially when waking up during the night with tremendous pain. Sent to urgent care on third day. Wasn't sure what was causing it but prescribed some Prednizon for inflamation. Swelling gradually went down beginning on 4th day and completely back to normal about 2-3 more days. Am cautious about the 2nd shot which is usually stronger.

patient experienced ankle, knee, and wrist stiffness/pain and dizziness beginning within 1 day following vaccination; symptoms continued into the 3rd day after vaccination (the day patient called and reported)

Approximately 48 hours after receiving 2nd dose of the vaccine, vaccine site became swollen, red and hot. Also the outside of the bicep was also swollen. Symptoms lasted for a coupled of days.

Chief Complaint: CHF exacerbation, atrial fibrillation Source of History: Patient History The patient is a 90 y.o. female with a past medical history notable for CHF, atrial fibrillation, arthritis, reflux, hypertension. The patient presents for evaluation of Worsening issues of shortness of breath in addition to fluid overload and swelling. Patient was also having rapid heart rate. Patient was recently stopped on her Cardizem as they thought that this was causing worsening swelling. Patient was set up for an outpatient echocardiogram however had not Got that completed yet. Patient notes that since diuresis patient is feeling much better. Patient is unsure about changes of heart medications. Patient did have close follow-up with Cardiology. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/12/21 remains admitted at Hospital - in patient

Patient required hospitalization for COVID-19 Seen at an urgent care 2/24 for sore throat. Clinically dx'd w/strep and started on cefuroxime and prednisone Continued to decline with anorexia, dry cough , mild sore throat and weakness. Was taken to ED 2/27 and diagnosed with COVID pneumonia. Had mild hypoxemia requiring oxygen. She was admitted from 2/27-3/3. She was treated with 3 doses of IV dexamethasone and Remdesivir. Because of the length of time from second vaccination ID was consulted. They SARS-CoV-2 IgG testing. Pt was negative. Therefore the pt was treated with one unit of convalescent plasma on 3/1 for passive immunity. She was able to be weaned off oxygen on 3/1 and was discharged on 3/3 Additionally her SARS-CoV-2 nasal swab was sent to the health department for genetic sequencing

Approximately 2 days after receiving her vaccine, she began to develop swelling and tender spots on both legs, mostly around the knees. These spots continued to grow in size, swelling and got more red in color. She developed more around the ankles. Edema of both legs worsened. approximately 20 days after receiving the vaccination she developed a similar spot over the right thumb. She also complained of scratchy throat, especially when lying down at night although she is noted to have chronic allergies. On March 25, she was re-evaluated. Given that her symptoms were worsening, and lab tests were abnormal she was treated with prednisone.

Might have Guillain-Barre Syndrome; her mother's legs "went numb and weak"; her mother's legs "went numb and weak"; her speech started to slur; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received BNT162B2 (Solution for injection) via an unspecified route of administration on 30Mar2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that upon returning home after the vaccination, her mother was unable to get out of the car under her own power, with the caller reporting her mother's legs "went numb and weak". Later on that day, her speech started to slur. They had contacted their family physician who thinks her mother Might have Guillain-Barre Syndrome. The outcome of the events was unknown. Information about lot/batch number has been requested.

Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing, Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds. Admitted to Hospice on 03/31/2021. Resident deceased on 04/03/2021.

It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors. She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.

She got her 2nd vaccine, and almost immediately into her shoulder had pain in her shoulder blade and into her neck and had a lymph node on the right side of her chin/upper neck, then she has another one that is smaller and back further, and possibly a third one that is almost to the right side of her neck, tiny in nature. None on the left side at all. She felt that they would eventually go away and didn't do anything about it. She went to see her Dr., and he did a neck scan on 4/7/21, and reported that it was not cancer and told her to watch it, but if they were there in 4 months that they would have to be removed, they are still there. They have not changed in size. She has not gotten any more either. She definitely can feel the two and the third one is there but tiny. Her arm is still very sore at the site of the shot at the muscle. Almost daily at the site it gets very very sore and she gets chills and has to lie down due to exhaustion that lasts about 40 minutes and has to go lay down and then she gets back up once the chills pass. She was having it every day at noon almost every day, and still continues pretty much on a daily basis, but the arm is still very sore.

RLE edema started on 6-30-2021. Extensive RLE deep vein thrombosis was diagnosed through the ER. Due to the extensive DVT, this has been growing for longer than the symptoms have shown.

Saturday night (4:45) 1-23-21 - swollen right ear, itchy head and some welts on upper body Sunday morning (8am) 1-24-21 - face and eyes swollen, itchy and welts or rash all over upper body

Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk. After sending photo to primary care physician had mom evaluated for a blood clot. It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.

She's been complaining about discomfort in her arm for a few days but yesterday I noticed that the arm was swelling.

On 2/9/21 patient received her first vaccination in her right arm. She only had a mild headache that afternoon that Tylenol took care of. On 3/2/21, patient received her second vaccination in her right arm. That same afternoon she had a mild headache that Tylenol took care of. On the evening of 3/6 she noticed a slight itchiness on her arm near the injection site. She took 1 24hr Fexofenadine and rubbed 1% hydrocortisone on the affected area. The following day, on 3/7 she noticed the swelling spread and the itchiness was worse and she took another Fexofenadine and used the 1% Hydrocortisone. As of today, 3/9 the itchiness is slightly better but the swelling & red area is still present.

SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)

Note from 3/25/2021: PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .Patient is a 91 year old female with PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .

Pt had her 2nd pfizer covid 19 vaccination on 3/30/2021. Hospitalized 4/21 for b/l pneumonia and sepsis. blood cx neg, covid/flu neg. procalcitonin <0.4 treated with antibiotics, ivf. discharged home 4/24/2021

Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination patient reported left arm and chest pain (over pacemaker), shortness of breath, and nausea resulting in poor oral intake. Initial vital signs in the emergency department within normal ranges except blood pressure 135/60 mmHg. No fever, cough, or dermatologic symptoms reported or noted. Only neurological symptom noted was lightheadedness. Patient administered aspirin, antibiotics, intravenous fluids, and acetaminophen and observed overnight. Pain improved with acetaminophen. Vitals were within normal ranges during observation period and symptoms resolved. Cardiology evaluated patient, determined pacemaker functioning appropriately, and patient discharged to home stable.

Pt had mild dementia prior to vaccine. Was able to walk, toilet herself, feed herself,. After Vaccine pt became bedbound within 12 hours, markedly confused, and anorexic

Patient reported numbness in left arm/hand that spread to right side of the body over several days. She also reported mild swelling of her face. She went to her primary care doctor who did not prescribe or provide any treatments but told her to monitor the situation and go to the emergency room if she experiences any difficulty breathing. She reported no issues breathing, and the numbness has lessened.

Swelling on left side of face; This is a spontaneous report from a contactable consumer reporting for self. A 92-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in left upper arm on 23Jan2021 at single dose for covid-19 immunisation. Medical history included osteoporosis and Kidney disease. There were no concomitant medications. The patient experienced swelling on left side of face on 23Jan2021 occurred shortly after the shot, it is going down, she was taking antihistamines. Outcome of event was recovering.

Lymph nodes hurting/burning pain on chest and breast area/ Her Lymph nodes are tender on the Left Side, it goes down the breast arm; This is a spontaneous report from a contactable consumer reporting for herself. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm right) on 26Jan2021 at SINGLE DOSE for COVID-19 immunization, at 92 years old. Medical history lung cancer 12 years before from 2009, breast cancer on an unspecified date, and a lump already on the breast from the surgery and she usually get pain there from an unspecified date. She is a cancer survivor. She had surgery for breast cancer on same side, that's where the pain was. She also had a stroke and speech is slurry from an unspecified date. The patient asked to bear with her as she had a stroke in the past and her speech is slurry. She lost the COVID card, she did not even know they gave a card, until somebody told her that they had their card. She lives in a Senior citizen facility, and she does not remember any card. They just gave her information sheets. It was reported that the patient had the vaccine and she was having a lot of pain on the left side, however she got the vaccine on the right side. She had surgery for breast cancer on same side, that's where the pain was, however the vaccine was on the other arm. Patient stated that she thinks it was the lymph nodes, she does not know what to do about it, since she is a Cancer survivor. The patient requested the call handler to talk slow, she is 92 years old. She cannot call the doctor because he is retired and so she does not have a doctor. The patient expressed that its especially in the Lymph nodes, she read the papers that she got, she thought this is common. Her First Dose was on 26Jan2021, probably around 9:30AM or 10AM. The Lymph nodes began hurting on 26Jan2021, it was a burning pain on chest and breast area. She took a Vicodin and it went away and did not bother her for the rest of the day, but it was bothering her this morning and it woke her up. She has a lump already on the breast from the surgery and she usually get pain there, but this is not the same pain today. As of reporting time, it was different, it was a stronger pain, it goes down the breast arm. Her Lymph nodes are tender on the Left Side which is the same side she had surgery on in the past. She got the vaccine on the right arm. Outcome of the event was not recovered. Information on the lot/batch number has been requested.

DVT in right leg discovered after swollen foot on 2/25/2021 via ultrasound. Clot extends from mid thigh to mid calf. Placed on Xarelto 15 mg 2x/day until next imaging appointment on March 30, 2021. First incident of blood clot for mother.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician, Dr. (Internal Medicine) in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw. X-ray showed arthritis and began taking prescription. On Wednesday, February 24, As day progresses, pain is now continuous. Thursday, February 25, Pain is throughout the day behind right ear/neck area. Late afternoon into evening, a small amount of rash has now developed on back area and side area of neck. Lymph node is swollen on right side back of neck. More pain behind ear. Pain is more severe late into evening. Trouble sleeping. Took Cefdinir as prescribed. Friday, February 26, contacted Dr. due to small amount of rash appearing on right side of face, right shoulder blade, behind neck, behind ear, and into hairline along with continued pain. Dr. diagnosed shingles over the phone. He prescribed medication for shingles and pain. Antibiotics were no longer taken. Shingles - Valacyclovir 1gm tablets. Pain - Aceteminophen/COD #3 as needed. Pain is more severe. Pain radiating into right ear. Can't sleep. From February 26 to March 5 shingles medication was taken daily. Additional rash developed. Pain was more severe/continued and trouble sleeping. From February 26 to March 4 pain medication was taken on Tuesday, March 2 and Thursday, March 4. One pill only to assist with sleeping. Monday, March 1, reported situation to Pfizer over the phone. Information on when to discontinue shingles & pain medication was obtained from Pfizer, and doctor prior to receiving second shot on Wednesday, March 10, at 9:30 same location as first shot. Shingles medication was finished on Friday, March 5. Pain medication was stopped on Friday, March 5 until after second shot. Pain medication resumed on Friday, March 12 and continues only as needed. Normally just one pill. As of Tuesday, March 23, rash, pain, swollen lymph node seems to be starting to improve.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw at Imaging Services. X-ray showed arthritis and began taking prescription.

This 92 year old female received the Covid shot on 3/16/21 and went to the ED on 4/2/21 and was admitted on 4/2/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia

The patient is having a hard time hearing me, she is hard of hearing in one ear; the pain was radiating in her ear and behind there; Rash/She still has the rash all over/ rash is behind ear, all down the back side of her neck, side of the neck up to hairline/right side of face/collar bone and little on back; swelling in the lymph nodes behind her right ear; trouble sleeping; sharp pain that would come and go behind her right ear/Ear pain was reported as worsened.; pretty big blotches; arthritis; shingles; This is a spontaneous report from a contactable consumer (patient's son). A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm up at the top on 13Feb2021 at 10:00 or 10:15 (Lot Number: EN6200) (at age 92 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shingles shot for immunization. The patient's son said that a week and a half after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, the patient developed shingles and severe pain. He wanted to know if his mother should still go ahead and receive the 2nd dose. If so, how long does she have to wait to receive it. He said his mother received the 1st dose on 13Feb2021, and was scheduled for the 2nd dose on 01Mar2021 or 10Mar2021. After the shot, a week and a half later (Feb2021), the patient got what the doctor thinks is shingles. The reporter and patient didn't know if she should get the second vaccine. The shot was not given by her doctor or at his office. The patient was healthy before and she's in quite a bit of pain, should she get the next shot because she's worried about it. The patient's second dose was scheduled already on 10Mar2021 but hasn't been able to get a hold of the place when calling them. The patient had the shot on 13Feb2021, on Monday 22Feb2021 the patient had sharp pain that would come and go behind her right ear. Patient stated she hates the pain. The patient had swelling in the lymph nodes behind her right ear a couple of days later. On 23Feb2021 the pain continued off and on behind the patient's right ear and she was having trouble sleeping. On 24Feb2021, the patient went to the doctor and he prescribed antibiotics because he wasn't sure that's what it was. There were no spots on the patient yet, the patient had more pain than before in the back, but she did not have a rash or swollen lymph nodes. The patient's lymph nodes were swollen in the back of her neck Thursday night (25Feb2021). The pain continued, it was more severe. The patient developed a rash on Thursday (25Feb2021). Friday the doctor prescribed the medicine for shingles. On 28Feb2021, the pain was radiating in her ear and behind there, you'll see her wince. The patient didn't get red blotches yet. Monday and Tuesday the pain was sharp, kind of sticks and then it was gone, it came and went, yesterday it was constant all day and Saturday it wasn't constant. Saturday the pain was constant. Thursday you could feel the knots in the lymph nodes, they have gone down some today. There is a little improvement in the patient's ear lymph node swelling. The patient has ear pain. The doctor looked in the patient's ear on Wednesday the 24th, the pain radiates, on the outside and the inside, it's just pain, shoots there and behind there. The pain has gotten worse over the week. The pain is intermittent, not constant and when it comes it's really sharp, she's had more over the weekend where its coming more often. The patient was having trouble sleeping starting Tuesday evening, it was fair but by Wednesday the trouble sleeping wasn't bad yet, the patient was still able to sleep, she has had to sleep sitting up, but by Wednesday, she hasn't been able to sleep well. The patient states that she has slept better now that she's on medication, last night was the first time she slept well. The shot was given in the left arm, all of this is on the right side. The patient has had no vaccines before, she wasn't sick before this. She still has the rash all over, the rash is behind the patient's ear, all down the back side of her neck, side of the neck, up into her hairline slightly, on the right side of her face, on her collar bone, and a little on her back. People say they got a bad case. No further clarification provided. Reports these are pretty big blotches (Feb2021). The rash was about the same, between Thursday, Friday and Saturday the patient developed more of them. With the rash, the reporter noticed more on Friday and Saturday. Today the rash is there but it has not changed. For her history, the reporter stated she's on normal medication, she didn't have anything before this. The patient is not in a nursing home, resides in her own home, not in a facility, she's is able bodied to stay at home. The patient is mentally alert, walks with a cane when needed, she does everything on her own. The patient's doctor sent her for x-rays behind her right ear and face, facial, shoulder, and behind the ear area, behind the neck area on 24Feb2021. The patient's doctor's office called and said it showed arthritis. The reporter states that this pain is not from the arthritis. The caller mentions that the patient got a shingles shot, it was a one-time shot, and she did not have a reaction to it. The patient was having a hard time hearing, she is hard of hearing in one ear. The patient was recovering from trouble sleeping and swelling in the lymph nodes behind her right ear; not recovered ear pain and rash; while unknown for the rest of the events.

Inability to "recall how to walk" and needed standby assistance; followed by onset of significant edema (more than pitting 2) of legs/feet; significant elevation in blood pressure, drop in oxygen saturation; required emergency hospitalization in cardiac unit for acute heart failure

Right sided facial swelling that extends from Jawline into neck. Also noted with redness to facial area. Onset 2/10/21 with worsening today 2/11/21

acute hypoxic respiratory failure, severe sepsis, acute COPD exacerbation, secondary to COVID-19 pneumonia. remdesivir Solu-Medrol 40 mg IV

Left forearm between the elbow and wrist swelled and some of hand is swollen; Left forearm between the elbow and wrist swelled and some of hand is swollen; swelling looks bigger when her sister gets up in the morning; received the shot in the upper arm close to the shoulder; This is a spontaneous report from a contactable consumer. A 93-years-old female patient (reporter sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left upper arm on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease from Jun2016 and cardiac disorder from 1998. The reporter stated the patient was (her sister) and was doing good with the heart problems. She was going to the heart doctor and will see the doctor in about 2 weeks. She stated her sister heart was doing good. The patient concomitant medications were not reported. On 10Mar2021, the patient received the shot in the upper arm close to the shoulder. On 17Mar2021 (reported as the next week), the patients left forearm between the elbow and wrist swelled and some of hand was swollen, swelling looks bigger when her sister gets up in the morning. It was been swollen for 11 weeks. The hand was not as big as the arm was. The swelling lightly in the hand. The patient took the vaccine because they thought they were supposed to get it and were told to get it. The reporter stated her sister has been to urgent care and talked to her regular doctor. Urgent care gave the patient a round of Prednisone 5 mg and it did not help. The reporters doctor gave her another round of methylprednisolone (MEDROL) 4mg. It helped some but she was still swollen. The patient has an appointment with (withheld) next week. And she will show him her arm. She was going for a follow-up. The doctor has already seen the swelling before, and they did not think nothing about it. The reporter did not think that patient medical history had anything to do with the adverse events. The package was not available to be returned and was throwed away. The package was sealed and intact. On 31Mar2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered unknown anatomical location as 2ND DOSE, SINGLE DOSE for covid-19 immunisation and had no problems with that shot. Patient received the treatment as Prednisone, methylprednisolone. At the time of reporting, the outcome of the events was not recovered. There was product quality complaint (PQC) present. Follow up attempts needed. Further information is expected. Follow-up (09Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information (To delete classification).

Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands./tingling in hands; both legs swelled some; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in right arm on 03Feb2021 as single dose for COVID-19 immunisation. The patient had no medial history or concomitant medications. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 as 1st dose, single dose for COVID-19 immunisation. On 04Feb2021, the patient's both legs became numb from the knee down, they swelled some, but numb as they can be and experienced tingling in her hands. The numbness in her legs got real bad in the night of 04Feb2021. On the morning of 05Feb2021, the legs were still partially numb but not as numb as in the night of 04Feb2021. The fingers were also numb on both hands. The tingling was just in her fingers. The patient was wondering if these were after effects of the vaccine. She didn't have a prescribing doctor and was advised by her doctors to get it though. She wanted to know if this was one of the side effects. She stated that she know no other reason other than this that she would get this reaction. Outcome of the events Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands/tingling in hands was not recovered while that of the event both legs swelled some was recovering. Follow-up attempts are completed. No further information is expected.

Possible cellulitis; slight redness in left upper within 24 hours; severe redness and swelling and warmth of entire upper left arm and half of lower arm; severe redness and swelling and warmth of entire upper left arm and half of lower arm; Some pain; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140) on 30Dec2020 at 12.00 pm at single dose Intramuscular on left arm for COVID-19 immunization. Relevant medical history included COVID 19 infection, on 19Jul2020, post COVID left femoral DVT oral anticoagulation, Alzheimer dementia, Osteoarthritis, Spinal Stenosis, Gait Dysfunction and Constipation. Known allergies included acetazolamide, penicillin and sulfa. Concomitant medications included apixban (ELIQUIS ) 5 mg twice a day, colecalciferol (VIT D3) 1000u once a day. On 31Dec2020 at 12:00 pm patient experienced slight redness in left upper within 24 hours. The patient also experienced possible cellulitis, severe redness and swelling and warmth of entire upper left arm and half of lower arm. Some pain. No fever. It was also informed that patient underwent nasal Swab test for Coronavirus (Abbott BinaxNOW) on 05Jan2021 and on 07Jan2021 and resulted negative, for both. Treatment received for cellulitis included Cefuroxime. Outcome for the event possible cellulitis was unknown. Outcome of other reported events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age and other underlying conditions cannot be excluded for a contributory role 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.

94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, "help me, help me", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF.

Patient had swelling around her jaw after her second shot of the covid , Pfizer vaccine ( .5 ml IM) on the Friday morning, January 29th, I took her to a follow up appointment with the cardiologist at 3:00 pm, as a follow up to a small heart attack event with hospitalization two weeks previously, at the cardiologist she was given the ok/all is well. That next morning early, she had a 911 event at her assisted living apartment and was sent back to the hospital, having had another heart attack. Patient died on the following Thursday, February 4, 2021. I do not know if the vaccination had any cause for my mothers death; but I feel it is necessary to report this series of heart attacks after she received the pfizer vaccine. Her Certificate of Death records the cause of death as "Coronary Artery Disease".

Day after vaccination pt found hypotensive at facility (SBP 70), pale. Has leukocytosis. No etiology found on blood tests, exam or imaging yet.

her knuckles are puffy; Hand swelling; This is a spontaneous report from a contactable consumer. This 94-year-old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EM9809/expiration date: unknown), via an unspecified route of administration on 03Feb2021 10:20 at single dose (at age of 94 years old) on right arm for covid-19 immunisation at a hospital. Medical history included hard of hearing for a while and wears hearing aids; she has trouble with her hands (her hands were falling asleep); she has vertigo and she had a stroke and heart attack three years ago, and heart disorder, all from an unknown date and unknown if ongoing. The patient had no prior vaccination within four weeks of COVID-19 vaccine. Concomitant medication included isosorbide 30mg; take one half daily by mouth for heart and metoprolol 25mg; take one half daily by mouth for heart and unknown thyroid medication. The patient experienced right hand swelling on 07Feb2021 with outcome of not recovered , her knuckles are puffy on an unspecified date with outcome of unknown.

started with dizziness, nausea, abd pain on 3/29/2021. treated conservatively. seen in office on 3/31/2021. She started improving the morning of 4/1/2021. Developed Left Bells Palsy on the afternoon of 4/1/2021. Seen in office on 4/2/2021

pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia. cardiology saw her. she was started on a heparin drip. infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021.

This is a spontaneous report from a contactable consumer (patient). A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Jan2021 (Batch/Lot Number: EL8982; Expiration Date: May2021) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) taken for an unspecified indication, start and stop date were not reported. The patient reported that she noticed after 2 or 3 days, she can't remember when she got a lump on her neck, 'she got the drug then the lump' (not clear nor clarified) then she had the second shot because she thought you know she didn't pay no attention to the lump. Second shot on the 12th and she still have the lump, so she went to the hospital and had a scan, she had dye put in her, they can't find nothing wrong with her and she was just wondering is it possible that this is one of the side effects. She had both shots. One was on 22Jan2021 and then on 12Feb2021. It was the Pfizer shots. She had no reaction and felt great. Her arm didn't hurt. She got a lump not on the side she got the shot but the other side of the neck. It is on the right side of the throat. The lump was smaller and seems bigger now. She noticed the lump about 2 to 3 days after she got first one. She didn't say anything to them because she wanted the second one. The shot was given on the left side, but the lump is on the right side. Sometimes it is below the chin and sometimes it seem in the middle. It seems like it moves. She can't see it when she looks in the mirror. Other people can feel it. She went to the doctor who sent her to hospital to get a scan. The lump was 9 x 20mm. The doctor said they should go further and get MRI with the dye. From that he couldn't find anything. He even checked the sinuses. Nothing is coming from her head or ear. There is no infection. They are kind of baffled. They sent her to the dentist to make sure it is not like an infection in the teeth. The dentist is also baffled. He is not stopping because he is concerned. He sent her to an oral surgeon. The oral surgeon doesn't want her to worry because of her age. He is not sure either. The oral surgeon didn't want her to do anything invasive. He said to wait until 16Mar2021 and come back and let him look at it. If he is still concerned and they will do biopsy. No one mentioned cancer but she is concerned and scared. The patient underwent lab tests and procedures which included investigation: unknown results on Jan 2021, magnetic resonance imaging: no reason for it or infection on an unspecified date, scan: can't find nothing wrong with me on an unspecified date, x-ray: no reason for it or infection on an unspecified date. Therapeutic measures were taken as a result of the event which included hot packs. The outcome of the event was unknown.Second dose given on 12Feb2021, lot number: EL9266, expires May 2021.

This 94 year old female received the Covid shot on 4/13/21 and went to the ED on 4/16/21 and was admitted on 4/16/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)

today, the foot is swollen; unusual pain on her left foot that has been worsening; This is a spontaneous report from a contactable consumer (patient's daughter). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm, on 22Jan2021, at the age of 95 years, at a single dose for COVID-19 immunization. Medical history included congestive heart failure diagnosed a year and a half ago, reported as "October last year"; blood pressure abnormal (reported as blood pressure), pain and headaches. Patient had no prior vaccinations within 4 weeks. Concomitant medications included metoprolol 50 mg tablet for blood pressure; amlodipine for blood pressure; and tramadol 50 mg tablet for pain and headaches, patient has been on this about a year and a half. It was reported patient gets anxiety from her concomitant medications. The reporter stated that her mother, the patient, received the first dose of the COVID-19 vaccine on the left arm, last Friday, on 22Jan2021. She explained the next day, Saturday (23Jan2021), her mother experienced some unusual pain on her left foot that has been worsening and today, 26Jan2021, the foot was swollen. She asked if her mother's experience was a reported side effect to the vaccine. The reporter added that yesterday, 25Jan2021, the pain was not quite as bad, but today, 26Jan2021, it has worsened and was now swollen. The reporter clarified again it was just her left foot, not her whole leg, and stated it was just odd. The events were reported as non-serious, and did not require a visit to Emergency Room nor the Physician Office. The outcome of the events was not recovered, reported as worsened.

Patient presented after falling on February 5 with injury to her scalp. She apparently also fell on 2/4/21. Family was uncertain as to whether patient loss consciousness. According to family, patient has been weak over the last day or 2 with no other complaints aside from some diarrhea. EMS was notified PM Feb 5, and the patient was found to have atrial fibrillation with elevated heart rate to the 160s and hypoxic to the low 80% range on room air. She had a low-grade temperature and elevated respiratory rate according to EMS. Evaluation in the ED demonstrated bilateral chest infiltrates on chest x-ray (right greater than left), elevated heart rate with atrial fibrillation, and back pain. Imaging demonstrated a T11 compression fracture (possibly new), elevated pro-calcitonin (2.80 ng/mL) and elevated troponin (1.45 ng/mL). Her venous blood gas showed mild hypoxemia (7.39/25/41/33/57), and head CT did not show acute changes and her cervical CT was negative for fracture. Pelvic x-ray did not show fracture. She was covid positive. Admitted for acute hypoxemic respiratory failure and severe sepsis secondary to COVID-19 pneumonia and acute metabolic encephalopathy. Received 3 days of remdesivir and 4 days of IV dexamethasone. Also ceftriaxone was given 4 days for possible UTI. Goal of care switched to inpatient hospice on 2/8/21.

Presented to ED with UTI symptoms with apparent septicemia. COVID-19 test upon hospital admission was (+). Patient had low O2 sats on RA at 88%. She also reported chills, fever and myalgias and cough. Denied SOB.

presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21

This 96 year old female received the Covid shot on 4/10/21 and went to the ED on 4/16/21 and was admitted on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

swelling and pain in the arm. The swollen spot was sizable for her small arms. There was no evidence of bruising or bleeding under the skin and no redness just swelling. We placed an ice pack on her arm for about 15 minutes and the swelling did go down some. By 5 pm the swelling was gone.

In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up. Patient's daughter was talking to her and she would orient to her but not answer any of her questions. EMS called and by the time they arrived patient was acting her normal self. Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult. Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with. These include her getting up at night and sundowning as well as yelling and screaming during the day. Daughter states that she gets in the shouting matches with the patient during the day. Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors. Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility Discharge summary Principal Problem: Comfort measures only status Active Problems: Chronic atrial fibrillation Essential hypertension Dementia with behavioral disturbance Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia. She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19. She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021. She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided. She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21

The following morning, grandma woke up with right wrist pain, mild swelling, and skin temperature is hot to touch. Sign and symptoms got worst for the next three days and up till today sign and symptoms are still evident.

I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.

Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.

Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.

Leukocytosis/WBC 17.2; This is a spontaneous report from a contactable physician. A 100-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), intramuscular (left arm) on 10Jan2021 12:00, at single dose, for covid-19 immunization. Medical history included chronic kidney disease (CKD) (on Procrit at 14-21 day intervals). The patient has no known allergies. Concomitant medication included epoetin alfa (PROCRIT) for CKD. The patient experienced leukocytosis/WBC 17.2 noted 8 days after the vaccine on 18Jan2021 13:30. The patient underwent lab tests on 18Jan2021 13:30 which includes 81% neutrophils, 8% monos and, 9% lymphs. The outcome of the event was unknown. No treatment was received for the event. The patient had no Covid prior vaccination and had not been Covid-tested post vaccination. It was unknown if the patient had other vaccine in four weeks. Information on the lot/batch number has been requested.

Resident presenting today with facial swelling that extends from Chin into neck area. Redness to face.

passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine

101 Y year old female with PMH significant for hypertension, CKD, hyperlipidemia, COVID + on 7/8/21 (reportedly got 2 doses of vaccine, though only have 1 documented in EMR) who presents with COVID pneumonia. ý Pt went to out of town for July 4th weekend. COVID + on 7/8/21. Housemate noticed pt seemed sicker upon returning with more fatigue, sleeping more, sinus congestion, intermittent cough. Denies any fevers, chills, chest pain, sob, abd pain, n/v/d, dysuria, loss of smell/taste. States that she got both her vaccine shots outside of clinic (Pfizer), but can't remember the date. Pt admitted on 7/10/21. Pt was found to be hypoxic and was treated with decadron. She was not a candidate for remdesivir due to low GFR. She was given lasix to alleviate leg swelling which improved. On date of discharge patient is afebrile and no longer requiring supplemental O2. She is to remain isolated until 7/20/2021