Pfizer

MORNING AFTER VACCINATION, DEVELOPED VOMITING, DIARRHEA, HEADACHE, LOWER BACK PAIN, LEG PAIN, AND RASPY VOICE. WENT TO ER ON 1/21/21

Ringing in ears and pain in both sides of neck. Pt alert, oriented, ambulatory, no weakness, no slurred speech

Shoulder hurts; pain in shoulder;this is not the first time I had trouble with the shoulder; Shoulder hurts; pain in shoulder; this is not the first time I had trouble with the shoulder; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) via an unspecified route of administration in right upper arm on 09Jan2021 at single dose for COVID-19 immunization. Medical history included rotator cuff surgery on her left shoulder about 15 years ago and it was perfect and it didn't bother her anymore, atrial fibrillation (A-Fib) and so taking blood thinners (unspecified medications) and had trouble with the shoulder. Concomitant medications included blood thinners (unspecified medications). The patient experienced her shoulder hurt after being vaccinated with COVID-19 Vaccine in Jan2021. The patient took two Tylenol Extra Strength and arthritis pill because yesterday on 17Jan2021, it just had flared up. And also, this was not the first time she had trouble with the shoulder. So, the patient was not sure, she have had problems with it before. The patient did not visited a Physician's Office or Emergency Room, she had a shot (Unspecified Medications) about 5 years ago when it was hurting her so bad and it hadn't bothered her much since but every now and then it flares up. So, it just may be a clear coincidence. The outcome of event was unknown.

stated she felt broke, clarified she was having all over joint pain that was very bad; no control of her kidneys/she has messed the bed up twice since yesterday; This is a spontaneous report from a contactable consumer, reporting for herself. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing urinary incontinence (stated she has always had a little trouble). There were no concomitant medications. The patient got a shot yesterday, 14Jan2021, stated she felt broke, clarified she was having all over joint pain that was very bad, stated she has no control of kidneys, states she has always had a little trouble, but since yesterday it just wont stop, stated she has messed the bed up twice since yesterday. She was taking Tylenol for the pain and that was all she knows to do. She was encouraged to reach out to her HCP for any medical advice if she has concerns. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

02/04/2021 2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit 02/05/2021 2:00am Set up to go restroom.. slight Forehead Headache.. upon standing Dizzy unstable. Weak.. Used walk and furniture for support.. after seated on the toilet head pain increased.. Felt Nausea (did not Vomit)..headache passed.. returned to bedroom. This took 35 minutes 02/05/2021 2:35am seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021 3:00am felt fatigued.. feel asleep 02/05/2021 9:00am Awoke no issues.. 02/05/2021 10:30am Injection site left arm itchy.. no swelling .. no bruising.. tender to touch.. itchy sensation over full body

pt stated that she had SOB, muscle aches, diarrhea, nauseated for about 2 days. Pt is now feeling better and has not contacted PCP.

The next day, patient was found down by children (lives alone.) Was confused, had had fecal incontinence many hours earlier (dried) . Neither syncope nor fecal incontinence had occurred before. Previously managed to walk w walker or holding on, do her own basic ADLs (toilet, use microwave, eat.) Now bed bound and requires 24 hour care, unable to stand even with assistance/PT. Mental state has returned to baseline. Spent a week in rehab but could barely comply w PT instructions due to pain/dizziness.

Patient reported 5 days of joint pain and fatigue after the second covid vaccination Did not seek medical advise, symptoms resolved on their own after 5 days with rest, hydration

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)

Confusion that appeared to be a stroke but turned out to be swelling in the brain; caused memory loss/confusion, weakness of muscles, bladder retention issues treated with antibiotics/ 8 day stay in the hospital currently needs PT and OT to try to get back to her baseline

3/30/21 ER HPIHPI Patient is a 90 y.o. female who presents with with complaint of weakness and poor appetite. Patient also complained of cough productive of brownish sputum. Patient got her 1st Pfizer vaccine for coronavirus on the 18th of March (3/19) and tested positive on the 20 (3/21)March 2021. Patient was admitted to the hospital treated and discharged on the 26th of March. Patient has no fever or chills, no shortness of breath, no chest pain, no nausea vomiting, no headache or dizziness. Patient says she is weak in both legs and afraid of falling Admitted inpatient to Hospital 3/31 Dx: Pneumonia d/t Covid-19

3/24 arm pain, 3/25 rt shoulder and back pain, Tylenol given, 3/25 body aches and tired, Tylenol given 3/25 visit with dr to discuss pain- urinalysis ordered, later Tylenol and biofreeze, temp of 101 noted. 3/26 urinalysis results returned- NNO---- later 3/26This nurse is called to resident's room. Resident noted to have emesis of all bile, pale and lethargic. Complaints of not feeling well. Temp: 102.0, tympanic. Call placed to MA help nurse to update. Await call back .3/30 to dr again, confusion and bp issuesMercy ER, admit to hospital dx of cholecystitis.

the vaccine does not seem to be working like the first one; arthritic pains; A medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left upper arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included arthritis. The patient previously took the first dose of bnt162b2 () for COVID-19 immunization. Concomitant medications were not reported. On 12Feb2021, the patient experienced a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine and soreness at the injection site. She stated that she felt the arthritic pains more after the 2nd shot than the 1st shot. The 1st shot felt good and cleared up her sinuses. On 12Feb2021, the patient experienced does not seem to be working like the first one. The patient reported that with the first one she did not feel as bad and it is taking her longer to get over the second shot. The patient stated that with the first dose, her sinuses and her joint pain cleared up faster. The patient reported that her symptoms seem to be a little bit better on the day of reporting. She clarified that she got over her symptoms faster last time. Her left ear feels clogged up and it cleared up faster with the initial shot. She has arthritis on her right side with her hips and shoulder and stated that the joint pain is still there. It is still quite sore. On 12Feb2021, the outcome of the event a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine was recovered and was unknown for the rest of the events. Information about lot/batch number has been requested.

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

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.

She doesn't know what she weighs, it is going down so fast; She has a urine problem and urinates often; Don't have any appetite now/lost her appetite, even for water; Loose bowels; Voice is so dry/voice had also been affected; having a sleep problem, sleeping has been very bad; This is a spontaneous report from a contactable consumer (the patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199) via an unspecified route of administration on 10Mar2021 at age of 90-year-old at single dose for COVID-19 immunisation. Medical history included the patient had cancer about 10 years ago, it went away and then it came back. Caller reported that it started showing up on her mammogram again. Concomitant medication included anastrozole taken for neoplasm malignant from 10Jan2021. Caller reported side effects from the Pfizer COVID vaccine. Caller stated that she didn't know if it was the vaccine or because of the cancer she has, but she didn't have any appetite now (onset date 24Mar2021). She was eating all right and taking the cancer drug, but on 24Mar2021 (reported as "about 2 weeks after the Pfizer COVID vaccine on 10Mar2021"), she lost her appetite, even for water. Caller reported that she could go two days without eating anything. At the same time she was having loose bowels. She didn't know if the loose bowels was from the medicine she was taking or something else. Her voice had also been affected, it was so dry, she couldn't even talk. The caller also reported that that she didn't know what she weighs, it was going down so fast because she was not eating since an unspecified date. Caller not sure about weight. Caller stated that she was having a sleep problem, sleeping has been very bad. Everything started about 2 weeks after she got the first Pfizer COVID vaccine on the 10Mar2021. Caller was supposed to go back for her second Pfizer COVID vaccine on the 31Mar2021, but on the 24Mar2021 she started having trouble with eating and sleep and loose bowels. Since symptoms started after her Pfizer COVID vaccine dose on 10Mar2021, she decided not to go back on 31Mar2021 for the second dose. Caller reported that she ate 2 French fries since 07Apr2021 (yesterday), from a sandwich she ordered yesterday but didn't eat the sandwich. Caller clarified that she couldn't even eat the 2 French fries and hasn't had anything since then. For loose bowels: caller reported that she had a urine problem and urinates often since an unspecified date. Caller stated that when she went to urinate and when she barely presses down, she would have a bowel movement, but it was very watery and loose, not a formed bowel movement. She talked to her cancer doctor and her regular doctor who both told her to go to the hospital but she did not go. For dry voice: caller reported that she didn't know if it was acid coming up in her mouth or just dry mouth. Caller didn't know what it was, if she kept her mouth closed and didn't talk and didn't get any air, it was not as bad. Caller reported that trying to talk was bad and it had recently gotten a little worse. The patient wasn't having these symptoms before she took the vaccine. The outcome of "she doesn't know what she weighs, it is going down so fast" and "she has a urine problem and urinates often" was unknown, the outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea

Patient reported today that she has pain in shoulder blade & rib area after 24 hours of receiving vaccine. She takes Oxycodone for hip pain but states no relief with rib & shoulder

neuropathy in feet; Weakness in legs; This is a spontaneous report from a non-contactable physician. A 90-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EL9262) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date. There was unspecified concomitant medications in two weeks. The patient previously received the first dose of bnt162b2 intramuscularly on 23Jan2021 (lot number: el8982) for covid-19 immunization at age of 89 years old. The patient experienced neuropathy in feet and weakness in legs on an unspecified date. No treatment received for the events. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of neuropathy in feet and weakness in legs 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

She went limp and slumped in my arms at 9:30 am the day after her 2nd injection, so almost 24 hours later. Blood pressure, pulse and respiration were absolutely normal. But she was unable to speak for the rest of the day, she would open her mouth but could not get any words out. She also was extremely fatigued and slept most of the day, had no grip in her hands and was very stiff when she was able to get up. Had a slight fever, which went down after taking 1/4 of a Tylenol. No pain in the arm at the injection site and also no redness or swelling. So the know side effects of fatigue and muscle/joint pain hit her very hard. She is much better today, 24 hours after experiencing the side effects.

pain in her shoulder/ shoulder hurting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient to received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 25Jan2021 at single dose in right arm (by injection once to right shoulder) for COVID-19 immunization. Medical history was none. Concomitant medications were none. Caller wanted to know if she can use Tylenol 8 hours to treat pain in her shoulder/ shoulder hurting (25Jan2021), she received the COVID-19 vaccine this morning. The patient had a COVID shot this morning, and shoulder was hurting so bad, she was going to take a Tylenol 8 hour, wanted to know if that was ok, and what about heat or ice. The Tylenol said for muscle aches, but she didn't know if she should take it, it had been hours since the vaccine, hurting a little bit, certain ways move it, was going to put heat, thought maybe ice. It was just a little sore, nothing she can stand, she didn't know whether to take a Tylenol for muscles, then heat or ice. Daughter kept vaccine card, caller had to go for the second dose, so her daughter kept the vaccine card in the car. Height: 5'6" to 5' 7". Weight: 170-180 pounds. No Investigation Assessment. The outcome of the event was unknown. Information on the lot/batch number has been requested.

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

legs were not working after the Covid-19 vaccine shot; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date 31May2021), intramuscular on her left arm on 23Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's legs were not working after the Covid-19 vaccine shot on 24Jan2021. She got the shot on Saturday afternoon. The patient seems to be ok today. The outcome of the event was recovered in 25Jan2021.

stiffness in neck and shoulder to the point that I almost could not raise my head, persisting overnight and into a second day

she couldn't urine/She couldn't urinate anymore; she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out; Always had burning on bottom of her foot/she felt like her body was burning up in side/Felt like she was burning alive; Had a fever every day and every night/Temperature was 100 degrees; she has an infection in her bladder; feel like I am dying/had a very strange feeling in her body/Something was going across the top and right side like a fluid was flowing or something strange; sweating/wet, perspiring all night./Got all wet with perspiration; gotten more sick; weak; tired; headache; lost a little weight; Eats very little now; afraid; pain was around the bottom of the foot now it's on top of the foot and goes up to knee; uncomfortable; sneezes; diarrhea; cramps; constipation; colon cancer; doesn't think the needle went in all of the way when the nurse administered her vaccine; shingles; Post herpetic neuralgia/the post-herpetic neuralgia was on her whole foot; pain at the bottom of my foot; impact on the nervous system; This is a spontaneous report from a contactable consumer (patient). This 91-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via an unspecified route of administration on 02Feb2021 at single dose in the left arm for COVID-19 immunization. The patient medical history included high blood pressure, kidney cancer, cancer in her bladder 20 years ago and coughing. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), losartan potassium for blood pressure, metoprolol succinate for blood pressure, amlodipine for blood pressure, acetylsalicylic acid (ASPIRIN 81). Patient had cancer in her bladder 20 years ago. That was taken care of. Had kidney cancer because her husband used to smoke and blow it in her face. Had rare type of kidney cancer. It was removed. Treated for bladder cancer. Patient has had no problem ever since and that was more than 18 years ago. Patient had a fever, headache, and was very tired. Burning up on side of the body and she got all wet. This was not normal and she felt like she was dying. Patient stated she had shingles and developed post herpetic neuralgia. Patient always had pain at the bottom of her foot but it was getting worse after she received the first dose of Pfizer COVID-19 vaccine. Patient noticed the liquid going thru arm to chest and in straight line to her leg, like a science fiction movie with an injection of some kind. The doctor thought the vaccine might have an impact on the nervous system and spike the symptoms of post herpetic neuralgia. Patient spoke to her doctor but nobody knows anything. Nobody was willing to help her. Patient felt like she was dying. She didn't want to die. Patient feel the symptoms are getting worst. She was burning up inside. Her pain was around the bottom of the foot now it's on top of the foot and goes up to knee. Patient was not blaming anybody but she thought it was the vaccine. Patient was sweating, wet, perspiring all night. The symptoms usually occur at night. Patient wanted to know if these symptoms were associated with the vaccine. Patient also mentioned she developed a bladder infection for which she was taking antibiotics. Patient had Pfizer vaccine on 02Feb2021, about 5 days ago. Patient followed instructions before vaccine. Doctor said to take paracetamol (TYLENOL) before the vaccine for a headache. Patient did that. Patient had injection and told to wait for 15 minutes before she went home. About 5 minutes, she was relaxed and sitting down. Vaccination given in left arm. All of a sudden she had a very strange feeling in her body on 02Feb2021. Something was going across the top and right side like a fluid was flowing or something strange. Then it felt like a straight line down her right foot and it stopped. Was a feeling like maybe the liquid of the vaccine went that way. Didn't have a vein going that way. Patient was afraid. She went home and didn't remember the next thing that happened. Every night she has gotten more sick. Patient had a feeling in her foot where she had shingles a few years ago. After shingles had post-herpetic neuralgia. Patient always had burning on bottom of her foot and would put it in ice water. Patient could handle that because it was just uncomfortable. After injection, she got so bad, the post-herpetic neuralgia was on her whole foot and it started to burn. It went up a little towards the knee or higher. Yesterday, at times, it quickly went over to the left leg. Patient had a fever every day and every night. Patient took paracetamol to cut the fever. Patient was coughing on call but stated that was nothing and the coughing was something she had. Every night she felt like her body was burning up in side. Felt like she was burning alive. Got all wet with perspiration. She changed clothes and every night it got worse. Patient called emergency, they listened to her, stating they have never heard of anything like this. Asked patient if she wanted to go to emergency. She stated ok. The doctor listened to her story and told her it was weird. Doctor told her to give it a few more days to up to eight days. Doctor wanted her to get a urine test, but she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out and it was brown. Not normal urine. Next day patient called 911. She wanted to be assured she was not dying at home. Did have room available at the hospital. Patient had to sit in a wheelchair and there was no bed for her to lie down in. Last time she was admitted from the emergency. Next day she came home and had to call emergency again. Really thought she was burning up. Patient didn't want to go to the hospital and suffered at home. Next night and third night was so bad. Patient couldn't urinate anymore. She had a fever, but not a high fever, because the paracetamol cut the fever. Temperature was 100 degrees. On the inside she thought she was being burned up a live. Never got better, always got worse. Yesterday, she was in the hospital all day. Now she has an infection in her bladder. Was put on a machine and everything. Had a long procedure, and got the urine going. Patient didn't miss not urinating. Has accidents like when she sneezes or cough. Usually gets up 2-3 times at night to urinate. When she finally realized she couldn't urinate, the doctor kept her there for a long time, eight hours. Was put on the machine, thought she may need a catheter. Her bladder was massaged in order to get her to urinate. Patient only had the left kidney. Correct problem about the urine. Doctor told her to make sure she goes back for second dose on 23Feb2021, but she was afraid. In the morning she was a little better, couldn't handle this. Patient was very weak and tired. One night she was in the emergency and didn't sleep because of the procedures. Patient didn't think the needle went in all of the way when the nurse administered her vaccine. Sensation started on the left, went across her chest, straight down like an arrow. Like something was trickling down to the end of her foot and stopped. Patient had symptoms every night since. So severe patient thought she was burning up. Patient got worse every night and didn't get any better. Patient said feeling at COVID-19 Vaccine injection site was not a natural thing. Last time she was in the hospital her blood pressure went up to 184. After COVID-19 Vaccine patient lost a little weight. Same time had this problem, was seeing a doctor with a colon specialty. Had so much constipation for a long time and tried to correct it with mediation. Medication was too strong and gave her diarrhea. Doctor thought maybe she had colon cancer. Stopped the medication. Wasn't 100% healthy, but that was just cramps. Patient eats very little now, not very hungry. Patient feels good in her bowels after something good from a restaurant. Patient attempted to clarify the medication that was too strong. She stated it was over the counter. She stated it was something that had to be mixed. She was supposed to take a cap full and mix it with 8 ounces of liquid. Needed something to make her have a bowel movement. Only took it for two days. Was way before the vaccine. It was too strong and she stopped it. Patient took a probiotic. After that patient was given gas relief medication called: Gas Relief Extra Strength Simethicone, 125mg. Provided: V11496, MSRS 53041 REV 0417, and 883928. Patient no longer has constipation. Now it is the opposite. Now bowel movements are soft and pasty. Patient tried a stool softener that didn't work, was worthless. Was over the counter. Patient didn't take stool softeners after the COVID-19 Vaccine. All the events started from Feb2021. Outcome of the events was unknown.

I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; torn rotator cuff; I have a slight headache in the back of my head too; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9262), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included High blood pressure. Concomitant medication included olmesartan medoxomil for high blood pressure and pravastatin sodium. The patient stated she was 91 years old and that was why she got the first shot of the Covid19 vaccine Pfizer about 10 days ago (27Jan2021). Last night (05Feb2021) she had such pain all night and she still had it. It was all around her neck and up to the top of the ears and then her right shoulder down the front and to the back, she had a torn rotator cuff there and all the way down to her fingertips she had pain. Event onset last night, during the night. Like 9 days well, coming into the 10th day. She did not know why she have it. It was fine until last night and now it was terrible. She had a slight headache in the back of her head too on an unspecified date in 2021. She had been taking Tylenol and put some Icy Hot, you rub it on when you have pain but it did not do anything. She wanted to know will she get the same type of reaction when she get the second shot. There was no expiration date on it. There was nothing else. The outcome of the event slight headache in the back of head was unknown and the outcome of the other events was not recovered.

Blood sugar has gone up/Blood sugar started increasing; Burning in chest; Had trouble keeping head up; Nauseous; Pain between shoulder blades; Pain at injection site; Did not feel good; Heartburn; Bones hurt worse than usual; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiration Date: 31May2021) intramuscularly, administered in left arm on 12Feb2021 at 14:55 (at age of 91 years old) at a single dose for COVID-19 immunization. Medical history included type 2 diabetes (Diagnosed 15-16 years before this reporting), high blood pressure prior to that. She lost a lot of weight since she found out she was diabetic, which was prior to getting vaccine, around 15-16 years before this reporting. She lost 50 lbs in 15 years. It has been gradually. She gets Prolia shots and did not get one this month. She has scoliosis and osteoporosis and that was one of the things that happened. She had previously broken her shoulder blade and some ribs on her right side. She confirmed that she broke it over a year before this reporting. She has a yellow mark and a little reddish mark that looks like someone hit you. It is still there and it is a fading black and blue mark and does not hurt any more. She takes blood pressure medicine. She does not take diabetic medication. She did in the past, but it caused her ankles to swell and then she started controlling it with diet. She was right handed and had trouble trying to do things with her left hand. This started prior to the vaccine. Family medical history included: Family heart issues and diabetes. Heart disease and cancer in the family. There were no concomitant medications. The patient previously took Prolia for back problems. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261, Expiration Date: 31May2021) on 22Jan2021 at age of 91 years old at a single dose for COVID-19 immunization. She didn't have any problems after the first COVID-19 Vaccine. No additional Vaccines administered on same date of the Pfizer Suspect. The patient experienced blood sugar has gone up/blood sugar started increasing on 15Feb2021 at 08:00, pain at injection site on 12Feb2021 at 14:55, pain between shoulder blades on 12Feb2021 at 20:30 to 21:30, had trouble keeping head up on 13Feb2021 at 07:30, nauseous on 13Feb2021 at 07:30, burning in chest on 13Feb2021 at 08:30, did not feel good on 12Feb2021 at 08:30, heartburn on 12Feb2021 at 08:30, bones hurt worse than usual on 12Feb2021 at 07:30. She has stated her blood sugar has gone up since she's received the second dose of Pfizer's COVID vaccine on 12Feb2021. Blood sugar started increasing was reported as worsened. She was type 2 diabetic and does not take any medicine. She got second shot on 12Feb2021, and her sugar was 89, then she started not feeling good the day after. On 15Feb2021, she was checking it and it was 119. On 16Feb2021, it was 145. On 17Feb2021, it was 144, and 18Feb2021, it was 145. She had never had them this high. It does not mention it can do anything to your sugar. She does not know her height. Last she was measured was 4'6"-4'7". Her highest was 5 feet. This was prior to the vaccine. She said her weight was between 80-85 lbs. The second shot hurt when they gave it to her. About 6 hours later, it felt like she was hit by lightning between her shoulder blades. She had previously broken her shoulder blade and some ribs on her right side. That has been bothering her and it felt worse when she got the vaccine and she could hardly lift her head up. The pain went from her left shoulder blade to right shoulder blade and stopped right away and then it felt like a lightening thing. She had trouble keeping her head up. She still has trouble with shoulders and is putting heating pads on them. She felt nauseous off and on. Her bones usually hurt, but after the second injection they hurt worse. As long as she puts heat on them, it feels better. The second dose feel like it hit the bone. The first one did not feel that way. The outcome of the event "Blood sugar increased, Chest burning, Feeling abnormal, Heartburn, Bone pain" was not recovered, for events "Shoulder blade pain, Heaviness of head, Nauseous" was recovering, for event "Vaccination site pain" was unknown.

She got the first Covid-19 vaccine yesterday and the nurse that had to put it in her, she felt it and it hurt.; really aching there in her left arm and shoulder high up; this morning and last night and didn't sleep good at all; couldn't even take off her pajama top; really aching there in her left arm and shoulder high up; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. The patient's concomitant medications included unspecified medications for atrial fibrillation which were considered as co suspects. Caller states she needs to know. She got the first Covid-19 vaccine yesterday (09Feb2021) and the nurse that had to put it in her, she felt it and it hurt. Her other friends said they couldn't tell they were getting a shot, but she did and it hurt. Where she went to get it was organized and wonderful and she got the shot about 12:00. Before it got to 6pm she was really aching there in her left arm and shoulder high up. Instead of a soreness she had pain. Had pain this morning and last night and didn't sleep good at all and couldn't even take off her pajama top. It was reported that she has history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. She has some Tylenol in the house but does not know with her heart condition if it is alright to take the Tylenol for the pain or should she not take it. Has not taken any pain killers last night for fear of not knowing what it would do. The facility where she had the shot she was taken to since she does not drive and it was very well organized and all. Was very glad to get this vaccine and if people in the county can take it eventually it can be cured. Again, mentions having so many friends say they didn't have any problems and not to worry about getting the shot and she was filled with so much hope. The literature says you can have some joint pains and tiredness and her problem is wondering if she can take Tylenol to ease the pain. No further details provided. Outcome of the events was unknown. Information on the lot/batch number is requested.

Unexplained hoarseness at 7:00 am 02/06/2021 and cough at 0:700 pm on 02/06/2021. Fall (first time ever), followed vomiting, and choking at 2:00 pm 02/07/2021. Ambulance called recorded vitals 97.5 Temp 102/70 BP, 98 HR at 2:51 pm at home and 146/90 BP 102 HR at 3:09 pm enroute to hospital; pt pointed to hip pain and answered questions in native language Polish (although pt spoke English). Pt delivered alert and kicking blankets off legs inside emergency room. Emergency room staff failed to communicate with pt. Pt was discovered unresponsive 20 minutes later when staff arrived to take admission vitals. Pt passed 02/07/2021 in ER. No causeof death given by ER doctor to family.

DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

15 minutes after receiving vaccine, she noticed legs becoming more numb than usual and difficult to move them. Had to have additional assistance ambulating, getting out of chair, getting into bed unable to raise legs into bed, assistance in the bathroom, had to hold onto her to stabilize.. This lasted for 30 hours with gradual resolution of symptoms. she remains with her usual neuropathy at this time.

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/21/21. ON 02/27/21 WENT TO ICC F OR RT HIP PAIN AND KNEE PAIN AFTER FALL ON 02/27/21 AND HAD XRAYS. ON 02/27/21 WENT TO ER AND HAD CT OF RT HIP WO CONTRAST DONE . DIAGNOSED WITH HIP PAIN (ACUTE,RIGHT) AND FALL (INITIAL ENCOUNTER). INSTRUCTED TO FOLLOW UP WITH PCP.

2/21 patient presented for leg weakness. Patient had UTI on work up treated with antibiotics. Patient discharged 2/22. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

DAY AFTER, PT COMPLAINED OF PAIN IN LEFT COLLAR BONE. PATIENT DECLINED IN FUNCTION OVER NEXT 11 DAYS. HOSPICE WAS CONSULTED AND PT PASSED ON 2/23/21

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.

Extreme joint pain for over three weeks. Knee joints, SI Joint, inner thighs, and even arms on certain days. Extreme fatigue. Mental fogginess.

Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine. The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done. Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine

Presented to ED on 1/12/21 slowly worsening constant myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter not acting herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless and expired at 0451.

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.

bad headache for 2 days, stomach ache for half day the first day , chills off and on the second day, muscular aches the second day, extreme fatigue for 2 days.

Pt states that at 11:13 her right hand started feeling tight. Pt stated she had the vaccine administered in her left arm. Pt's Vitals are stable. Stroke scale negative. Positive CMS in extremities. Pt was cleared to go home by onsite Doctor.

1st dose vaccine 1/30/2021; fall of unknown etiology at home on 2/1/21; went to urgent care 2/1/21 for back pain, sent to ED same day for eval; admitted to hospital on 2/1/21 from ED for T12 compression fracture.

garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30 as SINGLE DOSE for covid-19 immunisation Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 2021, The patient experienced spasms, mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding, bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events. The clinical outcome of the events was recovered with sequelae. .

Patient received vaccine and approximately 30 minutes afterwards began experiencing tongue swelling, bilateral hip, knee, leg and shoulder pain, and dizziness.

sleeping for 20 hours for four days after vaccine, low grade fever, chills, intense pain in right hip and left leg -intensification of arthritis pain, inability to walk on own, swollen left ankle due to inflammation, glucosed level increased for 1 1/2 weeks levels 171 to 261, brain fog , unable to do puzzles (puzzles helps with dementia. Symptoms subsided after 2 weeks and 1 day; brain fog still subsiding, almost back to level before vaccination.

This 93 year old white female hospice patient received the Covid shot on 1/20/2021 and went to the ED on 3/12 for COPD exacerbation, shortness of breath and extremity weakness. She returned to the ED on 3/13/21 and was admitted for generalized weakness and dehydration. The patient subsequently died on 4/13/21. 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.

She doesn't remember exactly when it started, approximately within 24 hours of vaccination Nerve pain in hands and feet, pins and needles feeling Worse after second vaccine Stiffness ongoing PCP started on Gabapentin to help with pain

they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine; sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red; increased redness at the injection site; The pain is also described as hurting up into the shoulder; arm is continuing to hurt and her lump is bigger and now it's getting red; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; mother has back problem and she is having back pain now too; This is a spontaneous report from a contactable consumer (Patients daughter) reporting for her mother. A 93-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 22Mar2021 11:30 (at the age of 93 years) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at dose number unknown, single for an unspecified indication. Medical history included dementia (Verbatim: dementia), myocardial infarction (Verbatim: 4 heart attacks), stroke (Verbatim: 4 strokes), angioplasty (Verbatim: 9 angioplasties), angiogram (Verbatim: reaction to the dye when she gets the angiograms), mother has back problem, thyroid. On an unspecified date concomitant medication(s) included ongoing warfarin (WARFARIN); unspecified thyroid medication(0.075mg) she doesn't think her mother needs her thyroid medication anymore, but the caller needs her thyroid medication because she doesn't have a thyroid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced they were told they were getting the moderna vaccination but she was given the paperwork for the pfizer covid 19 vaccine, sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red and ongoing, increased redness at the injection site, the pain is also described as hurting up into the shoulder and ongoing, arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow, mother has back problem and she is having back pain now too. Reporter stated, she wanted to know if her mother should take the second dose of the Pfizer COVID-19 vaccine since she has had these side effects after receiving the first dose, she should use hot or cold packs to help her mother's arm pain from the Pfizer COVID-19 vaccine injection, how long she can expect her mother's side effects to last after receiving the first dose of the Pfizer COVID-19 vaccine. She states it's difficult to determine exactly how painful her mother's arm is because of her limited cognition and ability to describe the pain, also states that at times the mother will refuse to use her arm and other times she will use it as if there is no problem. Her mother does have a pacemaker and defibrillator and the facility was advised of that before her mother had the Covid 19 vaccine. She reports that they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine. She's assuming since she had received the Pfizer paperwork that she and her mother had received the Pfizer Covid vaccine. Patient asking why her arm is sore and with her age and her dementia a few years ago her mother wouldn't have been complaining. She would have been different. She would have thought that her arm soreness was just part of the vaccine. Now reporter is concerned. She just wanted to call and check because her mother keeps holding her arm. Yesterday she put ice on it and she doesn't know if she should have done that. The caller reports she tries not to take her mother out because of Covid 19. She does go to the heart doctor because she's on the blood thinners and has the pace maker and defibrillator. Her mother has a tendency to get any infection easier now. Patient acts like a child sometimes in showing her arm and complaining about it. Daughter doesn't remember when her mother's arm started hurting. She remembers her mom saying there was a lump in her arm and the felt her own arm and felt a little lump in her arm too. Patient had open heart surgery also and the doctor went in and put a clamp on her leaking valve in her heart. She did have a reaction to an antibiotic during that time. reporter doesn't recall the name of the antibiotic. She reports it was done intravenously and her mother came out red as a beet, reporter states because of the Covid 19 you have to be in bad shape to go to the emergency room. The outcome of event arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow was not recovered rest of all event outcome was unknown. Description of complaint: Caller reports her mother is on Warfarin and occasionally the doctor has to change it up a little bit. The warfarin is in a pharmacy bottle. TARO is the manufacturer. Caller does not see an NDC/Lot/Expiry. No follow-up attempts are possible. Information on lot/batch number cannot be obtained.

elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm; is real tired and she even slept 14 hours last night; is real tired and she even slept 14 hours last night; This is a spontaneous report from a contactable Consumer (patient's husband). A 94-year-old female patient received the first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route of administration (right arm) on 21Jan2021 at SINGLE DOSE (arm right) for covid-19 immunisation. Medical history included left shoulder pain (on medication for years) from an unspecified date, and elbow that she fell on two weeks before on Jan2021. Concomitant medication included hydrocodone for left shoulder pain. On 24Jan2021, the patient experienced real tired and she even slept 14 hours the night before. Reporter was wondering if tiredness is a side effect of the product. The patient also had an elbow that she fell on two weeks before on Jan2021, and three days after getting the vaccine (24Jan2021), that elbow started hurting more, and it was on the same arm as the side she got the injection on, the right arm. The reporter was unsure of the lot number reported as E13249 or EL3249 (unsure which lot number is his, and which is the one his wife received). The patient received no other vaccines on the same day as the COVID vaccine. Outcome of the event "elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm" was not recovered. Outcome of events "is real tired and she even slept 14 hours last night" was unknown.

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

Received vaccine at assisted living facility on 02/12/2021- presented to this reporters facility ED on 02/16/2021 with generalized body aches- post immunization arthopathy.

Unable to write as normal next day Mental decline and unable to care for herself Hospitalized 2 weeks later for dehydration Noticed reddened and painful R arm down to elbow Now back in hospital 5/18/21 with unresponsiveness, UTI and dehyration

Pt had acute ischemic stroke involving right vertebral artery 16 days after dose number one of Pfizer vaccine. She developed sudden dizziness and loss of leg strength, fell to floor. it took 7 hours until she was found and taken to hospital, so did not receive TPA. CTA on 2/27/2021 showed occluded V4 segment of rt vertebral artery. residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and discordant occular movement.

been sick/she is kind of halfway sick; been sick; lost a bunch of weight; already had three of her shots; This is a spontaneous report from a contactable consumer (Patient). A 94-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced seriousness for been sick, lost a bunch of weight and already had three of her shots, she is kind of halfway sick, she confirms she didn't have any experience to report. Patient states she is calling because they didn't give her a card. When probed for telephone number, the caller explains she doesn't have but one number, and she is kind of halfway sick. Patient already had three of her shots at (#) She doesn't know what happened but she doesn't have a card. She clarifies she took three shots already. She was looking through her purse and she doesn't have a card for that, but she has already had three shots already. She confirms she didn't have any experience to report. they said she already had two shots already, but she still couldn't understand that the last one she had was taken at #,that's the hospital where she goes. Reporter clarifies she doesn't know if she got the Pfizer COVID-19 vaccine. Patient thought everybody was getting one. Patient clarifies # is her regular hospital. She went there the first time, and she went there the second time, and the last time she went, she thought that was it. She kept seeing in the papers that they might give her another shot later. She didn't pay that much attention, but after she left one hospital, she didn't know where to go for another one. She clarifies it was in some papers that gave her and she didn't look at it. It was her fault. The first time, she went back to the hospital, and the last time was at hospital. She will be sure she look good next time. It was her fault. She is not able to provide an NDC/Lot/Expiry date. She mentions she might get her granddaughter to call. Her granddaughter lives in #. The patient thought she wouldn't take the Covid-19 shot, but her granddaughter told her to take it. Her granddaughter took her shot at the same the caller did, the same date. She said when she went to get her shot, the hospital staff asked her if she was coming to get her shot. After she got the shot, the staff told her she was through, and that was her last shot. She was born in that section of the hospital where she got her shot. Patient will contact her granddaughter in #and tell her what happened about her getting sent a card. She was reading in the paper, or book, that she was supposed to get another shot, but the caller doesn't know. She really doesn't want another shot, she's too old. She did good. Patient underwent lab test and procedures included weight. The outcome of events was unknown. Information about batch/Lot number has been requested.

disoriented a little; Has been terribly sick, almost continually; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; eye sight went; hearing was not good to begin with but now her hearing is much worse; hearing was not good to begin with but now her hearing is much worse; Of course, is kind of out of it and doesn't know exactly what to say even though knows what wants to say; has no energy; terribly congested; has cough that turns into a violent sneeze, a couple sneezes; has cough that turns into a violent sneeze, a couple sneezes; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 (Lot Number: EW0151) as dose 2, single at the age of 94-years-old for covid-19 immunization. The patient medical history included: ongoing hearing was not good. There were no concomitant medications. The patient received the first dose of bnt162b2 (Lot Number: PN6208) on 10Mar2021 in left upper arm for covid-19 immunization. The patient will be 95 years old in just a few more days. The patient received the second dose on 08Apr2021. The patient was fine until about Dec2020. The patient had been terribly, terribly sick almost continually. The patient took half a pill Fenofibrate a day. The patient is going to be 95 years old very soon and the patient had always been very, very active. The patient was never sick. All of a sudden, the patient had shut down to almost nothing. The patient had no energy. The patient hurt so bad, whole body had been so sick and can do very little and had to rest. The patient hurts mostly in her back and her legs and had difficulty walking. This began a month ago, everything began a month ago. The patient's whole system is out of whack. The patient will have all kinds of time to get to the bottom of this. The patient was just at the primary care physician's office yesterday, 15Jul2021 and the physician was at the whit end. The patient was terribly congested, had cough that turned into a violent sneeze, a couple sneezes. The patient had a runny nose and all the symptoms of a bad cold but the patient didn't think she really had a cold. The patient clarified congestion and sneezing began a month ago. Patient stated everything occurring began a month ago. The patient's eye sight and hearing went at the same time, really bad. This began about a month ago. Everything all of a sudden happened over night. The patient felt great and was doing yard work and very, very active almost 95 year old. The patient is down to zero now. The patient stated her eye sight is worsening. The patient stated her hearing was not good to begin with but now her hearing is much worse. Of course the patient is kind of out of it and didn't know exactly what to say even though the patient knew what she wants to say. The patient is disoriented a little. The patient stated all of this began a month ago. The patient stated all of these symptoms did not come gradually, it was like overnight. The patient got up and everything was there at once, not one think after another. Everything was there when the patient got up, the patient was a different person. Outcome of the events eye sight went and hearing went was not recovered, of other events was unknown.

REPORTED DIZZINESS AND WEAKNESS IN LEGS AFTER RECEIVING VACCINE. HAD A PREVIOUS REACTION TO FLU VACCINE. WAS MONITORED FOR 30 MINUTES.

a bruise on her ankle and it split open; a bruise on her ankle it split open; soreness of her arm where she got the injection after the first dose; back spasms pain; back spasms pain; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer-sponsored program. A 95-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (at the age of 95-year-old) as single dose for COVID-19 immunization. Medical history included using a wheelchair. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness of her arm where she got the injection after the first dose at 12 noon and then at 10 pm she had the pain. On an unspecified date, she had a bruise on her ankle and it split open so she put POLYSPORIN (bacitracin and polymyxin B) on it. Then she bruised it again on her wheelchair. She also reported experiencing bad back spasms pain for 3-4 days which happens periodically (unspecified date). The clinical outcomes of the soreness of her arm where she got the injection, back spasms pain and a bruise on her ankle it split open were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

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.

Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.

I woke up in the night with severe indigestion, a pain in my left jaw and pain in the back of my ribs near my heart. It?s subsided in about one minute time. This morning I woke up with some right arm pain but it was short-lived too. I have felt fine since...

About 30 hours after receiving vaccine, resident was very emotional, called her family numerous times in the middle of the night. Was having increased weakness and hip/back pain which required use of wheelchair. She can normally ambulate with walker. Also complained of nasal congestion.

Bell's Palsy Left side-3/08/2021 Seen at Emergency Room and was given treatment of Prednisone, ValAcyclovir, and ointment to left eye at night. She experienced severe left sided neck and left ear pain on Saturday 3/06/2021 and then got drooping of left mouth and left eye around 3 pm on Sunday, 3/07/2021, and was seen at healthcare Clinic and Emergency Room 3/08/2021 2 Doses Pfizer given: #1 on 1/21/2021 and #2 on 2/11/2021

a dark spot like blood lower down on her arm; real sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 96-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 18:15 (Batch/Lot Number: ENS318) as SINGLE DOSE for Covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included thyroid disorder, blood pressure abnormal, vitamin supplementation, hip fracture (she broke her hip three years ago), neuropathy peripheral, blood cholesterol abnormal, hypertension from an unknown date and unknown if ongoing. Concomitant medications included benazepril (BENAZEPRIL) taken for blood pressure abnormal, 40mg, one in the morning, Oral; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, 5mg, once daily, Oral; amlodipine (AMLODIPINE) taken for blood pressure abnormal, 10mg, at night, Oral; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal, 5mg, one at night, Oral; gabapentin (GABAPENTIN) taken for neuropathy peripheral, 100mg, twice daily, Oral, Since unspecified date of Feb2021; ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]) taken for vitamin supplementation, once daily, Oral; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, 81mg, once daily, Oral; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication (taking for years), 125mg, once daily, Oral, all concomitant medications start from an unspecified start date and ongoing. Consumer stated she received the first dose of the Pfizer COVID 19 vaccine 04Feb2021 at 1815PM in the left arm. The place where the shot was, was real sore. The next morning (05Feb2021) she noticed a dark spot like blood further down on her arm. It was fading out some now. Stated Saturday the place with the shot hurt real bad and there was this big old place like a bruise on her arm further down. She failed to tell then she had low dose aspirin and was asking could that have caused this. She did call her doctor who advised maybe blood had pooled there from the shot but she did not understand what he was saying. She was scheduled for the next dose of the vaccine on 19Feb2021. Outcome of the event a dark spot like blood lower down on her arm was recovering and real sore was outcome of recovered on 06Feb2021.

Joint pain in arms and back, increased pulse, (120-135) slight fever 100.4 - my temperature is usually around 97, the next morning temperature was 94.4. cough. These symptoms lasted, off and on for about a week. I had fever once. Feeling limp as a rag. No energy.

Felling ill immediately- diarrhea & loose stool for a few days, headache for a few days, muscle aches- pain in back & side (new), low grade fever daily since vaccine

Left Shoulder pain and weakness leading to rotator cuff tendinopathy. This was addressed at our clinic initially on 2/8/21 and then on 3/3/21.

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.

First day very tired slept all the time appetite decreased Dash day after not drinking not eating complaint of headache back pain which was generalized to the whole body with her alzheimers hard to tell very weak by noon could not walk from the living room to the bathroom Not eating or drinking that day had to have Neighbor come over and help move her she slept in a reclining chair for the night ? the next day she was doing better Was in touch with the doctor ? did not take her to the clinic or to the hospital but has she been any worse we would have

Presented to ED with 3 week history of increased fatigue, rib pain, 3 day history of cough. Known COVID household exposure. Positive COVID-19 result by PCR after >14 days vaccination completion.

Patient began to show muscle weakness in late afternoon on 1/31/21. On 2/1/21 she was unable to walk, not even one step. She had difficulty swallowing, was unable to feed herself, and was extremely lethargic. She was unable to remain awake all day and had to be shaken unusually hard to wake up. She appeared confused/ disoriented upon waking. She did not have a fever or report of any pain. Her BP, pulse, and O2 were all normal. She did present with any indications of a stroke. Slight improvement began late afternoon on 2/2/21. On 2/3/21 all of these conditions had disappeared and she was back to her normal self and activities.

Client's daughter described events to me. Stated mother experienced tingling, weakness in legs about 7-14 days after receiving 2nd Covid vaccine. Also spoke with client for a few minutes. Stated could only walk a few minutes then legs felt like they were paralyzed and became really hot feeling. States toes felt like they were curling under left foot. Daughter took mother (client) to ER on Feb. 17 (after this had been going on for 4 days). Client was not admitted to hospital. Client stated no adverse events noted with 1st Pfizer Covid Vaccination. Client & daughter stated that client had bladder infection 1 week after receiving 2nd Covid vaccination. Client states problem with legs improving each day.

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

presented to the ED with substernal chest pain with right to left side radiation and continuous waxing and waning right sided abdominal pain with back radiation consistent with previous episode of acute cholecystitis; still admitted

on 1/26/21 Found laying on Bathroom Floor in Bedroom Apt. Complaint of Right Shoulder paiN bleeding (unknown origin) then discovered origin HANd/FiNgers. (Head on Floor towARds WALL) SeNT TO ER 1/26/21, Admitted 1/26/21 Diagnosis: AoRtic STENOSIS

Resident complained about back pain in the middle of the night and when they went to do a blood pressure examination, she passed away at 2:40 am.

medical history most significant for hypertension, type 2 diabetes, hypothyroidism, pacemaker, who presents to the Emergency Department today due to shortness of breath that began approximately 2 days ago. The patient reports that the shortness of breath had a gradual onset and is getting worse. She normally wears 1.5 L of oxygen at night. However, she has been wearing it throughout the day. Upon EMS arrival, she was satting well. However, with any exertion, she dropped her sats for which they started her on non-rebreather. She also reports bilateral knee pain that has been chronic along with chronic back pain. She denies chest pain, abdominal pain or fevers. She is COVID vaccinated. She received her 2nd doe