Pfizer

Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room

Patient reports she experienced lip and tongue tingling, "puffy eyebrows" and cheek swelling approximately one hour after receiving the vaccine. Patient reports she is still experiencing swelling under her eyebrows and cheeks at the time of report (01/20/21 at 8:37 pm).

Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.

Approximately 1 hour after the shot, I raised a hive on my upper lip. It very quickly (within 2 minutes) got to its maximum size. Not noticeably swollen to an observer, but it felt swollen, red and throbbing. It was not a serious adverse reaction. After about an hour, it was NOT going away, but it was NOT getting worse. I never experienced trouble breathing. The office where I had the shot is "not available" on Friday afternoon, and my personal physician is not in the office on Friday. I was advised by another doctor friend to take benadryl, which I did. While looking at the CDC website, he also advised me that (having had this reaction) I should not receive the second shot.

Severe anaphylaxis shock, received 5 drug injections at vaccination site, transported to ER for observation. released later that evening.

Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, Prednisone

A rash on my right arm (got the vaccine in my left arm) from my wrist to elbow. The rash had 3 raised bumps and was swollen. It was not painful but was itchy. It went away in a couple of days. I did not take anything for it but did put Cletrimazole and Betamethasone Dipropionaate cream on it.

felt funny; eye lids tender; lips tingled; face was swollen more than before; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 18Jan2021 at 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reporting on the COVID vaccine and who explained that she had a reaction to the vaccine. She had the vaccine yesterday (18Jan2021) about 03:30 in the afternoon and by the time she got home, within the hour, her lips tingled and she felt funny, and her eye lids tender. There was no one to call by that time and she did not think it was severe enough to go to the ER so she just took a Benadryl and went to bed. The patient woke up and her face was swollen more than before (onset reported as Jan2021). She doesn't think she is at the stage of life threatening, she can still breath, but doesn't know what to do at this point. Should she take more Benadryl or contact her healthcare provider. The patient asked if this makes her ineligible for the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.

Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,

Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened after the second dose/ it was very red and warm and itching/ it was a red area about 5 cm in diameter around the injection site in the upper arm; it was very red and warm and itching; Soreness of the arm/It hurt, it was warm, slightly swollen and raised from rest of the skin; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; This is a spontaneous report from a contactable Physician. A 76 year old female Physician reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK4176 Expiry date 31Mar2021), at single dose in the left Arm on 14Jan2021 at 2:30PM for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot E11865, Exp Mar2023) in the left arm on 23Dec2020 . Medical history included asthma and allergy. She had a contrast IV reaction before. She is Allergic to everything, inhalants, weeds, dust, trees, grasses, foods like chickpeas that have her bad asthma and fishes like Halibut. When she did a skin test she reacts to everything. She has been on prednisone. She was admitted to the hospital a year ago in November for an asthma attack. Concomitant drugs included inhalant steroid medication and other medication for Asthma. The patient reported that on 15Jan2021 after the second dose, approximately 2/3rds of the arm has swollen up, this lasted about 7 days. On the 8th day and it is beginning to go down. She also added that her arm was still red. The mild swelling actually started as itching, within 10-12 hours, when she woke up and looked it was a red area about 5 cm in diameter around the injection site in the upper arm. It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given, like upper back of arm. On 16Jan2021, it was close to half of the upper arm, well not exactly half the arm, but it was very red and warm and itching, on the left Arm. On 17Jan2021 it was at 2/3rd of the arm, almost 15 cm's in length at that point. Still very red, it wrapped towards the front of the arm, she could see the color without looking in the mirror. The swelling has ended, the raise part stopped around the 19Jan2021. The redness as of the 19Jan2021, it was less, the skin is slight pink, pinker than the normal skin, she has put some steroid cream skin lotion on the red area, she did that on 16Jan2021 twice a day. She also took Benadryl for 2 nights on 16Jan2021 and 17Jan2021. The itching stopped, when the skin was covered it was not that bad, but when the air hits it, it itches. Caller also added that there was soreness on the arm, it was achy, but it was very minimal now, she notices it when lifting things, that was when it hurts.

Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours

I have had a sore left arm since receiving the first dose on 1/16. VAERS report was put in and e-confirmation 294505. First dose was given in the right arm but caused pain in the left arm. With the 2nd dose due to the pain in the left arm, I got the 2nd dose in the right arm. There was just a sting when they put in the needle in. Today 2/10/2012 around 2-3 am I woke up and my arm is swollen. It is a little discomfort when I move my right arm.

BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.

One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.

Sometime between 1 am and 7am left eye and cheek swelled. Eye mostly shut. Could open a slit. Hot shower compress helped. Only slight swelling by 4 pm.

On second day after second dose (2/22/21) lump on arm below injection site, and enlarged lymph node on left side of neck.

4 days after 2nd dose: hives all over my body and swelling of face and eyes. Called Telemedicine at Urgent Care Huntsville Hospital. Was given instructions to take 40 mg of Prednisone first day and taper off, 2-3 doses of antihistamine and Hydrocortisone on welts. Needed to go to ER for IV if face swelling did not go down. Today (second day after call): Face swelling is down but hives are possibly worse (large welts over large portion of body plus on hands and feet and chin)

Received shot at approximately noon and within a few hours, began not feeling well and by that night developed fever 102 with loss of appetite, chills, weakness, unable to stand - her legs developed spasms and jerking. The next day, temp continued to climb up to 102.6 with continued issues with spasms and jerking to lower extremities. Did not seek medical care but did take natural herbs and nutritional supplements to treat. Symptoms have lessened each day but were persistent for 10 days post vaccination. Has a hx of CLL diagnosed in 2008 and WBC runs persistently high.

I was vaccinated on Feb 23, 2021, on the evening of Feb 24, 2021, I experienced soreness and swelling under my right arm pit. To date the swelling is still apparent, but most of the soreness and pain under the arm pit has improved.

Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking

Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes

Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow. Right cheek hurts because of the swelling. Took 2 Benadryl at noon. Right cheek is burning. Today is Monday and it is still swollen but not as red. It hurts and got more Benadryl to take. Took 2 at 3pm today.

Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.

Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.

Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.

? 1155 Pfizer covid 19 vaccine administered. ? 1210 Patient complained of bump, left deltoid. Ice pack applied to left arm. ? 1235 Nurse reiterated common side effects with vaccine, patient verbalized understanding and advised to contact pcp and/or urgent care if worsens. Left with no other complaints.

Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.

2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date

Took the Pfizer vaccine and within two days, swollen eyes and face. My face has been swollen since then I look like I have chipmunk cheeks, how long will this take before it goes away. It is over a month The eyes are sometimes swollen , but not as much, just bags under my eyes Is there any other suggestions besides ice on face and taking allegro, and benedryl, that will make the swelling go down permantly

she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21

Gradual eruption of hives with worsening itching, almost all on the right side of my body, with eventual swelling of my face, mostly on the right side, to the point of nearly closing my right eye.

Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On admission she was found to be + for SARS-Co-V2. She had no respiratory symptoms and was not treated. She was discharged to

Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on the upper right back; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiry date: unknown), via an unspecified route of administration in the right arm, on 19Mar2021 08:30, as single dose, for COVID-19 immunisation. Medical history included Alpha gal (allergic to all mammal protein). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; pravastatin sodium (PRAVASTINE); famotidine (PEPCID AC); and loratadine, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Feb2021 08:45, as single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Mar2021 at 12:30, the patient experienced right side of face swollen so the eye was almost invisible, rash on face, neck and hands, some on the upper right back. The events resulted to emergency room visit. Treatment included prednisone and Benadryl. The patient was recovering from the events.

swelling under arm that was vaccinated (lymph nodes?); This is a spontaneous case from a contactable consumer (patient).A 76-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6200; Expiration Date: UNKNOWN) via an unspecified route of administration in arm left on 18Feb2021 at 14:00 as a single dose for covid-19 immunization. Medical history included 2X cancer survivor, osteoporosis. Concomitant medications included alendronate sodium (FOSAMAX), pravastatin (PRAVASTATIN), calcium (CALCIUM), pyridoxine hydrochloride (B6) taken for an unspecified indication. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 20Feb2021,The patient experienced swelling under arm that was vaccinated (lymph nodes?) The outcome of the event was not recovered.

Painful swollen lymph nodes under left arm and close to breast. I keep my left arm in sling like position held close to my body to help alleviate pain. Left back shoulder aches. Sometimes painful when I breathe and feel pain under rib cage on left No fever

Death R41.82 - Altered mental status N39.0 - Urinary tract infection N17.9 - Acute kidney injury (CMS/HCC) A41.9 - Sepsis (CMS/HCC)

Increased shortness of breath for a few weeks and then acute worsening of this along with new chest tightness on 4/30 which led to hospitalization and ultimately diagnosis of pericarditis. Atrial fibrillation also developed during the course of the 4 day, 3 night hospitalization.

Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown. No follow-up attempts are possible. No further information is expected.

she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.

This 76 year old black female received the Covid shot on 2/27/21 and went to the ED and was admitted on 3/17/21 and again to the ED and admitted on 4/7/21 with the diagnoses listed below. Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction Non-ST elevation (NSTEMI) myocardial infarction Epistaxis

There is new onset, persistent swelling in both hands after vaccine. This swelling has caused multiple trigger fingers to develop in both hands. There have been three episodes of swelling in both legs and feet that were never experienced prior to vaccine.

Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.

uncomfortable shooting sensation down her arm repeatedly throughout the day every day since first shot. 5/4 entered the hospital and diagnosed with Sepsis and MRSA. They cannot explain the source of this infection and cannot get it under control

Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.

Erythromelalgia; 3/19/2021 Patient is a 76-year-old female who presents to the emergency department for evaluation of a pruritic rash. Is been present for just over 1 month. She relates that began after receiving her second Covid vaccination. She denies any new exposures medicines foods cleaning items or hygiene supplies. She denies any systemic symptoms. No airway symptoms. Physical exam significant for dry erythematous rash. Is suggestive of eczema. His primary to the right hand in the palm. It seems to spare the dorsum of the hand. There is diffuse swelling. No fissures or lesions. No evidence of secondary infection.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.

She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.

I took the Pfizer vaccine in January and had a anaphylaxis reaction which I reported earlier. This is not about that but a week ago I began experiencing sharp pain in my thumbs when I tried to open a jar, pull up my pants, rub my hands together, flush the commode, etc. I have never had this kind of pain before. I looked on the internet to see what might help and noticed that the pain could possibly be a reaction to the Covid vaccine. Therefore, I am reporting it to you.

Patient presented to the ED on 4/25/2021 and was subsequently hospitalized for COPD exacerbation. Patient presented to the ED on 5/27/2021 and was subsequently hospitalized for lower extremity edema. These visits are within 6 weeks of receiving COVID-19 vaccination.

Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge

Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.

SOB,Rash,4/14 anaphylactic shock admitted to Er remained overnight for observation, 5/9 rash returned after prednisone ER , 6/10 dermatolgist Dr rash returned. Took scrapping of skin, came back as Grover,s Disease.

Per PCP consult note: A: small lumps soft, randomly appeared on forearm, then resolved on own, still has residual bump on left arm - after visit, discussed with colleagues and learned that this appears to be a delayed side effect of the COVID vaccine

Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.

chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.

has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her right arm to her elbow was hurting; Swelling; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 05Feb2021 02:55 (Age at Vaccination: 76 years) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included PRESERVISION (reported as eyes) for AREDS 2, 1 twice daily from Feb2021 to ongoing started a week ago; hair skin and nails (reported as stye) as 2 gummies daily on an unknown date in 2020 (reported as 3 to 4 months ago). On 06Feb2021, the patient experienced swelling. On 07Feb2021, the patient has trouble moving her arm/ received vaccine in left arm, but right arm was hurting. The patient reported that when she woke up on Saturday her right arm was hurting. She received the vaccine in her left arm. The muscles in her right arm to her elbow was hurting. She also has swelling in her arm. She used Hemp Pain Cream. She is asking if she can take any type of pain killers. She is also having trouble moving her arm. She confirms that this started after receiving the vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. There were no prior vaccines administered within 4 weeks. The patient still had pain even after using Hemp Vana Pain Cream. Patient received treatment as Hemp Vana Pain Cream (Lot number: 37455C, expiration date: Dec2021). The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.

Swollen lips; Swollen neck; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications included NORVASC, LANTUS, lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 08:00, the patient experienced swollen neck and lips. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the swollen neck and lips was not recovered at the time of this report. Information about lot number cannot be obtained. No further information expected.

This is a non-interventional study report from the marketing program received from a contactable consumer (patient) based on information received by Pfizer. A 76-year-old female patient received BNT162B2 (Pfizer BioNTech covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 12Apr2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunisation. The co-suspect included upadacitinib (RINVOQ), oral from Oct2020 (Batch/Lot number was not reported) to an unspecified date, at 15 mg for moderate to severe rheumatoid arthritis. The patient's medical history included diabetes mellitus from 1960 to an unknown date, rheumatoid arthritis from 1987 to an unknown date, internal haemorrhage from 2018 to an unknown date, small intestinal resection from Dec2018 to an unknown date, abdominal hernia from 2019 to 02Jun2021, non-tobacco user from an unknown date and unknown if ongoing, knee arthroplasty from 15Feb2021 to an unknown date, difficulty in walking. It was unknown if she was enrolled in a COVID-19 vaccine trial. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for rheumatoid arthritis, start and stop date were not reported; gabapentin (NEURONTIN) taken for rheumatoid arthritis, start and stop date were not reported; prednisone taken for rheumatoid arthritis, start and stop date were not reported; flecainide taken for heart rate decreased, start and stop date were not reported; metoprolol taken for heart rate, start and stop date were not reported; warfarin sodium (JANTOVEN) taken for an unspecified indication, start and stop date were not reported; venlafaxine taken for pain, start and stop date were not reported. On an unknown date in Apr2021, patient experienced knee surgery. On 13May2021, patient had another procedure for her abdominal hernia. Patient mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20May2021 and was treated with unrecalled antibiotics and pain relievers. On 13May2021, the patient experienced could not open and close left hand and swelling of left hand. On an unknown date in 2021, patient stated that "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre", knee osteoarthritis. The reporter causality for the events knee surgery, knee osteoarthritis was not reported, blood sugar abnormal was possible, joint range of motion decreased, peripheral swelling, arthritic pains were not related. The manufacturer causality for all the events were no reasonable possibility. The patient underwent lab tests and procedures which included blood glucose abnormal: unknown mg/dl on an unknown date, blood glucose abnormal: unknown mg/dl on 09Jun2021, blood glucose abnormal: over 400 mg/dl on an unknown date in 2021, computerised tomogram: unknown on an unknown date, international normalised ratio: unknown on 09Jun2021, x-ray: unknown on an unknown date. The outcome of the events "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre" were not recovered. The outcome of the events, knee surgery, knee osteoarthritis, could not open and close left hand and swelling of left hand were recovering and the outcome of had another procedure for her abdominal hernia was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information provided in narrative, the events hernia repair, knee operation, Osteoarthritis is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association. The events hyperglycemia, joint range of motion decreased, peripheral swelling, and arthralgia is assessed as possibly unrelated to the suspect drug BNT162B2 since the reporter denies causality. Also, consider possible contributory effects from patient's medical history and/or concomitant medications. 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.

Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; It is still draining and is still a little red; It is still draining and is still a little red; right side of the face was swollen; both of her eyes were swollen; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 77-year-old patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 16:30 (at the age of 76 years) as a dose 2, single for COVID-19 immunisation. infliximab (REMICADE), via an unspecified route of administration from 27Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. Patient's medical history included ongoing crohn's disease, She's had it for about 3 years, immune system disorder from an unknown date and unknown if ongoing, She has low immunity, skin cancer from an unknown date and unknown if ongoing, She had skin cancer. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265 and expiration date was not reported), via an unspecified route of administration in arm left on 17Feb2021 as a dose 1, single for COVID-19 immunisation and remicade for crohn's disease. Additional vaccines administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were and AEs following prior vaccinations were none. It was reported that, Patient who had both doses of the Pfizer COVID Vaccine. She had a birthday yesterday (date unspecified), so she was 77 years old when she experienced the events. She had her 2nd dose on 9Mar2021 and had a Remicade infusion on 27Apr2021. After her infusion, both of her eyes were swollen, the right eye was sensitive to light, her eyes kept fluttering while looking up or bending over, and the right side of the face was swollen. This was constantly happening but is now getting better but not completely over. She mentioned that she talked to several doctors and they think that Remicade, since it lowers the immune system and decreases white blood cell count and the vaccine increases the white blood count, it has interfered with the signals with her eyes. She was also hospitalized from 29May2021 to 2Jun2021 for cellulitis and was given some antibiotics and steroids which she thinks helped with her symptoms. She was asking if this has been reported and if this will happen again on 24Jun2021 for her next Remicade infusion. she was taking Remicade before giving her the vaccine. she had concern, would the vaccine affect the Remicade and cause these reactions. Upon follow up, It was reported that, patient had her second dose of the Covid Vaccine on 09Mar2021, and on 27Apr2021 she had a Remicade infusion. Both of her eyes were swollen, and the right side of her face was a little swollen. She wants to know if it could be an effect of the vaccine and if she will experience this again after her next infusion this June. she comes on the line. Her right eye was the worst. When she looked up it started to go closed. If she goes into a bright light it would go closed and bending over it would go closed. It would keep fluttering, and she would have to go sit down and close her eyes until it settled down. It interfered with her activities, and she didn't feel comfortable driving because she didn't know when it would hit her. Every time she talked to a doctor, they acted like she is crazy. It only seemed after the Remicade that this started happening, and now she was due for another Remicade infusion on 24Jun2021. She had some other health issues earlier this month and was put on antibiotics. The antibiotics seemed to help the eye it is not completely gone but better. She was wondering now if she should get the Remicade on 24Jun2021. She had skin cancer, and when they removed it, she got cellulitis in her leg. She was in the hospital for 3 days. She asked the doctor there and they brushed her off. The last day before she came home the nurse came in and wanted to know if she had her shot. She asked the nurse the same question about the vaccine and Remicade, and the nurse said now they ask people before they get the shot if they are on Remicade. The nurse didn't have anyone that said yes. It was seeming like there is some kind of problem with Remicade and the vaccine. That is why she was a little bit concerned about having it again. Event details Both eyes swollen: They were still swollen. It was reported that, Sometimes her right eye will still go closed. It has gotten better. Right side of face a little swollen: It lasted for at least a month. Cellulitis in her leg: That would have started on 21May2021. She went to the hospital on 29May2021 and came home on 02Jun2021. She doesn't know if it went away. She finished her medication on Wednesday, she took the last of the antibiotics they gave her to take at home. It is still draining and is still a little red. She doesn't think it is quite as red, but it is still draining. It is about the same. Along the way she went to Urgent Care. They put her on steroids that didn't help. A couple weeks after she got an infection and they had her on 3 or 4 different antibiotics. She didn't know if one helped, or it was just the Remicade wearing off. She was on 3 different antibiotics. One was Doxycycline and that didn't help. The other one they gave her to take home was Amox Clav 875, and it was 125mg. She took it 2 times a day for 6 days. Both of the antibiotics she took are in amber colored pharmacy vials. She doesn't remember the name of the steroid that she took. She had her first dose of the Covid vaccine on 17Feb2021 and second dose of the Covid vaccine on 09Mar2021. She has been on Remicade for many years, at least 3 or 4 years. Before that she was taking a pill. The Remicade is an infusion. They mix it up when she comes in. She did not know a dosage. She had gone to the eye doctor, and she did a bunch of bloodwork. The patient underwent lab tests and procedures which included blood test and computerised tomogram with unknown details. She doesn't know what bloodwork she did. She also had a CAT scan of her eyes in the hospital. The patient was hospitalized for cellulitis / cellulitis in her leg (cellulitis) from 29May2021 to 02Jun2021. She was in hospital for 3 days. Events did not require a visit to Emergency Room, but Physician Office visit is required. For her eyes she went to Urgent Care, and they said to make an appointment with an eye doctor. Family Medical History Relevant to the events were none. It was the Product Complaint, Product strength and count size dispensed: Amox Clav 185: 125mg strength. Outcome of the cellulitis / cellulitis in her leg was not recovered, both of her eyes were, the right eye was sensitive to light, her eyes kept fluttering, right side of the face was swollen were recovering. Outcome of it is still draining and is still a little and it is still draining and is still a little red were unknown. Information on the lot/ batch number has been requested.

My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I had swollen glands under my jaw. 1)The morning after the shot I awoke to severe nausea and vomiting and had to get prescription anti-nausea meds. 2) A few days later my bowels went wild with lots of rumbling and gas and frequent bowel movements. 3) The swollen glands in my jaw cycled between getting better and then worse, and I had and bouts of feeling unwell and fatigued. I went from sleeping 7-8 hours per night before the vaccine to sleeping 9-10 hours a night. Some days I was fine. Then I would have a bad day. One day I was fine in the morning then crashed after noon -- like when I had mononucleosis at 17.

RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE. THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN

Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.

Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected

Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist

Patient states that a few hours after getting second vaccination she experienced edema and nerve pain in her legs that traveled up past her ankle causing her to not be able to sleep. She does have some edema and neuropathy as part of her history but she states that this was much more severe than normal.

-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also. - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related) Gradually became larger rash on right shin area. Right ankle and leg started to swell. - Last week of March, First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased. April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)

Pfizer vaccine given at a pharmacy. within 15 minute, pt complained of lightheadedness, face swelling, hand swelling, throat swelling, difficulty breathing. Per patient all symptoms resolved within 15 minute wait period. no medications were given for symptoms.

arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.

Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.

knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node; assuming it was a swollen lymph node, it was real sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (reported as injection in the right arm) on 09Jan2021 at single dose for Covid-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received the first dose of the Covid vaccine and now (10Jan2021) has a knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node. The patient added that it was real sore but now it is not quite as sore, it doesn't hurt. The patient asked if it could be from the vaccine and how long should it be there. She also asked if she should still get her second dose on the 30th (30Jan2021). The outcome of events was recovering.

arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm. It's become difficult to move her arm and had worsened since the injection. She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.

her face got swollen something like that; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included tooth canal/a tooth it's going bad on Jan2021. Concomitant medication included celecoxib (CELEBREX), and levothyroxine sodium (SYNTHROID). The patient took the first vaccine and what happened is that she had a tooth canal then right after. The first dose happened on the 16Jan2021 which is last Saturday then after that it seems that the effect that her face got swollen something like that on an unspecified date in Jan2021. The patient stated, "Yes, but it has nothing to do with the vaccine or an allergic reaction. It's just a tooth it's going bad. So I needed to go to the dentist and probably get an antibiotic (Unspecified medication captured as suspect) for it but I wanted to make sure that's not going to negate the strings of my vaccine. I didn't know what it would do to that. No, it's not because of the vaccine. I had actually had it X-rayed on the 13th and he didn't see anything that looked bad but it's gotten worse and it has pores, two pores it has nothing to do with the vaccine. I just I am concern about getting an antibiotic because I don't want it to affect my vaccine. As I said before the vaccine has nothing to do with my problem." The patient underwent lab tests and procedures which included X-ray: didn't see anything that looked bad but it's gotten worse and it has pores, two pores on 13Jan2021. The outcome of the event was unknown.; Sender's Comments: Face swelling is not related to the vaccine use but due to the underlying tooth canal issue.

About 2-3 hours later, and my body was just swollen, the back of knees were swollen, my arm and body is swollen. Like the first dose it was my lymphatic system that caused the swelling. I have been having treatment (PT) for my arm 3 times a week to try and get the swelling down. I have seen Doctor on 01/11/2021 and 02/09/2021. Doctor was the one who put in the referral for home health. The PT and RN have been been coming out to my home to see me.

Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain, swelling, lymphadenopathy persist now Taking acetaminophen. At home for now. Also adv warm compresses/drinks for comfort. Adv to FU with HCF trouble breathing or if symptoms persist/worsen.

dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.

Patient received 1st dose of Pfizer Covid19 vaccine today at the Health Department at approx 10:56 AM; pfizer lot number EN5318. Patient has history of feeling 'flushed' after paxil, sulfa, flexeril, codeine; no history of anaphylaxis. Patient alerted the guardsman at 11:09AM that she was experiencing swelling and burning on her face and lips. Nursing and medic staff responded and observed swelling over her right eye and cheek. The medic reported a significant increase in swelling from her pre-vaccinated appearance. BP 118/76. EMS already on site. Epi 0.5mg 0.5ml (Lot 339384) administered RD IM and Benadryl 50mg IM LD administered at 11:11 AM. EMS called for 2nd transport vehicle and arrived at 11:23AM and assumed care of patient. Patient transported to hospital. Called patient on 2/11/2021. Patient stated feeling better. Stayed at hospital and was observed for 4 hours. IV and oral Prednisone given. Still has some facial swelling. PCP recommends not getting second dose.

One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.

jan 6 first dose--jan 27 second dose calling to report arm swelling after the second dose of vaccine vaccine--went down with ice--started this Sunday Feb. 7--subsided on Wednesday Feb. 10----claims to day she got a big red/rash mark underneath the naval--no other s/s she went to the hospital today

Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left side) and painful throbbing on right side of neck.

Itchy burny skin rash started in right armpit and lower back, then migrated sequentually to left armpit, the sides of both breasts, the back of the right shoulder, the left thigh, and finally to the abdomen. The rash starts as fine red spots that later become inflamed and join to form large irregular patches that could be a 2 or 3 inches in diameter. Televisited primary care physician who prescribed Zyrtec twice a day and Caladryl topical lotion and referred me to a dermatologist who prescribed 0.05% Clobetasol Propionate Ointment and Benadryl as needed. The rash persisted and became worse after the 2nd shot 21 days later, but was fading slightly and was less itchy and burny just before the 2nd shot. Will report 2nd shot events separately later.

on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms

Itching all over my body - arms legs back. Extreme itching hen starched causes swelling and/or hives.

Redness, swelling, and warmth over the right deltoid area. States there is tenderness to the site as well.

swollen glands in left neck, ER room visit, IV vincomyacin and anti-inflammatories, 3 days in hospital, transferred to oral antibiotics (Clindamycin and Cipromyacin),

Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.

Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This morning she had swelling in her arms, real bumpy about 2 1/2" in diameter, looks like rocks, red/pink area 1 1/2". It is very painful throbbing area on her arms, getting worse. She has been taking Tylenol. She felt a little relief of the pain with the Tylenol. She rested all day yesterday. She left at 10:00 for her bridge club and that's where she noticed the reaction and has gotten home around 3:00 and not feeling well. They told her to call us as they did not have any side effects from the vaccine. She does have an appointment on 3/11/21 with her PCP.

Pt states she developed swollen lymph nodes under her left armpit towards her breast. The next day she had a itchy red rash at the injection site. Pt contacted her PCP and she was told to keep an eye on it and make a VEARS report since she had a reaction to taking the vax.

Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen, left foot swollen, weakness, small blood clot in myopic of middle finger, small modules in upper thigh, sore on lower lip right side

Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took three more days for symptoms to disappear.

"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care

facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset. Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms

Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.

Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate

Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)

possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling erythematous rash, eye swelling 2-3 weeks after vaccinations (twice).

Received vaccine 3/4/21 second dose. On 4/2/21 got soar throat and both glands swollen. Called doctor right away and was given prescription for Z Pack. Felt better in 2 days.

Swollen lymph nodes right armpit 03/10/2021, still visible 4/13/2021. Swollen lymph nodes under left eye 03/09/2021 to 3/11/2021 gone.

Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thromboses. History of redness and swelling to entire left leg starting on 3/1/2021. Received Heparin infusion in hospital. Currently receiving Eliquis p.o. Pt also underwent trombectomy with iliac stent placement by IR.

allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC

3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21

could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibodies and they are there but not very strong; anaphylactic reaction; excruciating pain in the body; felt like if her internal organ were shutting dow; was so weak her husband fed her and made sure she was drinking; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Mar2021 15:30 (3:30 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hashimottos (reported as hoshimottos) Diagnosed 35 years ago, hypermobile Diagnosed 20 years ago, and disorder nomia Diagnosed 25 years ago; all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID); diazepam (VALIUM); and levothyroxine (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 on 15Feb2021 for covid-19 immunization first dose at the left arm and experienced immobile for a day, cannot walk, weakness and sore arm. The patient was to know if there is going to be a booster for the Pfizer covid vaccine. The patient stated she received the Pfizer covid vaccine both doses and she is calling to report the reaction she had with the first and second dose to help other patients, she said she was close to death after the second dose. In the middle of the night she was awaken due to excruciating pain in the body, like truck ran over her. The patient heard that someone had same reaction who was in the hospital, with similar symptoms to covid. She said she felt like if her internal organ were shutting down. She does not do well with the antibiotic, and does not go to the doctors. She could not walk or eat after the second dose. She said she has hashimoto dysautonomia hypermobility. she said she thinks she might have had anaphylactic reaction. The patient added that she has lived through it and her experience has been very unusual. The caller has underlying conditions that may have caused this event, she received the second dose on 08Mar2021, it was a horrible experience but since she is still alive she would want to report it. The caller does have strange reactions to chemicals and she typically goes to naturopaths and holistic doctors because of this. The caller also has multiple autoimmune disorders and feels like that may have played a part in this reaction. It was added that further added that she received her second dose 08Mar2021 at 3:30pm and had a little bit of a sore arm, she was thinking positive thoughts about all of this because she never gets vaccines. At 2:00am on 09Mar2021 the caller was awaken in excruciating pain, every surgery she has had or accident manifests in the greatest pain. The pain was excruciating the caller took over the counter pain medicine and diclofenac and it didn't help. The caller is unsure of what she took, she may be making this up. The caller felt like she was dying, she felt like her internal organs were shutting down, it happened all week. The caller was so weak her husband fed her and made sure she was drinking. The caller thinks she would die if she had to have a booster shot of this vaccine. The caller has never had anaphylactic shock, could this have been anaphylactic shock? All of the pain from a surgery all occurred at once and her entire body was wrecking, in horrible pain, that she does not think heroin could have taken care of. After the second vaccine she was literally so weak that she felt like all of her vital organs were shutting down and it lasted for 6 days, like she got hit by a truck, like had beat her up. The caller knows that there are new found reactions with (Company name) and they stopped thousands of doses because of it, she saw this in the news today. The patient wanted to make note that she has underlying autoimmune diseases, she is unsure if there is a correlation between this and her reaction. The caller was changing from her thyroid medicine and her thyroid went very high with the generic brand so she was swapped to Synthroid in the middle of this. The caller was on levothyroxine and it wasn't working, her thyroid was sky high (Unknown lot number and expiration date Feb2022). The caller was going through all of these changes as well when she received the vaccine. The caller's doctor took a test and the caller has antibodies and they are there but not very strong. The caller doesn't want to be spreading something because she is feeling healthy and fine today. The outcome of the events was unknown.

sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.

4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swollen lympth node on the left side of jaw. MD stated there was an infection and prescribed Augmentin for 14 days. 4/23/21: back to fast med. Still has no healed and was prescribed Doxycycline for `14 days 4/26/21: Patient developed a vaginal itch and raw legs * Stated had a headache during this whole duration

February 8th started right arm swelled up like a baseball bat for 3-5 days, went away after using ice pack. Symptoms came back around March 12th with rash on left arm, black and blue mark about 1-2 inches, no pain, lasted about two weeks. March 23rd had red 3.5 inch lesion, soar, painful, no itching.

SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.

Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.

Patient presented to the ED and was subsequently hospitalized for Severe sepsis with septic shock within 6 weeks of receiving COVID vaccination.

Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)

cold sore/fever blister/ used abreva and it started spreading; This is a spontaneous report received from a contactable consumer. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534 and Expiration date was not reported), via intramuscular route of administration, in arm right, on 17Mar2021 (last Wednesday) (at the age of 77 years), as a single dose for COVID-19 immunization. Patient received ABREVA (Batch/lot number: D54N) on 20Mar2021 for oral herps. The patient medical history included appendectomy (Since she was 18 when she had an appendectomy). There is no Patient History and no Investigation Assessment. Patient stated that she had the Pfizer vaccine last Wednesday and the following day (18Mar2021) she had a cold sore or fever blister. Later clarified as cold sore. On 20March2021, she used abreva and it started spreading, while getting the abreva in store, a lady she was talking to, said she got one (cold sore) after her 2nd one. Patient asked if cold sore/fever blisters were reported by others after getting the vaccine. Patient stated that she was trying to treat the cold sore and it keeps spreading. Patient stated that she has not had a cold sore since she was 18 when she had an appendectomy. Stated that the pharmacy tech mentioned that she had the second shot and could not make the connection that it was to her cold sore. Stated that it was unknown which shot she had. Patient stated that she was using Abreva and has not dried it up. Stated that it has spread from her lip down to toward her chin. Stated that it is clusters and not just one spot. Clarified that the medication stopped the itching part but it is still growing. Stated that she was using a product and it has not helped. Provided a lot of BO193113Y. At the time of this report event outcome was not recovered. No follow-up attempts are possible. No further information is expected.

hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

had anaphylactic reaction/throat and mouth swelled so much dentures pushed out of the top; This is a spontaneous report from a contactable nurse. A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8734, expiry date unknown), intramuscular, administered in the left arm on 02Apr2021, dose 2, single for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension (HTN), arthritis, atrial fibrillation, diabetes mellitus (DM), breast cancer which was in remission all from an unknown date and unknown if ongoing. Concomitant medication included isophane insulin (NPH INSULIN); potassium (manufacturer unknown); sertraline (manufacturer unknown); levothyroxine (manufacturer unknown); acetylsalicylic acid (BABY ASPIRIN); calcium (manufacturer unknown); trazodone (manufacturer unknown); dicyclomine (manufacturer unknown); famotidine (PEPCID); insulin human injection, isophane (NOVOLIN N); carvedilol (manufacturer unknown); magnesium (manufacturer unknown); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and codeine and experienced allergy. The patient previously received the first dose of bnt162b2 (lot number: EN6208), intramuscular on 12Mar2021 at 07:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, seven days post the second dose of the Pfizer vaccine at 19:30, the patient had anaphylactic reaction to shrimp in which she never had this reaction ever before, eating shrimp all the time, eating other items in the dinner all the time, throat and mouth swelled so much dentures pushed out of the top. The patient's husband called EMS and the patient was given Benadryl x 2, epi x2, shots x2, was intubated and woke up two days later in ICU. The patient's allergy and blood tests were negative for any possible food allergies that she had consumed on that day. The patient's doctor stated this event could have been absolutely related to the vaccine. The event resulted in a visit to the emergency room/department or urgent care and was hospitalized for 10 days. The patient received epinephrine, magnesium, antihistamine and steroids as treatment for the events. The patient was intubated and placed on a ventilator. The patient has not recovered from the events. The events were considered as a life-threatening illness (immediate risk of death from the event).; Sender's Comments: Based on the information currently available and the known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported anaphylactic reaction cannot be completely excluded. This case will be reassessed upon receipt of additional information.

Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown. No follow-up attempts were possible; information about Lot/batch number could not be obtained.

red blotch with lump on left arm, black and blue marks left leg, itchy little bumps, top left foot, very black and blue on top of right foot going on to toes took pictures on my cell phone

Redness, swelling and extreme pain. Started right after injection and it continues as of today. She was started on Keflex at first and is now on amoxicillin.

Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.

Her face is swollen up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing (she is a diabetic on an insulin pump), breast cancer from an unknown date and unknown if ongoing, kidney disease from an unknown date and unknown if ongoing (she is unsure if she had that either, but she had the symptoms), Allergies from an unknown date and unknown if ongoing (she also has extreme allergies. allergies continue year round), Lung surgery from an unknown date and unknown if ongoing (lung surgery because of the allergies and the drainage in her lungs). The patient historical vaccines included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiration date of 31Aug2021), via an unspecified route of administration on an unspecified date (at 77-year-old) for COVID-19 immunization and experienced Her face is swollen up, Memory, swelling in the face, forehead, eyebrows and she feels it moving. The patient's concomitant medications were not reported. The patient experienced her face is swollen up on an unspecified date. It was reported that, the patient was calling about Pfizer COVID vaccine. Her face is swollen up, wondering if this is a symptom. She just got the last one, it swelled up with the first one, but she did not call, this is the second one. Stated when she got the shot, she told them all the health problems she is having, they said it's ok to get it, she is a diabetic on an insulin pump, has breast cancer, she has had it, so she was questioning having it again, and they say she has kidney disease, she is unsure if she had that either, but she had the symptoms. This was all diagnosed before she took the shots. She told the doctors that before the shot. She is unsure if it's that or not, but her face swelled up the second or third day after the first shot. Another thing she noticed- memory, her memory was kind of worse. That started after, she noticed more after the shot, the first shot. Face was swollen over her eyebrows, over eyes and lips. She also noticed it moved from one side to the other in a matter of hours. Memory outcome: seems like it was improving, as soon as she found out what was wrong, as soon as she was alerted, she was not remembering too good. Another one, she had last one the 24th, 24Jun2021, so she is going to get a biopsy, is it too soon to do that? It was not even a week of getting it. The biopsy is today. She was informed that she had the appointment yesterday, which is why she called to find out, is it too soon, with not even been a week since she had the COVID shot. She has swelling in her face and she said she can feel it moving. Her face is swelling, and her forehead is protruding. There is swelling around her eyebrows and forehead. She can feel moving of the swelling, moving from one side to the other. She has a biopsy scheduled for today and was wondering if it was the wisest thing to do to get the biopsy today. Caller is also concerned about when one gets the Covid shot, is more than one vial used to give the shot and does it get mixed with something? She spoke with the pharmacy about her concerns because of cancer. She has had cancer before and was questioning that and also kidney problems and kidney disease. Patient states she also has extreme allergies. She has had lung surgery because of the allergies and the drainage in her lungs. The allergies continue year-round. The pharmacist said it was still ok to get the shot. Outcome of the event was not recovered. Information related to batch/Lot no. was requested.

her memory was kind of worse; swelling in the face, forehead, eyebrows and she feels it moving; swollen over her eyebrows, over eyes and lips; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus (she is a diabetic on an insulin pump), breast cancer, kidney disease and patient had unknown allergy (she was allergic to something but cannot provide what it is specifically). The concomitant medications of patient were not reported. Patient stated that her face was swollen up, wondering if this is a symptom. She just got the last one, it swelled up with the first one, but she didn't call, this is the second one. Caller stated that her face swelled up the second or third day after the first shot. She stated that she got her both doses on 03Jun2021 (1st dose) and 24Jun2021 (2nd dose). Caller declared that her face has swollen up after her 1st dose and has persisted since the 2nd dose. It was swollen over her eyebrows, over eyes and lips. She also noticed it moved from one side to the other in a matter of hours. She knows she was allergic to something but cannot provide what it is specifically. Caller informed the vaccination site that she has serious case of diabetes, allergy, kidney problems and had cancer. Caller mentioned that she was questioned if she does have the cancer again. However, the vaccinator proceeded with her shot. Another thing she noticed was her memory was kind of worse. That started after, she noticed more after the shot, the first shot. She stated seems like it was improving, as soon as she found out what was wrong, as soon as she was alerted, she was not remembering too good. After the first dose of the vaccine on 03Jun2021, she experienced swelling in the face, forehead, eyebrows and she feels it moving. The doctor wanted to do biopsy of it. Caller stated that she was scheduled for biopsy today (29Jun2021) and wanted to know if that is too soon, with not even been a week since she had the COVID shot. Caller wanted to know if more than 1 vial can be used to give the vaccine as she thinks that more than 1 vial of the Pfizer covid vaccine was used to give her shot. She was asking if Pfizer use two vials with the vaccine because she saw them use two vials and wanted to know if something is mixed with that. Seriousness was reported as no. The outcome of event memory impairment was recovering and for rest of the events outcome was unknown. Information on Lot/Batch number has been requested.

Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Around 3PM about 7 hours later of shot The left side injection / problem left side of Face from cheek bone to jaw line redness , puffiness plus skin irritation chaffing . her left side of lip she complained of slight numbness it was suggested that if irritation take Tylenol which we did two over 4 hours before bed around 1AM took one Advil she was restless to go to sleep fearful finally around 3AM tired enough to fall asleep About 11AM called my niece Nurse Hospital she said take Benadryl but speak to DOCTOR First he said same thing did for about 4 days Swelling and Redness went down numbness lower lip still slight their now about 10 days later acceptable feeling still wondering why??

Left side of her face is swollen; This is a spontaneous report from a contactable consumer reported for grandmother. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included root canal from 04Jan2021. Concomitant medications were unknown. The patient got the vaccine on 15Jan2021 and 'this morning' the left side of her face was swollen on Jan2021. The patient was taking Benadryl as treatment. Outcome of the event was unknown.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

This 78-year-old female has a history of allergic reactions to ciprofloxacin and latex. She received a COVID-19 vaccine this morning at approximately 11 AM. In a matter of minutes after receiving the vaccine she developed tingling to the left side of her lower lip as well as some pressure in her tongue and behind her eyes. She reported a sensation like her face was swelling. She denies difficulty breathing, difficulty swallowing. There is been no nausea or vomiting. She was observed in the vaccine area, and then ultimately referred to the emergency department after approximately 40 minutes of symptoms. No chest pain or chest pressure. No rash.

Approximately 30 minutes after injection patient presented to the emergency department with mild facial swelling. Both cheeks and around her lips feel a little swollen. Denies trouble breathing or swelling in her tongue or intraoral area. Patient treated with diphenhydramine, prednisone and famotidine. Symptoms resolved.

Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No treatment rendered for the localized reaction however antipyretic medication given and resolution of temperature achieved. Primary care physician ordered allergy to the COVID-19 vaccine.

The right arm started itching on2/13/2021. It was a little redish, itched was why I noticed it. Am going to see my Health car doctor Monday 2/15/2021. I have filled this out as best I know how. I have had no pain, no syptoms of any thing else. Just the itch swelling .

Vacinne given left arm 2/2/2021 3 days later Fri. 2/5 I left side of my face developed a sore face began to swell all way to my mouth.I've had cellulitis in the past. Began taking Kleflex saw my general medicine who advised me to contact your office

My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.

1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed

freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Pt received 2nd Covid-19 Pfizer vaccine on 02/26/2021. Pt noticed symptoms the next day 02/27/2021, swollen axillary glands to right and left side that are about half the size of a golf ball.. Pt stated that she called to inform her PCP of the symptoms. PCP advised pt on treatment for symptoms but PCP also informed pt to contact facility that administered the vaccine so that we can report the adverse effect accordingly.

Swollen lymph node under arm where shot was administered. This was painful. I used heat and pressure so I could sleep. Pain lasted approximately two days. Guess that means the vaccine is working?!? I did report this to my Dr. and she said I should report it to you.

Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.

Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking; began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments. While hospitalized patient has developed double vision.

Extreme fatigue, lightheaded and dizziness, extreme joint pain, vision blurryness and sore eyes, starting Wednesday March 3rd and continuing through today Monday, March 8th. Also beginning Friday, March 5th woke up with right arm swollen just below the elbow. Not sure if any of this is related to the Covid shot or having other problems. Just noticed that my vaccine card shows Lot #EN6202 but the letter sent says Lot #EL9263, for the 2nd dose.

I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.

vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.

Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen face Mar 20, 21, 22. Fatigue and brain fog for 10 days. Went to emergency room twice. Mar 18 and 21.

Pt received 1st dose of Pfizer on 3/17/21 at 2pm in right arm. Then, on 3/18/2021, at 7pm, patient noticed rash under armpit of left arm while in the bath. Patient called PCP who instructed her to take benadryl. Rash progressed, so patient went to ER. ER doctor recommended patient not take any further medication (patient had already taken benadryl prior to going to ER). 3/19/2021 patient decided to continue benadryl 25 mg three times that day. By 3/20/2021, rash had progressed further down her legs, so patient returned to the ER. Rash was only on the arms and legs, and was NOT on torso or chest. No itching, no SOB, no lip/tongue swelling, no fever. In ER, patient was instructed to continue benadryl and was given medrol dose pack, which she was encouraged NOT to take. Patient discharged from ER and returned home. On 3/21/21, new lesions were still appearing, and patient was told to visit PCP on 3/22/2021. On 3/22/2021, patient noticed her left hand was swelling, so medrol dose pack was started. Patient had dramatic improvement in rash and swelling with 24 hours of steroids. On 3/25/2021 patient returned to PCP, rash was resolving well.

1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy for about 1 week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 14Feb2021 13:15 (Lot Number: EN6201) as 0.3 mL, single for COVID-19 immunisation. Medical history Thyroid Nodules, Mild macular degeneration, postmenopausal syndrome, HBP, total hysterectomy w/ oophorectomy, gall bladder removal, appendectomy, penicillin allergies, adhesives allergies, HOH allergies, allergies: contrast dye. Concomitant medications included valsartan (DIOVAN); estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); pravastatin; colecalciferol (VIT D3); famotidine (FAMO). The patient previously took nitrofurantoin (MACRODANTIN) and experienced allergies, claritine (CLARITIN) and experienced allergies. The patient experienced 21Feb2021- 1 giant hive at vaccination site - itchy for about 1 week, started 2 days after injection (16Feb2021) - very mild - arm was not sore at all. Treatment received for the events which included self medicated with benadryl & Aleve. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.

measles like rash on left chest; low grade fever; chills; 2nd shot, swollen glands in neck; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: El), via an unspecified route of administration in left arm on 11Feb2021 at 11:45 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COPD (chronic obstructive pulmonary disease). Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. The patient did not have any known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not test for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. It was reported that the patient experienced 2nd shot, swollen glands in neck on 11Feb2021 at 16:00, second day (12Feb2021), low grade fever and chills, third day (13Feb2021), measles like rash on left chest. All gone now. The patient underwent lab test and procedures which included body temperature: low grade fever on 12Feb2021. No treatment was received for the adverse events. The outcome of the events was recovered on an unspecified date in Feb2021.

Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Urinating like crazy/had to urinate non-stop; Sick; Swelling on her right eyelid; Pain down her neck; Everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 19Jan2021 (at the age of 78-years-old) at a single dose for covid-19 immunisation. Medical history included mastectomy (she had a mastectomy before, so she has no lymph nodes, she doesn't let them touch her left arm. She says this was done 26 years ago when she was 52), arthritis (she has bad arthritis in her back), Blood pressure high (she takes a high blood pressure medication), High cholesterol (she takes a high cholesterol medication) and eye surgeries (she has had all kinds of eye surgeries before this). The patient's concomitant medications were not reported. The patient experienced swelling on her right ear, symptoms of the flu/side effects like the flu, diarrhea/bad diarrhea, urinating like crazy/had to urinate non-stop, sick, swelling on her right eyelid, pain down her neck, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side on an unspecified date in 2021. The patient stated that she had a lot of side effects and she talked to her doctor who said to go ahead and get the second dose. She says she had no fever, but had all the rest of the side effects, such as swelling of her neck, ear, and eye, which all went away fast. She says she was sick almost 4 days, and her doctor said side effects shouldn't last that long, so she called to get advice about whether to get second shot or not. She says her appointment for her second shot is the 09Feb2021, she would like to know if it is safe for her to get. She says her side effects started in the evening, the swelling of her right ear didn't last, it went away. She says during the night she woke up and had to urinate non-stop that started that night a day later. She says that lasted the next day, then the day after, until Saturday she felt better. She says she had all side effects like the flu, then later bad diarrhea too. She says she finally took something for diarrhea (no further information provided about this) and took Tylenol. she doesn't see the expiration on that bottle, she thinks it is good for 2021. She says that she doesn't see too good. She clarifies that they Tylenol she had took before, with no issues, and her not seeing too good had nothing do with the vaccine, she has had all kinds of eye surgeries before this. She says her right ear was swollen, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side. She says that the pain started about a day later Pfizer COVID-19 vaccine. Caller says that she called her doctor today, that was the first time she did that, she was trying to wait and see, and her doctor said normally side effects don't last that long, so he has her worried. She says if she does not take the vaccine she will not be protected, but if she does, she may have worse side effects. Therapeutic measures were taken as a result of diarrhea/bad diarrhea. The patient recovered from the event swelling on her right ear on an unspecified date in 2021, outcome of the event Urinating like crazy/had to urinate non-stop was recovering, while outcome of other events was unknown.

Two weeks and six days after the first shot, my left arm became swollen, as if it was lymphedema, something I don't get, or perhaps gout. After the second shot, the arm swelled more, with the hand looking like a balloon and a few days of tiredness. I put on a few pounds. Dr wanted to rule out a recurrence of breast cancer so she sent me for ultrasound, mammograms, and CT scans, with a week gap to take antibiotics for a UTI. At a coincidental checkup with my glaucoma doctor, he said the intraocular pressure had shot up and added 0.5% Timolol eyedrops, a beta blocker. In a few days, the swelling is less and the extra weight gone.

Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to her face and went throughout body.; She also had swelling and itchiness with the rash.; She also had swelling and itchiness with the rash.; Low grade temperature 99.3 degrees; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hodgkin's disease from 2007, cardiac disorder was the patient taking concomitant products. Concomitant medication(s) included losartan (LOSARTAN) taken for cardiac disorder from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for cardiac disorder from an unspecified start date and ongoing; warfarin (WARFARIN) taken for anticoagulant therapy from an unspecified start date and ongoing; Toprolol taken for cardiac disorder from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient did not administered any other vaccine on same date of the suspect. Caller on the line calling about the COVID 19 Vaccine. She was informed to call and report any reactions to the vaccine. She received the vaccine on 02Feb2021 and three days later she developed a rash. The rash started on her feet and spread throughout her whole body. She also had swelling and itchiness with the rash. Caller went to her primary care doctor on Monday 08Feb2021 and it was suggested to her to go see an allergist because the primary care doctor could not determine what this reaction could be other than the vaccine. The rash got worse from day to day as it spread throughout her body. It started on her feet went to her ankles. She then had swelling with it; it was itchy, very itchy. The rash went from there to her face and went throughout body. She noticed it in the afternoon on 05Feb2021. She had socks on and her socks were getting tighter due to swelling. She took her socks off and then noticed the rash. She also added, she had a low grade temperature. It was 99.3 degrees. Initially stated the low grade temperature started on Thursday 04Feb2021, but then stated it could have started Friday, she is not sure. It was one of those days. She thought she had a low grade temperature for two days. She did not even take the temperature the second day because she felt so crappy and did not feel like taking it. The caller was given a name of an allergist and she would go see the allergist on 18Feb2021. The patient did not visited to emergency room. The patient visited to physician's office. Outcome of the events rash, she also had swelling and itchiness with the rash were not recovered and unknown for other event.

3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider

Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:

Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. Doctors notes state she was diagnosed with gout with a Uric acid of 8. The doctor states the covid vaccine could trigger gout and that she is taking HCTZ which can predispose. This was the pt's first episode of gout. She was treated with a medrol pak. Doctor's notes state that pt improved 1 day after taking steroids. she has not had any recurrence of gout.

Arm started hurting the next day. Hard to lift arm above shoulder. Did not get better. After a month I called the dr. and was told to take 2 naproxen twice a day to relive swelling. T his helped, but when I stopped the pain came back. Does not hurt just sitting, only when I try to lift something. Think injection was given in a muscle. Hurts when I left arm above shoulder.

Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tenderness disappeared in approximately 25 days. Dr viewed it on April 13th & confirmed it was a swollen lymph node

nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.

This 78 year old white female received the Covid shot on 1/29/21 and went to the ED and admitted on 4/7/21 with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019 J18.9 - Pneumonia R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)

intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered

numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years). The patient medical history was not reported. On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm. The patient's concomitant medications were not reported. The patient experienced pain with walking left leg on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee on 04Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: unknown results, ultrasound joint: numerous blood clots below the knee on 04Apr2021 , vital signs measurement: unknown results. Course of the event: The patient waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg. She took Aleve for a few days. It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to Hospital for an Ultrasound of her leg on 04Apr2021. After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee. Was prescribed Eliquis 5mg. She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous. It thins the blood and can cause bleeding and the blood clot can go to her heart. Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event

Within 24 hours of her first Pfizer vaccine, she developed angioedema of lower lip only. Took Claritin w/o any improvement. Seems to be spontaneously resolving. Of note, she is also on lisinopril and has been for years. Denies any dyspnea, dysphagia, facial swelling, tongue swelling.

Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.

Swollen lymph nodes/lymph nodes enlarged in right arm pit; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the right arm on 05Feb2021 (17:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer; clot in the right leg; factor V deficiency; clotting blood disorder; and bilateral mastectomy. Concomitant medications included warfarin sodium (COUMADIN), amlodipine and acetylsalicylic acid (ASPIRIN 81). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the right arm on 15Jan2021 (10:00) (when the patient was 78 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient had swollen lymph nodes/lymph nodes were enlarged in the right armpit. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.

right knee arthralgias and effusion started day after, persistent at office visit 6/15 concerning for reactive arthritis

Lips tingling/Tongue started to tingle; Face red which felt like swollen; Face red which felt like swollen; Her face "felt tight"; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:00 (Batch/Lot number was not reported) as 1st dose, Single Dose for Covid-19 immunisation. Medical history included Von willebrand's disease Von Willebrand syndrome and Glanzmann's disease and allergies. Family history included bleeding disorder. She was poisoned by pesticides and formaldehyde years ago and they burned her entire respiratory system. There were no concomitant medications. The patient never had a reaction to a vaccine. No vaccines administered on same Date of the Pfizer suspect. No prior vaccinations were given within 4 weeks and no adverse events following prior vaccinations. On an unspecified date of Feb2021, the patient experienced lips tingling, face red which felt like swollen, tongue started to tingle, her face felt tight. The events lasted about 1- 2 hours. Patient wanted to know; can she take a Benadryl before the vaccine. The second dose is due on 16Feb2021 so the first dose was 3 weeks before that one was due. After getting the shot, her lips started to tingle, tongue started to tingle, and her face felt real tight. When the nurse came out to check on her, she was told by the nurse her face was really red. The nurse was going to get an EpiPen and wanted to call EMS. The reporter states she told her to just give her a Benadryl, she normally has them in her car but had run out. Patient stated she was allergic to everything. Anything coming in contact with her respiratory system such as hair spray, scents, any chemical causes her problems. The patient explained that she was re-reading the information about telling the vaccination provider about medication conditions including allergies and bleeding disorder, both of which she has. She was concerned about getting the second dose. She wants to know if the first dose will offer any protection. She had the first dose of the covid shot on 26Jan2021. She started feeling funny. The patient called the nurse and reports her lips were tingling and her tongue was starting to tingle. Her face was really red. Her face felt like it had pressure like it was blowing up but it did not feel swollen, it was tomato red. The patient queried if she does not get the second dose what will that do. She knows there needs to be given a certain amount of time between the doses. She heard on the tv that it can be given up to 45 days and still be effective. She heard all kinds of information, she heard that someone should get the second dose within 28 days and the paperwork states something different. Asked if her reaction will be worse with second shot. She was supposed to go back on 16Feb2021 for the second dose. Patient stated she took Benadryl after her reaction from the vaccine. She wanted to know if this affects the vaccine. Patient mentioned the fact sheet states that patients should tell the vaccination provider if they have a bleeding disorder or are on a blood thinner. She states she has a bleeding disorder. Therapeutic measures were taken as a result of the events. She took a Benadryl for treatment. The outcome of the event was resolved on an unspecified date of Feb2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consisted of 2 weeks of antibiotics and steroids and, eventually PT with a specialist in lymphedema swelling. This side of the patient has many of her lymph nodes removed in conjunction with a surgical removal of a right breast cancer lump removal some 25 years ago. No lymphedema symptoms had ever incurred in the patient prior to the covid vaccination. PT is ongoing but little improvement after 2 weeks of treatment.

Flu like symptoms; Headache; Aches and pains; Sore arm; lower lip broke out with cold sores; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186, Expiration date and NDC number are unknown, time the vaccination was given: Noon), via an unspecified route of administration, administered in Left arm on 03Jun2021 at the age of 78-years-old as 2nd dose, single dose for covid-19 immunisation. The patient s medical history including any illness at time of vaccination were osteopenia, osteoarthritis and fibromyalgia, diagnosed over 20 years ago in 2001. The patient s concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date and NDC number are unknown), via an unspecified route of administration, administered in Left arm on 13May2021 at the age of 78-years-old for covid-19 immunisation. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. History of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the pfizer suspect were none. It was reported that event happened after the second dose of the vaccine. About a week after receiving the second dose, her lower lip broke out with cold sores on an unspecified date in Jun2021 and she has been fighting this more than a week now. She tried Zovirax (NDC and lot unknown, expiration date 31Mar2021) which usually helps with this but it did not this time. It has been years since this has happened. Yes, this has happened to some other people. It has been two weeks now. The Zovirax tamped it down a little but did not get rid of it like it normally does. She thinks her immune system is working and her immune system is causing the issue. It was reported that she had the normal flu like symptoms and headache on 04Jun2021 and it went away in under three days, she thought it was normal. The caller also had a sore arm on 03Jun2021 and aches and pains on 04Jun2021. By the fourth day the caller was fine. The caller wanted to make Pfizer aware that someone else had the herpes complex problem. The adverse events did not require a visit to Emergency Room or Physician Office. It was reported that age at time of onset of reaction/event was 78. Time of onset of adverse events was unknown. There was no investigation assessment. It was reported that she is tired of lock down and she does not want to wear a mask the rest of your life. She googled to see if anyone else had this come up and it seems to be a minor amount of people that have experienced it. She didnt expect for this to happen to her. The reporter assessed events as non-serious. The reporter assessed events relatedness to Pfizer covid vaccine as Related. The outcome of event, lower lip broke out with cold sores was not recovered while for other events was recovered on an unspecified date in Jun2021. Additional information is requested.

Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".

Lump; Redness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 78-years-old) as a single dose for Covid-19 immunisation. Medical history included controlled HBP (as reported), diabetes and cholesterol. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL9262) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient previously received Rofecoxib (VIOXX) (no longer made) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, the patient experienced redness and lump persisting for 5 days. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the redness and lump was not recovered. No follow-up attempts are needed. No further information is expected.

One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.

Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.

Has terrible fatigue; The blood work showed swelling and the doctor is monitoring that; The caller states people can verify seeing the caller walk with a cane; Dizziness; Body aches from the left side of body that move through neck and to the head; Has been having migraine headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient's concomitant medication included prednisone (PREDNISONE: Started out taking 10mg, after told Doctor it was bothering the caller, reduced to 7.5mg and now the caller was on 5mg once a day.) on 13Apr2021, furadantin taken in 1985 (PRE Covid vaccine) where she was hospitalized and in a coma for 3 days. On 01Mar2021, the patient had migraine headaches. On 03Mar2021, the patient experience Body aches from the left side of body that move through neck and to the head, had terrible fatigue was reported as worsened and dizziness. The migraine headache started three hours after receiving the second dose Pfizer Covid Vaccine. The migraine that day lasted for 10 hours and finally got the headache to go away. The headaches have been on and off. Body aches from the left side of the body that move through the neck and to the head. The body aches had the reporter in the bed. The caller had two good days and then four bad days. The doctor had the reporter on Prednisone for rheumatoid arthritis. Body aches from the left side of body that move through neck and to the head: The patient was lying down because this was one of the days the patient cannot move around. Everything was aching on the caller's body. The patient was trying to get up. She had never had arthritis. The doctor was treating her for arthritis. The patient had never heard of onset arthritis three days after receiving a vaccine, second dose Pfizer Covid Vaccine. The patient states she called the number on the paper that was provided from the vaccination facility and mentioned everything. The reporter states it was just like a recorded thing. In the meantime, the reporter thought every morning when the caller woke up, thought it would all be gone, and the caller would be fine. The reporter was a normally healthy woman with no underlying side effects, no underlying conditions rather. When asked if it was Pfizer the patient called and reported the events to, the reporter replied she did not keep the paper, but it said to call Pfizer at this number, no person answered, and it was leaving a message. Had been having migraine headaches: The reporter had migraine headache on the left rear quadrant of the head. The headache was like something piercing the head all by itself. The reporter states a migraine headache lasted 10 hours and began three hours after receiving the second dose Pfizer Covid Vaccine. body aches: two days later, had terrible fatigue and it was difficult for the patient to get off the couch and the terrible fatigue had been on and off. The caller had one good day and one bad day. Had been having migraine headaches: The terrible fatigue began as soon as the caller was up with migraine for 10 hours. The migraine continued with a moderate headache which persists still today, 02Jun2021. The reporter may go a day or two without the headache, but it keeps coming back. The patient underwent lab tests and procedures which included blood test: showed swelling and other than that was normal. The outcome of events swelling, and gait disturbance was unknown, and the outcome of remaining events was not recovered. No follow-up attempts are possible. No further information is expected.

Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. Then her face ended up developing a long last swelling and rash episode that lasted for 1.5-2 months. Patient thinks it was a reaction to the amoxicillin she was given, but it persisted despite not being on the medicine, being given steroids, and antihistamines. Patient was in the ED twice for the facial swelling. Also saw Dermatology. Pt later saw an allergist and she is not allergic to amoxicillin, only other new thing had been the vaccine when it all started. Then the patient suddenly develops severe bradycardia to the point of syncope and episodes of sinus arrest. Patient then ended up requiring a pacemaker to be placed.

hospitalized with SIRS the next day, 2/20/2021, thought to be due to the immunization. discharged 3/4/2021

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe

Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.

Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis

Pain worsened; swelling of feet, legs, hands, arms and lips and is still ongoing; This is a spontaneous report from a contactable consumer 78-year-old female consumer (patient) reported for herself that: A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 10:00 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included cardiac failure congestive from 2004 and ongoing. The patient's Concomitant medications were not reported. The patient experienced Swelling of feet, legs, hands, arms and lips and is still ongoing on 09Jul2021, Pain worsened on an unspecified date. There was no Investigation Assessment. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect administration date of the suspect vaccine. AE(s) did not require a visit to Emergency Room and Physician Office Doctor came to her home. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. Communication: Reference number provided. Caller initially said her first dose was on Thursday, then clarified it was on 07JUL 2021 when looking at vaccine card. Provided with phone number and hours of operation prior. The outcome of event was not recovered.

and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/ weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still there on joint.

WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.

79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.

injection site pain, subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm noticeably swollen down into hand, still present.

Initially some soreness and swelling which went away by day 3. Then 9 days after injection, here was a swollen warm, itchy, sore, 2-3 cm red spot at injection site. It slowly faded over the next few days and is not visible on day 12.

She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day.

Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.

arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.

day after the shot her face swelled along with a rash on face and neck took her to the doctor today because her face is even bigger rash worse.

Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.

On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that is painful. I am not sure if it is a clot or not. I have not been to Urgent care . I informed people giving me vaccine I was on blood thinners. Nobody seem to show concern about that. I have already received 2nd shot, which I got very sick after, but symptoms seem to happen to others. My concern is the lump on my leg if it is a clot and concern if I will get more now that I took the 2nd vaccine.

Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included losartan. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.

Patient was a 79 yo F who presented to hospital on 1/29/2021. On admission patient was severely hypoxic with symptoms of SOB, cough, and severe dyspnea . The patient was COVID-19 positive on admission with symptoms starting 4 days prior to admission. Patient's labs on admission showed elevated ferritin, CRP, and d-dimer. Patient was diagnosed with COVID-19 infection with sepsis and respiratory failure with hypoxia. On arrival to hospital patient's O2 sats were in 60's and improved to upper 80s after nebulizer treatment. Patient was started on azithromycin 500mg once daily for 3 days, ceftriaxone 2g once daily for 2 days, dexamethasone 6mg once daily for 3 days, zinc 220 mg once daily for one dose, and duo-neb 3ml q4h for 3 days. Patient's respiratory status declined and was placed on BiPAP and comfort measures. The patient continued to decline until her passing on 2/3/2021.

severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever. Responded to 400 mg oral ibuprofen.

I had a delayed response to Covid 19 vaccine by one week, March 13th 2021. I had a bright red rash on hand, thighs, buttocks, with small blisters in between fingers and inside upper and lower lips. Also, had hives, welts, and swelling of these areas. Severe itching that did not subside. On March 14th I went to urgent care, by Tuesday March 16th it was worse, went to see Doctor and she increased Pepcid and prednisone dosage that I was given at urgent care. She increased my Zyrtec that I was taking from home and added Singulair. She did labs at this time. I was much better the week of March 21st and advised to see an allergist. Saw him on March 23rd, and he advised no more vaccines until her could test me. So far, April 1st there is no Pfizer vaccine available for test. I'm making another virtual appointment for April 20th.

couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful; equilibrium was totally off; tired; pink blotches and a red rash on her legs; pink blotches and a red rash on her legs; didn't feel good; her legs started burning; her eyes were bloodshot with dark circles; This is a spontaneous report received from a contactable female consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. The patient did not have any relevant medical history. Concomitant medications includes: Plavix (CLOPIDOGREL BISULFATE) 75mg, once a day, Oral, Losartan 100mg, 1/day, Oral for blood pressure high, toprol XL (METOPROLOL SUCCINATE) 50mg, 1/day, Oral for Blood pressure high, ezetimibe (ZETIA) 10mg, once a day for , Oral for High cholesterol. Vitamin C (ASCORBIC ACID) 1000mg, 1/day, Oral. Omega 3 1000mg, 1/day, Oral, taking for 2 years. Vitamin D 1000IU, 1/day, Oral, taking for 6 months. Multivitamin dose unknown, 1/day, Oral. Aspirin (ACETYLSALICYLIC ACID) 81mg, 1/day, Oral. All the Concomitant medications started dates was unspecified. It was reported that Consumer states she got the first dose 11Feb2021 of the Pfizer COVID 19 vaccine at 0945AM in the right arm. Adds she had no reaction the first day. Then about three days later (14Feb2021), she noticed pink blotches and a red rash on her legs; and she didn't feel good. About five days later she called the doctor who did a blood test. No results known. The doctor put her on Prednisone and she took three doses and on Feb2021 her legs started burning so she stopped. Adds she doesn't think it had anything to dowith the Prednisone; it was the vaccine. Reports she started to have balance and coordination problems, on 25Feb2021 her left knee and left hip were so painful that she had to use a cane and could not walk straight and her equilibrium was totally off so that she was she was walking into the wall. Mentions that on 17Feb2021 she was tired, on Feb2021 other eyes were bloodshot with dark circles. Mentions she did lots of research on her phone and decided that all of her symptoms seem to relate to GBS, Guillain-Barre syndrome. Clarifies she does not know if she has GBS. She has been to the doctor again and they are telling her not to get the second dose of the shot. Mentions that pretty much everything cleared up by 1Mar2021. Additional information includes plavix was used for head and neck blockage, taking for 10 years, Losartan patient took off the water pill portion HTZ part of months ago, toprol XL taking for 13 years. Zetia taking for 8 years. Vitamin C patient taking for her immune system, taking for 3 years. Omega 3 taking for 2 years. Vitamin D was taking for 6 months. Multivitamin. Aspirin patient taking for taking for keep blood flowing since 14 years. Outcome of the events didn't feel good, couldn't walk straight and use a cane and Guillain-Barre syndrome was unknown. Outcome of the events left knee and left hip were so painful, equilibrium was totally off and recovered on 01Mar2021. Outcome of the event her legs started burning was recovered on Feb2021. Outcome of the events her eyes were bloodshot with dark circles on 04Mar2021. Additional Information has been requested/ Additional information on lot/batch number has been requested.

thrush on her tongue; cold sore; pulsing in her right ear; States she had a lot of wax; dry skin; earache; This is a spontaneous report from a contactable consumer(Patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, It was stated that after the 2nd dose about 2 days later the patient had experienced got thrush on her tongue, she has never had thrush in her life and her doctor prescribed her a swish in her mouth for 4 days, 4 times a day. on the 5th day she got a pulsing in her right ear that started, and she still has that and it seems like just today it may be getting a little dimmer and not as bad and then she had cold sores and has been prescribed with NYSTATIN 1000, she was 79 years old and is healthy. she walks every day for an hour, doesn't take any medications, states her ear doctor wants to do a scan of her head and throat. The patient wanted to know if there are other complaints about ear complaints after getting the shot. And she had also stated that she had a lot of wax and dry skin and her ear was compacted in that right ear. The patient also experienced thrush on her tongue (oral candidiasis), cold sore (oral herpes), pulsing in her right ear (tinnitus), states she had a lot of wax and dry skin and her ear was compacted in that right ear (excessive cerumen production) , states she had a lot of wax and dry skin and her ear was compacted in that right ear (dry skin) , earache (ear pain). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.

I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - received first dose 2/25/2021 and second dose 3/18/2021 Patient wint intermittent persistent occipital headache for 2-3 days. Pain was rated 8/10. Also with bilateral lower extremity rash without itchiness persisting for 2 days. no vision change, no photophobia. Denied any fever, chills, SOB, cough, loss of smell or taste, myalgia, nausea, vomiting, diarrhea, weakness or any focal neurological deficit. Admitted for ITP (also with epistaxis and severe low platelets, hyponatremia, acute cystitis without hematuria. No chest pain, no GI bleed.Treatments included 2 units PRBC transfusion (4/6), plateletpheresis (4/6), dexamethasone IV (changed to prednisone oral on 4/7), IVIG infusion from 4/5 to 4/7, and B12 replacement. Discharge home with prednisone oral, folic acid, cyanocobalamin

Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena. 1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI 2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21. 3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup. 6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy. 7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB. 8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP 10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen. 11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol. 12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.

SEE LIST FOR LIGHT HEADED , FACE FLUSHED 5/6 DAY OF 5/9 AWOKE 00:45 WITH SHORTNESS OF BREATH, FACE PRICKLY feeling , CHILLS, oxigen sat 99/% lung clear,

muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

itching; swelling; red and swollen,fever in area, 5x6 cm; This is a Spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiration date was not reported), via unknown route of administration in left arm on 14Feb2021 at 15:15 (at the age of 79-year-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included known allergies. Concomitant medications were not reported. Patient took unspecified other medications in two weeks of vaccination. The patient did not receive any other vaccine in four weeks. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 21Feb2021 at 12:00, the patient had itching, swelling, red and swollen, fever in area, 5x6 cm. No treatment was received for the events. The outcome of the events was reported as recovering. Follow up attempts are completed. No further information is expected.

no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.

Since getting the vaccine I have had 3 bouts of painful cold sores. I used to get cold sores as a child and young adult, but had not had any for many, many years.

Patient was found unresponsive "guppy breathing" at home on 6/7/2021. Intubated by EMS at home, administered rapid SARS-CoV-2 test in field which resulted as positive. Admitted to ICU on ventilator. Remains in same condition as of reporting date (6/10/21).

2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.

huge cold sore in my upper lip, between the lip and nose; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 79 and a half years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 79 and a half years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a huge cold sore in her upper lip, between the lip and nose on past Friday (05Feb2021), had a sick Friday (05Feb2021), and yesterday this thing. The patient stated that she was scheduled for second dose on Wednesday, 17Feb2021. She wondered if she should go for the next appointment. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Emergency hospital visit on 6/22/2021 for high blood sugar and symptomatic. Glucose at bedside point of care was 548 on 6/22/2021 at 2153 and 395 on 6/22/2021 at 2304. During emergency encounter, based on EHR record, sodium chloride 0.9% infusion at 200 mL/hr, Intravenous, CONTINUOUS, Starting on Tue 6/22/21 at 2053 and insulin regular (human) (HumuLIN R) 100 units in sodium chloride 0.9% 100 mL infusion administered at 2153 CDT at 5 Units/hr or 5mL/hr. Impression provided by attending radiology provider, "Mild diffuse interstitial thickening throughout both lungs. Faint interstitial infiltrate at the lung bases, right greater than left. Minimal blunting of the right costophrenic angle. Normal cardiac and mediastinal contours. No pneumothorax. Percutaneous gastrostomy tube in place."

full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved. Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.

Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering around eyes,burning itchy peeling rash neck,chest,around ears,burning itchy rash fingers to shoulder. On going progressive to present date. Prednisone finally prescribed at Hospital emergency. 40 mg. Per day for 5 days. Dr. is lowering the dosage. The first three weeks are prescribed 40 then 20 on going to 20 and an appointment July 22 to decide on the dosage to continue. I have photos documenting every horrible symptom. I was advised to do that.

On February 18, 2021, three days after receiving the Pfizer vaccine, patient was rushed to the emergency room with rapidly dropping blood pressure and difficulty keeping conscious. After being in COVID isolation for 24 hours, I saw her in a hospital bed and she looked like a corpse. The initial diagnosis was severe Sepsis with liver, kidney and heart problems and blood clots in both lungs. She had never had any of this before getting the Pfizer vaccine. Her WBC count was also very high. She was hospitalized for 10 days and then sent to a rehab facility for 14 days before returning to her independent living facility. She is now taking blood thinners for the blood clots which she didn't have prior to taking the vaccine. He did a miracle in sparing her life!

she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

Patient reports started having weakness and numbness in feet in mid March 2021. She reports she saw a neurologist and was diagnosed with Guillian Barr Syndrome on 06-15-2021. She reports her weakness is improving with Physical Therapy. She received her first dose of COVID 19 Pfizer vaccine on 01/25/2021.

rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.

Pt w/ gradually increasing fatigue, multiple joint pain and swelling, and muscle pain over the following weeks. This is did not subside but increased in April and May, becoming severely painful. Began to self treat pain/swelling with OTC po and topical pain relief of joints/muscles, contemplated ER visit multiple times and finally decided to seek medical care early June. CPK over 900, ESR and CRP also elevated. CPK 2 weeks later 1,256 and pt started losing muscle mass, lost 7 lbs in 3 weeks, is exhausted and in pain. Waiting on Rheum consultation. No family history of ALS or other typical associated diseases w/ these labs.

Pt. states that after receiving the 2nd dose of Phizer 03/30/2021, started experiencing symptoms 04/12/2021 liver enzymes have gone up along with blood pressure reading. Rash appearing all around the thighs and legs with swelling, continuing to appear throughout the body. 04/13/2021 Primary visit, 06/14/021 Primary visit with Prednisone prescribed, and 07/20/2021 Primary continuing the previous prescription.

lump that looks like the top third of a small egg, on the clavicle; closer to the joint than to neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined; Aches after movement, such as going for a walk or vacuuming; right lymph node in my neck was tender; scratchy throat; slept on-and-off for most of the day; following the second vaccine I ran alow grade fever the following day.; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 17Mar2021(at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease stage 3 from an unspecified date. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 16:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 the patient experienced low grade fever. On 20Mar2021 at 06:00 the patient experienced mass, ache, lymph node tenderness, itchy throat, sleep disturbance. It was reported that third morning following second vaccine, the patient woke up with a lump, that looked like the top third of a small egg, on her clavicle; closer to the joint than to her neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined. The past few days it was back with a vengeance. Aches after movement, such as going for a walk or vacuuming. Also, following the second vaccine she ran a low-grade fever the following day, her right lymph node in her neck was tender and she had a scratchy throat. As it progressed, it felt as if her throat was closing, and then it disappeared just about the time she was getting concerned. She had slept on-and-off for most of the day. The next day she was fine, but still had the bump. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events mass, ache, lymph node tenderness, itchy throat, sleep disturbance, low grade fever was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

Within one hour- flushing, headache, and swelling and sore lymph node- right side. Over nite and for 3 days fever of 100.2. Tired, skin hurt and sore throat- swollen lymph node lasted for 4 days.

welts all over (her) body; Itching; Red welts all over body; This is a spontaneous report from a contactable consumer. An 80-year-old female consumer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 13Jan2021 at 12:00 p:m at single dose for COVID-19 immunization. Relevant medical history included penicillin and bee stings allergies. Concomitant medications were not reported. On 13Jan2021, about 3 hours after vaccine patient experienced red welts were all over her body, face, arms, and under breasts. She was itching all over. Patient took three allergy pills and the reaction subsided. Patient didn't provide product name of allergy pills. Patient informed she had a reaction before to Penicillin and clarified her reaction with Penicillin was red welts and itching, but her tongue didn't get sick on an unspecified date. Patient was supposed to go back and get second COVID-19 Vaccine, but she was not going to take it unless there is a COVID-19 Vaccine without Penicillin in it (as reported). Provided date on patient card of 03Feb2021. At the time of the reporting event outcome was unknown.

2 hours post vaccination nurse noticed angioedema in 1 eye and puffiness in the other eye. Nursing staff gave 25mg of Benadryl and used a cold compress. Swelling went down quickly and patient is doing well.

PATIENT STATED THAT AFTER 3 HOURS OF RECEIVING THE FIRST DOSE OF THE COVID-19 VACCINE, HER LEFT EYE BECAME RED AND PART OF HER CHEECK BECAME SWOLLEN, PT STATED THAT SHE TOOK BENADRYL AND IBUPROFEN. DIDN'T SEEK MEDICAL ATTENTION.

Extreme intensification of fibro and polymyalgia symptoms (almost unable to do anything). Need to use a walker and still do. Also leg and foot swelling

The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.

RECEIVED 1ST PFIZER COVID19 DOSE ON 02/10/21. ON 02/21/21 REPORTED TO ER COMPLAINING OF SHORTNESS OF BREATH(HX OF AFIB AND DUE TO HAVE CARDIOVERSION SOON). DIAGNOSED WITH ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ELEVATED TROPONIN, ELEVATED BNP LEVEL, AND LOWER EXTREMEITY EDEMA. ON 02/21/21 ADMITTED AS INPATINET IN HOSPITAL.

2 days after her first shot, woke up with sudden onset, acute edema of her right hand and right arm, not associated with any trauma or injury to that extremity. Her edema has continued since then. One day after her second dose of Pfizer vaccine (lot # EN6201) on 2/20, which she received in her left arm, she developed sudden acute edema in her right foot and leg. She was seen on 2/22 by a nurse practitioner and had ultrasounds of her right arm and right leg. The ultrasounds ruled out DVTs and/or vascular abnormalities. Her physician concluded that her edema is an adverse effect of the Pfizer vaccine.

COVID arm and swelling to right jaw with extreme pain that lasted about 24 hours the week after the injection.

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

SEVERE FACIAL SWELLING, PATIENT WENT TO ANOTHER FACILITY 24 HOURS AFTER VACCINE ADMINISTERED AND WAS TREATED WITH AN INJECTION AND A STEROID DOSE PACK PER HER REPORT. SHE PRESENTED TO OUR VACCINE CLINIC FOR HER SECOND INJECTION AND REPORTED THE REACTION.

A little lump developed on the front side of the arm on Monday, today hot and red but almost flat. Silver dollar size.

red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.

On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- muscus membrane swelling mainly -- not much phlegm to be cleared out - settled down about an hour later without taking any medications. Starting on 3/7/21 - Sore & stiff muscles in both arms - aching joints and muscles in legs also, stiff neck and waves of nausea that come and go. - also very groggy & fatigued On 3/8/21 - Woke up more aching, swollen glands under left arm and headache starting - took only Tylenol for the headache . Rest of symptoms still in effect. Stayed home from work to take it easy. Hoping things will pass by tomorrow or Wednesday

Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

white count was low; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.

Patient reported swelling on back of the neck about 5 minutes after receiving vaccine, was given Benadryl 25mg. Several minutes later reported difficulty swallowing and was administered 0.3mg of epinephrine. Daughter called 911, patient reported feeling better after emergency response arrival.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.

patient presented to ED 2/6/2021 with CC of SOB. Patient reported that she started having a cough and runny nose 14 days prior to presentation. Patient was admitted due to further evaluation of respiratory failure. Patient was started on IV decadron due to symptomatology and worsening hypoxia. Infectious disease was consulted for this patient and recommended supportive care and dexamethasone. Patient hospitalized for 10 days due to shortness of breath and oxygen requirements.

Patient is a 80 y.o. female who presents with: 2 months of itchy rash that started 2 months ago after 1st COVID vaccine. Was only on her lower leg. After the 2nd shot a month ago the resh got worse. It is on her arms, chest, upper and lower legs. It itches and she has been scratching it and picking it to where it is all scabbed up and hurting with redness. Discharged with Cellulitis, unspecified cellulitis site - Primary Relevant Medications clindamycin (CLEOCIN) 300 MG capsule mupirocin (BACTROBAN) 2 % ointment fexofenadine (ALLEGRA) 180 MG tablet Came back to doctor office 8 days later with complaints: Patient was seen on 3/30 and was treated with Clindamycin and Mupirocin. Patient did not f/u with Derm. Per patient and husband everything seemed to be healing except an area over her right breast and her left lower leg is now hot and swollen. Patient still complaining of itching and admits to itching until she breaks skin. NO fever reported. Admission to hospital for IV antibiotics

Knot has developed on arm where the vaccine was administered - the arm has become swollen and the pain is increasing and not decreasing pain.

Starting 4 days following my 2nd vac. dose, I've had episodes of unusual inflammation in my knees or ankles at different times and lasting for a week at a time, causing pain, stiffness and swelling. This has continued for six weeks though there were also periods when I was symptom free. I hope that my immune system has returned to normal. I have not heard of these symptoms reported previously.

very ill and had to be taken to hospital; terrible pains all over; dehydrated; headache; feeling like something was choking her in mouth; coughing real hard; it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like; joint pain; patient was like fainting; panicked; allergic reaction/face swollen up; and lymph node was swelling up; white lumps on lip; some white patches on face/couple of patches around mouth; white lips; Short of breath; sore around mouth; face swollen up; pneumonia; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200; Expiration Date: 06May2021) as single dose for covid-19 immunisation. Medical history included insomnia from an unknown date and unknown if ongoing. Patient weight was 155 now. Patient was overweight because this eating and eating. Feeling inactive, not going out so patient gained a lot of weight. Patient took blood pressure medication and for heart some basically and patient didn't sleep well, so patient took Alprazolam to relax to sleep, but patient was an insomniac but that was basically problem. The patient's concomitant medication included isosorbide. Patient had the first Pfizer shot and wasn't even sore or anything, patient was so happy but that about 4 or 5 hours later about maybe 5 o'Clock, patient had allergic reaction and started to feel a sensation in lip and when she looked in the mirror, what was all that on lip and one side on lip it had turned white and it had lump was extended along lip line, lymph node was swelling up and patient had white lumps on lip which still had but it was going down and some white patches on face. Nothing happened on the 24Feb2021. Patient thought it was the 25Feb2021 that was when all trouble started. Patient felt like nightmare because she started feeling like something was choking her in mouth and next minute patient started coughing, coughing real hard and that was terrible cough then after this strange voice and patient realized it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like. Patient start to get out of bed and then waken to kitchen, patient had terrible headache, joint pain, pain all over from head to foot and patient was certainly dehydrated. She had no water in at all, she was like don't know something come over and felt like she was sort of leaving the world, patient was like fainting, and panicked. Patient had terrible pains all over and felt like patient was dying, patient was going to die. Patient said she need an ambulance, patient was very ill and had to be taken to hospital. They came within a few minutes, they started questioning about what was happening and they put patient to the emergency room and well they test patient for Covid as well naturally. It was negative, they did it 2 times and it was negative. When they took patient to one of the room in fact patient was frightened because they didn't told patient it was negative. Patient said she got the virus, they said not but patient had to take the oxygen as it's surge to scan on lungs. They said patient had allergic reaction to the vaccine. Patient was supposed to have it but at the same time there was the variant, doctor said patient was 70% covered, didn't have it but patient want to just check the status was with a person like her was allergic. Patient had shots in face and patient did tell them that she had all sorts of things on face. Now patient still had the white lips and couple of patches around mouth and naturally patient was worried like what to do. The patient didn't take the second shot because she was too nervous. Patient went hospitalization on the 25Feb2021 very early, and was relieved on 27Feb2021 (not sure). Reason of Hospitalization: On the University hospital. They put down to the Pfizer injection but that was older happens to patient, they infused patient with antibiotic they gave pills. Patient said she won't be able breath with them and that was what they did, they 'reflect' her, they said patient had pneumonia which she did not have (Further clarification was unknown). Early the next morning they put patient down 2' o'clock in the morning. Patient wanted to go home, they said patient can't as she had very bad infection in lungs which was completely untrue. The next morning (the same morning early), patient was okay because the pains and everything was gone but she believe the medication they put patient on that caused to short of breath and patient said please don't give her the medication and they did. They only give generic medicine in the hospital and patient took brand name. On 26Feb2021 patient actually called the doctor for all results and she told nothing, patient didn't get the result. Anyway they took patient off one medication, they didn't give it to her and this medication you can not get off of it and through that patient had a headache the whole of the day and the whole day on the 26Feb2021 patient was suffering with very bad headache and kept asking for the medication they said they would give to the patient. Finally the doctor gave only to the aspirin and paracetamol (TYLENOL) that both the same and in the end patient husband have to go and get the pill because they still hadn't given it to patient all day long. Patient said to doctor because she was breathing hard and she said the doctor did this to her by giving these pills that don't agree with her. She told she can not take this medication, anyway the doctor said to patient husband go home and get her medication, and he said so now you are medicating yourself. By the next day patient was ready, she was breathing normally and was ready to go home but late afternoon they said patient should go home but she still had those white patches but they were not as prominent as what they were. Patient whole lip turn white, whatever they did, whatever they gave, patient had sore around mouth and face swollen up. Patient didn't know whether she was allergic to the medicine or what but her face, it looked like she had, patient was fine anyway couldn't get an appointment with GP to the Wednesday (unspecified week) but it free appointment on the Tuesday and patient went in and showed him what it looked like. He said it should return to normal within 2 weeks and it but still face like normally excepted lips. Outcome of events pain, short of breath was recovered in 2021, and outcome of other events was unknown. Date of second shot was 17Mar2021, it was reported patient had got the both shot of covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404239 similar report from same reporter

The caller reports that approximately one week after her second COVID19 Pfizer vaccine, she experienced swelling of her left axillary lymph node with related discomfort and pain. She reports the symptoms resolved in about 1-1.5 weeks without further complication.

Patient reports getting cold sores in her mouth and by her nose. These happened the day after getting her first dose of the Pfizer covid vaccine. However, she dose have these episodes happen occasionally, typically when she has a cold/sinus issues. Most sores have resolved by the time of her second dose on 3/18/21. The main symptom was pain. With this information, it does not appear to be vaccine related, but more of an occasional happening for the patient. the patient did note this was the first time this happened after getting a vaccine

One week after receipt developed pain at the injection site, followed by progression to her shoulder to her elbow and wrist, with edema distal to her mid elbow. She reports the second injection seemed less careful and the site was too high. She has normal strength and reports her baseline is very strong as she has played tennis for 40 years. The pain has continued to increase and went to community ER 14 APR 21. EKG, U/S were normal. She is trialed Tylenol and NSAID and they have helped. Symptoms mostly resolved on f/u 06 May 2021. She occasionally gets a small amount of burning pain in her deltoid, but it is not significant. She is otherwise well.

First dose March 24, second dose April 14. About a week later developed facial swelling. Was seen by her primary MD and given antibiotics for presumed facial cellulitis (clindamycin and cephalexin). The facial swelling improved but then her right eye became red with worsened vision (3 days prior to presenting to ophthalmology). Exam found new onset of inflammation of the conjunctiva and all internal structures (panophthalmitis). She is a long-time patient at the eye clinic since 1993 and has never had inflammation in either eye prior to this episode. There is no other explanation for the sudden presentation of an acute inflammatory condition.

Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.

chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021. Follow-up attempts are completed. No further information is expected.

This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's Son). These two consumers reported for 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL9261; Expiry Date was not reported), via an unspecified route of administration in arm left on 02Feb2021, (80-years -old at the time of vaccination), as first dose, single dose for COVID-19 immunization. The patient's medical history included fall, she went to the hospital for this, was a year ago and diabetes mellitus. The patient's concomitant medications included Metformin that she could take it only when her blood sugar is up, and Flu shot had it 3 weeks ago. On 03Feb2021, the patient experienced face swelling, the swelling was mostly around the eyes as if she was sting, it looks like little water bags, it doesn't hurt, there was no pain, it was underneath both eyes and down the cheeks, just swelling, swelling feels warm to the touch, and the skin was red, it's not red all over but in patches on cheeks and below the eyes, there was also redness right below chin, and it stops at the chin and there was redness on the forehead. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: 98. The outcome of all the event face swelling was not recovered and the event swelling feels warm to the touch and the skin was red was unknown. Follow-up attempts are completed. No further information is expected.

on her right arm she experienced Bursitis or swelling on her elbow/Olecranon bursitis/Popeye's Bursitis; on her right arm she experienced Bursitis or swelling on her elbow.; hard of hearing; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264; Expiration Date: 30May2021) via an unspecified route of administration, in right arm on 08Feb2021 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient did not receive any other vaccines on the day of vaccination. On 08Feb2021, the patient got her first dose at her right arm and she experienced popeye's bursitis or olecranon bursitis/ Bursitis or swelling on her elbow. Patient stated that she was also hard of hearing on an unspecified date in 2021. Patient confirmed that the bursitis was located in her right arm. Patient was wondering if there was a connection, if the vaccine could have caused it as she had never had anything like that before. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Finger tip swollen, red; Raspy throat; The initial case was missing the following minimum criteria: as there is no indication that the consumer experienced an event under BNT162B2. Upon receipt of follow-up information on (11Jun2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported similar events for three patients. This is the first of three reports. A 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in arm on 12Feb2021 12:30 (at the age of 80-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included she has allergies, allergies to latex, sulfa; patient is a breast cancer survive, diagnosed on an unspecified date in 2008 (survivor 13 years), mastectomy from on an unspecified date in 2008. The patient concomitant medication included diphenhydramine hydrochloride (BENADRYL) via oral route from 22Jan2021 to 23Jan2021 and 02Feb2021 to 03Feb2021. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL1283, Expiration date: 30Apr2021), via intramuscular of administration, administered in arm left on 22Jan2021 10:00 AM (at the age of 80-year-old) at a 1st dose, single dose for COVID-19 immunization and experienced headache, her finger tips got red and she had swollen red hands, red puffed up, chills/terrible chills, throat raspy was with a dry mouth, muscles hurting. Duration of reaction was 21 days. Events were recovered on an unspecified date in 2021. Patient previously took flu shot prior vaccinations (within 4 weeks), Cipro and experienced allergies to cipro. The patient experienced finger tip swollen, red; 5 minutes after it raspy throat on 12Feb2021 10:00. Patient said she, her husband and her sister received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 22Jan2021 and was scheduled to receive the 2nd dose 2 weeks after the 1st dose. Patient got the first shot on 22Jan2021 and was sent an email that her second dose is scheduled for 05Feb2021. Patient had an allergic reaction to the vaccine she is nervous about getting the second shot. Outcome of the events was unknown. Follow-up attempts completed. No further information needed.; Sender's Comments: Linked Report(s) :PFIZER INC-2021128085 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/drug/AE and different patient

Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the touch, as if nerves inflamed. Doctor suspected shingles, but no blisters appeared. Pain stopped after five days. Swelling lasted a couple of weeks. Irritated nerve sensation in trunk persists,

This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 80-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 80-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and had pain in her arm. The patient reported that she had first shot on 25Feb2021 and followed the procedure 21 days later and received second shot on 18Mar2021 after the first shot. When probed for second shot vaccination timings, consumer stated, "her second shot was on "319" (Further not clarified). On 19Mar2021, she woke up and her teeth were killing her like she slept she was fine but in the morning she had terrible toothache and she was taking care of her teeth, she had Flu like symptoms her eyes puffed up, swelled and runny nose, she went to a Dermatologist Doctor and she gave her some medicine to take swelling down, she had severe leg cramps and could hardly barely walk. She was trying to find out if she could have blood clot, she could have everything, she went to funeral and she had to leave early, she left and fly back Home, it disturbed her, it could be from Pfizer shot. She was 80 years old and she was not be able to, she should be hardly be able to function. Consumer stated, she was in pain and on pain medication, she was in terrible pain because her legs and back hurting so much. Her eyes swelled up badly. When probed for any laboratory test, consumer stated, she had pain today, she walks 3 miles a day, today she probably walked a mile and it was painful. She went Dermatologist for her eyes. Consumer stated, she went to a Dermatologist to see why her face is swallowed up. She would like to be followed up, what she was to do with her pain, she was like crippled, she was in pain all the time, she would like to know Pfizer to tell her what medication she needs to take. She did not know, the Doctor knows what to give. She needs them to recommend what they are giving to other people those are having these severe reactions. Consumer stated, she had two Pfizer shots (both doses) and she had a severe adverse effect. Now it was difficult she had severe pain in her legs. she walks 3 miles a day. she had her eyes swell as well, she went to a Dermatologist. She walks to her Doctor after the severe pain from the Pfizer shot, he gave her some pain treatment Tramadol and "Ibuprofen" (not clarified) besides the fact that it will help. She started to walk, she sneeze a lot, swelled up like her eyes swelled up and she had sticky stuff that was for 9 days, no apparent reason then she went to the Dermatologist. She had severe swelling then she had her teeth ache, for eye condition and skin she went to Dermatologist and he gave her "Hydrocortisone" (name not clarified) several days for two weeks and her teeth have no pain in her teeth. She woke up this morning and felt cry it was painful and she don't know what to do about this adverse effect. she wanted to ask to Pfizer people to get medicine. The caller has had severe adverse effects after receiving the Pfizer Covid 19 Vaccine. The caller could barely use her legs, the legs were in severe pain. The caller was a person that walked and exercised, walked 3 miles a day. The caller could barely get around, and up and down in the morning is hell. The caller was so weak and the legs hurt so bad. The other effect was the caller's eyes swelled up and ran sticky oozy stuff. The caller went to the dermatologist and was given cortisone and after 14-15 days that cleared up, it was white. The caller went to her doctor about the pain in her legs. The caller was taking Tramadol and Ibuprofen and they were not a lot of help. The doctor said it will run its course. The caller asked how long it will be and the doctor said the good news is it will go away and that is about all the doctor would say. In the mean time, the caller was in severe pain and is asking what can be taken for the legs. The caller states she had been in severe pain since February. The caller states if she is not going to get any help why this was not put on the news report. All it is go get another shot. No reports on how it may have these adverse effects. Another thing is the caller goes to bed at night fine and wakes up in the morning with jaws and teeth killing the caller. The caller had excellent dental work. The caller's eyes still run, continually run. The caller states she specially asked what the caller can get for some relief from the pain or is the patient to call the rest of her life. The caller states she could walk. The caller said Pfizer doesn't report a thing, no side effects, everybody is shut up on tv. The caller thinks the side effects, percentages and dangers for the elderly like the caller and the young, young children should be told. The caller states she did talk to her doctor and he gave the caller tramadol (50mg, Expiration date: 12Jul2022) and Ibuprofen (Expiration date: 21Jun2022). Outcome of the event toothache was recovered in 2021; eye discharge was not recovered; other events was unknown. Information about the Lot/batch number has been requested.

Watery drainage from her right eye; Nose feels full; congestion; Phlegm; Fever blister on her tongue (sore blister on the right side of her tongue); sores on her tongue; Feels a little weird; Dizzy or dizziness like vertigo (funny feeling like vertigo); Headache; Slept hard - she never sleeps that much; Drinking a lot of water; Fever; feverish; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, Expiration Date: 30Apr2021), via an unspecified route of administration, on 11Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history included colitis and diverticulitis (chronic; diagnosed years ago); and allergies. The patient's concomitant medications included chlordiazepoxide/ clidinium bromide (LIBRAX) for colitis, omeprazole (PROTONIX), levocabastine hydrochloride (ZYRTEC) for allergies, and cyanocobalamin (VITAMIN B12) for colitis. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899, Expiration Date: 31Mar2021) on 21Dec2020 for COVID-19 immunization and experienced a little sore on site; and varicella zoster vaccine (SHINGLES VACCINE) for immunization and it hurt and she got blisters at the injection side. The patient just got her second shot on Monday (11Jan2021) at 9 in morning. After a couple of hours (11 AM), the patient feels a little weird, dizzy or dizziness like vertigo (funny feeling like vertigo), and headache. That night, the patient took ibuprofen (MOTRIN) and paracetamol (TLENOL) and she just slept hard - she never sleeps that much, she is drinking a lot of water. The patient also had a fever that night and received treatment for this. On Tuesday (12Jan2021), the patient was okay but, in the evening, she started feeling feverish and has a fever blister on her tongue (sore blister on the right side of her tongue). The patient never had a fever blister before. Last night (13Jan2021), the patient was a little feverish, still has the sores on her tongue and she was having watery drainage from her right eye and her nose feels full; congestion and phlegm. The patient wanted to know if she should go to work tomorrow but was encouraged to reach out to a health care professional for medical advice. The patient asked health employee and they told her to call the company. Got the vaccine from work at a center. The patient recovered from "Dizzy or dizziness like vertigo (funny feeling like vertigo)" in Jan2021. The outcome of "Feels a little weird", "Headache", "Slept hard - she never sleeps that much", and "Drinking a lot of water" was unknown. The patient had not recovered from the remaining events.

Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness. Admitted to hospital 1/29/21 and diagnosed with Guillen Barre. Initially paresthesia was from feet to groin and has been improving.

Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) via an unspecified route of administration in left arm on 20Jan2021 mid-afternoon at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation diagnosed about 25 years ago, Canker sore on 18Jan2021 (she did go the doctor for that and the doctor urged her to rinse it with salt water to she's been doing that), some soreness in her month on 18Jan2021, gout reaction. The patient concomitant medications were not reported. No Pfizer vaccine was administered on the same date. Prior Vaccinations (within 4 weeks) was none. The patient got a reaction that she thought should be noted. She has had a very slight history of gout. She woke up this morning on 21Jan2021 and her big toes hurt. She knew that this was a symptom of what she had had in the past which was gout. The patient confirmed her big toes hurting was pretty much staying the same. It's not that uncomfortable. She knew from past experience that this was what happens, like when she ate certain foods like seafood or whatever, she would have this kind of gout reaction. This morning on 21Jan2021, she also felt the glands in her neck on the right side were swollen. The swelling seemed to have gone down. Her army was also very sore. She stated the soreness began last night, in the evening on 20Jan2021. The soreness had pretty much stayed the same. She expected the soreness, but she didn't expect her toes to hurt. It was important to note "she is able to able the gout". She had only had gout really bad time once and then she's had a little bit every so often. The gout just seems to be connected to the vaccine- she could not say nothing that she ate would indicate other wise. The events did not require visit Emergency Room or Physician Office. She had an appointment for 10Feb2021 to get the second COVID-19 vaccine. The outcome of event glands in her neck on the right side swollen was recovering, outcome of events was not recovered.

Chills; Fever of 101; Swollen glands or lymph nodes at the base of her skull; lymph node venapathy; Aches; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right deltoid, on 16Jan2021 (also reported as 15Jan2021), at a single dose, for COVID-19 immunization. The patient's medical history included therapy for her back. There were no concomitant medications. After the patient got her first vaccine on 16Jan2021 (also reported as 15Jan2021) which was almost a week now, she was experiencing side effects. In Jan2021, the patient had chills, fever of 101, swollen lymph nodes, and aches. The patient had swollen glands or lymph nodes at the base of her skull, the lymph node venapathy (unspecified; as reported). The patient underwent a COVID-19 test yesterday (21Jan2021) to be sure (unknown results). The patient asked that if this is from the vaccine, how long could she expect to have these side effects. The patient was scheduled for it for the second dose in February. As treatment for the events, the patient was taking ibuprofen (MOTRIN), had taken paracetamol (TYLENOL EXTRA STRENGTH) at 1000 mg every 6 hours, and ibuprofen (ADVIL) at 400 mg. The patient had not recovered from the events. The patient considered that the events had a causality with the suspect product. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

my right foot swelled up and turned bright red. It was incredibly painful. I couldn't walk. It lasted 2 days and then receded. I took 5 Tylenol for the pain in 48 hours.

Swollen tongue. Swollen neck glands. Headache, Racing heart. Blood pressure went to 190/95 Occurred after I arrived home. Called Fire Department. I was still able to talk and breath so they did not use Epi pen. Stayed with me because of BP concern. Offered to bring me to Hospital. Said to take Benydryl if symtoms began anew and to call them back and they would take me ER but as day progressed, symptoms subsided somewhat. Higher BP readings continue and my PCP prescribed mild BP RX..

As I washed up in the morning, about 8 a.m., I noticed my underarm was sore. As I examined the area several times during the next couple of hours I noticed a lump. The lump was moveable, but seemed about the size of a nickle. It scared me even though it was not actually in my breast. The doctor told me since it was moveable and felt smooth he thought it to be a reaction to the Covid vaccine, but ordered a mammogram. I called for the mammogram and was told I could not have one until 4 weeks after the 2nd shot. I have a mammogram scheduled 3/26/2021.

muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.

Developed pain Lt axilla with swelling of 1 lymph node this lasted for 3 d then the swelling of the lympn was no longer apparent, the pain in the axilla persists. I then developed pruritus generalized without rash or uticaria. This lasted for 10 d

When I swallow or when I gulp like a whole glass of water or half a glass of orange juice or something like that, my gland on the side of my neck hurts, it hurts me, it is sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, on 18Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient had her first Pfizer shot and it will be three weeks, it was on 18Jan and on Monday (02Feb2021) she developed when she swallow or when gulp like a whole glass of water or half a glass of orange juice or something like that, her gland on the side of neck hurt, it hurt her, it was sore. She did not know if that was the part of the side effects. That was it and she was going to get the second shot on Monday. It happened on Monday when it started hurting. She thought it would go away. It started going away with hot, when I drink something like hot tea but it was still there, when she swallow. The outcome of the event was unknown.

gained about 3 pounds now; The next day, her cheeks, face, and the part under her chin became swollen/her body also became swollen; she feels something in her throat which she can't describe; she feels something in her throat which she can't describe; her vision on her good eye became a little depleted; inside of her lips was swollen; This is a spontaneous report from a contactable consumer. This 81-year-old Female consumer reported for herself that she received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose on 27Jan2021 for COVID-19 immunisation. Relevant history included food allergy. Relevant concomitant drug was unknown. The patient received her 1st dose on 27Jan2021 and stated that she was feeling fine for about 10 minutes and when she got back home which was not very far from the vaccination site, she noticed that the inside of her lips was swollen. She mentioned that this was not strange for her since she was mostly allergic to food but usually it was the outer portion of her lips that became swollen and not the inner portion. The next day, her cheeks, face, and the part under her chin became swollen and she felt something in her throat which she could describe. She also noticed that her vision on her good eye became a little depleted which got her a little concerned and her body also became swollen and stated that she already gained about 3 pounds now. She wanted to know if anyone had reported the same reaction she had and if it was recommended for her to get the 2nd dose or not. Outcome of events was unknown. The information on the LOT/Batch number has been requested

No side effects in 30 minute waiting period and none on day of injection--some mild itching began night of injection. Day after, Saturday, itching intensified, throat tightened (muscular feeling); and tongue began to become sore, and began to show redness on sides. Bad enough that I finally took a 4-6 hour dose of Benadryl, and slept afternoon. Felt better when I woke up but when effects of Benadryl wore off, the tongue swelling intensified and frightened me. Decided against emergency call on weekend and took Benadryl (4-6 hour) about 8 or 9 Pm and next morning (about 5 or 6AM) noted that I felt okay and tongue had become pink not red though still some swelling on the sides of tongue. Had no strong adverse effects after first dose, some chills in the evening and arm swelling/pain that resolved by 3AM.

headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then it ran straight to my back; suffering pain; arm was real sore /pain in the left arm/her arm felt like it was going to fall off; sick as a dog; She was very upset; nausea; her back still hurts to move/it ran all way over to my back; didn't feel like eating; sneeze; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she was administered with the first dose of the vaccine on 26Jan2021, and she has been feeling sick as a dog since she got it. The patient wanted to know about the ingredients used in the formulation of the Pfizer's COVID-19 vaccine. It was reported that patient had been suffering pain on 26Jan2021. The patient took pain pills for the pain. On 26Jan2021, the patient arm was real sore, her arm felt like it was going to fall off/pain in the left arm and on 27Jan2021, the patient experienced hurting in her head/ headaches. The patient reported that she would not have taken the vaccine if she had known her arm would hurt like that. On 27Jan2021, she started having sharp pain across her shoulders, through her shoulder blade to the middle of the back . She tried a heat pad, ice packs and the pain just keep shooting and she believes she had a fever with it. She threw up. She was very upset with all of this and mentions that her husband had passed away. It was reported that patient took pain medication referring to Robaxin 500mg and it didn't work. She also took Methocarbamol 500mg and it helped a little but not a lot. Adds she called the paramedics. The paramedics examined her and told her they had been to the Navy hospital several times and it was very crowded and they advised her to take Tylenol. She took the Tylenol 325mg and she went to sleep but when she woke up she still had the real sharp pains. She thinks the Tylenol helped some. She also took Ibuprofen via oral route at a dose of 400mg as needed per the instruction of the paramedics at. Mentions her symptoms were improved but her back still hurts to move on an unknown date in 2021. She has not eaten except to take medicine. She didn't feel like eating on an unknown date in 2021. She was scheduled to receive the second dose on 16Feb2021 but wanted to refuse because she heard it is even worse than the first time. The patient reported that she experienced sneeze on an unknown date in 2021. The patient reported ‘top of my arm swollen and then it ran straight to my back and I cannot get no relief on 26Jan2021; I really get sick with pain I mean with pain, it ran all way over to my back (as reported). It was reported that Pain is so bad; I have been in pain; I have been laying, it's hurt me so bad (as reported). The patient also experienced nausea on an unknown date in 2021. The patient was suggested to rest until feel fine. The patient called the ambulance but they (staff) confirmed no need of emergency room and want the patient to rest until she was fine. They told her not to get up and she don't want to get up either. Therapeutic measures were taken for suffering pain, pain across her shoulder, headaches/her head hurt, her back still hurts to move/it ran all way over to my back, top of my arm swollen/her arm was real sore and pain in the lefts arm/her arm felt like it was going to fall off. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events pain, sick as a dog, nausea, her back still hurts to move/it ran all way over to my back, didn't feel like eating, sneeze, she was very upset, arm was real sore /pain in the left arm/her arm felt like it was going to fall off was unknown while for other events was recovering.

Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21

Clot; Swelling and pain in left foot, ankle, and calf; Swelling and pain in left foot, ankle, and calf; This is a spontaneous report received from a contactable consumer (Patient's son). A 81-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (believes in afternoon) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient previously took history vaccine included shingles shot received on Nov2020 and Flu shot typically gets every year. On 02Jan2021, patient received first dose of COVID vaccine (BNT162B2) for covid-19 immunisation. The patient experienced severe swelling and pain in foot, calf, and ankle on the left side shortly after the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. She was hospitalized and placed on Xarelto for treatment by her cardiologist and was scheduled to follow-up to have other procedures performed as deemed needed. Doctor advised patient had a clot and was put on Xarelto. An angio and cath was suggested to see if she had something closing up in her. Patient was going back in a few weeks to see about the clot. she never had this clotting concern before, and this was all new right after the second COVID vaccine. Swelling and pain in left foot, ankle, and calf was either 04Feb2021 or 05Feb2021. she first noticed left foot was swollen. she stated her foot was sore. It was unknown if it went to her ankle and then from there. It was stated that the pain and swelling was better. She was informed by the nurse administering the COVID vaccine that second dose would be a little bit stronger. The patient underwent lab tests and procedures which included MRI on 15Feb2021 and diagnosed the clot. The outcome of the event Clot was unknown. For other events was recovered on unspecified date in 2021. Information about Batch/Lot number has been requested.

got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose. Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm. Information on the lot/batch number has been requested.

Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feeling really bad and may go to emergency room; in lots of pain/had some pain Sunday; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration, at dose 1 administered in Arm Right (Arm Right Upper) on 04Feb2021 15:30 to 04Feb2021 15:30 (at the time of 81-years-old) as single dose for covid-19 immunisation (due to age 81). The patient's medical history was not reported. There were no concomitant medications. She was in a lot of pain this morning. Yesterday she was fine and on Sunday she had some pain on Feb2021. Today she feels unwell and her lower back is killing her, has left leg pain, the left thigh is swollen and the calf of the left leg is swollen on 10Feb2021. Mentions she had her first Pfizer BioNTech Covid-19 vaccine last Thursday. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Later mentions she feels really bad and might go to the emergency room. No further details provided. The outcome of events was not recovered. No follow-up attempts (needed or possible). No further information expected. Information about lot/batch number has been requested.

Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events 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.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction

Presented on 4/27/21 (5 days after 2nd dose of Pfizer COVID vaccine) with acute onset of chest pain around 7am the same morning. Testing ultimately confirmed the diagnosis of acute pericarditis.

swelling of lower lip and other parts of face; swelling of lower lip and other parts of face; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (Batch/Lot Number: ELI283) as single dose for covid-19 immunisation. The patient medical history included hypertension, arthritis, vertigo from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products with Codeine, Z-pak, some Sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and, zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swelling of lower lip and, swelling of face on 20Jan2021 03:00 primarily noticeable to me and others who know me. Otherwise, not particularly noticeable .The patient visited Emergency room/department or urgent care for the event.Outcome of the event unknown. Follow-up attempts completed. No further information expected.

A whole-body rash was evident 2-3 weeks after the first vaccine dose. Subject was unsure at the time if it was vaccine related. Severe swelling of hands and legs began the same day after the second vaccine dose with general malaise and concerns about fainting. Oral steroids were prescribed for 2 weeks, and progression of the symptoms seem to stabilize during steroid treatment. After steroid treatment, the symptoms resumed at full strength with swelling in the hands and legs causing the superficial skin to peel off and split down into the dermis with bleeding and pain. Joints in the hands and legs were painful. Severe swelling and pain in the hands and legs persisted for at least 6 weeks after the second vaccine dose. A diuretic was prescribed at about 4-5 weeks after the second vaccine dose. The subject is currently reporting improved symptoms.

feeling weak/had no energy all day; nervous; a lot of pain in the injection site (left arm); chills; a mild fever/Fever chills; one swollen lymph node on the right side; muscles aching; tiredness; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), via an unspecified route of administration, in left arm on 01Feb2021 11:30, as 1st dose, single for covid-19 immunisation. Medical history included sinusitis from an unknown date and unknown if ongoing, neuropathy peripheral from an unknown date and unknown if ongoing and anxiety. Patient explained that she had trouble with the flu shot prior, having weakness and low blood pressure and that's why she got so nervous to get it, she was exhausted from that. There were no concomitant medications. After the onset of events, her husband suggested to take benadryl, and so she took 1 yesterday. Patient received the first dose of the Pfizer COVID vaccine 01Feb2021. Medical Conditions was she actually had a physical a week ago, her heart is fine, the doctor said her blood work was normal. Patient was calling about the Covid Vaccine, she got it the day before yesterday. She experienced "a lot of pain in the injection site (left arm) the first night after the injection. She also experienced tiredness on 01Feb2021, chills, a mild fever on 02Feb2021, one swollen lymph node on the right side on 02Feb2021 and has been feeling weak. She reported that she spoke with someone else prior to speaking with medical information and stated she gave them "her information" about the side effects. Her muscles aching, the chills, the swollen lymph node on the right side started on 02FEB2021. She was also mostly tired with no energy she had a little bit fever since she had the chills. She was just feeling unwell like she got the flu. Caller stated that it was just the normal flu shot, she hasn't had it for 5-6 years now. She has no lot number to provide. Her doctor said if it causes trouble then don't get it, a couple times she was in urgent care because of the low blood pressure, like she was going to pass out. The chills she just had once or twice yesterday. She didn't take a temperature. She clarifies that it was just 1 lymph node that was sore and raised, she can barely feel it today, it went down. Today she still felt the weakness and tiredness. Caller would like to know if it was ok for her to take Tylenol for her post vaccination symptoms. The patient underwent lab tests and procedures which included blood pressure abnormal was low and blood test was normal. Investigation assessment included All tests were normal. Patient does have anxiety; however, caller thinks that it was this covid situation and the depressing news every day. Outcome of the events tiredness was not recovered, event one swollen lymph node on the right side was recovering and unknown for all other events. Follow up (03Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported, new information included: Description of the reporter patient characteristics (age weight, height), relevant medical history and concurrent condition, reaction/events (onset date outcome), suspect Information, lab test were updated. Follow-up attempts are completed. No further information is expected.

Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling; Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non hcp (patient). An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Deltoid Right on 25Feb2021 13:00 (Batch/Lot Number: EN6198) (at the age of 81-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included restless legs syndrome from an unknown date and unknown if ongoing, multiple allergies from an unknown date and unknown if ongoing, Handicap from an unknown date and unknown if ongoing (7 years), ongoing end stage osteoarthritis (No surgical procedure), allergic to Ampicillin and Penicillin from an unknown date and unknown if ongoing (Patient has had previous allergic reactions 7 years ago and allergic to all other major antibiotics), ongoing chronic pain (No surgical procedure), ongoing fibromyalgia (no surgical procedures), ongoing high blood pressure (no surgical procedures), Lung cancer from Mar2019 and ongoing (MRI's show tumour diminishing. Had radiation in 2019- Stereotactic body radio surgery), allergic to major antibiotics from an unknown date and unknown if ongoing (she had a thick tongue and a puffy roof of her mouth and irritated tongue) and Stereotactic body radio surgery on 2019, chemical sensitivities from an unknown date and unknown if ongoing and PEG reaction to Nutelee from an unknown date and unknown if ongoing. Concomitant medication(s) included oxycodone (MANUFACTURER UNKNOWN, Strength: 10mg) taken for pain from an unspecified start date and ongoing; paracetamol (TYLENOL, Strength: 500mg) taken for pain from an unspecified start date and ongoing; losartan potassium (COZAAR, Strength: 100mg) taken for hypertension from an unspecified start date and ongoing. The patient did not receive any other vaccine prior to bnt162b2. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL8982) via intramuscular administered Left Arm deltoid at 13:00 (at the age of 81-years-old) on 04Feb2021 and experienced Headache, soreness in the arm, random itchiness, increased fatigue, inside of cheeks were puffy, Irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021 and mucous membranes inside her nose were burning on 05Feb2021, her restless leg was increased, joint and muscle pain. The patient previously took Ampicillin and experienced allergic to Ampicillin and rash (30years ago). The patient experienced Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling on 25Feb2021 at 17:00. The patient was advised by physician in phone to take 10mg of Claritin the day before, day of a several days after 2nd dose. It was reported that patient was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient heard that whatever side effects experienced during first dose they will be more intense after the second dose. Caller says she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient Claritin 10mg for allergic reaction from 24feb2021 to 28Feb2021 as suggested by the physician. The patient had undergone covid test on 27Oct2020 resulted negative and on 25Jan2021 resulted in negative, and MRI on an unknown date was resulted in tumour diminishing. The patient kept in contact with the allergist through phone. The outcome of the events Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling was resolved on 02Mar2021.

experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10Mar2021 (age at the time of vaccination was 81-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) on 17Feb2021 for COVID-19 immunization. On unspecified date, she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable. She reports putting ice packs on the knot for treatment and after 3-4 weeks it gradually got smaller. The Consumer reports that she is still experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee. She states that the feeling doesn't bother her but just wants to know if others have reported this same symptom. Treatment included ice packs for the event "she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. Outcome of the events burning sensation and Peripheral swelling was unknown while pain in arm was reported as recovering. Information on the lot/batch number has been requested.

My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder was swollen; I got up and my arm, shoulder was swollen, that hurt and then it stop hurting; This is a spontaneous report from a contactable pharmacist (patient).A 81-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 11Jun2021 (Lot Number: EW2178) at the age of 81-year-old as a single dose for covid-19 immunisation. Medical history included back injury from an unknown date and unknown if ongoing and patient on morphine for back injury. The patient's concomitant medications were not reported. The patient's arm has been sore which just been killing her and pain was also over her neck. patient was on morphine but that morphine did not even touch this and her neck is about to kill her. On 12Jun2021 patient's arm, shoulder was swollen and that hurts. The outcome of events pain in arm, shoulder pain was recovered and event pain neck, swollen arm, joint swelling was unknown. No treatment received for the events..

Per EMS report, within 15-minutes of vaccination, patient underwent an anaphylactic reaction. Patient's care was managed on site.

Slight ache at injection site....lasted about 2 days Woke up Friday am...approx. 15 hrs. after injection...with large swollen area in throat under right side of chin...presumably a lymph gland, which is sore to the touch and uncomfortable when swallowing. Has not gone away yet. Seeing my Doctor tomorrow.

touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events. Information on the Lot/Batch number has been requested.

got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.

blue finger tips--red spots on upper legs that turned black the next day--100 degree fever-nausea-headache--upper legs swelled up and was discolored for a few days

Swelling, pain, redness, left neck to ear. Temperature 99.0 F. Pain increased with eating. symptoms wax and wane. Primary physician not in office but nurse advised me to see Dentist.

throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable consumer. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan2021 10:15 at single dose on Left arm for covid-19 immunisation. Medical history included has a lot of allergies, reactions to honey and penicillin, She experienced neck swelling after receiving penicillin. Caller took the 1st dose last 26Jan2021. she and her husband got the Covid-19 vaccine yesterday. While reporting on her husband, caller states she had a reaction to the vaccine. After receiving the shot, Caller was put on the side for half hour and 15 min later, she experienced her throat tightening on 26Jan2021. Caller was given Benadryl and observed for 10 min. Her husband received his shot but "he did not feel the needle going into his arm. Weight is between 120-123lbs. Caller mentioned that she has a lot of allergies. They watched her for 30 minutes after getting the vaccine. Within 15 minutes her throat was feeling a little tight. It cleared after about 10 minutes. Her vital signs were checked and were fine. Thy also gave her some Benadryl. She takes vitamins and minerals because she believes in them. Outcome of the event throat tightening recovered on 26Jan2021 and events was unknown.

Pain on the lymph nodes/lymph nodes hurting; Hurting really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date: 31May2021) on 21Jan2021 (07:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). Medical history included being a diabetic from 2005 and ongoing (was not on insulin, only on pills); ongoing chronic obstructive pulmonary disease (COPD) in her 50's (also reported as "it has been a while"), and was not on oxygen; ongoing anxiety attack; had a problem with her left lymph nodes in her breast; and had pleurisy that was not really that bad (taking paracetamol (TYLENOL)). Concomitant medication included ongoing metformin for being diabetic. In Jan2021, the patient had developed pain on the lymph nodes after receiving the vaccination; and the patient was hurting really bad. The patient was previously diagnosed with pleurisy (prior to the vaccination), and it was described as "bad enough for her to take Tylenol" and it was just distracting before. After getting the vaccination, in Jan2021, the patient's pleurisy got really bad, and stated that the vaccine might have attacked her lymph nodes especially the lymph nodes on her left breast, left chest, under arm and back, and that she thought the vaccine had made the pleurisy worse. The patient's condition was so bad that she had to go back to the doctor; events resulted into physician office visit. The patient was informed to take two ibuprofen 200 mg a day as treatment for the reported events. The patient had a chest-ray in Jan2021 after the doctor had diagnosed her with pleurisy (results were not provided). The outcome of the events was not recovered for 'pleurisy that got really bad'; and was unknown for 'pain on the lymph nodes' and 'hurting really bad'.

a bad stiff neck on my left side; one of my lymph nodes were swollen; the pain on my left side of my neck; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 82-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, in the left arm on 30Jan2021 at 10:45 AM (at the age of 82-years) as a single dose for COVID-19 immunization. Medical history included asthma, and hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 05:00 AM, the patient woke up with a bad stiff neck on her left side. When she touched her neck, she realized that one of her lymph nodes were swollen, and pain on her left side of my neck. The patient was not sure whether the pain on her left side of her neck had anything to do with this swollen node. After four days, she still had the swollen node and a lot of pain on her left side of her neck. No treatment was given. The clinical outcome of bad stiff neck on my left side, one of her lymph nodes were swollen, and pain on her left side of my neck was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on lot number was requested.

she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5

Pain for 4 or 5 days in left leg (that leg also has varicose veins), some swelling and tender to the touch . Fifth day became raised and warm to the touch, so went to Urgent Care Diagnosis: Occlusive and nonocclusive thrombus within a superficial vein underlying the region of concern

After her 1st dose, she had an allergy so bad; Swelling and hives all over body; Swelling and hives all over body; This is a spontaneous report from a contactable nurse, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the arm on 23Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was on blood thinner therapy; allergy to a lot of medications, mold and cut grass; operation to remove clots in Nov2020 (two months prior to vaccination); thyroid disorder. Concomitant medications included unspecified thyroid pills and apixaban (ELIQUIS) as a blood thinner. The patient previously took moxifloxacin (AVELOX) and experienced allergy and rash and was in the hospital. On 24Jan2021 (the next day after vaccination), the patient experienced an "allergy so bad", swelling and hives all over her body. The patient went to the emergency room due to the events and was "hooked up" with intravenous (IV)s for an hour before she could go home. The reactions were assessed as related to the vaccination by the patient. The patient was scheduled for her second dose on 23Mar2021. She was not given the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers until after being administered the first dose of the vaccine. If she had been given the fact sheet for recipients and caregivers before being administered the first dose, she would not have gotten the vaccine because the sheet says not to get the shot if you are allergic to other medications or other reasons for allergies or on blood thinners. The patient questioned whether she should get the second dose as her physician said she should not get the second dose while on apixaban. The clinical outcome of "after her 1st dose, she had an allergy so bad" and "swelling and hives all over body" was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on temporal relation and known safety profile of the vaccine, a causal relation between events allergy to vaccine, swelling, hives and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 10+ days, diarrhea for 3 days starting 1 week after shot,

Patient is an 82-year-old female who came to the emergency department today complaining of shortness of breath. Patient also reports that she has cough, low oxygen and recently received her second Covid shot and when EMS picked her up she was 83% oxygen saturation on room air. Patient has what sounds like pooling secretions in her throat and patient had suctioning done by respiratory which caused her to bleed blood noted in teeth and around mouth. Patient reports that her throat has been hurting her and that is why she has been unable to eat. Patient's daughter is at bedside and is historian for majority of the assessment. Patient's daughter reports she has not been eating or drinking for the last 2 days. Labs in ER showed WBC 11.61, lactate level 3.3, creatinine 2.0, procalcitonin 5.33, magnesium 1.5, BNP 2100, glucose 474. Chest x-ray showed no acute findings.

Began Swelling in right foot 4 days after receiving injection. Then swelling began up the right leg, a week later the left foot began to swell the up the left leg. Never experienced swelling in legs before

COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness. But the last few days have been very painful. I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful. Since Saturday my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse. Additionally I ache all over and feel like a very bad case of the flu. I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour. Now I'm using Advil, which helps for several hours. Is there anything I can do to get relief. This is the 8th day....and it seems to be getting worse instead of better.

Patient developed diffuse arthralgias and myalgias associated with left arm weakness starting 2-3 weeks after but becoming unbearable at 4 weeks from 2nd dose. pain was resistant to NSAIDs.

could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot and puffy; might have some fever; This is a spontaneous report from a contactable consumer (Patient himself). An 82-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, ExpirationDate: Unknown) on 30Mar2021 via unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient stated the next morning she could not open her mouth, could not chew, face was hot and puffy, might have some fever also. She took a couple of Aleve, and it went away after couple of days. The patient stated she didn't know for sure if it was related to the Covid-19 vaccine or not. The day that she got the Covid-19 vaccine, later provided as 30Mar2021, she felt fine and never had a sore arm or fever. It was reported that it was almost like lockjaw, that she couldn't brush her teeth or chew. The patient reported that later in the day, the side of her face was all hot and might have been swollen and she took ibuprofen and that the inability to open her mouth went away in a couple of days. The reporter assessed the events as non-serious. The patient reported that she went to the chiropractor a couple of days later and the chiropractor said that he had heard about patients experiencing lockjaw after receiving the Covid-19 vaccine and she looked on Pfizer's website and the AE she experienced was not listed as a side effect. She is just a little concerned as she is scheduled to receive her second dose of the Covid-19 vaccine next week on 20Apr2021. She is afraid that the lockjaw might come back and might be worse. She is just curious if she is the only one that experienced the inability to open her mouth. The patient reported she does not know anyone that had this reaction and it is not listed as a side effect on Pfizer's website. The outcome of the event was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I had a lot of reaction from the COVID shot. I had a bad bad flare with my arthritis by being off of the Xeljanz; I have been extremely fatigued; I had a few headaches which is extremely rare for me to have a headache; Can't use left hand/Painful to sit down and straighten the leg up; Right leg and knee and joints are so swollen; A lot of pain; Hard to get up from a chair or get in and out of bed; This is a spontaneous report from Pfizer Sponsored Program. A contactable 82 year old female consumer (patient) reported for herself, took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number EN6206, Expiration date were unknown), via unspecified route anatomical site of injection administration stated by the patient was Left upper arm on 18Mar2021 for COVID-19 immunization and had a co suspect as Tofacitinib Citrate( XELJANZ) as prescribed 5 mg tablets which was stopped by the patient to take BNT162B2. The patient's medical history reported was rheumatoid arthritis, Chronic kidney disease, AFibrillation and unspecified allergy. The concomitant medications included were Paracetamol(TYLENOL) was taken for pain whenever she needed. Apixaban(ELIQUIS) as 5mg twice daily, Bumetanide(BUMETANIDE) as ongoing, VITAMIN D3 as 1000 units daily, Ubidecarenone (COQ-10) 30mg once daily, Metoprolol(METOPROLOL)50mg twice daily, Prednisone(PREDNISONE) 5mg once a day, Cyanocobalamin(VITAMIN B12 CYANOCOBALAMIN) ongoing, Digoxin(DIGOXIN) 0.125mg once daily tablet ongoing. She had to take anit-histamines at this time of the year. They said she should not take Covid 19 BNT162B2 and Tofacitinib Citrate( XELJANZ) at the same time. She had been off it for two weeks and she had a lot of reaction from the COVID shot. She had a bad flare with her arthritis by being off of the XELJANZ but she was back on it for a little while. She had to delay her second dose of the vaccine because of it and that she would have to go off of it for another two weeks when she get the second dose for 8Apr2021. She was not sure if she should try as her right leg was in bad pain. stated that she had been off XELJANZ to take the COVID 19 shot. Patient was afraid to take that second shot. She had been extremely fatigued and had a few headaches which was extremely rare for her to have a headache. They did not last very long, they were more of like just pain in her head and uncomfortable for a few minutes and it went away. Her main concern was that her hands were so swollen, that it was very difficult to take care of herself. And her legs as well as it was hard to get up from a chair or get in and out of bed as it was painful. She did not know what to do as to go off of the XELJANZ for two weeks, which unfortunately both are Pfizer medications. She could not use her left hand and her right leg, knee and joints were so swollen. It was painful to sit down and straighten the leg up and she was in a lot of pain. She was supposed to stay off of this XELJANZ right after taking the first shot which she did, did not take XELJANZ until 3Apr2021 which was a full two weeks period, that was her Rheumatoid Arthritis. Outcome of the events was unknown. Additional information has been requested.

Swelling in the lower legs and feet; This is a spontaneous report from a contactable consumer (Patient). A 82-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in left arm on 22Feb2021 at 10:00 AM as single dose for COVID-19 immunization. Patient had historical vaccine (at 82-year-old) BNT162B2, first dose in left arm on 01Feb2021 11:00 AM for COVID-19 immunization. There was no other vaccine in four weeks. Patient medical history included glaucoma, high blood pressure, pacemaker and known allergies from Sulfa. The patient took concomitant medications (Other medications in two weeks). On 01Mar2021 at 08:00 AM, the patient experienced swelling in the lower legs and feet. There was no COVID prior vaccination and not tested for COVID post vaccination. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Right arm completely swollen all the way to the fingers. Whole hand on right side swollen for over 8 days.

Fatigue, water retention - in feet/legs and lungs resulting in A-fib. These symptoms continued for weeks. After seeing PCP on March22, 2021, I began taking lasix and potassium for swelling. After seeing cardiologist on April 1, 2021, I began taking Eliquis, entresto and metoprolol. My heart is now back in sinus rhythm. The "pumpability" of the heart in March 30, 2021 echocardiogram registered at 20 (should be 50 or above). A follow up pet scan on April 16, 2021 show it improved to 35.

right leg: sore, pinkish, swelling, puffiness, sore walking and climbing steps dr. visit, on March, sent to ER for ultrasound, admitted to ER for visit and tests Deep Vein Thrombosis in right leg and superficial blood clots in right leg diagnosed eliquis prescribed for 3 months

This 82 year old female received the Covid shot on 2/16/21 and went to the ED on 5/3/21 and was admitted on 5/3/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome)

J18.9 - Pneumonia, unspecified organism R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

Scratchy throat; Swelling in left arm; lymphedema; This is a spontaneous report from a contactable consumer (patient). A 82-years-old non pregnant female patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration, administered in right arm on 26Jan2021 14:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. Medical history included Knee replacement surgery.Breast cancer for several years from 1996 surgery. Patient did not had allergies to medications, food, or other products. Concomitant medication included simvastatin taken for an unspecified indication, dorzolamide hydrochloride/timolol maleate (COZOPT) taken for an unspecified indication, acetylsalicylic acid (ZORPRIN) taken for an unspecified indication, ubidecarenone (COQ 10) taken for an unspecified indication. On 29Jan2021 the patient experienced scratchy throat, swelling in left arm, lymphedema. The events were considered as non-serious by reporter. No treatment was given to patient.The outcome of events was unknown. The action taken in response to the events for bnt162b2 was not applicable. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

leg swelling; ultrasound showed an occlusive clot in her femoral artery; femoral vein clot; had pneumonia; fever; developed chills; then chest pain; shortness of breath; This is a spontaneous report from a contactable physician. An 82-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19), dose 2 intramuscularly administered in the right arm on 04Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. Medical history included hypertension, hypothyroidism and osteoporosis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19) on an unspecified date for Covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); calcium; acetylcysteine, calcium levomefolate, mecobalamin (METAFOLBIC PLUS); losartan; hydrochlorothiazide; denosumab (PROLIA) and trazodone; all indication, start and stop date were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that in the evening of the vaccination (04Mar2021), she developed chills and fever, then chest pain and shortness of breath. The physician obtained a CXR (chest x-ray) on the patient on 04Mar2021 and found that she had pneumonia. She was treated with levofloxacin and prednisone. The physician rechecked her in one week and gave her Kenalog injection and Rocephin injection. The physician rechecked her on 22Mar2021 and she was improved, but she returned to the office 12Apr2021 with left leg swelling. The ultrasound on 12Apr2021 showed an occlusive clot in her femoral artery. The patient was admitted to the hospital (Apr2021) for 1 day and placed on heparin, then sent home on Eliquis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and the patient received treatment which included antibiotics and steroids for pneumonia and blood thinners for the femoral vein clot. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events leg swelling, occlusive clot in her femoral artery and femoral vein clot were recovered on Apr2021 while the outcome of the other events was recovered on 22Mar2021. Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events peripheral swelling, peripheral artery thrombosis and venous thrombosis limb and the suspect drug BNT162B2 cannot be excluded.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

SWELLIN OF THE HANDS AND FEET AND LEGS; SWELLIN OF THE HANDS AND FEET AND LEGS; SWELLIN OF THE HANDS AND FEET AND LEGS; This is a spontaneous report from a contactable, consumer. A 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) 1st dose on 11Mar2021 at 09:45am, solution for injection in the right arm, via unspecified route of administration for Covid 19 immunisation. Medical history included diabetes. The patient had a history of codeine allergy . The Patient has tested as negative and the test name was not provided on unspecified. Since the vaccination, the patient had been tested for COVID-19. On 12Mar2021, the patient had swelling of the hands and feet and legs. The patient has recovering from the event of swelling of the hands and feet and legs at the time of reporting. No follow-up attempts are needed. No further information is expected.

Encounter Details Date Type Department Care Team Description 04/22/2021 - 04/29/2021 Hospital Encounter Acute respiratory failure with hypoxia (Primary Dx); Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present; Pneumonia due to COVID-19 virus; Pneumonia due to 2019-nCoV; Simple chronic bronchitis Details of the Hospital Course: Patient is a 82 y.o. female with COPD follows with the respiratory disease specialist outpatient, history of mediastinal mass s/p VATS procedure done by Dr. in June 2011, pathology came back benign thymoma, she subsequently developed a slowly growing posterior mediastinal recurrence that was resected by Dr. in June 2016 and was felt to represent "recurrent/metastatic thymoma?type AB", with surgical margins < 1 mm; she declined postoperative XRT, last seen by Dr. in April 2020 recommended repeat CT in 1 year for evaluation who presented to the ER on 04/22/2021 with complaints of shortness of breath, found to be hypoxic on room air with pulse ox of 87% and found to be positive for covid 19 (of note: patient received her first COVID 19 vaccination mid April). Chest xray showed radiographic evidence of pneumonia in RLL but without evidence of acute PE on CT scan. Patient was requiring 15 L of supplemental oxygen to maintain oxygen saturations and so was placed on high flow nc with better response 4/23 remained on HFNC 4/24 BCx from 4.22.21 growing out gram positive cocci in 1/2 bottles 4/26 HFNC at 50% and 45L 4/27 off HFNC and on 6 L NC/ awaiting PT evaluation 4/28 per, OT assessment -- pt dropped into 70's on 6L 02 with short walk to bathroom and toileting tasks. cues for rest and PLB needed to increase 02 into 80s. with a seated rest break over 5 mins 02 increased to 88% on 6L COVID pneumonia (first dose of Pfizer vaccine mid April) S/P remdesivir X 5 days, now on day 8/10 decadron but will go home on oral decadron Acute hypoxic respiratory failure slowly improving (not on home oxygen therapy) now off HFNC, was on 10 L oxymask. Patient's pulse ox this morning at rest on 4 L was 86% but improved to 92% on 5 L NC -will need 5L home oxygen therapy at discharge (new) -discussed the need to follow up with Dr or PCP to wean off supplemental oxygen. Patient agreeable with this plan Transaminitis levels trending downwards. History of thymoma s/p VATS 2011 -outpatient follow up Positive blood culture on admission, contaminant in 1 of 2 blood culture bottles. Repeat blood cultures showed no growth. Not on antibiotics Associated attestation - 04/22/2021 3:39 PM EDT Formatting of this note might be different from the original. Patient seen and examined. Current status reviewed with resident staff. I have reviewed pertinent physician documentation, laboratory and radiographic data. I have initiated therapies based upon this reviewed In brief 82-year-old woman with history of COPD, mediastinal mass status post VATS with benign thymoma with local recurrence presented with respiratory tract symptoms since 6 days prior to admission COVID testing is positive. In the emergency room she was noted be hypoxemic requiring 15 L of supplemental oxygen to maintain oxygen saturations. She is currently on high-flow feels much improved. I concur with exam as per Pulmonary fellow. Laboratories and imaging reviewed in detail. Impression COVID-19 infection COVID-19 pneumonia Severe hypoxemic respiratory failure requiring high-flow oxygen Thrombocytopenia which is new since 2016 and a poor prognostic sign History of benign thymoma with local recurrence COPD with exacerbation Doubt bacterial pneumonia Recommendation: Remdesavir 5 days Corticosteroids. Optimum dosing induration of corticosteroids has yet to be fully defined. Decadron 6 mg daily is reasonable however if develops progressive disease in the next 24 hr would escalate corticosteroids and would also add IL 6 inhibitor Additional minerals and vitamin supple role is unclear but probably benign If thrombocytopenia worsens may need alternative anticoagulation. Would check venous Dopplers Supplemental oxygen for saturations greater than 88% Daily PPI unless anticoagulation intensified then would go to q.12 hours Would favor discontinuing antibiotics

my right foot started to bother me on the ball of my foot. It is swollen and hurts to walk on.; my right foot started to bother me on the ball of my foot. It is swollen and hurts to walk on.; pain down the left side then nothing else but a little in the arm; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 82-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in top of left arm on 26Jan2021 (at the age of 82-years) as 0.3 mL, SINGLE DOSE for covid-19 immunization. Medical history included: sinus disorder, gastrooesophageal reflux disease, cholesterol. She has had cholesterol for years. She has sinus problems on and off. She suffers from GERD. She was on a pill to help with the stomach prior, but not on it now. She took the last one on 30Jan2021. She had been on it for two months. She doesn't remember the name of the medication. It was a time released capsule. The patient did not receive any prior vaccinations within 4 weeks. Concomitant medications included: ongoing simvastatin (20 mg at night) taken for blood cholesterol and unspecified vitamins. She has been on simvastatin (generic for Zocor) for about eight years. She was on Lipitor (strength: unknown) for years and changed to Simvastatin. She got off Lipitor because she felt like it wasn't doing what it was supposed to do. Caller doesn't have product to provide lot number. She hasn't been on it for 10 to 12 years. No vaccines administered on same date of the Pfizer suspect. On an unspecified date in Jan2021, the patient had pain down the left side then nothing else but a little in the arm. On 30Jan2021, the patient's right foot started to bother on the ball of her foot. It was swollen and hurts to walk on. The clinical course included: the patient got her COVID shot on Tuesday (26Jan2021). She did in the middle of the night have pain down the left side then nothing else but a little in the arm. Then on Saturday (30Jan2021), her right foot started bothering her on the ball of her foot. It was a burning sensation. Yesterday was very bad and she could hardly walk. It is swollen on the bottom of the ball of her foot and across the top where her toes are. Her son just kept calling and telling her to check her temperature and pulse rate. She took Tylenol (strength: 500mg, Lot number: HDAO52; she had only taken two of them and it expired on Feb2019. She took one yesterday afternoon and one last night when she went to bed), applied ice (off and on), and elevated it and the swelling didn't go down. She did elevate it above her heart. Again, this morning she has the same thing. She was having a heck of a time walking. It was very painful. She was hoping she can walk normal again. It was still painful today. If she accidentally bumps it, it hurts. It was swollen. It started 4 days after receiving the vaccine. Caller stated she no longer had the problem with her arm. She has recovered completely. It was only bothering her a little bit on the twenty seventh (27Jan2021), but nothing to be concerned about. Investigations included: She hasn't been able to taste for some time and had a COVID test in December and she was negative. She was still having trouble tasting and had a CT scan of her sinuses last week (results not reported). She will follow up with her doctor about that. The outcome of event pain down the left side then nothing else but a little in the arm was resolved on an unspecified date in 2021 and for other events it was unknown. Follow-up attempts are completed. No further information is expected.

Patient was admitted to referring hospital on 5/24/21 for tongue swelling . Per chart review, patient's husband reported spontaneous bruising of right arm and swelling after received 2nd dose of COVID vaccine, which eventually came down. Repeat swelling occurred about 2 weeks prior to index admission, and was started on antibiotic for suspected cellulitis (cephalexin). Also reports of spontaneous brusing, as well as one episode of bleeding/oozing. At the ED, blood work revealed low hemoglobin (5.6) and PT 14.3, PTT >120. She was nasally intubated for airway protection. She was transferred to our institution on 5/25/21 for hematology work up and evaluation. Hematology evaluation is highly suspicious for acquired factor VIII inhibitor, and later confirmed with laboratory tests. She received recombinant factor VIII replacement (Obizur) as well as Emicizumab, as well as rituxamab for treatment acquired factor VIII inhibitor. Patient current still hospitalized.

Lymphedema in her legs/ got lymphedema about 5-6 days after the second Pfizer vaccine; Legs were hurting like the devil; Legs were about six times the size they should be/ she has intense swelling; Peeing too much; Doesn't feel right; she is just so weak; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May202, NDC: 59267-1000-2), via an unspecified route of administration, administered on left arm on 06Feb2021 at 12:00 as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing emphysema, ongoing breast cancer from 2007 (she did not take chemo, just radiation) and ongoing follicular lymphoma from 2014 (did not take chemo, just radiation. Cancer was in the bone marrow, said she didn't think that has anything to do with it, has had two operations) and bone marrow cancer. The patient previously took budesonide/ formoterol fumarate (SYMBICORT) she was using SYMBICORT, but her doctor switched it a few months ago, back to ANORO), prochlorperazine maleate (COMPAZINE) she takes a couple of times per month, takes 10mg when she feels nauseated and pseudoephedrine hydrochloride (SUDAFED) she takes when she needs it. Concomitant medications included furosemide (LASIX) at 40 mg, twice a day (one 40mg pill in the morning and one 40mg pill at night) from 1985 to an unspecified date and then increased to 80 mg, twice a day (two pills (80mg total) in the morning and two (80 mg total) at night) from on an unspecified date and ongoing for blood pressure; ongoing simvastatin (ZOCOR) taken for high triglycerides; umeclidinium bromide/ vilanterol trifenatate (ANORO). Patient thought she has been on Lasix since 1985 but can't remember back that far. She was taking Zocor for a long time and stated Anoro Inhaler was a fairly new medication. For Anoro inhaler, patient stated she pulls back the thing and didn't know, maybe it pinches a pill and inhales the white powder. Relevant family medical history included none and both parents were deceased. Patient stated that her oncologist does blood tests once every four months, a test for markers and stuff like that, CBC, metabolic panel and bloodwork every 4 months. The patient previously took first dose of BNT162B2 (Lot number: EL3246, Expiration date: 30Apr2021, NDC: 59267-1000-2) via unspecified route of administration in left arm on 14Jan2021 12:00 pm for COVID-19 immunisation. It was reported that, the patient has very sexy legs, but she doesn't anymore, says she got lymphedema about 5-6 days after the second Pfizer vaccine in Feb2021. She was now going to physical therapy, to bear her out and try to understand what she's saying. Caller states 30% of the people there that have had cancer and had radiation, get the same side effect she has had, some people have it in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs look like they belong on an elephant. Caller said at the physical therapy place, 30% of people who have come in for help had radiation treatment for some kind of cancer, all have different kinds of cancer, but the swelling, the lymphedema, was the side effect they've all experienced. Caller states that no one has called Pfizer and let Pfizer know, states she won't take the booster, won't have anything to do with this, says it's too scary. Caller states she was an active person, never had a problem with legs swelling or anything like that and now, her look like legs that belong on an elephant. Caller states the correlation seems to be with radiation treatment, because she has bone marrow cancer, and other ladies have breast cancer, states the only thing we all have in common was different treatments but in her own case she had no chemo, but she did have radiation. It seems like with radiation this swelling was an after effect. Caller says it's 2 or 3 things, not just that they had cancer or radiation treatment, says those of us who had radiation also got this swelling. Caller states she never had any trouble with legs or anything, says she was an active person. States some people experienced this four days after the vaccine, says hers started six days after the vaccine, says she woke up one morning, and her legs were huge. States usually legs were smaller in the morning. Caller wonders what were the ingredients that causes swelling. Caller states she doesn't know how to explain it, says like overnight turned a switch on and now her legs were going to be big and fat and ugly. Caller states the reason she's calling was because at physical therapy last Thursday, other people who had the shot had the same side effect, says the only thing the lady said, she wasn't sure if she was a nurse or not, was the relationship was not with the kind of cancer, but the radiation treatment and the shot has been causing this and wasn't surprised. Caller says she was told that about 30% that they're handling now had the Pfizer vaccine. Caller thinks that's all they gave in the state NC, no other vaccine here, says it just seems to be with this. Caller states the lymphedema, hers was in her legs, others have it in their arms, she doesn't know why it's happening. Caller states about six days after the second shot, she can't remember exactly what day, about six to seven days, she woke up one morning, and her legs were hurting like the devil in Feb2021, stated her legs were about six times the size they should be in Feb2021. Caller states usually in the morning, the swelling goes down, but this woke her up out of the blue like zap, says no warning, no nothing, just one day she woke up and that where it was. Caller states her doctor increased Lasix, she used to take one 40mg pill in the morning and one 40mg pill at night, increased it to two pills (80mg total) in the morning and two (80 mg total) at night. Caller states she is now only taking one-and-a-half-pills this morning, because she doesn't feel right and she was peeing too much in Feb2021 and was not feeling right. She doesn't want to get dehydrated. Caller states she has a doctor appointment 10Jun2021 and was going to tell him she was taking less because she was just so weak in Feb2021. Says she was weak because she's taking too much Lasix, states she was taking two 40mg morning and night. Caller states she was just concerned, she has big legs, fat legs, she calls them fat. The patient not visited emergency room. The events result in the patient visited physician office. Patient reported that she has had no shots for four months however she was going to get the high dose flu shot on 01Oct2021. No relevant tests were performed at the time of this report. The outcome of the events lymphedema and Legs were about six times the size they should be was not recovered and outcome for the other events was unknown. No further details provided. Follow-up attempts are needed. Further information requested.

Had a little temperature; Under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen/Like the under pit and a little bit down there; Itchy; This is a spontaneous report from a consumer (patient's daughter) reported for the patient. A 82-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 82 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The reporter stated that her mom got her Pfizer vaccine shot (unspecified vaccine) the second one on 02Jun2021 and she was fine maybe had a little temperature but now she saw under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen, asked if that was normal. Like the under pit and a little bit down there. This was the same site she got a needle. It was little itchy too. The reporter was informed about Pfizer Medical information department and was provided with the number. The reporter was informed for the role of Pfizer drug safety. The reporter stated that last night, she noticed it. She didn't know he just checked today but last night it started. Last night, she found out she didn't know if it was like maybe after and she noticed it now. The reporter stated that she just really needed to call to see if she gets the info, they were almost done. The outcome of the events was unknown. Follow attempts are needed; information about lot number/batch number can be requested.

Systemic: SWELLING OF THE HAND-Severe, Additional Details: PT DIAGNOSED WITH RHEUMATOID ARTHRITIS FOLLOWING VACCINE

Swollen lymph nodes under left arm; swollen left breast; redness on breast; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 15Feb2021 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to wasp bites. Concomitant medications received within two weeks of vaccination included statin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via an unspecified route of administration in the left arm on 25Jan2021 at 00:00 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021, the patient experienced swollen lymph nodes under left arm, swollen left breast and also redness on breast. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph nodes under left arm, swollen left breast and redness on breast was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off the wall; Swelling of the face; Mouth was swollen, just her face and her lips were real swollen; Mouth was swollen, just her face and her lips were real swollen; Tiredness; Had a bowel movement, it was white-looking and smelled like a chemical; Urinating cloudy and with a chemical smell; her eyes were so foggy; Running from nose; Coughing; Having trouble thinking; This is a spontaneous report received from a contactable consumer or other non hcp. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported; Expiration Date: Feb2022) via an unspecified route of administration in Arm Right on 05Mar2021 13:20 (age at vaccination 82years old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure measurement. The patient's concomitant medications were not reported. The patient experienced running from nose, coughing, her eyes were so foggy, urinating cloudy and with a chemical smell on 05Mar2021, blood pressure and heart rate off the wall, swelling of the face, mouth was swollen, just her face and her lips were real swollen, weak, tiredness, had a bowel movement, it was white-looking and smelled like a chemical on 06Mar2021, having trouble thinking on Mar2021, blurred eyes on an unspecified date. She has never reported the side effects that she had, and her daughter told her should have done that. She found her papers and now she is 82 and she got her first shot on 05Mar2021. Patient reported as she felt fine then she got up to leave and her nose started running and it was just like water was pouring out and she made it up to the front and had Kleenexes in her pocket, then started coughing violently, her nose was running violently and trying to come out of her mouth, and she sat down on the chair there and she thought it will pass. she walked out to look for the person that took her out there and she saw exactly where they parked, and her eyes were so foggy she could hardly even see the car. She felt okay then the next day, she got up and her mouth was swollen, just her face and her lips were real swollen. However, her whole face was swollen. she didn't read the side effects to it and thought oh well, it's just some-thing. The next day her blood pressure was going off the wall, her heart rate was horrible, she called the doctor, they wanted her to go to the hospital. The doctor told her to take Benadryl, and Benadryl bothers her, and she said that made her worse. It made her worse. She further clarified made her worse as, it made her heart worse, dizzy and lethargic and she was already tired anyway. she would have been better off not taking it. Her heart rate, which is always normal or very good, and it was like it was going ninety miles an hour. she would get it to slow down then it would feel like it was going 90 miles an hour for a few days then she was really weak and her mind, which at her age she has a very good mind, they tested that, she was having trouble thinking. she guesses she would call it foggy. she wanted to sit down and pay bills, but she couldn't even concentrate. Her question is she had the first shot but now she's afraid to get the second shot because of what it did the first time around. she's afraid it will do double; they say it's a worse reaction. The card that she had, she said that her nose was running so bad, she shoved the card in her purse and looked in her purse later and she can't even find that card. She will say she can't get the flu shot because in the past, she had a very bad reaction from the flu shot, she was questioning whether to get this vaccine or not. It wasn't a live vaccine. she is scared to death of the virus and her kids wanted her to get it now, hurry, hurry, and she thought she would try it. Since she has reactions to suspect product, she's concerned about getting the second one. That was 10 years or more that she had the bad reaction. She is a person that her body is very sensitive. Her doctor has trouble getting medicines she can take. She has a bad back, she has tired every painkiller there is and she can't take any of them, they are worse than the pain. She has trouble seeing too. She keeps every-thing up, they don't give as many papers and it changes every week. She doesn't know how the people in the medical profession can take it, she imagines they change things on them overnight. She has macular. She couldn't understand with that shot why she could see whenever she went in and after she got the shot then everything was fogged when she came outside, but she knows it still wasn't as bad as getting the virus. She's still weak, but she's gotten better. They said she could leave, her nose started running and she started coughing. The girl said is she okay and thought she was, and she made it out then started coughing violently and that water was almost drowning her. She sat down in the chair, and it finally calmed down and got in the car, kept wiping that water with paper towels in her car and coughing and by the time she got home it was slowed down. She is more tired than usual, and her eyes haven't cleared up as good as they should. She doesn't know what that happened, it just came out of there and thought well god what has happened to her eyes. She has an appointment with the Optometrist at the end of April. Another thing she forgot, they are going to think she's looney, she started urinating that evening and she thought, this is not good, something was going on with her kidneys, because it was cloudy-like and had a chemical smell and then the next morning, she still smelled the same thing and her bowels were the same way, just smelled this chemical. That evening her urine was like that and the next morning she noticed it was like that into the next day, whatever was in there had to come out and then her urine and things cleared up. Started on 05Mar2021, that evening, when she urinated before she went to bed it was cloudy and had this chemical smell, maybe it was something she ate or something. The next morning, she urinated a lot and it was cloudy and the bowel movement, it was white-looking and smelled like the chemical and cleared up. She has recovered completely after whatever was in there got out the next day. She states she was okay after she did all that, she cleared up. The clinical outcome of the event blurred eyes was unknown, another events week, her eyes were so foggy, having trouble thinking, tiredness was recovering, and event running from nose, coughing recovered on 05Mar2021, blood pressure and heart rate off the wall was recovered on 09Mar2021, swelling of the face, mouth was swollen, just her face and her lips were real swollen was recovered on an unspecified date Mar2021, urinating cloudy and with a chemical smell and had a bowel movement, it was white-looking and smelled like a chemical was recovered on 06Mar2021. Therapeutic measures were taken as a result of swelling of the face (swelling face), mouth was swollen, just her face and her lips were real swollen (mouth swelling), mouth was swollen, just her face and her lips were real swollen (lip swelling). Information on Lot/Batch number was available. Additional information has been requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Patient left the clinic after 15 minute observation. 5 minutes later called and reported facial and lip swelling. No other c/o's. Instructed patient to go to ER. Arrived at ER 5 minutes later. Symptom improved and resolved to bassline without intervention. Patient left ER after 15 minutes with no intervention.

swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.

Experienced severe swelling from elbow and all of upper arm. Had to be taken to the emergency room, diagnosed as an allergic reaction to the vaccine. Required couple days in the hospital. Patient was on blood thinner Warfarin and doctors diagnosed as her having internal bleeding after the vaccination.

5 cold sores, red blotch on cheek, fever, fatigued, gastro distress, Woke up the next day, 1/23/21 with these events. All was gone the next day except the cold sores which are now healed.

her left side of her face which was the site that she had the shot on, on her arm was swelling; she had the shot on, on her arm was swelling; it could be a swollen lymph node; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated this morning on 23Jan2021 when she woke up her left side of her face which was the site that she had the shot on, on her arm was swelling and she was looking at all the paper work and it says it could be a swollen lymph node. Consumer stated, she asked a doctor about getting it and he said yes, is that the doctor you want.

Two days after injection noted swelling to lips not both at the same time but goes back and forth between the two, then two days later noted fever blister on bottom lip and tongue felt sensitive. These sx have continued off and on.

Grossly swollen legs and feet and ankles BP RISING TO 202/ 86 . i NEVER HAD THAT LEVEL OF HIGH BP BEFORE and it still is persisting up until today. highest BP for years was usually in the 130 range or rising a few times into the 150's when greatly stressed

RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFICULTY SWALLOWING, SORE THROAT, SOA, WEAKNESS/TINGLING IN BLE. ADMITTED ON 02/13/21 FOR DIAGNOSIS OF WEAKNESS, HYPOKALEMIA, CARDIAC ENZYMES ELEVATED, CHF, AND LEUKOCYTOSIS.

Itchy Left Foot, Congestion, Swelling and Itchy Arm 8 days after shot. I had itching and congestion during the week after the shot, but nothing like the reaction I had on the 14th of February. Also was dizzy and felt like I was going to pass out.

pt states that her left arm started swelling and developed a 4" feverish rash that is spreading down the arm. Pt states she is going to contact her PCP for medical advise.

Left jaw visible swelling, and perceived left side of tongue and left side of throat "felt swollen"; this occurred at 2 am, 17 hours post vaccination, and again a week later at 11 pm at night; both times symptoms did not impared breathing or swallowing and resolved after taking Benadryl, sipping water, and gargling with salt water

PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES

Instant sender headache lasting 4 days, extreme high blood sugar, fatigue, tender left underarm lymph nodes, brain fog for 5 days

she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.

Sever swollen hives on face, head, neck, and torso. Itching. Went to ER, they gave a injection of dose of Pepsid and told her to take claritin and pepcid daily. Said it should clear up. She has been doing that now her eyes are itching and body again, plus has a sever sore throat now.

Redness (4"x6" about 2" below injection site) started 2/26/2021. Noted swelling and warmth but denied pain. Tried benadryl and other creams with no improvement. Ibuprofen seemed to help.

Blood clot, swelling noticed a few hours aftee vaccine. Probably coincidence but felt it should be reported. Im not sure if the doctor she saw for blood clot knew she got the vaccine. It was a different clinic.

My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.

Almost immediately the patients face turned extremely red and swollen on the complete right side of her face. She immediately went to her physicians office and was directed to the emergency room at hospital. She was admitted and received an unknown I.V. and an unknown injection. After 2 hours she was released and was given 2 prescriptions to receive at her local pharmacy. The swelling lasted for 3 days. Five days later she had an identical reaction but it was on her left side of her face. A month later her blood was tested and she has had an abnormally low blood platelet count.

83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc without treatment who presented to ED 03/15/21 via EMS complaining of generalized weakness. She had felt well and had been in her usual state of health, and was able to cook and enjoy a turkey dinner with 5 individuals on 03/07/21, but on 03/08/21 she began to develop progressive generalized weakness up to the point where she remained in bed for several days. She could not support herself when attempting to rise from bed. She noted poor PO intake with nausea, no vomiting. Loose stools for several days, no noted stool blood. Did endorse waves of lightheadedness and had fallen backwards three times in the prior week, reportedly due to poor balance when standing. She was unable to elaborate regarding the falls but admitted to hitting her head at least once, unable to say if she lost consciousness or if she felt presyncopal symptoms before falling. She had initially presented on 03/12/21 to ED for evaluation, workup negative, labs and imaging normal. CT brain found no acute process. She was sent home with arrangements for home PT. She returned to ED 03/15/21 when symptoms had not improved. In the ED she was found to be afebrile, significantly hypertensive, mildly tachycardic, + orthostatic vital signs. Labs significant for heme occult positive stool, proBNP 397, WBC 10.1, H/H 13.4/39.9, PLT 493, UA neg for infection. COVID neg. CXR found slightly increased interstitial markings. MRI brain found no acute intracranial abnormality. She was evaluated by PT and found to be unsafe to DC home as she could not ambulate without leaning backward and to the right and needed 1-2 assist. She was admitted to HM service for further management. She has remained consistently afebrile. She continues to experience significant gait instability, cognitive slowing, and difficulty with finger-to-nose testing with noted dysmetria, no focal weakness.

Trouble speaking; legs are swollen and numb; legs are swollen and numb; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6202, via an unspecified route of administration, administered in left arm on 27Feb2021 18:00 as single dose for COVID-19 immunisation. Medical history included Parkinson's disease. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient experienced trouble speaking, and legs are swollen and numb on 01Mar2021. The patient was hospitalized due to the events. No treatment was received. The outcome of the events was not recovered.

polymyalgia rheumatica; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; This is a spontaneous report from a contactable physician. An 83-year-old female no pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included Hypothyroidism, known allergies: Morphine. No covid prior vaccination. Concomitant medications included Levothyroxine. No other vaccine in four weeks. In Feb2021, since receiving vaccination, patient developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP. Responded to prednisone. Patient insists no symptoms until she received first dose. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab in Mar2021: Negative. Medrol/prednisone were received. Outcome of the event was recovering. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.

Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber ad expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine. The patient previously took morphine, and had allergies; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization, and had polymyalgia rheumatica, RS3PE, elevated ESR and elevated CRP. On an unspecified date in 2021, after the second dose of vaccination, the patient's developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened. The reported events have resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized on an unspecified date in 2021 for two days due to the reported events. The patient had received methylprednisolone (MEDROL) and prednisone as treatment for the reported events. The outcome of the events, 'developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had a nasal swab test in Mar2021 that was negative post-vaccination. Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible temporal association, a causal association between the reported 'polymyalgia rheumatica and RS3PE including elevated ESR and CRP ' (aggravated, already reported after the first dose of vaccine) and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), dose 1 via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. There was none medical history. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Her leg was swollen and there was edema and there was a lump on the side and it was pink or getting red and she was on medicine (Clarification Unknown) for 7 days, twice a day and the leg is still (incomplete sentence), the edema has gone down some. The leg was still pink and it is tender to touch and if she stand on her leg for too long or walking around too much it hurts. She got pain. She was also sleeping whereby she was watching television and all of sudden she was sound sleep and she wake up over an hour or two after that and then she awake for a while but she have no trouble sleeping at night again. She had chest pain and it's not angina because that she did have (Further clarification was unknown if consumer had angina in past hence not captured on tab) but it's a sharp pain and it does not want her taking Nitroglycerin because it went away and it last for maybe (incomplete sentence) it just like a stabbed wound. She was dizzy. That's still, it's not like what it was but it is getting less but she was still dizzy. She cannot walk a straight line. She lived in an apartment house and she had to walk down the hall to go down the stair but she sometime had to stop because she was dizzy. she kind of lean against the wall for few seconds and then she continued on. Concern was not the word for it. It made her very nervous and the circulation was very poor in both feet now and one leg, the right leg that has the pink and still the tenderness in that leg. The foot turns very dark pink and the big toe that she had turned dark purple. She wrote everything down and she will say this at the time after the injection she did not have any problem until about four days later but she did have problem with doing my cross- word puzzles and doing her puzzles. She could not do any of her puzzles, nothing was computing in her brain (Clarification unknown) but that's coming back slowly, so is that to be expected. Start date of event: Consumer stated "It was 4 days after the 5th, about 09Feb2021. She went there and saw a doctor an MD of course and she went there on 12th so it was a week later. She went because the pain was terrible. The outcome of events Leg is still pink and it is tender to touch; If I stand on my leg for too long or walking around too much it hurts, I got pain; Dizzy; is not recovered, all of sudden she was sound sleep; Cannot walk a straight line; Nervous; Circulation is very poor in both feet now; Foot turns very dark pink and the big toe that I have turned dark purple; Nothing was computing in my brain; pain was terrible was unknown, outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.

This 83 year old female received the Covid shot on 1/28/21 while under hospice care and went to the ED and admitted 2/4/21 and again on 3/3/21 and again on 3/25/21 and 4/15/21 died on 4/24/21. GI bleed, duodenal ulcer with hemorrhage, SIRS (systemic inflammatory response syndrome, shortness of breath, acute heart failure, acute respiratory failure, cough, pleural effusion. 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.

Her conditions (leg swelling, coughing) get deteriorated after the vaccination. She was found pericardial effusions and plural effusions 2 weeks after the second dose. She stayed in ICU for 6 weeks and passed away.

gland swelling under chin, upper neck; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (BNT162B2, Pfizer Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 30Jan2021 12:30 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included ongoing diabetes type 2. There were no concomitant medications. The patient received dose 1 (lot: EL3246) on 09Jan2021 for Covid-19 immunisation. The patient experienced gland swelling under chin, upper neck in Apr2021. The patient underwent lab tests and procedures which included ultrasound thyroid with unknown result on 08Apr2021. The outcome was recovering. No follow-up attempts are needed. No further information is expected.

Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16). Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake. Found to be febrile, hypotensive w/increased confusion. Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia. Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24

Pain; soreness in that left shoulder; swelling; Area was warm to touch; could not sleep last night; had light mild pain in left shoulder at the site of injection; This is a spontaneous report received from a contactable consumer (husband). This consumer reported for a 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. On an unknown date Medical history included cancer of thyroid, mitral valve replacement and use of a pacemaker. Concomitant medications were not reported. On Apr2021 the patient experienced had light mild pain in left shoulder at the site of and could not sleep last night; On 20Apr2021 the patient experienced pain and soreness in that left shoulder, swelling, area was warm to touch, could not sleep last night. The report received as, the reporter's wife got the first dose of the Pfizer Covid 19 vaccine on 07Apr2021 and had light mild pain in left shoulder at the site of injection for 2 days. Then 12 days later, on either 20Apr2021 or 21Apr2021, she developed pain and soreness in that left shoulder again, down to her elbow, with swelling and area was warm to touch. She did not have a fever. It bothers her and she could not sleep last night. She is scheduled for the second dose on 28Apr2021. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Swollen arm; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Headache; Body ache/arm from the shoulder to the elbow looks normal it was achy; cellulitis; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201, Expiry date: Jun2021) via unknown route of administration on 21Feb2021 10:30 AM at single dose for prevention/COVID-19 immunisation. Medical history included LBBB (bundle branch block left, heart problem), osteoarthritis, thyroid (patient was taking thyroid medications, thyroid elevated), chronic lymphoma leukaemia (that has been initiated for 9 years), slight heart problem. Concomitant medications included ongoing furosemide (strength: 10 mg) 10 mg once a day and amlodipine (strength: 10 mg) 10 mg once a day. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL8982, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 (at age of 83-year-old) for COVID-19 immunisation and experienced sore arm. It was reported that patient stated, on 22Feb2021 Monday morning I woke up about 2:00 AM with a headache and all over body ache, on Tuesday I felt a little better, on 23Feb2021 the injection site red and hot to touch and very sore, injection site is 3 times bigger than it was before, on 24Feb2021 Wednesday my arm quite swollen, so I had an appointment with my primary care, they prescribed antibiotics 'Streptomycin' (not clear) 500 mg. This was my 3rd day and my arm was still swollen now 3 times more it was before and very sore." Consumer added, "My left hand was also swollen but since I have been on antibiotics that has gone down. By the 24Feb2021 her arm had about the size of a half dollar, a big red spot that was sore and she went to her primary care who gave her an antibiotic called Cephalexin and 2 days later she couldn't get back in there, because there were no doctors available so she went to the Emergency Room which was 30 miles from where they live and they increased the Cephalexin from 2 times per day the 3 times per day and added Bactrim to it as well so she did that for 2 days and then on the 28Feb2021 she went back to the ER because it kept getting bigger and bigger and it was almost down to her elbow and so then they sent her and they admitted her into a ER observation and she stayed there for 3 days and they gave IV Clindamycin and she came home on the 03Mar2021 with 7 more days of Clindamycin to take orally. She has the Cephalexin she had already put them in the bag to be recycled she had just a few tablets left. She sees NDC 67877-0219-05, it says beyond use 27Feb2022 she does not see lot number on the pharmacy vial. It says plan DSER and she sees Ascend labs. On the Bactrim vial it says NDC 65162-0272-10. It was also in a pharmacy vial. It says beyond use 25Feb2022. The Clindamycin IV she received in the hospital. She has the Clindamycin tablets they sent her home with. The Clindamycin is also in a pharmacy vial she does not see lot number. NDC 65862-0185-01 and it says beyond use 03Mar2022. The diagnosis was cellulitis in 2021. She clarifies she first noticed the red spot on her 23Feb2021 it was about the size of a quarter, on the 24Feb2021 it was larger and she went to her primary. It was ongoing but at this point she was a couple days into the antibiotic and the arm from the shoulder to the elbow looks normal it was achy this morning when she woke up at 4am but she was now hoping she was on her way. She was in pretty good health overall. For events vaccination site erythema, vaccination site pain, vaccination site warmth, vaccination site swelling and peripheral swelling seriousness criteria was reported as hospitalization from 28Feb2021 to 03Mar2021 and patient went to emergency room for vaccination site erythema, vaccination site pain, vaccination site warmth, vaccination site swelling and peripheral swelling. The outcome of events headache and general body pain was recovering, cellulitis was unknown and for rest of the events was not recovered. No follow-up attempts are possible. No further information is expected.

patient developed muscle and joint stiffness 5 days after vaccine administration that persisted, she was diagnosed with PMR on 3/24/21 when her symptoms were not resolving

blood vessels are not reacting properly; Swollen lymph nodes; Legs keep swelling; Oozing fluid out of legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 83-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 01Apr2021 at the age of 83-years-old (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization. Medical history included hip arthroplasty from Jan2021 to an unknown date.Provide other relevant medical history including but not limited to these conditions were diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine. Patient took first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot number was EN6206) on 11Mar2021for COVID-19 immunization. Family Medical History Relevant to AE was not reported .The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Unspecified May2021, (these symptoms began about 3 weeks ago) between 1pm to 2pm after vaccination the patient experienced swollen lymph nodes, legs keep swelling, oozing fluid out of legs, on an unspecified date blood vessel are not reacting properly. The patient underwent lab tests and procedures which included blood potassium: normal on May2021, blood test: normal on May2021.Therapeutic measures were taken as a result of swollen lymph nodes, legs keep swelling, oozing fluid out of legs treatment included "10 water pills."which have all been taken, last water pill was on 18May2021. Other Conditions includes still recovering states that she had a messed up physical therapist. The outcome of events swollen lymph nodes, Legs keep swelling was not recovered, oozing fluid out of legs was recovered on 21May2021, blood vessels are not reacting properly was unknown. Information on lot/batch number was available. Additional information has been requested.

tiredness; little soreness; other day arm, her felt very heavy from the swelling; she felt a little bump over where her muscles; a red patch in little down from injection/it was itching a little bit and she noticed the patch and that her arm; itch/itching, it was itching a little bit down from the injection; swelling a little bit down from the injection; a red rash, down further, not around the vaccine itself; redness is not right on top of the needle mark, it is down a little bit from there.; Body chills; This is a spontaneous report from a contactable consumer (patient) and Other HCP. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 30Jan2021 13:30 single dose for covid-19 immunization. Medical history included COVID-19, she confirms that was before received the vaccine and She did get COVID back on 20Nov. Medical history included diabetes mellitus, blood pressure abnormal, thyroid disorder, blood magnesium decreased, and vitamin D decreased from an unknown date and unknown if ongoing. she was a little chubby. Concomitant medication(s) included insulin glargine (LANTUS) (reported as Lantus Solostar) taken 40 units once daily injection for diabetes mellitus, levothyroxine taken 75 mcg once daily by mouth for thyroid disorder, losartan potassium 50 mg once daily by mouth taken for blood pressure, magnesium oxide (Mag Ox) (2x/day (400 twice daily by mouth) taken since she was low on magnesium, cholecalciferol (3000IU) taken for low vitamin, and she taken 3000 units per day, there is 1000 units in her multivitamin and 2000 IU in her Vitamin D3. The patient reported that she received vaccine on 30Jan2021, and everything was fine until 31Jan2021 and said, 'Everything was fine until Sunday afternoon', she patient experienced itch and swelling, a red rash, down further, not around the vaccine itself. It's still there. She tried cold compresses yesterday which seemed to help. 'No fever, just tiredness.' A little soreness'. She stated that, the redness was not right on top of the needle mark, it was down a little bit from there. It was like a patch, a red patch and it was a little down from injection, because she put the needle high up on her shoulder and it was down a little further from there and it was a little red. She thinks it was about 3 inches wide, it looks like lighter now, but she can't see good in her room. She says the Tylenol seems to help it. She confirmed she got the first dose 30Jan2021 and she was supposed to get the second one 20Feb2021. She noticed the red patch the next day, 31Jan2021 and the itching, it was itching a little bit and she was just rubbing it and soothing it and she noticed the patch and that her arm was swollen a little bit in that area. It hasn't worsened; she was going to go to the bathroom because it was very sunny in the room and she can't tell how it was. It looks like its fading; the redness was fading she can still see the outline but it's very pale compared to yesterday. It has improved since the other day arm, her felt very heavy from the swelling, she didn't realize until she felt a little bump over where her muscles were, but it seems to be much better today. On unknown date in 2021, the patient also had body chills. She wants to know how long this will last and was she still eligible for the second shot. Patient used Tylenol & cold compresses for adverse events. The patient did not require medical intervention/ emergency department visit/ hospitalization and intensive care unit admission. The outcome of the events was resolving except for "chills" which was found to be unknown. No PQC involved. No follow up attempts are possible. No further information is expected.

downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet. Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week. Went to ER and was kept overnight. Was told sodium was low and she was sent home. Now her arm is blue and her vision is decreasing. Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.

red swollen area at top of forehead/swelling at top of nose between the eyes; red swollen area at top of forehead; This is a spontaneous report from a contactable consumer (Patient). A 83-Year-old (non-pregnant) female patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on 24Feb2021 10:00 (at the age of 83-years-old) as a single dose for COVID 19 immunisation. Medical history included cancer survivor, 4.5 years thyroid and part of parathyroid removed. The patient received other vaccines prior to the COVID vaccine within 4 weeks date 03Feb2021. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and Expiry date: Unknown) via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunisation. Facility type vaccine was Hospital. On 05Mar2021 12:00 patient on day 9 after second dose developed red swollen area at top of forehead and by day 10 swelling at top of nose between the eyes which has continued to day 11 patient tried to call # today and after almost 2 hours on hold operator picked up and hung up on me when I was 4 in que. Patient was not received treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; This is a spontaneous report from contactable consumer 83-year-old female (patient) reported for herself. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in arm left on an unspecified date as 2nd dose, single for COVID-19 immunization (at the age of 83-year-old). Medical history included ongoing gout, ongoing High blood pressure and ongoing pain. Concomitant medications included allopurinol taken for gout, aspirin (ACETYLSALICYLIC ACID), losartan taken for high blood pressure, felodipine for high blood pressure, diclofenac sodium taken for pain. The patient administered BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration, administered in arm left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On an unspecified date, the patient experienced Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine. The patient stated she wanted to go to the Urgent Care, but it was crowded. She feels stressed out, because she was waiting for her daughter to take her to the hospital. She cannot figure out why she hurts so bad. The patient stated she was a lady who can get around and take care of herself and stated several examples of how she was independent, and she exercises. The patient stated her daughter was going to take her to the hospital, because she feels there was something serious going on that day. Outcome of the events were reported as unknown. Information about lot/batch number is requested.

It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daughter's and I had no reaction. I came home and slept fine. After 7 days, I got hot spells and I keep taking my temperature. Sometimes it varies from 98.7-97.9. I started getting headaches and a lump in my neck after 3 weeks. I saw an ENT and he said these symptoms would go away. I was coughing and I asked my doctor to get a CAT scan. I had inflammation on my chest. It was last week that my PCP told me to see a pulmonary doctor. The disk that she had given him was not clear and that he couldn't determine anything. I have told my doctor about the weird headaches and acid reflux that I have been getting.

Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were watering; Pain in lymph nodes in neck when touched; Loss of appetite; Felt like heart was going to go through her head; Heart was racing; Felt like her throat was closing up a little bit; This is a spontaneous report from a contactable consumer (Patient). A 83-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (age at vaccination: 83-yesr-old) as single dose for covid-19 immunization. (Vaccination facility: Clinic). Medical history included bursitis, arthritis, High blood pressure, High cholesterol all from an unknown date and unknown if ongoing, body aches many years at least from 10 years ago. Concomitant medication included ubidecarenone (COQ-10) taken for myalgia (started shortly after she started taking the cholesterol medication and she found out she was having body aches many years at least 10 years ago), acetylsalicylic acid (ASPIRIN CHILDREN) taken for cardiac disorder (started since long time ago probably 15 years or better), LISINOPRIL taken for blood pressure measurement (stated since many years), SIMVASTATIN taken for blood cholesterol increased (from same time as the lisinopril, at least 10 many years). Vaccine not Administered at Facility. It was reported that patient stated she and her husband received their second dose of the Covid shot clarified to be the Pfizer Covid 19 vaccine. She stated that she got almost every symptom on the list. Later that both she and her husband experienced fatigue. reported that she broke her hip a few years ago and that her husband told her that she did better after breaking hip than after receiving the Covid 19 vaccine. She reported that she does not usually experience any side effects after vaccinations stating that she normally sails right through the flu shot. She stated she just retired from a full time job in the first part of February, and if she had still been working she wouldnt have been able to go to work. Patient reported that within 12 hours of receiving the Covid-19 vaccine she was woke up in middle of night around 2 AM with her heart was racing she felt like she was going to have a heart attack, and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. She stated it could have been her heart or her blood pressure that she felt like she was speeding. She also reported that she was running a fever had chills pain and a splitting headache. She stated that within 48 hours the worst had passed. headache improved after the first night but that for a few days after she would get a shot up the back of her neck into her head. She reported that it was quickly resolve on its own. fatigue was worse after the second dose and they are both still experiencing fatigue. She was stated that she feels that the fatigue has improved but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. She is still having some lightheadedness if she stands up too quickly, she has to take a moment to balance herself before she proceeds, this was began after receiving the Covid 19 vaccine. She stated she was Felt like her throat was closing up a little bit, she did not feel that it was emergent or life threatening that she thought it was related to her swollen lymph nodes. she noticed pain around her breasts when she put her bra on mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. She was unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05 Mar 2021. She reported that the pain gradually diminished. She stated that it didnt bother her, she was noticed it when getting dressed. She stated she was just slightly nauseated but that she didnt throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later around 06Mar2021 or 07Mar2021. Reported that the watering eyes have cleared up. She stated that it resolved quickly maybe a day or two after they began on 04 or 05Mar2021. She also reported had Pain in lymph nodes of neck she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry but her stomach just didnt feel like it had the room for food. She reported that the loss of appetite resolved a few days later around 06 or 07Mar2021. Received treatment with Tylenol she stated during the 48 hours after symptoms began she stayed in bed and slept. She reported that she was get up to get a drink or take Tylenol just a couple a day and was drank water. She reported that she drank lots of fluids. She stated that she was get up would take something and then go right back to sleep. Tylenol helped a little bit Tylenol doesn't do a whole lot but it's better than nothing. Adverse event not resulted in Physician Office visit or ER visit. The outcome for the event Fatigue and Lightheadedness was resolving, for events Loss of appetite, Eyes were watering, Nauseated outcome was resolved on Mar2021, for events Felt like heart was going to go through her head, Heart was racing outcome was reported as resolved on 03Mar2021 and for events Fever, Chills, Splitting headache, Felt like her throat was closing up a little bit outcome was resolved on 05Mar2021, and for remaining events outcome was resolved on unspecified date. Follow-up attempts are completed. No further information expected.

Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upset; Lightheadedness; Loss of appetite; Felt like her throat was closing up a little bit; Eyes were watering; Pain in lymph nodes in neck when touched; NAUSEATED; Fatigue; Felt like heart was going to go through her head; Heart was racing; fever; Chills; Splitting headache; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EM98089, Expiration date: Unknown), dose 2 via an unspecified route of administration in Arm Left on 02Mar2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient medical history included bursitis, arthritis Verbatim: Arthritis, hypertension, ongoing blood cholesterol increased. The patient also received first dose on bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 09Feb2021 as dose 1, singe for covid-19 immunisation. The patient concomitant medications included ubidecarenone (coq-10) taken for myalgia, start and stop date were not reported; acetylsalicylic acid (aspirin children) taken for an unspecified indication, start and stop date were not reported; lisinopril (lisinopril) taken for blood pressure measurement, start and stop date were not reported; simvastatin (simvastatin) taken for blood cholesterol increased, The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Caller reported that within 12 hours of receiving the Covid-19 vaccine, she woke up in middle of night around 2 AM with her heart racing, she felt like she was going to have a heart attack and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. Caller reported that it could have been her heart or her blood pressure, that she felt like she was speeding. Caller reported that she was running a fever, had chills, pain, and a splitting headache. She stated that within 48 hours the worst had passed. Caller stated that the headache improved after the first night, but that for a few days after she would get a shot up the back of her neck into her head. She reported that it would quickly resolve on its own and also that both she and her husband experienced fatigue after receiving the first dose of the Covid-19 vaccine, but that the fatigue was worse after the second dose and they are both still experiencing fatigue. Caller stated that she feels that the fatigue has improved, but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. she was still having some light-headedness if she stands up too quickly. She reported that she has to take a moment to balance herself before she proceeds. She stated that this began after receiving the Covid-19 vaccine. Felt like her throat was closing up a little bit: Caller reported that she did not feel that it was emergent or life threatening, that she thought it was related to her swollen lymph nodes. Caller reported that she noticed pain around her breasts when she put her bra on, mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. Caller stated she is unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05Mar2021. She reported that the pain gradually diminished. She stated that it didn't bother her, that she just happened to notice it when getting dressed. she was just slightly nauseated but that she didn't throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later, around 06Mar2021 or 07Mar2021, went along with throat feeling like it was closing up. Caller reported that the watering eyes have cleared up. She stated that it resolved quickly, maybe a day or two after they began on 04 or 05Mar2021. she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Caller reported that the loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry, but her stomach just didn't feel like it had the room for food. She reported that the loss of appetite resolved a few days later, around 06 or 07Mar2021. Caller reported that during the 48 hours after symptoms began, she stayed in bed and slept. She reported that she would get up to get a drink or take Tylenol, just a couple a day, and would drink water. She reported that she drank lots of fluids. She stated that she would get up, would take something, and then go right back to sleep. Tylenol helped a little bit, Tylenol did not do a whole lot, but it's better than nothing. Tylenol: UPC/lot/expiry not provided. Caller stated that she was not supposed to take ibuprofen, saying the reason was something to do with blood pressure or something. She reported that if the AEs she experienced had gotten severe, she would have called her doctor and had them check it out or at least asked advice. She stated that because symptoms began resolving after 48 hours, she thought it was ok. She reported that she is going to the doctor in May for a routine check-up, and they will inform her if anything has changed. The outcome of events was fatigue was resolving and outcome of other events Felt like heart was going to go through her head, fever, Chills, Splitting headache, Felt like her throat was closing up a little bit was resolved on 05Mar2021, Heart was racing on 03-MAR-2021. Outcome of events Loss of appetite, Lightheadedness, Eyes were watering, Pain in lymph nodes in neck when touched, High cholesterol, stomach felt a little queasy or upset on an unspecified date. Outcome of Bursitis, High blood pressure was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Swollen lump that is quite sore on her left arm; Swollen lump that is quite sore on her left arm; This is a spontaneous report from a contactable Nurse (patient). A 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: Apr2021) via an unspecified route of administration in Jan2021 at single dose for vaccination. Dose injection to left deltoid around 14:00. Medical history included car wreck, hypertension, scoliosis. Concomitant medication included ongoing celecoxib (CELEBREX) for car wreck, amlodipine besilate, benazepril hydrochloride (AMLODIPINE/BENAZEPRIL) from 2017 and ongoing for anti-hypertension. The patient reported she had the Pfizer COVID-19 Vaccine a week ago and it did not really bother her until she started trying to do exercises of her arm. On 15Jan2021 she had a swollen lump that is quite sore on her left arm that did not go down and it had been 3 days now. She did not have a fever, the area was not red, it's just swollen. She just wanted to know if this event was customary with the product; and if her second dose should be given in a different anatomical location. It was just painful and swollen; had not been hospitalized for this event. She could see the difference, she was quite wrinkled now with age; but at the site of her swollen lump on left arm she had no wrinkles right now. Her second dose is scheduled for 02Feb2021 at 14:20. The outcome of events was not recovered.

Generalized weakness and body aches. Clinic stated that the pt was anxious and was "not feeling good". Pt states she feels SOB. O2 is 97% on RA. Pt does have bilateral edema in lower extremities. Pt does have a history of dementia. Clinic sent patient to the emergency room due to these symptoms.

left arm was blue from her shoulder to her elbow almost whole circumference going under arm /left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color; slight left arm swelling; left arm discomfort; This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: Apr2021), via an unspecified route of administration in the left deltoid on 12Jan2021 14:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, her left arm was blue from her shoulder to her elbow and almost the whole circumference going under her arm. On Jan2021, she has a slight left arm swelling and left arm discomfort. The discomfort was bearable. The discoloration of her left arm has become bad. She was at the COVID-19 vaccine clinic, some nurses looked at her arm, and insisted she contact Pfizer and her doctor to report what happened to her arm. She has an appointment with her doctor the afternoon of 20Jan2021. Her second COVID-19 vaccine dose is scheduled on 02Feb2021. Her left arm swelling and discomfort is the same now, but her left arm discoloration is awful. Her left arm discoloration is the only change she has experienced since her first report. Her left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color. The discoloration of her left arm is uncanny. The discoloration stops before her left elbow like a completely straight line drawn by a ruler. The discoloration continues from her left elbow up to her left shoulder for which the discoloration spreads out unevenly. Outcome of the events was not recovered.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.

Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>

C/O chills, aches (new onset), headache (chronic) 12 days after COVID dose #1. Patient found to be hypotensive and tachycardic in ED, was admitted due to complex medical history. Hypotension, tachycardia, and AKI resolved after 1L LR.

Leg/foot edema. Furosemide dose increased and if no significate improvement by today, will call into doctor by afternoon today for further instructions.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe

The patient received her covid 19 Pfizer vaccine on 2/25./21. Later that day her daughter went to her home to check on her. Upon arriving, she found that her mother's skin was red and itchy, her face was swollen, and she was having trouble breathing. The patient was taken to the hospital thereafter. Her primary care physician is aware and does not want the patient receiving the second dose.

My face is swelled; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration (at the age of 84years) on 29Jan2021 at 09:00 at single dose for covid-19 immunisation and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included have a pacemaker. Concomitant medications were unspecified as stated, "I am taking lot of medication." The patient reported, "My face is swelled" on 29Jan2021. Consumer stated, "I got the Pfizer vaccine today and I looked in a mirror a couples of hours ago and my face is swelled. So, my question is should I take diphenhydramine hydrochloride or not? It got a little better but it is still swollen. I wonder if I took diphenhydramine hydrochloride would that be helpful. I am getting better." There was no treatment for the event. The action taken in response to the event for diphenhydramine hydrochloride was unknown. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) at age 84 years (as reported), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included warfarin sodium (COUMADIN). The patient previously received shingles vaccine (believes it was more than four weeks before getting the COVID vaccine). It was reported that the day after (26Jan2021), the patient experienced sore arm like everyone else. The sore arm has gone away, but does not know what day it went away. The day after the vaccine the patient had a swollen face (26Jan2021) and today it is worse; it is more swollen. On 01Feb2021, the patient experienced an itchy nose and sneezing. The outcome of the event sore arm was recovered on an unspecified date, the event swollen face was not recovered, while unknown for the events itchy nose and sneezing. Information on Lot/Batch number has been requested.

Vaccine administered 2:30 pm March 4, 2021, March 6, 6:30 a.m. RIGHT hand was red and swollen could not make a fist, Pain, in hand, wrist and elbow. March 7, 6:30 a.m. Improving. March 7, 4:30 PM could make a fist. March 8, 6:30 a.m. appears normal.

Patient fell and hit back of head (remained conscious). Silver dollar-sized swelling. No bleeding. BPs 233/85, final BP 202/90. O2 sat 97%. Sent to ED.

Pfizer COVID vaccine was administered at about 12:30 PM. Patient called staff over around 12:35 PM due to facial swelling, flushing and voice change. Benadryl was administered at 12:40 PM via IM in the Right Deltoid. At 12:45 PM pulse was 78, Respirations were 20, and BP was 118/84. At 12:50 PM pulse was 76, Respirations were 21 and BP was 140/90. At 12:55PM pulse was 72, Respirations were 19 and BP was 132/82. Patient denied ambulance services. Stated that she felt better at this time. Monitored patient for a total of 30 minutes and stated she felt fine at that point. Patient was followed up with the next day. She stated that no more Benadryl was needed at home. She slept a few hours after and continued to have slight facial swelling that lasted for a couple of days. Patient is unsure if she wanted to get the 2nd dose, but wanted to keep her appointment for it still. Her doctor recommends getting the second vaccine dose and told her to just take Benadryl and Pepcid before the vaccine. We educated her about the possibility of getting that second dose at her doctor's office or at Hospital in order for her to have more immediate access to emergency care.

Client fell at home on the night of 01/29/21, woke up on 01/30/21 with left sided weakness, dysarthia, left sided facial weakness, left hand pain and swelling. Client transported via ambulance and admitted to Hospital. Transferred to rehab care on 02/02/21 and discharged on 02/16/21.

3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints of back pain, nausea, and abdominal pain. Patient approximately 1 week ago was bending over to pick something up and fell to the floor landing on her coccyx, and has had increased low back pain since that time. Patient does have a history of congestive heart failure and atrial fibrillation. Patient states that she had noticed increasing lower extremity edema and mild shortness of breath with exertion. The patient states that her back pain escalated and she was unable to stand or walk on her own. Patient was then brought to the ER for further evaluation per EMS. The patient did have a CT of the abdomen and pelvis which showed no definite acute intra-abdominal/pelvic abnormality, and mild acute during L2 superior endplate compression fracture with approximately 4 mm of displacement into the spinal canal. Patient also had a CT of the lumbar spine without contrast which showed acute appearing mild L2 superior endplate compression fracture with approximately 2 mm of displacement to the spinal canal, and multilevel degenerative disc disease. This morning upon entering the room the patient was standing with assistance of a walker and hospital staff. Patient tolerated fair. Patient does complain of severe pain with standing and movement. Patient does have 3+ pitting edema to bilateral lower extremities. Denies numbness or tingling to lower extremities. Bilateral lower extremity pulses are 1+ 1+, with CMS being less than 3 sec and skin is pink warm and dry. Patient's EKG in the emergency room did show atrial fibrillation with RVR with a rate of 137. Patient was given Cardizem IV in the emergency room, and then was started on Cardizem CD 100 80 mg p.o. daily. Patient's rate is controlled at between 92 and 96 beats per minute and continues to show atrial fibrillation on the telemetry. No shortness of breath is noted at this time. Patient did also have lab work drawn in the emergency room CBC: White count is 9.4, hemoglobin 14.4, hematocrit was 43.7, with a platelet count of 261. Patient's CMP showed a BUN of 21, creatinine 1.2, potassium was normal at 4.6, and her GFR was noted at 41. Patient also had a BMP drawn which was noted at 322. Patient also had a urinalysis performed which shows negative for leukocytes, nitrate negative. Patient was admitted to medical inpatient as it is deemed that she will need longer than a 2 midnight stay for cardiac monitoring and will work with physical therapy and occupational therapy for gait training and strengthening with relation to the compression fracture of her L2 fracture, and pain control.

?Pfizer-BioNTech COVID-19 Vaccine ? Patient hospitalized after fall with UTI, hyponatremia, and C7 cervical fracture several months after receiving vaccine.

Sore besides my eyebrows; Jaw joints hurts; Swollen red forehead; Swollen red forehead; Itchy; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL8982) on 18Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included diabetes type 2. Concomitant medications were not reported. Historical vaccine included COVID-19 VACCINE. Patient experienced swollen red forehead and itchy on 19Feb2021, sore besides eyebrows and jaw joints hurts on 20Feb2021. Investigation Assessment was no. Patient reported that she has come up with some peculiar reactions to the Covid thing. She has developed swollen red forehead and that is itchy and it looks like a dog bone across of her forehead. She had second shot on Thursday evening at about 5:30. So, this developed the next afternoon, Friday afternoon, during the afternoon it became a little swollen and a little itchy and then last evening so this is another day later she was sore beside eyebrows and her jaw joints hurt. No treatment was received. The outcome of the events was unknown.

Patient had increasing shortness of breath resulting in hospitalization requiring high amounts of oxygen. Patient has new onset of pulmonary fibrosis diagnosed by CT of chest with contrast

severe anaphylactic shock; High blood pressure; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 23Feb2021 09:30 (Lot Number: EN6200) as single dose for covid-19 immunisation at age 84 years old. Medical history included low thyroid and allergies to grasses. The patient was not pregnant. The patient had no Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine taken in four weeks. The patient previously received the first dose of BNT162B2 administered in left arm on 02Feb2021 09:30 AM (lot no: EC9265) for COVID-19 immunization. On 16Mar2021 09:15 AM, 15 minutes after eating usual breakfast: avocado/toast, coffee, almond milk, the patient went into severe anaphylactic shock: extreme itching on palms, red welts on body, explosive diarrhea, dizzy/fainted, extreme blood pressure drop to 60/XX, in/out of consciousnes, loss of bowel/urine. Rushed to ER. High blood pressure 7 days after (Mar2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, emergency room/department or urgent care and were considered life threatening illness (immediate risk of death from the event). Treatment given in the emergency room includes unknown (as reported), prednisone, Pepcid. Outcome of the event was unknown.

around her neck looks swollen; rash on neck is brown; itchy; worried; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 23Jan2021 (at the age of 84-years-old) at single dose for COVID-19 immunisation. Patient's medical history included heart troubles. Patient's concomitant medication was heart medication. The patient experienced around her neck looks swollen, rash on neck is brown on 03Feb2021 and it was still ongoing and itchy, worried on an unspecified date. Patient stated she read information about a rash all over the body after the COVID vaccine. She has had none of the side effects. She read about severe allergic reactions. She does have a history or heart troubles. She was washing her hair on Wednesday, and she noticed around her neck it looked swollen. Like a little band around her neck. It could have been there before the vaccine. She called her doctor that same day and she said to call Pfizer, and that she thinks she should cancel the second one. She got her first COVID vaccine on 23Jan2021, and she is scheduled for the second 13Feb2021. She does take a heart medication. The place on her neck is not itchy. She knows the vaccine could cause a severe allergic reaction. She sees her dermatologist for Basal cells and other things that are itchy. This place on her neck, if it is a rash, is brown not red. She gets a lot of those places on her skin. Her doctor told her to call Pfizer and then cancel her second appointment. She just wants to speak to medical information first. She doesn't even know if it is a rash. She hasn't had any side effects. Her arm didn't even hurt. This little rash is only on her neck. She had worked as a dental assistant. She is just worried now about getting the second shot. The outcome of event for itchy and worried was unknown and for other events it was not recovered. Information on the Lot/Batch number has been requested.

rash on my left wrist on the outside; large cold sore; This is a spontaneous report from a contactable consumer (patient). A 84-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Feb2021 (Batch/Lot number was not reported) at a SINGLE DOSE for COVID-19 immunisation. Medical history included atrial fibrillation and thyroid condition from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0140), on 20Jan2021 04:00, right arm at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient had not tested positive for COVID-19 since having the vaccine. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN) 50mg. About a week after the second dose, patient developed a rash on her left wrist on the outside. It has been about a week and it is finally going away but not completely and patient experienced a large cold sore that is still there. The events were considered as non-serious. No treatment was given for the event. The outcome of the event rash on left wrist was recovering, while the outcome of the event large cold sore was not recovered. Information on the lot/batch number has been requested.

3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnosed with sepsis and died 02/22/2021.

3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history of unresponsive episodes related to cardiac issues, declined hospitalization.

small size lump in axillary area primary doctor who told her he didnt believe in the vaccine recommendations to use warm compresses 10mins on/off caller verbalized understanding and that she is going to she her cancer doctor friday since her PCP offered her no advise. 4/28-contacted the patient , lump hasnt gotten any better or worse , will get biopsy on friday

N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; caller asks does Pfizer have options to get rid of the swelling; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 (Batch/Lot Number: EW0161) (at the age of 84-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included ongoing Afib (diagnosed with Afib five years ago) and memory problems. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 1 administered in Arm left on 30Apr2021 (Batch/Lot Number: EW0158) for covid-19 immunisation and had lumps down the front of the arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. On 22May2021, the patient reported now it got the lumps going down it and they are tender. The patient went ahead and received the second dose Pfizer Covid 19 Vaccine and now its got the lumps going down it and they are tender. They are not really going down, still there. Wondering if there was some kind of anecdote to take care of it? The right arm was not as serious. The marks or lumps are sort of in the same places on both arms, like in the bend of the arm in the elbow. The patient doesn't know anyone else having this problem. Are these lumps on the caller's arms lymph nodes? The caller states she has been concerned about the lumps on her arms but not concerned enough to go to the doctor. The patient stated she has not talked to anyone at her primary care physician's office yet. The patient did not visited to emergency room or physician office. It was suggested the patient go to have the lumps looked at but the patient never did. The patient asked does Pfizer have options to get rid of the swelling, to treat it? Oh, Pfizer doesn't have anything for that, the patient was giving Pfizer a chance to treat it. No relevant tests done. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown. No follow-up attempts are possible. No further information is expected.

ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: ischemic stroke; infection

I am the epidemiologist reporting on behalf of patient. Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573.

ADMINISTRATION ERROR: Pt.'s daughter called stating Pt. received Moderna 06/10/2021 and then again received the Phizer 06/28/2021. Low blood pressure since 2nd vaccine, 100/39 decreased HBP meds, doctor recommended No vaccine because of the Antibiotics due to pneumonia. No consent given by family. More pronounced swelling in the legs, a little more difficulty finding words to community. Pt. states soreness throughout the whole body.

My mother received the FIRST vaccine about 5:30 pm on Jan 13, 2021. She did fine and went to bed without any issues at all. When she awoke the next morning, she had a HUGE fever blister/cold sore on her bottom lip. She had not had a fever blister in decades. When she called me, I immediately took her Abreva. She treated it with that 4-5 times a day for about 7-10 days. It dried up and has finally gone away. I just thought this was such an unusual reaction. After doing some internet research and checking with several doctor friends, they had never seen or heard of this side effect.

Called physician one week later and was diagnosed with "COVID arm" delayed hypersensitivity reaction. It was red/swollen, itchy. Physician advised her to receive 2nd dose.

"Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.

left arm swelling, appeared within one hour of second vaccine dose. Swelling progressed with soreness of arm. Swelling worse day after. Started abating by Thursday 2/25/21 evening. Advised ice pack on arm, but pt. said it was too sore on day after dose given (Wednesday) to apply. Pt. took one aspirin on Wednesday morning. Advised her she could take a second later in the day. (Yesterday pt. stated she had taken a Tylenol. Today upon review she realized that she took an aspirin. Ibuprofen is also available. Advised pt. take an ibuprofen now over the phone as I waited. Taken at 8:13pm EST. No further medication taken on Wednesday. (Also encouraged ice pack on neck Wednesday for ongoing strong headache / neck pain yesterday. Pt. does not remember if she tried that. Head/neck pain resolved today.) Pt. states swelling today (Thursday) is mild-to-moderate, less than yesterday, but still noticeable. Doesn't hurt as much as it did yesterday, she says. She can now lift her arm without pain.

Lower lip angioedema within 15min of injection. Dose of benadryl given. Tingling in feet/hands 15min later, resolution of lip symptoms. 3 days later recurrence of the angioedema, treated with benadryl

Extremely swollen at the site of injection. She knew something wasn't right immediately after injection. A little white dot appeared where needle was inserted. Arm swelled. Initially thought it was common. But was not getting better and was painful and made her not feel well. She went to the doctors thankfully a few days after and was advised that it was infected. Could have been dangerous for her if infection continued to move through her body. She is now on antibiotics. This is strange to have an infection which makes us feel the needle was not properly sterilized? Something foreign entered at the time of that shot and we would like to have answers. The doctors could not even identify why this happened. Company Pfizer..

was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021, the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown. Information on the lot/ batch number has been requested.

02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x; fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited

Pt reports that 48 hours after the inital vaccine she developed headache, chills, nausea, heart palpitations. Had blood work completed by her primary provider and was dicovered to have a significantly high WBC. Was admitted to hospital with diagnosis of UTI and started on IV antibiotics. Provider directed client not to get booster.

swollen lymph nodes after vaccination; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain; Right arm bicep muscle is so sore and is a hard knot; the muscles if you were going to make a muscle is very sore and hard/If I try to lift something too heavy, its excruciating pain; the day I got the shot, my hand became a little weak; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 21Dec2020, Stomach problem, Acid reflux, fatigue felt tired , little fever , historical allergies, Neuropathy , High blood pressure. Concomitant medications included atorvastatin; gabapentin for neuropathy peripheral,; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication. The patient previously took codeine and experienced she almost passed out, demerol and experienced she almost passed out. It was reported arm that received the injection, "the muscles if you were going to make a muscle is very sore and hard". Caller says this is not the same area/muscle that the injection was given. the day I got the shot, my hand became a little weak. It went away. "Caller also says she had covid infection in Dec2020, This consumer was administered her first dose of Pfizer COVID-19 Vaccine 10Feb2021 at (Facility name). She had no problem whatsoever until 16Feb2021. Starting 16Feb2021 her right arm bicep muscle is so sore and is a hard knot; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain. She has no fever. She cannot get ahold of her doctor because their office is closed today due to the weather. She called to ask about these events; if she should put ice or heat on the affected area; how many Tylenol she should take for this. She initially reported that the affected area is the area of the muscle that you make, not in the backside muscle where the Pfizer COVID-19 Vaccine injection was administered; affected area is the front muscle, bicep that tightens when you flatten your hand forward and curl upward with the lower arm. If she raises her right arm up so far it's very painful, but not so painful that she cannot stand it. She also developed swollen lymph nodes after vaccination. Therapeutic measures were taken as a result of right arm bicep muscle is so sore and is a hard knot (muscle swelling), the muscles if you were going to make a muscle is very sore and hard/if i try to lift something too heavy, its excruciating pain (myalgia), the day i got the shot, my hand became a little weak (muscular weakness), if she accidentally picks up something or tries to pull on something with right arm she has excruciating pain (pain in The outcome of the event Swollen lymph nodes; Muscle pain; was unknown; Pain in arm; Muscle swelling was not recovered; Hands weakness of was recovered;

drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her face feel hot; under her eyes it was sticky and hot/some areas on her face feel hot; This is a spontaneous report from a non-contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:15 (at the age of 85years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 03Mar2021 in the left arm (unspecified route) for Covid-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had the second dose on Wednesday (24Mar2021) and four days later (as reported) (on 28Mar2021) she has swelling on her face and drooping of her face on the left side. It was further reported that it seems to be getting better today (31Mar2021); the drooping is almost all gone but some areas on her face feel hot; under her eyes it was sticky and hot. The reported asked if it was normal, or should the patient see the doctor. The patient was given Tylenol and she seems better. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Severe and acute swelling of right hand. Hand was swelled to an extent that only the top first joints of the fingers were discernible and this prevented use or any movement of fingers. Swelling began on April 19th, late afternoon. Swelling peaked on the 20th very severe, and gradually subsided over following days. Now 10 days later, hand is again usable, with very little residual swelling, though still visible different from left hand. Took Advil for 4 nights beginning on the 20th, and everything seems fine now. Despite 30 years of rheumatoid arthritis, no such swelling event or attack had ever occurred for any reason, so we believe it was related to the vaccine, and felt we should report it. But everything seems fine now. No other reactions or side effects were noted.

blood clot it is from my hip all the way down to my left leg to my ankle; blood clot but it is the big one from my hip all the way down to my foot; foot going down the swelling went up to my leg/foot and my leg is swelled my toes all over up to my leg swelled; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left upper arm on 10Apr2021 at the age of 85-years-old as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis and ongoing chronic obstructive pulmonary disease (COPD). The patient reported that she was not taking anything for arthritis, just some Tylenol once in a while over the counter (it was not prescription). The patient was taking an inhaler for COPD. The patient was taking unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER2613), administered in left upper arm on 20Mar2021 at the age of 85-years-old for COVID-19 immunization and experienced bladder infection and viral infection. The patient got the first Pfizer vaccine on 20Mar2021 and was alright for a few days afterwards. Then all of a sudden, she started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a real bad bladder infection then she went to the doctor and she got medication for that. She was with bladder infection then she came down with the viral infection. The patient reported that she has not even been going anywhere because of the virus and she has been staying home. She just goes to the grocery store and clinic to the doctor, that was it. The patient had an antibiotic for the bladder infection. Sulfamethoxazole was the name of the medication that was for bladder infection. They didn't give the medication for the viral infection. The patient reported that it was just a viral infection, it was not the Covid. Since then, she had her second dose of the vaccine on 10Apr2021 and from an unspecified date in 2021, her foot started, her foot swelled up and she didn't know. She takes lot of retention pills, so she thought maybe it was that. So she took her pills and everything and washed and start getting but the next day instead of the foot going down, the swelling went up to her leg and then the next day it went all away up to her hip. The swelling on the left side from the foot all away up to the hip. She went to urgent care on 21Apr2021 (reported as "21st") and saw a doctor and she was tested and she had blood clots. Regarding lab test, the patient reported she had two infections and then she got the blood clot that was from her hip all the way down to her left leg to her ankle. She could not figure out that they called the test and what they tested. But they had a lab work done then one has a test, veins, and everything. She can't remember. The patient reported that her foot and her leg was swelled, her toes all over up to her leg swelled. She had a fat foot and a fat leg just one side. She would say since she has started taking medicines for that, she took the first dose at the evening of 21st (21Apr2021), the day she went to the urgent care, and she would say it was not any worse. The medication was supposed to break up the blood clot, but it was the big one from her hip all the way down to her foot. Just a little bit better. The outcome of the events was recovering.

Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HPI, given patient's AMS. Daughter reports that she went over to see her mom at approximately 930 this morning and found her alert and oriented x3 with complaints of nausea, congestion and cough s/p her second COVID-19 vaccination, which she received yesterday. Daughter reports that at approximately noon, her mom had an episode of emesis, with her arms clenching up and shaking for approximately a minute, for which she called EMS. Daughter reports that her mom has been lethargic with AMS s/p episode. Daughter reports her mother has never had seizure activity before, but she has had several previous TIAs. She denies any recent injury, fall or medication changes. Patient lethargic with AMS noted, unable to follow simple commands, does tell me her first name with several prompts. PATIENT REMAINS HOSPITALIZED AT THE TIME OF THIS REPORT.

Patient departed from vaccination clinic in no distress with no changes. Presented to ER with left sided facial droop which started on her drive home. Per ER note, patient did have aphasia and shortness of breath. Patient had quick change of respiratory sounds with suspected flash pulmonary edema. Noted to also have facial swelling. Anaphylaxis suspected. Patient intubated and admitted to ICU with guarded condition.

a fever blister bigger than thumbnail; This is a spontaneous report from a contactable consumer (patients daughter) or other non hcp. An 85-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left (Guessing left upper arm near shoulder for both doses) on 13Jan2021 17:30 (at the age of 85-year-old) as 1st dose, 0.3 ml single and second dose via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL9263) as 2nd dose, 0.3 ml single for COVID -19 immunization. The patient medical history and concomitant medications were not reported. No medical history of previous immunizations was reported. It was reported that patient was on other medications (unspecified), but not related to the fever blister. It was reported that patient did great after first COVID shot. Patient did not receive any other vaccine within 4 weeks. Patient did not require to visit to emergency room or physician office for AES nor been prior vaccinated for AES. Patient did not have any family medical history. On 14Jan2021, the patient woke up with a fever blister bigger than thumbnail or cold sore on her lip after her first dose of vaccination. Patient had not a cold sore or fever blister in years. Reporter stated that this was something unusual; hoping she would not have it again tomorrow. She received her second dose almost an hour ago after physicians advised. Patient received Abreva (had no ndc/lot/exp to provide) as treatment for the event and fever blister was almost gone. She applied Abreva two to four times a day. Abreva controlled the fever blister. The skin was still a little irritated but takes time for it to smooth back over. Fever blister was no longer active. The scab part was gone. At the time of report, event outcome was resolving. Follow-up attempts are completed. No further information is expected.

rash was a little big but after the second shot it got quite worse. As far as worse she states itching and swollen; rash is on her face and down onto her neck and her left shoulder, she received the shot on her left side and it itches; rash was a little big but after the second shot it got quite worse. As far as worse she states itching and swollen; she received the shot on her left side and it itches; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6200), via an unspecified route of administration on 23Feb2021 14:15 (at the age of 85-years-old) at 2nd dose, single dose in the left arm for COVID-19 immunization. Medical history included ongoing rash. The patient has no concomitant medications. Historical vaccine included first dose of BNT162B2 received on 02Feb2021 for COVID-19 immunization and experienced rash (in the first shot but it was nothing worth). The patient reported that before receiving the second dose on 23Feb2021, she developed a rash which was a little big. She thinks that the rash may have been there a little before she received the second shot. Then after receiving the second dose of the vaccine, she reported that the rash got quite worse. Further stated that the rash was itching and swollen. The patient saw her doctor a week ago, on 03Mar2021, and the doctor felt that this rash was insignificant and did not prescribe any course of treatment. The patient stated that the rash was on her face, down to her neck and left shoulder. The patient received her Pfizer COVID vaccine shot on the left side, and it itches. The patient stated that it has been over 2 weeks and she still have the rash. But the patient stated that the rash was improving, it was not as red and was less itchy. The patient asked when it will go away. The patient had a blood work done on an unspecified date, before going to see the doctor, and reported that the results were normal. For the patient, the rash was not life threatening, however it was uncomfortable. The events rash aggravated, itchy rash, and swelling resulted in physician's office visit. The patient did not receive any treatment for the events rash aggravated, itchy rash, and swelling. Outcome of the event rash aggravated and itchy rash was recovering, and for other events was unknown. Follow-up attempts are completed. No further information is expected.

Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.

Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she continued with GI upset, fever, and body aches. Toward the afternoon with Tylenol she appeared to be feeling better. At around 6pm she had sudden onset shortness of breath and respiratory distress. Nebulizer was given without improvement, O2 sats were in the 70's and 80's. Tenant was transported to the hospital via ambulance

right side of her face swollen; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246, expiration date not reported), intramuscular on the upper left arm, on 12Jan2021 at a single dose to develop immunity for Covid 19 virus. The patient has no medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID). The patient stated she got Pfizer Covid 19 vaccine two days ago at a hospital in the city and right side of her face was swollen and had extreme fatigue on 14Jan2021. Stated she is resting now and is feeling fine. She stated that it happened this morning. Stated that she waited for 15 minutes after the vaccine and had no side effects. She stated that her next dosage is 02Feb2021. There was no treatment received for right side of face swelling. Outcome of the events was recovering.

stated that she woke up and her left foot was swollen; This is a spontaneous report from a contactable consumer, the patient. A 86-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot # EL3248), via an unspecified route of administration in the right arm on 19Jan2021 'at about 9:30 AM' as a single dose for COVID-19 vaccination. Medical history included hip arthroplasty in 2012, blood cholesterol abnormal and blood pressure abnormal. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. On 20Jan2021 the patient experienced that she woke up and her left foot was swollen. Consumer stated I got a vaccine yesterday and I am not feeling bad or anything. I just took a shower and my left foot is swollen. She inquired if vaccine caused that and wanted to know if she needed to go and get the second shot on 09Feb. No treatment was given for the event. The clinical outcome of the event left foot swollen was not recovered. Consumer stated, I got a vaccine yesterday and I am not feeling bad or anything I just took a shower and my left foot is swollen. I just want to see if vaccine caused that. I just want to see if vaccine made my feet swell. I took a COVID-19 Shot (COVID-19 Vaccine) yesterday and today my left foot is swollen. I just want to know if that could have come from the vaccine." When probed if it was the Pfizer COVID Vaccine, Consumer stated, "I took one shot yesterday. Consumer was provided with the number of Pfizer Medical Information. Product details (LOT# and expiration date): Consumer stated, I don't have vaccine.

Per report from family member illness started with fever, chills and increasingly progressed to needing emergency care

24 hours post event patient had vomiting and fevers. She was unable to walk to the ambulance and had to carried. Patient was admitted to hopsital and diagnosed with pneumonia on CXR. COVID PCR negative. CT did not show pneumonia and only showed bibasilar atalectasis. Pt's WBC was 37,000 on Day 2 of admission. This resolved with antibiotics. No source was found.

2/8/21 pt noted to have BLE weakness. 2/10/21 pt admitted to Hospital and diagnosed with Guillain-Barre Syndrome. She received 5 days of IVIG treatment. 2/15/21 she was discharged from acute care and admitted to inpatient rehab where she is still admitted at this time.

Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home

cold sore; tuned a little red, it was sensitive in the center where the shot went in; tired; arm which was very sensitive to touch; Shaky; Sore arm, it was sensitive in the center where the shot went in; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the left arm, on 27Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medication. The patient experienced, after she pulled put from getting it, she got shaky on 27Jan2021. It went way after about 5 minutes. She gets that when gets a shot for dental work, so maybe it was the same reaction her body does, but it was gone before got home. On 27Jan2021, she had a sore arm for about 4.5 days, and it was difficult to sleep on that arm which was very sensitive to touch, and it turned a little red on 28Jan2021. She noted the soreness that night. She can lay on it now, it was sensitive in the center where the shot went in, but not bad. She was also tired that evening of 27Jan2021. She doesn't know if this has anything to do with it, but she got a cold sore, when she is stressed she gets a cold sore on her lip. This was noted yesterday (01Feb2020). She has medication for it from the doctor, and had to take for 3 days, and it usually clears it up. The cold sore was blistering, but she was susceptible to them with stress, so she was not surprised. Patient recovered from the event of tremor on 27Jan2021, turned a little red on 01Feb2021 and tired on 27Jan2021. Event sore arm was recovering while for the remaining events was unknown.

The daughter of the patient stated that her mother is a cardiac patient and has a stent. The patient always has edemas on her legs but the day after the vaccination she observed edema and report pain on the left thigh. The following Monday she visited the MD and he order a venous Doppler. The result was a thrombosis on the right leg . The patient was put on medication (Xarelto)

After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; slight dehydration.; This is a spontaneous report from a contactable 86-year-old female non-pregnant patient (nurse) received first dose BNT162B2 (Solution for injection, lot number: EL3247, COVID 19, brand: Pfizer) on 19Jan2021 12:30 PM on Arm Left for COVID-19 Immunization. Patient medical history included Hypetension, mitral valve prolapse, cornea transplants both eyes, Allergies: sulfa. Concomitant medications included metoprolol, furosemide (LASIX), KCL, losartan, apixaban (ELIQUIS), cefalexin (KEFLEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks even after taking an antihistamine, Allegra after the 3rd day of onset of symptoms on 21Jan2021. The symptoms progressed to redness swelling of the face, including swelling around the eyes on 21Jan2021. No shortness of breath. Went to physician on 05Feb2021 who prescribed lab work and chest X-ray to rule out SVC syndrome; chest X-ray was normal. Lab work was normal. With exception of slight dehydration on 21Jan2021. He gave her a shot of steroids and a prednisone dosing pack as well as ointment for the arms and hands which were still red and itching on that day. Redness of face was much improved within 24 hours and most facial swelling resolved by 08Feb2021. The physician did advise her not to take the second COVID shot. He do have photographs of the reaction on her face, arms and hands. No Seriousness criteria reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Clinical presentation is suggestive of allergic reaction. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pt has a history of dementia. She reported numerous symptoms including feeling lightheaded, body aches, "puffy face, tongue and throat." Denied SOB, rash, CP or other symptoms. There were no objective abnormal findings on exam. BP 130/80, HR 67, 98%. The pt noted that she felt improved after several minutes. EMS services and ER evaluation were offered but the son declined and elected to take her home. He believed that symptoms were related to anxiety.

she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her jaw felt like it was getting huge; Blood pressure went up to 170; Rash on her back; Hives on her legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ET7534), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 86years) as single dose for Covid-19 immunization. Medical history included diabetes mellitus, blood pressure high, multiple sclerosis, and wheelchair user; all from an unknown date and unknown if ongoing. Concomitant medications included ongoing baclofen (10mg, three times a day), metformin (750 mg, twice a day), amlodipine besilate (10mg, once a day), losartan (50 mg, once a day), magnesium (two times a day), metoprolol (50 mg, 3x/day), cyanocobalamin (VITAMIN B 12), and glimepiride (takes 1mg in one meal and as another meal she takes half of a mg); and Statin (unspecified) 10 mg, once a day; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received Pfizer Covid vaccine on 18Mar2021 and she did fine but an hour later when she got home, the reporter tried to help her up off of her wheelchair onto another chair and she could not stand. She had extreme weakness and then she felt like her throat was, like somebody was choking her, like their hands around her throat and then her jaw felt like it was getting huge. Then, her blood pressure went up to 170, the patient was given lots of continuous water and blood pressure pill. She started to feel better after that. The reporter further stated, "She has had various different problems. I do not know if it is allergies or what from what she already has but she did have a lot of it and exhausting stuff afterwards. There is mainly that choking feeling that is frightening that she had one hour after". It was also reported that the patient developed some rash on her back and hives on her legs. It was not right away. It was kind of a day or two after. The outcome of events was unknown. Follow-up attempts needed. Further information is expected.

blood pressure systolically reached 170/Blood pressure shot up; blood pressure systolically reached 170/Blood pressure shot up; Felt like someone was choking her; Felt like her jaw was swelling/felt like her jaw was "getting large"; Extreme weakness; Couldn't stand; This is a spontaneous report from a contactable consumer via Medical information team. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing multiple sclerosis , ongoing hypertension, ongoing diabetes mellitus, myocardial infarction from an unknown date and unknown if ongoing stent placed and spasms; and from an unknown date and unknown if ongoing. The patient previously had flu shot and feel a little bit sick, it hit her lot harder with the flu shot. Concomitant medication includes, unspecified, diabetic and hypertensive medication and medication for spasms. On 25Mar2021, 45 minutes to an hour after the patient's first dose, the patient felt like someone was choking her and felt like her jaw was "getting large" without physically getting large. The patient was not able to get out of her wheelchair, even though she was normally able to do so on her own, and her blood pressure systolically reached 170. Her mother was given "excess water" and was given her hypertensive medication "a little early" which caused her pressure to come down quickly. Based on this reaction that her mother had, caller would like to know if it was safe for the patient to receive her second dose of the vaccine. They stayed about 15 min at the drive thru to make sure there was no reaction. It was about a 30-minute drive home with traffic. It happened within the hour, right when she got in the house. The patient had a reaction to the first dose, and the caller wanted to know if it was safe for her to get the second. Within the first hour the patient felt like someone was choking her, she felt like her jaw was swelling, she felt extreme weakness and could not stand, and her blood pressure shot up. It shot up to 170, but she did not know the diastolic. The patient felt like she was choking so she was doused with water to push anything through in case that would help. Within a couple of hours, the patient started to feel better. They gave her excess fluids and gave her blood pressure medication a little bit earlier and everything came back down. She was frightened when this first occurred. The feeling of choking and the feeling of jaw swelling got better and went away within a few hours. The patient had multiple sclerosis so weakness is always an issue and mobility is always an issue. She knew her tolerance and what she could do. That day they had taken her in a wheelchair from the car to the house and she could not get out of the wheelchair, which was not normal for her. This happened within an hour of the shot. The weakness lingered the longest. That side effect did linger. It took a couple of days. She was using a Hugo again to get herself around the house and believes this extreme weakness has gone away. She was exercising on a stepper when the caller was talking to her. Caller did not believe there had been any lasting effects. Blood pressure shot up: Started within an hour of the vaccine. She had been hypertensive for quite some time historically. Her medication had been keeping it under control. They administered her dose early that day and it brought it down, it did not linger. The patient had been housebound since the pandemic started. The outcome of the event blood pressure shot up was recovering, while the outcome of the event couldn't stand was unknown; and the outcome of the rest of the events was recovered on 25Mar2021. Information on lot/batch number has been requested.

J18.9 - Pneumonia I95.9 - Hypotension R09.02 - Hypoxia I48.91 - Atrial fibrillation with rapid ventricular response (CMS/HCC) A41.9 - Sepsis, unspecified organism

swelling in right hand; right hand pain; right hand pain worsened; This is a spontaneous report received from a contactable consumer. The consumer reported for an 86-year-old female patient (mom) that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL9269) intramuscularly administered in right arm on 09Feb2021 11:30 as single dose for COVID-19 immunization. The patient medical history included atrial fibrillation (diagnosed about 15-20 years ago, more like 15 years), thyroid, blood pressure, and for heart issues, sinus issues, cholesterol and arthritis all are ongoing. Concomitant medications included atorvastatin, fexofenadine hydrochloride (ALLEGRA), levothyroxine, metoprolol tartrate, spironolactone and warfarin. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL3249 or EL2249) intramuscularly administered in right arm on 19Jan2021 11:30am as single dose for COVID-19 immunization and She has been getting the flu vaccine for years. On 10Feb2021, the patient experienced pain in her right hand, she got the vaccine shot in her right arm. On 10Feb2021, the right hand pain was reported as worsened. On an unspecified date, the subject noticed swelling on her right hand, the patient did not think she had the swelling before. It was reported that the swelling was not huge, but it was troublesome, and the patient had to take her coffee with her left hand. It was reported that it had just been 36 hours after the patient had the injection and she was still experiencing the pain. Around 9 or 10 last night her mom was complaining, and she wonders if it happened because of the injection. The patient did not experience injection site swelling. The patient did not take any treatment she was just resting. The outcome of events right hand pain and right hand pain worsened was not recovered and swelling in right hand was unknown.

Admitted to hospital 4/12/21 for acute hypoxic respiratory failure due to COVID-19 pneumonia. Treated with remdesivir (full course) and dexamethasone 10mg x1 then 6mg daily x 9 days. DVT treated with heparin IV Ibrutinib held -- CBC at baseline (WBC ranged 23.5 - 35.1) Infectious Disease MD ruled out other infections, including pneumocystis pneumonia Hypoxemia progressed to severe -- 60L high flow oxygen, unable to wean - patient does not want to be intubated On 4/22 the patient desired for comfort measures only and weaning of oxygen. The patient died on 4/25/21.

Began with tingling of feet then swelling of feet, then swelling of both legs. Medical tests. .. echo cardio gram, vascular ultrasound, MRI of pelvis, neurological exam of nerves, rheumatologist and immune system. Multiple blood samples all of which were negative with exception of one that showed inflammation somewhere. After all the above test there is no conclusion or diagnosis to the continued swelling . Have never had adverse event following any previous vaccines

She also reports developing a rash in the middle of her chest /she describes it as, "looks light pink, little teeny tiny bumps, middle of the chest near the neck."; left ankle was itching me like crazy; felt cold/ cold feeling; tired; looks light pink, little teeny tiny bumps; Two weeks after her 1st dose she felt chills and swelling in her lymph nodes.; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer- sponsored program. An 86-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration on 15Apr2021 11:30 (at the age of 86-year-old) at dose 1, single for covid-19 immunisation. Medical history included Parkinson's disease, autoimmune disorders (she states that she has 4 autoimmune disorders), allergic to an antibiotic, headache. Prior Vaccinations (within 4 weeks) was no. History of all previous immunization with the Pfizer vaccine considered as suspect: no. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Concomitant medications were not reported. Patient previously received Pneumovax23 vaccine last year for which patient had experienced Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, spinal stenosis, difficulty walking and dry mouth and pneumonia vaccine, flu shot for which patient had experienced sore arm. On an unspecified date, the patient experienced developing a rash in the middle of her chest /she describes it as, looks light pink, little, teeny tiny bumps, middle of the chest near the neck, left ankle was itching me like crazy, felt cold/ cold, tired, looks light pink, little, teeny tiny bumps, two weeks after her 1st dose she felt chills and swelling in her lymph nodes. Reporter is an 86-year-old female consumer who has received the first dose of the Pfizer COVID-19 vaccine. She is calling today to inquire about whether she should receive the second dose. She states that she has 4 autoimmune disorders, and she thinks she may also have Parkinson's disease. She is concerned that the vaccine might worsen autoimmune disorders. She states that she has Lichen Sclerosus, spinal stenosis, trigger finger on the right hand which started after she received the Pneumovax23 vaccine last year, spinal stenosis, difficulty walking and dry mouth. She does not take any prescription medications. She reports being allergic to an antibiotic that starts with an e and it caused her to have a severe long lasting headache but she cannot recall the name of the medication. She also reports whatever medication they gave her for a stress test caused her heart to race and made her feel like she was going to have a seizure. She states, my arm was not even sore after getting the vaccine, is that normal? My arm was sore after the pneumonia vaccine and the flu shot but not after my covid vaccine, is that normal? The caller then went on to report that "the day after the Pfizer COVID-19 vaccine my left ankle was itching me like crazy. It was a strange kind of itching. It was bothering me, I don't know and then it went away. She also reports developing a rash in the middle of her chest about 2.5 weeks after the first dose of the Pfizer COVID-19 vaccine. She noticed it this past Sunday 02May2021 and she describes it as, looks light pink, little teeny tiny bumps, middle of the chest near the neck. Reporter wants to know if the itching and rash that she experienced with the Pfizer COVID-19 vaccine have been reported before. The reporter stated that she is concerned about taking the second dose of the Pfizer COVID-19 vaccine because she is worried that it could make her autoimmune disorders worse or that she could develop new autoimmune disorders because of the vaccine. Reporter asks how long she can postpone or reschedule her second dose of the Pfizer COVID-19 vaccine until she speaks with her doctor. Reporter stated that she heard 6 million people have not returned to receive their second doses of the Pfizer COVID-19 vaccine and wants to know if we have information as to why they chose not to proceed with the second dose. Reporter stated that she is thinking about not getting the second dose of the Pfizer COVID-19 vaccine as scheduled this Thursday and waiting until September, October or November and just get the booster shot like they are talking about. She wants to know what this agent thinks about that plan. Reporter stated that she has heard getting the second dose of the Pfizer COVID-19 vaccine can cause swollen lymph nodes and that concerns her. Responded per page 2 of the attached document, Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. She is transferring her to report adverse events she experienced after the dose of the COVID vaccine. Two weeks after her 1st dose she felt chills and swelling in her lymph nodes. she has questions about the efficacy of the second dose. The caller clarified the details provided by the transferring agent. She did not have chills. She was just saying she was on her computer in the other room the other day, and all the sudden she felt cold. She always has her house on the same temperature of 76. It is on air-condition because she will be away. The last lady said chills it wasn't chills. She just felt cold. Her nose is stuffed up but was way before the shot. It will be 3 weeks ago tomorrow that she got the vaccine. The cold feeling happened two weeks after the first. The second shot is due tomorrow. She is wondering if she should get it. She noticed she started to feel cold 2 weeks after her first Pfizer vaccine. Is that normal to feel cold. She didn't think about it being the Pfizer vaccine when she got cold. She used to be 5'4.5 but is now 5'0. She got the vaccine at the see formal field Her doctor told her to go to the hospital to get it not a drug store. She waited 30 minutes. She doesn't know if the cold has improved persisted or worsened. She knows she didn't have to put on another layer yesterday. She did still feel a little colder than normal yesterday. She got the vaccine at 1130 am. She didn't even feel it. She didn't have pain in her arm at all. It was like she got no shot at all. She is a little tired now. She needed to take a nap in the last couple of days. This started a couple of days ago. It has almost been 3 weeks wince her first one. see formal field She is wondering if it is normal to have 2.5-week later side effect. She did have a rash on her chest 3-4 days ago, but that was reported. Her doctor is a rheumatologist who deals a lot with the immune system. She did have a stuffed nose before the vaccine for several months now. Adverse event did not lead to visit to Emergency Room, Physician Office. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Sore arm; swelling in arm; fatigue; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration on 13Jan2021 12:30 PM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included bad back and bad left knee. Concomitant medication included unspecified drug (reported as "Other medications in two weeks: Yes"). The patient previously took Levaquin and experienced allergies. Facility type vaccine was hospital. No other vaccines in four weeks. No COVID prior vaccination. The patient experienced sore arm, swelling in arm and fatigue for 24 hours after the shot on 13Jan2021 12:30 PM. Slowly dissipated over next 24 hours. All adverse events went away after 48 hours. No treatment for the events. Patient was not tested for COVID post vaccination. Outcome of the events was recovered on 15Jan2021 12:30.

She developed chills, headaches and weakness starting the day after vaccination 1/14. Profound weakness. She was unable to get out of bed. She developed hypoxia 86 to 90%. She was sent to the emergency room, she was noted to have a urinary tract infection.

Redness and itching in lower legs beginning after 2 days (2/25/21). Redness of skin on face beginning 2/27/21 with swelling and redness by 3/1/21

She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.

I'm concerned about COVID vaccine possibly triggering a recurrence of post herpetic neuralgia in my mother, who hadn't had post herpetic neuralgia since 2015 14 hours after dose 2 of COVID vaccine administered on 2/23, patient awoke with sudden onset severe right ear and forehead pain, site of her initial herpes zoster rash in 2004. No visible rash or changes on eye exam (Pt is taking valtrex for eye sequellae of zoster). Other symptoms have included fatigue, bilateral axillary and neck lymph node tenderness, and some breathing discomfort. All symptoms are much improved but persist now (4/12/21).

Early on Sunday morning, April 4th, patient woke up with swollen right hand with immense pain. On Monday, April 5th an ultrasound confirmed a blood clot in her right forearm.

I ended up with Covid Toes. The fourth toe on the left foot pulsated with pain for several hours that night. Two nights later the same thing happened on my right foot. Several of my toes ended up with scabs on the tips of the toes. My dermatologist told me that my toes had hemmouraged on the inside and the scabs were a result of that. She had not seen anything like that. I have looked at all the images of Covid Toes on the internet and have not seen any with scabs on the tips of the toes.

ED to Hosp-Admission Discharged 5/19/2021 - 5/24/2021 (5 days) Last attending ? Treatment team Acute respiratory failure with hypoxia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission From admission " Patient is a 88 y.o. female who presents to the hospital today withincreasing weakness, falls over the last few days. She has not been eating or drinking well. It appears she recently started a sulfonylurea. EMS arrived blood sugar 58 and upon arrival to the ER blood sugar was 35 and she was lethargic. Given orange juice and a dextrose bolus with improvement of her blood sugar. Room air sat was 88% on room air however she only feels short of breath but she did not wear oxygen at home. Family member has Covid but she does not endorse any contact with them. In ED she was found to be positive for COVID19, with AKI and SIRS and internal medicine was asked to admit the patient." Hospital Course Patient mandatory medical surgical floor. She was found to have acute hypoxic respiratory failure due to COVID-19 pneumonia. She was found to be 88% on room air and was requiring 3 L of nasal cannula oxygen fourth her first 3 days of admission. She received treatment for her viral infection with IV remdesivir as well as IV dexamethasone to complete 5 days. She also was treated with azithromycin and ceftriaxone. However this was later stopped as her procalcitonin level was not negative. Because her urine showed pyuria she was continued on IV ceftriaxone. However her culture only grew 30,000 colonies of E. coli in 50,000 colonies of Streptococcus and get gnosis. She was fully treated for a UTI. She was successfully weaned off of oxygen onto room air on May 23 and remained stable overnight into the day of discharge. She was seen by physical therapy due to her history of ambulatory dysfunction and rehab was recommended for her. However the patient refused she felt that she had enough family support and assistance at home to return home. Home services were also recommended including home physical therapy which the patient also declined. She will need to follow-up with her family doctor in the next 7 days. A referral for pulmonology was also made on the day of discharge for 1-2 days.

knots on both sides of her neck underneath her chin; two knots on neck under chin on either side was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old female patient received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL8982) as 1st dose, single for covid-19 immunisation. Medical history included a lung problem, and a pacemaker, diagnosed a good while ago, no details provided. Has had pacemaker for about 8 or 9 years. There were no concomitant medications. On 29Jan2021, the patient experienced knots on both sides of her neck underneath her chin, two knots on neck under chin on either side was reported as worsened. The patient stated that "she can press on the knots and they can push down". Caller stated she had the Covid shot on 22Jan2021, stated that on Friday she started to get these knots on both sides underneath her chin on her neck, they are like good sized knots, wondered if that could have anything to do with the vaccine. States she tried to get to her regular doctor today but it snowed and they were closed today. Caller was encouraged to reach out to them when they are open. States she can press on the knots and they can push down. She stated that she read the vaccine could cause swollen lymph nodes.The events were considered as non serious. The outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.

1) Sudden Blurring of vision, lasting more than one month (still occurring), 2) partial loss of hearing in both ears, 3) nerve sensitivity when moving body and when objects (seats, walls, bed) touch skin, feeling like shooting pain on contact. 4) loss of muscle strength, and extremely sharp pain (like spear stabbing) when using muscles (see symptom #3 above). 5) fatigue and spontaneously falling asleep, even when standing or doing dishes. 6) toe nails deformity within weeks of shot, curling and turning sideways. 7) uncontrollable leg adema, severe with water leaking out of legs.

5/5/21 Admission to Med Surg: The patient is a 88 y.o. female with a past medical history notable for CHF, diabetes, CAD, hypertension, hyperlipidemia. The patient presents for evaluation of worsening issues with swelling and shortness of breath. Patient was found to be 3-5 lb from baseline weight. Patient shows significant lower extremity edema in addition worsening rales bilaterally. Patient is on the fevers or chills. Patient struggle with fluid balance due to dietary need to restrictions in addition to patient's diabetic diet. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient's who was agreeable to in-patient diuresis 5/19/21 ER: 88 y.o. female who presents with chest pain. Patient reports that approximately an hour and half ago while at assisted living facility she began having chest pain. Patient describes her chest pain as located across the central part of her chest. She describes it as a pressure. She currently gives it an 8/10. Patient denies any radiation of the pain. Patient does report associated shortness of breath, lightheadedness, dizziness, but denies nausea, vomiting, or diaphoresis. Patient also reports feeling her heart racing in her chest. Patient denies prior history of atrial fibrillation. Bedside monitor shows AFib with RVR. Patient also reports recurrent swelling of the bilateral lower extremities dx: NSTEMI Transferred to a different hospital

Resident was vaccinated. Pt was admitted on 6/28 with dx of pneumonia, cdiff and sepsis. On admission pt noted to have dry cough and lethargy. Pt had signs of aspiration and dyspnea and was sent to ED for evaluation within five hours of admission to Beecher Manor. She was treated for aspiration pneumonia w/diagnosis of pneumonitis r/t food and vomit. She was re-admitted to Beecher Manor on 7/3 with orders for Augmentin PO 7/4 - 7/9. She continued to decline w/plans by family to begin Hospice care. She expired during process of initiating hospice care.

1 week after vaccine, developed 11x9 cm area of erythema, warmth, and swelling. Pt reported it was itchy but not painful.

On the 28th, she began complaining of sore right shoulder. By 30th, moving her arm was extremely painful. That morning, her temp was 95, By 8pm, her temp was 101. We took her to the ER. The ER drained fluid off her shoulder and found extremely high white blood cell count and sepsis had set in. They hospitalized her last night (Jan 30). She is on high dose of antiobiotics. She hasn't been ill and this week, only trip from home was for a curbside pickup.

Patient started having fever 2 days after second dose of Pfizer mrna vaccine. First dose occurred January 19, 2021 and was uncomplicated. Fevers continued and she started to have delirium and increased neurologic symptoms that mimicked stroke 6 days after vaccination. She was admitted 6 days after vaccination with fever 102, delirium.

Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML

Itchiness (immediate) followed by swelling (half dollar size) and turned reddish colour. Also dizzy and sluggish condition. As of this morning is pinkish colour.

My mother had an "adverse event" to the first dose of the Covid-19 PFIZER mRNA vaccine. Her whole upper arm became swollen (inflammation) and somewhat "hot to the touch" and was reddish in coloring. The inflammation did NOT look like a golf ball, but rather like a small hill on her upper arm, with a slope. After that, she reported to me .... that she was getting "winded", on walks with her best friend. They both live in a senior citizen residence center, which is NOT an "assisted living" facility. Now, the swelling (inflammation) is gone. My mother has now had the 2nd dose of the Pfizer vaccine and yesterday .... she did NOT report, any adverse reactions (yet) from her second injection.

Breathing problem. Couldn't get air in. Had fever of 103, headache, chills. Arm pain as expected, swelling red and raised hot area. table salt for breathing p roblem and it helped me breathe. I was not well for over 2 days. 3rd day I began to feel better but 100% day 4. Please note I would never have made it to the hospital alive, not being able to breathe. I did not get the 2nd shot!!

Patient reported that three days after receiving the vaccine, she developed swelling in left leg, ankle, hip, shoulder and hand. The symptoms stayed for a week and patient's leg was tingling, left hip aching, left shoulder pain, left hand feels like pins and needles, Achy all over and felt unwell.

throat closing, tongue swelling, face swelling and a hard time breathing/ diagnosed her symptoms as angioedema; potassium was low and sodium was low; potassium was low and sodium was low; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) at the age of 88-years-old, via an unspecified route of administration in left deltoid on 19Feb2021 at single dose for COVID-19 immunization; losartan potassium (lot number: LJ5020047-A, expiration date: Aug2023), via an unspecified route of administration from 2011 to an unspecified date in 2021 at 50 mg, 1x/day for blood pressure high; diclofenac sodium modified-release tablet (lot number: PW6V5QFTAF61, expiration date: May2022), via an unspecified route of administration from an unspecified date to an unspecified date in 2021 at 75 mg, 1x/day for an unspecified indication; ibuprofen (ADVIL LIQUI GELS, 200 mg strength, lot number: CY1426, expiration date: Jun2022) capsule, via an unspecified route of administration from an unspecified date to an unspecified date in 2021 at 2-4 capsules, as needed (daily) for an unspecified indication; and aflibercept (EYLEA) injection, ophthalmic from an unspecified date to 11Mar2021 at 1 DF (injection), every 8 weeks in each eye for macular degeneration. Medical history included macular degeneration (the wet kind), blood pressure high, spinal stenosis, and thyroid disorder (reported as thyroid something) she provided that it was something like hypotramea (as reported). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) at the age of 88-years-old, via an unspecified route of administration in right deltoid on 29Jan2021 at 0.3 mL, single for COVID-19 immunization. The patient was calling about the Pfizer COVID-19 vaccine and mentioned that she had a reaction but didn't think it was from the vaccine because it was 5 weeks to the date after the second shot. The reaction was very severe, and she had to visit the emergency room. The patient experienced throat closing, tongue swelling, face swelling and a hard time breathing. She saw her primary care provider after that, and she also saw her PMR doctor- physical medicine and rehabilitation. The doctors recommended that she report this reaction to the COVID 19 vaccine five weeks later. Both doctors thought it might be from the vaccine and it was worth reporting. When asked about the symptoms and if they occurred at that same time, the patient stated yes, and they diagnosed her symptoms as angioedema in the emergency room. This happened on 26Mar2021. The patient was never admitted to the hospital. When asked if angioedema improved, worsened or was persisting, patient stated it was nonexistent now. The events happened after the second dose of the vaccine. The patient had to stop her medications because her primary care provider was unsure what may have caused this reaction, but it may be her medications. She has been taking losartan potassium for about ten years but now had to stop because angioedema could possibly be the result of that, even after ten years. She also had to stop diclofenac sodium because they may have caused that kind of reaction. Having to stop ibuprofen broke her heart as she has taken it for years. This too could have that type of reaction. For aflibercept, she mentioned that she gets the injections in both eyes every eight weeks. She had it 31 times in the right eye and 30 times in the left eye. The reaction she was speaking of, the emergency room, came exactly 2 weeks after she had her last injections, which was on 11Mar2021. Angioedema was an emergency situation, if the throat closes and they couldn't open it up, they may cut into the neck and windpipe. The description was enough to scare her. Both doctors suggested the Pfizer vaccine as just possibly a late reaction. The patient had a basic metabolic panel while in the emergency room. She reported that potassium and sodium was low. Chest Xray- the patient did not have a report on it. Nasal scan was fine. COVID nasal test was negative. Swab for many other kinds of viruses was negative. All of these tests were done on 26Mar2021. The action taken in response to the events for losartan potassium, diclofenac sodium, ibuprofen, and aflibercept was unknown. The outcome of the event "potassium was low and sodium was low" was unknown and recovered on an unspecified date in 2021 for the other event.

Patient daughter in-law stated that patient started having Facial swelling that started on 05/11/2021 on one side and later in the day patient had facial swelling to her entire face. Patient was seen by her PCP and prescribed Cephalexin 250mg TID time 7 days, steroid injection, and follow-up with PCP on 05/12/2021 with complaint of sore throat and facial pain. Prescribed Prednisone injection and Valacyclovir. Reporter asked if patient was diagnosed with Shingles and daughter in-law stated that the doctor mentioned that diagnoses but was not sure that it was Shingles.

Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks. She was seen in her PCP's office and diagnosed with a UTI and gout. The x-ray of her knee later showed a fracture of her proximal tibia. A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome. She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy. Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.

Patient developed rash 24-36 hours after vaccination received to L deltoid, started on arms and has spread over body. 48 hours after vaccination patient reported painful swallowing due to swollen lymph nodes. Patient has been monitored at home by daughter, given tylenol as needed for discomfort, denies worsening symptoms at time of reporting to this clinic 1/25/21 10:00 am. Daughter denies need for evaluation at ED or office visit at this time, continuing to monitor. Discussed reporting any new or worsening s/s and seeking emergency medical treatment.

on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30 Min Later. complaint of & Noted Diarrhea, Shivering, and vomiting SenT To ER 2/1 And Admitted Diagnosis: Sepsis

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DIARRHEA, VOMITING AND AMS. ADMITTED AND REMAINS HOSPITALIZED ON 3/17. PATIENT TESTED POSITIVE FOR COVID-19 ON 3/15 AND HAS RECEIVED BOTH DOSES OF VACCINE MORE THAN 2 WEEKS AGO. HOSPITALIZATION REPORTED TO BE RELATED TO PATIENT SEPTIC WITH GI INFECTION. POSITIVE COVID INFECTION IS INCIDENTAL. PATIENT ON ROOM AIR. NO FINDINGS ON CHEST X-RAY.

Felt fine the same day. The next day:. Shoulder SEVERELY swollen with HUGE bump in and around lymph node, reddened, swelling, heat at inj. site, turned pink then purple then dark purple, throbbing in neck and head, severe headache plus migraine, difficulty hearing, could not move arm/wrist/fingers/hand, unable to hold fork etc. This lasted for 10 days after onset.

severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering. Information about lot/batch number has been requested.

Swelling of the face; itching back; This is a spontaneous report from a contactable Other Health Professional (patient). A 89-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 15:00 (at the age of 89-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included Afib, Hypertension, mild allergy to dust and known allergies: detergents with sents from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); furosemide sodium (FUROSEMIDE [FUROSEMIDE SODIUM]); metoprolol (other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. On 18Jan2021 15:00, patient experienced swelling of the face, itching back. The patient visited doctor or other healthcare professional office/clinic for adverse events. Patient received loratadine, prednisone, triamcinolone topical cream as treatment for events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Jan2021. Therapeutic measures were taken as a result of swelling of the face, itching back. The outcome of events was not recovered. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.