Pfizer

Onset of swelling in neck. Reported via phone that he has 2 lumps that began yesterday. He also said he started experiencing an allergic rash on his back. Advised to seek medical care.

Metallic taste beginning 20 min after injection. Chills beginning 15 hours after, then fever up to 100 F at18 hours after. Treated with 400 mg ibuprofen every 6 hours. Fever resolved at 20 hours after injection. Lymphadenopathy in left axillary nodes with tenderness.

swelling on my right side of neck. i took Benadryl.. Dr told him to take steroids which he didn't take.

One week after 2nd vaccine, Friday 2/19, woke up with my right eyelid red, swollen, itchy, discharge. Saw eye doctor, OD., whom I work for. She diagnosed "Swollen sub-mandibular & pre-auricular lymphatic nodes." I am being treated with: 1) Erythromycin Ophth Oint 3.5GM 2) Prednisolone AC 1% Ophth Susp 5ML 3) Pataday Doctor believes that my viral infection might be a result of the Covid 19 vaccine, and gives assurance that her treatment will resolve issues. She is unsure whether, or not, I am considered contagious during this time? Inquiries at the college were unfruitful. I hope my reporting this is not a violation in any way. Many thanks.

angioedema - swelling of upper lip; This is a spontaneous report from a contactable physician. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via intramuscular on 03Feb2021 12:00 at single dose in left arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypertension (HTN). No covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via intramuscular on 14Jan2021 12:00 at single dose in left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced angioedema - swelling of upper lip on 05Feb2021 08:00. The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone/diphenhydramine/Pepcid. The outcome of the event was recovered in Feb2021.; Sender's Comments: A causal relationship between BNT162B2 and the event angioedema cannot be excluded based on 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 RAs, Ethics Committees, and Investigators, as appropriate .

Swelling in both lower legs and severe rash and itching. Lasted for 2 days. Still experiencing some form of it on day 3. But swelling has subsided and rash is healing.'

Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA. BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP walked patient out of clinic.

3-4 days after 2nd dose, large areas of bruising on arms (bilat), torso (all areas) and one on left thigh. Increase of pedal edema from Trace/1+ to 2-3+. Unexplained breaking of all finger nails. No pain or itching (pruritus) associated with bruises. No new meds (Rx or OTC) started during the week prior to first injection to this day. No real symptoms to treat so nothing done. Areas of bruising hace increased but are now starting to fade. No specific treatments done as there was nothing to be done other than to consult my PCP.

Muscle pain in shoulders with more extreme pain in the left shoulder, Left wrist. This muscle pain occurred on March 16 and dissipate 2 days later. Then on March 18, 2021 I started to feel muscle pain and swelling in and around my left ankle. On March 20th, 2021 the swelling remain in and around the ankle but the swelling and pain migrated to the first joint of my left big toe. The pain on a scale of 1 to 10 ten is about a 3. The pain elevate to a 10 when touched. Pain is unbearable if I attempt walking on the left leg, as a result I am not able to walk. Swelling has not subsided in 3 days

The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injection site pain, weakness/fatigue, chills, swollen lymph nodes/sore throat. 96 hours later (as of this writing) still have diminished sense of taste, swollen lymph nodes/sore throat, quick fatigue.

I received my vaccine on a Tuesday morning, and five days later on Sunday morning I woke up with very swollen checks--my head looked like a pumpkin. When my girlfriend saw me in the afternoon, she said, "I'm taking you to the emergency room!" But, I told her that I had no fever and no other symptoms, so we should wait. The swelling was bad enough that my jaws ached and my cheeks felt like they were going to burst, but if I didn't chew any food, the swelling would subside slightly, and my jaws would stop aching. I read online that people with botox who get the vaccine can have facial swelling and a 24 hour course of benadryl will knock down the swelling. I have never had botox injections, but I took some benadryl for two days, which made me feel really tired. I ate only soup and yogurt, so that I didn't have to chew any food. I don't know if the benadryl had any effect, but over about 5 days, the swelling subsided, then I could eat again without causing my jaws to swell up.

On Jan 22, Developed sudden onset of left hand swelling , progressed to left hand throbbing pain with decreased ability to preform simple task. treated rleased / march 23- developed same symptoms / march 28th recurrent symtoms. On 1/22/21 treated at ER w/ oral predisone , with improvement. / 0n jan 25th eval at Health Center . for Eval/ On march 23 seen at ER for recurrent symtoms . Had Xray, treated with oral prednisone // On 3/28 recurrent symptoms.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

Pain at injection site. Progress to under the arm. Also lymph nodes under arm are noticeable to the touch and water build up on the right under arm chest wall. Some coldness in hand and occasional tingling. Shoulder area feels heavy.

Swelling on the face ( eyes and mouth) the next morning after getting the injection as well as rash all over the body to combat the reaction the patient took 2 benadryls.

Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.

PATIENT HAD DIZZINESS AND LUMPS UNDER HIS LEFT ARM DAY AFTER HE GOT 2ND DOSE OF COVID*19 SHOT. HE MADE AN APPOINTMENT TO SEE HIS DOCTOR. HE CAME TO PHARMACY AND TALKED TO PHARMACIST, HE WAS TOLD BY PHARMACIST TO TAKE TYLENOL IF NEEDED AND KEEP HIS APPOINTMENT WITH HIS MD

After receiving the 1st vaccine I experienced pain in my arm, chills and swelling of both hands and both knees After receiving the 2nd dose I experienced the same symptoms except the pain in my arms and the chills. I'm still experiencing swollen hands and knees. Not able to make a fist and lot's of pain in both knees and both hands especially the mornings. Joint pains and swelling in my hands are affecting my ability to hold things firmly without dropping everything.

on the crook of left arm, on the elbow part of the arm part, within 30 minutes, it turned a deep purple-red color and developed a bubble on the top. there was no pain associated with it. it is 4 days later and still visable

Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.

Immediately I lost my sense of taste - that lasted for four days. I had a little swollen in my arm- I felt nauseous but I wasn't sick. I had a fever but just slightly elevated. Two days after vaccine, my kidneys were in pain. It took a couple of days for it to go away and then it stopped. Called the doctor but he had said just to wait it out -and I kept taking my regular meds but no additional.

pain and swelling in right arm with severe swelling and severe pain in right hand and wrist. pain and swelling appears to affect joints as lower back and fingers on left hand has become swollen and painful several days after injection

developed itchy red rash around elbows with swelling and the spreading to for arms, legs at this time, applied hydrocortisone cream 1% several imes a day, rrecieved 8 mg shot of predisone shot on 4-19-2021

Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough. Admitted to ICU with acute hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis. Reportedly received 2nd dose of COVID-19 vaccine 2 days prior. Shortly after admit, pt developed worsening respiratory status requiring intubation @1045. Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15. Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation. Repeat arrest with PEA@1135 with return of spontaneous circulation. Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.

Large swelling in and around my left armpit with soreness. Appears to look like a lump under my left armpit with veins visible with the eye. Swelling appeared after within 36 hours of receiving the 2nd Pfizer Covid-19 vaccination shot.

I experienced a very sudden and intense Gout flare up that caused and is still causing an unbearable swelling in my right foot and ankle. I have not had a flare up of this intensity and severity for over 12 years. My Gout has been successfully managed by Allopurinal for over 12 years and I have not experienced any significant events during this time. This time includes over 20,000 miles on my road bicycle and dozens of days over 100 miles. Never have I had a problem. Last Tuesday, I received the second dose of the Pfizer vaccine and I have yet to be able to walk or sleep through the night for six days and counting. This adverse effect should be followed and researched. I also will be requesting reimbursement for out of pocket expenses due to this event.

Tender lymph nodes; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that this 60 years old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6207) single dose in right arm on 17Mar2021 for COVID-19 Immunisation. Medical history and concomitant drugs were not provided. The patient had tender lymph nodes in the morning on 09Apr2021. He clarified side effect experienced initially as swollen lymph nodes, but clarified it was not swollen, but tender lymph nodes. Outcome of the event was not recovered. No Follow-up attempts are needed. No further information expected.

-12 hours after 2nd Pfizer vaccine, woke up repeatedly throughout the night with bizarre, vivid dreams; also awoke 3 times with eyes open and distinctly heard my cat purring on the bed, even though she passed away two years ago. These symptoms ended after the first night post-vaccine. -18 hours after 2nd Pfizer vaccine, in the morning noticed distinct neck puffiness and swelling, especially just under the jaw line. After 1 week the puffiness persists, but is slightly less. -48 hours after the 2nd Pfizer vaccine, noticed high-pitched buzz (tinnitus) in both ears. In a completely quiet room, I continue to hear it throughout the day and night after one week.

Sudden bilateral leg weakness a little over 2 weeks from vaccine dose. Also had the inability to walk. Bilateral increasing numbness to both arms and legs. Progressive weakness. Admitted to hospital. Had CT scan, MRI scan, LP puncture, blood work. Findings/lab work state GBS (Gillian Barre syndrome)

Losing strength in his right leg; Muscle pain; Joint pain; Muscle spasms in his neck because he has neck pain too; Muscle spasms in his neck because he has neck pain too; His leg kept getting worse; He just cant walk anymore; Leg is swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: ER6208) as single dose at the age of 60-year-old for COVID-19 immunisation. Medical history included disability. The patient's concomitant medications were not reported. The patient experienced losing strength in his right leg in Mar2021, his leg kept getting worse in 2021, he just can not walk anymore in 2021, leg is swollen in 2021, muscle pain in Mar2021 with, joint pain in Mar2021, muscle spasms in his neck because he has neck pain too in 2021. The events losing strength in his right leg, his leg kept getting worse, he just can not walk anymore and leg is swollen were assessed medically significant. The patient underwent lab tests and procedures which included magnetic resonance imaging: leg is swollen in 2021, X-ray: nothing showed up in 2021. Therapeutic measures were taken as a result of losing strength in his right leg, muscle pain, joint pain. The course of events was as follows: Around 21 Mar2021 or 22Mar2021, he had problems with his leg. Patient was experiencing muscle pain and joint pain, losing strength in his right leg. Patient stated that was a problem. Patient had an MRI and X-ray that looked to see what the problem was. Patient received second dose on 14Apr2021. Patient hasn't even seen his prescribing Healthcare Professional yet, until Monday. He hasn't worked in five years, he's been on disability. He wanted to get off disability so he went and got a job. He started the job 28Mar2021 and everyday, his leg kept getting worse. He had to leave the job the other day because he just cant walk anymore, he has to do a lot of walking on the job. He called the doctor and told them something was wrong with his leg, they took an x-ray and nothing showed up. They did an MRI and all it shows was that his leg was swollen, no bones or nothing is broken. He was looking at Pfizer paperwork that a facility gave him and the two of symptoms are on there, so this problem was related to the vaccine. He never hurt his right leg, never had a problem until he got this shot. He was losing all his strength in his right leg, all the pain. They have been giving muscle relaxers and ibuprofen and they did not seem to work or be doing anything. First, he went to the emergency room and they gave him Ibuprofen 600 mg tablets and they gave him Cyclobenzaprine 10mg tablets. They said that he was experiencing muscle spasms in his neck because he has neck pain too. So he made an appointment with his family doctor, which there was no openings and had to see another PA. He did not know the HCP last name, but he/she was a PA in the office and he saw him/her, who requested the x-ray, and he had the x-ray done and saw him/her again and nothing showed up so he/she requested an MRI. He went to the hospital to have that and nothing showed up except his leg was swollen. Now they are going to send him to a bone specialist, but there was no reason to because now he stated he knew what was causing this. Patient took Cyclobenzaprine, 10 mg, three times a day by mouth. He states it did not seem to do nothing. Patient verified it was a prescription from the pharmacy: NDC: 0137517-19674, unsure of LOT, expiry date. The quantity of the first bottle was 15 but he went through that already and he got a new bottle that has 42 in it. This current bottle he has 12 or 13 left. The first bottle was completely gone. Patient took Baclofen 5mg tablets, three times a day: morning, noon, and night. They were not doing anything either, well he did not think they are. Patient provided NDC: 0135391-19674. The first muscle relaxer they gave him, the 10mg one, he took it that day, it knocked him out. Caller states when he saw his doctor, he said he can not take that one while he works, he will take it at night time, so that is why the doctor gave him the other muscle relaxer, Baclofen, to take while he worked during the day. He took one muscle relaxer at night of one kind and the other kind he takes the ones that won't take him out as much. Patient stated that he had to leave his job because he cannot do it, he cannot walk. Patient took Ibuprofen (NDC: 0139246-19674, to use before 22Apr2022) 600mg, by mouth, three times a day. He took one with the muscle relaxers. Patient took verified all medications Cyclobenzaprine; Baclofen; Ibuprofen were prescriptions from the pharmacy. The outcome of muscle pain and joint pain, losing strength in his right leg, his leg kept getting worse, was not recovered of he just can not walk anymore on, leg is swollen, neck pain was unknown. Reporter seriousness for muscle pain and joint pain, losing strength in his right leg and neck pain was unspecified Patient received his second dose of Pfizer Covid 19 Vaccine (LOT: EW0161, unsure if ER or EW) on 14Apr2021. A Product Complaint was filed. No follow-up attempts are needed. No further information is expected.

Pt notices right hand and right toes swollemn upon rising. This is new since receiving the first dose. Swelling improves with heat and movement, although swelling is never completely resolved. Pt experiences swelling in hand and toes as well.

Within 30-min: Muscle pain across shoulder and arms. Joint pain: shoulders, elbows, fingers, knees, and toes. Mild swelling and redness in hands. Next day; mild swelling of face.

5/5/2021 - developed a scratchy/painful throat, markedly enlarged lymph nodes on left side of throat and chills. 5/10/2021 - seen by PCP. negative monospot, strep. Elevated CRP and SED rate. Treated with augmentin 5/12/2021 - seen by ENT. Improvement of tonsil size post augmentin. Prescribed Medrol dose pack and CT ordered 5/13/2021 - seen by PCP. Continued improvement of lymph node size even though Medrol dose pack was not started. Upcoming CT and return appointment by ENT.

Saddle pulmonary embolus diagnosed 5/12/21 with unilateral leg swelling starting over one month prior.

About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild

Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swelling. Took two doses of Benadryl and has now developed chest tightness and throat swelling. Per doctor's notes: Patient is a very pleasant 60-year-old gentleman who comes in for evaluation after a possible allergic reaction today, possibly related to a second dose of Pfizer Covid vaccine that he got at 8 AM this morning. About an hour later he started to feel flushed. He felt like his face was warm and his ears were warm. He started to feel like the inside of his mouth had filled with a rubber ball. His tongue felt full and he started noticed progressively that he felt like he was having difficulty swallowing. States that he never actually had any lip swelling, contrary to the triage note, just felt funny in the interior of his mouth. Did feel like his tongue was slightly swollen, both based on the fact that it felt "thick" when he was talking, and on direct inspection, as well. Took 50 mg of Benadryl around the time that his symptoms started, and lay down to nap for a little while. When he woke up he was still feeling like he was having more difficulty swallowing. He also felt like his face was a little bit puffy, prickly under each eye. He also felt like he had a blotchy rash on his chest and upper back, which his wife corroborates. He felt like his chest was a little bit tight and that something was heavy on his chest, though he was not wheezing or acutely short of breath, per se. Took another 50 mg of Benadryl at about 2:15 PM, and presented to the emergency department for further evaluation. Currently still has a little bit of chest tightness and throat tightness. He feels flushed. Symptoms have not worsened, but they have not completely resolved, either. He has had anaphylaxis in the past and has had to be admitted to the hospital. And this was in relation to taking doxycycline, it sounds like. Patient presented again to the ED on 4/22/21 with the same symptoms. He was admitted with anaphylaxis. Per ED notes, also diagnosed with Angioedema, improved. Likely related to second covid vaccine. Cant rule out secondary to Lisinopril.

Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and painful after 3 months since the first injection.

Pain at injection site, sore muscles, headaches, painful and swollen lymph node on left side of neck under left ear -- still painful and swollen after 3 months since injection

TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. 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 experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering. Follow up needed, further information has been requested.

About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after the vaccine my left eye started to get very red & swollen; Numbness on the left side of my face; Swelling on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:30 as SINGLE DOSE for covid-19 immunization (Facility type vaccine: Pharmacy or Drug Store). The patient's mdical history was reported as none. Patient has been not taking any other vaccine in four weeks. And no other medications in two weeks. Patient has not tested covid-19 positive prior to vaccination. Patient has no known allergies. It was reported as on 07Mar2021 at 04:30 PM about 4 hours after the vaccine his left eye started to get very red and swollen along with some numbness and swelling on the left side of his face. Four hours later it was started to get better with cold compress. Patient has not tested covid-19 positive post vaccination. The outcome of the events was reported as resolving. No follow-up attempts are possible. No further information is expected.

1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.

Swelling under right arm pit for 3 to 4 days. Self apply pain relieving patches that contains Methyl salicylate 10.0%, Menthol 6.0%, Camphor 3.1% for 4 days before the swelling slowly disappear.

About 35 days later I woke up early morning about 4:30 a.m. with a sharp pain in my left underarm. I felt a lump about the size of a quarter in my left armpit. Contacted doctor's office and went to see the my primary care physician the following day who determined or believes I had a infection possibly of the glands and wanted to wait a week before doing anything. After 7:00 or 8 days the pain subsided and the lump was smaller. Today July 2nd 2021 the lump is gone down considerably and there is no more pain.

Persistent swelling, hives, anaphylaxis (over 30 days). Able to suppress with prednisone 20mg daily. No long-term solution yet

On June 29, 2021, 47 days after the 2nd injection of Pfizer-BioNTech COVID-19 Vaccine EUA, a sever skin rash or hives occurred over the entire body and has persisted for a week now. Sever swelling of facial tissues, especially the lips and cheeks has required treatment of Prednisone 40 MG per day to reduce swelling, this prescribed by order on July 1, 2021. This has never occurred before in this individual and there has been no other known cause for this condition. There are no known food allergies or other allergies know to cause such a reaction in the history of this patient and no event, insect sting, bite or unusual exposure to any allergen has been found to have occurred.

Seen in the Emergency room on 4/29/21 for chest pain and nausea, vomiting, numbness and tingling in feet and hands. Various tests were performed to rule out a heart attack. We were told they felt the symptoms were due to side effects of the COVID-19 vaccination. Told we could go home, if symptoms worsened or persisted to check with our primary or return to the ER if needed. We returned home, symptoms did worsen, returned to the ER on 4/30/21. PT was admitted to the hospital and eventually diagnosed with Guillain-Barre Syndrome, type AIDP (acute inflammatory demyelinating polyneuropathy), elevated troponin levels, low vitamin B12, and hypertension. He was hospitalized through 5/11/21 receiving IVIG treatments and then referred to an acute rehabilitation facility through 6/24/2021. Released to home and receiving in home therapy services currently.

Swelling of the lips (inside mouth); Swelling of cheeks (inside mouth); Dry mouth (inside mouth and forward to lips); Cracked lips; Extremely dry lips; Abnormal hair growth around mouth; Emergence of black hair in beard when previously white; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route administration in the left arm on 02Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure and obese (obesity). Concomitant medication was not reported. The patient did not have any allergies to food, medications, or other products. 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 04Mar2021, the patient experienced swelling of the lips and cheeks (inside mouth), dry mouth (inside mouth and forward to lips), cracked and extremely dry lips and abnormal hair growth around mouth (new hair along lip line and emergence of black hair in beard when previously white). No treatment was received for the events experienced. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events swelling of the lips, swelling of cheeks, dry mouth, cracked lips, extremely dry lips, abnormal hair growth around mouth and emergence of black hair in beard were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

A day after the vaccine, I started itching , the itching was localized to arms and soon to my back. Having allergies , I started on my OTC medications to include Hydrocortisone cream . As the days progressed, the rash was over my entire body to include swelling of face and legs.

Swelling (size of a large grape), inflammation, soreness of the Supraclavicular lymph nodes on the left side of neck.

Guillian-Barre Syndrome; my ongoing struggles with strength and mobility; cannot walk independently; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (Pfizer COVID19 Vaccine, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient had received other medications within two weeks Finasteride, Omeprazole, Advil, BUT/ASA/CAFF patient previously received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on APR2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included BPH without urinary obstruction, achillies tendinitis, elevated PSA, ejaculatory dysfunction, chronic dental health issues August 2020-February 2021, drug hypersensitivity amoxicillin from an unknown date and unknown if ongoing. Concomitant medications included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (A S A) taken for an unspecified indication, start and stop date were not reported; CAFF;CHLO MAL;ETHEN;HERB;METHO HYDROB;METHY HCL;PARA;THIA SULF;VB2 taken for an unspecified indication, start and stop date were not reported; BUT-2-ENEDIOIC ACID MONO-(2-DIETHYLAMINOETHYL)-ESTER; COMPOUND WITH VINYLBENZENE taken for an unspecified indication, start and stop date were not reported patient didn't had COVID prior to vaccination patient was tested for COVID to post vaccination. On 08Apr2021 21:30 the patient experienced guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently. The patient was hospitalized at Hospital for guillian-barre syndrome and for my ongoing struggles with strength and mobility and for cannot walk independently for 12 days patient had Emergency room and physicians office visit for the events patient had disability due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021. Therapeutic measures were taken as a result of guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently IVIG treatment for Guillian Barre Syndrome. The outcome of the events guillian-barre syndrome, mobility decreased, gait inability was not recovered.

Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out); Delirium; Worse after 2nd COVID-19 vaccine; fevers; Lymphadenopathy; Transaminitis; Splenomegaly; Anemia; This is a spontaneous report from a contactable physician. A 60-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8735, expiration date unspecified), via intramuscular route on 25Apr2021 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient reported she was healthy before vaccination. Medical history included depression and gastroesophageal reflux disease from an unknown date. Concomitant medications (received within 2 weeks of vaccination) included sertraline, lansoprazole (PREVACID), both concomitant medications taken for an unspecified indication, from an unknown start date. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EP7533, expiration date unspecified), intramuscularly on 03Apr2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 60-year-old) and experienced altered mental status. 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 the vaccination. Since the vaccination, the patient had been tested for COVID-19 (on 17May2021, Test: COVID-19 PCR, Nasal swab) which was negative. Clinical course of the events was reported as: Previously healthy 60-year-old male, presented to hospital with altered mental status 6 days after the first COVID-19 vaccine, on 09Apr2021. Had a negative neurological work up but continued to decline, worse after 2nd COVID-19 vaccine (fevers, lymphadenopathy, transaminitis, splenomegaly, anemia, severe thrombocytopenia, delirium). Suspected to have lymphoma ruled out but ruled out; bone marrow showed hemophagocytosis, and labs showed high soluble IL-2 receptor (33,903). Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out). Positron emission tomogram (PET) scan negative for malignancy. Patient improved only after starting Etoposide and dexamethasone, now (as reported) in remission. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 68 days for the events. The events assessed as serious (life threatening and caused/prolonged hospitalization). Outcome of the events at the time of report was resolving.; Sender's Comments: Limited information precludes a comprehensive causality assessment ,however causal of BNT162B2 vaccine cannot be excluded for the reported events 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

A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath. I also noticed the calf muscle in my lower right leg began to swell. The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg. I started using an ice-pack in an attempt to reduce the swelling. I also sat/lay with my leg up (horizontal) as much as possible. On 6/28 I visited with my primary care doctor to seek help in addressing the swelling. My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs. I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.

I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.

Per the patient's description, about 36 hours after the first dose he began having pain and tingling sensation and feeling of swelling in both feet and less in both hands. He had difficulty walking for about 2 days. No fever or anything else. After the second dose given on January 5, 2021, Lot number EL1284, he had a milder reaction that lasted for one day and started 2 days after the shot.

left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Liver function test abnormal; This is a spontaneous report from a contactable other HCP reporting for himself A 61-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced liver function test abnormal on an unspecified date with outcome of unknown. The patient stated he is getting worse everyday. Chemistry AST/ALT 183, Alkaline Phosphate 241, C reactive 44. Had previous Chemistry panel normal. The patient is asking for treatment recommendations. HCP ordered infectious hepatitis test.. The patient stated: "Being passed around. Your vaccine is killing me". The patient underwent lab tests and procedures which included ast/alt ratio: 183, blood alkaline phosphatase: 241, C-reactive protein: 44. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Approximately 72 hrs after administration developed axillary lymphadenopathy; This is a spontaneous report from a contactable consumer (patient himself). A 61-year-old male patient received his second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administrationin the left leg on 14Jan2021 16:00 at SINGLE DOSE for Covid-19 immunisation. He received the vaccine in a hospital. Medical history included multiple seasonal environmental allergies. He received his first dose of bnt162b2 on 24Dec2020 12:00 in the left arm. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (ADVIL), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) and acetylsalicylic acid (BABY ASPIRIN). Approximately 72hrs after administration (17Jan2021 23:00), he developed an axillary lymphadenopathy (non-serious). Since the vaccination, he had not been tested for COVID-19. No treatment given. The outcome of event was not recovered. Information on the lot number has been requested.

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

RECEIVED PFIZER VACCINES ON 01/08/21 & 01/29/21. 02/05/21 SAW PCP IN OFFICE REGARDING NEW RT ARM REDNESS/PAIN. X2 DAYS. DX: CELLULITIS 02/09/21 WENT TO ER TO REPORT WORSENING ARM REDNESS R/T CELLULITIS. REFUSED INPT TREATMENT ABX AND WAS DISCHARGED ON ORAL ABX. 02/12/21 RETURNED TO ER FOR WORSENING ARM CELLULITIS DESPITE ORAL ABX. ADMITTED FOR DX SEPSIS AND CELLULITIS.

Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 days beginning approximately 48 hours after first shot; almost constant Fever; Body Aches; Strong lower back and hip pain; Bilateral pedal edema; dehydration; inability to absorb fluids for 5 days; arm, ankle, hip, back, shoulder, and wrist joint pain; difficulty getting out of bed in the morning, or getting up from the stationary position. Symptoms finally resolved day 7 just before I anticipated going to ED in local hospital, and were gone for two days. Symptoms returned on day 9 following vaccination and lasted 5 additional days, with symptoms resolving for good only on the 15th day after the initial injection.

After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took a shower, and when he went to wash under his armpit was very swollen, and very tender. He put some ice on it which did not help the swelling. It bothers him when his T-shirt touches the area, so he tried to wear a regular shirt. He also had achy pain in his back, weakness in his arms, sore throat and a little cough, no fever. The armpit still hurts and is still swollen. Other than the ice he did not take anything else as he takes a lot of medications as it is. He has not called his doctor because it happened over the weekend, but is going to call her today. He did have a COVID test yesterday drive through facility at the community hospital as he has a surgery coming up, and they were going to call him if it was positive. He is scheduled for surgery on his right knee on Thursday.

Chilling, shivering, muscle and joint ache, fatigue for about 24 hours, then tapered off. Lymph node under left arm swelled and pain for about a week.

Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky. Prickly feeling throughout body.

45 minutes after injection slight lip swelling and swelling in left cheek hei 's and years took 20 Tech and histamine and symptoms subsided in a few hours. *Important, 30 hours after injection the following night at 11:00 p.m. began to experience pronounced generalized Fasciculations - Similar to those I experienced After receiving the 3rd of 5 doses of the rabies vaccine in 2008. Strong , generalized muscular Fasciculations are now persisting 7 weeks after receiving the 1st dose of the Pfizer Covid vaccine.

Gout in my left foot at the base of the big toe has flared up. Some swelling and redness in the area, was warm to the touch when it started. Significant pain and lack of flexibility in the joint. Has persisted for four days.

Patient had his first covid vaccine at 1340 and within 10 minutes the patient's neck began to swell, turn red and he felt like he was having trouble breathing. Rapid response called in building, Epi pen administered, Benadryl 50mg IM administered and pt sent to hospital via 911 ambulance at 1418

significant swelling at and around the site of injection, along with significant pain shortly after time of injection. Subsequent bruising. Bruising continues and has been increasing to this date (4.9.21) and the bicep and shoulder have a generalized swelling.

Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain

61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills. Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen. Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin. Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.

About two weeks after the 1st shot I noticed my facial skin was very itchy. This was a constant thing. Two days after I had the shot shot my face swoll up and was very itchy. I was waking up in the middle of the night several times a night because of the itches and I was going my best no to scratch. i rubbed moisturizer in to my face and later started using some over the counter itching creams that would work for a few hours. I began to realize the itching was worse in places where I had five years ago had Bellafill infected into acne scars and deep wrinkles by a licensed cosmetic surgeon. I like the results and have no issue with the doctor or filler, but this stuff itched terribly. I see on the internet some complaints from others, but I wanted to report that I too have this. As of today, weeks later, it is not as bad, but as I write this I want to itch a place above my right cheek bone that was injected with Bellafill. I thought it was a problem with the Bellafill, I am convinced now it is a side effect of the vaccine. Guess this means it is working to adopt to odd things in my body.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic three days after vaccination reporting pain and swelling in left lower leg starting shortly after receiving vaccine. Vital signs all within normal ranges. Physical exam shows asymetrical left lower leg edema with pitting edema 2+ to the level of knee. Both knees have decreased range of motion and effusion (during visit underwent bilateral knee arthrocentesis). Normal pulmonary effort and no respiratory distress. Patient diagnosed with deep vein thrombosis (DVT) and started on anticoagulation.

1 week after the shot my Lymph Node on the left side of my chin started to swell and become painful. AN off share rash also appeared on my left forearm.- The rash has mostly disappeared after 3-4 days. The Lymph Node swelling has reduced, but remains somewhat painful even after 5 days. (Mostly like a sore throat today)

Patient came to see me in the office on 4/12/21 and reported an adverse event that had happened after he got home from the drive thru vaccine clinic on 3/17/21. He had the vaccine around 11 am and later that evening, he is not positive of the time but between 7-9 pm, he developed severe swelling of his face and lips and tongue, he also felt nauseated. He called EMS and they found his bp to be low. He was not given EPI. His symptoms resolved on their own but reoccured the following evening; he went to ER and was monitored there; he was not given EPI at the ER. He was not admitted to the hospital. Symptoms have not reoccured and he is asymptomatic at this time. He was not sure if this was releated to the vaccine, but could not identify any new environmental or food items that would have triggered the reaction.

Edema near lymph nodes under arm in which vaccine was injected. Noticed this after Monday morning swim while showering and swelling has persisted

Upper respiratory: Cough/Phlegm producing General feeling of malaise Swollen (L) Lymph node (Submandibular) All symptoms coming to a head ~ (2) weeks post second shot

Fever of 101.5, which persisted for 3 days. Headache for two days (04/09 PM thru 04/11) not elevated by 2X Tylenol dose. Pain and swelling at the vaccine sight. Left upper arm swelling and hot (102.4 with digital thermometer. Marked swelling in underarm (arm pit) grossly visible (photos taken) and arm it temp over 102 to 2 days and over 101 for 4 more days (total of 6 days) with notable swelling and elevated temperature in the area. Appears normal at day 8 DPI. This is the most adverse reaction I have ever had to any vaccine in my memory. As I have been working in Asia, I have had several vaccines in my life and in recent years. Never a reaction like this.

found a deep blood clot.; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 61-years of age), dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 12:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included blood clot after a back fusion about 16 years ago (2005), and had a knee replacement 3 months before the vaccine (Dec2020). The patient's concomitant medications were not reported. The patient previously took ANCEF [cefazolin sodium] and had allergies; and oxacillin which the patient had allergies and hepatitis. The patient was not diagnosed with Covid prior to vaccination nor was he tested for covid since vaccination. The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. It was reported that the day the patient received the first vaccine his calf, foot, and knee swelled up by evening. It stayed swollen for a week and he went to see his doctor. He did an ultrasound on his calf and found a deep blood clot. He was now on blood thinners. He mentioned that he had a knee replacement 3 months before the vaccine but it was progressing fine. Usually blood clots occur after surgery within a 2 week period. He had a blood clot after a back fusion about 16 years ago. He was reporting this because his doctor was not sure why he got the blood clot and it coincided with the vaccine. The patient underwent lab tests and procedures which included ultrasound scan: found a deep blood clot in Mar2021. The events started on 17Mar2021 18:30 with outcome of recovering. The events resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events with LOVANOX and PRADAXA. Follow-up attempts are completed. No further information is expected.

Patient reports developing itchy raised hives 4-5 days after receiving first dose of vaccination. Hives located on left arm, top of head and back. Improved spontaneously, now has slightly raised areas of skin where hives were located. No longer itchy.

Heart arrhythmia; shortness of breath; slight swelling of face and neck; slight swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) via an unspecified route of administration into left arm on 21Mar2021 12:30 as single dose for COVID-19 immunisation. Medical history included heart disease, food and environmental allergies and diabetes. The patient's concomitant medications were not reported. On 23Mar2021 01:30, patient experienced heart arrhythmia, shortness of breath and slight swelling of face and neck. No treatment was given to the patient. Outcome of events recovered on an unspecified date.

Swelling around the nose and eyes to the point of my eye swelling shut. Pain in that area with a palpable lump. The swelling has lasted for the last 2 days, but it is starting to go down.

Swelling, cramping, redness, pain, and warmth in left leg. He went to Urgent Care. The ultra sound lady said she saw a small clot. The PA he saw reported the radiologist did not diagnose a clot. The PA cautioned from prescribing any blood thinners for fear of interacting with DM medications (metformin and lisinopril).

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.

Lump on left side of face near ear, Lump on left cheek, Lump on left side of neck, lump on right side of neck Dizziness and Lightheadedness Fatigue Seen by Dr. Ultrasound of impacted areas

Significant face and neck swelling; Significant face and neck swelling; redness 20 minutes after injection; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 59267-1000-01), via an unspecified route administration in the left arm on 12Mar2021 at 17:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included mild hypertension. Concomitant medications were not reported. The patient was allergic to bee stings. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced face swelling, neck swelling and redness on 12Mar2021 at 17:35. It was reported that events were not anaphylactic and the condition peaked within 1 hour, returned to normal within 4 hours. The reported events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the face swelling, neck swelling and redness was recovered on 12Mar2021. No follow-up attempts are needed. No further information is expected.

swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; Racing heartbeat; I have degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared; This is a spontaneous report from a contactable consumer, reporting for himself. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 01Mar2021 11:15AM (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. Relevant medical history included asthma, arthritis, degenerative disc disease and type 2 diabetes. The patient had latex allergy. He did not have COVID prior to vaccination. Concomitant medications were not reported. About 30 minutes after injection, the patient started to get some swelling and numbness in face and lips, racing heartbeat. Breathing was normal. As of 05Mar2021 he was still having these symptoms. On a positive note the patient had degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared. No treatment was received. The patient was not tested for COVID after vaccination. The events were non-serious and not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

herpes; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as single for COVID-19 immunization. The patient's medical history included developed herpes in 1978 although patient had developed resistance thru out the years and outbreaks were once in a while and basically mild after the shot outbreaks have been constant almost like patient body's attention has been diverted to fight this virus. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 15:00 the patient experienced herpes. The event was reported as non-serious. The outcome of the event was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Did well with first shot. Second shot was okay, pain and tenderness in shoulder. Did not worry about it at first, figured it was vaccine related. 2 weeks later i was still having issues, noted weakness when reaching up and out to pick up things. Got to point I was reaching across body with right arm/hand. 2+ months later still having issues reaching for medicine in medicine cabinet, keys in closet, soap dispenser at work. Got to point i was dropping things. Thinking i somehow unknowingly injured myself and needing to get better quickly (ice, heat, Tylenol, limited use was not working), went to orthopedic 7/19/21.

tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.

tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shivering. Throat and back of tongue started to feel swollen. Started on a benedryl drip and in about 20 minutes I started feeling better, chills stopped, throat improved. After 45min to an hour I went home. Received shot around 10am, symptoms started about 20min later. Received treatment 15 min after reporting symptoms. Took benydryl at 5pm, 9pm, 2am. Took tylenol at 5pm. Jan 6 woke up felling like a fever and minor tingling in mouth and lips. took benedryl at 7am. Slept through the night without symptoms. Taking a 25mg bendryl every 5 hours and ibprofen/tylenol alternating every 6 hours.

Swelling in axilla on same side as vaccine. Vaccine given in deltoid. Swelling in axilla. Does not appear to be infectious; no redness, no temperature. No parasthesia to hand. Parasthesia to site only. Started the day after the vaccination, which was

Chills; body aches; Massive right axillary adenopathy (10cm); headache; This is a spontaneous report from a contactable physician reporting for himself. A 62-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in the right arm, on 07Jan2021 at 04:00 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Previously, on 21Dec2020 at 05:00 PM, the patient received the 1st dose of bnt162b2, intramuscular in right arm. The patient experienced chills, body aches, massive right axillary adenopathy (10cm), headache all on 08Jan2021 at 04:00 AM with outcome of recovering. The events required physician office visit. The patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.

On January 18, 2021, I experienced extreme weakness of both legs to the extent that I was unable to stand. I experienced an exacerbation of baseline numbness over many areas of my body. I had an elevated resting heart rate of over 108 bpm. I was transported by ambulance to that afternoon. I was admitted in the early morning hours of January 19, 2021. I was diagnosed with, "Exacerbation of multiple sclerosis; SIRS (systematic inflammatory response syndrome). I was given multiple intravenous antibiotics. I had a CAT scan. I had a chest x-ray. I had many blood tests. The adverse event resolved on its own. I was discharged January 16, 2021.

I got the pfizer covid vaccine on 1/18/21 my initial reactions were slight soreness at injection site and a mild headache for 2 days. I took some ibuprofen for the headache. Prior to the vaccination I have not been ill. When I woke up on Sunday morning , 6 days after my initial injection I have a swollen gland on the left side of my neck about 2 " directly below my ear lobe. The swollen gland is mildly sore. Initially i think the size was about 1.75" by 3/4 ". Now on day 4 after it first presented itself the swelling is slowly going down to about 1"x 1/2 ".

Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5             Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.

woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events. The outcome of the events was recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Slight lump in throat, of the kind experienced with previous anaphylaxis episodes, that developed a couple of hours after vaccination, and is continuing.

Left side of face pain and swelling, under jaw and ear pain, tongue pain. Difficulty swallowing and speaking. This continues after four days!

Significant (2X normal) swelling in two fingers on right hand with dark red/blue areas 1-1.5cm in diameter.

Second COVID vaccine received 01/06/21. Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea. Duration 8 hours, clinical dehydration, missed one night ED shift(HCP). 5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21. Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional. 02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo. 03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis. Continue high dose aspirin, colchicine, metoprolol, flecanide. Have not returned to work.

Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body

itching nose and had some swelling/welts nose that he could not see but he could feel. Itchy inflamed and swollen left arm distally 3 days after vaccine had some swelling and itching more proximally on left arm 4 days after had itching and welt right side of jaw. No shortness of breath No tingling of lips or tongue No fevers.

Hives on the head, neck, torso, extremities, 2 fingers left hand and palm of the right hand, there was swelling, lips, swollen jaw, swollen crotches, it is been 4 days.

Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Presented to ED where he was found to have fever to 101.3, tachycardia, tachypnea, leukocytosis to 25, and lactate 6, meeting SIRS criteria. Pt was admitted and started on Zosyn, but infectious w/u completely unremarkable (neg BCx, unremarkable CXR, normal UA, normal abdominal imaging, no elevated LFTs given h/o cholangitis). He was observed for 24h off of Zosyn and did not develop any further hemodynamic instability or recurrent fevers and rigors. His WBC improved daily 25 -- > 11.5 -- > 7.1 and lactate cleared on night of admission with fluid resuscitation.

Initial injection site swelling and pain, resolved with cold pack and movement in 2 days. Lymph node swelling in my clavicular and elbow areas with tenderness to palpation which continues through today. No treatment such a heat has reduced symptoms, although initial pain was worse.

Pt. has a swollen spot under his left arm pit the size of a small apple, and it is sore to touch, and feels like an achy muscle. This was noticeable after the second injection of the Pfizer vaccine.

leg pain, left side of his body; swelling to his left arm; swollen lymph nodes, swollen neck lyphnodes to the left side of his neck; inabilitly to move his jaw accompanied by severe pain; inabilitly to move his jaw accompanied by severe pain; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from another company (manufacturer control number: US-AMGEN-USASL2021043173), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021043173) was reported to a company on 18/MAR/2021 by a consumer from a commercial program (PSP00086) and involves a 63 year old male patient who experienced leg pain, left side of his body [PT: pain in extremity], swelling to his left arm [PT: peripheral swelling], swollen lymph nodes, swollen neck lyphnodes to the left side of his neck [PT: lymphadenopathy], inabilitly to move his jaw accompanied by severe pain [PT: jaw disorder], inabilitly to move his jaw accompanied by severe pain [PT: pain in jaw] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Reusable Autoinjector on an unknown date. On 22/FEB/2021, the patient took his previous injection to recent last dose. At that point patient's Enbrel was put on hold for getting first Covid (coronavirus disease) vaccine. On 02/MAR/2021, the patient was administered first Covid (coronavirus disease) vaccine. On 12/MAR/2021, the patient restarted Enbrel. On 13/MAR/2021, the patient woke with swollen lymph nodes, leg pain which was right below the knee and had inability to move his jaw which was accompanied by severe pain. The patient reported all the pain was located on the left side of his body. The patient also had swelling to his left arm. The patient reported that he was seen and treated in the emergency room and all reported symptoms resolved post unspecified treatment. On 18/MAR/2021, the patient developed swollen on neck lymph nodes to the left side of his neck. The outcome of the event lymphadenopathy was reported as not recovered/not resolved. The outcome of the events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were reported as recovered/resolved. The events pain in extremity, peripheral swelling, jaw disorder, pain in jaw were resolved on an unknown date in MAR/2021. Action taken with Enbrel was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. Action taken with Reusable Autoinjector was reported as unknown for the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder and pain in jaw. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Enbrel was not provided by the consumer. The causal relationship between the events pain in extremity, peripheral swelling, lymphadenopathy, jaw disorder, pain in jaw and Reusable Autoinjector was not provided by the consumer. Follow up has been requested. The reporter's assessment of the causal relationship of the events with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment. Company's Causality Assessment: The events Leg pain, Swelling arm, Lymph nodes enlarged, Jaw disorder, Pain in jaw were considered as non-serious and related to etanercept.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drugs to the reported events "leg pain, left side of his body", "swelling to his left arm", "swollen lymph nodes, swollen neck lyphnodes to the left side of his neck" and "inabilitly to move his jaw accompanied by severe pain" cannot be completely excluded based on 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Developed Angioedema/hives on leg about 60 hours after 2nd vaccine and severe Angiodema on face/lips about 85 hours after 2nd vaccine

About 10 days after the injection, I experienced severe joint swelling and pain in my shoulders, neck, wrists, hands, hips and knees. The knee and hip pain made walking difficult. My doctor ordered blood work that showed my CRP marker at 57.6 and she diagnosed polymyagia rheumatica. I am on a six day regimen of prednisone. Swelling and pain have decreased.

soreness starting 10 days later in lymph node underarm of same arm where vaccinated. Lasting at least 1 week. Doctor examined with no apparent swelling.

episodic chest pain that began this morning (4/5). Pain described as a severe, sudden, fleeting "lightening bolt" that resolved after roughly one second. Associated SOA after episode that has resolved. No radiation. Residual chest tightness after episode. No diaphoresis, N/V, calf tenderness or edema. Potential improvement after taking antihypertensive medication and aspirin.

'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

2 hours after shot, hands were itchy...Minor 6 hours after sot, no change 8 hours after shot, hands were very itchy and feet were beginning to itch. Groin are began to itch 12 hours after shot, itchiness was almost unbearable. The more I rubbed or even touched, the worse it got. Rash on inside of legs in groin area raided and itchy. Applied a topical hydrocortisone cream. Seemed to give a little relief...long enough for me to settle down and not rub. 18 hours after the shot, hands were very swollen. Could not make a half fist. Very sensitive to heat.. Continued to apply Cortizone-10 for temporary relief 21 hours after shot, went to Urgent Care. Received a shot of a steroid and a Benadryl Capsule. 25 hours after shot, hands are still swollen. Developed red blotches on the palms of my hands, Some are perfectly cylindrical about 1 CM in diameter. Groin area still blotchy and raised. Does not itch as much as hands. Waiting for relief......

5-6 inch oval rash around injection site and some additional spots on left side of chest and back. Treated with 2 Benadryl tablets every four hours, four times a day for 3 days. Receded starting after 3-4, by day 8 still visible but nearly gone. Inflammation of lymph nodes under left armpit. Started on 3rd dat post-vaccine and lasted for 36-48 hours

Patient was given covid shot at 3:15 about 10 mins later he started having extreme edema and swelling only on his hands. no signs of hives, and only on hands. Patient reported no shortness of breath. edema 2+. Patient was immediately given benadryl 50 mg and water. Nurse assessed vitals (below). Patient said he's never had this type of reaction to any shot before. Patient was observed for 30 additinoal minutes and the swelling had marked improvement on hands. Patient left with no lasting problems.

Lymph node started swelling Saturday night at 9:00 pm and went to urgent care at 8:00 am Sunday morning. Doctor said swelling is normal but mine appeared to be larger than others. Prescription for Ibuprofen and keep warm damp cloth on it.

Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15. Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.

Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temperature/redness extending from axilla into Right pectoral region with pain/discomfort also. Performed gentle lymph drainage massage to Right trunk/shoulder regions and added Lymph Tone II homeopathic drops 3 times daily, with resulting dissipation of fluid in the pec region and decreased soreness.

Got vaccine 4/10/2021 4 days later started having left lower extremity swelling, on 4/22/2021 was diagnosed with DVT

The first Pfizer shot was on 4-1-21, and I had no reactions to that. The second Pfizer shot was on 4-22-21, and a few hours after, I started feeling soreness in my arms, shoulder, neck, armpits and had chills (although no fever). Throughout the next couple of days, the chills and body aches went diminished and/or went away--except for my left armpit. My left armpit is still sore and it is swollen (now at 52 hours).

On Friday night I noticed my knees were itching terribly. After about an hour, I noticed little swellings all over my body. Taking 2 Benadryl eliminated the itchiness within 45 minutes. After 48 hours, the itchiness still continues, and the Benadryl continues to eliminate the itching.

Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise

Fever (101.2), chills, malaise, muscle ache, headache lasting over 24 hours no appetite swollen lymph glands in armpits lasting 48 hours +

This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported. The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021. No follow-up attempts are needed. No further information is expected.

Hospitalization, on ECMO, deteriorating lung function - now on lung transplant list, hx. sarcoidosis. Question of whether vaccination caused worsening of lung function / sarcoidosis. Still currently hospitalized. Transferred to our organization for ECMO. Hospital Course: Patient is 62y.o. male with PMH of Sarcoidosis who presented to the hospital with worsening shortness of breath. Over the past 2 weeks, patient has had worsening shortness of breath on exertion and also while talking. On 4/23, patient noted intermittent fever, TMax 102F. Patient was seen by his PCP on 4/25 and started on a zpack, and was also seen in our ED on 4/25. He was discharged home with OP pulm follow up. Since then, patient has been feeling progressively worse, He noted 4/27, that his pulse ox was in the 70s with ambulation and that the cough and shortness of breath were worsening. In ER, patient has been placed on 6 L of oxygen via nasal cannula. He was also febrile with TMax of 101.5 F. POC COVID-19 testing was negative. WBC was slightly elevated at 10.7, Na level was noted to be 129. PCT was negative. CTA PE protocol was negative for PE, there was significant interval progression of nodular and consolidative opacities throughout both lungs when compared to 2017, compatible with interval progression of sarcoidosis. Patient was admitted for further workup and management. Patient's oxygen requirements gradually increased. He was initially treated with IV antibiotics and antifungals. He underwent extensive testing, including urine histoplasma, cryptococcal, respiratory viral panel which will negative. TB QuantiFERON was indeterminate, along with elevated IgM mycoplasma for which he received azithromycin. Patient was also placed on IV Solu-Medrol initially, transitioned to IV Decadron. Inflammatory markers were elevated. D-dimer was noted to be greater than 10,000, he was placed on therapeutic Lovenox dosing. Patient did have Covid testing which was negative, he was also vaccinated. His oxygen requirements continue to increase, he was eventually placed on BiPAP, although due to lethargy and increased work of breathing patient was eventually intubated and sedated. He was also started on paralytics. Patient was transferred to another hospital for possible need of ECMO or lung transplantation.

Anemia, Elevated Ferritin, Inflammatory markers, Transaminitis, Splenomegaly, Lymphadenopathy, HLH syndrome

Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae. Follow attempts are needed. Further information is expected.

5/11/2021 DEVELOPED WHAT HE DESCRIBED AS RED BLOTCHES THAT BECOME MORE PRONOUNCED ON HIS CHEST. HE APPLIED BENADRYL TOPICALLY. ON 5/20/2021, AGAIN DEVELOPED BLOTCHES ON HIS THIGHS AND ALSO STATED THAT THE RIGHT SIDE OF THIS FACE WAS SWOLLEN & FELT LIKE HIS LIPS WERE BRUISED. HE FILLED OUT A VAERS REPORT 525166 ON HIS OWN ON 5/20/2021.

3/26/21 After Pfizer vaccine noticing hives on chest and left arm as well as facial tingling and slightly left eye itchiness. Received 2 dose of Epinephrine during ED visit. 5/13/21 After Janssen vaccine he received at this morning around 8:10 AM. After that he had almost the exact same symptoms with a shooting pain in the left arm and neck some left hand tingling and swelling to the point where he can't get his wedding ring off and a sensation of pressure/tingling/fullness in the left side. Given Benadryl and steroids, initially there is no airway concerns or compromise. However after a period of time, he thought his voice was different. He did sound just slightly raspy, though I did question whether this could be related to dryness from the Benadryl. Regardless given that he did note a change, we opted to go ahead and give a dose of epinephrine, which did resolve his symptoms

GBS. Sensory issues, numb feet, can?t walk. Received 5 Ivig treatments in the hospital in a step down unit

Since 5/10/21 (through today 5/29), Left Shoulder / Arm soreness and swelling especially in left elbow which spread to lower left leg especially in left knee.

Patient presented to the ED and was subsequently hospitalized for severe sepsis with septic shock on 5/10/2021; this is within 6 weeks of receiving COVID vaccination.

Swollen lymph nodes at jaws; rash on stomach; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 12Mar2021 11:00 AM (at the age of 62-years-old) as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 13Mar2021 13:00 PM, the patient experienced swollen lymph nodes at jaws and rash on stomach. It was unknown if treatment was received for the events. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The outcome of the events was not recovered. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.

2 months later I had two insect bites and the second day I had a severe case of hives (I have never had hives before). This lead to anaphylactic shock resulting in low blood pressure and passing out. EMTs administered saline/epinephrine/steroid. Currently Doing follow up for allergies. Stopped taking lisinopril.

Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative

Painful lymph node left armpit; Swollen, painful lymph node left armpit; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, moderate sleep apnoea and seasonal pollen allergies. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam 15mg (MANUFACTURER UNKNOWN) and pravastatin 50mg (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 62-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. On 25Mar2021 at 21:00, the patient had swollen, painful lymph node left armpit and this had persisted longer than other symptoms. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events swollen, painful lymph node left armpit. The clinical outcomes of the events swollen, painful lymph node left armpit were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.

Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up. I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist. The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping

MUSCULAR MILD ACHES GRADUALLY DEVELOPED TO STRONG ACHES TO PAIN AND MUSCLE TIGHTNESS BY 3 HRS OF SYMPTOMS ONSET.(ARMS AND THIGHS). TENDERNESS AT LYMPH NODE AREAS OF AXILLA AND GROIN. LIGHT SWEATING W/O FEVER BY 8 HRS OF SYMP ONSET. GENERALIZED MALAISE AND TIREDNESS FOR 15 HRS FROM SYMPS ONSET. TOOK TYLENOL 650 MG PO., Q 4HRS WITH IBUPROFEN 800 MG

One week after the vaccine his left great toe and foot became red, warm and swollen. He had difficulty walking for several days and is still experiencing swelling. He has been using ice, elevation and Motrin.

Fever, soreness at site of vaccine and headache were only present early on and resolved in 48 hours of the vaccine. Then after a few days, these symptoms started (below): PAIN in every joint, large and small, including vertebral spine, shoulders, hips, knees, elbows, hands and feet, fingers and toes, as well as costochondral joints in the ribs; SWELLING and REDNESS in many joints including most of right foot, some of left foot, knees, hips and sacroiliac joints. On and off headache. Slight reduction, but still present after 3 weeks.

It felt like there was water in the ear; The right cheek was swollen; lymph nodes were swollen; He felt a pressure in the right ear; It impaired his hearing due to the pressure/trouble hearing; The face felt achy with hives; The face felt achy with hives; This is a spontaneous report from a contactable pharmacist (patient's wife). A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL9262), via an unspecified route of administration injection in the left upper arm on at a single dose on 21Jan2021,10:00 for covid-19 immunization. Relevant medical history included blood pressure (unspecified), diabetes, stomach acidity, lipid lowering all from an unknown date and unknown if ongoing. Ongoing concomitant medications included irbesartan blood pressure, metformin for diabetes, famotidine for stomach acidity, atorvastatin for lipid lowering colecalciferol (vitamin D) for unknown indication. The patient experienced lymph nodes were swollen, felt a pressure in the right ear, felt like there was water in the ear, right cheek was swollen on 21Jan2021 17:00; impaired hearing due to the pressure/trouble hearing, face felt achy with hives on 21Jan2021. The events were mild, thought it would go away by itself. The events did not require a visit to emergency room and physician's office. It was further reported that around 5-6 hours after getting the vaccine, in the evening, he started to have the lymph nodes on the right side of his face swelling. Along with that he had trouble hearing. It was like swimming and lots of water got in the ear and that water could not come out. He also had hives. He had hives under his eye. It was like on his cheek between his eye. It was red and about the size if a finger nail. She would like to speak to someone about him taking the second dose. She wanted to know if there was any concern in him getting the second dose. The issues with trouble hearing is getting better, he is almost back to normal. When he touches his ear it still feels sensitive. The hives is still there, but it is like paler, but still there. It is like weaker at this point . Outcome of the event lymph nodes were swollen, impaired hearing due to the pressure/trouble hearing, face felt achy with hives was recovering, while unknown outcome for the event pressure in the right ear, felt like there was water in the ear, right cheek was swollen was unknown.

fever, chills, mouth swelling on my right side of my face around my ear and jaw and temple and it is painful, with meds it was 100.7 and with out its 101.0

Day three mild swollen tongue that lasted 5 hours, day five mild swollen upper right lip that lasted 5 hours, day six moderate swollen left face/cheek that lasted 24 hours, day seven swollen left hand/wrist that was extremely itchy that lasted 24 hours and counting.

Shortness of breath - Initial ED Comments: Patient is a 63 y.o. male patient presenting to the ED via EMS with c/o shortness of breathin which began this morning. EMS reports that the pt had a bilateral lung transplant 1 year ago and has been on cyclosporine and cellcept. EMS also reports that the pt recently received his COVID vaccine. Pt denies fever, chills, chest pain, abdominal pain, back pain, nausea, vomiting, or lower extremity edema. EMS reports that the pt does not normally require supplemental O2 but states that his O2 sat was 75% on 3 L NC home O2. EMS reports that they gave 2 albuterol, 1 Atrovent, and solumedrol. EMS also reports that they placed the pt on 10-15 L NRB and states that his O2 sat was stable at 100%. Pt denies any aggravating factors for his symptoms

States two days prior to vaccine he first noticed a fever blister. Reports since receiving first vaccine dose last Friday (2/26/21) he has not been feeling well, notes swollen eyes (lid overlap eyelashes), eyes wet/watery constant, swollen throat, face swelling, and fatigue. Reports this has improved somewhat. Denies any pain/injection site reaction from vaccine.

left leg swelling on quad, unable to move with out pain. When i first got it, it felt like a cramp while in bed. I have gotten them before but nothing like this. Left leg is swollen. I thought that after one or two days it would go away but nothing and it has not improved.

Approximately 32 hours after vaccination a rash (purpura) with Urticaria appeared on upper side of left forearm to wrist. Took Benadryl, used Hydrocortisone cream and Calamine lotion. At the time of this report (5th day after vaccine) the rise and itch have substantially subsided for the 1st time. The purpura is starting to burst and leak clear fluid. Estimate 50% improvement from 12 hours ago.

After the injection my left arm was sore so I took Tylenol for the soreness. The soreness never went away but became worse on March 11, 2021, My wife noticed my arm was swollen down to my left hand. I called pharmacy and they instructed him to take Tylenol and use ice packs. If the swelling is not down by noon tomorrow, go to clinic or emergency room.

I started to develop a headache and became a little nauseous right after. After two days, my fingers started swelling and hurting. I couldn't make a fist. It caused my immune system to go crazy. That lasted about 5 days. After taking Aleve and Tylenol, it helped reduce the pain. My kidney doctor told me to stop taking Aleve because it was interacting with my BP meds. The doctor from Northwest Arthritis prescribed Tramadol to help with pain. I still have pain, but it's tolerable.

Swollen lymph node in neck (left side). No treatment given. Lymph node swelling resolved 16Mar2021. Extreme fatigue - start 16Mar2021 - on going as of this report. No treatment given.

Guillain-Barre Syndrome- prosimal upper limb malgias, followed by progressive 4-limb (prox>distal) weakness, hand paresthesias, bifacial weakness, areflexia, over 4-5 days. Course complicated by SIADH and hyponatremia. Currently treating with plasmapheresis.

Neck, shoulder, arm, trunk pain. chills. neck and axilla adenopathy. possibly related to using NSAIDS around vaccination

Woke up on Sunday 3/28/2021 with a sore neck and back of the head, sore arm, underarm, and shoulder. At first, I thought I had just slept wrong but the symptoms did not decrease for a couple of days. On Tuesday 3/30/2021 I began taking a stress dose of Hydrocortisone (I have Adrenal Insufficiency due to surgery to remove a Pituitary Tumor). I contacted my Primary Care the next day, by phone and after discussing my symptoms he diagnosed me with lymphadenopathy. I continued the stress dose until Saturday 4/3/2021 when I began to taper off. Symptoms are considerably decreased but not completely gone, nevertheless I intend to get the second dose on Tuesday 4/6/2021 based on my discussions with my PC.

1. Peripheral neuropathy in arms and legs, no treatment, perceived same day as getting the vaccine, symptoms continue. 2. Arthritis in neck, shoulders and hips, no treatment other than ibuprofen , perceived same day as getting vaccine, symptoms continue. 3. Metallic taste on tongue and tingling of tongue, no treatment, perceived same day as getting vaccine, symptoms seemed to have subsided. 4. Stomach muscle fatigue, no treatment, perceived same day as getting vaccine, symptoms including burning sensation continue. 5. Itchy head, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 6. Stuffy head - unable to clear ears, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 7. Generalized sore muscles, no treatment, perceived on same day as getting vaccine, symptoms continue. 8. Generalized aching joints, no treatment, perceived on same day as getting vaccine, symptoms continue. 9. Enlarged or swollen lymph nodes, no treatment, perceived a few days after getting vaccine, symptoms have lessened over time. 10. Testicular pain, ice pack as needed, perceived a few days after getting vaccine, symptoms continue.

severe chest pain and left shoulder down to hand and neck; severe chest pain and left shoulder down to hand and neck; internal swelling; Feeling discomfort; unable to perform daily activities; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration, administered in arm right on 30Mar2021 13:00 (at the age of 63-years-old) as a single dose for covid-19 immunization. The vaccine was administered. The patient medical history included diabetic and blood pressure. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), administered in arm left on 09Mar2021 11:30 PM (at the age of 63-years-old) for covid-19 immunization and had left shoulder joint pain for about 10 days. 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. The patient's concomitant medications were not reported. It was reported that after the second dose, on the second day (reported on 02Apr2021 at 06:00 AM) had to go to emergency hospital due to severe chest pain and left shoulder down to hand and neck. Developed internal swelling 10 times more than normal. Feeling discomfort and unable to perform daily activities. The events resulted in Emergency room/department or urgent care, Hospitalization for 1 day. No treatment was received for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

On 4/4/21- 4/7/21 I had swollen lymph nodes in the left armpit and left chest. On 4/9/21 I woke up with swollen groin lymph nodes and a fever of 100.7. Fever spiked to 102. On 4/10/21 I went to the urgent care and was told to take Tylenol to control the fever. That night the fever spiked to 103.4. On 4/11/21 went back to the urgent care. They took a urine sample and chest x ray. (said all was normal). They said to continue with the Tylenol. Fever spiked that night to 103.4. On 4/12/21 - fever spiked to 103.4. Got a comprehensive blood test

Approx time frames: 3/10-3/17- soreness and lesions on toes, both feet 3/15-4/1- Purple flushing of toes, numbness, pins and needles 3/20-4/20- Extreme coldness of feet., so much so that it was waking me up at night. 3/22- podiatrist visit- diagnosis chilblains. Prescribed nitro-gel and 325mg aspirin 1x/day for one month took nitro-gel one night- very bad headache, continued aspirin 3/25- took warm bath, felt turbulence in blood vessels of ankle area, toes flushing purple and white. Seemed to improve condition somewhat. 3/29- Second Pfizer 4/4- 4/15- hives and itching all over body 4/12- 4/20 Edema on feet and ankles

he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently. He does not know if it just the progression of the pain or if it is coming from the injection. The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe. He added that he has had nausea with the cancer, so this nausea would be very light. But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works. The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this. He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice. He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

his eyes and feet are really swollen; his eyes and feet are really swollen; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 06Apr2021 at 09:05 (Lot Number: EW0150; Expiration Date: 31Jul2021), at the age of 63 years, as a single dose for COVID-19 immunization. Medical history included cerebrovascular accident, diabetes mellitus since 2008, hypertension since 2008, both ongoing. Concomitant medications taken within two weeks of vaccination included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN), atorvastatin taken for blood cholesterol since 04Mar2021, carvedilol (CARVEDILOL ABZ) taken for blood pressure since 05Mar2021, and insulin lispro; all ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:15, when the patient woke up he experienced his eyes and feet are really swollen. The reporter informed that when the patient woke up today his eyes were really swollen. It looked like he was stung by a bee or something. The reporter was wondering if that is a common side effect of the Pfizer vaccine. The patient had not received any treatment. The clinical outcome of the eye swelling was not recovered, and the clinical outcome of swelling of feet was unknown. No follow-up attempts are needed. No further information is expected

enlarged lymph nodes under left arm; This is a spontaneous report received from a contactable healthcare professional (patient). A 63-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration on 17Mar2021 at 09:00 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, pre-diabetes, and high BMI. Prior to the vaccine, the patient had not been diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 24Feb2021 at 09:00 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 19Mar2021, the patient experienced enlarged lymph nodes under left arm. The event was reported as non-serious. The patient was not hospitalized for the event. The patient visited a doctor or other healthcare professional office/clinic as a result of the event. The patient did not receive any treatment for the event. The outcome of enlarged lymph nodes under left arm was recovered. It was also reported since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

A large patch of redness at the injection site, getting larger, hot painful at times, I put ice on to ease the pain and swelling and redness, today I noticed just this afternoon my LEFT armpit my Lymph node is VERY LARGE and sore if you feel around it, Also last night I noticed my RIGHT lypmh node just under my RIGHT ear has popped out.

4-3-21- received my first covid 19 shot 4-10-21 went to have foot blister examined- they admitted me and started an IV of Vancomycin which sent me into anaphylaxis and this stopped my heart. I required cpr, defibrillator to get things going again. I was on life support for the better part of 4 days and then finally come back

1. Sever hemi hyperesthesia R arm/chest/back which lasted about 72 hours. 2. Edema R arm & hand which lasted about 24 hours. 3. Fatigue which lasted about 1 week. 4. Pain & weakness in R shoulder which has not resolved.

The very next day after my second dose, Left hand pointing finger, primarily joint between distal and middle phalanx became swollen and very sore. Felt like I had sprained the finger. Then, on 05/03/2021 I had a blood test for my annual exam and my ESR and CRP levels are elevated, and my hemoglobin was low.

-abnormal reaction to covid-19 vaccination, states having lip swelling, body swelling, red rash in upper extremities, itching, chest tightness that resolved at the end of the day. -had an adverse reaction to 1st covid vaccine, pfizer, had facial swelling, leg and arm swelling, resolved after 24 hours

Within 5 minutes of getting shot, my right forearm and hand tingled, turned red and started swelling. Next, I felt dizzy and light headed. A nurse then placed a BP cuff on me and measured my BP at 185/150. My oxygen level was 98. My face, neck and arms turned very red and my face - cheeks, nose and lips started to swell. They gave me apple juice and crackers. After about 45 minutes, my right arm was normal, the color in my face, neck and arms returned to normal, my BP was 150/90. My cheeks, nose and lips remained swollen. After another hour passed, I felt ok, so I left. I took Zyrtec and then Benadril, but they didn't help. My doctor prescribed prednisone but took me off of it after 3 days as it had no affect. After a week, the swelling in my cheeks and nose subsided, but as of today 5-6-21 my lips are still swollen.

Client received first vaccine on 03/13/2021. Client states woke on 03/29/2021 and noted right hand was swollen with itchy, red raised areas. Client states seen physician on 03/30/2021 and was given an antibiotic and ointment. Client received second vaccine on 04/03/2021 and when he woke on 04/04/2021 he had similar symptoms he had to his right hand to his neck, left armpit, and right calf area; symptoms consist of itchy red raised "bump" areas. Client states the "bumps" are intermittent and last approximately 3 days, but prior to the bump resolving new bump appear each day. Client states right hand symptoms resolved on 05/01/2021.

Extreme flare up of gout. The worst gout I ever experienced. I can be prone to gout so am familiar with the issue. This began immediately the following morning after the first dose and is still a problem now 3 weeks later. My entire foot, ankle and lower calf were completely swollen and the foot turned blue. Finally now 3 weeks later the swelling has reduced to the big toe but I am still limping. I was schedule for the second dose yesterday and we cancelled. I am very concerned about taking the second dose, especially since we have a wedding trip planned in early June. I can not suffer with this again during that trip and not sure if a 10% increase in immunity from Covid is worth the risk of another major gout flare up like that. Naturally I am concerned about permanent joint damage also.

Patient presented to the ED and was subsequently hospitalized for COVID-19 within 6 weeks of receiving COVID vaccination. He was in intensive care with pneumonia and severe sepsis.

Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15 (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.

First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm. My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much. Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor. Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.

it was tricking his immune system; had herpes pop out on his lip; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 15:00 as single dose for covid-19 immunisation. Medical history included herpes. Stated he had a situation in his world where he got herpes if he was in the sun or if he caught a cold and the herpes popped out on his lip. The herpes normally pops out and the Valtrex eliminated the pain because when the herpes pops out and it puts pressure on the lip it hurt a little bit and he has taken the Valtrex over the last year or so and when he has the herpes it happens a couple of times per year. There were no concomitant medications. There was no additional vaccines administered on same date. The patient received the 1st dose on 17Mar2021 10:00am and the 2nd dose was supposed to be administered on 06Apr2021 which was 21 days after the 1st dose, but the 2nd dose was administered on 14Apr2021. Both doses administered in left arm. He stated he was not out in the sun and he had the Pfizer COVID Vaccine 2nd dose and had herpes pop out on his lip and it began he thought on Saturday 17Apr2021 or 2-3 days after the 2nd dose of the shot and the herpes was ongoing and was getting better because he took generic of Valtrex. He took 1 pill per day of the generic Valtrex and it worked. He had no further treatment for the reported event and stated it took time to heal and it pops out then goes away and he was not sick the next day after the Pfizer COVID Vaccine and did not feel anything in terms of sickness and then after the 2nd dose of the vaccine, the herpes popped up a couple of days later maybe it was his body feeling the illness and it was tricking his immune system. The event did not require a visit to ER or MD office.The outcome of had herpes pop out on his lip was resolving and for the event it was tricking his immune system was unknown. No follow-up attempts are needed. No further information is expected.

scabbing; shingles; marking that showed up on the face/sore dried up on his face; allergic reaction; swelling on neck and cheek; swelling on neck and cheek; tooth ache; stuffiness in ear; pain right side of the face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in arm on 19Mar2021 10:00 (at the age of 63 years old) as 1st dose, single "to get myself vaccinated". Medical history was reported as none. There were no concomitant medications. The patient called about the COVID 19 vaccine, stated that he had side effects that he felt he needed to report and questioned if he needed to know anything before getting the second dose. He stated that he received the first dose on 19Mar2021 and on Sunday (21Mar2021) he began to have symptoms. He stated on Sunday 21Mar2021, he had swelling on his neck and cheek and stuffiness in his ear which he thought might had been a tooth ache or an allergic reaction. He stated that a few days after those symptoms developed he had pain on the right side of his face on 21Mar2021 and markings that showed up on his face on 22Mar2021. Further stated that he went to the urgent care as there was no need to go to the emergency room on 25Mar2021 and was diagnosed with shingles. He began treatment that day for shingles on his right side of his face and it was a seven day course of medication and his last treatment will be finished at the end of that day of the report. He reported that the markings were better and he did not have nerve pain and the sore dried up on his face which was consistent. He went to the doctor on 29Mar2021 just to be on the safe side and the symptoms seemed to be better. He received the next vaccine on 09Apr2021. Further stated he thought it would be good to report his symptoms and see if there was anything Pfizer could tell him. Further stated that the scabbing on unspecified date was getting better. Treatment was valacyclovir. Therapeutic measures were taken as a result of all of the events. The outcome of the event tooth ache and allergic reaction were unknown; pain right side of the face was resolved on 29Mar2021; stuffiness in ear, swelling on neck and cheek were recovered on 31Mar2021; shingles and marking that showed up on the face were recovering.

April 13 - April 14, 2021 Numbness in fingers and toes. May14, 2021 confirmed GBS (Guillain Barre syndrome) Admitted to hospital May 14, 2021 for IVIG treatment

my left top forearm started itching; purpura; Urticaria/Hives; swelling; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:30 (Batch/Lot Number: EN6200) as 1st dose, single for covid-19 immunization. The patient's medical history included peripheral arterial occlusive disease (PAD), chronic obstructive pulmonary disease (COPD), osteoarthritis (OA) and known allergies to CT contrast dye. Concomitant medications included prednisone; rivaroxaban (XARELTO); rosuvastatin calcium (CRESTOR); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Interferon, Ribavirin for 48 weeks then Inf, Riba, Telapriver for 48 weeks between 2009 and 2012 and patient had purpura. The patient previously given Hep C and had leukocytoclastic vasculitis and cryoboluenemia (sp due to Hep C). On 03Mar2021, Wednesday evening at 17:00 approximately 28 hours after vaccination, the patient's left top forearm started itching followed by purpura and urticaria. By midnight it was much worse. Patient used Benedryl itch relief spray and Boudreaux's Butt Paste till he got hydrocortisone cream, calamine lotion and Benadryl tablets in Saturday morning. It was Wednesday night and for the 1st time he was not itching. The itching was gone. The Hives (rise) was gone. The purpura was now bursting and draining clearish. The swelling was all but gone. It was reported that other than the oozing purpura, all is good now. Patient would like to know if he should get the 2nd shot, in different arm. The outcome of the event purpura was recovering and recovered on unknown date from all the other events.

Left arm was very swollen from shoulder to his neck; Stiff arm and stiff neck; headache; dizziness; muscle and joint aches; muscle and joint aches; Everything hurt; Thought he had the Flu/ flu symptoms; Couldn't lift left arm; Chills; Temperature got up to 99.2; Bed sweats; Nauseous; This is a spontaneous report from a contactable consumer. A 63-year-old male consumer (patient) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the left arm on 28Feb2021 16:30 (at the age of 63-year-old) as single dose for COVID-19 immunisation. The patient medical history included type 2 diabetic. Concomitant medications were not reported. The patient reported that he was calling to report a reaction to his first vaccine dose. He had no medical questions at this time and requested to be transferred to safety. 30 calls ahead, caller was agreeable to holding for the safety department. Got COVID-19 vaccine on Sunday afternoon 28Feb2021. Was okay after the fifteen-minute waiting period. Got home and took a nap. On 28Feb2021, the patient woke up at around 6:30 PM, he was feeling a bit nauseous. He drank ginger ale and went back to bed. On 01Mar2021 at around 01:30, he reported of everything hurt and thought he had the flu/ flu symptoms, could not lift left arm, chills, temperature got up to 99.2 and bed sweats where he had to change his bed and t-shirt twice. Never had a fever, but his temperature got up to 99.2. Last time he had the flu was 10 years ago, which was why he thought he must have the flu. Thought it was a coincidence he received his COVID-19 Vaccine and then got the flu. That morning, 02Mar2021, he felt great. On an unspecified date, he reported that his left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness, muscle and joint aches. Did not know what that was, but glad it was gone. His left arm was the injection arm. Arm was very swollen from his shoulder to neck. He felt his armpit and did not feel like his lymph nodes were swollen. Felt like a stiff neck and stiff arm. Did not have any trouble breathing. Did not have heart palpitations. No prior vaccinations within four weeks. He tested positive for COVID-19 Virus on 01Feb2021 around 4:30PM. Believes it was a PCR COVID-19 test. End of his isolation was 11Feb2021 and he tested negative. Was getting tested for a procedure that was scheduled for 03Feb2021. However, the procedure is now moved to 15Mar2021. No further details provided. Last vaccination was a Tdap and he did not have any problems with that. Tdap was forever ago and has no NDC/Lot/Exp to provide. Would like to speak to a consulting Nurse. Had first dose of covid vaccine and had bad reaction. Has surgery scheduled very close to second dose appointment of vaccine. Clarified surgery was scheduled before first dose of vaccine. Wants to know with having reaction to first dose and being close to surgery, should he get second dose. No unaddressed medical questions referred or forwarded to Medical Information. He was having surgery (hip replacement) on 29Mar2021 and was scheduled for his second Pfizer vaccine on 30Mar2021. Since he had several side effects with the first vaccine dose, he enquired that should he not get the second vaccine dose the day before his scheduled surgery. He was having a heck of a time getting scheduled for his second dose, window was supposed to be 20-25 and he was able to get it scheduled on the 28th, he had a severe reaction to the first dose, night sweats, no fever, but classic flu symptoms, lasted about 24 hours, started on 1:30am Monday morning is when he started having the symptoms. Had shot Sunday afternoon 28Feb2021. He was having a hip replacement on 29Mar2021, will it be a problem if he has another reaction, cannot cancel surgery. First surgery was cancelled because he tested positive for Covid on 01Feb2021, prior to vaccine, tested negative for covid on 11Feb2021, hip issues and surgery were scheduled prior to vaccine. Was it okay for him to get his hip surgery the day after his second dose of the vaccine. Investigation assessment was unknown. Outcome for the events left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness and muscle and joint aches were unknown. Outcome for rest of the events was resolved. Follow up (02Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics, relevant medical history and concurrent conditions, vaccine details, case narrative information. Follow-up (11Mar2021): This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported which included verbatim and event description, medical information. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included event details (no new events). No follow-up attempts are possible. No further information is expected.

Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; Sciatic pain, worsened, after second vaccine; Swelling of left foot and numbness of toes on left foot, after second vaccine; Swelling of left foot and numbness of toes on left foot, after second vaccine; Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 11:30 (Batch/Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunization. Medical history of the patient included ongoing arthritis and egg allergy. Concomitant medications were not reported. Patient did not receive any other products and doesn't get the Flu vaccine because he has an allergy to eggs. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 11:30 (Batch/Lot Number: EN6198) as 1st dose, single dose for covid-19 immunization and felt a little arthritis pain after the first vaccine.On an unspecified date in Mar2021, after the second dose at night, patient's arthritis pain was doubled and it had increased, skyrocketed, his arthritis included pain and swelling of hands, thumbs, right shoulder and knees. Patient stated that, he mentioned his increasing pain to his pain management doctor twice, and his doctor told him to call Pfizer. His sciatic pain kicked up, and clarifies as worsened, after the second vaccine. Pain went higher than an 8, sometimes from a 7 to a 9 on the pain scale. Patient experienced swelling of left foot and numbness of toes on left foot, after second vaccine and the swelling goes down, and results in numbness of patient left foot toes, swelling was off and on, and the numbness was more frequent. Reportedly, patient would normally feel the arthritis pain a day or two before bad weather, and his usual pain would elevate. The patient felt the same way after his second shot, as if it was a day or two before bad weather. He experienced this after the first and second vaccine, but worse, after the second vaccine. Patient states that he has been getting a needle, with medication, in his hand, for the pain, and it was not working. Patient could not tolerate the pain of his arthritis, and the needle, with medication, did not helped his pain. Patient states he does not know what medication he was injected with and cannot provide any specific details about this medication. Outcome of events Sciatica aggravated Numbness in toes, Swelling of feet were not resolved and outcome for rest of the events were unknown. No follow-up attempts are needed. No further information is expected.

63 y.o. man with hx of prediabetes, diverticulosis, and family hx of CAD who presented on 4/12/21 with chest pain.(Pt had first dose of Pfizer Covid Vaccine on 3/25/21, with no causative factors for Pericarditis). He developed sternal CP radiating to both shoulders while working in the garden on 4/11. The pain improved with acetaminophen and sleeping overnight, but still was present in the morning, prompting him to go to the ED. EKG showed diffuse 1-mm ST segment elevations, prompting emergent cardiac catheterization + coronary angiography --- > no obstructive CAD. cTnI and CK-MB were normal. He had WBC 14.1 & CRP 9.3, which raised suspicion for acute pericarditis, although his symptoms were not typical. Overnight 4/12-4/13, he developed new-onset rapid atrial fibrillation which was treated with IV diltiazem and metoprolol tartrate. He is discharged with colchicine and metoprolol tartrate. The CP resolved postprocedurally and did not recur.

Received second dose above on 1/8/21. Developed a blood clot in left leg early February, Went to doctor after a week or so on February 8. Bad Swelling in left calf

At 8PM the day after the shot I felt chills as if I had a fever. I went to bed and woke up at 2AM. The fever was gone but I felt a swelling in my left armpit (the arm in which I had the shot). For several days I could not raise my left arm more than half-way. On the 5th day after the shot I could raise my arm straight overhead, but it was difficult and painful. By the 8th day the arm and armpit were back to normal.

On the week of March 14, symptoms started mild and by the following week they were unbearable. On both legs, my muscles from my hips to my ankles became fatigued and got burning sensation when I was just standing up or sitting down. The pain was mostly relieved when laying down. I did not sleep well. Also, I got fevers only at night when asleep. Measured about 101 degrees temperature. Got up with tee shirt wet with sweat. On March 22, I went to my doctor and did some blood work and was told I had a lot of inflamation. Started on Prednisone. Went to RA doctor at Rheumatology on March 30, and went to an infectious disease doctor. I was told that I had an auto-immune response. I was on Prednisone from March 25 to May 16.

Injection site pain; Upper body muscle crumps/severe pain - most around neck area; Swollen lymph nodes; Headaches/ Any body movement causing head pain; neck pain/ Any body movement causing neck; Tiredness; Felling unwell; Dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. This report received from a 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 11Mar2021 (at the age of 63-years-old) at 11:30 as a single dose for COVID-19 immunisation. The medical history reported that the patient had two ablations, otherwise regular exercise, active living style. The patient had not received any medications within two weeks of vaccine. 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. The patient had not been tested positive for COVID-19 since having the vaccine. On 13Mar2021, the patient experienced vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as results of events and included the treatment with naproxen 500mg, baclofen 10mg. The clinical outcome of the events vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

- Severe lethargy - Chills - Dehydration - Limited torso flexibility - Rash - Swollen back of neck - Weight loss (20 pounds)

SHOULDER PAIN IN BOTH, GENERAL MALISE PAIN IN MY LEGS, MY HAND SWELLED UP, MY KNEE SWELLED UP. THE PAIN COMES MORE WHNE I RECLINE IN A CHAIR OR LIE IN BED FEELS LIKE THE BLOOD IS POOLING IN MY ARMS.

severe swelling in both hands; moderate joint pain; moderate muscle pain; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0259, expiration date: an unknown date in Jul2021) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included osteoarthritis. Patient did not have any allergies to food, medications or other products. Concomitant medications included sildenafil citrate (VIAGRA) 100mg from an unknown date for unknown indication, bupropion XL 400mg (MANUFACTURER UNKNOWN) from an unknown date for unknown indication, and vortioxetine hydrobromide 10 (TRINTELLIX) from an unknown date for unknown indication. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 03Apr2021, the patient experienced severe swelling in both hands, moderate joint pain, moderate muscle pain and fatigue. Therapeutic measures were taken as a result of adverse events and included treatment with Ibuprofen (MANUFACTURER UNKNOWN) 600 mg x 1 time. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe swelling in both hands, moderate joint pain, moderate muscle pain and fatigue were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

acute inflammatory demyelinating polyradiculoneuropathy (AIDP, aka Guillain-Barre Syndrome) treated with IVIG 5/14-5/17/21: sudden onset noting numbness in fingers and toes around 4/13/21 and 4/14/21 and about 10 days later saw Primary Care for evaluation, but since this time notes progression of symptoms up to knee and forearm level. He also notes loss of fine motor abilities due to reduced sensation, and also has difficulty holding a pen to write. He notes development of loss of reflexes over this time period. Notes tingling sensation in hands and feels as if walking on rocks on feet and feels as if everything is tight, also notes burning pains and discomfort even with touching keyboard. No diarrheal illness, no change to bowel habits.

Received vaccine in the morning 08:00 am, took acetaminophen 1 GM at 09:00 am due to pain in arm. By 10:30pm, I began having flu like symptoms, (aches, low grade fever, sinus symptoms) took another acetaminophen 1 GM. At 11:00 pm, developed severe rigors that lasted for approximately 2 hours. I am an RN and I have seen many cases of sepsis and felt like I was experiencing similar symptomatology. By 1:45 am, the rigors finally ceased and the body, muscle and joint pain became severe (on a pain scale of 1-10, it was an 8). At 7:00 am, I took another acetaminophen 1 GM, the body pain became much less and I was experiencing a global headache. I do not get headaches, so this was unusual. By 10:00 am, the headache was minimal, body aches were gone, only sinus symptoms persisted.

Left supraclavicular and left axillary adenopathy. CT scan of chest on 01/14/2021 supported that the lymph nodes looked reactive in nature. The patient was reassured and he is being observed with follow planned for 02/01/2021.

Report of left shoulder pain with swelling started the next day post vaccination. Treatment: Advil and ice. Outcome: No improvement with pain, ice helped with swelling. Continues to work, no interference with ADLs. Consulted his primary doctor via telemedicine.

Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: "due to sepsis (related to bed sores) and aspiration pneumonia"

Diaphoretic immediately after receiving the shot; had something to eat and drink-diabetic. Denied any SOB; reported feeling legs felt swollen.

102 fever, swollen lymph nodes underarm ( side of injection), tenderness of swollen area. Skin rash

ONSET 1 hour after injection. --Swelling of face/hands/arm/feet. Surface veins in hands were black. Tingling of tongue and throat. Severe headache. Body aches. Extreme fatigue. Pregressing over the three hour period - treated with Benedryl, caffeine, ibuprofin, bed rest for 48 hours. Symptoms cleared by 72 hours.

Swelling under left arm pit area.I received my shot in my left arm and I thought that may have caused the swelling,but the swelling is still there .

Patient called to inform me that she had a reaction to vaccine. Vaccinated on 3/5/21 with Pfizer #2. Reported arm swelling, redness below the site of administration. Reports the redness and swelling progressed and raised up to the size of an "orange" on 3/8/21. Pt sought medical treatment at local emergency room on 3/8/21 and was diagnosed with cellulitis. Rcvd ABX for treatment and pt reports treatment is responding well. Pt also reports she experienced "welts" and "redness" "rash-like" to the face and neck after vaccination.

Swollen lymph nodes left arm pit; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 15:00, in left arm, for COVID-19 immunisation. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products: no. Within 2 weeks of vaccination the patient was taking unspecified blood pressure/lipid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 at 01:00 AM the patient experienced swollen lymph nodes left arm pit. The event required a physician office visit. No treatment was received. Since the vaccination the patient had been tested for COVID-19 (nasal swab was negative on 08Feb2021). The event was reported as non-serious and was resolving.

Pt presented to the ER on 1/4 2021 with worsening sob, found to have acute ST elevation MI and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021

Anaphylaxis, dizziness, flush, itching, nausea, headache, heart racing, difficulty breathing. Gave me EpiPen. Was in ER for 4 hours after. Took antihistamine every 6 hours for 3 days.

This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown),via an unspecified route of administration on Arm Right On 02Feb2021 01:00 at single dose for COVID-19 immunization. The patient historic vaccine include second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown), via an unspecified route of administration, On Jan2021at single dose for COVID-19 immunization. concomitant medication was not reported. On 04Feb2021 patient experienced swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event recovered on 06Feb2021. On 07Feb2021 patient experienced swelling in face primarily around the eyes(ongoing), face was as red as a beet as if he had a sunburn (ongoing). Patient took treatment Benadryl. The first dose was 21 days exactly prior to the second Vaccination. Vaccination Facility Type at Hospital. The outcome of swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event was recovered on 06Feb2021 and red as a beet as if he had a sunburn, event eye swelling, erythema Recovering. Information on the lot/batch number has been requested.

Patient stated he had a red face and it was puffy about 1.5 hours after vaccination. Patient was able to take some Benadryl and 2nd doses was fine.

Got the vaccine, he was fine while he was there, the following day his arm starting itching, and then had a big rash about 3" x 3" immediately after the vaccine. The swelling did not go down, he went to see his doctor and she gave him a steroid shot and some Pepcid, Zybek OTC to take. These are still itchy as of 4/7/21, but trying to dry up and scaly. He has been putting ointment and peroxide on the area.

approximately 24 hours after the second vaccine, I noticed 3 swollen lymph nodes in left neck, same side as vaccine administered. at approximately 30 hours after the vaccine, pain became about a 4-5 on a scale of 10. not unbearable but too uncomfortable to sleep. by 4/4, approximately 6 days after the vaccine, one of the lymph nodes became large and very firm requiring a Dr. visit. My primary care physician immediately referred me who performed a needle biopsy on the reactive lymph node on 4/6. Test results show no cancer cells and determined it was most likely a benign reactive node. It is not known if this is a direct result of the vaccine.

CLIENT REPORTS THAT HE WOKE UP 4/4/21 WITH PAIN IN HIS RIGHT KNEE AND SWELLING IN HIS RIGHT CALF, WHICH HAS INCREASED FROM HIS RIGHT KNEE DOWN TO THIS DAY. HE ALSO HAS NOTICED IT IS WARM TO THE TOUCH TODAY. CLIENT CALLED HEALTH DEPT TODAY TO REPORT THIS SYMPTOMS. PUBLIC HEALTH NURSE CALLED CLIENT FOR INFORMATIION AND ADVISED HIM TO SEE A MEDICAL PROVIDER TODAY REGARDING HIS SWOLLEN AND PAINFUL R LEG/CALF. CLIENT AGREEABLE. CLIENT STATES HE HAS APPOINTMENT TODAY AT 2:45 WITH A PROVIDER.

Swollen lymph nodes under left armpit. Noticed tenderness on 4/15 and swelling on 4/16. Still swollen on 4/19 (today).

Pain in left arm (injection site), right upper arm muscle (less pain than left arm), left and right upper chest between collar bone and shoulders, chills all night with headache and tossing and turning, swollen lymph nodes behind both ears with an ear ache in right ear, profuse sweating, fever and temperature but not checked until 16 April around 9:00 AM. Read 100.4; 10:30 AM Read 100.6; continued going down from there. 17 April 7:00AM temperature read 97.1.

Per family, patient received 2nd vaccination and began experiencing swelling and shortness of breath the following day. This progressed over the course of 2 weeks until this today when he suffered a cardiopulmonary arrest and could not be resuscitated. Death resulted on April 24th 2021.

Dose #1 EN 6199 3/10/2021 Dose #2 ER 8132 3/31/2021 Acute PE/DVT on 4/6/2021 Hospitalized with leg swelling shortness of breath Diagnosed with submassive PE, right lower extremity extensive DVT Anticoagulation started subsequently discharged home

My husband who is 64 years old, was a previously in good health. Only history was mild cardiomyopathy diagnosed 12 years ago. And elevated blood pressure, which was normal with medications. He was very active, maintained a demanding full time job and was a great husband of 2 children. He received his 2nd dose of Pfizer on approximately 4/1/21. He didn?t complain of any side effect. However, on the morning of 4/27/21 he woke me up saying that he could not breath. We started driving to the hospital, however he got worse and we stopped at the fire station. They gave his oxygen and rushed him to the hospital. We came to hospital and when the fire truck was pulling in, I was told that my husband went into pulseless electrical activity. CPR was started and after approximately 5 minutes he regained pulse. He was taken to the ICU and therapeutic hypothetic protocol was completed. Since then, he is still requiring mechanical ventilation. He opens his eyes spontaneously, at times appears to obey small commands and is bedridden.

pt with 1- of dry cough followed by fever to 102 on 5/7/21. Pt was not hypoxic on home but on arrival to ER had hypoxia, requiring high flow NC. condition has not improved despite treatment for bacterial infection, PE and atypical pathogens ( possible tick bite). Admitting inflammatory CRP > 15 , Ferretin > 1100, IL6 > 50 and D dimer > 5. Pt with mild thrombbocytopenia COVID IG G pending

Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more that 18 to 20 hours after taking this vaccine. server swelling of my entire body especially inside my head and heart pains. I also, suffered from episodes of memory loss even now. Problems with my balance when walking....never ever suffered from anything like this in my entire life. this vaccine is extremely dangerous and should not be given to everyone. nearly 19 hours later my face and feet numb.

On 4/21 patient was seen at urgent care with symptoms for several days: history of fever up to 101, abdominal pain, nausea, vomiting, diarrhea and body aches, 1 week post 2nd dose of vaccine. Patient admitted to ED on 4/30 with high fever up to 104, generalized body aches and a lack of energy. Patient was diagnosed with AKI on CKD, secondary to sepsis and polycystic kidney disease, patient was given fluids and ceftriaxone. discharged 5/3

ED Discharged 4/19/2021 (2 hours) Last attending ? Treatment team Cough with exposure to COVID-19 virus +1 more Patient presents with ? Fatigue HPI: Patient presents with a 3-day history of illness, started with a cough, generalized fatigue, some nauseousness and decreased energy. He is here today with wife, over the last 2 days has not really ate or drank much, only had 1 cup of chicken noodle soup, states he has not really ate or drink anything secondary to no appetite. Denies any diarrhea. Denies history of problems with his heart or lungs such as asthma COPD smoking heart failure or heart attack. Denies any new or different swelling in his lower extremities, denies hemoptysis. Patient had a COVID-19 test at pharmacy and was told the results may take 2 to 7 days. He has received one of his Covid vaccines but not the second, he was recently at an orthopedics appointment, otherwise denies any recent known exposures or other sick individuals to his knowledge. Wife was fully vaccinated for COVID-19. He does admit to feeling more short of breath. Patient is retired Clinical Support 4/23/2021 COVID-19 Dx Medication Infusion Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 4/23/2021 ? ? Signed 12:30 pm: Patient arrived in clinic for MAB infusion, wheeled to the clinic on a wheelchair, reports generalized weakness and a cough, no SOB. VS acceptable . 12:52 pm - Commenced on MAB infusion 01:15 pm - Infusion ended successful with no adverse reactions. VS stable. Will observe for 1 hour before discharge. 02:15 pm - Patient stable post infusion. Given a pulse oximeter and shown how to use it, educated on when to seek help.Navigators to make home follow up calls.Discharged home. Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide ED Discharged 4/26/2021 (5 hours) DO Treatment team Bilateral pulmonary embolism (CMS/HCC) +6 more Patient presents with ? Shortness of Breath History of Present Illness: Patient is a 64-year-old male who presents for respiratory distress. Patient has recent history of Covid approximate 10 days ago who presents for shortness of breath. Patient says he woke up acutely short of breath with pain in the center of his chest. EMS arrived, they said patient was diaphoretic and they could not get a pulse ox. Patient's blood pressure was normotensive. Patient now continues to feel like he cannot breathe. Patient reports some mild pain in the center of his chest. Patient denies history of DVT or PE. Patient denies history of COPD or asthma but he is a former smoker. Patient said he was started to feel better from a Covid standpoint until this morning. Admission Discharged 4/26/2021 - 4/29/2021 (3 days) Last attending ? Treatment team Pulmonary embolism associated with COVID-19 (CMS/HCC) Principal problem Discharge Summary (Physician) ? ? Internal Medicine INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/29/2021 DOB: 10/28/1956 Admission Date: 4/26/2021 Length of stay: 3 Days Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pulmonary embolism associated with COVID-19 (CMS/HCC) Yes Essential hypertension Yes Other hyperlipidemia Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Graduation Infusion Date: 04/23/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

Left calf and ankle swollen after 2nd dose on 5/2, d-dimer blood test 0.54, ultrasound found a Baker's cyst. No treatment yet and left calf is still swollen after 4 weeks.

Hospitalization same day as Pfizer COVID-19 Vaccine (4/8/21) post-syncopal episode, hypotensive, CHF exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 4/11 nephrostomy tube placed. 4/20 pt stable to disch to LTAC.

Swollen glands under left arm for four days then after 6 days swelling of glands in both armpits and under jaw. Has not improved in almost 2 months.

Within 24 hours, my right foot swelled, especially the middle of the sole, but also the toes and top of the foot. After a two-week delay due to a misdiagnosis by my PCP, I was seen at an urgent care center. An ultrasound of the right leg discovered a blood clot. I was placed on Eliquis 10 mg twice a day for the next 7 days followed by 5 mg twice a day. After 7 days, the swelling was reduced by 90%. The swelling has remained at that level since then. I changed my PCP on May 21 and was cleared for most activities. She advised me to continues with the Eliquis for three months from May 3, with no need for further testing.

Swelling & rash on left side of face affecting left ear, temple, cheek, nose, left eye & upper lip. 1 week Predisone, but symptoms remained severe for at least 4 weeks. Now, 7 weeks later I still have numbness on left side of my nose with a lot of itching feeling in nostrils, temple, cheek & left eye. Still taking 3x Gabapentine 300mg, Amitriptyline 10 mg & eye drops/ointment Neomycin & Polymyxin B Sulfates & Dexamethasone Ophthalmic. I have not had my Shingles vaccine but plan on getting it in about 3 months

After my second dose, I experienced fatigue and fever but my symptoms only lasted 4 days. I now have a white mark on my skin that is inflamed, located on my left forearm radiating to my left hand. I do not know how I got it and my PCP sent me medication to my home address, where I am to take this pill orally to help decrease my inflammation. I did not have this mark before receiving my Pfizer vaccine and this is very concerning to me.

Approximately 3 1/2 weeks after vaccine- increasing neck pain on right, enlarged lymph node right axilla, then pain in wrists, right > left, painful to do pushups or turn lids, red and swollen. LN resolved with zpack. Still some pain in wrists and swelling in fingers, pain in right side neck.

Postsyncopal episode; Hypotensive; CHF exacerbation; Sepsis; pyelonephritis; E.coli bacteremia; This is a spontaneous report from a non-contactable pharmacist. A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 08Apr2021 at the age of 64-years-old (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, diabetes, coronary artery disease (CAD), heart failure with reduced ejection fraction all from an unknown date (HFrEF). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 08Apr2021, the patient experienced post-syncopal episode, hypotensive, CHF (Congestive heart failure) exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 11Apr nephrostomy tube placed. 20Apr patient stable to discharge to LTAC. The patient was hospitalized for the events from 08Apr2021 to 20Apr2021. Therapeutic measures were taken included antibiotics, fluid, cardizem, nephrostomy tube. The outcome of the events was resolved in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available clinical data, reported events were most likely intercurrent medical conditions not related to vaccination with BNT162B2. Patient's history of diabetes, atrial fibrillation and heart failure are known risk factors for the occurrence of events that patient experienced. 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.

getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.

I got the 2nd vaccine on 3/24/2021 and around 6/1/2021 I got 2 fever blisters on my bottom lip. The fever blisters lasted for 4 to 5 days then it went away.

swollen glands in arm and neck; the glands were very uncomfortable under his left arm; This is a spontaneous report from a consumer (patient) via Pfizer COVAX support. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8729 and Expire Date: unknown) via unspecified route of administration, in left (upper) arm on 07Apr2021 13:45 in the afternoon (age at vaccination: 64 years) as DOSE 2, SINGLE for Covid-19 immunisation. Patient's medical history included diabetes and immune system disorder (immune system is not the same) from an unspecified date and unknown if ongoing. Since he was diabetic so he was skeptical to get the vaccine because he knew his immune system is not the same as most people. Concomitant medications were none. Patient previously received first dose of vaccine (Lot no: ER2613, expiry date: unknow) via unspecified route of administration, in left (upper) arm on 17Mar2021, as single dose for Covid-19 Immunisation. There were no other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine. After second dose, on 08Apr2021 the patient reported he had swollen glands under his arm and neck. It was reported that when it first started swelling, it wasn't extremely painful but the glands were very uncomfortable under his left arm and then after a few days it got better but then on the 5th or 6th day all the glands got swollen. He confirmed that was still ongoing, it had pretty much been persisting the same since that 6th day after the shot. He said it had been almost 10 weeks. He went to his GP and they took one look and did a blood test and a urine test and it was all normal and because this was such a new thing no one knows what to do. Since the blood test and urine test was negative the patient was sent to the ENT and he looked at his under arm and neck and said come back in a month if he still has it, this is why he was calling because no doctor knows what to do with it. The patient underwent lab test on 30Apr2021 which included CNC, CMP and urine test, results of which were negative. The sample was collected on 30Apr2021 the report was given on 01May2021. The adverse event resulted in visit of physician's office. Patient believed that his other 2 sisters got the Pfizer shot, and they had no reactions and they also have immune compromised systems. The outcome of the events was not recovered.

Migraines; hand and feet swelling; This is a spontaneous report from a contactable consumer (patient) or other non HCP, via Medical Information Team. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENG202, Expiration date: unknown) (age at vaccination 64-years-old) dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Heart attack in 1994; kidney removed, left side in 2015; One kidney in 2015 and ongoing; Weak left side of heart. The patient's concomitant medications were not reported. On an unspecified date in May2021 Migraines, hand and feet swelling on unspecified date in 2021. thigh pain, arm pain bilaterally, shoulder pain, back pain, hand and feet swelling. They began after the first dose and have continued after the second dose. patient had a history of having a heart attack in the past and has concerns about effects on his heart later on down the line. he only have one kidney. he don't know what the vaccine is affecting. he have the one kidney and a weak left side of heart. his ejection fraction is down. Patient primary care physician and specialist have given tramadol for the pain. He had a headache and stiff neck really for no apparent reason and they continued. Then he noticed out of his peripheral vision was bad, his vision was bad. He called his primary care provider and told him about this, and he was prescribed a steroid pack and for 2 months he was provided a muscle relaxer to help. They provided some relief but didn't get rid of it. Believes the steroid was a Zpack for inflammation. Unable to provide the name of the muscle relaxer or the NDC, Lot, or expiry for either Zpack or muscle relaxer given. Eventually, they continued and after he had the visual distortion, he went to an eye doctor to make sure nothing was wrong like a tumor that was causing the headaches or stiff neck. Eye doctor told him nothing wrong with his eyes and they are fine, not tumor, he just had migraines and he never had migraines before. He saw a neurologist for the migraines and was diagnosed with migraines. On the first neurology appointment they gave him an injection in the stomach, but he does not know the name of it. The second visit was given shots in the back of head and back of neck. On that next visit he got a shot in the stomach and most of it quiet down with the migraines and the visual distortion and he still had them. Was then given a drug to take to help when they flared up, for break through migraines. It was Ubrelby 100mg. He was given the free ones and he could only take up to 10 in a month. He was given 4 of them and only had to use 2 of them and the migraines and visual distortion has gone away. Provides Ubrelby NDC , lot number 1843724 and expiry of Jul2022. He started this in Apr or in May after his first visit with neurologist, (withheld). During the same time, he had the migraines he started having pains in his upper thighs, felt like in his muscles. States imagine little bubbles like they are going to pop was how it felt. They went away and stopped. He then started to have back stuff, pains that started in Mar or Apr. They stopped after 7-8 days later and then they were gone. He was then sent to a nerve specialist and they did a conduction nerve test to see if what happened affected his nerves and the test was fine. then all of a sudden, after one thing happened and went away another one would start. Then his lower back got so painful he could hardly walk and so he went to an orthopedist thinking it could be a pinched nerve. They did x-rays but could not see anything that caused this kind of pain. They didn't give him anything, but in 7 days after that he was fine ever since, and it just went away. He also had pains in the upper arms that felt like someone was giving him shots at the same time in both arms. It was the kind that hurt and stays hurting. Felt like they didn't pull out the needle, like someone was pressing the needle in the arm, directly in the area you are getting a shot, but this feeling lasted much longer. Had this very same feeling in the top of both shoulders and they were intermittent. one minute he would have them and the next they could last about 5 minutes, or it could be gone for 5 hours and show up again in 5 minutes. It was not consistent and happen every hour. This also resolved in May along with the migraines. patient had pains at top of shoulders fell in line with his neck, where the soft spot between the collar bone is; it was like getting a shot in his arm. Again, he no longer has these. No problems with vaccines in past. Provides he had second dose on 17Mar2021 in left arm and lot number of ENG206. No further details provided. Started in the beginning of Jun probably, it's been about 2 1/2 weeks. He had not been able to use his hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. He can't grip anything. Extending from the tip of his fingers all the way up to the shoulders, in his left arm especially causes the wrist to hurt. It hurts all up to the left shoulder. In the right arm it only goes up to the bicep and these have gotten worse and are continuing to get worse. Was given Tramadol for that pain. Unable to provide NDC, Lot, or expiry from orange pharmacy Tramadol bottle. He takes 50mg, 1-2 tablets by mouth four times daily. It was prescribed 16Jun2021 and expires 16Jun2022. These pain pills help some, it takes the pain away, but does not allow him to grip with his hands or anything else. Now it may sound crazy, but when he coughed it would make him feel like the inside of his biceps were going to explode. It went away and only lasted a week. After a week this went away, but to touch it hurts after he coughed. Still had tenderness in both sides in the muscles, but at that time it felt like they were exploding outwards. Again, mentions he no longer has this. His feet are swollen up and he has never had that before now. Went back to see his heart doctor. He had gone to have a Covid test and heart test in Jan2021. With the swelling in the feet, he felt it had something to do with the heart and he went to see the Cardiologist. cardiologist asked about testing done with the primary care provider. Had ANA testing done with primary care and that test came back with no arthritis in the hands on unknown date. Mentions he had a heart attack at age 38 before he had Covid vaccine, since he is 64 now. He has not had any chest pains and didn't fall under those heart symptom questions asked. None had anything to do with his heart and the provider felt symptoms probably due to with the vaccine, but there is not enough information out there on it yet. He saw about 6 specialist and they all say the same thing. Still having feet and hands swelling. He had a heart attack in the past or how it will affect his muscles in his heart because he does not want to find out later that it had affected his heart, and nobody knew. Had MRI of the brain, blood vessels and nerves ordered by his Neurologist as well. The outcome of events was recovered

Patient recieved the first pfizer vaccine on 3/15 and tolerated without side effect. On 4/5/21 he recieved the 2nd vaccine and 72 hrs later he felt extremely weak sweaty had some nausea and then developed the swelling over the temples on 4/12 he had no visual loss he had no headaches he had no PMR type symptoms. He developed neck pain shoulder pain or hip girdle pain. He had no visual changes. he was referred to our office with a high sed rate and elevated glucose. Saw Dr 4/26/21 for initial evaluation. pt was started on prednisone, temporal swelling had already resolved.

New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thighs developed stiffness (R>L) in morning with AM stiffness for 1/2 day, and finally wore off day before second shot. Then, got 2nd shot 5/17/21, with fever first day, body aches starting the next day. After few days, felt better. However, Friday morning 5/21 woke up with pain in biceps, triceps, could not abduct arms above 7 o'clock position due to severe pain -- bedridden 4 days, felt like someone beat him up or got hit by a car, then improved sligthtly. 1 week later, developed stiffness in low back, hips, and thighs. Also with night sweats few nights.

First dose on January 14, 2021 - No adverse events. Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening. I was in the waiting room for observation. Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction. She had to hold me under my arm to help me walk back to the nurses who gave the vaccines. When I arrived, my vision got black and I passed out. I passed out from the reaction to the vaccine. I have a history of Anaphylaxis, I carried episode pens for years. I forgot my episode pens that evening but I carried my own benadryl. I stopped the reaction by drinking liquid Benadryl. I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl. My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.

hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; not been able to use hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. can't grip anything; not been able to use his hands; wrist to hurt; peripheral vision bad, his vision was bad; visual distortion; peripheral vision bad, his vision was bad; visual distortion; given a drug to take when they flared up (migraines); pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything was worsened; hardly walk/ lower back got so painful; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG206), via an unspecified route of administration in right arm, on 17Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. Medical history included heart attack from 1994, left side kidney removed in 2015 and single functional kidney on right side from 2015. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG202), via an unspecified route of administration in right arm, on 24Feb2021 at 13:00 as dose 1, single for COVID-19 immunization and experienced headache, stiff neck, peripheral vision was bad, migraine and swelling of hand and feet. The patient previously took (UBRELVY) for migraine and visual distortion. The patient had a headache and stiff neck really for no apparent reason and they continued. Then he noticed that his peripheral vision and vision was bad with visual distortion in Mar2021. He called his primary care provider and told him about this, and he was prescribed a steroid pack and for 2 months he was provided a muscle relaxer to help. They provided some relief but didn't get rid of it. Believes the steroid was a Zpack for inflammation and was unable to provide the name of the muscle relaxer or the NDC, Lot, or expiry for either Zpack or muscle relaxer given. Eventually, they continued and after he had the visual distortion, he went to an eye doctor to make sure nothing was wrong like a tumor that was causing the headaches or stiff neck. Eye doctor told him nothing wrong with his eyes and they were fine, not tumor, he just had migraines and he never had migraines before. He saw a neurologist and was diagnosed with migraines. On the first neurology appointment, they gave him an injection in the stomach, but he does not know the name of it. The second visit was given shots in the back of head and back of neck. On that next visit, he got a shot in the stomach and most of it was quiet down with the migraines and the visual distortion and he still had them. The patient was then given a drug to take to help when they flared up, for break through migraines in 2021. It was 100mg. He was given the free ones and he could only take up to 10 in a month. He was given 4 of them and only had to use 2 of them and the migraines and visual distortion has gone away. Provides NDC, lot number 1843724 and expiry of Jul2022. He started this in Apr2021 or in May2021 after his first visit with neurologist, (withheld). During the same time, he had the migraines and also started having pains in his upper thighs, felt like in his muscles. States imagine little bubbles like they are going to pop was how it felt in 2021. They went away and stopped. He then started to have back stuff, pains that started in Mar2021 or Apr2021. They stopped after 7-8 days later and then they were gone. He was then sent to a nerve specialist and they did a conduction nerve test to see if what happened affected his nerves and the test was fine. Then all of a sudden, after one thing happened and went away another one would start and then his lower back got so painful so that he could hardly walk and went to an orthopedist thinking it could be a pinched nerve in 2021. They did x-rays but could not see anything that caused this kind of pain. They didn't give him anything, but 7 days after that he was fine ever since, and it just went away. He also had pains in the upper arms that felt like someone was giving him shots at the same time in both arms and also a kind that hurts and stays hurting. Felt like they didn't pull out the needle, like someone was pressing the needle in the arm, directly in the area you are getting a shot, but this feeling lasted much longer. Had this very same feeling in the top of both shoulders and they were intermittent. One minute he would have them and the next they could last about 5 minutes, or it could be gone for 5 hours and show up again in 5 minutes. It was not consistent and happen every hour. This also resolved in May2021 along with the migraines. Patient had pains at top of shoulders fell in line with his neck, where the soft spot between the collar bone is which was like getting a shot in his arm. Again, he no longer has these symptoms and no problems with vaccines in the past. Provides he had second dose on 17Mar2021 in left arm and lot number of ENG206. No further details provided. Started in the beginning of Jun probably, it's been about two and half weeks. He had not been able to use his hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. He can't grip anything in Jun2021 and also got worsened in 2021. Extending from the tip of his fingers all the way up to the shoulders, in his left arm especially causes the wrist to hurt in Jun2021. It hurts all up to the left shoulder. In the right arm it only goes up to the bicep and these have gotten worse and are continuing to get worse. The patient was given tramadol for that pain and unable to provide NDC, Lot, or expiry from orange pharmacy for tramadol bottle. He takes 50mg, 1-2 tablets by mouth four times daily. It was prescribed 16Jun2021 and expires 16Jun2022. These pain pills help some, it takes the pain away, but does not allow him to grip with his hands or anything else. Now it may sound crazy, but when he coughed it would make him feel like the inside of his biceps were going to explode. It went away and only lasted a week. After a week this went away, but to touch it hurts after he coughed. Still had tenderness in both sides in the muscles, but at that time it felt like they were exploding outwards. Again, mentions he no longer has this. His feet are swollen up and he has never had that before now. Went back to see his heart doctor. He had gone to have a Covid test and heart test in Jan2021. With the swelling in the feet, he felt it had something to do with the heart and he went to see the cardiologist where they asked about testing which was done by primary care provider and also had antinuclear antibody testing done with primary care and that test came back with no arthritis in the hands on an unknown date. The patient mentioned he had a heart attack at age 38 before he had COVID vaccine, since he is 64 now. He didn't have any chest pains and didn't fall under those heart symptom questions asked. None had anything to do with his heart and the provider felt symptoms probably due to with the vaccine, but there is not enough information out there on it yet. He saw about 6 specialist and they all say the same thing. The patient still had his feet and hands swelling. He had a heart attack in the past or how it will affect his muscles in his heart because he does not want to find out later that it had affected his heart, and nobody knew. The patient also had an magnetic resonance imaging (MRI) of the brain, blood vessels and nerves ordered by his Neurologist as well. The outcome of peripheral vision bad, his vision was bad; visual distortion was recovered in Mar2021; pains in upper thighs was recovered in May2021; lower back got so painful so that he could hardly walk was recovering; felt like bubbles in muscles like they pop was unknown while the other events was not recovered.

myocardial infarction; Fluid; Shortness of breath; Chest pain; This is a spontaneous report from a contactable nurse (patient's wife). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 11Jun2021 10:00 (64-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 21May2021 (64-year-old at time of vaccination) for COVID-19 immunization. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced chest pain on 17Jun2021, fluid and shortness of breath on 25Jun2021, and myocardial infarction on an unspecified date. Patient's wife (a registered nurse, recently retired) just wanted to report this. She can't say that it is the vaccine or anything. Her husband received the second COVID-19 Vaccine on 11Jun2021 and he died at the emergency room 2 weeks later of a cardiac event. She couldn't do the report online because it was making her the one she was reporting on. Chest pain: She took him to the emergency room on 25Jun2021. He had been having chest pain that he reported to her that Monday before. He told her that it actually started the Thursday before on 17Jun2021. He had some chest pain that felt a little better over the weekend, then Monday it was worse. He wasn't a complainer, but he was obviously having chest pain. He was very stubborn and so he just kind of let it progress and it got worse during the week. He wouldn't go to the doctor. She kept telling him she read about myocarditis mostly with adolescent males. She thought what if it is something like that. Time of Onset of Chest pain: He reported it on Monday that he had chest pain on Thursday. She became aware when he woke up at 06:30 on 21Jun2021 and she knew something was wrong when he went for the Ibuprofen. Fluid and shortness of breath: The day she took him to the emergency room the chest pain had worsened and he had fluid and shortness of breath. The fluid and shortness of breath started on 25Jun2021. Death: He died on 25Jun2021. The cause of death was a myocardial infarction. They didn't do an autopsy. The reason they gave for not being able to do an autopsy was they were overwhelmed with drug overdoses and homicides. Indication for COVID-19 Vaccine: He didn't want it, but he needed to go back to the office and didn't want to wear a mask. Adverse events required a visit to emergency room. Investigations: She doesn't have his medical records yet. Essentially they were recording him. She can't believe she got him in in a wheelchair. Immediately they were doing resuscitation efforts. Relevant Tests was reported as none. The outcome of myocardial infarction was fatal; outcome of other events was unknown. The patient died on 25Jun2021. No autopsy was performed. The cause of death was a myocardial infarction. Causality: the reporting nurse has no opinion. She just thinks that the patient didn't randomly die any of his other 64 years. It may be a coincidence.; Sender's Comments: The event myocardial infarction with fatal outcome is considered unrelated to suspect product (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180). The compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity may explain as alternative cause.; Reported Cause(s) of Death: Myocardial infarction

On 07/18/2021 late that night my right knee swollen rapidly, about 1:30am called EMS, Xrays indicated fluid, Blood testing said my INR 7.1, the DR took my off Warphrine and bed rest. I was in the hospital for 6 days.

Patient reported as breakthrough infection requiring hospitalization. Received dose #1 of Pfizer on 3/4/21 and dose #2 on 3/25/21. Patient hospitalized from 7/12-7/15. Below is copied from discharge summary: Pt is a 64 y/o M with pmHx of Afib on eliquis, HTN, chronic HFpEF, anxiety/depression, chronic pain who presented with c/o generalized weakness x 2 days after having an exposure to COVID-19 from a family member. He also reported fever and chills with reported temperature of 102F. He completed COVID vaccine back in March. He tried tylenol with mild improvement. He denied chest pain, cough, SOB, n/v/d, loss of smell, LE edema, orthopnea. He was found to be meeting sepsis criteria in the setting of COVID 19. CXR showed bilateral hazy pulmonary opacities and left sided pleural effusion. Initial vitals showed sinus bradycardia and home amiodarone and coreg were held. He was not requiring oxygen on admit. He was admitted for further management. Procalcitonin was elevated at 0.33 and pt was started on azithromycin and ceftriaxone for possible superimposed bacterial PNA. On 7/14, pt was found to be hypoxic and required 3L of oxygen and was started on Dexamethasone. An echo was done showing mild concentric LVH, EF 50-55%, moderately enlarged RV. He did receive a few doses of IV lasix while inpatient. His home coreg and amiodarone were resumed. He was seen by PT/OT who recommended HH services which was ordered. He was feeling well on 7/15 and back on room air. He passed a walking desaturation study. He had completed 4 days of azithromycin and ceftriaxone and was discharged with Augmentin to complete a 5 day course.

injection site pain; facial swelling; fever; joint pain; chills; aches; feeling unwell; This is a spontaneous report from a contactable physician who reported for himself. A 65-year-old male patient received the first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at left arm at 05:00 PM 02Jan2021 for Covid-19 immunization in his workplace clinic. The patient had a medical history of controlled hypertension. The patient had no known allergies to medications, food, or other products. Concomitant medications included telmisartan for blood pressure. The patient had not received other vaccines within four weeks. Commencing exactly 24 hours after vaccine received, on 03Jan2021, the patient developed facial swelling, fever chills aches joint pain feeling unwell, injection site pain lasting for 18 hours. The patient had not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All the events resolved. The patient considered that the events were non-serious. Information on batch/lot number was requested.

Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.

"pretty big" right arm swelling; flu-like symptoms the day after vaccination; vesicle formation on his one big toe; Herpes Whitlow; This is a spontaneous report from a contactable HCP reported for self. This 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations was not provided. The patient experienced reported "pretty big" right arm swelling, and flu-like symptoms the day after vaccination (10Jan2021), both of which have resolved. He is asking about the incidence of what he described as "Herpes Whitlow" vesicle formation on his one big toe. The patient stated that it could be from beginning to run after a couple week hiatus. The patient stated he had been running which he hadn't been doing for a week or two. He has reviewed the literature and can find nothing. The outcome of events swelling in the right arm, and flu-like symptoms was resolved. The outcome of other events was unknown. Information on the Lot/batch number has been requested.

Back pain in the muscle; Back was swelled up; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose (lot number: EL3249) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced back pain in the muscle and back was swelled up started yesterday 12Jan2021 in the evening. Treatment included Advil. Outcome of events was recovering.

I had an ongoing localized skin rash on left leg and right hand at time of covid vaccination. Approximately 2 day after shot I had single bumps/ rash on back of neck, arms and face. I have been treating with Zyrtec and Hydrocortisone Cream.

Pfizer-BioNTech COVID-19 Vaccine EUA Monday February 1, 2021 Injection in left shoulder was at 1 PM Monday. First noted slight pain at injection site about 12 hours after injection. Tuesday February 2, 2021 Shoulder pain at injection site increased to moderate level, slightly more than fall flu shot . Noted some body and joint aches. Wednesday February 3, 2021 First noted left lymph node under left arm (armpit area) was swollen approximately 43 hours after injection of vaccine after waking up on Wednesday morning. Shoulder pain at injection site is still considered to be moderate.

He c/o of infected tooth on 01/23/21, antibiotics began Swelling in both hand began on 01/30/21. Resident c/o of itching in arm. Antibiotics discontinued, benedryl given as needed. Symptoms resolved 02/02/21

1-7-21 - Posterior lumbar interbody fusion @ L3-4 (N/A spine lumbar) by Dr. 1-19-21 - 1st dose Pfizer Covid-19 vaccine given. 1-26-21 - Swelling of (R) calf (H/O peripheral edema) 1-29-21 - 1-31-21 - Hospitalized with DVT (R.leg) & PE (lungs bilaterally)

Severe loss of muscle strenth in waste, legs, knees, ankles......difficult to stand and walk. Severe joint pain in both knees and ankles. Extreme swelling in both ankles and feet.

Swelling, pain and weakness of left wrist and hand. I have had this to date since adverse reactions started.

Swelling and numbness in right side of face. Physician recommended icing and swelling went down after a day. Still have tingling sensation at times

Patient with ascending sensory deficits consistent with AIDP. No weakness or respiratory weakness but areflexic. PLEX started on 3/4. Sensory symptoms stable. Still inpatient

Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer vaccine on 2/26/2021. Patient is admitted for sepsis secondary left diabetic foot ulcer.

Within about 36 hours I noticed the biggest herpes outbreak I have ever experienced. I did not seek medical attention as I have been living with herpes for over 35 years. 72 hours after the herpes presented, it is quickly subsiding and should resolve in a few more days.

Swollen lymph nodes under left arm pit. Very noticeable when raising arm. Look like sunken baseball in my arm pit.

One week after getting the first Pfizer vaccine, my superficial vein thrombosis returned with a vengeance. I had gotten the vein ablation treatment several years ago for varicose veins, and the problems I had went away, but one week after the first shot, my calf muscle was swollen and felt sore and aching, and the rest of the leg was in pain, just like it was before getting the vein operation. The varicose veins returned and my leg now has prominent black and blue areas on it, like it had before my surgery. I'm returning to the vein clinic in two weeks for them to look at it. My leg still hurts. I should also add that my arm is still sore where they gave me the shot. My strength has not yet fully returned, even though I work out in the gym regularly.

Patient developed fevers the day after vaccine, arthralgias/myalgias. daily fevers persisted, and he was eventually admitted to the hospital for FUO workup. fevers finally stopped after prednisone initiated on 3/11 (3 weeks after vaccine) presumed Still's disease type phenomenon from vaccine (has high ferritin, high WBC, low albumin, mild LFTs abnl, persistent fevers), never had rash

2 days after receiving 2nd COVID 19 vaccination, woke up with pain, tenderness, and swollen left armpit. Received vaccination on left arm

areflexia throughout/decreased sensation to pinprick; B/L CN 7 weakness; areflexia throughout/decreased sensation to pinprick; Bilateral lower extremity weakness and pain/patchy weakness in RLE > LLE; Bilateral lower extremity weakness and pain; paresthesia in bilateral hands and legs; acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre syndrome); lumbar puncture showed no WBC and significantly increased protein to 107; lumbar puncture showed no WBC and significantly increased protein to 107; This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261), intramuscular on 24Jan2021 at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included 'Cryptogenic cirrhosis s/p liver tx 20Jun2020, T2DM on insulin, Factor V Leiden, CAD s/p stent x3 (2008), hyperlipidemia', NSAIDS allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, acetylsalicylic acid (ASPIRIN), bupropion hydrochloride (WELLBUTRIN), carvedilol, citalopram, ergocalciferol, insulin glargine (LANTUS), melatonin, metformin, omeprazole, senna alexandrina (SENNA). The patient previously took atorvastatin and experienced Allergies to Atorvastatin, promethazine and experienced Allergies to promethazine, tolmetin and experienced Allergies to tolmetin, INSULIN for T2DM (Type 2 diabetes mellitus). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bilateral lower extremity weakness and pain and paresthesia in bilateral hands and legs on 26Jan2021. Symptoms began two days after first dose of the Pfizer vaccine (received on 24Jan2021) and have continued to progress over the last 2.5 weeks. His neurological exam now (10Feb2021) includes areflexia throughout, patchy weakness in RLE > LLE, decreased sensation to pinprick and B/L CN 7 weakness. His lumbar puncture showed no WBC and significantly increased protein to 107 in 2021. This is all consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association in 2021. The patient underwent lab tests and procedures which included lumbar puncture: no WBC and significantly increased protein to 107 in 2021, neurological examination: areflexia throughout, patchy weakness in RLE > LLE and B/L CN 7 weakness on 10Feb2021, Rapid SARS-CoV-2 (COVID-19) by PCR Nasopharyngeal swab on M4 (NASO): negative on 06Feb2021, skin test: decreased sensation on 10Feb2021. The adverse events result in Emergency room/department or urgent care. Hospitalization for all the events. Therapeutic measures were taken as a result of events (IVIg). The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, patient developed signs and symptoms which were consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association. In addition, a contributory role of patients co-morbidities cannot be excluded. 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.

Developed Guillian Barre Syndrome with Miller Fisher variant; Bell's palsy; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received the second dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 08Jan2021 at a single dose for COVID-19 immunisation. He received the vaccine at a school/student health clinic. The patient did not have COVID prior to vaccination. He did not receive any other vaccines 4 weeks prior to receiving BNT162B2. Medical history included hypertension and hypercholesterolemia, both were from unspecified dates and ongoing. Concomitant medications included ramipril (ALTACE) for hypertension, rosuvastatin calcium (CRESTOR) for hypercholesterolemia, acetylsalicylic acid (ASPIRIN), loratadine (LORATIDINE), evolocumab (REPATHA) for hypercholesterolemia. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number was not reported), intramuscular, on 18Dec2020 for COVID-19 immunisation, at the age of 65-year-old. It was reported that patient developed Guillian Barre Syndrome with Miller Fisher variant 10 days (as reported) after receiving the 2nd dose of the COVID vaccine on 18Jan2021. He lost the ability to use his hands/legs. He received 2 g/kg of IVIG over 4 days starting on 21Jan2021. At the time of initial report (02Mar2021), he was recovering in an inpatient rehab center. The patient also experienced Bell's Palsy on 24Jan2021. The patient further reported that all started with a headache on 18Jan2021 and then he began to lose the ability to use his hands and legs. So, he visited the ER (emergency room) on 20Jan2021 and got hospitalized. On 22Jan2021, he was completely unable to walk. On 24Jan2021, he was also diagnosed with Bell's Palsy which was still ongoing at the time of report. The patient stated that he just got out of the inpatient rehab center on 03Mar2021. At the time of follow-up report (04Mar2021), he stated that he feels better but it is not recovered yet. The patient had undergone laboratory tests and procedures on 20Jan2021 which includes: Blood test: normal, Urine test: normal, CR Protein: elevated, Covid19 test: negative, CT (computer tomography) Scan: normal, MRI (magnetic resonance imaging): normal. It was reported that adverse event Guillain Barre Syndrome with Miller Fisher variant required visit to ER. The patient was hospitalized for Guillian Barre Syndrome with Miller Fisher variant from 20Jan2021 to 03Mar2021. The patient received treatment for Guillian Barre Syndrome with Miller Fisher variant, while he did not receive any treatment for Bell's palsy. Outcome of the event Guillian Barre Syndrome with Miller Fisher variant was recovering, while outcome of Bell's Palsy was not recovered. Information on batch/lot number was requested.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events Guillian Barre Syndrome with Miller Fisher variant and Bell's palsy 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.

Sore arm at injection site for a couple of days. Developed a light red rash on the shoulder of the injection site 2 days after injection. Developed a ping pong ball size swelling under the right armpit 2 days after injection. Currently at day 8 and the rash and swelling have not yet subsided. There is some tenderness of the swelling if compressed by the arm in specific motions.

After about 5 min of receiving his second Pfizer vaccine, pt suddenly developed generalized raise erythematous rash on arms legs, back . Hx: In anticipation onset of anaphylaxis, after appearance of rash on lt arm, pt put on stretcher , undressed immediately, and generalized rash noted. none pruritic. v/s and sat NORMAL. airway NORMAL. lungs clear. given pt's very concerning rash but lack of indication of impending anaphylaxis, given 50mg po benadryl. rescue called for trans and observation in ER where given 30mg prednisone po and monitored. was observed in ER and discharged after 2 hrs observation. 24 hrs later, pt continues to do well. Dx : acute allergic reaction to pfizer vaccine.

I don't know if it's related to vaccination or not, but I got an earache in left ear 3-days after vaccination. Ear and Face were swollen, warm to touch, painful and could not hear. I am still having difficulty hearing in that ear (3-25-2021), sounds like liquid in that ear. I called a tele doc service on Sunday, 02/14/2021, they prescribed Amoxicillin -Clav. Temperature and swelling went away, still having difficulty hearing in that ear.

C/O numbness and edema in both legs and inability to walk since Wednesday night. States"I'm crawling around because it feels all mushy when I try to walk" Pt states he got the 2nd Covid vaccine on Tuesday morning. States I had something like this when I took Hepatitis C medication" Pt states he had nausea and body aches on Tuesday. The patient called nurse triage 4/1/21 and was sent to the Emergency room 4/1/21 for a possible allergic reaction to the vaccine. DIAGNOSIS at time of disposition: 1. Renal insufficiency 2. Elevated liver enzymes 3. Leukocytosis, unspecified type 4. Vaccine reaction, initial encounter 5. COVID-19 ruled out by laboratory testing 1721 Arrived 1739 Sodium Chloride 200 mL/hr 1814 Complete Blood Count w/Differential 1839 COVID-19 PCR, Rapid 1913 Sodium Chloride 1000 mL 1937 Comprehensive Metabolic Panel (CMP) Lactic Acid, Blood Level Lipase, Blood Level Magnesium, Blood Level NT - Pro BNP (B Natriuretic Peptide) Blood Level 2052 Discharged

Received second COVID 19 vaccine in left arm on 03-08-2021. Woke up on 03-09-21 with pain under my left arm pit. Looked at my arm pit in the mirror. My lymph node was swollen approximately the size of a tennis ball and hanging down approximately 4" under my left arm pit. I tucked the lymph node back under my arm and squeezed my arm against my side for approximately 1 hour. The lymph node no longer hung under my arm pit. I then used ice pack and a heating pad to for the next 5 days aid in reducing the swelling. As of this date (04-02-2021) the lymph node is still slightly swollen approximately 1" to about 1 1/2". A little tender when pushing on it, but not painful. This was the only side effect I had after receiving both Pfizer Covid 19 vaccinations.

Enlarged and painful node in right neck Resolved five weeks after administration of first dose Burnt/scorched tongue sensation Some loss of smell and taste Both ongoing through administration of 2nd dose

Carpal tunnel swelling and pain in right hand (of right handed patient). Sharp pain in both hands, between ring finger and middle finger (mostly in right hand). Pain and swelling continuing to subside after second dose.

He was admitted with acute right sided pulmonary embolus and extensive left leg DVT. His vaccine second dose was mid Febrary ( I do not have the exact date). He had brief swelling in left leg a few days after vaccination that resolved. This recurred 4/3/21 and he was admitted 4/6/21.

Small red bumps on left arm the first day on Sunday the April 3rd. Then on Next day slight swollen red bumps covering chest and abdomen and right arm. Then next day after taking Benadryl more red bumps on face and neck slightly swollen. No problem breathing or other symptoms. It is the 8th of April still taking Benadryl and bumps haven?t gone away. Did call Dr. office and spoke with pharmacist. We?re told to take Benadryl. If not better by tomorrow will go to urgent Care.

He received his first COVID19 shot (Pfizer) reportedly on 3/2/21, then began a new chemotherapy regimen on 3/10/21. On 3/18, he fell to the floor and could not get up. He was admitted to the hospital for sepsis, pneumonia, and chemotherapy-induced neutropenia, treated on IV antibiotics and discharged on PO antibiotics. His home insulin was also decreased but continued to have hypoglycemic to hyperglycemic events. Insulin was decreased in clinic afterward and was compliant on antibiotics. Returned to hospital again a few days later for sepsis and pneumonia/effusion. He later went to a nursing facility / on hospice. He ultimately required supplemental oxygen and breathing increasingly became labored. Patient ultimately died on 4/9/21.

I am diagnosed with Gillian Barr Syndrome after 2 weeks of extreme pain in my hand,legs and feet. This is a rare Auto Immune Disease that was brought on after the second dose of the Pfizer vaccine.

First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks. ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.

Patient was recently hospitalized for pulmonary embolism with acute cor pulmonale. First noticed increased shortness of breath on 4/4/21 when shoveling mulch and describes feeling "more winded than usual" with physical activity. He presented to the outpatient primary care clinic on 4/6/21 for evaluation and serum labs and TTE were ordered. Labs were notable for a WBC 13.22 and Cr 0.76. TTE showed hyperdynamic LV function with EF >65% and no tricuspid regurgitation with no concern for right heart strain. A follow-up d-dimer was ordered and returned at 1661 resulting in the recommendation to present to the ED. Upon presentation to the ED, he was hemodynamically stable with an SpO2 of 97% on room air. CT Chest PE protocol was ordered and showed multiple bilateral lobar, segmental, and subsegmental PE with findings suggestive of right heart enlargement was well as areas of pulmonary hemorrhage and developing infarcts. He was given a heparin bolus and he was admitted to the Adult Hospitalist Service. The following morning, patient's hemoglobin remained stable and he continued to feel clinically well. He was transitioned from the heparin infusion to subcutaneous enoxaparin. He was discharged on 4/9/21 with a plan for self-injection of enoxaparin and close follow-up with his PCP.

65-year-old man with PMH significant for hypertension, who began to experience neck pain shortly after he had his second dose of the Pfizer COVID-19 vaccine on 4/14/2021. He reports pain started out as aching in his neck and down into his back. His pain got worse and he went to see a chiropractor the next day, where he had massage and neck manipulation which temporarily provided some relief but then the pain worsened. He was seen in ER that night for neck pain and spasms. He was treated with Valium and DC with Rx for Flexeril. He took several doses but pain persisted. This morning, he noticed tingling in bilateral hands, as well as tingling and inability to move his legs. He called EMS and was brought to ED for evaluation. Pt was evaluated by neurologist, was found to be quadriplegic. He was immediately ordered for CT head, CT cervical spine as well as MRI of cervical and thoracic spine. Imaging is notable for enlargement of the spinal cord from the C2 down to C7-T1. Felt to be likely transverse myelitis. Pt also noted to have superimposed cervical spinal stenosis, most significant at C5-6. The patient was then taken for emergency neurosurgery for a C3-C7 decompressive laminectomy, medial facetectomy on 4/16/2021. Due to lab work findings an infectious workup was completed, patient noted to have MSSA positive blood cultures, and subsequent ECHO demonstrated mild to moderate aortic valve calcification and mobile strands of the aortic cusp. Treatment was begun for endocarditis.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Pt received his 2nd covid 19 vaccination on 3/31. Presents on 4/26 with 3 days of nausea, vomiting, diarrhea, fever, chills. admitted with severe sepsis and gram negative bacteremia of unknown etiology. being treated with ivf , zosyn and supportive care

Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions. Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction

Admit 4/16. Vaccine 3/3, 3/24. Admit for sepsis, PNA, however MD states difficult to attribute it to COVID. Treated w/abx and steroids. DC'd home.

Left arm swelling with hive; Left arm swelling with hive; left hand fingers numb; Fever; headache; Right Arm tingling; This is a spontaneous report from a contactable consumer reporting for himself. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:00 (Batch/Lot Number: EL9267) at the age of 65 years as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included colectomy Colon resection 14 years ago. The patient's concomitant medications were not reported. On 11Feb2021 22:00 the patient experienced left arm swelling with hive, left hand fingers numb, fever, headache, right arm tingling all with outcome of not recovered. Therapeutic treatment: Tylenol. No follow up attempts are possible. No further information is expected.

massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes all over body and face swollen/red rashes erruptions.; face swollen/worsen with swelling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received he second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration at the age of 65-year-old at arm Left on 14Apr2021 14:30 at single dose for COVID-19 immunization. Medical history was reported as no illness ever before, Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP7534) at the age of 65-year-old at left arm on 26Mar2021 01:15 PM for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Since the vaccination, the patient hasn't been tested for COVID-19. In 8 hours of receiving vaccin second shot on Friday (as reported) red rashes all over body and face swollen on 14Apr2021. Went to Urgent care on Saturday (as reported) the hospital on Sunday (as reported) as situation worsen with swelling and massive itching and red rashes erruptions on 17Apr2021 12:00. There was resolutions till date its painfull itching sleep interrupted on 17Apr2021 12:00, over two weeks now. The patient was hospitalized for one day for events. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment (steroid intravenous then oral till date) for the adverse event. The outcome of events was not recovered.

Guillian barre Syndrome ~2 weeks following second shot of Pfizer vaccine ; ultimately resulting in intubation and invasive ventilation

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient came to pharmacy and stated that his doctor looked at his medical history and said he can get a COVID vaccine. Answered questionnaire and stated no allergies to anything. Gave pt the vaccine, and then patient told us that he had history of Guillain-Barre Syndrome. Gave patient cold water. Patient requested some table salts and 2 tabs of 25mg diphenhydramine. Patient refused Epipen and calling 911. He sat for at 45 minutes to an hour before leaving. He said he was feeling okay when leavin

Swollen painful veins in RT leg calf. Taking prescription of Eliquis. Pain has gone away. Swelling is as it was before Covid19 shot. Will continue Eliquis for 3 months.

Several days after the shot I had severe, crippling pain in both hands, wrists, shoulders, elbows, knees, upper arms that migrated from place to place. It lessened somewhat over the next couple of weeks but did not fully resolve before time for the second shot. After the second shot the symptoms came back even worse, to the point I had to seek medical care. The doctor prescribed Prednisone, which has helped some, but has not resolved symptoms. I have had increased swelling in feet and ankles, so a diuretic was prescribed. The pain has affected my ability to work, activities of daily living, ability to sleep at night because of pain. At times I need help to dress. I am in the process of being referred to a specialist. I also have fatigue and tire easily.

Swollen lymph in right neck throat; painful and difficult to swallow.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6205), via unspecified route of administration in the right arm, on 05Mar2021 at 09:00 AM, as a single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications included Ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol and vitamin B not otherwise specified (MULTIPLE VITAMINS), Saw Palmetto 320,NSK-SD™ 100 mg. The patient was allergic to Shell fish. On 06Mar2021 at 10:00 AM, the patient experienced Swollen lymph in right neck throat making it painful and difficult to swallow. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Inflammation of left calf: 5/27 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Ultrasound on June 2 for possible DVT was negative. Exam by orthopedic provider on 6/4 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 5/28 began experiencing swelling and tenderness in ankle, groin area, and testicles. Has continued to present. Ultrasounds on 6/8 confirm no clots in leg. Also confirm fluid retention in leg, groin, and testicles. Cough: Have experienced persistent slight cough from 5/28 to present. No sputum or nasal congestion. Treating with over the counter cold remedies with no change. Chest xray and CT scans on 5/8 reveal no fluid in lungs or heart Night Sweats and fever: Extensive night sweats and low grade fever 5/28,29,30,31. .Other information: Had COVID February 17- March 5 Received monoclonal antibody therapy on 2/24 ( casirivimab and imdevimab) Had recovered from Covid and was in good physical health exercising daily prior to vaccination. Had no previous injury in left calf preceding the vaccination.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient said they experienced redness, swelling, and itching of the face, specifically around the eyes, which began the same day as the COVID-19 vaccine administration. The patient said they were "OK" and did not have to go to the hospital, however, they made an appointment to follow up with their doctor.

right lower extremity swelling and redness. He had an outpatient venous duplex of his RLE done earlier in the day and was referred to the ED due to extensive DVT. Heparin Drip

Only slight injection site pain for first shot. With the 2nd shot, I had pain at injection site that radiated into my shoulder 8-15 hours after initial injection. Noticed swollen lymph glands in armpit of vaccinated arm after 24 hrs. All these particular symptoms disappeared after 36-48 hrs. Along with these symptoms I began to have very loud tinnitus which I have suffered from for years but nothing to this volume. Approximately 11 days after the 2nd dose I came home from working a short day and after a meal began to feel like my blood pressure was up because my head felt pressured and I could tell my heart was racing. Checked my blood pressure and it was at rest 140/105 w/ 96 bpm. I am not on any bp meds because I have never been prone to high blood pressure. Bp prior to this occurrence has always been in the 117-120/76-80 range with a bpm of around 64-70. Chest pain radiate from front to back to front and stayed that way until I went to emergency room 3 days later believing I may have had a heart attack. I was administered an EKG, had blood serum tests and a CT scan - all of which were normal and or showing no signs of a heart attack. I was kept overnight for observation with blood being drawn middle of the night and vitals being monitored. The morning of the next day I was administered a stress test which I apparently passed no problem.

On the same day as dose one-pain and lose of range of motion. A month later on May 5th I went to see my primary dr.-he prescribed PT and I still have the pain and lose of motion. Dr stated the condition is Subacromial Bursitis/SIRVA-Shoulder Injury related to vaccine administration.

The day after the vaccine, I had low grade fever, felt tired and unwell. On day 3, a rash (hot, red, and raised) appeared on the trunk, hips, stomach. On the right side of the body, there was a 3 inch strip of hives/rash from arm pit and collar bone area to waist, hip and pelvic area. I did take Benadryl. On 3/21/2021 at 10am, the rash increased from neck to groin, legs and arms and sprinkled on the back and across the shoulder to buttocks. I continued to take Benadryl. The hives had also spread to my face. My eyelids and cheeks were swollen. I had a fever of 101.3. I did take Tylenol for the fever. On 3/22/2021 the hives on the chest greatly improved but the hives on the back and face had worsen. I could barely open my left eye and my face was swollen. Around midnight 3/23/2021 I decided to go to the ER since my face, mouth and hands begin to swell. At the ER, the doctors said I had an allergic reaction to the vaccine and was given Prednisone and Tylenol and was discharged with a prescription for prednisone to continue. I took the prednisone and everything seem to improve. It took about 3 day for the body rash to go away. On 3/26/2021 a chicken pox like patch appeared on my face to the right of my chin. The rash looked like raised pustules. I went to the doctor on 3/27/2021 and was diagnosed with herpes and I was prescribed Valtrex. It took about a week for the herpes to go away. I have photographs of the rash if needed for more documentation.

Numbing sensation from the neck to the left pinna occurred, I could not feel my ear. It has subsided, however, numbness and tingling sensation still present in the external ear. After that, I started feeling symptoms similar to those in the disease ALS; ie, extreme fatigue, weight loss due to loss of muscle mass, especially in the legs and buttocks, muscle weakness, edema in the lower extremities and face, blurred vision, imbalance, clumsiness, and lightheadedness/dizziness.

There was no issue from the vaccination itself; sore arm, a bit tired and achy the next day only. I was stung multiple times by hornets yesterday, and the reaction to the stings was much more severe that what I have experienced in the past. My wife has also experienced the same thing with stings she has received since getting our second shot. basically swelling, redness in ~2" radius from the sting location, itchy as heck. Typically I would have ~0.3-0.5" redness radius. Took Benadryl (25mg) no other issues other than the reaction to this still is much worse than in the past, and i was wondering about the vaccine (pfizer) possibly influencing this and figured i'd report my experience.

Tingling/numbness in feet on 3/27/2021. By 3/29/2021 woke up and could not stand. Went to local ER. Transferred to other hospital that evening. Put on ventilator 3/30/2021 for 2 weeks. Diagnose Guillian Barre Syndrome. Adverse reaction to GBS treatment caused kidney failure and many complications. In ICU 2 months then dies on 05/29/2021.

65 y.o. African American male who suffered from COVID-19 PNA earlier this year, as well as MRSA endocarditis with septic brain emboli and fungal empyema. He was in rehab and presented to SMC ER with persistent cough without fever x 1 week, and associated chest pain. He states he was unable to produce sputum for some time, but he has finally been able to expectorate clear/ yellow phlegm in the last day or so. The cough disrupts his sleep. He notes pulmonary wheezing.. He smokes 2-3 cigarettes per day at this time and does not use any inhalers. He also reports persistent diarrhea and new right foot swelling which started morning of admission. Patient reported being fully vaccinated for COVID19 and was found to be positive via PCR. His CXR showed CM, central vascular congestion, RT small effusion/atelectasis, but no infiltrates and no clear pneumonia. The patient was discharged to a SNF 7/2/21.

Office of the Regulatory Authority reported to the Dept. of Health that this patient had a "sudden collapse witnessed by a friend" approximately one hour after receiving vaccine. Notified in March. At that time no VAERS reports found or noted by CDC. As of today, no VAERS received from CDC for this patient so submitting the limited information available. Final findings were released on 7/18/21 (decided on 7/16/21) were: "CAUSE A: Anaphylaxis CAUSE B: Status post COVID vaccination Should you have any questions about this case please contact Dr. Please note he is leaving state service at the end of this month."

Fall/ The second fall put him back in the hospital; He had a fever of 104; Endocarditis; got sick; sepsis; stroke; fell and broke his hip; weak; get a partial hip replacement; enlarged heart; know which bacteria caused it; his blood sugar was in the 600s; sleeping all of the time; lost his appetite; could not get out of bed; Patient was not eating or drinking; This is a spontaneous report received from a Pfizer sponsored program. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm on 14Apr2021 around 15:00 to 15:30 as dose 1, single for covid-19 immunisation. The patient's medical history included atrial fibrillation, patient was diagnosed years ago, before his stroke in 2015, a long time ago, cardiac failure congestive, aortic valve disease, cerebrovascular accident, diabetes mellitus, hypertension, last year patient had a blood infection, so he had to take four antibiotics. The patient's concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation. It was reported that patient received the first dose of the vaccine in mid-April and got sick 2 days later(18Apr2021). Patient had a fever of 104. Caller took him to the doctor and patient was diagnosed sepsis. Patient was in the hospital and was then tested for and diagnosed with Endocarditis due to the sepsis. Patient was currently in a rehab facility and was weak. The rehab facility wanted to give patient the second dose of the covid vaccine. But the rehab facility was not sure if they will get the Pfizer covid vaccine. Reporter was worried about patient getting a second dose of anything. This was not the first-time patient has had endocarditis. Patient has been diagnosed with it before. Patient has a history of congestive heart failure, a bad aortic value, past stroke, and diabetes. They do not know if patient still had endocarditis, but patient has completed the antibiotics. They are unable to test patient again for endocarditis because he is in such bad shape. Patient had one side that was weak, and then he fell and broke his hip. Patient was not a candidate for open heart surgery because of his enlarged heart. Before patient received the first dose of the covid vaccine, patient was sleeping all the time and reporter thought it was due to the sepsis. The doctor told reporter that the sepsis was there before patient got the first dose of the covid vaccine. Patient has A-Fib and takes Eliquis. It was reported that patient had a stroke while he was in the hospital. Patient fell because of the weakness from his stroke. The second fall put him back in the hospital. Patient was in poor shape; his blood sugar was in the 600s. Before patient went to the hospital, he was sleeping all of the time, and he lost his appetite. They did not know if patient still has endocarditis because he could not have the follow up procedure done because he was in bad shape. Patient had weakness and fell and broke his hip. Patient was currently in rehab for physical therapy. Reporter clarifies that she took patient to the emergency room, and then he was admitted to the hospital. Patient's fever did not start out at 100 degrees, it gradually went up to 104 degrees. By the second or third day, patient's fever got up to 104 degrees. Reporter is back to square one for help. Reporter is asking if there is anyone who would know what to do. Patient's cardiologist said for patient to get the second dose of the covid vaccine. Reporter knows that no one had that in the clinical trial. Before the covid vaccine, patient was having a crown done in his mouth. Last year patient had a blood infection, so he had to take four antibiotics. Reporter thinks they were called amoxicillin, and they were 500mg each. Patient had to take them all at once as a preventive. Patient is on a lot of things, that reporter does not even know. Patient has had a lot of things done to his heart. Patient has had to have ablations. Patient has a very bad heart. Patient has a question about herself. She had the covid vaccine and had no reactions. She is on Celebrex 200mg. Reporter stopped taking a day and a half before the covid vaccine. Reporter is asking if she could have messed herself up by taking an anti-inflammatory, and if taking Celebrex could have prevented her from getting the full effect. Prior to taking Covid vaccine her husband has had Endocarditis, congestive heart failure, bad heart valve and a stroke. 1st dose of vaccine mid-April. 2 days later had a fever of 104 and was admitted to the hospital with sepsis. The sepsis caused endocarditis again. Husband is in rehab facility, and they want him to take a second dose. Should he be getting 2nd dose of Pfizer or a different Covid vaccine. Wife wondering if husband should get 2nd dose at all. Reporter does not think that this has anything to do with the covid vaccine, since they know which bacteria caused it. Reporter thinks that maybe patient getting the first dose of the covid vaccine put patient over the edge. This is the second time that patient has had vegetation, the first time was last year. Reporter thinks that all of patient's doctors are panicking over the covid vaccine. Reporter knows that patient is in bad shape. In the clinical trial, there was nothing in there about congestive heart failure, or nothing about endocarditis. Patient may still have endocarditis. Reporter does not know what will happen to patient if he gets the second dose of the covid vaccine. Reporter states that unfortunately patient does not go to the best cardiologist. Reporter thinks that patient is so bad off, that he could be on palliative care. The only reason reporter waited so long to call Pfizer is because patient is in rehab now, and they might be getting in the Pfizer covid vaccine. They asked reporter if she wanted patient to get the second dose of the Pfizer covid vaccine. They should get them in on 16Jul2021. Reporter said yes, about a week ago, but it has been on her mind to call and ask the source. Reporter took patient to the hospital, and the doctors diagnosed him with sepsis: Patient was not willing to go to the hospital at first. Patient could not get out of bed. Patient was not eating or drinking. Reporter was trying to give him stuff. Reporter is not a scientist. An infectious disease doctor told reporter that patient already had sepsis before the covid vaccine. Patient was in terrible shape. Patient had a stroke while he was in the hospital. They figured out he had a stroke about five days after being in the hospital. After the stroke, patient had two weeks of physical therapy there. Dates of Hospitalization: He was in the hospital for a few weeks. Patient was home for two days he fell because of the weakness from his stroke. The second fall put him back in the hospital. Patient had to get a partial hip replacement. For about a week now, patient has been in rehab. Patient has A-Fib, since the stroke, he is not on Eliquis. Patient was not on Eliquis before. Patient also has hypertension, but it is under control. Therapeutic measures were taken as a result of endocarditis and fell and broke his hip. The outcome of the events was unknown.

I received the pfizer vaccine on 12/19/20 and 1/9/21. I am a physician. My only immediate reaction was some pain at the site of injection which subsided within a day. About 2 months after the vaccine I began to notice severe itching which did not respond to local steroid creams or antihistamines. At about 3 months post vaccine the pruritis became intolerable and I saw a dermatologist and later an allergist. By that time I was starting to develop bullous lesions and I was started on prednisone, which relieved the symptoms but every time I tried to come off the prednisone the itching would recur. I had a punch biopsy which diagnosed "epidermolysis bullosa acquisita. Currently I am taking prednisone 20 mg/d and dapsone 50 mg 2x per day with good results. I never had an autoimmune disease before and thing that the vaccine may heave triggered this reaction. I have had multiple vaccines in the past, including yearly flu vaccine without incident, but this was the first rna based vaccine for me, obviously.

After the first dose I had no side effects but after the second dose I had various reactions: - about thirty minutes after the shot I developed a strange sensation on the left temporal area of my head extending to behind my eye. This went away after a few hours but when it started I thought of Bell's Palsy. - Later my arm got extremely sore at the site of the injection it still hurts and in a large area of the arm 5 days later - Painful area below the left armpit and in an area about 3 inches in diameter (area of the lymph node). Still have pain although less after 4 days.

DVT and probable pulmonary embolus based on hypoxia Patient is physician who cares for patients in NH and ALF where there is documented COVID First dose COVID vaccine 12/20/20, second dose 1/10/20 Some shortness of breath developed about 1/10, not severe 1/30 Leg pain, fever to 101.6 abrupt onset extreme fatigue, ER eval 1.31 negative eval including neg rapid and PCR COVID tests Persistent sx led to repeat ER eval including LE dopper confirming occlusive femoral vein thromboxis; no hypoxia at rest but desat to 85% on exertion (climbing one flight of steps) Started anticoagulants 2/4/21 on home treatment; not working since 1/30/21

Swollen and painful lymph nodes in armpit of same arm as injection site. I also experience slight pain and tingling in same arm

The vaccine was given on 1/28/2021. The patient reported to the Medical Center ED on 2/7/2021 with complaints of worsening bilateral lower extremities pain, swelling, numbness L>R leg for about a week. He reports significant purple discoloration of his legs, "purple spots on lower legs", pain in bilateral legs worse with rest and standing still and associated DOE. Denied chest pain, abd pain, palpitations, fever, chills, NVDC, sick contacts, recent trauma/falls/injury. Denies regular use of NSAIDs, antiplatelet meds or chronic anticoagulation, clotting or bleeding disorders, history of DVT or PE. Patient was seen here by the ED staff on 2/3/2021 after a syncopal event at home where he described feeling light

Sore left arm and felt bad a couple of days, then early this week my blood pressure spiked to 145/100 and has stayed in that range. It is accompanied by chest pain when I have any physical movement. If I walk across the room I have chest pain and caused the blood pressure to go up.

Headaches, muscle pain, chills, night sweats, joint pain, fever, swollen lymph nodes in neck and armpit left arm

Bilateral pain and swelling at location of Preauricular Lymph Nodes (below right and left temple and jaw joint, pain location where lower ear attaches to side of face, with swelling from temple area down to rear of lower jawline). Onset at about 4-5 days after injection.

Both legs from knees down got swollen and were painful to touch, walk on, etc.; Both legs from knees down got swollen and were painful to touch, walk on, etc.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EX923, in hospital, via an unspecified route of administration in left arm from 19Jan2021 at 20:45 (at age of 66 years) at single dose for COVID-19 immunization. Medical history included spinal stenosis, arthritis and allergy to penicillin, all from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included gabapentin, meloxicam (MOBIC), zinc, ascorbic acid (VIT C), magnesium and cinnamomum verum stem bark/elettaria cardamomum fruit/syzygium aromaticum (CINNAMOL). On 24Jan2021 at 16:00 both patient's legs from knees down got swollen and were painful to touch, walk on, etc. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The reported events were resolving at the time of the report.

After getting my Pfizer second shot. 15 hours later I began to get itchy through I whole body. And the swelling of my glands in my throat. Went to the ER to get treated. I was medicated with different antihistamines. And I was observed for five hours. The swelling of the glands didn?t go down some what. But I am still itchy not as drastic as it was yesterday Monday, March 1 of 2021. But my body is still itchy. Medication?s are Benadryl, famotidine, and prednisone. I will be seeing my family doctor this afternoon as a follow up from yesterday because I am still itchy most around my body. No fever, no bodyaches, but the itching Has not some subsided.

received Pfizer dose 1 on 2/27/21 in R deltoid. Approx 2 days later, began having R elbow and forearm cellulitis w/olecranon bursitis. Hospitalized and underwent I&D of R olecranon. Receiving treatment with antibiotic therapy.

Started with Hives like rash on left elbow and left knee. Progressed to Angioedema affecting upper area over lips, left palm and left foot sole.

Redness in administration area and Axillary Lymphadenopathy After mRNA COVID-19 Vaccination, onset two days after second dose administration

First I have not suffered any injury since getting the vaccine.Arm and shoulder area has increased in pain until heat was applied on March 10, 2021. Next day pain was increased and range of motion declined. By Friday, March 12th I could not raise arm more than 6 inches. Went to the Dr. on 3/12/21 and was referred to the Orthopaedics. Saw PA on 3/12/21. Xrays were taken I believe the diagnosis is in part subacromial bursitis.. Received Cortisone shot. Range of motion was much improved and has stayed about the same through today. Iced shoulder last night because of mild pain. Woke up in considerable pain which has continued today. I have iced the shoulder and upper arm at other times also since 3/10/21.

elevated spots of itching and swelling on his body. He said the elevated spots didn't change color/elevated spots on his thighs and part of his back; elevated spots of itching and swelling on his body. He said the elevated spots didn't change color; swelling on his body; he doesn't know if the spots would be considered hives; Reported 1 day after getting his second COVID-19 Vaccine dose, his muscles were tight; he felt lazy when starting off, until his muscles loosened up, and then he felt better; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021 at 10:25 am as single dose for COVID-19 immunization. The second dose of the vaccine was given at a hospital. The patient's medical history was not reported. No family medical history. No additional vaccines administered on the same day. No prior vaccinations within 4 weeks other than the first dose of BNT162B2 (lot number: EL3247), on 16Jan2021, intramuscularly on the left arm for COVID-19 immunization and experienced itching around his waist, spider bite, the spot on his waist looked like shingles, spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. There were no concomitant medications. On 10Feb2021, 1 day after getting his second COVID-19 vaccine dose, his muscles were tight. He said he felt lazy when starting off, until his muscles loosened up, and then he felt better. The patient took a dose of Tylenol 325 mg caplet that night and said when he woke up the next day on 11Feb2021, he felt good. On 12Feb2021 at 03:00, the patient experienced elevated spots of itching and swelling on his body, he said the elevated spots didn't change color, elevated spots on his thighs and part of his back. He doesn't know if the spots would be considered hives. The patient reported he put rubbing alcohol and anti-itch lotion on the itchy, elevated spots on his thighs and part of his back. He said the rubbing alcohol soothed the spots for a second. He said he then he put the anti-itch cream on the elevated spots. The events did not require physician's office or emergency room visit. The outcome of the event muscles were tight and felt lazy was recovered on 11Feb2021 while for the rest of the events was recovered on 12Feb2021. Reported he had blood work done for his urologist between his first and second COVID-19 vaccine doses. He said everything was OK with his blood work, and there was nothing negative.

My lymph nodes swelled three days after the first shot. Got very sore under my arm and got sore in the groin area too but just on the left side. Soreness has decreased but I can still feel it a little bit.

AT 1433, patient complained of left side facial swelling. We closely watched the patient for 15 more minutes. At 1449, patient told staff that he was feeling well enough to return home. He was advised to go to the Emergency Room if any symptoms returned.

Patient presented to oncologist on 3/5 with SOB, fatigue, increasing lymphadenopathy from chest CT on 3/4/21. Patient was prescribed a pulse dose of steroids. Patient was admitted to the hospital, lymph node biopsy was performed demonstrated active disease. Patient also had active EBV virus. Patient was started on IVIG which resulted in an increase in platelet count. Patient will be initiated on rituxan therapy this is being treated as an EBV lymphoproliferative disorder. Brentuximab therapy will be held.

Pt's daughter called to report her father's reactions after dose 1 of pfizer vaccine. about 4 hours after receiving the vaccine, he started to experience a headace, facial swelling, puffy, watery eyes, and nausea. This morning his symptoms have worsened to severe headache, continued facial swelling and double vision. Daughter was advised to bring pt to the ed for evaluation. Allergy consult has been requested.

Patient reported itchy, red bumps to bilateral inner elbows. Patient reports having a similar reaction to the first does of Pfizer vaccine and patient's HCP instructed him to take Benadryl. Administered diphenhydramine 25 mg PO liquid to patient at 1100. Red bumps and itchiness subsided after 25 minutes. Patient reports no other symptoms. Patient left facility at 1126.

fluid retention required a visit to the emergency room; shortness of breath; fluid retention; This is a spontaneous report from contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN9581), via an unspecified route of administration on 04Feb2021 at 09:00 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family history was denied. However, the patient did say that he had fluid retention prior to the vaccination (duration not specified). The patient further reported that he had illness at vaccination; he specified that he was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine Concomitant medications were not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that he had fluid retention and shortness of breath and was admitted to the hospital "the week of 20Feb2021." He was discharged that weekend, on Friday. He knows it was that week because on 25Feb2021 he was supposed to get the second shot and he missed it because he was in the hospital. He has fully recovered now from the fluid retention and shortness of breath. Adds he had the fluid retention prior to receiving the first dose of the Pfizer COVID 19 vaccine and was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine. The received unspecified treatment for the events. The clinical outcomes of the events fluid retention and shortness of breath were reported as recovered on 27Feb2021.

My Ooxgyen was dipping into high 70s tolow 80s with oxygen @4 lpm, Also very dehydrated and went to hospital dur to feet and ankles swelling up alot.. In the hospital for 9 days to lower clots from legs and constant high oxygen therapy also hemoglobin and hematicrit went upper range. Im home now doing better, but I dont think I should take the 2nd dose.

The patient reported L leg swelling leading to weakness. This was interpreted as a possible stroke, so he was admitted as a stroke code. However, MRI did not show a lesion. This could have been a TIA. For the leg swelling, lower extremity dopplers were negative for DVT.

1) Within 4 hrs of injection #2, highly fatigued, took two hours nap; 2) evening of Day 1, mild headache. Day 2: mild fatigue, no headache, mild lymph node swelling in neck. Night of Day 2: woken from sleep by nasal congestion, moderate airway constriction, wheezing. Cleared by next morning without need for rescue inhaler . Day 3: continued mild fatigue

Headaches; muscle pain; chills; night sweat; joint pain; fever; swollen lymph nodes in neck and left armpit; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9266; Expiration Date: Unknown) via an unspecified route of administration in arm left on 18Feb2021 at 10:30 as single dose for covid-19 immunization. Medical history included Artificial aortic heart valve from Dec2013. known allergies to Penicillin. Concomitant medications included metoprolol 25mg, warfarin 7.5mg, losartan 25mg. On 19Feb2021 at 04:30 the patient experienced headaches, muscle pain, chills, night sweat, joint pain, fever, swollen lymph nodes in neck and left armpit. Patient had covid prior vaccination. No covid tested post vaccination. Patient did not receive any treatment for the event. The outcome of the events was recovering.

Within 48 hours of receiving vaccine, patient developed intense swelling of left side of face and left neck with progressive dysphagia lasting more than 3 weeks

a big old puffy bag under his right eye; face was swelling; left eye is a little bit swollen; lymph nodes are swollen coming down to his nose and down on his cheek; This is a spontaneous report from a contactable consumer reported self. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 18Mar2021 as single dose for covid-19 immunisation. Medical history included blocked artery that can't put a stent. None family medical history. None other vaccines administered on same date. Last vaccines were 50 years ago as a child and there were no issues. After his first dose, patient was asked to sit for 15 minutes and he was fine and got in the car and drove home which takes 5-7 minutes and by the time he got home, he had a big old puffy bag under his right eye which drew his attention to look in the mirror and he saw his face was swelling. It started under his right eye and his left eye is a little bit swollen and then on the side coming down to his nose and all the way down on his cheek, lymph nodes are swollen on both sides as well. He went to the pharmacist and they told him they don't recommend him taking anything so he left it alone thinking it would be gone when he woke up. His daughter asked him called an ambulance, so he did that at 2:00-3:00a.m. When they came they said that there is no swelling any other place, they could recommend to take Benadryl, following morning he got the tablets and has taken all 24 and it is still there. No emergency room or physician office visit. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA: healthy patient training for moutain climbing expedition presented to emergency department (ED) reporting falls in the setting of new onset numbness, weakness, ataxia, paresthesias, and speech changes for a week and a half. Admitted to hospital, diagnosed with Guillain-Barre syndrome, received intravenous immune globuilin (IVIG), and transferred to physical rehabilitation program where symptoms initially improved but patient subsequently developed worsening weakness and numbness in extremities and significant dysmetria and dysarthria. Patient admitted to hospital for another course of IVIG.

Pt was hospitalized with severe sepsis and septic shock with hypotension, hypothermia, bradycardia, AKI, pancytopenia requiring pressors on 3/11/21. This was 14d after the initial vaccine. He received his second vaccine on 4/2 and was hospitalized with severe sepsis again on 4/27/21 with similar symptoms. First episode c/o diarrhea but no pathogen identified. Second episode with bilateral multifocal pneumonia but no pathogen identified.

fever; fatigue; dry harsh cough; severe bilateral edema feet and legs; calf skin turned red; calf skin hot and tender; calf skin hot and tender; This is a spontaneous report from a contactable consumer (patient) reported that a 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 18Feb2021 18:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure and cholesterol both from an unknown date. The patient had known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in left arm on 28Jan2021 06:00 PM (at the age of 66-years-old) for covid-19 immunisation. Concomitant medications included losartan potassium (LOSARTIN); rosuvastatin; alfuzosin; and potassium; all were taken for an unspecified indication, start and stop date were not reported. A month after 2nd dose, started having daily fever with fatigue and dry harsh cough. This has continued for 4 weeks and in third week developed severe bilateral edema feet and legs. Then, the calf skin turned red, hot and tender; all on 12Mar2021 14:00 (as reported). All medical reports have come back normal and doctors were unable to diagnose the root cause which is why the patient suspected the Pfizer COVID vaccine may have caused this adverse reaction. The events resulted in doctor or other healthcare professional office/clinic visit and hospitalization. The patient was hospitalized for 5 days. Therapeutic measures were taken in response to the events as patient received Tylenol, Antibiotic and steroid. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

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

Z79.01 - Chronic anticoagulation J18.9 - Left lower lobe pneumonia R29.6 - Multiple falls A41.9 - Sepsis (CMS/HCC) R09.02 - Hypoxemia J44.1 - COPD exacerbation (CMS/HCC) I50.9 - CHF exacerbation (CMS/HCC) R79.89 - Elevated brain natriuretic peptide (BNP) level

One week after first shot, a genital herpes outbreak, followed by a second, third and fourth in March, April, May, all four weeks apart. I normally have a single outbreak every one or two years.

severe itching; swelling; 'significant reaction' in legs; felt like a severe sunburn; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 12Feb2021 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included heart tx patient (as reported), on immunosuppressant drugs. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of the Pfizer covid vaccine on 12Feb2021 and that that night he had a 'significant reaction' in legs; reported severe itching and swelling. He stated it felt like a severe sunburn. Reports it resolved 4 days later (16Feb2021). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.

He got his vaccine, he had no symptoms at all. About 3 weeks later he woke up in the morning, his arm was swollen from the elbow down to his fingers, so swollen that he was not able to make a fist which took a week to 10 days to go back down to normal He went to the doctor and they sent him for x-rays of the elbow, which showed arthritis and nothing else. they took his BP on both sides to see if there was a difference, there was a 15 point difference in that. His doctor decided to do an US to see why there was a difference in that pressure. The US was a week later showed that he had a blockage underneath his right collarbone, narrowing with no plaque. He has had surgery on his carotid artery 6 years ago, so they sent a report to his vascular doctor. Talking with him they blockage is 50% to 99% and he asked his staff that he has had CAT scans prior to that due to the carotid surgery and they felt that they had prior CAT scans that showed no blockage. The vascular surgeon is going to watch it for now as it shows no plaque in the artery and is not sure if it is due to the vaccine or not. They told him to call us and file the report. He is having light headedness daily, which he did not have prior to the vaccine.

After 1st and 2nd shot Mild flush face sore arm same night no other problems Until on or about 5/1/21 Headaches dry throat rapid heart beat legs angels swelling cold not flashes can not sleep every night and sometimes in morning

Pancreatitis in tail of pancreas; fever (101.2F) for four days; left side abdominal pain; diverticulitis; headache; This is a spontaneous report from a contactable physician reporting on behalf of patient. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EP7533) as 1st dose single for covid-19 immunisation. Medical history included ongoing high cholesterol which was diagnosed decades ago at least, kidney stone. Concomitant medication included simvastatin (strength: 20mg) from 2011 and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The reporting physician is the patient's primary care physician. The patient came to the physician's office on 16Apr2021 for the fever, left sided abdominal pain, and headache which had been going on for 4 days in Apr2021. Physician reported that the patient thought his left-sided abdominal pain was caused by a kidney stone. Because of the high fever of 101.2 and the persistence of 4 days of fever, the patient was admitted to the hospital. Patient had an elevated white blood cell count of 13000. The patient had a very high D-dimer test which kept rising. The patient's C-Reactive Protein was very high. white blood cell count was 12.6 on admission and went to 6.8 after IV antibiotics were administered. The patient's fever resolved within 24 hours of starting IV antibiotics and fluids. When queried for seriousness criteria, physician reported that the patient's headache was just nagging. Physician reported that he doesn't have the patient's chart, but he is guessing that the patient's headache resolved within 3 days of admission to hospital. Regarding pancreatitis in tail of pancreas, physician reported that there was a possibility that the patient's abdominal pain was diverticulitis, it was unclear if the inflammation was from diverticulitis or the pancreas. Physician reported that the patient had a GI consult. Physician reported that the GI provider did an MRI on the patient's abdomen and the final word was pancreatitis. Physician reported that since the patient was hospitalized, all of the inflammatory markers, D-dimer, sed rate, CRP, have come down. Physician stated something happened. The patient has no risk factors for pancreatitis. He doesn't drink, isn't on any medications that would cause pancreatitis, doesn't have high triglycerides, and doesn't have gallstones; the Pfizer Covid-19 vaccine was the only variable. Physician is thinking that the whole inflammatory process was part of a reaction to the Covid-19 vaccine. Patient is clinically recovered, he was hospitalized from 16Apr2021 to 22Apr2021. Physician reported that the patient hasn't been checked radiologically but the physician is hoping to repeat the patient's MRI in a couple of weeks. He eventually got better and went home. He is now wondering if he should get the second dose of the Covid-19 vaccine. Physician is a little hesitant to tell the patient whether or not the patient should get the second dose of the Covid-19 vaccine. Physician does not know if the patient's adverse events were related to the Covid-19 vaccine and stated that risking another pancreatitis episode is a big deal. The patient's lipase never went up unless it was high 4 days before admission. Physician reported that the patient didn't seek attention then. Patient underwent lab tests and procedures which included D-dimer: 416ng/mL (16Apr2021), 959 ng/mL (18Apr2021), 933 ng/mL (19Apr2021), 818 ng/mL (20Apr2021), 842 ng/mL (21Apr2021), 686 ng/mL (22Apr2021); White blood cell count: 12600 (16Apr2021), 6800 (22Apr2021); C-reactive Protein: 148 ng/mL (16Apr2021), 109 ng/mL (18Apr2021), 84 ng/mL (20Apr2021), 73 ng/mL (21Apr2021), 51 ng/mL (22Apr2021), less than 1 ng/mL (12May2021); CT abdomen (16Apr2021): Inflammation in tail of pancreas; Covid-19 test: negative on 16Apr2021 and 18Apr2021; Erythrocyte sedimentation rate: 68 mm/hour (19Apr2021), 20 mm/hour (12May2021); Blood cultures: negative on 16Apr2021; Alk phos: 123 IU/L (26Apr2021), 85 IU/L (12May2021); ALT: 46 IU/L (26Apr2021), 40 IU/L (12May2021); GGT (Normal range: Up to 65 IU/L): 92 IU/L (30Apr2021), 59 IU/L (12May2021); CT angiogram chest, abdomen, pelvis on Apr2021 and revealed negative, no thrombotic event (Apr2021). MRI Abdomen: Pancreatitis localized to tail of pancreas (Apr2021); CT head was Negative (Apr2021). Outcome of diverticulitis was unknown, outcome of other events was recovered in Apr2021. The reporting physician assessed fever as serious with seriousness criteria hospitalization, left sided abdominal pain is serious with seriousness criteria medically significant and pancreatitis is serious with seriousness criteria medically significant, disabling. Physician reported that the Covid-19 vaccine potentially yes caused the patient's abdominal pain, but he did not know if the headache and pancreatitis were related or not to the Pfizer Covid-19 vaccine. Physician reported that in the absence of anything else, he is suspecting that the patient's headache and pancreatitis were caused by the Covid-19 vaccine. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a contributory role of BNT162B2 to reported events cannot be fully excluded. Case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Developed symptoms of Fatigue, shortness of breath, fluid retention prominently noted around the date of May 8. Went to urgent care on May 17th and was admitted for new onset atrial flutter/fibrillation with slow heart rate in the 30's with pauses > 3 seconds. My condition was monitored via telemetry, echocardiogram, TEE, CT scan of the chest, and cardiac cath Monday PM through Thursday. I had cardio conversation on Thursday along with a pace maker placement. I was diagnosed with a pericarditis (pericardial effusion), pulmonary edema, new onset A Fib, and bradycardia.

Elevated heart rate; that was floating heart that was all over the place it was inconsistent; my heart rate was at 150 and it was bouncing all over the place; white blood cells were high; Fever; temperature was 101; Headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 09:45 (Lot Number: ER8736) as second single dose at the age of 66-year-old for covid-19 immunization. Medical history included low thyroid/hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for low thyroid/hypothyroidism, start and stop date were not reported. No prior vaccination within 4 weeks. The patient previously took BNT162B2 (Lot# EW0150) in left upper arm on 13Apr2021 09:45 am as the first single dose at the age of 66-year-old for COVID-19 immunisation. When after the patient get the second shot (05May2021) he had the fever and headache and held for two days and temperature was 101 Fahrenheit. Two weeks later (May2021), he ended up getting elevated heart rate for about two weeks. That was floating heart, all over the place it was inconsistent. And he had that about two weeks and he finally went to the hospital. The patient ended up in the hospital and they put him in for two weeks his heart rate was at 150 and it was bouncing all over the place and they send him home two days later. The patent still had the elevated heart rate. He was still taking medication for that he was going to back to the doctor for that in three weeks, not the 100 percent cured yet. He was still trying to be better. The patient was hospitalized for the event elevated heart rate from 02Jun2021 to 03Jun2021. Lab test showed the patient had a high rate of white blood cell. His white blood cells were high. Treatment for the event elevated heart rate included: two blood thinners, Eliquis 5mg, Metoprolol Tartrate 50 mg. Outcome of fever and headache was recovered, of heart rate increased was not recoevered, of white blood cells were high was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660357 same reporter/drug/event, different patient

Onset in May of gradual accumulation of dependent edema, resolved with elevation. In June more progression without resolution became 3+ pitting to both knees acutely. BP noted to be elevated 161/95. BP elevation progressed exceeding 190 systolic associated with pounding headache over the next 2 days. ER evaluation 6/15 and hospitalization for 4 days for testing.

Starting the next morning, patient started noticing slight chest pain with deep breaths. Pain grew significantly over the next three days and mild fever began. Went to the ER and was sent home after doctor ruled out heart attack. Returned to ER the next day with significant increase in pain when breathing, especially when lying down. Fever increased significantly to 102.5. He was then admitted with a diagnosis of pericarditis and discharged two days later. He returned to the ER the day after discharge with increasing pain, ever, and breathing difficulty. CR-P was nearly 200. Diagnosed then with Cardiac Tamponade. About 500 ml of fluid was drained in an emergency procedure. He was admitted again. Over the course of the month of March, he was in the ER five times and admitted four times. He continues to suffer with thickened pericardium and is still being treated with anti-inflammatories, including ibuprofen, colchicine, and Prednisone as of June 30, 2021. Doctors are trying to taper the steroids but have had to increase the dose several times during this process as some symptoms return on tapering. CR-P has finally started to go down and is currently at 3.

body aches and pains; slight fever; greatly enlarged lymph node under right arm, size of an orange; 6 days later; large red swollen area on right arm; very warm to the touch and serious shoulder pain, can hardly lift arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6208) via unspecified route of administration in the right arm on 14Mar2021 at 13:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) and fatty liver. The patient had a history of allergy to Percocet. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9266) via unspecified route of administration in the right arm on 21Feb2021 at 15:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, which was in a size of an orange. 06 days later he had large red swollen area in the right arm, also had very warm to the touch and serious shoulder pain where he could hardly lift arm. No therapeutic measures were taken for the reported events. Adverse 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 severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, large red swollen area on right arm, and very warm to the touch and serious shoulder pain, can hardly lift arm were not resolved at the time of this report. No follow-up attempts possible. No further information expected.

chest pain, sweats, nausea, diaphoretci, tachypnea, possible V2 and V3 ST elevation, pancreatitis, gastroduodenitis, elevated lipase, leukocytosis, hyperlipidemia, myoclonus/twitching of face muscles

redness on my hands; swelling on my hands more on the right one than on the left one; Rash; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown), via an unspecified route of administration in the right arm on 31Mar2021 at 10:45 ( at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, patient experienced rash, redness and some swelling on hands, more on the right one than on the left hand. The patient did not receive any treatment for the adverse event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash, redness and some swelling on hands were unknown at the time of report. Information about lot number cannot be obtained. No further information is expected.

Swelling under arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 66-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, back and neck(unspecified). Concomitant medications included losartan (MANUFACTURER UNKNOWN), isosorbide (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), paroxetine (MANUFACTURER UNKNOWN) and ga (as reported) for an unknown indication. The patient had a history of allergy to tetracycline. 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 vaccine within four weeks prior to the COVID-19 vaccine. On 07Mar2021, at 23:30, the patient experienced swelling under arm. The adverse events were resulted in doctor or other healthcare professional office. The patient did not receive any treatment for the reported events. The clinical outcome of event swelling under arm was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Nausea; abdominal pain; rash purpura on lower legs; Leg sweling; low grade fever; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease and penicillin allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 11:15 (at the age of 66-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 has been tested for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 the patient experienced severe headache. On 27Mar2021 the patient experienced low grade fever, purpuric rash on lower legs and leg swelling. On 28Mar2021 the patient experienced nausea and abdominal pain. On 29Mar2021, patient felt better and also the symptoms was resolved on 30Mar21. On 29Mar2021, the patient underwent lab tests which included covid virus test (nasal swab) and the result was negative. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of the reported event was unknown. The clinical outcome of the events severe headache, low grade fever, purpuric rash on lower legs, leg swelling, nausea and abdominal pain were recovered on 30Mar2021. No follow-up attempts are needed. No further information is expected.

Raised blood pressure 165/74; aching joints; muscle pain; swelling of the face; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot: el 1284, via an unspecified route of administration in the left arm on 30Dec2020 at 10:45 (at the age of 67-year-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food or other products. Concomitant medications included lisinopril and sertaconazole nitrate (SERTALIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 31Dec2020 at 04:00, the patient experienced raised blood pressure of 165/74, aching joints, muscle pain, swelling of the face and fatigue. The events resulted in a doctor or other healthcare professional office/clinic visit, and an emergency room/department or urgent care visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the raised blood pressure of 165/74, aching joints, muscle pain, swelling of the face and fatigue was resolving.

vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was "different". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt "okay". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a "growling" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states "no". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate.

Starting the day after the vaccine he began having a flare of his CRPS symptoms including bilateral swelling of the knees, ankles and feet along with acute stabbing and burning pain, coldness and burning sensations. Symptoms have improved somewhat with treatment overnight.

Isolated fever to 103.2 on 2/4 - resulted in hospitalization. He was febrile to 102 on arrival with WBC count 11.9 with a L shift, leukocytosis resolved within 2 days, no further fevers documented afte rthat. CXR with most likely atelectasis. Pt unable to provide history, staff not observing respiratory symptoms, pt on room air. Initially started on vanc/zosyn despite negative procalcitonin -> AKI -> repeat procalcitonin minimally elevated (likely due to vanc/zosyn combination), stopped antibiotics, AKI resolved and procalcitonin again normal.

My husband has had a fever and extreme exhaustion every day, all day. for 16 days, since he go the Pfizer vaccine. He is retaining water, does not sleep at night, has heavy night sweats, and is emotionally spent. He has no appetite and forces himself to eat. He tastes what little food he eats. He visited his family doctor, a gastroenterologist, and has been in the emergency room two times for sheer exhaustion and pain. He was released both times after tests. Each time, no one could find a cause and no one sent him to other doctors for help. They would not admit him because there was no guarantee he could see other doctors any faster than if he were at home making appointments. He was referred to an infectious disease specialist by the gastroenterologist, but that appointment isn't until March 9, 2021. He will have faded even more by then.

swollen lymph nodes, runny nose, nausea, jittery, chest and bronchia congestion, low energy NO headache, NO cough, NO fever took benadryl at 12 noon - relieved some symtoms slightly

About 36 hours after vaccination and after experiencing Flu like symptoms, body aches, fever and lethargy I developed swelling under right arm pit about the size of a baseball. Flu like symptoms had started to improve when swelling was observed. Swelling not painful but in area of lymph nodes and appeared to be fluid. Has subsided very slowly but still observable today, now the size of a golf ball.

Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine. He had a podiatry clinic visit after his vaccine same day. It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm. Emergency medical personnel were not able to revive him. Patient died at approximately 4:45 pm on 2/23/21.

Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632.

Injection site pain, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, swollen lymph nodes.

Arm sore, head aches, very tired, restless, lack of sleep, flu symptoms, fever, swollen leg left side, knee swollen and foot, made neuropathy worse, sweat a lot, hard to walk, knee giving out while standing, vision blurry, nose running more, been out of work 2 days a week since shot, body aches, just cough

Two days after vaccination had swelling in both wrists and both hands and fingers. Seeming arthritic condition. Never had any type of arthritis or swelling of hands or wrists. Slight pain in hands and inability to grip or hold items. First took acemetacin for several days with no relief. then tried normal aspirin for several days. After two weeks someone suggested taking ibuprofen. I took 200mg per day and found slight relief. Contacted my PCP on 2/28/2021 to request a video visit that occurred on 3/3/2021 at 8:00 am. Doctor agreed that swelling and arthritic condition was the result of vaccination and advised to take 600 mg of ibuprofen every 8 hours for a week. Have had some relief from this medication. Doctor advised not to take the second vaccination shot.

Vaccine shot at 10:20 am Sunday. Severe swelling of lips, face and around eyes starting at 6:00 pm on Monday. Several days for swelling to go down. Not anaphylaxis. No swelling of tongue or throat. No trouble breathing. Exactly the same reaction and time line after second shot, 3/7/2021.

Vaccine shot at 10:20 am Sunday. Severe swelling of lips, face and around eyes at 6:00 pm on Monday. Several days for swelling to go down. Not anaphylaxis. No swelling of tongue or throat. No trouble breathing. Exactly the same reaction and time line after first shot, 2/14/2021. I reported first event as well.

The patient states that he had a bilateral hand /forearm dermatitis that was getting better when he received his first dose of Pfizer vaccine. Thereafter in about 24 hours the dermatitis erupted again and he developed hand swelling, redness and itching. he consulted his physician and was given oral prednisone at 50mg /d for 7 days which calmed the dermatitis. We reviewed the possibility of his rash erupting again after he receives dose 32--for which he is here today--and the possibility that the previous corticosteroids that he was given might inhibit a full immune response from the vaccine. He opts to receive the second dose today anyway and it is administered. This is to report the worsening of the dermatitis after the first dose was given. He still had remnants of a dermatitis (wrinkled skin, etc)

Patient developed Gilliam Barre after administration of the second dose of Covid vaccine on 2/15/21; After multiple calls, clinic was where patient received vaccine with LOT #EN6200 (expiration date unavailable in computer system per pharmacist); pt then went to a hospital and was diagnosed as above; treated in the ED for several days per notes at the hospital and was not put in a room due to bed shortages so was transferred to another hospital; patient subsequently developed an NSTEMI, seizures, and was intubated.

Swollen lymph nodes left side of neck. 12:00 pm 03/12/2021 Headache pain in left temple 12:00pm , 03/18/2021 Treated at clinic 03/21/2021 Swollen glands (Parotitis). 4:15PM 03/22/2021. Treated at clinic on 03/ 23/2021.

My leg and foot swelled on Thursday. We elevated and treated with heating pad & Advil. The swelling went down, so we started for home, drove 4hrs. My leg & foot swelled back up. We went to the ER they gave me an ultrasound, and said I had 2 blood clots in my leg. They prescribed, Eliquis.

a 67-year-old male with past medical history hypertension, CVA on aspirin and Plavix, diabetes mellitus on Metformin who presented to ED 3?30?-30-2021 secondary to shortness of air. Patient son is at bedside and states he has had complaints of cough, chest pain and shortness of air for the past 3 to 4 days. He has associated subjective fevers at home. Patient son states that his daughter checks the patient's blood sugar daily. He has not missed any of his medications or had a change in medications. His blood sugar was checked this morning and noted to be high and he thus presented to ED for further evaluation. Patient was ill-appearing on arrival to ED with respirations in the 30's as well as tachycardia and mild hypoxia. He was placed on 2 L with O2 stats stable. He states he has some relief with IV fluids but continues to have chest pain and shortness of air. He is tachypneic with Kussmaul respirations noted. Pertinent ED labs: Elevated lactic 3.0, potassium 6.8, glucose 760, BUN 33, creatinine 1.8, WBC 16, D-dimer 2636, decreased GFR 38, sodium 124, bicarb 5 VBG with pH 6.97, CO2 25, bicarb 6 Patient started on insulin drip, 2 L IV fluids, IV antibiotics, calcium in ED.

Knot detected in lymph node under right arm; Redness continues to spread after 6 days after receiving shot along with fever on this area; Redness continues to spread after 6 days after receiving shot along with fever on this area; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:00 (Lot Number: EN6206) (at the age of 67-year-old) as single dose for COVID-19 immunisation. Medical history included leukemia and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced knot detected in lymph node under right arm and redness continues to spread after 6 days after receiving shot along with fever on this area. No therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.

loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.

Swelling /inflammation of face on left cheek near nose; periorbital swelling around eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male 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, in Arm Left on 30Jan2021 17:00 as single dose for covid-19 immunisation (age at vaccination 67 years) at Clinic. Medical history included sulfa drugs allergy, asthma, GERD (gastrooesophageal reflux disease), glaucoma, high BP (Blood pressure), hypothyroidism, depression. Concomitant medications the patient received within 2 weeks of vaccination included acetaminophen; albuterol sulfate; brimonidine tartrate. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 at 01:00 A.M, the patient experienced swelling /inflammation of face on left cheek near nose and another site as periorbital swelling around eye; both occurring on left side of face only. Patient spoke with triage nurse who indicated to use ice. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Case was reported as non-serious. Outcome of events was not recovered. Information on the lot/batch number has been requested.

chills overnight, low fever, up to 100. Normal is 97.6. Body aches, especially in lymph nodes, side of hip, side of throat

2 days after first inj. developed cold sore upper lip treated normally and went away after week or so. 3 days after second dose another sore on bottom lip felt and looked like a burn, used vaseline and better after week and a half. 3 days after second dose extreme tinnitus started in left ear, 4 th. day hearing loss in left ear, stuffy plugged feeling, no pain. Continues to this day. Also feeling fatiqued.

Spitting up blood. Spontaneous. Started 2 days after. has continued to this day on perhaps 15-20 days during that time, maybe more. Accompanied. by giant hives and rashes. Thick hives. Bizarre shapes and sizes. All over my body. Had CT scan of chest and Sinus - normal. ENT normal. Blood tests including many for sed rate and other blood or infectious related things, all normal. Urine normal. Phlegm and sputum cultures normal. Going to see pulmonary on April 19. Going for second opinion ENT April 7. Chest pains and general body aches and pains and straining pains in mornings four times including this morning. Dermatologist says he has seen hives from vaccine because there is no other cause when so many patients show up with it; however mine are the most extensive, large and thick he has seen. Suggested Claritin and Benadryl and hoped it would go away in time. I am a physical mess and had zero problems before the vaccines. Please contact me immediately I should have come too sooner.

Two days after shot woke up with sunburn like rash on face and back. Was short of breath and dizzy. The rash looked like little blisters on top of bumps on my face, with red rash looking spots on back, legs, and chest. The skin on my face started pealing on my face and it burned and itched. Went to see my Pulmonary Doctor first, than Infectious Disease Doctor than Primary Care. I was treated with steroids, creams and inhalers. Symptoms would get better than repeat for the first month. Still not feeling like I am ok. Have two more doctors appts. coming up.

Pt said he felt kind of weak after the vaccine shot on Sunday but can still walk to bed. Waking up on Monday, he could not walk. He could not sit up due to hip muscle weakness. Later on Monday, he developed a fever with a T-max of 101.6 °F. MRI C/T/L spine demonstrated cauda equine nerve root enhancement, lumbar puncture w/ protein 58 and lymphocytic pleocytosis (atypical for GBS), patient was started on IVIg (had infusion reaction) and switched to PLEX (s/p 3 sessions) with clinical improvement. At time of discharge, was able to walk with a walker.

swollen lymph node on side shot was asministered; This is a spontaneous case from a contactable consumer (patient). A 67 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 19Feb2021 10:00 (Lot Number: EL9269) at the age of 67 years old as single dose for covid-19 immunisation. Medical history included heart attack from 2012; Known allergies: Naproxin. The patient's concomitant medications were not reported. Facility type vaccine was Other. The patient experienced swollen lymph node on side shot was asministered on an unspecified date in Feb2021. No treatment received for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovering.

Sudden rapid heartrate upon even slight exertion, sudden blood pressure spike in the range of 165/100 to 225/110, headache, blurred vision, pain in right side intermittently

ECHO FEB 8, 2021; EF 55%. REREAD AGAIN IN APRIL AND EF 55% CONFIRMED. ON MARCH 5, HE PRESENTED WITH A 5 DAY HX OF SOBOE, ORTHOPNEA AND SEVERE PRECORDIAL CHEST PAIN. HE DESCRIBED THE ONSET AS SUDDEN, ABRUPT AND SO SEVERE THAT HE WAS UNABLE TO CALL 911. THE SEVERITY OF THE CHEST PAIN DISSIPATED SOMEWHAT, BUT THE DYSPNEA AND ORTHOPNEA HAD WORSENED. HE TRIED ALBUTEROL AEROSOLS BUT THESE ONLY GAVE HIM VERY PARTIAL RELIEF. PHYSICAL EXAMINATION REVEALED A NEW CARDIAC S4, CLEAR CHEST TO AUSCULTATION BUT HE WAS UNABLE TO TAKE A DEEP INSPIRATION DUE TO TO THE PLEURITIC CHEST PAIN. HIS WEIGHT WAS UNCHANGED. NO PERIPHERAL EDEMA NOTED. EKG SHOWED RBBB, LPFB; BIFASCICULAR BLOCK. NO PREVIOUS EKG FOR COMPARISON.

Day after shot - low grade fever 99.5, extreme fatigue & body aches. That evening - pain under left arm, could not sleep on left side. Next morning swelling under arm. Large area swollen, still painful.

After 3 days developed bulge under injection arm pit 4" in diameter and 1.5" in depth, feels 75% solid, after 2 week became 33% smaller and getting more "jelly like". After 30 days from date of injection is still same.

Acute interstitial pneumonia with significantly elevated CRP - occurred 3 days following vaccine administration. Steroid responsive. BAL negative for expanded infectious workup. No other constitutional symptoms of note.

SYMPTOMS- excessive vomiting, high fever/ chills , back pain; TREATMENT - diagnosed with Idiopathic Necrotizing Acute Pancreatitis Developed blood clots(SMB Thrombosis) , esophageal ulcers/ internal bleeding, internal fluid sacs retention (+25lbs- abdominal and thoracic,) jaundice. Required insulin injections; oxygen nasal cannula; nasogastric tube; TPN Central line and Physical Therapy to regain legs mobility TIME COURCE - One Hospital 8 Days; Another Hospital - 22 Days ED, ICU(20 days), Stepdown; Rehab Center - 9 Days

Hearing loss; Vertigo; Nerve damage in my ear; Rash on the back of my head and then swelling at the right side of my head; Swollen canal, my ear canal; Rash on the back of my head and then swelling at the right side of my head; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809) dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 as single dose for covid-19 immunisation. Medical history included blood pressure. The patient's concomitant included unspecified blood pressure medication. The patient previously received the first dose of bnt162b2 on 27Jan2021. The patient experienced hearing loss on unspecified date in Feb2021. He reported that it was first started two weeks after the second dose as a rash on the back of his head and then swelling at the right side of his head but not real swelling but in the canals in his ear. So, he wanted to report that. The patient reported that he had vertigo now. He went to a doctor a month ago and they said he had a nerve damage in his ear and had swollen canal, his ear canal. He had both the doses of the vaccines. He reported that all started two weeks after he got his Covid shot. The patient underwent lab tests and procedures which included blood test which was fine. The outcome of the events was unknown.

swollen lymph node in the neck; swollen face and throat; swollen face and throat; arm pain; throat irritation; tightness around the top of his head; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported himself that a 67-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EN6201), via an unspecified route of administration on 19Feb2021 14:00 on left arm as single dose for COVID-19 immunisation. The patient's medical history included narcolepsy and blood pressure high. Patient's medical history (including any illness at time of vaccination) was none. He got the flu vaccine in Nov1994, and 2 weeks later he got the flu, and it was the worst he has ever had. Concomitant medications were not reported. The patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EP6955) via an unspecified route of administration on 15Mar2021 at 11:30 on left arm as single dose for COVID-19 immunisation. On 07Mar2021, about a week ago, he was outside on his deck and his face was in direct sunlight, and his face started to swell up and was tightening on one side. Where his face was covered nothing happened, but the side of his face that was in the direct sunlight started to swell up and tightened. Stated that his face felt heavy around his lips where it was in the sun. He went inside, and his wife told him he was having an allergic reaction to something and to take Benadryl. He took the Benadryl and splashed ice-cold water on his face, and the swelling went down. On 14Mar2021, that Sunday, he noticed a lymph node on his shoulder by his neck on the same side where he got his vaccine, at the 5th level according to the research he did. States that it's rubbery and movable so he didn't know what it was, but it seemed to be getting larger until yesterday. On 19Feb2021, there was no pain, but he did notice a little swelling around his throat. He has a doctor's appointment on Tuesday to see his primary care doctor. Clarified that his face swelled up and tightened on 07Mar2021. He has not gone back out in direct sunlight since this happened. He only had the face swelling and tightening for that day. Once he went inside and took Benadryl and put ice on his face it went down. Clarified that he noticed the lymph node on 14Mar2021, and it was now persisting. When asked when he first noticed the swelling around his throat, he stated that he has had throat irritation and tightness around the top of his head since the day of the 1st dose which was 19 Feb 2021 at 2PM. He also had arm pain that also started that same day, and went down his arm to the wrist, and up his shoulder to his neck, but the pain only lasted 1.5 days. On the side where the lymph node was, there was some pain in his upper throat when he touches it; when they measure the muscles in the neck, it was that 1st level where the pain was; but the pain was only on the left side. There were none other relevant diagnostic and confirmatory test results for events. The outcome of the event swollen lymph node in the neck was not recovered; swollen face and throat and throat irritation was recovered while outcome of the remaining event was unknown.

I had surgery on my back in July 2020. After receiving the vaccine in March of 2021, my scar started itching about 2 months after . Eventually the itchiness spread to my arms, back, legs, belly and especially my back. A bubble appeared in the palms of my hands. If it was touched, it was itchy. It then spread to my fingers. The more I rubbed them together to receive the itching, the worse it got. I went to the doctor who at first thought it was psoriasis. She then determined it might be eczema. I went home and then it got worse. I went back and the doctor prescribed triamcinolone 0.5%. I put this on the bubbles on my hands and fingers. It relieved the itching but it has dried my skin and it is now peeling. It is like when your hand is in water for a long time. Even though the itching was relieved, there is still itching present. The doctor told me to use the triamcinolone for 10 days and after the 10 days, just use as needed. The triamcinolone has overall helped. Heat makes the itching worse.

His face swelled up; Lips felt dry; A black and blue bruise from inside of elbow up to shoulder; The left side of face and lips started feeling funny/the side of face hurt a little bit. A couple of days later, it moved into his lips.; The left side of face and lips started feeling funny/the side of face hurt a little bit. A couple of days later, it moved into his lips.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration administered in arm left on 17Mar2021, 11:30 as single dose 1, for covid-19 immunization (at the age of 67-years-old). Medical history included, body height decreased from an unknown date and unknown if ongoing (shrunk before getting the vaccine) and ongoing Sty in eyelid from an unknown date. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.), 1x/day (87 mg the baby one, once daily)) taken for platelet count increased, start (from two years) and stop date were not reported and azithromycin (250 mg, 1x/day) taken for Sty in eyelid from 15Mar2021 to an unspecified stop date. The patient previously received pneumonia vaccine a year ago and the second one this past year at his doctor's office and no further details provided. It was reported that on 17Mar2021, the patient received the first dose of vaccine and stated that on an unspecified date he experienced that his face swelled up and on 19Mar2021 had a black and blue bruise from inside of elbow up to shoulder, the left side of face and lips started feeling funny/the side of face hurt a little bit, a couple of days later, it moved into his lips and lips felt dry. The patient further reported that he went to his doctor and they said to take Benadryl and he has been taking it and he was due for second shot this Wednesday and was wondering should he get it. He also stated that used to be 6'6", but as he gets older, he has shrunk. He did not provide his height now and he shrunk before he got the vaccine and mentioned that over time everyone gets shorter as disc gets compressed. He also stated that he was on an antibiotic for a sty on left eyelid for 5 days and he took first one Monday and Tuesday and got COVID shot on Wednesday and then a couple of days after, maybe a day or two or three, his face did not hurt, but when he went to floss his teeth, when he put fingers in mouth on left side, the side of face hurt a little bit. A couple of days later, it moved into his lips and he did not have a lot or expiration for the azithromycin as it was in a pharmacy vial and they told him to come back in 4 weeks, which would be this Wednesday. He called drug store on 02 Apr 2021 and they said to call physician and he called them on Friday and got a call to come in on 06 Apr and told him to take Benadryl. He stated that he was kind of skinny and when you see people in TV when they give injections, they grab the skin in the arm. There was not a whole lot of meat or muscle in his shoulder to grab, from his left shoulder down to elbow, he had a black and blue bruise from inside of elbow up to shoulder and he noticed it a couple of days later. There was still some of it there. He stated the start date was a day or two later after 17Mar2021. It was finally fading away and turning lighter and lighter. It was like most of it has gone, but you can still see some of it. Therapeutic measures were taken as a result of events with Benadryl. The patient was recovering from the events of contusion, lip pain and facial pain and outcome was unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Shortness of Breath onset for "awhile" per family. on exertion and when sleeping Pt is a 67y.o. male presenting to the ED with chief complaint "shortness of breath." Patient states that for the past week he's been experiencing gradually worsening shortness of breath. He states that symptoms are especially worse with exertion and while lying flat. He denies any history of MI/stent placement, asthma, COPD or heart failure. He reports he is a former smoker and quit approximately 2 years ago. He admits to a nonproductive cough. He denies any fevers, chills, sick contacts, chest pain, abdominal pain, nausea, vomiting, diarrhea, lower extremity edema. He reports that he is fully vaccinated for COVID. He has no other complaints at this time. Review of Systems Constitutional: Negative for chills and fever. HENT: Negative for rhinorrhea and sore throat. Eyes: Negative for pain and redness. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for frequency and urgency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Negative for weakness and headaches.

Swelling under left armpit; Sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 08:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) of 81mg, loratadine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 08:00 (at the age of 67-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 01Apr2021 at 06:00, 48 hours after the shot, the patient experienced swelling under left armpit size of his open palm and sharp pain for four days till the time of reporting. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of swelling under left armpit and sharp pain were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Vacinnated on Friday..following Sunday evening noticed bumps, blisters, hives on both of my hands in the pad areas of my hands. extended into the tips of index fingers and thumbs. very sensitive to the touch. I took some Benedril which helped with swelling. that was the most severe after effect. I'm pretty sure it was the vaccine because i had not been anywhere that weekend and had not put my hands on anything unusual that i don't normally touch. It only happened to my hands. Other than that i had minor flu like symtoms from the shot, achiness and slight fatigue feeling. I had an ER doctor look at my hands when i went in today to get help for my bronchitis, which i had some before the covid shot. It got worse on Monday. He perscribed prednisone which has pretty much taken the hand spots away..i was tested negative for covid today(1/19/21) by the way.

My feet had been tired and sore from standing and working a lot anyway but seemed to be calming down. About 24-36 hours after the first injection noticed pain in the ball of my left foot. Shortly after that swelling began in both feet. Swelling became worse, doctors conclusion was metatarsalgia. Rest, ice, ibuprofen. Swelling got worse on Friday Jan 29, went to emergency at hospital. Diagnosis was nueroma, given a prescription for prednisone. Began Prednisone Saturday Jan 30. Swelling began to subside on Sunday evening. Has been improvement slightly throughout the week but still has not gone down. Small pockets of dried blood are pooling the bottom of my feet where the swelling was the worst.

Pt notes that he was very anxious prior to the administration of the vaccination and did not go to sleep the night before. Following administration of the vaccination pt reports to no immediate reaction during the 20 minutes observation. Upon arrival at home he noted some chills and went to sleep and when he woke up he describes his face became "slightly swollen"(involving areas under his eyes, around his cheeks, glands under under his neck) with no lip/tongue/throat swelling and no difficulty with eating/drinking/breathing. He reports that after about 1.5 hours the swelling resolved.

very pruritic maculopapular -purple and red rash diffusely throughout body and extremities and neck. Sores in the mouth and blisters forming on palms of hands and soles of feet with some pain, ureteral meatus erythema and anal erythema. pain with swallowing

Numbness to left side of the face, drooping ness of left eye and eyebrow, not able to smile with left side, swelling of right side of the face.

swelling migrated from right lower jaw region over lips and stopped at the left side of lips; slurred voice; rash with whelps across his back and down both legs with itching irritation; rash with whelps across his back and down both legs with itching irritation; swelling migrated from right lower jaw region over lips and stopped at the left side of lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 06Feb2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included metformin, gabapentin, atorvastatin, and alprenolol hydrochloride (ATENENOL). The patient previously took Demerol and aspirin experienced allergies (known allergies). 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. On 18Feb2021 06:30, the patient experienced swelling migrated from right lower jaw region over lips and stopped at the left side of lips, some swelling has continued, and slurred voice (more pronounced when standing). On the same day at 06:30, the patient experienced rash with whelps across his back and down both legs with itching irritation. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Zyrtec and Kenalog. The patient has not been tested for COVID-19 since the vaccination. The patient has not recovered from the events.

I didn't sleep last night; parts of face and under chine was swollen; BP102 at 3pm blood pressure was 132/82; This is a spontaneous report from a contactable Other HCP. A 68-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 05Feb2021 08:15 at single dose, right arm for COVID-19 immunization. Medical history included high blood pressure, Crohn's disease and mental health issues. Known allergies included valproate semisodium(DEPAKOTE) and fluoxetine hydrochloride(PROZAC). The patient's concomitant medications were not reported. The patient didn't sleep last night. Parts of face and under chine was swollen, blood pressure(BP) 102 at 3pm blood pressure was 132/82. Noticed after waking up at 2:30PM. The patient went to sleep at 9:30pm. Events start date was 05Feb2021, 03:00PM. Events resulted in: Doctor or other healthcare professional office/clinic visit. There was no covid prior vaccination, no covid tested post vaccination. No treatment received for the events. The outcome of the events was recovering.

About 1 week after 1st dose, had severe itching under in both armpits. Noticeable swelling in RIGHT armpit that still remains (injection was in LEFT arm). Consulted a dermatologist who didn't believe it to be lymph node related. A day after the second injection, swelling and slight pain in LEFT armpit. As of this date, neither side has resolved.

itching of scalp; forehead had slight swelling; cold sore; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received second dose for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN5318), via an unspecified route of administration, on the left arm, on 29Jan2021 at 12:00 at a single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL), chronic acid reflux, and Caisson's sickness. The patient has no known allergies. The patient has other unspecified medications taken in two weeks. The patient previously took his first dose of bnt162b2 (lot no. EN3246) on 08Jan2021 at 12:00 PM, on the left arm for Covid-19 immunization. The patient has not taken other vaccine in four weeks. On 02Feb2021 at 21:00, several days after vaccine had strong itching of scalp, lasting several hours prior to bedtime. Noticed that his forehead had slight swelling at bedtime. Overnight this cleared up, patient had taken valcyclovir the prior day for a cold sore. He was reporting this, but may be a red herring. The patient has no Covid prior vaccination and not Covid tested post vaccination. Outcome of the events was recovered on an unspecified date in 2021.

small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.

Very swollen lymph node in left neck under ear. Mild swelling of lymph node in neck under jaw.. No other symptoms. No treatment. No change as of time of report.

all of his lymph nodes were swollen under his arm and in his neck; joints were swollen; Huge bump on his arm at the injection site; his fingers are swollen; fever of 101; General feeling of unwell and malaise; This is a spontaneous report from a contactable healthcare professional (patient's wife). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 03Mar2021 at about 15:00 (lot number: EN6201 and expiration date: 30Jun2021) at a single dose, received at the hospital for COVID-19 vaccination. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy and patient was immunocompromised. The patient's concomitant medications included immunoglobulin human normal (IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL]) from 02Mar2021 to 02Mar2021 for chronic inflammatory demyelinating polyradiculoneuropathy. The patient previously received flu vaccine on 15Oct2020. The patient's wife called to report on the side effects that the patient was experiencing after he received the Covid-19 Vaccine. The patient had a fever of 101 started at about 23:00 on 03Mar2021 (his regular base temp is about 97). At midnight of 04Mar2021, all of his lymph nodes were swollen under his arm and in his neck; even in his fingers were swollen. Also noticed that his joints were swollen and had a huge bump on his arm at the injection site on 04Mar2021 after midnight last night. The reported added that patient also had a general feeling of unwell and malaise on 03Mar2021. The patient received treatment for the events. Outcome of the events was not recovered. The events were reported as serious (other medically important condition) and considered related to COVID-19 vaccine (source of assessment was primary source reporter and method of assessment was global introspection).; Sender's Comments: Based on available information, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded due to temporal relationship and current known drug safety profile. 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 placed in observation area post Pfizer COVID vac administration. After Approximately 10 minutes, patient Passed out and was found on the floor with wound on (L) side of forehead with bleeding noted. Large knot noted above (L) eyebrow. BP 116/60 Awake, responsive, diaphoretic, bounding pulse, pale. Patient was assisted to stretcher with O2 at 2L NC and ED team transported to ER. Given fluids in ER.

cellulitis; right lower leg was swollen and bright pink; tiny blisters; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 at 14:30 (Lot number was not reported) (at the age of 68-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took sulfa and experienced drug allergy. On 05Mar2021 at 19:00, the patient experienced cellulitis, right lower leg was swollen and bright pink and tiny blisters seeping fluid. The events required physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.

I am an internal medicine provider and have an 18-year h/o rheumatoid arthritis that had been well-controlled for years allowing me to stop treatment with MTX/leucovorin 3 years ago. On 2/28/021 I developed pain, erythema, warmth and swelling at the 4th MCP in my L hand which persisted for several days. I contacted my rheumatologist, and saw him on 03/04. Since this was my first episode of inflammation in years, we elected to treat it conservatively with naproxen OTC. My symptoms resolved after several days, but then I had successive episodes of pain, erythema, warmth and swelling in my R 5th MCP, R ankle, L 5th TMT, L 5th MCP, L knee and R wrist over the next 3 weeks--- in the pattern of palindromic rheumatism similar to that my symptoms had first began 18 years ago. Given the number and severity of these episodes, doctor recommended treatment with prednisone 10mg PO qdaily for 30 days and restarting MTX 15mg (six 2.5mg tabs) PO qweekly and folate 1mg PO qdaily.

weakness, fatigue, body ache Narrative: 67-year-old male with past history of diabetes type 2, hyperlipidemia, left BKA, who presented to hospital 2/14/21 with generalized weakness, fatigue, body aches and left leg pain for the past 5 days. He reported it started after receiving his COVID-19 vaccine on 2/09/21. He also had associated nausea, vomiting, diarrhea. He denied fever, chest pain, shortness of breath, abdominal pain. Labs showed mild leukocytosis 12k, AKI with Cr 4.6, K 3.2, Bili 2.9, trop 0.01, lactate 2.2. He was given 3L IVF, vanco blue in ED at 18:35. Asystole on monitor. ACLS initiated and once eventually stabilized he was transferred to ICU. Pt again coded 2 more times while in ICU with were halted due to medical futility.

cheek swelled up like he had mumps; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; body aches; low grade fever; dull ache was causing some headaches; sensitive area in lower right portion of jaw; parotid salivary gland infection; This is a spontaneous report received from a contactable consumer (patient himself). A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and lot number: EL9369), via an unspecified route of administration on 10Feb2021 as a single dose in the left arm for COVID-19 immunisation. Patient had no medical history and concomitant medications. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL3246), on 20Jan2021 in left arm for COVID-19 immunization. On 10Feb2021 (about 6-8 hours after second dose), the patient developed body aches and low-grade fever. It was reported that at same time as body aches, he had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only. Stated everything went away after 36 hours except the ache in his jaw and ear, states it became very low grade, thought it was his ear and after a week, the dull ache was caused some headaches in 2021 and he went to doctor who told him to see an ENT, states he saw an ENT, they looked deeply, it was fine, states they did find there was a sensitive spot down by his jaw, told him to just take Ibuprofen. On 21Mar2021, patient cheek swelled up like he had mumps and went to the periodontist, he probed and found no infection, did find a sensitive area in lower right portion of jaw, prescribed cefalexin. Swelling went down, and then suddenly it came back and told him to go to oral surgeon specialist, oral surgeon did a CT, did not find an evidence of tumours or anything in 2021, based on symptoms he said he had parotid salivary gland infection in 2021, when it gets infected it creates a mump like condition and prescribed amoxicillin. Clarified the jaw pain started out severe dropped down to low grade annoying pain and stayed that way. then on the 21Mar2021 it got severe again with the swelling. Stated today, it seems to have gone away, still has 5 days of amoxicillin left. Outcome of body aches, low grade fever was recovered on 11Feb2021, dull ache was causing some headaches, cheek swelled up like he had mumps, sensitive area in lower right portion of jaw and parotid salivary gland infection was unknown and had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only was not recovered. Information on the lot/batch number has been requested.

10 to 15 days lymph nodes on right side of neck swelled. Was placed on antibiotics for 10 days . No significant change. Some swelling has gone down however we are now 6 weeks after vaccination.

Swollen right leg in AM four days after vaccine. Diagnosis of DVT next day, five days after vaccine. Have been on eliquis for about 4 months. Leg is still swollen. Not surprising since the covid spike protein causes blood clots.

Lower leg pain, swelling. Admitted to the emergency room on 03/29/2021. Ultrasound was done. Diagnosis was left leg DVT. Treatment prescribed is 15 mg of Xaralto twice a day. Had a follow up visit with a physicians assistant on 04/09/2021. She prescribed 20mg of Xarelto once a day for the upcoming 2-3 months. Also prescribed Bisoprolol Fumarate 2.5 mg once per day.

3 weeks later elevated temp (102), aches, chills, dizziness/vertigo, continuing for about 2 weeks. Same reaction as to first vaccine. Slowly going away.

Chest pains which were eventually diagnosed as a result of Pericardial effusion. Sternotomy was performed to remove fluid.

Following the first shot I had typical flu-like symptoms - fever, aches in joints and muscles, headache and brain fog. The second shot had the same symptoms as the first but after about 22 hours I apparently had some type of anaphylactic reaction - I remember going to the bathroom - but I woke up on the floor by the bed, and could not think how to get back in bed. My wife called 2 neighbors who helped me up. It was difficult to form complete sentences. I was transported by ambulance to ER. The ER ran a battery of blood tests, CT scan and chest x-ray. The ER doctors and oncologists concluded that I must have had a delayed reaction to the vaccine. Today, April 28, things are back to normal.

Leg started swelling 4/22 and became painful. Saw Dr. on Monday 4/26 and had venous ultrasound which showed a "blood clot" was started on xarelto

Left side pain under left arm and into left heart region; right side facial swelling associated with lymph nodes; right side facial swelling associated with lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 10Feb2021 at 10:15, at single dose, for COVID-19 immunisation. Medical history included type 1 diabetes mellitus (for 48 years), penicillin allergy, sulfonamide allergy. Patient did not have COVID-19 prior to vaccination. Patient received unspecified medications in two weeks. Patient did not receive other vaccines in four weeks. The patient experienced right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), left side pain under left arm and into left heart region (non-serious) on 12Feb2021 at 21:00 with outcome of recovered in 2021. The patient did not know if this was swollen lymph nodes or heart condition. Patient did not test for COVID-19 post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

3/4, admitted 3 days after covid vaccine. Presented to ED with complaint of weakness, onset 1 wk ago. Endorses fatigue, leg swelling, ankle swelling, fluid retention. Last EF was 6 and "he feels like that same feeling now". On Eliquis and 4mg of Bumex 2x daily. Acute exacerbation of CHF (congestive heart failure) patient with known severe heart failure and ejection fraction of 24% presented with shortness of breath,profound edema, 11 pound weight gain. Respiratory PCR negative. IV Lasix 40 twice daily-continue with Lasix 40 p.o. twice daily at home. Metolazone 2.5 once a day as needed weight in excess of 235 pounds. Patient continues on Toprol-XL and spironolactone. Spironolactone was raised to 25 twice daily to try to help manage his potassium fluctuations.

death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES

my feet had been a bit sore from working so much lately; on the second day after the vaccine swelling in both feet began and worsened throughout the week; This is a spontaneous report from a contactable consumer (himself). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 23Jan2021 15:15 (age at vaccination 68-year-old) as 1st dose, single for covid-19 immunization in School/ Student Health Clinic. The patient medical history was not reported. No allergies to medications, food, or other products. 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 and not tested for COVID-19 since vaccination. Concomitant medication(s) included glucosamine (GLUCOSAMINE), vitamin d nos (VITAMIN D NOS) taken for an unspecified indication and from unknown dates and unknown if ongoing. Patient received other medications Multivitamin/ Glucosamine/ vitamin D within 2 weeks of vaccination. On 25Jan2021, the patient's feet had been a bit sore from working so much lately, on the second day after the vaccine swelling in both feet began and worsened throughout the week. Therapeutic measures taken as a result of the events were prednisone. The outcome of events were recovering. Information on the lot/batch number has been requested. Follow-up (16Apr2021): 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.

11 days after first vaccination, in left arm I noticed lymph node swelling in left neck between ear and clavicle. Consulted Dr. He recommended getting next vaccination in right arm. Did so, and noticed no change in left neck and no swelling in right neck. Dr. arranged for ultrasound exam of neck. Findings suspicious of malignancy led to CAT scan with contrast, fine needle biopsy, and PET scan . All indicated likely malignancy and a potentially primary tumor on the left tonsil. Excisional biopsy of tonsil confirmed HPV-mediated Squamous cell carcinoma. Seven weeks of cis-platin chemotherapy and radiation were implemented starting May 18 and planned to continue until July 7, 2021.

Pain in the back becoming so severe level 8. Went to local doctors in Healthcare for four weeks trying to get help. Could not walk after the fourth week. Went to medical center and diagnosed within two hours of having acute osteomyelitis. On the verge of sepsis.

My father became ill after the 2nd does and did not recover. His legs began to hurt. He found it hard to walk. He didn?t want to go to the doctor from fear of COVID. But his legs began to swell and he couldn?t walk, so he went to ER on 4/18/2021 and released on 04/20/2021. He then went to his PCP on 04/28/2021. He went to see a cardiologist who said his heart was good on 04/30/2021. He passed away on 05/06/2021 in his sleep. Please help.

Many years ago my left ear would break out, starting with an itch and progressing into an open wound. My doctor told be that if I had chicken pox as a child that was more than likely have residual effects from the pox. This would happen once or twice a year. Ever since my second shot not both ears break out weekly including enlarged nymph nodes. I have also am experience allergic reactions that have been dormant since my early 30's. Both of my ears become inflamed and then break out into an open sore/

About 4 hours after the second dose I began the most intense headache I have ever had. I kept expecting it to go away. After 10 days of enduring this I went to the ER. I was admitted with blood clots and bleeding from the face. (but probably more wrong) I was initially treated for a PE and meds to try to stop the headache. Nothing seemed to work. About 3 days into the hospital stay, my pre-existing Stills disorder began to show. I was then treated with 60mg of prednisone daily to control the Stills. About the same time, we discovered that a standard migraine medicine would control the extreme headache, morphine would not. My CRP results were off the charts and almost 4 months later it is still high. My treating doc says 2 more months of prednisone treatment. I had an immediate weight loss of 25 pounds in the hospital. I am struggling to this day to put the weight back on. I have lost hearing in my left ear as a result.

Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness Narrative: Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER

Excessive swelling and Hives on right side of face, right eye, neck back, right arm. Benedryl 25mg, at 11pm. EpiPen injection at 12 midnight. continued 50mg benedryl on 1/8; continued 50mg benedryl on 1/9 and Cetirizine 10mg. 1/10 10mg Cetirizine; 1/11 10mg Cetirizine 1/12 Patient is calmer and swelling is decreasing; pimply rash on forehead and top of head. Followup with Pharmacist phone call on 1/11

When I received vaccine I had a uri/sinusitis illness without fever. One day later I had body aches, chills, headache, no fever, these symptoms lasted 2.5 weeks. 2 days after receiving vaccine I had scrotal and ankle edema and a 3 kg weight gain that lasted 5 days. I also developed a worsening of uri and cough symptoms, which now 3 weeks later are slowly resolving

Chest tightness, Body Aches and Pains, Headache, Fatigue, inpaired decision making, swollen lymph nodes, lost of appetite, chills, vision had yellow color, and just feeling unwell.

12 hours following the injection I developed a severe anaphylactic reaction including extreme swelling of lips, tongue, soft palate; difficulty breathing when reclined; difficulty swallowing and difficulty speaking coherently. My wife called 911 and I was transported by ambulance to the ER at Hospital. While enroute I was given epinephrine and Benadryl. I was admitted to the hospital overnight for observation. On February 4th I was evaluated by an allergy specialist who ordered a RAST blood test for food allergies since I had eaten shrimp that day. Tests for all food allergies were negative.

Lymphadenopathy. Twelve hours after injection, noticed soreness in left armpit. Now, 47 hours later , slight swelling and still discomfort. Twenty minutes after first notice of pain, I started getting chills. I took Tylenol and the chills subsided. Temperature was 99.7 degrees. No chills or fever after 24 hours from injection time.

I have a swollen armpit in the right arm in which I received the shot. It is sore but I have no other adverse symptoms at this point.

Evening of vaccine administration and still ongoing 2 weeks later - headache, chills, fatigue, achy, SOB on exertion, occasional tremors, dry cough which has subsided considerably. 1 1/2 weeks out hives again covering entire body and not subsiding with 50 mg Benadryl every 6 hours. 2 weeks - sore throat and swollen glands

Pfizer first vaccine- high fever, body tremors, chills, delirious, oxygen 82 heart rate 130, blood pressure extremely high, ambulance called and he was rushed to critical care ER. He has sepsis, kidney function worsened, on BiPap. He was absolutely fine prior to vaccination. He is still. in isolation Hospital as of the date of this report. May have aneurysm in leg as well.

Patient e-mailed provider on 3/1/21 - "I have pretty good inflammation in my mouth, lips, face, throat, shoulders, neck and knees. Eyes fill a little weird too. I also feel a bit fatigued and lack interest in normal Monday morning activities"; It was recommended pt tx s/s with Loratadine and diphenhdramine. On 3/15/21, pt said swelling was better but he now had a rash on the front of both shins as well as a bruise on the top of his right foot and his left thigh. CBC drawn 3/16/21 showing platelets of 40k.

admitted to the ICU with acute respiratory failure. h/o DM and HL, prior h/o smoking and EtOH and opium abuse (none x 28 yrs, per family). Received second dose of the Pfizer COVID vaccine in AM of 3/16, having had severe adverse reactions (fever up to 104, n/v) to the first dose three weeks earlier. Experienced recurrent fevers (up to 103) beginning by the evening of 3/16, for which he took acetaminophen. Awoke at 3 AM w/ recurrent fevers, for which he took ibuprofen. Felt better in AM, had breakfast, and retired back to bed. Awoke shortly after noon w/ severe n/v and AMS. Was brought to the ED by the EMS. Febrile (T 39.6) w/ rigors, tachycardic, tachypneic, and poorly responsive on arrival. Continued to experience episodes of emesis, and was felt to have possibly had a seizure episode ("looked to the side and was shaking"; no clear tonic-clonic movements noted). Was thus intubated for airway protection. Initial laboratory w/u revealed presence of mild leukocytosis (WBC 12.6, 47p49L0Eo), lactic acidosis (LA 5.2), hyperglycemia (glu 297), elevated lipase level (161) renal insufficiency (Cr 1.23). extubated on 3/19. received antibiotics for positive blood culture (streptococcus parasanguinis). diagnosis: ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE

Patient was admitted to the ED with left deep peroneal vein thrombosis on Feb. 9 2021 after patient noticed prolonged edema in both ankles. Patient started talking 10 mg of Eliquis twice a day on Feb. 11, 2021. And on Feb. 17 2021, 2 more blood clots were found in the patient's peripheral veins within the limbs. Patient descreased dose of Eliquis to 5mg twice a day on Feb. 18 2021. Patient continues to take 5mg of Eliquis twice a day.

Patient is a 69 y.o. male patient who originally presented to the hospital on 3/23/2021 due to shortness of breath. Patient had 1 week of shortness of breath. He starts experiencing 2 weeks of pain in edema right lower extremity. Did notice increasing dyspnea on exertion. Was noted to have bilateral PEs with evidence of RV strain on CT scan. She admitted to the ICU on heparin drip he did undergo tPA. Echocardiogram documented to be improving. Patient now baseline ambulatory in the room without oxygen stable.

multiple deep vein thrombosis of left lower leg, started on Xarelto, hematology referral, swelling improving

On 04/06/2021: Headache, overall body ache, exhaustion - dissipated by midday 04/07/2021; On 04/08/2021: Numbness in lips upon awakening (dissipated by afternoon), overall body ache, itchiness everywhere; On 04/09/2021: Bright red flush in face, back, legs, and hands; puffiness in face and hands; continued itchiness over all parts of body;

Patient developed ascending lower extremity weakness ultimately requiring hospitalization with clinical diagnosis of Guillain-Barre syndrome.

The patient is a poor historian and history is obtained from him and his partner. His symptoms have started yesterday after receiving the second dose of a Covid vaccine. The couple went to eat a meal of Chinese food, and that evening the patient developed persistent nausea and vomiting. He had multiple episodes of emesis. According to his partner, he continued to have episodes of emesis this morning. The emesis was nonbilious and nonbloody, described as watery. The patient says he woke up this morning and may have felt some palpitations. He thinks the palpitations may have been worse than usual. He says he generally just felt unwell. He could not get out of bed and move around very much due to the nausea and vomiting. He says that for this reason, he activated EMS who brought him to the hospital. Regarding his atrial fibrillation, he says he is mostly compliant with taking his medications, however he did not take any of his home medications today.In the ER, he was hypertensive to 141/111 and tachycardic to 141, tachypneic to 23. His heart rate went up to the 170s and he was given multiple doses of IV metoprolol. On labs, he had a leukocytosis with a white blood count of 12 and the D-dimer was elevated greater than 20. CTA was obtained to rule out pulmonary embolism which was negative. However, down in the scanner he developed an episode of unresponsiveness with questionable seizure symptoms. He was treated with an LR bolus 500 cc but due to the findings of increased pulmonary vascular congestion, was diuresed with Lasix 80 mg IV x1. Blood cultures x2 were obtained.

Incident 1: Evening of March 15, noticed itching at top of anus. This progressed to intense itching of the scrotum and testes as well as swelling. Antihistamine (Fexofenadine) oral was taken and symptoms resolved over a couple of hours. Morning of March 16 noticed swelling near penile head which was not painful which resolved over the course of the day. Incident 2: 4/14/2021 evening, noticed itching of left buttock - clear soft swelling which could be seen as a raised area; antihistamine treatment led to resolution. Incident 3: 4/20/21 morning. Eating breakfast and noticed left side of mouth especially tongue was numb/swollen, progressed to where had difficuty pronouncing words and was quite scary; took antihistamine and resolved over a couple of hours. Seemed as though it was borderline anaphylaxis but did not progress to throat tightening or difficulty breathing.

Patient developed upper extremity weakness starting two days after first dose of pfizer vaccine progressing to the point of being unable to lift arms. Was hospitalized and apparently treated with Prednisone and then re-hospitalized on 4-22-21. He has absent reflexes in upper extremities with 1/5 shoulder strength bilaterally, normal strength and reflexes in lower extremities. Seen by neurology who feels presentation consistent with an atypical form of Guillen Barre or Acute Inflammatory Demyelninating Polyneuropathy.

Blood clots; Delirious; Oxygen was down to 80%; Sepsis; E. coli/sepsis with cultures of E. coli; C-diff; sick; Shaking uncontrollably; Achy; Extremely high fever/a high fever of 103 F; Chills; Aneurysm in his leg; Bleeding from somewhere; weak; missed his second dose of the Pfizer COVID-19 vaccine; Caller says her husband's kidney was failing too while he was in the hospital; This is a spontaneous report from a contactable consumer reported for her husband. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 11Mar2021 18:00 (Lot Number: EV6206) as single dose for covid-19 immunization. Medical history included Kidney transplant from 1998, same kidney all these years, on immune medication, polycystic kidney disease from 1998, the transplant saved him in 1998, blood pressure high went along with the polycystic kidney disease, had it for a while, Type 2 diabetes mellitus this was diagnosed probably about four years ago and immunocompromised. There were no concomitant medications. The patient had the first dose of the Pfizer vaccine on 11Mar2021, "he felt okay first evening, Friday was okay, Saturday 13Mar2021 achy, Sunday running a high fever of 103 F, he started to get chills. Then Around 3am (Early Monday on the 15Mar2021) called the ambulance, oxygen was down to 80% he was shaking uncontrollably, temperature was still 103 F when they took it and even at the hospital was the same temperature. He was delirious on 15Mar2021. When he got to Emergency Room he was in critical section, had to put on BiPAP with 100% oxygen, When in the ambulance they tested for covid and was negative each time he was tested for covid he was negative. He was in the hospital from 15Mar2021 to 24Mar2021, in critical care unit. He Turned out having sepsis, E.coli, had to put him on strong antibiotics. He developed CDIFF on 15Mar2021, and an aneurysm in his leg in Mar2021 and needed a blood transfusion. They were trying to rule out blood clots and did sonogram and found it. His blood was going down, he was bleeding from somewhere and had to have a transfusion. They did a procedure on the leg to break up the aneurysm twice. On BiPAP for a few days and then did the medium one and then able to take off oxygen when he went home. He came home on antibiotics and tons of medication. Should he get the second vaccine? Is it related? Is it to late to get the second vaccine? following Sunday he had an extremely high fever and was shaking uncontrollably on 14Mar2021. He was told to get the shot by his provider. She had to call an ambulance, he almost died, and she didn't know if it is related to her husband getting the vaccine. They put her husband on a BiPAP with 100% O2 when he went to the hospital by ambulance and was admitted on 15Mar2021, which he was on the BiPAP a couple days then went on to the second level, then right before he came home he was weaned off of oxygen. They kept testing him for COVID every day, because the symptoms were similar but they tests kept coming up negative. On 15Mar2021, the patient had sepsis, with cultures of E. Coli, and very contagious C-diff, he was sick from the 15th to the 24th for all those things. She didn't know if the vaccine brought it on if it was brewing in him before that, or if it had to nothing to do with vaccine. He also had an aneurysm in his leg and had a medical procedure where they had to go in and take care of it to break up the aneurysm. The patient's kidney was failing too while he was in the hospital. The patient missed his second dose of the Pfizer COVID-19 vaccine due to his hospitalization from 15Mar2021 to 24Mar2021. She would like to know if it would still be recommended for the patient to get the second shot of his COVID-19 vaccination since he is past the deadline to get it, is it going to be too late for him to get the second dose to be fully vaccinated and effective to get it after waiting this long? His first dose was injected about 06:00PM in unknown arm. The patient had a fever Saturday evening, clarified to being 13Mar2021, which was higher the next day on 14Mar2021 and reached 103 degrees Fahrenheit, and he went to the hospital by ambulance at 03:00AM 15Mar2021. His fever started getting higher late Saturday to Sunday and he got progressively worse. The patient had had serious complications before related to his health problems, but she had never had to call an ambulance before this. The patient had chills on Saturday 13Mar2021 and then Sunday evening he was shaking and it wouldn't stop so she gave him Tylenol, then she called the ambulance Monday morning. The patient can't take anything more than Tylenol, and he never usually takes anything. The patient's kidney function was getting bad while he was in the hospital, his Creatinine went high and was 3.8, which is high for someone with a transplant. The patient was doing better, he was still very weak, he was under a doctor's care, he was on very strong antibiotics for a month, Vancomycin and other medications which also make him weak. The patient was on IV antibiotics at the hospital and then came home on oral. The 3.8 for the Creatinine was probably at the beginning when he went into the hospital. The outcome of the event Sepsis was Resolved with Sequel and the outcome of the other events was unknown.

Death A41.50 - Gram-negative sepsis, unspecified K81.0 - Acute cholecystitis E86.0 - Dehydration E83.42 - Hypomagnesemia N39.0 - Urinary tract infection E87.2 - Respiratory acidosis R06.89 - Hypercarbia T85.518A - Cholecystostomy tube dysfunction, initial encounter D72.829 - Leukocytosis, unspecified type

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Swelling in both hands; This is a spontaneous report from a contactable consumer, a patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) on 10Mar2021 at 02:00 pm (at the age of 69-year-old) on right arm as a single dose for COVID-19 vaccination. Medical history includes heart condition from an unknown date. The patient had no known allergies. Concomitant drugs include Apixaban (ELIQUIS), Motropolo(MANUFACTURER UNKNOWN), Amiodarone(MANUFACTURER UNKNOWN) and Stain(MANUFACTURER UNKNOWN). Patient was not diagnosed with COVID-19 prior to the vaccination. Patient has not tested for COVID-19 since having the vaccine and did not receive any vaccine 4 weeks prior to COVID-19 vaccination. The patient experienced swelling in both hands on 15Mar2021.Therapeutic measures for swelling of both hands includes Script for steroid pack and Benadryl on an unknown date. The clinical outcome of swelling in both hands was recovered/resolved. Information about lot/batch number cannot be obtained. No further information is expected.

Next day, periorbital angioedema. Lasted 1 day. Pre-treated with cetirizine and montelukast for second dose and no symptoms noted.

cold sores, at least 2/3 of the way around his lips; This is a spontaneous report from a contactable Consumer (patient). This 69-year-old male consumer reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 09:50 (at the age of 69-year-old) as single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, and bleeding ulcer (Feb2021). No concomitant medications were reported. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient received no other vaccine on the same date with Pfizer vaccine. Patient received no prior vaccination within 4 weeks. It was reported that the patient called about COVID vaccine. He had the first dose on Saturday 13Mar2021 and yesterday, on 15Mar2021, he broke out with cold sores, at least 2/3 of the way around his lips. He did not have a cold sore in years and usually it would just be one small one. The patient wanted to know is this a side effect of the vaccine. He looked on the internet, but it just had common side effects listed. No emergency room visit, or physician office visit required for the event. No relevant tests were performed. When querying weight, he stated he had some problems recently and he lost 15 lbs. It was reported that the patient had scheduled for blood check for his diabetes, next week. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

PAIN IN LOWER RIGHT LEG (STARTED 6/03/2021) CLOTS FOUND VIA ULTRASOUND SCAN (6/08/2021) LOVENOX INJECTIONS FOR 7 DAYS (120MG SUBCU) ELLIQUIS RECOMMENDED FOR 3-6 MONTHS (5MG 2X/DAY ) CURRENTLY STILL UNDER TREATMENT AS OF 6/19/2021

Stiffness in left arm, fever, extra warmth at injection area, muscle soreness (next day), fever (next day), body aches, muscle weakness in left arm, swelling in left arm, skin flushed area at injection site

The adverse reaction started as a cough. I've had a cough before the vaccine so it's been a few months. I went in for a routine blood draw in May and the results showed that my white blood cell count was high and now I have Mantle Cell Lymphoma. Since it's a rare strain, I was referred from hematology oncology. I will go to my first appointment on 07/07/2021 and there, I will find out treatment options.

Within one day, Muscle pain in legs and muscle weakness in legs. Legs felt "heavy" and weakness is progressive; pain resolved in about 2 weeks, balance/walking unsteady, trunk muscle weakness, fasiculations both quadriceps, swelling of lower legs, espec. right, pins and needles feeling bottom of feet with pain walking diagnosed as peripheral neuropathy. As of 7/10, muscle weakness in legs progressing and can't be on feet more than 20 minutes

Pruritis; Urticaria Severe itching wrists, lower arms. Severe itching lower legs with swelling of legs.; Urticaria; Pruritis; UrticariaSevere itching wrists, lower arms.Severe itching lower legs with swelling of legs.; Pruritis; Urticaria Severe itching wrists, lower arms. Severe itching lower legs with swelling of legs.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 21Mar2021 at 11:45 (at the age of 69-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes hypertension. Concomitant medications include omeprazole, amlodipine besylate and diphenhydramine hydrochloride (BENADRYL) taken in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261) via an unspecified route of administration, administered in left arm on20Feb2021 at 12:30 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. Patient had no known allergies. Patient received no any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. On 22Mar2021, the patient experienced pruritus; urticaria severe itching wrists, lower arms, severe itching lower legs with swelling of legs. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was initiated with Kenalog 40 mg injection. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Multiform, extremely pruritic red, raised rash. wheals ,angio edema Initially thought to be scabies and treated for 2 weeks PHCP referred to Dermatologist referred to Allergist Started Tx's: Permetherin - 2 courses, approximately 4.15.21 Prednisone x 12 days, Kenalog 40 IM by Dermatologist then Pepcid, Zyrtec, Singular, Hydroxyzine, Kenalog Cream- no long-lasting relief Pepcid, Zyrtec, Hydroxyzine- doses doubled - by Allergist

Approximately 2 weeks after vaccine administered, I started getting prickly, sore sensations in my feet and legs. Mostly feet. I asked my GP if it's possible that the vaccine could cause this. He said it's possible, but not likely. My feet became quite tender, almost like shingles pain. Doctor gave me 6 day course of prednisone for my earache, and said "we'll possibly kill two birds with one stone". The prednisone helped with the ear problem, but not the prickly, stabbing sensations. So, I went ahead and got my second covid vaccination on 2/13/21 and the problem didn't get any worse or better.

Pain in Right and left shoulder/Pain in my joints and right knee; Wrist and fingers swollen and numb; Wrist and fingers swollen and numb; Pain in right arm and hand; Wrist and fingers swollen and numb; Over all general weakness; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 07Apr2021 at 09:00 as single for covid-19 immunisation. Medical history included enlarged prostate. Concomitant medications included finasteride at 5 mg and doxazosin at 2 mg. No known allergies present. 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. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, 69-years-old at the time of vaccination) via an unspecified route of administration, administered in arm right on 17Mar2021 at 06:00 as single for covid-19 immunisation. On 23Apr2021 at 12: 00 am, patient experienced pain in right and left shoulder, pain in right arm and hand, right hand, wrist and fingers swollen, and numb, left hand wrist and fingers were beginning to swell, pain in his joints and right knee and over all general weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability, or permanent damage. Patient did not receive any treatment for the events. Outcome was not resolved for all the events. Was requested for additional information.

Itching; Inflammation of the face with small bumps, painless but itchy; Inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw; Swollen lymph nodes; Rash; Hives; Swelling of the face; acute allergic reaction; lymphopathy; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Jun2021 18:00 (Batch/Lot Number: EW0196) at age of 69-years-old as single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included metoprolol received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient experienced swollen lymph nodes, rash, hives and swelling of the face on 25Jun2021 with outcome of unknown, inflammation of the face with small bumps, painless but itchy/some lumps on his face on his cheeks and under his jaw on 25Jun2021 07:00 with outcome of not recovered, itching on 25Jun2021 07:00 with outcome of recovered in 2021, all reported as medically significant. AE resulted in Emergency or urgency room/department. Treatment to against allergy was received. Clinical course reported as follow: Patient received the first shot of the Pfizer Covid-19 vaccine on 24Jun2021 and the next day he had an allergic reaction. He went to withheld Hospital in withheld to the emergency room because his face was swollen and he had some lumps/"bumps" on his face on his cheeks and under his jaw. The treatment he received was diphenhydramine (BENADRYL) 25 mg oral capsules, oral tablets (2 tablets a day for 4 days); Prednisone 20 mg oral tablets, and Hydrocortisone topical 0.1% cream. He had to take 2 tablets of Prednisone 20 mg for 4 days. He took the treatment for 3 days and now has stopped it. He no longer has the itching he previously had. He had internal swelling on the face, like if the swelling was coming from his glands. He currently has no itchiness swelling was internal, like lymph nodes. The diagnosis the doctor gave him was acute allergic reaction (2021) and they described it as itching on the face and swelling. He was due to get his second dose of the COVID-19 vaccine on 15Jul2021. He needed to explain that the swelling on his face was supposed to be on his neck but because of an allergic reaction, he got this on his face. It was called lymphopathy (2021). The lymph nodes were supposed to come out on his neck but nothing came out on his neck, they came out on his face was what the doctor were informed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Swelling under nose and under the lower lip along with redness. Client released home after evaluation by onsite paramedic and physician at 3:43 pm.

Narrative: Patient seen in ED 1-17-21 with c/c of "bloated with epigastric pain". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been "feeling kind of bad all day". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report.

Reactive arthritis affecting the hands (left more than right) and right knee and ankles. Given toradol in ER. Given prednisone taper on 1/21/21. No outcome yet

On 1/24/2021 states on that Sunday his tongue became numb and developed pain behind right ear. Took ibuprofen, went to bed that even. When he awoke the next morning, Monday, 1/25/2021, the right side of his face was disfigured, puffy, and his mouth was drawn down. He drove to family member approximately 1 hour away and upon arrival, family member took him to local hospital. MRI was completed and returned with diagnosis of Bell's Palsy, which was confirmed by three physicians at the hospital. Was informed may take 6 - 8 weeks for full recovery. Was discharged with prescription for Lacrilube eye drops, Vibramycin, Prednisone (Deltasone), and Valtrex. One 1/29/2021 had follow up visit with neurologist and was told to discontinue Prednisone. Neurologist researched injection follow the 1/29/2021 visit. Client received call from neurologist on 2/1/2021 and was instructed was able to take second dose of vaccine, physician was not 100% sure same issue would not occur with second dose.

Hospitalized for community-acquired pneumonia and sepsis 6 days following administration of COVID-19 vaccine, complicated by acute hypoxemic respiratory failure and acute kidney injury requiring. Admitted to ICU, treated with intravenous antibiotics and initial pressor support. Intubated on hospital day #3, extubated on hospital day #8. Remains in ICU at time of this report.

Patient felt fine until time of first vaccine on 1/4/2021 after which he developed fatigue and fever and then developed a cough. Started cefpodoxime x 3 days, further work up included chest xray with no findings on 1/11/21 and a chest CT on 1/13/21 with large lower lobe consolidation. He was directly admitted on 1/13/21 for pulmonary abscess. On admission he had leukocytosis and fever of 103. Workup did not identify an infectious cause but raised concerns for an auto immune cause such as Wegener Granulomatosis. Remained febrile for about 14 days

Hives - Rash all over my back , arms , legs . also itchy welps and bumps everywhere . swollen left hand with red bumps in the palm of my hand.

Pt develops left leg pain The day after vaccination in AM subsequently drove approximately 150 miles On his way back stopped at his brothers place for lunch. He then collapsed coning down the steps, EMS started CPR. took him to ER Resuscitated briefly but went into CardioPulm Arrest again and PEA Resucitaion for aprox 1 hour but was unsuccessful. Noted to have Left leg more swollen than Right by 3 to 4 CM presumed to have died from massive Pulmonary embolism and inferior wall myocardial ischemia

Widespread body itching, hive like bumps, very itchy. Started 3 - 4 days after injection. It is ongoing as of one week after injection. Have used topical Benadryl cream on a couple locations.

My arm hurts. My arm is hot. My arm is not red so I do not suspect infection. No fever. My arm is hard and swollen.

Slight swelling of toes (first on right foot and ca. one week later of a couple on left foot) accompanied by blotchy appearance and tenderness and inflammation. Blistering sort of phenomenon (although no open sores). Looks the same as what I see on internet as "COVID-toes", although I've not seen any sign of it as a reaction to the vaccine itself.

large lower extremity deep venous thrombosis and small pulmonary embolus; outcome: responded well to anti-coagulants, with decreased pain, swelling and improved oxygenation

On Jan 27, 20021, I fell and have a displaced fragment of the 5th metacarpal base. About 34 hours after my shot, I started feeling discomfort from my fracture. By 36 hours I had great discomfort and pain with some swelling. More pain than with the original fracture /fall. Talked with vaccine hotline at around 36 hours after shot. They advised I talk with Doctor. I did call doctor. He advised elevation, two ibuprofen and on Tylenol every 4 to 6 hours. I did that. Now 48 hours out from shot, extreme pain gone; Have swelling and discomfort. Only took two rounds of ibuprofen and Tylenol.

I woke up with slightly itchy, severe skin rash on 2/23/2021 following second vaccine injection at 10:58 am on 2/21/2021. The rash completely covered both buttocks, the top front inside of both thighs, both hips, the front groin area, inside/bottom of both feet. Given the extent and intensity of rash, it must have started on Monday 2/22/2021. The rash was red-purple with white spots (perhaps hives). I contacted my primary care physician's office on 2/23/2021 and had a televisit with the nurse. Her diagnosis was Allergic Dermatitis/Itching. She prescribed Banophen (50 mg), Triamcinolone cream, and Cetirizine HCL (10 mg). I took the medicine. Continued below.

today he presents with complaints of dyspnea at rest, associated with a cough, abdominal and scrotal edema and bilateral leg edema. He also reports getting his 2nd COVID vaccine yesterday which causes him to have a 102 temperature and worsening cough. He reports a 30lb weight gain since January. He was on tikosyn for AF rate control which was recently stopped, but he was unsure why. He was regularly using CPAP machine, but stopped using about last year due to concerns with coronavirus. He was previously active going to the gym which she is also stopped during the pandemic due to inaccessibility

Patient reported for immediate care visit with complaints of body aches, fever and chills on 3/12/21 that began four days prior eyes have become puffy swollen and red. Facial swelling also reported. Tested negative for Covid, Treated with PO benadryl. Of note patient with history of previouos conjuctivitis in 2019, hx of glaucoma, and cataract

Swelling; Redness; minor Pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, vaccine location: left arm), via an unspecified route of administration from 29Jan2021 12:45 PM to 29Jan2021 12:45 PM at a single dose for COVID-19 immunisation. The patient medical history included COVID-19 (if covid prior vaccination: Yes). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included nortriptyline, levothyroxine and celecoxib (CELEXA) and other vaccine same date product (Pfizer product, lot number=EL3247), on 29Jan2021 (dose number= 01, vaccine location=left arm). Patient previously took allopurinol, Bactrim and experienced Allergies. Since the vaccination, Patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date. The patient experienced Swelling, Redness, minor Pain (non-serious) on 31Jan2021. The outcome of events was not-recovered. Information on the lot/batch number has been requested.

Patient has a progressive dry cough and dyspnea on exertion that started a few days after receiving the second dose of the COVID vaccine. He received a 10 day course of doxycycline for CAP as an outpatient without any improvement, hence he was admitted to the hospital for further workup. CT scan was performed revealing findings concerning for ILD. Of note a CT done in 2018 shows some possible early signs of ILD. Pulmonology is seeing the patient and he was started on steroids today (3/17/2021).

Chills and fever twenty fours after receiving second dose followed by slight swelling and redness in left upper arm. Swelling and redness still exist as of 03/19/2021

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on rump x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to the hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

Fever, low oxygen saturation, severe encephalopathy, kidney failure, bilateral pulmonary infiltrates, sepsis, tachycardic, acidotic, intubated on ventilator since admission, paralyzed/sedated, ABG results showed high CO2 and O2 retention, edema, electrolyte imbalance, ARDS, low hemoglobin and hematocrit levels, blood transfusion needed

CHEST PAIN WEAKNESS - GENERALIZED Hyperkalemia Lactic acidosis Hyponatremia SEPSIS EKG abnormalities Acute kidney injury (CMS/HCC) Neutropenia (CMS/HCC) DEATH

Adverse events: Fever (104 degrees Fahrenheit unresolved by medication) Fatigue Weakness Confusion High Blood Glucose (350) Loss of motor control (shaking, inability to hold posture or to sit, stand, or walk without assistance) Elevated white blood cell count Low blood sodium Lab results indicating liver health were not good Jaundice Treatments: IV saline solution, antibiotics, steroids, increase Prednisone, change intake of insulin Outcome: The patient returned home after a week of hospitalization experiencing less confusion and no fever. Motor function has improved since hospitalization and complexion shows less jaundice. Liver numbers have improved and the patient has decreased Prednisone dose. The patient still experiences fatigue and body weakness.

Pt reported he was in his usual state of health, back to work following his surgery in Dec 2020 for intraabdominal abscess s/p small bowel resection when he reported sudden nausea developing the day after his second covid 19 vaccination which continued to progress to then development of abdominal pain resulting in ER visit on 3/20/2021 with resultant hospitalization(still hospitalized as of 4/2/21 with working diagnosis of mesenteric ischemia and AKI.

I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I couldn't walk, sit, or lay on that side; I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed; I'm unable to work at my physical part-time job, and have extreme difficulty sitting for 8 hours for my banking job; It hurts to stand too long; I'm miserable; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at11:15 (at the age of 70 years old); (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included stroke, high blood pressure, overweight. The patient has no known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)), ; lisinopril (LISINOPRIL); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); atorvastatin (ATORVASTATIN). Facility in which the vaccine was a Public Health Clinic. No other vaccines were given. Since the vaccination the patient had not been tested for COVID-19. On 06Mar2021 at 18:00 The patient experienced Bursitis, Pain in hip, Unable to walk, Pain, Impaired work ability, Difficulty in standing and Feeling miserable. The events were reported as a disability. The clinical course is as follows The day before, the patient was totally healthy. Day after, I have excruciating hip pain in which the patient's doctor diagnosed as bursitis of the left hip. I couldn't walk, sit, or lay on that side. I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed. Oxycod/Acetamin only barely takes the edge off. The patient was unable to work at his physical part-time job, and have extreme difficulty sitting for 8 hours for his job. It hurts to stand too long. In short, I'm miserable and need help. The adverse events resulted in Physician Office Visit . Treatment given for the events include alternate hot/cold packs, oxycodin/acetamin. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.

Per triage note of 4/7/2021: "Chief Complaint: pt presents with Nausea & vomitting, ha, body ache, unable to sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020" Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021 Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV. Patient transferred to Medical Center 4/7

Patient had swelling of face/puffy eyes, came to ER and admitted, and was treated as facial cellulitis -- but there could be an element of angioedema

Received first injection Jan 12, 2021. RT Arm pain and mild headache, resolved in 48 hours. Second injection Feb 2 had similar pain in other arm. Then developed adenopathy in anterior cervical chain of neck. This expanded and pushed against Portocath in lot IJ. On Feb 22, 2021 a CT was preformed that showed several nodes in the neck, largest 4.5 cm, as well as 2.5 cm in rt axilla. No hilar adenopathy. The large node enlarged to 7.5 cm and was biopsied on Apr 9, 2021. The report came back that this is a malignant transformation of Marginal Zone Lymphoma to Large B-cell Lymphoma.

I26.99 - Pulmonary emboli (CMS/HCC) J18.9 - Atypical pneumonia N17.9 - Acute kidney injury (CMS/HCC) R73.9 - Hyperglycemia A41.9 - Sepsis (CMS/HCC)

26 DAYS AFTER 2ND SHOT - PAIN in upper arm/thigh/buttocks. SEVERE in the morning/lesser in evening. Difficult to raise arms/stand up/sit down/roll over in bed. Has gotten much worse. Also FATIGUE. Been working with the clinic. Still waiting for any relief.

thumb swelled; This is spontaneous report received from contactable consumer A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration on left arm on 22Jan2021 at single dose for Prevention of COVID-19 pandemic. The patient medical history included kidney problems. The patient concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266), via an unspecified route of administration on left arm on 12Feb2021 at single dose for Prevention of COVID-19 pandemic. On an unspecified date, thumbs swelled after he received his first COVID-19 Vaccine. The next week, patient had swelling in both of his hands. The following week, patient hand swelling got worse, and had pain with the hand swelling. The third week, the patient went to a doctor at a place where he could get an appointment the same day and then went to his primary care doctor. The patient continued to have hand swelling, and then he was taken to the Emergency Room. The events resulted in Emergency Room visit. The patient had to go to a Rheumatoid Arthritis specialist and then this morning patient woke up, and half of his face was swollen. The patient hands swelled after his second COVID-19 Vaccine, it progressed from a little bit of swelling to lot of swelling. The Pain of the hands on the scale of 1 to 10 is reported as 3 or 4. The relevant lab test included doctor did tests on patient for Rheumatoid Arthritis and Bursitis, and both tests were negative. The Emergency Room doctor did an ANA test that was inconclusive, and an ESR test that was negative. The patient's primary care doctor gave him more lab tests, and did another Rheumatoid Arthritis test, which was negative. The treatment included Prednisone and his hand swelling went down for 3-4 days. when patient stopped the Prednisone, the swelling in his hands came back. The patient primary care doctor provided the patient with Rheumatoid Arthritis medicine to take, but patient stopped taking the medicine after 2 days. The patient received the Colchicine twice because he was been told not to take it anymore. So, they repeated that (Colchicine) if it was arthritis then it would help and it would go down but it did not and they told him to stop taking it. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Follow up (02Apr2021):Upon follow up, new information included anatomical location details, lot details,treatment details like colchicine.

At about 10:09 AM on Wednesday, April 14, 2021 I received my second dose of the COVID-19 Pfizer Vaccine. At about 5:06 AM, the next morning of Thursday, April 15, 2021 I awoke with a swollen, reddish and painful big toe and upper foot with the pain centered around the lower joint of the big toe of the right foot. I did not know what caused the condition. Origninally, I guessed that I had somehow sprained my foot or had a blood clot. After searching the internet, I found informaton regarding gout - The symptoms exactly matched my symptoms. Additionally, afterwards, I discovered an article in Podiatry Today that reported gout attacks after vaccinations.

I started feeling discomfort from my fracture. By 36 hours I had great discomfort; pain with some swelling.; pain with some swelling.; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), second dose via an unspecified route of administration, administered in right arm on 25Feb2021 07:45 as single dose for covid-19 immunization. The patient was 70 years old at the time of vaccination. Medical history included osteoarthritis and on 27 Jan2021 patient fell and have displace fragment of the 5th metacarpal base. Patient had no known allergies. On 04Feb2021 at 8:00 am patient received first dose of Bnt162b2 (lot number EL9265) in right arm. The patient was not test positive for Covid prior to or post vaccination. Concomitant medications included ROSUVASTATIN, FAMOTIDINE, AMLODIPINE BESYLATE and losartan potassium (LO), all taken on unspecified date and unknown if ongoing. On 26Feb2021 about 34 hours after the shot on 25Feb, the patient started feeling discomfort from his fracture. By 36 hours he had great discomfort and pain with some swelling. More pain than with the original fracture /fall. Talked with OSU vaccine hotline at around 36 hours after shot. They advised he talk with Doctor. He called doctor and was advised elevation, two ibuprofen and on Tylenol every 4 to 6 hours. He did that and after 57 hours out from shot, extreme pain gone, have swelling and some discomfort. Not yet to pre-shot levels of comfort but great improvement. Only took two rounds of ibuprofen and Tylenol. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

THE DAY AFTER THE VACCINE I AWOKE WITH A LUMP ABOUT 1/4 INCH BELOW THE INJECTION SITE. THE LUMP LOOKED LIKE (IN SHAPE AND SIZE) AN EGG CUT LENGHTWISE AND PUT UNDER MY SKIN. THE LUMP FELT LIKE A DR SCHOLLS SILICONE GEL HEEL PAD INSERT. THE SITE WAS ONLY VERY SLIGHTLY SORE. IT IS OVER SIX WEEKS AND THE LUMP HAS NOT GONE DOWN OR CHANGED AT ALL IN ALL THIS TIME. OCCASIONALLY THE SITE IS SOMEWHAT SORE WERE THE LUMP IS. I REDIEVED MY SECOND INJECTIION IN THE RIGHT ARM AND HAD ONLY VERY SHORT LIVED MINOR SEWELLING.

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on butt x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot. Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

Blood clot in right foot. Swelling. I didn't immediately consider the possible connection to the Pfizer vac. Sorry for the delay.

Patient describes upper arm pain starting early April. Was seen by physician 5/12/2021 for generalized muscle aches, weakness and pain. Patient was diagnosed with Polymayalgia Rheumatica based on elevated CRP/ESR and started on prednisone 15mg daily .

Polymyalgia Rheumatica; had a fever of 100; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; Severe morning stiffness; ESR (sedate) was 52 mm/hr; C reactive Protein 32.3; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 06:00 (Batch/Lot Number: Unknown) as 2ND DOSE, single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; tamsulosin hydrochloride (FLOMAX) taken for an unspecified indication, start and stop date were not reported; lisinopril dihydrate (PRINIVIL) taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 (as reported), the patient had a fever of 100 after the second shot for one day and then he felt fine. About 6-7 day (on 03Apr2021, as reported), he started having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck. On 03Apr2021 (as reported) he experienced severe morning stiffness to where he couldn't even put on socks. He went to the doctor and had blood test drawn on 03Apr2021 with the results: "ESR (sedate)" was 52 mm/hr C reactive Protein was 32.3; he was diagnosed with Polymyalgia Rheumatica on 03Apr2021 (as reported). He was put on Prednisone (15mg) and within a few days he felt much better, but his doctor said he has to be on this from 6months to a year. The outcome of event "had a fever of 100" was recovered on 04Apr2021; Outcome of all other events was reported as recovering. It was reported that the patient receive treatment for all events. Follow-up attempts are completed. The following information on the batch number has been requested.

After second vaccine had body aches and joint pain. Three week later had swollen feet and high heart rate.

Patient is a 70 year old male with past medical history of HIV (most recent CD4 count 378/ viral load negative on 3/31), latent TB treated in 2019, alcoholic cirrhosis, Hypercholesteremia comes in from his neurologist office for concern for AIDP, CIDP. His symptoms started back in March of this year. He received his COVID vaccine (second dose) on March 6th and then went on a trip out of the country where he went deep sea fishing from March 7-15th. Three days later, on March 18th he developed a flu like illness, fevers, chills, headache, cough and diarrhea one week later. His COVID test at that time was negative. He reports that he drank the water in other country and also used ice cubes at smaller restaurants when he went out to eat. He denies eating any raw/ uncooked foods. His wife states that he typically walks 5 miles per day normally however since his trip, he has had to use a walker and needs assistance when walking. He is followed closely by a Dr in ID clinic for his HIV and was found to have positive stool cultures for Blasto and Giardia. He was treated with Tinidazole and his repeat stool studies were negative. Since that time, he has been experiencing worsening GI bloating and abdominal distension, back pain, and trouble walking. He was seen by NSG for his back pain however his scans showed bilateral degenerative changes. He was seen by GI and was given lactulose without improvement in his symptoms. CT head at that time showed evidence of ventriculomegaly however he denies urinary and bowel incontinence. He reports worsening shortness of breath and states that he "feels like a balloon is inside his stomach" He feels a band like sensation across his abdomen and states that his symptoms are worse at night time. He has not been walking since May 7th and has basically been immobile.

6 days after the vaccine (2/17/2021), patient c/o sore throat, severe right ear pain, swollen right face, swollen lymph nodes and was seen at Urgent Care. On 2/19/2021, patient c/o difficulty swallowing, unable to open mouth, continue to have severe right ear pain, severe sore throat, swollen lymph nodes and was seen at facility by APRN. Patient was advised by APRN to go to ER due to throat pain, swelling, abscess and needed ENT Consult. Arrived at ER at 1 p.m., CT Scan confirmed swollen cervical lymph node, Tracheal Deviation with AIRWAY OBSTRUCTION. Rocephen and Steroid IV given. Patient transferred to second ER by Ambulance at 5 p.m. where he was admitted and hospitalized for 4 days(2/19/2021--2/22/2021).

The second shot was administered 5/15/21, 7:10PM at right around 3 ;30AM 5/16/21 I was awoken by excruciating pain in my hip and groin of my right leg. I assumed the pain would go away but it has been about 6 weeks now and it only getting worse

Deep Vein Thrombosis of left upper extremity in left subclavian vein that does not extend to SVC. No known cause for this. Started on Xarelto on 7/9/21. Swelling in left upper extremity remains on 7/16/21. Tolerating Xarelto well.

Fatigue; Joint pain; Swollen lymph node on the right side of the face; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the arm left on 30Mar2021 at 09:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as many. The patient had received many medications (unspecified) within 2 weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the arm left on 09Mar2021 at 09:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. 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 31Mar2021, the patient experienced fatigue, joint pain and a swollen lymph node on the right side of the face. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue, joint pain and swollen lymph node on the right side of the face was resolving. No follow-up attempts are needed. No further information is expected.

Sudden headache, nausea, BP 160/90 seated, lightheaded, reddened. 2 episodes, lasting about an hour each. BP returned to normal between episodes. Slight fever. Muscle aches and even foot discomfort Sore arm. Arm and hand swelling and redness starting the night of the 24th, remaining today, Jan. 25, 2021

Client has a history of some allergic reactions to medications. (Did not indicate this on form) Rc'd vaccine in a drive thru clinic and with in minutes delt flushed in his eyes and cheddls. He proceeded to Recovery area and was seen by Dr. No SOB or respiratory distress but had overt facial flushing and mild swelling. Client given 50 mg of PO Benadryl and observed x 30 minutes w/o improvement and worsening flushing. Transported by EMS to local hospital.,RN per Dr written vaers form and incident report form.

I took the vaccine at about 11:00 AM on 2/12/21. On 2/13/21 at about 10:00 PM, I suddenly got major swelling in both sides of my lower jaw and lower cheeks. Both my hands have become itchy. Earlier in the evening on 2/13/21 I had a feeling of air stuck in my upper chest, so I took an Alka-Seltzer, then later an Allertec allergy pill. All of the above is currently happening. I have not yet talked to any medical people, just writing this down as it occurred. It is now 2:00 AM on 2/14/21.

1/30/2021 Began with spiking BP and extreme pain in right shoulder - taken to ER. Given pain med, BP came down and sent home. 2/2/2021 - Spiking BP and chest pain, numbness and tingling in hands and feet. - taken to Medical Center. Admitted. Series of heart and brain assessments done. Each day he got weaker until he could no longer stand, walk, arm and hand strength depleted and dexterity issues. Spinal Tap on 2/8/2021 revealed Guillain Barre Syndrome 2/12 Admitted to Rehabilitation Center, 2/15 at Hospital plummeting BP, 2/18 return to Rehabilitation Center

71 year old with HTN, HLD, CAD s/p CABG, ischemic cardiomyopathy, AAA s/p EVAR, and COPD presented for elective left heart cath without intervention. Allergy consulted due to anaphylactic reaction several hours after procedure. Patient was stable on RA at time of presentation and vitals were normal and stable during the procedure from 8-9 AM. Procedure log reviewed. He received fentanyl, versed, heparin, omnipaque, and xylocaine during the procedure. No immediate reactions noted and no change in vitals during procedure. He tolerated procedure well and was transferred to the cardiac recovery room on RA with normal vitals.   At 1217, patient received percocet and at 1 PM, desaturations noted on flowsheets (84% from RA). Noted pain level of 10/10. HR increased to 130s-150s and BP did drop as low as 99/87. Per notes, he developed shortness of breath, rash, and itching with this. Given albuterol, racemic epinephrine, diphenhydramine IV, famotidine IV, and solumedrol. After developing nausea, he was given IM epinephrine at 2:10 pm. Then, symptoms rapidly improved and he was transferred to CVICU. He was shortly weaned from BIPAP (briefly hypercarbic) to nasal cannula and eventually 1-2L NC.

HISTORY OF PRESENT ILLNESS: The patient is a 71-year-old male patient with a complex medical history with multiple problems and cancers and debilities. He received a second dose of COVID vaccine yesterday about midday. Shortly thereafter, he started having shivers and shakes. The concern that I had when he called the office was a possible bacteremia. He was sensitive emergency room for evaluation. He was noting that he was chilled and was unable to get warm. He said his temperature was up to 100.5. He had generalized weakness and inability to get up and walk and had malaise. He has no known exposures to pneumonia or other illnesses. He has basically been homebound for the past year with the COVID. He was evaluated in the emergency room and found to have an elevated white blood cell count on the right upper lobe pneumonia on portable chest x-ray. Blood cultures and urine culture were obtained since he had a urine abnormality as well. The patient was admitted to observation while we wait on cultures and we treat the pneumonia with antibiotics.

[Pfizer-BioNTech Covid-19 Vaccine EUA ] ? fever; chills; intense stomach pain; night sweats; leg cramps; leg/feet swelling; weakness; joint pain; light-headed; not feeling well. --If these had lasted only a few days, I would accepted them as typical. However, stomach pain; leg muscle pain; joint pain; swelling and weakness have lasted OVER THREE WEEKS! And, still ongoing. I have not heard of this anywhere else.

Received 2nd dose of Pfizer COVID vaccine on 2/24/21. No reported adverse reaction at that time. On 3/10/21, developed worsening of chronic back pain. On day of event, took a dose of celecoxib and rivaroxaban (concurrently). He had been avoiding taken chronic celecoxib since at least the time of his last COVID-19 vaccination, and potentially took this fairly rarely due to concern for interaction with his DOAC. Beginning about 5 minutes after these medicaions were taken, patient felt weak/strange and asked his wife to take him to ED. In ED he was initially somnolent but arousable, but then developed hypotension and hypoxemia. Given IV benadryl initially, but then acutely worsened with development of facial, hand, and neck swelling. Reportedly had substantial "frothing at the mouth." Treated with SQ epinephrine, IV methylprednisolone, IV famotidine and was intubated with difficulty. Started on an epinephrine infusion due to persistent hypotension (dose up to 0.1 mcg/kg/min) and transferred to referral center ICU (reporting center). On arrival here, notable hand edema, some facial edema. Ventilator support rapidly weaned to minimal settings. Evaluation and hospitalization ongoing. Overall clinical assessment is anaphylactic reaction to celecoxib unrelated to COVID-19 vaccination.

Diarrhea since 03/06/2021. Pain-sensitivity-TMJ/lockjaw type symptoms in the right side of face from temple & ear-cheek-jaw, down to right side of neck. Area that's worse is upper right jaw, aligned with ear & running down & underneath jaw bone. Entire right side face feels swollen and jaw is tightening up.

suspect anaphylaxis; passed out while driving.; entire body itching; vision issue; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular Right arm on 22Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included diabetes mellitus (DM), hypertension (HTN), hypercholesterolaemia. No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. Clinical course reported as: Patient got vaccine with no issues. 36 hours later he developed entire body itching. He then developed vision issues and passed out while driving. He was hospitalized and no cardiac or neurologic issues were found. The reporting physician suspected anaphylaxis since patient had severe itching with the event. There were no other likely triggers found during history other than the vaccine. Events onset date reported as 23Jan2021. Events resulted in Emergency Room Visit and Physician Office Visit. Covid test type post vaccination: Nasal Swab on 06Feb2021 result: Negative. Treatment received for the events. Outcome of events was Recovered/Resolved with Sequel. Information on the lot/batch number has been requested.; Sender's Comments: A causal relationship between the events suspect anaphylaxis, passed out while driving, entire body itching, and vision issue and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 71-year-old male patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Day after injection lymph node under right arm pit swelled to size of a small lemon, This reaction didn't occur after my first injection.

my doctor said it is an Olecranon Bursitis. where my left elbow has a fluid knot on it. it came up after i left the area of my shot. it has no pain.

Pt admitted 3/22/21 with several week history of Chest congestion, cough, fever, shortness of breath. Had COVID vaccine just before started having symptoms. Decline in respiratory status requiring high flow O2 delivery and admission to ICU for monitoring.

Within a few days of the first vaccine, patient experienced pain, numbness, and tingling in his toes L>R. After this, the pain diminished, but he noticed swelling and redness in his toes. Over the next few weeks, he noticed black patches on the toes. Now, he is noticing darkening/bruising on the toe nails

developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 02Mar2021 16:00 (at 71-year-old) as single dose for COVID-19 immunization. Medical history included Arthritis in knee. High blood pressure. Patient had no covid prior vaccination and no covid tested post vaccination. Patient has no known allergies. Concomitant medication included hydrochlorothiazide. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient developed blood clots in my left leg that began swelling some on 12Mar2021 17:00 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting. So he went to urgent care and they sent him to hospital ER. The patient was hospitalized for 3 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Events treatment included Ultra sound, CT scan, heparin blood thinner. The outcome of the events was not recovered.

Within a few days of the vaccination, I developed extreme flatulence, with frequent and copious discharges of exceedingly foul-smelling gas throughout the day, sometimes as often as four or more times within an hour. My digestion seemed sluggish and irregular, and I experienced a sense of being bloated (which the discharges somewhat relieved). All these symptoms continued for about three weeks. At first I thought they simply had to do with something I might have eaten, but this seemed not to be the case. Throughout, my diet, dietary supplements, residence, sleep, environment, and daily routine remained the same -- and the same as they had been for months before. Additional information for Item 18: Finally, about two weeks ago, I began taking an Ayurvedic digestive medicine (Dashamularista), once daily after lunch, which helped greatly. The discharges of gas reduced considerably in frequency and copiousness and were no longer abnormally foul-smelling. As of this day, however, flatulence still seems somewhat more than usual. Of course, I cannot unerringly testify to a cause-and-effect relationship between the vaccination and the symptoms I have described. But I see no other likely candidate for a cause. I should mention that within the last few days I have developed mild but disturbing inflammation in the joints of both hands, particularly the knuckles. I have not had this before. I have also felt somewhat listless. (This, however, is not a symptom new for me.) in the last few days I have also developed a mild edema in both feet. But I have had this before from time to time, and the present instance might be attributable to variables such as a change in weather. (In the past this edema was diagnosed as lymphatic in origin, not circulatory.)

Joint pain and swelling primarily in both shoulders and hands. Nearly 60 days later the joint pain and swelling has settled into both hands. The resulting adverse effects are slight joint pain, loss of dexterity and flexibility, and swelling in all fingers.

pt says he had chills, fever, headache, body aches and pain. Lymph nodes were swollen under his left arm. A couple days after taking the vax he was passing blood clots when using the bathroom. Pt states this lasted about 4 days. By 4/3/2021 all symptoms had subsided.

Hands and feet swollen for three weeks. Joints and /or tendons painful, but left hand pinky finger still swollen and extremely painful, Can not use finger because it no longer can close- since Covid19 Vaccination shot.( no longer can I play my violin). Went to my primary care doctor, 3/24/2021, who referred me to Doctor of Acting Chief of Hand Surgery, Medical Center- He administered a steroid shot into my finger on 03/29/2021. No improvement- MRI scheduled on 04/20/2021.

difficulty breathing; low oxygen blood level; potassium level increased; extra fluid in his body; shivering and quaking and chills; nauseous and vomiting; nauseous and vomiting; Panic attack; was freaking out; soft pain in left side of chest; fast pulse; This is a spontaneous report from a contactable consumer (Patient's wife) A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 10Apr2021 at 17:00 at single dose via an unspecified route of administration on arm right for COVID-19 immunization. It was informed that patient had vaccination on right arm because he had a dialysis fistula in his left arm. Relevant medical history included also ongoing End stage renal disease, dialysis on 13Apr2021. The patient received first dose of BNT162B2 (lot number: EP6955) and experienced arm pain and headache. Concomitant medications were not reported. On 11Apr2021 the patient experienced shivering and quaking and chills, nauseous and vomiting, panic attack, 'was freaking out', soft pain in left side of chest, fast pulse , all provided as non serious. On the same day 11Apr2021 the patient also experienced difficulty breathing, low oxygen blood level, potassium level increased and extra fluid in his body which led to the emergency room and admission to the hospital. Clinical course was described as follows: everything was going good until Sunday at 3:29 am. Her husband woke up shivering, quaking, and he was freaking out repeating oh my god, so she called emergency number. When her husband found out that she couldn't get into the ambulance with her husband and ride to the hospital, so her husband refused to go to the hospital. She states that her husband also felt nauseous and vomited in this period of time. She stated that he had no fever, though. So fast forward to 8:30 am her husband was having difficulty breathing, and she called again and this time they had 7 paramedics come out to the house. She states that all of them were very nice. An EKG was performed because patient reported that he had a soft pain in his left side of his chest. She states that everything was cool with that, except his pulse rate was high. She states that he also had low blood oxygen level. She states that they strapped in her husband in and drove him to the hospital to the ER. At the ER they discovered that potassium level increased and she said that he had some extra fluid in his body. He was a dialyses patient so they gave him dialysis on Sunday evening. He had calmed down at that point and they were constantly taking blood from him. She found out about the COVID vaccine had potassium and phosphate as active ingredients and her husband shouldn't have that. She also informed that they had to give him a tranquilizer because he was having a panic attack during this whole episode. She says that they gave him alprazolam. Patient doesn't know exactly when the side effects went away because he didn't have a clock or a phone. Patient's wife also clarified that he vomited twice before going to the hospital but then he felt like he had to vomit afterwards but he did not. She stated that his breathing problems didn't stop when paramedics came and gave him oxygen. They made it to their house by 8:40 am, and he still had low oxygen level, they were still giving oxygen the whole time he was in the hospital. The patient was discharged on 13Apr2021. At the time of the reporting event outcome was unknown.

Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit immediately following vaccination patient reports eyes watering, redness on face, throat swelling. Vital signs all within normal ranges. Provider noticed swelling of soft tissue around eyes and cheeks. On physical exam no hoarseness noted; lungs clear without wheezing, rhonchi, or rales. Administered diphenhydramine in clinic and advised to continue at home and referred to allergy/immunology clinic for follow-up.

After receiving 1st dosage on 2/24/21 me as wife got 2X facial rash . 1st time very red looking like a racoon facial rash. 2nd time less strong. I began to suspect her had gotten the vaccine and NEVER TOLD ME. I had begged not to before as I 9 +(+HIM) ARE TOTALLY IMMUNO COMPROMISED after 2nd dosage ON 3/17/20121 he developed a rash trunk /back ( which I took picture day after very red skin). he also developed his right foot totally BRUISED AND LOTS OF SWELLIN OF LOWER LEG

I had my first Pfizer shot Jan 23, with minor muscle aches. After the second shot on 2/13, the next day, I had severe aches in my upper arms and upper legs at hip (which ached every time I sat down or stood up using those muscles). Once seated, my legs did not ache. The legs seem to be okay now. However, my upper arms still ache, particularly every night when I go to bed. I sleep on my side. I find that about 3-4 in the morning, it wakes me up because my arm is uncomfortable with aches and I move to the other side. It is hard to find a good position to place my arms that do not ache. During the day I do not notice it as much, although reaching behind my back is painful. Hands are starting to feel stiff.

ED, Discharged , 3/13/2021 (4 hours), Hospital ED, MD Last attending o Treatment team Shortness of breath +1 more Clinical impression Chest Pain o Shortness of Breath o Dizziness Chief complaint, Patient presents with o Chest Pain, o Shortness of Breath o Dizziness. History of Present Illness , Patient is a 71 yr.. male with Hx of stage IIICM Metastatic Adenocarcinoma of the sigmoid Colon, Coronary disease, Hypertension, Dyslipidemia, Chronic Renal insufficiency, presenting to the ED with chest pain. Patient notes that he woke up this morning with pain in the right side of the chest with some associated shortness of breath. Notes symptoms. Additional information for Item 18: Notes symptoms are worse when he is up trying to exert himself and gets incredibly short of breath and fatigued. States he tried to do some workout in the garage but was unable. Denies chest pain worsening with exertion, but has been fairly constant since it began. Reports it is a dull ache. Pain is dissimilar from his previous heart attack. States he has had a mild cough, but no significant production. Denies any fevers, chills. No abnormal nausea or vomiting other than typical chemo induced side effects. Given continued issues, decided to come in for further evaluation. Review of Systems; Constitutional: Positive for fatigue. Negative for appetite change, chills, diaphoresis and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Positive for cough and shortness of breath. Negative for choking and chest tightness. Cardiovascular: Positive for chest pain. Negative for palpitations and leg swelling. Gastrointestinal: Positive for nausea and vomiting. Negative for abdominal pain and diarrhea. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash. Neurological: Positive for light-headedness. Negative for seizures, syncope, numbness and headaches. ED to Hosp-Admission, Discharged, 4/5/2021 - 4/25/2021 (20 days) Hospital, MD, Last attending Treatment team Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present. Principal problem Discharge Summary, DO (Physician), Inpatient Discharge Summary; BRIEF OVERVIEW; MD, Discharge Provider: DO, Primary Care Physician at Discharge: MD, Admission Date: 4/5/2021, Discharge Date: 4/25/2021. Discharge Diagnosis; Medical Problems ;Hospital Problems; POA, (Principal) Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present, Yes, Essential hypertension Yes, Chemotherapy-induced peripheral neuropathy, Yes. Overview Signed 5/10/2019 2:03 PM by MD, Pins and needles and numbness in tips of finger and toes, Lung metastasis Yes. Hypoxia Yes. COVID-19 Unknown, Acute respiratory failure with hypoxia Yes, Palliative care encounter Not Applicable, Declining functional status No. DETAILS OF HOSPITAL STAY; Presenting Problem/History of Present Illness/Reason for Admission, Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present. Acute hypoxemic respiratory failure due to COVID-19,Respiratory failure. Sigmoid perforation with abscess. Hospital Course; 71-year-old male prolonged admission for acute hypoxic respiratory failure secondary to COVID-19. No history of colorectal adenocarcinoma with lung mets. Prior resection of bowel, prior chemotherapy. Required management in the ICU due to worsening respiratory failure over the time that he has been admitted to Hospital (20 days). He had remained on BiPAP therapy throughout that time, received appropriate corticosteroids, and antiviral therapies. Approximately 1-1/2 weeks ago he began to develop mild left lower quadrant abdominal pain. In the last 48 hours this is significantly worsened. CT abdomen and pelvis was obtained on Friday, which displayed pneumoperitoneum, sigmoid abscess with sigmoid perforation. There is a prior anastomotic site distal to this. Given his overall complexity he was to be medically managed to avoid the need for OR and intubation. He did well through the initial 24 hours of IV antibiotics, fluids and bowel rest. This afternoon he became increasingly dyspneic, required implementing nonrebreather mask, and subsequently developed severe rigors, tachycardia. I obtained a stat follow-up CT scan which shows similar findings of free air within the abdomen. Given signs of impending sepsis, BiPAP therapy was initiated, bolus IV fluids were given. Blood gas, blood counts, lactic acid are pending. He is receiving empiric Zosyn. I discussed this with general surgery, whom is well-known to the patient. In agreement the patient likely needs surgical intervention. However given his overall complexity and in light of the fact that this area surrounds the ureter, and we do not have urology coverage. It was felt he was most appropriate to be managed in Hospital. Case was discussed with Dr. at Hospital, patient will be transferred there via air transit. At this time his blood pressure appears stable, he is tachycardia, is currently on BiPAP which will be transitioned to CPAP for transport. He has received several doses of Dilaudid, for improved pain control. No further advancement of airway was performed prior to discharge. Case was discussed with family at length, all risks and benefits of transfer were discussed with wife and patient. It is recommended to involve pulmonary critical care services including surgical ICU care as if requiring surgery he is high likelihood for prolonged vent needs. Operative Procedures Performed Treatments: See above; Procedures: Na Consults: pulmonary/intensive care and general surgery. Pertinent Test Results: CT abdomen pelvis with contrast [3279871876] (Abnormal) Resulted: 04/25/21 1811. Order Status: Completed Updated: 04/25/21 1812. Narrative: PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis With Contrast, Exam date and time: 4/25/2021 17:36, Age: 71 years old, Clinical indication: Abdominal pain; Additional info: Sepsis, bowel perf. HX of Covid19 +, malignant colon with lung metastasis. Bowel perf. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis with contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. Contrast material: 350 OMNI; Contrast volume: 80 ml; Contrast route: INTRAVENOUS (IV); COMPARISON: CT ABDOMEN PELVIS W CONTRAST 4/23/2021 16:46, FINDINGS: Tubes, catheters and devices: Catheter terminates in the right atrium in satisfactory position. Lungs: Moderate airspace opacities throughout the lung bases are similar to prior and consistent with Multilobar pneumonia consistent with the history. Liver: No hepatic masses. Gallbladder and bile ducts: Cholelithiasis. Pancreas: No ductal dilation. No masses. Spleen: No splenomegaly or focal lesions. Adrenal glands: No mass. Kidneys and ureters: 10 mm benign left renal cyst, no follow-up necessary. No renal masses or Hydronephrosis bilaterally. Stomach and bowel: Redemonstration of perforated proximal sigmoid diverticulitis. Small pneumoperitoneum is stable. Predominantly gas containing, 25 x 28 mm collection adjacent to the inflamed sigmoid colon similar to prior; a fistulous tract extends toward the midline containing gas and fluid, with suspected fistula to adjacent loops of small bowel. Moderate to severe descending and sigmoid diverticular burden. Minor right diverticular burden. No small bowel obstruction. A somewhat clumped appearance of small bowel in the right lower quadrant near the colon enteric fistula. Appendix: No evidence of appendicitis. Intraperitoneal space: Mesenteric edema around the small bowel, slightly increased, however no new mesenteric collection. There is no extravasation of enteric contrast into the collection adjacent to the sigmoid colon. Vasculature: Mild aortoiliac atherosclerosis. Lymph nodes: No significantly enlarged lymph nodes. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: Degenerative changes in the spine. Multilevel disc space narrowing. Multilevel central canal and neuroforaminal stenosis in the lumbar spine. No acute fracture or subluxation. Soft tissues: Small fat-containing right inguinal hernia. Small fat-containing left inguinal hernia. Large ventral abdominal hernia containing gas, which has replaced the previous contents of fat and bowel loops. Volume increased compared to prior. IMPRESSION: 1. Redemonstration of perforated proximal sigmoid diverticulitis. Small pneumoperitoneum is stable. 2. Similar perisigmoid collection; colon enteric fistula, probably at least subacute in duration. The perisigmoid collection is prominently gaseous and there is no frank abscess. 3. Suspected mild enteritis the small bowel loops or loops associated with the fistula. No obstruction. 4. Additional findings as described are similar to recent prior imaging. COMMENTS: Any incidental renal lesion less than 1 cm or classified as too small to characterize, or any incidental cystic renal lesion characterized as simple-appearing, is likely benign. No follow-up imaging is recommended for these lesions per consensus recommendations based on imaging criteria. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD, CT abdomen pelvis with contrast (Abnormal) Resulted: 04/23/21 1804, Order Status: Completed Updated: 04/23/21 1804, Addenda: THIS REPORT CONTAINS FINDINGS THAT MAY BE CRITICAL TO PATIENT CARE. The findings were verbally communicated via telephone conference with RN at 6:03 PM EDT on 4/23/2021. The findings were acknowledged and understood. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD Signed: 04/23/21 1804 by, MD. Narrative: PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis With Contrast, Exam date and time: 4/23/2021 4:42 PM, Age: 71 years old Clinical indication: Abdominal pain; Localized; Left; Additional info: HX of colon cancer. Worsening left sided abdominal pain. HX of colon cancer. Worsening left sided abdominal pain. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis with contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. Contrast material: OMNIPAQUE 350; Contrast volume: 80 ml; Contrast route: INTRAVENOUS (IV); Other contrast: Oral, omnipaque 12mg premixed solution, 500mL pt unable to drink 1000mL; COMPARISON: 1. CT ABDOMEN PELVIS W CONTRAST 2/12/2021 11:06 AM, 2. CT ABDOMEN PELVIS W CONTRAST 11/13/2020 11:42:26 AM, 3. CT ABDOMEN PELVIS W CONTRAST 8/24/2020 10:14:40 AM, FINDINGS: Lungs: Bilateral lower lung consolidation. Liver: No mass. Gallbladder and bile ducts: Cholelithiasis, no biliary ductal dilatation. Pancreas: Normal. No ductal dilation. Spleen: Normal. No splenomegaly. Adrenal glands: Normal. No mass. Kidneys and ureters: Normal. No hydronephrosis. Stomach and bowel: Collection of fluid and gas adjacent to the proximal sigmoid colon where there are multiple diverticuli, extraluminal gas arises from a proximal sigmoid perforation which is proximal to the sigmoid anastomosis. No bowel obstruction, no wall thickening at the anastomosis. Appendix: No evidence of appendicitis. Intraperitoneal space: Pneumoperitoneum. Small collection of fluid and gas in the left pelvis and left lower abdomen, maximum short axis diameter approximately 2 cm, arising from the proximal sigmoid colon. Vasculature: No abdominal aortic aneurysm. Lymph nodes: No significant adenopathy. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: No acute findings. Soft tissues: Ventral hernia containing bowel without entrapment. IMPRESSION: Perforated diverticulitis, small pericolonic abscess; the sigmoid perforation is proximal to the sigmoid anastomosis. Physical Exam at Discharge; Heart Rate: (!) 131,Resp: (!) 42, BP: (!) 168/92 Temperature: 37.1 °C (98.7 °F) Weight: 107 kg (236 lb. 12.4 oz.), General appearance: alert, appears stated age, cooperative, severe distress and morbidly obese, Head: Normocephalic, without obvious abnormality, atraumatic, Neck: supple, symmetrical, trachea midline and thyroid not enlarged, symmetric, no tenderness/mass/nodules. Lungs: retractions and diminished breath sounds Heart: tachycardia, RR. Abdomen: Distended significantly tender in the left lower quadrant with guarding throughout. Extremities: Trace pretibial, Skin: Skin color, texture, turgor normal. No rashes or lesions or Ecchymosis areas throughout upper extremities. Neurologic: Alert and oriented X 3, no focal deficit. Discharge Instructions; Condition at Discharge, Discharge Condition: critical. Admission, Discharged 4/25/2021 - 5/1/2021 (6 days) Hospital, MD, Last attending Treatment team Respiratory failure, acute. Principal problem, Discharge Summary MD (Resident) Cosigned by: MD at 5/18/2021 1:24 PM; Final Summary for Deceased Patient, BRIEF OVERVIEW; Admitting Provider: MD; Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 4/25/2021, Discharge Date: 5/1/2021, Final Diagnosis, Principal Problem: Respiratory failure, acute. Active Problems: Malignant neoplasm of sigmoid colon. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present COVID-19. Perforated viscus. DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Respiratory failure, acute, Hospital Course; Patient is a 71 yr.. male with history of metastatic colorectal adenocarcinoma with lung metastases, prior bowel resection and chemotherapy. The patient initially tested positive for Covid in early March. His symptoms at that time are mild and resolved. He was later vaccinated and that month. He started having severe symptoms again on 4/3 for which he presented to Hospital. Since that time, he has received full course of Remdesivir and steroids. He had a CT scan performed on 4/23 which revealed pneumoperitoneum secondary to presumed perforated sigmoid diverticulitis with focal sigmoid abscess. Patient was weaned down to minimal nasal cannula settings but somewhat suddenly earlier on 4/25 patient had increased work of breathing, became tachycardia, and had rigors. Hospital ordered repeat CT scan which showed similar findings in the abdomen. Patient had been maintained on Zosyn. Repeat labs were sent which were largely unremarkable. Given concerns for worsening sepsis and potential need for surgery, he was subsequently transferred Hospital. On admission to hospital, he had a normal lactic acid and no leukocytosis. He did not have evidence of peritonitis. The decision was made to treat his diverticulitis conservatively. However, early on 4/26 the patient started to develop a lactic acidosis. An extensive discussion was had with the patient and his wife regarding surgery and the possibility the patient may never be able to separate from the vent given his worsening Covid pneumonia. The patient elected to undergo an exploratory laparotomy with with segmental resection of distal descending and loop transverse colostomy. However, as the days progressed the patient had worsening respiratory status that required deep sedation, paralytics and proning all of which were unsuccessful in maintaining his oxygen saturation greater than 88%. His wife, knowing that he would not want to have a prolonged course on the ventilator, elected for transition to palliative extubating with comfort care on 4/30 and the patient expired roughly 10 minutes after extubation.

felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

eyes were also red; Swelling of the face also in the mouth area, mainly on the right side; Swelling of the face also in the mouth area, mainly on the right side; This is a spontaneous report from a contactable consumer (patient's wife). A 71-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration Date was not reported), via an unspecified route of administration on 26Jan2021 as single dose (at the age of 71-years-old), for COVID-19 immunisation. Medical history included ongoing high blood pressure (it has been a while since he was diagnosed with this), ongoing high cholesterol (it has been a while since he was diagnosed with this), type II diabetes mellitus from 2020 and ongoing. The patient's concomitant medications included bunch of unspecified medications but does not had them on hand at the time of report. On 29Jan2021, it had been 3 days, this morning his face was swelled up also in the mouth area, and mainly one side of the face. The entire face was swelled but more on the right side than the left including the mouth area. Like someone popped him in the mouth and knock up the side of head on the jaw area and patient eyes were also red on an unspecified date. The swelling had gone down a little. Patient had received no treatment, but she was getting ready to get Benadryl. The patient was enquiring about Benadryl okay to take or how long it lasts. The outcome of the events was recovering for swelling of the face also in the mouth area, mainly on the right side and unknown for eye were also red. Follow-up attempts are completed. No further information is expected.

Patient hospitalized on 4/1/2021 for heart catheterization, was diagnosed with Severe (+3-4) degenerative mitral valve regurgitation. Patient hospitalized on 5/5/2021 for hypomagnesemia and severe mitral valve prolapse. Patient presented to the ED on 5/20/2021 and was subsequently hospitalized for severe sepsis without septic shock. These visits are within 6 weeks of receiving COVID vaccination.

night sweats; stomach aches; leg cramps; leg swelling (water retention); leg swelling (water retention); weakness; prickly skin; fever; chills; joint pain; slight cough; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (solution for injection, Lot Number: el926) via an unspecified route of administration, administered in Left arm on 09Feb2021 (at the age of 71-year-old) at 10:30 as 1st dose, single dose. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccination in four weeks. On 09Feb2021, the patient experienced night sweats, stomach aches, leg cramps, leg swelling (water retention), weakness, prickly skin, fever, chills, joint pain and slight cough. The patient did not receive any treatment for events. The patient was not tested for covid prior vaccination but was post vaccination. The patient underwent lab tests which included nasal swab: negative on 01Mar2021. The patient received bnt162b2 (Lot number: en6199) on 02Mar2021 at 10:00 as 2nd dose, single dose for COVID-19 immunization. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

First episode Feb 18 (16 days after first Covid vaccine): fainting, shortness of breath at onset of light exercise (called Dr., advised to drink more water). Second episode: Feb. 23, one day after second Covid-19 shot: inflamed left calf, redness of skin. Dr. and ER visit Feb. 24, diagnosed with critical DVT and multiple pulmonary embolisms. ER put me on heparin IV drip, Overnight stay in hospital, discharged with Eliquis blood thinner prescription. Continuing that med for life, per hematologist

Unexplained pain in joints and tendons with swelling and redness over a period of 3-4 weeks. Treated with prednisone 10 mg for one month and then withdrawn gradually. No firm diagnosis, possible polymyalgia rheumatica or gout or pseudo gout.

Extreme pain and swelling in both feet, hands and left knee, to extent that I was unable to walk for two weeks. Treated with Prednisone for two weeks. Had immediate relapse, so then treated with Prednisone for one week. Another immediate relapse, so treated with Prednisone again for two weeks. Now off Prednisone, no swelling, but taking Meloxicam oral tabs for joint and muscle pain.

Warm sensation (numbness) in left thigh. Spread to spine and mid chest and all the way down to the left toe, groin and left butt cheek. Burning and numbness down entire left leg, ongoing. Left toe swollen and red, nail turned black, fell off. Wasn't an infection and it wasn't gout. Also had vertigo for 4 or 5 days starting around the 5th along with the numbness.

Extreme join pain, shortness of breath, water retention, sleeplessness, decrease urine output, urine odor, fatigue, weakness, lack of appetite (all came on suddenly about three weeks after 2nd dose of Pfizer COVID vaccine).

Muscle pain, weakness in lower torso, legs, moving to upper torso. Cannot sleep due to pain. Diagnosed as GBS. Immunoglibin infusions treatment prescribed.

First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the 2nd dose on 4/12/2021. 7/14/21: Patient arrived to ER with COVID symptoms after testing positive on 7/7/2021. Per ER records, the patient received the positive result on 7/10/21 and went to see his PCP who prescribed the patient a Zpack and cough medicine. The patient finished the Zpack but was still having body aches, shortness of breath, fever, loss of appetite, and fatigue. 7.15.21: in the ED patient found to have hyperglycemia, anion gap metabolic acidosis, worsening kidney function, and multifocal pneumonia. Diagnosed with acute hypoxic respiratory failure due to COVID-19 pneumonia, sepsis secondary to COVID pneumonia. started on remdesivir

Neuropathy of the feet Swelling of the legs I went to the doctor in March 2021. I am still dealing with numbness of my feet and toes.

Lose of ability to stand to feet, tingling in both feet then to hands, weakness in legs, arms, and hands. Could not lift legs.Swelling in feet and lower leg ,bothsides! Infusions with IVIG given in hospital for five days... infusions given every three weeks since released from hospital total of two with next one scheduled 08/04/2021.treatment is ongoing with indication as to how long; Diagnosis is CIDP

Lose of ability to stand to feet, tingling in both feet then to hands, weakness in legs, arms, and hands. Could not lift legs. Swelling in feet and lower leg, both sides! Infusions with IVIG given in hospital for five days... infusions given every three weeks since released from hospital total of two with next one scheduled 08/04/2021.treatment is ongoing with indication as to how long!

Lose of ability to stand to feet, tingling in both feet then to hands, weakness in legs, arms, and hands. Could not lift legs.Swelling in feet and lower leg ,bothsides!

discomfort in his arm; like a little bit of hydraulic pressure from injecting fluid into tissue; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0176, Expiry date: Unknown), via an unspecified route in the left arm on 29Apr2021, as a single dose for covid-19 immunization. Medical history included diagnosed with high blood pressure probably 3 years ago, ongoing and had two hip replacements, one in Sep2019 and one in Sep2020, ongoing. Concomitant medication included began taking lisinopril a couple of years ago for high blood pressure, periodically takes ibuprofen or naproxen for aches and pains, he's had 2 hip replacements, and it's not the hip itself because it's synthetic, but the muscles around them every once in a while, get a little sore, so sometimes he has to take them more regularly, like lately they've had incredible weather that's been very rainy. Patient mentioned that he is still pretty active, very active for 71 years old, and working. On 29Apr2021, patient experienced some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue, that went away in a day or two and fatigued. He did consider general muscle pain in his shoulders as a source for the discomfort in his arm. The clinical outcome of some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue was recovered, muscle pain in his shoulders was unknown and fatigued was recovered on 30Apr2021. No follow-up attempts are possible. No further information is expected.

Itchy left arm, redness, swelling under left arm, painful and tender. Still sore and swollen today 01/25/2021.

severe angioedema resulting in intubation to protect his airway and ICU admission. pt recieved the 2nd dose at 0755 am, woke up from a nap at 2200 the same night with tongue swelling.

chills, headache, nausea, tiredness, allergic reactions( primarily on left side of head, swollen ear, jaw, neck, rash on scalp, some weakness and dizziness)

Violent sneezing with runny nose, followed by swollen lymp node under right chin. No fever, no pain. The lymp node is still swollen. I have been treating with warm compresses.

Insidious onset of redness and swelling of the middle and distal phalanges of the 3rd, 4th and 5th fingers of the right hand with progression to swollen fingers with painful finger tips during week 2 of ADR. Initial erythema began about one week after the first dose of Pfizer COVID-19 vaccine. Also redness and swelling of the distal phalanges of the 1st, 2nd and 3rd toes of the left foot with similar onset. Also headache and sore left arm for 2 days after vaccination. Association of "COVID Fingers and Toes" with vaccination was noted about 3 weeks after the 1st dose. Fingers were treated with topical corticosteroid and intense erythema coalesced around the nail beds of 3rd & 4th fingers of the right hand. Also..noted "brain fog" with poor attention and loss of context during weeks 2 and 3 of reaction. Cutaneous manifestations are ongoing.

Pfizer-BioNTech COVID-19 Vaccine EUA: The evening of and the next day after receiving vaccine patient developed arm discomfort, facial swelling, and extremity rashes that resolved within 24 hours. Patient took acetaminophen for arm pain and diphenhydramine every twelve hours for swelling. During clinic visit to refill anti-hypertensive medications two days after vaccination patient reports symptoms resolved. Vitals within normal ranges except blood pressure elevated. Patient discharged from clinic visit to home stable.

Within about 10 min of vaccination, patient reported feeling shaky, weak, nauseas, and was reported to be pale. His heart rate was 120. His blood glucose was 64. Patient was admitted to the hospital for IV fluids with dextrose.

02/25/2021: Noticed spots of itchyness all over body (30 hours after shot) Remained this way for 5 days 03/01/2021: Woke up with puffyness in right lips/cheek, itching in throat, felt itchiness all over body 03/01/2021: All sx resolved by end of day without taking any medication 03/02/2021: Woke up with Left cheek/left lip swollen, itchy throat, general itchiness around body, a few red spots here and there around body 03/02/2021: Took one benadryl at 10:00 am, did not notice that it "did anything." But by 4:00 pm, sx were gone 03/03/3021: No sx 03/04/2021: "All hell broke loose" - Awoke with R swollen eyelid (r lid up to right eyebrow), itchy throat, hives patchy, rash. Took one benadryl at 09:00am and then at 11:30am, felt somewhat better, hives remained in evening, itchy throat remained. Went to healthcare facility. Given medications starting 03/04/2021 in the evening. Diagnosed as mild urticarial reaction. Doc says it was delayed hypersensitivity reaction. Prescription given: hydroxyzine, famotidine, prednisone. Recommended Claritin, which patient is taking. 03/05/2021: General itchness, around body. Back, legs, arms. Throat somewhat itchy. No other symptoms.

Patient received Covid19(Pfizer) vaccine on 02/26/2021 at 3.55pm and on 02/27/2021 in the morning he had swelling in his left leg ( patient had knee replacement in same leg 9 months ago). He waited 2 days and still no improvement. He went to Beaumont urgent care on 03/03/2021 and he was referred to emergency room at hospital. He was admitted due to blood clot in left leg and lungs, where he had leg surgery. He was prescribed Eliquis 5 mg twice a day.

After arm soreness, headaches and sleeplessness the first day afterwards, those resolving by yesterday, I noticed On second morning after shot a swelling, sensitivity, and hardness of lymph node in armpit on same side of body of vaccine shot, continuing today. No treatment has been undertaken.

terrible terrible stomach pain; bug in his colon; white blood cell 18000/19500; his blood pressure was out of the roof; could not eat anymore; he's lost 10 pounds; dehydrated; vomiting 5 times; nausea; feeling warm; broke out in sweats; arm was sore; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar event for 3 patients (for herself, her husband and their doctor). This is 1st of three reports (husband case) and only this case is serious. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 16:15 (Lot Number: EN6202) at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and blood pressure abnormal; both from 2007 and ongoing; about 13-14 years, he does not take insulin, he takes oral medication. The consumer is calling for her husband who is in the hospital. His symptoms started after Covid 19 injection. He suddenly, out of nowhere, got a terrible, terrible pain in the middle of his stomach, it doubles him over, and he broke out in sweats and this was Saturday, 27Feb2021, in the morning. The sweating went away but the pain continued and continued. He went to urgent care on 27Feb2021 they thought he was constipated and was treated for constipation. The caller reports she should have given him Maalox but they had Dulcolax at home and the urgent care doctor said that was fine to take. Besides that he took 2 of Citrucel tablets and then managed to give him a little apple juice. He could not eat anymore his bowels are pretty messed up and he was going to the bathroom a little bit. He hasn't been eating very much. He was going to go to the ER Saturday night but it was a zoo in there, somehow he made it through the weekend. They have been putting frozen peas wrapped in towels on his stomach. He was miserable with pain. On Monday, 01Mar2021 he went to his primary care doctor and told him to go straight to the emergency room. The caller reports that, in fact, when she and her husband were at the primary care doctor, the doctor told them that, this is anecdotal info, that she (the doctor) received the Pfizer vaccine and it was about the same amount of time that she experienced the same kind of pain but hers went away after about 2 hours. Caller reports the doctor is young. With all the laxatives the patient had taken, he had the runs. They admitted him to the hospital and they ran all kinds of tests. His white blood cell count was 18000. Because he was in so much pain, his blood pressure was out of the roof. Patient is still in the hospital running tests. They are treating him with antibiotics. They think he may have a bug in his colon. To be on the safe side they are wearing gowns if someone goes into his room because they don't know what kind of bug/bacteria it is. He has not been able to provide a stool sample. The caller is waiting on a call from her husband's nurse. When querying weight caller states he's lost 10 pounds, he's 142 pounds if he's lucky. The patient received the first Covid 19 vaccine at around 4:15pm on 25Feb2021. At about 8:45 AM Saturday morning, 27Feb2021, the caller was still in bed her husband was getting in the bed and he said he didn't feel good, he never complains, so she knew something was wrong. He was making a bowl of cereal, he got the cheerios in the bowl and he went to get the milk and just that quick the pain came on just in the middle of his stomach. Kind of like in that area below your breast bone and ribs and rib cage, where it all meshes together. And the pain was just intense. He said it doubled him over and he broke out in a sweat. In the hospital he was given morphine and that didn't work, didn't help the pain. He was also given a "GI cocktail", asked caller what was in the "GI cocktail", she said something to numb him. Lidocaine was in the "GI cocktail" but she is not sure what else. GI cocktail took a long time before there was even a bit of relief. Caller states the nurse said don't look at the "GI cocktail" it's kind of gross. The caller found out that she can only go during certain hours to visit. Caller reports yesterday her husband looked better and his pain level was under control. He was given like hydrocodone or one of those "codone" medications and the nurse said he had not complained of pain in 7 hours. But his white blood cell count was higher at 19500. The caller believes the combination between hydrocodone for pain and maybe the antibiotic is starting to work. But the white blood cell count was still so sky high, eventually the white blood cell count would have to come down if the medications are working. He is more comfortable because of the pain meds. Her husband has had several different times when he has gotten all sweaty and is wanting something to wipe his forehead, feeling warm/hot. The sweating has come back but he never had a fever. She reports her husband's and her own arm were a little sore. Soreness was more noticeable by 26Feb2021. When querying the outcome of her husband's sore arm caller states since the stomach pain he hasn't said anything about the arm pain. She thinks his arm was much more sore than hers was because he was complaining quite about that. Caller reports when they were asking questions at the hospital, like how would he get this bug, how did he get it, did it come from food, like drive thru fast food. The nurse said it could have come from anywhere even medicine. Caller and her husband made sure that all the doctors, all three doctors and they were baffled and they mentioned that he had received the covid 19 vaccine. The nurse said that it could have come from the Covid 19 vaccine. And now her husband is scared to get the second shot. The caller reports she thought with the mrn or whatever it is, with how the vaccine was made she didn't think there was medicine in the vaccine that could cause a bug to grow. That it could be from some kind of medication. The timing is suspicious. She reports they stay out of the fray and try to reduce the fray and stay out of the numbers. They miss every one of their family and friends. The medications he is on, he has been on for a long time. He takes medication to control his blood pressure. The patient also had a CT scan, the main reason for the CT scan was to make sure there wasn't a blockage in his bowels, but the CT scan came back normal. Within the first few hours of being at the hospital, they took his blood 4 times. They were told immediately that he was going to be admitted. They also did a Covid test, it was negative, otherwise he would have been moved a to a different floor. There's more stuff, his oxygen, he had to be put on oxygen and also his blood pressure, it was 214 over something, it stayed really high because of his intense pain. And now that he's there he has to have something for being a diabetic. They tested his urine. He has not been able to provide a stool sample. They are waiting for a stool sample to determine the type of bug he has. The nurse told her there are 2 bugs that are dangerous and highly contagious. Anyone who goes into his room has to wear a special gown. He was told in the hospital that he was dehydrated. He couldn't get anything down. Also on Saturday, 27Feb2021 he threw up like 5 times. He has had some spells of nausea, like when your mouth gets wet. Apparently he was going to the bathroom a little bit he had 2 full doses by the time he was checked in to the hospital Monday, 01Mar2021 at 1200. His bowels were empty that's why they haven't been able to do the stool sample test. Event severe stomach pain and bug in his colon lead to emergency room and physician office visit. The patient was currently hospitalized. The patient underwent lab tests and procedures on unspecified dates which included computerised tomogram (CT): normal, covid test: negative, urine analysis: unknown results, white blood cell count: 18000, white blood cell count: 19500, blood pressure measurement: 214 over something (really high; was out of the roof), weight: lost 10 pounds. Therapeutic measures were taken as a result of terrible terrible stomach pain and bug in his colon. Events terrible terrible stomach pain, bug in his colon, broke out in sweats, feeling warm was recovering, event vomiting 5 times was recovered on 27Feb2021, event nausea was recovered on 01Mar2021, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021253476 Same reporter/product, similar event and different patient;US-PFIZER INC-2021253512 Same reporter/product, similar event and different patient

This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date: 30Jun2021) on 27Feb2021 (14:27) as a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included broken right shoulder; dizziness (not ongoing); and "sugar diabetes". There were no concomitant medications. The patient previously took meclizine HCl for dizziness, and was not working; paracetamol (TYLENOL), and reported he would be feeling good, and then his symptoms would hit him again; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9581; Expiration date: 31May2021) on 06Feb2021 for COVID-19 immunization. On an unspecified date in 2021, the patient was "feeling dementia"; had diverticulitis; pancreatitis; could not stop hiccupping; and had gastroesophageal reflux disease (GERD). On 09Mar2021, the patient had nausea; stomach was upset; had vomited in quantities (described as "had filled up two containers of trash"); was sick as a dog as/sick all day; did not sleep at night; and had lost weight (lost 30 lbs.). On 10Mar2021, the patient had dizziness. The patient clarified that the dizziness reported was a different dizziness from what he had before. The patient had taken meclizine as treatment for dizziness; and paracetamol (TYLENOL) as treatment for the upset stomach and nausea. The outcome of the events was unknown for 'feeling dementia', 'diverticulitis', 'pancreatitis', 'could not stop hiccupping', 'gastroesophageal reflux disease (GERD)' and 'did not sleep at night'; was recovering for 'nausea', 'dizziness', 'vomited in quantities' and 'sick as a dog/sick all day'; and was not recovered for 'stomach was upset' and 'lost weight'.

4-5 hours after vaccination he developed swelling in the back of his throat and a sensation of his throat closing. He had a change in character of his voice with hoarseness. He developed chest tightness and difficulty swallowing saliva. His uvula was edematous. He had severe throat discomfort. He was evaluated and hospitalized and required treatment for anaphylaxis with epinephrine, famotidine , IV methylprednisolone and diphenhydramine.

Stabbing pains, fever and chills in upper body, changed to severe pain 3 days later changed to severe upper body pain, especially shoulder and hands

Rash on hands and feet. Swelling of feet ( edema). Rash on right shin. Rash on right hand got worse is very painful. Went to ER on 3/23. They say I have Vasculitis. Condition still getting worse after 8 days. Treatment is steroid ( Prednisone).

Patient's daughter reported to pharmacy that patient was experiencing fever (101.7F), vomiting, congestion, chills, headache, swollen glands, and general body aches that started somewhere around 12 hours after vaccine was administered.

swollen lips and cheeks/Lips got very swollen; swollen lips and cheeks/bottom of cheeks on his face swollen; body aches/Did not feel good all over and was achy; Did not feel good all over and was achy; Neck ache going up to head; Neck ache going up to head; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (reporter's husband) who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EN6205) on 06Mar2021 (at the age of 72-year-old) intramuscularly in arm left at single dose for COVID-19 immunisation. Relevant medical history included arthritis in his neck. Concomitant medications were not reported. The patient experienced not feeling good all over and was achy on 12Mar2021, neck ache going up to head on 12Mar2021, lips got very swollen on 12Mar2021, bottom of cheeks on his face swollen on 12Mar2021. Clinical course was provided as follows. The reporting consumer and her husband both received first dose of vaccine on 06Mar2021. Her husband did not feel good all over and was achy. His neck up to his head was also achy. His lips got very swollen and bottom cheeks of his face were also swollen. They were supposed to go for second shot on Saturday 27Mar2021. Swelling improved within 2 days. They did go through COVID test through this and both tested negative. At first they thought it was the virus. The patient has arthritis in his neck and thought it was a reaction from the vaccine because he was not having any issues before. She thought he was having a stroke. No ER or physician's office was required. On Saturday 13Mar2021, the patient went to his Primary Care physician. No other medical treatment other than taking Pepcid 20mg and Benadryl 25mg 2 tablets orally, both taken from 13Mar2021 to help with symptoms. The events were resolving at the time of report.

Swelling of Right Foot / Ankle / Calf. Swelling has subsided somewhat over last couple of weeks - but still some swelling - - added a compression sleeve - to see if it helps with swelling reduction - as recommended by doctor

Fatigue, shortness of breath, worsening orthopnea, leg swelling, chills, nausea, runny nose, productive cough, loss of taste

This 72 year old male received the Covid shot on 2/26/21 and went to the ED on 3/11/21 and was admitted on 3/11/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome)

Bells palsy, right sided; ED Note: 72-year-old male who is presenting with 2 days of right facial droop, not sparing forehead and as such concerning for a peripheral CNS etiology. On exam, he is hemodynamically stable though slightly hypertensive, saturating well room air no acute distress. Cardiopulmonary exam is unremarkable, abdomen soft and nontender, lower extremity with very mild trace edema. On neurological exam, there is a right facial droop which does not spare the forehead, there is otherwise no other focal neurological symptoms, patient able to ambulate without any issues, no slurred speech or dysphagia. His presenting symptoms is somewhat associated with a COVID-19 vaccine which he received recently. Do not suspect a CNS pathology (no other symptoms except weakness, sensation intact), given that he has presented within the timeframe, will give patient prednisone 60 mg, artificial tears, eye patch and have recommended that he follow-up with an eye doctor.

Wife reports that patient started declining on 4/5/21 after his second covid immunization. He started to have intermittent intermittent fevers, shortness of breath and labored breathing. Wife reported he would "get sweaty and hot " and therefore she would give him tylenol. He saw his pcp 2 days later on 4/7/21 for these symptoms. In addition she noticed him to present with decline in his cognition and hemibody weakness and swelling. His pcp was also concerned about diastolic dysfunction. He received an outpatient ECHO. He was placed on lasix and referred to cardiology. On 4/19 He saw cardiology who ordered EKG and reviewed his echo. Felt that his afib was likely contributing to his shortness of breath. His echo and recent blood work revealed preserved EF. He had occasional scattered wheezes on exam and therefore inhaler and cxr was ordered. On 4/22 he presented to the Emergency room for breakthrough seizure. Breakthrough seizure lasted longer than usual (20 minutes), so ED performed a CT head, which showed an age indeterminant lacunar infarct in the anterior limb of the internal capsule. ( new from MRI 2 months earlierI) .

Swollen glands in neck. Strong neck pain, still continuing. Trouble swallowing. Have been seen by personal physician. No redness inside throat, no fever, no other indications. This is not a "sore throat". This is strong/severe pain in my throat that is persistent without relief. Never had this ever before having this vaccine. Obviously, due to having the vaccine. Will not go away.

My ankles swelled up a day later on March 7th nd they are still swelled up now both ankles and up into my calves. Skin is so tight. Have had the following done on April 12th - Heart test along with Kidney and Liver test which were all good. Also had a blood test and for 73 years old I hd a perfect blood test with cholesterol number at 150 and my HDH and LDL and triglycerides were all 2 to 3 times better than recommended. 12-weeks later my ankles and calves are still swelled up. On May 25th I had an Ultra Sound on both legs from the groin down and it came back with NO blood clots.

The patient made two visits to primary Dr. with swollen feet and ankles. Visits were a few weeks apart. Dr had Lab done the second visit and didn't see anything The next month Right foot was continuing to be swollen and had pain on bottom of foot.

C-reactive protein of 31.3 (high); poly-myalgias; Aching all over; overall aches in the arms and legs/painful bilateral legs; overall aches in the arms and legs/painful bilateral arm pain; This is a spontaneous report from a contactable physician and other health professional. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ), via an unspecified route of administration, on 02Mar2021 (batch/lot number was not reported), as 1st dose, single dose, at age 72 years old, for COVID-19 immunization, at a clinic; and simvastatin (trade name unspecified), via an unspecified route of administration, from an unspecified date (reported as "long before Oct2017") to 16Mar2021 (batch/lot number was not reported), at unspecified dose and frequency, for an unspecified indication. Medical history included penicillin allergy, high cholesterol, and being slightly overweight, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. On 06Mar2021, 4 days after the first dose, the patient was aching all over, had overall aches in the arms and legs, had painful bilateral legs and bilateral arm pain. On 07Mar2021, 5 days after the first dose, the patient experienced poly-myalgias. The patient had no fever. On an unspecified date, the patient underwent high sensitivity C-reactive protein test which was 31.3 (high) and blood creatine phosphokinase (CK) was normal. The patient's CRP was usually 3 (unspecified date). The events required physician's office visit on 16Mar2021. Treatment for the events included Depo Medrol 80. Simvastatin was discontinued by the MD on 16Mar2021. On 22Mar2021, the patient went back to his physician and he was no better. He was aching all over on his arms and sides. The reporter believed that there was an adverse reaction and thought it could the simvastatin of maybe the vaccine. The patient repeated the high sensitivity C-reactive protein test on 22Mar2021 with unknown results (pending). The reporter stated that they had the patient stop simvastatin in case there was a reaction, but he got worse instead of better. They were expecting for him to get better. The reporter asked if they should not give the 2nd dose which was due on 23Mar2021, if there are any labs that they should follow besides the High Sensitivity C Reactive Protein, how long will it take to go away and is there any treatment that would be recommended. The action taken in response to the event for simvastatin was permanently withdrawn on 16Mar2021. The outcome of the event "C-reactive protein of 31.3 (high)" was unknown, and the remaining events was not recovered. Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information given in the narrative the causal association between events Pain, Pain in Extremity Lower limb, Pain in Extremity upper limb, Myalgia, C-reactive protein increased and the suspect vaccine BNT162B2 cannot be excluded. 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.

Slightly swelling; Pain; This is a spontaneous report from a contactable consumer (reported for himself). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (at the age of 72-year-old) 10:15 as 1st dose, single dose for covid-19 immunization. Medical history included hypothyroidism. patient had allergic to Pollen, variety of food. Concomitant medications included levothyroxine sodium (SYNTHROID); fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium (CALCIUM); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID; TOCOPHEROL]). It was reported that, 45 minute later the patient experienced slightly swelling, pain on 15Feb2021 11:00 . He was exposed 24 hours a day for 10 days to his husband 8 days after he had the vaccine. He (Husband) had a positive Covid test on 22Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Mar2021. Patient did not receive any treatment for events. On an unspecified date in 2021, the patient had recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Admitted 5/26 from outside facility for GI bleed, cardiac arrest and severe sepsis. COVID+. Treated with tocilizumab, vit C, vit D, alinia, zinc. Family opted for comfort care and W/D life support. Expired 6/5.

uncomfortable swallowing; swollen lymph nodes, especially on the left side; I've had some sinus issues, sinusitis; feels like if I had TMJ; Jaw pain/right jaw is the one hurting; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , gastrooesophageal reflux disease from an unknown date and unknown if ongoing He takes Protonix daily capsule for this, cluster headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced jaw pain/right jaw is the one hurting on 22Feb2021 with outcome of unknown, uncomfortable swallowing, swollen lymph nodes, especially on the left side , He had some sinus issues, feels like if he had temporomandibular joint syndrome on an unspecified date with outcome of unknown. Therapeutic measures were taken with Tylenol and Ibuprofen as a result of jaw pain/right jaw is the one hurting (pain in jaw), uncomfortable swallowing (dysphagia), swollen lymph nodes, especially on the left side (lymphadenopathy) No follow-up attempts are possible. No further information is expected.

Asymptomatic screening for admission for AKI ED to Hosp-Admission Current 6/22/2021 - present (3 days) MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem Review of Systems Constitutional: Negative for chills and fever. General weakness. HENT: Negative for ear pain and sore throat. Eyes: Negative for pain and visual disturbance. Respiratory: Positive for shortness of breath. Negative for cough. Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain and vomiting. Genitourinary: Negative for dysuria and hematuria. Musculoskeletal: Negative for arthralgias and back pain. Skin: Negative for color change and rash. Neurological: Negative for seizures and syncope. All other systems reviewed and are negative.

Five weeks after the second dose on 05/08/2021 I woke up in the morning with a lump on my left leg near my shin that was the size of a golf ball. I had a Telehealth visit and I monitored it. I went to the Urgent Care on 06/08/2021 because it was getting worse. I had started to have some swelling, pain and discomfort in my legs and ankles. It was confirmed that I had Deep Vein Thrombosis in my left leg. They did not check the other leg because the medication would take care of any DVT in that leg. I also had heart palpitations at that time. I was prescribed injections of Lovonox and now I take Pradaxa. I still have pain and discomfort but no swelling in my left leg. I went to my doctor and a Hematologist with a Cardiology appointment scheduled.

elevated WBC counts; voice is very raspy.; his bone marrow is not working great; COVID-19 Vaccine caused an allergic reaction; sinus infection; joint pains; diarrhea; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer and Other Health Professionals reported that a 73-year-old of male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (Lot Number: EL9263) (at age of 72-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure. There was no other vaccine in four weeks. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 administered in Arm Left on 12Jan2021 (Lot number: EL3246) at age of 72-year-old for COVID-19 immunization. The patient experienced sinus infection (sinusitis) (hospitalization) on Apr2021, joint pains (arthralgia) (hospitalization) on Apr2021, diarrhea (diarrhoea) (hospitalization) on Apr2021, elevated WBC counts (white blood cell count increased) (hospitalization) on an unspecified date, voice is very raspy. (dysphonia) (hospitalization) on Apr2021, his bone marrow is not working great (bone marrow disorder) (hospitalization) on Apr2021 , covid-19 vaccine caused an allergic reaction (hypersensitivity) (hospitalization) on Apr2021. The patient didn't start to get sick until April 2021. It began with sinus infection, joint pains and diarrhea. He was admitted to the hospital for 8 days. Caller also inquired if there have been any reports of elevated WBC counts. Patient was experiencing side effects a month after second dose of Pfizer COVID-19 vaccine. Ended up in hospital for 8 days. White blood cell count spiked up. Received second dose Feb2021. Didn't start getting sick until apr2021. Began with sinus infection, diarrhea, and then joints started to hurt. Wound up in hospital. Had many tests taken in the hospital. All of sorts of tests completed after he was released. Couldn't figure out what's wrong. Patient still being tested. Three doctors said it was a result of the vaccine. Sinus infection: Outcome: Lungs are clear, but still has a mucus drip and voice is very raspy. Diarrhea: Subsided. End date: ended at the end of his hospital stay. Joint pain: Is just subsiding now. Was put on 40mg prednisone. When it started, joints were very bad. Couldn't get dressed, button anything, couldn't walk, was incapacitated. Still hurts, but Prednisone is making the pain subside. It has gotten better because of the Prednisone. Discharged from hospital either 01Jun2021 or 02Jun2021. Caller stated her COVID-19 Vaccine card is probably the same as his because they both got theirs on the same day. No further details provided. Besides all of the tests they did, a colonoscopy was performed. Doctors saying this infection attacked his colon and kind of shut down his kidneys. Originally doctors were looking at parasite, but came up empty on that. Did all sorts of GI test and that stuff. Is on a new medication for high blood pressure. Hospital couldn't figure out what the mystery infection was. Really thought it was a parasite and everything except the COVID-19 Vaccine. Every time a test was performed, it was all negative. Went to hematologist who did various tests and identified his bone marrow is not working great nor is his immune system. Has some kind of abnormal protein being made in his bone marrow. Going for a bone marrow extraction. A theory from his medical team is that there was some kind of infection brewing and the COVID-19 Vaccine caused an allergic reaction that whacked it all out. Started Losartan Potassium yesterday, had nothing to do with it.Stopped Lisinopril 5mg. Has no NDC/LOT/EXP because it was discarded. Was told the Losartan Potassium has less allergic reactions. The outcome of the events sinus infection, joint pains, 'voice is very raspy' was resolving , of diarrhea was resolved on Jun2021, of the rest of events was unknown.

developed paralyzed vocal cords; There is inflammation; swelling; suffering so much lately with issues like diabetic neuropathy; Bell's palsy; This is a spontaneous report from a contactable consumer (the patient's wife) via medical information team. A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9263), via an unspecified route of administration, administered in upper left arm on 11Feb2021 16:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunisation. The vaccine was not administered as military facility. Medical history included diabetic neuropathy from an unknown date and unknown if ongoing (He has been suffering so much lately with issues like diabetic neuropathy. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Batch/Lot number: EH98991), via an unspecified route of ad-ministration, administered in Arm Left (reported as upper left arm because he was right handed) on 21Jan2021 16:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunisation. The patient previously had flu shots (FLU ZONE) his whole life and pneumonia shot. They always managed to get Fluzone. Then the government changed it and flu vaccines were only made by one manufacturer. They were careful with the flu shot and had no issue ever. There was no AE with prior vaccinations. Patient had no other vaccines within 2 weeks. No additional vaccines administered on same date of the pfizer suspect. On 01Apr2021, the patient developed paralyzed vocal cords. On an unspecified date in 2021, the patient experienced bell's palsy, there was inflammation, swelling and diabetic neuropathy. The reporter stated on 01Apr2021 her husband suddenly developed paralyzed vocal cords and they could not determine if it was caused by the vaccine. Reporter would like to know if Pfizer has any information regarding paralyzed vocal cords being reported by others and if Pfizer has a solution. Reporter would like to notified if additional information regarding this side effect was to become avail-able. Reporter stated she heard and this is purely alleged that some COVID vaccines were linked to Bell's palsy which is paralysis of the face so she thought that there could be a link to the vaccine and paralysis of the vocal cords. Reporter would like to know if Pfizer have any information regarding Bell's Palsy being related to the vaccine because she heard that one of the COVID vaccines had a direct link to this side effect. The patient had a pH study and video stroboscopy and there has been no solution. They are calling it idiopathic. That was done last week and he was going back to ENT on Monday. She thought she would get the ball rolling just in case. The reporter further stated that the patient has been suffering so much lately with issues like diabetic neuropathy. She was not accusing Pfizer's products of being the cause she just thought it was her duty to report it. There was no solution. They are going back to another doctor in the facility. The left vocal cord was paralyzed that was finally discovered. That was all they know and they do not know why. The vocal cord and box was irritated. She has no idea if it was related to Pfizer, but he has never had an issue in his 73 years of existence with his vocal cords and hoarseness. The reporter stated that the patient has never left the country and had no symptoms. He had zero incident with the vaccination. He had no site pain. No arm pain. They sat for half an hour before leaving. They also did a CAT scan of neck and thorax. It was negative for cancer. The doctor wanted to make sure to rule out cancer before started any other treatment. Reporter clarified the paralyzed vocal cords are ongoing and persisting. It was reported that at first they thought it was hoarseness. There are lots of pollen and mold in the air. The patient was outside and he wiped the counter top outside off and developed hoarseness. He thought it was allergy. He was seeing (state) ENT and Allergy. They may determine he was allergic to something in the air. Pfizer may not have any responsibility at all in this. Reporter thought she should explore the option in case Pfizer said there are 20 people that had this and have a solution. The doctor said that this may be permanent. There was inflammation and swelling. Maybe if he can get rid of swelling maybe this would improve. He still has to go to the doctor. On an unspecified date in 2021, the patient underwent lab tests and procedures which included CAT scan: negative (It was negative for cancer), video stroboscopy: no solution, pH study: no solution. Patient was six foor and shrunk over the years. Adverse events required physician office visit. The case was reported as non-serious. The outcome of event developed paralyzed vocal cords was not recovered (ongoing and persisting) whereas the outcome of all other events was un-known.

Patient reports swollen lymph nodes in right armpit that developed 6 days after vaccination and remain swollen 5 days later. Patient denies any pain, reports swollen area is soft, and describes it as a sack of fluid.

I WAS SICK (NON-RESPIRATORY) WITH COVID FOR TWO WEEKS, THEN FATIGUE FOR TWO WEEKS. RECEIVED THE COVID VACCINE ~ 5 WEEKS AFTER COVI D SYMPTOMS/DX. ONE WEEK AFTER VACCINATION ONSET OF A GENERALIZED ERYTHEMATOUS, BLANCHING RASH, AND SWELLING OF HANDS AND FEET; NO ITCHING OR PAIN. NO SYSTEMIC SIGNS (NO CONJECTIVAL OR MUCOUS MEMBRANE INVOLVEMENT). IS THIS A LATE COVID RASH OR A RASH 7 DAYS AFTER VACCINATION IN SOMEONE WHO RECENTLY HAD COVID?

1st dose COVID vaccine 1/30/21; developed shortness of breath 2/7/21; worsening symptoms SOA, falls, chest pain; seen in ED on 2/12/21; Admitted to Hospital for severe sepsis, acute respirator failure.

Severe pain in the joint of the arm that the shot was given and in the shoulder/Throbbing in the shoulder; Pinky finger was red and swollen; Pinky finger was red and swollen /Finger is swollen down to the knuckle; Very uncomfortable; Reluctant to use that arm because it is painful; This is a spontaneous report from a contactable consumer reporting for her husband. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date unknown) via an unspecified route of administration on 26Jan2021 at single dose into his arm (shoulder) for COVID-19 immunization. Medical history included wheelchair user, nephrectomy on an unspecified date, previous immunotherapy (unspecified medication, first dose in Dec2019, second dose in Mar2020) and side effects (Bullous pemphigoid, it's blistering of the skin) from the immunotherapy. The patient had a test for kidney function in Jan2021, results not reported. The patient received the vaccine on 26Jan2021 and he experienced severe pain in the joint of the arm that the shot was given, in his shoulder and his pinky finger was red and swollen and that finger was swollen down to the knuckle. He was very uncomfortable and he said it was throbbing in the shoulder and he was reluctant to use that arm because it was painful. The event onset date was 29Jan2021. The patient was given paracetamol (TYLENOL) as treatment. The result of the events was unknown.

neutropenia of unclear origin or significance noted on labs 2/11/21 WBC 2.2, NT count 35%, other cell lines within normal limits last labs done was > 1 year prior and had normal WBC count 6-7 repeat labs 2/22/21 WBC 1.9, NT 25%, ANC 570 Asymptomatic, no infections, no fevers

Extreme bloating of stomach and chest area. Some swelling in neck and face. Hospitalized after normal Upper GI series for CT Scan and other testing. Release from hospital for outpatient Endoscopy . Treated with colace, miralax for constipation. Did not resolve discomfort.

enlarged, swollen, very sensitive lymph nodes under right arm into right breast...did not occur until 10 days or so after date of vaccine

Patient presented to ED with progressively worsening angioedema presumably due to either h/o heraditory angioedema, lymphoma, or in combination with recent Covid vaccine. Patient had swelling to the lips, throat, and neck. Patient had similar symptoms in the past that resolved spontaneously within a day or received ecallantide on a different occasion in 2015. Suspected angioneurotic edema per hematology and was treated with epi, Benadryl, Pepcid, Solu-medrol, and Kalbitor for HAE. No edema visualized, clear voice, and no issues with swallowing on the next day.

Patient received second Covid vaccine 3 days prior to admisssion. He presented to the emergency department for worsening shortness of breath, cough, decreased appetite, and generalized weakness for about 2 to 3 days associated with diffuse abdominal colicky pain. He reports of a progressively worsening weakness/fatigue over the last 3 days associated with poor oral intake with nausea but no vomiting.

Adverse reaction was not to the immediate vaccine. The adverse reaction being reported is that patient has tested positive for COVID-19 on 3/10/21, almost 1 month after second vaccination. Pt has been hospitalized since 2/20/21 for 1. Suspected acute toxoplasmosis 2. Severe sepsis with encephalopathy, transaminitis and acute respiratory failure d/t #1. He had tested negative for COVID per NP PCR tests twice prior to testing positive for discharge to SNF with associated chest pains. This has prolonged his existing hospitalization

Received shot in left arm and somewhat sore shortly thereafter. Next morning my left hand was stiff and fingers swollen. Now my left hand thumb Locked and trying to move it very painful along with no movement at times.

I got my 1st Pfizer Covid-19 vaccination on 3/4/2021. No real adverse effects immediately - just a little sore right arm at the injection site and a watery, runny nose a day or so later that eventually stopped. I have allergies so I'm used to the runny nose symptom. However, on Monday evening, March 15, I noticed some slight pain where my lymph nodes are located underneath my jaw and close to my ear on the right side. There was a small lump that was tender to the touch, about the size of a small raisin or grape, under my jaw along my neck on the right side. To a much lesser extent, and barely noticeable, in a similar location, on my left side as well. I went to my primary care physician the next day, 3/16, who confirmed that I had swollen lymph nodes - and also told me they could notice them further down my neck as well, which I was not aware of previously. I had no other symptoms, e.g., no temperature, etc. They said that, yes, the swollen lymph nodes appeared to be consistent with earlier reports of swollen lymph nodes as a resulting side effect in some patients following a Covid19 vaccination, but also mentioned that often, this side effect was more noticeable several days after the vaccination. Since my swollen lymph nodes occurred nearly 10 days later, my PCP team said to go ahead and get the 2nd Pfizer vaccination as scheduled 3/25/21, but to return to their office two weeks later for another checkup to make sure there weren't any other issues going on.

Severe headache, severe head pressure, swollen nasal passages , lump in throat, itching in throat, itching around heart, trouble swallowing, burning eyes, burning in ears, fluctuating blood pressure, burning tongue with sharp needle like feelings, sore gums and roof of mouth, cramps across top of shoulders, itching in hands and under finger hails, fever blisters. However, no fever (98) and steady heart rate )65=/-5 bpm)

Patient received 2 dose of Pfizer COVID vaccine on 3/17/21. Patient drove ~3 hours for vaccine. Several days later he noted swelling in hs right leg that progressively worsened. He denies injury to leg. He presented to PCP office on 4/5/21 due to swelling. Extensive acute DVT extending from calf to groin was identified via ultrasound. Patient was placed on blood thinner.

The adverse event occur the day after receiving the 1st dose of the Pfizer covid-19 vaccine. I received the 1st dose on Sunday March 28,2021 and start feeling pain on my right leg in the calf area. The area was hot and swollen and in pain, these symptoms started Monday March 29. 2021.

Vaccine triggered Guillian Barre Syndrome, 90% paralyzed from the waist down, hospitalized for 12 days, rehab hospital for 12 days Still doing out-patient rehab. Walking and doing daily activities, but with limited strength and stamina

he was not feeling well; Really swelled up; his arthritis is getting worst; Hard of hearing; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 10Feb2021, the patient experienced really swelled up, his arthritis is getting worst, hard of hearing and he was not feeling well on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event he was not feeling well was unknown while for the rest of the events it was not recovered.

Joint pain in wrist and ankles lost strength in hands total body stiffness swelling in hands fingers. Like arthritis over night.

infection in ear lobe; ear infection/tissue inside his ear dried up and bleeding/infection started in his ear lobe that migrated to his whole left side of his face; Pain localised; Ear bleeding; Skin fissures; Shingles; Fluid discharge; Axillary abscess/substantial bubble of puss under arm; fever/Temp of 105; Chills; weakness; Swelling face; Eye swelling; This is a solicited report based on the information received by Pfizer. A 73-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 intramuscular on 01Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot Number: 1132646) to an unspecified date, at unspecified dose, subcutaneous from an unspecified date (Batch/Lot Number: 1136949) to Mar2021, at unspecified dose for moderate to severe hidradenitis suppurativa. The patient medical history includes ear infection. Concomitant medications were not reported. On unknown dates, the patient experienced tissue inside ear dried up and had bleeding, second infection in ears/painful when touched, felt pain on top of head, skin was cracking up, minor infections in ears, possible shingles and whole left side of face and eye swollen. In 2021, the patient experienced infection in ear lobe, feeling low energy and whole left side of face and eye swollen. On 02Mar2021, the patient experienced felt weakness and chills. On 08Apr2021, the patient experienced substantial bubble of pus under arm. On 10Apr2021, the patient experienced thick white odorous liquid almost syrup came pouring out of armpit. In Apr2021, the substantial bubble of pus under arm resolved. On unknown dates, felt pain on top of head, minor infections in ears and whole left side of face and eye swollen resolved. Covid-19 vaccine was also considered suspect. In Feb2021, the patient saw his physician twice for an ear infection. On 01Mar2021, the patient got his first vaccine shot. The next day he had chills and fever and feeling of weakness the next day. He went away after a short time and he felts better. He went to the physician twice in the past two weeks for minor infections especially in his ears. The tissue inside his ear dried up and bleeding. On the first visit he had a fever due to the infection in the ear. His physician prescribed antibiotic for a week. He got another infection in the same ears. He was painful when touched it. He went back to physician and physician prescribed another anitbiotic. The physician said the infections were to be expected with Humira because Humira weakens immune system. Partly because of his age. His age may be a contributing factor as well. He agrees to have physician contacted. On 29Mar2021 to 1Apr2021, he was in the hospital his infection started in his ear lobe that migrated to his whole left side of his face. His eye was swollen and felt pain on top of his head. His Temp of 105 when he went in. The patient was given intravenous antibiotics. He was tested to make sure infection had not spread to blood or bones. The Humira might have played a role because it lowers the bodies resistance to infection. They asked him not to take the Humira for two Saturdays. He did not take Humira on 09Apr2021 or before. He was stable. His skin was cracking up. Thought it might be shingles. He was prescribed an oral antibiotic first time, but then a week and a half later, it acted up again and he went back and got a different antibiotic and that worked until it. He was feeling completely better since he got out of the hospital. He had more energy than he had in a while. He had been feeling low energy for a while due to the infection. His physician did not think he should stop taking Humira but if he got a fever he needs to investigate immediately to see if he needs to hospitalized. In 08Apr2021, he had substantial bubble of puss under his arm. He gave him a steroid injection to control that. On 10Apr2021, he had thick white odorous liquid almost syrup came pouring out of his armpit and he thinks that was the end of it. On 11Apr2021, he had his second Covid vaccine manufactured by Moderna then after he was released from the hospital. He was no issues or reactions with either injection. He was careful when he went out around people. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events adalimumab was not applicable. The outcome of event infection in ear lobe, eye swelling and swelling face recovered in 2021, weakness and chills and fever recovered in Mar2021, ear infection and pain localised recovered on unspecified date, Axillary abscess/substantial bubble of puss under arm recovered in Apr2021; event ear bleeding was recovering; event fluid discharge, skin fissures and shingles was unknown. The reporter's causality for adalimumab (Humira) on the events infection in ear lobe, tissue inside ear dried up and had bleeding unknown onset, tissue inside ear dried up and had bleeding unknown onset, second infection in ears/painful when touched, felt pain on top of head, minor infections in ears, substantial bubble of puss under arm, whole left side of face and eye swollen onset in 2021 and whole left side of face and eye swollen unknown onset with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt weakness and chills with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of feeling low energy, thick white odorous liquid almost syrup came pouring out of armpit, skin was cracking up and possible shingles was not provided. Opinion is that there is a reasonable possibility that the events of infection in ear lobe, feeling low energy, thick white odorous liquid almost syrup came pouring out of armpit, second infection in ears/painful when touched, felt pain on top of head, skin was cracking up, minor infections in ears, possible shingles, substantial bubble of puss under arm, whole left side of face and eye swollen onset in 2021 and whole left side of face and eye swollen unknown onset are related to humira(adalimumab). Opinion is that there is no reasonable possibility that the events of felt weakness, chills, tissue inside ear dried up and had bleeding unknown onset and tissue inside ear dried up and had bleeding unknown onset are related to humira(adalimumab).; Sender's Comments: Pfizer comment: The serious events Ear lobe infection and Condition aggravated were considered as unlikely related to Pfizer BNT162b2 vaccine. A possible contributory role of BNT162b2 cannot be completely excluded for the non-serious asthenia, pyrexia and chills, which occurred in a close temporal relation, namely, one day after the first dose BNT162B2 injection. The other reported events were confirmed as non-serious, while the causality was confounded by ADALIMUMAB administration. The infectious events were to be expected with co-suspect due an immunosuppression activity with increased infection susceptibility, such as Herpes zoster and Ear lobe infection aggravated, in this case. Furthermore, swelling face and eye swollen with unknown onset in 2021 may be attributable to the co-suspect and unrelated to the vaccine. 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.

Severe sepsis with acute hypoxic respiratory failure secondary to COVID-19 infection. He was given remdesivir and Decadron. He completed remdesivir.

Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.

Got the shot on Thursday at 2:00 PM. Felt fine until next day around 1:00 PM. Came in from work and had to lay down because I was very tired, upset stomach, low fever, and very weak legs. All I could do was sleep. I was sick for 6 or 7 days. After about 10 days, my feet began to swell and my toes started turning purple and black. My feet were extremely painful and I was unable to walk. Over 3 months after the shot I am still having trouble with my feet.

May 20 Had felt "fatigued" most of day - attributed it to having to rise earlier than usual and having not slept well. Evening of 2nd dose date I began to feel somewhat more fatigued. (Had also drank a shot of tequila before dinner and had a glass of white wine with. Was also smoking high quality cannabis in moderation.) At 11:00 pm I rose from my chair having been seated for probably an hour and symptoms hit me full force: chills, the mild soreness in my upper arm became moderate to severe and spread to my shoulder and lower back, whole body particularly joints (including fingers of left hand) aches, mild nausea. Rough night May 21 Symptoms continue with less severity. Especially notice pain in lymph gland areas - armpits, lower back, sides of neck. by evening (with the help of 1/2 Percocet (10/325) I was feeling ok and stayed up til 1:30am May 22 Awake @ 8am. whole body particularly joints still ache including left hand (exacerbated by phone use). Upper left arm & shoulder still sore but mid-back left side more so. May 23 Pretty much back to normal. "Flu symptoms" ran their course. Still have a tough immune system at 73yo apparently (I rarely get sick at all)

severe anaphylactic shock; Unconscious; This is a spontaneous report from a contactable consumer (patient). This 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 73-year-old) (Batch/Lot Number: EN6200) as single dose (unknown if first or second dose) for COVID-19 immunisation and bendamustine from an unspecified date, 5th dose in what was to be a series of 12, for Waldenstrom's macroglobulinaemia. Relevant medical history included Waldenstrom's macroglobulinaemia. The patient's concomitant medications were not reported. The patient previously took bendamustine for Waldenstrom's macroglobulinaemia (the patient received 12 doses over 6 months 2 years ago). On 03Mar2021, the patient experienced severe anaphylactic shock and loss of consciousness; the events were considered serious as life-threatening. The patient specified that 5 days after the vaccine, the patient was undergoing chemotherapy with bendamustine. He had Waldenstrom's macroglobulenemia. This was his 5th dose in what was to be a series of 12. He had received 12 doses over 6 months 2 years prior to this report. During the treatment, the patient went into severe anaphylactic shock. He was unconscious in about 10 seconds from the onset of his first symptoms. He was treated on site and transferred to an E.R. The severity of the event and the fact that both drugs were playing around with his immunoglobulins led him to file this report. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a nasal swab on an unspecified date which was negative. He recovered from the events on an unspecified date.

Weight gain of 15-20 lbs. Swelling in left hand, arm, under armpit, and under breast. Has not improved, only has gotten worse within 3 months. Was put on antibiotics bactrim and zovox. Did not improve.

Assessment/Plan Patient is a 74yo male with PMHx: HTN, DM Type 2, Obesity & STOP BANG 5 OSA + who is seen this morning for shortness of breath. He was directly admitted to the Medicine service after being transferred from the Hospital for sepsis, confusion and respiratory distress. #Sepsis #Leukocytosis - unknown source at this point - Vanc/Zosyn, Blood cx pendiing - Trend CBC, CRP, Procalcitonin - IV LR@150mL/hr #AKI - initial Creat. - 1.46/eGF 47 - probable pre-renal variant - increase hydration - minimize nephrotoxic drugs #DM Type 2 - POC BG 269 - Lantus 8U, SSI, CC, CC Snacks - Hgb a1c pending - Metformin (Home) #HTN - Avg BP 110-120/50-70 - Lisinopril, HCTZ - Propranolol, Chlorthalidone (Home) - Continue to monitor #Obesity, morbid - BMI 42.7 - OSA STOP-BANG score: 5

This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 03Feb2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included dialysis for past four and half years, colon cancer since 2008, multiple myeloma and chemotherapy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), colecalciferol (D 3), cyanocobalamin (B 12), nasal sprays (MANUFACTURER UNKNOWN) and unknown renal so medications, all from an unknown date, for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 13Jan2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 20:00, the Saturday evening, the patient experienced terribly itched head through the Sunday morning and patient stopped taking some chemo related medications, which were started on 24Mar2021. On28Mar2021, the patient experienced forehead swelling by the dinner time. On 29Mar2021, Monday, the patient experienced swollen eye lid, it was very swollen. On 30Mar2021, Tuesday, the patient experienced swelling moved to the area under the eye. The patient visited oncologist office on Monday, Tuesday and they said they never saw this type of reaction to chemotherapy. Began medications on 29Mar2021, Tuesday and was suspecting if this could this be related to the vaccine and if she was a part of the clinical trials as she was a chemotherapy patient. The event resulted in doctor or other healthcare professional office/clinic visit on 29Mar2021. Therapeutic measures were taken as a result of adverse events included treatment with Benadryl for itching and cold compression to reduce swelling. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date and was found to be negative. The clinical outcome of head itching was recovered on Mar2021 and forehead swelling, eyelid swollen and swelling of under eye area was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.

CVA; ischemic; suffered hemorrhagic bleed; Swelling; This is a spontaneous report from a contactable other health care professional. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 73-years-old) for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history included coronary artery disease (CAD), hypersensitivity lung disease (HLD). Concomitant medications within 2 weeks of vaccination included bisoprolol, ASA, clopidogrel bisulfate (PLAVIX); all taken for an unspecified indication, start and stop date were not reported. The patient does not have any known allergies. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and had not been diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19 was unknown. On 22Jun2021, the patient experienced with cerebrovascular accident (CVA), ischemic, clot removed, then suffered hemorrhagic bleed; now swelling, on mannitol in ICU. Patient was hospitalized for 14days. Adverse events (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for AEs was unknown. device timestamp 04Jul2021. The outcome of the events was reported as not recovered. Information on Lot/Batch information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Cerebrovascular accident, Ischaemia, Haemorrhage, and Swelling and the suspect drug 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 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.

74 y/o male, BMI 34, PMHx of CHF, CKD, DM, hyperlipidemia, HTN, Cdiff, and MRSA, admitted for leukocytosis on 4/1/21. Pt received 1 dose of 2 g IV Rocephin, then ID recommended holding further abx. Pt placed on PO vanco for Cdiff. Pt discharged on 4/4/21.

Severe joint pain in toes; Numbness of feet; swelling of the foot and ankle both feet are affected the left foot is the worst; swelling of the foot and ankle both feet are affected the left foot is the worst; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included coronary heart disease. The patient received unspecified medication within two weeks, Prior to vaccination. The patient had no known allergies to medications, food, or other products. Prior to 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 vaccination within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 15:45, the patient experienced severe joint pain in toes, numbness of feet and swelling of the foot and ankle both feet were affected the left foot was the worst. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe joint pain in toes, numbness of feet, swelling of the foot and ankle both feet are affected the left foot is the worst were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

shortness of breath, chest xray with pulmonary edema, periorbital edema Narrative: 73 yo M w/ PMH HTN, HLD, EVAR (2013) for AAA c/b persistent type II endoleak s/p multilple repairs (2015 & 2017) c/b glue embolization down into the R CIA secured with additional stent placement with the R iliac limb, s/p b/l Iliac artery aneurysm stent 08/31/20, and PTSD. Former smoker, quit 12+ yrs ago. 11/1/20-11/6/20: Hospitalized for acute on chronic back pain, found to multiple hypermetabolic lesions in the axial skeleton. Diagnosed with epithelioid angiosarcoma. Patient discharged to facility. 12/17/20: Patient received his 1st COVID-19 vaccine w/o complications at facility. 12/21/20: Underwent cyberknife treatment. 12/31/20: Transferred from facility to ER for new O2 requirement, SOB, cough, chest X ray / pulm edema, tachycardic and new periorbital edema. 12/31/20: Admitted to ICU before transfer to acute care. 1/1/21: Pulmonary consult, "Labs are notable for progressive left shift with bandemia, markedly elevated inflammatory markers (D-dimer, ESR, CRP, ferritin, LDH), mild elevation in procalcitonin, mild elevation in lactate that has improved, and negative viral panel including COVID-19 x2. CT chest is notable for b/l GGOs along with some interstitial infiltrates with an upper and particularly mid zone and perihilar predominance, septal thickening and crazy paving, and numerous cystic lesions or pneumatoceles. There is a lack of lobar consolidation and pulmonary nodules. Of note, PET/CT about 2 months ago only demonstrated some mild to moderate emphysema mostly in the upper lobes. Therefore, there has been a relatively dramatic change in a few months, suggesting a more subacute process, rather than an acute infectious process such as a viral pneumonia, including COVID-19 infection, in which the GGOs tend to be subpleural and peripheral. Overall, our suspicion for COVID-19 is relatively low, with negative testing x2 yesterday, negative testing a few weeks ago, and lack of sick contacts, but it is possible. Therefore, higher on the differential is a more subacute infection or chemotherapy-induced pneumonitis. Risk factors include malignancy, chemotherapy, and use of steroids (equivalence of about 27 mg of Prednisone in the form of Dexamethasone since 11/6/20 without PJP prophylaxis). These risk factors, along with consistent imaging and elevated LDH, make PJP quite likely. Fungal infection is less likely based on imaging. Chemotherapy-induced pneumonitis is a possibility, especially given the more subacute picture based on imaging. Both Gemcitabine and Docetaxel can cause pneumonitis. However, the patient has been on steroids, which is used to treat drug-induced pneumonitis, although this does not exclude it completely." 1/2/21: Transferred to ICU for worsening hypoxemia as patient reached 40L/100% FIO2 and remained on COVID isolation/COVID patient under investigation per ID recommendation. 1/4/21: Isolation precautions discontinued due to lower suspicion for active COVID infection to explain current presentation 1/6/21: Went into atrial fibrillation w/o RVR overnight 1/6. Tolerating, with MAPs in low 60s and HR in high 90s/low 100s. Suspect due to being-1L yesterday from diuresis, lasix stopped. S/p amiodarone bolus + drip, albumin 5% bolus 1/5/21: Macrocytic anemia NOS w/ slowly worsening H/H s/p PRBC x 1 unit 1/7/21: Per ICU Life-sustaining treatment note, "Following discussion w/ patient that his lung dx has been refractory to txt and hasn't improved despite maximal therapy, patient agreed to transition to hospice after he settles affairs. " 1/7/21 Infectious Disease note: "This is an immunocompromised host due to cancer on active chemotherapy (albeit ANC>4000 on admission) and notably had been on daily PO dexamethasone 1 mg TID (total daily dose 3 mg, equivalent to 20 mg PO prednisone) since 11/6/20 without any PJP ppx. There was elevated c/f COVID-19 infection in setting of patient's presenting symptoms, especially in conjunction with b/l GGOs on imaging. Has undergone multiple COVID test that have all resulted negative. Discussed radiographic findings with radiology colleagues, and overall, it is difficult to definitively narrow the differential with imaging alone, but overall density of GGOs seem to appear less likely PJP and more in line with chemical pneumonitis vs COVID, although less typical for viral pneumonia as well. Given false-negative COVID tests are not unheard of, especially in the immunocompromised population, patient was kept on isolation precautions as a PUI for abundance of caution. He is now off precautions. In setting of patient having been on prednisone for some time without PJP ppx, he was also started on treatment dose TMP/SMX. Beta-d-glucan has returned positive, and although not the ideal test for PJP, this can certainly support a potential dx of PJP. Unfortunately, DFA from sputum was not performed due to insufficient sample and currently the patient is unable to produce an additional sample for testing. He is tolerating the high-dose TMP/SMX; we adjusted the dose to three SS tablets TID based on his somewhat declining UOP. Other fungal etiologies are pending work-up as well. Lastly, patient's chemotherapy is known to cause pneumonitis, but per pulmonology team, he receives prophylactic dexamethasone with his chemo cycles that should help to prevent drug-induced pneumonitis. Remains on the differential for now and this should also be concurrently treated with the steroids he is receiving." 1/10/21: Comfort care initiated. All non-comfort measures were discontinued. Time of death: Jan 10,2021@14:56; immediate cause of death per death note is "hypoxic respiratory failure"

Flushed, reddened cheeks, itchy, tingling eyes, slight swelling, tingling lips, slight swelling 20 minutes after injection Untreated symptoms significantly reduced after 3-4 hours except itchy, watery eyes Itchy, watery eyes is ongoing a week after the injection, now being treated with Lotemax steroid eye drops

2:30 PM joint pain, aching, 3:00 AM swollen throat and neck, trouble breathing, chest and jaw pain. 5 AM all good but he joint pain remained.

Right cheek swelling (looks like cellulitis) started 1 day after first vaccine dose, submandibular, drainage to ear area, throbbing and aching. Seen in Urgent Care and prescribed Kelfex 500 mg BID, along with Valacyclovir (for Herpes Zoster).

Lymph Nodes in armpits; COVID-19 vaccine was administered on the same date as the other vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient receive the 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 the right arm on 17Jan2021 at 07:45 at a single dose for COVID-19 immunization. The first dose of another vaccine (unspecified trade name; reported product: "Phizer," lot number and expiration date were unknown) was also administered on the same date on 17Jan2021, via an unspecified route of administration on the left arm at unknown dosage and frequency for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported. Concomitant medication included morniflumate (FLOMAX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 at 07:45, the patient experienced lymph nodes in armpits, which was considered as non-serious. COVID-19 vaccine was administered on the same date as the other vaccine on 17Jan2021. The patient did not receive any treatment for the adverse event "lymph nodes in armpits." The patient was not recovered from the event lymph nodes in armpits. Information on the lot/batch number has been requested.

Swelling in the groin area above the hip; skin is swollen and there is lump; skin is swollen and there is lump; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 18Jan2021 at first single dose for covid-19 immunisation. Medical history included: the patient had pre-existing conditions, he was hospitalized in Dec2020 and he was undergoing a lot of testing and there was possibility that he had a form of cancer and they discovered something on the next to his lungs. The reporter stated they did not have all of the diagnosis of it yet and he was waiting to be seen for specialist. The patient's concomitant medications were not reported. On 20Jan2021, the patient had a swelling. Swelling in the groin area above the hip. Skin is swollen and there is a lump. The reporter was trying to find out with the list of side effects if the lymph glands can swell and what areas of the body would you may be see swelling in the lymph nodes. The reporter wonder if there be lymph gland located for the men or the lymph gland located on the either side of the reproductive organ, in that area. What had happened to the patient, they were not sure if that was a side effect. One of the side effects the reporter knew it was listed on the website was lymph glands swell up. So the reporter just trying to find out if there were lymph glands in that same area where the patient was experience swelling right now. He did not have this issue before he got the vaccine, so it just sort of seemed this is. The reporter talked to the physician's office briefly when this happened just to see did they need to bring the patient in immediately for an appointment to check if it's (incomplete sentence). So far the patient just received topical ice packs over the area for the events. Outcome of the events was unknown.

At 14.48pm, after given the vaccine patient came back complaining of tingling of both arms, redness and swelling. Hives to forehead, no itching nor fever. Vitals taken at this time, BP was 128/72. Patient was given 0.5ml of Benadryl left deltoid site. At 15.02pm second vitals taken, BP was 130/84, no redness, no swellings on both arms and no hives at this time. Patient was asked to sit back for 15 mins for further observation. At 3.15pm, patient was stabilized and asked to leave.

Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.

Lymphadenopathy . A swelling at the intersection of the upper lip and the groove up to my nose. And rigidity of my nose. Minor pain at the injection site 3 or so hours after, continuing 36 hours until fading away.

Headache, Fatigue and Fever - for 36 Hours. IMPORTANT NOTE: After the Fever and headache left, I had (And continue to have) swelling in my lymph node under the left arm - where I had the shot. At first it was painful but after several days, the pain subsided but I can feel a little pain ehen I touch the area.

Two days after receiving vaccine, I experienced severe rashes covering about one half of lower left leg and considerable edema there and swollen lymph node in left groin and a little less rash and no edema on lower right leg. The rashes are most acute at the sites of dog bites from April, 2020.

pt states he has a sore arm, shakes, chills, fatigue, nausea, vomiting and general feeling of being unwell. He said he has abdominal swelling and felt like his body has swollen up like a balloon but couldn't release the pressure. Pt states these symptoms lasted about 12-18 hours. He says he is still tired and still has some pressure in his belly but is feeling better. He has to take dialysis today and will discuss these symptoms w/ them.

Pain in upper right thigh on day after vaccine and next day. Badly swollen calf on third day after vaccine. Hospitalized with "Right femoral acute thrombosis; no compression; no flow detected."

Deep Venous Thrombosis: DVT extending from the right common femoral to the popliteal vein. Swelling of entire Rt Leg and Numbness

Patient reports developing swelling of L index finger/"trigger finger," about a week after receiving 1st Pfizer vaccine. Finger continues to be swollen/bent. Reports this has happened in the past to a finger on his right hand. Denies any other s/s or concerns. Did not seek medical care.

3/31/2021 - Nausea 4/01/2021 - Fatigue, stood up after nap and fell with injuries 4/03/2021 - Lymph Node Left Arm enlarged to size of Golf Ball 4/04/2021 - Left Arm very noticeably swollen with rash on both fore-arms 4/05/2021 - Loss of Appetite (not loss of taste or smell) 4/06/2021 - Lymph Node swelling now size of lemon+ 4/09/2021 - Dr visit: Stat Ultrasound: no blood clots. Started on Antibiotic CEFDINIR 300mg 4/10/2021 - Still reduced appetite, arm swelling the same

Started to feel pain in right shoulder and beginning numbnes in right hand. 2 days after first dose. From that pain in left shoulder began. Shortly, thereafter, severe pain in both knees, and swelling in hands, knees, and ankles. Pain continued and seemed to exaserbate after 2nd dose on February 26,2021. Tested for rheumatoid arthitis. results were negative and within normal range. some arthitis found in right shoulder by xray. 2 Orthopedic doctors and Neurologist comfirmed presence of carpal tunnel in right hand.

DEATH Narrative: Patient passed away after Covid Vaccine. 2/8/21: brought to the ER for evaluation for leg weakness and a recent fall associated. He was in a facility- per patient he fell when standing from the bed, he though he could do it and did not ask for help. He has been with hip and pelvic pain since then. The CT/XR shows evidence of lytic lesions, an IR bone biopsy was done and came positive for metastatic bladder carcinoma. 02/17/21: transferred to the facility for PT and pain management, originally for short stay rehab then changed to hospice care. 02/19/2021: received covid vaccine 03/05/21: discharged from facility on home hospice 03/23/21: pt passed away at home Patient with prior covid infection; tested positive last on 9/25/2020. Vaccine did not likely contribute to patient's death, as he was on hospice due to malignant cancer. No evidence of reaction immediately after vaccination or before date of death.

Patient was vaccinated on 2/05/2021 with 2nd Pfizer vaccine and was hospitalized for Guillain Barre On 03/11. Has been In hospital since.

guillain barre syndrome; Paralysis from the waist down; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Guillain-Barre syndrome and Paralysis from the waist down on 21Mar2021 13:00. Adverse event (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Therapeutic measures were taken as a result of events included Intravenous immunoglobulin (IVIG) and now needing long term care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The outcome of the events was recovering.

my left elbow and forearm began to swell into a large ball shape near the elbow joint; my left hand became noticeably swollen as well; Swelling of the armpit, elbow and forearm areas; Swelling of the armpit, elbow and forearm areas; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: env201), via an unspecified route of administration, administered at left arm, on 24Feb2021 11:00 AM at single dose for COVID-19 immunisation. Patient medical history included allergies to sulfa based drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Amlodipine - 10mg. The patient stated that no prior reactions to the annual flu, pneumonia, or shingles vaccinations. Because of a scheduled prostate biopsy in early Apr2021, I wanted to complete the vaccination for COVID-19 in advance of this procedure. On 24Feb2021, within 5 mins of receiving the vaccination shot in my left arm, my left elbow and forearm began to swell into a large ball shape near the elbow joint. At the same time, patient's left hand became noticeably swollen as well. Fortunately, Patient did not experience trouble breathing or have any numbness in fingers at that time. The observation staff nurses took patient to a separate room to check blood pressure and heart rate which were both in the normal range. The patient also experienced swelling of the armpit, elbow and forearm areas are still present the next day. The patient received the treatment as Benadryl in response to the adverse events reduce swelling. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome for events was not recovered. No follow-up attempts are possible; No further information is expected.

Development of polymyalgia rheumatica 2 days after 2nd shot. Pain and stiffness in shoulders, neck, pelvic girdle.

Patient went to a pharmacy in the area on 2/11/21 to receive his B12 shot and pfiser vaccine. In error pt was given 2 covid-19 pfiser vaccines that same day at the same pharmacy from different lot numbers. Pt had vaccine cards for proof. Pt then received a 3rd dose on 3/5/21 at a medical facility. Pt then returned to the same pharmacy where he had been given the first (2) shots on 4/17/21 and was given a 4th pfiser vaccine. Pt has proof of all of said administrations. On one vaccine card pt states that when he returned to first pharmacy a staff member tore the sticker off of one of his vaccine cards and shows that indeed the vaccine card seems to have been altered and something torn off. Pt came to clinic on 4/28/21 where writer had nursing visit with pt for dizziness, body aches, urinary incontinence, dry mouth, burning sensation of skin, worsening leg edema.

J96.01 - Acute respiratory failure with hypoxia (CMS/HCC) R57.9 - Shock (CMS/HCC) A41.9 - Sepsis, unspecified organism

about a week after getting the second dose of the covid vax he developed a severe case of rheumatoid arthritis. His neck became stiff, his hands became hot and swollen. All of the joints were inflamed including his hips, knees, feet and all parts of his body that came on all at once. He states it was so dramatic he had problems getting up and down and moving around. He saw his PCP, in April. He was prescribed prednisone. He was instructed to take naproxen sodium after finishing the steroids. He has improved about 90% at this time. His doctor says if his symptoms do not improve then will do blood work and refer him to a Rheumatologist.

right leg/knee became severely swollen; right leg/knee became severely swollen; couldn't walk; fatigue; fever; aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration, administered in left arm on 18Feb2021 at 12:00 (at the age of 74-year-old), as first dose, single, for COVID-19 immunization at school or student health clinic. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included atorvastatin calcium (LIPITOR); morniflumate (FLOMAX) losartan potassium (LOSARTAN POTASSIUM) and plus more (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's right leg/knee became severely swollen and he couldn't walk and also the patient had fatigue, fever and aches on an unspecified date on 2021. The events were reported as non-serious. No treatment was received for the events. The outcome was reported as recovered on an unknown date in 2021 for the reported events.

Full body rash; swelling; itching; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 05Mar2021 11:45 as unknown, single dose for covid-19 immunisation. Medical history included asthma, high blood pressure, atrial fibrillation (AFib). There was no known drug allergies (NKDA). There were no concomitant medications (no other vaccine in four weeks). There was no covid prior vaccination and covid not tested post vaccination. On 06Mar2021 04:30, patient experienced full body rash, swelling and itching. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given for adverse events prescribed methylprednisolone. The outcome of event was recovering. No follow-up attempts are needed; no further information expected.

1. Initially only mild pain after first vaccination. Beginning an hour or so after buster (second vaccination), swelling of shoulder and upper arm, completely ceased/frozen to torso with acute pain and immobility for many days and inability to articulate. Acute pain at shoulder and upper Humerus region when any motion was attempted. Sleep disrupted when I turned to the right side during sleep. Symptoms lasted for almost a month. Symptoms are better now, but NOT completely gone. Pain is milder, (page 2) 2. While mild tinnitus existed before the vaccination, post buster the tinnitus has become virtually intolerable. Constant head pain accompany loud tinnitus onset, but constant when arm reaches towards back waist.

Shoulder and back pain that has persisted. After second vaccination, 02-27-2021, administered at 1:50 pm, nausea and vomiting for two days that started that night. Abdominal pain that has persisted, radiating to back, exacerbated by eating fats and sugars. Pancreatitis diagnosed by labs and imaging. Treatment: Creon and diet.

had arthritis in these areas; The pain interrupted his sleep; pain in his left hip, left arm, left lower back, feet and left shoulder; right arm/shoulder felt like bursitis; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in right arm on an unspecified date (age at vaccination: 74 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was hypertension, blood cholesterol and arthritis.Concomitant medication included lisinopril taken for hypertension for over 10 years and was ongoing; simvastatin taken for blood cholesterol for over 10 years and was ongoing; famotidine taken for reflux from 2019 and ongoing. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 and the patient experienced low grade "flu", body aches and was sleeping a lot. On an unknown date, the patient experienced had arthritis in these areas, the pain interrupted his sleep. On an unknown date in Mar2021, the patient's right arm/shoulder felt like bursitis, pain in his left hip, left arm, left lower back, feet and left shoulder. It felt bad and achy. The event of arthritis was determined to be medically significant. His doctor had information where it could areas prone to arthritis. This started a couple days after getting the second dose. The patient took Aleve as treatment for the adverse events. If he did anything like driving the tractor and turning it became aggravated. He has been going to physical therapy for arthritis and was not had any problems in over 10 years. His doctor prescribed him steroids. He will see the doctor next Monday for a routine check-up. The adverse events did not require a visit to emergency room or physician's office. The patient did not receive any prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The outcome of arthritis and sleep disorder was unknown; outcome of other events was not recovered. Information on lot/batch number has been requested.

Severe systemic inflammatory response syndrome (SIRS) Pericardial Effusion Travel to Hospital emergence room by ambulance following 911 call. In emergency ward until late evening 3/6/21 Moved to intensive care area for 24 hours (3/6/21 to 3/7/21) Moved to regular ward in evening (3/6) or early morning (3/7). Tests showed low blood pressure at times, and a racing heart rate while resting. Released 3/9/21 - new medication: Colchicine and Benzonatate 06/18/2021 additional inflammatory response Dr.

After receiving the 2nd vaccine, I had pain in my left shoulder which I thought was normal . However , it has been 6 months and the pain has not subsided. I am awakened at night with severe shoulder pain. I have had pain and weakness in my left shoulder despite taking Aleve and Aspirin. I used to enjoy lifting weights, but have been unable to do so since the second shot.

muscle pain and weakness mid April 104.1 fever May 31 hospitalized June 1 released June 9 facial parthesia -- hospitalized June 29 - July 1 EMG -- July 13 -- revealed Gullian - Barre Syndrome

Redness and swelling of the right lower leg. Diagnosed with cellulitis. Prescribed an antibiotic and discharged.

Moderate arm pain day 2, lymphadenopathy L armpit Day 3-7, localized L upper arm erythema and itchy rash Day 5- present

Apparent lymphadenopathy on top of left shouder measuring ultimately roughly 10 c long, 4 c wide and 2 c high. It may have extended down to just above the clavicle next to the neck (4c away), where it receded over 36 hours from onsetat 8 pmJan 29. Continuing as of this report as soft circular swelling about 5c diameter, 2 c high and sitting just above the clavicle. Clinician recommended no treatment as no other symptoms presented and breathing/swallowing were unaffected. I am likely to recieve chemo from newly recurring (Dec 2020) NHL -a biopsy is pending Feb 8 with diagnosis likely by Feb 16. Treatment TBD.

allergic reaction; redness at the injection site; swelling at the injection site; redness and swelling at the injection site that moved down his arm/then it traveled; redness and swelling at the injection site that moved down his arm/then it traveled; itching at injection site; pain at injection site; several hours before checking infection site; bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled/middle of injection site there was a white area, raised; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 75-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 09:15 at a single dose for covid-19 immunization. Medical history included cholesterol (blood cholesterol abnormal) and blood pressure blood pressure abnormal). Concomitant medication included hydrochlorothiazide for blood pressure, atorvastatin for cholesterol, fish oil and vitamins NOS (MULTIVITAMIN). The patient reported that he got the first dose of the covid vaccine on Friday (22Jan2021) and he had symptoms following the injection which included redness and swelling at the injection site that moved down his arm. The patient also mentioned that he experienced like a bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled. The patient mentioned that he was seen at his PCP and reports that he was told he had an allergic reaction to the shot, hopefully it would not spread any further, and states his doctor seemed to be very concerned his physician prescribed him with an epi pen to have for if he gets the second dose of the vaccine and the reporter stated that he has never diagnosed with allergies. The patient inquired if the injection wasn't put in correctly and it was put in the tissue and not the muscle. The reporter mentioned that his wife said the needle didn't go in as much as when she got her injection, so he was wondering if it was administered in the right way and also asking if part of the needle could have broken off and if that is what is causing the redness and swelling to his arm. His doctor assured him the needle could not break and stated that his said that it did not look like the injection was as deep as hers since she was watching him get his vaccine. The reporter also inquired if that could have caused an issue if it was not administered deep enough. He mentioned that he waited several hours before checking infection site [pending clarification] and noticing the swelling and redness. States it is also itchy and painful, not a painful to the touch but an itchy, knifey kind of pain, states sometimes it feels like he needs to rub it and sometimes it feels like someone is stabbing him. The outcome of the event allergic reaction was unknown while the outcome of the other events was not recovered. The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077371 Same reporter/drug, similar events, different patient

Fever 101.7 - chills - malaise Starting approximately 18 hours after injection. Lasting approximately 24 hours. Multiple (5+) herpes sores on upper and lower lips and surrounding face. Started 02/09/21 and still ongoing.

Anaphylactic shock 5 days later. Rash over body, redness of body, itching, swollen tongue and throat, shortness of breath. Treated at ER immediately. With sodium chloride, Benadryl at4:56,Epinephrine given twice at 4:46 pm and 5:15 pm, Pepcid at 4:58.

4 1/2 days after second shot, develop swelling in right arm pit and breast. That was a week ago. Subsequent a rash has developed and I continue to have temperature (as high as 100.9), chills and significant night sweats. Swelling continues. I get some relief from Tylenol and Ibuprofen

Diagnosed as Angioedema; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL9265) via an unspecified route of administration on 28Jan2021 10:00 into left arm at a single dose for COVID-19 immunisation. The patient medical history included Hypersensitivity Pneumonitis (PF-ILD) Interstitial Lung Disease and the patient allergies to Lisinopril, meclizine, and Bactrim. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications within two weeks included nintedanib, atorvasatin, Vitamin D3, cyanocobalamin (VITAMIN B12) and acetylsalicylic acid (ASPRIN). The patient diagnosed as angioedema on 30Jan2021 and result in emergent room/department or urgent care. The patient awoke on 31Jan2021 with facial swelling, lip swollen right side of face. No swelling of throat. The patient received methylprednisolone (Solu-MEDROL) injection 125mg, tranexamic acid (CYKLOKAPRON) 1 g in sodium chloride 0.9% 100 ml IVPB (mini-bag plus) as treatment. The patient did not test COVID post vaccination. The outcome of the event was recovering. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.

PATIENT REPORTED FEELING AS IF LIPS WERE SWOLLEN. SHORTNESS OF BREATH AND DIFFICULTY SWALLOWING. RN ASSESSED AND GAVE 50 MG BENEDRYL AND EMS ALERTED.

anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; This is a spontaneous report from a contactable consumer (the patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on 05Feb2021 at 11:10 AM (at the age of 75 years), as a single dose for COVID-19 immunization. Medical history included kidney transplant. Concomitant medication included tacrolimus, mycophenolate mofetil (MYCOPHENOLATE), prednisone. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), on 14Jan2021 for COVID-19 immunization). On 05Feb2021 at around 18:00 PM, the patient had what he believed was an anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest (he clarified that upper chest as where the neck meets the chest. It may have been a little lower, but not that far down that he would have worried. It was the upper chest where the neck meets the chest. Not in the chest to the left or right). It lasted intermittently for 4 days. He reported that it was not continuous, it would come for 2-3 hours dissipate and then come again. It wasn't all day and all night. He reported "I'm better now". The clinical outcome of anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest was recovered on 10Feb2021.

During the evening of his vaccination he started having chills with severe shaking associated with fever. Presented to ED on 2/28/21. Fever was 104F. Disoriented on presentation, CRP of 18, mildly elevated troponin, persistent hypotension, headache. Received fluids and Rocephin. Admitted to ICU 2/28/21. Discharged 3/1/21. Final Diagnosis- hyperpyrexia, hypotension, related to immunologic reaction from second Pfizer COVID vaccine. Cannot rule out septic shock from RLL pneumonia and pleural effusion. Hx of COVID 19 myocarditis, chronic systolic CHF and cardiomyopathy EF of 45%, with current mildly elevated troponin. Mild hyponatremia, lactic acidosis. Acute encephalopathy related to hyperpyrexia.

Swelling and redness in left arm, just below the vaccination site. After one week the swelling and redness seem to be somewhat reduced

On Sunday Feb. 21st, in the evening before bed, I noticed that my left lower leg and ankle were swollen, (as complared to my right leg.) I was also experiencing shortness of breath.

Reactive lymphadenopathy axillary region of left arm swelling goes down into left breast no pain, no erythema

03/24/21: Patient presented and was admitted through the emergency department for CC of Shortness of Breath, generalized body ache and low-grade fever for last 2 days. Patient has a past medical history of Atrial fibrillation, Cancer, COPD, CRI , Diabetes mellitus, , HTN , Hyperlipidemia, On home oxygen therapy. Labs were remarkable for a leukocytosis of 18.2, hyperglycemia of 336, and an AKI with creatinine of 1.38. Chest x-ray was performed and revealed bilateral patchy opacities. COVID-PCR negative. In the ED the patient was seen to have A. fib. Per the EUA, Hospitalizations are to be reported irrespective to attribution to vaccine

Chief Complaint Pt reports increased weakness today, unable to get out of bed. Also increased left arm pain from a fall weeks ago. No recently fall or injury in last 24 hours. History of Present Illness A very pleasant 75yo M who presents to the ED today for evaluation of weakness and left arm pain. He reports that about a month ago, he tripped over his dog and fell, hitting his left shoulder against the box spring on his bed. At the time, he reports he did not have pain in the shoulder, but did have low back pain. He went to his PCP's office on 3/16/21 for evaluation and was not having left shoulder pain at that time; an XR of the lumbar spine was performed which revealed chronic degenerative

Patient presented to Medical Center ED on 4/1/2021 with complaint of 2 day history of bilateral upper and lower extremity weakness that is increasing. Patient had received Covid vaccine 12 days ago and had a self-limited 3 day diarrheal illness 1 week ago. Admitted to hospital, diagnosed with Guillain-Barre, and has undergone plasmapheresis. As of 4/8/2021, patient is showing signs of improvement with movement of his lower extremities.

WBC count has gone up; via subcutaneous; This is a spontaneous report from a contactable consumer reported for himself. This 75-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous on 17Feb2021 at single dose for COVID-19 immunisation. Medical history included prostrate operation 11 years ago, psoriasis and hypertension which was controlled. The patient did not have any blood disorders. Concomitant medications were unknown. The patient had his second dose of the pfizer Covid 19 vaccine on 17Feb2021. and something that had never happened to him before, he had 3 blood test and on all 3 his WBC count had gone up since the Pfizer vaccine dose. The patient asked if the vaccine caused this. He had asked his doctor but he was not able to answer the question. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

swelling on his right arm; swelling on his right arm next to his chest; where his breast is on the right hand side and it is about the size of a baseball, doctor said lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right in Mar2021 (Batch/Lot number was not reported) at vaccination age of 75 years old as single dose for covid-19 immunisation. There was no medical history. There was no family medical history relevant to events. There were no concomitant medications. No events following prior vaccinations. No additional vaccines administered on same date of the Pfizer.The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 as single dose for covid-19 immunisation. The patient took the Pfizer vaccine about a month ago and after a week or two, he got swelling on his right arm next to his chest where he took the shot at. His arm was still swollen and he went to doctor. The doctor said it looked like a swollen lymph node. It was where his breast was on the right hand side and it was about the size of a baseball. He was supposed to go back to doctor on 14Apr2021. Clarified this happened about two weeks after his second dose, and it was on a Thursday. They were supposed to do more tests on Wednesday of this week (14Apr2021). They were talking about giving him an ultrasound, but he was not sure. Time of event onset reported as 10 AM. Events did not require emergency room, required physician office. The outcome of events was unknown. No follow up attempts are needed; No further information is expected.

6. March 4 Descending stairs from bedroom to living room, pain and burning now throughout legs and feet; left leg pain behind knee, walking with limp; suspect some swelling in both legs 7. March 7 Consult with on-call doctor at clinic on Sunday who recommends emergency room visit; decide to wait until Monday 8. March 9 Call my vascular physician?s office; Dr. recommends emergency room visit; it is late, decide to wait until next day 9. March 10 Emergency room visit. Doppler exam shows no vascular change; attending physician suggest neuropathy as possible cause for leg pain 10. March 11 Dr. exam confirms no vascular change; also concludes possible neuropathy explanation for pain 11. March 15 Barely ambulatory, son helps me walk to emergency room visit; also having low back and left pelvic pain; no etiology 12. March 18 Dr. video teleconference; prescribes MRI of lumbar region and x-ray of left knee 13. March 27 Second Covid19 shot 14. March 30 MRI and X-ray at hospital; can barely walk to appointment, must use wall to support me when I walk between procedures; numbness and burning over whole body, especially extremities; numbness and tingling in face and throat 15. March 31 Speech therapy appointment; still unable to walk without holding on to objects and walls; other symptoms the same 16. April 6 Dr. in-person appointment; still difficulty walking; other symptoms the same; Dr. prescribes Duloxitene, 30mg initially, 60mg therapeutic dose; recommends neurology appointment with Dr. 17. Present: Tingling/burning in all limbs; tingling in left side of face; difficulty with balance

COUGH 3/15/2021 - 3/19/2021 (4 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Admission diagnosis: Primary Admission Diagnosis Hospital Problems * (Principal) Pneumonia due to COVID-19 virus Yes Hyperlipidemia Yes HYPERLIPIDEMIA NEC/NOS; Hypertension Yes Obstructive sleep apnea Yes Sick sinus syndrome (CMS/HCC) Yes S/p atrial pacing History of placement of stent in LAD coronary artery Not Applicable Acute deep vein thrombosis (DVT) of popliteal vein of left lower extremity (CMS/HCC) Yes Hypoxia Yes Disposition: discharge to home with home health care CODE STATUS (LOI): Full Code Consulted Services: none Operative Procedures Performed _ Active Issues Requiring Follow-up COVID19 pneumonia with acute respiratory insufficiency-Home O2 evaluation completed and the patient requires 1 L of oxygen with rest and 3 L with exertion. He will be discharged with 5 more days of Decadron to complete a 10-day course. He received convalescent plasma while hospitalized. He completed a 5-day course of remdesivir. He already received his first Covid vaccine. His second Covid vaccine was rescheduled for April 9 at 1245 at the Hospital. Acute DVT of the left popliteal vein-started on Eliquis. Patient will complete 7 days of 10 mg p.o. twice daily then start on 5 mg p.o. twice daily Coronary artery disease-aspirin was decreased to 81 mg since he was started on Eliquis Iron deficiency anemia-started on iron replacement. Recommend further work-up as indicated as an outpatient. The patient does report he had a colonoscopy 2 years ago which was normal. He has had intentional weight loss over the past year of 35 pounds so this could be from his dietary changes but discussed outpatient monitoring through his family doctor.

a blood clot in his left arm; possible sepsis; malnourishment; dehydration.; became so weak he slumped down; health has steadily declined; This is a spontaneous report from a contactable consumer (patient's son). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (batch/lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included Parkinson's disease, essential thrombocythaemia, and chronic kidney disease which were all under control; and allergies to latex and iodine. The patient's concomitant medications were not reported. On 01Mar2021, shortly after second dose, the patient became so weak, he slumped down and had to be lifted by reporter's uncle, after this incident, his health has steadily declined and now he was hospitalized again on an unspecified date with a blood clot in his left arm, possible sepsis, malnourishment and dehydration. He has Parkinson disease, essential thrombocythemia, chronic kidney disease; however, all were under control until he was vaccinated with the second shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. 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 and since the vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures which included covid test: negative on an unspecified date. Outcome of events was not recovered. Information about lot/batch number has been requested.

Feeling unwell; Injection site swelling; Joint pain; Nausea; Swollen lymph nodes; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient had blood type o-negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included vitamin B-complex (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), beta carotene (MANUFACTURER UNKNOWN), St. John's wort (MANUFACTURER UNKNOWN), CLARITIN-D for unknown indications, FLOMAX for benign prostatic hyperplasia and unspecified medication for high blood pressure, all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021 at 13:45, the patient experienced injection site swelling, nausea wave on inject date, swollen lymph nodes, joint pain, tiredness and was feeling unwell through most of the day. The patient had no temperature issues and had not received any flu injection for past 15 to 20 years. The patient did not receive any treatment for the adverse events. The clinical outcome of the events injection site swelling, nausea, swollen lymph nodes, joint pain, tiredness and feeling unwell was recovering. No follow-up attempts are needed. No further information is expected.

I have been feeling extremely tired and fatigues in my feet and legs; my ALT, AST, and Alkaline Phosphate levels jumped very high; my ALT, AST, and Alkaline Phosphate levels jumped very high; my ALT, AST, and Alkaline Phosphate levels jumped very high; Some of my lymph nodes showed little growth; have no energy to do anything; I can not do any activity being always tired; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 21Feb2021 14:30 (Lot Number: EL9261) as single dose (at age of 75-year-old) for covid-19 immunisation. Medical history included hodgkin's lymphoma from 2014, Stent in heart. Patient had no allergies. Concomitant medications included isosorbide (ISOSORBIDE); losartan (LOSARTAN); metoprolol (METOPROLOL). First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 in Left arm (at age of 75-year-old) for covid-19 immunisation, lot number: EL9262. Patient stated that since he got his second dose of Pfizer COVID 19 vaccine, he had been feeling extremely tired and fatigues in his feet and legs. Few days after that his Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Alkaline Phosphate levels jumped very high, although with time they were coming down slowly in Mar2021. The tumor marker did not show any signs of liver cancer in Mar2021. Some of his lymph nodes showed little growth. Patient was maintaining his weight constant. His doctors had no explanation for his tiredness and fatigue. Patient had no energy to do anything. Before the vaccine he used to walk 3 miles a day and doing bike too. Now he could not do any activity being always tired. Onset date for the events Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. Patient was recovering from ALT, AST, and Alkaline Phosphate levels jumped very high, while he had not recovered from the other events, at the time of the report. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.

swollen arm; some pain; This is a spontaneous report from a contactable consumer (Patient's wife reported for husband). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021, as a first dose single dose for COVID-19 immunisation. Medical history included over the holidays, in which patient was hospitalized for COVID virus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that reporter and the patient both received their first dose of the COVID vaccine on 30Jan2021. On an unknown date, patient's wife stated that her husband (75 year old, male), did not have a reaction like her and only had a swollen arm and some pain. Patient's wife states that they are in both excellent physical shape, walking and biking daily and she was not on any medication. Caller asked due to her previous reaction from the vaccine, is it absolutely necessary to take the second vaccine or does she have enough immunity from already having the Covid virus and the first vaccine. Caller asked, What about the 6 people in the clinical trial that had Covid, did they get the second dose. Caller stated that she is trying to get an authoritative answer, which is why she directly called Pfizer. Caller asked if there was someone else that could answer her question or if I could pass the question along, so she could receive a recommendation on if she absolutely needs to take the second dose. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. .

Patient is a very pleasant 75y.o. year old male with a known history of metastatic colon carcinoma currently receiving chemotherapy, presenting to the hospital with complaints of odynophagia and dysphagia with both liquids and solids over the past 2-3 days. Additional complaints included intermittent shortness of breath related to "asthma" - unchanged in character or severity from previously.. He denies any cough, chest pain, fever, chills, sweats. At presentation he was afebrile with stable vital signs and was maintaining an O2 sat of 100% breathing room air. Laboratory revealed a WBC of 40.4 with a predominance of neutrophils on the differential as well as toxic granulation (patient had just recently received Neulasta on 6/17), mild elevation of his alkaline phosphatase of 199 with a normal bilirubin, and normal renal function. CXR was negative for any acute pathology. For reasons that are unclear, testing for SARS CoV 2 by NAA was performed and was positive. The patient has a history of having had Covid in November 2020, and also received vaccination for Covid with 2 doses of the Pfizer vaccine in April of this year. His any recent contact with anyone with Covid 19, and states that he has severely limited travel outside of his apartment to avoid social contact during the pandemic. ID is consulted regarding the above presentation. Significance unclear. This patient has little in the way of symptomatology to support a diagnosis of Covid 19. He had symptomatic infection with SARS CoV 2 in November 2020. Prolonged positive testing for SARS CoV 2 by NAA as been noted for months following Covid 19. In addition, prolonged shedding has been noted in patient's who are immunocompromised, although I would doubt that is the situation here as he is asymptomatic for Covid 19 (intermittent shortness of breath likely related to his underlying asthma as she is maintaining an excellent O2 sat breathing room air at this time and has a negative CXR). I do not think any therapy for Covid 19 is indicated at this time. Would doubt he is shedding infectious virus, but will continue isolation for now

April 4, 2021 could not catch my breath. Later analysis (scan) showed large pulmonary embolism and small emboli May 5, 2021 venous doppler showed "extensive" DVT in left leg. Immediately admitted to Hospital ER. Stayed two nights. Put on heparin, then lovenox, then Eliquis on my discharge. Currently on Eliquis for at least six months. Left calf still swollen. Blood clot specialist says the PE and DVT were "unprovoked." Cause unknown.

under his armpit is a little swelling on the left side where he took the shot; felt like something was sticking in his back; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0181) via an unspecified route of administration, in the left arm on 19Jun2021 (at the age of 75-years-old) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for pain and inflammation, start and stop date were not reported. The caller was calling about the Pfizer covid vaccine. The caller took the vaccine on 19Jun2021. The first week the caller didn't notice anything. The past 7 days the caller has felt like something was sticking in his back (on 24Jun2021). Then yesterday the caller was washing and under his armpit and noticed a little swelling on the left side where he took the shot (on 30Jun2021). He noticed his left arm pit (left arm where he got the vaccine) was kind of puffy and swollen but the right arm pit appears normal. When he laid down there was a slight discomfort, almost like the caller took the shot in his back and not his arm. Caller mentioned that he asked his girlfriend to check if there was something in his back but the girlfriend said his back was clear. Caller wanted to know if these are reported side effects of the vaccine. Reporter seriousness was unspecified for both events. Outcome of event sticking in his back and under his armpit was recovering and under his armpit was a little swelling on the left side where he took the shot was not recovered. Follow-up attempts are possible. Further information is expected.

Swollen lymph gland on left side 15 days after last vaccination.; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 15Mar2021 at 08:00 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 31Mar2021 at 22:00, the patient experienced swollen lymph gland on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for swollen lymph gland on left side. The clinical outcome of the event swollen glands was not resolved at the time of this report. No follow-up attempts are needed; No further information is expected.