Pfizer

Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.

Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.

Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.

pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days

WHEN I RECEIVED THE PFIZER -BIONTECH COVID-19 VACCINE THE NEXT 2 DAYS 12: 45 AM I TOOKA SHOWER AND WENT TO BED THEN I FOUND MY LEFT SIDE OF THE BODY FROM MY AMPIT ALL THE WAY TO MY FEET ARE NAMBED AND ALSO SOMETIMES MY LEFT LEG GIVE UP ON ME FEELS WEEK ON MY KNEE. I WENT TO MY DOCTOR AND ALSO I CONTACTED MY WORK PLACE THAT IS EMPLOYEE HEALTH AND THEY TOLD ME TO CALL THE AGENCY.

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

I received my 1st shot and 2 and a half weeks now, I have numb finger tips on several fingers. I am making a Dr. appointment.

MODERATE PAIN IN LOWER EXTREMITIES (FOCUSING ON HIPS/KNEES). TO TREAT: LOCAL WARMTH, FLUIDS, IBUPROFIN.

1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030

Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache, loss of appetite. Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.

Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful, including tongue lips, teeth eye, skin. Some soreness continued after 2 days.

Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherwise had no symptoms. By Tuesday 1/19/21, he was having shooting pains through his shoulder and down to his elbow. By late Wednesday, he had started to develop hives on his palm, between his fingers, and up to the elbow. Pt states he has a history of a pinched nerve in his neck and elbow, but this pain is nothing like his usual pain. On 1/22, pt presented to the ED for left uper arm pain and rash. He denied new detergents, foods, clothes, wooded area exposure. Denied decreased ROM in shoulder, but ROM makes his shoulder sore. BP 161/82, otherwise vitals normal. Rash did not apear infectious. No evidence for DVT. Pt received ketorolac 30 mg IM x 1 in ED and was prescribed hydrocodone-APAP 5-325 mg tabs PO Q6h PRN #8. Pt was instructed to follow up with PCP in 1-2 days. By 1/25/21, pt reports the hives have become dark purple, like bruises. He states he has trouble making a fist and is not using his left arm at all - when this writer spoke to him, he said it was "gimpy." Pt stated during the phone call that he was about to call his PCP for a follow up appointment.

Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm, I started getting a bit nauseated, pit in my stomach . Lasted until went to bed around 9:00pm. In morning felt fine except my arm felt much more sore at the shot point for about 2-3 hours after I woke up. 10:00am everything is normal.

This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.

Bell's palsy On 1/11 Patient began experiencing tingling in his left jaw On 1/18 he began experiencing aches in his teeth On 1/22 paralysis of L side of his face, did not spare the forehead

Seizures Narrative: Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witnessed. Employee intubated in internal ED. Employee drank 1/2-1 gallon Vodka, last drink 24 hours prior to onset. Employee has history alcohol-induced seizure.

Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed his immune system; This is a spontaneous report from a contactable consumer (patient; a direct care staff for a group home). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 613247, expiration date: May2021), intramuscularly to the left arm on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. He was given the vaccine at work. It's a group home facility. The patient's medical history included high blood pressure, and positive for the covid virus from 09Jan2021 to an unknown date. Concomitant medication included benazepril from 22Jan2021 and ongoing for high blood pressure. He saw a doctor on 22Jan2021 and he prescribed Benazepril; it was started on 22Jan2021. The patient previously received a flu vaccine on Sep2020 for immunization. The patient called about the Covid vaccine. He reported that on 09Jan2021, he was positive for the COVID virus. He was then cleared on 16Jan2021 to go to work. His work then offered the COVID vaccine on 21Jan2021 and he got it. Then on 29Jan2021, he was diagnosed with Double Covid Pneumonia. His doctors were concerned that the Covid vaccine had taxed his immune system. The patient was a direct care staff for a group home. He cares for adults that are developmentally challenged. He has a CPR license. The patient confirmed that he received his first dose of the vaccine on 21Jan2021. He started feeling tired and weak about evening of 22Jan2021. He then started feeling out of breath Wednesday 27Jan2021, 28Jan2021 Thursday, and Friday 29Jan2021. He thought maybe he might be having a normal side effect. He stated that the Double Covid Pneumonia was detected on the X-ray that took place on the 29Jan2021. He is scheduled for second dose on 11Feb2021. The patient stated that the weakness was horrible. They gave him antibiotics; he was starting to recover. He was off of work till Saturday due to the pneumonia. He doesn't know if he will be getting the second dose. The patient was prescribed antibiotic Cefuroxime Axetil 500mg 1 tablet by mouth twice a day for 7 days, antibiotic Doxycycline Monohydrate 100mg 1 tablet by mouth twice a day 7 days, a Steroid Prednisone 20mg 2 tablets by mouth daily at same time in morning for 5 days, and a breather Albuterol HFA 90mcg/att inhale 2 puffs by mouth every 4 hours as needed for shortness of breath, wheezing, or cough. It was reported that they did a Covid Nasal Swab Test on 09Jan2021, then on that Sunday or Monday he got positive result, and by that time he had fatigue. After he got the vaccine, he went back to work. After the vaccine, it was a big surprise about the double Covid pneumonia, and they think it was taxing the immune system. He has had no issues with vaccines in the past. He had a Flu vaccine recently and there was no problem, that was Sep2020. He wants to know should he get the second dose.The outcome of the events double Covid pneumonia and "doctors were concerned that the Covid vaccine had taxed his immune system" was unknown. Regarding his double Covid pneumonia, the doctor said his O2 level will determine how he is doing. They will also do another lung X-ray. The doctor said the antibiotic should take care of it. The doctor did warn him that things could get worse. They said he can possibly go back to work on 06Feb2021, but this is not certain at the moment; it could change.

Few days after receiving the 1st dose, developed tingling paresthesia in both hands. He received his second vaccination despite the symptoms. Symptoms continued to progress to his feet, and also developed weakness, particularly in his legs. Also had some weakness in arm but more so on the left side. He had difficulty climbing ladder when deer hunting due to weakness in his thighs/legs. He ended up falling in his home on Jan 17, 2021 as well, which caused significant hip pain. Had a neurosurgical evaluation- finding lumbar disease L3-4 requiring fusion. Following surgery, paresthesia and weakness persisted and actually worsened, , developed uncontrolled twitching in both thighs. Further developed loss of function in his L-hand. MRI revealed transverse myelitis. Symptoms have improved with corticosteroid therapy. Patient was hospitalized due to these symptoms for two days, discharged on corticosteroids.

3 days after the first injection of the Covid on the left arm the patient developed numbness on the left side of the body. 21 days later, he received a second injection on the right arm and 3 days later developed right-sided body weakness. I saw the patient for the first time on February 17, 2021

Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness. Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.

Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his words and mumbling. VS 97% RA, HR 92, temp 99.8, BP 168/92. Pt is conscious but unable to tell me his name or location. Skin is clammy, patient?s hands are shaky. Wife was notified that we are calling an ambulance for further assessment. Ambulance arrived at 11:48 and pt was taken out shortly before noon.

Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.

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.

Numbness of left hand fingers; stiffness started 15 minutes after vaccine. BP readings: 141/90 (pulse 86), and 148/89 (pulse, 84). 100% O2 sat.

The described waking up around 9pm after going to be early the day after he received the vaccine. He said that his hands burned and itched. He took Benadryl and the symptoms eased after about an hour. He reports he had a similar experience after being exposed to rubella many years ago. At that time the symptoms spread to his whole body.

I got my second Pfizer COVID vaccine on Friday February 26. On Saturday February 27 I started getting a droopy lip and a droopy eye lid on the ight side of my face. I went to my doctor on Monday March 1 and after and examination and a CT scan (to eliminate other things), I was diagnosed with Bell?s Palsy. I am now on steroids and antiviral medication. I still have Bell's Palsy at this time,

Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No issues after lunchtime on the 12th.

Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss of energy and headache began around 8:00 pm on 3/1/2021, and persisted with gradually decreasing intensity until 3/5/2021.

Pt complained of lightheadedness , itching which worsened and he became flushed. Progressed to generalized pruritis and redness. BP 117/74, HR70 )2 95% Epi 0.3 IM and Paramedics notified, transported to hosptial

RN responded to pt's report of centralized face numbness (reaching out to eyebrows, mid-cheek, upper chin). Denied other symptoms. VS: BP 130/80, SpO2 98%, HR 55, RR 18. RN stayed with pt for 10 minutes, pt reported numbness stayed the same, no new symptoms reported. VS rechecked at 15 min: BP 130/90, HR 55, RR 16, SpO2 99%. Arm strength 5/5 bilaterally. RN called EMS due to facial numbness; gave report when EMS arrived. EMS assessed pt, released him to home with instructions to call 911 if any further symptoms. Pt said that he was returning home and he would have a family member there.

fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.

FIRST: An ache at the injection site progressing to a throbbing aching. The peak-pain lasted 18 hours. Icing the area did nothing to reduce the throbbing. SECOND: Progressive Myasthenia Gravis weakening began about 20 hours after the injection. It was escalating toward being a full-blown crisis. I have an emergency stash of Prednisone, and I alerted my Neurologist that I began taking it. Prednisone effect saved me from a full-blown bulbar deficit, which would have required hospitalization. For MG, I've long only needed to take CellCept to be symptom-free. The Pfizer shot IS to blame for the MG exacerbation

Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. All over skin tingling and pain that lasted 24 hours. Treated with Tylenol and ibuprofen alternating every 3 hours. Applied cold compress to back of neck.

Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60, HR54, O2 sat 98. He stated that he had not had a meal today and it could be his sugar. His glucose was evaluated and was normal. Pt. was taken to NWMC and was accompanied by his wife.

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

Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.

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.

Flu like for 24 hours. Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.

Client reported dizziness and warm feeling "all over" 15 minutes after vaccination. Care initiated by on site paramedics. B/P 140/80. Monitored x30 minutes. Client reported no further symptoms prior to exiting site.

Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and was taken to the hospital and diagnosed with an ischemic stroke

Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.

1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp jabbing pain, lasts for an instance, yet whole arc "lights up"/pain felt throughout arc. Jabbing every 10-15 secs. Started ~08:00pm 03/03/21 (day after vaccine administered), and continued through the night, till mid-next day 04th. 2) Headache 3/02/21 6pm for the week ( through to 3/9/21) 3) right arm, site vaccine administered, bruised to the touch.

Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing , this is the most problematic symptom. Headaches come and go infrequently

WARM SENSATION FROM FEET TO HEAD Narrative: Patient received 2nd dose of Pfizer COVID vaccine and experienced warm sensation from feet to head twice a few minutes later. No SOB, hives or other symptoms. BP 144/91, P 58, PO2 98% NAD remained stable and improved. Released with instructions to seek medical care if symptoms return.

ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes BNT162b2 Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit. Treatment was given for the events. The clinical course is as follows the day after I went to the (Withheld). Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

series of 4 periods where I became quite hot inside and broke out in a heavy dripping sweat over a period of 6 hours or so. It would happen each time, lasting only 15 minutes or so.

Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some diaphoresis to face, denies dyspnea. Pt has hx of a vaccine reaction three years s/p 3 years.

Distal digits (finger tip digits) of fingers on both hands have reduced tactile sensory capability. My finger tips feel numb. Thumb is included in this numbness . First inoculation was 25 Feb. No lingering symptoms. Second inoculation was 19 March. Finger numbness seemed to appear about two days after second shot around 21 March. Numbness still persists even after a week. I felt this numbness was a strange development after the second shot and worth reporting.

At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature and within 30 minutes diarrhea and stomach cramps and bodyaches

Right eye lid drooping, could not raise right eye brow, could not blink right eye, could not smile on right side of face, could not eat on right side of mouth, pain behind right ear.

numbing of right hand side of face/mouth and right arm. symptoms subsided after about 10-15 minutes but continued to present every few days. I advised when i presented for my 2nd shot and they told me they had other reports of that and that is was fine/safe for me to take the 2nd shot, but to wait in a holding area for 30 minutes after the shot.

Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold around 9:45PM. Woke up throughout night with lower back/neck pain and headache. Now (7:18AM) experiencing headache, nausea, neck ache, chills and lower back pain. Feels like a hangover.

About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center of my head... and got very dizzy. It started in the center of my head and spread in all directions to fill my head. I was driving and had to pull over. It passed after about five minutes. After that I felt a bit weak and slept that afternoon and most of next day.

loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered. Information on the lot/batch number has been requested.

Site: Pain at Injection Site-Medium, Systemic: daughter described it as \"ants crawling under skin\"-Severe

Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.

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.

Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Jan2021 15:00 as a single dose for COVID-19 immunisation. Medical history includes Hypertension, Gastrooesophageal reflux disease (GERD), prostate cancer and broncholith left lung. The patient has no known allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, losartan, pantoprazole, hctz, and acetylsalicylic acid (ASPIRIN). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 17Dec2020 and experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. On 19Jan2021, the patient developed severe back and leg pain resulting in spinal fusion surgery on 25Jan2021. Postoperatively, the patient developed spastic twitching in thighs on 31Jan2021. On 07Feb2021, he woke up with weakness and clumsiness in left hand. At post-op check for spinal surgery on 10Feb2021, the neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on 15Feb2021, he was again admitted to hospital for more extensive work up and was admitted for 6 days. Diagnosis made of Transverse Myelitis and was started on high dose steroid treatment and was discharged to home on 17Feb2021. Since then have had profound leg weakness, right side greater than left, which severely impairs mobility, especially stairs. He completed 5 day course of 1000 mg methylprednisolone per day as an outpatient on 20Feb2021. He is in PT and is unable to predict date of return to work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment for the events included high dose steroid therapy, PT and exercise. The patient underwent COVID test post vaccination via nasal swab on 24Jan2021 and was negative. The outcome of the events was recovering.; Sender's Comments: Based on available information the reported events are unlikely related to BNT162B2. These are intercurrent medical conditions. Case will be reassessed if additional information is received. 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.

Very bad stomach cramping, nausea and vomiting. Started when I woke up this morning around 7am. Also, I go from being hot to being cold.

mild numbness and tingling arms and legs; mild numbness and tingling arms and legs; weakness in legs; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), dose 1 via an unspecified route of administration, administered in Arm Left on 17Dec2020 15:00 (at the age of 60years) as single dose for Covid-19 immunization. Medical history included hypertension, GERD (gastrooesophageal reflux disease), prostate cancer, broncholith left lung; all from an unspecified date. Concomitant medications included amlodipine, losartan, pantoprazole, hydrochlorothiazide (HCTZ), and acetylsalicylic acid (ASPIRIN (E.C.)); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020, the patient initially experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. The patient was hospitalized for 6 days from an unspecified date to an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, and Disability or permanent damage. The patient was tested for Covid-19 post vaccination (Nasal Swab) 24Jan2021 with negative result. The outcome of events was recovering.

Pt got vaccine at pharmacy off site clinic - this is notes from clinic staff "summary - pt was unable to speak and became somewhat unresponsive 15 minutes after 2nd Pfizer covid dose. family informed clinic staff after he had returned to the car. history of hypertension/diabetes/kidney transplant. Insulin was administered this morning. 911 was immediately called, taken to er. current condition unknown. blood glucose was 500+ when paramedics checked"

Had shot at 2:30 Pm, Sitting in my truck and about 2:35 i started getting a warm feeling in my legs and feet (waist down) (Felt like same feeling when getting a CT scan when getting the dye put in veins,) Lasted about 25 minutes . then stated to feel it wear off. tired next day but dont know if from vaccine. (did not go to doctor)

First injection: Sore arm that received initial injection for about one day. No treatments. Second injection received on other arm (right): Sore arm. The next day arm was sore, perhaps sooner. Also, the next day I was lethargic/sleepy, had a slight chill and was sore in at least some joints, including ankles. No treatments other than staying in bed. The second day I was close to back to full energy. Now a month later I'm occasionally naps these days, which I wonder whether are prompted by the vaccination.

after receiving my second pfizer vaccine, i blacked out, broke my nose, and had a concussion. I had maxillofacial surgery the next day. 5 weeks later, i developed DVT, and now have pulmonary embolisms.

4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas 4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief

His left arm is numb waking up this morning. He is dizzy and having trouble comprehending things. He has never acted this way before. Its like he in slow motion.

Starting Monday at work I began to feel very tired, my muscles started aching across my back at shoulder level, and my hands went numb. I went home and took Tuesday off to rest. Wednesday this has continued and I may leave work again. I have also had some very sharp pains in my joints.

lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood pressure 199/98.; nausea; Arm pain first day.; fatigue; palpitations; shakes; joints and muscle pain; joints and muscle pain; headache; Chills; night sweats; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (Batch/Lot Number: EN6199) as SINGLE DOSE (at the age of 60 years) for covid-19 immunisation . Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , covid-19 from Mar2020 to Sep2020, (COVID 19 Long-Hauler from Mar-Sep2020). Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); simvastatin (SIMVASTATIN). The patient previously took aspirin [acetylsalicylic acid] and experienced anaphylactic reaction, zantac and experienced rash and experienced peripheral swelling. The patient experienced feeling like fainting (medically significant) on 13Mar2021 14:30 with outcome of recovering , that happened parallel to erratic high blood pressure 199/98 on 13Mar2021 14:30 with outcome of recovering , palpitations on Mar2021 with outcome of recovering , lightheaded on 13Mar2021 14:30 with outcome of recovering , stomach pain on 13Mar2021 14:30 with outcome of recovering , shakes on Mar2021 with outcome of recovering , joints and muscle pain, headache on Mar2021 with outcome of recovering , chills on Mar2021 with outcome of recovering , night sweats on Mar2021 with outcome of recovering , nausea on 13Mar2021 14:30 with outcome of recovering , arm pain first day on 09Mar2021 with outcome of recovering , fatigue on Mar2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 120's-30's/70's, blood pressure measurement: 199/98 on 13Mar2021, platelet count: 99, sars-cov-2 test: Several negative tests on unspecified date. The patient went to Urgent Care twice. The patient took no other vaccine in four weeks and the patient was not COVID tested post vaccination.

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.

weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-dependent enhancement

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.

Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.

Left arm tingling and numbness from hand to shoulder. Aching. No injection site redness or swelling. No palsy or other symptoms. Symptoms began on Day 10 post injection and continue. Had brief, faint chest pains last night, 4/12, while walking to car after restaurant prepared sea bass meal. This morning my arm is tingling and aches like it has been slept on or is not receiving proper blood flow. Right arm is fine. BP normal. Breathing normal. No other issues.

Patient was with Medical Examiner. She was reviewing his allergies (PCN, bee stings) and discussed with patient need to wait 30 minutes after vaccine for observation. She then gave him pfizer vaccine. Within 1 minute of giving vaccine, patient began to have seizure. He was assisted to ground by MD and RNs at vaccination site. He was assessed and assisted to remain safe throughout seizure, 911 called and arrived on scene. Meanwhile, caregiver with patient stated seizures are "normal" for him and he has 4-5 a day. She reported that in line he was not feeling well and had precursors to seizure. Patient had reported to MD that he felt fine today and did not report seizure history to her previous to giving vaccine. It was also later reported that he had a seizure the night before as well. IVF were started by RN's. When emergency services arrived, patient was recovering and refusing to go to ER - against medical advice. He was assisted back into wheelchair by emergency services personnel. Patient was alert, and oriented and able to make decision not to go to emergency room. Patient left facility with caregiver in private vehicle. Patient was instructed to contact his primary care physician and let them know what happened and ask if 2nd dose of pfizer is appropriate for him. Patient was also instructed if MD wants him to get 2nd dose to go to a more controlled setting then Mass vaccination site.

Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.

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.

This was the second shot. I didn't expect to get sick since I had been sick after the first one. Symptoms were for the first night uncontrollable shaking, vomiting & light fever (100). This is the second day and I feel tired although I slept about 20:00 hours yesterday and 12 today. Expect to recover tomorrow!

Acute onset left foot pain (5th metatarsal protuberance), lasted six days, resolved with ibuprofen, colchicine, Keflex. Prompted urgent care clinic visit on 4/13/2021 where x-rays showed no abnormalities. Diagnosed as probable gout flare (my first first diagnosis of gout, but second episode of this type of pain).

Pt. with hx of hypoxia, oxygen at night, CAD, seizure disorder. Started feeling light headed, SOB of 4-5 min. after injection. Pt.brought to procedure room. Initial vs at 4:20, 118/78, p 105, r 18. O2 placed, sat up to 98% on 2l. 911 called. Started feeling better on o2. SOB improved. Due to hx of CAD, epi not given. PE: heart rate reg 95, lungs cta, upper airway without stridor, swallowing well. Squad arrived. Repeat bp 120/80, sat 98%, r 16. pt. exhibited some shakes and felt he might seize. Shakes stopped in 10 sec. Transported in stable condition to ED.

Presented to ER on 4/8 with slurred speech, left sided weakness, and facial droop. Was diagnosed with right posterior cerebral artery occlusion and started on Alteplase for tPA and transferred to Medical Center on 4/9.

60-year-old male with essentially no past medical history who developed acute left-sided weakness and aphasia. EMS was immediately called and he was taken to healthcare facility. He underwent an immediate work-up with an NIH of 12 with left hemiparesis. CT scan of the head did not show any evidence of acute bleed CTA was consistent with a right M1 occlusion. Patient was given TNKase at 0 755 and taken immediately for thrombectomy. Therapies successful. Patient has not had Covid during this pandemic but did receive the first dose of the pfizer immunization yesterday in his left arm.

numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering. Information about Lot/Batch number has been requested.

Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730), via an unspecified route of administration, in left arm on 27Mar2021 at 12:00 (at the age of 60-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced arm pain, tired and abdominal swelling on 29Mar2021. The events were reported as non serious. The patient didn't receive any treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Several minutes after injection patient began feeling hot and fainted - Patient never lost consciousness, breathing remained regular, but complained of neck pain

Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat. Vital Signs: BP 150/80 HR 72 O2Sat 97% Skin Signs: Warm and dry, Other - Very red and flushed warm to touch Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally No increased res. effort Initial treatment: Continue observation. Patient observed to be flushed prior to vaccination. HX of rosacea. Patient states HX of sun exposure prior to clinic. 11:13 AM Vital Signs: BP 138/74 HR 76 Resp. 16-18 O2Sat 95% Possible irregular HR noted while getting BP Skin Signs: Other - Flushed A/Ox4 Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation. No increased res. effort. Neg S/S anaphylaxis. 11:19 AM Vital Signs: BP 122/80 HR 78 Resp 14-16 O2Sat: 95% Skin Signs: Warm and dry, Other - Flushed A/Ox4 Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Vitals at 11:32 AM BP 130/72 HR 81 O2Sat 94% Lung sounds clear bilaterally Resp 16 Patient states no dyspnea upon sitting. Cap refill <1sec No nausea Patient instructed to update son. Released home by self.

Left perioral and lower cheek numbness or anesthesia. Began shortly after leaving facility. Lasted 48 hours. No loss of motor function. No other symptoms.

Slight numbness in left cheek. Sensation can be described as like one had a novocain injection 3 hours earlier. It has persisted for 2 days. All functions (speech, eating, drinking, etc) are normal. No treatment.

Rash around injection site. Hard warm lump where needle was inserted and vaccine injected. Approx 1 in by 4 in. Shoulder is sore and feels hot. Painful to touch.

Developed left facial numbness-minor left lower periorbital + cheek with gradual increase and decrease after he left the vaccine clinic. Reaction resolved in 48 hours.

Had 2nd covid vaccine shot April 8th at 1:15PM. Friday evening started feeing tingling in left arm and skin on stomach. Saturday noticed rash on stomach. Sunday rash had grown. Wend Sunday April 11th to urgent care and was diagnosed with shingles. Was given a 7 day prescription for Valtrex. Two weeks later finally beginning to to see a reduction in the rash and pain.

To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs, & no feeling in feet & legs. Very difficult to breathe. Was alert. Wife up to BR, looked over, I was trying to say help. Brought me water. she assisted me up , then back to bed, still shivering uncontrollably. 30 mins to 1 hr later, my son saw me in the hall and said, "Dad, you look like ****". I could not make a sentence. Per my son all I said was, "Gatorade". I drank it then fell asleep. next morning 101 temp, severe fatigue, severe aches and pains, could not make complete sentences I was told. I did have COVID 19 for 4 weeks Oct-Nov 2020.

Bony pain; night sweats; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 20Feb2021 12:45 (Lot Number: EN6201) at the age of 60 years old as single dose for covid-19 immunisation. Medical history included Covid prior vaccination, Hypertension, Diabetic, No Known allergies. The patient's concomitant mediations received in two weeks included medications for Hypertension and Diabetic Medication. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Bony pain and night sweats on 21Feb2021 at 11:45 AM. No treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. The report was serious per the reporter.

Paresthesia of the right leg/thigh after getting the vaccine; This is a spontaneous report received via Pfizer sponsored program from a contactable physician (patient). A 60-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 9231) via intramuscular route in left arm on 29Dec2020 01:00 AM (at the age of 60-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID- 19 (nasal swab and Abbott Antigen) on 14Feb2021 and resulted negative. On 09Jan2021 13:00, the patient experienced paresthesia of the right leg/thigh after getting the vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered/not resolved.

Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after injection.

new numbness and pins & needles in left leg; It causes paralysis in muscles; CPK increased; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at single dose in right arm for COVID-19 immunisation at the age of 60-year-old. Medical history and concomitant medications were unknown. Historical vaccine included fatigue with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for Covid-19 immunisation at the age of 60-year-old (1st dose, at 09:30, leftarm). The patient got up one day and legs where paralyzed on 08Apr2021. The patient kept trying to stand and walk thinking it was just legs fallen asleep, but the patient was falling every time she would try to walk it off. On 08Apr2021 at 07:30, new numbness and pins and needles in left leg. The patient was hospitalized due to the events and they were considered as disabiliting and life-threatening. The patient then had a bad moment when on his way to leave for pcp appt (as reported), a steel cabinet fell on him. The patient was taken by ems to trauma unit in Hospital. Creatine phosphokinase (CPK) levels were over 2,000 on unknown date. The outcome of Creatine phosphokinase increased was unknown, the patient was recovering from other events. Information on the Lot/Batch number has been requested.

migraine headaches/cluster migraines; This is spontaneous report received from contactable consumer (patient) reported for himself. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 at age of 60 years old at single dose for COVID-19 immunisation. Medical History: patient typically has had migraines, cluster headaches in the past and he had figured out what it was that was causing it. Patient states it was certain supplements that he discontinued and hasn't had a migraine in three years. Patient states he had diagnosed with migraines maybe in 1992, 1993, 1994, the early 90s. Food allergies. Allergic to caffeine. Concomitant medications were not reported. Patient previously took sumatriptan succinate (IMITREX) for migraine headaches. Patient states typically he can take ibuprofen (ADVIL), pseudoephedrine hydrochloride (SUDAFED), and loratadine;pseudoephedrine sulfate (CLARITIN-D), but they were not really helping his headaches. Patient had a history of migraines. He received his vaccine on 27Mar2021. Since the next day, he has had migraine headaches non-stop (28Mar2021 and ongoing). It had been 3 years since he last had migraines, however they started since the vaccine. He has had 2 emergency room visits, he missed 2 days of work last week due to the headaches. He feels the cluster sparks as a dull migraine at this moment. He had a side effect after the first dose of the vaccine. Asked if he should get the second dose. Response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Patient would like to know whether there was anything he can take for his migraines. Patient replied that he was not helped by the information provided to him. Migraine headaches and they have been non-stop was reported as worsened. Patient stated he had the first vaccine shot and he was reading information and it mentioned something about allergies. Patient states he has food allergies and he got migraine headaches. Patient states he took the first vaccine two Saturdays ago and as of that Sunday evening, Monday, he started having migraine headaches and they have been non-stop. Patient states he is wondering if he should take the next shot and if there was something he can do or take for the headaches. Patient states it was cluster migraines, he has not had migraines in like three years. Prescribing Healthcare Professional: Patient states he is getting ready to change. Patient states he was supposed to have an appointment today and she cancelled on him. Patient states it seems like every time he makes an appointment in the afternoon, she cancels on him. Patient states he had the vaccine on Saturday, 27Mar2021 and the migraines started Sunday evening. Migraine headaches: Patient states on Monday evening, early Tuesday, he went to the emergency room because it was just excruciating, unbearable. Patient states what has worked for him in the past was sumatriptan succinate (IMITREX). Patient states they gave him a couple of things, but that's only temporary. He stayed for a few hours and then send him home. Patient states he missed two days of work last week and missed yesterday due to the headaches. Patient states they start around midnight, 1230 every night and it goes for several hours. Patient states typically he can take ibuprofen (ADVIL), pseudoephedrine hydrochloride (SUDAFED), and loratadine;pseudoephedrine sulfate (CLARITIN-D), but they were not really helping his headaches. Patient states they are helping a little bit as a temporary thing, but he finds himself having to take more because the pain gets worse. Patient states he was taking two Advil and it was helping a little bit but now he is taking four, which is 800mg. Patient states he does not have the bottles with him; therefore is unsure of NDC, LOT, or Expiry dates for Advil, Sudafed, or Claritin-D. Migraine headaches: Patient states now it was a dull headache, but he had to come to work today, but he has a headache. Patient states he can feel the shooting clusters going through on the right side. Patient states he thinks it was BioNtech, but doesn't remember the dosage. Patient unsure of NDC, LOT, or Expiry date. Pfizer Covid Vaccine: Indication: Caller states for safety reasons and his mother had received it and she lives with him. Caller states his family was getting it and just for precaution. Test Results: Caller states he went to the emergency room last Tuesday morning, they did draw blood and they did a CAT scan and blood work but they said they didn't see anything. Caller unsure of blood tests they did. Caller states but like he said, whenever it occurs, it was always on the right side, right above his eye to the rear of his head. Caller verifies he received medicine, Imitrex, then was sent home a few hours later. He was not admitted overnight. Time the Vaccination was Given: appointment was at 0845, so around 0900 or 0915. There is no history of all previous immunizations with the Pfizer vaccine considered as suspect. Caller verified he has only received one dose. Caller states he is due to get his next one on 17APR2021, which is a Saturday. There is no additional vaccines administered on same date of the Pfizer suspect. The adverse events (AE) migraine headaches require a visit to Emergency Room, Caller states they gave him blue tablets and then Imitrex. He has allergic to caffeine so he can not have that, and then they sent him home. And caller states he was supposed to have an appointment today to see his doctor, but she cancelled. Prior Vaccinations within 4 weeks, there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller verifies that he is wondering if he should take the next shot and if there was something he can do or take for the headaches to hopefully eliminate them. Caller states he was reading the information sheet and it said if he has an allergic reaction, not to take the vaccine. Outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.

he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coughing; This is a spontaneous case is received from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced he got positive with covid-19 (sars-cov-2 test positive), dizziness on 06Apr2021, chills on 04Apr2021, muscle spasms on 04Apr2021, coughing (cough) on 01Apr2021, woke up sweating (hyperhidrosis) on 06Apr2021, cannot eat (feeding disorder)on 03Apr2021. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. Therapeutic measures were taken as a result of, woke up sweating (hyperhidrosis). The outcome of the events sars-cov-2 test positive was unknown, chills, cough, feeding disorder were recovering, dizziness, hyperhidrosis were recovered on 06Apr2021, muscle spasms were recovered on 04Apr2021. Follow-up activities have been completed and no further information is expected.

Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted about 22 hours.

My left arm is painful above the elbow, arm is very weak, trouble carrying things. Joint pains, stiffness, extreme pain in my knees, painful to the touch, sharp pains when I step or turn wrong.

Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Caller was discharged and has had some chills since then. Also reports fogginess and tension headaches. States he was in the ER last night and was treated and released.

Lower back and left leg spasms (LLE spasms q/min or <), patches of BLE dermatomes. Bilateral anterolateral thigh muscle burning sensation during prolonged exertion. Difficulty standing from a crouched position. G.U. Urgency. Symptoms similar to viral transverse myelitis diagnosed in 2013

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spread to cover a large portion of his back and to his legs and arms. The rash appeared the 3rd day after the vaccine. Rash is very itchy and burns/stings. PCP gave prednisone - may have helped a little but has now quit responding. Will begin tapering.

Stroke from blood clot. .Surgical thrombectomy . After initial full paralysis on left side, not adverse effects.

pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the top of his left shoulder down to his fingers. He says it hurts from the skin to the bone. He cannot lay down, he has to sleep sitting upright. he said the pain is constant but is not as bad when he sits up and when he lays down the pain is so bad he has to get back up. He is taking aspirin for his pain.

Sharp pain in right side of abdomen near appendix; bloating; distended abdomen; flatulence. Discomfort began 3 hours post vaccine. Peak discomfort lasted for 10 hours. Subsided overnight. Almost gone 20 hours post vaccine. Alka Seltzer & Tums

After first dose-Numbness and tingling that started in the left jaw area, moved into era and throat, then moved up to the scalp on the left side only. (I thought I was getting shingles) Pricking sensation in left arm. After second dose tingling and numbing in different parts of the body with pricking at different time ALL over my body randomly. Sometime feeling of cold and other times the feeling of heat. It takes 1-3 day to subside and as it subside I get an itchy feeling. Comes back what seems to be every 2 weeks. It is like my nerves are "firing off", again, all over and randomly.

On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.

Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days. Did not seek treatment since I knew these were normal reactions that would subside. Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.

4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.

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)

Fever lasted 2 days, headache lasted 3+ days, chills lasted 2 days, body aches lasted almost 2 days, sore arm lasted 2-3 days. Took 500mg Acetaminophen one time about 23 hours after symptoms began.

Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his second dose. Another 15 minutes later as he has a seizure and then was still very delirious. Ambulance was called but patient refused to go to the hospital.

Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. I had violent & severe neck pain and severe headaches. Also an extremely stiff neck where I couldn?t turn it 1/8th oh an inch to either side. It all got so severe that I didn?t eat for days at a time and was literally not with it. Couldn?t respond when spoken to, and became excessively weak where I couldn?t walk w/o help, and speech was slurred. It all lasted 5 days where it was so severe. With medication it slowly began to back off.

Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn't have any oxygen; Got really winded; didn't have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn't get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn't get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn't get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn't get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.

Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.

Bell's Palsey; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8734) in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine (CLARITIN) and fexofenadine hydrochloride (ALLEGRA). The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204) on 11Mar2021 at 14:00 (at the age of 60-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 04Apr2021 at 12:00 (reported as 3 days after the second vaccination), the patient experienced Bell's Palsy and it was difficult to close the left eye and move the left side of his mouth. The patient visited a doctor or other healthcare professional because of this event. It was unknown if the patient received treatment for the event. Since the vaccination, the patient was tested for COVID-19 via a molecular nasal swab on 15Apr2021 with negative results. The clinical outcome of Bell's Palsy was not resolved.

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.

had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no 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 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.

Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside facility 04/15/2021 through 04/19/2021 for similar symptoms

leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from a contactable consumer (patient's sister). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer said the patient took the COVID shot, and has taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him. She said that with the first shot he had some leg cramps at the top of his legs at night and that was it. He had it for like 2 nights and then it went away. She stated that she didn't know his age when he got the 1st vaccine because she didn't know when he got it, but that it was sometime in March (Mar2021). She stated he did receive the vaccine at hospital. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste

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.

Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face; virus attacked right side of my face; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 15:15 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included meniere's disease from Oct2020 to an unknown date. There was no known allergy. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on 13Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization and experienced vertigo. Three weeks after his second shot, the patient developed Bells palsy, and virus attacked right side of his face at 27Apr2021 07:30 AM. These events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. This event did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. Treatment for the events included Zaltrex - antivirus, Prednisone. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.

Immediately after the injection I felt a warm sensation flowing through my body and my head felt warm but I did not have a temperature. This subsided within 20 minutes. Prior to the vaccination I had slight Tinnitus on a scale of 1-10 I would say it was a 2. I had no trouble sleeping at night and did not use any sound machines to mask the tinnitus. I would characterize myself as a great sleeper. About 48 hours after the vaccination in my left ear my Tinnitus went from a 2 to a 5. Now to sleep I must run a fan or noise machine to mask the tinnitus and sometimes have to take benadryl or Tylenol PM to sleep.

On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bear weight on right leg. Reduced to crawling around house on hands and knees. Went to former Primary Care Physician on 4//14/21, where I was treated for Sciatic Nerve flare up. Returned to Dr on 4/19/21 in severe severe pain. Dr referred me to hospital where I was again treated for Sciatic related symptoms. Symptoms worsened daily. On April 28, 2021, I crawled into Hospital, was admitted. Received injection in spine. Symptoms worsened. Changed Primary Care Physicians to Dr on 4/11/21.

Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: At this point in time, patient was taken by paramedics and they took him to the local hospital. Additional symptoms,issues, or outcome unknown.

Patient felt fine after shot, then started feeling weak, hot, lightheaded, then lost consciousness. Tapped patient, yelled his name, called 911, monitored breathing and blood pressure, provided him water, banana, oragne juice when he woke and waited for Ems. He left with ems but was feeling much better.

Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F. EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded. Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath. He does use inhalers and nebulizers and also continues to smoke. He also has a history of melanoma who follows with provider. In the ER he was found to have hypotension and was given 2 L of IV fluids. He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed. Because of the hypotension and drop in hemoglobin he was admitted to the ICU. He was started on Protonix IV. Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process. He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out. He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued. Patient's troponin was elevated with an elevated delta. He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued. he did require albumin but not pressor support. As he was more stable he was transferred out of the ICU to the medical floor. He was started on midodrine. His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics. At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found

After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 diastolic 115 (despite Ramipril 5mg morning and evening) Vertigo Acufene General discomfort duration of symptoms: 5 days

Pt described feeling a feeling similar to Pop Rocks but in his brain. Describes the sensation as lightning bolts in his brain. Pt denies any vision changes, hearing changes, light headedness or dizziness.

Left arm, Epilepsy (Parkinsons) Can?t lift arm, muscles cramp, hurts under his arm, never had this problem before, Received Moderna May 20th. Takes blood thinner depakote and triacetone,. Being seen by Health Department.

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.

Injection given in left upperr arm. About a week or so later I started to get tingling on my left palm. This was sporadic at first, but it is getting more common (ie all the time, with some slight numbness) as well as tingling in my pinky and ring fingers. I have not had any trauma or other change in circumstances that would be a reason for having the tingling. I am not on any other meds nor do I use alcohol. I am concerned that this might be a reaction to the vaccine and for this reason I am hesitant to have a second dose. Please advise.

Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness. Client was evaluated by Emergency response team and relocated to the Emergency response tents. At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water. Client at this point was reported to be unable to speak in full sentences. Epinephrine was administered by Emergency Response physician at 10:50 AM. EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.

21 days after my 2nd Pfizer shot in my Left Arm, I started having an on going "tingling" sensation from my left elbow down into my left hand. Now after 2+ days I still have a tingling sensation.

Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date. Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

EE called hotline stating he received a call from Urgent Care that he has a POSITIVE covid test result from 5/28/21. He was called from Urgent Care providers. EE symptomatic. EE went on his own on 5/28 to Urgent Care and was swabbed. EE was not swabbed through EH hotline. Results not available on Epic. EE called dls and Urgent Care for a copy of his results, but they have not given it to him. Instructed EE to email a copy of positive covid results to Employee Health and covid surveillance. EE to update manager. Spoke with nurse at Urgent Care who verified that EE is Covid Positive. States she will email the results. EE states he is fully vaccinated, last dose on 1/13/21. EE states he is not a part of the SARS study, but he would like to do the antibody blood test. EE to do antibody testing after quarantined. Orders placed and instructions given to EE to obtain blood test at DLS. Instructed EE he will need to isolate & quarantine at least 10 days and/or until symptom free. EE to call hotline when he is released from DOH and to update us on his symptoms. HISTORY 5/28/21: EE stated he woke up with sore throat, feeling lethargic, fever, and cold sweats today 5/28/21. EE stated he went to Urgent Care on his own today, swabbed for strep which was negative and swabbed for covid; awaing covid test results. EE instructed to quarantine while results pending; if negative no longer needs to quarantine. EE instructed to call the hotline with his results. EE informed when he calls hotline, he will be given further guidance for clearance and will be asked to email the results to employee health. EE informed to keep his manager updated.

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.

Very painful left arm pain. location where shot was given there is a lump under the skin. The pain is still going on when raising my are or supporting weight on it. . My Fiancée also had the shot in her arm before I did and her arm as well is having site pain. She had the same shot that I did at pharmacy.

Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical history. LPN arrived on scene after vaccinator was yelling for help. Patient was "in and out of consciousness", awake and alert and then would have LOC for a few seconds and then become awake and alert again. This happened about 4 times with LOC with also some "convulsing like movements in the arms". Emergency responders and clinical lead, RN called. Patient laid back in seat as far as the seat would go, face pale and lips white. Pulse-ox put on and BP taken, 36 bpm (according to pulse-ox) and oxygen level 89%, BP 100/54. LPN gave epinephrine injection at this point at 1151, 0.3mg IM in right thigh. HCP arrived on site, patients VS after epi: pulse 76, 100/76, O2 sats 94% at 1155. Patient awake and alert, oriented to person, place and time. Lips and face pink. Care turned over to Paramedics who arrived on site at 1200.

HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE

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.

Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog and little confusion 2nd shot fatigue- sore arm which lasted a week more brain fog more confusion couldn't get his words out. could not work his phone or computer Went to doctorMay 24th

24 Hours after - completely dibilitating lasted for 2 days. gradual recover to being able to somewhat function but still dizziness - vertigo - always a little bit but massive if moving head rapidly,

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.

20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted with night terrors' upset stomach and shaky legs this continued for two days 5 days later i became strong enough to continue with daily activities

Pt reported experiencing tingling on left side of face, arm, fingers leg and toes. Tingling progressed to numbness on the fingers.

A few days after his second dose he developed left neck, left arm, and left thigh pain. He described it as a burning pain and a poking pain. It felt exactly like his post-herpetic neuralgia from 2019 - which he developed after herpes zoster.

Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet and back. Also pins and needle feeling. Started taking Advil and Benadryl. Helped a little. Moved to Advil and Zyrtec during the day. The intensity varies during the week. To a little sunburn feeling to more intense on other days. Been doing on for two months now.

Commencing approximately 18 hours after the vaccination (which was my second Pfizer vaccine), I developed a rash that started under my arms and on my lower abdomen. Within approximately 4 hours the rash had spread across my chest, up my neck to the chin, around my waist and up the center of my back, and down the insides of my arms. The rash remained inflamed and red, and the skin sensitive, for approximately 72 hours before it began to fade. Within 5 days of beginning, the rash had subsided completely.

Severe shoulder pain vax site spreading to other shoulder. Numbness right side of face. Large swelling left shoulder below vaccination site.

Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore arm; started taking Ibuprofen throughout the day. Tuesday 6/15 experienced fever, chills, still aches and pains, headache.

Patient developed Unilateral (Left)numbness and tingle 3 weeks post 2nd vaccination. Symptoms have not improved. Patient says his left side is very sensitive to hot and cold now. Its his entire left side from left side of face to his foot. Describes it like a line down center of body. No prior episodes of anything like this in teh past. Says it was sudden onset . went to bed fine and woke up with it.

Severe pain in left arm over 2 week; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03May2021 12:00 (at the age of 60-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included meloxicam, pravastatin and cetirizine all taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced severe pain in left arm over 2 week on 05May2021 08:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of the event on 17May2021. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.

Chest pain in heart region at night progressing to pain radiating down left arm and up left side of neck and slight nausea. Symptoms similar to beginning of heart attack, so went to emergency room for observation. No signs of heart attack were detected and emergency room doctor suggested follow up with heart specialist. Follow up also showed no heart attack occurred. Pericarditis not detected with stethoscope but was suspected. Pain in heart region was not severe, ~level 2, but was persistent. Heart doctor said that was not consistent with heart attack which tends to be severe but episodic. Slight pain noticeable in heart region for weeks afterward and still evident but now very slight. Not acute, but joint pain seems slightly increased after the vaccine.

Pain in the thighs and legs, in the lower part of the buttocks; Pain in the thighs and legs, in the lower part of the buttocks; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 10:00 (Lot Number: EN6207) as single dose for covid-19 immunization at the age of 60-year-old. The patient medical history and known allergies were none. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; verapamil taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in the thighs and legs, in the lower part of the buttocks on 20Mar2021 01:00 and resulted in visit to doctor/other health care professional (HCP) office. The outcome of the events was not recovered. Therapeutic measures for events included Prednisone. The patient further received second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Apr2021 11:15 (Lot Number: EW0179) as single dose for covid-19 immunisation. The patient underwent Covid Test post vaccination (polymerase chain reaction: Nasal Swab) which was negative on 07May2021.

Started to have chest pains a few days after vaccine. I passed out and was unresponsive with no pulse and breathing. Received cpr from my partner who found me on the floor at approximately 2:00am on 5/16/21. I was taken to the emergency room of the hospital and underwent extensive tests of the brain: CT scan, MRI, Angiogram, and Spinal Puncture. All tests negative. I cannot walk without a walker and have other cognitive neurological symptoms. I was discharged from hospital on 6/2/21 to sub-acute rehabilitation facility. I was discharged from rehab on 6/12/21. Neurological and neuromuscular symptoms are still present.

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.

Abrupt worsening of his chronic neuropathy 5 days after receiving dose 1 of COVID19 vaccine series. (He did receive dose 2 later without any change in symptoms). Workup shows axonal polyneuropathy somewhat responsive to steroids. An alternate cause of his abrupt worsening of neuropathy not found. He was taken off of his disulfiram which he had started on fall 2020. This did not seem to help. He did show some improvement with 1g IV solumedrol daily x5 days.

Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post second Pfizer vaccine. was diagnosed with a STEMI heart attack and then coded on April 26, 2021.

Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tired, fatigued, no energy. Symptoms worsened. Started to experience bilateral numbness in both legs, gradually moving up into arms. 4/30-5/3 developed coordination issues,. Stated, "I wouldn't be able to pass a field sobriety test." Tripping, stumbling, dropping items. 5/3 had a CT scan of brain (did not show history of stroke) Early am on 5/4 fell and lost all movement on left side. MCA occlusion removed/stent placed/brain swelling worsened. Informed by neuro team that he was experiencing more brain swelling in 24 hours than a stroke victim had in 4 days.

Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in left arm on 10Mar2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFUTURER UNKNWON), allopurinol (MANUFUTURER UNKNWON) and famotidine (MANUFUTURER UNKNOWN) all for unknown indication and from an unknown date. On 11Mar2021 at 09:00, patient experienced sore arm. On 12Mar2021, the patient experienced moderate headache which lasted for 15 hours and on 13Mar2021, the patient felt hungover. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of sore arm, moderate headache and felt hungover was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wrist, hands; Infrequent headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm, on 19Mar2021 at 15:30 (at the age of 60-years-old) for COVID-19 immunisation. Medical history includes Barretts esophagus and crab allergy (seafood allergy). The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:00 patient experienced numb tingly fingers, upper body joints ache, neck, shoulders, elbows, wrists & hands, infrequent headaches. The patient described numb tingly fingers as worst. Therapeutic measures and treatment were not received as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of numbness in fingers and tingling (in fingers), joints ache and headache were not resolved. No follow-up attempts are needed. No further information is expected.

Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't 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. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.

Numbness, burning and pain sensitiveness in palms and fingers; Numbness, burning and painsenstiveness in palms and fingers; Numbness, burning and pain senstiveness in palms and fingers; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 04Mar2021 at 18:00 (at the age of 60-years-old), as a single dose for Covid-19 immunisation. Medical history included blood pressure and psoriasis. The patient had a history of allergy to sulpha drugs. 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 15Mar2021, the patient had experienced numbness, burning and pain sensitiveness in palms and fingers. The patient received Neurontin as a part of treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events numbness, burning and pain sensitiveness in palms and fingers was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.

On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 05Mar2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation and experienced sore arm. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. 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 not been tested for COVID-19. On 26Mar2021, the patient experienced fever, headache, body aches, dizziness, sore arm. No treatment was taken for the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.

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.

Reoccurring cluster migraine headaches. No medical diagnosis due to history of adverse event. Headaches occur generally around the same time each day, 9:30 PM. Headaches last around 1 1/2 hours. This headache cycle lasted until 4/29/2021 (day after 2nd vaccination shot).

Left arm pain at injection site; he was bite by a dog about 10 years ago on the right calf and 1 week after the vaccine began to feel pain in that right calf area where the dog bite occured and felt as though the bite had just happened all over again. Still occurring about 3-4 times per week for about an hour then goes away

Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.

Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7533) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 60-years-old) at 14:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 not been tested for COVID-19. On an unknown date in Mar2021, the patient had experienced sore arm. The clinical outcome of the event sore arm was unknown at the time of the report. No follow-up attempts are needed. No further information is expected.

Numbness in upper extremities and hands. Numbness and lack of power in hands and arms. Numbness and lack of power in legs oh my God I'm ready to get you medical testing laboratory results related to the

Twitching face; This is a spontaneous report from a contactable consumer, the patient. A 60-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 shoulder on 13Mar2021, (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not had any allergies to medications, food and other products. Concomitant medications were not reported. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 14Mar2021, the patient experienced twitching on left side of the face. 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 patient did not receive treatment for the reported events. The clinical outcome of the event twitching face was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

headache/severe headache; sweating among other side effects/breakdown in sweat; arm still hurts/pain to arm where he received the shot; Lethargic; issues with his vision; sensitivity to light; absolutely miserable; light headed; chills; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient (reporter's husband) via medical information team. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0165), via intramuscular route of administration, administered in left arm (left upper arm) on 22Apr2021 at 10:30 (at the age of 60-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included propranolol hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via intramuscular rout of administration in the left arm (left upper arm) on 01Apr2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. No other prior vaccination was administrated. The patient got his 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 22Apr2021 and experienced headache, sweating among other side effects until "today", almost 2 months after getting his 2nd dose. The reporter would like to know if it was normal to still experience the above-mentioned side effects for this amount of time. The reporter stated that it was okay, so her husband had the Pfizer vaccine his second dose was two months ago, and he has been having adverse "I" think almost immediately afterwards he got severe headache. He was lightheaded, breakdown in sweat his arm still hurts after two months. He was lethargic, issues with his vision. He was just wiped-out walking across just across the room. He breaks out a sweat and has got a whole bunch of symptoms. "They" are very similar to COVID symptoms, but they gave him a COVID test, and he does not have COVID. "We" had gone to his regular doctor two or three times. They did not know what was wrong with him and how to fix anything. "They" did not know what kind of doctor to send him to they did a blood test, and nothing was out of line. "They" did a COVID test send it for stress test. He was absolutely miserable, severe headache "you" know sensitivity to light; all kinds of things and "we" need to do something. The reporter like to report it and hoping "you" can connect "me" with somebody who has some knowledge about whether anybody else in the world was having similar symptoms after two months and what can be done, what kind of doctor we go to. The reporter stated, "Okay so the first one I have a LOT Number, I don't have an expiration number. The LOT number was ER8733 the second one was EW0165." The reporter stated, "It was his left upper arm and was a shot. I did not know, i think It was in the muscle was not that what they are yes." Reporter stated, "That was also 10:30 in the morning." The reporter stated, Well, yes, the pacemaker, there was only one thing he not taking really. Okay, so he does not want to take medications the only thing he takes was Propranolol Hydrochloride looks like it was 60 mg once a day. He had a blood test couple weeks ago and everything was normal and had a stress test on "Monday" and "I" did not have the results from it yet. He was still experiencing the symptoms that "we" are calling about yes. That's why reporter was called. Events was persistent and has tried taking Aspirin or Tylenol and he was tried some Benadryl, and nothing has relieved his symptoms. The reporter has been complaining of chills, pain to arm where he received the shot, headaches which came on even if he was having a conversation. The patient underwent lab tests and procedures which included blood test: nothing's out of line on an unknown date in 2021, stress test: don't have the results on an unknown date in 21Jun2021, COVID test: he doesn't have covid (negative) on an unknown date in 2021. Therapeutic measures were taken as a result of headache/severe headache. The outcome of headache/severe headache, sweating among other side effects/breakdown in sweat, arm still hurts/pain to arm where he received the shot, lethargic, issues with his vision, sensitivity to light, absolutely miserable, light headed was reported as not resolved; chills was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high degree of pain occurring one week after 2nd injection.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient briefly lost consciousness and came too once we were able to lie him down and elevate his feet. Ambulance was called and they took him for further evaluation. per patient the next morning they observed for and hour and a half and he was released. was fine the next day

Initially, the event consisted of a fever on and off for 5 days reaching 103 at one point. Took Tylenol. Covid test on 4/15 resulted positive; Covid test on 4/18 resulted negative. Sporadic fever resumed 1st week of May on and off for a few days; visited doctor. 2nd Covid vaccine administered on 5/13 at same location (Pfizer EW0165). Since then I've experienced sporadic fevers lasting 1-3 days at a time each 2-3 weeks. Fevers are usually between 99 and 102. Most recently (7/14), experienced violent trembling with 102 fever. Visited doctor on 7/16 where bloodwork, urinalysis and chest x-rays were taken for "fever of unknown origin". Results not in yet.

Patient developed Bell's Palsy, about 2 days after getting his pfizer vaccine. Patient also developed hookworms. Patient has visited several doctors, and had prescriptions for hookworms. Patient is still having pain from rashes, and he state that his sturnum had popped out and the rashes have affected his groins.

3 days later after receiving the vaccine, I started to feel a light facial numbness. I indurated for the next 3 or 4 days. On the 23rd of April, I was taken to the ER. The ER thought I was having a stroke. They did a lot of procedures. They determined there was not nerve or brain damage as to why I had facial numbness. All of the test I had proved nothing. They could not find anything. The facial palsy persisted. It has been identified as trigeminal neuralgia. I have been given many medications to deal with this facial numbness. I was given carbamazepine for facial numbness and then switched to pregabalin for trigeminal neuralgia. Sometimes its a pain and burning sensation down my cheek, underneath my cheek, and towards the nose. Sometimes above the eyebrow, my eyelid would twitch. The numbness is getting stronger, and it gets worse each week than the previous week before.

Woke up small area of inflamation burning on right index finger. Seems to have developed into a small area of shingles. I had chicken pox as a small child. Affected area has calmed down and skin is peeling mildly and I seem to be recovering.

Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane level occurring on right side of temple. After a month, headaches are not as bad, still persistent. Dizziness to the point that i have gotten nausea 5 out of 5 times being a passenger in a car, 2 of those times vomiting. Driving a car is fine with no dizziness or car sickness. 2 intense bouts of vertigo, starting 1 week after the vaccine Could hardly walk, bumping into things, like i got off a spinning carnival ride drunk. I took zanax and went to bed, and woke up fine. Overheating, hot flashes, and fatigue also come and go.

Pain started at the left shoulder and kept like traveling through the elbow to the side left to little finger and pounding of heart

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/30/21). Patient presented to ED on 7/25 c/o rash on his back, feeling generalized fatigue and weakness for last few days and had tested positive for SARS-CoV-2. Patient remained stable and was discharged from ED on same day. On 7/29 patient returned c/o headache and SOB, he was placed on 3.5L NC and given albuterol neb, acetaminophen and prednisone.

initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days. The real adverse reaction I've experienced and has actually been getting worse is a racing heart. It may have actually started in May but I simply thought I had gotten out shape. I really noticed it going uphill. But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land. I have to stop and rest when I haven't really exerted myself. There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.

right eye lost vision; visual disturbance; migraine headache; He saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. Stacked on top, was like a snake looking thing.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: FA6780) via an unspecified route of administration in right arm on 09Jul2021 at 12:30 (age at vaccination 60-years-old) as first dose, single for COVID-19 immunization. Medical history included atopic allergies. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC) one pill, once a day for atopic allergies (It was working perfect. Patient had been taking for about two years). Prior vaccinations (within 4 weeks) were reported as none. On 15Jul2021, around 00:15 to 00:30, patient started to get a migraine headache. He normally did not get migraines or headaches. His head was still hurting on the right side. The pain started on the right back side of his neck. Then it moved to the cortex of his brain, just on the right side. It spilled into the right side of his brain. After he saw things, then his head was hurting so bad. He could feel the right side of his brain. It got terrible to the point that his right eye lost vision. His vision did not go black, it went white. The weird thing was that he could see two to three feet in front of him. He saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. He really could see nothing, but it was clear at the same time, and he could still see the light. At first, it got whiter, and then it got black and white. Stacked on top, was like a snake looking thing. It was circling, and then moving back and forth, and then turned into an S. It straightened up and turned its head towards him. Then it started fading away. He had to leave his job because his head was hurting. He felt it on the right side of his brain. He was driving home, and it started happening again. He held his right hand over his right eye, and he could still see it. He knew that it was not an illusion, it was in his head. He was like what the hell was going on. When he got home he drank water and laid down and feel asleep when woke up can still feel pressure in head and the pressure /pain had gone away but if moved head can still feel a little bit in the right side of his brain, feel like it was still there a little. Also stated that he did have topical allergies and they do "explode" from time to time and patient was Zyrtec for that and it had been working and he did have an allergy attack about 3-4 weeks ago with sneezing. He wanted to know if that had something to do with the COVD vaccine. He vividly knew what he saw. The patient did not visit emergency room or physician office. Relevant tests were reported as none. The outcome of the events he saw little pyramids connected together, then it had a thing with a pyramid shaped head at the edge of it. Stacked on top, was like a snake looking thing was recovered on 15Jul2021, migraine headache was not recovered and right eye lost vision, visual disturbance it was unknown. Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.

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.

Right side of face tingly, slightly numb. Tingly feeling was gone the next day. Slightly numb feeling lasted at least three or four days. Right arm was sore for four days. Until 12/28, pain in upper right arm would start for no reason, usually in the evening.

5 days later December 31st Noticed weakness on my left side of my face. Tearing on the left eye . Unable to open wide on my left lips

Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No sick contacts and no contacts became sick.

tingling from fingers thru body to toes, cold sweats, flushing, elevated BP/Pulse (170/110,130) Date of Onset: about 40 min after receiving vaccine. Patient went to ED and received Medrol, benadryl, and famotidine,

"Pain like a torn rotator cuff, i couldn't lift my arm. After about 2 weeks i was back to 80% mobility. on 1/7/21 i am almost back to 100%. No other symptoms"

Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed seated for an extra 10 min, still felt not ok but enough to go. Went home and still felt dizzy and then I felt like I need to pee but I was very cold , urinated 3 more times thinking it was because it was due to being cold but doctor explained it was due to me drinking lost of water. Went to bathroom and bassed out and woke up about an hour later, but during the fall I injured the neck by heating your head on the sink, back and broke my nose, when I woke up I was still very dizzy. Also felt a fast heart rate, chest pain, very nauseas and started sweating a lot.

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.

High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.

Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea! I felt bad most of Monday. Tuesday today, i feel fine!

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.

headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance

Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hours. Took 2 Tylenol. All symptoms gone after 30 hours.

Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 61-years-old male patient received bnt162b2 (BNT162B2; Lot # EH9899), intramuscular in the right arm on 17Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included lung neoplasm malignant , adenocarcinoma from an unknown date and unknown if ongoing. Concomitant medication included duloxetine (DULOXETINE), levetiracetam (LEVETIRACETAM), omeprazole (OMEPRAZOLE), olanzapine (OLANZAPINE), hydromorphone (HYDROMORPHONE) , fentanyl (FENTANYL PATCH), bisacodyl (BISACODYL). The patient experienced Bell's palsy on 02Jan2021 with outcome of recovered. The patient had to be treated in Emergency room/department or urgent care; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's palsy cannot be excluded, considering the plausible temporal relationship. 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.

RIGHT BRACHIAL PLEXOPATHY SYMPTOMS WITH WEAKNESS FINGER EXTENSORS. SYMPTOMS ARE IMPROVING. 50-60% BETTER ALMOST A MONTH LETTER

Right Brachial plexopathy. Began with right periscapular muscle spasms x 5 days followed by right arm paresthesias on day 6 followed by right wrist and hand weakness on day 7 of adverse event.

All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.

Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.

Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well. Went to bed, started to get chills, nausea, and vomited around 9:30 PM. Did not sleep well. The next day I had a headache, felt tired and wiped out. Started to feel better around 2:00 PM . Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days. It felt like someone had hit me in the shoulder with their fist

I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.

felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; achy arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team a Pfizer-sponsored program, Pfizer First Connect. A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization administered at the hospital. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number and expiration date unknown) on 22Dec2020. Relevant medical history included high blood pressure and diabetes; both were diagnosed in 2006 and ongoing conditions and were under control. Concomitant medications included metformin, lisinopril for high blood pressure, and semaglutide (OZEMPIC, injection), which was a once a week injection kind of like "Trulicity" that encourages his body to make more insulin. The patient said that when he got the second dose of the vaccine on 12Jan2021, he got an achy arm and it went away. At the time of the report on 18Jan2021, almost a week later, he felt like he got the vaccine in his arm again and it was going into his shoulder. The patient was asking if it was normal. He was driving at the time of the call. The patient had been a scrub technician (tech) and an endoscopy tech for 20 years. During the first surge, when they shut down the outpatient surgeries, he went and worked as an aide in the COVID ward. He was glad to get the shot. He did what his kids would do when they were young and would get a shot. He took ibuprofen. Later that evening for the achy arm, he took more ibuprofen. The achy arm lasted only a day. He thought he wasn't going to have any side effects at all. It felt like a flu shot. The patient clarified that at the time of the report (18Jan2021), his arm felt achy like it was the day he got the shot and the day after. He got the vaccine as he was in the first bunch in the city and he works in healthcare and the fact that he was over 60 years old. The patient stated he could live through it and he was just curious. The reporter assessed the events as non-serious. The events did not require any visit to an emergency room or a physician office. The patient had no relevant tests. Therapeutic measures were taken as a result of achy arm, which included ibuprofen. The patient recovered from the event "achy arm" on 13Jan2021, while the outcome of the event "felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after" was unknown. Information on the batch/lot number has been requested.

tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELQ142), via an unspecified route of administration on 12Jan2021 at single dose at left arm for covid-19 immunisation. Medical history and concomitant medications were none. Patient experienced tingling outside of left arm where he had the shot, progresses to pinky finger which was most numb. Stated thumb and pinky finger that it was not there. Stated when woke up had numbness tingling feeling that had never gone away. Above symptoms started on 16Jan2021. No treatment was received for the events. Outcome of the events was not resolved. The second dose was due on 02Feb2021.

This is 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 and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/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.

1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.

31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Monday-Same as above 2 Feb-Tuesday-feeling a little better 3 Feb-WED-more fatigued 4th Feb-TH-home from work-later that day 5th Feb-Fri-no work-at home 6th FEB-Sat-feeling up & up-has a migraine-takes aleve 7th Feb-Sun-still diarrhea-stayed in bed 8th Feb-Monday-**diarrhea-taking Immodium AD

Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy

headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient) This 61-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 at left arm on 26Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Medical history :none. Concomitant medication included atorvastatin calcium (LIPITOR ) bupropion hydrochloride (WELLBUTRIN), acetylsalicylic acid (ASPIRIN) 81 mg.The patient experienced left arm sore and minor headache on 27Jan2021 06:00 .No treatment received.Events reported as non serious.Outcome of the event was recovering.No Prior to vaccination, was the patient diagnosed with COVID-19 .Since the vaccination, The patient hadn't been tested for COVID-19

Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.

This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 61 years. The vaccine was administered at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) received on 05Jan2021 at 01:30 PM at single dose in left arm and the patient experienced sore arm. Medical history included Supraventricular tachycardia (SVT), Herpes, Hyperlipidemia, idiopathic mesenteric lymphadenopathy. The patient has no known allergies to medications, food, or other products. Concomitant medications included Valacyclovir, cyclobenzaprine, Metoprolol, lipitor. The patient reported second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. Patient was lethargic the whole next day with severe headache. Normal 2nd day after. Adverse events start date was reported as 26Jan2021 16:00. No treatment was received for the events. The events were reported as non serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events were resolving (as reported).

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.

Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021. Approximately 48 hours later, he developed left-sided lip paralysis. He went to his doctor that day, no medications were prescribed and no tests were ordered. Over the next 24 hours, he states that his symptoms progressively worsened and now the left side of his face seems "completely paralyzed." He described left ear pain, increased sensitivity to loud sounds, runny nose, and inability to close his left eye. He saw another doctor the next day, who diagnosed Bell's Palsy and prescribed valacyclovir for 7 days. Patient also noticed a transient "crooked smile" after his first dose of Pfizer vaccine, but did not relate this

Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore. Mind somewhat clouded. Modest temperature, 101. Chills. Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad. Very minor nose congestion and sore throat. Symptoms all ended by 36 hours after 2nd shot

he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an "allergic reaction"/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, "feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.

Shoulder Pain starting 48+ hours after injection. Initial arm soreness went away in less than 24hours. At time of injection the shot was given high on my shoulder and sent pain through my back an up my neck. The shot was administered into my shoulder not my muscle This is problem from the injection not the vaccine. SIRVA type injury

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.

had total paralysis of the left side of his face; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Feb2021 11:00 AM at the age of 61-year-old at single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at left arm on 30Jan2021 11:00 AM at the age of 61-year-old for COVID-19 immunisation. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. There was no known allergies. Other relevant medical history was reported as none. Concomitant medications were not reported. There was no other vaccine in four weeks. Patient had total paralysis of the left side of his face on 22Feb2021 at 07:00 AM. It was reported that the event resulted in disability or permanent damage. Outcome of the event was not recovered. No treatment for the event was received. Information on the lot/batch number has been requested.

BELL PALSY left side of face and mouth. taking prednisone 20 mg tablet 3 each one time a day for 7 days. started 3/1/21 still have BELL PALSY left side of face and mouth as of 3/5/21.

Within two hours of injection, I began to feel numbness in my right foot. Later that day, I experienced tingling in my fingers on both hands. This has continued for several days now and has worsened today (three days after injection), with the tingling being stronger and moving into my calves. I have had no loss of strength or coordination. I had similar peripheral neuropathy about 20 to 25 years ago; no reason was ever found, and it went away. This is the first recurrence in many years, and by far the most widespread on my body and the most acute sensations.

Approximately two hours after getting the shot, I felt clammy and had a fever. Very fatigued, left arm very sore. In bed by 7 p.m.. Slept till 7 a.m. Friday(3-5). Chills and fever subsided that morning. Headache and ringing in my ears. This and extreme fatigue lasted until Sunday(3-7). Unable to work for 2.5 days. Lost income. Went back to work Sunday morning, but not completely recovered. Felt back to normal by Monday morning .

Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<

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

patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm flushing feeling, and feeling a little fuzzy in the head, heart rate 64bpm, patient blood pressure on the monitor did not appear to be accurate indicating 180/118 and this was also tried on the right wrist. Patient did not have any complaints with the elevated with this blood pressure, patient was conversing and without headache, patient denied any itching or signs of anaphylaxis. patient was monitored for a total of 55 minutes before being released. Patient was instructed to call 911 with signs of anaphylactic reaction and to call his provider with any other symtpoms that he was concerned with.

significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced "significant redness" and swelling at injection site with minimal pain. He described it as "Out of proportion to what should be expected". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events "swelling and redness at the injection site with minimal pain" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the product. 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.

Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-hospitalization in 2020. Seems to be abating finally (approx 18 hrs from detection). Severe headaches, chills and fatigue commenced approx 8 hours after injection. LAsted two days. On third day, headaches and fatigue continued, but mildly.

Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.

Cold sweat at 2am Achy all over and especially upper joints Injection site sore Cannot get warm Slight intestinal discomfort

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.

migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive

Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 Dizzy Started 03/14 High Blood pressure Started 03/14 Slight nausea

Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that lasted about 1 minute followed by generalized tremors that lasted about 10-15 minutes and resolved with administration of rectal Diastat 5mg. Tremors resolved within 5 minutes. Temp treated with Ibuprofen 600mg and cool sponge bath. Temp down to 101 within one hour and afebrile after 8 hours. Temp did not recur. Normal postictal mental status. Somewhat lethargic for a day or two then gradual return to baseline cognitive and physical functioning over 10 days. Wilmer has had this type of seizure with high fever in the past.

Grand mal seizure, wife found patient lying on the ground with eyes fixed and loss of urine. Wife called EMS around 2:22 and patient came to about 15 minutes later.

immediately after vaccination, patient developed arm numbness and weakness. he was monitored at vaccine site x15-20 min and was sent home. when he arrived home about 35-40 minutes after vaccination, that sensation traveled throughout his body. he described feeling weak all over, had lightheadedness, and tingling on his lips and tongue.

Within 24 hours noticed right lower facial twitching. The frequency varies between a few in an hour to several in 5 minutes.

On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).

UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL STATUS CHANGES, SYNCOPE VS SEIZURE ACTIVITY, LOSS OF CONSCIOUSNESS. NEURO CONSULTED AND THOUGHT POSSIBLE ADVERSE REACTION TO COVID VACCINE #2 AS NO OTHER REASON HAS BEEN FOUND WITH LABS, IMAGING, ETC. NEURO CALLING IT A 2 HOUR FUGUE EVENT.

My left after 5 hours or so got really sore and just got worse during the day. It also got me really tired and had to go to bed early and slept for 10 hours. Got up and felt good. The soreness in my arm was almost gone. By mid day no more soreness. I did take 800 mg of Ibuprofen twice in a 24 hr period. I don't believe it did any good.

By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptoms for 1 week after vaccination. Reports severe bruising on left arm from collar bone to elbow. "It was black".

Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain rash started still didn?t think anything about it March 29 he went to family doctor said it was a muscle spasm gave him muscle pills March 29 he was taken to the emergency room in excruciating pain emergency room doctor did test bloodwork CT scan urine sample came back that he has shingles he has the rash. His wife also had the same shot and she also has rash on her side no pain.Do not know if this has anything to do with the shots but wanted to report us because he never had it before he got the shot or neither did she

he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.

Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.

On 3/18/21 was providing vaccinations for its employees I was asked if I wanted to take advantage of the extra vaccine. I did and got the 1st vaccination Pfizer EN6208. On 3/19/21 Shortly after arrival at work 08:00 I began to feel numbness/ tingling of both my feet. The numbness/tingling had moved up to my knee?s by Noon and once at home at approximately 6:00pm while at home the numbness/ tingling had moved up to my waist. The numbness/ tingling remained from the waist down. In addition my groin and rectum region also have the numbness/ tingling. When I sit down it feels like I am sitting on a gel pad, kind of squishy. On 3/22/21 had an appointment my vitals were checked a couple of physical tests were done and he recommended a full panel of blood work.

1:00 am on 4/1 chills and slight fever. Remainder of day on 4/1: fever, chills, exhaustion and headache Friday 4/2 Headache and numbness in left hand. Tired most of day Saturday 4/3: slight numbness in left hand.

Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen Lasted 2 days

Pfizer BioNTech COVID-19 Vaccine EUA Patient experienced a seizure 9 hours after receiving his first dose of COVID-19 Pfizer vaccine. Patient has a history of seizures but has been well controlled with levetiracetam and has been seizure free for several years. Patient's wife called the pharmacy to report the event 6 hours later, and the pharmacist recommended the patient to follow up with primary care physician as soon as possible. Patient was evaluated by his physician and had dosage of levetiracetam increased. Patient was referred for further testing.

While sleeping had heart attack, seizure, went into cardiac arrest. No warning signs and did not have a previous heart condition. CPR was performed, shocked four times at home once in ER and placed on a ventilator. Catheterization procedure performed, full blockage of the right coronary artery received two stents. After surgery was in ICU on a ventilator for three days then went to step down unit for two days. Now being treated by cardiologist, pulmonologist, neurologist and primary care physcian.

Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car while driving and had to be taken to the Emergency room where he later passed away. Cause of death on the death certificate per the coroner is Pulmonary Embolus. Patient was just seen my his family physician in January and was in good health no medications taken other than eye drops.

He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; discovered he had COVID; discovered he had COVID; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 61 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of Pfizer's COVID vaccine on 06Feb2021. He had 2 seizures that following Monday, 08Feb2021 and another seizure on Friday, 12Feb2021. He also stated he discovered he had COVID. He was at the hospital for the seizures and diagnosed with Covid. He was due for the second dose which was supposed to be given the third week. He he spoke to the nurses there and they advised him not to do anything until after 90 days or something like that. He was told by the doctor that his second dose should be delayed until 30 to 90 days and heard from Department of Health that he had up to 42 days that he'll be ok. He stated that he just spoke to themDepartment of Health. He stated that they said after 40 or 42 some odd days, and there was an extra 7 days of leeway, he could get the second dose. He stated that his 42 days was up either today (24Mar2021) or yesterday (23Mar2021). He had an opportunity this Friday (26Mar2021) to get the second shot. He had to get the shot at the same location. He was tired of this. The patient stated when should he take the second shot? Should he wait the 90 days? He stated his primary said to see a neurologist, but he didn't see them until 05May2021 and the neurologist said they couldn't say anything because he was a new patient until they see him, so they say to go to his primary care. Dates for tested positive for covid after first dose of Covid Vaccine was unspecified. The outcome of events was unknown. Information on the lot/batch number has been requested.

Parasthesia - both arms, most remarkable in hands, concentrating on lower palm and pinkie, ring and middle finger

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

Patient was monitored for 30 minutes without complaint. Patient returned approximately 45 minutes after vaccine complaining of lips and mouth tingling that transitioned to numbness. Patient received 25mg of Benadryl PO approximately 50 minutes after vaccine. 30 minutes after Benadryl patient continued to complain of lip numbness and tingling on both palms. Patient was transferred to ED for further examination/treatment.

March 26, 2021: One week to the day after receiving my second dose of the Pfizer COVID19 vaccine, my right eye suddenly had double vision and facial pain behind the right eye and all around the right eye (forehead, right temple, around to under the right eye on the cheek). The right eye would not move correctly. March 27, 2021: I went to see Optometrist. He performed an eye exam with dilation and stated that the right eye was slow to track, and that the nerve behind the right eye was inflamed. He recommended blood work, CT scan, and an MRI. March 27, 2021 ? March 28, 2021: We went to ER at 9:00pm. After waiting six hours, I finally was able to see an ER doctor. No medical history was taken. No bloodwork was done. ER Dr performed a CT scan as Dr requested. CT scan w/o contrast showed no masses or hemorrhages. ER suggested to follow-up with Nuerology. March 29, 2021: Went to Neurologist and he examined me. He called in another Dr for a second opinion. They stated that it may be a possible cranial nerve palsy and ordered multiple MRIs. March 29, 2021: The earliest MRI appointment available was April 7, 2021. Scheduled the MRI. April 1, 2021: Had blood drawn at lab as Dr requested. April 2, 2021: Two weeks from the day of COVID19 vaccine #2, my right eyelid would not open at all and the pain was getting worse. April 5, 2021: Went to ER at 4:30am. Triage nurse sent me straight to an ER room and within minutes an ER doctor was there. Within 15 minutes after seeing the ER doctor, a Neurologist was examining me. The nuero doctor was very thorough. While waiting for the MRI, other neurologists and residents also examined me. MRI scans with and without contrast were performed. MRI images were clear ? no tumors, no aneurisms, and no stroke. They concluded that it was a micro-vascular injury to cranial nerve #3. (Similar to the Bells Palsy that I had in 2015.) They prescribed gabapentin to help calm the nerve pain. Follow-up will be with nuero-ophthalmologist.

headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 04Feb2021 at 09:00, patient experienced headache, teeth hurt, leg pain, chills and low-grade fever. Since the event onset date was presented as 04Feb2021, however, PRD was noted as 08Feb2021, query was raised to provide the awareness date of AEs. The patient responded that the symptoms started on 04Feb2021, the day after receiving the second vaccine shot. Patient reported this to the health clinic on 04Feb2021 and filled out the report when he returned to work on 08Feb2021. The date of start of event in the report is correct and the date of receipt of the most recent information is on 08Feb2021. The outcome of the event was recovered. Information on the lot/batch number has been requested.

After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours. Then it went away with mild fatigue for a couple days.

About 30 minutes after getting the vaccine his developed a headache. Shortly after that he developed left leg weakness and inability to use left leg. The next morning his symptoms somewhat improved. Friday morning, 2 days later, his left leg weakness returned. He was directed to the ER where stroke was confirmed.

Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 hrs after vaccine administered). Arm pain lasted a day, fatigue about 12-18 hours.

4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.

Bilateral arm and hand pain, numbness in fingers. Arms go completely numb when driving or holding grandson. Only time they are not numb is when he is standing up. It started the same time he got his COVID vaccine.

Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggling to use arms, trouble using legs, unable to stand well. Wife noticed slurred speech, drooping left side of face. Called 911. Was taken ED and transferred to another Hospital. Was found to be having ischemic Stroke.

Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via unknown route, on 22Mar2021 (last Monday) as a single dose for COVID-19 immunisation. Patient's medical history included Bell's palsy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number and expiry dates were not reported) for COVID-19 immunisation. Patient stated that patient received COVID-19 Vaccine second dose last Monday, (22Mar2021). He had started with annoying headaches for 3-4 days. On Friday (26Mar2021), had lost control with talking, eyes were droopy etc. Patient mentioned that he had Bells palsy once before, and that now got it again. Patient asked if it would be possible that the vaccine caused the disease?. He mentioned that the hospital gave him Prednisone and Valtrex. Seriousness of the events was considered as hospitalization. Outcome of the events was unknown. Information on about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down. He has thrown up 3 times. His bones are aching and light headed. He has not taken anything for the reaction, just trying to stay hydrated, very little appetite. Does have an appointment to see his doctor today at 4:20 PM.

Bells palsey on left side. Had stiff neck several days before with first shot and more with second shot that escalated to bells palsey.

This patient came in to the community center to receive his 2nd dose of his Pfizer vaccine at approx 10:06am. At approx 10 minutes after sitting in the observation area, the patient started to fee hot, dizzy, some tunneled vision and nausea. This attendee did not have any sort of reaction to his first dose. This was brought to the attention of one of the observing staff members. This nurse, was called over to the patient. The attendee was asked to lay down on the cot provided and we elevated his legs. RN, measured his vital signs: bp 110/70, HR: 60, Resp 16, O2 97%. This patient denied any shortness of breath. Lung sounds were clear, and no wheezing or rhonchi were observed. This patient stated he has a history of Asthma and took his asthma medications this morning as normally directed. This patient was directed to lay down for approx 10 minutes, then stated he felt much better and wanted to sit up and take a sip of water. The attendee tolerated the water well. This nurse, advised for this attendee to stay for another 10 minutes until he had no symptoms present. The patient quickly felt better and stated that his wife was out in the car and would be driving him home. This nurse advised for him to go to the Emergency Room if he felt any of these symptoms again.

After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore. However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.

8 days post 2nd covid vaccine (given on 4/6/21), patient awoke with stroke like symptoms. Evaluated in the ER and diagnosed with Bell's Palsy.

Joint pains. 1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint. 3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior

Skin on the side of my forearm is hypersensitive and paimful to the touch. It is the same arm as I received teh injection. It first presented after my first dose (03/19/2021 and started to subside. After the second dose the pain and sensitivity increased. It has bee 1 week since second dose.

Patient received vaccine was sitting for 15 minutes and got up in the middle of his 15 minutes to approach the pharmacist and the pharmacist sat him down again and he passed out onto the floor hitting his head with a cut on his eyebrow and nosebleed. Ems arrived and got patient back into chair and he again passed out and began seizing. He again regained consciousness and was taken away in a stretcher.

POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTER ONCE PLACED IN TRENDELENBERG ON STRETCHER. VS MONITORED THROUGHOUT OBSERVATION. HX OF HTN, TAKES BP MEDS QHS. ONCE SYMPTOMS RESOLVED, PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1200, INSTRUCTED TO MONITOR BP AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED OR WORSENS. PER ON-SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL REACTION-RESOLVED. 1120 INITIAL BP 193/100 HR 70 SATS 99% RA 1125 BP 185/94 HR 75 SATS 100% RA 1135 BP 186/105 HR 65 SATS 99% 1155 STANDING BP 175/98 HR 59 SATS 98%

Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (intermittent, 9pm 20 Apr to present), severe fatigue, diarrhea, dizziness, periodic nausea (all thru current)

Patient was vaccinated with first dose of Pfizer on 4/1/2021. Patient reports having no known allergies and no known chronic medical conditions. He states he experienced his "cheeks go numb" an hour following his first dose of the Pfizer vaccine. This symptom lasted 3-4 minutes. He denies having taken or consumed anything that would have brought on these symptoms. The numbness resolved on its own without medication. Patient consulted with primary care provider following adverse event.

Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and reported to have Left facial droop, and slurred speech same night after first dose. He reports as soon as he made it home he "felt sleepy and went to bed, and woke up around 8:00 pm with my tongue swollen and Left facial droop, and unable to speak." States he did not follow up with PCP or ER.Uon assessment by LVN and MD facial droop swollen tongue still present 2nd COVID vaccine not give and instructed on EC visit. Pt diagnosed with CVA in EC. Pfizer noted as an allergy.

I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next morning, my Parkinson's symptoms, overall weakness, "frozen foot" and (left) foot-turned-in-bent-at-ankle, resulting in my needing assistance to walk, get up out of chairs, use the bathroom, worse than I had experienced prior. Normally I have much relief with Rytary, Carbidopa-Levodopa, and deep brain stimulator, but nothing helped. I'm now at 65-70% of where I had been. While I can't say with certainty that my medication failure resulted from the vaccine, I have no other explanation. I would rather risk whatever one vaccine has done for me against COVID, than go through this again, or worse!

First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Mar2021), via an unspecified route of administration in Arm Left on 05Jan2021 13:30 (at the age of 61-years-old) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia, herpes virus infection, lymphadenectomy and idiopathic mesenteric lymphadenopathy. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]); cyclobenzaprine (CYCLOBENZAPRINE); metoprolol (METOPROLOL) and atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient experienced first dose sore arm. Patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Apr2021), via an unspecified route of administration in Arm Left on 26Jan2021 13:15 (at the age of 61-years-old) as single dose for COVID-19 immunization. Second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. I was lethargic the whole next day with severe headache. Normal 2nd day after. Since the vaccination, patient not tested for COVID-19. The outcome of the event was recovering.

Starting 3-4 days after injection, began to have increasing pain in buttocks. Pain became more severe, spread to hips, then to knees/quadriceps over next 3 days - during this time, pain was relieved with Tylenol for 2-3 hours, then the pain would "break through" the Tylenol. Three days after onset pain was unbearable and consistent for 2-3 days. The pain slowly subsided over next 3 days without intervention. Morphine and Valium was required to manage pain in ER.

Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely tired

Pain in left arm still persist. Pain is unexplained. It seems like mud is applied and it has dried out. it is kind of annoying pain. Pain keeps moving from lower part of arm (wrist) to shoulder. sometime it hurts then it goes down.

muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog; This is a spontaneous report from a contactable consumer reported for himself that a 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733, expiry date: Jul2021) at the age of 61-years, via an unspecified route of administration in right arm on 29Mar2021 11:30 at single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced 7days brain fog, muscle cramp, tightness in chest, shoulders cold sweat with no fever and body weakness. These events started since unknown date (reported as 28Mar2021, pending clarification). No treatment received for the adverse events. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain. I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.

he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events 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. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.

Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.

Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine, still have this side effect Dizziness - no treatment Ear ache , ears burning - no treatment Flushed feeling in head - no treatment Anxiety and stress - went to ER with chest pains, found nothing wrong with heart

Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. Patient admitted to anxiety discorder. Nurse and EMT assessed patient and obtained vitals. Patient got out and walked and stated that he felt better.

Zero symptoms after the first dose aside from a sore arm for 24 hours. Almost no immediate symptoms after second dose aside form a sore arm again for 24 hours. However, a few days after the second dose, I noticed a very slight metallic sort of buzzing or ringing in my ears. After consulting a week later with my family doctor, he mentioned the possibility of tinnitus and we have an appointment set with an ear/nose/throat specialist on May 3rd.

Very sore arm 10 days post vaccination accompanied by sensitive teeth on left side of mouth and a stye on left eye. Recovery took 2-3 weeks

Arrhythmia lasting about 5 - 7 minutes. Unpleasant and got light-headed. Resolved itself instantaneously.

sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication

Arm soreness which came up within hours of injection, slightly limited range of motion , got slightly worse into the night but was gone by morning. Pain would be described as minor.

headaches; bad migraine/Migraine headache and headache which has not improved; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Mar2021 14:30 (Lot Number: EN 6208, Expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced the day after he took the shot on 17Mar2021, a migraine, it was awful, the migraine came down to a headache and he haven't had that level of migraine. Since then his headache is not gone away and he does not know if he has migraine right now but it was not improved on 17Mar2021. Patient reported he was not going to take the second shot. But he is scheduled to take the second shot tomorrow, but there is no way he could take that. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of bad migraine. Nabumetone 500 mg twice a day was taken as treatment for migraine. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis. Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER). On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known. The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.

On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and under left arm and biceps, and broke out rash on Sunday 4/18/2021 and on Monday, 4/19/2021 he developed blisters and he went to Urgent care and was diagnosed with Shingles. He received a prescription for the rash, (Valacyclovir TID x 7 days), but he used Calamine lotion and applied that to the rash which improved. . Went to see his health care provider a week later on 4/26/2021. and received pain medication Tramadol, which was very helpful with reducing the pain. He was advised to get the 2nd dose of Pfizer vaccine on 4/29/2021. As of this date no complaints. He was encouraged to use V-Safe and he is being followed by them at this time.

About a week after the first vaccine pt started having numbness and tingling in the injected arm. He states it comes and goes and hasn't seemed to improve at time of second dose. He stated no previous issues with carpel tunnel or other nerve issues in his hand or arm. He did want to go ahead with the second injection.

I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.

Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions. Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib). Pain came on 5-10 minute intervals for 4 hours. Day 4 was at a hotel in another city. Pain was gone by Day 5. Neck was sore throughout the 5 days post vaccine.

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).

having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.

diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spontaneous report from a contactable consumer (patient's stepbrother). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Arm Right on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunisation. The patient was feeling very weak and has fallen twice and no fever or flu like symptoms. He ended up going to the hospital where they did a blood test which came back showing he had very high glucose levels and he was now convinced that the vaccine has given him diabetes. The patient experienced Patient says he is feeling very weak and has fallen twice but no fever or flu like symptoms on 24Feb2021, high glucose levels and diabetes on an unspecified date. The patient underwent lab tests and procedures which included blood glucose increased: high glucose levels on an unspecified date.The patient was not tested for COVID-19 since the vaccination. Outcome of the events patient says he is feeling very weak and has fallen twice was not recovered and unknown for other events. Follow-up attempts are completed. No further information is expected.

On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down right arm, on May 1 fely tingle in legs knee down to toes and also arms , from that point I have have pins and needles, burn, tingle numb pulsing off and on in arms to fingers, knees to toes and also in face numbness , have seen muscles soften and skin sag and lost autonomic nerve sensation in privates area and have not had bowel movements for over a week and a half other than wit hlaxative until last 3 days have had very small bowel movements , also eyes had been for years but vision has gotten worse , additionally anxiety i high and not sleeping well as worry and concern increases .

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.

Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client turn red and become flushed to the skin. RN provided supplemental nutrition and fluids. Client accepted. At 1740 RN and PHN responded to this event. At 1741, vital signs are blood pressure 150/90, heart rate 100, oxygen saturation 96%. Client reports anxiety, no dizziness, no headache, no blurred vision, no chest pain. Client reports history of hypertension, takes blood pressure medication every morning (today's morning dose was administered via self at home), takes over the counter aspirin as needed, and no known allergies. At 1745, vital signs are blood pressure 144/88, heart rate 101, oxygen saturation 95%. Client reports no complaints with the 1st dose. Per Client had a very stressful day. The flush reaction of the face happened within 2 minutes of administration. RN educated Client in regards to ED precautions and common adverse effects of COVID vaccine. At 1750, vital signs are blood pressure 140/88, heart rate 90, oxygen saturation 98. Client reports symptoms have resolved and skin tone returned to appropriate coloration to ethnicity. At 1800, vita signs are blood pressure 130/88, heart rate 92, oxygen saturation 97%. At 1801, Client stood up with no complaints. At 1802, Client walked out of facility with a steady gait.

Patient presented at the pharmacy on 05/20/2021 stating he has arm pain from the COVID vaccine he received 04/08/21. Patient states he has limited range of motion and the arm has pain radiating down. Patient received his second COVID vaccine in the left arm without incident.

Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to present (May22)

Numbess/tingling all through right arm, still ongoing. Some days not very much, some days its more noticeable.

blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per minute; Not feeling well; Sore arm; felt strange; his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Apr2021 (lot number: EW0158), as 1st dose, single, for COVID-19 immunization, at a clinic. Medical history included high cholesterol (controlled with diet); bone spur in left heel (bone spur in his left heel began coming on gradually, probably for 10 or 12 years) which has gotten little worse and made it hard for him to walk in the evening, in long distances, it was like a knife in his heel and he would get that real soreness and pulling after a walk; and allergy to sulfa drugs, more specifically sulfa antibiotics (he was given them 25 years ago and had a reaction). The patient has not had any vaccines or shots for years. He reported that he is very healthy and has not had the flu or anything in 25 years. The patient does not smoke and is careful with what he eats. There were no concomitant medications. On 09Apr2021, within minutes of receiving the first dose of the COVID-19 vaccine, the patient was not feeling well, he felt strange. He wondered if it was his imagination or if something was going on. Then it got worse and worse within 12-15 minutes after the COVID-19 vaccine. The staff member sent paramedics over to him. The paramedics set him up with a blood pressure cuff and heart monitor. Apparently, his blood pressure dropped a lot/dropped a good deal and his heart rate went to 30 beats per minute. His heart rate is normally around 65 beats per minute. The paramedics informed him that if his blood pressure and heart rate didn't come up, he was going to have to go to the hospital. The paramedics instructed him to stand up and it seemed to bring his blood pressure and heart rate back up to normal. The patient reported that everything returned to normal within a 15-20-minute time frame. He was then able to leave the vaccination facility. His health care provider advised him not to take the second dose of the COVID-19 vaccine. His physician informed him that he could possibly go into cardiac arrest. The patient did not have any problems after that other than a sore arm later in the day on 09Apr2021. His arm was sore for a day or two. The patient stated that this was the only effect after the incident in the vaccination facility. The patient also reported that on the weekend after receiving the COVID-19 vaccine, in Apr2021, he can walk long distance and his bone spur in his heel quit bothering him immediately. He reported that if he walks a mile and back, it quit the hurt. He reported that he would get that real soreness or pulling after a walk and that kind of stopped. The patient thought this was really strange. The patient reported that he cancelled the appointment for the second dose and did not get it. He was a little apprehensive about the second dose of as he didn't know if his reaction would be worse. The patient asked if the vaccine is 80% effective after one dose, if Pfizer has heard of that type of reaction from others, if his reaction was rare, and if he should get the second dose of the COVID-19 vaccine. He mentioned that he would like to have a second dose of the Covid-19 vaccine, but he is afraid to get it because he doesn't want to go into cardiac arrest. The patient recovered from "blood pressure had dropped a lot/blood pressure dropped a good deal", "his heart rate was 30 beats per minute", not feeling well and felt strange on 09Apr2021, and from sore arm in Apr2021. The outcome of "his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped" was not recovered. No follow-up attempts are needed. No further information is expected.

AS SOON AS WE COMPLETED VACCINE , HE START FELLING HOT AND NAUSE AND HE SAID HE FEEL LIKES HE WILL PASSOUT , WE GAVE HIM 1 TABLET OF BENADRYL 25 MG AND CALL 911 ,AFTER 5 MINUTES HE START FEELING GOOD AND EMS ARRIVED IN 10 TO 15 MINUTES CHECCK HIS BLOOD PRESSURE AND PULSE AND HE FELT GOOD AFTER 15 MINUTES AND WALKED TO HIS CAR.

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.

numbness on his left leg and one time with left arm/His left leg went numb seven or eight times; could not walk; This is a spontaneous report from a contactable consumer (the patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0164, expiry date Aug2021), via an unspecified route of administration on 13Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and allergic to bees. The patient had an EpiPen. He would have to use it if he ever got stung. He has never had to use an EpiPen. Concomitant medications included: hydrochlorothiazide/ lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for hypertension, for maybe 8 years. The patient had other unspecified concomitant medications. After receiving the Pfizer COVID vaccine, the patient experienced numbness on his left leg and one time with left arm. His left leg went numb seven or eight times. His left arm went numb one time. He thought maybe it was just going to sleep. He usually slept on his arm, and it woke up that way. But he was walking, and it went numb; it was very strange. There was no pain. It began about two and a half weeks ago (2021). It has happened twice today, so he thinks it is getting worse. It was also lasting longer. Today (unspecified date 2021), his left leg went numb so much that he could not walk. He was walking, and he had to stop and stand there for 10 minutes before the feeling came back. It was very strange. His leg numbness was the most serious today. After this last episode of leg numbness, he called his insurance company, and made an appointment with his medical provider on Monday. He was reluctant to take the second dose of the COVID vaccine. The patient stated he occasionally took vitamin D, fish oil, vitamin C, and aspirin. The outcome of the event could not walk was unknown. The outcome of the other event was not recovered.

First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extremities, joints, ankles, wrists, knees, neck pain, high fevers and intermittent sweating. Something that triggered me and that I had never suffered before was ALLERGIES TO POLLEN. Today a week later I still feel sick from it. A lot of headache, runny nose, and sneezing. I assume they are allergies to pollen because I took some pills for that {CLARITIN} and I calm down and we feel them a bit, however I do not take it off.

Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb; Burning sensation; Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Shooting pain like flu; This is spontaneous report from contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, (patient not sure if it's right arm or left arm) on 13Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE, for covid-19 immunisation. The patient took the second dose on 04Apr2021 (Batch/Lot Number: ER8732). The patient medical history and concomitant medications were not reported. The patient stated that "I wanted to report about suspected side effects to covid-19 shot. I'm not sure if it's the Covid-19 shot or not or has to do with it but I wanted it to be documented may there's some coincidence, you can tell me about. All extremities hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb. Burning sensation, shooting pain kind of like flu but no body temperature change, body temperature is 97.7 down there, it's been occurring now past my 2nd shot." The patient later corrected it as," It's 5-10 days after the 1st shot." When paraphrased, the consumer stated," I've got a number of doctors working on trying to figure out what's wrong with me. So, if we cannot find anymore answers then I'm sure, I'll contact Pfizer. I don't know if it has anything to do with the shot or not, I don't even know if the side-effects are from Pfizer or not. Doctors are suspecting I might have mucous or blood colitis, we are just not sure." When asked for the anatomical Site of administration of Vaccine: The patient stated, "I'm not sure if it's my right arm or left arm." For the event start date: patient stated, "18 or 19 June, somewhere around there. I am not sure. (pending clarification)" The patient also added: "Do you guys also report to VAERS? I don't know my physician asked to say, if you guys report to VAERS, otherwise I should call VAERS and report my symptoms." The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous report from a non-contactable consumer(patient). This 61-year-old male patient reported that he received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 17Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient (frontline worker), received his first dose of the Pfizer COVID vaccine on 17Jan2021. On an unspecified date the patient had a very sore arm at the injection site which he was never had with a vaccine before, and the patient had no side effects except these. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.

He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine. He also has had numbness in his hands. He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing. He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him. He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe. He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil. They told him to take Advil. The cardiologist has not given him any results yet. He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.

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.

Nothing major; slight redness at injection site and a sore arm for 24 hours; Sore arm; 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, Batch/Lot Number: EN6195), via an unspecified route of administration on 04Mar2021 12:30 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has not had other vaccine in four weeks. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced nothing major; slight redness at injection site and a sore arm for 24 hours on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

reports numbness and tingling on L hand radiates to elbow continues with symptoms at this time. Motor skills intact

Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0172) via an unspecified route of administration (Age at vaccination 61-year) in Left Arm on 06May2021 13:30 as single dose for COVID-19 immunization. It was reported that the second dose of the COVID vaccine given over 21 days after the first dose. Medical history included allergy to animal (The only allergies he has are to dogs, cats, horses, seasonal allergy); ragweed; blood pressure measurement, He takes a blood pressure medicine and a cholesterol medicine. He started taking all of his medications after age 55, blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for blood pressure measurement; amlodipine besilate taken for blood pressure measurement; lisinopril taken for blood pressure measurement; rosuvastatin taken for blood cholesterol from an unspecified start date and ongoing. On 06May2021 the patient experienced sharp pain in his arm. On an unspecified date the patient underwent lab tests and procedures which included blood test: nothing for his arm. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered. Batch/Lot number was obtained. Further information has been requested.

I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; 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, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.

ACTIVATION OF TRIGEMINAL NEURALGIA FROM 04/16/2021 RESULTING IN DEBILITATING PAIN CONTINUING TO THIS PRESENT REPORT

Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, nose, tongue, throat, and lungs. The sensation is constant and continuous. It seems to be getting stronger with time.

First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.

I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.

Migraine headache after the shot. Since the shot on 3/16/2021 I have a headache. This headache is 24/7 all day every day. It has not gone away or improved. I have visited my primary care physician, ENT doctor, ophthalmologist and two neuologists. I have been prescribed numerous presciptions. I have had a CT scan, MRI and MRA. My headache has not improved after 3 months from the initial vaccine. I had no history of headaches prior to receiving the vaccine.

Patient came in for his second dose after 3 weeks and I asked him if he had any issues with his first dose. He responded that his arm became numb after his first dose and it is still numb.

Sudden onset of right upper back pain with radicular symptoms radiating to right pinky on afternoon of 3/5/2021. Discovery of right pinky weakness in extension and abduction with EMG confirmation of Parsonage Turner Syndrome on 6/8/2021

Legs ache/cramp when standing or walking. Unknown cause--not circulatory or nervous system. Taken off medication-Atorvastatin. Stopped taking the Vitamin D/Calcium. High Blood Pressure is being controlled. Using a CPAP machine (1 month now) for treatment of sleep apnia.

30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm. high blood pressure, headach, shortness of breath 2 days after vaccination he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis, numbness of left upper arm and slight shortness of breath

I received my vaccine, I was monitored for 15 min with no effects. I walked outside to my truck when I got in I could not breathe, I was gasping for air. I am on 02 for my Copd and had to turn it up and sit for 30 minutes until I could drive because I could not catch my breathe. I lost my voice it is raspy and have had a COPD exacerbation since my vaccination. I have been hospitalized twice since receiving the vaccine, and still have no voice. No treatments are working.

Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the fourth day around 1:30 in the morning I woke up in a cold sweat and I felt my heart racing and also uneven heart beat. My blood pressure was up to 150/100. Over the next 20 hours this condition subsided and finally went away completely after 20 hours or so.

Pt presented to the ER with x5 days of dizziness, ataxia , and lightheadness. Imaging studies showed and Acute left Cerebellar Infarction. Patient was recommended for inpatient acute rehab upon discharge which he refused, patient discharged home with home health services.

Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 61-years-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via an unspecified route of administration in the right arm on 12mar2021 at 1:30 for COVID-19 immunisation. TMedical history included asthma and sinus. Concomitant medications included antibiotics received within two weeks. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. and prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Chills, lack of energy and slight fever on 20Mar2021 at 9.00.The patient did not receive any treatment for reported events. The clinical outcome of the events Chills, lack of energy, slight fever was not recovered . No follow-up attempts are needed. No further information is expected.

some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report freceived rom a contactable other health care professional. A 61-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration and administered in left arm on 05Feb2021 10:00 (at age of 61 years) as dose 1, single for COVID-19 immunization. The patient didnot had covid-19 and was not tested for covid-19 prior vaccination. The patient was not tested covid post vaccination. The patient had no other vaccines in 4 weeks. The reporter was not aware of known allergies. The patient medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE), vitamin D NOS (VITAMIN D NOS). The patient experienced arm Soreness, some diarrhea issues the first 2 days with some stomach cramps, he have a bit of dizziness that he awoke to this morning. The patient didnt received any treatment for events. The outcome of events was recovering. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.

Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

Stroke; Blood pressure high; Vision peripheral decreased; Joint stiffness; Numbness on left side of body; This is a solicited report from non-Pfizer sponsored marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3921608-00). A contactable consumer reported that a 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at age of 61 years old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2016 (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe adult crohns disease. Medical history included alcohol use started from 1976, rarely use beer and red wine; tobacco use from 1976 to 2021, a pack of cigarettes a day; and moderate to severe adult crohns disease. Concomitant medications included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (BABY ASPIRIN); both taken for prevent another episode of stroke. The patient previously received the first dose of bnt162b2 intramuscularly in Mar2021 at age of 61 years old for COVID-19 immunisation. The patient experienced stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body on 14May2021. Event stroke was serious per hospitalization, other events were reported as non-serious. Event details: On 14May2021, the patient experienced numbness on left side of body and peripheral vision on left side was affected. On the same day, he had stroke and was hospitalized due to that. He had physical occupational therapy after within two weeks when he returned home from the hospital. His blood pressure was high but could not remember the exact number. His joints got stiff with colder weather. He had unspecified high blood pressure pill as part of his concomitant medications. The action taken in response to the events for adalimumab was dose not changed. The outcome of event stroke was resolving, outcome of event blood pressure high was resolved, outcome of event joint stiffness was not resolved, outcome of other events was unknown. Causality for adalimumab: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with adalimumab was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with adalimumab was not provided. AbbVie's opinion was that there was no reasonable possibility that the events of stroke, blood pressure high, vision peripheral decreased, joint stiffness were related to adalimumab. Causality for bnt162b2: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with bnt162b2 was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with bnt162b2 was not provided. The reporter's assessment of the causal relationship of the events joint stiffness and numbness on left side of body with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. Information on the lot number cannot be obtained.; Sender's Comments: The events stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body were considered as unrelated tot he use of bnt162b2. Patient received 2nd dose of bnt162b2 in Mar2021 and the events occurred on 14May2021. The temporal relationship between the events and bnt162b2 is weak.

his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration administered in Arm Left on 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.

Had a seizure that lasted an hour and 15 minutes. My blood pressure and heart rate have been unstable since the seizure.

Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.

It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; Pain in arm; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; 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: EP7533), via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications of the patient included atorvastatin (MANUFACTURER UNKNOWN) 20 mg and acetylsalicylic acid (ASPIRIN) low dose for unknown indication from an unknown date. The patient did not have allergies to food, medications, 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 23Mar2021, the patient experienced pain in arm, loss of strength, pulled muscle, pain upon movement. The patient reported pain in the left arm which persisted until the day. It felt like he had pulled a muscle and noticed pain in movement and lack of strength and felt like someone had repeatedly punched his upper arm. The pain was persisted for 6 days so far. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, loss of strength, pulled muscle, pain upon movement was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.

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.

I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.

Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration on unknown date 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 not been tested for COVID-19. On 05Apr2021 the patient experienced vertigo, dizziness, arm pain and fatigue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vertigo, dizziness, arm pain and fatigue were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Felt tight around right shoulder joint centered on 1st injection site; Right side of body didn't work correctly. Right leg and arm felt odd, muted sensation in right arm and leg not numb, tingling or pins and needles feeling; Lack of fine motor control in right fingers; This is a spontaneous report from a contactable consumer, the patient. A 61-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 arm left on 30Mar2021 at 12:00(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included borderline diabetes and body mass index (30BMI). Patient had no allergies to food, medications or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), ascorbic acid, copper gluconate, zinc oxide, tocopheryl acid succinate, xantofyl, zeaxanthin (AREDS 2 VISUAL ADVANTAGE), cetirizine hydrochloride (ZYRTEC), cannabidiol (CBD OIL) and glucosamine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm right on 09Mar2021 at 12:00(at the age of 61-year-old) as a single dose for COVID-19 immunisation Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 07:00 the patient experienced lack of fine motor control in right fingers and right leg and arm felt odd, muted sensation in right arm and left; not numb, tingling or pins and needles feeling. On 06Apr2021 the patient experienced tight around right should joint. He woke up 2nd day after the second dose, the right side of his body didn't work correctly. Lack of fine motor control in right fingers which got better during the day, almost 100% . He called and doctor said he has heard several cases like this and prescribed anti-inflammatory medications. Symptoms lessened each day and by 06Apr2021 he was walking normally, right fingers regaining fine motor control but feel tight around right shoulder joint centered on 1st injection site. The event lack of motor control and tingling resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tingling and lack of motor control and included treatment with (SULINDAC) 200mg twice daily. The clinical outcome of the event lack of motor control, tingling and feel tight around right shoulder was recovering. No follow-up attempts are needed. No further information is expected.

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.

Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved

Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM. Since morning no additional symptoms including no tiredness/lethargy. I currently feel completely normal. Last dose of naproxen was at 6:00 AM and no symptoms since. Currently 1:45 PM.

PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.

Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushed and pt. asked to lay down @11 am in the observation area. Staff able to get pt. to cart before she "passed out." She immediately responded but RRT was called to assess the patient. BP low, per RRT (84/54 P 53, 108 /65 P 51) and pt. was taken to the ED at 1112. No SOB, nausea noted. Per ED and final report was that the reaction was not an allergic reaction nor a side effect of the injection.

Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again. I had no reaction to 1st dose.

Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

insidious onset lateral right foot pain at fibularis tendons from lateral malleolus to the base of 5th metatarsal

Bell's Palsey- 1-10-21- c/o rt eye not closing all the way the night before, lower lip shifted to left side with decreased movement and pt reports trouble drinking fluids. Physician assessment- vss, left lower lip decreased movement rt side, lt sided weakness, some pain in eye, eye red and injected. prescribed prednisone. Assessment 1-11-21- patient eye droop visibly improved, still left sided weakness and having issues drinking, due to hx herpes cold sores prescribed famciclovir in addition to prednisone.

Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.

Rash to Left torso spreading to midline of abdomen and to left side of back. Observing for past 30 hours. Slightly itching and internal hot flashes occasionally

Chills, Rigors, extreme sensation of being very cold with intense lethargy, Low grade fever 100.3degrees po. The reactivity was intense enough to be described as incapacitating for a period of approximately 10 hrs

Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable healthcare professional who reported for himself, a 62-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included CVA no residual, patent foramen ovale and known allergies to iodine. Concomitant medications included apixaban (ELIQUIS) and atorvastatin (ATORVASTATIN). Patient did not receive other vaccines in four weeks. On 08Jan2021 at 06:00 AM, the patient developed fever 102.7 F, chills and extreme weakness. Treatment for the events included Tylenol, tepid bath and "cleep". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The outcome of the events was not recovered.

Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.

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.

fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch

Approximately 8 mins after receiving vaccine, complained of numbness to left side of face, gums and lateral tongue to midline. No other symptoms of adverse reaction and vital signs were stable. Numbness progressed from lateral aspect of tongue to midline so MD ordered Benadryl. Symptoms resolve approx. 40 mins after Benadryl dose

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.

headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.

Worsening of sciatica in right leg. I don't believe this is related to the vaccine but understand it is appropriate to report any effects which are temporally related to the vaccine

Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He called me on the phone and his voice was slurred and he thought he was being held down by some things that were flying around. I was able to direct him to sit up after ensuring him that he wasn't being held down and eventually get him to walk to the bathroom, turn on the light and look in the mirror and describe to me what he saw (he lives at a different address than I do). By this time, he had "woken" up and his voice was no longer slurred and he was "making sense". My concern was that he had had a stroke or Bell's palsy or something. He was fine and slept well the rest of the night. I will bring him to my home after his second shot just in case this happens again. He hallucinated after his anti-anxiety medications for the first couple of weeks and to a more minor amount with his other medications, again for the first couple of weeks. I am assuming that his brain reacted to the vaccine with hallucinations but I don't know. This may be nothing or it may be something that other patients are experiencing, who the heck knows.

Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.

Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done

muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced 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 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.

Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (patient). A 62-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, cerebrovascular accident, Penicillin allergy. The patient experienced intense pain to R foot within 12 hours on 30Dec2020 01:30 with outcome of recovered with sequelae. Treatment received for the adverse event included: MRI, Ultrasound, Interventional radiology. The patient was hospitalized for intense pain to R foot within 12 hours for 9 days. The patient underwent lab tests and procedures which included Interventional radiology, magnetic resonance imaging, Nasal Swab test: negative, ultrasound scan.; Sender's Comments: The 62-year-old male patient had medical history included hypertension, type 2 diabetes mellitus and cerebrovascular accident. The reported intense pain to R foot was more likely due to intercurrent condition/disease, and less likely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information, including MRI and Ultrasound findings and Interventional radiology details, 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well

About 30 minutes or so after injection, patient had reaction. The patient had really bad tremors, blood pressure was ok but pulse was fluctuating. Nurse was at bedside providing oxygen through mask. He was given aspirin and didn't need EpiPen. 911 was called and patient was transported

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.

Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am

severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.

Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21. PT did not knowingly have COVID prior.

Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patient passed away in ED

sciatic nerve diagnosed as inflamed only left leg and shot provided left arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 08Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included blood pressure. Concomitant medication included unspecified blood pressure medication. On 09Jan2021 at 2pm, sciatic nerve was diagnosed as inflamed only on left leg and shot (treatment) was provided in left arm. Patient visited emergency room/department, methylprednisolone sodium succinate (PF) was given as treatment. The event was reported as non-serious, patient was not hospitalized. The patient underwent lab tests which included COVID-19 Nasal RT-PCR: negative on 25Jan2021 (Nasal Swab). Outcome of the event was recovering. Information on the lot/batch number has been requested.

Patient felt burning in left arm, and said he felt flushed approximately 15 minutes after receiving 1st dose of the vaccine. Patient refused transport to nearby hospital. He waited an additional 10 minutes before leaving.

Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of BNT162B2. 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.

Since the injection, I've had ongoing tingling and weakness in my arm. Unable to open a jar with my hands, which I could do previously. I feel a bit off and this has been going on since I received the shot 2 weeks ago. Concerned about getting the second dose, which is due 3/15 - I don't want these symptoms to worsen and need guidance.

After my vaccine, I went to the hospital because I experienced weakness some shortness of breath and some tremors. I am a doctor of training, one aspect the aspect of covid-19 affects testosterone. I got Covid after my first dose. I am still having some symptoms and scheduled to return back to work the third week of March 2021.

Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to observation area. I kept feeling more dizzy and started to feel tingly in my fingers and legs (both sides equally) After 15 minute observation time was over, I tried to stand up and immediately sat down again as a wave of dizziness hit me. Doctor in observation area saw me and came over. I told him how I felt. He put his fingers to my wrist and felt my pulse. It was initially between 40 and 90, then steadied off around 90-100. He called for EMTs on duty to come over with a stretcher because he thought I should be laid flat. The EMT took my blood pressure and it was 155/94. The doctor said at one point my pulse was thready. By this point the dizziness was stronger and I felt tingly in my teeth as well as other areas. I was asked about my breathing and I said that it was okay. An ambulance was called for and arrived. I don't remember the exact time. The moved me from the wheelchair to a stretcher. I could not stand up on my own and lurched toward the stretcher. I am grateful strong people were there to get me on stretcher and strapped in. All throughout this my normally barely noticeable Atrial Fibrillation was quite apparent and more erratic. This was a major reason for ambulance call. Some of the stroke protocol was done including gripping EMT's fingers equally and following his finger with my eyes. I was very cold throughout. I was brought to the waiting ambulance outside and driven to Medical Center. The EMT took an EKG which showed atrial fibrillation and a line was put into my arm. When we got to the hospital, I was brought into the triage area and had all my vitals taken. Blood pressure was high, so was pulse then for a half hour, I was very hot and sweated a lot after being cold.

12 hours after the second Covid 19 injection I got a severe debilitating migraine with chills. The migraine was the worst I have ever had in my life. It lasted for 10 hours. I have had migraine throughout my life but nothing this severe. I took Tylenol and used cold compress on my forehead.

62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had "pain all over". When she asked if it was chest pain, he said he didn't know. He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive. Wife called 911 and was instructed to begin CPR. EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol. Pt pronounced at 3:15 am. Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history. He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it. He refused to seek medical evaluation despite her urging.

he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 pm, by 310 he reported feeling weak with rapid pulse and heart fluttering. Gave water to drink, he declined food. 315 he felt hot sweaty and took off his overcoat. 325 said he felt better after drinking the water and declined to have his bp or pulse checked. Follow up phone call 3/14 to check on condition, said he felt ok after leaving pharmacy and has no allergies, no current illnesses and no vaccines within past month.

Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.

Several minutes after vaccine administration, patient was flushed and diaphoretic. No shortness of breath, No chest pain. No dizziness. Has history or DM and HTN. Denied nausea. PCP had changed his DM medication and he took the new prescription this morning. Felt better after 22 minutes and discharged home.

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

Left side of face from cheekbone to chin feeling like novacane wearing off - warm, tingly, slightly numb.

Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain

Severe grade v, Bell?s palsy on left face. Started 3days after second covid-19 vaccine. Patient has history of Bell?s palsy on the same side about 10years ago but had near full resolution with only mild facial asymmetry and eye lid droop prior to this. Patient sought care in our ER 3/24 and I did a video call with him 3/25 confirming severe left facial droop and inability to raise left eye brow or close eye, consistent with house-Brockman v Prednisone/valacyclovir initiated

Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Around 4 am the next morning, 2/8/21, he woke up and didn't feel good. Around 12 pm on 2/8/21 he reported feeling "weak" especially on one side of his body. His daughter said she took him to the hospital around 9:30 pm that night, after he continued to feel unwell throughout the day. At Hospital he was diagnosed as having had a stroke. He was admitted to the hospital and kept for observation for 2 days. When his daughter reached out to the patient's PCP to ask if he should get the 2nd Pfizer dose, she was told he should wait at least 3 months and advised to report his stroke to the public health department.

Cold sweats 64.5 hours later, causing fainting, followed by vomiting 6 times and diarrhea once. Recovered after 1 hour.

Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hours later, there was an episode of chills, accompanied by severe shaking. Face and neck became very warm and flushed. After about an hour, the episode ended, and even the long-lasting headache felt better. Have not had any adverse effects that were not known to be occurring in some after the 2nd Pfizer vax.

Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus." Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.

Patient experienced severe arm pain in his shoulder at 8:00am. Blood pressure at 8:00am was 151/80 (normal for patient) and heart rate was 79 beats per minute. At 8:15am pain was radiating down the patient's arm. At 8:40am the patient was feeling better and felt comfortable leaving with his wife because she is a nurse

Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder. started on 6th day with max pain on 8th/9th day. pain subsiding on day 10. treated with Advil/Acetaminophen Dual-Action and lidocaine medicated rub.

A few minutes after receiving the vaccine felt tongue "thickness" but only lasted about a minute. Then about 4 hrs later felt headache, dry throat and sore arm. At about 7 hrs after injection noticed pain in the left wrist, same side as vaccine. Went to bed and all symtoms were resolved this morning except sore arm.

1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slight fever within four to five hours of the shot. Later that night I noticed a decided lack of energy and some arm soreness at the shot site when I touched it. The chills and fever subsided after about two to three hours, but the rest of the symptoms continued until I fell asleep around midnight, which was about 12 hours after getting the shot. The aches, arm soreness and weakness all lasted for about a week afterwards, with the weakness being the last thing to go.

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.

Left arm, left eye/face numbness (front teeth and cheek numb) and some lightheadedness. Vitals: 02 sat 98% on RA, BP 122/70, HR 60. No rash, itchiness or wheezing. Throat/neck/thorax clear. Patient given 25 mg PO Benadryl and 20 mg PO famotidine.

Shortly after receiving vaccine, participant's wife summoned nurse, found him sitting in car with eyes open, but unresponsive. After approx. 30 sec. he was responding to questions; c/o feeling light headed, nauseated and had 'limited' vision. B/P 110/74, O2 sat 87%, HR 51. EMS arrived and assessed participant. Repeat B/P160/102 and BG 118. Due to cardiac hx., participant agreed to be transported to E.D. On 4/1/21 made a f/u phone call to participant and he stated that lab work in the E.D. indicated that he was anemic.

Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. 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. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.

PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.

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.

sore muscles. arthritis flare up Gout in my foot swelled up like a balloon (extremely painful). all symptoms are receding as of 4/2/2021 8:30

I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning inside out. I blacked out and woke 2 hours later with severe flu like pain in my entire body and a severe headache. I do not do drugs and I had no alcohol in the 3 days before I wa vaccinated. It is now 47 hours after the vaccination and I have moderate flu like symptoms.

Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to the left and couldn?t raise my arm. Had both shots in the left arm. Still have slight pain in those areas.

1. Ringing in both ears. Note: I have had very mild tinnitus for the past 20 years that comes and goes, but after receiving the vaccine, the sound became louder and as of this writing it has not stopped in both ears since 11:15, 31 March, 2021 2. Fiery nerve pain thought my entire body that reached pain levels of 8-9 that I have not experienced since 2016. Note: I have been diagnosed with Immune-Mediated-Neuropathy since 2016. Prior to the vaccine, I had pain levels 1-3, and only on parts of my body at times; mainly legs. However, about 45 minutes after the vaccine, my entire body lite up with fiery nerve pain thought my entire body.

This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3302, Expiration date: unknown) via an unspecified route of administration in left arm on 26Jan2021 at 14:30 at single dose for COVID-19 Immunization. The patient medical history and family history were none. No prior vaccinations within 4 Weeks. Current condition included, hypochondriac. History Of All Previous Immunizations was Not provided. Additional Vaccines Administered On Same Date Of Pfizer Suspect was reported as no. Concomitant conditions were not reported. On 27Jan2021 patient experienced sore arm, "more pronounced than normal flu shot" On 28Jan2021 patient experienced the events, "nose starting dripping/running", "eyes dry", "dry hacking cough". "sinuses swollen a little bit" the patient said that symptoms were similar to "cold symptoms" and still experiencing nasal drainage and "tickle in throat", "eyes dried out", Paranasal sinus discomfort. Nose dripping stopped after about a week and turned more into sinus pressure. Patient underwent lab test Swab COVID test on 01feb2021, results negative on 02Feb2021. No other testing since the COVID-19 Vaccine. His eyes are dried out and it feels like a cold that progresses into different stages. Arm soreness: lasted two day. More pronounced than flu shots he's received. Lasted through 28Jan2021. Tickle in throat with cough: Has a little tiny bit of irritation still. Not a constant cough. Is talking now and feels like he wants to cough, but doesn't. Nose is not dripping as much. Never been totally stopped up. Feels pressure underneath eyes. Adverse Events did not require Require A Visit To: no, it is just mild, but weird. Relevant Tests included Swab COVID test on 01Feb2021. Negative results came back on 02Feb2021. No other testing since the COVID-19 Vaccine. The patient did not received any treatment for these symptoms. Product Complaint was Yes. Not provided, if a sample of the product available to be returned. No information provided whether product Packaging sealed and intact. Outcome for all events were reported as unknown. No follow-up attempts are possible. No further information is expected.

8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp. 24 hours still was dealing with 104.7 temp - showers and cold compress with tylenol would bring it down, but would spike back up 36 hours temp of 101

After 17 hours: Uncontrollable chills, though temperature was only slightly elevated at 99 degrees. Malaise lasted 10 hours. Pain at arm lasted 40 hours. Slight pain with pressure continues now. (about 60 hours)

bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization. Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering. No treatment was received for the events. Information on the lot/batch number has been requested.

approximately 10 days post vaccine shot, onset of headaches and tiredness for two days. On the 12th day, I ended up with facial droop and being rushed to the emergency room. Ct. scan and subsequent mri ruled out a stroke and diagnosis after spending two days at hospital was Bells Palsey.

Patient seen at the Vaccination Center on 4/9/2021. He had just received his first dose of COVID-19 vaccine. He was feeling dizzy and felt like he was going to pass out. He was transported by EMT to the Adverse Reaction Area and then moved. Representative served as sign language interpreter via tablet. His wife was also present and is deaf. Patient stated that his heart rate was very slow, and he felt dizzy, hot, and sweating. He also fel very weak and it appeared that was going to pass out. He was also shaking. Ambulance was called due to the above symptoms. Patient also stated that he thought he may need to go to the ER. Vital signs: 9:53 am: Blood pressure was 143/71, heart rate was 71. Patient was given an ice pack. He also took sips of water. He then noted that he felt better, after laying down. Ambulance crew arrived and he declined to go the ER. He got up and walked around stated the he felt better. He notes that his head feels like it's slightly buzzing, so he lay down again. Vitals signs: 10:25 am: Blood pressure 138/63, heart rate is 64, temperature is 98.1 Patient felt better and noted no more buzzing in his head. He also walked around and felt normal. Patient notes that he blacked out as a child whenever he got shots/injections. He was not surprised that this happened to him today. He wanted to know whether he should get the second vaccine injection. It is recommended that he get his second vaccine injection and we also discussed that he may have the same reaction as today. He should allow for extra time and be well-hydrated. He felt safe to go home and his wife would be driving him home. Should he feel worse, then he should go to the ER. The patient and his wife understand this. All questions were answered.

Continued soreness in injection arm every day since first injection. Near-continuous cognitive befuddlement / inability to think clearly - only have had this before with severe sinus infection / head cold (I'm a practicing degree'ed engineer - very scary to me). Had a bout of "double vision" for approximately a minute - never had this before - another very scary thing. Two days ago experienced "highway hypnosis" - zoned out while driving for 10 minutes - lost time event / can't remember driving the route I did - never had this before - another very scary thing.

Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight) Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately) Overnight Tue/Wed upset stomach

About 1 day after vaccination, there was pain in the muscles around the right hip joint to the extent that I had difficulty walking up the staircase. It lasted for 2+ days and gradually diminished. Then, sporadic pains appeared in the right collar bone for a day, then in the left collar bone for a day or 2; and then intermittent ache in the left elbow and left hand; and then soreness in finger joints of both hands, especially in the morning; and, beginning 5 days ago and ongoing, RA-type pain is felt in the left shoulder, especially when I try to lift the arm or holding something with the left arm stretching out. this pain seems to be growing. Sometimes, tingling sensation in the toes and soles of both feet.

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.

My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt sick on Sunday the 4 of April at around 7pm he had a upset stomach. He got worse at night. in the morning Monday the 5 April we decided it was time to take him to the hospital. Due to the covid 19 restriction we were not able to go in with him He was stable until 1 pm when he suffered 4 heart attacks . He Died . He was healthy he exercise and was active every day . We were told to report this because it was close to dates of vaccination.

Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient started C/O SOB, Abominal Pain, and Weakness. Patient states that the SOB and abdominal pain were experienced prior to vaccinations but got worse. Patient shared medical history of CHF, DM and Hypertension. Patient requested to be transported to the nearest ER. 911 Called by writer. Pulse Ox 98%, RR 20, BP 130/80. Temp WNL. Patient alert and responsive oriented x3. Patient Transported to ER.

Stroke symptoms (numbness on left hand, then developed into loss of control of left hand and left leg, and also drooping of left side of face) showed up about three weeks after 1st dose of Pfizer COVID19 vaccine, and stroke occurred on 04/12/21 which is two days after the 2nd dose of Pfizer COVID19 vaccine.

Calf soreness; stiffness; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer reported for himself that: A 62-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:30 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity; drug hypersensitivity the patient's concomitant medications were not reported. The patient experienced calf soreness and stiffness on 28Mar2021 and the events were assessed as Non serious by health authority. and outcome of the events was Not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Sore arm later in day of injection; Slight fever; Slight fatigue; This is a spontaneous report from a contactable consumer(patient).This 62-year old male consumer(patient) reported for himself that: A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:45 as SINGLE DOSE, via an unspecified route of administration, administered in Arm Left on an unspecified date as an unspecified dose for covid-19 immunisation. Medical history included hypertension hypertension controlled with lisinopril, Allergic to penicillin. Concomitant medications included lisinopril taken for hypertension, the patient experienced sore arm later in day of injection, slight fever, slight fatigue on 30Mar2021 and The events were assessed as serious (medically significant) by health authority.outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

The next morning after first shot Patient stood up and fell. Due to brain stem stroke there are balance issues. Patient fell twice within first week of shot. He was extremely weak/unstable. He was starting to walk without his cane or walker. He could no longer walk on his own. He refused to talk because he was drooling all the time. There was little to no drooling before first shot. All the progress he made in the last 6 months is gone. He is just starting to feel like himself. Patient's second Pfizer shot was cancelled and will not be rescheduled.

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.

The patient passed out while sitting in the waiting area about 15 minutes after the vaccine was given. They were pale but became responsive very quickly after the fall. After about 20 more minutes the patient was able to stand up and felt "all better". The paramedics were called and assessed the patient before the patient left.

Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .

Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.

March 15th COVID shot. March 16th started to get severe dizziness and fatigue. Went to bed early. March 17th speech was impaired and difficulty with gait and balance. Admitted to MAMC ER, which confirmed a stroke and released. March 18th early AM admitted again to ER due to unable to move/walk. Due to lacking proper equipment and space was transferred via ambulance to hospital in March 18th until March 24 Obeservations Inpatient at Hospital. March 24 to April 16th Inpatient rehab.

Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.

Fatigue. Onset a few hours after the second shot and lasted about 36 hours. The fatigue was similar to that experienced when I had covid19 in March of 2020, but not as intense. Other information After the first shot I only experienced arm soreness in the arm that was injected. I was donating antibodies to the through about September/October 2020. I stopped donating for personal reasons, .

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).

Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.

Tenderness in left shoulder after first dose; This is a spontaneous report received from a contactable consumer (patient, self -reported). This 62-years-old male patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8727 and expiry date: Jul2021) via Intramuscular route, into left upper arm in the muscle, on 22Mar2021, at 13: 15 (at the age of 62-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 23Mar2021 at 02:00, the patient experienced tenderness in left shoulder after first dose. Outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

reported tingling in bilateral arms post vaccine , set of vitals were in normal range after comfort measures were taken discharged to home

pain in his left leg, very severe; he can hardly walk now; he could hardly stand on his feet for 5 minutes; 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 11Mar2021 (Lot Number: EN6205) (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril oral at 10 mg once a day taken for high blood pressure, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 18Feb2021 (Lot Number: EN6201) for COVID-19 immunization. The patient reported that he experienced: "pain in his left leg, very severe, he can hardly walk; he went to work, he could hardly stand on his feet for 5 minutes" on 05Apr2021. Caller stated that: "the pain goes from his ankle to his hip on his left leg". The patient due to the events visited the emergency department on 07Apr2021. Therapeutic measures were taken as a result of the events and included injection of some pain medication (not specified) but hasn't seen any improvement. The patient underwent lab test and procedure which included X-ray (left leg): unknown results on an unspecified date. The patient outcome of pain in his left leg was not recovered and unknown for the other events. No follow-up attempts are needed. No further information is expected.

felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spontaneous report from a contactable nurse. The nurse reported similar events for herself and her husband. This is the second of two cases. A 62-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril (manufacturer unknown) taken for high blood pressure, start and stop date were not reported (reported as for over 5 years). The patient did not have prior vaccinations within 4 weeks from the the COVID vaccine. On 10Mar2021, the patient felt funny in his chest, like a really weird, really warm and heavy feeling. The patient did not freak out and didn't want to appear weak. It lasted 5 minutes and then it went away. It was a warm feeling in the chest and not being able to breathe. The patient also had a sore arm on 10Mar2021. The outcome of the event felt funny in his chest, like a really weird, really warm and heavy feeling was recovered on 10Mar2021 and the outcome of the event sore arm was recovered on 11Mar2021. The event felt funny in his chest, like a really weird, really warm and heavy feeling was reported as medically significant. The patient received the second dose of the vaccine on 31Mar2021. Relatedness of the suspect drug with the reaction 'felt funny in his chest, like a really weird, really warm and heavy feeling' from the Primary Source Reporter (method of assessment) is unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Chest discomfort and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021408430 same reporter and drug, similar events, different patient

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

numbness + tingling in both fingertips. No redness, swelling, rash, hives noted. No CP, SOB, dyspnea, blurry vision, HA. A&O x 4, able to speak in full sentences. Refused transport. VS: 100 HR, 97% RA, 177/87 (noncompliant with HTN meds), BS: 96. Observed for 30 mins.

his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; This is a spontaneous report from a contactable consumer reported for himself. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller reports that his arm was going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling. Reporting that his arm was going through that constantly back and forth even when doing nothing reporting that at one point its good, then the next minute it felt like the circulation was off. The patient was asking if his symptoms are normal and if he should get the second dose with these symptoms. Patients query was responded as he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider would know his health situation and had access to information that could better help inform this decision.The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: Jul2021), via an unspecified route of administration at left arm on 12Apr2021 at 13:15 as single dose for covid-19 immunisation. Patient had historical vaccine first dose of BNT162B2 (at 62-year-old) lot number: ER8727, Expiration date: Jul2021 at left arm on 22Mar2021 for covid-19 immunisation showed tenderness in left shoulder. There was no patient medical history. There was no family history. There were no additional vaccines administered on same date of the COVID suspect. There were no prior vaccinations (within 4 weeks). No AE following prior vaccinations. The patient did not take concomitant medications. Patient experienced his arm is a little tender now on an unspecified date and received second dose that was clear on 12Apr2021. He received the first vaccination 3 weeks ago and this morning got the second vaccination. When he arrived, there was 30 minute delay. He saw the vaccines that were administered were transparent. It seems like it is not according to COVID standards. The person giving it said when it is diluted, it becomes transparent. He took it and is worried that it is not effective. The first dose was off white a little bit. It was not transparent and was exactly as described by the company. But now, it is transparent. He said that maybe they kept it too long outside, but they said it was correct. This same transparent one was given to several people before him. He did not provide any information on any others that had it. He wanted to know if that means it is not effective. They are doing it all the time. He later stated maybe the first one wasn't effective either. He just doesn't know. He later stated with the first dose, they knew what they were doing. He said he got the vaccine at pharmacy, does not have sample and didn't take photo. He thinks pharmacy did not dilute the vial correctly that's why it was clear, or they left it out too long. The pharmacy RPh told him they did it correctly. He doesn't believe it since the product is supposed to be off white after diluting. He did not see them do the actual diluting or shaking, just saw the vial sitting there. Site and PQM aware. He stated his arm is a little tender now and his temp is 98.4, it usually runs lower than that. He said he asked the company if he should get a third vaccine, he said they could not answer that. He said if anyone should know, its the company. Advised him to discuss his concerns with his doctor. No ER or physician's office visit required. The patient underwent lab tests and procedures which included body temperature was 98.4. Report not related to a study or program. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking fluids. Lasted about 24 hours; felt fine the next day. Note: no reaction to first COVID vaccine injection 3 weeks earlier.

Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms of some RUE tingling and R-sided facial tingling after RUE injection along with some neck tightness. The patient also reported mild generalized itching without rash, which he felt may be due to seasonal allergies. He requested 50mg oral Benadryl. Oral Benadryl given per request. Returned to baseline with monitoring.

I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R47.81 - Slurred speech R29.810 - Facial droop Z86.69 - History of Bell's palsy R51.9 - Headache"

Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep.; The pain runs to my chest and behind to the back of my ribs.; The pain runs to my chest and behind to the back of my ribs.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old male patient received 2nd dose of BNT162B2 (lot_number EP6955) on 25Mar2021 at single dose on Left Arm for COVID-19 immunisation. Medical history was heart attack and was hospitalized to rule anything out, Hugh blood pressure, Cholesterol. Historical Vaccine was 1st dose of BNT162B2 (Lot number=EN6199) on 04Mar2021 on Left arm for COVID-19 immunisation. No other vaccine in four weeks. Left arm is in a lot of pain. It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep. The pain runs to my chest and behind to the back of my ribs. I have a history of heart attack and was hospitalized to rule anything out. Events started from 08Apr2021. Events results in healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (3 days), disability or permanent damage. Treatment was Pain meds. Outcome of the event was Not Recovered. No covid prior vaccination. No covid tested post vaccination. No Known allergies. No follow-up attempts needed. No further information expected.

After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse. Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician. The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks. Being advised to move and rest moderately. Received again information about Deep Vein Thrombosis. Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021. Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check. Another blood clot had developed. Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks. Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave. Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.

fever, dizziness, lethargy, diplopia, and shakiness in arms. acute encephalitis. Intravenous immunoglobulins started 5/2-5/6. slow cognitive improvement. slow improvement in gait. Transferred to inpatient rehab.

Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!

Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams

Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COVID vaccine. Symptoms continued and worsened over next two weeks. Went to ER on April 11th, 2021, due to immense head pressure, BP over 200, and ringing in ears. My blood pressure and heart rate were checked at ER and were high, but came down after laying down for a while. I was given blood pressure medication, Amlodipine, 10 mg tablets. Medication had minor positive effects but symptoms continued to get worse. Returned to ER on April 14th, 2021. Same diagnostic testing was performed. I was given more BP medication and recommendations were made for how to lower blood pressure with diet and exercise.

I recieved the 1st shot at about 5:30 pm and by 10:00 am the following morning is when the symptoms started: head aches, nauseous (that lasted for 4 days), body aches. Hot and cold flashes followed by upset stomach and throwing up. Dizziness chills and trembling of the hands and then diarrhea (that lasted for about 8hrs or so); Sleep was internment for about 3 days and then the symptoms slowly started to fade. Taste for food and nauseousness (after I ate) last for about 5 days after the shot.

1st dose 15Mar2021; 2nd dose 01Apr2021; diagnosed with Bells Palsy; On Wednesday, 14Apr I started experience numbness to the right side of my face; 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 EP7534), via an unspecified route of administration, on 01Apr2021 at 16:30 (at the age of 62-years-old) as a single dose administered in the left arm for COVID-19 immunization.The patient's medical history was not reported. The patient has no known allergies. Prior to vaccination, the patient had not been diagnosed with COVID-19. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205) in the left arm on 15Mar2021 at 16:30 (at the age of 62-years-old) for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID vaccine. The patient stated that on Wednesday, 14Apr, she started to experience numbness on the right side of her face. She went to the ER and was diagnosed with Bell's Palsy. The patient experienced diagnosed with Bell's Palsy on 14Apr2021 at 16:30 with outcome of recovering and "numbness to the right side of my face" on 14Apr2021 at 16:30 with outcome of recovering. Therapeutic measures were taken as a result of Bells Palsy and and hypoaesthesia and included the administration of prednisone (not further specified). It was also mentioned that since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

severe cramps in calf's and thighs; cramps as bad as bruises and calf's bruise; This is a spontaneous report received from a contactable consumer (patient). This 62-year- old male patient received his 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 09Apr2021 for Covid-19 immunization. Medical history included anxiety. Concomitant drugs included cariprazine hydrochloride (VRAYLAR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clonazepam for anxiety. Patient had been having severe cramps in calf's and thighs in Apr2021. Patient had a shot on "Friday" and it started "Tuesday" (also reported as "may be 12 or 13Apr") night. Patient had been having cramps as bad as bruises and calf's bruise and the muscles "that are lined". No treatment received. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Took covid vaccine on 1/26/2021 first dose with reaction of fever on post vaccine day 1 and 2 and cough starting 3 days ago Fever free for last 24 hours . Last fever was 1/27/2021. Dizziness today for 4-5 mins ,non since . No rapid or slow heartbeat, chest pain or other sx Tingling of both upper extremities. Feels like the world is spinning around him. Also gets some tingling in hands and arms which is mainly on the left. Feels some spasms and body aches. Legs hurt at times. Feels like he is out of his skin..

7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ... A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...

Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.

He has been having diarrhea for the past 2 weeks ever since he received a second Covid vaccination he has been increasingly weak and could barely make it into the pulmonary function lab. At the pulmonary function lab, he was found to have new onset atrial fibrillation and worsening hypoxemia from baseline. Taken to ED from the lab on 5/12, found to have right middle lobe and right lower lobe consolidation and ground glass changes. Admitted. Conditioned worsened, respiratory acidosis and shock, started on biped and pressors. Taken to ICU. Found to have RV failure. Today he was intubated.

it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown. Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts. Information about lot/batch number has been requested.

Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient went to observation area where they felt fatigue, sweating, and clammy. Patient alerted nurse they were not feeling well, and nurse noted patient was breathing fine. No rapid response was called, however patient was sent over to ED with wheelchair. Patient appears stable, but is being worked up in ED now.

Started getting muscle twitch in right side of neck and shoulder. It lasted from minutes to hours. Doctor suspected pinched nerve and recommended physical therapy. Started PT 4-28. Neck muscle twitch stopped after 2nd PT session on 4-29. Completed PT on 5-20. I am now getting muscle twitches in my back, left arm, left hand and left eye. The twitch is random and lasts about one to two minutes. As of this date (5-23) it has not resolved.

4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squeaking sounds 3 different occasions. Thought I might have an ear infection and called Teladoc was prescribed Oxi Clav 825 mg . 2x day. 4/25-4/26 significant temporary loss of control of left arm and left leg felt wobbly but intensity subsided to minor loss of mobile control.4/27 Left leg went totally numb from the knee down with no control couldn't wiggle toes , Left should went numb 2x left face went numb 1x Stroke, total blockage of left corroded artery

Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infection Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All Assessment/Plan TENT. 1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees. If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone. Diagnoses and all orders for this visit: COVID-19 virus infection - CBC; Future - Comprehensive metabolic panel; Future - CT angiogram chest pulmonary embolism with and without contrast; Future Fatigue, unspecified type - CT angiogram chest pulmonary embolism with and without contrast; Future Other chest pain - CT angiogram chest pulmonary embolism with and without contrast; Future Tachycardia - CT angiogram chest pulmonary embolism with and without contrast; Future

Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.

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

This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262) dose 1 via an unspecified route of administration on left arm on 26Jan2021 at single dose for covid-19 immunization. Time the vaccination was around noon. No prior vaccinations within 4 weeks. Medical history included ongoing blood pressure high. Concomitant medications included metoprolol 50mg once a day taken blood pressure from an unspecified start date ongoing. On 27Jan2021, Wednesday he started to feel pain in his arm which he knew was normal. But now he started to feel his temperature rise and usually takes his temperature every day as he works with the fire department. On 28Jan2021, Thursday he started to notice the rise in temperature. Then it was kind of within normal, but it was 98.4. However, this morning when he took his temperature it was 100 degrees. His usual temperature was between 97-98 degrees. He also had a cough last night and did not had the cough this morning. More, or less the main thing bothering him is the temperature. He has taken some Tylenol 500mg. He stated he does not know if he should be taking Tylenol. He was drinking more tea, coffee, and juice. The pain in his left arm was not immediate and was delayed. He does not know what time it started, but it was early in the day. He was coughing last night but he was not doing it on a consistent basis. Later he was doing it all day but did not know what time it started. He said as pretty much has subsided, no additional details provided. The patient underwent lab test which included body temperature resulted as 98.4 on 28Jan2021 and on 29Jan2021, body temperature resulted as 100. The clinical outcome of the event pain in arm and cough was recovering and the clinical outcome of the event rise in temperature was unknown. Follow-up attempts are completed. No further information is expected.

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.

Eyes open in fixed stare for approximately 30 seconds. Would not respond verbally. Was pale and skin clammy. Cool cloth to base of neck. Waiting in personal van with passengers seat partially reclined. Back to normal state by end of 15 minutes wait. VS were BP 97/66, pulse 57, pulse ox 97% Held for additional 15 minutes to further monitor. Was able to lay down for first Covid vaccination and had no adverse reaction(s). States his mother also reacts porky to any injection.

I received my first vaccination on March 24, 2021 at 9:50 am at Hospital. Within 24 hours I started to get migraine headaches. I never have gotten migraine headaches. The migraine headaches never went away. After several weeks I contacted my doctor. He prescribed migraine medications. The first two medications didn?t work, the third helped. I had taken them for about two weeks and thought I would try to go off of the medicine, no luck, the migraine continues to exist. It?s been over two months. I finally had a MRI which came back negative. I really need some answers to try to figure this out. I had never had migraines in my life and now I have a constant migraine all the time. Looking for solutions not medications. Thank you.

pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.

shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event shortness of breath cannot be excluded. The 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.

Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Apr2021 16:30 (at age 62-year-old) (Batch/Lot Number: EP7533) as 1st dose, single dose for covid-19 immunisation. Medical history included neurofibromatosis from an unknown date and unknown if ongoing. There were no concomitant medications and no other vaccines received in four weeks. The patient experienced Bell's palsy on 23May2021 08:00. Prednisone and Valtrex was given was treatment. Outcome of the event was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.

Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), severe cranial pain/headache, open sore in esophagus/lower throat that prevented eating solid foods for 10 days and liquids for at least the first week, even water. Painful area surrounding sternum (uncertain if it was from the vomiting action or possibly heart damage), which also prevented food or liquid to pass down the throat due to spasms, localized pain and possibility of inducing vomit reflex. High blood glucose (ketoacidosis). General overall weakness/lack of energy. Loss of mucous in nose, throat and stomach. Loss of saliva in mouth for first week. Insomnia. High blood pressure.

Belle's Palsy, Left side of face. Treatment Anti-Viral and Prednisone. Has not normalized to date.

Arm hurt a little; This is a spontaneous report from a contactable consumer. A 62-years-old male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date and NDC number were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On an unknown date, the patient reported that his arm hurt a little bit after first shot of vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain. 7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc. The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced. Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between. By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.

AT about 11 pm I got up to go to bed, and all of the sudden I felt like I was freezing and shaking violently. I couldn't even hold my phone to call 911. I passed out. I woke up about 3AM on the floor. I was shivering. I got to bed, called my girlfriend, then fell asleep. The next morning it felt like I had COVID again, I had COVID back in December. I called the doctor, and they if I experienced it as bad as the night before then I should go to the ER, otherwise stay in bed, rest, and drink fluids.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; 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: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.

Two days following vaccination, I began to experience at random a pronounced tingling sensation along the path of the nerve in my right arm EXACTLY where I had presentation of shingles three years prior (mild case, limited to right arm). Each presentation of tingling lasted only a few moments to perhaps 30 seconds; it was NOT painful at all, and it was NOT debilitating in any way (did not interfere with function of my arm). Presentations occurred usually hours apart, initially experienced perhaps 4 or 5 occurences during waking hours. Over the next three weeks (prior to my second shot on 5/20/21), presentation of tingling sensation abated in degree and frequency; however, even up to this date (6/17/ 21) I experience SOME tingling from time to time.

As soon as she did the injection I can feel the med going into my arm and it started tinging and I stayed for the 15 mins and then my hand and arm started feeling numb. During the 15 mins I was waiting I ask the guy do this suppose to happen and he said that after the 15 min way, it should go away. An then the next day my hand was still hurting and the next I called my PCP and said, nothing that we can do. An then I waited and I called a doctor friend at Clinic and take Claritin because it was itching and so he said to try calamine lotion. It seemed to help but I would still have the numbing feeling. It felt like nerve damage. So I called Dr. and she gave a prescription for Betamethasone Dipropionate cream USP (Augmented). It has helped but it is still there on my arm. I can only use it for 2 weeks. It has only been a week. So, we will see what happens.

Pain in finger joints when waking up in the morning. My wife got the vaccine the same day and we both developed the same finger joint pain

Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy. Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.

numbness in left toes - mainly middle toes; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration into left arm as first single dose for COVID-19 immunisation on 18Mar2021 at 10:30 (at the age of 62 years). Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient had allergies from dust mites and grass. Concomitant medications included nexum (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, floranase (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, florachrome (MANUFACTURER UNKNOWN) for unknown indication started from unknown date, alegra (MANUFACTURER UNKNOWN) for unknown indication started from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 16:00, the patient experienced event numbness in left toes, mainly on middle toes. The clinical outcome of the event numbness in left toes was not recovered at the time of report. No follow-up attempts are needed; information about lot number cannot be obtained.

I had pain in my injection site and it has subsided but literally for 4 months from march until early June I had pain at the injection site. I had an acupuncturist come and massage the injection site. I went to my doctor and she took an MRI and my whole left hand tingles. I still have a slight tingle now. I had to get a pain killer because I had to take the MRI and I lay on my left shoulder and I could not move but it was painful so I took the pain killer. As the pain has subsided the tingling has increased. What my doctor said is that I was injected in my rotator cuff.

chest heaviness/discomfort/ dull pain next to left arm till today no treatment usually constant discomfort till today

On the left side of the callers face down to his chest, pain and itching and burning and a rash. The caller went to the ER and the doctors gave benadryl and cream and said it was an allergic reaction. there is still a rash, and it is burning and painful.

Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination. Information about lot/batch number cannot be obtained. No further information is expected.

Exacerbation of MS Symptoms. Including nerve pain and Cognitive difficulties along with heavy fatigue.

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

left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after injection.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 12:00, (at the age of 62-years) as single dose for COVID-19 immunisation. Medical history included C5, C6 quadriplegia and spinal cord injury in 1977. The patient did not have 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 received other unspecified medications within two weeks. The patient experienced left leg and foot have tingled, felt semi-dizzy after the injection, and I had an involuntary bowel movement moments after injection on 17Mar2021.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 treatment for the reported events. The clinical outcome of left leg and food had tingled, felt semi-dizzy and had an involuntary bowel movement was unknown. No follow-up attempts are needed. No further information is expected.

faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. 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 did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.

63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and intolerance to exertion that has become steadily worse despite supportive therapies. He reportedly completed outpatient ABX from PCP within the past 2 weeks and suffers ongoing deterioration of his breathing accompanied by night-sweats, chills and fever. 1st Vaccine on 5/27/21, 2nd 6/17/21. hypoxemia secondary to large left sided pneumonia.large left sided effusion with compressive atelectasis and question of infectious vs malignant origin.acute hypoxemic respiratory failure requiring HFNC. Patient admitted to the ICU on our service for ongoing care.Hospital Course:Mildly elevated BNP and non-diagnostic EKG.Findings consistent with bilateral pneumonia, large left complex parapneumonic effusion versus empyema with compression of left lung and evidence of external impingement on LV. Systolic blood pressures ranging in the 80s to 90s with MAPs ranging from mid 60s to mid 80s with heart rates in the 90s, which may be attributed to diminished LV filling. Transferred 6/26/21.

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

2nd vaccine- 01-04-2021; initially started to feel loss of appetite, a lot of weakness and just feeling sick. I got to the point where I could not sit in my wheelchair, literally had no core strength in me. I went to the ER and they gave me a rapid swab for covid. They decided to do blood cultures, were getting ready to plasma when an infectious disease doctor came in and said to that I did not have covid but rather a UTI and my UTI went into sepsis. I was hospitalized, 2 ½ months. I believe that this started with the Pfizer vaccine. I also went to a rehab place to regain my strength. I continue to have today with weakness to my body and struggle with core strength. I do not have lot# to provide.

Bells Palsy diagnosed at Emergency Room Paralysis of right side of my face Pain behind my ear Woke up at 5am on July 4 and my eye wouldnt close. Looked in mirror. Right side of Face was drooping and I couldn't

Aching; Muscle Cramps in Left Arm; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via unspecified route of administration in left arm on 19Feb2021 at 23:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and also received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via unspecified route of administration in left arm on 14Mar2021 at 12:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient medical history included ascending aortic aneurism, high blood pressure and high cholesterol. The concomitant medications included metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) for an unknown indication. The patient had no known allergies. 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 had not been tested for COVID-19. On 21Feb2021, the patient experienced soreness, aching, muscle cramps in left arm. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events soreness, aching, muscle Cramps in left arm were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

Violently Sick; Throwing up/ Violent vomiting to Biel for 6 hours straight; cannot drink fluids or foods for 12 hours plus.; Chills; Joint pain; barely able to move or walk; Fever/Fevor 101; barely able to move or walk; Muscle pain; Nausea; Feeling unwell; Injection site pain; Tiredness; arm pain; Headache; injection site redness; injection site redness & swelling; He has minor discomfort; Diarrhea; 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: EW0180), via an unspecified route of administration, administered in arm left on 02Jul2021 at 10:30 AM (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included valtrex for infection in right eye, known allergies: mold, mildew, blue grass, dust, mites, cockroaches (start - 10 to 15 years). The patient concomitant medication included valaciclovir hydrochloride (VALTREX), allergy shots taken for allergy (patient stated it changes based on vials). Patient did not receive any other vaccine within 4 weeks prior vaccinations. Patient was not diagnosed with COVID prior vaccination. Patient was not tested COVID post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Jul2021 at 05:45 PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced he has minor discomfort, diarrhea on an unspecified date in 2021; injection site pain (the date patient received the vaccine), tiredness, arm pain, feeling unwell (subsided from feeling violently sick yesterday), headache, injection site redness, injection site redness & swelling on 02Jul2021; nausea on 04Jul2021; violently sick (It started at 5am (67 to 68 hours after vaccination). It has mostly subsided, gone away. Patient stated he has recovered with lasting effects because he was so beat up from throwing up) on 05Jul2021 at 05:00 AM, throwing up/ violent vomiting to biel for 6 hours straight (at 5 or 6 am yesterday. It lasted around 6 hours until noon), cannot drink fluids or foods for 12 hours plus, chills (around 5 or 6 am), joint pain (5 to 6 am), barely able to move or walk, fever/fever 101 (5 to 6 am, patient temperatures are normal now), muscle pain (around 5 or 6 am) on 05Jul2021. Adverse events did not result in emergency room, physician office visit. Adverse event: 12 of the 17 listed side effects on fact sheet revised 10May2021. injection site redness and swelling, arm pain. Feeling unwell, off. Joint and muscle pain, barely able to move or walk. Chills & Fevor 101. Violent vomiting to bile for 6 hours straight. cannot drink fluids or foods for 12 hours plus. Patient is calling about the vaccine, stated covid 19. He got the vaccine, his second shot and had a reaction that is on the paperwork. The patient underwent lab tests and procedures which included fever was 101 on 05Jul2021. The patient received tylenol, advil and pepto-bismol as treatment medication for the events joint pain, nausea, headache, fever/fever 101, muscle pain. Outcome of the events violently sick, feeling unwell, he has minor discomfort, diarrhea was unknown; tiredness, arm pain, cannot drink fluids or foods for 12 hours plus, joint pain, headache, injection site redness, muscle pain was recovering; injection site pain, throwing up/ violent vomiting to bile for 6 hours straight was recovered on 05Jul2021; chills, barely able to move or walk, nausea, injection site redness & swelling, fever/fever 101 was recovered on 06Jul2021. Follow-up (PRD/SRD 08Jul2021): Follow-up attempts are completed. No further information is expected.

Leg pain, hips and waist later moved into shoulders and arms Dr. visit June 2021 PMR returned and diagnosed July 2021

About 2 weeks after vaccination received, patient states he began to have more fluctuations in his glucose levels as well as heart palpitations. Reports that his glucose levels do not generally go above 180. As glucose levels kept increasing, patient began exercising more. In early July, started to have levels in the 400s. Started to feel more dizzy & weak and had polydipsia and increased frequency of urination. He went to the Emergency Room on 7/8/2021; glucose level was 373. He was given IV fluids and 6 units of regular insulin. Glucose level came down to 252 prior to being sent home and instructed to follow up with his Doctor. Patient had follow-up labs on 7/12/2021, which show hemoglobin A1c of 10.0% and glucose level of 272. Prior to vaccination, patient's hemoglobin A1c was 6.5% and glucose level 135 on 1/29/2021. Historically, this patient's A1c has been between 5.3 and 6.5 since 2014. His BMI is 28, actively exercises and has been adherent to his diabetes regimen of metformin 500mg twice daily.

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

Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest

I had a very small, left sided C5 dermatome breakout of a rash that appeared to be herpes zoster (shingles). I?ve never had a rash like this before. It?s now been 2+ weeks and is fading, leaving me with mild burning and itching in same area. I went ahead and had 2cd dose on 1/7/21. FYI: I?m an Emergency Physician myself.

COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "COVID-19 PCR test/he was positive per the PCR test" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded

About seven hours after I received the second vaccine I had migraine headache foggy feeling in my head a little bit of achiness, same thing the following day not as bad. Two days after the shot I am feeling fine

Progressive symptoms of mild itchyness of skin all over body on first day to painful pin and needles sensation with continued itching over entire body only occuring at night by day 7 . Symptoms are temporarily relieved with zyrtec and famotidine. Symptoms are ongoing and getting progressively worse each night. No rashes are observed so far. Headache and severe dizziness with nausea were experienced on day 4 but only lasting 4 hrs.

Severe join Pain/ all over/ groin pain/ muscle pain/ night cramps/headaches/ injection pain/ feel unwell/ like sinus infection/ fatigue/ fall asleep midday. 3 weeks later. Still have some body pain/ still fatigued/ unwell and headache. Dizzy sometimes. Not my normal/ alert athletic self. Haven?t felt like exercising since took shot.

Sore arm on day of vaccination (dose 1); This is a spontaneous report from a Non-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 08Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced sore arm on day of vaccination (dose 1) on 08Jan2021. The event happened on Friday, 08Jan the patient became aware on the evening of Friday, 08Jan. He reported the event on Saturday, 09Jan using the information he had received on the 8th (He did not receive further information on the 9th). The most recent COVID-19 vaccine was administered at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pt awoke multiple times in the early morning sleeping period profusely sweating and needing to change of clothes, sheets/blankets and undergarments at times 1:00AM, 3:00AM, 5:00AM, fever, headache. Symptoms have improved with Panadol medicine dose. Pt states since 1st dose feeling of drunkenness' and imbalanced has persisted.

Severe shoulder ache followed by muscle tightness in neck, lasting several hours. On subsequent days muscle pain continued sporadically in neck, mid-back , and chest. Hot/ fLushed feeling accompanied back and chest pain but no elevated temperature was observed. On day 5 the left shoulder pain returned with a vengeance for about 4 hours, centered at the injection site.

Change in taste (not loss of) in food, coffee, and alcohol. Foggy sensation in head. Increase in metabolism leading to being warm all the time ( no sweating). Two weeks after second vaccine and while experiencing the above symptoms, I had sudden palpitations with a rapid ventricular response ( 186 beats per minute), severe light headedness, ambulance transport to hospital leading to admission for two days. This has never happened to me or any family members before. Discharged from hospital after 2 days in normal rhythm. Also at this time, taste has returned to normal and foggy feeling has improved.

left sudden sensorineural hearing loss , ear numbness. symptoms began 48 hours after vaccination. Treatment began 3 days after onset of symptoms and included high dose prednisone and trans-tympanic dexamethasone shots. The patient partially recovered after 3 weeks of treatment.

After receiving first dose of covid vaccine and sitting the observation area, patient complained of a tingling sensation around his lips. The observation nurses continued to observe him, and a few minutes later he developed numbness on his nose, followed by a dry cough. Within a few minutes his lower lip started to swell. Patient showed no signs of respiratory distress, and was alert and oriented. He was then escorted by RN in a wheelchair to the ED for evaluation

strong shaking; teeth chattering; temperature went up to 101; consumed very little food in 48 hours; This is a spontaneous report from a contactable other-HCP, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3249), via an unspecified route of administration on 16Jan2021 at 08:45 (at the age of 63-years-old) as a single dose, in the left arm for COVID-19 immunization. The patient has no relevant medical history, no known allergies and no prior vaccine reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen at an unknown dose, for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jan2021 at 10:45, the patient experienced strong shaking, teeth chattering. On 16Jan2021 the patient experienced fever up to 101 and on an unknown date in Jan2021 the patient experienced consuming very little food. The patient did not receive therapeutic interventions for the events. The patient described the clinical course as follows: two hours after vaccine administration the patient experienced strong shaking and teeth chattering as would be normal for influenza or Noro Virus per patient. The patient's temperature went up to 101 and the patient was in bed with fever for 40 hours, the patient consumed very little food in 48 hours, and maintained fluid intake. The patient reported he had no nausea, no diarrhea. The patient stated it was unpleasant to the point of not being to do anything but lay in bed. Then, at about 40-48 hours temp was gone, and the patient felt very close to normal and the patient resumed eating. The clinical outcomes of the strong shaking, teeth chattering, temp went up to 101 and consumed little food were recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

fatigued and tired; weak; This is a spontaneous report from a contactable consumer (patient's wife). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (arm) on 19Jan2021 at single dose for Covid-19 immunization (also reported as Covid protection). The patient has no medical history. The patient's concomitant medications were not reported. The reporter confirmed that the patient does take other medications, but they never make him tired or weak. The reporter also confirmed that the patient did not receive any other vaccines on the same day as the COVID vaccine. It was reported that the patient took the Covid 19 vaccine on Tuesday (19Jan2021). The patient was fatigued and tired on 21Jan2021. It was further reported that the patient was tired and weak on 21Jan2021. The reporter added that that she knows tiredness and weakness are known side effects of the product, but she wanted to know how long after they get the vaccine those side effects last, and to what degree do they occur. The outcome of events was unknown.

Morning after Could not go to work And I have worked 30 years without one sick day. Low grade fever in am with shaking but not cold. Started around 6 AM by 9 AM couldn't stand very weak slightly lightheaded Threw up till almost choking. At noon my temp hit 103.7 Took tylenol all AM and wasn't lowering temp. That was the highest temp Then gradually began to come down At 5:00 PM temp at 100 and able to put soup down. Woke up 4 AM next day in total sweat that had to move to other side of bed Soaked but felt OK On 23rd Got headache above right eye to side of frontal lobe, Not any strong headache at all Dull Like a 2 out of 10. My concern is I still have the exact same headache as I did three weeks ago Not a smidgen lower at all SAME. And I booked second vaccine for Sat 2/27th I am concerned as I have heard second can be worse. I have never had the flu and this was my first ever vaccine of any kind Please advise

Pain in left arm/ runs/ cotton mouth/ Very poor ability to sleep for everyday after/some light headed/ cough / chills/ shakes/ extremely warm/poor appetite

Client stated feeling warmth and flushed face after receiving Pfizer Covid-19 vaccine, dose. Client was sitting in post vaccine waiting area. At 1023 EMT noticed client appeared uncomfortable in chair and asked how we was feeling. Client stated feeling warm and EMT saw face was flushed. PHN was alerted. When PHN arrived, client was sitting near doorway, face flushed, and was speaking with EMTs. Client alert and oriented, stated feeling warm and sweaty. EMT assisted client to remove jacket to take vitals. 1027 vitals:blood pressure 145/90, pulse 66, o2 97, respirations 16. Client denied shortness of breath, chest pain, dizziness, headache. Flushed face, did not radiate past face, no swelling noted or rash. Allergy to penicillin and client was already aware to wait 30min after vaccine. Per client did not take blood pressure medication this morning. List of medications: allopurinol, toprol, pantoprazole, colchicine, lasix, potassium, crestor, vitamin D, praluent, eliquis, spironalactone, nitroglycerin and hydrocodone. Client given water and instructed to take small sips at a time. Client informed he would be observed for 30 minutes. Vitals 1034: blood pressure 150/70, pulse 60. Flushed face same, not improving. PHN offered client if he would like benadryl, client denied. Vitals 1040: blood pressure:130/90, pulse 61, o2 95 , respiration 16. Client stated symptoms improving. Last set of vitals at 1053: blood pressure 120/80, pulse 60, o2 95, respiration 18. Client alert and oriented, stated warmth feeling improved, face still flushed, not worsening. Client advised to speak with provider prior to receiving second dose. ER precautions given, wife driving client home. Client left facility with steady gait.

Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; 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 and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events. Information on lot number/batch number has been requested.

On date on second dose, 2/27/2021, the pt began have fatigue and diarrhea at around 10:30 am. This continued to the following day. On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence. She found him unresponsive at 5:30 pm in their bedroom. EMS was called and the decedent was declared deceased. The pt had his first dose on 2/9/2021. Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose.

Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 63 years on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue on 29Jan2021 (not sure if related) and sore arm on 30Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date. Information on lot/batch has been requested.

The vaccine was given in the left arm. The left arm began to tingle and get heavy as expected. However, during the 15 minute waiting period after receiving the vaccine, the left side of my face began to feel ever so slightly thick and numb. It felt as if I had been to the dentist for a filling a hours ago. I never lost speech or had a discernable facial deformity, but the numbing caught me off guard. The facial feeling faded in about the same manner as the arm recovery.

Headache--2 days Diarrhea--6 days Fever--1 day Weakness--4 days Fatigue--4 days Arm pain--2 days

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.

Received second dose of vaccine on 2/19. presented to this ED on 2/20/21 with generalized weakness.

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.

body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever; mildly sore arm; Bad prostate and bladder infection; Bad prostate and bladder infection; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team and Pfizer-sponsored program COVAX US Support. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ lot number: EL9269, Expiration date: Unknown, NDC number: Unknown), via an unspecified route of administration in left shoulder area on 08Feb2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included ongoing asthma for about 60 years, ongoing high blood pressure for about 3 years and was on blood pressure medication, issues with thyroid for about 3 years and was on thyroid medication (ongoing). Concomitant medication included ongoing thyroid medication. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient experienced bad prostate, bladder infection, sore arm on an unspecified date in Feb2021. On 11Feb2021, the patient experienced body aches, feeling worse, shivers, headache, mild fever. It was reported that, caller received his first dose of bnt162b2 on Monday 08Feb2021. He's reporting adverse events and would like to know: If he takes Tylenol to treat his symptoms, would it decrease the effectiveness of the vaccine or not. Also, if he were to go for a COVID-19 viral test, would the fact that he was received the vaccine interact with the test and cause a false positive result or not. Patient was reporting that yesterday, day 4, he started with body aches, headache, and "when he got in bed, he had chills and shivers real bad, little chilly" so possibly a mild fever. Enquired could these all be side effects of the vaccine or not. If he go for the COVID test - would it be positive or not. He also states he has a history of asthma and has been hypervigilant about avoiding COVID infections. Caller, reporting on the COVID vaccine and who explains that he got the first shot on Monday and he had a mildly sore arm- this lasted 2-3 days, no big deal. Then 5 days later he had really bad body aches and a headache. He went to bed cause he was feeling worse but before going to bed he noticed he had shivers really bad, uncontrollably almost which lasted over an hour. He presume they are fairly normal side effects but wants to confirm this could happen after five days. Also, he was told not to take Aspirin or Tylenol before getting the vaccine because it could affect the efficacy, but he wants to know could he take a Tylenol now 5 days later for the headache and body aches. He was better now than he was doing. Caller clarified the event was 4 days after the shot, the shot was Monday and events started Thursday. On Thursday evening, 11Feb2021, was when he had the bad body aches, headache, and shivers. At this point he still has the headache and body ache. He felt like, last night, he had a fever, but he didn't check it. At the same time, he had the chill and the shivers. Those feelings were resolved by this morning. Caller received COVID vaccine on 08Feb2021-Internal Infection-Bad prostate and bladder infection. Adverse events did not require visit to emergency room and physician office. No relevant tests. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the events mild fever, feeling worse, bad prostate, bladder infection was unknown, recovering for body aches, headache, recovered on 12Feb2021 for shivers, recovered on an unspecified date in Feb2021 for sore arm.

I was engaged in moderate physical activity for about 2 hours when I suddenly became very weak. I stopped working and took a shower. Within an hour I started having severe cramping around my chest and torso that last about 24 hours. Since the second day, I haven?t been able to be active without starting to sweat and suddenly feeling weak and having to sit down. Even repotting a plant this morning started symptoms in minutes. I also have been experiencing dehydration since the day of the injection.

First: Site swelling & pain (about a week - 03/04 to about 03/10/21) Second: Headache, muscle pain, joint pain, tired (started day after - 03/05 to 03/06/21 - about 1-2 days) Third: Serious pain in left arm (mid-upper arm & lower arm down to the hand). Bones hurt, muscles hurt, and joints hurt. Rash on upper and lower left arm. Sensitive to touch and slightly red. Serious diarrhea just after arm started to hurt. (started 03/17/21). Still on-going.

numbness and tingling in left hand diarrhea , fever chills nausea vertigo malaise increased heart rate decreased 02 stat

difficulty speaking... hesitancy. Fuzzy thinking. Dizzy. Achy. Laying down and watching TV was about all I could do. constipated Started when I awoke and was mostly done by 5 PM The next day I spent quite a bit of time on toilet.

Vasovagal, vitals normal after oral fluids but patient felt weak, flushed nauseated. Drove himself and did not feel comfortable driving home. Asked that we call ambulance

Developed Bells Palsy, Right side 5th cranial nerve affecting the motor branch. No muscle movement from the top of head all down the right side of face. Numbness feeling all in cheek. Right eye does not open or close, cannot raise eyebrow, right side of mouth is drooping. No muscle movement at all - paralysis of right side of face from top of the head to the jaw.

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.

Patient experienced tingling down right lateral arm immediately following vaccination, symptoms had already started to resolve by 20 minutes, reassuring physical exam, no medications given

About 18 hours after my 2nd Covid vaccine I had trouble swallowing, The liquid would come out the left side of my mouth and I couldn't control it. The next day my left eye hurt and would not stop watering. Yesterday it was worse, I had a crooked smile and more severe eye pain and watering, Went to Urgent Care and after ruling out a stroke I was diagnosed with Bell's palsey. I have not been diagnosed with Bell's in the past.

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

Within a few hours I experienced some tingling in my right leg. By the next day I had bad sciatic pain which continues. I have not had any pain like this in several years.

on 3/16 client had fever to 100.4 with severs shakes. Ambulance called next morning 3/17. Patient had confirmed diagnosis of EColi infection and was treated and discharged 4 days later

Approximately 5-10 minutes after first covid vaccine, patient was witnessed to become pale, eyes roll in the back of head, become stiff, and fell backwards in chair and onto floor. Patient hit back of head after fall. Patient was laying supine on floor and lost consciousness for approximately 30-60 seconds. He did not respond to name or place when asked. He had a strong pulse and was diaphoretic. After approximately one minute, patient opened eyes and stated his name and where he was. During this event, Code Medic was called by another staff member. Patient continued to talk to writer while waiting for code team to arrive. He stated that he had no pain and was starting to feel better. Report given to code team and care transferred. Patient taken to ED for further evaluation.

could not move; fever went to 102.3; shaking so bad; my legs felt like rubber and every time i would try to get up i would fall down; terrible pain; serious discomfort; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer reported that he received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6208) on 15Mar2021 02:00 PM at right arm for COVID-19 immunisation. Medical history included kidney disease, known allergies: Penicillin and high blood pressure. The patient had received other medications in two weeks. The patient reported everything was going great. He took a nap 15 hours after shot, woke up hour later and could not move. Fever went to 102.3 and he was shaking so bad and his legs felt like rubber and every time he would try to get up he would fall down. He was so scared he called somebody to come be with him, things got better about 28 hours of terrible pain and serious discomfort. He was in such pain and he need to know if he should arrange someone to be with him for second dose. Event onset date was reported as 16Mar2021 10:00 AM. The event resulted in: Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment was received as paracetamol (TYLENOL EX). Outcome of the event was not resolved.

10 minutes after received shot, left arm went numb, then both arms turned blood red. Two hours later had H/A, fever, chills, increased heart rate, 102.8, nauseous, caused UTI. Wife had to help him get into the car due to feeling of illness. No shortness of breath or difficulty breathing

mucsle aches, nausua, night sweats, chills, cough, major fatigue had 2 telehealth conversations with 2 drs through primary care In the meantime doctors encouraged and strongly supported receiving second vaccine - symptoms continues and primary care presecribed antibiotic (arithomiziathan) or possible pneumonia, tylenol PRN for bilaterl lowert extremity pain follow up call a week later -f/u call-with another general practicioner - rx antibiotic (levofloxacine750mg x 7 daye) ) CC- same syptoms, dr said to "follow the course", eventually sent ED at local hospitalwent to Hemotologist = Blood cultures, stool cultures, and on the verge of bone marrow biopsy

At about 5 PM on March 20th, 2021, I felt so dizzy that it was almost impossible to walk. I had to hold onto furniture as I made my way across the room. After this continued for several hours, I did some research on the web and was led to believe that being dizzy was a serious event. At 7:11 PM, I got a ride to the hospital and checked into the emergency room. I was there at the hospital for about 30 minutes and noticed that the dizzy feeling was gone. I walked out of the hospital without every going back to an examination room. I caught a ride home at 8:08 PM. Note that the only other adverse event was a sore arm and a vague feeling of not being well.

Pt developed left facial numbness and sensation of heat and numbness in the left arm and numbness into the leg and foot. Symptoms started at 1:36 pm while walking to catch train. Pt noted numbness and felt light headed. Pt had mild headache that he associated with not eating much. Pt returned back to urgent care because of symptoms and RR team called. Pt had given blood for tests (12 vials) and abdominal ultrasound earlier in the morning as work up for his chronic renal insufficiency. Pt drank several cups of water before the ultrasound. Symptoms initially improved but did not resolve, so he was sent to ER for stroke. Pt had 3 more episodes of worsening left sided numbness and lost consciousness on 2 of those occasions per the patient. Neurology evaluated patient and said that they were likely thalamic strokes. Pt was unable to have an MRI because of metal in his eye.

Passing dizziness at time of inoculation - not reported Painful palpable enlarged gland under left jaw All over body rash - extreme discomfort from itching

Thursday, 3-25-21 12:30 p.m. - Started feeling slight soreness and pain, slight numbness in my right hip. This progressively got worse throughout that night. Friday, 3-26-21. 7:00 a.m. - Woke up in more pain in my right hip and right leg. I almost cried trying to get out of bed. Felt like a car ran into my right hip. Very painful to walk. Saturday, 3-27-21. Extreme pain to get out of bed, walk. EXTREMELY painful to lift my right leg to try to go up stairs. Wife wanted me to go to the Emergency Room, but I suspected this was a reaction to my Covid shot. Sunday, 3-28-21. Same pain in the morning. Suddenly, about 1:00 p.m., the soreness started to subside. At 3:00 p.m. I could walk up and down the stairs without extreme pain. There was still a lot of soreness, but not extreme. Monday, 3-29-21. Woke up this morning and can get out of bed without much pain at all. This afternoon I am about 90% back to normal walking, without pain.

blood filled right eye/My eye was diagnosed with hemorrhaging; sore arm; mild headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), via an unspecified route of administration at left arm on 08Mar2021 at 15:15 at single dose for COVID-19 immunization. Medical history included acid reflux. The patient has no known allergies and has no COVID prior to vaccination. Concomitant medications included omeprazole, naproxen, and calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS). The patient has no other vaccine in 4 weeks. The side effects started the day after the shot, on 09Mar2021 at 05:00, the patient reported that his arm was sore, and he was having mild headache that lasted throughout the day. Two days later (as reported), he woke up with headache and blood-filled right eye. After being seen in the ER, at the advice of his primary doctor, they sent him to a retinal and macular surgeon. His eye was diagnosed with hemorrhaging and he was prescribed a medication. The patient has follow-up visits scheduled to check on the progress of his eye. He was not tested for COVID post vaccination. Therapeutic measure was taken as a result of the events and included treatment with prednisone. The outcome of the events was recovering.

Extreme bout of peripheral neuropathy that lasted 4 days - still occurring Brain fog that lasted 3 days

Developed left-sided tinnitus 3 days after vaccine given. Getting louder. Mild pain in left breast.

Pt c/o unable to eat, vomiting and weakness starting after vaccine. Patient admitted for Diabetic ketoacidosis without coma associated with other specified diabetes mellitus (Primary Dx); Weakness. DM Type I/DKA - POA. Patient with a blood sugar of 351. He was admitted to the ICU for insulin gtt and closer monitoring. The next day patient was switched to high dose sliding scale, standing AC insulin with long acting insulin at night. The patient was transferred to the medicine floor later that evening.

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.

DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Stroke-like symptoms [R29.90] HOSPITAL COURSE: A 63 y.o. male who presented with chief complaint of left facial droop, left forehead droop and slurred speech. Patient reports his symptoms started on Saturday and failed to improve. He contacted his PCP and he was recommended to go to the ER for evaluation. Patient had his COVID-19 vaccine-1st dose 2 weeks prior and was concerned that he might be having 1 of the rare side effects from the vaccine. On admission patient had normal vitals. His labs were within normal limits. Patient's presentation was discussed with Neurology who recommended admission for stroke workup given his comorbidities-hypertension, hyperlipidemia, diabetes and obesity. Patient received 1 dose of prednisone 80 mg in the emergency department for treatment of Bell's palsy (patient's symptoms more consistent with Bell's palsy presentation). Patient was admitted to medicine service for workup of stroke with MRI brain without contrast and monitoring for any worsening of neurological symptoms. Patient's CT head on admission was negative for any acute abnormality. CTA head and neck showed near occlusion of intracranial left vertebral artery. MRI brain without contrast was negative for acute infarct. Patient's facial paralysis slightly improved with 1 dose of 80 mg prednisone. Patient's presentation was consistent with Bell's palsy. Patient worked with PT OT and speech therapy and was recommended outpatient physical therapy and speech therapy. He was discharged home in stable condition on oral prednisone 80 mg daily for 7 days and valacyclovir 1000 mg 3 times a day for 7 days. Patient was recommended to follow-up with Ophthalmology as outpatient for possible left eye patch if his symptoms fail to improve. Patient's Lipitor dose was increased to 40 mg daily from 10 mg daily due to finding of atherosclerotic changes on CT head and neck. Active Issues Requiring Follow-up Issue: Bell's palsy and abnormal finding on CT head and neck. Recommended follow-up provider/specialty: PCP What is needed: 1. Referral to Ophthalmology for an eye patch if symptoms fail to improve. 2. Referral to neurovascular surgery for CT head and neck findings. 63-year-old male with history of hypertension, hyperlipidemia and diabetes mellitus admitted for workup of stroke-like symptoms. * Stroke-like symptoms Assessment & Plan Patient presented with left-sided facial droop, left forehead droop and slurred speech. - CT head on admission showed no acute intracranial process. - CTA head and Neck shows near occlusion of intracranial left vertebral artery. Patient reports his symptoms started 3 days ago. Patient's presentation appears similar to Bell's palsy. He received 80 mg of prednisone in the emergency department. Patient's symptoms were discussed with stroke Neurology who recommended MRI brain without contrast to rule out possible stroke given his underlying comorbidities-hypertension, hyperlipidemia and obesity. Plan: - will obtain MRI brain w/o contrast. - Check A1c and Lipid profile - continue Aspirin and statin. - monitor on tele - Neurochecks q4h Bell's palsy Assessment & Plan Patient has loss of left forehead wrinkles, left eyelid droop, droop of his left corner of the mouth. Patient's presentation more consistent with Bell's palsy. Patient reports that he had COVID 19 vaccine 2 weeks prior to developing symptoms and read it as one of the rare side effects online. Patient received one dose of Prednisone 80 mg in the ED. Will continue with Prednisone taper until MRI results are back. SLP ordered. Patient advised on following with ophthalmology for eye patch.

Soreness at the location of shot, fever, chills accompanied by shaking, bad headache, body aches, general weakness and fatigue. Began about 11 hrs after vaccine was administered.

I am current diabetic and have a recent history (1 year ago) of muscular dystrophy. I use a cane to assist with mobility, and cannot lift my legs far to go up high stairs, nor lift my arms past my chest as a baseline. Later in the evening/middle of the night, after the second shot, I got up around 3:30am to use the rest room and after each step, my knees, legs, hips, and arms gave out, falling forward on my face and head. I had no strength to catch myself from falling, nor could I lift myself at all. Initially, I could not even roll over. It took 10 minutes with help from my wife to roll over, but I remained on the floor. I was on the bathroom floor/snake crawling for 2 hours trying to figure out ways I can get up, but I had no strength at all. After snake crawling to the bedroom, my wife called the paramedics to get me up at 530am, Tuesday April 6th. Later that night of the 6th I did a little better, with help I could sit up in the bed. Overnight I tried to lift up to stand, and barely could stand, but my legs were too shaky, body bruised of course, and weak. April 7th, the next day, I was able to sit up. Later that day I was able to get up to go to the bathroom with my wife?s help and the use of a rolling walker with wheels, brakes and a seat, about 3:50am this morning. I have 35-40% of my strength, and can sit on the side of the bed. I need assistance to the bathroom and I have a ways to go to recover to my baseline.

shot was given on march 27th 2021. 10 days ago and alot of weakness in right arm i can hardly raise my right arm above my head. very weak that i can only hold it a there a few seconds. weakness seems to be in shoulder therefore making it hard to raise my right arm, also now going on 10 days i feel very weak and tired fatigued every day . No energy.

Patient suffered a stroke 6 days after receiving the 1st dose of his Pfizer vaccine. He initially developed left arm numbness and tingling which prompted admission to ER. Later that same day, he had significant worsening with left hemiparesis. MRI demonstrated right hemispheric ischemic stroke and focal right carotid ruptured plaque. Somewhat unusual given his overall good health and lack of risk factors. Has never smoked, exercises regularly and carotid duplex performed in 2017 demonstrated less than 50% right internal carotid artery stenosis. Takes aspirin daily. Currently remains hospitalized with significant left upper extremity paresis. Minimal left leg function. Did require carotid endarterectomy. The plaque rupture was focal and hemorrhagic with no significant evidence atherosclerotic plaque beyond the focal ruptured plaque.

developed Bells Palsy on the left side of my face almost 2 months to the day from my last Covid vaccine; having a severe ear ache in the left ear; This is a spontaneous report from a contactable consumer. A 63-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 Left on 08Jan2021 14:30 (Batch/Lot Number: EK5730) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 week prior to the COVID vaccine. The patient received first dose of bnt162b2 on 18Dec2020 10:00 in right arm for COVID-19 immunization. On 26Feb2021, the patient started having a severe ear ache in the left ear. On 06Mar2021, he developed Bells Palsy (medically significant) on the left side of his face almost 2 months to the day from his last Covid vaccine. The Palsy has since totally resolved and his facial. The patient received treatment for the events: prednisone and anti viral medication for 7 days. The patient was not diagnosed with COVID19 prior to vaccination, and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered. Follow up needed, further information was requested.

The day after vaccination a large lump (orange-sized hematoma) appeared on my lower left leg. Painful when touched. About 3 days later a second lump appeared 2 inches below the first. Area between the two lumps painful. I applied ice and wrapped for another week. After two weeks the second lump was almost gone. First had decreased in size. I went to my physician 2 weeks after the day of the shot.

When Patient presented for his 2nd dose of vaccine he stated about 2 hours after receiving the 1st injection he noted he had slurred speech, was incoherent and was not able to move. Symptoms lasted about 24 hr. and resolved completely in 24-48 hr. Patient denied any history of hypertension or heart disease. He did not report this to his PCP. 4/13/2021--2nd dose of Covid vaccine NOT given per recommendation of Chief Medical Officer--Patient and spouse instructed to contact PCP for additional evaluation and to reschedule appointment for 2nd dose.

20 minutes after injection shoulder area started to become number at the injection site. 35 minutes after the injection my neck and face started to become numb. As the numbness traveled from the injection site (left to right) across my neck and face, the numb areas became a "tingling" feeling on face, lips, chin and below the eye. Again traveling from left to right (the injection was in the left arm). Day two the above symptoms have lessened but have not gone away. Starting the same evening of the injection I experienced a progressively worse headache. As of 4/13/2021 I still have some numbness and tingling on the left side of my lower face between my cheek and chin. Headache is going away slowly.

I received the shot around 9am, That evening my left arm was a bit sore as well as my neck muscles. The next day I had several of my old Shingles symptoms return, weird feeling in my left eye, itchy eyebrow muscle, itchy skin on left side. (I had the shingles about 15 years ago, LEFT side, not too bad, mostly itchy, with recurring odd things just mentioned maybe once a year) The the 2nd day I got a weird tingling, buzzing feeling in my left upper back above shoulder blade, like those TENS device electric muscle stimulators. This is similar to my shingles twitches, but different and NEW. Maybe I should have taken the shot in my right arm? I may take the second shot in my right arm.

Pfizer-BioNTech covid-19 Vaccine EUA: Sore arm 1st day after about 4 hours - better by next morning, no other symptoms until 3 days after the shot then I had Chills, Fever (101.8) Nausea, Fatigue, Headache. These went away within 24 hours but a bout of Diverticulitis had started up right when the symptoms started and made everything feel worse than it would have. Went to doctor and was put on antibiotics the following Wednesday.

Extreme pain in lower R leg, which had had a femoral bypass in May 2020. After a couple days I called my vascular team and they took me into surgery immediately. They did some kind of pharm treatment to break up the clot. Had procedure everyday for 3 days where they ultimately used some balloon device to open up the artery again. Still monitoring, am scheduled for another follow-up next week. I'm still vertical, but they had said the leg itself might be in jeopardy. Not happy with Pfizer, that's for sure.

dizziness and loss of coordination in left leg; diagnosed TIA at hospital per symptoms; MRI and echocardiogram were normal

Family member reported to this Nursing Supervisor patient suffered stroke 04/13/2021 at the patients home. Family discovered patient 04/14/2021 and taken to Hospital then life flighted to another hospital. Family reports he has left sided paralysis, slurred speech, nasogastric tube placement and currently in neuro ICU.

Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury.

Patient was complaining of being really hot & dizzy. His eyes rolled and he lost consciousness for a few seconds. He was pale and diaphoretic. Made some chocking sounds. Denied any swelling of the throat or tongue. He was lowered to the ground and ice packs applied under his arms. 911 was dispatched and the medics came to attend.

The patient presenting with worsening stroke symptoms and now new-onset slurred speech, can not rule out an extension of his stroke or new stroke. The patient does report he has been doing a lot of therapy but I don't think that would cause such a dramatic decrease in strength, worsening coordination, or cause his new onset of slurred speech that was present today. The patient requires a higher level of care and additional imaging and testing for further evaluation and treatment. Will send the patient to Hospital. send to ED for eval Out to Hospital. on 2/23 and returned on 2/25 with diagnosis of worsening CVA ... Patient also with previous diagnosis of CVA

tingling and jolting pain down left leg starting in lower back, pain level 10 out of 10, unable to work remainder of day and the following day, pain resolved later Tuesday, back to work Wednesday

Less than two days after the vaccine was administered, I developed difficulty urinating and a burning sensation while urinating. This occurred again after the second vaccine and required hospitalization.

Mild soreness in art for about 1 day after first dose About 12 hrs. after receiving 2nd. dose, fatigue, exhaustion, but could not sleep. I felt cold and had chills with movement (but not severe chills). Adverse effects subsided after about 12 hours and another 24 hrs. required for complete recovery (36 hrs. all together).

multi focal pneumonia; atrial fibrillation/the second worst feeling he has ever had since he had his first heart surgery; arm started hurting real bad/a severe pain that radiated down to elbow, arm, chest; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021(Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included acute diabetes, acute thyroid disease, covid like in 2021 (10 weeks before), 3 heart surgeries with 12 stents, ongoing chronic obstructive pulmonary disease (COPD)slight case diagnosed in 2016-2017, bad thyroid from 2006 and ongoing and told he had full blown Hashimotos in 2017, bad diabetic from 2015 and ongoing and went into diabetic type coma on 18Dec2015 (sugar when got him out of the parking lot cause he had to drive there was 738 or 768 put him in ICU from 18Dec2015-25Dec2015. Had to give him shots like every 2 hours. Started giving him insulin there but insurance wouldn't approve it so kept him on Metformin. Like 5th or 6th day got it under control), bad heart from 2007 and ongoing (In 2017 he had a heart attack they call 'widowmaker', he was told he hemochromatosis like his brother and sister. Caller stated they got it from his parents, but the doctors can't find it now. He had 3 different heart surgeries and has 12 stents in him. 9 weeks before (2021), he went to the hospital because of his heart, got a real bad heart, been put on a heart transplant list, they told him his blood tries to flow backwards and all of it's going over to the right chamber; after 2 hours after he had been admitted to the hospital they told him he had had a heart attack, level 3-they knew from blood tests they'd done. About 1 hour later said test was positive for COVID. He had no symptoms. While in hospital they gave him Zinc, Vitamin D3, Vitamin B1 and that was it. They kept him 5 days at the hospital. Also reported that went to the hospital for triple bypass heart surgery when he got in said somethings wrong, watch everything on the monitors wouldn't tell him nothing; said your widow maker is completely blocked up 99% had to go in and unblock that up so they can't do any kind of bypass on him again. The only thing they can do was heart transplant or heart graft where they take part of the left chamber and he din't have but like 18% of that left, take it come over whatever they're talking about, he doesn't know it's a heart graft whatever they're talking about there), 2 hernia operations, hemochromatosis (little sister and older brother has hemochromatosis-patient got hemochromatosis (too much iron in the blood) from 1 gene from his mother and 1 gene from his father. Brother doesn't have it anymore; but patient's and his sisters mutated); ongoing blood pressure abnormal; anxiety; ongoing wheezing; ongoing chronic Atrial fibrillation. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken to help blood to be thin from 2007 and ongoing; levothyroxine taken for Bad thyroid from 2006 and ongoing; metoprolol succinate taken for blood pressure from 2015 and ongoing; clonazepam taken for anxiety from 2012 to an unspecified stop date; fluticasone propionate taken for sinuses from 2015 and ongoing; insulin glargine (LANTUS) taken for diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for diabetes from 2019 and ongoing; salbutamol (ALBUTEROL HFA) taken for wheezing from 2018 and ongoing; budesonide, formoterol fumarate (SYMBICORT) taken for COPD from 2018 and ongoing; amiodarone (AMIODARONE) taken for atrial fibrillation from 22Mar2021 and ongoing; amoxicillin, clavulanate potassium (AUGMENTIN) taken for an unspecified indication from 22Mar2021 to 29Mar2021; apixaban taken for prevent blood clots and chronic Atrial fibrillation from 22Mar2021 and ongoing. The patient had pneumonia shot and flu shot took that in Sep2020. The was no vaccinations within 4 weeks prior to the BNT162B2.The patient previously received Xanax for anxiety from unknown date to 2012; received Humalog , Glipizide and Metformin for Diabetes. The patient got his first Pfizer COVID-19 Vaccine shot on Monday 15Mar2021 at sometime between 15:30-16:00. Not even an hour after he got the Pfizer COVID-19 Vaccine shot his arm started hurting real bad, felt like a hot ice pick was in his arm-described as it started locally just in one spot, then started getting worse going down to his elbow. About 30-45 minutes after got out of there, he was sick, didn't know what was wrong with him. Also reported as by 16:30 he felt bad and pulled up to a friends house. He would say it was an allergic reaction; starting in his arm, a severe pain that radiated down to elbow, arm, chest, it was hard to breathe since 18Mar2021. He went to a friends house after getting the shot, and by the time he got to the friend's house, he felt sick and laid down for about two hours and just kept feeling worse and worse. After that he went home and went to bed. He stayed in bed Tuesday, 16Mar2021, Wednesday, 17Mar2021 and was able to drag himself out of bed to at least go to the bathroom on Thursday morning, 18Mar2021. When he got out of bed, he couldn't breathe. When he got up Thursday morning he couldn't even move his whole left side, had to grab nightstand and pull himself up to stand up out of the bed; stumbled to the bathroom about 3 feet away.He made his way to the phone and called his sister to tell her to call an ambulance because he couldn't breathe. When he got to the emergency room he was told he was in atrial fibrillation. He stayed in the hospital with primary diagnosis as multifocal pneumonia with atrial fibrillation. Feeling like heart beating out of his chest, machine going off every 2-3 minutes. It took about 9-10 hours to get the atrial fibrillation under control. He stayed in Hospital for 4 days-admitted 18Mar2021-discharged 22Mar2021. He spoke to his heart doctor who said it was hard to breathe due to the Atrial fibrillation and all his doctors say they did not know whether it was a reaction to the covid vaccine.He heard the doctors talking and they were saying they didn't think he was going to make it. His heart rate was going between 80 and 200. He had 3 different IV's going in each arm shooting different heart medications in him and the doctor explained that the medications didn't mix well, could not go in the same IV at the same time. The patient shared that this was the second worst feeling he has ever had since he had his first heart surgery. He meant they thought he was dead or dying he lost feeling of everything. His arm felt better, but every now and again felt like a little knot or something was in there. He was breathing better, they gave him inhalers, albuterol. He thought that his heart doctor was going to start him on oxygen. He went to his Cardiologist on 01Mar2021 on Monday, 2 weeks before getting his first Pfizer COVID-19 Vaccine: cardiologist told him his triglycerides raised up about 15 was about 268. All his Cardiologist did was change his blood pressure medicine. Went to his Endocrinologist on 08Mar2021 Monday, 1 week before he took the Pfizer COVID-19 Vaccine: Endocrinologist raised his Lantus SoloStar U-100 insulin 100 units/mL (3mL) from 60 units nightly to 64 units nightly then. All his other blood tests were good, they just said keep doing what you're doing.The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.

Within 1 or 2 minutes after getting the vaccine I started to feel like the left side of my face was becoming flushed. Then I felt my face, and especially my lips, tingle; then I seemed to be having a neurological reaction--it was like the left side of my face was becoming numb. For the rest of the day, the left side of my face felt very different from the right-side. There was some pain around the temple. The next day, and even through today, 5 days later, the problem has been mainly around my eye. My eye often feels irritation when I blink and there is some muscular quivering of my lower eyelid. After speaking to my brother who is a radiologist he decided that it was unlikely to be an allergic reaction, and because the feeling of my face on the left side was reminiscent of the feeling I had a year ago when I had shingles around my left eye, he thought the reaction could very well be related to shingles. In other words, there was a activation of a response that resembled my shingles episode. This was bolstered by my speaking with my neighbor who also had the pfizer vaccine who said she had a very similar reaction affecting her face that lasted several days, and she,years before, had shingles on her face (as well as the shingles vaccine).

I received the COVID-19 shot on 03/24/21 at 1:30 in the afternoon, perfect health at the time, not even a headache, then 24 hours later my entire left ankle was swollen from the COVID-19 vaccine shot. I contacted my primary care doctor, and was looked at and was verified as being swollen. I was referred to a foot doctor who did verify the foot was swollen. The foot doctor gave me a steroid shot in my left ankle, and the foot was still sore. I was back at his office after my appointment on 4/9/21 to get a foot boot. It was suggested about being in a boot to keep my foot off the ground, Today the swelling comes and goes and is really painful

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.

high fever (over 102, 103.7, 102.7, 99 or 100); Blurred vision; shaking like crazy; has no energy; it was double vision, like looking in a fun house mirror; he is still freezing; does not feel like himself; Had been feeling tired and rundown; Headache; horrible chills; night sweats; This is a spontaneous report from a contactable consumer (sister). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient medical history: no. Family medical history: no. The patient's concomitant medications were not reported. Vaccination facility type: hospital. Vaccine administered at military facility: no. The patient experienced high fever (over 102, 103.7, 102.7, 99 or 100) on 04Apr2021, blurred vision on 04Apr2021, headache on 2021, horrible chills on 2021, night sweats on 2021, shaking like crazy on Apr2021, has no energy on Apr2021, had been feeling tired and rundown on 2021, it was double vision, like looking in a fun house mirror on Apr2021, he was still freezing on Apr2021, did not feel like himself on Apr2021. On Saturday, her brother was out shopping with her and stated that he felt very tired and run down and had a headache. He started running a high fever but stuck it out at home. On 04Apr2021, he was taken to the emergency room and admitted to the hospital. They had been running test after test and can't seem to find anything wrong. The doctor thought that it was some kind of reaction to the vaccine. The patient was still running a high fever over 102 and was still experiencing fatigue and headaches on and off, and horrible chills and night sweats. The patient wanted to wait until the day after Easter to go to the hospital but started experiencing new symptoms. He was starting to experience blurred vision. Was then taken to the emergency room. The fever went down with Tylenol but continued to go up again when Tylenol wears off. Temperature was 103.7 at one point and has mostly been over 102, stating that this morning was 102.7. It had been one week that he was still having these symptoms. It was strange because the patient was feeling all right for the first 2 weeks. At the hospital, they kept giving him Tylenol to bring the fever down. He had been shaking like crazy. Had horrible chills and night sweats. He had no energy. He had not had the second dose. They cannot find anything else wrong. He was a health nut and run five miles a day. Took good care of himself. He seemed ok the first 2 weeks. Had been a week that he still can't break the fever. When looked up the symptoms, he had everything except for nausea. He also had blurred vision. They did a spinal tap, echocardiogram, EKG and blood work. He had seen 5 different doctors. The fever was highest at 103.7 and has consistently been over 102. With Tylenol, it had gone down to 99 or 100 but always shoots back up. 2 weeks after the shot, he took his temperature and wasn't feeling good all day. He stayed home from Wednesday until Sunday when he started experiencing new crazy vision symptoms. Stated that started Saturday. He was taken to the hospital on Easter and was admitted to the hospital, and was still there. The vision problem was new and it started to develop Saturday night. It was double vision, like looking in a fun house mirror. He still experienced the double and blurry vision now but only occasionally, when he tried to get up. It was on and off when he had to get up to go to the bathroom. He was still freezing and had shake and chills. He got night sweats and fever, chills, and did not feel like himself. The reporter didn't think he had high cholesterol or high blood pressure, diabetes, or anything like that. Tests: They did bloodwork, CT scans, MRI of the brain, echocardiogram, EKG, spinal tap. There were no white blood cells found in the spinal tap and that the echocardiogram was good. Everything came back normal. He had seen cardiologists, neurologists, gastroenterologists, primary care doctors, and no one can find anything. They did another kind of test regarding his vision. Her brother was depressed and wanted his energy back. It had been a whole week. The outcome of the events high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision was not recovered, outcome of the remaining events was unknown. The patient was hospitalized for high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision from 04Apr2021 to an unknown date. The reporter was not sure if this was happening because of the vaccine. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.

My father complained of soreness and body aches from the shot Sunday night to my mom and Monday morning to his boss at work. My sister found him that afternoon in my parent's home unresponsive and call proceeded to call 911 and start CPR. But it was to late and he was already gone.

patient stated his daughter found him ?unconscious and he was rushed to the hospital, he stated he still has facial paralysis and is experiencing difficulty eating?. I attempted to contact patient and voicemail was full. Alternate number was given and wife answered the phone. interpreter use during call. Wife reported her experience with vaccine and reported husbands as well. States, her husband is at work and cannot talk on the phone, he may be home late?. Wife states her husband received Pfizer vaccine on a Friday 4/9 and then woke the following Monday with a ?crooked mouth, migraine headaches, very sleepy and heavy arm?. Wife states he did not loss consciousness but was take the Hospital on Monday 4/12/21 and was not given an answer to what was wrong with him. Advised wife I cannot share any medical information about her husband with her, that he could return my call.

IN 24HOURS my husband had a seizure and I found him unresponsive and was taken to the hospital in an ambulance, 2 weeks in hospital with organs failing etc and his kidneys are still coming back. He appears to hopefully be a full recovery. Doctors say they do not know enough about the vaccine to say it was the cause although he had blood work taken 3 days prior. and all good. He had a lot of tests due to finding that he had 2 very old strokes.

The first day after the vaccine I felt a total lack of energy as well as muscle soreness and general aches. By the second I was pretty good. On the 11th day It all came back and more. Dry and soar throat, headache , total loss of energy, no apatite, muscle aches. This has gone on now for 5 days. On the 2nd day I had a covid test- came back negative. On the 4th day I had another at a different facility, came back negative. Could this still be a reaction to the first vaccine and should I have the second?

unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill; high fever" of 104; really bad pain in his arm; delirious and out of it; This is a spontaneous report from a contactable nurse (patient's wife). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sick from Dec2019, down to the eye, diarrhea and fever. There were no concomitant medications. The patient experienced high fever" of 104, had really bad pain in his arm, was delirious and out of it and he was very ill on 08Apr2021. The reporter also stated that the patient also was unconscious at times, perspiring profusely, had bad cough, was coughing until he throws up on an unspecified date. The event pyrexia was assessed as life-threatening and pain in arm was assessed as disability by the reporter. The patient underwent lab tests and procedures which included fever: 104 on 08Apr2021. Therapeutic measures were taken as a result of pyrexia included Tylenol. Outcome of the events was unknown. Information on about lot/batch number has been requested.; Sender's Comments: The information currently provided is very limited, hence the reported events are conservatively assessed as related to the administration of 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 RAs, Ethics Committees, and Investigators, as appropriate.

Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness With my first shot, all I had was a sore arm for 4+ days. The second shot I has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM, By Noon that day, I was fatigued but able to go to work. A week later, I had chills again and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.

Patient's shoulder joints began hurting after vaccine. It kept getting more and more severe, up to the point where he couldn't raise his arms. He also had some pain in thigh muscles but not as severe. Pain got so severe he went to ER - who did labs and told to see PCP. PCP gave naproxen for pain, which helped some. 3 days later - he went back to ER and he was given a muscle relaxer and IV morphine. He returned back to PCP and was given steroids and 2-3 days later had complete relief but still being treated on steroids.

Patent experienced seizure like activity. Unable to follow commands, LOC x2-3 minutes. EMS immediately summoned over. Fire rescue notified, responded. Patient refused transfer to hospital, signed liability waiver with fire rescue and departed

Pt stated that about 1.5 hours after receiving second dose began feeling burning in leg, headache, burning and numbness in first finger all unilaterally. He went to the hospital and was treated over the course of 2 days. He identified as having symptoms of stroke though hospital staff stated it was a seizure.

Patient had Pfizer vaccine #2 on April 22, 2021, at pharmacy. He presents to the office today with fairly sudden left facial droop that started around noon today, April 28, 2021. He has normal vision, normal hearing, and has incomplete paralysis of the left face (partially able to close eye).

Slurred speech, drooping left upper lip, feeling funny. One episode at @ 9:00 am, second episode @ 3:00 pm on the same day. Treatments at ER: Plavix, IV fluids

Started with moderate arm pain about 11 hours after injection. Progressed to fatigue, moderate muscle and joint pain and slight fever over the next 12 hours. Felt terrible for about 24 hours and slowly began to feel better within 48 hours.

help knock pain down for joints hurt like heck; a pinching like pins and needles trying to get out on your stomach area, it comes and goes; first time the rash itched underneath; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Started freezing all over the place, hands are ice cold; Starts effecting different joints in the body, hit the muscle or joint; Starts effecting different joints in the body, hit the muscle or joint; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Started freezing all over the place, hands are ice cold; a little pain in the muscle; A paramedic gave vaccine and hit an artery; bleeding underneath skin above injection site, 7 droplets of blood above injection site; When stood up couldn't breath and throat was like closed off; When stood up couldn't breath and throat was like closed off; Severe sharp pain in your head that comes and goes each day to this day; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6208 and expiry date not provided) via intravenous, in left arm in shoulder area on 18Mar2021 (at the age of 63-years-old) as a single dose for covid-19 immunisation at hospital. Appointment was for 8:40, told facility he had allergic reactions to allergies. Medical history included patient had life and death lung surgery in 1997, lost bottom lobe on lung, less breathing capacity than normal person. There was no relevant family medical history. Patient was told by family doctor, should get the Covid shot. Concomitant medications were none. Patient did not have prior vaccinations within 4 weeks. No additional vaccines were administered on same date of suspect vaccine. There was no investigation assessment. AE(s) following prior vaccinations: Patient stated it was not like this, usually just sore arm where put needle in, never had blood fly out of arm on rubber glove, or bleeding, after pulled syringe out, kept pressure on arm. Patient has never had anything like that happen. Patient did not provide NDC/lot/expiration for vaccine that made arm sore where put needle in. Never happened again after that. On 18 Mar2021, a paramedic gave vaccine and hit an artery, and injected the vaccine into his blood stream, when stood up patient couldn't breath and throat was like closed off and bleeding underneath skin above injection site, 7 droplets of blood above injection site. Patient still has one today that didn't go away yet. Patient stated that he suggested to the Paramedic that he pull out the needle and put it in the right arm and start over. Paramedic was just staring at the blood coming out underneath the syringe and continued to shoot the first dose Pfizer Covid Vaccine into the blood stream. After a few seconds caller's throat opened back up. States it was freaky. Never had that happen before. Throat opened back up, but scared patient real good. Just happened for a few seconds after standing up, maybe patient stood up too fast and that caused the problem. When patient got home he had blood on his arm and shirt. On 29Mar2021 11th day after first dose Pfizer Covid vaccine, patient experienced like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes, also patient started freezing all over the place, hands are ice cold, was wearing long johns two sweatshirts and a winter coat in house to be warm. Patient puts hands in coat pocket to warm up. This is still going on every day, still going on this morning. It started effecting different joints in the body, hit the muscle or joint, joints targeting on and off, still happening every day, No effect on joints yet. Patient hopes does not have anymore.. First symptom started after first dose Pfizer Covid vaccine, for seven days underneath the muscle. It was that 20 minutes one time it showed up. Patient clarifies that this began on the 7th day after receiving the first dose Pfizer Covid Vaccine. Patient had a little pain in the muscle. Felt something in the muscle are for about 20 minutes. It was ongoing and persisting. Also had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit. It was a pinching on the inside trying to come out through the skin. That's what the rash feels like. Reports this was still coming and going. Clarifies the rash underneath the right arm and on the chest is what patient was referring to. Last night for first time the rash itched underneath patients right arm in the muscle, it started to itch, still hot. It was never itching before but started itching last night, 20Apr2021. Rash came back on right arm between elbow and shoulder in muscle area. Red rash came, felt the pinching like trying to come out from under the skin. Patient went to the bathroom and looked and it was itchy for the first time. Patient didn't want to itch it, rubbed lightly with flat hand so nothing would happen. Improve a little bit, not all over chest like it was, going on in different locations of the body. On 20Apr2021, patient having a symptom from yesterday and today a pinching like pins and needles trying to get out on your stomach area, no rash there but it comes and goes. Patient pushes finger on it and it seems to calm it down a little bit. Reported this was another symptom that was appearing. Patient states he was still having these symptoms. On an unknown date in 2021, patient experienced severe sharp pain in head, he has a stabbing pain in forehead that comes and goes each day to this day. After that started experiencing, never had headaches before, that was a severe sharp in your head that comes and goes each day to this day. Treatment received ibuprofen 300mg once in a while to help knock pain down for joints hurt like heck. Patient doesn't know when he began taking, after symptoms occurred he began taking. Other than that the patient did not take it. Patient was not a big fan of taking medication. No relevant tests were done. Patient visited emergency room in a hospital due to events 01Apr2021. Patient was discharged from emergency room. Pleaded with emergency room to give patient an epi pen to stop the side effects from occurring to get back to normal life and not deal with problem. Emergency room refused to give patient the epi pen, saying the epi pen would give the caller high blood pressure. Patient does not have high blood pressure. Patient thought that would be better than the reactions he was having. Patient stated that gave him a steroid. Patient was hoping there was an anecdote to stop the side effects to not continue going through this problem. Shot was not designed for where it was put, guess have to deal with unless answers. Patient asked what are the long term effects to the brain at end of blood stream? Have any idea? Nobody has answered. Vaccine should have been aborted, not injected into blood stream. Patient underwent EKG (Electrocardiography) in emergency room on 01Apr2021 and result was unknown. Patients second dose was scheduled for 27Apr2021, 41 days after first dose Pfizer, not 21 days. The seriousness for all the events was unspecified. The outcome of event paramedic gave vaccine and hit an artery was unknown and for other events was not resolved. No follow-up attempts are needed. No further information is expected.

aching in the arm for a week; Injecting the vaccine too high and it's like so much into the shoulder; Poor administration, too high up on the shoulder instead of down in the muscle; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program named Pfizer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Lot Number: ER8734) as single dose for covid-19 immunisation . Medical history included hyperthyroidism and Pott's disease. Concomitant medication included carvedilol. The patient experienced aching in the arm for a week, injecting the vaccine too high and it's like so much into the shoulder; it has to be do with poor administration too high up on the shoulder instead of down in the muscle. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Plus one day: prickly all over; don't touch me feeling similar to the feeling at the beginning of a common cold or herpes outbreak. 600 mg ibuprofen mitigated symptoms Plus two days: rash covering 80% of abdomen

Right after vaccination recipient became pale, cool, had narrowing vision, near syncopal episode, bradycardia, and increased BP. Recipient was stabilized by onsite EMS and transferred to the hospital.

Severe left first toe/hallux pain, patient unable to bear weight, intermittent without redness, warmth, swelling. Morning stiffness. No risk factors, personal history, or family history for gout.

After getting the first dose of the Pfizer vaccine, I just experienced arm soreness for the first 24 hours, but then I noticed my tinnitus which I had slightly for many years had become louder and constant. Right now I'd say it is a 3/10. My concern is that if I get the second dose that it will become even louder. My second dose was supposed to be today, but unless the tinnitus diminishes I do not want to risk a second shot for a 10-15% efficacy increase for Covid

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.

Less than 24 hours later experienced severe dizziness, almost passed out. took me 20 minutes to regroup to be able to drive back to jobsite. The next day ,I was shakey ,but I got threw half of the day. On friday ,I drove from Cape Cod to Maine. I was doing fine ,but I had another spell

blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same patient/reporter, different AE/first dose

urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose

passed out; no energy; Tired/exhausted; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Lot Number: RW0150) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6207) dose 1 in the right arm on 24Mar2021 for COVID-19 immunization. Medical history included ongoing hormones are low. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hormone from an unspecified start date and ongoing; hydrocortisone taken for hormone from an unspecified start date and ongoing. The patient took the second dose of the COVID-19 vaccine, the next day he was tired on 15Apr2021. The patient had never been tired in his life like that. The patient was completely passed out. His wife wanted to call an ambulance and the caller told her no ambulance please. He knew the tiredness would eventually go away. The patient had no energy, zero, for 4 days or so. He has blurred vision for some reason on 15Apr2021. He thinks that the vaccine was no good. The patient has never had blurred vision before that that he is still experiencing some blurred vision. The blurred vision is what concerns him. His vision is not right and his side effects were severe. The tired disappeared, but the blurred vision is still there at time of call on 23Apr2021. The patient was wearing his reading glasses but that something has happened with his vision. He had 20/20 vision and now something is not right. The patient was exhausted, passing out, and not polite. The patient has to go to the doctor for the doctor to check his eyes. The outcome of tired was recovering. The outcome of the event blurred vision was not recovered and the outcome of the rest of the events was unknown.

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.

While this first vaccine gave no side effects other than a slightly sore arm, 17 days later on 4-17-2021 I suffered a TIA (Transcient Ischemic Attack). That occurred at 5:15 pm and I immediately took 4-81 mg aspirin and headed for a nearby Emergency Room. They said it was a stroke (and it did show on an MRI the next day but sub-centimeter and I was told the size of a pinhead. AT the ER the double vision in my left eye and numbness in left lips, gum and tongue were already subsiding, but the DR there gave me a Plavix and within 5 minutes I was completely back to normal (or close). I am not sure IF that first dose of vaccine had anytrhing to do with this TIA, but it might have? I had also stopped taking my 81mg aspirin several days before this TIA as I had a Periodontal appointment for insertion of an implant post and wanted to control the possible bleeding. The thoughts of my Doctor at Hospital as well as the Neurologists was that the omission of the aspirin PROBABLY was the main cause of the temporary clotting that caused this event HOWEVER I did not tell them that I was 17 days post-Covid Pfizer vax #1 and so the possibility remains that the vaccine could have been partially the cause of this event? As listed previously, Dr at Hospital was my Doctor and might shed some light on this and her thoughts. I felt it was important enough to report as I have heard stories of all of the vaccines possibly causing some clotting and this might fit.

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.

Developed Bell's Palsy in right side of face. This is the second time I have had Bell's Palsy; the first time was about 10 years ago. The ER physician said it was very unusual to get this twice in a lifetime. I was diagnosed with Bell's Palsy about a month after my second Pfizer Covid-19 shot and thought it could be related since this adverse event did happen during the trials.

Right sided Bells Palsy with right facial droop and right eye ptosis. Also had headache. Currently on prednisone. Mild improvement noted

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.

feels like a neuropathy, a nerve pain; nerve pain in the right leg; Right Leg weak and painful when he stands; Right Leg weak and painful when he stands; Has been in bed for two weeks; This is a spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date was unknown), via unspecified route on 17Apr2021 at 13:00 (patient was 63-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included bad back which was ongoing he had this issue since he was 20. He has been going on for about 45 years. The patient received first dose of BNT162b2 (Lot number: EN6200), and patient didn't have any problems with the first dose of the Covid Vaccine. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient had not received any additional Vaccines on Same Date of the Pfizer Suspect. On 27Mar2021 The patient's concomitant medications were not reported. On 17Apr2021, 8 hours after vaccination, the patient experienced right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before, he has been in bed for 2 weeks now. He can get up, but if he does he will have about an hour of pain afterwards. He was putting ice on his leg for about 2 hours at a time but he doesn't have to do that anymore. He can walk for about 2 minutes, then has to lay down, Then he will feel back to normal, then he can walk two more minutes, then he has to lay back down. Reporter stated the pain is only in his right lower leg and good. Reporter stated it feels like a neuropathy, a nerve pain. Reporter stated that 8 hours after his second dose of the Covid Vaccine his right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before. He has been in the bed since then. His right leg went numb and is very painful when he walks but not as much when he in bed; he never experienced this before. Reporter wanted to know about any reports of neuropathy or autoimmune disease reported with the covid vaccine and how it might be treated. On an unspecified date, the patient visited physician's office. Reporter stated that his doctor doesn't know what is wrong with his leg. He also stated he had a MRI yesterday, no results from that known yet. The patient asked has anyone else reported neuropathy. Offered transfer to and initially declines. He doesn't think they can help him. When asked what kind of help he was looking for states that he wants to know if anyone else has reported neuropathy. Informed to reporter that has the most recent product information for the Vaccine. The patient was referred for hcp for further guidance. The outcome of the event muscular weakness and bedridden were recovering, while outcome of the other events were unknown. Follow-up #1 (30Apr2021):This is a Follow-up spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself that: Relevant medical history (Historical vaccine, medical history), suspect details, new events (neuropathy and neuropathic pain), outcome and lab data added. Follow-up attempts are needed. Further information is expected; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Muscular weakness, bedridden, neuropathy and nerve pain 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.

Diagnosed with a blood clot; Diagnosed with stroke; not feeling well; wakes up at night; Numbness of left hand and mouth; Numbness of left hand and mouth; Constipation; severe headache, described as he felt his eyes were exploding out of his head.; Temperature of 100.2; Could not sleep; This is a spontaneous report from a contactable consumer (spouse reporting on behalf of husband). A 63-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing rheumatoid arthritis started few years ago, ongoing back pain (for many years), ongoing pain (for many years) (patient is a farmer 'seeing another doctor' for back pain/pain, testis cancer from 1986 and ongoing. Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from an unspecified start date ' a few years ago.' and ongoing; tramadol (TRAMADOL) taken for back pain from an unspecified start date ' for years' and ongoing. Vaccine was not Administered at Military Facility. No other vaccines were given within 4 weeks. No additional vaccines were administered on the same date of the Pfizer suspect product. The patient experienced diagnosed with a blood clot, diagnosed with stroke, numbness of left hand and mouth on 12Apr2021, severe headache, described as he felt his eyes were exploding out of his head, temperature of 100.2 (in the evening.) , could not sleep on 03Apr2021, constipation on 05Apr2021, not feeling well and wakes up at night on an unspecified date. The patient was hospitalized for stroke and blood clot from 12Apr2021 to 14Apr2021. The patient underwent lab tests and procedures which included body temperature increased: 100.2 on 03Apr2021; computerized tomogram: first cat scan, a blood clot was diagnosed on unspecified date., computerised tomogram head: unknown result on an unspecified date, electrocardiogram: unknown results (husband was not having a heart attack) on 12Apr2021 , laboratory test: unknown results an unknown date , sars-cov-2 test: negative on 12Apr2021, computerised tomogram: negative on an unspecified date. Treatment was given thrombosis, Stroke, Headache, Insomnia. On an unspecified date patient contacted his primary care doctor and was told to take some extra Motrin, twice a day but Motrin was not effective for his headache. The patient was not feeling well he went to his primary care doctor. Caller states her husband was at his doctor on 07Apr2021, and he went to radiology for a Cat Scan on an unspecified date and the results was negative. He had lab work drawn and a CT of the head. Her husband was given a medication to help him sleep, medication not specified. Caller mentioned she rescheduled her husband's second vaccine. On 12Apr2021, in the evening when he was getting out of the shower, he developed numbness in his left hand, and added later in the report, numbness of his mouth. Patient went to the emergency room, where they performed several tests, Multiple Cat Scans. Results of the first Cat Scan, a blood clot was diagnosed, and an EKG because they thought he may be having a heart attack but it was confirmed he was not having a heart attack.. When her husband was in the emergency room, they did a Covid test and it was negative. The patient was diagnosed with a blood clot and got Tissue plasminogen activator. At 7:33 pm, when he was given tissue plasminogen activator. After the treatment, the headache went away, but she is not sure if he has lasting effects. He was admitted to the Intensive Care Unit and was in the hospital for two days and diagnosed with a stroke, but he was able to walk out of the hospital. The patient still gets an ache in his head, and it comes and goes. Caller states it seems that these events were not coincidental, as they all happened after he got the vaccine. Since her husband has been home from the hospital, he is sleeping better but normally does not get a full night of sleep, and he usually wakes up at night and husband gets constipated when he takes Motrin. Caller mentioned that her husband is not fully constipated anymore, but he feels that his system is not back to normal. Caller assumed the stroke has cleared up, but is not sure. Caller rescheduled her husband's second vaccine, and she is not sure her husband should get the second vaccine. Caller states if these events were caused from the Covid vaccine, what will happen in the future? The clinical outcome of the events Clot blood, Stroke, malaise and wakes up at night was unknown; Numbness of left hand and mouth was recovered on 12Apr2021, Fever was recovered on 04Apr2021, while headache and Constipation was recovering. Follow up attempts are needed. Further information has been requested.

Patient was admitted 2 days after 2nd dose of Pfizer vaccine with right-sided facial weakness, numbness in addition to headache and found on imaging to have central venous thrombosis, he was started on OAC and got better and discharged home.

Low grade fever, extreme fatigue and approximately 40 minutes of uncontrollably shaking. Shaking was so hard the entire bed shook.

He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to the Parkinson's. He got more confused, more dizzy, and worsening of his Parkinson's. He was very thirsty and drank a lot of water (4 liters of bottled water). He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body. He was urinating more than he normally does. He started getting harder for him to breath. He noticed he had a bad taste in his mouth similar to when he had the COVID virus. He got a horrible splitting headache/migraine type that kept coming and going. He still has the taste in his mouth, and it affected the taste of food. These were all symptoms similar to when he had COVID. The headache was worse than when he had the virus. No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half. He is not having to drink as much as he did before and not feeling like he was dehydrating. Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved. He also had a sore throat which he still has. He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two. He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease. His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.

Client complained of dizziness, little shortness of breath shortly after receiving his 2nd Pfizer vaccine. BP=100/60, 98%, 89 RR. Complain of pain in left hand rating it as 5/10 d/t gout. States that he stopped drinking 5 days ago (ten beers a day).

Leg pain initially, diagnosed with blood clots may 17. receiving treatment currently 15mg xarelto twice daily.

He got his vaccine, immediately where the needle went in he had a bruise and just stayed the same. Then a few days later he started feeling stiffness and pain in his right neck and shoulder area. He did not have any rash, fever or other symptoms. He does still have the swelling at the injection site. He has taken Aleve for the discomfort. He has not called his doctor. He is able to work, but is having the pain in the neck and the shoulder every day.

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

Patient reports week-long, not yet resolved, numbness in fingers, pain in elbow of injected arm. Also ?hard to bend? and injected arm ?darker than other arm?

Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentration; Disrupts sleep and concentration; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left arm on Apr2021 10:00 am as 1st dose, single dose for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration in left arm on May2021 09:00 am as 2nd dose, single dose for COVID-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On Apr2021, the patient experienced continued soreness and sharp pain in upper left arm since first dose. Disrupts sleep and concentration. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as not recovered.

Arthritis pain in back, hips, shoulders and hands; Sore arm; He is not doing anything to cause the pain; This is a program spontaneous report from a contactable consumer or other non hcp (patient himself). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0185; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 19May2021 08:00AM as 1st dose, single for covid-19 immunization and would scheduled to receive the second dose on 10Jun2021. The patient's medical history included bad Arthritis, Allergic to Penicillin from an unknown date. The patient's concomitant medication included Apixaban (ELIQUIS) 25mg tablets a day patient was taking blood thinner this since he was 48-year-old. On 19 May2021 after the vaccination the patient experienced with a Sore arm, on 20May2021 then the second day after the vaccination the arthritis started for no reason and had more pain in back, hips, shoulders and hands and prior to vaccine he would had minor pain here and there, every day, but now his arthritis had really flared up badly, had to take the pain medication every day. Patient stated that He was not doing anything to cause the pain. It had stayed the same since the pain started, since patient got the vaccination, his arthritis had been getting worse. could not take arthritis medications because he had 2 blood clots for that he was on blood thinners. Patient had a type of arthritis called DISH, which was in his back and was the worst rheumatoid arthritis and osteoarthritis a person can have. Patient was in a lot of pain and took just pain killers and pain medicine as treatment as prescribed Norco by his doctor, 7.5-325 tablets to take as needed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event pain in back, hips, shoulders and hands was not recovered, and the other events was unknown. Follow-up (24May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable 63-year-old male consumer (patient) reported that included patient weight, age, concomitant medication, treatment received, outcome of events. No follow-up attempts are needed. No further information is expected.

1ST SHOT 3-5-2021. 2ND SHOT 3-26-2021 C/O ARM BEING ACHY & STILL TENDER TO THE TOUCH AFTER THE 2ND SHOT. NO ISSUES WITH THE 1ST. STATED HE HAS FULL ROM. JUST C/O OF STILL BEING SORE AFTER 2 MONTHS. ENCOURAGED HIM TO F/U WITH HIS PCP.

Experienced lightheadness about 1/2 hour after shot. Then days later, symptoms come and go. Naseua and shortness of breath continue for months. Bloodwork done, EKG showed irregular rythm, referred to cardiologist. Feeling better at time of visit, all additional tests ok. Weeks of extreme fatigue and lightheadness occur for periords lasting 6-24 hours at average. Any major activity would cause debilitating weakeness the next day. Felt so badly one night, thought he was dying, didn't go to ER (was affraid of expense). Another day again we drove to ER, but started feeling better during wait time and decided not to stay. Was going to return if not feeling good, but felt better for 3 days, longest period to date.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Injection site still sore 1 month after 2nd shot. Rash still present around injection site. Numbness from left forearm to hand gradually increased over days & weeks & is now completely numb & patient struggles to use hand & grip/pick up things. Hasn't seen MD yet since he's concerned about cost. Said this never happened before.

shooting pain down both arms; shooting pain down both arms; 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), via an unspecified route of administration, administered in Arm Right on 25May2021 (Batch/Lot Number: EW0185) as single dose for COVID-19 immunisation. Medical history included 8 years ago he threw his back out at work and his left leg died almost overnight, lost all the muscle, it was just bone, caller was tearful, 4 years ago he had a viral infection and abscess on L4, L5, vertebrae. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/lot number: EW0171), administered in right arm on an unspecified date for COVID-19 immunisation. It was reported that the patient got second shot on 25May2021 and his arms were killing him. Got shot in right arm and it was his left arm that was having a constant shooting pain that goes all the way down his arm. The patient stated that he will just be relaxing and then all of a sudden the arm would feel like he was having a shot in his arm, he could feel the veins popping out of his wrist, and felt like they were stretching. Patient called his doctor but they will not call him back. The patient was encouraged to reach out to a HCP or urgent care for any medical advice. There was no investigation assessment. Outcome of the events was not recovered.

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.

Within 2 hours of 1st Pfizer COVID injection pt had sudden onset left-sided paralysis with facial droop and slurred speech and then brief loss of consciousness with loss of bowel and bladder function. This happened on 5/21/2021. His wife is here giving the history. Him and his wife have the first Covid injection by Pfizer on 5/21/2021 at 3:30 PM at pharmacy. Within 2 hours they were back home sitting on the porch relaxing and he had the sudden onset of stroke like symptoms as noted above. EMS was called. Apparently by the time EMS arrived he had recovered to baseline and they advised him he did not have to go to the hospital for evaluation if he did not want to apparently. Since that time he has had no further stroke like symptoms but has continued to feel a bit foggy in the head with a slight dizziness.

I had a rash appear and it was very itchy. Discoloration on my skin at site of the injection. I called doctor, they said I should put a hot towel on it and keep the area clean and it should go away. My arm was sore.

The day after I had fever, aches, sore arms, and chills for the first three days. On 03/26/2021 I was rushed to the hospital which resulted in a diagnosis of Atrial- Fib.

feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away. On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.

worst case of the flu; Shakes; aches; headache; muscle pain; Still had a mild temperature; This is a spontaneous report from a contactable consumer, the patient. The A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6225) solution for injection, administered on the arm left on 15Mar2021 19:00 (at the age of 63 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) solution for injection, administered on the arm left on Feb2021 14:00 as a single dose for COVID-19 immunisation. Patients medical history included blood pressure, prostate and cholesterol medications. Concomitant medications were not reported. The patient does not had any allergies to medications, food, or other products. At other facility the most recent COVID-19 vaccine was administered to the patient. The patient does 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. The lab test includes body temperature and the result was max 100.2 degrees. On 15Mar2021 at 22:00, he experienced worst case of the flu. First 24 hours, he felt like the worst case of the flu he has had in decades. Shakes, aches, headache, muscle pain and hard to concentrate. Absolutely miserable. Still had a mild temperature. The patient does not receive any treatment for the adverse event. The clinical outcome of worst case of the flu was resolving. No follow-up attempts are needed. No further information is expected.

COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT. CANT SLEEP AT NIGHT AFFECTING MY JOB . MISSING TIME FROM WORK. NECK PAIN LEFT SIDE. PAIN IN MY CHEST LEFT SIDE. PAIN IN LEFT SIDE ARMPIT.

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.

It started to ache on April 3 in arm and shoulder and progressed, and on the 4th I went to ER because I could get comfortable and it raised my blood pressure. ER doctors gave me ibuprofen and Percocet.

The first day, I was fine. The next day, I was fatigued. Over the weekend, I was very exhausted. I did not have any sweats or anything. Easter weekend, that's when it all hit. I woke up at midnight feeling ice cold to the point that I couldn't get up to get another blanket. I slept pretty much all day the next day. About a week or so later, I started noticed little red bumps on my ankles that itched. It then spread to my knees, elbows, and lower arms. That was towards the middle of April. I kind of ignored it. I began to wonder if I was having a reaction to the shot. I started hearing a ringing in my left ear and I am still experiencing that. My PCP told me to see a dermatologist after looking at the bumps because he didn't know. I saw the dermatologist on May 19, 2021. He told me to take Zyrtec 3xday. My PCP told me to take prednisone and it didn't do anything. I also saw an ENT on June 8, 2021. He did a hearing test and said there was some loss of hearing in my left ear. He put me on an extended period of prednisone. It did not make it go away in my case. I went back to see him about 2 weeks later. He recommended for me to have a cortisone injection into the ear drum or behind the ear drum. I decided not to do that. My PCP concurred with my decision. The red bumps are now sporadic. Every 3 or 4 days they show up. I think whatever is causing it is now moving through my system. I have noticed a change in my eye sight on the left side. I have a scheduled eye doctor appointment on July 6, 2021. I have noticed an all of a sudden difference in the last 6 weeks.

within 24 hours I experienced sciatic pain, which I have not felt in years.; 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: 59267-1000-01), via an unspecified route of administration in the left arm on 15Mar2021 at 12:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN) at the dose of 10 mg. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19.On 16Mar2021, the patient experienced sciatic pain. The patient did not receive any treatment for the sciatic pain. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of sciatic pain was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

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.

Just about a week after the second vaccine, I felt some unease in my testicles a little pain and I noticed they were sagging. a week after I realized I has very little appetite for for sex. I was got worried and and when the time came, I realized I have a major ED issue. It is still the same. I was never like this and was very full of appetite before doing the vaccines.

Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection. Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).

Felt like punched in arm; Some soreness and some stiffness at the injection site; stiffness at injection site; 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: UNKNOWN), via an unspecified route of administration on 24Mar2021 at 16:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included mild obstructive sleep apnea. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) 40 mg and omeprazole (MANUFACTURER UNKNOWN) 20 mg daily; both for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 19:00, the patient experienced like punched in arm, some soreness and some stiffness at injection site. The patient used an ice pack and once taken 800 mg ibuprofen helped reduce this no worse than mild pain or soreness. Moving left arm overhead with a back-and-forth motion also provided relief. 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 events felt like punched in arm, sore injection site and injection site stiffness were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Had headache on June 30(day after 2nd Pfizer vaccine injection). Headache became persistent migraine after day 4 and only started to subside after taking 2 advil tablets per day for about 5 days in a row. In addition to migraine headache, general dizziness(lasted almost two weeks now) loss of appetite(lasted week and a half) intermittent pains in stomach active bowels(going to bathroom 4 or 5 times a day rather than once) SEVERE PAIN in left leg which could best be describe as a general Neuropathy(no pain in muscles or bones) - had to take two advil tables on separate nights to relieve pain. After fourth day of this leg pain and having taken the advil, the pain subsided and seems to be mostly cleared up. NOTE: This leg pain started on July 2(4 days after injection) and lasted 4 days. NOTES: I rarely get even mild headaches and never get any of the other symptoms.

Left arm between shoulder and elbow has become very weak and painful. It is difficult to raise my left arm (or extend it to close a car door for example).

I got symptoms like allergies but I don't know if they were allergies or not. Nothing that I thought wasn't more seasonal than anything else. The worst was extreme macular aches and pains and severe join paints. Muscles spams and cramps to the point of muscle tearing. Nothing has changed for me and time has gone on and I'm not getting them muscle spasms or pains. I'm not sure if the headaches I was getting was in relation to it or not.

So severe sinus congestion started on 2/6/2021 and on 2/7/2021 woke up with continued with congestion and body aches and flu like symptoms. Quite uncomfortable, then at about 5:00PM I started taking Tylenol. Mainly just body aches, no fever, some chills. I felt better after about 24 hours. I think I contacted my DR or something but I do not remember it was so long ago. I think I just went to my DR at the urgent care just to make sure everything was okay, he is very close to my house.

The vaccine was not diluted when given; The vaccine was not diluted when given/Given 6 times the the normal amount because they didn't dilute the vial; The vaccine was not diluted when given/Given 6 times the the normal amount because they didn't dilute the vial; Arm is feeling sore; not anything extreme; This is a spontaneous report from a contactable consumer (wife, caregiver). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jun2021 at 10:00 (at the age of 63-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Patient medical history included cardiac disorder from 2019 and implantable defibrillator insertion from 2019 both were ongoing. Patient had covid-19 In Sep. Concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO), carvedilol (COREG) ), clopidogrel (CLOPIDOGREL), atorvastatin (LIPITOR [ATORVASTATIN]), all were taken for Heart Disease, Started 2 Years Ago which were Ongoing. Reporter said that, been wanting to get it (vaccine dose) but had to get Echo and tests, got approval from heart doctor yesterday. History of all previous immunization with the Pfizer vaccine considered as suspect was None.Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were None. patient's Medical History (including any illness at time of vaccination)? Heart Disease and Defibrillator Family Medical History Relevant to AE(s) was None. It was reported that, Patient who received the first dose of the Pfizer BioNTech COVID-19 Vaccine today, 29Jun2021", received "6 times than the normal dose". It was reported that, "The vaccine was not diluted when given" according to the reporter. Reporter called the "CDC and they referred her to Pfizer Medical information". Reporter wanted to know if there was any information about patient's experience. Reporter seriousness for the events were Unspecified. Reporter stated that, patient got the shot today, 29Jun2021 at 10:00a.m. and then the pharmacy called about an hour later stating that they accidently gave him 6 times the normal amount because they didn't dilute the vial. patient was already nervous as it was, and he just got a release from his heart doctor yesterday because he has heart issues and a defibrillator, and he took a bunch of heart medications, but he knew it was important and then this happened. Patient's arm was feeling sore, but he is taking it easy not doing much. According to the phamacist that administered the shot, this is not the first time that this has happened, and they only type of reactions known with more dose is severe arm soreness. Patient's arm soreness is not anything extreme. patient had Covid in September and was hospitalized for 4 days. he got plasma, the shot for antibodies in the hospital, and they said he should be good to go, so first thing this morning, he got the shot. Treatment received for the event was None. Events did not require a visit to, Emergency Room or Physician Office. Relevant Tests performed were None. Outcome of the event was unknown. Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.

Patient/patient's wife reported reaction as "inflammation" and lack of energy/stamina with things such as climbing stairs, difficulty with normal activities that require exertion. Reports that normally he is active, fit and healthy, and that he has been having issues since the day after his second shot. Was treated by urgent care with prescriptions for azithromycin and prednisone filled 6/12/21, saying Dr. at urgent care was thinking possible pneumonia, but treatment did not help per Gregory's wife. This was reported to pharmacy today 7/19/21. Wife reports that he is still not improved.

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.

numbness in both legs; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient (brother-in-law). A 63- years- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided; 63-years-old at time of vaccination) via an unspecified route of administration, on 28Mar2021 11:00, at unknown dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (on 07Mar2021, unknown arm) for COVID-19 immunization had Numbness in leg (1 week after vaccination of first dose). The reporter stated that the patient received his first vaccine and started to have some side effects. His legs were numb with the first (on an unknown date in Mar2021). He then went back to get the second one and was still experiencing numbness in the legs. The reporter spoke to the patient last night and said that he has seen a doctor but has not gotten any treatment not anything at all. Further stated It happens in the mornings and in the evenings. Started like a week after the first vaccine. Then it started again, a week after the second. He was still experiencing this now, It has not gotten any better and is very concerned. He was not taking any medicine at all as Treatment. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

During check in, Pt stated that he had hives that started 1 week after his first Covid vaccine.Pt received 2nd Pfizer Covid 19 vaccine. During the post vaccine observation time, pt was slumped over in the chair and moaning. 0858 This nurse sat beside pt. Asked questions, pt did not answer. Attempted to assist pt to a sitting position and pt slid and was assisted to the floor. Pt lips were pink and pt was rolling on the floor and not answering direct questions. 0900 911 was called. 0902 Pt had gasping breaths. EpiPen administered in L thigh. Breathing improved.0908 Pt calm, pulse ox placed HR 92, sats 99%. 0910 Pt began rolling around again. 0913 Paramedics arrived.

Immediately - I just had moderate fatigue the day after the vaccine - and it was gone after the following day. No treatment. I started having chronic hoarseness in March. I had a visit with the doctor's partner and she came in on that same visit - on May 17th. I had a laryngoscopy that day and that is where they found the vocal chord nodule. I had surgery on the 26th of May to have the nodule removed. They did a pathology and a culture and it was HPV related and found that it was cancerous. I am still getting monthly surveillance as I had vocal chord cancer - monthly scopes. I have developed scarring and some inflammation. The voice is better but it's not where it needs to be. New med: Omeprazole - 20 mg twice a day -to make sure they can keep from getting acids on the vocal chords so they can heal (I had a diagnosis of reflux.) I was also diagnosed with Melanoma in February on my left arm. I had an incision of that and that was done on February 1st - Melanoma In situ. I will start speech on August 10th. April 20th - I had a physical with my primary care doctor and that was fine.

Sore arm; Severe tinnitus in both ears; 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: FP7533) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and tinnitus. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient received varicella zoster vaccine rgE (CHO) (SHINGRIX), dose number 1 in the arm on 27Mar2021 for an unknown indication. The patient previously took simvastatin and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 (day 1) at 18:00, the patient experienced sore arm with no other significant symptoms. On an unknown date in Apr2021 (day 5), the patient experienced sudden onset of fairly severe tinnitus in both ears, continued constantly through day 6. The patient had minor tinnitus from time to time before, but this was more intense. It was annoying, but not debilitating at the time of this report. 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 the events. The clinical outcome of the events sore arm and severe tinnitus in both ears was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Intense Intense pain at site immediately.; then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 01Apr2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included losartan potassium (LOSARTIN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 11Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 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 01Apr2021 at 09:00, the patient experienced Intense pain at site immediately then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin. The patient received ibuprofen (MOTRIN) as treatment for the reported events. The adverse event 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 vaccination site pain and pain in extremity was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

SECOND SHOT: He felt nauseated; His hiatal hernia had gotten worse since his car accident; Reported his neck was injured; my head just Spun; I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up; might have messed up my certain position of my neck and I had neck issues; SECOND SHOT: he had gotten real dizzy; SECOND DOSE: He passed out behind the wheel of his 2015 Mitsbushi Eclipse the day after he had his second Pfizer COVID-19 Vaccine; SECOND SHOT: he felt antsy after he got the vaccine shot; FIRST DOSE: with his first Pfizer COVID-19 Vaccine shot, he was down for a week; FIRST SHOT: he felt antsy after he got the vaccine shot; SECOND SHOT: He felt really weak now; This is spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0161 and expiry date 31Jul2021) via an unspecified route of administration on 15Ap2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0176 and expiry date 31Aug2021) via an unspecified route of administration on 06May2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 2, single for COVID-19 immunization. The patient's medical history included Stomach cancer, 14Feb2021 after being exposed to heavy metals. The patient's concomitant medications were not reported. Reported he had an adverse reaction to the Pfizer COVID-19 Vaccine. He said it had been one heck of a ride, and he felt like the Pfizer COVID-19 Vaccine almost killed him. He passed out behind the wheel (of his 2015 Mitsubishi Eclipse) the day after he had his second Pfizer COVID-19 Vaccine, and he knew it was the Pfizer COVID-19 Vaccine shot because he felt antsy after he got the vaccine shot. He said he felt antsy after his first Pfizer COVID-19 Vaccine shot, too and with his first Pfizer COVID-19 Vaccine shot, he was down for a week. Reported his doctor seemed to be the least concerned about him being knocked out. His doctor did not appear to be receptive to what his complaints were after he received his second Pfizer COVID-19 Vaccine shot. His insurance company was aware he was going to change doctors. The patient reported that he collapsed on 14Feb2021 after being exposed to heavy metals, and was hospitalized, stating his primary care doctor had not helped him at all. On an unknown day he felt nauseated. It was reported on 07May2021, the day after his 2nd Pfizer COVID-19 Vaccine injection, he felt antsy by the time he got home, threw his body in bed, and was down for a day. He felt nauseated, but (on 07May2021) did some sheets at the laundromat. While coming home he had gotten real dizzy, and passed out. He ended up flooring the gas pedal on his car, and bounding over the curb in his apartment complex's parking lot. He bounced his head on the front passenger side seat. He clarified he passed out over the center console of his car, and his rib cage went over the car's center console. His head bounced off of the passenger seat. He said his rib cage was pushed up inside him when it hit the car's center console, and had to do something to his insides. He said it was a one car accident, and his apartment manager may have the car accident on film. He was looking in three directions and my head just Spun, I get the sick feeling. Reported his car accident caused a tear in his hiatal hernia in his stomach and he needed surgery. Reported his neck was injured. He had follow ups with his doctor since then, and his neck had been getting worse. He felt like something foreign was stuck in his throat, so he went to the Emergency Room (on 22Jun2021). The patient needed to see an endoscopy doctor to be ruled out for stomach cancer. He was told by the Emergency Room doctor that he had a mass in his stomach, and his hiatal hernia needed repair. His hiatal hernia had gotten worse since his car accident. He stated that he went home and laid down after his car accident. He said he felt ok and had his own pain medication to take to help recover from the car accident. He clarified he took Hydromorphone that was prescribed by his pain doctor. He did not have the Hydromorphone , Lot, and Expiry Date. He had an appointment on 23Jul2021 to see doctor for a new Hydromorphone prescription. No further details provided. The patient reported he was concerned about the stomach thing. He recalled his stomach swelled up after his car accident. He tried to take oxygen through a CPAP machine after the car accident to help him feel better and using the CPAP machine was not normal. His CPAP machine worked perfectly before the accident, but now he had a problem, and could not take the CPAP machines pressurized breathing. He now fought to get a breath while the CPAP machine was pushing oxygen in because he was trying to push his breath out at the same time. He felt really weak now, and the CPAP had helped all along. I did passed out behind to wheel of my car and 'it doesn't stopped'(Further not clarified) and I didn't have any information to you because all the information I had is in back of my car. The first shot I was given 09Apr2021 no 15Apr2021 looks like, I think this was she said worked down 15Apr2021 (Further not clarified), second shot I received on May 6, but on 07May2021 at 5 pm I just passed out upon pulling into my Apartment complex and the snakes you known 'just slow you down'(Further not clarified) you know of course I didn't have any problems to slow down but there were 4 cars behind me, I am looking at the cars, I am looking at the rare view and I am looking ahead of me to make sure , you know I am following 'snake' and everything's being cool and I am been forced to go fast what I mean I was driving car but I was looking to those 3 different areas my head just Spun, I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up and I think I might have messed up my certain position of my neck and I had neck issues, that happened on 07May2021, the day after the second Covid shot, I think if I had not gotten, if I stayed down may be the thing better but First time I got the first shot, it was 3 months the same thing I felt the same like I have to be really careful you know what I did, if I did it (Further not clarified, hence event not captured ). The second one I didn't feel that way. The patient required emergency room and physician office visit. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Extreme dizziness; Nausea; Vomiting; Hot flash; Some congestion; Hoarseness; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and penicillin allergy. Concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), both on unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021 same day after vaccination (also reported as, on evening of second injection - 02Apr2021), the patient experienced extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness for the first time. The patient had sudden recurrence daily of dizziness, nausea and sometimes vomiting. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I had a stroke. My headaches were only on the left side of my temple. I've been getting a lot of nerve pain all on the left side on my body, back and leg. This pain has been occurring for over two months.

After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has severe pain in area. This limits pt's mobility.

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.

64-year-old male who presented to the clinic with complaints of left-sided weakness on his face. He stated when he woke up this morning he noticed that the left side of his mouth drooped and that he could not close his left eye all the way. Yesterday he felt fine. Today he went to work. Patient stated that on 12/18 he got the COVID vaccine. It was on a Friday. The following day he had a headache and he felt flu-like. He stated that those symptoms resolved quickly. He then had the facial weakness today (11 days after the vacciantion). He has not had any fever, sweats, or chills. Patient stated that he had called ask a nurse, and he was advised to hang up and call 911 and go to the emergency room. However, he stated he was an EMT and did not feel that was necessary. He denies headache. He has not had any vision change. He has been eating and drinking well without any difficulty. PHYSICAL EXAMINATION: General appearance - patient was not in any distress. He was conversant, pleasant and appropriate. HEENT - normal conjunctivae and lids. Sclerae anicteric. Pupils equal and reactive to light. Patient was not able to close his left eyelid. Normal ear canals. TMs are pearly gray with bright light reflex. Neck - supple. No lymphadenopathy. Skin - pink, warm and dry. Neuro - alert and oriented. Deep tendon reflexes 2+ upper and lower extremities with no focal weakness. Normal range of motion. Patient can raise his right eyebrow. Could not raise his left eyebrow. There was impaired eyelid closure on the left; tight closure on the right. Smiling of the face revealed lateralization to the right side. When frowning, he had upper and lower facial paralysis on the left with flattening of the forehead. The patient could not tighten the left side of his mouth.   ASSESSMENT: Bell's palsy.   PLAN: Discussed pathophysiology of Bell's palsy. Advised patient I recommended him to call the number that he got with the information when he received his COVID vaccine. Advised patient that I could not definitively correlate the Bell's palsy with the COVID immunization, but that he can call the number he has to let them know of his symptoms. Discussed treatment options. Since patient woke up with his symptoms this morning, I advised patient that he would have hopefully the best outcome because he would be able to get on the steroid and antiviral soon after developing the symptoms. He is to wear an eye patch to prevent corneal drying or abrasion of the left eye at night. Using Lacri-Lube at night before placing the eye patch and then following up by using artificial tears during the day.   Patient was placed on prednisone 60 mg once a day for 1 week to be taken with food. Valtrex 1,000 mg 3 times a day for 1 week.   Side effects of medication discussed. Handouts were provided. He will follow up with PCP if any changes or concerns. Advised patient that it may take up to 3 weeks before all his symptoms have resolved

Bell's palsy on the left side of his face; Headaches; Overall was not feeling well; This is a spontaneous report from contactable consumers (including the patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in right arm on 18Dec2020 04:00 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. On, 19Dec2020, the patient had headaches and overall was not feeling well. On 28Dec2020, the patient experienced bell's palsy on the left side of his face. He said it was a little hard to talk as his mouth was not working at the moment. The provider he saw gave him steroids- Prednisone, and Valaciclovir. He was also told to get some eyedrops as one eye does not close very well. He laughed and said it was a little hard to drink his coffee. The outcome of the events headache and not feeling well was recovered on 21Dec2020 while the outcome of bell's palsy was not recovered. The information on the batch/lot number and expiration date has been requested.

Vasovagal- Lightheaded, weakness with standing- patient said he was not dizzy. Stood up/ sat down 3x. Outcome: Rest, recovered.

Confusion, numbness right cheek bone area, difficult to talk and concentrate for around 15-20 minutes. Felt better and didn?t seek treatment till next day, never heard back from Dr.

Severe diarrhea, followed by severe muscle cramps; Severe diarrhea, followed by severe muscle cramps; This is a spontaneous report from a contactable nurse reported for himself. A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EL1283), intramuscular in right arm on 05Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, ulcerative colitis, prediabetes, previous hypertension, hypothyroidism, partial heart block and known allergies: Sulfa. Concomitant medication included mesalazine (LIALDA), indometacin (INDOMETHACIN), levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), zolpidem tartrate (AMBIEN), metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced severe diarrhea, followed by severe muscle cramps on 05Jan2021 16:00 with outcome of recovered in Jan2021. The events were reported as non-serious.

significant arm burning et flu like s/sx which started the evening after receiving vaccine.. Sx lingered for approximately 48 hrs Kept well hydrated et took tylenol 650mg po q 4 hrs which helped. Feel "back to normal" today 1/13/2021.. lots of sleep!!

Evening of injection started significant arm pain et flu like s/sx which lingered for ~ 48 hrs Was well hydrated et took tylenol 650mg q 6hrs.. Lots of sleep.. Feeling back to normal 1/13/2021..

Facial tingling, itching and redness; Facial tingling, itching and redness; Facial tingling, itching and redness; This is a spontaneous report from a contactable nurse (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 08Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included mild adrenal insufficiency. Concomitant medication included hydrocortisone to 06Jan2021. The patient previously took lidocaine and experienced allergies to lidocaine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. 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 had not been tested for COVID-19 since the vaccination. The patient experienced facial tingling, itching and redness on 08Jan2021 10:45. Therapeutic measures were taken as a result of facial tingling, itching and redness and included treatment with self administered chlorpheniramine 12 mg. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.

Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats

Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. Code was the result of PEA secondary to hypoxia (</= 85%), despite being on the vent, with PEEP 12, FiO2 of 100%, with acidosis. After 95 minutes of active resuscitation, the patient was found not responsive to painful stimuli. There was no palpable pulse. No spontaneous respirations. No heart or breath sounds by auscultation. Absence of pupillary light reflex.

feels tired; Exacerbation of anxiety; feels shaky; feels flushed; feels like his pressure his up; Jitteriness; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 at single dose on Left arm for covid-19 immunisation. Medical history included ongoing anxiety (had for many years), Quadraple Bypass from 2008, TAVR valve replacement from 2020, Pegylation of lung from Mar2020. There were no concomitant medications. The consumer reported he took Covid 19-vaccine (Verbatim): for protection from Covid-19 because he has comorbidities, had a few ailments. The patient experienced feels shaky, feels flushed, feels like his pressure his up, jitteriness on 11Jan2021, feels tired and exacerbation of anxiety on 12Jan2021. The event outcome of feels tired was recovering, outcome of other events were not recovered. Information on the Lot/Batch number has been requested.

fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one. He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.

15 minutes after second dose of COVID 19 vaccine patient was brought to nurses due to lip swelling. Patient took personal liquid benadryl prior to nurses. Unsure of dose patient states took "2 large swigs". VS taken. 911 called by patient refuses ambulance dispatch. Patient denies need to go to hospital states already took own benadryl and they will not do anything else. VS monitored q 5 minutes by nursing. House supervisor called and down to speak with patient. Patient denies difficulty breathing. Continues to deny need for ambulance to hospital for assessment. Patient alert and oriented and carrying on conversation without difficulty. No further increase in lower lip swelling noted by nursing. Nursing noted some flushing to face, patient states he does that from time to time but does not notice it but coworkers will tell him he has flushing. No increase in lip swelling but states now feels some nasal congestion. Patient continues to deny difficulty breathing. Patient does states still does not feel "quite right". Patient encouraged by multiple nurses to allow 911 transport. After 15 minutes of monitoring patient now agreeable to be assessed by ER and 911 called. Patient did notify spouse by phone that he was going to requested hospital- hospital Patient continued to be monitored by multiple nursing staff until ambulance arrival and transport to hospital.

Mild numbness noted in the outside of aspects of both feet and finger tips. Noted that Saturday evening two days following the vaccine. It has almost completely resolved over the next week. I am fully functional at this time.

Twitching in right shoulder area, twitching in right butt area, or another word to use is TREMORS. ITS BEEN ABOUT A WEEK NOW.

Pt received first dose of Pfizer COVID-19 vaccine on 2/6/2021. Pt subsequently developed symptoms of COVID-19 and presented to the ER on 2/15/2021. Chief complaint was cough, fever, and shortness of breath. Reports that he had a negative nasal swab as recently as 2 weeks ago. Reported that symptoms of cough, sob, and weakness started 3 days prior to presenting at ER (2/12/2021). Chest Xray had features of bilateral pneumonia. Pt is still currently inpatient at our hospital, receiving treatment for COVID-19, including dexamethason and remdesivir. He is currently receiving 3L of supplemental O2 via NC.

After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became lethargic, clammy and passed out. Patient was revived with smelling salts, for a few seconds and the faded in and out of conciseness. Sternal rub was preformed in order to attempt to keep patient awake and present. Vital signs where taken, BP was elevated at 155/ 115. Patient was still not coherent at this point patient was team lifted to wheel chair and taken to the ER. Patient remains in the hospital at this time admitted for observation.

Immediate pain in left arm day of vaccination. Next day pain radiating down left day. Worsting day bay day. 12 days later, unable to walk. Went to hospital 2/15/2021, for inability to walk and radiating pain down both legs. At that time, found out that i possibly diabetic in addition to the pain.

Elevated blood pressure. Brother picked him up after it went down a bit. He felt hot after the vaccine and has a past history of heart problems. Heart rate and pulse were normal.

Patient reports right sidedness numbness starting two days after vaccination. Next day numbness was on left side. Numbness has resolved.

Patient is a 64-year-old male who has received 2 doses of the pfizer coronavirus vaccine. He received his last dose last week and started having pain in the shoulder which gradually spread to include the upper back and neck region. The pain would radiate down into the arm. he describes the pain as a very deep constant ache with no real aggravating factors. The pain is worse when he is lying down at night. It is best when he is up and active. He has no specific pain with movement of the neck, back, or arms/shoulder. He denies any lumps or bumps at the injection site. He denies any color changes in the overlying skin or swelling. He feels numbness in the entire hand in a stocking glove distribution.

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

Fever (to 103F), Encephalopathy (Confusion, somnolent) - improved with resolution of fever (with Tylenol)

Sunday, February 28, 2021 around 7:30 to 9:00 consumer said the left side of his mouth felt different. Then as time went by we both noticed the left side was different. Couldn't smile on left side like the right side. His right eye blinked a lot more than the left eye. We did FAST testing for strokes. He was fine with his arms & legs. We went to the medical center around 2:00 p.m. They checked him out did a CAT Scan, they seem to think it is Bell's Palsy. The put him on Prednisone and Valacyclovir and Eye Lubricant Drops. Consumer had a follow up with Dr on Tuesday March 2, 2021 at 8:45. He agrees with the diagnosis, however Dr wants consumer to Have an Ultra Sound on Neck and MRI Wednesday March 3, 2021 at 3:00 for US and 4:00 for MRI.

Within 5 minutes felt flushed , high blood pressure and heart rate, body trembling, red skin rashes.

It was reported to us that at @1822 the patient sustained a Seizure at home. EMS was called and arrived to initiate CPR. CPR was performed but the patient was declared deceased by EMS at his home.

Less than one hour after shot - extreme sense of needing sleep. Took 30 minutes nap in car after stopping at convenience store. Over the next 36 hours, loss of strength, extreme aches and joint pain, fever up to 101.2, fatigue,

The day after receiving the COVID injection I started experiencing shooting pain and tingling in left arm, then a day or two later experienced a burning sensation in lower left arm. The pain in left arm significantly increased over the next few days and on Friday evening developed blisters in the palm of left hand. On Saturday, March 6, 2020 was diagnosed with Shingles potentially caused from the COVID vaccine.

Client had clonic/tonic seizures x2 within one minute of receiving the COVID-19 vaccine, first dose. Within 3-4 minutes of the seizure activity, client was awake, alert, oriented x3. Client was placed on a stretcher by paramedics and transferred via a stretcher to the observation area. Client remained awake, alert, oriented x3. No incontinence noted. Client was transferred to the hospital by the paramedics to the hospital within 10-15 minutes after seizure activity. No other family members were present with client.

Arm soreness at injection site Temp 102 F for 48 hrs Severe shaking chills, rigors for 48 hrs Headache 72 hrs Severe myalgias for 72 hrs Joint pain 72 hrs Sweats, particularly at night for 72 hrs Fatigue for 96 hrs Took multiple doses of Tylenol 1000mg over course of 72 hrs.

I took my nightly statin pill about 6 hours after receiving my 1st vaccination shot and went to bed. About 4 hours later, I woke from a sound sleep with the most painful cramps in both lower legs that I've ever experienced. Both feet were flexing upwards and my lower calf muscles taught uncontrollably. I managed to get out of bed and onto my feet to put my weight on them; but had to balance on a nearby chair. Only after an intensely painful 45 minutes did the muscles begin to relax!! (When first prescribed statins 10 years ago, I found they particularly could cause a cramp in one of my legs at night. Only after trying several varieties of statins and lower doses did I find one --the generic Pravastatin-- and dose that would not trigger this nighttime cramping. In further defense, I also try to stay hydrated and drink a glass of water before going to bed each night.) *NOTE: In order to avoid that incredible pain, I DO NOT plan to take my statin pill the night when I get my 2nd dose!!

Terrible cramps diarrhea nausea vomiting constipation a high fever of a 103 or more Muscle aches sore skin joint ache Worse than the flu

SORE LEFT ARM AND NECK, LETHARGIC, LIGHT HEADNESS, HEADACHE, SOME SOB TX- SLEPT/ REST MORE AND DRANK EXTRA FLUIDS

Extreme muscle weakness beginning 48 hours after second Pfizer shot. Confusion and slurring of some words. Difficulty walking. Still experiencing mild symptoms almost one week after the second shot.

Immediate onset of uncontrollable chills and fever of 100.8. Muscle aches and major malaise. Later chills/hot flashes occurred.

Low blood sugar; felt a little warm; Headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9809), via an unknown route, on 19Feb2021 (at 13:45) at a single dose on the right arm for COVID-19 immunisation, administered at hospital. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318) administered on right arm on 29Jan2021 at 12:30 PM. Relevant medical history includes type II diabetes. No known allergies. Relevant concomitant medications included metformin, insulin detemir (LEVEMIR) and insulin lispro (HUMALOG).The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. On 19Feb2021 (in the evening), the patient had a bit of a sore arm and slight headache, she took 2 ibuprofen before bed. She took medications as normal, food intake nothing unusual. She was woken up at 2:00 am by her continuous monitor which she kept at the side of her bed alarming her of low blood sugar. She never got that. Sugar level was 40. She had a glass of milk and some candy and it reversed. The monitor saved her. On 20Feb2021, she just had a slight headache, felt a little warm and she took Ibuprofen. The event low blood sugar was considered a life-threatening condition. The remaining events were assessed as non-serious. Post-vaccination COVID test was not performed. The patient was recovering from the events.

Extreme chills started at +/- 8:30 pm. Patient went to bed - fell asleep at about 8:45. Woke up periodically during the night drenched with sweat. Got up the following morning at about 8:00 am. Arm was sore but tolerable. Temperature was 98 F.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: initial dizziness, loss of consiousness for roughly 30-60 seconds, body rigidity before waking up-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: 4-5 minutes after vaccinating patient he reported feeling dizzy, when accessing patient he became unresponsive and breathing became louder, he became pale and lost consciousness. 911 was called. His face began turning red and with the help of 2 individuals we lowered him to the floor, his arms became rigid for abotu 5 seconds, and upon trying to wake him/checking for vital signs, he came to and was aware of where he was and that he had just got a vaccine. he did not recall the event post dizzine

Fatigued, strong dull headache and body ache from Sunday afternoon until Tuesday afternoon, flu like symptoms without the fever. Injection arm slightly sore, 1st injection much more sore than 2nd. Took (2) each 200mg ibuprofen every 4-6 hours through Wednesday afternoon.