Pfizer

lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulation Symptoms are mild with a loss of taste and smell continuing

Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts dose on 19Dec2020; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date not provided), via an unspecified route of administration left arm second dose on 07Jan2021 07:45 at singled dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation (first dose, Anatomical Location: Arm Left and lot number EJ1685). On 07Jan2021, the patient experienced Headache, blurry vision, fevers, chills, body ache. The patient did not received treatment for the events. Second dose on 07Jan2021 (19days) after first dose on 19Dec2020. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Since vaccination patient was not tested for COVID-19.

30 seconds after receiving COVID19 Pfizer vaccine # 1, felt dizzy, felt HR and BP increase, and pressure in throat. RN at vaccine clinic confirmed HR to be tachycardic (rate unknown) and BP (170/98) to be elevated. 50 mg IM Benadryl administered and brought via wheelchair to ER which is connected to. ETA 2 -3 minutes.

About 3 minutes after the shot I begin to taste it in my mouth and seconds after that my pinky and ring finger on my left hand went numb and has been like that ever since. At one point my whole hand tingled. I even had pain in my bicep on the same side

Developed fever on the 3rd day after injection but only lasted over night then on the 5th day there was a lose of sense of smell and taste that lasted for 3 days. Two covid test results were negative

Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer. A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Inmate seen in health services with complaint of left ear pain extending into left cheek and around his mouth. He has some drooping of the left side of his mouth and he is not able to blink or close his left eye. He noticed symptoms on 1-23-2021, the Saturday after getting the COVID 19 vaccine on 1-21-2021 (Thursday). Had some trouble swallowing liquids without having them dribble out the left side of his mouth and he says that he is not able to chew on the left side without biting his tongue. Says that his left ear is causing him a great deal of pain.

STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT ARM AND AXILLARY PAIN ,

I have a reaction to the flu shot so my MD recommended that I premedicate with Zyrtec. I did one hour prior to injection. Around 5 minutes after my injection I could feel my throat swelling. I alerted the nurse and took a Benadryl tablet. The swelling stayed consistent and I was able to breathe so I waited for an hour and then went home. When I arrived home I felt and increase in the swelling so I took another Benadryl. The swelling slightly decreased but was still present for 5 hours post shot and then disappeared. The only other reaction I had was metallic taste in my mouth and extremely sore arm where injection was given for 2 days.

Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed. States speech was affected due to tongue swelling. No respiratory distress. Took Benadryl 25mg approx. 45 minutes after symptom onset. Symptoms improved 1 hour after taking Benadryl dose. Does NOT plan to receive 2nd dose due to immediate allergic reaction.

Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.

Within a few days of the first dose of the vaccine patient noticed extreme thirst, then increased urination frequency. Patient noticed unintended weight loss starting 2 weeks after first dose, and totaled 20 pounds in 5 weeks. Patient noticed some burry vision at night. Symptoms seems to lessen 2-3 weeks after first dose, but returned with increased intensity after second dose. Patient consulted a physician and lab work and blood sugar testing was ordered. Blood sugars were as high as 400 and A1C of 11. Patient went on a low extremely low carb no sugar diet for three days while waiting to see physician. Patient continued to monitor blood sugars. Blood sugars started to lower remained in the 170-260 range. Physician ordered repeat lab work and suspects Adult Onset Type 1 diabetes. Patient was placed on a long acting and quick acting insulin on 2-15-21. 23 Days after second dose.

My parents live with my family of four. My father was exposed to COVID when he was in the hospital from 1/19-1/21 getting his hip replaced. My mother and wife lost their sense of smell on Sunday 1/24. They got rapid and differential PCR tests on Tuesday 2/2. The rapid test came back positive for both of them. I served as primary care provider for all four of them during their illness. I started to experience mild symptoms on 2/13. Symptoms included: reduction in sense of taste and smell (could not smell cinnamon or taste spicy foods), headaches, runny nose, waves of nausea. I went to an medical center on 2/16 to receive the Rapid, PCR, and flu differential tests. My Rapid test came back negative but my PCR test came back positive on 2/17.

Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.

After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my tongue became numb and felt s=slightly swollen, throat became extremely dry, pulse rate increased from low 50 BPM to 100 BPM. Drove to a nearby store and stopped, felt a bit disoriented when trying to call my wife. Drank water and waited at a store for approximately 15 minutes until I felt better. This was about 40 minutes after the vaccine was administered. When driving home still some discomfort/numbing of the tongue and throat. Ate at 1:30 and symptoms had stopped.

I received the second Pfizer-BioNTech Coronavirus Vaccination on February 18th and on February 20th i started to experience and currently am experiencing Bilateral Tinnitus ringing in both ears for the last 14 days. The Tinnitus is shifting in quality at times. Doing some head tapping on the lower back of the head with my fingers does temporarily help with the symptoms.

began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1

Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeling you get right before you go under from anesthesia. My heart began to race and I was lightheaded. I reported the reaction and was given an oximeter to check oxygen and heart rate. Heart rate was 140, oxygen 99. BP was also checked and was normal. Was given water and sat for another 10 minutes. Felt better and heart rate was under 100 until another wave of lightheadedness came over me and heart rate spiked again to over 120. It came down again. A few minutes later lightheadedness came back, shaking started, and heart rate spiked again. It lasted about 10 minutes. After 55 minutes of staying at facility I was able to leave. However, did have one more brief episode of lightheadedness and heart rate spiking. Sore arm and extreme ringing in one ear were only side effect the following day.

Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection; mild and lasted for 1-2 hours.

patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb. he also felt shaky & dizzy

Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hours

Began with myokymia (twitch) in left eye which persisted for almost 2 months. Has since spread to right eye. Now experiencing blurred vision, double vision, and random muscle twitching in limbs.

Within a day and a half swelling of the face, especially around eyes. Rashes on face at brow and cheeks with flaking skin, in addition to hive on forearms. The following morning, today, it has become much more severe.

5 minutes after taking the vaccine, my right part of the upper lip felt swollen and after 4 days I noticed most of my upper lip is swollen. Today after 6 days I feel both lips are swollen

8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour. Afterwards mild headache, fatigue, nausea persisted for 2-3 days.

Started to develop a clogged ear feeling 2 weeks after shot and started to hear ringing in the ear that seems to change in its frequency

Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been clenching it for a long time.

Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked up and could not bare weight on it). Tiredness; Second dose 48 hours; Fever 101.8; Tiredness; Severe headache; Sore Arm; Approximately 1 month after 2nd dose unknown if related. Sudden hearing loss left ear; Tinnitus; Lightheaded.

Strange/metallic taste in mouth within 10 minutes of administration. Lessened by 24 hours post administration; resolved by 60 hours.

Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2) Extreme thirst: symptoms are still active; At the minimum, I consume 366 fluid ounces (2.859 gallons) of water per day. (3) Blurry vision: symptoms are still active; (4) Dizzy/lightheadedness: symptoms ongoing; (5) fatigued/tired/muscle fatigue: symptoms ongoing: (6) fever/chills: symptoms no longer present as of April 6, 2021. (7) Extreme weight loss (30 lbs/13.64 kgs); (8) Neuropathy of both left and right hands: symptoms still ongoing; (9) Mental fatigue: symptoms still ongoing.

Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg

Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pain on the left side the evening of the vaccine. H/A is recurrent and has not changed. Has treated with ibuprofen , Sudafed, and Nasacort. Was seen by PCM on 4/7 and diagnosed with Neuritis and given Prednisone 30mg taper.

bump on tip of tongue. unsure of it was there before. no numb, no tingle, no angioedema, no sob, no stridor. no acute distress. declined further assistance and ER.

COMPLAINED OF TONGUE TINGLING, NO SHORTNESS OF BREATH OR SWELLING. NO ITCHING, GIVEN 25 MG DIPHENHYDRAMINE. LEFT IN STABLE CONDITION

patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every 10minutes patient later after third set of vitals stated he was feeling back to normal patient was escorted back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18 o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.

Tinnitus developed around 3/22/21 after first dose. Never had Tinnitus before and it has not gone away.

Post Vaccine COVID. 2/4/21, onset of congestion and funny taste. PCR + 2/5/2021. Had multiple family members in the home +

Blurred vision, sensitivity to light and trouble focusing sight. It began a few weeks. After first dose. I have no prior vision issues.

Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after second shot, has not stopped yet. No treatment.

Woke up with chills and fever of 102. Treated with ibuprofen and acetaminophen. Had fever and muscle aches all day Thursday. Woke up this morning with a strange pain in my left eye socket, felt like a headache but inside my eye ball, it goes away when I sit and lie down and comes back when I stand up. Vision in that eye was blurry, but slowly returning. Continue to have muscle aches and fever, but they are lightening.

Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within two hours

note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.

Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.

Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, blurred vision for extended periods of time during multiple days.

My lips became extremely red and swollen a couple of hours after the shot. I think there was some other minor face swelling around the nose, but the lips were the main issue. I took Benadryl for a few days and the lips were back to normal in about a week.

I have a constant ringing in my ears and sometimes a ringing/reverberation sound when people talk or listening to almost anything. It has not improved overtime.

Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had a really big temporal headache. I thought it was a reaction to vaccination, I took Tylenol PM, layer down and woke up in the middle of the night, in a full body sweat. I went strait into chills, changed my clothes. Layed back own and awoke the next morning, with chills and temp of 101. I had body ache but proceeded with my day. I continued to have chills, I went out to my elderly parents, took them food and had dinner. Upon arrival home, had high fever 103...no Tylenol. Awoke still w/ chills and high fever and this was Sunday. Stayed in Sunday then the afternoon, felt like I needed to seek help. I went to get a rapid test at Medical Center and it came back Neg. Went back home, I could now sense that my taste was altered. I then continued to have a high fever but they would only come at night. Body sweat, aches, chills cont'd on Sunday. Monday still had same s/s and Tuesday, I thought that I should seek more medical attention. I went to an Urgent Care 3/9/21. They then did a nose swab and felt that it would come back Neg. I went home and on Thursday 3/11/2021 I got a call that I was positive. Did isolate. But from 3/5 to 3/11 then I lost taste/smell. Came out of isolation 3/20 and on 3/21 my whole left side of fact, shoulder and leg went numb for approx 1hr. Then my wife said that I was talking a little slow in my response. Next morning my left shoulder was hurting and I had pain. The Urgent care provider wanted to r/o TIA so he sent me to ER for full work up and that doctor said he saw nothing. He didi say that it could be Covid related and/or possible TIA. "I am feeling good today" There is no residual but because of the left shoulder pain I did go back to Urgent Care. Got cortisone inject and MRI. My PCP then told me that I had a partial "tear" in my left shoulder but I do exercise every day and could have done it then.

Tinnitus within the hour of shot. Ringing continues in ears indefinitely. Other symptoms that went away within 48 hours were fatigue, cold chills, lethargy, and head ache.

Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the next day only), and tiredness (for a couple days). However, I have experienced tinnitus starting the evening of injection, and it hasn't disappeared or even dampened since.

Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following issues: Present on Admission: ? Intraventricular hemorrhage (HCC) ? Bilateral thalamic hemorrhage ? Acute encephalopathy ? Abnormal eye movements ? Respiratory failure requiring intubation (HCC) ? Mucoid impaction of bronchi

Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/21. Patient alerted EMT. Patient stated that she was sweating a lot and felt like his vision went blurry/dark for about 3 minutes. Patient stated that he also felt nervous. EMT alerted PHN. PHN suggested to move patient to zero gravity chair. Patient walked with assistance from EMT to gravity chair. Patient walked over and sat down safely on gravity chair. EMT took patients vital signs. BP: 118/60, pulse: 65, O2: 97%. Patient was given water. PHN recommended that patient stay an extra 30 minutes. Patient agreed. EMT re-assessed patient. Patient stated that he was feeling a lot better and that his vision was completely fine now. Patient left vaccination site unassisted and with a steady gait at 1150.

4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Shakiness-Mild

Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.

Started with continuous ringing sound(mild) in right ear, 3hours after pfizer covid-19 2nd shot. It decreased intensiveness, but still happening sporadically. It is kind of beat around 10 times per minute. No quality of life issues.

Pt was given the 1st Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol. After 10-15 minutes, he came to the pharmacy counter stating he felt hot and sweaty. His eyes then rolled backwards and he collapsed on to the floor. He was unresponsive, his head and back arched and he slightly rocked while on the ground. I went to make sure he didn't hit his head and patient became responsive. We tried to have pt stay on the ground, but he refused. Therefore we moved him to a chair and elevated his legs. 911 and store medical assistance were called. After the ER services arrived and examined pt, left on his own and stated he felt fine now.

Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on 4/2/21 and 2nd vaccine on 5/7/21 around 1500 pm today. Pt. received 2nd vaccine in left arm. Symptoms started twelve minutes in 1522 pm and in cluded: headache, back of shoulders feel "super tight", soreness to the back of neck, and headache is b etween patient's eyes as well as blurry vision. Pt. states that his shoulder pain is 10/10 and headache is an 8/10 Pt. denies shortness of breath, denies chest pain, denies trouble breathing. Pt. denies numbness, d enies tingling. Instructed patient to go to the Urgent care for evaluation.

low frequency hearing loss; Right Ear Fullness and Ringing/Tinnitus; Right Ear Fullness and Ringing/Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 40-year-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 15:00 (Lot Number: ER8737) as 1st dose, single for covid-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced right ear fullness and ringing/tinnitus. No symptoms before and it had been constant since. Followed up with Hearing test showing low frequency hearing loss on 02Apr2021. Previous (unrelated) hearing test 3 months earlier shows no hearing loss (normal) in 2021. The events were serious disability. The events start date was on 02Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken including prednisone. The events outcome was not recovered.

Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.

Tinnitus in my left ear; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 15:00 (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included high blood pressure and Allergy: Penicillin. The patient's concomitant medications were not reported. On 01May2021 at 15:00, the patient experienced tinnitus in his left ear. The outcome of the event was not recovered. The event results in doctor or other healthcare professional office/clinic visit. The event was considered serious with disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

In the face sensation in my mouth like anesthesia from a dentist difficult to breathe my nose was completely stuffed up I had to go to the emergency room.

Patient with swelling to left side of lip, throat, and difficulty swallowing after receiving covid-19 vaccine . Pt had vaccine on 5/22/ 2021(Saturday) and had delayed reaction on 5/23/2021 (Sunday). Pt treated in ED with Sodium Chloride 0.9 % IV Bolus, diphenhydrAMINE Inj 25 mg (BENADRYL), Famotidine (PF) Inj 20 mg (PEPCID, methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF).

50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.

Bradycardia, hypotension Diaphoresis, pallor, visual disturbances - Patient treated for hypotension via IV/Fluid administration. - Patient transported to Medical Center

Tinnitus, I now have a very high pitched sound in my left ear. It is high pitched like a dentist drill. That is the best I can describe it. It had a onset of approximately 24 hours after my first shot of Pfizer.

Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now after breathing and trying to call myself down as it panicked me. Cuts and scrapes on hand and knee and elbow from falling. Scary as luckily I made it home driving ok.

Developed sudden hearing loss in right ear. Along with Tinnitus and fullness with a day or two of the vaccine.

Tightness, pressure on chest. Shortness of breath when I take short steps. Dizziness when I stand too long and shortness of breath. Blurred vision

I immediately had numbness in my mouth and face as well as a metallic taste in my mouth. Since receiving the first shot I have had allergic reactions to various foods at an alarmingly increased rate. I have not been able to isolate which foods/ingredients. Symptoms include swollen lips and tongue, splotchy red face and the slight constricting of my esophagus.

Severe tinnitus post vaccine. Has not abated for a full month after vaccine . No tinnitus history prior to vaccination.

I had a headache an hour after the shot. Then I had muscle pain in my arm for five days after. Then, in the afternoon, my ears started ringing and it lasted weeks. I saw a doctor who told me he had seen it in other patients who experienced the same. Said it was inflammation.

Patient stated he had experienced usual side effects from the vaccines including fatigue, frequent urination (every hour) and blurred vision. Those symptoms only lasted 3 days after his first covid vaccine, but persisted since he received his second dose on 6/8. He denied having shortness of breath, irregular heart rate, hives or any other anaphylaxis reactions. No new medications or health conditions as he was aware of. He will continue monitor more symptoms and he has scheduled an appointment with his primary provider in couple weeks

I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.

From the second week of the vaccination I began to perceive a smell of burning or smoke. It started gradually on Thursday July 1st with low intensity of the odor and few events per day. AS of Sunday July 4 the smell reached its maximum and the events per day were prolonged. On Monday July 5 and Wednesday July 7 the events were similar to that of July 4. On Tuesday 6 and Thursday 8, the intensity of the odor remained but the events decreased. As of Friday the 9th the events have been few (1 to 3 a day) with less odor intensity than past events, and the duration periods have decreased. On Thursday 8th I consulted with an otolaryngologist, he asked me for a PCR COVID 19 test, which was negative. As a result of the above, he suggested me to contact you and inform of this. As a treatment, he asked me to do olfactory retraining smelling lemon, rose water, cloves and eucalyptus in series, 4 times a day for 2 weeks.

Tinnitus - ringing in the ears. I was working from home that week while my family was out of town and noticed the intensity of ringing ramp up over the course of the week. I received my shot on Monday afternoon and by the following Sunday morning, the intensity was so great that it was difficult to concentrate/comprehend what was said during a church service. I saw my ENT doctor the following week and got a hearing test, which picked up some slight hearing loss. Since then, intensity has fluctuated day to day and in different environments. The left ear is worse than the right ear. At the time of this report, I've experienced several days of consecutive ringing that has been about the most intense that I've experienced. I've been told there is no effective treatment for the condition, but I've utilized lipo-flavonoid with mixed results. Ringing seems to be less intense after nights where I've slept well, but that is increasingly challenging.

Tinnitus immediately in right ear, a week or so later progressed to complete hearing loss in right ear. Corticosteroids had no effect. Complete deafness in right ear still present 3 months later.

right eye looks like he has pinkeye; consistant dry cough; He tested positive this week.; He is ill with Covid-19; cold; being knocked out; being in bed all day; He is ill with Covid-19; He had chills and sweats; He had chills and sweats; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 40-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) via an unspecified route of administration in left deltoid on 26Feb2021 14:06 as dose 1, single (at the age of 40-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left deltoid on 19Mar2021 for COVID-19 immunization (to protect from the Covid19 disease caused by SARS-2, as reported). He had a PCR 24Jun2021. He received positive results today. Vaccine was not administered at Military Facility. Patient medical history included ongoing pernicious anemia which was diagnosed 6 years ago. The concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) intramuscularly at a dose of 1 ml weekly with daily dosage as 0.143 ml taken for pernicious anemia. Patient received both doses of the vaccine. He had been out of the country since last Saturday (for 5 days) and stated it was not correct that he had been out of town for a few weeks. He had a PCR test last Thursday and it was negative. He started having symptoms on Tuesday and thought it was a cold because he was vaccinated and there were always colds going around. He went to get a decongestant after being knocked out and being in bed all day. The antigen test for Covid was positive and the antigen test was validated by a PCR-24 test yesterday. He stated somehow in the last 7 days he has become Covid positive. He was ill with Covid-19 and was isolated. His flight was tomorrow and he could not come back until he was negative. He stated it was very inconclusive that he may be testing positive, vaccinated or not, for up to 90 days. He stated he cannot afford that. He heard it tossed around on the news that breakthrough cases generally create mild to moderate infections that do not last as long. He spoke with his doctor who said he can test positive for up to a month. In the news they stated that even if people get infected, after the vaccine there is a level of protection. He stated the people he was with did not test positive for Covid. He wanted to know how long it will be until he tests negative. He stated he felt kind of duped with all the masks being removed because clearly there are risks. He understood that it was not 100 percent effective. He stated he felt like he was being hustled because he had been diligent and tried to really believe in science and the federal government that he would be protected. Additionally, he stated there must be research on breakthrough cases of Covid and how long until they test negative if they have already had the vaccine. He felt like he had no resources to understand what you would be looking at with antibodies from the vaccine combined with a Covid infection. He wanted to know if people get infected with Covid after having the Covid vaccine, was the level of protection just from symptoms or is it the length of viral load.He has has had both Covid shots. He went out of the country a few weeks ago and was fine. Then he left and went to #. He cannot come back because he is positive for Covid. He had a PCR 24 last week and was negative. Had symptoms which he thought was a bad cold. He tested positive this week. He went to for a walk to the pharmacy on Wednesday to get a decongestant because he thought he had a cold. He did not go to any meetings because he did not want to get anyone sick. At the pharmacy they were doing antigen tests. He knew that he needed one to travel back to the United States. He took the tested and waited 15 minutes. He received the results which were positive. He did not have a fever. He had chills and sweats but did not have now. Yesterday (01Jul2021) he developed a consistent dry cough. Today (02Jul2021) his right eye looks like he has pink eye. He took some natural cough syrup and it helped. He had a PCR 24Jun2021 with positive results. The events did not result in emergency room or physician office visit. Description of Product Complaint included patient tested positive for Covid after receiving both doses of vaccine (Lot number- EN6206). On an unspecified date in 2021, the outcome of the events chills and sweats was resolved, outcome of the event dry cough was recovering, outcome of the event COVID-19, vaccination failure and pinkeye was not recovered, while that of the other events was unknown. Information on lot/batch number is available. Other information is requested.

When I woke up the morning after the second shot my upper lip was inflated and numb.; When I woke up the morning after the second shot my upper lip was inflated and numb.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 18.45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B. The patient had no known allergies. Concomitant medications included tenofovir disoproxil fumarate (VIREAD). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 19:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021 at 07.00, the patient woke up in the morning after the second shot and experienced inflated and numb upper lips which got much better by noon. The patient did not receive any treatment for the reported events. 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. On 25Mar2021, the patient have undergone nasal swab and the result of the test was negative. The clinical outcome of the events inflated and numb upper lips was resolving at the time of this report. No further information is expected. Information about lot/batch number cannot be obtained.

Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.

Ringing in ears-tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 27Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 06Mar2021 at 14:30 (at the age of 40-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 02Apr2021 at 12:30, the patient experienced ringing in ears-tinnitus. 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 event. The clinical outcome of the ringing in ears was not recovered. No follow-up attempts are needed. No further information is expected.

Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and nausea.

About 30 minutes after the injection my throat became swollen, and I felt pressure in my ears. I had difficulty swallowing, and some pain in my upper longs with coughing.

Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriate schedule of vaccine administered; Joint pain; Significant body aches; Lethargy; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient previously took augmentin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. 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 06Apr2021 at 15:30, within 30 min the patient experienced warm sensation from left cheek down left arm. Within 3 hours headache. Within 12-18 hours post: dry mouth, significant body aches, joint pain, headache and lethargy. No therapeutic measures were taken as a result of 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 warm sensation from left cheek down left arm, headache, dry mouth, significant body aches, joint pain, headache and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient's reaction(s) noted during COVID vaccine observation period: lips tingling like when he eats shellfish; has shellfish allergy  Actions Taken: Vital signs taken and within normal. Pt felt okay enough to go home.  Disposition: Patient declined ED visit

Nurse working in Emergency Dept, developed first COVID sxm (mild cough) on 03 Jan 2021. On 05 Jan 2021, he received dose #2 of COVID vaccine (Pfizer lot EL1284). On 06 Jan 2021, sxms progressed to include fever, congestion, impaired taste and smell. On 06 Jan 2021, NP swab for PCR was performed and confirmed positive... patient being managed as outpatient.

Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swelling. I was placed in the Immunizations Clinic treatment room, had my airway assessed, and vital signs taken. My initial vital signs at 0950 were BP 197/99, HR 106, O2 sat 99%, temp 98.3 F, and 0/10 pain. Over the course of the next 2 hours, I repeatedly had my vital signs taken, was monitored, was provided with water, and remained hypertensive and tachycardic, although down-trending. I also experienced cottonmouth and bilateral blurred vision/dry eye. At the end of the 2 hour monitoring, the throat swelling seemed to subside, my systolic BP in the mid 140s and diastolic BP was in the mid 90s. At time of release from monitoring, I felt better, but dry eyes and dry mouth continued without difficulty swallowing. I was instructed to report to the ER if my symptoms worsened and to consult by primary care manager about the incident. Upon walking back to my office, I realized I was experiencing dizziness as well and a mild headache. I attempted to submit this form online but I received an error message, so I completed the fillable version to upload, in case a partial duplicate record appears.

Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.

Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.

Approximately 13 hours after receiving COVID vaccine #2 (no events occurred after dose #1) patient developed hives over his face and neck, followed by tongue itching and swelling. He took oral antihistamines but due to ongoing tongue swelling he contacted 911. He was taken to the ER and given IV steroids and Benadryl, then discharged after being monitored for 1 hour.

Approximately 13 hours after receiving vaccine #2 patient developed hives over his face and neck, then felt tongue swelling & itching. He took benadryl and zyrtec and due to tongue swelling called 911. He was evaluated in the emergency room and given IV steroids and benadryl, then released after being observed for 1 hour.

received dose 1 at 8:40am and woke up the next morning at 7am with hearing loss in left ear and constant ringing in the left ear. have never had this issue before.

Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning. Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.

his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021), via an unspecified route of administration in arm on 13Jan2021 02:00 at single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). Concomitant medication included hydrochlorothiazide and lisinopril, both for blood pressure. The patient just took the vaccine on Wednesday (13Jan2021) and had a reaction, not sure if it was from the vaccine or not and he was just calling that in to report that as it can be related. The patient got vaccinated on Wednesday at 2 O' clock and no major issues, just sore arm. However, Friday (15Jan2021) afternoon he had woke from a nap and his eye felt irritated. He was still experiencing a swollen eye. So, he was calling about the swollen eye, red eye. He never had something like this before, didn't take anything that might cause it, the only thing unusual was because he got the vaccine. Treatment included using a cold compress only, not ingesting anything. The outcome of events sore arm, eye felt irritated and red eye was unknown, swollen eye was not recovered.

2 days after my vaccination, randomly, the right part of my mouth went numb and the right part of my upper-lip swelled. I only get relations like this to things I eat. This happened while at work around 2:30pm and lasted until about 7pm

teeth are extra sensitive to cold and sugar; headache; some chill; This is a spontaneous report from a contactable consumer reporting for himself. A 41-year-old male patient received bnt162b2 (BNT162B2, Lot no: EN5318), via intramuscularly on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications was not reported. 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 stated: "my teeth are extra sensitive to cold and sugar a day or two after my vaccine. Otherwise just a headache and some chill, but those went away after 12 hours. Tooth sensitivity persisted 48 hours after vaccine." No treatment was received for the events. The outcome of sensitivity of teeth was not recovered, headache and chills was recovered on an unspecified date.

Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.

Rash started in left armpit and around left armpit. Two reddish/purple spots below waistline. As the days after onset the rash continued to spread and the reddish/purple spots enlarged. Eventually after 2 weeks there is one large red spot between bellybutton and privates stretching between the hips. Rash has spread to mouth, neck, both upper arms, both armpits, front and back of upper torso, and is on the upper legs. Used benadryl pills and cream, hydrocortisone cream 1% and 2.5%, permethrin cream, Zyrtec, hydroxyzine HCL 25mg, prednisone, and montelukast 10mg

Reports swelling/tingling of lips to 2nd dose. For 1st dose, reported same, swelling of lips 2 hours after. EMT called to assess pt. Vitals taken. No other symptoms.

He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.

Severe pain in the left eustacean tube from the ear to the throat, including jaw. Feels like intense pressure/blockage, but still able to voluntarily open the tube (pop your ears) and no increase in mucus discharge or congestion. No swollen lymph nodes in the neck. Pain got up to a level 6/10. Took Extra Strength Tylenol and went to bed early. Following day it still aches some, about the same as the arm area of the shot. Not sharp pain any longer but sore.

Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous

Metallic taste in mouth starting ten minutes after injection, reporting event approximately 8 hours later and metallic taste is still present.

Slight metallic taste on front of tongue starting 2-4 minutes after injection, lasting at least 30 minutes. (Still experiencing it as I write this.)

Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising and gum bleeding.

suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Patient received vaccine on Thursday. Did not start experiencing adverse reactions until Sunday morning. Patient had swollen lymph nodes from neck to ear canal with fever and pain. He also had hives above the left eye on the eyelid and eye was red and itchy. He also experienced a headache and low grade fever. These reactions have not resolved (as of Monday), however, they are slightly improving.

03/31/21 10:31 am 1 minute after the first dose, metal taste in my mouth (like a mouthful of nickels) that lasted about 5 hours. 04/02/21 08:00 am small headache when I woke up and whistling in ears feels like a small hangover but i haven't been drinking anything for weeks

Day after the vaccine I was very tired with muscle aches and a headache. Two days after my right ear has been ringing and wont stop.

Noticed all dairy had different metallic taste. Drank milk at approx 2:30pm same day of vaccine, and noticed a very metallic taste. Also ate macaroni and cheese at approx 6:30 pm same day, and metallic taste was still prevalent. All other foods tasted normal.

Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic

Presyncope (lightheadedness, nausea, blurry vision). Normal vitals. Symptoms improved with supine rest and oral rehydration.

Extreme Nausea and runner vision within 30 seconds of vaccine administration. Symptoms went away on their own

Bilateral Conjunctivitis with sensation of heavy eye lids, photophobia, and increased lacrimation started as mild symptoms day after vaccine then became more noticeable over the next few days. patient states that his symptoms seem to be better in dimly lit environment

Very loud tinnitus developed in left ear. Have always had low grade tinnitus, but never to this degree.

complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.

Anaphylaxis treated with EpiPen, Steroids & Benadryl It began as a hives on 04/16 around 8 PM, the morning of 04/17 I had swelling in my eyes, lips and tongue, Along with difficulty swallowing. I was treated with epinephrine on 04/17 around 1 pm and then again on 0/18 around 11 am.

Bilateral high pitch ringing in ears with aural fullness. Ringing started one day after I received the 2nd dose of the Covid vaccine. Once it stated it has not stopped or even diminished. I did not previously have any ringing in my ears. The duration has now been over 2.5 months.

Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.

Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migraine like headaches and nausea. Symptoms are lessened with sunglasses. Onset is within minutes of being in direct or overcast sunlight. Symptoms have persisted for 8 consecutive days since vaccine.

Patient had received his 2nd dose of Pfizer vaccine at 1020. After about 5-7 minutes he started to feel "flush". He spoke with medical personnel onsite and it was explained that reactions like that are common. Was advised to remain onsite for further observation. Approximately 10 minutes later PT started to feel a tingling in his lips, face and a little on his tongue. Medic on site administered 0.5ml of liquid antihistamine, and was advised to wait another 10 minutes for more observation. After next block of time PT stated that he "felt well enough to leave and was comfortable with everything" PT left site at 1108

lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; tired, really tired; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41-years, at single dose in left upper arm on 16Mar2021 at 12:00 (Lot Number: EP6955) for covid-19 immunisation. The patient medical history was none. Weight was 99.79 kg and Height was 191 cm. There were no concomitant medications. The patient previously received tetanus vaccine for immunisation when he was a kid. The patient reported that he had his first shot and was scheduled to take second shot today (on 06Apr2021). He stated that two days after the first shot, on 18Mar2021, he didn't have any arm pain, nausea, vomiting, or headaches. He lost hearing out of right ear. He already went to the physician about it. He was scheduled to go to Ear Nose and Throat doctor on 12Apr2021. He stated they checked his ear and everything. The hearing loss was not related to any kind of ear wax or anything. He went to urgent care, so they were limited to what they can do, and he was referred out to Ear Nose and Throat. He said everything sounded muffled and liked a constant buzzing in that ear. He had never had this problem. That doctor was going to check his ears and would do a hearing test on 12Apr2021. He confirmed that the hearing loss started on 18Mar2021. He also confirmed that the hearing loss was still ongoing and it was about the same, or persisting. The patient also reported that after the first one he didn't have the side effects that they claim to have. He hadn't died from it. He was just tired really tired, two to three hours after the shot, he got the shot at 12 noon, so about 2 to 3 o'clock. He laid down to rest and went to sleep. He woke up the next morning, went to work and was fine. He stated that other than that no headache, no arm pain, no diarrhea, no vomiting. He just felt foggy like brain fog the following morning after the vaccine till about mid-day and it went away. It only lasted four or five hours. He confirmed that was on 17Mar2021, as well as, that he had recovered completely. The patient received treatment and included that prescription medication for ear: Ofloxacin 0.3%. Instill five drops in the right ear two times a day for seven days. There was no additional vaccine administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event outcome for Hearing loss, Muffled hearing in both ears and Ear buzzing was not recovered, while for Tiredness and Foggy feeling in head was recovered on 17Mar2021.

He tested positive for Covid on 30Mar2021; bad cough; severe fatigue; lost his sense of taste; loss of appetite; everything tasted like metal; Lost 15 pounds in 2 weeks; feeling sick; inflammation; This is a spontaneous report from contactable consumer (patient's mother) via Pfizer sponsored program. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination 41 years), Solution for injection) via unknown route of administration, in the left arm on 23Mar2021 at single dose for COVID-19 immunization. Medical history included asthma, the reported stated that it was quite scary. Concomitant medications were not reported. On 24Mar2021, the patient had bad cough couldn't stop coughing for 2 weeks, it was awful and the patient was a nonsmoker and he sounded like someone who had been smoking for 70 years. It was a deep horrible cough. He was afraid to get the second shot, and she doesn't want him to be afraid if the symptoms weren't from a reaction and the patient went to the emergency room and they sent him back. She almost lost the patient as an infant with aspiration pneumonia and had severe fatigue which had gone better just in the last day or 2. The reporter had minor symptoms, but her son's symptoms progressed to the point where they told him he had to get a COVID test. The patient was not feeling right beyond 48 hours and was still thinking it was a reaction from the shot. On 30Mar2021, the patient tested positive for COVID. On an unknown date in 2021, the patient started loss of appetite almost right away a couple days after he got the vaccine. He must have had COVID at the same time. Patient was gaining his appetite back. Patient had lost his sense of taste too. Patient had also lost her sense of taste and her sense of smell. He just said that everything tasted like metal. Nothing tastes normal it was the same for her as well. His appetite was coming back, and his cough was subsiding. The patient had inflammation, which was treated with steroids and inhaler and the patient was little overweight and lost 15 pounds in 2 weeks, feeling sick. The reporter asked 4 different doctors and got 4 different answers. Her son was exposed to COVID through his children from school. They had closed the classroom because the teacher had COVID. No one else in the house was positive. On 08Apr2021, (Yesterday), the patient felt a little better which was a blessing. She thinks he was getting better due to the medicine from the pulmonologist. He got a pulmonologist to have a virtual visit and they gave him steroids and an inhaler which has helped and just starting to get a little better. The patient was due for his second dose of the vaccine on 13Apr2021, but she doesn't know if it was okay for him to get it now. The patient had chest X-ray was negative and the patient did not have pneumonia. The outcome of the event cough, fatigue, ageusia, decreased appetite, dysgeusia, was recovering and the other events COVID-19, weight decreased, malaise was unknown. No follow-up attempts are possible. Information about batch/lot number could not be requested

I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.

Dr., reports that pt experience Bells Palsy 12 days post-vaccination. Dr., reported that pt went to Hospital on 4/17/2021 and released same day; pt was prescribed Medrol dose Pak and Acyclovir. Pt was seen by Dr., (general practitioner & ophthalmologist), Dr., discontinued the Medrol dose Pak and Acyclovir and prescribed Prednisone 60/40 to be taken for a week and Valtrex 1 mg to be taken TID x7 days; Dr., also ordered protein spikes for IgM and IgG Herpes Zoster & Herpes Simplex, basic blood test. Pt have follow up appt today with Dr., since pt is starting to develop dry eyes and he cannot close his eyes, pt is prescribed artificial tears drop for use during the day and CELLUVISC eye ointment to used during the night. Dr., recommends that pt refrained from getting the 2nd dose until more is known based on pt.'s condition; from his professional experience Bell's Palsy can dissipate in 4-6 months and not uncommon after post flu vaccination. Advised Dr. per CDC Bell's palsy is not a contraindication to getting 2nd dose of the vaccine. Advised we agreed with his recommendations that pt should postpone his second dose to see if his symptoms dissipate first. 4/21-Spoke to Dr. and he had concerns of patient receiving second vaccination shot. I advised currently per CDC there are no contraindications with vaccine and Bell's Palsy. Recommended for him to contact CDC hotline for further advice and transferred his call to CDC Covid hotline. Dx with Bell's Palsy; feeling more movement on the face today. Working with Dr. in regards to treatment and second dose of Pfizer vaccine. Will contact next week to follow up.

24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus, bloody gums/tongue the next morning(heavy). Sinuses went down, bloody nose stopped in 3 hrs, and teeth stopped bleeding a few hours later. No more bleeding now, but still have a little headache.

At the medical facility, within minutes of taken the shot, my left eye vision started to get blurry. I started to sweat. Medical personnel took my blood pressure and said it was high. They had me rest on a bed for 10 minutes. They gave me water and juice. After 2 days of the vaccine, I feel strange heart palpitations every 1 or 2 hours. My blood pressure reading is at 147/88.

On 4/25/21 he began experiencing congestion, sore throat, fevers, loss of taste and smell. He recently returned from travelling and tested negative for COVID on 4/23/21.

I got the shot (this my second in the series). No adverse effects immediately. I went to bed that night, and woke up just after midnight to tremendous ringing in the ears. I thought I was hearing something outside, but it was in my ears. I also had very sore body muscles. I got up the next day the the symptoms persisted.l throughout the day. The body aches slowly diminished and eventually went away, but the constant ear ringing has persisted. Today is the 9th.

Tinnitus in both ears. Started a few days after 1st vaccine. Received 2nd vaccine on 4/29. No change as of 5/10.

Tinnitus with onset the next day after first injection. Hissing sound in both ears. Has lasted 5 1/2 weeks so far. Some days it is barely noticeable and other days it is very distracting and causes anxiety.

Eye irritation which progressed to severe swelling, such that patient could not fully open his eyes. The swelling occurred on the eyelid and below the eye to about the jawline. Went to urgent care on 5/4 and was prescribed steroid. Swelling persisted until roughly 5/10 before returning to normal. At the same time, patient broke out ink a series of rashes on his arms, legs, ears, and torso. The rash continues to evolve, spread to new locations, and change appearance.

Joint aches Dry mouth Soar throat Bump under armpits (right side) Back pain Shivering Tiredness Hedache

Dizziness & Right sudden sensorineural hearing loss - profound - still undergoing treatment, minimal recovery of hearing thus far. Dizziness Symptoms started within 2-3 days after 2nd Pfizer COVID vaccine.

Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.

Tinnitus, popping sound in the ear. Two days after the vaccine it started. it was happening once or twice a day, but has become more frequent. Symptoms started after the first shot of the Pfizer vaccine. Will NOT be returning for the second shot.

Got LURRY, DIZZY, COOL, CLAMMY- legs raised, icepack applied to neck, apple juice and crackers given, fan air patient felt better, patient mentioned not eating much earlier today

had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.

2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 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. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events. Follow-up attempts are completed. No further information is expected

Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.

I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started feeling bad (I was seated). My whole body was sweating and my vision was affected (everything was bright). I was able to return to the store but was close to passing out. I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well. After that time the sweating stopped and my sight was no longer affected. This was not anxiety and I have no history of fainting with shots. This was a reaction to the shot. After about an hour I felt fine except for muscle soreness at the injection sight. If the reaction was any worse I would have passed out or asked for help. I am hesitant to get a second dose out of concern that the reaction could be worse.

1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.

My arm was tender for a couple days. I had a slight deal with my eye where I had swelling in my right eye lid. I went to the Family Clinic and was given some lubricant to put in my eye.

Shortly after my shot I developed a phantom smell of smoke, while it is not an unpleasant smoke smell, it smells like firewood burning in a fireplace. It is concerning because I can't tell if I am smelling a real smoke smell or a phantom smell should a fire occur. It goes away but comes back. I notice the smell more when I am getting ready to go to sleep or when I am not actively doing anything . At first I thought it was someone in my neighborhood burning firewood all the time, but as time went on I asked my wife is she smelled it and she said she smells no smoke. So I just monitored my self, but as of today I am still experiencing the phantom smells since March 2021..

headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea

I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing in my Right ear as well but not nearly to the extent I have in my left ear. I also experienced frequent, daily headaches for about the first month or so after the shot. I also experienced neck/right shoulder stiffness for about 3 weeks following the shot. I continue to wake up on a daily basis with a feeling in my head and ears like I've been listening to loud music or been in a loud sporting event for several hours (on top of the still nonstop/constant ringing in my left ear that will not go away). I have also experienced swelling in my feet and ankles anytime i'm active for an extended period of time

About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination. Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.

Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness

Moderate tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via unspecified route of administration in the left arm on 21Mar2021 at 10:00 AM (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in the right arm on 28Feb2021 at 10:00 AM (at the age of 41-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 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced moderate tinnitus. The patient did not receive treatment for the reported event. The clinical outcome of moderate tinnitus was unknown. No follow-up attempts are needed. No further information is expected.

Dizziness; Metallic taste; Metallic smell in mouth and nose; Eyes feels warm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration on left arm, on 23Mar2021 at 09:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On an unknown date, the patient had experienced dizziness, weird metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain. No therapeutic measures were taken as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness, metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain was unknown. No follow-up attempts are needed. No further information is expected.

After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines. 4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed. 4/292021 Dr. prescribed steroids and stronger antihistamines. 5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines. 6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run. 6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.

On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Sunday, July 4th, I still had the lightheadedness, tightness in my chest, rapid heartbeat, and it was more difficult to breath unless I was sitting a certain way. On Monday, July 5th I had severe chest pain, difficulty breathing, fluttering and pounding heart, when I took a deep breath I would feel my heart pounding but at a much slower rate and then it would go back to normal beats, severe ringing in the ears, extreme tiredness. This lasted for about 1.5 hours and I went back to bed and when I awoke 4 hours later my heart seemed to beat fine. Chest pain lightened up a bit, but breathing is still difficult. I?m very healthy and have not had any health issues. The heart issue this morning was so bad that I?m not sure if I should get the second dose. If things worsen, I will contact my doctor. I?m hoping that it goes away soon and this will be alleviated on its own, but I?m really worried about getting the second dose even though I want it.

Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. 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. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown. Information on the lot/batch number has been requested.

Restlessness, anxiety, tinnitus, vertigo. Prior to the second dose of the vaccine I wasn't under a doctor's care for any of those issues. One or more of the above issues have impacted me daily since 3/30. I visited the emergency room on 4/2 because my anxiety was so bad it felt like I was having a heart issue.

Loss of taste and smell, resolved within 2 weeks. Fatigue, intermitant dull pain left side chest. Worse at night laying down. Not as noticeable during the day. Fatigue and chest pain are ongoing.

Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling of hand; high blood pressure; rash on legs; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from biopharmaceutical company (MFR Control No. # 21K-163-3802407-00) from a non-contactable consumer (patient) A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 single intramuscular on 04Mar2021 (Batch/Lot number was not reported) at age of 41 years for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 7 D) for ankylosing spondylitis . Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss (medically significant) on Mar2021 with outcome of not recovered , swelling at injection site after covid vaccination (non-serious) on Mar2021 with outcome of recovering , vertigo (non-serious) on Mar2021 with outcome of not recovered , swelling of hand (non-serious) on Mar2021 with outcome of recovering , high blood pressure (non-serious) on Mar2021 with outcome of recovering , rash on legs (non-serious) on Mar2021 with outcome of unknown , allergy caused eye to swell (coded as allergic oedema) (non-serious) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure measurement: high on 2021 . The clinical course was reported as follows: The patient had a relevant medical history of asthma.On an unknown date, the patient experienced allergy caused eye to swell. In March 2021, the patient experienced hearing loss, swelling at injection site after Covid vaccination, vertigo, swelling of hand, high blood pressure and rash on legs. Pfizer BioNTech Covid-19 vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 04Mar2021, after taking Covid vaccine patient had swelling at the injection site, high blood pressure, hand swelling, rash on legs, hearing loss and vertigo. He had an allergy that caused eye to swell.The action taken with Humira was unknown The reporter stated that there is no reasonable possibility that the events are related to HUMIRA .While for Pfizer Biontech Covid-19 Vaccine reporter's causality was reported as probable for Hearing loss and vertigo and unknown for the other events. AbbVie's causality for all events vs Humira was reported as follows: No reasonable possibility The reporter's assessment of the causal relationship of all the events except for hearing loss and vertigo with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow up attempts are possible. Information about lot/batch number cannot be obtained; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events deafness, vaccination site swelling, vertigo, peripheral swelling, hypertension, rash, and allergic edema and the suspect drugs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of face felt numb; mouth and left side of face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. 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 03Apr2021 at 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, 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 headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.

Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. 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 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,

left eyelid severely swollen; eye lid or perhaps eyeball under lid sore to touch; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: unknown), via an unspecified route of administration on 29Dec2020 13:00 in left arm at single dose for COVID-19 immunization. Medical history included seasonal allergy and asthma from an unknown date and unknown if ongoing. Concomitant medication included zinc, vitamin C [ascorbic acid], vitamin B3 and Elipta for asthma. The patient had historical vaccine Tetanus and experienced allergies. On 30Dec2020, the patient woke up the next morning with left eyelid severely swollen then took anithistamine Allegra, it got better as the eye lid or perhaps eyeball under lid sore to touch for next 24 hours but getting progressively better. The facility where the most recent COVID-19 vaccine was administered in a nursing home or senior living facility. 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 outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. Information on the lot/batch number has been requested.

Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.

In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and still on steriods and breathing treatments and still haven't gone back to work.

I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 after the vaccine, I developed a severe headache with ?brain fog,? confusion, and hyperacusis. The headache has now persisted for 10 days and was severe enough that I missed several days of work this week as I was unable to carry out my clinical duties. I was seen in ED this past weekend and ultimately followed up with neurology after the headache had persisted for 7+ days. The working theory is that I may have developed aseptic meningitis as a side effect of the vaccine and I am currently on a steroid taper which has resulting in partial but significant improvement in my symptoms. I am back at work but still experiencing a mild headache and facial parasthesias. I did request a Covid test in ED 1 on 1/10/21 and tested negative.

Received 1st dose of Pfizer-BioNTech at approx. 10:00. While waiting in observation area for 15 minutes after vaccine, client started to feel dizzy and notified nurse. Client requested EMSA at this time. Client moved to the floor to lay down and legs were elevated. Client then reported numbness of the tongue. No swelling visualized. 02 via nonrebreather mask initiated at 10:21 and EMSA called at 10:25. BP monitored (130/82 at 10:23, 142/78 at 10:27, 130/81 at 10:37). Client reported the numbness in his tongue went away. EMSA arrived at 10:41 and transported by ambulance to hospital for further evaluation.

Client reported dizziness and requested an ambulance. BP taken and client continued to report dizziness. Client moved to lay down on the floor and elevated feet. Client then started to report numbness in his tongue and the room "spinning." EMSA called. O2 via non-rebreather given. BP continued to be monitored (130/82 at 1023, 142/78 at 1027, 130/81 at 1037). Client reported symptoms improved- tongue no longer numb. EMSA arrived at 1040 and client transported to ambulance and taken to hospital for further evaluation.

This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included salbutamol (ALBUTEROL) for asthma. The patient experienced left side of his face went numb, his eye became swollen on 09Jan2021 with outcome of recovered. Caller stated this lasted 8 hours and then went away. Caller stated he used an ice pack during the reaction. The outcome of the events was recovered on 09Jan2021.

On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.

Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine. 3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity. 3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that "it's nothing." 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired. 4:55 PM: Patient was transported to the emergency department for further evaluation.

Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today

Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi administered on site. Patinet transferred to ED and discharged with prednisone.

I have a history of auto immune anemia and ITP. I checked with my hematologist when scheduled if I should take the shot. They stated to take it as not enough data was present to prevent me to take. On 02/11, I spoke with doctors onsite and discussed my medical history. They advised to take the shot as not enough data was present to prevent me to take. On 02/14, I noticed bleeding in gums and petechiae at the injection site. I went to hematologist on 02/15, and platelets were at 2,000. I started 60 mg of prednisone immediately on 02/15. By 02/19, took blood sample and eceived one 70g dose of IVIG. Blood results came back on 02/20, and platelets were at 22,000 but did not cover results from after IVIG treatment. Hematologist decided to stop follow up IVIG treatment and stick to 60mg of prednisone daily as in the past my body has reacted well to it. On 02/24, platelet count went to 300,000. I've started to taper prednisone to 50mg and will continue with weekly blood tests to verify that platelets remain strong. Hemoglobin and all over blood levels in the CBC remained normal during this time. Hematologist has advised not to take second Pfizer COVID-19 shot due to risk.

He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored every 5 minutes, and he was given 20 mL (50 mg) liquid Diphenhydramine. At 11:50 A.M., his heart rate dropped from 99 to 51, and he experienced a brief loss of consciousness for about 3 seconds. He also became diaphoretic and very pale at the same time. His pulse was weak but present, and his eyes rolled back in his head. 911 was immediately called, and a sternal rub was provided to help patient regain consciousness. EMS arrived at 11:56 A.M. and transported patient to the hospital for further evaluation. Patient was alert and talking upon transport.

Coughing; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable consumer (reporting for himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3302, expiration date unknown) via an unspecified route of administration in the left arm on 25Jan2021 (at 42 years old) at a SINGLE DOSE for COVID-19 immunization. The patient received the vaccine at a Hospital, reported as "Military Base." The patient had no medical history and had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID since the vaccination. On 26Jan2021, the patient experienced coughing, loss of taste and smell. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient treatment for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.

After the first vaccination I had a scratchy and sore throat. 42 hours after the second vaccination, I developed hives all over my chest, neck, and back and my tongue swole and became numb. I went to urgent care and the symptoms began to diminish, but the doctor prescribed prednisone and antihistamine.

Approximately 20-25 minutes after receiving the vaccination, it became difficult for me to swallow. My ability to breathe was unaffected, but it was incredibly difficult to swallow, like I could not generate any saliva naturally. Approximately 20 minutes after that, my tongue went numb. The symptoms went away several hours later after taking a couple of doses of Benadryl and Loratadine.

Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.

Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Patient returned to clinic at approximately 10:45 with complaints of left arm numbness, tongue tingling, tongue swelling, and speech difficulty. 0.3mg Epipen and 50mg benadryl was administered and patient immediately reported resolution of tongue swelling and speech difficulty. Patient was transported via EMS per clinic protocol.

Tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 14:45 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient had no 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 didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within two weeks of vaccination. On 03Feb2021, at 16:00 the patient experienced tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop. The patient visited physician office. It was unknown whether the patient received any treatment for the event. The event was reported as non-serious by the reporter. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Starting on day 13 after my first dose of the COVID vaccine I started having tinnitus bilaterally. I?ve never had any ear issues prior. The ringing is constant. I initially did not think much of it until it got louder 2 days after my second dose of the Pfizer COVID vaccine. I got my second dose on March 12th and 48 hours later the ringing got much louder.

Approximately 15 minutes after injection, I first felt tightness in my left neck area, followed by a numbness sensation on the left side of my face and abdomen. Sensation has subsided in the abdomen area but remains on the left side of the face. Lower left eyelid twitches on its own throughout the day.

Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.

Pt. passed out for about 2 minutes. Skin and lips were very pale. pt hunched over to the right while in chair. eyes flattering and very diaphoretic. Pt was helped to lay down on the floor in supine with legs elevated. clothes loosened, applied cold icepacks and deep breaths were encouraged. Pt . gained consciousness and was able to retell what had happened.

Patient received the vaccination and after he got up from the chair, he passed out and fell to the floor. The intern notified the pharmacist. When I went to see that patient, he was laying on the floor with his eyes rolled in the back of his head and was unresponsive. He was not alert. He started having a mild seizure and I rolled him over on his left side. While I was bracing the patient, pharmacist came in and administered an Epi-pen to his left thigh. Patient stopped seizing so I rolled him back on his back. He became alert and was able to provide me his name, DOB and what he was at the pharmacy for. I rested my hand under his head and monitored his pulse until the paramedics arrived

2 weeks after the 1st vaccine shot I was diagnosed with bell's palsy. The right side of my face shut down. I lost the sense of taste on that side. I was prescribed Valacyclovir HCL 1 gram tablets and Prednisone 20 MG tablets on 3/15/21.

Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop

Has urticarial swelling of upper face, periorbital areas and upper back; no wheezing or throat swelling

I have mild to moderate tinnitus. My tinnitus became moderate to loud following the injection (began one day after I received the jab) and has not subsided since.

Patient suddenly became diaphoretic eyes rolled back in head, almost passed out . Onsite EMS was called vitals HR 42 BP 95/59 98% O2 refused glucose check. Patient felt better and reluctantly was transported to local hospital. No reaction to 1st vaccine on 3/12/21

3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS IF HE COULD NOT GET AIR. nO STRIDOR OR WHEEZING NOTED. PT.SPEAKING WITHOUT DIFFICULTY. PLACED ON STRETCHER, PALE, DIAPHOREETIC. EPI PEN INJECTED TO LEFT QUAD. BP 147/100sat 100% ON ROOM AIR HR 92. MD AT BEDSIDE AND PATIENT TRANSFERRED TO ER FOR EVALUATION.

I developed ringing in both ears. I had never had this condition before and it does not go away. There are days where the ringing is louder than others. It's hard to function like this.

Started having neck pain on a Thursday, my taste buds became less sensitive but I could still taste on Friday and late Saturday night my left side of face started feeling numb. Went to hospital on Sunday morning when I woke up since left side of face was completely numb. Diagnosed with Bell's Palsy.

Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services

anaphylaxis. throat closing, tongue tingling, couldn't breathe within a few minutes of injection epipen and Benadryl given on site, sent to hospital for observation, treatment with allergy medications and steroids for five days after. Observed in hospital for four hours. Advised by primary care doctor not to get second dose or any other covid vaccines due to reaction.

Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services

I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receiving the vaccine. I went to urgent care. Was diagnosed with Bell's Palsy. I had Bell's Palsy about 20 years ago and went away after a couple weeks. Haven't had any symptoms since.

Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomnia, fever, chills, brain fog

All symptoms ongoing and have not stopped Bi-lateral tinnitus (high pitched ringing) Ear Ache both ears Swollen Lymph glands in neck Fatigue Body Aches

42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation

Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightness, difficulty breathing, feeling lightheaded. Patient noted to be diaphoretic, less responsive, and having left eye deviation. Patient assessed/examined by Dr. and Medics on site. Vital signs taken: at 10: 38 a.m., BP 177/126, HR 118; at 10:39 a.m., BP 172/120, HR 110, O2saturation 96% on room Air; at 10:41 a.m., BP 173/123, BG: 333, sinus rhythm on cardiac monitor. At 10:47 a.m., BP 158/78 (with manual cuff). Fire Metro Paramedics called; Patient transported to Hospital at 11 a.m.

Tingling lips that progressed to tongue and later to throat. Epinephrine.3 mg was given and pt sent to hospital via ambulance.

About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.

Loss of hearing in right ear followed by tinnitus; Loss of hearing in right ear followed by tinnitus; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:00 (Batch/Lot number was not reported), age at vaccination of 42-years-old, as single dose for covid-19 immunisation. Medical history was none. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported. The patient experienced loss of hearing in right ear followed by tinnitus on 03Apr2021. The events resulted in emergency room/department or urgent care; it was unknown if treatments were given for the events. No other vaccine given in in four weeks. The patient was not tested for covid prior vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 08Apr2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.

debilitating headache; Pressure in both ears; Tinnitus, a constant ringing in his ears; the pressure was so painful in one of his ears/felt like it was physically painful; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732 and expiration date not provided), via an unspecified route of administration, in arm left, on 01Apr2021 14:00 (at the age of 42-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. Medical history and concomitant medications were reported as "no". No relevant family medical history. The patient experienced pressure in both ears on 01Apr2021; tinnitus, a constant ringing in his ears on 01Apr2021; the pressure was so painful in one of his ears/felt like it was physically painful on 01Apr2021; and debilitating headache on 06Apr2021. The patient had the vaccine on 01Apr2021 (reported as "last Thursday"), and the same night, he developed pressure in his ears and tinnitus, basically a constant ringing in his ears. The pressure was so painful in one of his ears that it felt like it was physically painful. He compared it to a child having their first ear ache- it was maybe something like that combined with a really bad headache. He clarified he had a debilitating headache, and it was probably so bad that he considered for a moment going to go to the hospital but he did not, instead he took three ibuprofen (ADVIL) and that helped. Patient had not been to the doctor yet in regards to his symptoms, and stated he had a scheduled appointment Friday with an ENT doctor. Patient didn't have pressure in ears before the vaccine. He had constant ringing in his ears that doesn't subside. There's a link between his symptoms and the vaccine. He was in completely normal shape before he decided to get the vaccine. Patient's weight was 225-230 lbs (unknown date). The outcome of the events "pressure in both ears", "tinnitus, a constant ringing in his ears" was not recovered, of other events was unknown.

initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.

Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.

Woke up that night with excessive tinnitus that is continuing 18 hours later (now 27 hours after injection). It is constant and loud enough that I am having great difficulty hearing people speak, listening to radio at normal volumes (it must be very loud to be heard over the tinnitus)

Left ear sudden hearing loss; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (Batch/Lot Number: Er8734) as a single dose for COVID-19 immunisation. Medical history included asthma. Allergies were unknown. The patient's concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 12:00 PM. The patient experienced left ear sudden hearing loss on 14Apr2021 20:00. Event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included high dose steroids. The patient underwent PCR COVID Nasal swab test: negative on 14Apr2021. Outcome of event was recovering.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event left ear sudden hearing loss cannot be excluded completely. The case will be reassessed once more 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.

Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.

Sudden Idiopathic Hearing Loss; clogged ear feeling; Hearing whistling noises; approx. 30-50% of hearing in right ear; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 18:30 (Lot Number: EP6955) (at the age of 42-year-old) as single dose for COVID-19 immunisation. Medical history included eosinophilic oesophagitis, hypertension and enlarged prostate, all from an unknown date and unknown if ongoing. The patient did not test positive to COVID-19, pre or post vaccination. Concomitant medications included clonazepam; lisinopril; omeprazole and tamsulosin, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced allergy. On 17Apr2021 at 09:00, the patient was diagnosed as "Sudden Idiopathic Hearing Loss" in right ear. He woke up to clogged ear feeling. Hearing whistling noises and approx. 30-50% of hearing in right ear. The events were serious, disabling. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone. The patient outcome of the events was not recovered.

Shingles like rash along v cranial nerve on the left side only, extreme pain in left ear, left eye, left upper jaw.

Started with tongue becoming numb (4/27)and by next day (4/28) his face was sagging and he couldn't feel the left side of his face - called PCP and they suggested he go to the ER to rule out stroke . While there they diagnosed him w Bell's Palsey and issued prednisone and an anti viral ( not sure of name). said to reschedule 2nd does 10 days out so rescheduled for 5/10. On 5/10 Husband called PCP office as his ear has been bothering him to see if he should still get his 2nd dose - Nurse called back and said they don't suggest it . He has PCP follow up on 5/13 - rescheduled 2nd does later that day in hopes he can receive it for full vaccination . As of 5/11 he can kind of blink on left side and can open his mouth more . mentioned that side of his face feels sore / bruised

Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report from a contactable consumer reporting for himself. A 42-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Apr2021 12:00 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation (Age at vaccination 42 years) . The patient medical history was not reported. The patient received the first dose of BNT162B2 vaccine on 14Mar2021. The patient's concomitant medications were not reported. The patient experienced ringing and buzzing in ears and head on 06Apr2021 08:00 with outcome of not recovered , insomnia on 06Apr2021 08:00 with outcome of not recovered , high blood pressure on 06Apr2021 08:00 with outcome of not recovered. All the reported events were considered Important Medical Events. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Apr2021 Nasal Swab. The patient received prednison and zolpidem (AMBIEN) as a results of the event. Information on Lot/Batch number was available. Additional information has been requested.

Severe ringing in both ears. I have not sought treatment. The ringing is a constant high pitch ring and throughout the day as the ringing gets worse it will also throb to the pace of my pulse.

1) Rapid heartbeat, multiple incidences in the days after vaccination. No treatment, still in process of experiencing these incidents. 2) Tinnitus

metallic taste in mouth; breathing problems; This is a spontaneous report from contactable consumer as a patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 04Mar2021 at 14:00 pm in the left arm as a first dose for COVID-19 vaccination. Medical history included gastro esophageal reflux disease (GERD) and asthma. Patient was allergic to Penicillin (manufacturer unknown), Doxycycline (manufacturer unknown), trees, nuts, shellfish and environment. Concomitant medications within two weeks of vaccination included Xyzal (manufacturer unknown), Omeprazole (manufacturer unknown), Vitamin D (manufacturer unknown) and Multivitamins (manufacturer unknown). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic. On 15Mar2021 at 02:00 am (10 Days after the shot), the patient had breathing problems and metallic taste in mouth. The adverse event resulted into Emergency room/department or urgent care. The patient reported that, he was never admitted before for asthma. Therapeutic measures for the reported events were Albuterol (manufacturer unknown) and Albuterol, Steroids intravenous injections (manufacturer unknown). The clinical outcome of breathing problems and metallic taste in mouth was reported as recovering. Information about lot/batch number cannot be obtained and no further information is expected.

Pt got vaccine in R arm and began to feel arm and shoulder pain five minutes after. Pt also began to feel lip and facial numbness. NO sob. No rashes noted vitals assessed and patient released. Last VS: T: 1259, P: 76, BP: 136/99, SpO2: 98%.

Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, chest pain, loss of taste. All were subsiding and have come back since the first injection and have not abated for 2 weeks. Fatigue is particularly intense in the morning, loss of taste is now constant.

Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.

Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday with my By Sunday the 16th I began having pressure and some irritation. Went to urgent care Monday the 17th. They said I had pink eye. I immediately began using the prescribed eye drops. It's important to mention no one in my family has or had pink eye nor have I knowingly come in contact with it. By Friday the 21st there was no improvement from the medication and I began t developed severe light sensitivity and blurry vision. I went back to urgent Care 5/22. They prescribed a different medication for pink eye and referred me to an eye specialist.

? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm started to get sore. ? 17:30 EDT - dizzy after sparring class. Blood pressure 107/71. Pulse 59 BPM. Burping. Gassy. A bit nauseous. Watermelon smelled like cut grass (awful). Forcing myself to drink orange juice. Tastes terrible, like Sweet Tarts (My wife says it's just me). ? 20:30 EDT. Found antidote. Antidote is pie. Cherry pie. After kimchi chicken and smokra. Update: Feelin' fine. ? Thursday, May 20, 2021: ? ~ 05:00 - hard relapse. Arm very sore (8/10). Fairly nauseous. Almost regurgitation level. At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat. Bad headache (7/10). Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad. ? By 9:40, temperature up to 99.6. ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79 ? 2:50 temperature 99.7 ? 3:30 temperature 99.6 ? Friday, May 21, 2021: ? Update about yesterday (Thursday): I ended up spending the entire day in bed. Very nauseous. Couldn't eat. Spiked a high fever (my baseline is around 97.5° F). Blood pressure fluctuated. High pulse (mine is usually around 50 bpm). Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up. Except for not vomiting or coughing, it felt like the flu. ? Head still hurts (4/10). Weak. Tired. Arm still pretty sore (3/10). Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021: ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine. Still have the headache (2/10). ? Sunday, May 23, 2021: ? About mid-afternoon, the headache finally receded. Left arm still sore in a 1/2" radius from the injection site (1/10).

Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.

pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for 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. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Head pressure began 4 days after 2nd dose and continue to persist today (45 days) after 2nd dose. The head pressure causes dizziness. The head pressure sometimes is mostly on the left side and shifts to sinus pressure and left ear pressure. When the head pressure shifts to sinus and ear pressure, dizziness subsides. The head pressure almost everyday but there were a few days where the the pressure subsided. Took zyrtec for 4 weeks but had no effect. Took flonase for 1 week and had no effect. Sudafed sometimes helps relieve pressure for a few minutes but it persists soon after.

Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patient reported that he experienced left sided body muscle aches/spasms, fatigue, neck pain and visual disturbances on 5/29/21. Stated his heart felt like it was racing for a short time but it may also have been anxiety because he knew his dose was given early. Symptoms resolved by 5/30/21.

Eye and facial swelling; Eye and facial swelling; This is a spontaneous report from a contactable consumer (patient). A 42-years-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, administered in Arm Right on 07Mar2021 as FIRST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient previously took clindamycin and experienced drug hypersensitivity. On 07Mar2021 16:30, the patient experienced eye and facial swelling. The patient has not received any treatment for adverse events. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minutes post vaccination to monitor for reactions, she noticed he was staring blankly at her. She asked if he was ok. Site Lead overheard her ask the patient and came into the room. RN noticed that he was slumped over and having a seizure. RN picked him up and placed him on the floor on his side. RN told MA to get an onsite MD and advised another RN in the room to call 911. Patient continued to seize. Blood pressure, oxygen level, and glucose levels were checked. All were within normal limits. Patient awoke and told RN he has a history of seizures but has not had his medication for a couple months. He stated that he has seizures when he gets nervous or upset. His last seizure that he could recall was a month ago. He then went into another seizure. EMS was on the scene. He came out of that seizure quickly. They placed oxygen on the patient. He wanted to sit up. RN helped him to sit up and helped him walk to the stretcher. He was awake, alert and oriented to person, place and time when he left the clinic. He was transported to Hospital per his request.

Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.

Received Pfizer vaccines on 12/28/20; 1/19/21. Tested positive for COVID by PCR on 6/14/21. Tested d/t symptoms of anosmia, dysguesia.

Slow swelling of lymph nodes in neck following by sinus congestion, headaches, and TMJ. Ears became full with fluid and pressure then extreme tinnitus developed. My regular doctor prescribed 2 different antibiotics which had zero effect on tinnitus. It is almost 12 weeks after the tinnitus began and I still have ringing in the ears. It has reduced to 50% over the 3 months. I have never experienced this symptom previously and it has become the worst health event in my life. I have not been exposed to any loud sounds. I have been to see 2 ENTs and they believe the condition is permanent. I had a CT scan completed and it shows there are no issues. I am hoping it is inflammation and will go away over time. I am currently taking Prednisone and hoping it reduces any possible inflammation. The ringing and popping noises in my ears need to stop ASAP.

Severe tinnitus in left ear. On going since the 10 day mar. At 42 days second shot was administered as tinnitus had subsided mostly. Day 3 after second shot tinnitus came back strong.

The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.

I was given a double dose of the second shot of Pfizer my arm is still hurting today. Blurry vision as well.

Approximately 7.5 hours after the fist dose, at a basketball game, I began to sweat profusely, my vision blurred, and became extremely nauseated. My partner had to help me out of the venue and drive us home as I sincerely thought that I might lose consciousness at any moment and was unable to operate a vehicle. By the time we reached home, my fever had spiked to 103.1 and I was vomiting. I was severely ill for the next 48 hours. Since the having the vaccine I my vision is still blurry for things closer than about 18 inches from my face. I have never required reading glasses before, but now do.

parosmia/ rotten/fecal smell; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic hay fever and sinusitis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included emtricitabine; tenofovir alafenamide (DISCOVY), bupropion (WELLBUTRIN), levocetirizine (XYZAL) and prednisone (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021, 4 days after receiving vaccine, the patient started to experience parosmia. There was an underlying rotten or fecal smell that persisted, and the patient could smell it everywhere. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the event parosmia. The clinical outcome of the event parosmia was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Diagnosed w/ Thyroid Cancer 1 week after vaccine, started with sore throat, shooting pain into ear whenever you swallow. No issues before the second dose, and then things suddenly manifested. Thyroid has since been removed, plan is to start chemotherapy soon (iodine treatment, has not begun yet). Hospitalized for several days

Double vision,can no longer see with both eyes open- I realize this will be written off as a diabetic thing but no, this has never happened before

The patient was in the post vaccination waiting area for about 10 minutes when I noticed that he and his daughter got up in a hurry. I came out to see what was wrong, they stated he was having an allergic reaction. They moved toward the health clinic. I retrieved the cart and met them in the health clinic where the patient stated his tongue was swelling up. I asked the staff in the health clinic to contact the ambulance. The patient was drinking water. I observed the patient and determined that his tongue was swelling and delivered one dose of epinephrine 0.3mg to the left lateral thigh. I waited approximately 5 minutes and the patient requested benadryl. I dispensed 25mg of diphenhydramine liquid. The patient requested another dose of diphenhydramine in about 10 minutes (because he says he normally takes 2 pills when this happens). I dispensed the 2nd dose for a total of 50mg of diphenhydramine. Meanwhile the patients vital signs were being taken intermittently. The ambulance arrived and tended to the patient. The patient ultimately came back into the store and thanked us for helping him with his response and was inquiring about his second dose of vaccine. The patient was referred to his doctor for further guidance.

Tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Em9809) via an unspecified route of administration in the right arm on 28Feb2021 at 09:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021, the patient experienced tinnitus in both ears, it was reported that the patient did not have any noise exposure. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient had received any treatment for the event experienced. The clinical outcome of the event tinnitus was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-10th. However, woke up on April 11th with a high pitched changing ringing in my right ear. Over the course of about 3-4 weeks ringing became louder and more intense. Culminating to such a loud ringing in my ear April 29-May 5 or so. Was so loud I could not get normal sleep for almost a month. Went to see my primary doctor who didn't seem worried about it. Was told it was anxiety. Went to see an Audiologist to have my hearing checked. Hearing was fine. Went to see an ENT and confirmed hearing was fine and no infection. Was told the Tinnitus would go away or not go away. No likely cause. Over the last 3 months since the loud ringing the sound has abated ever so slightly week by week. I can tolerate quieter environments ever so slightly. I hear multiple tones. At first it was a loud screeching modem type sound. Then that went away/got quieter. Was replaced with a loud EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE. That got quieter as well then was replaced with a high pitched hissssssssssssssssssssssssssssssssssss, which has changed/got quieter but is still around. There is a third sound that sounds like grinding metal ever so slight. I noticed as the sounds dissipated I could pick up sounds that were not audible. I first remember hearing the fridge running, then hearing crickets, to my PC fan etc. As the ringing got quieter I could pick up minute sounds again in my right ear. Still the ringing is there.

I experienced minor sneezing, diarrhea , headaches, nostrils discomfort, lower right leg felt weird, back of my ears started itching and general bodily itches. All the symptoms have subsided except mild headaches and mild itches.

Body aches; Chills; Dizzy; Felt like the flu was coming on; Felt very hot; Very blurry eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, depression and COVID-19. Concomitant medications included clonazepam (KLONOPIN) 10 milligram (mg) and testosterone (MANUFACTURER UNKNOWN) 200 mg. The patient did not have any known allergy to any 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 diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, immediately after vaccination, the patient experienced very blurry eyes. On the same day at 17:00, about 3 hours later, the patient experienced chills, dizzy and felt like the flu was coming on and all the night, the patient felt very hot with chills. Next day, on 04Apr2021, the patient had chills and body aches. The adverse 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 any treatment for the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches. The clinical outcomes of the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches were resolving at the time of report. No follow-up attempts are needed. No further information is expected.

swollen throat; Bad taste in mouth; sore throat; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 11:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced throat swelling, sore throat and bad taste in the mouth. The adverse event resulted in emergency room or department or urgent care. The patient was tested for COVID-19 post-vaccination. The patient underwent a SARS-CoV-2 nasal swab test on 04Apr2021, and the result was negative. The patient received pain medicine as the treatment for the adverse events. The clinical outcome of the events throat swelling, sore throat and bad taste in mouth were not recovered at the time of the report. No follow-up attempts are possible; information about the lot number cannot be obtained.

Dry eyes; Small Migraine; Haziness; Soreness; This is a spontaneous report from a non-contactable pharmacist. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8131) via intramuscular route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no allergies to medications, food, or other products. Concomitant medications included amlodipine 10 with unspecified units (MANUFACTURER UNKNOWN), perindopril 8 with unspecified units (MANUFACTURER UNKNOWN) and finasteride 1 with unspecified units (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via intramuscular route of administration in the left arm on 09Mar2021 at 10:30 (at the age of 42-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 05Apr2021 at 00:00, the patient experienced dry eyes, small migraine, haziness and soreness. 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 reported events. The clinical outcome of the events of dry eyes, migraine, hazy vision and pain was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Diagnosed with Bell's Palsy. My face paralyzed and droops on the left side . My eye, mouth, and all facial muscles on the left side are weak and won't move. My tongue felt numb and and I have no sense of taste. I have a hard time talking because the left side of my mouth doesn't move. My eye is watering a lot and I can't shut my left eyelid all the way. I have headaches and jaw pain. I went to the ER and then to my primary doctor and was given an antiviral medicine and prednisone. I am still currently having all of these symptoms and the jaw pain is worse.

10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.

Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of Diphenhydramine 25 mg dose. Back to normal in 1 hr.

Employee rec'd COVID vaccine. Monitor for adverse reaction. Employee c/o tingling in lips/no swelling noted upon assessment. No other complaints offered, VS taken at 1757 BP 128/74 HR POX 98 Rapid response/ER offered-refused, Continue to monitor Last VS taken 1828 BP 133.77 HR 82 POX 100 Employee reports tingling in lips to be minimal/no swelling no other complaints offered Refusing rapid response/ER eval DC'd from monitor area

12/23 I woke up around 3am in the morning with a headache, body ache, fatigues, no fever or cough. 12/26 went to an Urgent Care for COVID-19 and got results 12/27 I was positive for COVID. On 12/27 I lost my taste and smell and started experiencing SOB which lasted for the next couple days.

After receiving Covid Vaccine EE c/o tingling in lips no swelling noted no other c/o. B/p 128/74HR 70 )2 Sat 98% monitored employee for total of 30 minutes RRT and eval in the ED refused upon leaving EE reports the tingling to be minimal.

2 hours post vaccine runny nose, next day myalsia, back pain injection site discomfort, fatigue through Friday and Saturday I felt better and Sunday I lost sense of smell Monday I tested positive for covid, the rest of that week I felt sick and slowly symptoms resolved , I took one tylenol on 22nd

On 1/18/2021 in the evening, he noticed some inflammation of the left lower lip, then he noticed some hives on his left wrist, then across the beltline. He reports taking Benadryl without improvement. He denies any other skin manifestation, shortness of breath, chest pain, or any other symptoms associated with an allergic reaction. He was following closely with his PCP and had an appointment to see an allergy specialist on 1/19/2021. The allergy specialist diagnosed him with and adverse effect of a vaccine and in the note documented delayed urticaria and angioedema secondary to COVID vaccine #2. .

Metallic taste in mouth and unusual sensation in posterior pharynx (1st and 2nd vaccination courses)within 15 minutes post IM injection. Approximately 4.5 hours post IM injection (2nd vaccination) again unusual taste in mouth with swelling of posterior pharynx. Swelling not relieved by 20 mg prednisone X , Benadryl 50 mg and Pepcid 40 mg. Second dose of prednison 20 mg alleviated throat symptoms. Approximately 24 hour post IM injection (2nd vaccination), subject felt itchy, especially the eyes. Subsequant dose of Zyrtec and Pepcid alleviated symptoms within one hour.

Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after vaccine. Some tingling on face and left had Resting to see if it goes away.

Inflammation and skin welts noted in areas of clothing and watch contact with skin; Inflammation and skin welts noted in areas of clothing and watch contact with skin; acute swelling of lip without trauma; This is a spontaneous report from a contactable physician, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 12Jan2021 at 09:30 (at the age of 43-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, that patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 on 29Dec2020 at 09:30, intramuscular in the right buttocks. On 15Jan2021 at 12:00, the patient experienced inflammation and skin welts in the areas of clothing and watch contact with skin; and developed acute swelling of the lip without trauma. Therapeutic measures were not taken and the events resulted in a physician or other healthcare professional office visit. The clinical outcome of the event skin inflammation, skin welts and lip swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Mild tingle in tip of tongue 30 minutes after injection; This is a spontaneous report from a contactable 43-year-old male consumer reported for himself who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9261/expiration date: unknown), via unknown route of administration, on 21Jan2021 07:45 AM (at the age of 43 years old) as a single dose on left arm for COVID-19 immunisation at a hospital. Relevant medical history included and concomitant medications were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 at 08:15 AM, the patient stated that he experienced mild tingle in tip of tongue 30 minutes after injection. The patient received no treatment for the event. The outcome of the event "mild tingle in tip of tongue 30 minutes after injection" was recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness. Has lasted so far four hours Jaw bones hurt Running temperature. Started three hours after injection. Current temp is 100.2. taken orally at 4:15pm PST I called in sick for work, stating it's vaccine related for my shift on 2/5/2021. My shift would have started at 11:00pm.

11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera

hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.

Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevated heart rate 131 at its highest.

Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

I received my first dose of Pfizer vaccine (lot # EN6200) around 10 AM. I was perfectly fine after the shot. However, 6 hours later around 4PM my Left outer ear turned bright red and get itchy (no raised or macular rash, no hives, no signs of insect bites or anything) No other redness or rashes in any other parts of my body. I did not develop any other symptoms (no SOB/difficulty breathing, etc) My R ear is fine too. I observed myself to see if the redness/itchiness will spread but after about an hour or so, the redness and itchiness went away. I did not take any antihistamine and did not I apply any hydrocortisone. Just went away on its own. Four days later, it happened again, my L outer ear turned red again, this time it is not itchy but more like throbbing pain. It went away after 1-2 hours without any treatment.

Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.

After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.

Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medications and consultation/follow up instructions.

@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head. Another set of VS was taken @ 0837 with BP 92/50. 911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily, before leaving with wife @ 0905.

Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.

Approximately 25 -30 min after receiving vaccine I felt pressure in my left ear, the side of the shot, and listening to my car stereo sounded like I was underwater. That lasted about 60-90. After the pressure subsided, I was left with a semi severe ringing in my ear for about 2 days before diminishing to a slight ringing that continues to persist.

Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and second at 4 days after first dose I've had occular migraines in the past, but haven't had one in the past 10 years. I've had two in the last 24 hours. Occular migraine event for me is temporary blindness with floating bright object in line of vision with mild dizziness. Requires about 20 minutes to fully subside.

Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or coherent thoughts or sentences. Started with blurred vision around 5:45pm. I immediately sat down on the couch, and tried to explain to my wife what was going on. However, I was unable to complete the thoughts I was trying to form. Eventually I began confusing words (such as saying "king" when I wanted to say "kind" or "kite") and was unable to produce more than one word every 1-2 seconds with great difficulty. Then a headache came that was both extremely painful and somehow "painless," as if I was observing myself having the pain as a bystander. All of this happened within one minute of onset. I laid down and after about 10 minutes from onset the difficulty speaking subsided and I could make complete sentences, although with some difficulty. After around 20 minutes from onset my vision had fully returned. I called 911 out of concern for stroke-like symptoms. The dispatcher sent an ambulance, and I was taken to the Hospital Emergency Department for treatment. Around three hours after the onset of the incident I was diagnosed with a complex migraine and discharged.

That evening had tachycardia symptoms and trichina symptoms (about 12 hours after vaccine). I had fatigue and headache the following morning. Severe myalgias - in the epigastric cisternal area and in the back of my shoulder blades. 36 hours later - low grade temperature. At 48 hours I felt normal. Eye - 10 days later (vaccine) - I noticed a visual deficit in the left eye along with a line and the following day - on the 17th, I saw my ophthalmologist - left branch retinal vein occlusion. Since then I've had an Forestine Angiogram: and a video of my retina - branch retina arterial occlusion - so they are having trouble telling the difference between the two. I still am being followed for my eye. They did a carotid ultrasound - my carotids are fine. I am due to get an echo cardiogram. I am taking baby aspirin mg for now - not sure if it's helping or not. It takes a year and a half to go away.

3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEAD AND THROAT ACHE 10:00 PM. CHILLS AND SWEATS 12:00 PM. EYES WATERING 3/14/21 THROUGHOUT THE DAY. SWEATS AND CHILLS, WATERING EYES, HEADACHE, FATIGUE TOOK 2 TYLENOL EVERY 4 HOURS 3/15/21 8:00 AM - SLIGHT WATERY EYES. 9:00 AM - UPPER LIP BEGAN TO SWELL, TOOK TWO ALEVE 10:00 AM. UPPER LIP COMPLETLY SWOLLEN AND ON FIRE. TOOK 2 BENADRYL 11:00 AM. FATIGUE 12:00 PM. CHEST BEGAN TO TIGHTEN AND SHORTNESS OF BREATHE, TOOK 2 BENADRYL 4:00 PM. TIGHTNESS OF CHEST AND BREATHING WORSENED 4:30 PM. WENT TO EMERGENCY ROOM. 3/16/21 - 3/20/21. FATIGUE, SWELLING OF UPPER LIP, TIGHTNESS OF CHEST, SHORTNESS OF BREATHE 3/22/21 - PRESENT. TIGHTNESS OF CHEST, SHORNESS OF BREATHE

Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears. It's sometimes louder than other times. It is piercingly loud when exposed to loud noises. It started the day after the vaccine injection. Other events are: - Frequent headaches (every 2 or 3 days). They started the day of the injection and are current. - Sore throat. It started 2 days after the injection and has decreased in the last few days. - Dry throat and chills. They started a week after the injection and are current. - Soreness in the arm where injected. This has gone away. I visited my healthcare professional about this. No treatment was given. The healthcare professional decided that we'll have to monitor the symptoms for any changes. If the tinnitus gets worse or persists after a month, then it is suggested that I see an ENT (Ear, Nose, & Throat) doctor.

redness and swelling around both eyes. the swelling became visually evident 3 days after the vaccine was administered and has gotten progressively worse since then.

3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular

Hearing a high pitch noise in my head that will not go away. Pointer finger on left arm is numb and tingles with movement or touch. Both symptoms started on the afternoon of the 21st. Both came on at the same time and were very noticeable together.

skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue swelling and discoloring; tongue swelling and discoloring/ he saw that his tongue was dark chocolate like he had just eaten a black licorice; felt like breaking out in hives/chest was beat red was referring to hives; chest started to get broken out and got beat red; allergic reaction; got beat red; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EP6955), via an unspecified route of administration in the left arm, on 15Mar2021 3:00 PM (received at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included Attention deficit disorder, cholesterol, benign heart palpitations. He also had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED (emergency department). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unspecified date and ongoing for Attention deficit disorder; metoprolol from an unspecified date and ongoing for benign heart palpitations; simvastatin from an unspecified date and ongoing for cholesterol; vitamins and minerals; ubiquinol from an unspecified date and ongoing; fish oil from an unspecified date and ongoing. The patient previously had a flu shot in Aug2020. The patient previously took epinephrine and experienced insect bite were worse, and metoprolol and experienced reaction linger. The stated he thought he had an allergic reaction to the Pfizer covid19 vaccine on 15Mar2021. He states that his tongue was swollen (15 min after receiving the vaccine, at 03:15 PM), he broke out into hives. He was in the restroom of the facility where he received the vaccine and that he did not have hives yet after getting the vaccine, but then asked the nurse if he could take Benadryl and was told yes. He states they then let him go because he had no trouble breathing at that time. He drove home and was going to reroute to hospitals if needed. He took 50 mg fast melt Benadryl as soon as walked out of the facility. He drank water, drank two larger bottles of water. His chest started to get broken out and got beat red. He took another 25 mg of Benadryl and then drove home. He then proceeded with Benadryl 50 mg every 6 hours. At 1 AM, the next morning (16Mar2021), he woke up with trouble breathing and tongue swelling and went to ER. They gave him Prednisone 60 mg and then started on 5 days of prednisone. They told him to continue Benadryl, and water and to follow up at hospital if worsens and to follow up with his physician. He stated that he had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED. He added that this experience with the Covid19 vaccine was milder comparatively as they gave him just steroids and not epinephrine this time, and, they told him he was not having trouble breathing this time. Last night, 16Mar2021, at around 10:30 pm, a half hour before next dose of 6 hour Benadryl was due, his skin was burning itchy and red so he took Benadryl a half hour early and set alarm to wake up before next dose. He woke up 4 hours later and waited to see if he would have a reaction and he has not taken it since. He took the morning dose of Prednisone with improvement and is carrying Benadryl in his pocket just in case. He later clarified that he took his 11 o'clock dose last night and then set a 2:30 am alarm to see if it was worse again or about the same. Regarding the allergic reaction, he first noticed around 3 pm Monday 15Mar2021. Within 15 minutes after the vaccine, he was going through his phone and thought he felt strange while waiting at (Name) after the vaccine to see if he had a reaction. This feeling continued until 11 pm last night, 16Mar2021. He took 50 mg of Benadryl when this first happened on 15Mar2021 and then took another 25 mg 15 minutes after the first initial dose. At the time of call, he notices no redness or itchiness or swelling of the tongue. He feels like he is going in the right direction. He noticed tongue swollen within 15 minutes of receiving the vaccine and that it was also discolored (15Mar2021 15:15) and asked a friend who has allergic reactions if this happens and the friend told him that it sometimes happens to other people with allergic reactions. He went to the ER on Tuesday 16Mar2021 at 3 am, exactly 12 hours after he received his shot, because of the swelling of the tongue. This was his first-time experiencing difficulty breathing and gasping for air as well. States that he does not have it now. Prednisone and Benadryl have knocked it out. He was not admitted and was released from the ER about an hour and a half after he got there (discharged at 4:30 am from the ER). He did notice at 3:30 pm that his chest was beat red. He was hanging out and his body would tell him when it was close to 6 hours that he needed to take Benadryl because he would be breaking out in hives. He has to take Benedryl within 6 hours. This is ongoing but he has not had any today. He clarifies that the chest was beat red was referring to hives. He felt yesterday 16Mar2021 that he had a sunburn and that his face was kind of red but he had not been in the sun. He clarified on timeline that he went to check for swelling and hives in bathroom after receiving the vaccine on 15Mar2021. At that time, he saw that his tongue was dark chocolate like he had just eaten a black licorice. There was no redness or anything but he felt like it was going to be occurring so he asked the facility if he could take Benadryl. He is scheduled for his second dose of the vaccine on 05Apr2021 and may be possibly returning but is not sure. He also noticed on Tuesday 16Mar2021 that while sleeping on the couch at 3 am he was going to take the next dose of Benadryl and woke up gasping for air. He got up to drink more water and took a shower and made coffee. Then, he went to the ER. He was really tired. He wanted to be alert to drive. It seemed like the water helped and he drank a lot of water. He did not want to take the next dose of Benadryl. He noticed that it did get better, and he did not want to stay home so he went to the ER. Outcome of the event allergic reaction was recovered with sequel on 16Mar2021. Outcome of swollen tongue, skin was burning itchy and red, got beat red and hives was recovering. Outcome of other events was unknown.

Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.

Ultra high pitch, continuous ringing or hissing in both ears characterized as tinnitus. Around day ten the tinnitus ceased in left ear but continues in right. Intensity varies from day to day and never disrupts sleep or poses any difficulty in hearing or concentrating. I mention the pitch as any momentary tinnitus I've experienced in my life were fleeting (minute or less), accompanied by muffled hearing, and much lower pitch. Tinnitus persists to today, 4/7/21, and I've scheduled my first appointments for intervention with a specialist (ENT).

Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.

- 36 hours after vaccine administration I start to experience loud ear ringing; - few hours later the ringing reduced in intensity and stays constant until now; - it is a high frequency noise in both ears; - audiogram revealed high frequency hearing loss and ENT found the external ears to be normal; - I have received no treatment or any other type of care;

Severe headache, started about four hours after vaccination and continued for 72 hours. Including sensitivity to light and sound (with no history of migraines or head injury) Flu-like symptoms with body aches and extreme fatigue for 72 hours after vaccination. Currently scheduled for an abdominal ultrasound after recent blood work in April 2021 showed elevated renal values (no history of renal problems)

Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain in all fingers, hands, knees, toes and neck.

Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also feeling numb

Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute. During this time there was a little bit of tingling around my lips. This came and went for a few hours. 15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes. I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home. I didn't experience any further allergic reactions, just the expected ones.

Ringing in my ears.; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534), via an unspecified route of administration, at the age of 43 years, administered on the left arm on 24Mar2021 18:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6202) on 03Mar2021 in the right arm for COVID-19 immunization. The patient experienced ringing in ears (disability) on 26Mar2021 15:45. No treatment was received for the event. The outcome of the event was not recovered.

PFIZER-BIONTECH COVID-19 Vaccine EUA PFizer 2nd dose taken on 4/13 12:30 PM 4/14 around 11 AM had shortness of breath / cough for 5-10 minutes 4/14 around 11:30 AM started seeing swelling on both left /right top Eye lids like a big sty.

Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips

Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday April 12th 715 a.m. left side of face paralysis Monday April 12th 740 a.m. went to e.r. and went through tests for stroke or bell's palsey and was determined it was bell's palsey, also had a CT scan and was determined to be ok, was prescribed 5 days worth of prednisone and 7 days worth of antiviral valacyclovir

The night after I received my first dose, my tinnitus has gotten very loud, to the point where I find it hard to sleep or function. That started on 04/09/2021 and still just as loud on 04/17/2021

Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and 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 has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events. No follow-up attempts are needed. No further information is expected.

Patient had tinnitus for 3 days following Pfizer vaccine, and then sudden sensorineural hearing loss ~ 4 days after the Pfizer vaccine.

Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.

Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms

Extremely painful and loud ear ringing. I thought my ears were going to bleed. Extreme rotary vertigo for 24 hours. Treated with large doses of benedryl to stop the spinning. Tinnitus ringing is back to regular levels. I've had tinnitus for 30 years, this vaccine triggered something I have never experienced before.

Typical and expected side effects were fatigue for ~24 hours and soreness at the site of injection for ~48 hours. In addition, the morning after the injection I woke up with a bright red face rash and draining on the left nostril, the left eye crusted shut with yellowish drainage, a red blister-like spot on the left lower eyelid, bloodshot eye, and swelling from the eyelid and down into the cheek. The swelling got worse after a couple of days, leading to medical treatment with eye drops and an antibiotic.

Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand very numb, loss of bladder contorl, basically every MS exacerbation symptom I've ever had showed up simultaneously."

Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of Thursday 4/22/21, he felt tingling on tongue and back of throat. Friday tingling increased and by evening, per pt, increased tingling, shaking of lips, itchiness all over body. Pt called PCP advise nurse and was advised to take benadryl, Per pt, he took benadryl on Friday evening. On Saturday, there was increased tingling and itchiness, took another benadryl and eventually symptoms subsided on Sunday. Pt advised to f/u with PCP.

Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable

Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completely dry instantly and could not swallow. This was 28 min after initial shot (2nd dose). Concerned that airway would be restricted. In a panic went to ER at different hospital that I was near. No signs of anaphylaxis. Waited in hospital for ~3 hours. Symptoms did not get worse and could breath through nose. Decided no steroid shot (did not want to negate covid shot). Went home without additional treatment. Mouth was dry for 1 additional day, but not as extreme as initial dryness.

Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm, on 18Mar2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced loud ringing in ears and numb/tingle in left pointer finger on 21Mar2021 at 17:00. The events were reported as non-serious. The clinical outcome of experienced loud ringing in ears and numb/tingle in left pointer finger was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

1. Immediately upon injection, my tongue started to go numb, and it was numb/tingly within 10 seconds. 2. Over the 15 minutes I sat and waited, the sensation spread to much of my mouth and started to go down into my throat. I did not feel like anything was swelling per se, but definitely numb. 3. At 15 mins, it still seemed to be progressing, so I notified staff and went back to the first aid area. I was monitored and we waited to see what would happen. The numbness went a good way down my throat. 4. When I had some water, I noted that I was able to swallow fine but could barely feel the water going down. I also noted the tingling sensation had spread to the lower part of my face (that had been covered by my mask), though my face was not completely numb -- it felt like when local anesthetic is wearing off. 5. I stayed for a while longer, was evaluated by a doctor, and was eventually released. The numbness largely subsided by 4-5 hours after injection. 6. Notably, I have never had any sort of reaction to a vaccine before. 7. Concerned at a stronger such reaction to the second injection, an immunologist suggested I skip it and instead.

Tinnitus has worsened greatly. Ringing would only occur sporadically in silent rooms. Now ringing is persistent.

Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.

43 yo male with allergy of bee venom and PMH significant for GERD. Pt received first dose of COVID-19 vaccination on 3/26/21 with no adverse reaction. Received second dose on 4/16/21. The next day after second dose pt reports experiencing tinnitus that worsened over the next couple of days. Reports that he can hear it over music he is playing. Advised to follow up with PCP to look at treatment options.

Ear pain and ear ringing started the day after the shot, lasted the weekend (Sat/Sun) and went away for the most part during the week. However it returned 5/8-5/10. I also have a fever of 99.8 this past weekend. I don't know if I had a fever previously because I didn't check.

client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client was not feeling good. Client sitting in chair, pale, stated feeling dizzy and seeing blurry. EMT began taking vitals at 1405: blood pressure 142/110, pulse 75, oxygen 98%. Per client had just received vaccine. Client able to transfer self to anti-gravity chair at 1407. Client asked for water, PHN advised to take small sips. Vitals 1410: blood pressure 140/110, pulse 77, oxygen 99%. Per client vision slightly better, dizziness same, new onset of headache and nausea. PHN gave client emesis bag. Per client no pertinent medical history, no current medication and no history of allergies. Per client does not know if he has hypertension, does not regularly follow up with provider. No history of vision problems. Vitals at 1415: blood pressure 138/110, pulse 75, oxygen 98%. Client stated feeling the "room was spinning", nausea. Vitals at 1420: blood pressure 138/108, pulse 77, oxygen 97%. Per client dizziness, nausea same, vision improving slightly. PHN asked client if someone would be able to pick him up, per client no one, he would drive home. Vitals at 1425: blood pressure 140/106, pulse 74, oxygen 97%. Client stated headache to temporal and occipital area. 1430 client stated feeling eyesight heavy. Client alert and oriented. Vitals at 1431: blood pressure 134/108, pulse 75, oxygen 97%. Per client when he moves head quickly is when dizziness worsens. Client denied history of vertigo. 1434 PHN offered client paramedics so client could be further evaluated, client denied. Vitals at 1435: blood pressure: 132/103, pulse 73, oxygen 97%. Per client blurry vision, nausea and dizziness same. Per client wanted to leave facility and go home. PHN advised client to stay longer in observation as symptoms had not resolved and he wanted to drive home. Client declined, stated he felt well enough to drive. PHN asked client to stand by chair to see check dizziness and if client could walk without complaints. Client was able to stand and take steps without assistance. PHN gave client ER precautions, asked client if he wanted to anyone else to pick him up and he declined. Client left facility with steady gait at 1441 against medical advise, symptoms had not resolved.

Ringing in ears. Started out as being noticeable only at night and has progressed to being noticeable throughout the day, sometimes louder than others.

Received 1st Shot 4/10/21. A few days after 1st Shot of Pfizer: My eczema flared up and I was waking up from itching in the middle of the night. I was being treated for eczema for a few months prior to vaccination. I had never woken up from itching prior to vaccination. Flare up areas were on shoulder opposite of vaccination arm. This area had never flared up before. Also had period of flare up behind right knee for first time as well. All of these were more severe than before vaccination. I used topical steroids sparingly in the few weeks after 1st Dose. After 3rd week it seemed to ease. Received 2nd Shot 5/1/21. After 2nd Shot of Pfizer: I had Tinnitus side effect in both ears seemingly from the vaccine. I did not have worsening skin rashes/eczema after 2nd Dose.I did not have Tinnitus after 1st dose. 2 weeks later, symptoms seem less but not completely gone. Eczema is similar to what it was before both vaccine doses.

Pt states they were "fine" prior to vaccine administration. Pt was given vaccination and then began to experience immediate partial hearing loss, dizziness and lethargy. Reaction went to assess pt and brought pt water. Pt transported to MO1 on wheelchair. MO1 received 2 sets of VS and both sets were appropriate for pt age and current state. Last vitals taken @ 1655: P: 76, R, 20, BP: 143/84, SpO2: 100%.

Pt returned for 2nd dose 5/24 but was turned away due to allergic reaction. Pt reported Dizziness, tongue swelling after first dose on 5/3. Timeframe for development of allergic reaction is unclear. Unknown if patient took any rescue medication.

Developed tinnitus four days after first shot and this has persisted four weeks out. Of note tested positive for COVID 3/29/21 (about three days before his first shot)

client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90, pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%. 1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.

Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twitched. He was like this for 10 sec and was disoriented when he became aware of surroundings. EMS was contacted. They assessed him and took him to the hospital

Primary symptom is tinnitus in both ears (more left) that has increased slowly since second vaccination. Of possible relevance, two additional temporary symptoms occurred roughly one week following second dose: two separate incidences of scintillating scotoma (bilateral visual artifact on left side of visual periphery; each episode lasting approx. 40 minutes; occurred two days apart); and two or three incidences of very brief (5 sec.) SSHL (sudden sensorineural hearing loss) in right ear (incidences occurred approx. two days apart).

I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.

Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.

Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)

Loss of hearing in my right ear. Tingling sensation then couldn't hear anything. Had annual physical with primary care physician first , then waited a week or two to see if there was improvement. Went to ENT physician for audiology exam. Ear structure and everything internally appears to be normal. Audiology exam had abnormal results in the right ear. Left ear was fine. Physician injected a steroid into the inner ear. Then prescribed methylprednisolone for a six-day course of therapy. Will see physician again in less than three weeks. No improvement. Only less and less hearing in the right ear.

Started out as strong flu-like symptoms for several days starting about 54hrs after first Pfizer injection 5/26. Fever 101+, body termperature regulation out of whack (intense chills or sweating) body aches and soreness intense headaches and sharp pains in head. Aceteminophin and Ibuprofen alternated and symptoms would subside for a couple hours at a time. Into the second week still had more mild flu-like symptoms that have persisted to today, 18 days after shot. These include headahce, low-grade fever (99-100), continuous tiredness and fatigue, strong aches in lower back, and occasional sharp pains in head, aching behind eyes and occasional chest pain.

Patient describe pressure related to the ear drum which is mild in nature. Patient described during his 2nd appointment. Patient took second dose and has not taken any medication for this symptom

pt reported being out in the sun the day following vaccination and noticing lots of "floaters in his eyes". He reports that he used to have floaters in his eyes but that they had resolved years ago. He says they returned bilaterally the day after vaccination

Dysgeusia -- first attempted to start eating around 10 AM today. Noticed that my tongue feels like I burned it on hot food (which I didn't), and my taste is altered with the foods I'm eating this morning.

1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7AM (~12kHz tone and slight ~4kHz tone both in both ears). Sleep is interrupted Treatment: None Outcome: Saw primary care (5/25/21), had an audiogram and tympanometry (5/27/21) showing normal hearing, and saw ENT (6/10/21). Bilateral Tinnitus and resulting interruped sleep persists. 2) Slight dizziness accompanied the Unilateral Tinnitus only (5/16/21 9PM)

With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.

At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat. Skin warm and dry. Forehead is slightly flushed and war, Cap refill good, breath sounds clean bilaterally. Had patent lay down for vital signs, sat up and given water. Patient became dizzy upon sitting, returned to supine position. 1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally. 1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20. Sitting 140/100.. Patient discharged in stable condition in the company of his wife. Pt is alert and oriented times 3. Skin pink, warm and dry. Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.

Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.

I began to feel a slight pressure shift in my left ear, like one would feel in a pressurized cabin, and began to hear a loud ringing in my left ear. The Tinnitus has persisted without stopping since 5/31/21. It has significantly affected my hearing to that side and is uncomfortable.

Felt extreme dizziness that would come and go throughout the day. Dizziness subsided considerably after 2 weeks, then returned back. Around June 9th, dizziness was profound while driving, vision went dark as in a downward motion from left to right, 2 times, about 10 seconds apart. Never lost consciousness.

About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it was the left ear but the fact is both are ringing and the left side is worse. I was panicking and I didn't know what was going on. I went to urgent care three days later and they found nothing that was causing the ringing. They urgent care doctor made a phone call a specialist and she stated that the ringing in the ears is a rare side effect of the COVID vaccine and it should go away. I then went to my primary care doctor and she thought she saw some redness in my left ear and thus prescribed me methylPREDNISolone and an ear drop with the name Ofloxacin. They both did not work. She then prescribed me Azithromycin which also did not work. Since I was not responding to medication, I was diagnosed with tennitus by my primary care doctor. About a week later after the vaccine, I was been experiencing popping in my left ear as well as the noise. But on the right ear, there is only noise. Prior to vaccination, I never had any issue with my ears before. The tennitus is debilitating and life altering in so many ways. I'm still not getting more than four hours of sleep even with melatonin and I'm someone that has never used melatonin or had sleeping issues prior to vaccination.

I didn't have near the change in stamina after second shot; A hint of chill; Hint of a muscle ache; Headache; The blurriness seemed to snap back once he got his second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration on 15May2021 as dose 2, single (age at vaccination 43-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0158) 1st dose on 24Apr2021 (age at vaccination 43-year-old), administered on left shoulder, for COVID-19 immunization. The patient experienced I didn't have near the change in stamina after second shot, a hint of chill, hint of a muscle ache, headache, the blurriness seemed to snap back once he got his second shot on an unspecified date. Caller is a consumer (43 years old, male) who is inquiring about additional information for revaccination following getting a complete 2-dose series of the Pfizer covid-19 vaccine. Caller reports when he received his first dose of the Pfizer Covid-19 vaccine, the needle was longer and then with the second shot, the needle was shorter. Caller reports with the first shot I could feel a very deep tissue injection. In my arm was deep tissue sore from my elbow to my shoulder and it hurt to move, but what took me aback was the vision issue. My energy level was depleted to negative levels, walking felt like my feet were stuck in cinderblocks, walking down the hallway took me 20 minutes to get down the hallway. I remember being on the text meeting for work and I'm telling them I'm at 35 percent now and if people say the second is worse than I need to take days off. My thinking was cloudy, felt unbalanced, legs felt weird like my feet were in someone else's shoes, no stamina, wanted to sleep, no energy. I was still quite tired with low energy the next day. A couple days after the shot I had a significant change in vision, was pretty much unable to read anything. If it was a certain point size I couldn't see it. I could see objects, driving wasn't an issue, but reading emails and newspaper were difficult. Thank goodness for the expandable screen on the iPhone. But then, my vision almost snapped right back to 90 to 85 % normal after second shot. It was definitely a shorter needle. Felt superficial, didn't hurt near as bad, effects more mild and were sort of spread out over a longer time. The first shot was compressed into 4 to 5 days. I was on my back for 5-7 days. I didn't have near the change in stamina after second shot. Just a couple days ago I started to feel like I can work out again. I had light symptoms: a hint of chill, hint of a muscle ache, headache, my vision popped back into place, they were a hint and then disappeared over a week and a half and now I'm feeling like I normally had been, but I am turning 44 next week so that might have something to do with. Caller states so it felt thicker with the longer needle, thought it was different substance deeper into the muscle. Caller states I didn't know if that was part of some instruction of which would come first or why it would be at different depths. Why would it feel thicker and feel deeper the second time enquired. The number on my card are different than other people's. I had the opposite side effects than other people had. I just want to make sure what they're doing is correct. Caller states again, I just want to make sure it was safe or if there was some other element I should know. Blurriness: His first shot was administered on 24Apr2021. Around the 27Apr2021, it was not immediate he had a Saturday appointment. This shot had him flat on his back, negative ability to do anything. The blurriness seemed to snap back once. He got his second shot. Ever since he hit 42. He doesn't if it was natural or it has do to with the thing. He was unable to see really up-close it could be he was getting older. Treatment: He was going to see an optometrist Feet could hardly move: Start: The evening of the 24Apr2021 around 11 o'clock. gone away to the real heaviness stopped around 29th the sluggishness and depleted amount of energy until the 07May2021.The patient underwent lab tests and procedures which included chest x-ray: clear on an unknown date, pulmonary function test: unknown on an unknown date. The clinical outcome for all events was unknown. Follow-up attempts are needed. Further information is expected.

Patient experienced vasovagal symptoms, dilated pupils, increased HR, syncope, and had pale skin tone within less than 1 minute of administration.

Patient experience headache after receving vaccine on 7/21/21. Took pain med (Tylenol alternating Ibuprofen 2 days after with no relief). 7 days later still have ache on right side of head along with pain in right side of eye and ear.

Loss of taste; Loss of smell; This is a spontaneous report from a non-contactable consumer, the patient. A 43-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 in the left arm on 02Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:30, the patient experienced loss of taste and loss of smell 49.5 hours after taking the vaccine. 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 loss of taste and loss of smell was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

At around 1330 a few minutes after pt received 1st dose of Pfizer COVID vaccine he stated that he needed to take off his mask for a little bit because he did not feel well. Pt states that he was having a tingling and numbing sensation on his lips and tongue. Pt denies having any SOB or difficulty breathing. He states that he has never had a bad reaction to a vaccine before. PT is diaphoretic and speech does sound slurred. PT denies any dizziness or faint feeling. He states that he is a little bit light headed. Pt is ok to sit in the chair. Dr. notified of reaction and came to immunizations clinic to assess. PT continued to have tingling sensation in his lips and continues to not feel good. PT was transferred to the ER via wheelchair at around 1355 pt was alert when transferred

Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient started to receive BNT162B2 (also reported as " Pfizer COVID-19 Vaccine"), Lot number: EL0142, via an unspecified route of administration on 27Dec2020 18:45 at single dose (dose 1) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Medical history included food allergies: shrimp. Concomitant medication included guaifenesin (MUCINEX). On 28Dec2020 06:00, the patient experienced back of left eye hurts, sinus near left eye feels swollen and mild headache. The outcome of the events was not recovered.

Patient received 2nd dose of Pfizer COVID-19 vaccine at our COVID-19 vaccination area. During the 15 minute observation period, patient reported feeling his tongue swelling and eye getting puffy. No SOB notes. Patient is an ICU physician in our med center. After 30 minutes of observation, he was discharged without any other issues. Follow-up call done after 2 hours and he was fine. He went back to work.

extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/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 BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, 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.

his arm being sore from the vaccination; experienced increased heart rate/Heart rate went up; Mouth dry; He was calling because he is wondering if this is (increased heart rate, mouth dry) considered a severe allergic reaction; This is a spontaneous report from a contactable physician who reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) 1st dose via an unspecified route of administration on 17Dec2020 in the evening time (around 6-7 or maybe a little later) at single dose on arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. After getting the COVID Vaccine that same day, his heart rate went up and then it came down and he was fine. Later that night while sleeping he got up again because he could feel his heart rate going up. It was not way up, but he could tell it was up. He was trying to catch an actual reading on the monitor of his heart rate, but he was not able to before it came back down. He was calling because he is wondering if this was considered a severe allergic reaction. He got the vaccine and was able to walk to his car. His mouth got dry right after the vaccine within a minute or two and noticed his heart rate went up. Treatment: He took some deep breaths and drunk water and it got better. He drove home, but that at nighttime while sleeping he noticed his heart rate went up a couple of times, but then it came back down. He could not get a reading of heart rate right away. The highest he saw on the monitor that he was able to capture was 101 and then it came back down. He was not sure if this was because he was nervous. He just had a couple of episodes that night and then nothing again. He also experienced his arm being sore from the vaccination. However, he stated that is to be expected. He stated the arm sore started a few days after getting the COVID Vaccine and then it was gone. Stated he was calling because he was concerned because Pfizer said to report any issues. He started to feel better and added this may not even be an issue. He just got concerned. Mentioned he was not sure if real side effects or if he was over thinking things. Outcome of the events was resolved.

About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they could see it and they could. The twitch in that muscle stopped that evening. Both of my eyelids occasionally twitch for the past few days

Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing in am

Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.

Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also has some numbness of the right side upper lip. Denies other symptoms.

My lips started having a burning sensation as of i have eaten some spicy sauce and the sauce is giving my lips have a mild burning feeling. I haven't eaten anything or done anything out of the ordinary prior to or after my vaccine shot. Since the vaccine is the only thing different in my life and it has been a few weeks i thought it was the only common denominator that would be causing this feeling. it doesn't affect anything in my daily life other than a bit of an annoyance to constantly feel this.

The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I thought nothing of the shortness of breath as I am asthmatic. The next couple of days I felt completely drained, fatigued. Ten days later I have partial facial paralysis. I saw the emergency physician at the hospital who prescribed prednisone, acyclovir, over the counter eye drops, and an eye patch to wear at night.

Started itching of mouth face and upper body within 10 minutes of injection. Became dizzy with tunnel vision. Went to urgent care had elevated blood pressure of 178/110. Receive steroid injection and prescription for hydroxyzine.

My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensation around my nose and upper lip. Prior to this, my blood pressure had been in the 120's / 70's. I went to the emergency room and was sent home 4 hours later. I had headaches every day, multiple times a day, for the next 10 days and my blood pressure was fluctuating between 130/90 to 150/99 during that time. On February 25, my blood pressure dropped back down to 123/88 in the morning, but shot back up to 152/93 by the evening. My blood pressure continues to fluctuate from 124/89 to 146/106.

Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, experienced lip burning/numbness/swelling and facial swelling and drooping. Went to ER and given IV Benadryl and IV Pepcid. Discharged a few hours later. All symptoms have since resolved.

1 week following my vaccine I (1/21/21) started experiencing a clogged sensation in my right ear. My symptoms have continued to escalate. I have suffered from hearing loss, consistent dizziness/off balance, and blurred vision.

sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went numb, tongue swelling and lower jaw numbmess. Notified the MD's taken out of car had BP given claritin was being monitored and BP kept rising given epipen. The epipen helped felt swelling go down started to relax. Taken by ambulance to hospital. Treated with Steroid and benadryl and prevacid. No breathing treatments given epipens there and taken home prescribed. after he went home sore arm, dizzy, tired then symptoms started to come back took steroids and bendadryl which helped the reaction to go away. sx lasted 2-3 days. mild towards the end.

Tongue felt numb -- "Like he burned his tongue" Tingly sensation. At 6 p.m. on 3/19/2021 his tongue still feels the same. No swelling in his tongue. Denies other symptoms

RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGERS LASTING ABOUT FORTY FIVE MINUTES. SEVERE VERTIGO LASTING AROUND ONE MINUTE PER EPISODE EXPERIENCING FIVE EPISODES SO FAR OCCURRED AFTER FIRST WEEK OF VACCINATION 1ST DOSE.

patient reported lips feeling number ~15 minutes following injection of vaccine. patient was given benadryl which helped the symptom. patient was monitored for 45 minutes following dosage, no other symptoms

my sense of taste became altered with everything tasting bland or bitter; administration date=12Jan2021, dose number=2/administration date=26Dec2020, dose number=1; This is a spontaneous report from a contactable nurse for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL 1284) via intramuscular route of administration in the right arm on 12Jan2021 18:30 at SINGLE DOSE for COVID-19 Immunization in the workplace clinic. The patient had no medical history. The patient's concomitant medications were not reported. The patient had allergies to doxycycline, ciprofloxacin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EK 9231) via intramuscular route of administration in the right arm on 26Dec2020 07:45 at SINGLE DOSE for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking second dose on 14Jan2021 08:00 the patient's sense of taste became altered with everything tasting bland or bitter. He has been told by workplace this was symptom and not a known side effect and to get COVID- 19 virus test, which was negative. The event assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent saliva test for COVID-19 on 15Jan2021 which was negative. Symptoms resolved on its own on 16Jan2021. The patient did not receive treatment. The outcome of the event was recovered on 16Jan2021 and outcome of the other event was unknown. No follow-up attempts are possible. No further information is expected.

I had Eye allergies issues with gritty feeling in the eyes, swelling, burning sensation, and watery eyes. Also had sour throat and cold symptoms after the vaccine with headache and drowsiness

Loss of smell. Could not smell my coffee first thing the morning after receiving the second dose of the Pfizer vaccine. Not seeing this documented anywhere as a known side effect.

Developed Acute Labyrinthitis of the Right Inner Ear, lost hearing in the right year, vertigo, dizziness.

Severe headache that started the day after the shot, developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110

Voice loss - Occurred next day after injection No hx of smoking/chewing/drinking CPAP machine prescribed 2 days before injection No rxn to injection day of. No redness/swelling Spoke with patient on 04/14/2021. Patient stated voice was 'altered' - voice loss by the end of the day each day. PCP visit, no allergy/irritation doctor could find. Prescribed Zyrtec. 2 weeks later, patient still claims voice loss/'altered'. Describes as 'tickle' in throat

Slightly over a month after receiving my second COVID vaccination (1st vaccination January 29, 2nd vaccination February 26) I awoke with markedly worse tinnitus in my left ear and noticeable hearing loss.

verything tastes like metal. nothing is good to eat, everything tastes bitter or like it's gone bad. a metal taste lingers in my mouth. doubt it's anything important, but wanted to mention it for data collecting sake as i'd not heard of it from anyone else. other side effects were fever and achiness, however it seems to be more severe in my case than in others I personally know with their 2nd shot, probably not statistically worse than the general population if I were to guess at it, however.

Tinnitus. After receiving my first shot on February 19, 2021, I began to experience a faint and intermittent ringing in my right ear and ignored it. After receiving my second shot on March 12, 2021, the ringing in my right ear became louder and has continued. Sometimes is it still faint and intermittent, and other times it is more intrusive and distracting. At this point, I have not sought treatment, but may do so if it continues.

This is a 44 year old male, history of high cholesterol, not currently on medications. Patient presented for Pfizer covid-19 vaccine today, approx. 9 minutes post vaccination, patient reported he felt dizzy and light headed with left arm pain at injection site. Patient then began to report seeing flashes of lights, frontal headache, left arm and left leg heaviness and felt sweaty and if he was going to pass out. EMS was activated, patient was transferred to the ED.

Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.

I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function

4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient

Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!

Patient came to get his 2nd dose vaccine today 4/21/21 and upon asking him if how his first dose went, he mentioned that he had ringing in his right ear and swollen lymph nodes around his right neck area about 3 days after getting the vaccine. The swollen lymph nodes lasted for a full week and then it went away. He still has ringing in his right ear but is very faint as compared to when he first noticed it.

2ND Pfizer covid-19 vaccine administration 1/14/2021. Patient symptom onset 3/16/2021 - headache, 3/21/2021 - rash diagnosed to be herpes zoster V1/V2 distribution, 4/12/2021 - herpes zoster ocular involvement with scratchiness, visual halos and decreased visual acuity of 3 days duration.

Developed strong tinnitus in left ear. This ear has very slight high pitched hearing degradation prior. After first dose slight intermittent tinnitus developed. Almost immediately after second dose persisting tinnitus developed in left ear. Right ear appears unaffected.

Several lumps on right side of head and neck.; Several lumps on right side of head and neck.; Welt on Eye/swollen eyelid right side; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 23Mar2021 12:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, calcium, vitamin, fluticasone propionate (FLONASE) and multivitamins. The patient experienced several lumps on right side of head and neck, welt on eye and swollen eyelid right side on 26Mar2021 07:00 with outcome of not recovered. No treatment was given for the events.

low grade, continuous ear ringing (tinnitus)/tinnitus became severe and is constant; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Mar2021 (lot number and expiry date were not reported) as a single dose (given at the age of 44 years old), and then dose 2 via an unspecified route of administration, administered in the left arm on 01Apr2021 12:30 (lot number and expiry date were not reported) as a single dose, for covid-19 immunisation. Medical history included blood pressure (abnormal), and patient had COVID over a year ago (date unspecified), and had lingering inflammatory issues since that time, but not tinnitus. The patient had no known allergies. Concomitant medications included unspecified blood pressure medications in two weeks prior to vaccination. The patient had no other vaccine in four weeks. It was reported that within a few days after the first shot, patient had low grade, continuous ear ringing (tinnitus) started (Mar2021). Patient went to the doctor, who thought it would resolve on its own and advised to get the second shot. The tinnitus did not resolve prior to the second shot (3 weeks later). Within 2 days of the second shot, the tinnitus became severe and was constant. Doctor prescribed a high dose cycle of steroids (6 days) starting that day; steroids have not improved symptoms. It's been over a week since the second shot-no relief. The patient was not tested for COVID post vaccination. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event tinnitus was not recovered. Information on the lot/batch number has been requested.

chill; half face was swelling; fever (99-100F); much stronger pain with the tooth; much stronger pain with the tooth; This is a spontaneous report from a contactable consumer reported for himself. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 15:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included one tooth with some inflammation and pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. None allergies to medications, food, or other products. The patient's concomitant medications were none. The patient experienced much stronger pain with the tooth on 24Mar2021 18:15 with outcome of recovered, half face was swelling on 25Mar2021 (next morning)with outcome of recovered, fever (99-100f) on 25Mar2021 (next morning)with outcome of unknown, chill on unspecified date with outcome of recovered. The chill, swelling and pain last 3-4 days post injection. Therapeutic measures (Advil) were taken as a result of much stronger pain with the tooth. Follow-up attempts have been completed and no further information is expected.

Hearing loss and ringing in left ear. Hearing is only about 10%. Shortly after getting 1st shot, my household also get colds. I went to doctor and was prescribed Amoxacilin. I thought hearing loss could have been from minor infection. Once antibiotics were complete and I still could not hear (& tinnitus) I went to primary doctor and he prescribed Methylprednisolone (a steroid). That treatment has now completed and hearing loss & tinnitus still persist.

This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not reporting side effect. The adverse effect date and time is a mandatory field. This is the reason I filled adverse date and time. I had my 2nd dose of vaccine on April 25, 2021 at campus at 1.20 PM. I just felt the syringe just touched the peripheral of my skin. I told the nurse that I do not feel I get the shot. Later, I do not feel any side effect any effect. I had no pain, or the site of injection was not swollen. I am worried I did not get the 0.3ml dose. During the first shot on April 4, 2021 at 1.43 PM, I felt pain on shoulders. I felt my tongue got thickened/ some tingling sensation on tongue and a little slur in speech. After 6 hours, I felt headache, a little chill, light head, nausea, more pain on shoulders and the next day, I felt light headedness and I felt tired for few days. I consider these as normal side effects and nothing unusual from what I read in internet and what I heard from others. So, I did not report it and it was a normal thing for me. Since I experienced this in first dose, I expected a more severe reaction than first dose. But I did not even feel pain at the site of injection nor any usual symptoms that usually appear. This made me to doubt I got required dose or the vaccine was correctly withdrawn from the vile. I do not know how to confirm that I got correct dosage. If I have not received the full dose, I am ready to take an additional shot and I would be flexible to take the shot at the available time near to my living place on any day. Again, I am not complaining anything. Probably the nurse is very proficient in taking shot with no pain. I do not know why my body does not react to the second dose.

Burning itchy eyes. Feeling like he has something stuck in the back of his eyes. Client stated he had similar reaction after receiving first dose.

my ears won't stop ringing, specifically my left one on the same side as the arm I got the shot in, and it is driving me crazy

Main side effect I am reporting is ringing in ear. Overall it lasted about 72 hours. The ringing was very strong (like I had been at a concert) starting ~16 hours after the second dose. By about 24 hours after the vaccine dose (4/27, approximately 5pm) it had subsided by ~80%. It was not until late in the day, Friday 4/30 that it had fully subsided, ~96 hours after the vaccination.

Significant worsening of tinnitus. Upon visiting doctor, she reports that I?ve lost some low-end hearing in my left ear as well.

Ii have had recurrent aphthous ulcers every week since mid Jan, without any respite. Previosly I would have 3-4 per year but it is now a weekly occurrence.

Flashes and blurred vision in the left eye, various eye exams conducted and fluid drained in an attempt to lower pressure and remove clot (unsuccessful). The event resulted in Central Retinal Artery Occlusion and loss of vision.

A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.

Continued issues - Burning in left hip, clicking in left pointer finger, night sweats, migraines, light sensitivity in right eye. Recovered - muscle spasm and cramp in right thigh

subjective fever, malaise, right upper quadrant abdominal pain, pain, cough, sneezing, poor appetite, decreased smell and taste

Loss of feeling in right foot and blurred vision on evening of second day after vaccination. Symptoms developed at same time as fever started. Fever lasted the evening with bed soaked in sweat then broke by the morning. Lose of feeling in foot improved by next day and feeling returned entirely after 5 days. Blurred vision improved by next day but has been lasting one and off for two weeks. After feeling returned in right foot there was one evening of right ankle cramping. Finally fasciculations and "pins and needles" feeling happened in the face, right wrist, and right leg happened during the 2nd week after the shot but improved by the third week.

Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/21, requiring ER visit on 4/12/21 then hospitalization for 5 days. Comprehensive labs done. Follow-up advised with Dr. (has not occurred). Per Dr. (Neurology), do not get second dose of Covid-19 vaccine as there is a chance the vaccine contributed to development of these symptoms. Doctor said it could possibly be Guillain-Barre Syndrome. As of 5/11/21, significant vision impairment still exists and patient is unable to work. Patient is uninsured.

Sudden loss of hearing in right ear in upper frequencies, pressure and fullness in inner ear for 2 weeks straight now. Nerve damage to left ring finger tip with less feeling to touch.

Slight fatigue after first shot. A lot more fatigue after the second shot. Developed Tinnitus 5 days after the second dose.

Strange metallic and wood-like taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the unspecified anatomical site on 15Mar2021 at 15:30 (at the age of 44-years-old), as a single dose for COVID-19 vaccination. The patient's medical history was not provided. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. On 15Mar2021, the patient had strange metallic and wood-like taste in mouth for 3 hours. The clinical outcome of strange metallic and wood-like taste in mouth was recovered on 15Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to go to the ER because it was really bothering me. They only helped with the anxiety and did an eye exam. It seemed to have gone away some but now it's coming back and it's like having dirty contacts in and having hypersensitivity to light and dark textures.

Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vision; This is a spontaneous report was received from a contactable consumer (patient). A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), via an unspecified route on 08Apr2021 at 13:15 as 1st dose, single in the left arm for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Betamethasone Dipropionate Cream USP 0.05%. The patient had known allergies with Keflex (cephalexin). 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 08Apr2021 (5 minutes after vaccination), the patient experienced sweating, minor tightness in the chest and blurred vision followed by fainting and remained unconscious for a few seconds. After regaining consciousness, continued sweating for maybe 10 minutes. The patient visited emergency room. The patient did not receive any treatment for the events. On an unspecified date in APR-2021, the patient had recovered from the events.

Received 1st dose covid vaccine 4/8/2021. Few days after c/o fatigue, muscle aches, headache, drowsiness and dizziness which overall resolved after 1 wk but still mild headache, muscle aches and still some drowsiness and dizziness did not resolve. After 2nd dose, 2d after started experiencing drowsiness and dizziness, still ongoing, improved while sitting or resting. 1 wk after 2nd dose, muscle aches resolved. Also 2 weeks after 2nd dose, dry mouth, 8/10 throat pain which is now 2-3/10. He feels it is improving every day.

I hear a high-pitch ringing or buzzing sound constantly. I hear it at all times since it set in a day or two after my second dose covid vaccination. I believe this is called tinnitus. A week after my second dose, it is still loud and may be getting louder. I believe this is called tinnitus. I can still hear quiet sounds, at least in other frequency ranges. But it is quite annoying, particularly when I am in a quiet environment with nothing to distract me.

sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 15 days with various symptoms

fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the vaccine

WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT DIZZY, AND MY FACE WAS NUMB. WITHIN MINUTES OF TAKING THE SECOND SHOT, MY BLOOD PRESSURE AND PULSE SPIKED. SINCE THE SHOTS, I HAVE EXPERIENCED DIZZINESS, FEELING OF FAINTING AND ELEVATED BLOOD PRESSURE. I HAVE EXPERIENCES PIERCING PAIN IN MY HEART, PRESSURE IN MY CHEST AND INCREASED PULSE EVEN WHEN RESTING. I HAVE EXPERIENCED HEADACHES, BLURRED VISION.

Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began about half hour after injection then went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.

5 days after vaccination ears began ringing, now 2 weeks later they are still ringing. Very high pitched ringing.

Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.

Fever, between 100 and 101 degrees approximately 12 hours after inoculation. Injection site soreness, muscle aches, fatigue, and a lip blister.

Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.

Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given 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. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.

Patient said at time of Abilify injection he has experienced partial blurred vision out of right eye on right side. He described it as "seeing like he is in the movie Abyss". I told him blurred vision is a side effect of the COVID vaccine and I would report it due to minimal studies with abilify and covid vaccinations.

Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was provided medication by healthcare professional. (Prednisone 10mg)

I have been suffering from Tinnitus, HOWEVER I HAVE NO IDEA IF THIS IS RELATED TO THE VACCINE OR THE VIRUS ITSELF AT ALL. I am a musician and started this Tinnitus after practicing with headphones AT VERY LOW LEVELS, since I am mindful about my hearing. In fact, in previous audiology tests years ago not only was my hearing above average for the general population, it was above average for musicians that play amplified music. A few weeks ago I was also doing audio training at home and the Tinnitus seemed to increase. Again, it didn't make sense to me since I do this at average listening levels. I have NOT gotten treatment for it yet, as I though it was a temporary thing.

Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods. Doctor's were unable to diagnose him with anything. He stated that he has a history of mental illness,

Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treatment.

The patient stated he was getting tunnel vision. At this point I came to the site of the patient and his pupils dilated. He became unresponsive. The patient started responding after about 1 minute. When the patient finally became responsive he began sweating quite a bit. We immediately began the emergency response and called 911 and called for store help. I stayed with the patient and when the paramedics got there they took over in the patient's care. The patient remained hypotensive, so the paramedics advised him going to the hospital. The patient agreed and was taken to the hospital.

Burning sensation in outer edge of left ear; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-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 in the left arm on 30Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to any medications, food, or other products. Concomitant medication included naproxen (MANUFACTURER UNKNOWN). 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 experienced burning sensation in outer edge of left ear. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the event. The clinical outcome of the event burning sensation in outer edge of left ear was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

At 2 days after the vaccine patient says he experienced a rash that started on lips, then to the back of his hands, and also to his groin and left leg. Patient took benadryl and used alcohol topically to dry out bumps for 10 to 12 days

Blurred vision, dizziness for several days. Developed Ringing of the ears and some chest pains. Vision disturbance and ear ring still present on this date Of report.

Patient tested positive for COVID-19. Symptoms include sinus congestion, partial anosmia, partial ageusia

received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.

palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure. Evaluated in ED received solumedrol, benadryl. Discharged home and returned to hospital as direct admit due to continued symptoms. Pertinent labs reveled AKI, elevated LFTs. AKI and LFTs improved with IVFs.

polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EJ1685) at the first dose in left arm on 17Dec2020 12:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included ongoing back pain (thinking it was due to running/physical therapy overuse injury). No allergies to medications, food, or other products. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. It was reported that 20Dec2020 morning: new left forefoot paresthesia. no weakness. Patient thought this might be due to the back pain he had been watching for 3 months, thinking it was due to running/physical therapy overuse injury. On 21Dec2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending). On 24Dec2020 9 pm, paresthesia both hands and feet, no weakness nor other symptoms those continued and were slightly worse on 27Dec2020 morning, including face/teeth. no other symptoms; 27Dec2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy. Neurologist appointment will be 07Jan2021, 2 hours before 2nd shot was scheduled. The patient had been tested for COVID-19 test type post vaccination: negative on 22Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of events was not resolved.; 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 polyneuropathy and facet joint diagnosis/new left forefoot paresthesia due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions 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 nerve conduction tests, 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.

Rash Rash on face and facial swelling Narrative: Developed a rash the day of the vaccine and then woke up with eye and facial swelling the following day. States he took Benadryl which helped the rash go away, but some of the swelling remains today. States it was difficult to open his eye lids first thing in the morning.

Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth. Lower lip swelling, administered Epi-pen, called rapid response. Transferred to ED at 09:11am

Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body

He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out, feeling unsteady, sweaty, nauseated. They would last for about less than a minute, but he had several episodes. He had pulsatile tinnitus. He also had an elevated LFT.

loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.

Burst blood vessel in left eye 24 hours after vaccine was given.; This is a spontaneous report from a contactable other-HCP. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number not available, via an unspecified route of administration on 21Dec2020 07:45 AM at single dose for covid-19 immunization. Vaccine location was left deltoid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included morbid obesity and blood pressure high. No known allergies. Patient didn't do relevant test. Concomitant medication included amlodipine (AMLODIPINE) at 5mg daily. The patient experienced burst blood vessel in left eye 24 hours after vaccine was given (eye haemorrhage) on 22Dec2020 08:30 with outcome of recovered. No treatment received. The action taken in response to the event for BNT162B2 was not applicable. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the eye haemorrhage and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Twelve hours after vaccination (1/20/21), left side of tongue felt swollen/dry/tingly. Was able to sleep. In morning (1/21/21), developed same sensation, plus lips and off/on left side of face felt tingly. I am not ruling out anxiety.

PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/100 P: 110 RESP 16 SPO2 99%, ELEVATED BP AND PULSE. 1145: ADMIN OTC BENADRYL x 2 CAP PO. PT TOLERATE WELL. 1148: V/S TAKEN BP:150/96 P: 92 RESP 12 SPO2 99%. 1150: PT STATES THAT HE IS FEELING BETTER. A&Ox4. 1153: V/S TAKEN BP:150/96P: 92RESP 12 SPO2 99%. 1200: V/S TAKEN BP:146/92P: 91RESP 12 SPO2 98%. PT INSTRUCTED NOT TO DRIVE, AND F/U WITH PCM IN REGARDS TO H/O OF TIA WITH TODAYS V/S ELEVATED BP AND PULSE. PT WAS FEELING BETTER AND STABLE.

hives; itching; itchy feeling tongue; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LEK5230), intramuscular at the right arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization at a hospital. Medical history included allergies with latex, sulfa., and penicillin (PCN). Concomitant medications were unspecified. The patient previously took erythromycin (ERY) and experienced allergies. The patient experienced hives, itching and itchy feeling tongue on 18Dec2020 09:30. Patient took 50 mg of diphenhydramine (BENADRYL), 20 mg famotidine (PEPCID) and 10 mg of cetirizine (ZYRTEC). The patient has not been tested prior and post vaccination. The patient was recovering from the events.

large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital. Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.

Patient finished observation period and went to his car 50 minutes post vaccine where he then started feeling tingling to tongue and fat and fuzzy feeling. Returned to site - received Benadryl IM with good resolve. DC'd home to care of friend for further observation.

well that night i lost all taste and smell that was Friday today is Monday and still no better - Saturday was the hardest i just tried to sleep the pain away- by Sunday i had full on covid19 symptoms and was very sick - now 4 days in i still have a headache , cant brethe these symptoms arent just mild and i worry about someone older then me taking this

Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered. After 3 hrs all swelling was gone and was discharged.

Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vaccination. At about 29-30 hours, noticed mild numb feeling along right jawline from middle of mouth to right ear, and around the right ear. By morning (about 48 hours post vaccination), numb feeling appears gone on right jawline, but seems to have moved to left jawline (still mild). No trouble breathing or eating at all. Consulted primary care doctor out of concern over odd sensation, but not treatments at this time. Considering taking a benadryl tablet just to see if it has any effect.

2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations. Vision (only have one eye) has been hazy when looking at computer. This is still on going. Work up done by optometrist at this point eye checks ok but problem persist. Referral to ophthalmologist is place. Feeling of fogginess in head - "drunk like feeling" persisted for several weeks. This still seems to be on going. Palpitations and some check pain. - This was never a finding prior to 2nd dose of vaccine. This has resolved.

Patient received his first dose on 2/1/21 and was observed for 15 minutes. He reported that after returning home he has dizziness and weakness that lasted 45 minutes and then resolved without treatment. He did not seek care. On the day of his second shot (2/22/21) he said he had not taken his blood pressure medication that morning. His blood pressure was143/98 and pulse 70 prior to vaccination. At 10 minutes after the injection he reported feeling dizzy and having shortness of breath and feeling dry mouth. His O2 sat was 98%. Pulse had increased to 82 and then several minutes later was 110. He was placed on a monitor but a large size cuff was not available at the vaccination site. He continued to feel weak and more short of breath, so he was given a dose of epinephrine by autoinjector and EMS was called to transport him to the ER. At the ER, he was given diphenhydramine and his condition continued to improve. He was observed in the ER for 3 hours and discharged home.

large mass under the armpit. possible swollen lymph nodes. muscle pain, fatigue, tingling feeling on the lower lip left hand side,

1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER

Weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly; His tongue looks like he has swollen taste buds or something; Itchy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) intramuscular on the right arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications included supplements and vitamins. The patient got the COVID Vaccine on the 21st of January the Pfizer one and the following day he felt fine but he has this weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly and then his tongue looked like he has swollen taste buds or something, but he said he felt fine but the reporter don't if that's a side effect. "Should he be worried, should he go to a doctor?" Reporter stated, "Because we weren't sure what it was, he did take one Benadryl like the ones you find at the drug store and then that was it. And then I put Calamine lotion, so topically couple times just to prevent him from scratching but not regularly just when he feels really, really itchy." Outcome of the events was unknown.

Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.

NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.

Got much louder Tinnitus starting about one week after 1st dose of pfizer vaccine. Had preexisting Tinnitus in same ear for 5 years as well as 35db hearing loss.

Sudden hearing loss; Tinnitus. ENT doctor prescribed Prednisone for 2 weeks (80mg per day for the first week, then a progressively decreasing dose for the second week).

After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable. BP 106/67 98% o2sat HR 65 RR 16

Blurred vision began 4 hours after vaccination, lasted throughout evening. Incident gone as of March 26 AM.

The patient reported vision changes and not feeling normal. Patient returned to baseline after 15 minutes.

Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.

Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ,jaw and tongue. Left eye does not blink so constantly tears, slurred speach and no taste. Symptoms started on 3/21/21 and got worse. Meds prescribed acyclovir 800mgs , prednisone 10mg and Diclofenac sod dr 75 mg for pain.

Swollen gland in the neck, sore throat (left side), ear pain (left side), and swollen lymph node in armpit (left armpit)

Tinnitus in both ears almost immediately after first shot, worsened almost immediately after the second one. I still have it today and it's not getting any better.

Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.

Noticed a ringing in my ears 10 minutes after vaccination and tinnitus like symptoms are not improving the day after.

Approximately one day after vaccinations starting having subtle tinnitus in both ears. It is not overwhelming but has been consistent over last few days.

A few days after receiving the first dose of the Pfizer COVID-19 vaccine, I developed a constant sense of smelling smoke.

Within 4hrs of receiving the 2nd dose of Pfizer COVID-19 vaccine I began to experience ringing in the ears followed by onset of extreme headaches and body aches somewhat dissimilar from the flu. These aches felt like painful internal construction of the head neck back and thigh muscles. Severe pain in the left arm where I received the jab. I was extremely fatigued and could barely make it from bed to the bathroom. I treated the condition with Tylenol 1g every 4hrs followed by 200mg of Motrin. I also ensured adequate fluid hydration and electrolytes 120+ oz per day. The symptoms continued for about 36hrs. I began to feel better but 48hrs later I relapsed with the onset of ringing ears then headache followed by extreme fatigue. I treated the 2nd round with continued bed rest over 3 days with Tylenol (1g) and Motrin (400mg). I eliminated Tylenol day 2. I reduced Motrin to half on Day 3. I felt better for 48hrs and again relapsed but only needed smaller 200mg doses of Motrin for a day along with bed rest. The ringing in the ears have been consistent since the onset of the symptoms 4hrs after receiving the 2nd shot. The ringing is greater when I?m active and late in the day. The ringing in the ears is less after min of 6hrs full sleep during the night. I have yet to be able to exercise since racing that 2nd dose. I?m slowly progressing in reducing the fatigue by consuming 30mL shots of ginger juice daily along with 500mcg of Vitamin B12 as directed by my Dr.

Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.

Several hours after 10:30am vax, odd sensations in left ear canal/drum, as like needing to equalize pressure. Unaffected by scratching or wiggling. Then it turned in to tinnitus by about 7pm. of moderate intensity, lasting for about 5 hours that night. Was bad enough did not think I'd be able to sleep, but abated while reading in bed, and was gone in morning. No further issues since.

Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was leaving when his wife and his mother mentioned he had swollen eyes. Pt said he was feeling well and that his eyes were fine. However, family member insisted he had an allergic reaction to the vaccine and he mentioned he started to feel lightheaded and nervous afterwards. His BP was 107/81 mmHg and pulse 100 bpm and he mentioned he wanted to take something for allergies, so patient was given 50 mg Benadryl after confirming his weight (80 kg). After 15 minutes waiting, patient mentioned he was feeling fine, and he wanted to leave. BP was taken again and it was 125/76 mmHg and pulse was 89 bpm. Pt refused calling 911 because he was feeling ok and he did not feel his eyes swollen.

Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111, O2 100, @1419 HR 77, BP 166/97, O2 100 Pt discharged to home with others at 1432

Left jaw is pretty sore. Not all the time. But it gets sore. I believe its effecting the temporalmandibular. No I've never had a broken jaw or injury to it in past. Also my wife had the same shot the same day the same arm.and has the same effects? And I can taste a chem taste at times also.

2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.

SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.

Metal taste in mouth about 12-20 hours after second injection. Lasted approximately 2-3 days. Ran slightly elevated temp (~100F) for a day, but fever responded well to Tylenol and subsided within 48 hours.

2 days after my second shot I broke out in Hives and welts down my torso, Arms, and legs. I went to urgent care and they gave me a shot of prednisone and gave me a pack of the same steroid to take over the next 6 days they also prescribed some prescription Claritin and Famotidine.. The following day 4/16/21 around 1130pm I woke up to my face being swollen as well as my tongue. I was taken to the ER where the triage unit gave me epinephrine as well as another steroid to stabilize the swelling as I was having trouble breathing. Once stabilized I was released and took 50 mg of Benadryl every 6 hours as well as the Claritin, famotidine, and the prednisone. I had hives for a few days after and followed up with my primary doctor, but as of today I feel like i am back to normal.

Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.

False smell of smoke that happens periodically throughout the day, lasting 3-5 minutes. I had a web-call with doctor and he asked that I report my symptoms. I have a follow-up in one week and if the smell doesn't improve, he will refer me to an ENT specialist.

Tinnitus. The ringing in my ears has become so bad that I can?t hear and I can?t concentrate. I don?t want to live any longer like this.

Fatigue, shortness of breath, thirsty, joint pain, lower left back pain, nausea and chills. All symptoms have been going on for 5 days now

Tinnitus increased from mild/barely noticeable to very noticeable in both ears, with the left ear being louder.

2-3 Days after first shot I developed ringing in my left ear. I tried many things and have been doctors but nothing has helped. I'm reporting as I'm positive its a vaccine side effect and hoping that CDC can help here.

When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.

stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.

It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .

Per MD, Pt c/o swelling in the roof of his mouth about 3 minutes after receiving the vaccine. No itching, no SOB. Exam NAD 145/93 P88 O2sat 100%, Lungs CTAB This represents possible angioedema and I recommend that he forego the second dose of Pfizer. Pt provided with 25 mg of benadryl PO x1. He was d/ced home in stable condition. Cancelled 2nd dose and made appointment for Johnson & Johnson vaccine.

12/10/20 - 12/25/2202 COVID with mild symptoms 3/10/2021 1st Shot Pfiizer 2pm 3/13/2021 Brief Vertigo 3/31/21 2nd Shot Pfizer 4pm 4/4/21 running and throwing all day with kids 4/3/21-4/4/21 Tingling in shins like sunburn Week of 4/4/21- 4/11 progressive burning lower legs and arms as well as instability standing and sensitivity to light . Weakness in peronials right lower leg. Dizziness as well as wobbly gait, like I was stepping over a curb. Neck soreness and stiffness as well as a burning in the spine when I laid down. Weakness in right and left arm consistent with a pinched nerve. (history of trauma and nerve damage in right arm from an accident) TMJ jaw soreness and eye focal issues. -During this time i could still balance on on leg and passed several basic neurological exams -Balance on toes and heals 4/11-4/13 Symptoms dissipated by 30% Chiropractic helped some. Still had neurological instability like I had cold or Woozy head feeling with stiff neck 4//14 Primary Care Doc . Prescribed me Predizon 10 mg - 4pills 3 days, 3Pills 3days, 2Pills 3 days, 1 pill 3 days. Took at least 6 days but physical symptoms were about 85-90% gone I was left with Bilateral burning ( intermittent ) in hamstrings, feet lower, legs left and left glute. And tingling in Scrotum. I have L5 bulge. I also still had a ?woozy or unstable feeling intermittent as well as a intermittent visual focal issues I also have/had a light sunburn like tingling intermittent in outer arms, abdomen and legs. intermittent tmj bilateral tension.. 4/26 - Ophthalmologist looked at my eyes and said everything was perfectly fine I may need reading glasses and that the symptoms I was experiencing were not related to anything he found 4/27 - Spoke to a Rheumatoid Arthritis Doctor ( I had elevated levels on blood work) He said nothing that suggests RA at all. I told him my story and he said he has heard of this and it is most likely some reaction to the shot and may take a couple of months to work itself out. Referred me to a neurologist to be sure I have nothing else going on. He put me on 5mg of Prednisone daily for 30 days as well ad 200 mg of Celebrex for 30 days with a follow up call in 30 days Helping all physical symptoms almost immediately 4/29 - I currently have Intermittent visual focus issues, sensitivity to light and sore neck and slight instability. Like my body is recovering from a virus. My cognition and energy are improving and I finally slept for more than 4 hours straight.

Lymph node on right side behind ear swelled up then entire right side of face and ear swelled up to the point I had water blisters on ear eye swollen shut and ear was so swollen couldn?t even put a Q tip in my ear nose swelled all up

Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tinnitus was quite bad, then the next day it settled down to be two or three times as noticeable as my baseline tinnitus was prior to the vaccine, at least. At this point, normally don't hear it, but when I'm going to sleep it's very noticeable. Ten weeks later, it's steady and hasn't gotten worse or better since it steadied out on the third day.

Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.

A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.

cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a car was coming and didn't even see them; Not able to make good decision/made the wrong decision; weak when he walks and knees are bending; left side very slow and weak, unable to use left side; weak; could not stand up or be on his feet/ left side weak an unable to stand or walk; cannot type on the keyboard; fell on the floor; numbness on his left hand/numbness and tingling in hand; tingling in hand/numbness and tingling in hand; This is a spontaneous report from a contactable consumer (Patient, self-reported) via medical information team. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER729; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Hand Left (shoulder) on 10Apr2021 12:00, as 2ND DOSE, 0.3 ML SINGLE; for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes dose 1 (Batch/Lot Number: EP75334, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Hand Left (shoulder) on 20Mar2021 02:30PM, as 1ST DOSE, SINGLE. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on 10Apr2021 and he started experiencing numbness on his left hand and next morning he could no feel anything on the left side of his body, it was so weak that he could no lift his hand, walk on stand on his feet. He went to the ER, they made some tests, but primary care doctor did not provide a diagnosis. He started feeling better but today he could not stand up or be on his feet, he cannot talk properly, cannot type on a keyboard and the left side of his body is very slow and weak. Reportedly, the primary care provider was not able to provide him with any diagnosis. He was feeling better, but today, he noticed that he was not able to stand up on his feet again. He cannot talk properly due to weakness. He cannot type on the keyboard. The left side is very slow and very weak. It has been several weeks and he is not feeling better. Stated that he is 46 and was 46 when he experienced these events. Last week, patient went to the neurologist and no one had helped him. The only thing was about the side effects and were not telling him how that can be fixed. Numbness in hand has been more than 2 weeks. He doesn't feel numbness now but is very weak. The left side of his body has less strength. The numbness was minutes after the shot and the tingling was immediately after. The numbness and tingling lasted 30 to 40 minutes after the shot. The emergency doctor gave him some medicine but he does not remember what medicine. They also gave him fluids and then he got some strength. Woke up the next day and was unable to stand. He tried to go to the restroom and was so weak, he fell on the floor. They did all the tests and could not find anything. He is still not feeling normal. His right hand is fine. The left side, where they did the shot had less strength. He can't even move his finger properly and can't type on the keyboard, from the left hand side. if there are any cases like this and how that person got better and what was the root cause. So many weeks, this has been affecting his day to day life. He can not work. He is a software programmer. He needs to use his hands. He can't use his hands. Is feeling like his body and mind are responding slow. When he drives, he is not able to make good decisions. One time he really made the wrong decision. It affected him and he didn't know a car was coming and didn't even see them. States that he spoke to medical information, they could not provide any medical advice. Everyone is making this hard. They could not find another person with similar symptoms. Patient did not receive other vaccine in four weeks of vaccination. On an unspecified date, the patient experienced cannot talk properly, on 10Apr2021 12:05, numbness on his left hand/numbness and tingling in hand, 12:01 tingling in hand/numbness and tingling in hand, on 11Apr2021 weak, could not stand up or be on his feet/ left side weak an unable to stand or walk (was reported as worsened), fell on the floor, cannot type on the keyboard, weak when he walks and knees are bending, left side very slow and weak, unable to use left side, on an unspecified date his body and mind are responding slow, it affected him and he didn't know a car was coming and didn't even see them, not able to make good decision/made the wrong decision. Patient went emergency room on 11Apr2021 they made some tests, but primary care doctor did not provide a diagnosis. Patient was sent home to recover at home. wife was with him and brought him home. They gave him medicines and fluids. He was able to walk and stand up and somehow was recovering well. The patient underwent lab tests and procedures which included blood test: didn't find anything, nothing significant, electrocardiogram: didn't find anything, nothing significant, laboratory test: didn't find anything, nothing significant on an unspecified date. Therapeutic measures were taken as a result of left side very slow and weak, unable to use left side (asthenia). Outcome of the events numbness on his left hand/numbness and tingling in hand and tingling in hand/numbness and tingling in hand was recovered on 10Apr2021 12:45; left side very slow and weak, unable to use left side was not recovered and other events outcome was unknown. Follow-up attempts are needed. Further information is expected.

Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.

Two to Three days after my 2nd dose of the Pfizer vaccine I woke up around 4 am by a foul odor taste and or smell i stayed in bed the smell and taste got very bad for 2 weeks and went away on it's own,on the 4th day after vaccine i woke up and went to brush my tooth It Felt like I pour acid into my mouth with a severe burning feeling followed by severe gum and tooth pain also some sporadic chest pain.I looked into my mouth and noticed my entire mouth looks like bumps and or hives looking about 7 days later most of the bumps/hives turned into ulcers.this symptoms is still present,also around day 4 or 5 I shaved my short beard and noticed a tiny balled patch of beard under my chin ever since this is getting worse and it is about the size of a quarter or more.I went to see my Family Physician and was told these symptoms i having could be from nasal polyps and or sinuses she did blood work to check for sickness everything came back negative,i was told to talk to my Immunologist and or an ENT I went 05/25/2021 to see the Immunologist and he said their was no evidenvce of nasal polyps that the vaccine must have did something to my immume.

client complained of dizziness 3 mins after receiving vaccine. Client signaled EMTs for assistance. EMT began assessment and vitals and EMT informed PHN and PHN. Upon arrival client sitting upright in chair, alert and oriented x4. PHN continued assessment. Per client felt dizzy, blurred vision and sweaty. Vitals at 1854: blood pressure 148/96, pulse 71, oxygen 99%. Client denied chest pain, shortness of breath, headache, no swelling or flushing noted. Medical history of hypertension, per client takes medication at night. Medication Micardis for blood pressure. No known allergies. EMT gave client water. Vitals at 1900: blood pressure 149/98, pulse 72, oxygen 99%. Client stated dizziness improving and blurry vision resolved. Vitals at 1905: blood pressure 139/86, pulse 70, oxygen 98%. Vitals at 1910: blood pressure: 147/92, pulse 68, oxygen 98%. Per client normal blood pressure 130s/80s. Per client dizziness resolved. 1915 vitals: blood pressure 128/91, pulse 68, oxygen 98%. PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1920: blood pressure 140/95, pulse 64, oxygen 99%. Per client all symptoms resolved, able to stand with no dizziness. Wife present with client and would drive client home. Client left facility at 1922 with steady gait.

15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.

Tongue swelled up and felt tingly 50 minutes after Pfizer vaccine dose #1 administered. Admitted to ER. Tongue swelling subsided 90 minutes after vaccine administered. Tongue tingling subsided 2.5 hours after vaccine administered.

I had a mild COVID-19 infection in January, 2021. My symptoms were mild congestion and slight body ache. I did not lose any sense of smell or taste, nor were those senses altered in any way during my infection. I waited 3 months for my COVID-19 vaccine. About 10 days after I received my first shot of the Pfizer COVID vaccine I started to experience weird tastes and smells with certain foods such as eggs, corn chips and popcorn, and strawberries. I did not lose my sense of smell or taste, but they have been altered. When I eat these foods I have a bad taste and smell. The sensation seems to have dissipated a bit but is still with me 3 months after the first dose.

under his eyes felt swollen and painful; under his eyes felt swollen and painful; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; dark red streaks down the back of his throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; his arm was hot to the touch around the area where the COVID vaccine was; soreness in his arm/but then on the second day he had soreness but for the second COVID vaccine it was the worst on the first day; little bit of dizziness right after the vaccine; flash fevers where he would get hot almost to the point of him sweating; flash fevers where he would get hot almost to the point of him sweating; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162, age at vaccination 45 years), dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 as single for COVID-19 immunisation. Medical history included thyroid condition (he thinks it is hypothyroid, it is a new condition to him he was only diagnosed a couple months ago), kidney stones and asthma. Concomitant medications included spironolactone, potassium citrate, both taken for kidney stones and thyroid medication taken for thyroid condition (he thinks it is hypothyroid). The patient previously took the first dose of BNT162B2 (Lot number: ER8733) as single for COVID-19 immunization and experienced his arm didn't feel too bad when he got it but then on the second day he had soreness. On 20Apr2021, the patient has had soreness in his arm and on-and-off fevers for the last two days. For the second COVID vaccine they happened that day which was the worst day for the arm soreness. He also had a little bit of dizziness right after the vaccine when he was sitting there. And a couple times throughout the day he had like flash fevers where he would get hot almost to the point of him sweating with some and then it would go away and that happened throughout the night. On 21Apr2021, the soreness had let up on his arm a little and he had more movement, but his arm was hot to the touch around the area where the COVID vaccine was and it was a little hard. Also, he had some headaches on and off but they would last only a few minutes and then they would go away. On 22Apr2021, his arm was still sore and hot but he had some more movement but that was about all that he had noticed so he thought that he was getting better. On 23Apr2021 night, he woke up at around 04:30 in the morning with an intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured too/ face pressure. As he started going through the day, he realized that his throat was sore. He looked in the mirror noticed that he has dark red streaks down the back of his throat and he knew that he can get a sore throat and headaches after the COVID vaccine but was it normal for him to get the redness in the back of his throat or was that something that he should talk to someone about. The patient further reported that his arm was still tender to the touch and if he rolls or bumps into it or his arm was just hanging for a while, it would get achy. He was feeling it but he can move it without much pain, but it was still painful. It got better with each day a little bit. With his first COVID vaccine it was kind of opposite, his arm didn't feel too bad when he got it but then on the second day, he had soreness but for the second COVID vaccine it was the worst on the first day. Caller confirmed that his dizziness was only after the COVID vaccine on 20Apr2021 and he says that the flash fevers were from 20Apr2021 to 21Apr2021. He confirmed that the intense all around headache, his sinuses feeling pressured and the sore throat began today, 23Apr2021 at around 04:30 when he had woken up. He confirmed that he was still experiencing this to now and when probed for outcome he reported that the headache has gotten a little better. He has been trying to not drink any caffeine to try and open things up a little and he knew that part of this was in his sinus area, so he has tried using steam to get it to open a little bit. He can still feel it on his temples and it was still there. It was not as intense but it was a discomfort. Later in the call, he confirmed that the arm soreness that began the day after his first COVID vaccine began on 31Mar2021. The patient thought it was the 3rd day that it had gotten pretty decent. Still, again, there was a little bit of pain but it wasn't very noticeable and it didn't limit anything he was doing. The patient assessed the events as non-serious. The outcome of events pain in eyes, eyes swollen, rash and vaccination site warmth was unknown, dizziness was resolved on 20Apr2021, fever and sweating was resolved on 21Apr2021, and was resolving for the rest of the events. No follow-up attempts are possible. No further information is expected

Ringing ears (left ear more noticeable than the right ear); This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on left arm on 17Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to walnut from an unknown date. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. On 20Mar2021 at 13:00 the patient experienced ringing in ears but left ear had more noticeable when compared to right ear. The patient did not receive any treatment for events. The clinical outcome of the event ringing ears (left ear more noticeable than the right ear) was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Sudden hearing loss and tinnitus in my right ear.; Sudden hearing loss and tinnitus in my right ear.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6957), via an unspecified route of administration at the age of 45-year-old administered in arm left on Mar2021 (01:15PM) at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. There was no Covid tested post vaccination. Concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. The patient had no past drug event. The patient experienced sudden hearing loss and tinnitus in his right ear on 31Mar2021. His hearing has not improved since the onset of the sudden hearing loss. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Disability or permanent damage. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Since the vaccination, the patient hasn't been tested for COVID-19. This report was reported as serious. Seriousness criteria was reported as disabling/Incapacitating. The patient received prednisone shots in his right ear. oral prednisone. The outcome of events was not recovered.

The patient stated that one hour after receiving his second dose, everything started to turn yellow, he got dizzy and lightheaded, and his hearing was "off"/impaired. He closed his eyes for about 20-30 seconds, and when he opened his eyes again, he felt better. He has not had any issues since that episode.

Experienced twitching in right ear in or around ear drum at night after my second dose in the afternoon. The twitching produced a sensation of throbbing sound and was very frequent and constant, occurring almost every other second. The next day was even worse with constant twitching throbbing sensation and I my sleep was hugely affected. I would stay up and walk at night. Got an appointment on May 11 with my Dr. who said basically I have ringing ears, Tinnitus, which might be due to hearing loss from childhood etc. He checked hearing which was still fine. I did mention it all started happening right after 2nd dose of COVID vaccine but he didn't think there was any connection with that. He did say he will keep this in mind and see if any link between vaccine and Tinnitus is found as cases are reported. He said there is not much that can be done for Tinnitus other than reducing noise levels.

No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected with Covid-19. Started with symptoms Tuesday Dec. 29 2020 at 6am (Chills, severe body aches) I currently work in a jail setting with active covid-19 cases. Exposure to covid-19 at work high. Covid symptoms as of Jan. 3 2021 have been: mild headache, body aches, muscle stiffness, chills, sinus congestion/runny nose, mild cough, loss of taste/smell.

He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.

Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs" plus dizziness. After monitoring for 30 minutes, patient reported symptoms started to resolve. Upon follow-up, patient reported that tingling in lower legs had resolved after 3 days.

Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. That evening his eye started blinking.... Bells Palsey. Difficulty with face movement. Today still persisting. Now taking a steroid. He is a MD.

Non-pulsatile, constant headache in bilateral temporal areas of head that radiate into neck and trapezius muscles bilaterally - also feel pressure being the eyes when the headache is bad. Bending over to pick things up definitely makes all this worse.

Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on the inside of the bottom and top lips , burning sensation that covered the facial area. Doctor instructed to keep taking Valtrex and prescribed a Z pack , I was already taking the Valtrex with little to worsening effect BUT after administering the Z pack condition quickly deminished and went completely away within 2 days.

subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.

At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.

AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIISON AND HE SAID IT WAS FROM THE VACCINE, RINGING IN EARS FOR 11 DAYS NOW, CAN'T SLEEP, THINK, WORK, SCHOOL, ALL EFFECTED.

The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over my left arm only. But the second dose of this vaccine (on 2/7/2021) was different. In addition to the severe pain on my left arm, I had (and still) a severe headache, pains all over my body and bones, high fever (102), dizziness, shaking, fatigue, cold at all times, and a little bit taste loss (as of right now, 24 hours after the vaccine). It looks like a hard flu symptoms exactly.

On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.

This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 12:15 PM at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient reported that he felt fine after the shot for the rest of the day and the first night other than the soreness where he received the shot. The patient went to bed around 11 pm and woke up the next day (14Jan2021) at around 6:30 am with very bad dizziness. He felt like his eyes were rolling around in his head which made him very nauseous and sick to his stomach. His wife called a friend who is a nurse and she said to keep an eye on him for a little while and see how he was in an hour or so. She said that if it gets worse call 911 otherwise get him to the clinic at 10 am. He reported that he was feeling much better by then but went to clinic at 10 and doctor saw him asked questions gave me something for nausea and dizziness. He felt good the rest of the day with slight lightheaded. He mentioned that he needs get his second shot on 03Feb2021 and was concerned about getting it. He inquired on what is the recommendation on getting dose #2. It was not reported if the patient been tested for COVID-19 since vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events. They gave me ondansetron (ZAFRAN ODT [orally disintegrating tablets]) 4 mg for nausea. The patient considered the events was non-serious. The outcome of the events was recovered on an unspecified date with sequelae (recovered with lasting effects).

1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading

On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to become paralyzed. On 2/28/2021, left side of face became totally paralyzed and went to ER because worried it was a sign of a stroke.

Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Resolved. BP 137/83 (pulse 80).

Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.

Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hours. Major spasm that prevented me from turning my head or laying down at around 6-8 hours. Upper back, neck, and muscle pain in my head and jaw continue today (3/17/21) but symptoms are slowly decreasing in severity.

Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.

Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- ongoing.

Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse All Subjective male who was seen at Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension and rapid progression of symptoms. Pmh: htn, hld and sleep apnea. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches (negative for headaches) Denies vision changes.: +lightheaded, lips tingling: Previous Reactions: none Objective Vitals Vitals: 03/16/21 1429 03/16/21 1432 BP: (!) 182/96 (!) 173/105 Pulse: 86 SpO2: 99% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is obese. He is not ill-appearing. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Tingling resolved. Still feeling lightheaded. Pt rested and had snacks and water. Slowly lightheadedness was reducing in severity. After 15 minutes of observation, he was able to stand w/o increased lightheadedness. He ambulates the bay w/o difficulty. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheadedness/elevated bp. Anxiety as well. Review of his prior bp numbers in epic records show fluctuation of his bp ranging from 180's to 140's. Recommended that he monitor bp at home. He doesn't have red flag symptoms related to elevated bp. He's to follow up with pcp accordingly. Electronically Signed 3/16/2021 2:29 PM

Diplopia and headache, found to have ring enhancing lesions on MRI brain. Ddx broad right now, but given proximity to vaccination reporting in case this is an adverse event. May be CNS lymphoma vs infection vs autoimmune.

Tongue swelling and protruding. Benadryl 50mg IM given. Also, Epi pen administered. 911 called. Patient transported to ER.

Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body Aches 4. Fatigue 5. Headache 6. Metallic Taste in my mouth. Nothing tasted good yesterday. 7. Nasal Drip with Nausea

Client received 1st Pfizer dose and approx. 7 minutes later c/o being "light-headed", having "tunnel vision" and was observed to be diaphoretic and pallor. He was led to a zero gravity chair by EMT and experienced syncope for several seconds. When he regained consciousness, V/S were taken every 5 mins, all WNL. At 9:50am, he reported feeling a little better but a light headed. At 10am, he was observed to have normal skin tone, no diaphoresis, and walked away unassisted with a friend who came to pick him up. He reported "feeling better." Client reported to RN that he has a history of "passing out when giving blood." No medication was given.

I already suffer from mild tinnitus. About 14 hours after the 2nd vaccine dose my tinnitus became noticeably worse for a period of about 24 hours. I also experienced the typical flu-cold like symptoms after the 2nd vaccine dose including muscle ache, stiff and achey joints, and general I'll feel for a period of 8 after that began 14 hours after the 2nd dose was administered. I experienced fatigue for roughly 4 days after the 2nd dose. I had no symptoms nor adverse reaction after the 1st dose. My biggest concern was the tinnitus. The cold and flu like symptoms I understand should be expected.

Within 15 minutes of receiving injection, ringing started in both ears. Ringing is persistent and has not dissipated.

Beginning same day, severe intermittent each ache in right ear only. Continuing during the following day (Saturday)

tested positive/tested positive for the COVID-19 Virus; pepperoni tasting funny; This is a spontaneous report from a contactable consumer. A 46-years-old male patient received bnt162b2 (Pfizer-BiONtech COVID-19 vaccine, formulation; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL3247) as single dose Covid-19 immunization.The patient medical history included Flublok Quadrivalent Vaccine on 20 an2021 ,9 days before his first COVID-19 Vaccine dose. He clarified he received the Flublok Quadrivalent Vaccine. He did not have the NDC, Lot and Expiration Date.The concomitant medications was not reported. The patient stated that received his first COVID-19 Vaccine dose on 29Jan2021, and then tested positive for the COVID-19 Virus on 09Feb2021. He said he wife had COVID-19 Virus symptoms the evening of 29Jan2021. He said he believes his wife was exposed to the COVID-19 Virus on Monday, 25Jan2021. He said he tested negative for the COVID-19 Virus on 03Feb2021, and then tested positive for the COVID-19 Virus on 09Feb2021. He said he tested negative, again, for the COVID-19 Virus on 14Feb2021. He clarified that all 3 COVID-19 Virus tests were 'rapid' tests (where the test is done 1'deep with 5 circles around) and the test results were back in a half hour. he had received a flu vaccine on 20Jan2021, 9 days before his first COVID-19 Vaccine dose. He clarified he received the Flublok Quadrivalent Vaccine. He did not have the NDC, Lot and Expiration Date. He considered 03Feb2021 his first day of minor symptoms. He clarified his only symptom was pepperoni tasting funny. He said his kids tested positive for the COVID-19 Virus on 03Feb2021. He was pretty sure of his COVID-19 Virus exposure time frame. He said his wife was exposed to the COVID-19 Virus when she had a hospital test done on 25Jan2021. He said his wife's COVID-19 Virus symptoms started on 29Jan2021. he is scheduled to get his second COVID-19 Vaccine dose on Friday, 19Feb2021. He said 19Feb2021 will be day 11 after testing positive for the COVID-19 Virus. He said he wanted to confirm if he should still get the second COVID-19 Vaccine dose on 19Feb2021, or if he needs to reschedule his second COVID-19 Vaccine dose to a later date. The patient underwent lab tests and procedures which included COVID-19 rapid POC test: negative on 03Feb2021, COVID-19 rapid POC test: positive on 09Feb2021, COVID-19 rapid POC test: negative on 14Feb2021.The outcome of the event tested positive/tested positive for the COVID-19 Virus was Recovered/Resolved on 14Feb2021 and outcome of pepperoni tasting funny was unknown.

On 04/04/21, I lost all hearing in my right ear and can only hear a ringing (tinitus). This might not be COVID Vaccine related, but I have not taken any other medications and overall feel healthy. Went to the emergency room on 04/04/21, CT scans performed with no issues found. They gave steroids and antibiotics to take. I Saw ENT on 04/06/21 and a hearing test was performed and it was determined that I had Sudden Sensory Deafness in my right ear. Taking 60mg Prednisone each morning and 500mg Valacyclovir twice daily. The symptoms have not changed (improved or worsened) as of today.

Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away. I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am. I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now. Before the shot I was perfectly healthy. I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem. This shot was the ONLY thing that could have caused this. I'm not sure what to do next or if I should get the second shot which could make it worse. I'm very worried because the ringing and aches have been constant for 10 days.. some days worse than others.

4/9/21 - second covid vaccine recorded at 9:30 AM. 730 PM started to get sleepy 830 was exhausted went to bed and slept 14 hrs. Also started having tinnitus when woke 4/10/21. Has decreased over 24 hrs.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient reported rash/itchiness on the chest area post vaccine shot. does not report any other symptoms and no swelling of the mouth areas (face, lips, tongue). no trouble breathing. patient had also picked up allergy medications earlier in the day for an unrelated allergy symptoms of the body. Counseled patient on benadryl and will follow up next day as well. Patient reported okay to drive home and will take benadryl when he arrives at home safely.

A few minutes after receiving vaccine, L eye had some visual disturbances, guest quoted seeing "wavy lines and mirage". Was assessed by RNs. Guest denied blurry vision, diplopia. Denied any headache or dizziness, Guest reported having experienced visual disturbances previously. The visual changes resolved at 15 minutes.

Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection. Client given Benadryl 50mg po x1 approximately 5 minutes after symptoms began. Client reported increased in facial/mouth tingling and complained of nausea. No vomiting. Client continued to report increasing symptoms of facial/mouth tingling which resulted in transport to the local ER. No notable external edema observed in facial area or otherwise.

Sulfur taste and smell about a month after second dose. Coffee Peanut Butter Sulfur taste in my mouth all the time

He presented with worsening redness and swelling to his left eyelids. States he received second dose of his COVID vaccine on 4/6 and a rash developed on 4/9, then worsening redness and swelling to the area after taking amoxicillin which was prescribed by an urgent care provider. Therefore, he was advised to come to the ER for further evaluation. He denies any fever or chills. Denies any visual disturbances. He is afebrile. White count is 4000, hemoglobin 13, hematocrit 41. He has been started on intravenous antibiotics, Rocephin and vancomycin. He had a CT of his facial bones, which confirmed left preseptal cellulitis without fluid collection or abscess. Blood cultures are currently pending. Preseptal cellulitis of the left eye. No abscess noted on CT. He received COVID-19 vaccine 4/6. He noticed a rash to his left eye on 4/9, then developed redness and swelling. Denies trauma or insect bites. Questionable if this is related as possible delayed reaction to his vaccine. Brand of Covid-19 vaccine is UNKNOWN.

Began experiencing constant ringing in both ears (tinnitus) hours after receiving the second dose of the Pfizer COVID-19 vaccine.

Either just before or immediately following the second dose of the Pfizer vaccine for COVID-19, developed tinnitus in both ears. Has persisted for approximately a week so far.

Faint high pitched ringing; Faint high pitched ringing; Higher pitches not audible; This is a spontaneous report from program. A 46-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 01Apr2021 13:30 (Batch/Lot Number: EP6955) at a single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. He was not also diagnosed with COVI-19 prior and since vaccination. He has not been tested positive with Covid-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced penicillin allergy. The patient experienced faint high pitched ringing and higher pitches not audible on 02Apr2021 02:00 with outcome of not recovered. In addition, it was also described as faint high pitched ringing began about 12 hours after administration. Persists. Frequency ~ 13kHz (I do music/audio stuff so checked against tone generator). Higher pitches not audible, unknown if related to the symptom or simply age.

Left ear ringing started 12+ hours after receiving second dose of Pfizer. Lasted for approx 2 days. Worse at night.

THE PATIENT STARTED TO HAVE BLURRY VISION AT ABOUT 10 MINUTES AFTER VACCINE, THEN TONGUE IN ONE SPOT ON FRONT TINGLING, STARTED TO GET TINGLING ARM. BP TAKEN AND AT 151/111 AT 10:45 AM. CALLED 911, SQUAD TOOK PATIENT AT AMBULANCE AND LEFT PROPERTY

Ringing in both ears, started a few hours after vaccination and continues. Left ear is more audible. Headache in the evening left temple

Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw hard to swallow very difficult to breathe a little bit of chest pains, called EMS and paramedics to took blood oxygen levels, blood pressure which were all normal by then the symptoms had started to subside

Fever up to 102.3 degrees, severe chills, body aches, headache, loss of taste & smell, fatigue, dizziness. Most symptoms including fever lasting at least 36 hours. Still experiencing fever, fatigue, dizziness.

Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El3248), via an unspecified route of administration, administered in the left arm on 18Jan2021 as a single dose for COVID-19 immunization. Medical history included Hashimoto's disease, high cholesterol and is prediabetic all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient did not have COVID prior to vaccintion and has not been tested for COVID post vaccination. Concomitant medications included empagliflozin (JARDIANCE); levothyroxine (manufacturer unknown); metoprolol (manufacturer unknown); rosuvastatin (manufacturer unknown) and fish oil (OMEGA 3 [FISH OIL]), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: Es1685) on 28Dec2020 at 12:00 PM via intramuscular route on the right arm for COVID-19 immunization. The patient experienced loss of hearing in left ear, tinnitus/echoing and numbness around area of left ear all on 22Mar2021 at 12:00. The ENT prescribed prednisone 10mg as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully 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.

After a few weeks, my right ear started to have constant tinnitus as not subsided. Note that I have Meniere's in my left ear, but this is the first time my right ear has had tinnitus for a sustained period of time.

Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting having body aches, dizziness, headache and filling flushed. On 4/24/2021 lip swelling started and now both lips, sides of mouth with clear blisters. Per Client, allergic to shellfish and no other known past medical history. Per Client has taken Benadryl and Ibuprofen, but symptoms are still presenting. PHN recommended that Client follow up with PCP, be seen at urgent care, ER and to call 911 with any respiratory concern or medical emergency. Client verbalized understanding information provided by PHN and plans to follow up and seek medical attention.

Metallic taste in mouth since dose 1 on March 27. As of April 28th I still have the taste. It gets worse at night before bed.

Tinnitus, fainting, low blood pressure. Chills when IV was administered. Two bags of IV administered. As of today, day five, still have ringing in the ears (tinnitus).

46yo male experienced minor allergic reaction following dose #2 of COVID-19 vaccine (Pfizer). Tolerated dose #1; hx of COVID-19 in January 2021. About 90 minutes after vaccine, pt became lightheaded with blurred vision while in physical therapy gym (inpatient rehab due to spinal injuries). RN noted rash on both arms and welts to L arm and L trunk. No SOB or CP. Patient treated with diphenhydramine 50 mg with apparent resolution of sx.

46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.

I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I woke up at approx. 1:30 am feeling very warm. I got out of bed. While in the bathroom, I began to feel very lightheaded and passed out while I was washing my hands. My wife heard me crash to the floor. I returned to consciousness but passed out again while trying to stand, unresponsive to my wife. I returned to consciousness after about 1 minute. I stayed sitting for several minutes while my wife brought me some water. I felt thirsty and it's possible I was dehydrated, but I had been drinking fluids (water) the day before as normal. Due to the two fainting spells and a possible head injury, I went to the Emergency Room for treatment at approx. 2 am.

Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-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 right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination. No follow-up attempts are needed. No further information is expected.

calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sweating pretty; felt a little too ill to get up and walk away; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 13Apr2021 15:00 (Lot number was not reported) (at age 46 years old) as single dose for covid-19 immunisation in a pharmacy. Medical history included covid-19 from an unknown date and unknown if ongoing. Patient was not covid tested post vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 13Apr2021 15:00, within one minute of receiving the vaccine, his ears were ringing, he felt faint, and began sweating pretty significantly. He took a seat immediately, and these symptoms seemed to pass after about 8-10 minutes. He stayed seated for 40 minutes after in the pharmacy as he felt a little too ill to get up and walk away. Next day, on 14Apr2021, symptoms are mild fatigue, mild fever, mild cough, and moderate muscle aches. Treatment not given for the events. The patient was recovering from the events. Information on the batch number has been requested.

Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Took Benadryl tablets about an hour after receiving the vaccine. Took Tylenol for the fever. Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.

transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus or the vaccine (or combination of all 3). Sx included areflexia, bilateral paresthesia (legs and feet), double vision, cord damage from cervical region to conus of the cord. Also developed urinary retention.

Starting Friday evening severe rash and hives. Treated with multiple Benadryl. Starting today (5/3) - swelling of the tongue. Have tried Benadryl. No improvement yet.

For both the first dose and the second, I experienced belching that tasted very bad, watery diarrhea, gas, bloating, and abdominal cramps.

Within 5 minutes after receiving the shot, patient started having headache & heartache on and off for about 10 minutes. Patient also complaint about his throat/mouth was dry. 15 minutes after he started to have numbness around his mouth and on tip/ middle part of his tongue. Numbness lasted for about half an hour. That night he vomited and has chills. Next day he had very mild fever, pain in the right lung when he sneezed / coughed. He didn't have much symptoms on the 3rd day except for an sore arm and tireness.

Patient had a diffuse hive-like rash as well as joint aches, body aches, dry mouth, and itching. Patient was evaluated in urgent care (not the vaccination site where he received his vaccine) and given IM Kenalog on day of evaluation. Patient was then prescribed a 10 day Prednisone taper regimen to start the next day as well as Claritin and Benadryl prescriptions. Unknown outcome after treatments.

Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour later I had exhaustion and then injection site arm began hurting. This lasted for 48 hours and then I was fine. It came on fast and stayed. I had difficult time thinking or retaining a memory. Second shot had no instant reaction, injection site just slowly began hurting. An hour later, and very suddenly, brain fog hit me and i lost all short term memory, mid sentence. Similar to what I would consider a form of Alzheimer?s. At the same time I developed a headache, not as severe as the first shot, but I was more exhausted than the first shot. Forming sentences, being able to think was very difficult for 72 hours. I was exhausted, arm hurt. After the 72 hours, I lost my sense to smell. I am in my 96 hour since my second injection and still have no sense of smell. I can taste. Never had a fever but for both shots it felt like it was absorbed by my muscles and was then converted to something else which was then released back into my system. It was like I had sore muscles it was like my muscles became the poison. This effect was grossly more profound after the second vaccine. The ability to think was the scariest side effect.

Pt c/o swelling and tingling of tongue, dizziness, LE heaviness. Denies SOB, chest pain. BP 121/85, HR 70, RR 17, O2 100% RA. Benadryl 50mg IM given. No tongue angioedema, rash or puffy face noted. Pt still c/o mild numbness on tongue and pt advised to go to ER and was accompanied by RN.

clogged ears, loss of hearing acuity. Sudden onset.; clogged ears, loss of hearing acuity. Sudden onset.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), via an unspecified route of administration, administered in left arm on 19Apr2021 14:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. On 22Apr2021 20:30, the patient experienced clogged ears and loss of hearing acuity, sudden onset. There was no therapy for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.

Saturday, May 8th woke up with severe tinnitus and then suddenly lost all hearing in left ear. Went to urgent care and go prednisone and ENT on May 10th. Hearing loss in my left ear is totally gone. They have little to no hope of recovery. Will be doing an MRI.

Mild Tinnitus. Consistent mild tinnitus with intermittent moderate tinnitus. I experienced mild tinnitus after 2nd dose of vaccine and just assumed it would go away. I've never had chronic tinnitus and in general I am in very good health. I am 5'11 and 170 lbs and very active. I have experienced tinnitus on occasion after a loud concert or other but this is different. My hearing is otherwise perfect. Due to Covid I am still working from home and very much notice this adverse event as it is rather quiet at home with little background noise. I have now had this issue for over 2 months and recently have had issues where it is quite bothersome which prompted this report.

Right submandibular lymph node swelling, facial/ear pain (ongoing but getting better-antibiotics given) Right facial numbness/droop diagnosed as Bell?s Palsy right side (ongoing)

Sudden Sensory deafness in my right ear, and severe ringing.; Sudden Sensory deafness in my right ear, and severe ringing.; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in left arm on 25Mar2021, at 09:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies were noted. No other vaccines or medications were noted within two weeks . Prior to vaccination, no diagnosis with COVID-19 was noted. The patient noted sudden sensory deafness in my right ear, and severe ringing on 04Apr2021. Therapeutic measures were taken as a result of the events; 60 mg of prednisone daily was administered. No COVID test was administered post vaccination. The outcome of sudden sensory deafness in my right ear, and severe ringing was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

My right eye (white of the eye) became irritated and swollen; My right eye (white of the eye) became irritated and swollen; It continued to be swollen until about 7:00am. It is currently inflamed but no longer swollen; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported for himself. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date unknown), via unspecified route on left arm on24Feb2021 at 10:15 (patient was 46-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included allergies to bananas, walnuts. The patient's concomitant medications included atorvastatin, lisinopril, metformin, Farxyga. 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. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, at 9:30 pm the patient experienced right eye (white of the eye) became irritated and swollen, It continued to be swollen until about 7:00am and currently inflamed but no longer swollen. The patient received treatment with Benadryl, ibuprofen. The outcome of the event eye irritation and eye inflammation were recovering while, eye swollen was recovered at 26Feb2021, at 07:00. Follow up #1 (03Mar2021): This is a follow up-spontaneous report received from a contactable Other HCP. This Other HCP reported for himself that: This is not part of a study/SAE/AE form. This is personal experience, self-reporting of use of PFE product. I received the Pfizer vaccine on 24Feb. On 25Feb, I experienced the swollen eye issue, so yes that is the first moment an employee of Pfizer was aware. Information about lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a 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 RAs, Ethics Committees, and Investigators, as appropriate.

Roughly one week after my first Pfizer shot I developed tinnitus. Has resulted in a high-pitched ringing in ears. It was in both ears three weeks following the shot and is now mainly in by right ear.

Patient arrived to the Emergency Department today with facial droop and left sided facial/mouth numbness and headache.

Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy feeling, flush on face which lasted a minute or 2 followed by very rapid / hard beating of my heart (I could see my shirt move on my chest from the beating). This lasted for almost 10 minutes. Very scary. Paramedics were called about 5 minutes into the episode. (I had a similar reaction of dizzy, flush with rapid and hard heart beat reaction after 1st dose about 5 minutes after it was given which lasted couple minutes then subsided). When the paramedics arrived, I was laying down in my bed trying to relax and breath. By then the rapid and very hard beating of heart was calming down but was still elevated pulse for a resting position...~128bpm. My BP was measured at 154/87. They connected the 12point electrodes and the reading came back normal...only elevated pulse. Paramedics ran 3 more scans during the 20 minutes they were there for...all came back normal. My O2 was 100%. I elected to no go to ER since we live only 2 miles from the local hospital and I was feeling much better by then...but would go if I had another heart episode. I have had none since. Only other strange side effects was sore arm for 2 day and I notice is constant ringing in my ears all the time...strange. I hope that will go away soon...very annoying.

Loss of hearing in my right ear - Sudden Sensorineural Hearing Loss and now constant Tinnitus 10 days after 1st Phizer Covid vaccine I woke up with a plugged ear. A week later I went to an Urgent Care to have my ear checked out. I was put on antibiotics. After that not clearing up my ear, I visited an ENT doctor who diagnosed me with Sudden Sensorineural Hearing Loss. I also now have constant Tinnitus in my right ear. Dr did 2 injections into my eardrum with steroids and I was also put on Prednisone pills for 2 weeks. After these course of treatments I had no improvement in the hearing loss.

I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.

Extreme vertigo, full feeling behind ears, nausea, vomiting, involuntary eye movements left right like pendulum Started 7 days after 2nd dose. Worse into 8th day.

swollen eye; pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 01May2021 12:15 (as reported) (Batch/Lot Number: ER8737) as single dose, and dose 2 via an unspecified route of administration administered in left arm on 01May2021 (as reported) (Batch/Lot Number: Ew8170) as single dose for COVID-19 immunisation. There was no other medical history, no known allergies. The patient had not had COVID prior to the vaccination. COVID was not tested post the vaccination. There was no concomitant drugs, no other vaccine in four weeks. The patient experienced swollen eye and pain on 02May2021 02:00, serious due to hospitalization. The events were treated with antibiotics and eye medication. The events were not resolved.

patient returned to store with a very enlarged lower lip on 6/2/21 patient reported this started after receiving dose of covid-19 vaccine saying it started on 6/1/21 advised to take Benadryl and if not resolved by end of day to consult doctor attention

Doctors appointment on May 18th to address right arm swollen lymph node identified on May 13th. On May 19th I experience the lost of my sense of taste and after my doctor's visit, Steroids and NAC were prescribed. It is now June 7th and I have yet to regain my sense of taste.

feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.

Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed, Tingling and numbness from left eye to jaw. Drooping of left eye and lips. Memory and processing information issues. One month later still some head pain off and on and numbness around left eye. Still have memory and processing issues. I've never had any other prior issues with the head or face. No falls or activities such as boxing

Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with left sided facial droop and tingling sensation for 2 days. He reported symptoms onset at 1330 on 6/10/2021 while driving a truck. He also had left sided occipital headache and rested for 1 hour. His symptoms improved after the nap but never resolved completely. He got into a location and rested there for 1 night. In the morning after waking up he was having difficulty chewing food on his left side. He called EMS and was brought to hospital. While in the ED, he received workup including CT Head W/O, CTA Head/Neck with perfusion scan that were all negative. Other labs obtained included BMP, CBC, Troponin x1, Coag studies & CXR which were largely unremarkable. Neurology were called for stroke alert and given ASA 325mg and ordered MRI. Patient's MRI was unremarkable for stroke or masses. He was started on Prednisone 40mg once daily for Facial Nerve Palsy. He was seen by physical therapy and occupational therapy, they recommended him go home to family. His symptoms improved after therapies were initiated but are not completely resolved. Patient will continue taking his home medications per his primary care doctor. He will complete a 7 day steroid course, has 3 days remaining. He will take Acyclovir 5 times per day for 10 days. We also gave him lubricating eye drops since he continues to have difficulty closing his left eye. He spends a lot of time outdoors and works with horses. He reports getting tick bites before in his body but never noticed a rashes. He has never received treatment for Lyme Disease. He is a long-haul truck driver and has driven all around. He reports walking in wooded areas when he stops in the rest area. We obtained Lyme Titers, which were eqivocal for IgM and negative for IgG. Western blot was ordered to rule out Lyme disease. He should followup with PCP for treatment if he is positive. We will call him with results when available. Of note he received Pfizer 2nd COVID vaccine on 6/9/21 (LOT #EW0178). He reported fever and diarrhea that night and next morning. He then reports having presenting symptoms after 7 hours of driving. We also believe the cause of his facial nerve paralysis could have been a side effect of his vaccination.

Patient was waiting in our observation area when he began to experience dizziness, cold sweats and tunnel vision. He lay down on the floor, and our technician asked him if he was OK. I immediately went out to him, and he told me he was already feeling better. I had him put his feet up on the chair, and he told me that he thought this reaction was due to anxiety. He was talking and breathing normally. I offered to check his blood pressure and get him some water, but he declined. He rested on the floor for approximately 5 minutes and then said he was feeling well enough to go.

Shortly after receiving the second covid19 vaccine, I started experiencing tinnitus in my ear/s. I cannot tell which ear it is coming from since closing off my ear canal does not stop the sound. The only way to describe the loud sound is a constant sound the cicada makes. The only time I don't notice the sound is in loud environments but it is constant if my surroundings are silent.

Facial Numbness, partial swelling to nose, upper lip, cheeks ( Dr. Visit Tested for Herpes - Negative Possible Lupus)

Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021. Pt pain became worse despite treatment and then started to have lower ext wkness and numbess and unable to walk. Pt also had loss of hearing Diagnosed with Guillain Barre syndrome while in the hospital by a neurologist

PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER RECEIVING VACCINE. AMBULANCE WAS CALLED BUT HE REFUSED TO BE TREATED AND LEFT UNDER HIS OWN POWER.

Patient received his first dose of the Pfizer Covid-19 vaccine on 7/2/21. Later that day the tip of his tongue had no taste. About 72 hours later, patient experienced numbness/tingling down the side of his face. He went into the emergency room and had workup/CT scan. Patient was diagnosed with Bell's Palsy.

I had swelling in my right armpit lymph node and a mild rash that developed on the 4th day. I also developed Bell?s palsy in the right side of my face. I went to the ER where I was prescribed prednisone and valacyclovir. These medications both helped a little. On June 25th the rash got worse, and the doctor prescribed a steroid cream which has helped. The rash has gone away from under my arm, but my lymph node is still swollen. On June 25th the doctor also said my face was more symmetrical, but I still have weakness and pain on my jawline and lip area. The pain is like a nerve pain and still comes and goes but it is not as bad as it was initially.

Patient received the first COVID Pfizer vaccine, left the immunization room, walked to a chair, and sat down. Less than a minute later, patient lost consciousness (not sure if just passed out or had seizure), lips turned blue, was gurgling, pupils were dilated, and went limp. His companion helped me get him to the floor, where he was breathing. He remained unconscious for less than a minute longer. We called 911, who instructed us to leave him on the floor until help arrived. His blood pressure was normal when they arrived and patient refused to be further evaluated in the ambulance and refused to go to the hospital. Patient walked out of the store.

Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.

Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.

High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself. This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Approximately 3 weeks after second shot I developed tinnitus. Fully examined by ENT, no hearing loss or other explanation. Tinnitus still ongoing 3 months later.

Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below

Bells Palsey in the left side of the face. Lasted approximately 2 weeks and still have numbness in my tongue. Prescribed prednisone 60mg for 7 days. Also experienced extremely swollen lymph nodes in my left neck for approximately 4 days.

Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.

Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associated symptoms noted

Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had creep to the face, right cheek was not responding fully. Described the numbness like having a Novocain at the dentist. Symptoms lasted 3 days

Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real dehydrated; Kidneys started hurting and felt like kidneys were overworking; Mouth dry; Kept having to go to the restroom; Kept using restroom and had to pee a lot; He is a little sore, but the pain is not as bad; Pain in kidneys woke him up from sleep.; Arm is still swollen but swelling went down; red spot under his arm that looks irritated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 via an unspecified route of administration in upper right arm on 02Jan2021 between 07:00-07:30 at single dose for covid-19 immunization. Medical history: None. There were no concomitant medications. The patient experienced swollen under arm and a knot/upper part of shoulder and chest area was swollen on 03Jan2021 18:00, nauseated, real dehydrated, kidneys started hurting and felt like kidneys were overworking, mouth dry, kept having to go to the restroom; kept using restroom and had to pee a lot, he is a little sore, but the pain is not as bad, pain in kidneys woke him up from sleep all on 03Jan2021. Got COVID Vaccine on Saturday. Was swollen up under arm. Over kidneys, started hurting. Swelling went down. Took Naproxen and Ibuprofen. Mouth was really dry. Felt like kidneys are overworking. Keeps drinking water and going to the restroom. Kidneys started hurting. Received through work. Employed at a mental health and mental retardation school. Arm swollen with a knot. Got off Sunday morning, 03Jan2021. By 18:00, under arm was swollen. Thought he slept wrong or he had an issue with an artery. Under arm and into upper part of shoulder and chest area was swollen. He was nauseated. Felt really dehydrated. Kidneys started hurting. Felt like kidneys were overworking. Felt similar to when he previously had a kidney infection. Knew something wasn't right. Kept using restroom and had to pee a lot. Kept drinking. Kidneys were hurting from 03Jan2021 to yesterday. He is a little sore, but the pain is not as bad. Was drinking water, cranberry juice, and orange juice to flush the COVID vaccine through. Pain in kidneys woke him up from sleep. Is a little swollen. Pain is better than what it was. Between 02:00-03:00 it was done. Swelling was really bad. Start taking Naproxen and Ibuprofen. He was hurting too. Arm is still swollen but swelling went down. There is a red spot under his arm that looks irritated. Supposed to receive second COVID Vaccine on 30Jan2021 but was not going to take it. Clarified he took Naproxen with Ibuprofen in it for the anti-inflammatory. Confirmed he was only referring to one product. Naproxen was just bought from the store. Unable to provide NDC/Lot/Exp because he does not have product at time of call. Formulation: 200mg per pill, took two pills then six hours later took another two for Voluntary; high number of COVID Cases at his work. Scared to take second COVID Vaccine. The patient underwent lab tests and procedures which included Covid Test: unknown results on an unspecified date (He has to take COVID tests twice a week). The outcome of events was unknown. Vaccination Facility Type: which is a mental health and mental retardation school. He has to take COVID tests twice a week. No additional vaccines administered on same date of Pfizer suspect. The event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Prior vaccinations within 4 weeks was none. Adverse event follow prior vaccinations was none. Relevant tests: none. Information about Lot/Batch number has been requested.

Tingling in the back of the throat, dry feeling, metallic taste in mouth. No lightheadedness, pain in chest or difficulty breathing.

1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.

Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.

Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.

Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then tingling in bilateral fingers and hands. That progressed to tingling in feet and toes. The nerves coming into my arm pits were very painful and I couldn't put my arms against my body. Petechia rash on my torso. Numb left lower lip and jaw area, numb right shoulder, numb shins and calfs. when the numb lip began my PCP had me go to the ED for evaluation. All blood work and Electrolytes came back normal. All this lasted over a week and the petechia spots are still on my torso, but seem to be going away.

I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.

Transient numbness inside mouth buccal mucosa for about 3-5 minutes; Slight swelling upper left lip; 2cm petechia on border of left upper lip stopping at the midline; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), Intramuscular at left arm on 15Jan2021 11:00 at SINGLE DOSE for covid-19 vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. On 15Jan2021 11:15, the patient experienced transient numbness inside mouth buccal mucosa for about 3-5 minutes, slight swelling upper left lip, 2cm petechia on border of left upper lip. Stopping at the midline. No treatment received for the events. No covid-prior-vaccination, no covid-tested-post-vaccination, no known allergies. The outcome of the events was recovering.

Extreme rash all over body. Very red, very itchy. Hands and eyes very swollen. Alternating Benedryl and Claritin to lessen itch and swelling.

I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the left ear. I also experienced headache, vertigo, chest heaviness, vertigo, and chills for 3 days following the vaccine. Still have the ringing. I cancelled the 2nd vaccine.

Severe headache, severe chills, could not move(full body stiffness). Extreme thirst. Subsided after 5.5 hours.

Patient reports "tongue was a little numb and felt a tingle on his lips" shortly after vaccination and during wait period. States he tasted "a metallic taste" with injection that resolved immediately. Did not alert staff while waiting 30 min post vaccine. Reports s/s resolved "about 10 minutes after leaving. Denies SOB, rash, tongue/face/throat swelling.

Two days after shot I started getting canker sores in my mouth and on third day there were more. Very painful and hard to eat food. Went to clinic and he gave me Mylanta and told me to take. It does seem a little better but still not gone.

Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't close all the way. Started Sunday night to the morning went to ER. Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.

tinnitus Received a second shot of the Pfizer vaccine shipped to Hospital. Next day had fever , noise and ringing (both). Fever disappeared after 3 days but noise and high pitched ringing remained and is still an issue as of today. Saw PCP, they were not sure if it is related and could not identify a cause. It seems moderate but affect ability to concentrate at work and read.

I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint pain, severe fatigue, severe dry mouth, muscle and body aches, nausea, pounding headache, also just feel "out of it"

After leaving facility, had numbness in tongue, trouble swallowing. Waited 20-40 more minutes, then felt dizzy and began to have hives in addition to previous reactions. I went to Urgent Care where they took vitals. Blood pressure and heart rate were elevated, throat was abnormal, and I had hives. They gave me antihistamine and steroid shot. After 30minutes - and hours, vitals returned to normal.

Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors

Tinnitus. More prevalent in the right ear than the left. The high pitch noise in my ears will not go away. The right ear ringing worse the left. This did not result from any loud noises (I came directly home and had been in the house the entire time), the tinnitus started with 18 hrs after the 2nd covid shot was administered. There was no issue with the first shot.

Around 3/19/21 shortly after patient started taking the (flonase), He had what felt like earache/infection. that went away in a day or so, but started having issues with the left sided drooping of my face. My PCP diagnosed it Bells Palsy, some nerve got swollen up/aggravated.

Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mild brief tonic (arms) preceding syncopal x1 activity, patient was pale, clammy. Paramedic held patient up in chair to avoid fall. Patient taken to OBS medic tent for observation for syncopal event. Observed, water offered, orthostatic positioning, rest. Patient walked out after recovery.

tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle. other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later. left arm sore for rest of the day, back to normal next day.

facial swelling. lower lip and left check swelling. Woke as result of swelling at 4am. took 2 oral benadryl and swelling appeared to stop growing. went back to sleep and woke at 7am with swelling still at same level. started to subside at 10am and by 5pm (the time of this submission) had almost fully subsided.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status

feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 minutes after shot on drive home. Took allegra and it went away in 30-60 minutes. Tongue was sore the next day. I also suffered a mild anxiety attack at the same time. Treatment for that was meditation and cessation of throat swelling symptoms. Lastly, I also had a severe flare up of my fibromyalgia symptoms in my forearms starting 3 days after the injection. I don't know if this was a primary effect from the vaccine, or secondary from the additional nociceptive input from the joint and muscle pain I was experiencing in my forearms. I increased my lyrica to compensate. Two weeks out from the shot I'm almost back to baseline.

Experienced intermittent, temporary loss of hearing ( seconds duration) in ears during 4/8 and 4/9 (approximately 3 times per ear) Each ear was was affected individually, not simultaneously. Subjectively, hearing seemed to recover, but hearing test has not been performed, yet . Since 4/9, have persistent tinnitus in both ears. Had telemedicine visit on 4/11 and will schedule evaluation with ENT specialist.

Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while eating. Patient went to the ER at 1634 on 4/8/2021. ER report- positive for swollen tongue, weakness, negative for respiratory distress, Respirations were normal with mild scattered bronchial sounds

this is a positive but odd event: I had a heightened and dramatically improved sense of smell and taste after my shot. I could smell the new plastic smell of my laptop which I never smelt before. It was so odd. And I could really taste the cream in some pistachio ice cream. I can really say this was a dramatically heightened sense of smell and taste.

Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.

Headache, fogginess, malaise. These have mostly resolved as of 07:31 on 4/13/2021. Ringing in both ears and slight pressure in ears(pressure was mildly painful 4/11-4/12. Ringing and pressure still present as of 07:31 on 4:/13/2021.

1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITTING POSITION. PT TURNED TO BACK WITH ASSISTANCE FROM STAFF. PT QUICKLY REGAINED CONSCIOUSNESS AND NOTED TO BE WITH DILATED PUPILS AND TRYING TO FOCUS. NOTED CLAMMY SKIN. VS WITH HEART RATE IN 40'S WEAK RADIAL. BP 122/76. NOTED APPROX 1/2 INCH ABRASION TO RT TEMPORAL AREA FOREHEAD. PT ORIENTED TO SURROUNDINGS AND SITUATION. STATES "I TRIED TO RAISE MY HAND TO TELL NURSE I FELT FUNNY, THEN I FELT LIKE I WAS IN A DREAM AND WOKE UP WITH YOU ALL AROUND ME" EMS NOTIFIED IMMEDIATELY. PT DENIES ANY MEDICAL HX. VS MONITORED WITH BP 90/36 ON 2ND CHECK. EMS HERE AND TOOK POSSESSION OF PT

tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Given zyrtec PO, symptoms improved. Doctor and EMT on site and released to go home.

About a week after receiving my 2nd dose, I began to get an itchy rash that broke out all over my body, but mainly my shoulders, neck, and arms. A couple of days ago, I began experiencing swelling of my lips.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose

My taste and smell have changed (not been lost). Certain smells trigger a horrible smell to me now. For example, I first noticed it with my shampoo. I started smelling a weird smell every time I washed my hair. Then it got stronger and stronger as time went on and then also with other smells. It is an awful smell, but only triggered by certain things. I can smell other things just fine. Also very similar to my taste. Some things taste horrible now. I can't eat peanut butter, orange juice, nuts, and then many foods taste just ok, and I part of it tastes ok, and part tastes horrible. About a month after the first vaccine it was at it's peak and it has stayed the same since.

i have mild tinnitus for many years. maybe 8 to 10 years. my symptoms worsened after getting the first shot almost immediately.

No immediate or other reaction at all to vaccine; injection site completely pain free. Felt perfectly healthy except for this new tinnitus condition. About 48 hours after Pfizer vaccine dose #1, ears began to feel full/pressure. The next day was peak "fullness" but also noticed start of tinnitus. The tinnitus has remained constant ever since. It sounds like a bilateral/stereo 18 kHz sine wave at 30 dB. Primary care doc referred to audiologist, audiologist referred immediately after testing to ENT. After discussing with ENT, was prescribed tapering course of prednisone (60mg/day for 10d, 40mg/day for 4d, 20mg/day for 5d), which I began on 4/14. Symptom has continued unabated.

20 minutes after the patient received the second vaccine the patient experienced a mild headache, tightness in chest and tingling in the throat. The issue resolved without concern.

04/16/21 - General fatigue and lack of focus for several hours, beginning approx 4 hrs after injection. Unknown duration (was gone after sleeping) 04/16/21 through 04/17/21 - Injection site soreness for approx 24 hours. 04/17/21 - Body chills and feeling of low-grade fever (did not take temperature) for approx 10 hours, ending around 2am on 04/18/21.

Patient began to exhibit mild symptoms (malaise, low grade fever, headache, myalgia) that persisted and became worse by day 4 post vaccine. Then with worsening headache, fever >101 and oral ulcerations that persisted/became worse through 4/19 when he was seen again. Seen in ED on date of first visit at clinic 4/16/21. Extensive testing with elevated protein CSF. Otherwise unremarkable. Seen again 4/19/21 in clinic setting, fever improved but headache present and ulcerations worse. CHF w/u showed no viral or bacterial meningitis or encephalitis.

Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days and eye almost closed completely. Wanted to report the blood shot eyes and puffy ness around left eye

My husband's face swelled up. The right side of his face around his nose including his lips. It happened suddenly with no warning. He had been feeling ok but that morning experienced sudden onset of severe pain in his hip. He had taken ibuprofen for the pain a few hours before the swelling in his face happened. He has never had any reactions to ibuprofen. He has no known allergies. Nothing like this has ever happened to him before. The swelling got worse overnight but during the following day the swelling started to go down. By that night it had gone down completely. Now he is fine but his lips look a little bruised, However, now we don't know if he should get the second vaccination which is scheduled on the 30th April. We did not contact a Dr.

Pt complained of blurry vision for four days, went to Urgent Care. At UC, blood glucose was >600 and pt stated that his PCP was investigating possible type 2 DM. Pt was sent to ED. Blood glucose 652 in ED. Pt admitted to hospital with dx hyperosmolar hyperglycemic state.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.

Afyer first dose, extreme nausea and dizziness for about an hour. Almost called 911. Slowly subsided over the course of day one. After that, ten days of extreme fatigue. Ringing in my ears that resurfaced after second dose.

1. Injection site of second doese started to have pronounced discoloration after day 2 that looks like a bruise. The site had a little bleeding as the male nurse adminiter the dose. Redness faded but circular yellowish discoloration about 2 inches in diameter is still visible on left arm after 7th day. 2. Eyes started itching the first shot and left eye had itchy corner like dry skin or something. Itchiness faded then came back again after second shot. Same reaction, itchy eyes the next day and the left eye corner started itching and drying up. Applied 1% cortizone to relieve itchiness and dryness on 3rd day. Seem to have releived the itchiness and dryness but still monitoring it. Will report this reaction with my provider when I see them next week,

Experienced momentary loss of hearing (seconds duration) in each ear, which seemed to resolve; have persistent tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient himself). A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) via an unspecified route of administration on 05Apr2021 at 11:45 am as a single dose for COVID-19 immunisation. The patient's medical history included Allergy and GERD. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccines included omeprazole, daily vitamin B-12, D3. Prior to vaccination, patient was not diagnosed with COVID-19. COVID vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 08Apr2021 at 11pm, the patient reported that she experienced momentary loss of hearing (seconds duration) in each ear, which seemed to resolve, but currently she has persistent tinnitus in both ears. The patient reported that she did not take any treatment for the events and the events led to physician visit. Outcome of events was not resolved.

On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogged sensation changes depending on how much I move around, but it has not gone away. I can clear my eustachian tubes, so whatever it is seems to be further in the ear. I can still hear, it's just muffled in the right ear. The only other adverse reaction I've had was on Monday, April 19, where I had very sore hips/back around 8pm and around 11pm when I went to bed, I had chills as if I had a fever. Those symptoms were gone by the morning of Tuesday, April 20.

At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up. Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.

Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.

Tinnitus started in the early morning after the shot. Was loud for about 24 hours. The second day after, I woke up, and it has subsided a bit. As I type this at 01:23 PM on 4/28/2021, it seems to be getting louder again. Primary care doctor said there was nothing they could do.

11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat feels dry, getting the urge to pass stool. In the mirror I see the arches around the uvula swollen and red 11:50 Inform the nurse. Body starts shivering, talking and breathing is labored- according to my wife my voice sounded very different. Nurse checks lungs through stethoscope and SPO2+ heart rate- All normal, does not detect any constriction of lung air passages. But I am panting while talking. 11:55 I decide to wait and monitor. Shivering slowly stops, breathing slowly starts to return to normal (in about 20 mins). The urge to pass stool stopped. 12:22 No change either way- Breathing is ok, but mild tingling around lips, and feeling of tightness at back of throat. I take 5mg Cetrizine HCl. [Note: My mouth and throat felt like I have felt in the past with a reaction to shellfish.] 1:15 Redness at back of throat is less, and I feel normal. I drive off the parking lot of the vaccination site Next day Throat feels sore, but otherwise ok

Patient received first dose of Covid-19 vaccine on 03/08/2021 and while waiting the 15 min period after getting the vaccine the patient stated they felt their tongue swelling. Patient was still able to breath, but felt more like a panic attack. Patient was given 25 mg of Benadryl, and after waiting the patient felt fine and said he no longer felt any symptoms. Patient left the pharmacy.

Flared up peripheral neuropathy symptoms within 30 minutes including numbness tingling in toes, hands, feet, legs, face/head, and back. Included muscle pains and spasms and ear pain. Pain from pressure on almost any part of body. Worst the first week but symptoms have continued 3 weeks afterwards. Still muscle pains, numbness and tingling:

Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. Ringing and headaches persist to this day. -Antibiotic as well as Claritin and Flonase prescribed with no change in symptoms.

Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went to the emergency, given Meclizine, baby aspirin, Atorvastatin Calcium I still have difficulty walking, double vision comes and goes my balance is still off

Ringing in ears is much louder after getting the second vaccine shot. It has not gone away after 5 days

I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter. I also notice the same smell in my body odor and feces (which may be related to eating the above objects). These may be related in the sense that they are all dry roasted. I am an MD and have a PhD in immunology -I have looked at vaccine smell changes, and the best I can find is that changes in smell resolve after a few days. Mine has not diminished at all.

Patient stated he had food allergies and was starting to feel itchy (face/mouth) after 15 minute wait period. Advised to wait 15 more minutes. After another 15 minutes, his lips were feeling numb. Was administered Benadryl

Tinnitus in both ears. It is a constant high-pitched ringing. By my estimation it is approximately the same volume as music playing at 50 dB as measured by a smart phone.

Bilateral tinnitus, right greater than left, developed 7 days following the second Pfizer Covid-19 vaccine and has persisted to date. No history of tinnitus, loud noise exposures, hearing loss.

Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next week. Had a prolonged headache. All of that eventually cleared but the lasting change is I now have tinnitus. It is constant and it does not go away.

After receiving the second dose of the COVID vaccine my autoimmune disorder has gotten worse and the adverse effects of my Celiac are present without any exposure to Gluten. Before the vaccine l exposure to gluten would case painful canker sores in my mouth and a growth on my tingur and gastrointestinal issues. Since the vaccine, I have not been exposed to gluten because I no gastrointestinal issues but I have had a very painful mouth with cankers that have not gone away for weeks. This is the only time this has ever happened. In addition I have some symptoms from additional autoimmune disorders buy I have yet to go to a doctor to verify this additional issue.

1) Extremely sleepy - began the same evening as vaccination (5/7/21) and continues through current date and time - fell asleep on the job while operating forklift the following night (5/8/2021); 2) Eyesight has worsened (depth perception, double vision) - began within a couple days of vaccine and continues through current date and time - had eye exam (5/18/21) needed new prescription - previously always near-sighted, now needs bi-focals; 3) Confusion/lack of concentration - began 5/9/21 and continues through current date and time; 4) Abnormally "lazy"/unmotivated - began 5/9/21 and continues through current date and time; 5) Little interest in sexual relations - began 5/9/21 and continues through current date and time; 6) Seems distant/ somewhat despondent - began 5/9/21 and continues through current date and time; 7) Generally speaking he is not himself

Got dose 2 on 04/16/2021 and had soreness at the injection site for several days, Not much else initially - Headache and fatigue on day 1&2 and a few sparse and self resolving episodes of ringing in ears in the weeks that followed and the occasional light headache or itching sensation at the site of the injection. Woke up on 05/16/2021 with persistent high pitched tinnitus have seen an urgent care doc and ENT and Audiologist since all to no avail or relief. The condition persists and may be permanent at this point they don't know.

Systemic: Bell's Palsy-Medium, Systemic: Ear pain as well-Mild, Additional Details: States issue started 24 hours after vaccine. Right side of face is drooping and states has ear pain. He also stated same issue happen to him when he was younger and lasted for about 6 weeks. Stated he remembers being treated with steriods that which helped. I advised patient to seek medical attention from hospital/urgent care to see if they can help.

Swelling of lower lip starting one day after vaccine administration, and lasting a week and a half. Patient reported lip also appeared to look like a chemical burn. Symptoms went away by themselves after a week and a half.

Patient received vaccine at 1402. During observation period at 1428 patient began to complain of neck tightness, dizziness, ear fullness, and ears popping. Vital at 1430: BP 126/94 HR 88, SpO2 99%. Does carry an epi-pen, but did not feel that he needed it. He was given and given benadryl 50 mg oral. Declined ED evaluation. Monitored for additional 30 minutes: 1435: BP 124/84, SpO2 99%, HR 82 Felt that his throat was improving with no more tightness. 1453: BP 116/82, Sp02 99%, HR 82 Patient feeling improved, only felt drowsy from benadryl. Patient continued to decline ED evaluation. Wife accompanying and able to drive him home.

Right sided tinnitus, which has persisted ever since. Right sided blurry vision, which has also persisted, but is improving.

loss of taste; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6206), via an unspecified route of administration in left arm on 15Mar2021 at 12:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 at 06:00, the patient experienced loss of taste. On 18Mar2021, the patient underwent nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event loss of taste was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected

Patient reports feeling dizzy, lightheaded, then lost consciousness for approx. 20 secs., skin color pale then reddish, eyes rolled back. Patient then regained consciousness.

Patient's (mom) caregiver reported patient was experiencing right arm numbness within 10 to 15 minutes of his 2nd covid-19 immunization. In addition, pain in the right arm was initially reported. Over the next few minutes, while discussing the arm pain, patient reported worsening of symptoms extending to right leg and right side of mouth. Emergency services (EMT) was called and patient was taken to Emergency Departemnt.

eye with the new cornea turned bright red; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205) via unspecified route of administration in the left arm on 15Mar2021 at 12:30 PM (age at vaccination 47-years-old), as a single dose for COVID-19 immunisation. Medical history included keratoconus, cornea transplant, epilepsy, depression. Past drug included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: EN6209) via unspecified route of administration in the left arm on 22Jan2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Concomitant medication included levetiracetam (KEPPRA), venlafaxine (EFFEXOR), ibuprofen (UNKNOWN MANFACTURER), for unknown indications from unknown date. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that recently had a cornea transplant. My eye with the new cornea turned bright red after the vaccinations and also sore arm. On 15Mar2021 16:00 the patient experienced bright red eye, sore arm. Therapeutic measures included as Steroid eyedrops for the events bright red eye. The clinical outcome of the events bright red eye and sore arm was recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient name added in general tab, 47 years added as age/units for Historical Vaccine since DOB and 1ST DOSE date provided, Start Date/Time and Stop Date/Time of 2nd dose updated to 15Mar2021 12:30, Vaccine Facility Information added, Keppra, Effexor, ibuprofen added as Concomitant drug, Onset Date/Time of events updated to 15MAR2021 16:00.

About 3 days after the 2nd dose, I started to feel chest pressure like a muscle pull on the chest. About 7 days after the vaccine, it started to worsen. I felt pain, chest pressure, back shoulder pain, jaw pain, and shortness of breath. I called the main local hospital number and was instructed to go to the ER. I did go to the ER and they did blood work, EKG which confirmed that I was having a heart attack. I was stabilized and was then transferred my via ambulance to A Medical Center which is bigger hospital and better equipped. I was admitted and the next day, I had surgery for a heart catheter. They also placed 2 stents in my heart. I was in the hospital for 4 days and was discharged with a prescription for Furosemide 40mg, rest, cardiac rehab, and to follow up with cardiologist. Prior to the heart attack, I only had hypertension.

Horrible tinnitus with very bad neck pain; Horrible tinnitus with very bad neck pain; Tension headaches; vision issues; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 at 14:45 hours as dose 2, single (at the age of 47-years-old) for covid-19 immunization. Medical history included known allergy to penicillin from an unknown date and unknown if ongoing and had no other medical history. Patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ELG9266 and Expiration date was not reported), via an unspecified route of administration, in left arm on 14Feb2021 at 14:00 hours as dose 1, single (at the age of 47-years-old) for covid-19 immunization. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. On 21Mar2021 at 19:00 hours, patient experienced horrible tinnitus with very bad neck pain, tension headaches and vision issues. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the events. Patient had various ongoing treatments for all the events. The events were reported as non-serious as per the reporter. The outcome of all the events was not recovered.

"Member got COVID vaccine and noted ringing in both ears. Got 2nd dose 4/20. Ringing started after the first, got worse after the second. Is constant. Not sure about hearing loss. Seems worse in left ear by a little bit. No dizziness or vertigo. Was told it could be wax buildup or congestion but does not feel like this No other unusual symptoms. No medication changes noted. No trauma to head Diagnoses and all orders for this visit:

Patient c/o dry cough, left sided headache, since returing in may. was seen in ER on 5/17. COVID test neg. symptoms improved and patient received I dose of COVID vaccine on 6/4 21. since then c/o constant left sided headache, left eye pain, on/off blurring of vision, severe dry cough. c/o loss of vision in left eye, headaches and feeling "a lot of pressure" for about 3 weeks since receiving the vaccine, sees 2 spots in the left eye that got larger than before. Had 4 episodes of vision in left eye only going black for several seconds, then when vision comes back it is "no good" for 20-30 minutes, last occurrence was 10 days ago. Pt also felt dizzy. patient has a history of stroke. After multiple provider and specialist visits patient was diagnosed with iritis and transient vision loss. Patient received second dose of vaccine on 06/27/21 (both at pharmacy) and reported return of symptoms which resolved as reported on their 06/30/21 follow up with PCP and vision specialist.

I started to get a tooth ache which started around June 15th or 18th (in a tooth already root canaled) and it grew into a strong infection and they drilled the root canal. Infection did not go away. I was treated with 3 different antibiotics. And just started the 3rd on on Saturday the 17th.

Blurry vision; Double vision; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) from unknown date from unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 09Mar2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 1700, after second dose, the patient experienced blurry vision and double vision which lasted for around five hours. The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of blurry vision and double vision were resolved on 30Mar2021 at 22:00. No follow-up attempts are needed. No further information is expected.

Blurred vision; dizzy; This is a spontaneous report from a contactable healthcare professional. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. It was unknown prior to the vaccination whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient tested for COVID-19. It was unknown if any other vaccines were taken within four weeks prior to the vaccination. On 31Mar2021, the patient experienced blurred vision for 30 minutes and was dizzy for 20 minutes. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events blurred vision and dizzy was resolved. No follow-up attempts are needed. No further information is expected.

his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.

It started with three days of mild fever and then on day four 02/08/2021. I lost function of my muscles, I couldn't walk, I couldn't lift my arms, I couldn't chew and my kidneys shut down and quit working. My blood pressure was 80/50 at the hospital. There is a heart enzyme troponin its supposed to be 4 if it reaches 40 you're having an active heart attack and mine was 37. I was in the hospital for four days. In a weird series of events during this time they found some heart conditions that I had. Had I not been hospitalized they would have never found these heart conditions. The condition I had was similar to the reaction I have had to steroids before hence why I don't take steroids.

Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered tongue and blistered inside and outside of right ear (very painful).; Blistered tongue and blistered inside and outside of right ear (very painful).; This is a spontaneous report received from contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 AM (Batch/Lot Number: ER8735) at the age of 47 years as single dose for covid-19 immunisation. Patient had no medical history and no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Major headaches started 05Jul2021. Noticed crooked mouth and paralyzed on right side of face in the morning. Blistered tongue and blistered inside and outside of right ear (very painful). Admitted to Emergency room on 08Jul2021. Date of start of reaction/event was 05Jul2021 9:00. Treatment received included valacyclovir hcl and prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome of events were not recovered.

Permanent hearing loss in left ear on 4/13/2021. Urgent care visit on 4/23/2021, prescribed antibiotics. PCP visit on 5/12, referred to Ear specialist. Ear specialist visit on 06/18/2021 stated likely permanent hearing loss in left ear, may have been triggered from the vaccine. MRI performed on 7/2/2021, results are normal. Follow-up with Ear specialist on 7/22/2021 with no improvements, and further evidence showing permanent hearing loss in left ear.

12 days (7/24) after taking first dose woke up with severe eye irritation in right eye. Then, two days later (7/26) woke up with subconjunctival hemorrhage in left eye.

Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events. Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The 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.

large taste buds in the back of the throat became swollen and sores bumps were seen in the throat; large taste buds in the back of the throat became swollen and sores bumps were seen in the throat; tired; randomly break out in a sweat; the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it; the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it; developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in the left arm on 28Mar2021 15:45 (at the age of 47 years old) as dose 1, single for COVID-19 immunization. Vaccination was done in a pharmacy or drug store. Medical history included allergy: penicillin, high blood pressure and borderline diabetic, all from an unknown date and unknown if ongoing. There was no other vaccine in four weeks. Concomitant medications included lisinopril, metformin, atorvastatin and omeprazole (PRILOSEC), all taken for unspecified indications, start and stop dates were not reported. The patient experienced the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it, large taste buds in the back of the throat became swollen and sores bumps were seen in the throat, tired and randomly break out in a sweat on an unspecified date in Apr2021; and developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm on 31Mar2021 19:00. It was reported that three days after the injection, the patient developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm. Three days after that, the "spot" became irritated and inflamed turning into a rash. The location was painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it. He applied hydrocortisone cream to the area and took Benadryl thinking it was a reaction. Four hours later, the large taste buds in the back of the throat became swollen and sores bumps were seen in the throat. He admitted himself to the ER to be treated. He was tested for strep throat which came back negative. He was examined and the attending doctor who didn't know what to make of it. He was given lidocaine to ease the sensation of the swollen taste buds and bumps in the throat and released. The day after, he experienced being tired and randomly break out in a sweat. The adverse events resulted in emergency room department or urgent care. 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 underwent lab tests and procedures which included Streptococcal throat test: negative (tested for strep throat which came back negative) on an unspecified date in 2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.