Pfizer

2 hours after receiving Pfizer COVID vaccine, vision in left eye presented with new floaters, flashes of light, and visual disturbance. Described as constant by patient, has not resolved 3 days s/p vaccination

One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt like I was getting a cold and had to keep clearing my throat. I told my wife I feel wired and she mentioned my right eye looked different. In about two more minutes my right was swollen closed and speaking became difficult due to the swelling. My wife drove me to Hospital and I received Epinephrine and Benadryl and fluids.

4.5 hours after receiving the COVID-19 vaccine second dose I experienced a sudden 50% loss of hearing in my right ear. I was otherwise asymptomatic. This persisted for 8 hours at which time my hearing mostly returned with perhaps only a 10% reduction. I had complete resolution after 24 hours.

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

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

Abdominal rash with hives, right arm rash with hives, eye itching, nasal itching, throat swelling sensation

0900 - Pfizer Shot 1000- noticed eyes looked puffy 1100- rash started on left arm below bicep in the elbow area 1115- rash now showing on right arm in the same area Around 1230 - 1300 seen by EMT - at that time I was given a shot of Epinephrine and IV of Benadryl transported by ambulance to ED to be evaluated for allergic reaction. was released from the ED around 1545 no other treatment needed

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

Second shot vaccine was end of Jan 2021 chills that lasted 48 hours, I lost appetite the next day for 24 hours, I continued working, I started getting headaches and ringing in ears I perceived this as hypertension and it lasted 2-3 weeks, losartan 12mg per day, I checked it and it was high it?s never been that high so I took 24mg instead. I took 50mg total of losartan and it?s taken until now to get down to 25mg daily. I may have been exposed in Jan of 2020.

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

2nd dose EL8982. About 6 hours after 1st vaccine had visual disturbances in left eye, got a little better after a week or so, but still has a floater in left eye, had 2nd dose and after 72 hours had to leave work (never left work before) to get emergency eye exam - thought I was going blind - diagnosed with "Posterior Vitreous Detachment". Now I still have a BIG thing in field of vision making it hard to see and "thousands" of tiny black floaters. Hard to see out of right eye.

1/6 18 days after the vaccination I woke up with floaters in my right eye. Much more developed throughtout the day. The next day Thursday I had a visual deficite in my eye along with the floaters. By Friday evening I went up to see the eye doctor while at work and was advised I had 5 tears to the retina of my right eye and was advised it needs to be repaired immediately. On 1/9 I had a vitrectomy and the tears in the retina were repaired as well. I was advised the surgery had an 85% success rate but advised I will develop a cataract in the eye within 6months but within 6 weeks it developed. 2/22 I had the cataract removed and a lense replaced in my right eye.

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

1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensified and loss of vision out of the right eye. Subsequently, he presented to the ED and was found to have a left occipital lobe intraparenchyma hemorrhage & 1-acute subdural hemorrhage posterior left tentorial. He was air transport to another facility for treatment:/monitoring. He is currently still admitted . He remains without right eye vision.

Loss of taste; right kidney pain severe; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 25Jan2021 at 10:00 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic back pain, scoliosis, kidney stones, 3 double hernias, venous deficiency, fibromyalgia, 2 torn ligaments right foot, diabetes, and diabetic neuropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. The patient did not have COVID-19 prior to vaccination. The patient received unspecified concomitant medications. The patient previously took morphine from an unknown date for an unspecified indication and experienced allergy. On 25Jan2021 at 10:15 the patient experienced loss of taste, right kidney pain severe, and injection site pain. The patient was not treated for the events. The outcome of the events 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.

15 minutes following COVID vaccine administration pt observed to have periorbital erythema and edema. Pt administered 25mg/10ml diphenhydramine. Erythema and edema improving, increased pt wait time to 30 minutes. Pt left observation area in good condition.

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

Tinnitus has been going on in top section of my head since about 3 hours after the vaccine. I believe I have a compromised blood brain barrier due to the fact that I had taken prescribed anti inflammatory for 15 years for my lower back pain. So now if I take anything with anti inflammatory effects I get tinnitus but it goes away soon afterward, depending on strength of dose. It has been 4 days now with no sign of relief. I am eating a low salicylate diet right now to help my body process any anti inflammatory.

pt. experiencing some lightheadedness. L. sided neck pain and metalic taste in mouth. Medics present. pt. denies any difficulty swallowing &/or other s/s. Resolved with calming / comfort measures. Advised pt. to go to ER via EMS/ have someone come pick him up d/t increased BP. Pt. refused. Pt. asymptomatic prior to leaving vaccination site. Pt. advised to pull over & call 911 if anything changed / symptoms return- pt. agreeable. Advised to f/u with PCP/ Cardo. pt. communicates understanding. BP 216/117 at 1337 HR: 73; SPo2: 93% - smoker- 0.5 PPD x 27yrs. BP: 206/122 at 1443 HR 1443, HR 71; BP 187/112 at 1448, HR :69; BP 180/109 at 1453 HR: 72; BP: 173/103 at 1458 HR: 72; BP: 176/105: HR 71 at 1503.

Loss of Balance - unsteady - stagger - dizzy. Is more severe with motion - head up, down, standing up, bending, walking. -- not severe when not in motion - sitting-lying. Nausea when symptoms started but have subsided since the first full day. Some blurry vision at times and ear ringing - not constant. Does pass but continues with motion. Does not have a time frame as it is continuous when in Up-Down-Bending-etc - motion

10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke two hours later with a fever of 102 and severe chills. That lasted 6 hours. Body temp went down to normal. Ate a little breakfast. Tired and achy. Went back to bed. Awoke several hours later. Fever was back. Though not as high, 100. Entire body hurt. Joints, head, abdominal pain, pain in left armpit. Stayed for several hours. Went back to bed about 4:00PM woke up an hour later fever down to 99. Ate a little supper. Acid reflux uncontrollable. Went back to bed. Awoke at 8:00PM . Fever still at 99. Stayed awake until 10:30. Went to bed. Tossed and turned with body aches all night. Had to get up every two hours to urinate. Awoke at 7:30AM. No fever. Feeling somewhat better. Still pain in left armpit. Headache almost gone. Joint pain almost gone, abdominal pain still present. Worst is over.

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

within 24 hrs - swelling like a cold sore under lower lip - 3 days - chapped lips- ongoing for a week and diminishing

I have had minor tinnitus for years. It was noticeable when I was going to sleep, but had never bothered me during the day. After getting my first vaccination it has gotten much worse. It makes it hard to get to sleep and hard to concentrate on work during the day.

Patient with longstanding history of bilateral exostosis. Noted to have left sudden hearing loss, unsure about timing ~ 1-2 weeks after. Treated with oral and intertympanic steroids

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

Couldn't see out of right eye. Called eye doctor, sent to retina specialist. Blood and swelling by retina.

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

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

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

stroke of the 4th cranial nerve; Dizziness; double vision; This is a spontaneous report from a contactable nurse. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), intramuscular, in the left arm on 16Mar2021 at a single dose (at the age of 60-years-old) for Covid-19 Immunization; vaccinated in the hospital. Medical history included hypertension and allergies to sulfa. Concomitant medications were not reported. No other vaccine in four weeks. The patient had no COVID prior to the vaccination. On 16Mar2021, the patent experienced dizziness and double vision. He saw the eye doctor who stated that he had a stroke of the 4th cranial nerve. No treatment was given. The patient was not COVID tested post vaccination. The nurse assessed the events as non-serious. The patient was recovering from the events.; Sender's Comments: A contributory role of BNT162B2 to event a stroke of the 4th cranial nerve cannot be excluded based on limit information. Case will be reassessed when further 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.

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

I don't know if I hallucinated that or not; I feel like I am on drugs like I on 'some acid'; my vision is blurry and it's kind of hard to concentrate on television; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported)\ via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included mental issues since 1988. The patient stated "I am calling about an adverse reaction to the second Pfizer shot. If you guys have anybody called in and find out if anybody is having the same. After the second shot, about a day after the shot, it was terrible. I got the shot last Tuesday and I feel like I am on drugs like I on 'some acid' (not clarified). But I am not hallucinating, I am not seeing things, I am not hearing things, I just physically feel that way. Everything is kind of blurry, my vision is blurry and it's kind of hard to concentrate on television and stuff like that. It seems like some people are playing mind games with it but I don't think they have (further clarification unknown, hence not captured as event). I don't know if I hallucinated that or not (consumer was not sure). That's pretty much here I feel like I am on drugs constantly and it is just kind of scary. I have mental issues since 1988, I take psych meds but it seems whenever I take my psych meds (unspecified medications) I feel worst for couple of hours." Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Symptoms: hearing loss and tinnitus. States he had an evaluation by PCP and an ENT was treated with a steroid shot. Unknown if symptoms related. Plans to continue to follow up with MD's.

4/3/21 Fever 101.6 F, minor headache, moderate fatigue, slight throat discomfort 4/4/21 adverse reaction gone

Patient started to experience tinnitus about 3 days after receiving the second vaccine. He states that he recently went to the doctor to have his hearing checked and that he has experienced approximately 8000 Hertz drop in his hearing function.

large left horseshoe tear on the retina in the left/tear on the right retina/small tear right eye; detached retina on the left; vision loss/can't see at all/thought he was going blind; streaks of lightening; section of vision lost in the left eye; Posterior Vitreous Detachment; floaters; sick; This is a spontaneous report from a contactable consumer (patient wife). A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) dose 1 via an unspecified route of administration on 06Jan2021 (Lot Number: EJ1685, expiry date not reported) as single dose; and dose 2 via an unspecified route of administration on 29Jan2021 (lot Number: EL8982, expiry date not reported) as single dose; for covid-19 immunization. Medical history included eye surgery (he already had surgery once) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received first dose of the Pfizer vaccine on 06Jan2021 then on 29Jan2021 the 2nd dose. He experienced side effects: floaters on 06Jan2021, and streaks of lightening then vision loss on 15Mar2021. There was a large left horseshoe tear on the retina in the left and a detached retina on the left and a tear on the right retina on 19Mar2021. He already had surgery once. He will have 2nd surgery on the other eye. Reporter reported a follow up. He can't see at all. He was recovering and has to lay on face for 2 weeks. Reporter stated she read about retina problems related to the virus but not to the vaccine, could not find information. Patient was a retail pharmacist. He deals with customers and several customers stated they had vision problems with the vaccine: double vision, loss of sight. "There was a problem out there, but maybe they were not reporting it took reporter 2 hours to report so they may not have the time to sit there to report". Reporter knew they can't prove it was the vaccine that caused it. Reporter don't believe in coincidences. It seemed quite obvious to them it's related to the vaccine. Reporter appreciated all the help and stated they didn't have all the answers. Reporter sure it was the vaccine because it was within hours after the first vaccine, but since there was no information regarding the sight problems related to the vaccine patient didn't think about it. Then the floaters got worse and started to block his vision, after the 2nd vaccine it was dramatically; within hours it was worse. He's never been sick in 36 years (2021). Patient hoped no one else has to deal with what he has to deal with. Patient also reported that on 10Feb2021, patient had section of vision lost in the left eye. It was then reported that patient was well versed in the virus and the vaccine. He was unable to speak on the phone at this time as he was recovering from surgery. Patient received the first dose of the Pfizer COVID 19 vaccine on 6Jan2021 and right away began seeing hundreds of floaters. He didn't correlate it to the vaccine but it didn't go away. Then he received the second dose of the vaccine on 29Jan2021 and within hours he thought he was going blind. He went to an optometrist 01Feb2021 who sloughed off the idea of it being related to the vaccine and diagnosed him with Posterior Vitreous Detachment. It was previously reported to Pfizer when he got the diagnosis of the PVD and all the events mentioned were previously reported. Reporter stated that from that day on the floaters got larger; the around 15Mar2021 he noticed every time he bent over he saw streaks of lightning; and he started to have a black hole, a loss of about 20% of his field of vision in the left eye. He went to another local optometrist 19Mar2021, who saw a large horseshoe tear in on left retina; and a detached left retina. The local optometrist sent him to a specialist and who verified the tear and the detachment and said the other retina in the right eye also has a small tear. Patient then had eye surgery, Monday at 0700AM, 22Mar2021 by outpatient surgery, to drain the fluid in his eye; insert a gas bubble and a silicone band to repair the retina; and did laser surgery on the tear. The specialist advised that the surgery damages the lens so he will need the lens replaced in the future. Now her patient has to lay down with his face down for 23 hours a day for two weeks and take 6-8 weeks off work. He had a doctor's visit yesterday and the doctor seemed satisfied with his progress but he can't see out of the eye, everything was cloudy so he doesn't know if the floaters are gone or the eye sight is recovered yet. The doctor was planning to do the right eye tear repair on Thursday 25Mar2021. Reporter had searched online to see if other people have this, but she can't seem to get the stories online about problems with the retina and the vaccine. She wanted this to be known and documented. Reporter was asking if company have information about if other people have had this. As per reporter, the events were not serious. Therapeutic measures were taken as a result of the events reported. The patient required physician's office visit for the events reported. The patient had not recovered from section of vision lost in the left eye, large left horseshoe tear on the retina in the left/tear on the right retina/small tear right eye, detached retina on the left, and floaters. The outcome of the other events reported was unknown.

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

Pt anxious and states lightheaded and numbness in mouth area. Pt was in ADA drive thru observation; laid seat chair back, removed mask and encouraged sips of water. Noticed pt had portable oxygen in passenger seat, states he was COVID positive in Jan and was discharged with the O2 to be used prn. Medics evaluated pt; VSS, O2 sats 98%. Pt left but was not in distress.

The day receiving the second dose I began to have problems in my ears . They felt plugged and there was a ringing in both . It gradually worsened for the remainder of that day and the next . Currently I have no hearing in my left ear . The ear feels plugged but I am unable to clear it . It has a ringing noise within the ear that is constant . The doctor observed no wax build up or infection and said the looks great . Prescribed steroids . The ringing has not stopped and there is very little hearing on the left side .

Developed Pulsatile Tinnitus in right ear which lasted for 3 weeks, causing difficulty sleeping. After 3 weeks, symptoms became intermittent and then stopped after 4 weeks.

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

Tinnitus (high pitched tone) in right ear started the morning after vaccination and has continued to date. Noticeable and annoying but tolerable. Note I've had tinnitus a few times in the past, though I believe this is the longest it's persisted.

Sudden onset of tinnitus with hearing loss in right ear. Starting at 0200 on 01 April 2021. Tinnitus and hearing loss is ongoing. Tinnitus has decreased in intensity, but there was a sudden increase of tinnitus the evening of 08 April 2021, the same day that I received the 2nd vaccine dose. Hearing loss in right continues. Minor hearing loss in left ear was detected with audiology testing also.

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

My tinnitus symptoms have been raging since I have received my second dose of phizer covid-19 vacination. I can not say 100% that the vacine is the the sole reason for the extreme symptoms but can tie nothing else to the change. The ringing, screeching and high pitch sounds are louder than I have ever e,peri encased in my 15 years with tinnitus. I TS constant, unnerving, stressful, and never ending. Difficult to impossible to sleep and if I do happen to fall asleep the symptoms wake me up within an hour. Kinda at my wits end at this piint.

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

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

I've had a mild tinnitus for about 5-6 years. 6-7 days after my first Pfizer shot, my tinnitus has become very bad. In the last week, twice I was awakened by it in the middle of the night and was not able to fall back to sleep because it is so loud. In the past, I never heard it during the day, but now it is very loud even in the daytime. This is very serious. Not being able to sleep and rest at night is very hard to cope during the day. I'm not sure what to do as there is no cure for this tinnitus.

Prior to vaccine, no ringing in ears. Since, have SIGNIFICANT ringing in both ears. Saw ENT and he said there was no treatment for this. Sometimes the ringing is so loud I can't hear myself think. But it is constant and has been since a couple weeks after second COVID shot.

Received dose #1 on 3/21, dose #2 on 4/14. Tried to use v-safe to report this reaction, but it has my first dose recorded as 4/14 , which is actually date of second dose (no way to correct in system). Had no reaction at all to second shot until 4/29, while on a 4-hour airline flight. I thought it was just the plane noise or pressurization that was causing ringing in my ears. It came and went over the last 48 hours, but has been pretty consistently ?on? today. Went online to check tinnitus and vaccines and I see this has been reported by others. Hope it goes away soon!

Severe pain and inflammation in right eye starting on 4/15/2021 @ 3:30am. Condition worsened followed by blurred vision. Went to my eye doctor on 4/26/2021 who diagnosed condition as Panuveitis. My eye doctor prescribed Prednisolone AC 1% Eye Drops (1 drop into right eye four times daily). Treatment with Prednisolone eye drops is current with moderate improvement. I continue to have intermittent pain with blurred vision as of this writing.

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

He has been experiencing pain; Sensitivity on the right side of his gums; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. He received the Pfizer Covid-19 vaccine last Thursday or Friday of last week and a day or two after he has been experiencing pain and sensitivity on the right side of his gums, which is the same side where they administered the vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

Patient experienced flare of oral graft versus host disease symptoms manifesting as problems swallowing/mouth soreness and large patches of skin coming off tongue, lip sores not improving, Also developed rash on foreskin on penis which may have been manifestation of flare of skin GVHD. Patient was started on topical triamcinolone for rash (now resolved), and dexamethasone swish and spit for mouth, then ultimately treated with prednisone 1 mg/kg and then tapper off over a month.

About 2 weeks after Pfizer COVID 19 vaccine 1st shot, I developed significant tinnitus in both ears which still persists to this date. I have some hearing loss too. I?m not getting the second shot.

At approximately 9 AM the following day, it seem like all my joints are very achy and sore. All liquid ingredients that I tasted seem to taste very strange Seems to have cleared up by the third day. Other than taste buds.

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

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

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

Relatively minor, but troubling. The adverse effect was that my teeth sensitivity to cold became severe enough that I could not drink any fluids directly from the refrigerator or any drinks with ice. I have never had cold sensitivity with the teeth before. This side effect went away gradually and is mostly gone now, which is about 6 weeks after the first shot. I had no additional side affects from the second shot.

Tinnitus presented 8 days following first dose (2/22/2021) and has persisted since with concomitant high frequency hearing loss.

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

Extremely loud tinnitus developed after my second vaccine shot on 4/22/21. Tinnitus has not subsided. Loud ring 24 hours per day.

tinnitus; This is a spontaneous report from a contactable or other health care professional (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in arm left on 27Jan2021 13:00 as dose 2, single (age at vaccination 60-years) for COVID-19 immunization. The patient's medical history included allergy to thimerasol. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication. The patient did not have covid prior vaccination and was not tested covid for post vaccination. The patient did not receive any other vaccine within four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 29Jan2021, the patient stated that approximately 48 hours after second dose experienced constant tinnitus. Has not stopped at all for over 2 weeks. The treatment was not received for the event. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected.

Clogged; Right hear started ringing; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248) via an unspecified route of administration on the left arm on 13Jan2021 at 12:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high cholesterol. The patient had a known allergy to penicillin. The concomitant medication included metformin 500mg (MANUFACTURER UNKNOWN) taken for an unknown indication. 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, the patient had not tested positive for COVID-19. On 15Jan2021, the patient experienced right ear started ringing and was clogged. The patient checked with a physician but nothing was found, there was no wax or infections. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotics and sinus medication, but nothing worked. The clinical outcome of the events right ear ringing and clogged ear was not recovered at the time of this report. No follow up attempts are needed. No further information is expected

June 2021- painful left ear lobe, erythema and abscess, treated at home with warm compresses, lanced small abscess, topical triple antibiotic ointment resolved in 1 week June 2021 - 1 week later - painful right ear lobe, erythema and abscess, treated at home with compresses, lanced small abscess, topical triple antibiotic ointment resolved in 1 week. June 2021 - 3 weeks later - redness on right side of neck at the collar line extending from the angle of the mandible to chin associated with a large grape-sized lesion. Treated with warm compresses, 2 weeks of Keflex, currently on Bactrim

pt called on 5/24/21. Pt c/o productive cough with greenish mucus, congestion, feeling sinus pressure from stuffy nose, feels tired, headache, chills on/off, loss of taste since 5/19/2021(wednesday) next day after he got his 2nd dose covid vaccine Pfizer on 5/18/2021. Pt speech clear. AO X3. Also denies emergency sx at this time. Scheduled an appt with urgent care provider telephone f/u 5/24/21 for further treatment and evaluation .Notified pt if any emergency sx arises call 911 or go to nearest ED.

I started having pain in my lower back and shoulder. I had SOB. Pain in back that went up to my jaw. I went to the hospital. They did a cardiac work, came back negative for heart attack. The COVID-19 test came back negative. They did a chest CT scan to rule out PE. They show the I had COVID-19. I got swab the next for COVID-19, was negative. I still having SOB that is getting worse. They said I had a mild carditis.

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

Tinnitus started 12 hours after first injection. It got worse with the 2nd injection.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00 (at the age of 60-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204), via an unspecified route of administration in the left arm on 17Mar2021 at 18:15 (at the age of 60-year-old) as a single dose for COVID-19 Immunisation. Medical history included prostate cancer and suspected COVID-19 on 29Feb2020. Concomitant medications were reported as leuprorelin acetate (LUPRON), apalutamide (ERLEADA), Timolol (MANUFACTURER UNKNOWN), Tumeric (MANUFACTURER UNKNOWN), Vitamin D3 (MANUFACTURER UNKNOWN); all for unknown indication from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other product. On 25Feb2021 at 06:00, the patient experienced tinnitus started 12 hours after first injection and got worse with the second injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of tinnitus was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

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

Left eye got really swollen; Red eye; Itchy eye like an allergic reaction; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not take 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 COVID vaccination. On an unspecified date in Mar2021 after the first dose, within 4-8 hours the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events, left eye got really swollen, red eye and itchy eye like an allergic reaction were unknown. On 30Mar2021 at 21:00, after the second dose, within 4-8 hours, the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events left eye got really swollen, red eye and itchy eye like an allergic reaction were recovering at the time of report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

Lip swelling; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to aspirin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measure taken as a result of the event experienced included benadryl (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the event lip swelling was resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

tinnitus/noticed a ringing in my ear; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 60-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533, Expiration date: unknown), via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation.The patient medical history included patient had known allergies. The patient concomitant medications were not reported.The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route on 21Mar2021 at 13:00 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient experienced tinnitus noticed a ringing in his ear. Patient stated that prior to the vaccine he did not had any issues with my hearing. Subsequent to the vaccine he noticed a ringing in his ear.The patient underwent lab tests and procedures which included COVID Nasal Swab test was negative on 06Jul2021.The patient did not receive treatment for event. The event was assessed as serious disability. The outcome of the event was not recovered.

The patient stated he started having tinnitus in one ear the morning after the 2nd Pfizer covid vaccine and has had it since.

Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8727) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any 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 take any other medications in two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 00:00, the patient experienced loss of taste. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event loss of taste was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Loss of taste; Tasted very salty; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 24Mar2021 at 12:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and gout (Taking tablets) both are under control. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); Both from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 03Mar2021 at 18:30 (at the age of 60-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 25Mar2021 the patient experienced loss of taste. Everything was bland (no flavor), although some foods taste very salty back to normal the day after. 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 event loss of taste and taste very salty was recovered on 26Mar2021. No follow-up attempts are needed. No further information is expected.

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

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

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

Upper lip swelling on date of vaccination 1/5/21 starting on 1/8/21, developed severe generalized urticaria - still active

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

Chills; Right eye was swollen; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing diabetes and blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medication included metformin at 500 mg for diabetes. On 06Jan2021, the patient experienced chills and right eye was swollen. The patient outcome of chills was recovered and the outcome of "right eye was swollen" was not recovered.

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

Pt began to feel dizzy and light-headed with progressing headache pain within 15 minutes. Pt BP was 170/86 at time of event and HR 74 bpm. Pt given O2 at 5 LPM . Pt lungs clear bilaterally and pt denied SOB. Pt O2 saturation at 99% on 5 LPM via mask. Pt stated vision was blurry but resolved after 15 minutes. Pt advised to go to ER via ambulance but denied transport, pt wife at facility to transport pt to ER.

the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

pt noticed a couple days after getting the vax he developed itchy hives on arms and legs that come and go. States he takes Benadryl before he goes to bed. He also had swelling in his lips that come and goes. Pt has not contacted his PCP at this time.

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

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

On Saturday he felled very tired, Monday experienced tongue numbness, and Monday experienced loss of taste.

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

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

2 days following first Pfizer dose, upon awakening noticed right ear was stopped up. He could not hear any sounds except a roar in that ear. It changed tones. He had no pain or other signs of illness.

onset of self-described 'sinusitis' a week after vaccine administration, and then 2 days after that developed severe tinnitus

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

My tinnitus, which is usually relatively quiet and manageable, got much louder! There is no treatment that I am aware of. I haven?t gone to a doctor yet, as I was hoping that it would go back down to a normal level on its own. It has not gone back down yet, as of day 9 (following the first shot of the Pfizer Covid vaccination)

Deafness in the left ear, tinnitus in the right ear. Slight dizziness. Started 28 hours after the injection.

Blood Vessels in Right Eye; Eye is extremely red/eye is blood red; had a little soreness to injection site; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 09:40 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included amlodipine besylate taken for hypertension from an unspecified start date (Started years ago) and ongoing. Patient states he took his Pfizer covid19 vaccine on Sunday morning. When he woke up on Monday morning there were some blood vessels in his right eye and his eye was extremely red. States that while he is uncertain of the exact time that this happened to his eye as he was sleeping; he noticed it Monday morning around 0700 when he woke up and looked in the mirror. States he had a little soreness to injection site, but nothing serious. Outcome of event eye red was not recovered, of others was unknown.

Shortly after vaccination within 5 minutes. Patient complained of lips tingling and numbing. Patient was evaluated by EMS. A few hives found on center of chest. IM Benadryl and Pepcid given by EMS. Patient was monitored for 45 minutes and released.

Patient presented to the emergency room 10 hours after receiving first COVID-19 vaccine with progressively worsening tongue swelling and minor shortness of breath. Patient received IV solumedrol, benadryl, pepcid and fluids. Patient's symptoms improved post treatment

Lost hearing on my right ear, same side the shot I had; Tinnitus and still I have ringing in my right ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration in right arm on 03Mar2021 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. Concomitant medications included amlodipine besilate/ valsartan for blood pressure high, hydrochlorothiazide, atorvastatin for cholesterol, and alprazolam. The patient stated "I had a really bad side effect from my 1st (dose) Pfizer vaccine for Covid shot. I probably got it 16 days ago on Wednesday, the date I got it, I received it on Wednesday 03Mar2021 of this year. It was the Wednesday, this Saturday I was feeling great, feeling fine and I became, I lost my hearing on my right ear, my right ear at the same side as the shot and I still have tinnitus then I have taken steroids (prednisone) for it (treatment). Four days later, I experienced low hearing in my right ear, low hearing, I lost my hearing in my right ear. I have tinnitus, still I have ringing in my (right) ear. Yes, I want them to follow up because I don't know if I should take the 2nd shot. I am not sure if I am going to take the 2nd shot because I will just the "affect" (not clarified), I don't want to get deaf. I got, my hearing, my hearing is back. I don't know what extend, I am going to the doctor next week to get a hearing test. I have been taking prednisone, a steroid for my hearing; 10 mg tablet, I started off of it's 6 tablets 3 times a day and decreased to 5 tablets 3 times a day, 60 mg for 3 days in a row then 50 mg for 3 days in a row and then 40 mg for 3 days in a row, I got a table at time, so I was getting a bad reaction to the prednisone, So my doctor told me to stop it. (Dosage further not clarified) I was getting super anxiety, I couldn't, I can't sleep at night and can't sleep at all. I am on antibiotics and steroid (treatment), I am on steroid to regain my hearing and now next weekend I am supposed to do for my second shot and I don't to take it but I "still" (not clarified) have tinnitus and I lost my hearing in my right ear, I don't know what to do, so I just waited at home let's see what happened this. Are those side adverse effects or what, I don't know?" Outcome of lost hearing was recovered and of tinnitus was not recovered.

Tinnitus in left ear. Soft high-frequency crickets when my throat gets stressed, including hiccups, burping, stretching, sometimes yawning, muscle tensing, sometimes swallowing, stretching to wake up in the morning. Last for the duration of the stress, a few seconds. Left eustachian tube slightly sore, slight earache. Has gone on for almost a week now. Best guess is nerve is pressured or damaged? Will try hydroxide in ear next, in hope it kills whatever's going on. Whether this will go away or not is unknown at present.

tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me. I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue

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

A few weeks after my first shot I've developed ringing in my ears. it gets worse at night trying to sleep.

Morning of 4/9/2021, mild headache. Also cough that lasted about 10 minutes. That night, headache become more severe, swelling, inflammation in right eye. Also burning in right eye, similar to peeling onions. Damp clothe to eye provided relief. Acetaminophen relieved pain.

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

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

Immediately have ringing in ears. Bouts of confusion if too many people are talking in a room voices become muffled. I have lost my concentration. I'm a programmer I'm praying I get it back or I will loose my job... Also erratic mood swings. I received the second shot 4/9/2021 and still have these simptoms.

Stroke twice Acute idiopathic spontaneous intraparenchymal intracerebral hemorrhage (CMS-HCC) Loss of vision in lower left quadrant

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

I had minor Tinnitus in my left ear but after my vaccination, ringing has increased and is now present in both ears at an equal level.

Ringing (crickets) I hear in ears that I already had got louder (intensified) within a couple days of the vaccine. It?s constantly louder than before but at times has been extremely loud in right ear . Like birds chirping rather than Crickets.

Tinnitus, ringing in ears, sounds like a bunch of rattle snakes in a room next door. Started after first shot. Continues to date. Hoped it would go away, but it hasn't. No symptoms before shot. Keeps me awake at night. Leave the television on all night to cancel out the noise. Like locusts or crickets or rattlesnakes.

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

shingles, started in right eye, then right side of face, up to top of head. intense pain, swollen eye lids, lot of bumps/rash Treating with Valacyclovir and Erythromycin for the eyes started 1 month after 2nd Pfizer vaccination.

Right eye sclerisis and irisis diagnosed 2 weeks after the second dose of Covid 19 . No known underlying autoimmune disorders, recent (6 months) blood work normal.

blurred/double vision; blurred/double vision; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 16Mar2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin (reported as "pennacillin") allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took procaine (NOVOCAINE) and experienced allergies. Approximately 28 hours after vaccination, on 17Mar2021 at 12:00, the patient developed blurred/double vision. There was no treatment received for the events. The outcome of the events was not recovered. No follow up attempts are needed. No further information is expected.

metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 12:45 as single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination, no covid tested post vaccination. No allergies. Concomitant medication(s) included Diltiazem ER 240mg, Rosuvastatin 10mg, Fortest 50. The patient experienced metallic taste in mouth beginning approximately 10 days after vaccine and still persisting 10 days later on 20Mar2021 with outcome of not recovered with no treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number. Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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

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

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

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

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

Pain in my chest ,swollen throat, light headed, dizzy, shortness of breath. sick for a week steroids, fluids

Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.

right eye went blind for several Minutes; hemorrhage behind eye; when it cleared I had white clouds that were blocking vision; PAMM; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left (unspecified anatomical location) on 12Apr2021 (Batch/Lot Number: ER8734), at the age of 61-years-old, as single dose for COVID-19 immunization. Medical history included overweight and elevated BP. The patient own allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 22Mar2021 02:30 pm (lot number: EP7534), at the age of 61-years-old. There are other unspecified medications in the last two weeks. There are no other vaccines in four weeks. The patient experienced right eye went blind for several minutes and when it cleared, the patient had white clouds that were blocking vision. Ophthalmologist saw hemorrhage behind eye called it PAMM. The events happened 4 hours after vaccine 2nd dose on 12Apr2021 18:00. Retinal specialist believed it may be vascular but could not determine cause. Dr. advised that he was one of several patients who had eye issues after vaccine. Therapeutic measures were taken as a result of the events. The patient had no prior vaccination, the patient was not tested for COVID post vaccination. The outcome of the event was not recovered. The events were reported as serious- disability.

chalky taste in my mouth; bad breath; stuffy and thus breathing issues; This is a spontaneous report received from a contactable Consumer reporting for herself. A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:45 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced chalky taste in my mouth on 29Mar2021 with outcome of not recovered , bad breath on 29Mar2021 with outcome of not recovered , stuffy and thus breathing issues on 29Mar2021 with outcome of not recovered. No follow-up attempts are needed. No further information is expected.

One week after receiving the vaccine the patient began to experience tinnitus in his bilateral ears, hypersensitivity

Loud ringing in my ears some days not quite as loud other days very loud thought it would stop but I've had the ringing since my 2nd COVID injection. Never had ringing in my ears until I got the 2nd shot

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

1. Had very itchy rash all over my body. Took Benadryl and itchy level went down. After 4 days, rash went away. 2. Continue to had burning smell since April 20, 2021 (11 days after 2nd shot) to present, especially in the morning, the smell is really intense.

his tinnitus has been "bothering me more than usual" and "seems like it's getting louder".; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (reported as "last Saturday") at single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were unknown. The patient's tinnitus had been "bothering me more than usual" and "seems like it's getting louder". The patient asked if this was a reported side effect after receiving the vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Please note: I am not sure this is necessarily an adverse reaction, or if it is my returning sense of smell. I had COVID in early Dec 2020 and lost all sense of smell and taste. At this time I have recovered about 60%. My 'issue' is I have started smelling Jet Fuel (kerosene) everywhere.

I woke up 7:00 am April 21st with ringing in my right ear. On Tuesday May 4th I went to clinic. The NP, gave me FLONASE and CLARITIN. Followed up on May the 11th. My symptom that day was better but I told the NP it still had ringing. She told me if I wanted the next step would probably go to a Ear, Nose, Throat.

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

Sudden sensorineural hearing loss in left ear noted Jan 12 2021 (4 days after 1st dose). Spontaneous recovery of some hearing within 48 hours. High-pitched tinnitus in both ears. another episode of sudden hearing loss noted Jan 31 2021 (5 days after second dose), with spontaneous recovery. Residual low frequency hearing loss in left hear; High frequency tinnitus remains in both ears as of reporting date (5/19/2021)

experienced hearing loss in his left ear/hearing loss on both ears; his right ear seems like there is water in there or it is underwater/left ear sounds like everything is echoing; immediately things were muffled; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right upper arm on 27Apr2021 11:00 (Batch/Lot Number: EWO171; Expiration Date: Aug2021) as 1st dose, single for covid-19 immunization. Medical history including hearing was about 80 percent in the left ear/loss of 20-30 percent which started 10 years ago when the patient was 51. The patient has no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. After receiving a dose of Pfizer Covid-19 vaccine on 27Apr2021, the patient experienced hearing loss in his left ear, it was barely noticeable but today (04May2021 12:00) there was a dramatic shift and he experienced hearing loss on both ears, it was instantaneous. The patient wanted to know if there are any reports of hearing loss and when could it go away. He has a hearing issue in his left ear that he has had, his hearing was about 80 percent in the left ear and in the right ear it was a 100 percent. Today, at noon he has almost lost his hearing in his left ear and his right ear seems like there is water in there or it is underwater. His left ear sounds like everything is echoing but, he can hear the call handler just fine. His right ear was perfect and now it is messed up. He is worried about that. The patient wonders why that happened and why did they both go. He reported that the shot may have had something to do with it and if it does, what should he do or maybe he is just getting old. He cannot hear in the left ear much; he was just testing it while on hold listening to the music to see how much he had. He felt like there is water in it, not a little, a lot of water and it echoes a little bit and seemed like it's underwater. Started 10 years ago when he was 51, he lost 20-30 percent and it stopped as far as he could tell. He did not get checked out then because he could hear clearly. Today at 12 pm, and it was not gradual, it was like turning a light on, immediately things were muffled. Even when he was putting his hands over his ears, there was like an echo. He was on the phone with his wife at the time. He did not know what happened, so, he went to work, and nothing is changed. He told her something just happened to his ears. He thought of doing something in the meantime and not trying to wait for it to get better. Right ear feels like it is underwater, maybe the left ear is affecting the right the or the weaker ear is being affected more. The right ear is the stronger ear over the left ear. That is what bothering him. His weaker ear is being affected more than his good ear, which his right ear has always been the stronger ear and he never had problems before with his right ear. It was a dramatic switch today at 12pm and his ears have been that way ever since. The left ear feels like its underwater, so much even if he blocks that ear with his finger or his palm. Still there is something going on in both ears. He did not notice the right ear because the other ear was such a shock and he was just dealing with that. He noticed the right side too after trying to see if he could hear out of the left. He had no baseline to go off of for sure or a history. No baseline to go from other than this hearing change of event, which may be totally him. He wanted to see if there is anything related to this because it was so dramatic. The events were not treated. The outcome of the event "experienced hearing loss in his left ear/hearing loss on both ears" was not recovered while the other events were unknown. Information on Lot/Batch number was available. Additional information has been requested.

Blister like bumps developed in the mouth within a hour or two of receiving the vaccine. There was no pain associated with the bumps. It is now 5/23/2021 and the bumps are still present in the mouth.

Tongue swelling through the night. Did not seek treatment. Went away next morning. Rash area on arms and legs.

Had itchy eyes, loss of smell, loss of taste, fever for 15 hours started 5/24/21 at 1pm until 5/25/21 4am.

Patient complained that he tatste the medicine and also dizziness after he received the first dose of pfizer vaccine. Assessment done and patient sent home in stable condition. Patient stated that he feels a lot better.

RASH ON BIL UPPER EXTREMITIES, SOB, CHEST TIGHTNESS, NUMBNESS ONLIPS, 10 MG ZYRTEC GIVEN PO, BENADRYL CREAM APPLIED TOPICALLY TO RASH ON UPPER EXTREMITIES AT 1:10 PM. EXTENDED MONITORING FOR 1 HR WITHI SYMPTOMS LESSENING. VITALS STABLEAT 137/87 BP, HR 76, RR 18, 97% OXYGEN ON ROOM AIR AT 1:50 PM. PATIENT ADVISED TO SEEK ADDITIONAL MEDICAL EVALUATION.

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

Dry mouth; chapped lips; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the left arm on 11Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included obese, high triglycerides, prostate cancer treatment 5 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN), VASCEPA, rosuvastatin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN). Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 07:00, the patient experienced dry mouth and chapped lips after five days of first vaccination. No therapeutic measures were taken for the reported events. The clinical outcome of the events dry mouth and chapped lips was resolving. Information about lot/batch number cannot be obtained. No further information is expected.

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

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

2 days after vaccine developed diarrhea & body aches, then loss of smell and appetite. ED visit 4/8/2021, lymphopenia noted, COVID PCR positive. Returned to ED 4/11/2021 with SOB, oximetry low 70s, cyanotic, respiratory distress, elevated D dimer, CXR: COVID pneumonitis. "Deteriorated quickly despite maximal medical management" per Discharge Summary. Died 4/24/2021 from hypoxic respiratory failure and multiorgan failure, shock. Had also developed heparin induced thrombocytopenia during treatment for DVT Right lower and upper extremities.

Twelve days after receiving the second Pfizer COVID-19 shot I had come down with a case of oral shingles. All of this was on the left side of my face: Swelling of lower lip, swelling of tongue, hardness to tongue, ulcers in mouth and tongue, numbness to lips, tongue, and gums, sensitivity to hot and cold on teeth, redness on face, some small outbreaks of oozing around chin, sensitivity of head, face, neck and shoulders all on that left side.

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

(Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration on the left arm on 10Mar2021 at 13:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient was tested for COVID-19, since having the vaccine. On 10Mar2021 at 20:00, the patient had experienced terrible ear ringing in both ears(tinnitus) and was not able to sleep. The patient did not receive treatment for the reported events. The clinical outcome of events tinnitus and sleeplessness were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

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

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

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

Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; This is a spontaneous report from a contactable consumer. This 61-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 16Mar2021 at 15:00 hours on left arm (at 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included cardiac failure. The allergies were reported as none. Concomitant medications included sacubitril valsartan sodium hydrate (Entresto) taken for an unspecified indication, carvedilol taken for an unspecified indication and spironolactone taken for an unspecified indication. On 18Mar2021 at 10:00 PM the patient experienced loss of vision, cerebrovascular accident and hemorrhagic stroke. The patient required emergency room visit and was hospitalized for 3 days. Therapeutic measures were taken with nir angiogram cerebral. The event outcome was unknown. It was mentioned that no other vaccine was received in four weeks, patient had no covid prior vaccination and was not tested for covid post vaccination. The device date was 03Jul2021.

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

Severe brain fog and ringing ears 3 full months after my 2nd shot. The symptoms started within hours of getting the 2nd shot and have yet to subside. I've been to my doctor twice, have had blood work and most recently a brain scan. Still awaiting the results of the MRI brain scan. I was prescribed Prednisone for a few weeks and I felt instantly great, which tells my doctor I have some swelling in my brain.

Tinnitus (both ears) Major Skin Rashes (very itchy) -lower back, abdomen, Minor Skin Rashes (very itchy) - legs, back of neck.

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

Heightened tinnitus in my left ear. I had a very minor issue but since the vaccine the ringing is much more apparent.

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

Developed tinnitus in both ears.; Had trouble sleeping the past few weeks but am sleeping better; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 12Mar2021 at 20:00 (at the age of 61-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 02Apr2021 at 17:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and blood pressure high. Concomitant medications included atorvastatin calcium (LIPITOR) 40mg and amlodipine (MANUFACTURER UNKNOWN) 5mg from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. After receiving the first dose on 12March2021, the patient developed tinnitus in both ears late Sunday on 21March2021 into early Monday 22March2021. The patient started to take some over the counter supplements to help. The patient's right ear was normal as of 06April2021 but had slight tinnitus in the left ear. The right tinnitus had resolved several days ago. The patient felt that the left ear was bit better as ringing can dissipate during different times of the day. The patient had trouble sleeping for the past few weeks but was able to sleep better at the time of reporting. The patient was still trying to get the left ear line the right. The patient would clean the ears daily with Q-tips (outer areas) and would always see wax and the weirdest thing was that there was no ear wax. The patient got nothing and no wax at all even if the ears were not cleaned for days which was very, very strange. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of tinnitus, trouble sleeping and included treatment with over-the-counter herbs with ginkgo biloba (MANUFACTURER UNKNOWN) and SYNAPSE XT from 22Mar2021 to unknown date. The clinical outcome of the events tinnitus in ears and difficulty sleeping were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

LEFT OCCULAR CONJUNCTIVITIS WITH DRAINAGE REQUIRING TREATMENT WITH ANTIBIOTIC AND STEROID OCCULAR DROPS FOR TEN DAYS. RESOLVED AFTER TREATMENT

I have constant tinnitus since about a day after receiving the first dose to the Covid-19 vaccine. It got worse over the New Year's weekend, and now seems to be stabilized as a constant ringing. I will be making an appointment this coming week to have it investigated, but wanted to get the preliminary information to you. I have experienced a much lesser degree of tinnitus in the past, always a momentary transient event, not nearly as loud as I am currently experiencing.

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

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

Angina Upper lip swelling/tickling and tongue tingling Narrative: 61 year old female with HTN and asthma with multiple allergies to meds and prior angioedema in past. Presented for her first dose of COVID19 vaccine; after the injection she felt her upper lip tingling and tongue. NO SOB, no throat symptoms, no change in voice, no rash, no hives. NO N/V. She did have some chest tightness. Diphenhydramine IV, famotidine IV, and methylprednisolone IV one-time doses given in ED with surveillance. Patient recovered, denied previous sxs, and was discharged from ED with a family member. ED physician note documents patient "will take" following medications at home (however no outpatient prescriptions found): Benadryl 50 mg po Q8H x 5 days, prednisone 40 mg po daily x 4 days, and famotidine 20 mg po BID x 5 days

Constant tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no other medical history. No known allergies. Concomitant medication included fish oil, allium sativum (GARLIC), ascorbic acid (VITAMINS C), vitamin D, vitamin K, and multivitamin. The patient did not receive other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced constant tinnitus on 30Dec2020 12:00. The event was reported as non-serious. The patient did not receive treatment for the event. The patient had not recovered from the event.

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

The fist day I started feeling dizzy and stomach didn't feel good. On the second day I started having problems with my vision in my left eye, I went blind for 20minutes. When I did get my Vision back I got and slight headache. About 3am in the morning, I woke up like someone hit me in the head with a hammer. After that every second or third day the pain would come back and it would be worse, it brought tears to my eyes. I started taking Tylenol but then it stopped working. it kept kept getting worse and I went to see my Dr. and she put me on some medication, but they did work and she sent me to a Neurologist and he put two medications. They seem to be working, I'm not having them as much. I'm calling tomorrow to see when my appointment is scheduled.

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

patient states the night after the vaccine he had a nosebleed and it stopped on its own. Then he complained of a sore, raw tongue and that it burned when he drinks juice and taste bad. Patient states he had not been exposed to a positive COVID case that he was aware of.

Hearing loss in left ear about a day after shot. Ear hurt as I suspected an infection. Went away after a couple of days. Hearing returned. Now my right ear is starting the same. Almost all hearing is gone same as my left ear did. Feels like and ear infection. Hope it comes back like the left ear.

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

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

Left eye, Transparent light brown half-moon shaped visible for approximately 15 minutes. It disappeared when I went into the cold weather. Both eyes have irritation, burry and itchy.

A noticeable increase in tinnitus in both ears. I have this condition normally but am able to manage it naturally. On Tuesday evening (day 3) I noticed a marked increase in volume and it is not subsiding.

Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful

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

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

Extreme headache beginning 2 days after vaccine was administered. Accompanied by chills and tiredness, and blurred vision. Today is the 6th day after the vaccine was administered and still have extreme fatigue and moderate headache.

Lip swelling Narrative: Patient's spouse called to report patient developed lip swelling 4 days after receiving his 1st COVID vaccine (Pfizer) on 3/16. He was evaluated at ER and discharged home the same day. No information on ER visit at time of writing.

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

Tinnitus - Left Ear - plus some hearing loss . The tinnitus comes and goes, and seems to also be related to my neck position

Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20 beats higher than normal. Mild tinnitus got louder. At 24 hours from shot fever has reduced to 100.

Have had a buzzing in my head and ears since the day after getting my shot. It stops for a few hours once in a while but keeps coming back. Seems to be getting louder.

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

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

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

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

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

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

Headache, metallic taste, tingling of tongue. BPs 148/88 (pulse 62), O2 sat 100%. BP 139/84 (pulse 64), O2 sat 100%. Benadryl 25 mg PO. Final BP 134/83 (pulse 55).

Patient stated that he experienced itching, swelling of the gums and tongue, and difficulty breathing about an hour and half after receiving vaccine. He reports going to Hospital ER on the Road where he was given Epinephrine, Famotidine, Benadryl, methylprednisone, Albuterol, and Racepinephrine . He was transported to the main hospital for further treatment.

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

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

can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him. He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.

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

Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: En6201) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) and losartan, both for unspecified indication. On 16Mar2021 at 16:00, the patient experienced ringing in ears and tough to sleep for a couple days. The patient did not received treatment for the events. The events resulted in disability or permanent damage. The outcome of the event was not recovered. The patient did not had COVID prior to vaccination and was not tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

On 04/09/2021, day after 2nd Pfizer vaccine, woke up with stuffy head/chills. As day progressed towards work, changed to loss of hearing in right ear with phase shifting and ringing. Very disorienting and dangerous to work in busy kitchen. Made through weekend now little to no hearing in right ear with whirring, roaring, chirping. Saw Dr on 04/13 and started treatment for ear infection. Steroids and nasal spray for 3 days to no relief. Started antibiotics on 04/15. As of now at 10:36am on 04/16 no let up in all symptoms!

Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a head cold. Some chills etc. by the time I went to work right side hearing was severely affected with what sounded like phase shifter in my head. No relief through weekend, too dangerous to work due to my job in a busy kitchen. Saw my Dr. on Tuesday 04/13. Treated as an ear infection. 3 day steroid with nasal spray. No relief. By now the ringing, whooshing, roaring and chirping in my right side are extremely disorienting! Started antibiotics on 04/15 with wait and see effectiveness. Today is 04/16 at 10:15am. To date no relief of symptoms.

vision very blurry; This is a spontaneous report from contactable male consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613), via an intramuscular route of administration in left arm on 02Apr2021 09:30 at single dose for COVID-19 immunization. Medical history included allergies, compromised immune status, respiratory Illness, geentic/chromosoaml abnormalities, endrocrine abnormalities, diabetes and obesity. The patient's concomitant medications were not reported. The patient did not receive prior vaccinations within 4 weeks. On 03Apr2021, at 08:30-09:00, the patient had very blurry vision. This was for 4-5 hours. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

24 hours after the shot, I started getting loud ringing on my ears. It is now 7 days since that shot, and the ringing in my ears is still very loud.

one week (04/12/2021) after 1st dosage injection 4/5/2021) in left arm, all of a sudden constant ringing/humming in right ear with occasional pings and has not gonna away, It started about 8pm on 04/12/2021.

Ringing in ears started about 30 hrs after 2nd dose Pfizer Covid-19 vaccine. Also had slight fever, chills, nausea but they stopped by next day. Ringing in ears subsided for a few days but has now gotten pronounced all the time.

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

Second injection on a Friday. Starting Sunday, 4/18, I have had waxing and waning hives - most pronounced at night but also periodically throughout the day. I also had a swollen lip when I woke Tuesday morning, 4/20/21. The swollen lip returned to normal after about two hours and has not returned. I still have recurring hives that wax and wane throughout the day and at night. I do not consider the hives to be a heavy rash. They are itchy enough today that I took a Benadryl. I would have taken one last night, but I had to drive 3 hours to a funeral today. In addition, following the first vaccination (on 3/26/21), I had a swollen lip that night. I did not consider attributing any of the foregoing symptoms to the vaccine until I read about symptoms at about 2 am this morning. The fact sheet given to me when I got the vaccination really doesn't highlight the potential for a swollen lip or the onset of hives a couple days after the injection. I did not have any immediate reaction to the injection (i.e., none during the 15 minute waiting period following either shot).

I have existing Tinnitus in my left ear, but it is hardly noticeable., On April 7, four days after my shot, I noticed a substantial increase in my Tinnitus in that ear, with a little on again off again in my right, which I never had. Since then it has gotten worse in both ears and is quite disturbing.

Several days after receiving my vaccination, my tinnitus symptoms, which had been fairly mild, changed to be much more noticeable and louder. It seems like before it was just in one ear and now it is both ears. It used to noticeable and bother me only at bedtime when things were very quiet and now I can hear the ringing all the time day and night.

Developed Tinnitus after 48 hours from receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:30 (5:30 PM) (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, high blood pressure, obese all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no covid prior vaccination and not covid tested post vaccination. The patient was vaccinated at a Public Health Clinic/Veterans Administration facility. There were no other vaccine in four weeks and there are other medications in two weeks (unspecified). It was reported that the patient developed Tinnitus after (reported as 48 hours from) receiving the vaccine on 24Mar2021 at 5:00 pm. Continuing to have tinnitus. The event was considered serious due to disability. The outcome of the event was not recovered. There was no treatment for the reported event. The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.

tinnitus, hearing loss, it has not stopped, it sounds like the room next door is full of rattlesnakes or locusts.

Shingles on left side of face, on upper lip, interior lip, nose, below left eye. Also left eye is aches, like a pulsating headache. Went to Urgent Care 4/28/2021. Prescription issued, Valacyclovir.

headache started about 45 min after shot, laid down on couch (at home) and fell asleep (30 min +/-) when awoke tongue felt a little thick, drank water then tongue felt sore on top and "hairy", but a lot less thick. headache subsiding. tongue top still sore 4 hours later

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

About 1 week after the 1st dose, beginning on 4/20/21, I started experiencing a significant increase in my tinnitus condition in my right ear. 2 wks later, it also started in my left ear. The ringing, buzzing and whistling sounds have become louder and very difficult to tolerate affecting my sleep and some other daily resting activities. I informed my doctor and was advise to do Audiology test and discuss with ENT specialist.

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

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

Pt experienced double vision three days after vaccination. Went to see Dr. on Thursday April 29th. He received a referral to get an MRI and is now awaiting his appointment to discuss the results.

Ongoing tinnitus on the second day following the second shot. First shot 4/4/2021 at 16:00. Second shot 4/25/2021 at 16:05

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

The vaccine has aggravated a tinnitus condition that I have had for around 20 years. The perceived "volume" of the ringing in my ears became much louder. This began the day after the vaccine (1st shot), and I have delayed the 2nd shot, and I am considering foregoing the 2nd shot. The volume has increased considerably, and stays fairly constant from day-to-day. To date, I have not seen either my Physician or an ENT - both of which I will be doing soon. Disappointing annoying. I think this was a known issue and was not communicated.

The initial dose of Phizer Covid vaccine exacerbated a preexisting condition. It caused significant hearing loss and made mild tinnitus very severe. Currently being treated with Rozerum sleeping aid and was just prescribed lidocaine patches

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

pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in throat only

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

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

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

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

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

I started having visions issues. I went to the emergency room. At the Hospital everything look normal - but it was detected that I had an Hemorrhagic Vitreous. I have been sick since.

I experienced a distorted vision problem covering the upper left corner of my visual field. I assumed it was fatigue. When it didn?t get better by 4/1/21, I went to Patient First be checked out. They sent me to Advanced Eye Care to follow-up with an ophthalmologist. She confirmed that the vision loss was being caused by something in my brain, at which time she sent me to the ER. At the hospital, an MRI revealed that I had suffered a stroke in the lower right rear side of my brain that was affecting my site in the upper left part of my visual field.

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

Sudden Hearing Loss in Right Ear along with very bad tinnitus. After steroid injection to my right eardrum, hearing came back. My 2nd vaccine was on April 8th Sudden Hearing Loss again in right ear. 2 more injections into right ear drum. Hearing came back till this last weekend. Lost right hearing again and extreme tinnitus. Seeing the Dr. this afternoon, 6/21/21.

Tinnitus both ears started a few days after 2d Pfizer covid dose on March 31. Consulted Doctor April 15. Had ear wax removed from 1 ear April 20. Tinnitus has continued.

my tongue has swollen; small red sores on the sides and underneath my tongue; small red sores on the sides and underneath my tongue; bitten my tongue in 2 places which are now white; bitten my tongue in 2 places which are now white; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiry date: unknown, age at vaccination: 62-year-old), via an unspecified route of administration in Arm Right on 26Jan2021 08:00 AM as dose 2, single for covid-19 immunisation administered at hospital. Medical history included hypertension, type 2 diabetes mellitus, asthma and seasonal pollen allergy. Previously the patient received first dose of bnt162b2 (Lot number EJ1686), in Arm left on 07Jan2021 07:15 AM for covid-19 immunization. Concomitant medications included terazosin hydrochloride (HYTRIN), metformin and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient was not tested positive for Covid-19. On 01Feb2021, the patient reported, he had his tongue swollen and had small red sores on the sides and underneath his tongue and because of the swelling he had bitten his tongue in 2 places which are now white. No corrective treatment was taken. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

On the first day after taking the shot: couldn't walk well; very dizzy; loss of balance; blurry vision; couldn't focus; difficulty riding my bike. I went to the doctor and I was recommended to see a neurologist. I gradually got better over time. I still have soreness in my ribs and I can walk somewhat normally. I feel like I have 90% recovered.

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

Early that morning I woke up seeing pink out of my left eye. I went to eye doctor and they found I had a mini stroke behind my left eye.

was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear; I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15. I'm 62 years old with no prior hearing issues.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration in Arm Left on 15Mar2021 13:30(at the age of 62 years old) as single for COVID-19 immunisation. Medical history included hypertension and sleep apnoea syndrome both from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. Concomitant medication taken within two weeks included acetylsalicylic acid (BABY ASPIRIN), nebivolol hydrochloride (BYSTOLIC), dronedarone hydrochloride (MULTAQ), and tamsulosin (TAMSULOSIN) all taken for an unspecified indication, start and stop date were not reported. Other vaccine taken within 4 weeks of COVID vaccine included SHINGLES dose 2 administered on 23Feb2021. The patient did not have COVID prior vaccination. Reported as, "I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15 (15Mar2021). I'm 62 years old with no prior hearing issues. I was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear by an ENT on March 19 (19Mar2021). I am on a 13 day progressive intervention of prednisone, which I started on March 20 (20Mar2021)." Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event with Prednisone. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were not recovered. Follow-up attempts are needed; information about lot/batch number has been requested.

I BEGAN HEARING LOW FREQUENCY NOISE AT VARIOUS TIMES OF THE DAY AND NIGHT. THE NOISE GOT PROGRESSIVELY WORSE, TO THE POINT IT WAS DIBILITATING. A FEW OTHERS IN MY AREA REPORTED HEARING THE NOISE, BUT NOT TO THE SEVERITY i HEAR IT.

Hearing loss; tinnitus; I feel off balance; headache; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 03Feb2021 at age of 62-years-old for covid-19 immunization and experienced Hearing loss and tinnitus. The patient medical history was not reported. Concomitant medication included fluconazole. The patient experienced hearing loss, tinnitus, feel off balance on an unspecified date with outcome of recovering , headache on an unspecified date with outcome of recovered. Ear nose and throat doctor prescribed prednisone. Seriousness criteria reported as disabling and incapacitating. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. Information on the lot/batch number has been requested.

Also had headaches for approximately two months but those have gone away for the most part; experience times where I feel off balance; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 at 15:00 (at the age of 62-years-old) and dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 (Lot Number: EL9266), both as single for COVID-19 immunisation. The patient did not had any medical history and known allergies. Concomitant medications included fluconazole. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 14:00, the patient experienced hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine. The onset was sudden and very abrupt. On 25Feb2021, the patient received the second vaccine and the condition continued. On an unspecified date, the patient "also had headaches for approximately two months but those have gone away for the most part" and "experience times where I feel off balance". The patient's hearing was so badly impacted that he had to get hearing aids for both ears. The adverse events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. The ear, nose and throat doctor prescribed prednisone. The outcome of event dizziness was unknown and was resolving for the rest of the events.

Double Vision which came on suddenly one morning. Over a 2 month time period the symptoms have receded slowly each day. I am almost 95% better.

Spoke to patient on the phone on 7/20/21. Patient claims that day of shot, injection site became a red "bullseye" lump/mark. Over the next few weeks up until today, patient claims a rash has continued to spread over his body that is very itchy. Also claims that he is now more sensitive to the sun (vision impaired) & can't physically tolerate being in the heat like he could before the vaccine.

Patient calls with report of irregular heart rate, shortness of breath, chest congestion, sinus congestion, loss of smell. There have been three positive COVID cases at his work. He is full vaccinated. Reports hx of afib.

Chronic severe Tinnitus. Non-stop ringing in the ears. Driving me crazy, Causing insomnia. This ringing in my ears is 24/7. Seems to be getting worse.

A large canker sore developed under my tongue; A large acne cyst on my left buttock.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the arm right on 31Mar2021 at 15:15 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included functional heart murmur, bilirubin elevated and psoriasis. Concomitant medications included ECITALOP 10milligrams since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:00, the patient experienced a large canker sore developed under tongue and a large acne cyst on left buttock. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events a large canker sore developed under tongue and large acne cyst on left buttock was recovering. No follow-up attempts are needed. No further information is expected.

Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto thyroiditis. The patient had history of known allergies to morphine (MANUFACTURER UNKNOWN). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and amlodipine (AMLODIPIN); all from an unknown date for unknown indication. 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 06Apr2021 at 13:00, the patient experienced metal taste in mouth. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The outcome of metal taste in mouth was recovering. No follow-up attempts are needed. No further information is expected.

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

Patient reported the tip of his tongue feeling "tickly" 10 minutes post injection. Denied any other complaints or concerns. At 20 minutes post injection, he reported it was starting to get better. Denied any other complaints or concerns at that time as well. Drank some water at this time and felt it was improving. Patient reported at 30 minutes post injection that the "tickly" feeling on his tongue was gone and requested to leave. Patient alert and oriented, no other signs or symptoms, denied any breathing concerns. Left clinic ambulatory. Encouraged to report to urgent care if symptoms returned or worsened. Agreed to plan and verbalized understanding.

Itchy eyes. Skin around both eyes turned red and puffy. Lasted about 24 hours. Stinging sensation in both eyes.

At home, approx. 45 minutes after shot, lips started tingling, then itching. Around 10 minutes later, throat began feeling irritated/scratchy. Approx. 10 minutes later lower lip became swollen. I took half a Benadryl. Never had any difficulty breathing or swallowing. Presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl.

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

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

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

Following morning patient was "Foggy" in the brain and unable to string words together in a sentence very well. He let me know he could not focus enough to read and retain anything. He wanted to talk but couldn't find the words. He remained very quiet but had no other symptoms of fever, pain, or anything else. 10 days post vaccine and he is doing better but still not feeling normal and not talking and holding conversations as usual. He is able to answer appropriately . The last two days he said all food is tasting bland without a lot of flavor. He has taken a couple Tylenol the last two days and drank Echinacea tea to try and make an improvement. Is there data or information to give us any idea how long this could last?

tinnitus; loss of hearing on Left side; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization at hospital facility. Medical history included benign prostatic hyperplasia (BPH) and hypothyroidism. The patient had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), tamsulosin hydrochloride (FLOMAX), and finasteride taken within two weeks of vaccination. The patient had no other vaccine in four weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK8330) via intramuscular route on the left arm on 16Dec2020 at 6:15AM. The patient experienced tinnitus and loss of hearing on left side on 13Jan2021, 7 days post 2nd dose. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Prednisone taper was given as treatment for the events. The patient had not been tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events tinnitus and loss of hearing cannot be totally excluded given the time association. The detailed clinical course about these events would be helpful for further assessment. 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.

lower lip became swollen; throat began feeling irritated/scratchy; lips started tingling, then itching; lips started tingling, then itching; This is a spontaneous report from a contactable Nurse (also the patient). A 63-year-old male patient (also the age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK4176, expiry date: Not available/provided by the reporter at the time of report), via an unspecified route of administration in left arm from 21Jan2021 10:00 AM at single dose for covid-19 immunization. The patient is vaccinated in a hospital. Medical history included bilateral iliac aneurysms on an unspecified and inferior wall MI in 2004. No other vaccine was administered in four weeks. The patient had no known allergies. No covid prior vaccination and not covid tested post vaccination. Concomitant medication included (reported as other medications in two weeks): aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), simvastatin, metoprolol succinate (TOPROL), alfuzosin, colecalciferol (D3), zinc gluconate (ZINC (GLUCONATE). It was reported that at home, approximately 45 minutes after shot (reported start time: 10:45 AM), lips started tingling, then itching. Around 10 minutes later (10:55 AM; 55 minutes), throat began feeling irritated/scratchy. Approximately 10 minutes (11:05 AM; 65 minutes) later lower lip became swollen. The patient took half a Benadryl. Never had any difficulty breathing or swallowing. The presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl (reported also as: No treatment was received for the events; pending clarification). The outcome of the event lips started tingling was recovered on 21Jan2021; and for all other events was recovered on an unspecified date.

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

45 minutes after injection lips tingling and itch. 5 minutes later throat irritated. 10 minutes later lower lip swollen. Benadryl 25mg 1/2 tab. Reaction no worse. 1 hour later symptoms began to subside. Never had any difficulty breathing or swallowing.

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

Lower abdominal pain; ringing in ears; aching joints, frontal headache, very tired/Felt like the worst flu ever; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiry date unknown), via an unspecified route of administration on 13Jan2021 10:30 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma and allergies: sulfa drugs. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did fine until 23Jan2021 09:00 through 25Jan2021 as the patient experienced lower abdominal pain, aching joints, frontal headache, ringing in ears, and very tired. The patient stated that it felt like the worst flu ever. He also stated that his concern was will it be worse on the second injection. He may not take it. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Outcome of the events was recovering.

About 9.5 hours after receiving injection I noticed a very LOUD high frequency in my head. Using an online frequency generator I have observed the frequency tone around 7,000hz. Always the same tone, same intensity. On a scale of 1-10 the intensity (loudness) around 7. I hear this tone from the time I wake up till I fall asleep, every second, everyday. This has never happened to me before in my life.

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

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

Did not connect adverse event to the vaccination until roughly three days after it was recognized. Had first dose of Pfizer COVID-19 on Friday, January 29, 2021. On the following Sunday or Monday (2 or 3 days post vaccination), I noticed ringing in my ears. I have always had perfect hearing, no issues whatsoever. I knew nothing about tinnitus, so just figured it would go away. Days later, it hadn't gone away so did some research and wondered if it could be associated with the vaccine. Searched the web, but found nothing. Considered calling a hearing specialist (long story so will keep it short), but all info found said there was little that could be done, so did not make the call. Since couldn't find relation to vaccine, received second dose on February 19, 2021 without any other issues. Tinnitus continues as originally noticed. Finally yesterday, I related the Covid vaccine to tinnitus after reading an article on J&J's vaccine candidate that stated tinnitus had been seen as an adverse reaction in the clinical trials.

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

I had an unusual reaction, my lips swelled up after I received the vaccination. I received the shot about 9:30 am. It started about 5:00 pm to the next morning and subsided. I also had more common symptoms as well headache aches and pains and diarrhea.

Tinnitus - ringing in my ears started 24 hours ago. Went online and read that this is a side effect, so have not done anything about it.

Constant pain on the bone area on top of the left eye and makes the left eye watery. This symptoms is soothed by taking one tablet of a Regular Strength Tylenol a day in the morning. With this I can sleep well at night and ok when I wake up but the pain start like an hour after I got up from bed.

Ringing in the ears started two days after the shot. Still have it five days after. No other symptoms.

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

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

daughter reports a few hours after receiving vaccine eye felt "bubbly" then became cloudy and then developed a black spot. received shot on 3/23/21 and daughter reported to pharmacy on 3/27/21. they were instructed to go to urgent care

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

Woke morning after first (and only) Pfizer covid vacc. with prominent left ear ringing. 3x more volume than normal level. Still ringing loudly two days before appointment to get second dose of Pfizer with some occasional right ear ringing also (which I never had before at any volume). So felt I had to cancel the second dose. Now going on 26 days of constant life changing tinnitus. Obviously hoping it subsides.

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

Body aches, chills, fever. On Saturday March 27, I woke up and noticed I had no sense of smell. Later in the day, my sense of taste seemed deadened. I had an odd metallic taste in my mouth. By Monday all symptoms were gone.

Within 8 hours of injection, developed loud tinnitus. Woke up the next morning with almost total hearing loss in left ear and vertigo to the point where I was in bed except to go to the bathroom. Called Tele Doc but was unable to assists. Was able to g appointment with ENT for March 23. Diagnosed with profound Asymmetrical Sensorineural Hearing Loss in left ear, tinnitus and vertigo. Elected treatment to include intratympanic steroid (24mg) injections and oral prednisone. Receiving PT for vertigo. Tinnitus is unchanged as of the date of this report. Hearing test on 3/31 noted a slight change in ability to comprehend speech (2 words vs 0 words).

Developed ringing in left ear a week after vaccine administered. Very loud at times. Worse at night making sleeping difficult. Exhausted. Has not improved 2 1/2weeks now since vaccine. Getting louder.

On the right hand between the thumb and the index finger there were itchy bumps under the skin/Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up; Lips were swollen; Right nipple was irritated and the skin around it dried up; This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 27Feb2021 16:00 (Batch/Lot number was not reported) at single dose (at the age of 63 years old) for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia, retinal tears and known allergies: Penicillin. Concomitant medications included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid (BABY ASPIRIN), all taken for an unspecified indication. The patient previously took NIASPAN and experienced known allergies. At 19:30 pm on the day of the vaccination, on the right hand between the thumb and the index finger there were itchy bumps under the skin. Patient assumed it was insect bite. Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up. Patient started taking OTC Benadryl and Claritin on 4-5 days after consultation with PCP. However, reaction continued and the lips were swollen as well. Patient was prescribed steroids 4mg tapering blister pack by a separate physician since the rash had progressed to the chest. Right nipple was irritated and the skin around it dried up. Patient went to a dermatologist on 10Mar2020 and got a biopsy. Condition has not improved. The patient underwent blood test on Mar2021 for COVID and the result was negative. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events were not recovered. Information on the lot/batch number has been requested.

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

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

1. Fever (100.7F), aches, and pains for 24 hours starting the second day. 2. Ear Ache and sore throat starting the third day.

Seven-eight days following vaccine I experienced ptosis in my right eye. It has been diagnosed as either Ocular Myasthenia or Myasthenia Gravis. First, I was examined by an opthalmologist. He referred me for CT scans of the head and neck. They were negative. Second, I was examined by a neuro opthalmologist. He prescribed a blood test which was positive for Myasthenia Gravis. Third, I was examined by a neurologist. We will follow up in two months to note progress of the disease. I am currently scheduled for a chest CT scan to rule out thymoma.

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

The day after his second Pfizer vaccine, he developed hearing loss and had a CT scan of head that showed a large temporal lobe intracranial hemorrhage

Around 330 on 4/6, I started feeling bad and arrived home around 530pm and had a slight Temperature (99) with hearing loss in both ears. But the right one had complete hearing loss. Thinking it would be a short term side effect, but realizing on Thursday am with was not, I called my physician office on Thursday and they called back on Thursday for a Friday 9am appt with the PA. She said it was sinus related , fluid in the ears was pushing the ear drum back and gave me a prescription for Fluticasone and to take my Zyretx and Sudafed. Call her in a week if symptoms did not away. On 4/12/21, I still have massive hearing loss and pain, so called a ENT for an appt and received a 1:15pm on the same day. This was the first day I had balance issues.

within 20 minutes after shot the left side of my face felt light the dentist shot me with a light does of novocaine . the left eye feels tired, tongue and lips feel slightly numb, left side of face feels strange along with a headache

Severe dulling of hearing in both right and left ears. Feeling of nasal/sinus congestion. Sudden onset within 2 hour period

Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the left side of my left eye was/is bloody; It's been about 2 days and for the first day and a half I experienced the normal flu like symptoms.; dazed; when I leaned back to put eye drops in eye I lost my balance a little which does not normally happen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534), via an unspecified route of administration, administered in left arm on 27Mar2021 14:30 at single dose for COVID-19 immunisation. The patient's medical history included asthma, prediabetic, low thyroid, overweight but not obese, and capillary in the white part of his eye bust (right eye) about 4 months ago. The patient's concomitant medications included alprazolam (XANAX), colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and levothyroxine sodium (SYNTHROID). The patient previously took cryproheptadine hydrochloride (CYPRO) and had known allergies. The patient also previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had no COVID prior to vaccination and has not been tested for COVID post-vaccination. The vaccine facility type was Public Health Department. The patient has no other vaccine in four weeks. On 29Mar2021 at 14:00, it's been about 2 days and for the first day and a half, the patient experienced the normal flu like symptoms. Now after about two days (29Mar2021 at 14:00), he feel just a little out of it, dazed. Also when he leaned back to put eye drops in his eye, he lost his balance a little which does not normally happen. Also within about 12 hours after taking the vaccine, a capillary in the white part of his eye bust and the left side of his left eye was bloody. No treatment was received for the events. The outcome of the events were not recovered.

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

Had covid systems on Feb. 2nd 2021, Got tested Feb 3rd, Received call Feb 4th positive. Recovered on Feb. 15th. First vaccine shot Mar.31 at 12:30pm. Apr 1st at 4:20am, woke up and felt like sitting in a tub of ice. Severe chills lasted 1 hour, Had terrible aches and chills, that lasted for about 30 hours. Stayed in bed the whole time, only got up to pee & get water hurt so bad to move. Ran a temp about 100. till Fri morn. Fri. morn about 3:00am, woke up and had flashes going off in the eyes, like looking at a strobe light, with eyes closed and open. That stopped after about 20 min. Finally got out of bed Fri. 9:00am. Still felt out of it for a day. This was worse that the whole 13 days of covid. During covid no temperture

Loss of hearing in my Left ear. I have had recent hearing test that documented sudden loss and f/u appt with ENT doctor confirming loss. He put me on high dose prednisone for the past week and no changes to date.

Hours after receiving the 1st Pfizer covid vaccine shot I developed tinnitus in my head seemingly not coming from either ear but is a constant high frequency tone in my head. I still have this condition as of 4/15/2021 and plan to see an ENT but am skeptical he/she can do anything about it. It is not an ear infection where my hearing is reduced. Seems as though my hearing is normal or possibly better if anything. I am very healthy, exercising by biking 20 miles a day 3 times per week on average. I have no physical problems at all. Just this constant tone in my head which I am sure is the result of the vaccine shot. Please help!

Ringing in my ears began gradually and has increased in loudness and severity. Now on a scale from 1 to 10 it is a 7 and is extremely uncomfortable. Most noticeable in right ear. Also some light headedness after the second shot on 4/5/21.

BILATERAL BUZZING SOUND IN EARS CAME ON SUDDENLY THE DAY AFTER THE VACCINE. NO PREVIOUS ISSUES WITH HEARING PRIOR TO THIS. HAS NOT CHANGED AND IT'S 3 DAYS POST VACCINE.

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

Double vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported), via an unspecified route of administration, administered in arm left on 13Mar2021 15:30 as a single dose (at the age of 63-years-old) for covid-19 immunisation. The patient had known allergies with shellfish and ragweed both from an unknown date. Concomitant medications included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 15Mar2021 10:00, the patient experienced double vision 2 days after vaccine. The patient was seeing 2nd image vertically located from both eyes. Ongoing for 3 days. No treatment was received for the event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

severe Sudden Sensineural Hearing Loss in his left ear; Vertigo; loud tinnitus developed in both ears; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration at left arm on 20Mar2021 at 13:15 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included epilepsy and chronic urticaria. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included lamotrigine, hydroxyzine, and omalizumab (XOLAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 8 hours of receiving vaccine (at 21:15 on 20Mar2021), loud tinnitus developed in both ears. Next morning (on 21Mar2021) he had severe sudden sensineural hearing loss in his left ear and vertigo. Seriousness criteria was reported as disability. Receiving steroid injections and oral steroids. Vertigo and tinnitus continue. Adverse events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Moderate to severe sudden hearing loss and tinnitus starting on March 27th - 10 days post-vaccination.

Nausea and dizziness 4/14 - 4/17. Sudden hearing loss and tinnitus in right ear on 4/17 (no prior tinnitus and previously only mild hearing loss in both ears).

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

I've had mild tinnitus for several years. Shortly after getting the first Pfizer shot, the tinnitus got much worse. The buzzing is much louder than ever before. It's now a constant buzz that impacts my sleep, concentration and just trying to relax.

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

Pfizer-BioNTech COVID-19 Vaccine EUA patient described having tingling in the throat. No swelling of lips or tongue. Patient said symptoms came on about 20 minutes after vaccine. Patient was observed over 30 minutes and patient left feeling fine.

Sever ringing in left ear. It lasted for about 2-3 hours. The ringing has lessened but not back to normal. Almost there.

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

tinnitus in my head; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL9261) via an unspecified route of administration in the left arm on 23Jan2021 at 10:30 (at the age of 63-year-old) as a single dose for COVID-19 immunization. Medical history included lung issues, poor kidneys and Known allergies: Prescription Drug Soma. Concomitant medication included omalizumab (XOLAIR) injections every 2 weeks for lung issues and poor kidneys. 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 23Jan2021 at 20:00, the patient started to experience tinnitus in head, very loud! on a scale of 1-10 about 7. After 3 weeks it remains the same, every second, every day around the 7,000 hertz frequency. Patient next vaccine shot was scheduled on 13Feb2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.

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

allergic reaction; body rash; Blood pressure has gone up; Ears ring a little bit; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EP4534) via an intramuscular route of administration in left arm on 28Mar2021 at 10:15 AM (at the age of 63-year-old) as single dose for COVID-19 immunization. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 at 10:15 AM, the patient experienced body rash, blood pressure has gone up and ears ring a little bit, on an unspecified date patient experienced allergic reaction. The events were considered as a non-serious. Therapeutic measures were taken as a result of body rash and treatment included diphenhydramine hydrochloride (BENADRYL). The outcome of the event body rash was reported as not recovered and other events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

Loss of hearing in my left ear along with chronic tinnitus which all started days after the injection.

Less than 3 hours after 2nd Pfizer vaccination headache, chest pain, fatigue and ringing in the ears occurred. Headache went away after 1 hour. Fatigue and ringing of ears persist. GP doctor prescribed asteroids for ringing in ears and fatigue. as of 4/29/2021 currently taking MethyIPREDNISolone tablets.

Have loud ringing in my ears; This is a spontaneous report from a contactable consumer reported for self. This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EWO153) at single dose on 13Apr2021 11:30 in left shoulder for COVID-19 immunization. There was no medical history or concomitant medication or investigation assessment. Patient had loud ringing in his ears on 13Apr2021. It just happened 3 hours ago. There was no treatment received. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.

Two most recent crowns (One crown was about a year ago, the other was 5 months ago.) on two teeth on left side became very painful. Very similar to the same pain I experienced right after the crown was applied, with the exception that the pain would come and go. I would have no pain at all, then 5 minutes later the pain would increase to about a level 5. After about a half hour to an hour, the pain would subside. This would repeat many times a day. One week from the shot, I visited my dentist, but they didn't find any problems with the crowns. They gave me Amoxicillin thinking it may be an infection. I don't think it was because it was both of the teeth, one on top, one on the bottom at the exact same time. In the course of the next week the pain gradually subsided. Today it is almost completely gone and only on the most recent crown.

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

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

He feels like something is stuck in his eyes; eyes were itching; He has a lot of sickness; Left arm warm and pain after second shot; Left arm warm and pain after second shot/ arm was sore; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LL3302) via an unspecified route of administration at left arm on 05Feb2021 at 12:00 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diabetes from 2009 or 2010 and ongoing; high blood pressure from 2009 or 2010 and ongoing; ongoing cirrhosis of the liver (As a little boy at 8 years old he got a cut on his right hand. His Mother took him to the Emergency Department and they gave him blood. All that time he didn't know, until he discovered it at age 32-34. He found out from his primary doctor he had Hepatitis C. His doctor asked if he shot up drugs. He said he did a little pot. He cut the main artery in his wrist); ongoing heart problems (He always felt problems with his heart. It started in 2014 when he went to the Emergency Room for pain in his chest. They checked his heart and found his blood didn't flow to the right. It flowed to the left. The Cardiologist told him sometimes his heart beats and sometime it doesn't. He had 2 veins with blockage, they couldn't do anything and put him on medication for that); prostate cancer From Dec2019 (He had Cancer twice. He was first diagnosed of Prostate Cancer and received Radiation therapy. He had an exam and the Cancer was back. He had surgery for the Prostate Cancer 18Feb2020); COVID-19 (in the past. His wife had COVID-19 and he had COVID with the same symptoms. He lost his taste for 9 days at the end of Dec2020. He got sick after his wife had COVID-19. His wife got better after having COVID-19. He had no appetite, it was pretty bad). Concomitant medications included a lot of medication (Details were not provided). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL3302) via an unspecified route of administration at left arm on 14Jan2021 at 16:30 (62-year-old at time of vaccination), at 0.3ml, single, for COVID-19 immunization and experienced left arm hurt. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient weighs between 158-159 pounds. Patient experienced left arm warm and pain after second shot was from 05Feb2021 to 06Feb2021. Patient states he received the second dose on 05Feb2021 and within 30 minutes he started to feel the shot, it was working up in his head, felt like something was working. It was warm and sore. Patient states a couple hours later he was taking Tylenol because his arm was sore. He applied the muscle rub/muscle wrap the next day and it was better. Patient states the day before reporting he began using eyedrops more than usual and using 5 drops because he feels like something is stuck in his eyes. States it's almost like COVID is in his eyes. In the past month he has been using eye drops more often. He had been using them before the vaccine. His eyes were itching and he would use the drops to flush them out. Patient would like to know if feeling like something is in the eye is something related to the vaccine or a symptom of COVID-19. He has a lot of sickness. Adverse events did not require a visit to emergency room or physician office. The outcome of Left arm warm and pain after second shot was recovered on 06Feb2021; outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

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

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

Since receiving a single dose of Pfizer-BioNTech three days ago on May 5, 2021, I now have Tinnitus as loud as the construction noise coming from a crew that's building a 3-story house 100 feet away from our home. Another comparison of the Tinnitus noise level I now experience is this: if you've ever boarded a jet from the tarmac while the jet's engines are running, that's the noise I hear now.

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

Severe arthritis pain in hands and back for about 2 weeks, Severe sinus paid over left eye that started day after shot and lost 6-7 days Tightness is chest that started say after shot and lasted 5 days Tinnitus that started on approx 5 days after shot and still exists as of today (May 9th)

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

patient stated that he took the vaccine on 3/24/21 and a few days later is when he started to experience ringing in the ears. He stated he thought he slept wrong on his neck and maybe the ringing was due to that. He doesn't c/o any other symptoms besides trouble sleeping and hearing (a high pitched sound). Patient stated he's tried tylenol and ibuprofen and its not helping.

has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown. No follow-up attempts are needed. No further information is expected.

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

A blast of pain in the right side of my head woke me up out of a sound sleep, i think i heard a slight pop right before and as soon as the intense pain came, it radiated outward and away from between my temple and right ear upward and was gone in a matter of 2 to 3 seconds. I have never felt anything like this, or scare me as much to make me think it might be life threatening as this. I couldnt sleep right after for 1.5 hours and I emailed my primary doctor immediately. In the morning, I spoke on the phone to 2 Nurses at my docs office before bs. hours who advised me to go to the emergency. rm for a CTA and did. I've never really had headaches that have amounted to much.

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

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

Hearing loss, audio distortions, ear pressure, additional and much louder tinnitus. Tried a 12 day course of Prednisone. No effect. Possible other treatments are pending while awaiting test results.

Shortness of Breath, cough, no taste, symptoms started Sunday afternoon, had send out covid on Monday was neg, (rapid was positive) pt has had both covid shots ? Nausea ? Fever ? Fatigue ? Headache ? Diarrhea Patient is on Rituximab and received doses on 5/12 and 5/29. which was 5 weeks after finishing vaccine.

Complete loss of hearing in right ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on an unspecified date (at the age of 63-year-old) in the hospital as single dose for COVID-19 immunisation. Patient had no relevant medical history, concurrent conditions or any known allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since, the vaccination patient has not been the patient been tested for COVID-19. Patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 04May2021, at 10:00, patient experienced complete loss of hearing in right ear and visited doctor or other healthcare professional office/clinic visit. Reporter considered the events as non-serious. Therapeutic measures in response to the event included treatment with steroid injections in ear and oral steroids. Outcome of the event was recovered with lasting effects (resolved with sequalae) on an unspecified date in 2021. Information on the lot/batch number has been requested.

uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6203), via an unspecified route of administration, administered in Left arm on 04Mar2021 16:45 as 2nd dose, single dose; and previously took 1st dose of BNT162B2 for COVID-19 immunization. No covid prior vaccination and no known allergies. The patient medical history and concomitant medications were not reported. No vaccines within 4weeks. On 04Mar2021 17:00, 18 minutes after vaccination, patient upper Right lip began to swell, slowly. 30 minutes later when home it was very noticeable and uncomfortable. patient reported it was only point of concern. 6 hours later after 2 Tylenols, the swelling has decreased, Somewhat. No covid tested post vaccination. Patient reported no treatment was received. Patient was not recovered from events. No follow-up attempts are possible. No further information is expected.

Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms. Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain is exacerbated by extraocular muscle movement, particularly when looking to his left. Patient spent one night at the Hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it's very unique and unusual. Patient did his research he?s very concerned since there?s not much information about the syndrome, and since he never experienced eye problems for the past 63 years.

Within a few days after completing the second dose, I started experiencing continuous tinnitus in both ears. The levels I am experiencing have not abated since I first noticed it. Before the vaccinations, I would just occasionally experience tinnitus, but those were very brief events that self resolved. The current symptoms are different than what I was experiencing previously.

This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration, unspecified anatomical location on 16 Mar 2021 (at the age of 63-years-old) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received no 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 was not tested for COVID-19. On 17Mar2021, the patient had "fatigue, diffuse pain and diffuse pain (including eyes)". No therapeutic measures were taken for events. The clinical outcome of fatigue and diffuse pain and diffuse pain (including eyes) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country was added. For suspect vaccine, "Unknown" removed from Lot# field. Event "pain in eyes" updated as "diffuse pain (including eyes)" for "Description as Reported". "None" removed from "Concomitant Therapy" field since only "if other vaccine in four weeks: No" reported, not mention in took any drug. Final sentence "Batch/Lot number cannot be obtained. No follow up attempts are possible. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." per SER055. Leading sentence "This is a spontaneous report received from a non-contactable other non-health care professional" updated as "This is a spontaneous report received from a non-contactable consumer." Initial information need review: adverse_event: Fatigue and diffuse pain (including eyes)

The caller states he still has pain around the head and what not and underneath the caller's jaw; tongue:gave the numbing sensation not a tongue pain.; got a headache, an all around headache; What is more concerning is the tongue has tongue pain; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, in Arm Left on 09Jun2021 10:35 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunisation. The patient medical history were not reported.concomitant medications included Repatha for cholesterol, start and stop date not mentioned.09Jun2021, the patient had all round headache, tongue pain. The tongue pain lasted for an entire day. the tongue pain had subsided, when he woke in the morning. On an unspecified date, the patient felt like a distant pain around the tongue area. He had pain around the head and underneath the jaw. The pain around head and underneath jaw is not as severe as it was on 09JUN2021. The patient still had pain in his tongue. The patient had Repatha shot for cholesterol earlier in the year and it went straight to the tongue and gave the caller a numbing sensation not a tongue pain. The physician had advised not to take after that first time, suspecting tongue swelling.10 minutes after the vaccine the patient felt tongue discomfort and he had to wait 15 minutes after vaccine and he started to feel the pain in tongue and headache all round. Th patient second dose was scheduled in coming weeks and he was wondering whether he should take a the second dose. The patient also stated that the tongue pain had improved but still has like as if the caller has connected like a sinus kind of pain around head and it is connected with the tongue. The patient's headache started about an hour after receiving the first dose Pfizer Covid Vaccine. The headaches are ongoing but are not as severe as 09Jun2021. The outcome of the events headache and tongue pain was recovering and other events outcome was unknown. Information on Lot/Batch number was available. Additional information has been requested.

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

I was suffering from allergies and it developed into a sinus and ear infection starting on 6/17 and coming severe on Saturday and that is the day I went to the Urgent Care. They prescribed me Amoxytaz antibiotic. That helped with my symptoms.

Left ear tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 17Mar2021 at 16:30, the patient experienced left ear tinnitus. No therapeutic measures were taken for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tinnitus was not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

Tinnitus developed the day after the vaccine. I saw him 3 months later and the sx were improving but still present

Received Pfizer vaccines on 3/16/21, 4/6/21; tested positive for COVID-19 by PCR on 7/11/21. Mildly symptomatic w/ congestion, dry throat, cough, fatigue. Received Monoclonal antibody therapy on 7/12/21.

He says that overnight after the vaccine his left ear now feels plugged and as a result he cannot hear well. He noticed it starting the morning after the vaccination and is still experiencing the same sensation 3 days later. It still feels plugged.

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

This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7534) via an unspecified route of administration in left arm on 24Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient medical history included atrial fibrillation, chronic obstructive pulmonary disease (COPD), benign prostatic hyperplasia (BPH) and tinnitus. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), WELLBUTRIN, atenolol (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), SYMBICOR received within 2 weeks of vaccination. The patient had known allergies to penicillin, terramycin and lomotil. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 25Mar2021 at 01:00, the patient experienced ongoing tinnitus in left ear that had intensified dramatically since vaccine dose. On 13Mar2021, the patient underwent nasal swab (rapid test) and the test result was negative. 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. No therapeutic measures were taken as a result of the event. The clinical outcome for the event tinnitus was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Severe eye floaters; This is a spontaneous report from contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8733); via unspecified route of administration in left arm on 26Mar2021 at 09:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID-19, since the vaccination. The patient did not receive any other vaccine within four weeks of vaccination. On 26Mar2021 at 10:45, the patient experienced severe eye floaters. The adverse event result in consultation to doctor or other healthcare professional office/clinic visit. It was unknown, if the patient received any treatment for the reported events. The clinical outcome of the event severe eye floaters was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Loss of taste (50%); This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to airborne allergies. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021at 16:00, two hours after vaccination, the patient experienced fifty percent loss of taste. The patient did not receive any treatment for the reported adverse event. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. On 31Mar2021, in the morning, the event fifty percent loss of taste was resolved. No follow-up attempts are needed. No further information is expected.

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

Sore arm; Severe tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and tinnitus. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient received varicella zoster vaccine rgE (CHO) (SHINGRIX), dose number 1 in the arm on 27Mar2021 for an unknown indication. The patient previously took simvastatin and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 (day 1) at 18:00, the patient experienced sore arm with no other significant symptoms. On an unknown date in Apr2021 (day 5), the patient experienced sudden onset of fairly severe tinnitus in both ears, continued constantly through day 6. The patient had minor tinnitus from time to time before, but this was more intense. It was annoying, but not debilitating at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm and severe tinnitus in both ears was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

At approximately 1:47pm the patient stated his throat was "tingly" and he kept clearing his throat. The pharmacist gave the patient 50mg of diphenhydramine of which the patient took 37.5mg. At 2:00pm the patient took 12.5mg more of diphenhydramine. He stated he was feeling better and his throat was no longer feeling "tingly." The patient said he felt ok to leave at 2:15pm and left the store. The patient was instructed that prior to his next vaccination he should pre-medicate with diphenhydramine 50mg and would be required to be monitored for 30-60 minutes after vaccination.

Shooting lights in left eye; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the left arm on 04Apr2021 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient received unspecified 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 COVID-19 vaccination. On 05Apr2021, on the second day, the patient experienced shooting lights in the left eye. The patient reported that he had no issues on the day of the shot. The events did not result in a 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 shooting lights in left eye was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report. Follow-up attempts are completed. No further information is expected.

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

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

Vaccine recipient received 1st vaccine dose on 12/16/2020. The vaccine recipient returned for the 2nd dose of Pfizer-BioNTech vaccine on n 1/5/2021. They reported at the clinic that 5 days after receiving the vaccine on 12/16/2020 developed bilateral tinnitus that was hissing in nature. The hissing abated after a week. Vaccine recipient reported that they will follow up with an ENT provider. The vaccine recipient was not sure if it could be related to the vaccine. Patient has a history of tinnitus but noted it was nothing like prior. Vaccine recipient is a physician. Pfizer-BioNTech COVID- 19 Vaccine EUA.

Headache, soreness of eyes, fever, chills, mild nausea, one episode of diarrhea, fatigue, slowing of cognitive function.

I did my Injection Friday 1/15/2021 at 09:00 PM and woke up Saturday feeling unwell, chills and muscle pain all day. Sunday 1/17/2021 I awoke at 6:00 AM with my Right ear swollen at least three times normal size. The ear has visable sores and is extruding a clear liquid all day Sunday 1/17/2021 and today Monday 1/18/2021. I made an appointment for 4:30 PM today with NP

Burning sensation in outer edge of both eyes. After initial injection in 1/5/21, I experienced this sensation in right eye only your about 7 days. I will be seeing an ophthalmologist on2/19/21. The sensation today, after the second shot is greater in intensity and affects both eyes.

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

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

I received first vaccination 12/22/2020 (Phizer), State COVID test 12/23/2020, noticed nasal congestion 12/24/2020, notified of positive COVID test 12/26/2020, lost taste and smell 12/27/2020, severe fatigue, received antibiotic/antibody infusion 12/30/2020, almost immediate improvement. Returned to work 1/04/2020. I think I was exposed on 12/18/2020 from positive coworker. We were masks but not gloves or other PPE. Pick up the same tools, touch same door handles etc.. Work at a hospital. Waiting 90 days from infusion for booster shot.

Started sneezing with watery itchy eyes 4 days after injection. On day 4 woke up with hives on back that has spread to right arm. Rash is small and not raised, but is quite itchy.

Extreme joint pain/achiness over entire body; extreme fatigue; fever that ran from low grade up to 101.5; cloudy peripheral vision (cloudy vision only lasted about 30 minutes). Fever does respond some to ibuprofen, but ibuprofen does not help joint pain or achiness.

a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pain. He clarified he had a Percocet prescription leftover from his hospitalization in Nov2020. He said he took another dose of the Percocet the week before 31Jan2021 for pain in his knee from the fall he had in Nov2020. He said his eye doctor told him his dry eyes could be caused by the Percocet. He said his eye doctor prescribed lubricating eye drops (Refresh Optive Mega 3, UPC Number: 0023577330, Lot Number: T095, and Expiration Date: Aug2022), that he is to use in both eyes every hour, and an eye ointment in his left eye only at bedtime. He had been using crutches when he walks because of the problem with his right knee since he fell in Nov2020. He said on 06Feb2021, he took a shower, and when he went to get out of the shower, his right leg gave out. He said he didn't fall, but he couldn't walk afterwards. He said he went to the Emergency Room on 06Feb2021, and an x-ray and sonogram were done of his right knee. He said he was told he had another soft tissue injury like he had when he fell back in Nov2020. He said he was given a leg immobilizer to use. He said when he first fell in Nov2020, he originally fell on his left knee. He said he has had PT since being discharged from the hospital on 17Nov2020. He said he also had a pacemaker implanted while he was in the hospital in Nov2020. He said after his discharge from the hospital on 17Nov2020, he went to take shower at home on 18Nov2020 and his left knee gave out. He said he was able to lower himself to the floor in the shower stall, but he couldn't get out of the shower stall. He said he was left sitting on his left leg and he couldn't use his right leg. He said he finally got himself to bed, and iced his right knee because he sat on it for over an hour. He said the next day (19Nov2020), he couldn't walk and had to have an ambulance take him to Emergency Room. He said he hasn't had PT since 27Jan2021, and needs clearance from his doctor before he can restart PT. He said he has been without PT for 2 weeks now. He said on 06Feb2021 he was unable to get a MRI on his knee because he had too much swelling that would have made the MRI imaging cloudy. On 06Feb2021 he was due for his second COVID-19 Vaccine, so before he was discharged from the Emergency Room he was given his second COVID-19 Vaccine dose. He was using the Refresh Optive Mega 3 eye drops constantly now. He said he had no fever, but is more tired than in the past. He said the last couple of days he can sleep for hours, and wake up and feel like he can go right back to sleep. He said he and his cardiologist are concerned because since 27Jan2021, he has only been on Aspirin 81mg. He said he has 3 cardiac stents since Oct2020, and should be on dual therapy. He said he had a CT of his abdomen and pelvis while he was in the hospital. He said he has been off of Plavix since 27Jan2021, and can restart the Plavix until he has a cystoscopy. He wants to know if UTIs in men are common after getting the COVID-19 Vaccine, so he can decide if he should cancel the cystoscopy and restart his Plavix. The second COVID-19 Vaccine Lot number as EL9261 or EI9261. He stated the vaccine lot number was handwritten on his COVID-19 Vaccine immunization card and was difficult to read the handwritten vaccine lot number. The patient underwent lab tests and procedures which included bacterial sepsis: gram negative urinary tract infection on 28Jan2021. Clarified he had no pain, burning, or urgency with the UTI. He said he was told by the hospital he had gram negative rods in his urine, when he was started on the IV Ceftriaxone on 29Jan2021. He stated he has never had a UTI before. Clarified his body temperature is rarely 98.6 degrees, and is normally 98.2 degrees and he had never had shingles before. He said he had chicken pox as a young adult, and he only had 1 spot of chicken pox. He had never had dry eyes before. Reporter seriousness for fever, UTI, injection site pain, injection site redness, injection site puffiness, rash, shingles were medically significant. For other events were unspecified. The outcome of event injection site pain, injection site redness, injection site puffiness was recovered on 31Jan2021, dry eye, tiredness was not recovered, while the outcomes of other events were unknown.; Sender's Comments: Based on the temporal association and the known possible local reaction, a possible contributory role of BNT162B2 to the development of injection site pain, redness, and puffiness cannot be excluded. The other events are considered as due to underlying or intercurrent conditions and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021134924 same reporter/drug, different patient, similar event

About 5 to 10 minutes after receiving his vaccine, the patient's eyes were excessively teary. He waited around for 45 minutes and they were still more watery than usual, but there were no other signs of allergic reaction. The patient said that it wasn't watery to the point of blurry vision and went home.

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

Intensification of sense of smell towards Onions, Garlic Aromatic foods, Bitterness aftertaste after eating most foods bearable but annoying. First noticed after brushing teeth.

Tinnitus ----- both ears. High pitched squeal around 8500 HZ. all the time. Scheduled to see an ENT on March 16.

Within two hours of vaccination, a taste/sense of chemicals appeared in mouth/nasal. Still ongoing as of the date and time of this report.

I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallowing

20 minutes after receiving Pfizer dose, he had metallic taste in mouth, felt dizzy. Vitals 111/58 HR 46. pulse ox 96% on RA.Patient given Benadryl. Metallic taste improved and dizziness improved. He stated at this point that it felt like his throat was swelling so epi was administered. He went to the ER as directed but not by ambulance. He was treated there rom 6:15 to 9:15. Received monitoring and decadron IV.

Very mild allergic reaction. Slight swelling of lips, redness of palms. Symptoms dissipated completely within six hours.

At about 4:15 am on the 16th I experience a sever case of Tinnitus that lasted over 1 hour and 40 minutes. I still hear a ringing in my ears though not as bad as when it started.

Spots in vision, dizziness, light headed, passed out multiple times, BP and sugar fluctuations on day of vaccine. approximate 5 days later developed a fever, vomiting and pneumonia. currently being treated at Hospital in by Dr.

I received my first Pfizer vaccine on 3/9. This past Thursday, 3/18/21, I woke up with increased tinnitus (I?ve always had some) and hearing reduction in my right ear. It reminded me of a middle ear infection I had in my youth but this one had resulted in no pain, fever, or dizziness. I do not have a cold or any infectious respiratory issues. I found that it did resolve somewhat if I?d move to a higher elevation and as the day progressed. My left ear would have short spells that would eventually resolve. This continued through Sunday evening when my right ear cleared and I noticed a foul taste in my mouth. Today it?s resumed somewhat, not to the level it was at before, with a little congestion in my left ear...it "crackles" a little when I swallow, but often will clear if I yawn or cough. I did a little research about the Pfizer vaccine and this situation is listed as a possible side effect that is supposed to be reported, so I am doing so.

I started to get faint bit of tinnitus in my right ear late in the afternoon of the day I got the shot. I was hearing chime sounds. This phenomena started again late in the day on the day after the injection although its intensity was less. Now, exactly two days later, I am not hearing this.

PT WAS AT CHCKOUT. PT LEANED OVER GRASPING HIS CHEST. PT PLACED INTO OBSERVATION CHAIR AND IMMEDIATELY BROUGHT TO OBSERVATION ROOM WHERE HE WAS ASSESED BY STAFF NURSES, MEDICAL PROVIDER, EMT'S. . PT MASK REMOVED UPPER LUP SWOLLEN. AIRWAY PATENT, NO S/S OF RESPIRATORY DISTRESS NOTED. PT GRASPING CHEST, MOANING IN PAIN. 12 LEAD EKG PERFORMED SINUS TACH. 18 GUAGE SL PLACED TO RT HAND, ATTEMPT X 1 PT TOLERATED WELL. BENADRYL 50MG IM X 1 DETHAMEXASONE 10MG IMX 1 CHEWABLE ASPIRIN 324MG PO X1 12:45 PT HR TACHY AT 132, RR20, B/P136/82 12:49 PT HR 125, RR20, B/P 138/88 12:54 PT HR 119, RR 19, BP 159/83 1300: RESCUE ARRIVED, CARE TAKEN OVER FROM THERE. PT REMAINS STATUS REMAINS FAIR AND STABLE UPN D/C

About 10 hours after receiving vaccine in left arm, I noticed I developed ringing in my left ear (left ear only). As of this writing at 7:00 am the following morning, it is more pronounced.

Patient stated: "feels like arm is broken, severe headache, hearing is off - misses every 3rd word in sentence"

broke out in hives 7 days later totally covering body. severe itching and controlled with Benedryl. On day two, lower lip swelled. No problems with breathing.

Almost immediately after receiving the vaccine, I felt tingling in my lips and the tip of my tongue. One week later, I developed large inflamed patches on the inside of my lips. I still have them (almost two weeks later).

Next morning I had a static or whooshing noice in my left ear only. Sometimes it is worse than others.I thought it wasn?t cell phone problem and went to repair outlet. It wasn?t that . The sound / ringing in left ear is bad enough that I can?t have a conversation. My right ear is fine.

Monday 3/22 and had real bad migraine left side headache and I can hardly see because my head hurts bad, the whole left side of my head hurts and the vaccine was given on the right side. My previous medical issues was Six nerve palsy where my left eye pointed to my nose, I had Bells Palsy in the past as well.

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

I have suffered from tinnitus for 20 years however 2 days after taking the first vaccine my hearing loss increased and the ringing in my ears got much louder. It is currently 4 weeks later and it is still very loud. I just received my second shot to day and am praying that it doesn't get worse.

Client in drive thru vaccination for 2nd dose of Pfizer vaccine on 4/6/2021. Reported to the triage nurse that he had been experiencing vaccine induced tinnitis since first vaccine. Tinnitis worse when eating high sugar foods and caffeine. Client told triage nurse that he had tried to do a VAERs report but did not have success submitting report. Called client on 4/7/2021 and left vm asking for additional information for VAERs report. Did not receive return call by the end of the business day so submitted VAERS with info I was given. Client did not receive the 2nd Pfizer vaccine.

Approximately 6 hours after the vaccination, I experienced a severe tinnitus, or ringing in the left ear. I have never experience this level of ringing before, although I have had mild and mostly unnoticeable tinnitus for some time. This was many times more severe. While the intensity has settled down somewhat, I now have a constant, unremitting ringing in my left ear that is loud enough to be bothersome most of the day. It is still many times louder than anything I have experienced before. I had no other noise exposure or out-of-the-ordinary events that might trigger this.

Dizziness, difficulty breathing for 3 days, fever in excess of 101.6 for 2 days, loss of taste, loss of appetite, severe fatigue, body aches especially in neck and chest,

feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). 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 shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.

Received vaccine on Thursday evening at 6:00pm. On Saturday, I felt that something has changed with my hearing. On Sunday morning I was deaf in my left ear.

drooping face on tight side, diagnosed as Bell's Palsy in the ER; Numbness of lips; This is a spontaneous report received from a contactable other non-Health Care Professional (Patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: En6201 and expiry date was not provided), via an unspecified route of administration, in Arm left, on 12-MAR-2021 10:45 AM (at the age of A 64-year-old) as a single dose for COVID-19 immunization. Medical history included Diabetes, high blood pressure and Allergies to medications, food, or other products Tetanus Shot. Concomitant medications received within 2 weeks of vaccination were Magnesium 500mg, Lisinopril 20mg, Chlorthalid 25mg. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that numbness of lips, drooping face on tight side. Diagnosed as Bells Palsy in the ER. CAT scan to rule out other causes on 19Mar2021. Patient went to Emergency room/department or urgent care, where the patient put on Prednisone for 5 days and anti-viral for 7 days for the adverse events. Outcome of the events was Not recovered.

Dizziness - within ~5 minutes, peaking in intensity at about 1hr. Lasted about a week, slowly decreasing in intensity over that period. Tinnitus, slowly building in intensity starting at about 30mins(?), peaking within ~6 hrs and remaining severe for about 3 days. Since then, it has slowly abated, but is still only about half gone. Its intensity seems to parallel my state of hydration.

Partial facial Paralysis--eye wont close; eyebrow unaligned with other, eye tearing; side of mouth distorted, cant smile, drooling from side of mouth

Patient woke up the day after his second Pfizer covid vaccine dose with an isolated right eye ptosis. No other signs of stroke or cranial nerve dysfunction.

Tested Positive on January 6th, 2021 Bad headache, I hurt all over just like when I had the Covid Virus, Joints were the most painful, My body had hives on all places I was able to see, Eyes were very red with red rings around the outside of my eyes and eye lids, Nausea, my skin had a red look and there were red lines on my arms and legs, Every vein on my limbs were very pronounced, I had a "restless" arm and leg" vibrations and I had to get up and walk to make the feelings stop. I fought against the symptoms.

I submitted. received error. Submitting this again. Previously I reported stiffness in the hands and developed a trigger finger. These occurred began on Feb 19th. See report 330994. I have had a cortisone shot in both hands. This has relieved the stiffness somewhat, but not entirely. No relief for the trigger finger. The new adverse event is a ear ache and tinnitus. These started about a week ago. They are continuous. I have tried sudafed and zyrtec to no avail. I will be seeing doctor shortly.

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

pt says he had numbness in his right side. this includes his arm from finger to shoulder and leg from knee to toe. these symptoms would come and go and he would have to lay down when this happened. His hands and feet were shaking like he had low sugar. this happened for 2 days. the 3rd day he could hardly walk saying his right leg was feeling paralyzed. the left side of his lips were burning like he had been given anesthesia. Every day about 5pm he would have these symptoms. He went to Medical Center ER on 3/26/21. they did EKG, Blood Work, X-RAY, MRI, nuclear medicine heart test. He was admitted and stayed overnight. Discharged to FU w/ PCP and Neurologist. Pt went to see neurologist on 4/6/21. On 4/7/2021 They did another EEG with normal results. On April 8th patient says he still has numbness in the right hand only but the numbness has moved to the left side of this body and everything is numb. He bites his tongue while he is sleeping and it is sore when he wakes up. He still has these symptoms today.

At about 10:30 on the evening of receiving the vaccine I started to get chills and became feverish. This ended at about 4 a.m. and did not return, but in the morning I had no appetite and had diarrhea. My appetite returned the following day but I also had an issue with my taste being off that lasted for 2 days after the vaccine. Basically with the second shot I got all of the symptoms I had when I got covid in November. After the first shot I only got about half of these symptoms.

Tinnitus may have started (low-level) after first shot (1/15/21), but was much more noticeable and steady/non-stop following second shot (2/1/21). It has grown somewhat louder over past few weeks.

Minor numbness in right side of upper lip, right-side of cheek above the lip, and and right side of nose. When I first noticed the numbness it affected only right side of upper lip and right side of tongue, but by that next morning the tongue had no numbness. The numbness has been consistent, now spanning 40 hours.

Significant hearing loss in right ear; some hearing loss in left ear. Right ear has persistent pulsatile tinnitus (pulsating heartbeat sound). Some hearing has been restored since the onset, but a great degree of hearing loss remains, especially in the right ear. Pulsatile tinnitus persists.

1- Mild cough became severe associated with shortness of breath starting from second day. Since the symptoms were progressively worsening, on doctors advice took one course of Z Pack (Azythromycin) starting from Wednesday04/14. 2- Still having mild cough. 3- Having dry upper respiratory passages leading to choking sporadically (once or twice on some days day). 4- Vision getting poor noticeable with watery eyes, started to feel 3 to 4 days after getting first doze COVID19 vaccination. Consulted an eye specialist on 04/24, who believes the vision issue is due to cataract getting progressively worse. As far as I know, cataract does not gets worse over period of 3 to 4 days, so there is likely hood of some adverse effect of the COVID vaccination.

approx. a week or more after the first shot i developed a ringing in my ears i told my doctor an she said it could be a side effect

Tinnitus. Constant high pitched ringing in my ears. Came on gradually and as best I can recall it started about a month/four weeks after my first shot

At approx. 3:40AM on April 9th I was awakened by a load sound as if a fire alarm was going off. When I stood up I realized it was not an alarm but very loud ringing in my ears. The ringing (tinnitus) in my ears has not stopped since that time.

Two hours after first shot of covid 19 vaccine- I experienced louder tinnitus in both ears. I have had tinnitus for years but it has always been manageable and mild. The vaccine has made it much louder

Started with a stiff neck turning to the right, then two days later woke up with a feeling of concussion syndrome, vertigo, head nausea, brain fog and then buzzing in both ears, this has been on going since the first vaccine, it got worse after the second vaccine on February 21st . I have had a brain MRI, and Neck MRI both appear normal, I have been checked by ENT for ear issues none noted, being treated by neurologist now for all the head symptoms

2021-01-28 Received the 1st shot of COVID-19 vaccine Pfizer and noticed on or about February 1, my farsighted vision began to change for the better in that I was able to read fine print and view the computer screen without wearing prescription glasses. 2021-02-19 Receive the 2nd shot of COVID-19 vaccine Pfizer and subsequently my vision changed where my nearsightedness became worst and I began to see halos when looking at lighted objects, especially at night. **Later I researched and found the Pfizer vaccine can cause symptoms of illness that can lead to high glucose levels.

After the COVID vaccine, it started numbness in hand fingers while sleeping, slowly, slowly and day by day it become more. Last four days I could not able to sleep, whole body getting numb while sleeping, and it getting all blood to the hands, legs and hand figures, foot fingers are becoming numb. And also getting pains in the bone joints, specially in fingers. Getting Itchy, eye pain due to no sleep. Some one should call and provide remedy immediately, otherwise I may die, this responsible is control organization. This I am entering at May 4th 2:00AM CST. I already registered online, no responded.

felt pain at injection site; dry mouth; feeling cold; dry eyes; rapid pulse; his breathing changed'; states it was hard to breathe; felt like he had fever; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 04Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated after injection, felt pain at injection site and felt like he had fever; fever lasted 2 days (as reported). Patient also added immediately after receiving the shot, he had a 'rapid pulse and his breathing changed' on 04Apr2021; stated it was hard to breathe. Patient stated he calmed himself and he was ok. Patient reported 2 weeks later after the first dose, he reported shortness of breath, dry mouth, feeling cold and dry eyes (unclear timing/onset). Patient stated these were ongoing currently. Patient was asking if these could be side effects. Patient also reported that he cannot take medications; he had allergies to medication (did not specify). Patient asked should he delay second dose given he had ongoing side effects from the first dose. The outcome of events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it might be allergy related he gave me Flonase. I have had no relief and experience insomnia, anxiety, dizziness and tinnitus 24/7.

Patient presented to nurse A&O x3, with calm affect. No history of reactions to vaccines. After prescreening patient the vaccine was given. Immediately, the patients eyes rolled back and he went limp. RN supported patient in chair until paramedic took over quickly..

ptosis of right eye; leg pain (both legs); This is a spontaneous report from a consumer. A 64 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (Lot Number: EN6208) as SINGLE DOSE (at age of 64 years old) for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing, restless legs syndrome from an unknown date and unknown if ongoing, sleep disorder from an unknown date and unknown if ongoing, Neurological Disease from an unknown date and unknown if ongoing, spinal fusion from an unknown date and unknown if ongoing (had 2 spinal fusions. One spinal fusion was of the cervical spine with hardware, and the other spinal fusion was of the lumbar spine with hardware). Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) strength 5mg/20mg taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; tadalafil 5 mg taken for enlarged prostate, start and stop date were not reported; alprazolam (XANAX) 0.5 mg taken for anxiety, start and stop date were not reported; ropinirole (ROPINIROLE) taken for restless leg syndrome, start and stop date were not reported; clonazepam taken for sleep disorder, start and stop date were not reported; carbidopa, levodopa 50mg/200mg taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 on 28Feb2021 (Lot Number: EN6205) dose 1, for covid-19 immunization at age of 63 years old. He received second dose on 18Mar2021; 30 days later 18Apr2021 woke up at 5 A.M., noticed ptosis of right eye on 18Apr2021. Concerned she took him to the hospital where he was assessed for stroke, TIA, all tests were negative. Consumer states, "my fiance was hospitalized over the weekend, we do feel it was exactly 30 days after second dose of Pfizer dose, from what I read in medical articles. I see that there were some cases of Palsy experienced by people in clinical trial. He is currently at home. He was in the hospital (emergency room)from 7am on 18Apr2021 and left at 3:50pm that same day against medical advise due to they did not have a neurologist. They wanted to admit him and transfer him to another facility because they didn't have a neurologist available. She clarified her fiance's adverse event as ptosis of his right eye. She said her fiance had diagnostics and blood work performed while at the Emergency Room. She said she wasn't positive if the blood work performed was a CBC and basic blood chemistry, but the blood work results were normal. She said the hospital she brought her fiance to did not have a neurologist on staff. She said the hospital wanted to admit and transfer her fiance to a specialized hospital with a neurologist on the premises. She said her fiance's condition did not worsen while at the Emergency Room, but she felt her fiance was not being monitored closely, and was not getting any care. She said since her fiance was not receiving anything at the Emergency Room, and the Emergency Room didn't have the bandwidth to address his issues, and nothing was done to transport him to another hospital, her fiance left the Emergency Room against medical advice (AMA). She said her fiance went to a neurologist on Monday (19Apr2021). Emergency Room Visit Treatment: Stated her fiance was given Oxycodone while at the Emergency Room. She said she did not know the Oxycodone dose, NDC, Lot, and Expiration Date. She said the Oxycodone was administered for leg pain (both legs) caused by a pre-existing condition her fiance had. She said her fiance normally took Ropinirole for his leg pain. Consumer reported her fiance had follow-up testing done at the neurologist on Monday (19Apr2021), and was waiting for the test results to come back. She clarified the neurologist was doing the follow-up testing to confirm or rule-out a diagnosis of Myasthenia Gravis. Consumer reported when she took her fiance to the Emergency room she thought he was going to be assessed for a possible TIA or stroke, but when it was mentioned her fiance may have Myasthenia Gravis, it was equally concerning. Neurologist Visit Treatment: She stated the neurologist prescribed Pyridostigmine 60mg on Monday (19Apr2021) for her fiance to start taking while the doctor waited for the blood work and repetitive nerve conduction study results to come back. She said the doctor's logic was to take the Pyridostigmine 60mg, and see if the ptosis resolved, and if the ptosis resolved the doctor would know the cause of the ptosis. She said her fiance's right eye ptosis had not improved, changed, or resolved since he started taking the Pyridostigmine 60mg. She said she did not have the Pyridostigmine 60mg NDC, Lot, and Expiration Date. The patient underwent lab tests and procedures which included blood gases (ABG): unknown on 18Apr2021, Vital capacity: normal on 18Apr2021, Blood test: unknown on 18Apr2021, COVID-19: negative on 18Apr2021; vital signs measurement: normal on 18Apr2021 . Therapeutic measures were taken as a result of ptosis of right eye. Outcome of the event ptosis of right eye was not recovered. Outcome of the event leg pain (both legs) was unknown.

I have been suffering fron a Pfizer vaccine reaction for about a month and it does not seem to go away. I went to the doctor a week after the Pfizer 2nd dose and he told me to take Benadryl. I did and it went away for a few days but it came back after a week. I have had hives on my chest and underarms for about two weks now. Today, I have a hives again and my upper lip is swollen. Where should I go for something like this? I was vaccinated at CVS with my second dose about a month ago. I am 64 and I think I had an anaphilactic reaction to shrimp about 38 years ago. Thank you,

I began to have ringing in my ears, symptoms of Tinnitus approximately 9 hours after I received the 2nd vaccination on 05/06/21. I did not get this condition/symptom on my first vaccination of 04/14/21. The ringing in my ear (more prominent in my right ear) has continued non-stop since receiving my second vaccination. I am concerned about this adverse effect and whether this condition will be temporary.

Tinnitus has been pronounced and continuous form 4-28-21 to present. Have also noticed "eye floaters" for the last two weeks also Have had some mild vertigo sporadically in the last two weeks blood pressure checked at doctor's office today; 134/86. Normal for me is about 130/74

fainted; fell and hit his head; fell and hit his head; felt lightheaded/Dizziness; blood clots in his lungs; he has a spot on his lung that they are monitoring; hypoacusis and has a new hearing aid; This is a spontaneous report from a contactable consumer (patient's wife). A 64-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (at the age of 64 years old) (Batch/Lot Number: ER8733) as 1st SINGLE DOSE for covid-19 immunisation. Medical history included severe sleep apnea from 18Mar2021 (received a machine not long after), gout (diagnosed about four years ago) , ex-tobacco user from an unknown date to an unknown date (two pack a day smoker over thirty years). Concomitant medication included colchicine (COLCHICINE) 0.6 mg, 1x/day taken for gout, start date was not reported to Apr2021. The patient experienced blood clots in his lungs (hospitalization, medically significant) on 02Apr2021 (also reported as 02May2021). , fainted, fell and hit his head, felt lightheaded/dizziness on 02Apr2021, The patient was hospitalized from 2Apr2021 to 4Apr202. It was reported the patient experienced hypoacusis and has a new hearing aid on an unspecified date. Caller says her husband has new hearing aids, which is why he is not doing the report himself. Patient has a spot on his lung that they are monitoring on an unspecified date. The patient underwent lab tests and procedures which included blood test: results unavailable on an unspecified date , 'they did a couple tests' (details not provided) results unavailable on 02Apr2021, urine analysis: results unavailable on an unspecified date. Therapeutic measures were taken as a result of blood clots in his lungs included Thrombectomy on 02Apr2021. The clinical course was reported as follows on April 2nd her husband received his first dose of the Pfizer COVID-19 vaccine. Approximately an hour later they went to the market and he felt lightheaded, so instead of getting out of the car they sat there 20 minutes. He started to get out again then halfway out the door he fainted and fell down on the ground. She says he was out for, 5-10 minutes, clarified to not even a minute. Since he hit his head she called an ambulance, and they took him to PRIVACY in PRIVACY. They did a couple tests and said since it was so soon after getting the vaccine that they did not think the vaccine had to do with his blood clots. Caller also stated he fainted because that was one of the side effects of the vaccine, but they were glad he got there since he had several blood clots in his lungs. On the same day (02Apr2021) he had a thrombectomy to remove the blood clots and put him on a blood thinner. Patient was admitted to the hospital April 2nd and was discharged April 4th. He is doing better, he is on a blood thinner now. She says there were a few doctors that had to weigh in on whether he should get the second dose, they decided it wouldn't affect it since the vaccine goes into his muscle. No other vaccinations on the same days as his Pfizer COVID-19 vaccinations or during the four weeks prior. Once they placed him on a blood thinner, they took him off Colchicine 0.6mg. He stopped taking Colchicine because they said the blood thinner doesn't work with that particular medication. It was also reported The patient is to schedule an appointment with a rheumatologist and a hematologist, they did blood work and a urine test and said he has a spot on his lung that they are monitoring. The clinical outcome of the event blood clots in his lungs was Recovered/Resolved with Sequel while the remaining events was unknown. The second dose bnt162b2 was administered on April 29th. LOT: ER8751, caller hopes that is a 5, the writing is very bad on there. The patient had no side effects from his second dose of the Pfizer COVID-19 vaccine.

Shingles. Active for about 1 month. Acyclovir 3/day x 7 days, prednisone, Augmentin 2/day x 10 days. Headache, earache, jaw pain, scalp pain, lesions from top of head to chin on left side of face, general fatigue

Tinnitus, distinct tone, right ear. Tinnitus would disappear when I turn head to right, to left or up. Chin down would attenuate the tinnitus nut not eliminate. Overnight sleep the tinnitus declined to to a constant hissing in right ear.

About nine days after the first Pfizer vaccine I noticed a pain in my left tooth where is was difficult to chew. I thought perhaps it was a cracked tooth or abscess but it spread throughout my mouth making it painful to chew any food. It seems that the nerves above the teeth were somehow infected or something. I had pain around my eyes and once in my left ear. I suspected Sinusitis or something but was not sure as I had never had this happen before. I had my dentist look at it. The metal tapping tool showed no cracks. The xrays showed no tooth problems, nor any sign of sinus inflammation. I reported it to me doctor and he told me to report it on VAERS as a possible side effect of the vaccine. It was severe for about two weeks and has since returned to normal.

Tinnitus; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration administered in left arm on 05Mar2021 at 11:20 (Lot number & expiry date were not reported) (at the age of 64-years-old) as 1st dose, single dose; then via an unspecified route of administration, administered in left arm (shoulder area) on 26Mar2021 at 10:30 (Lot number & expiry date were not reported) (at the age of 64-years-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccination facility type was reported as unknown and vaccine was not administered at military facility. No other vaccines given the same day and no problem with vaccines in past. There were no adverse events (AEs) following prior vaccinations. Medical history included ongoing multiple sclerosis (MS). History of all previous immunization with the Pfizer vaccine considered as suspect and family medical history relevant to AEs were reported as none. The patient's concomitant medications included Gabapentin and modafinil (PROVIGIL) from unspecified date and unknown if ongoing. The patient previously took interferon (unspecified) at 10mg. The doctor thought that since he has not had any relapse, he was okay not to take Interferon anymore. He wanted Pfizer to know he does have an auto-immune issue. He had used Interferon and then an oral medicine, but unable to provide NDC, Lot, or expiry for either product since it has been 3 years since he'd been on that. He did mention taking Gabapentin before bed and Provigil in the morning. The patient experienced tinnitus and fatigue on Mar2021 and ongoing. The patient reported side effects after the administration of the COVID-19 vaccine. He had the first dose on 05Mar2021 and second dose on 26Mar2021. After the first shot his tinnitus started and he was also fatigued. Patient clarified he didn't go to the doctor for the fatigue, but the tinnitus. He only mentioned the tinnitus. He also went to the doctor today and noticed since the vaccine and how ironic besides having the tinnitus how much more fatigue he has. He never took naps in the afternoon and now he does, he needs to. He is much more fatigued, and he even does yoga and notices his balance also. Before today's visit he had seen specialist, ENT (ear, nose, throat) doctor and told him the same thing and had asked if what he experienced was possible. He saw the ENT doctor on 31Mar2021 and was told he did not know if that was very common, but prescribed him steroids, which he took. He stated that with the steroids the tinnitus didn't get any better and he is not better now. He got ahold of his family provider recently to see if there was anything else that could be done like cleaning ears for wax or seeing if there was an infection, or something since he had no relief from the ENT visit. Later he clarified that steroids given by ENT was Prednisone 10mg tablets. He had 69 tablets and it was pretty strong and has used them all. He noticed the tinnitus maybe the week after getting the first dose. He didn't really think much about it, but it kept ongoing. This has been ongoing since after first and second shot. The event tinnitus did not require a visit to the Emergency Room but required a visit to Physician Office. Relevant tests done was unknown. The outcome of the events was not recovered. No follow-up attempts are completed; information about lot/batch number cannot be obtained.

Sudden hearing loss in one ear; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received bnt162b2 (Pfizer product), dose 1 via an unspecified route of administration, administered in arm on 18Apr2021 18:15 (Batch/Lot number was not reported) as single, dose 2 via an unspecified route of administration, administered in arm on 09May2021 18:15 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient experienced sudden hearing loss in one ear on 27Apr2021 16:30. Therapeutic measures were taken as a result of sudden hearing loss in one ear (sudden hearing loss) include prednisone on 27Apr2021 then again on 23May2021. He was treated by a doctor who sent him to another doctor that put him on steroids and he started getting better. He got his second dose and two weeks later the same thing happen, sudden hearing loss, he can't hear in his ear. Clarifies the sudden hearing loss is in one ear. The last outcome was unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.

Shortness of Breath for few days after vaccine #1; after vaccine #2 shortness of breath increased along 10 day period, so I contacted PCP. Clinical exam, chest xray, blood work resulted D-Dimer level increase, so CT scan ordered. Result was lungs full of PE. Placed on Eliquis and referred to hematologist. Hematologist ordered deeper dive in blood work as well as echocardiogram, which displayed a widening in aortic root and ascending aorta, but no ventricular or valve damage. Dr. will continue to monitor and refer me to cardiologist. Other symptoms include unprovoked fatigue, some shortness of breath, a strange smell of burning plastic and cramping of the upper part of my feet, only at night. Never tested posit positive for COVID with wife and son both had "undocumented" COVID in January and March 2020. They both have antibodies (confirmed with blood testing) and I did not have antibodies. Our physician would not authorize a test for COVID at the time of their symptoms as tests were so coveted and not authorized widely at the times of their illnesses. I really want someone to come forward and confirm the causation and correlation of my symptoms to the vaccine, because I am otherwise an extremely health and active 64 year old with no preexisting or predisposed conditions to widespread PE...not just a clot or two...it is wide spread throughout all lobes of my lungs!

3/25/21: woke up in the middle of the night to ringing in the right ear which was persistent. went to see ENT MD 3 weeks after event and diagnosed with partial hearing loss. 2 weeks after with follow up appointment with ENT and was diagnosed with complete hearing loss. will follow up again with ENT MD 7/1/21 for follow up diagnostic testing.

hot and cold with sweats; hot and cold with sweats; Shortness of breath; Eyes ache and itch a little bit; Headache, like stuffed up, sinus headache; Rattling in chest at night like fluid/ whistling sounds; whistling sounds; A lot of mucus in lungs; got real sick with flu-like symptoms; got real sick with flu-like symptoms; coughing up a lot of; heat flash; feeezing; cold, flu, and pneumonia feel like; chills; joint pain; Severe pain in left bicep; pulled muscle; muscle was tight; Eyes ache and itch a little bit; he was 215 and now 223 lbs. Seems like he gained weight; This is a spontaneous report from a contactable consumer (patint). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 21May2021 13:00 (Lot Number: EW0168) at the age of 64 years as 2nd dose, single dose for COVID-19 immunisation. Medical history included arthritis and pneumonia, had not been diagnosed with COPD, but took a lung test, and was prescribed this symbicort 3 months ago. During the pandemic he was never sick and never had symptoms of COVID, was never hospitalized or none of that. Patient was tested and was negative. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 30Apr2021 (Lot Number: EW0171) at the age of 64 years as single dose for COVID-19 immunisation. Within seven days of taking second shot, patient began to get real sick with flu-like symptoms, started 5 days after he took second shot. Was feeling fine, usually did an hour walk every morning. And 5 days ago, did an extra 30 minutes on his walk to boost himself and that's when he began to get sick. Confirmed date as 26May2021. Still came and went. Stated he developed mucus in his lungs began 27May2021, on 28May2021, got more mucus in his lungs. This past Saturday, didn't buy Mucinex, but got something for severe cold and chest to break up mucus from forming. Patient stated today he was able to start back walking and gradually coughing up mucus. Improving slowly, but surely. Denied shortness of breath. Has rattling in chest at night like fluid, which began on 27May2021. Hot and cold with sweats began on 29May2021 and were not as bad as they were. Stated women should have not men. Shortness of breath began on 28May2021. Not to the point of having to call emergency services. Stated it all came down on him at once. Stated he started to call for ambulance but didn't most emergency rooms sit there for 11 to 12 hours before looking at you or fall out dead. Reported slowly getting better. No sneezing, just felt like he was feverish, but did not have a fever, didn't have a thermometer so he could only go by sweat that he had and the chill he has. Patient stated joint pain that normally didn't bother him. Stated the first shot didn't affect him the way the second shot had. States he now had a little joint pain, like pulled muscles around his lungs, around biceps, sharp pains around biceps. Severe pain in left bicep on 27May2021. His friend thought he was having a heart attack, but wasn't. It was up above heart more like a pulled muscle than a heart attack pain. Patient stated this morning while outside after his walk, all of a sudden a pulled muscle pain in bicep on right side. Stated was this thing moving around on me since started on left side now on right side. Pain had stopped was just a sharp pain, muscle was tight. Stated has never had sharp pains to hit him like that since he was alive. Patient stated he did not have a runny nose, his eyes may ache and itch a little bit, but was coughing up a lot of, had whistling sounds and had a lot of mucus in his lungs. Patient had rattling in chest at night like fluid on 27May2021. Hadn't had runny eyes or stuff in the corner of his eyes. Patient felt like he has gained weight since taking the shot. He was 215 and now 223 lbs. Seems like he gained weight. Patient had headache, like stuffed up, sinus headache from 27May2021. Patient was taking generic brand Tylenol for joint pain. When having chills, he would take 2 in the morning and drink hot coffee. Then all of sudden, went along with joint pain and chills, after moving around and walk outside, broke out into a heat flash. Stated this was irritating. He's freezing one minute and about to burn up the next. Vicks Dayquil pill form for severe cold and allergy to help mucus in chest. Stated he was not able to make it that far to a drug store or Walmart and got from service station. Stated he had had a cold and knew what cold, flu, and pneumonia feel like, what he used to have before this Covid thing. Stated he knew how to recognize some things and not put himself to point of not getting any help. The Symbicort Budesonide didn't do anything to release the mucus. It seemed like it just bypassed that. AEs did not require a visit to emergency room or physician office. Outcome of events got real sick with flu-like symptoms, a lot of mucus in lungs, headache, like stuffed up, sinus headache, hot and cold with sweats, shortness of breath, eyes ache and itch a little bit was recovering, joint pain, muscle pain, pulled muscle, muscle was tight, was recovered and the other events was unknown.

Immediately within two minutes, strange disoriented feeling, heavy sweating and weakness. Sitting down I lost vision in my right eye (just dark grey with a tiny blurry spot of light in the center). Left eye could not focus. After about twenty minutes, both eyes became very sensitive to light (like a pupil dilation test in an eye exam). This lasted about additional 10 minutes. I remained pretty weak for the next hour but was then ok. The next day I felt 100%.

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

aortic widening; Strange smell of burning plastic; Top of feet cramping at night; showing lungs full of PE; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 64-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:00 (at the age of 64-years-old) as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 64-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for arthritis. The patient previously took Tylenol. The patient was not overweight, non-smoker and highly active. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. On 14Mar2021, after first dose shortness of breath lasted 2 days and experienced top of feet cramping at night. After 2nd dose shortness of breath worsening each day and reported to PCD on day 10. Series of blood tests ordered along with CT scan showing lungs FULL OF PE with no prior history. On unspecified date, other symptoms include strange smell of burning plastic and shortness of breath continues. Also found aortic widening w/echo. Treatment Eliquis was received for pulmonary embolism (PE). Patient visited doctor or other healthcare professional office/clinic visit and he visited Emergency room/department or urgent care. On unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: showing lungs FULL OF PE, Echocardiogram showed aortic widening. The outcome of the event shortness of breath was reported as recovered with sequalae on an unspecified date in 2021 and while for other events was unknown. Follow-up attempts are needed. Further information can be expected.

The D-dimer part of the blood work came back as 0.44; runny nose; lost his taste; lost his smell; coughing stuff up; coughing up phlegm; sneezing; This is a spontaneous report received from a contactable consumer (reporting himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207, Expiry 31Jul2021), via an unspecified route of administration in left arm on 17Mar2021 at 11:30 (age at the time of vaccination was 64-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COPD treated by CPAP (continuous positive airway pressure), high blood pressure, cancerous tumors removed from bladder, atrial fibrillation. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient had no additional administered vaccines on same date with the Pfizer vaccine. The patient did not required any visit to emergency room or physician office. The patient had no loss of taste and smell within 4 weeks of prior vaccinations. The patient had no adverse events following prior vaccinations. The patient had no predisposing factors. No culture test was performed. The patient's concomitant medications included Eliquis (apixaban) taken for cardiac disorder from Feb2021 to an unspecified stop date; lisinopril and metoprolol tartrate for an unspecified indication. The patient called about the COVID-19 vaccine. The patient had his first COVID-19 vaccine on 17Mar2021. The patient had no issues with the first vaccine. About 2 weeks after the first dose received maybe around 01Apr2021, the patient started sneezing, having some phlegm, and coughing stuff up. The patient used a CPAP (continuous positive airway pressure) machine at night. Around 09Apr2021, the patient lost his taste and smell. The patient was scheduled for his second COVID-19 vaccine on 10Apr2021 but thought his symptoms were worse than the patient originally thought. The patient went to his doctor on 09Apr2021. The patient's doctor did the nasal swab for the COVID-19 virus. The patient never had a fever or chills. The patient's doctor gave him some erythromycin. The patient also did some blood tests. The patient's COVID-19 virus test came back negative. On the results of his blood tests on the first page, the first thing it says are that the patient's COVID-19 results were negative. The patient's doctor told him that the patient's body showed no response to the COVID-19 vaccine. The patient did not see that this blood test was testing for antibodies. Later in blood test paperwork the patient saw that it said antibodies not detected, does not preclude acute Sars-Cov-2 infection. The patient's paperwork said IgG and IgM were negative. The patient provided the following in a historical context. On an unspecified date in Feb2021, prior to receiving his first dose of the COVID-19 vaccine the patient had some heart problems. The patient gone into atrial fibrillation. The doctor prescribed Eliquis and put him on a heart monitor. The patient took a nuclear stress test and that was ok and now the patient was wearing a heart monitor. The patient's reading from his blood test results. The patient's D-dimer result was 0.44. In the reference range it said anything less than 0.50 was a normal range. But the patient was taking Eliquis and his doctor told him his D-dimer should be zero. The patient's doctor told him his D dimer was elevated. The patient's doctor believed the first COVID-19 vaccine has something to do with his D-dimer result. The caller reports that the patient heard about the Johnson and Johnson vaccine and blood clots but he had not heard anything about Pfizer having problems with blood clots or anything of that nature. The patient now has his second COVID-19 vaccine scheduled for next day on 23Apr2021. The patient's follow up visit with his doctor was on 17Apr2021. The patient's doctor advised him to wait until mid May2021 and start all over with the COVID-19 vaccines but this time his doctor wants him to get the Moderna COVID-19 vaccine. The patient was not sure why his doctor was wanting him to stay away from Pfizer. Was there an indication that the patient was not aware of that the Pfizer COVID-19 vaccine would cause his D dimer to be elevated at 0.44. The patient was aware and there may be other factors that cause his D dimer to be elevated. The patient just wants to see if he can get his second COVID-19 vaccine. The patient just wants to get the vaccine and get on with his life. The patient would not get the vaccine if there was a known reason not to get it. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I had previously had covid as of early Dec 2020. I was negative some time mid to late January. I had a vitrectomy in my right eye in 2020 to remove a macular pucker and eliminate floaters. Dr. performed the surgery. The night of April 7 I had searing pain in my right eye and a sort of migraine on my right side. Pain dissipated some the next day but came back intermittently. I went to on call that saturday, received an avastin injection and was told to come back Monday. I was diagnosed with acute glaucoma, had surgery on the 12th of may and was blind in my right eye for about a month while the blood in my eye was reduced by meds and drops. It is still not back to normal, but I can see from the eye.

I developed vision abberations such that when i focus or concentrate (e.g. reading a book or computer screen) my vision would 'jump' or 'blink' or flicker causing me to not follow words I had been reading. Very clearly concentration of attention driven. This condition came on slowly. It took weeks after injections for the symptoms to develop. They remain. And seem to be getting more severe. My opthamologist has refered me to a neuroopthamologist. I can not think of any other causative factor in the last years, month, and weeks that could account for what I am experiencing. I have had NO illnesses. I have not had Covid-19 to the best of my knowledge. (Note: date & time given for #5 above is approximate)

A marked increase in existing tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received his second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The medical history included bipolar disorder, erectile dysfunction, tinnitus from an unknown date and patient had known allergies to opioids. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and sildenafil (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received his first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 13:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 10:00, the patient experienced a marked increase in existing tinnitus in both ears and would estimate the intensity has doubled. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The outcome of the event tinnitus aggravated was not recovered at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

07/01/21: cough, fever, runny nose, nasal congestion, shortness of breath, body aches, loss of taste and smell, loss of appetite

Taste rubber/vanilla milk; Vertigo prone sleeping; High blood pressure; Left arm sore; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en 6206) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 64-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removed on 11Feb2021. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 07Mar2021 at 04:00, the patient experienced taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore 5 days. Therapeutic measure was taken as result of event vertigo and included treatment with meclizine (MANUFACTURER UNKNOWN). The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore were resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Pronounced change in taste/smell. These senses were not lost, but changed in pronounced ways. Foods commonly left bad (metallic) aftertaste in mouth, and highly spiced foods sometimes caused either immediate sneezing (as in allergies) or gut discomfort. During this period I noticed episodes of sinus and/or ear infections. The symptoms started around the time of first injection, although I did not recognize them as a pattern for some time. The strength of the symptoms fluctuate in time. 3.5 months after the 1st injection it seems that taste/smell is becoming more normal, although there may be some residual, fluctuating symptoms.

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

mouth sore; This is a spontaneous report received from a contactable consumer, the patient. A 64-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 the left arm on 25Mar2021 at 18:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies to food, medications, or other products. 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 an unknown date, as a single dose for COVID-19 immunisation. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 06:00 (the day after second vaccine), the patient experienced mouth sore, which he never had one before. It was reported that the patient's sister did as well and it took one month to go away. 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 event. The clinical outcome of the event mouth sore was resolved on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366615 Same reporter/ drug/ AE, different patient

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

Congestive Heart Failure; Blurred vision; The caller was concerned the brother may have had an emboli,; Dizziness; Flu like symptoms; He had difficulty breathing/couldn't breathe; Headache; Cardiac issues; Fatigue; The blood pressure keeps spiking; Unable to stand very well; muscle & joint pain; muscle & joint pain; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in deltoid muscle in Jul2021 (Batch/Lot number was not reported, expiration date not provided) at age of 64 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestive heart failure on 10Jul2021, blurred vision (Life-threatening) on 10Jul2021 19:30, the caller was concerned the brother may have had an emboli, dizziness (Life-threatening), flu like symptoms (medically significant), he had difficulty breathing/couldn't breathe (medically significant), headache, cardiac issues, fatigue, the blood pressure keeps spiking, unable to stand very well, muscle & joint pain, all in Jul2021. The patient was hospitalized for congestive heart failure from 10Jul2021 to an unknown date. The patient underwent lab tests and procedures which included blood pressure: keeps spiking in Jul2021. The outcome of the events was unknown. Clinical course: The caller was a pharmacist calling in regards to her brother. The caller did not know if this has any correlation. The callers brother received the first dose Pfizer Covid Vaccine, a day later all the typical side effects of flu like symptoms occurred. Had to get up in the middle of the night to raise arms because couldnot breathe: The caller's brother had to get up in the middle of the night to raise his arms because he couldnot breathe. The caller states this occurred the second night after the caller received the first dose Pfizer Covid Vaccine. The caller did not know specifically what time this occurred. The caller told her brother to go to a hospital. The callers brother had every excuse not to go the hospital. Later that evening, the caller called her brother to check on him. The caller's brother was having more symptoms, the brother had dizziness. This was not just typical Pfizer Covid Vaccine symptoms. Ended up in the hospital with congestive heart failure: The patient ended up in the hospital with congestive heart failure. The hospital is still having trouble, this is the patient's second or third day in the hospital. The hospital is having trouble maintaining the patients blood pressure, the blood pressure keeps spiking. This could be coincidental. The caller is asking if anything different is presenting after receiving the Pfizer Covid Vaccine? The caller would like to present this information to the doctor if so. Is there any correlation at all? The caller states she knows there have been incidents of myocarditis, but the caller's brother is not a youngster, the patient is going to be 65 in less than a month. Received first dose vaccine, a day later all the typical side effects of flu like symptoms occurred: The caller states this occurred after the patient received the first dose Pfizer Covid Vaccine. The symptoms have gone away after the third day. The caller has not asked the specific question if the patient recovered with lasting effects or recovered completely and does not know. Had to get up in the middle of the night to raise arms because couldnot breathe: When asked when this began the caller states her brother must have had the first dose Pfizer Covid Vaccine on Friday, 09Jul2021, or it could have been Thursday, 08Jul2021. The caller called the patient on 10Jul2021. When asked if this was ongoing or went away, the caller replies the patient continued with other symptoms that happened. The caller was concerned the brother may have had an emboli, all sorts of things. The caller advised the brother to go to the hospital. Had dizziness: When asked when the patient's dizziness began, the caller states she can not answer that exactly. The caller clarifies the dizziness occurred after the patient received the first dose Pfizer Covid Vaccine. The patient had only received one dose of the Pfizer Covid Vaccine so far. The caller is not sure if the patient has been advised to receive the second dose Pfizer Covid Vaccine or whether this is something totally different. When the patient was having flu like symptoms he was also having dizziness. The dizziness became different the second day at night time at 1930 pacific time, the patient told the caller he went out to the car and got so dizzy and light headed and couldn't breathe. The patient was bringing groceries inside and got winded. It was not normal. Ended up in hospital with congestive heart failure: The caller states the patient was hospitalized yesterday 12Jul2021, the caller then clarifies, no it was Saturday night, 10Jul2021 the patient was admitted to the hospital. The patient is still hospitalized at this time. The caller states she asked the cardiac nurse at the hospital and the cardiac nurse says she thinks this has nothing to do with the Pfizer Covid Vaccine. The caller is not sure and has heard so many different reports. Causality: When asked causality for each symptom, the caller replies, she certainly thinks the flu like symptoms are related to the first dose Pfizer Covid Vaccine. The caller does believe something must have happened to cause his condition to spiral down hill. The patient had some symptoms prior to receiving the first dose Pfizer Covid Vaccine but these were all manageable and not a problem. The caller doesn't know if the patient having the flu like symptoms may have put extra stress on the patient's heart. Had to get up in the middle of the night to raise arms because couldn't breathe: The caller considers this life threatening. Had dizziness: The caller states when the patient had dizziness at night, the caller considered it life threatening. The patient had other dizziness and blurred vision and inability to breathe and it was clearly cardiac issues. blurred vision: The caller does not know when this began. The caller states when her brother called at 1930 on 10Jul2021, that is when he had the blurred vision, the caller does not know if the caller had the blurred vision before and can't answer that question. The caller does not know if the blurred vision is ongoing at the moment. The caller knows the blurred vision had mostly gone away, the caller does not know if any of the blurred vision has come back, she believes it is gone. The caller considers the blurred vision life threatening. Date of first dose: The caller is unable to provide the date the patient received the first dose Pfizer Covid Vaccine. The caller states she would have to be in touch with the patient. It was either 08Jul2021 or 09Jul2021. ~ Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event headache, fatigue, joint pain, muscle pain and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Angina Hx. of HTN, DM, pacemaker presented with CP that radiated to bilateral jaw/chin. VSS. Narrative: After covid19 vaccination, c/o CP with radiation to jaw/chin. denied SOB, nausea or diaphoresis. Monitored for 30 minutes with CP resolved but jaw/chin sensation remained. Brought to ED at 15:25 in stable condition. . In ED, stable vitals, a-paced rhythm w/o ST changes per ED note. Offered OBS admission for further cardiac workup but patient declined and was discharged in stable condition with no CP or jaw/chin sensations present.

Patient felt "tickle/scratchiness in throat" 10 minutes after vaccine; BP and pulse stable; no hives, itching, shortness of breath. Took 25 mg of Benadryl and monitored another 15 minutes. VSS; patient felt comfortable leaving; would be in hospital another hour or so,

After sleeping 2 hours at night I got up to use the restroom. After standing to wash my hands, I fainted and fell halfway into the bathtub and floor. My girlfriend came to help to find my eyes rolled to all white. After getting back to bed I was very hot, sweaty and tired. After a hour I was feeling better and slept until 10:00 AM. Being in this location for 6 months I really have no primary doctor and I went to the hospital. They?re tests listed below and all came back normal. Was given paperwork for Fainting (Syncope) and released. The Doctor stated that with all the causes of Fainting it seemed the only one that pertained to me was ?old age?.

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

Patient presented to the ED the morning after receiving his first COVID-19 vaccine with a chief complaint of tongue swelling and difficulty speaking. Patient received his vaccine at approximately 12:00pm and presented to the ED around 08:00am. Isolated tongue swelling and abnormal speech was appreciated on exam. Patient was given famotidine, methylprednisolone, epinephrine, and diphenhydramine in the ED. Patient was then admitted to the medical ICU for monitoring.

Sensation of tongue swelling after 10 minutes thinks it may have been anxiety about the vaccine 14:34: BP 120/78 HR at 60 RR 16 Tongue midline, not enlarged no lymphadenopathy color normal - not pale sitting upright S1 S2 at apical

a mild rash on my forearms and front of my legs; numb tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included mild hypertension, elevated cholesterol, allergy to sulfa, allergy to gluten and celiac disease. The patient's concomitant medications were not reported. On 18Jan2021 15:30, patient experienced mild rash on his forearms and front of his legs which was treated with diphenhydramine (BENADRYL) tablet. The patient also experienced numb tongue on 18Jan2021 15:30 with no treatment received. Outcome of event "mild rash on my forearms and front of my legs" was unknown while for the event "numb tongue" was not recovered. Information on the Lot/Batch number has been requested.

lost partial vision in my left eye for 10 minutes; tunnel vision; This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 14Jan2021 16:00 at single dose, left arm for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as No. The patient experienced "lost partial vision in my left eye for 10 minutes" and tunnel vision on 19Jan2021 18:00 with outcome of recovered. On January 19th at 6 pm, the patient had lost partial vision in his left eye for 10 minutes. He had tunnel vision. The patient went to his eye doctor yesterday and his vision was fine with not noticeable issues. No treatment received for the adverse event. Events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Patient received his first covid shot this past Saturday and about 20 minutes following he noticed a right sided facial droop. Droop began to worsen, and he had difficulty moving his right eye lid, so he decided to go to Urgent Care and was diagnosed with Bells Palsy. He was started on Prednisone and Valtex which are reducing his symptoms. Symptoms are almost resolved. He does feel fatigued and slightly anxious.

Patient complains of facial drooping on the left side. Started on 2/11/2021. Drooping of left side of mouth, inability to completely close the left eye. Treating for bells palsy with antivirals, steroid and artificial teas.

Vision issue, the right half of each eye became blurry and had calidescope colors and shapes lasting 40 mins

02/07/2021- AM have abundance of floaters in right eye, not had previously. Later in day had some nausea, headaches and extreme soreness at swelling site but those 3 issues went away after a few hours. That evening I started getting what I will call "Lightening Bolts" flashing along the outer right edge of my right eye when I moved my head side to side. 02/08 & 09/2021- "Lightening Bolts were constant and I went to hospital.

Woke up 6 days later with sever double vision. Eyes seems to work independently ok but close to mid-range sight is double. It's been going on now entering the 5th day.

Flush feeling; tingling in the face, hands and feet; swelling of the tongue and lips; swelling of the tongue and lips; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the left arm on 01Feb2021 10:45 at a single dose for COVID-19 immunization. Medical history included high BP and allergy sulfa drugs. Concomitant medication included losartan, acetylsalicylic acid (BABY ASPIRIN), colecalciferol (D3), zinc and ascorbic acid (VIT C). On 01Feb2021 11:00 AM the patient experienced flush feeling, tingling in the face, hands, and feet, swelling of the tongue and lips and dizziness. Diphenhydramine (BENADRYL) was used to control. Events were reported as non-serious, did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The events resulted to a doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 recovered on an unspecified date.

I had an oral sensation like I was tasting something cold.; This is a spontaneous report from a consumer. A 65-year-old male patient received first dose bnt162b2 (COVID 19, Pfizer, EN 5318), via an unspecified route of administration, Left arm on 27Jan2021 15:15 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. On 27Jan2021 at 16:15, approx. an hour after injection, the patient had an oral sensation like he was tasting something cold. No treatment was given for the event. Outcome of event was recovered on 2021. No follow-up attempts are possible. No further information is expected.

Twenty minutes after injection mental fog, then onset of headache which became debilitating, requiring 5mg of Oxycodon every four hours for five days to be functional. Woke up every night after four hours, from pain, took meds, an hour later able to sleep again. Stabbing knifelike pain over right eye, Able to transition to naprosyn, Advil and Tylenol after five days, but still in constant pain eight days later, even with meds. No sensitivity to light, some mild nausea for first few days.

Tingling of the tongue along with increased awareness of his tongue. No swelling. Vital sign taken. Symptoms resolved. Sent home and asked to follow up with PCP

Had tongue swelling at 2 am on 03/04/2020 the morning after getting the Pfizer COVID vaccine. 1 st dose. Patient did not have any trouble breathing or swolling. He too some benadrly. Home Health Nurse saw the patient at 7:30 am on 03/04/2021. Patient still had some swelling of the tongue but not having any trouble breathing or any other problems. Patient is going to take some benadrly though the day. Home health will follow up with him. He was advised to call 911, if he had toruble breathing

3/5 10pm My lungs felt like I had taken antihistamines. 3/5 11pm - 3/7 9am Entire body aches, chills and everything taste the same.

BLURRED VISION, PARTICULARLY FAR DISTANCE ON THE 7TH AND 8TH OF MARCH. Might be temporary, I will wait and see if the problem does not correct itself.

arm continuing to be sore,fFever of 101, weakness, bad chills for three hours, weakness, vision fuzzy even with glasses

101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatigue for first 10 days. As soon as eat breakfast have to go back to bed for 1-3 hours. Same with lunch, eat, go back to bed about 3 hours and same with dinner. Then go to bed for evening. Extreme brain fog and forgetfulness. Can't think of words or make sentences. Can't remember anything. Feels like a very heavy feeling in head like head weighs a lot and very cloudy. Pain from shot in arm moved up to neck, ear and jaw the day after shot. Arm quit hurting but couldn't lift it. Pain stayed in neck, ear and jaw for a week and now is a stiff feeling. I think the lymph nodes are swollen. Effects eating, hard to keep food down. Nausea and stomach pain. I have appetite but have to eat while nauseous and pain. Still severely fatigued every day and have to sleep most of each day or at least sit and rest. So exhausted. Also night of shot started getting hot and cold chills. Still have them over 2 weeks after shot. Bad tinnitus started night of shot and still have it over 2 weeks after shot. Very loud and nothing makes it go away. Bad headache started morning after shot. I have had a headache pretty much everyday, all day since the shot over 2 weeks ago. I feel sick like I have flu.

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

AE: pt reported chest pain and tingling/ numbness of lips approximately 30 minutes post vaccination Tx: EMS eval and vitals Outcome: pt refused further treatment and transport

Patient is non-verbal related to h/o CVA. Patient's wife stated patient started moaning with secretions coming from mouth. Patient's tongue appeared to be swelling. Given Epinephrine Auto Injector 0.3mg immediately. 911 called, and patient transported to Medical Center.

Pain in right shoulder x3 days; tiredness x1 day; increase in volume of Tinnitus in Right ear-continuing; stiff neck and headache-continuing; Advil x2 day for stiff neck and headache-continuing.

injection site pain, headache, left ear ache, sore left eye. Ongoing on second day. Took 1 aspirin. Still have swollen lymph gland from first shot 3 weeks ago.

Previous to Pfizer vaccines I had chronic tinnitus with mild symptoms. I'm a retired dentist. I wasn't aware of any changes in my tinnitus after the 1st vaccine. But after the 2nd vaccine I noticed a definite profound increase in my tinnitus. It is now on the verge of being debilitating in nature. It is now pulsating and much louder, very difficult to ignore even during day time activities. Before my tinnitus was bilaterally equal, now I would say my right ear is louder than my left. But both are louder than before. Today marks about 50 days since 2nd vaccine, and I think its actually getting progressively worse! Hopefully this is not permanent.

Tinnitus, which I have had for 20 years and was well habituated to, suddenly became much worse. Has made me nearly suicidal.

65yo male presented to ED with left eyelid droop, blurred vision, and headache. Pt reported that HA began 3 days after COVID-19 vaccination (Pfizer); pt presented to ED 10 days after dose #1. Unknown where patient received vaccine, but able to pull lot #, etc. from Shots Registry. Pt discharged from ED, but then returned 3 days later with worsening HA. At this time, he was admitted for 4 days for extensive work-up. Of note, pt with hx of R-sided Bell's palsy in the past. Per discharge summary from Neurology: "Despite extensive work-up, pt ultimately deemed to have a pupil-sparing CN III palsy likely related to either recent COVID vaccination or his history of DM."

Pfizer vaccine, shots 1 and 2, one month apart. 2-24-21, and 324-21. I began getting tinnitus in both ears within a week or so after shot one. It really got annoyingly noticeable in both ears after shot two. I would consider the after effects of each dose to be normal...dose 1 felt a little lousy the next day with headache and fatigue but ok after that, dose 2 felt lousy the next day with low grade fever about 100.5. Felt fine the next day. Except for the tinnitus.

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

Patient c/o dizziness, blurred vision. Skin hot to touch. Vital signs: 11:25am 130/76 81 18; 11:26am 120/82 80 18; 11:31am 130/79 75 18 O2 96% Temp. 97.2 11:41am 127/72 69 18 O2 97%; 11:48AM 130/90; 11:55am 132/84 70 18 O2 98%

About an hour after injection, began to notice slight irritation in my right eye. A bit of redness in the corner and a bit of tearing up. Not bad enough to keep me from going about my daily routine.

excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Dissiness, nausea, headache, preassure in head, extreme tenetus, feel as if I am spinning, unsteady on my feet (could fall), tingling of all left side of my body, mostly in joints, sleuring speech, brain not connecting to mouth...slow.

No sense of taste in my mouth; It is like 75% has gone/no taste, no taste buds/after Covid-19 Vaccine it got worsened; No sense of taste in my mouth; It is like 75% has gone/no taste, no taste buds/after Covid-19 Vaccine it got worsened; chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part; chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EL3247, expiration date unknown), via an unspecified route of administration on 05Feb2021 at the age of 65 years old at a single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis, started experiencing this problem with my taste in Aug2020. Concomitant medications included acetaminophen for arthritis, cetirizine (tablet) at 1 DF, once a day, vitamin D1, vitamins and multivitamins. Patient stated on 05Feb2021, got first Pfizer shot. Patient noticed that they told him to come back in about three weeks. From 05Feb2021, they told him to come back on 26Feb2021. He said okay. First of 15 minutes they told him to stay there to see if he had any reactions. He was okay. He noticed in probably the last week and half though that he had a sense like no taste, no taste buds, and no sense of taste in his mouth. It is like 75% has gone on an unspecified date in 2021. Other symptoms are, patient got some chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part area also on an unspecified date in 2021. Should he get his second shot coming up 26Feb2021, go ahead and get it?" was his question. Patient stated, "I am disabled vet (not clarified). I am like kind of regarded like 100% disabled vet. I am on 'test' in hospital where I got my shot. "Patient stated, "I just wanted to know if other people called in, told you about they start losing taste buds too, the sense of smell and taste." Patient stated, "I started experiencing this problem with my taste. It seems like around, probably Aug2020, I had like a some taste that I was losing but it seems like after I got this shot about when 4 months later, after I got the shot (Covid-19 Vaccine) I noticed it got worsened. But I am not running, no fever. I haven't had fever, cold or cough or chills or anything." The outcome of the events was unknown.

A few days after my 1st Pfizer vaccine my ear's started ringing, after my 2nd Pfizer vaccine 3.5 weeks later my ears started ring a little louder and as of today almost 4 weeks later my ears are still ring and I have developed a slight blood pressure.

Became ill several days after 2nd injection. Weak tired no energy. On the 18th of March a slight ringing in my ears developed. It became severe and I went to the doctor on April 1st. The week and tired feeling had left but the ear ringing stayed constant. The ENT said I have developed Tinnutius.

Starting on or about 4/5/21 severe headache that I treated as a sinus infection from seasonal allergies. Stayed inside. stopped smoking (marijuana), nasal mist. Very dry sinuses and eyes especially the left eye. The pain proceeded to worsen and I rinsed my sinuses with nasal mist which eventually relieved the pain. At one point during the rinsing I had a short flow of blood from my sinuses. I used eye drops for the dryness in my eyes. I had occasional pain in my legs during the week of the 5th followed by extreme back and leg pain on the 11th. This pain and spasms mainly effected regions where I have had long term weakness. I still have minor pain as is typical.

Constant low level ringing in ears (tinnitus), sometimes gets a little louder but then decreases back to the low level.

Patient stated that they will refuse the second dose of the Pfizer vaccine based on side effects experienced since. Complications include pain that felt like "lightning bolts", temporary loss of vision, and that their "mind went black" which has improved in the past few days. Pt. believes that his recent cognitive decline is directly attributed to receiving the vaccine and expresses concern with whoever else gets it.

Reported that 4-5 hours post vaccine he became very dizzy and unable to walk. HIs eyes at that time became sensitive to light; to this day he is still experiencing tenderness in his vision. His mind is foggy and feels anxious that he is not feeling better as of 04/14/2021. He went to his PCP on 04/13/2021 who referred him to a neurologist.

Sporadic Vertigo when getting out of bed at night or in the AM. Wait a few minutes until it settles down. VERY Mild headache for a few minutes or a few hours like an eyestrain headache after. Doesn't happen every morning.

increase in my tinnitus/ right ear is louder than my left; This is a spontaneous report received from a contactable other healthcare professional (retired dentist/ also the patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Chronic tinnitus from an unknown date and unknown if ongoing (Patient had chronic tinnitus with mild symptoms, Before the vaccines). The patient was not diagnosed with COVID-19 prior to vaccination, also not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took bnt162b2 first dose on 18Jan2021 (lot number: EK4176) on 18Jan2021 in left arm for covid-19 immunization. It was reported by the patient that: "previous to the vaccines I had chronic tinnitus with mild symptoms. I am a retired dentist. I was not aware of any changes in my tinnitus after the 1st vaccine. But after the 2nd vaccine I noticed a definite profound increase in my tinnitus (on 21Feb2021). It is now on the verge of being debilitating in nature. It is now pulsating and much louder, very difficult to ignore even during day time activities. Before my tinnitus was bilaterally equal, now I would say my right ear is louder than my left. But both are louder than before. Today marks about 50 days since 2nd vaccine, and I think its actually getting progressively worse! Hopefully this is not permanent." The outcome of the event was not recovered. The case was considered as serious (criteria-Disabling/Incapacitating: Yes). No treatment was received for the adverse event. Additional information has been requested.

Within 4 days of 1st Pfizer vaccine for COVID, developed fatiguable diplopia confirmed associated with vertical eye misalignment.

On 03/02/2021 a day after the first dose I noticed my vision was a little off the next day. It seemed to get better and then on 04/7/2021 I noticed the sight in my right eye was again blurry. My second dose was on 03/22/2021. The sight in my right eye has been getting progressively worse each day. I am now experiencing double vision. I went to an ophthalmologist and got numerous tests performed. After they could find the cause I was sent for an MRI which did not find the cause.

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

Pt reported to me on 4/23/2021: dry mouth, difficulty getting out of bed, h/a, fever and chills, feeling like was going to fall, some memory difficulties and ringing in ears. Reported that the sx gradually resolved and are completely resolved by date of reporting (4/23/2021)

Moderate tinnitus developed within two weeks of first vaccine dose. Tinnitus persisting unchanged eleven weeks after first dose. Second dose received March 2, 2021.

patient reported chest pain and tingling of lips 30 minutes after vaccination, refused furthered evaluation/transport

vertigo when getting up. Occasionally during the day dizzyness and tunnel vision. No improvement after 6 days.

Salivary gland reactions; Was told by this doctor that he has seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination; Sleeplessness; I can barely breath; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on left arm on 04Feb2021 at single dose for covid-19 immunization. Patient also received zolpidem tartrate (AMBIEN) and mirtazapine (manufacturer unknown) for unknown indication. Medical history was not reported and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: it looks like ELR84), via an unspecified route of administration in the Left arm on 14Jan2021 at unknown time as a single dose for COVID-19 immunization. On 25Feb2021, almost exactly 3 weeks after receiving his second dose of the Pfizer BioNTech COVID-19 vaccine, the patient started experiencing horrible dry mouth conditions for 6-7 weeks. He stated that due to this persistent dry mouth, he had only been able to sleep on average 3 to 4 hours a night for the past 6 to 7 weeks. Patient reported that he hasn't come back from an ENT specialist regarding this and was told by this doctor that he had seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination and/or COVID-19 itself. It was stated that his doctor also referenced an article in a journal that came out a few days ago that stated COVID-19 was shown to infect the salivary glands. He stated that his doctor was unable to give any further recommendations other than gave him things to keep him comfortable such as Salagen. He also mentioned that after receiving the vaccine, he was being awoken every 20 minutes all night long and many times had to urinate but reported that this side effects has subsided. He stated he read on the internet about a woman who also had COVID-19 who reported having bad dry mouth and was urinating more often than he had in her whole life. He called at the recommendation of her doctor nasal and throat surgeon who said he was going to speaking with his peers about this, but he suggested that he call him too. So, it would appear that he had and several of his patients had similar symptoms to him. He had been suffering from the extreme and when he said extreme, he said the most extreme case he had seen in his 45 years of medicine. Extreme case of might be dry mouth or sleeplessness to this point when he can barely breath. He had maybe 3-4 hours of sleep over the last 6 weeks. They kept thinking that she was allergic that the medication that she was on, but she did not off that medications for a week. They thought of food, he was ingesting they removed every food stuff he finally saw an ENT and he said well, he was the 5th patient he had seen like this, this month and she was telling them he cannot swear by it but it was COVID. He said the only thing that made any sense had seen medication before and they just don't know yet. This was not just enough information and he showed him an article for that he just found the other day that said this enough, COVID was infecting salivary glands or was believed to be so it would seem this might be something that was being recorded yet and might be somebody wanted to take a look at mine. He doesn't know but it was he can't find anything anywhere about this. He can't either except the story that he saw just a few days ago which was professional (Name) journal about COVID now infecting salivary glands that was exactly they know he was suffering it somewhat of freak salivary gland reactions that could be it or could had been COVID (Further not clarified hence PC filed conservatively). When probed for the Date of Vaccine administration for both COVID Vaccine shots, Patient stated that second dose was Feb 4th, and the second dose would be 4 weeks before that. When probed for the exact date of Vaccine administration for both COVID Vaccine shots, patient stated, if they hold on, she get her vaccination card. It would be there right. It was in January, he doesn't knew it looks like 14Jan2021. When probed whether the Vaccine was purchased or she got injected at the clinic, he stated that he got injected. The first on, it looked like ELR84 that was the first dose. When confirmed LOT# as ELR84: he stated, it looked like A but their writing was terrible. He though, it was A it said, or could be G. For second one, EN9581. (Hence second dose LOT captured in tab). Dose for both shots of vaccine: patient stated, that doesn't say. No one say about that. When probed for the site of administration for both shots of vaccine, she stated left arm. When confirmed the vaccine was administered on left arm both the times, stated, she did not remember. (Later confirmed as yes). When probed for Other medications, he stated that not now, no, he had been. (Further clarification unknown) Names of medications: he stated, that was taking Myrbetriq none of these were taken very long they expected these were causing the dry mouth. So, he stopped taking them. it was reported that It was Oxybutynin, let him get it. thought the dry mouth was being caused by the medications. So, they tried switching medications. He had several drugs in that stage for few weeks. So, Oxybutynin was the first one. He took Myrbetriq on February 25th 50 mg, Oxybutynin 50 mg tablet, 1 tablet her mouth daily and then they had Peficare that was for sulfonation and 5 mg,(Further clarification unknown) Tolterodine that was standard Detrol that was 4 mg, Darifenacin,(Was not clarified further hence not captured as concomitant medication) than there were sleep medications none of which worked, none of which solved dry mouth problem, they were Ambien that was Zolpidem 5 mg, Mirtazapine (hence captured as suspect) 50 mg and there was one more, looking that. On an unspecified date, the patient underwent laboratory tests, he was tested for Sjogren's Syndrome for the markers of Sjogren's Syndrome, and they were negative. It was approximately a 1 week ago, 7 days ago and here her result came like he cannot give them the exact date. The outcome was persisting. He was prescribed (further not clarified) Salagen (treatment) in order to generate more saliva. He stated that than there were sleep medication none of it worked, solved dry mouth problem, they were Ambien, Zolpidem 5 mg, Mirtazapine(treatment) 50 mg and there was one more, looking that. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Symptom #1: sixteen days after receiving second dose I developed a sinus infection. Had not had a sinus infection in 15 years. Dr gave me Z-Pack and prednisone steroid. Still no relief 7 days later. Symptom #2: also around 16 days after my second dose my tinnitus started getting louder with more shrill variations to the typical cricket chirp type of sounds I have heard for about the last 5 years. Never any relief from these sounds!

the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

After approximatly two weeks I started to see little "floaters" in my left eye. More like little hair moving toward the periphery of the eye and disappearing after blinking, but then appearing again.

Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving. Information on the lot/batch number has been requested.

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

There is pain in his shoulder; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; But his knees, bigger joints, was 2 days; Even up in my jaw bone. It hurt so bad I couldn't eat soup.; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them.; I had arthritic pain, on my thumb - like I broke my thumb; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; Even up in my jaw bone. It hurt so bad I couldn't eat soup.; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them./I can't lift my left arm (injection arm); Excruciating joint pain after receiving 1st dose Pfizer vaccine; I had arthritic pain, on my thumb - like I broke my thumb; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them.; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration (by injection), in left arm on 14Jan2021 (at 65-years age) as 1st dose, single for covid-19 immunisation; and ibuprofen (ADVIL [IBUPROFEN]), via an unspecified route of administration from an unspecified date (Batch/Lot Number: EC3203; Expiration Date: May2023) to an unspecified date, at unspecified dose for joint pain. Medical history included he sees a lung specialist for the last 5 years, he had pulmonary fibrosis, he was dyslexic. There were no concomitant medications. Patient experienced excruciating joint pain and it would move around on 17Jan2021 after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Three days after receiving the first dose patient had arthritic pain, on thumb - like he broke my thumb (put on aspercreme and took Advil) but night it went away. The next day my left foot (put on aspercreme and took Advil), then moved up to his right wrist same thing excrucitating pain, hardly move them. Pain in the joints even up in my jawbone. It hurt so bad he couldn't eat soup. He was into 16 days and could not lift his left arm (injection arm) for 4 days could not lift it. He went to see his rheumatologist. On the 04Feb he had his second dose, he did not want to go through all this pain. Caller wanted to know if he needed to get 2 doses again if he missed his scheduled second dose or delayed it. Patient having excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he was not able to move his left arm for 4 days. There was pain in his shoulder, he could move his shoulder, but to do the chicken wing with his arm, he could not do it. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints were there one day and gone, he puts Aspercreme on and took Advil, and by nighttime the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you could not drink soup. His left arm was going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4th. The doctor said he would call. he had a hard time getting around with oxygen. Patient received Aspercreme and Advil for joint pain, he puts Aspercreme(expiry AUG 2022, lot is 19H122) on and took Advil, and by nighttime the pain was gone, but the next day it was somewhere else. The outcome of the events was unknown. Follow up (02Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: patient information and dosing date. Follow-up attempts are completed. No further information is expected.

toothache; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9263) via an unspecified route of administration on 27Jan2021 as 1st dose single (at the age of 65-years-old) for COVID-19 immunization. Patient medical history included an ongoing toothache. The concomitant medications included ibuprofen taken at dose in-between 400-600 mg 3 times a day for toothache. Patient reported that he took Ibuprofen for his toothache before and after vaccination. Patient said that he received his first shot yesterday (28Jan2021) and he has been bothered with a toothache the last couple days and will be bothered with it for a day or two until he can get the tooth extracted. He says he read that it was not recommended to take Ibuprofen prior to vaccination and after vaccination, which he did, so he would like to know what is the situation. He said he did not had any problems. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 08:15 (lot number: EW0162) at the age of 65 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included PKD (Polycystic kidney disease), hypertension, enlarged prostate, meningioma, swollen retina, and allergies to ace inhibitors. Concomitant medications received within 2 weeks of COVID vaccination included eplerenone; tamsulosin; metoprolol; amlodipine; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 23Mar2021 at the age of 65 years old for COVID-19 immunization (product=COVID 19, Brand=Pfizer, lot number=ER8732, administration time=08:15 AM, dose number=1, vaccine location=Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. According to the patient, he experienced "severe visual distortion starting two days after second shot (15Apr2021 at 08:00 AM). Blurriness and extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked. The severe distortion lasted 2 1/2 weeks, however my vision is still blurry in my right eye. All effects were in the right eye." The events resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was given. 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 angiogram: unknown results on 2021, and 3 scans of the eyes: unknown results on 2021. The patient has not recovered from "blurriness/vision is still blurry in my right eye". The patient recovered from "severe visual distortion starting two days after second shot/extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked" on May2021.

Headache; Neck Pain from top of shoulder to neck on left side; Neck Stiffness; Really Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via intramuscular, administered in left arm on 03Mar2021 at 09:30 (at a age of 65-year-old during vaccination) as 1st dose, 0.3ml, single dose for covid-19 immunisation. The patient's medical history and family medical history were reported as none. The patient's concomitant medications were not reported. The patient had not undergone any investigation assessment prior or post vaccination. The patient had not taken any other vaccine 4 weeks prior to Covid vaccine. The patient no adverse events prior to Covid vaccination. On 03Mar2021, the patient almost immediately within 5 mins of vaccination experienced headache. He stated that he went home, and headache still lasting and then within a half hour after the vaccination the patient had neck pain from the top of his shoulder up to his neck and his neck was really stiff, and really dry mouth. He wanted to report his effects, he assumes he had a reaction to the shot. He stated that he was finally starting to feel better. He stated that he has his next one shot in three weeks. The patient had neither visited emergency room nor physician. He stated that his doctor may tell him to go to the ER if events worsened and it was not. The patient took Tylenol as treatment medications for the resulted events. The outcome of the event headache was not recovered and for the rest of the events was recovering. No follow-up attempts are possible. No further information is expected.

Injection precipitated a Lyme's Disease episode: fatigue, confusion, dizziness, low grade fever, ringing in the ears. Treatment: Amoxicillin. 1000mg twice a day. Continued anti-biotics for 30 days. Symptoms receded after 30 day treatment ended

Soon after the injection I experienced tinnitus. It has persisted chronically until now. There have been some times when the ringing wasn't as pronounced but currently I would describe it as loud and persistent.

Ringing in ears; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) as a single dose via unspecified route in the right arm on 25Feb2021 at 10:00 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had no 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. It was reported that the patient did not receive any other vaccines or medications within 4 weeks prior to the COVID-19 vaccination. On 03Mar2021 at 08:00, the patient experienced ringing in ears. No treatment was received for the event. The clinical outcome of ringing in ears was not resolved at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's detail contact information was added per reporter since reporting for self. 2. Patient's "Age at Vaccination" captured as 65 years per vaccination date=25Feb2021 and DoB. 3. "Relevant Med History" captured as "None" per source reported "other medical history: None" and also no allergy and "if covid prior vaccination: No". 4. "Unknown" removed from Lot# field for suspect vaccine. 5. For event: "Treatment Received?" captured as "No" per source reported "if treatment ae: No". 6. Final sentence "Information about Lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." 7. "Concomitant Therapy" captured as None per source "if_other_vaccine_in_fourweeks: No" and "other_medications_in_twoweeks: No". 8. Initial information need be reviewed: covid_vaccine_details: product=COVID 19, brand=Pfizer, lot_unknown=True, lot_unknown_reason=Other, lot_unknown_reason_other=Don't know , administration_date=25Feb2021, administration_time=10:00 AM, vaccine_location=Right arm, dose_number=1, other_vaccine_same_date_details: other_vaccine_same_date_vaccine_date=25Feb2021, facility_type_vaccine: Other, if_other_vaccine_in_four weeks: No, other_medications_in_two weeks: No, other_medical_history: None

After the 2nd Pfizer vaccine I started getting a ringing in my ears. Went to Dr. for the ringing and found out I had hyper tension (high blood pressure), I have never had any history of high blood pressure or the ring in the ear. The Dr has put me on blood pressure medication but the ring in the ears still continues.

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

Symptoms (24x7, for last 15 weeks) o Feels like pressure inside my head. Occasionally headaches, but mostly pressure. o Best description is that I feel slightly "hung over" every day. Or like I have the flu or some other virus o Constant light headed, balance issues – Worse in morning , a little better later in the day o No dizziness, no vertigo o Memory and cognitive skills not at 100% (forgetful, using wrong words occasionally, foggy) o Ringing in ears; vision changes o Exhausted, weak o Get car sickness which has never been a problem before o Stiff, painful popping neck o Nagging cough for months o Possibly increased nasal congestion o Occasional palpitations – seem slightly more frequent than before but unsure o Occasional headaches behind my eyes

his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; his lips swelled and his tongue swelled, so edema of the facial area around his mouth; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ENS318; Expiration Date: May2021), dose 1 via an unspecified route of administration on 04Jan2021 at 11:30 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunization. Patient medical history included ongoing multiple sclerosis had for 30 years. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no adverse event prior to vaccination. Patient had no relevant family history. Patient did not perform any relevant test. Patient concomitant medication history was not reported. The patient experienced lips and tongue started swelling started on 04Jan2021 at 16:00. The patient was given Benadryl, Tylenol and Aleve. It was completely gone at 04:00 in the morning on 05Jan2021. It was reported that, never had a reaction to a vaccine previously but he did have a reaction to a medication, that was 15 years ago. It was the same type of reaction which was why she knew what to do. She only has the name of the medication, it was modafinil.. Patient did not visit to emergency room/physician office. The doctor advised that patient to not get the 2nd shot due to this reaction. The outcome of the events were recovered on 05Jan2021 at 04:00. Follow-up attempts are completed. No further information is expected.

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

Large area of broken blood vessels in right eye; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 09:45 (at age of 65 years old) as single dose for COVID-19 immunization. Medical history included Diabetes 2, high Blood Pressure, High cholesterol. Concomitant medications included: BP meds. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. The patient experienced Large area of broken blood vessels in right eye on 13May2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was recovered in 2021. information on the lot/batch number has been requested.

This is a spontaneous report from a contactable consumer, patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6198) via an unspecified route of administration on 02Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient experienced itchy arm, itchy and watery eye on an unknown date in Mar2021.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 itchy arm and watery eye. The clinical outcome of itchy and watery eye was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

2 weeks after the 2nd shot I woke up with a pain going from my left armpit, along my collarbone to my neck under my jawline. It felt like a string from my armpit to my neck was too short and tight. I also felt slightly ill with pain behind my eyes for the 1st 2 weeks when pain began. I assumed it was my lymph nodes on my l eft side that was affected and not a muscle issue since rubbing it made it hurt more. By the 3rd week I was able to go back to swimming and other activities. It's 8 weeks now but still slightly tender on collarbone and neck.

At the end of the day, I was with some business clients at a meeting in and I completely lost hearing in my left ear and the next day, I did have a really loud ringing which persisted but not to the same degree as it did on the previous day. I went into my doctor and they performed an audiologist test was run by a hearing Specialist on 05/14/2021 and then sent to an ENT, who diagnosed Tinnitus on 05/17/2021. She also said that I had a hearing infection inside my ear and that it was contributed to the vaccine and that there was nothing they could do because it was one of the side affects from the vaccine. She advised me to come back to see if it my hearing became worst (any changes in my condition). I still suffer from an intermittent ringing in my left ear but occasionally once every two weeks my left ear shuts down and I cannot hear anything for two minutes and then my hearing reappears. I have no issues with my right ear at all.

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

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

His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.

Type 2 Diabetes ? November 2020 my bloodwork was normal, A1C was 5.7, HDL and LDL good, yet my triglycerides were high, 280, which has been the case for the last 20 years. I was in good health, no problems, only meds were fish oil and Simvastatin for the last 5 or 10 years for the high triglycerides. My second COVID shot was on 10 March 2021. In a week I became thirsty and noticed weight loss which I thought was good since I was 215 at the time and trying to lose weight. Over the next few weeks the weight continued to come off an my thirst became unquenchable. Mid April I saw Dr. who ordered blood work. I saw her for a follow-up on the 23rd and she put me on 2000 mg metformin and 20 mg insulin a day, my triglycerides were 4,132, blood suger (BS) over 400. Ordered me off sugar and carbohydrates, ordered a FreeStyle Libre 2 which that day pegged (350 mg). A week later not much was changing and Dr had me go to 30 insulin daily which helped the numbers start coming down yet gradually. Over the next 4 weeks the BS started bouncing between 250 and 350, then 150 and 250, and later 120 and 200 with one under 80 (i.e., low) event. During that time I reduced my insulin to 25 mgl a day, then after two more under 80 BS events I was ordered off insulin, and half metformin dose (1000 daily). This week I saw my Endocology specialist who said I was extremely lucky because folks with triglycerides over 2,000 don?t live long (months not years). He kept me on metformin and ordered new blood test adding urine saying the prior panel (when numbers were extremely high) were not valid for my current state being more normal BS numbers. I will see him again 7/29/21. I would appreciate any advice or observations you could provide of others all of a sudden become type 2 diabetes after receiving the covid vaccine, what their diagnosis was, treatment, results, etc. Also, does Pfizer have any advice or corrective action they could offer, or at least data from other folks having a similar problem as me?

After receiving the vaccine, it seemed as if I had a curtain come down over my right eye in a diagonal way. I had blindness that covered a third of my vison in the upper right corner. I didn't think anything of it at first, but then it happened a third time so I thought that was odd. I called my eye doctor the last time it happened. I thought it was a detached retina. I went to the doctor the next day but he couldn't find any signs of a detached retina. He was concerned I had a TIA. He wants me to have a doppler of carotid arteries in my neck. I had an appointment with an ophthalmologist on May 25th. My appointment for the doppler was on June 1st. On June 3rd, I went to my family doctorand he looked at results of the test. He was concerned about temporary blindness but doesn't know the cause of it. He wants me to see a neurologist. On June 30th I had an appointment with the neurologist and he said he didn't think it was a TIA. Nothing has been found or discovered as to why I am experiencing the temporary blindness. As of May 24th, that was the last incident I had with temporary blindness, and I haven't had it since.

PATIENT RECEIVED THE VACCINE AND WITHIN APPOX 15 MINUTES CAME BACK TO THE PHARMACY WITH SWOLLEN LIPS AND ITCHY HANDS AND WAS FLUSHED. WE ADMINISTERED 10ML OF ORAL BENEDRYL , PATIENTS BLOOD PRESSURE WAS FINE. CONTACTED 911 AND EMS RESPONDED AND TOOK PATIENT TO HOSPITAL.. BEFORE TRANSPORT PATIENT WAS PRESENTING SIGNS OF FEELING BETTER.

On 05/01/2021 (over 11 weeks from second dose) I noticed the injection site had risen to a bump with a head on it like a big mosquito bite.; On 05/01/2021 (over 11 weeks from second dose) I noticed the injection site had risen to a bump with a head on it like a big mosquito bite. This was not there previously. It itched significantly for 3 days and oozed with a crusty cap.; On 05/01/2021 (over 11 weeks from second dose) I noticed the injection site had risen to a bump with a head on it like a big mosquito bite. This was not there previously. It itched significantly for 3 days and oozed with a crusty cap.; On 05/01/2021 (over 11 weeks from second dose) I noticed the injection site had risen to a bump with a head on it like a big mosquito bite. This was not there previously. It itched significantly for 3 days and oozed with a crusty cap.; On the 3rd day my left eyelid was itching and by the end of the day it was significantly swollen.; On the 3rd day my left eyelid was itching and by the end of the day it was significantly swollen.; On 4th day injection site is just a small scab but eyelid is still significantly swollen.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. 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 an unknown date in 2021, (over 11 weeks from second dose) the patient noticed the injection site had risen to a bump with a head on it like a big mosquito bite. This was not there previously. It itched significantly for 3 days and on an unknown date in 2021, it oozed with a crusty cap. On the 3rd day on an unknown date in 2021, her left eyelid was itching and by the end of the day it was significantly swollen. On 4th day, on an unknown date in 2021, injection site was just a small scab but eyelid was still significantly swollen. The patient has had no exposure to mosquitos or other biting insects, and the arm location was exactly where the second Pfizer shot was administered. The clinical outcome of the events bump with a head on it like a big mosquito bite, itched significantly for 3 days, oozed with a crusty cap, eyelid was itching and significantly swollen, injection site was just a small scab was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Apprx 7 minutes after receiving vaccine, I experienced a sensation in my chest, upper arms, and neck areas. I also experienced a slight metallic taste in my mouth. I also sensed a somewhat increased heart rate and some slight dizziness. I did NOT experience any breathing difficulties but maybe had a very slight wheeze sensation. These reactions lasted only about 8 to 10 minutes then started easing away. I was monitored a full 30 minutes and then released after reporting I felt ok then.

My tinnitus, which I've had for about 3 months now, became much more intense beginning in the evening and through the night, and continues to be extra intense today.

Excessive thirst after both vaccines, just after second vaccine, face becoming bright red and blood pressure low, two days after second vaccine, unable to sleep, passed out when standing up X 1, nausea, fatigue

Tinnitus and diminished hearing onset 12/27/2020. Symptoms less evident, but still persisting as of the date of report.

I have chronic Lyme disease, with extreme symptoms of photosensitivity and photophobia. 12 years ago, I had a series of intravenous antibiotics for 9 months. That halted the progression of the symptoms. However, with the first injection of the Pfizer vaccine, I had an immediate and increasing photosensitivity/photophobia. For example, my computer monitor was at 6% brightness. I reset to 3% brightness, which is still too bright. My concern is that the second injection due on February 12th may further increase the symptoms. My Lyme doctor believes that the light sensitivity is perhaps coming from the thalamus. Additionally, the injection seemed to increase my INR.

2nd immun on 2/12 2pm. Noted taste of blood in mouth on 2/14. On Mondya 2/15 sent note to primary about adding a CBC for an already established appointment on Wed. Lab appointment was wet for 2/16 am. The evening of 2/15, my platelet condition worsened starting with profuse bleeding of gums following a waterpik session and subsequent identification of petechia on legs and blisters on month and tongue. I called my hematologist's after hour service and agreed to stick with original testing plan

Thirty minutes after 1st vaccine administered mental foggiest and headache and acrid taste in mouth. Then three days post vaccine return of brain fog and headache. Gradually headaches subsided within ten days.

12/21/2020 I had my first Pfizer COVID-19 vaccine and the second on 1/13/2021. Two days after my second vaccine on 1/15/2021 at 8:50 PM I had a scintillating scotoma in my right visual field in both eyes consisting of a bright flash of light in the center of my visual field that cleared but then it expanded into a C-shaped series of zig-zag lines that slowly expanded into the periphery of both right visual fields. It ended at 9:20 PM. I had no headaches afterward. While I have had migraines when I was younger, I haven?t had one in several decades and I never had an aura before it. I went to the ED where I was evaluated for a possible TIA and then admitted into Hospital. While there my platelet count was 400% of what it usually was. Other than the platelet count and anemia (I donated 2 unit of packed red blood cells on 12/17/2020) the rest of my blood work was unrevealing. The scintilating scotoma only lasted 30 minutes but the elevated platelets (although slowly coming down) continues to this day.

Tuesday Night - Interior of right eye had multiple color blockage (size of thumbnail) in lower section of eye that blocked out what I was seeing with horizontal orientation. Wednesday Morning - shape was reduced to 1/3 its previously stated size, vertical orientation, depending on what I was looking at the color changed, but still blocked out portions of what I looked at. Wednesday Morning - shape was 1/4 the original size, vertical orientation, varied in colors, but still blocking images completely

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

According to staff....Recipient received the above vaccination and went to sit for 30 minutes. He had already explained to the staff that he had had previous reactions to bee stings that required epinephrine so the nurse practitioner had instructed him that he was to wait for 30 minutes vs the usual 15 minutes. It is unclear exactly how many minutes into the post-vaccination period passed before he began to report numbness around his lips. The nurse practitioner then indicated he began a "rash" on the back of his neck. The recipient reported that this was feeling very much like his previous allergic reactions. They took his BP and it was reported to be around 180/100 at that time. He did not report feeling SOB but reported his throat felt like it had in previous allergic reactions. Recipient remained alert and oriented the entire time. It was decided by the two nurse practitioners on site that he be given the epinephrine and Benadryl IM. His BP remained elevated and then, following the epinephrine, he became very shaky and a bit foggy. 911 was then notified for further assistance from the EMT's and possible evaluation at the local hospital which was about 5 minutes away. Paramedics evaluated the recipient and agreed that evaluation at the hospital would be warranted. He never lost consciousness or required oxygen or other assistance. He was able to place himself on the gurney and was speaking with his wife (that was present)as he was taken out the door. The transfer was done out of an abundance of caution. We do not know if the hospital kept him following the incident.

He had first shot at their Covid immunization clinic. No reaction after first shot on 02/02/2021. No reaction after second shot 2/26/2021 until Tuesday March 2 when he lost his taste and smell, he had no temp and no other symptoms. He was tested on 3/3/2021 and it was negative. So only problem was the loss of taste and smell.

Patient is a 66 y.o. male who presents as a transfer to Hospital from an outside hospital for ICH. Patient states around 1130 he was running on the treadmill and noticed sudden left-sided weakness and decrease in station. He arrived outside hospital and was found to have left-sided hemibody weakness, left-sided decrease in station and a right gaze preference. CT at outside hospital showed large ICH with 3 mm of midline shift and vasogenic edema. repeat scan was performed and showed 7 x 2 x 4 cm frontal parietal region hemorrhage. Patient is now in rehab and states he has left sided paralysis

Increased BP and heart rate way above the my normal. No treatment and waiting outcome at this point. The same is true for my puffy eyes that are almost shut like I am squinting.

Patient stated he started to feel tingling in his lips 10 minutes after he got his vaccine. At 9:50 am he stated he thinks he just panicked and he feel ok now, but he wants to stay at observation for 10 more minutes. At 10:06 am he stated he feels good and is ready to go home.

right eye was blood shot, it was red; had to keep his eyes closed to keep light from coming in so he won't be in pain; had to keep his eyes closed to keep light from coming in so he won't be in pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he was having some symptoms that has got worse and wanted to know if he should do something and wanted to know something what went with his eyes. His right eye was blood shot, it was red and daily amount of light that hits his eye was very painful so he had to keep his eyes closed to keep light from coming in so he won't be in pain. Patient was not able to give the lot number because it hurts too much when he tried to turn on the light to reach that (vaccine). Events started on Feb2021. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.

I was monitored the recommended 15 minutes and was fine. I went to the car, was being driven home, and about 20 minutes after the vaccination I developed an odd sweet/metallic taste in my mouth, followed by increased saliva, some difficulty swallowing, nasal congestion, and some chest discomfort. They symptoms were already getting a little better by the time we got home (about 30 minutes after the shot), but I took a Benadryl and the symptoms resolved within 2 hours. After that I just had the expected arm pain and fatigue until the next morning. Since then I have been fine.

The patient presented yesterday to an urgent care center on 3/11/2021 with chest pain, jaw pain, and shortness of breath. He reports multiple occurrences over the past week. He was sent to the ED, where he was then admitted for hypertensive urgency/emergency vs. unstable angina.

I received the Pfizer COVID 19 vaccination on the morning of 2/17/21 with no resulting initial sequelae other than injection site tenderness. Approximately 2 weeks post-injection, I developed coryzal symptoms of nasal stuffiness and congestion without fever, chills, headache, or myalgias. On, or about, 3/3/21, I noticed diminution of hearing in the left ear without signs of drainage, fever, or dizziness. This was treated with a Z Pac, nasal and oral decongestants, and nasal steroids. Over the course of 10 days, the hearing decline had improved, but a clinical exam and testing by an ENT on 3/12/21 confirmed evidence suggestive of sensorineural hearing loss, with asymmetric impairment in the affected (left) ear.

I had the Pfizer vaccine in my left arm on Jan. 23rd. I had no side effects at the time, other than a sore arm, as with any shot. However, two days later I lost all hearing in my left ear. I had no history of ear infections or other ear or hearing problems, except for wax buildup two or three times. On Jan. 26th, I saw an ENT. To my dismay, there was no wax. He prescribed the standard treatment of Prednisone for Sudden Idiopathic Hearing Loss. No change after the first round, so I had a second round, and also had the series of three ear injections with Dexamethasone. Had an MRI, as well, which was normal. A couple of weeks into all this, I began to have a bit of sound-generated static in my ear, and this continues today. (Fortunately, I?ve only had the most minor of tinnitus in that ear, and even it is pretty much gone now.)

Throbbing of tongue and tingling; Throbbing of tongue and tingling; Tingling around eye and nose; little dizzy; Stuffiness; This is a spontaneous report from a contactable 66-year-old male consumer (patient). A 66-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 10:00 AM (at the age of 66 years old) as a single dose, for COVID-19 immunization. Medical history included HIV positive 31 years asymmetric high T-Cells undetectable viral load; Allergies to medications, food, Penicillin, sulfur drugs, Cypro and levofloxacin (LEVAQUIN); HIV positive, High blood pressure (HBP) and high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within 2 weeks of vaccination) included HIV medication, high blood pressure, high cholesterol. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced throbbing of tongue and tingling, tingling around eye and nose, stuffiness and a little dizzy, all on 07Feb2021 at 6:00pm. The patient went to the emergency room and was told it's probably a side effect to vaccine and they saw nothing serious. The patient reported that he called 911 a few days later and was told the same thing. This episode occurs at least 3-4 times per week and lasts for about an hour and then goes away. Treatment was not received for the events. The events of Throbbing of tongue and tingling, Tingling around eye and nose, little dizzy required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient was tested for COVID-19 (Antibody test as well as nasal swab) on 12Feb2021 with negative result. The clinical outcome of the events throbbing of tongue and tingling, tingling around eye and nose, little dizzy and Stuffiness was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.

Had a stroke 36 hours after getting second vaccine. Lost ability to speak and see clearly, had word salad. Was identified quickly by my wife and was taken by ambulance to hospital where they gave me TPA clot buster infusion after identifying a clot in my left back side of brain and luckily I responded well and have all speech function back we believe so far.

I got my first Pfizer COVID shot on March 2. On March 9 I had an episode of double vision for a couple of minutes but it went away. On March 10 it returned and worsened such that when I looked to the left my vision had a magnifying effect. After consulting with my Ophthalmologist and my primary physician it was decided that I should not at this time get my second shot scheduled for March 23 due to potential exacerbating problems from my March 2 first shot. Further it was seen that my blood glucose was showing me diabetic for which I have begun medical treatment for type 2 diabetes.

Red rash ( no itch ) at axilla ,groin, *forearms, and neck Eyes are slightly puffy with slight pink face * Have some pictures of representative rash area

Fever above 101 degrees, severe chills, severe headaches and fatigue for 48 hours. Two days later when appetite returned, I realized I had completely lost my sense of taste and smell, which has not yet returned. Still experiencing fatigue, mild headaches, and nasal stuffiness.

I have never passed out prior; 1 in.laceration above the right eye along; food is less flavorful and does not excite me; Feeling queasy; bruising to my upper arm, leg and back; don't feel right; About 10 hours after the second injection began to have chills and a low grade fever.; About 10 hours after the second injection began to have chills and a low grade fever.; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration (on left arm) on 06Mar2021 12:00 (at the age of 66 -years-old), single dose for COVID-19 immunisation. Medical history included Diabetes Type 2 (Doctor stated that I really do not fit either profile. Concomitant medications included pioglitazone, metformin, lisinopril, ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). Patient stays away from all Opioids they make him very nauseous. Patient typically gets a low grade fever (100-101) and chills 4 hours after a Flu Vaccine that last almost exactly 24 hours. The patient had the first dose of covid vaccine on 11Feb2021 for covid-19 immunisation and experienced only minor soreness at the injection site with the first dose. Experience only minor soreness at the injection site with the first dose. About 10 hours after the second injection began to have chills and a low grade fever. Sunday morning 07Mar2021 started feeling queasy. Patient thought that if I took a shower that I might feel better. As Patient was getting toward the end of his shower Patient just thought, Patient don't feel right. The next thing Patient remember Patient was picking himself of the floor of the shower. Patient have never passed out prior to this episode. Patient received a 1 in. laceration above the right eye along with bruising to his upper arm, leg and back. Patient basically ate nothing the remainder of Sunday nor Monday. It is as if the food is different. Even though he is a Diabetic and keep his blood sugar under control. Patient knows that this may sound weird, but it is as if the food is less flavorful and does not excite him. As 09Mar2021, he still does not feel together. The outcome of the events was not recovered. No treatment for any adverse event. No Covid prior vaccination, not Covid tested post vaccination.

Patient reports significant worsening of tinnitus, which he states was previously mild. He states it is progressively worse and has become much more prominent.

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

03/18/2021 Woke up with hearing loss, fullness and loud tinnitus in left ear; fullness and increased level of tinnitus in right ear. Had small amount of ear wax removed from left ear with no improvement. Erratic blood pressure and pulse rate. Doctor started me on Amlodipine which I have now discontinued as BP has returned to normal. Fullness and high level of tinnitus continues in both ears with some intermittent improvement.

developed coryzal sxs of nasal stuffiness; developed coryzal sxs of nasal stuffiness; ear fullness; decreased hearing L ear; unilateral hearing loss without dizziness or pain; sensorineural dysfunction; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), intramuscular, administered in left arm on 17Feb2021 09:15 as single dose for covid-19 immunisation at a hospital. Medical history included allergies to sulfa-urticaria, hypertension (HNT), hyperlipidemia, hypothyroidism, GERD, osteoarthritis, and coronary artery calcification per cardiac CT scan. Concomitant medications included levothyroxine sodium (SYNTHROID), atorvastatin, metformin hydrochloride (METFORMIN ER), hctz, famotidine, ergocalciferol (VIT D), and melatonin. The patient had no other vaccine in four weeks. The patient previously took fenofibrate and experienced allergies: photosensitivity. The patient received IM injection on 17Feb2021 with no sequelae initially. On or about 03Mar2021 at 13:00, the patient developed coryzal sxs of nasal stuffiness and ear fullness. The patient used Flonase and Z pack and Afrin. The patient also developed decreased hearing L ear confirmed yesterday by ENT doc. This was unilateral hearing loss without dizziness or pain. Hearing has improved but is still abnormal. Tympanograms are normal. Exam was consistent with sensorineural dysfunction. The patient was reluctant to receive the second dose scheduled for Wednesday, 17Mar2021. The events were assessed as serious due to disability or permanent damage and resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for Covid post vaccination. The outcome of the events was recovering. Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Mouth began to quiver/drool; was able to walk inside from outdoors; had been happening about 2 =3 minutes before I realized what was happening. Was standing so had him continue to do so while I held onto him to let the event pass. Recovered within 5 minutes with no adverse affects. Has been 1.5 years since any previous seizures so wanted to report this for fyi.

DIZZINESS AND VERTIGO AND APPEAR TO SEE FLOATERS / HAVE NOT HAD THIS AFFECT SINCE i WAS FIRDT DIAGNOSED WITH TINNITUS AND COMLETE RIGHT EAR HEARING LOSS vestibular disorder in 1985

Symtoms: headache, loss of vision in left eye, vertigo. Stroke took time to diagnos, I thought it was a vision problem. Long time delays occurred while scheduling further testing (CT and MRI). Summary from MRI: "Study Result Impression: There is diffusion restriction along the left thalamus consistent with subacute ischemia, greater than 6 hours in etiology but less than 2 weeks." Outcome: Vision is slowly improving, headache is mostly gone, vertigo & mental status slowly improving.

Covid symptoms. Fever of 102 for 3 days. Cough ( still occuring) sweating. Generally feeling unwell as well as runny nose. Headache. Pressure around eyes. Sensitive to bright light.

elevated blood pressure, garbled speech, TIA Pt presented for acute stroke-like symptoms (L hemibody weakness, dysarthria, L gaze preference, dysarthria, word-finding difficulties) following a COVID vaccination (about 1-15 min after) at 1230 on 3/18/21. PMHx notable for multiple prior TIAa, HTN, HLD, PVD c/b R femoral artery thrombus (2017, no intervention, on Plavix), T2DM (prior A1c 6.5%, recently 6.2% not on meds), COPD, prior splenectomy (childhood re: car accident), chronic L ulnar neuropathy, bilateral hearing loss, complex partial seizure disorder following Rocky Mountain spotted fever. Symptoms resolved fully within 24 hours of event; diagnosed with TIA. MRI without new ischemic findings; chronic small vessel disease and chronic small R cerebellar stroke noted. TIA likely occurred in setting of hypertensive event with systolic BP to 220s. ED attending reported an NIHSS of 9. Of note, blood pressure was in the 210s systolic on admission, and subsequently down trended. Per resident, initially had left gaze deviation however on exam had full ocular motility. Pupils were of equal (size: OD 3, S 3) and reactive. Ocular motility was full without nystagmus. Facial sensation normal. Initial mild left facial droop, which also resolved. As the exam progressed, the patient's symptoms began resolving. Patient was able to articulate his thoughts better without dysarthria and strength markedly improved in the left upper and lower extremities to full 5/5 strength within about 30-45 minutes. NIHSS improved from 9-1. Of note, the patient reported having several episodes similar in nature, in the setting of significant hypertension as well. Denied ever having a true stroke in the past.

Patient received 2nd Pfizer Vaccine approximately 11:10 am. Patient reported burning sensation in chest and lightheadedness and feeling warm. Taken to medic room. Initial vitals: BP: 144/94, P: 83, O2: 98%. Approximately 11:43 am: Patient reported left arm numbness and numbness in bilateral legs. Also reported blurry vision. Patient with of CVA, MI, Pulmonary Emboli, Seizure disorder. He did stop Protonix 2 months ago per patient and Keppra discontinued by PCP 2 weeks ago. On exam: grip bilaterally intact, sensation intact, oral mucosa intact, Heart regular rate and rhythm, Lungs CTAB. No rash noted. No oral swelling. Alert and oriented x3. Recheck vitals: 145/97, HR: 80, O2 saturation 97%. Continued numbness on left side and lower extremities. Burning sensation/reflux in chest still ongoing. EMS was called for further evaluation.

On April 11 at 1AM I noticed the light coming through the window was unusually dim. I glanced at the smoke detector light and noticed it was dim. Normally this light illuminated the nearby wall but I was barely able to see the light. My illuminated clock also was clearly dimmer than usual. It was as if my pupils were not adjusting to the dark. This symptom subsided last night and my night vision is now normal.

Patient experienced a 45 minute episode of kaleidoscope vision starting small and growing to 50% of vision before fading away.

Patient reports he got pfizer vaccine on 3/31. He developed metallic taste, and numbness on the left side of the face and left hand on 4/3. He was seen in my clinic on 4/6/2020. MRI brain ordered, showing right thalamic sub-acute infarct.

03/07-27 Progressive left and right hip pain 03/13-03/14 and 03/20 Significant hip pain after yard work 03/07-03/27 Progressive left and right groin pain 03/13-03/14 and 03/20 Significant groin pain after yard work 03/07-03/27 Progressive outside lower right calf pain (sporadic) 03/13-03/14 and 03/20 Significant lower right calf pain after yard work 03/28 Unusual reaction at night following second vaccine - flushed 03/28 - 04/01 Progressively acutely severe both hip, groin, and lower outside calf pain 04/02-05 start of indigestion, heartburn, brain fog, fatigue, leg tremors - leg pain less with Tyleniol 04/05 Significant chest pain - went to ER - EKG, blood work, chest x-rays checked OK, given GI cocktail 04/05 - 04/18 Leg/hip/groin pain (joint and muscle) - not as severe as first 5 days after 2nd shot), some heart burn, indigestion , cotton mouth, periodic tremors, periodic fatigue, feeling of thickening throat, slight eye burn, easily chilled o Each episode is preceded with an allergic reaction type feel o Each episode is near end of 8 hr Tylenol duration although seems worse at night

Pt c/o tongue feeling swollen and difficulty breathing. Observed pt to be having dyspnea and face flushed. BP: 130/80, Pulse: 75. EMS notified. Administered Epi Autoinjector 0.3mg x 1 IM (L vastus lateralis) at 10:02. EMS arrived at 10:05 and assessed pt. Recommended to go to hospital but pt refused. Wanted to see his MD.

Female who presents to the office today stating last Thursday on 2/25/2021 she received her first Covid vaccine which was Pfizer. She reports premedicating herself before the vaccination with 1 Pepcid and 2 Benadryl. However unfortunately within 13 minutes of receiving the vaccine she started to experience a and irritation of the tongue/throat with tingling sensation followed by throat hoarseness, a cough and a red face. She was experiencing a little bit of chest tightness in addition to a little bit of shortness of breath and therefore used her albuterol inhaler. Shortly thereafter her red face improved. EMS was called to the scene however by the time they arrived she was improving and was sent home. She took a Benadryl at home later in the evening and the following day on Friday she started Pepcid daily since that time. She states since the vaccine she has felt poorly describing exhaustion and feeling achy all over with continued raw throat. She has not warranted use of her albuterol inhaler since last Thursday and ran out of Benadryl Thursday evening only utilizing Pepcid daily and continues on her other medications. She reports a history of allergies to petroleum products including polyethylene glycol which is suspected to be the cause of her allergic reaction

Developed sensitivity/pain of the tongue as well as a change in the ability to taste some foods. As of today these symptoms have been present for 3 weeks and continue to persist.

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

Tinnitus in both ears. Appeared shortly after second shot. Popped up and took me a bit to correlate it to the vaccine. Never had Tinnitus before.

On Feb 26, after my vaccine, I arrived home at 6:30 pm and told my wife my ears are ringing loudly. This lasted a few hours. On March 26, after my vaccine, I arrived home at 6:30 pm and told my wife my ears are ringing loudly. This lasted a few hours.

Existing Tinnitus became much louder and more persistent the day after my 1st Pfizer Covid Vaccine. This really sucks.

tinnitus - very minor prior to vaccine; appears to be getting progressively worse. made an appt w/ Dr. 4/14 - vaccine did not come up in conversation. he recommended a 6 week treatment to clear up nasal passage ...follow up appt may 26. i will be calling him but read about many people experiencing similar side effect allegedly from the vaccine and felt compelled to file this report

Yesterday is when it really started to increase and has gotten worse since starting; has "intense" pain on all the joints; intense pain that started in the left side of his jaw, in the joint; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 10Feb2021 13:30 as single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus had for 5-6 years , ongoing hypertension had for about 8 years. There were no concomitant medications. Reporter stated that he had covid vaccine on 10Feb Wednesday and afterward he has had joint pain which he explains was intense pain that started in the left side of his jaw, in the joint. He also has intense pain in his left thigh, in the joint socket. He stated that he also got a headache, but it was gone away. Patient wants to know if this was a side effect. Patient stated that he got the shot on 10Feb2021 and the joint pain was noticed that day, it was real faint that evening. Yesterday is when it really started to increase and has gotten worse since starting. Patient stated that his wife got the shot too when he did and had some joint pain but is has gone now. Reporter stated that on the back of the card it says After: 03Mar2021. This might be when he gets the next shot. The outcome of the event has "intense" pain on all the joints and intense pain that started in the left side of his jaw, in the joint was not recovered. The outcome of the event headache was recovered. The outcome of the event yesterday is when it really started to increase and has gotten worse since starting was unknown. Follow up (12Feb2021): This is a follow up spontaneous report from a contactable Consumer. No new significant information was added.

2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2021. Rx Valacyclovir (7 days). Pain lasted 2 weeks. Fatigue since then has caused me to have to nap almost every afternoon, 1.5-2 hours. Unable to concentrate for as long as I used to. Shortness of breath and inability to walk as far as normal (regular 1.5m walk now a challenge). Worsening tinnitus.

right eye "floater" -- posterior vitreous detachment, occurred 2 days after 2nd shot of Pfizer Covid-19

Two days after I received my first vaccine, horrible pulsating, loud tinnitus started. A loud ringing in my right ear with every heart beat. I couldn't sleep for many days and still have trouble after all this time. The pulsating is non stop... 24/7. I am doing my best to live with this but it is unbearable at times, to the point of driving me close to insanity. I have some days where it is bearable, but never goes away. I would have never gotten the covid-19 shot had I known that the adverse effect would have been this bad. I has all but ruined my way of life up to this point.

I have been sick since the day after the first the first Pfizer shot. 24 hour head ache, drowsy, lost concentration, ringing in my ears and just cant seem to wake up. I have been to the doctor three times and had mutable blood labs, and am now seeing a neurologist who has ordered a MRI of my brain. The problem is none of the doctors have any experience dealing with these adverse symptoms from the injection, does anybody? So who is going to help me before the lights go completely out?????

Lost sight in left eye for 1 hour on 4/14/2021. Although the loss of sight and subsequent hospital visits MAY NOT HAVE BEEN DIRECTLY RELATED to the vaccine, the fact that this occurred 6 days following my 2nd dose makes me want to report it in case others have reported anything similar.

This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 20Apr2021 11:45 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included sertraline; beta carotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL); and ascorbic acid, beta carotene, copper, nicotinamide, selenium, tocopherol, xantofyl, zinc (LUTEIN +). On 22Apr2021, the patient experienced right eye "floater": posterior vitreous detachment. Doctor said probably not due to the vaccination, "just a coincidence". The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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.

Client complained of lip tingling after receiving the 2nd dose of Pfizer vaccine. Post vaccination waiting period was 30 minutes due to history of severe allergy to peanuts. Client VS were stable. Lip tingling improved prior to discharge home.

Fever, chills, myalgia, new loss of taste and smell Sore throat and Cough Shortness of Breath Fatigue Headache Diarrhea

SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS. He states he has been taking Motrin 800mg 1 TAB, PRN. HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal). Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.

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

Atrial fibrillation; mild stroke; my skin was kind of different looking you know like aging a little bit you know like wrinkling; seeing flash burn every once in a while; have a obstruction in the main artery of left eye; went totally blind in my left eye; probably got macular degeneration; pain in the arm; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration in the left arm upper muscle on 02Apr2021 11:45 at age of 66-year-old (Lot Number: ER8737) as 2nd dose, single for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number was EN6204) for Covid-19 immunisation in Mar2021, at age of 66-year-old and experienced pain in the arm. Medical history included Barrett's esophagus, Diverticulitis, Gastrooesophageal reflux disease, Generalised anxiety disorder, Cataracts, Kidney stones, Chlamydial infection, Left ventricular hypertrophy, Vertigo, hiatal hernia repair done, hypertension, had a colonoscopy quite often in another words to remove the polyps from his colon. Concomitant medication included omeprazole taken for GERD (gastrooesophageal reflux disease) and paracetamol (TYLENOL). The patient experienced atrial fibrillation on an unspecified date with outcome of unknown, mild stroke on an unspecified date with outcome of unknown, went totally blind in my left eye on 09Apr2021 with outcome of not recovered, probably got macular degeneration on 09Apr2021 with outcome of unknown, pain in the arm on 02Apr2021 with outcome of unknown , my skin was kind of different looking you know like aging a little bit you know like wrinkling on an unspecified date with outcome of unknown , seeing flash burn every once in a while on 09Apr2021 with outcome of unknown , have a obstruction in the main artery of left eye on 09Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included CAT scan and EKG both with unknown results on 24May2021. The events result in Physician Office Visit, no treatment was received. Clinical course: Consumer stated, "Well, I got my first Pfizer shot I just thought I should just call and discuss this with somebody bit of some sheet I got I got the Pfizer vaccine and I got that one on 15Mar2021 the first one and then I received the second one 02Apr2021 and when after I received the second one I had the pain in the arm like normal but it was a lot more severe than I got from the first one but it went away but you know normal 3 to 4 days it went away so I did not wasn't that concerned but I also know this to ask. After I got my skin was kind of different looking you know like aging a little bit you know like wrinkling but then all of a sudden it cleared up too that went away probably about the same time a week after I got the shot I started having vision problem(distorted voice and incomplete sentence). I visited an ophthalmologist an regular eye doctor it was an ophthalmologist (distorted voice and incomplete sentence) and he said no I don't see that you have a stroke I don't see that you have vision problems with your retina this time you probably got macular degeneration going on so anyways he said comeback if you have an issue then I said so you are telling me that even though my vision is going in my left eye I am not gonna go blind and I didn't have a stroke he said yes. Ok, so anyways exactly a month after that I went totally blind in my left eye my vision came back, my vision came back. I forgot to tell you my vision came back fully for a while but it was different in my left eye like I was seeing flash burn every once in a while when I was in the sunlight and stuff. Anyway a month later after I got the second shot when I went totally blind in my left eye and so I got upset about the doctor's here and I had to go to (Address) to pick my new eyeglasses anyway so I had to drive to (Address) with one eye which is 230 miles from me anyways, so when I got my glasses there at they were the right prescription thank god and I told them about the eye issue so they didn't throw a eye test really thorough and said yes I definitely see a problem in your left eye looks like a flash burn or something like that so then they had me setup an appointment with really good ophthalmologist in (Address) because I wanted a second opinion whether my insurance covered it or not. So I went to this retinal specialist and I was in his office for like 3 hours they were checking me out in there you know he said yes definitely you have an obstruction in the main artery of your left eye and that's why you lost your vision and this doctor said there's only two things it could be it it could be you had a stroke or that you had a bad reaction to the Pfizer vaccine and so anyway he wanted me to go either into the emergency room a good (Address) to further do testing, I said no I don't wanna do that because that's all out of my own pocket that would have been thousands of dollars you know, but I don't know I am all confused about this medical care. I am just trying to give you all a scenario from day 1 going forward you know anyway so I refused to go to good (Name) and he said well it should be okay anyway because it's been so much time since the original problem that you would be probably alright to just back to your hometown there and go to the hospital and have your testing then there I did and the next day I got back to (Address) from (Address) I went to the hospital there they did an EKG on my heart and they did a CAT scan on my head and they said they couldn't see anything from the EKG or the CAT scan that I had but that doesn't mean you didn't have(Incomplete sentence), so they said you could have a mild stroke and you know anyway we want you to go further testing well I had a primary care physician appointment two weeks later which is still coming up so I have to her so they want to order an MRI and some other tests on my heart because they think I have might have an AFib atrial fibrillation where the blockage I mean where the blood flow properly to my heart you know if I want to do those tests too but I am just letting you know this cause the one doctor said it could be that you have the eye problem because of the vaccine that's what I am calling you about." Consumer Stated, "Yes, you can follow up sure because I am more anyway cause on the 09June2021 I have an appointment with my primary care physician which is the one that have to do the order in heart chest and the MRI and the following week. I am going back to (Address) to that Ophthalmologist that said that it might because of Pfizer vaccine I am going back to him I got a follow up with him because he wants to me to take care of my eye issue so maybe I can get my eye sight back in other words or so." Date adverse event started: Consumer stated, "I had my first shot on Friday 02Apr2021. The exact day that I started having issues was exactly one week later on 09Apr2021. Other than the normal you now pain in the arms because that started and went away normal that started you know. Well that started basically right after I got the shot on 02Apr2021 with the pain and the arm thing that was right after I got the shot 02Apr2021 and it was the little bit more severe than the original shot. 09Apr2021 is when I stated having eye problem." Anatomical Sites of administered: Consumer Stated, "The first one I had them do it in my right arm in the muscle top in my right arm and the second one was done in the left arm upper muscle." Other Medical Conditions: Consumer Stated, "Nothing life threatening but I have chronic health conditions, quite a few of them. I got Barrett's esophagus, then Diverticulitis of the sigmoid colon then electro cardiogram(Further not clarified) they did was abnormal they said. I got GRD Gastroesophageal reflux disease. I got generalized anxiety disorder, GAD. I have Cataracts. They said I had a genital disorder I don't know what that means. I got history of Calculus in the kidneys, kidney stones but I haven't had a problem with that from quite a while, I changed my diet. I have past Chlamydial infection which is an STD. I had hiatal hernia repair done, so surgery. I have hypertension disorder they say, left ventricular hypertrophy which I guess has something to do with the heart, I think that's why they wanna do more test of my heart. I got polyps in colon (Further not clarified) and occasionally I get Vertigo so I have to have a colonoscopy quite often in another words to remove the polyps from my colon." Treatment medication for medical conditions: Consumer Stated, "Well they only I take Vitamin D3 and I take Vitamin C but that's vitamins basically the only meds and I am taking. I am using Eye Drops right now over the counter stuff basically the only meds I really take is Omeprazole which is for my GRD disorder you know my gas my stomach gas it controls my stomach gas and then extra strength Tylenol I take that as needed sometimes." Start date of taking the medication: Consumer Stated, "Well the Omeprazole I probably been taking that for 10 years at least 8 years or 7 years. I really couldn't give that to you without going through a pile of paper work." When asked about if consumer is taking any other medication, consumer Stated, "No, Just Omeprazole." Lab test: Consumer Stated, "Well they did an EKG and they did a CT scan and that was just recently because of my issue that I got right now going on. Yeah, that was done at (Name)." Date of test: 24May2021. Result of test: Consumer Stated, "Only the doctor has that I don't have that I have to go to my primary physician on 09May2021 to get those results." Event Details: Event Date: Consumer Stated, "When I had the first shot I didn't have any side effects at all except for the minor arm pain." When confirmed event date as 02Apr2021 and 09Apr2021, consumer stated, "Yes that's when I started having adverse side effects." Still experiencing the problem: Consumer Stated, "Yeah, I am still blind in my left eye yes." Outcome: Consumer Stated, "Well I don't know it's kind of early if they are gonna improve or not they want to do more testing the doctor know more when they did more tests I don't have all the information because they still doing test on me to figure out what's going on but I decided to call you know before it got too late in the whole situation you know." Treatment: Consumer took for the adverse events consumer stated, "No I don't think they gave me any drugs or anything for the tests." Consumer hung up abruptly hence further probing could not be done.

complete hearing loss in right ear; 10 fold increase in tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in left arm on 31Mar2021 13:30 (batch/lot number ER8733 and expiry date unknown) at 66 years of age as dose 1, single for covid-19 immunization received in a hospital. Medical history included ocular MG (migraine), benign prostate enlargement, hiatal hernia, high cholesterol, ongoing tinnitus. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no covid prior vaccination. Concomitant medications included omeprazole, simvastatin, finasteride; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he experienced 10 fold increase in tinnitus, complete hearing loss in right ear (medically significant). The patient informed that the adverse events start date was 27Apr2021 and start time 09:45 am. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient was not covid tested post vaccination. The patient received steroids due to the events. The outcome of the events was not recovered.

I have Eczema and on occasion will get a flare up lasting a few days / I have NEVER had a flare up as bad as this; break out with a rash, and pustules on my hands. This then spread to my legs, back, and swelling to my right eye; break out with a rash, and pustules on my hands. This then spread to my legs, back, and swelling to my right eye; swelling to my right eye; Both hands are loaded with bumps as well as both arms; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (at the age of 66 years) as DOSE 1, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history included eczema from an unknown date. The patient was not allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient having eczema and on occasion will get a flare up lasting a few days. However, the day after the patient received vaccine, on 04Mar2021, patient started to break out with a rash, and pustules on patient hands. This then spread to legs, back, and swelling to right eye. The patient has never had a flare up as bad as this and used usual routine to control the flare up and it was calming down some until patient received second vaccine on 24Mar2021 at the same location. The patient arms now look like the patient was an IV drug user and the rash on patient back was getting larger. On an unknown date in 2021, both hands are loaded with bumps as well as both arms. The patient has an appointment with a dermatologist on 07Apr2021. The patient was not received treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events rash and rash pustular was not recovered and other events were unknown. Additional information has been requested and will be provided as it becomes available.

Ringing/pulsating sound began in my right ear about 8 days after second Pfizer vaccine shot. It still persists to today, July 3,2021. I originally thought it was a condition associated with my Bell?s palsy that began on February 7, 2021 three days after my first Pfizer vaccine shot. But now I?m not sure. Saw my general practice doctor yesterday on July 2nd and she felt that the tinnitus may be separate from the Bell?s palsy. My usual doctor was out for the day. She prescribed a nasal spray which I have not received as of yet. I also went to see the doctor do to a rib injury. The tinnitus may be lessening the past ten days or so, but still very present all day long.

On June 01, 2020 during morning hours, my left eye was starting get watery and the upper eye lid felt heavy. Also the left side of my mouth commissure started to feel weak and hanging down.. The left border of my tongue was numb and I had a stabbing like headache on the left side of the back of the head. My left hand, finger number 4 and 5, felt numb and in my left foot I felt constant electric shocks. I also was having balance disorders, making me almost fall many times.

About 4 hours after my 2nd dose, I was driving on my way home and all of a sudden I felt like I was hallucinating. I saw what looked like a bug infestation coming across my vision line. It was a swarm of black spots. I had to stop and re-evaluate my situation on the way home. When I gained control again, I realized it wasn't a hallucination. It was my actual vision. When I got home I basically crashed for the rest of the day. The next day I contacted my optometrist and I went in for an evaluation. They said it was a cloud of floaters. I asked if there was any chance that it was a side effect of the vaccine. They told me no. They sent me to an ophthalmologist. He told me that it will never go away. I went back to my optometrist and they said it would go away. All that they could come up with is that it is a coincidence. I have also had dizzy spells. They weren't strong, but it was like a constant dizziness. I still have all of the symptoms going on. The floaters in my eye seem like they are starting to dissipate. I have had some mild nausea. I can take a nap and it seems like it dissipates. This all came on at one time. I have been extremely tired lately. I take 2-3 naps a day and that is just not like me. It's like the feeling of being hungover, but I haven't had a drink in months.

feeling a little hazy; Blurred vision; general weakness; minor aches; nausea; body aches; slight headache; soreness in injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 08:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic type 2 controlled and Psoriasis. The patient was allergic to cucumbers. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), tiagabine (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN) and seven more medication, all for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 09Mar2021 at 08:45 (at the age of 66-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 30Mar2021 at 13:00, the patient experienced slight headache and soreness in injection site(vaccination site pain). On 31Mar2021 the patient experienced headache, nausea and body aches. On 01Apr2021 the patient experienced vision impaired(blurred vision), slight headache, slight nausea general weakness and minor aches. On 02Apr2021 the patient felt slight headache, slight nausea, slight weakness. On 03Apr2021 the patient felt little hazy. 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 slight headache, slight soreness in injection site, nausea, body aches, vision impaired(blurred vision), general weakness, minor aches and feeling a little hazy were recovered with sequelae. No follow-up attempts are needed. No further information is expected.

I started waking up in the morning seeing fireworks in my left eye, which is weaker than my right one. By Sunday, it was getting worse. I held my hand my right eye to measure the eye sight of my left eye. I could see a line cutting through my line of vision; I could see above the line, but couldn't see anything below the line. I went to a clinic and was referred to a retina specialist. They called a Neural Ophthalmologist and asked if I could be seen that day. I went to the neural ophthalmologist who knew exactly what the problem was and how to treat it. I was diagnosed with NAION (Non-Arteritic Ischemic Optic Neuropathy) where half of one eye loses vision. He prescribed three medications and a low dose aspirin to reduce swelling around my optic nerve.

My left arm began to hurt almost immediately after the injection, and still hurts 24 hours later. That night at 1015 pm 8 hours after I received my shot I chest and upper arms started to itch . I took off my shirt and looked in the mirror. I could see redness across my chests and upper shoulders both sides have a reddish rash which does itch. I?ve had to buy anti itch cream. And today 24 hours after my injection my upper lip started to swell up and soon my lower lip swelled up and went numb.. even affecting my nostril area.

Tinnitus, high pitch frequency sound inboth ears; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old, male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route in left arm on 21Mar2021 (at an age of 66-years-old) as single dose for COVID-19 immunisation. The medical history of patient was reported as none. The patient had no allergies to medications, food, or other products.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route in left arm on 20Feb2021 (at the age of 66-years-old) as single dose for COVID-19 immunisation. The patient received citalopram (MANUFACTURERS UNKNOWN) and simvastatin (MANUFACTURERS UNKNOWN) started on an unknown date within 2 weeks prior to the COVID vaccine for unknown indications. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient had tinnitus, high pitch frequency sound in both ears. No treatment was given for the event. The clinical outcome of the event was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Terrible reaction as far as taste/bad taste starts in far back of mouth; bad smell/ seems to hang in the nostrils and sinuses; feeling of heat traveling down nostrils; disgusting taste and smell forces to stop eating; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:30 (at the age of 66-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 12:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy peripheral since unknown date and penicillin allergy. Concomitant medications included pregabalin (LYRICA) 300 mg daily and doxazosin (MANUFACTURER UNKNOWN) 8 mg daily, all received within two weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, shortly after first dose, the patient started experiencing a terrible reaction as far as taste in the foods (never had a problem previously) bad taste starts in far back of mouth, then a bad smell became associated with it which seems to hang in the nostrils and sinuses. When the patient continues eating the bad taste and smell, intensify and a feel of heat travelled down to nostrils. The disgusting taste and smell forces patient to stop eating small quantities of food like peanut butter, peanuts and potato chips. After second dose the foods peanut, pretzels, popcorn and tostitos got added. The patient did not receive any treatment for the events. The clinical outcome of the event altered taste, altered smell, feeling of heat and stopped eating was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

unpleasant taste and smell after receiving COVID-19 vaccine yesterday/unusual smell and taste in my mouth, silvery, metallic; unpleasant taste and smell after receiving COVID-19 vaccine yesterday; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 67-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had unpleasant taste and smell after receiving COVID-19 vaccine yesterday. The patient had his first covid vaccine on Friday. Later that evening (08Jan2021) he was experiencing an unusual smell and taste in my mouth, silvery, metallic, that became progressively stronger and continued today. He had an unusual smell in his nose and taste in his mouth that is kind of like silver or metal. He would like to know if that is normal or should he be concerned. The outcome of events was unknown. Information on the lot/batch number has been requested.

transient bilateral blurry vision; This is a spontaneous report from a contactable physician. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 11Jan2021 11:00 at single dose for COVID-19 immunization (Patient age and high risk medically). Medical history included ongoing spastic paraplegia. He has a genetic neurological condition, he has it is called spastic paraplegia. He does not have an onset date just that it was years ago and is still an ongoing thing at this time. He believes there is a remote family history of the same neurological condition. Patient is not diabetic. There were no concomitant medications. It was reported that the patient previously took flu vaccine on 18Nov2020, almost 2 months prior. The patient experienced transient bilateral blurry vision on 11Jan2021 11:20. Caller is asking for recommendations regarding the 2nd dose for the patient who experienced blurriness of vision. Caller reporting a patient who received the first dose of the Vaccine yesterday (11Jan2021) and developed transient bilateral blurry vision at 11:00am, 20-30 mins after the dose. He said that it was resolved within 18-24 hrs after. He is asking if there were any reports of this in the clinical trial. It was further reported that caller is calling about the COVID vaccine. He says he was curious, he is a clinical director in (and he was calling to report or see if anyone had reported this. The patient received his first dose of the vaccine yesterday (11Jan2021) and for less than 24 hours had transient bilateral blurry vision. He says by the second day it had totally resolved. It started about 20 minutes after the first dose and resolved within 24 hours. He did not think it met criteria to report but he wondered if they would like to him report that and see if anyone had seen that at all. Event began on 11Jan2021 about 15-20 minutes after the vaccine was given and was resolved completely within 24 hours. For the dose, he believed the patient received 0.3 ml, whatever the standard dose is. He thought the Pfizer one is 0.3 ml. He says the nurses do that he just does the medical screening but he thinks the Pfizer one is 0.3 ml and (name) is 0.5 ml but he is older so he may be wrong. No further information provided. For the anatomical location of administration of Pfizer vaccine considered as suspect, he stated it was on one of the deltoids, he is not sure which. Vaccination Facility Type was outpatient clinic. There were no additional vaccines administered on same date of the Pfizer suspect, they screen for those and he has not had any other vaccines for at least 2 weeks. It was further reported that vaccine given roughly about 11 AM and the symptoms began 11:20 AM. He called the patient this morning at 9:30 AM and he said the blurry had resolved. He says he spoke with the patient's wife and she asked the patient if it was resolved and he said yes. They did not provide the caller with the time that the blurry vision resolved. Caller says he did send the patient to their in house optometrist for an exam and the exam was unremarkable by the optometrist. There were no prior vaccinations (within 4 weeks). He also wanted to know if they could advise whether or not to give the second dose. The outcome of the event was recovered on 12Jan2021. Information on Lot/Batch number has been requested.

Full body rash with itching; Swelling in my upper and lower eyelids; Urticaria; Soreness at site; Headache; Fatigue; This is a spontaneous report from a contactable other HCP (patient). This 67-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284), via an unknown route, on 13Jan2021 (at 15:00) at single dose on the left arm, for COVID-19 immunization, administered at hospital. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 24Dec2020 (at 10:00) administered at single dose on the left arm. Relevant medical history included hypertension, benign prostatic hyperplasia, and allergy to NAIDs. Past drug history included allergy to acetylsalicylic acid (ASPIRIN). Relevant concomitant medications included losartan, simvastatin, eszopiclone (LUNESTA), dutasteride (AVODART) and tamsulosin. On 14Jan2021 (at 10:00), the patient had soreness at site, headache, and fatigue. On 15Jan2021, same symptoms but lower intensity. On 16Jan2021, she woke up with full body rash with itching, and swelling in her upper and lower eyelids. She took cetirizine hydrochloride (ZYRTEC) and the urticaria resolved within 90 minutes. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events 'soreness at site', 'headache', 'fatigue' and 'swelling of eyelid'. All the events resolved in Jan2021.

Urticaria. Very mild about one week after first dose on December 17 (ignored and not linked to vaccine in retrospect. Went away after a week). More severe urticaria starting on January 29 ( with second vaccine on January 17. Urticaria, pruritic rashes on extremities, back, chest, behind ears. A sense of itching in throat. A sense of fullness in lips but no angioedema. Some fatigue and mild malaise

Fever (tmax reported per 100.0; temp at clinic 100.9); Rapid heartbeat; Chills, Fatigue, Dry mouth, loss of appetite, nausea

PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING, RASH ON BOTH ARMS, AND WAS SLIGHTLY WARM TO TOUCH. WIFE REPORTED PATIENT HAS HISTORY OF ANXIETY ATTACKS, ASTHMA ATTACKS, AND ALLERGIC REACTIONS TO FOOD.

swelling on his lower gums; sensitivity to his teeth; redness on his gums; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via intramuscular route of administration on 14Jan2021 at 12:40 at 0.3 mL, single in the deltoid left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 23Dec2020 at 0.3 ml IM injection for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient experienced swelling on his lower gums in the front of his mouth and sensitivity to his teeth, no other symptoms. The swelling gums went away, it was mild and it went away. A few hours after, there was redness on his gums, no drainage or anything and then the teeth sensitivity went away through the day. He was wondering if those things have been associated with the product or maybe just a coincidence. The patient recovered from the events swelling on his lower gums and sensitivity to his teeth on 15Jan2021 while unknown for the other event.

Patient developed mouth tingling and facial rash within 15 minutes of receiving vaccine. Po Zyrtec given to patient.

pt states he has altered sense of smell. Says he has a constant smell of burnt molasses. Pt called his physician friend and was told just to keep an eye out for any other symptoms.

Lost hearing in right ear the day after, 2/6/2021, my first Pfizer Covid vaccine. Saw Doctor on 2/11/2021 for ear examination and full hearing test, showing pretty much full loss of hearing in right ear. She prescribed 60mg oral steroid dosage with taper down. Followup examination with Dr Pate on 2/18/2021 which showed minor hearing improvement, she administered a steroid shot into my right ear.

Community member stated was seeing "color" in peripheral vision. Stated more so in right eye. Denies dizziness or blurred vision. Symptoms resolved, stated vision cleared and ambulated with steady gait without assistance. Went home from observation area.

Woke up with medial aspect of right eye sclera hemorrhaged. The bloody look increased throughout the day. but never spread further than medical aspect of right eye. There was no pain, swelling or vision changes. There was no treatment.

Upon waking, some nausea, mild headache, sore arm, dizziness, inability to walk or stand without support, needed to look straight ahead. Subsided somewhat after a few hours and eating. Expect full recovery within day.

Started with numb feeling in my mouth, and that night my left eye wouldn't blink went to the ER and gave me Acyclovir and gave me prednisone 10 mg, Still cant blink my left eye.

Sudden onset of brief, recurring flashing lights in left eye visual field for 2 hours, then sudden onset of ring shaped floater in same left eye on the afternoon of 02/13/2021; one day after receiving first Pfizer-BioNTech vaccine at the COVID vaccine clinic on 02/12/2021 . No further lightening flashes since the initial day of symptoms (02/13/2021). Floater has persisted. Seen by ophthalmologist on Monday 02/15/2021 confirming posterior vitreous detachment.

No side effects until abruptly at 30 hours after the dose I had the most severe episode of very loud tinnitus and vertigo. Resolved after 150 minutes. Interestingly, 8 days after the first dose (lot number EL 3247) had a similar but slightly milder reaction that lasted 24 hours. I do have Meniere?s with intermittent episodes like this for many years, but these two events were profoundly more severe than any in the past.

Swollen ulcerated tongue, bleeding out of tongue. After applying pressure and 24 hours, tongue stopped bleeding. Swelling ended after 48 hours. Nausea, 2/8 in morning, 2/9 in morning Headache, 2/9 in morning Crawling skin on chest, 2/10 afternoon

Head ache, unable to concentrate, Blurred vision, cannot focus double vision. Started approx. 4 hours after the injection and is still an issue 7 days later.

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

approximately 1 hour after injection the following : metallic taste, itchy eyes, nose, ears, then face. My face became bright red and also itchy. the metallic taste lasted about an hour. the redness 6 hours. The itchiness until the following morning approx. 15 hours

PI Patient is a 67 year old male who presents with dizziness and left facial droop. The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy. That has since subsided. However, he noted some slurred speech and left facial droop. He woke up at 7:30 AM. He went to bed last night at 11 PM. Last known well is 11 PM, as he woke up with his symptoms. He reports some weakness of the left upper extremity and left lower extremity. Acute left arm, leg, face weakness, slurred speech and buring eyes. Symptoms came and went over 42 hour period.

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

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

His left eye started looking funny on Thursday night, 2/25/21. Friday morning the left side of his face wasn?t able to smile. Took him to medical center where, after CT scan and blood work, he was diagnosed with Bell?s palsy. Unfortunately the treatment for this is a steroid and antiviral medication. By Sunday night he was exhibiting signs of mania.

Pfizer-BioNTech COVID-19 Vaccine 3 minutes after vaccine, patient complained of chest pressure, flushing and felt clammy. A medical response was called and pt was placed in a recliner. He is alert and oriented and feels shaky. His wife is with him and states this is a normal reaction to similar situations in the past. Just not always something that happens. 1538 BP 158/78, HR 65, resp 20 1542 BP is 163/78, HR 60, resp. 20. Skin is warm and dry, he states his lower lip is numb and has a bit of trouble drinking from a bottle of water. Medical response felt he was improving and plan was to keep him in recliner for another 20 minutes. Was given a few sips of apple juice. No oximeter was available to check O2 sat. @1558 he again complains of mid-sternal chest pain, skin warm and dry, speech clear and moving all extremities without difficulty. Complains of tongue and cheek tingling. Brief episode of nausea. ER staff was called and patient was transferred to ER via Wheel chair. He at times complained of dizziness and trouble with keeping his eyes open. Denies pain in his arms. BP 190/84, HR 62, R 18. At ER: EKG with sinus bradycardia, no acute ischemic changes. Troponins x 2 are negative. Symptoms resolved. Discharged from ER after evaluation.

Blurred vision, severe dizziness (unable to stand or walk without assistance) unable to form words and sentences clearly.

I cannot move out of my bed; My vision is also blurred; It am dropping rather rapidly because I am not able to eat; It am dropping rather rapidly because I am not able to eat; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6200 , on 17Feb2021 at single dose in arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number ELI283) on 27Jan2021 and had no adverse effect. The patient was wondering if he hold the current record for the number of days consecutive for a person to have adverse reaction to the second vaccine because it was over a week and he could not move out of his bed. That almost killed him. His vision was also blurred. His weight was dropping rather rapidly because he was not able to eat. The outcome of the events was unknown.

About 2 hours after the injection, my right ear started ringing loudly. At 5:00 it's abating somewhat.

Toothache before 2nd dose/pretty bad tooth ache; This is a spontaneous report from a contactable consumer (patient reported himself) via Pfizer sponsored Program. A 67-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, toothache before second dose on 11Feb2021. He wanted to take pain medications. Caller stated, "he already had the first dose of Pfizer-BioNTech COVID-19 Vaccine 11 days ago, he was not sure about the exact date. Next dose was coming this Thursday (11Feb2021)". Caller stated he did not have any side effects from the vaccine, when he offered the warm transfer to DSU. Caller wanted to know if he can take Tylenol or Advil for a "pretty bad tooth ache", but his next Dentist appointment was until 11Mar2021. Outcome of the event was unknown. No PQC present. Information on the lot/batch number has been requested.

Tinnitus in right ear. Numbness in right ear and on right side of face, reaching to cheekbone and above upper jawbone.

Intermittent tinnitus in both ears a couple weeks after the second vaccine, continuous tinnitus the last two weeks.

Immune system -- mouth canker sores, previously controlled, began to flare up. A couple smaller ones recently subsided. The canker sores (under my tongue) remain incessant (painful) for well over a month.

Dry mouth with a metalic taste and lower and upper dry lips wich still persist , I checked with my primary care physician to see If i have a mouth infection ,he did not have any infection ,howerver he prescribed Biotin for my dry mouth ,but the sympthons still persist.

his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114; Sweating; he woke up in the morning, and the room was spinning / Vertigo symptoms; dizzy/extreme dizziness; he felt lightheaded, and was afraid he might fall; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; he was only nauseous when he was dizzy; Reported he eyes were not that good while he was reading the paperwork from the Emergency Room; he thought he had a heart attack; This is a spontaneous report from a contactable consumer (patient) A 67-year-old male patient received the first dose of the bnt162b2( PFIZER-BIONTECH COVID-19 VACCINE, Lot Number:EN6198, Expiration Date: Unknown), via an unspecified route of administration, left arm at single dose for Covid-19 immunization On 03-MAR-2021 (between 11:30-12:00). Additional vaccines administered on Same Date of the Pfizer Suspect was none. The patient medical history included depression reported he was diagnosed with depression years ago and has been on Wellbutrin for a while. No further details provided, Tinnitus he self-diagnosed himself a hissing sound mostly in his right ear for less than a year. He said he looked up his symptom on the internet and found someone else who had the same symptom as him, and that person said it was Tinnitus, Seizure he had a seizure about a year ago. Reported he had a seizure about a year ago. He said he had a brain scan afterward, and the doctor didn't find anything wrong. No further details provided. Concomitant medications were not reported. On 03Mar2021 Patient received his first Pfizer COVID-19 Vaccine (on) and was fine. He said about a week after getting his first COVID-19 Vaccine, he woke up in the morning, and was sweating, and the room was spinning, and he was dizzy. Little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room: He said the room spinning and him being dizzy had been continuing to go on. He said he thought he had a heart attack, and went to the hospital (Emergency Room). He said his blood pressure was high. He said he was nauseous too. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around, if he lowered his head below his shoulders, the dizziness gets really bad. the dizziness won't go away. the Emergency Room doctor thought his dizziness may be due to his inner ear. The Emergency Room doctor told him he should see an ear doctor about his dizziness. He said the his dizziness happened directly after he got his first COVID-19 Vaccine. Reported he went on the internet, and read that other people who got the COVID-19 Vaccine were experiencing same thing he was. No further details provided. It was Reported patient blood pressure was very high. He clarified his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114. He said he believed his blood pressure was taken again, and his blood pressure was a little bit better. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around. He said if he lowered his head below his shoulders, the dizziness gets really bad. He said the dizziness won't go away. He said he was nauseous too, but only when he was dizzy. He said his dizziness was fine last night, but then he got up this morning and the room started spinning out of control. He said he felt lightheaded, and was afraid he might fall. He said if he tried to pick up something off the ground, his dizziness really comes on. He said the Emergency Room doctor thought his dizziness may be due to his inner ear. He said the Emergency Room doctor told him he should see an ear doctor about his dizziness. He had an EKG done in the Emergency Room, and since the doctor didn't say anything about his EKG, he assumed there was nothing wrong with the EKG results. He stated that he went to hospital as he was fearful he was having a heart attack; it was determined that he was not. However, he was advised him to consult a specialist as he may be suffering from vertigo. Treatment was given a low dose of oral Lorazepam 0.3mg to calm him down. He stated he did not have the Lorazepam 0.3mg NDC. He said his paperwork from the Emergency Room listed his diagnosis as Vertigo symptoms, and it was recommended he go for a hearing test because his dizziness maybe caused by his inner ear. The outcome of event was unknown.

Swelling /inflammation of face on left cheek near nose; periorbital swelling around eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Arm Left on 30Jan2021 17:00 as single dose for covid-19 immunisation (age at vaccination 67 years) at Clinic. Medical history included sulfa drugs allergy, asthma, GERD (gastrooesophageal reflux disease), glaucoma, high BP (Blood pressure), hypothyroidism, depression. Concomitant medications the patient received within 2 weeks of vaccination included acetaminophen; albuterol sulfate; brimonidine tartrate. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 at 01:00 A.M, the patient experienced swelling /inflammation of face on left cheek near nose and another site as periorbital swelling around eye; both occurring on left side of face only. Patient spoke with triage nurse who indicated to use ice. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Case was reported as non-serious. Outcome of events was not recovered. Information on the lot/batch number has been requested.

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

A few days after receiving the vaccine I began to experience tinnitus. While it has varied in intensity it has remained with me to this date.

right vision described as "more cloudy", endorses left blindness, discharged home from vaccine clinic after observation

patient reported the development of a metal smell about 2 days after they received their second covid shot. Which has not yet resolved. The patient had expected vaccine reactions (fatigue and headache) which resolved within a day of getting the vaccine

He assumes he has COVID as well since he has the same symptoms and lives in the same household; He assumes he has COVID as well since he has the same symptoms and lives in the same household; Sharp needle type pain that went through heart side of chest; felt bitterness in stomach and mouth and was uncomfortable; felt bitterness in stomach and mouth and was uncomfortable; stomach and mouth and was uncomfortable; headache; fever/ highest was 104 degrees; Chills; Bone aches; leg and lower back pain; leg and lower back pain; panic; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203; Expiration Date: 30Jun2021) intramuscularly (in the muscle) in right shoulder on 14Mar2021 at age of 67-year-old at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen for an unspecified indication, but the reason for taken this drug was "get up and get moving", the patient took it for many years. Received call from consumer regarding the Pfizer COVID vaccine. He would like to speak with someone about the effects he had and any suggestions Pfizer may have to help him. There was no prescriber for the vaccine. He received the first dose on 14Mar2021 and on 19Mar2021, he started experiencing side effects. He said all 4 people in his household all got the vaccine and all had side effects. The moment the patient was helping his wife he felt like a sharp needle type pain going through the heart side of his chest. They were little ones, but it was uncomfortable. It caused him to panic. He hanged on to it and it went away in a bit. But 2 hours after that, he had chills and crawled in blankets and stayed until the rest of the night. He has not gotten up since 19Mar2021. He has bone aches and leg and lower back pain aches. He has a headache on 19Mar2021 and started checking temperature on 25Mar2021. The highest was 104 degrees on 25Mar2021 and ever since (Mar2021) then he had 101 degrees or 100 and something. It also reported he began to have fever on 19Mar2021 (pending clarification). He was told to use Tylenol for fever reducer and started taking it. It also reported he has been taking Tylenol for the headache and fever only and it has not been working, it has actually caused him to have a rash on his face and skull causing dandruff and severe itching and bleeding, so he stopped it. He would like to take Ibuprofen and wanted to know if he could. When he stopped taking Tylenol, his daughter gave him a lotion for face. Face is clear and only one place is left that is behind his neck on head. No further details provided for lotion that he put on the rash. He provided information on Tylenol Extra Strength 500 mg each. He took 2 for rash on 2 occasions every 6 hours and then he started only taking 1 because he has not eaten and felt bitterness in stomach and mouth and was uncomfortable (19Mar2021). The Lot is SSA011 and expiration is Oct2024. He has been taking Ibuprofen for many years and only taking one tablet instead of two. He needs to get up and get going and takes it to help him every day. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. He would like to know if he can postpone next dose or can he quit. Will this get better. If he could take Ibuprofen instead of Tylenol. The outcome of events "sharp needle type pain that went through heart side of chest" and "chills" was recovering, of "fever/ highest was 104 degrees", "bone aches", and "leg and lower back pain" was not recovered, of other events was unknown.

Extreme vertigo/dizziness causing sudden fall. Ringing/tinnitus in ears. Pressure in head with a fogginess feeling. Unable to function, work or drive, for 4 days. All symptoms still present after 3 and a half weeks but have subsided to the point I can function.

26 hrs after 2nd shoot vison became blurry in right eye (pain behind eye) and left and right could not focus together. Created an unsteady feeling and had to lie down.

I got an Embolic stroke on 4/4/2021- 9 days after I got the vaccines from Hospital. On 4/3/2021 afternoon, I suddenly couldn?t see well, felt dizziness. At 3 AM on 4/4/4021, called 911 because I couldn?t feel my left side. I couldn?t see well on my left eyes, couldn?t feel left hand, left leg, left face, and the rest of my left side are numbed and I am not able to move after I was brought to the hospital. I am now at rehab Center.

Significant increase in ringing in my ear (tinnitus). I have had ringing in my ears for 20 years but now the level is uncomfortably high, requires white noise to sleep.

Headaches started on 1/21/2021, then loss of vision left eye on 3/4/2021, on 3/14/2021-lost vision in right eye

Ear pain; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: ER2613) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021, the patient experienced ear pain and tinnitus. All the events were reported as serious, seriousness criteria as disability. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.

4/19/2021; 25 days after receiving vaccine. -Still experiencing ear aches, tinnitus, and a developing dry cough. -5 days after receiving the vaccine, I experienced a sudden onrush of pressure into the cranial area, giving way to the above symptoms.

After about 2 weeks from 2nd dose taken on Jan 13, 2021, starting having tinnitus (ringing in the ear ) in right ear started having a headache on back part of head where connects neck, First I Felt , I must have slept on the wrong side but this pain persisted over a month, now I get similar pain every 1-2 weeks for a day or so . When I chew, I am feeling noise on my left ear my eye sight has deteriorated and have to see ophthalmologist to get new prescription for eye glasses, I am also getting thorbing headache on my right side of head , comes and goes away ,happens once in a while

chills; sweats; tiredness; headache; eyes affected; nausea; joint pain; muscle pain; weakness in my legs and body.; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENG6200TA), dose 1 via an unspecified route of administration, in left arm on 17Feb2021 at 10:00 (at 67-years age) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, BPH, low iron, COVID-19 in 2020 and seasonal allergy. Concomitant medication(s) included clopidogrel, Tamsulosin, levothyroxine sodium, magnesium sulfate and ergocalciferol (VIT D) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have side effects until 8-10 hours after the shot. He previously had COVID last year, and it felt like he had it all over again. On 17Feb2021 at 18:45, the patient experienced chills, sweats, tiredness, headache, eyes affected, nausea, joint and muscle pain, and total weakness in my legs and body, but did not had fever. No treatment received for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.

He woke up panicked; Vision loss; Visual disturbances; Difficulty breathing; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included: heart attack a few years ago and takes maintenance drugs for the heart condition and asthmatic and takes medication but the medications come and go depending on how he is physically. Concomitant medications were not reported. This case was from the same reporter; this case is for the husband. On 2Apr2021 he experienced difficulty breathing and they did not know if it was attributed to the vaccine but he did not have any breathing issues until he got the vaccine but it was a general feeling of something was different but did not think it was severe until the vision thing. Reporter stated there is no medication her husband takes that is related directly to the episode he experienced. On 5Apr2021, he woke up from being asleep, asked if the TV was on (which it was) because he could hear it, but could not see it. His symptoms have also resolved. He had no history of anything like that happening previously with the first dose pfizer covid vaccine. Hi wife stated that he experienced visual disturbances since then, with no prior history of vision impairment. The outcome of the events could not see, Visual disturbances was recovered; the outcome of Difficulty breathing was not recovered; the outcome of the event He woke up panicked was unknown. Information on the lot/batch number has been requested.

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

Sudden hearing loss in left ear; worsened tinnitus; hearing had decreased by 20 percent; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:15 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included eosinophilic esophagitis, degenerative disc disease, and food and environmental allergies, and as reported " previously lost hearing in my right ear and partial in my left ear"; all from an unknown date and unknown if ongoing. Concomitant medications included meloxicam, omeprazole, azelastine, and triamcinolone acetonide (NASACORT); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Codeine, Cipro (ciprofloxacin), and Percocet and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sudden hearing loss in left ear beginning within a week of taking vaccine. Inability to recognize words and sounds was most apparent, in addition to worsened tinnitus. The patient stated, "I previously lost hearing in my right ear and partial in my left ear in earlier sudden hearing losses, so I was aware of what was happening and scheduled an ENT visit. The patient had a hearing test on an unspecified date, and it showed that hearing had decreased by 20 percent. The ENT started her on the injectable steroid treatment in her left ear. The start date of adverse events was 03Apr2021 (as reported). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with interaural steroid injections. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.

awoke 4/26/2021 with double vision and slight dizziness; saw eye doctor 4/29 and was told I was experiencing palsy in my 3rd Cranial nerve; saw eye surgeon 5/4/2021 after my right eyelid went completely shut, he confirmed issues with 3rd Cranial nerve. Now wearing eye patch on right eye to prevent double vision and I have follow up appointment on Tuesday, May 11.

Tinnitus right ear, seems to be constant. Began about three weeks after second shot. After the first shot, I had tinnitus 6 days after the shot, which only lasted one day.

tinnitus had gone up; hard to sleep.; blurry vision; This is a spontaneous report from a contactable consumer reported for himself. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (on Friday 8:30 am) as single dose for covid-19 immunisation. The patient medical history included tinnitus for several years. The patient's concomitant medications were not reported. The patient experienced after his first shot, tinnitus had gone up, hard to sleep, Friday night started getting a blurry vision. The patient asked what the efficacy after the first dose was and he was not planning on getting his second dose. He read online after the vaccine tinnitus can get worst. So many people have reported tinnitus post vaccination. Also Friday night he started getting a blurry vision. He closed eyes for 20-30 minutes and it got better. It felt like he was staring at a screen for 10 hours. It was odd. Outcome of the event blurry vision was recovering, of the other events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

2 days after the shot my tongue became red, swollen, and burned on the tip area. After 5 days the tongue was normal again. But any long term issues are not known at this time

shingles on his face and around his eye/ has shingles on his eye; eye irritation; This is a spontaneous report from a contactable consumer (patient) and via a Pfizer program. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 67-years-old), administered in Arm Left on 01Mar2021 09:00 (Lot Number: EN6202) as 1st dose, single for COVID-19 immunization; and ibuprofen, route of administration, start and stop date, batch/lot number and dose were not reported for pain. The patient medical history was not reported. There were no concomitant medications. The patient experienced shingles on his face and around his eye/ has shingles on his eye and eye irritation on Mar2021. The patient requested information on the use of OTC pain relievers like Ibuprofen and the Pfizer-BioNTech COVID-19 Vaccine because he read some articles on this topic and asked how far before would he need to wait to take ibuprofen, he stated: "I'm scheduled for second vaccine tomorrow (29Mar2021, confirmed it is second dose of Pfizer-BioNTech COVID-19 Vaccine. First dose was received on 01Mar2021). I don't take Ibuprofen on a regular basis, only take it when I need it because I have a medical condition causing some pain, last time I took it was the day before yesterday and I won't take any today. Stated he got his first dose of the vaccine on 01Mar2021. Patient stated that he was prescribed the eye drops for shingles on his face and around his eye. They are for the eye irritation. Diagnosed with shingles either this past Monday, Tuesday, or Wednesday; uncertain of which day (unspecified date in Mar2021). He is asking if he can take painkillers after the second dose that because he has shingles on his eye. The action taken in response to the events for ibuprofen was unknown. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. The events were considered as serious. The second dose scheduled for 29Mar2021. The patient wanted to know if he can take his shot while on these Fluorometholone eye drops. No Prior Vaccinations (within 4 weeks).

Patient presented at Emergency Dept. with chest pain, blurred vision left eye; headache; left arm, side and leg pain. BP 150/100; EKG, troponin, brain scan, all negative. Patient admitted overnight, echo stress test in AM also negative. Patient discharged at 3:00PM.

Left ear sudden hearing loss; increased tinnitus; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 11:00 in arm left as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613), via an unspecified route of administration on 22Mar2021 in arm left as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications in two weeks included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), citalopram (CITALOPRAM) and pantoprazole (PANTOPRAZOLE). It was reported that, the patient had no known allergies. No other vaccine in 4 weeks. No covid prior vaccination and no covid tested post vaccination. On 08Mar2021, the patient experienced left ear sudden hearing loss and increased tinnitus. Treatment medication included prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects.

Increased tinnitus/ringing in ears; This is a spontaneous report from a contactable consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: UNKNOWN, Dose: UNKNOWN), via an unspecified route of administration on left arm on 23Feb2021 at 1.00 pm as Covid-19 immunization. No medical history and concomitant medications were reported by the patient. The patient is allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received omeprazole (UNKNOWN MANUFACTURER), Allopurinol (UNKNOWN MANUFACTURER), Tadalafil (UNKNOWN MANUFACTURER), Vitamins (UNKNOWN MANUFACTURER) within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with Covid-19. Since vaccination patient was not tested for covid-19. The patient past medication history was not reported. The patient experienced an increase in tinnitus on 01Mar2021.the patient also reported that he had some tinnitus before but it was more noticeable and bothersome. The patient did not receive any treatments for the events. The clinical outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 30Apr2021 at 13:00 (Lot Number: EP6955) (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Apr2021 at 13:00 (Lot Number: ER8737) (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient experienced swollen red and burning tongue on 02May2021 with outcome of recovered on 08May2021. The events required emergency room visit (not the emergency room in the hospital, but one of those after care places) and physician office visit, both on 06May2021. Therapeutic measures were taken as a result of the events and included some mouthwash stuff and take a vitamin. No follow-up attempts are needed. No further information is expected.

Could not taste/ loss of taste; sore arm/Left Arm Hurts like Hell; Lethargic; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0182), via an unspecified route of administration in left arm on 18May2021 at 11:00 (at the age of 67-year-old) as a single dose for COVID-19 immunization. The patient's medical history included ongoing COPD, ongoing bad back, ongoing esophagus blockage, toe operation (he had a toe operation, and he could not walk), he could not walk (he had a toe operation, and he could not walk), took out his gall bladder (then they took out his gall bladder and his lungs are hanging where his gall bladder was), lethargic before because of my medicine, make him loopy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in left arm on 27Apr2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Adverse events following prior vaccinations was none. Prior vaccinations (within 4 weeks) was none. Additional vaccines administered on same date of the Pfizer suspect was none. States Dr. would know additional information for other conditions when that started. Caller states he was going next Thursday for his esophagus because something was wrong with it. Caller states last night he wasn't swallowing because the food was stopping at his throat because of the blockage, so he drank 6 cans of Pepsi to blow it through. States on Monday, he was going for COVID test, because they won't take him unless he has the test. Caller states last time he went to hospital for breathing, they made him suck 2 nebulizers and then he did two on his own and sat down and relaxed and he was okay after that. It was reported that, patient received both doses of the vaccine the first dose was on 27Apr2021 and the second dose was on 18May2021. Patient was lethargic on an unspecified date in 2021 and was lethargic before because of my medicine. Now patient could not taste on 19May2021, and patient have a sore arm on 19May2021. Enquired was loss of taste from the vaccine or not. Caller states yesterday, he got his second one and today he has no taste. Caller states he was also lethargic, and he wants to know if that was part of it or not. Lethargy adverse event: Caller states the lethargy was from all of the medication he was on and he has had it for a while. Caller states he doesn't know exactly when it started. Caller states the drugs he was on make him loopy but states he has been functioning. Caller verifies it was not from the COVID Vaccine, he had it before, but he was still experiencing it. Caller states his doctor was trying to balance the drugs in him. States his primary has taken him off one and put him on half another. States when he got up this morning, he said whoa, he thought he saw blood out of his eye, but nothing was there. Caller states his doctor told him not to take the Prednisone one day and not to take another one at night. Names of Medications, NDC, Lot, Expiration: Unknown. He states a company puts his pills in a pack and he was supposed to take them, but they screwed up on this last one. Call handler asks for clarification on what he means by the screwed up on the last one and he clarifies by saying his doctor has been trying to get the right pills for him because he has COPD, a bad back, he had a toe operation and he could not walk, then they took out his gall bladder and his lungs are hanging where his gall bladder was. Left Arm Hurting like Hell adverse event: States he called some friends and they said, oh that was normal it would go away. No taste adverse event: Caller states he said what was this soda and said was in this because he couldn't taste it and he can't taste his cheese noodles or coke or anything he has tried to eat today. No investigation assessment. The adverse events did not require a visit to emergency room and physician office visit. No treatment medications was received for the adverse events. The events were considered as non-serious by the consumer. The outcome of the event could not taste/ loss of taste was not recovered and recovering for the other events. Follow up activities has been requested.

floaters in both eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 (at the age of 67-years-old) as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Mar2021, 10 mins after the first dose, the patient experienced floaters in both eyes. The outcome of the event was not recovered; floaters in right eye resolved however the patient continued to have significant floaters in left eye. The patient was querying if this was a known side effect. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Blurred vision due to central RetiNal VeiN occlusion uccured 1 week after 1st Pfizer COVID 19 vacc on 2/10/21

1) On or about 2/9/2021 I began running a low grade fever daily of approximately 99.5 starting every day at 3:00 PM lasting until after midnight. The fevers continued daily until approximately 2/26/2021. 2) On or about 2/19/2021 I began to show a red spotted rash UNDERNEATH my skin. The rash covered all my torso up to my neck, my arms to my wrist, and my legs to my ankles. The rash mostly subsided within about two weeks however to this day I still show some mild traces of this rash on my torso. Please see continuation page below. Please see continuation page below.3) On or about 3/4/2021 I began to notice a ringing in both my years, this has continued continuously 24 hours a day, to this date. It seems to inhibit my hearing acuity. To this day my hearing seems to be diminishing at noticeable daily rate. 4) On or about 3/7/2021 I began to notice an impairment in my vision. This impairment is manifested in both eyes equally as a washed out field of vision making it hard to read and discern fine details. At times I also see some small sparkles in my vision and dark impairments (not floaters) that seem to last up to a few minutes and then disappear. These impairments occur at random times during the day for no apparent reason. To this day my vision seems to be diminishing at a noticeable daily rate. On 2/19/2021 I received an eye exam and at that time, my vision was normal and was diagnosed as such.